S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. (1994_si_139) | IE

ISB SI

Reg. 1 S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. Open official source

1. The objectives of these studies are

(i) to establish the highest likely residue levels in treated crops at harvest or outloading from store; and

(ii) to determine the rate of decline of pesticide deposits.

ISB SI

Reg. 2 S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. Open official source

2. MRL-Proposals are mainly based on results of supervised trials providing for worst-case test conditions — test conditions which in predictable circumstances will accommodate even the highest residues which may reasonably arise (maximum number of intentional applications, use of the maximum envisaged quantity) but which remain representative of conditions encountered in practice.

ISB SI

Reg. 3 S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. Open official source

3. MRLs are legal limits that are used for enforcement purposes, for the initial theoretical estimation of consumer exposure to pesticide residues and for facilitating trade. Hence, accuracy in their estimation is important, since Member States face very real difficulties when residues above the MRLs are determined. Factors influencing residue variability in crops should be taken into account when establishing a supervised trial programme. These would normally include for instance, climatic differences existing between production areas, differences in production methods, seasons of production, formulations

etc

. Data packages submitted which do not adequately take into account all possible sources of variability without satisfactory justification must be appropriately supplemented before a Community MRL will be further considered.

ISB SI

Reg. 4 S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. Open official source

4. Trials, in addition to being properly designed, executed and reported, must include treatments which correspond to GAP in the regions of authorization and use (

e.g.

minimum PHI, maximum rate and number of treatments, type of formulation).

ISB SI

Reg. 5 S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. Open official source

5. In general, for a comparable set of conditions, trials should be carried out over a minimum of two calendar years for crops with a single relatively narrow harvest period,

e.g

. grapes, apples. For products with an extended growing and harvesting season, such as, glasshouse lettuce, citrus fruit, sufficient data from two different growing seasons will normally do provided the GAP in question is the same.

ISB SI

Reg. 6 S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. Open official source

6. It is impossible and could be misleading to indicate the precise number of trials necessary to establish an MRL. However, experience indicates a minimum number of trials, below which the establishment of a MRL cannot be normally be considered. Minimum data requirements only apply where comparability can be established between production areas,

e.g.

concerning climate, methods and growing seasons of production

etc

Assuming all other variables (climate

etc.

) are comparable, a minimum of eight trials representative of the proposed growing area is required to establish a MRL for a major crop. For small geographical production areas, the number of trial locations may be reduced and replications conducted on fewer sites instead. For instance, instead of eight separately located trials, six trials with two replications per treatment or four trials with four replications per treatment may be acceptable. However, as variability mainly occurs between locations rather than within locations, the reduced number of trials must be truly representative of the production areas and the results show sufficient homogeneity between locations.

33

The text comprises an extract from Commission Document 2946/VI/93: Study, prepared By Dr Jörg-Rainer Lundehn for the Commission of the European Communities, Guidelines for the Establishment of Community Maximum Residue Levels (MRLs) of Plant Protection Products in Food and Feedstuffs of Plant and Animal Origin, January 1993.

ISB SI

Reg. 7 S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. Open official source

7. Due to the inherently higher level of homogeneity in residues arising from post-harvest treatments, trials from one year (growing season) will be acceptable. In the case of fruit and vegetables, a minimum of four trials per application method (spray, dip, wax,

etc

.) and store type, carried out preferably on different locations and varieties, should normally be sufficient.

In the case of post-harvest cereal, oil seed and pulse treatments, four trials with adequate sub-sampling to take account of residue variability within the store (

e.g.

vertical stratification) will normally be satisfactory for each application method.

Trials from one year (growing seasons) will also be acceptable for some protected crops

e.g.

mushrooms and witloof because residue levels are not affected by variation of weather conditions.

ISB SI

Reg. 8 S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. Open official source

8. A certain percentage of the supervised residue trials reported, must include data to show the effect of time on the level of residue present (test series) where

(i) it is clear that residues are likely to occur at or close to harvest;

(ii) if the plant protection product is to be applied when the edible portion or the portion to be used, has formed; or

(iii) it is clear that residues may occur at, or close to, the earliest harvest time, and harvesting can or does take place over an extended period

e.g.

root crops.

ISB SI

Reg. 9 S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. Open official source

9. In test series the number of points and the intervals between them will be influenced by the half-life of the chemical and the anticipated pre-harvest interval. However, curves should normally have five points with a minimum of three, initial deposit and deposit on the day of harvest should always be included. When designing trials, due consideration should be given to possible variation and changes in GAP. Inclusion of a number well chosen pre-harvest intervals may avoid the necessity of repeating trials following changes in GAP.

ISB SI

Reg. 10 S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. Open official source

10. Whilst full unabridged data should be available to the rapporteur, data on GAP and supervised trials should be summarized on the relevant summary reporting forms.

ISB SI

Reg. 11 S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. Open official source

11. Detailed guidelines relating to the design, conducting and reporting of residue trials are available, on request, from the competent authority.

Annex 2

List of major crops

Crops not mentioned are assumed to be minor crops

N = Northern Region (Europe)

S = Southern and Mediterranean Region (Europe)

W = World (except Europe)

N

S

W

Citrus fruit

Oranges

X

Mandarins/clementines/satsumas

X

Lemons

X

Grapefruit/pomelo

X

Tree nuts

Almonds

X

Pistachios

X

Hazelnuts

X

Cashew nuts

X

Chestnuts

X

Walnuts

X

Pecans

X

Coconuts

X

Pome fruit

Apples

X

Pears

X

Stone fruit

Peaches/nectarines

X

Plums

X

Apricots

X

Cherries

X

Grapes

Wine grapes

X

Table grapes

X

Berries and small fruit

Strawberries

X

Raspberries

X

Currants

X

Miscellaneous fruits

Dates

X

Avocados

X

Mangoes

X

Pineapples

X

Bananas

X

Papayas

X

Kiwi fruit

X

Olives (oil production)

X

Root and tuber vegetables

Potatoes

X

Sweet potatoes

X

Cassava

X

Yams

X

Taro (coco yam)

X

Carrots

X

Sugar beet

X

Fodder beet

X

Turnips/swedes

X

Bulb vegetables

Onions

X

Garlic

X

Fruiting vegetables

Tomatoes

X

Cucumbers and gherkins

X

Eggplants

X

Peppers

X

Watermelons

X

Melons

X

Sweet corn

X

Brassica vegetables

Cabbages, head

X

Cauliflower

X

Brussels sprouts

X

Kale

X

Chinese cabbage

X

Leafy vegetables

Lettuce, head

X

Spinach

X

Witloof/chicory

X

Endive/scarole

X

Legume vegetables (fresh)

Beans, green

X

Peas, green

X

Stem vegetables

Artichokes, globe

X

Leeks

X

Pulses

Beans, dry

X

Peas, dry

X

Chick-peas

X

Lentils

X

Oil seed

Soya bean

X

Peanuts

X

Sunflower seed

X

Rapeseed

X

Sesame seed

X

Linseed

X

Safflower seed

X

Cotton seed

X

Copra

X

Palm kernels

X

Cereals

Wheat/triticale

X

Rice, paddy

X

Barley

X

Maize

X

Rye

X

Oats

X

Millet

X

Sorghum

X

Miscellaneous

Sugar cane

X

Coffee, green

X

Cocoa beans

X

Tea

X

Hops

X

Tobacco leaves

X

Mushrooms (except wild mushrooms)

X

SIXTH SCHEDULE

PART 1

Regulations 19 (1)

PART 2

Regulations 19 (2)

PART 3

Regulations 19 (4)

PART 4

Regulations 19 (5)

SEVENTH SCHEDULE

Regulations 25 (1) and 26 (4)

Principles of Good Experimental Practice

1

Introduction

The prime purpose of the Principles of Good Experimental Practice (GEP) is to promote the development of quality test data. A further objective is to facilitate the mutual acceptance of test data for regulatory purposes by other Member States of the Community, thereby avoiding duplicative testing and achieving economies in test costs and time, where test conditions are shown to be comparable. The Principles of Good Experimental Practice are analogous to the Principles of Good Laboratory Practice (GLP). They are designed to facilitate the production of quality data, generated through testing at many sites, including those which are not directly controlled by those conducting tests, without imposing impractical quality assurance and inspection obligations.

These Principles of Good Experimental Practice apply to the testing of the performance (efficacy and phytotoxicity) of plant protection products, including adjuvants, in support of applications for the authorization of plant protection products. These Principles also apply to the testing of both active substances and plant protection products, with respect to physical and chemical properties and technical characteristics, where the tests do not relate to their properties or safety with respect to human health or the environment. Testing with respect to effects on honey bees and beneficial arthropods other then bees (paragraph 2.2 of the introduction to Annex II, paragraph and 2.3, Annex III, points 2.2 and 2.3), in accordance with these Principles of Good Experimental Practice, as opposed to GLP, will be accepted if initiated prior to 31 December 1999 (see point 2.2 of the introduction to Annex II and point 2.4 of the introduction to Annex III).

2

Definitions

2.1

testing facility

The persons, premises, and operational unit(s) necessary for testing. The term may include several sites, at one or more geographical locations, where phases or components of a single overall programme of tests are conducted. The different sites may include, but are not limited to

— laboratory(ies) where the test or other material is characterized, measured, or otherwise assessed;

— one or more agricultural or other in- or outdoor sites, including glasshouses, where the test material is applied to the test system; and

— where relevant a processing facility where harvested commodities are treated to prepare other items, e.g. conversion to sugar, flour, beer, puree, juice.

2.2

test

Technical operation that consists of the determination of one or more characteristics or effects of a given active substance, plant protection product, or adjuvant, according to a specified procedure.

3

Legal Identity

The testing facility shall be legally identifiable.

4

Impartiality, independence and integrity

The testing facility and its personnel shall be free from any commercial, financial and other pressures which might influence their technical judgement.

Any influence on the results of examinations and tests exercised by persons or organizations external to the testing facility shall be excluded.

The testing facility shall not engage in any activities that may endanger the trust in its independence of judgement and integrity in relation to its testing activities.

When products are tested by bodies, who have been or are concerned with their design, development, manufacture or sale, provision shall be made for a clear separation of the different responsibilities and for an appropriate statement as to responsibilities.

5

Technical competence

5.1

Management and organization

The testing facility shall be competent to perform the tests concerned. In the absence of a recognized test guideline, agreement between the client and the testing facility to the test procedure shall be documented.

The testing facility shall be organized in such a way that each member of personnel is aware of both the extent and the limitation of his area of responsibility.

The organization shall provide supervision by persons familiar with relevant test methods and procedures, the objective of such testing and the assessment of test results. The proportion of supervisory to non-supervisory personnel shall be such as to ensure adequate supervision.

The testing facility shall have a technical manager who has overall responsibility for the technical operations of the facility.

A document showing the organization and distribution of responsibilities of the testing facility shall be available and kept up-to-date.

5.2

Personnel

The testing facility shall have sufficient personnel, having the necessary education, training, technical knowledge and experience for their assigned functions.

The testing facility shall ensure that the training of its personnel is kept up-to-date.

Information on the relevant qualifications, training and experience of the technical personnel shall be maintained by the facility.

5.3

Premises and equipment

5.3.1

Availability

The testing facility shall be furnished with all items of equipment required for correct performance of the tests and measurements which it claims to be competent to carry out.

In the exceptional case where the facility is obliged to use outside equipment, it shall ensure the quality of that equipment.

5.3.2

Premises and environment

The environment in which the tests are undertaken shall not invalidate the test results or adversely affect the required accuracy of measurement. The premises shall have the equipment, energy sources and other services needed for the testing. When the testing so requires, they shall be equipped with devices to monitor environmental conditions.

Access to and use of all test areas shall be controlled in a manner appropriate to their designated purpose and conditions of entry by persons external to test sites shall be defined.

In the case of premises used by a testing facility which are not subject to the exclusive control of the testing facility, arrangements shall be made to control access to and use of test areas in a manner appropriate to their designated purpose. The conditions of entry by persons external to the testing facility and the means of ensuring compliance with those conditions shall be defined.

Adequate measures shall be taken to ensure good house-keeping in the testing facility.

5.3.3

Equipment

All equipment shall be properly maintained. Details of maintenance procedures shall be available.

Any item of the equipment which has been subjected to overloading or mishandling, or which gives suspect results, or has been shown by calibration or otherwise to be defective, shall be taken out of service, clearly labelled and stored at a specified place until it has been repaired and then shown by test or calibration to be performing its function satisfactorily. The testing facility shall examine the effect of this defect on previous tests and report its findings to the competent authority.

Records shall be maintained of each major item equipment used in testing. Each record shall include

( a ) the name of the item of equipment;

( b ) the manufacturer's name and type identification and serial number;

( c ) date received and date placed in service;

( d ) current location, where appropriate;

( e ) condition when received (e.g. new, used, reconditioned)

( f ) details of maintenance carried out; and

( g ) history of any damage, malfunction, modification or repair.

Measuring, testing and dispensing (including application) equipment used in the testing facility shall be calibrated where appropriate before being put into service and thereafter according to an established programme.

The overall programme of calibration of equipment shall be designed and operated so as to ensure that wherever applicable measurements made in the testing facility are traceable to national and international standards of measurement. Where traceability to national or international standards of measurement is not applicable, the testing facility shall provide satisfactory evidence of correlation or accuracy of test results (for example by participation in a suitable programme of inter laboratory comparisons).

Reference standards of measurement held by the testing facility shall be used for calibration only and for no other purpose.

Reference standards of measurement shall be calibrated by a competent body that can provide traceability to a national or international standard of measurement.

Where relevant, testing equipment shall be subjected to in-service checks between regular re-calibrations. The calibration of application equipment shall be checked on each occasion on which it is used in a test.

Reference materials shall where possible be traceable to national or international standard reference materials.

5.4

Working procedures

5.4.1

Test methods and procedures

The testing facility shall have adequate documented instructions on the use and operation of all relevant equipment, on the handling and preparation of test materials, and on standard testing techniques. All instructions, standards, manuals and reference data relevant to the work of the testing facility shall be maintained up-to-date and be readily available to the personnel.

The testing facility shall use methods and procedures required by or acceptable to the competent authority for the testing of plant protection products. The experimental protocol to be followed shall be provided to personnel performing the test, together with all relevant documented instructions on the handling and preparation of test materials, and on standard testing techniques.

The testing facility shall reject requests to perform tests according to test methods that may endanger an objective result, have a reduced validity or are unacceptable to the competent authority.

Where it is necessary to employ test methods and procedures which are non-standard, these shall be fully documented.

All calculation and data transfer shall be subject to appropriate checks.

Where results are derived by electronic data processing techniques, the reliability and stability of the system shall be such that the accuracy of the results is not affected. The system shall be able to detect malfunctions during programme execution, to permit appropriate action to be taken.

5.4.2

Quality System

The testing facility shall operate a Quality System appropriate to the type, range and volume and intended purpose of work performed. The elements of this system shall be documented in a Quality Manual which is available for use by the personnel responsible for and involved in testing. The Quality Manual shall be maintained current by a nominated responsible member of the testing facility personnel.

A person or persons having responsibility for quality assurance within the facility shall be designated by the facility management and have direct access to top management.

The Quality Manual shall contain at least

( a ) a quality policy statement;

( b ) the structure of the laboratory (organizational charts);

( c ) the operational and functional activities pertaining to quality, so that each person concerned will know the extent and the limits of his responsibility;

( d ) general quality assurance procedures;

( e ) reference to quality assurance procedures specific for each test, as appropriate;

( f ) where appropriate, reference to proficiency testing, use of reference material, etc. ;

( g ) satisfactory arrangements for feedback and corrective action whenever testing discrepancies are detected; and

( h ) procedure for dealing with complaints.

The quality system shall be systemically and periodically reviewed by or on behalf of management to ensure the continued effectiveness of the arrangements, and any necessary corrective action initiated. Such reviews shall be recorded together with details of any corrective action taken.

5.4.3

Test reports

The work carried out by the testing facility shall be covered by a report which accurately, clearly and unambiguously presents the test results and all other relevant information.

In addition to the information to be reported as specified in relevant test guidelines, each test report shall include at least the following information

( a ) name and address of testing facility and the precise location where the test was carried out;

( b ) unique identification of the report (such as serial number) and of each page, and total number of pages of the report;

( c ) name and address of client;

( d ) description and identification of the test material;

( e ) date of receipt of test material and date(s) of performance of test;

( f ) identification of the test guideline or description of the method;

( g ) description of sampling procedure, where relevant;

( h ) any deviations, additions to or exclusions from the test guideline, and any other information relevant to a specific test;

( i ) identification of any non-standard test method or procedure utilized, and a full description of the test method;

( j ) measurements, examinations and derived results, supported by tables, graphs, sketches and photographs as appropriate;

( k ) a statement on measurement uncertainty (where relevant);

( l ) a signature and title or an equivalent marking of person(s) accepting technical responsibility for the test report and date of issue; and

( m ) a statement to the effect that the test results relate only to the items tested.

Particular care and attention shall be paid to the arrangement of the test report, especially with regard to presentation of the test data and ease of assimilation by the reader. The format shall be carefully and specifically designed for each type of test carried out, but the headings shall be standardized as far as possible.

Corrections or additions to a test report after issue shall be made only by a further document suitably marked, e.g.

NOTE

Test results could be measured values, findings from the visual examination or practical use of the test material, derived results or any other type of observation from the testing activities. Test results could be supported by tables, photographs, or graphical information of any kind, appropriately identified.

"Amendment/Addendum to test report serial number ...(or as otherwise identified)", and shall meet the relevant requirements of the preceding paragraphs.

A test report shall not include any advice or recommendation arising from the test results.

Test results shall be presented accurately, clearly, completely and unambiguously in accordance with instructions that may be part of the test methods.

Quantitative results shall be given together with calculated or estimated uncertainty.

5.4.4

Records

The testing facility shall maintain a record system to suit its particular circumstances and comply with any existing regulations. It shall retain on record all original observations, calculations and derived data, calibration records and the final test report for as long as the substance or product concerned continues to be authorized or placed on the market in the Community. The records for each test shall contain sufficient information to permit repetition of the test. The records shall include the identity of personnel involved in calibration of equipment, sampling, and reading of measurements.

All records and test reports shall be safely stored, held secure and in confidence to the client and the competent authority, unless otherwise required by law.

5.4.5

Handling of test samples or items

A system for identifying the samples or materials to be tested shall be applied, either through documents or through marking, to ensure that there can be no confusion regarding the identity of the samples or items and the results of the measurements made.

The system shall include arrangements to ensure that the samples or items can be handled anonymously, e.g. to other clients.

A procedure shall exist for bonded storage of samples or items where necessary.

At all stages of storing, handling and preparation for test, precautions shall be taken to prevent damage to the samples or test material, for example contamination or the application of stresses (temperature), which would invalidate the results of testing. Any relevant instructions provided with the samples or materials to be tested shall be observed.

There shall be clear rules for the receipt, retention and disposal of samples and test materials.

5.4.6

Confidentiality and security

The personnel of the testing facility shall be bound to observe professional secrecy with regard to all information gained in carrying out its tasks.

The testing facility shall observe terms and conditions to provide for confidentiality and security of its practices as required by the user of its services.

5.4.7

Subcontracting

Testing facilities shall themselves normally perform the testing which they contract to undertake. Where, exceptionally, a testing facility subcontracts any part of the testing, this work shall be placed with another testing facility complying with these requirements. The testing facility shall ensure and be able to demonstrate that its subcontractor is competent to perform the services in question and complies with the same criteria of competence as the testing facility in respect of the work being subcontracted. The testing facility shall advise the client of its intention to subcontract any portion of the testing to another party. The subcontractor shall be acceptable to the client.

The testing facility shall record and retain details of its investigation of the competence and the compliance with the requirements of these Principles of GEP of its subcontractors and maintain a register of all subcontracting.

6

Cooperation

6.1

Cooperation with clients

The testing laboratory shall afford the client or his representative cooperation to enable him to clarify the client's request and to monitor the performance of the testing facility in relation to the work to be performed. This cooperation shall include

( a ) affording the client or his representative access to relevant areas of the testing facility, for the witnessing of tests performed for the client. It is understood that such access shall by no means come into conflict with rules of confidentiality of work for other clients and with safety; and

( b ) preparation, packaging and dispatch of test samples or materials needed by the client for verification purposes.

The testing facility shall have a defined complaint procedure. This shall be documented and made available on request.

6.2

Cooperation with competent authority

The testing facility shall afford the competent authority and its authorized officers such reasonable cooperation as is necessary, to enable the competent authority to monitor compliance with these requirements and other relevant obligations. This cooperation shall include

( a ) affording authorized officers access to relevant areas of the testing facility, for the witnessing of tests;

( b ) undertaking any reasonable checks to enable the competent authority to verify the testing capability of the testing facility;

( c ) providing access to and copies of all relevant documentation and records necessary to verify compliance with these requirements;

( d ) preparation, packaging and dispatch of test samples or items needed by the competent authority for verification purposes;

( e ) participation in any appropriate programme of proficiency testing or comparison testing that the competent authority may reasonably deem to be necessary;

( f ) permitting scrutiny by the competent authority of the results of the testing facility's own internal audits and where appropriate, proficiency tests; and

( g ) where requested, making available, prior to the commencement of a test, detailed information concerning it, including its location and the materials to be tested.

6.3

Cooperation with other laboratories and with bodies producing standards and guidelines

Testing facilities are encouraged to participate in the drawing up of national, European or international standards and guidelines in the area of testing, where appropriate.

Testing facilities are encouraged to take part in an exchange of information with other laboratories and facilities having test activities in the same technical field where appropriate. The object is to have uniform test procedures and guidelines and to improve the quality of testing where appropriate.

In order to maintain the accuracy required, regular comparison of test results by proficiency testing should be arranged where appropriate.

7

Further duties of testing facilities

Testing facilities shall

( a ) before undertaking testing, ensure that necessary authorizations for trials purposes have been issued by the competent authority, unless the testing concerning is to be conducted in accordance with the terms and conditions of a valid trials permit;

( b ) ensure, where relevant, that testing is conducted in accordance with the conditions of the relevant authorization for trials purposes;

( c ) at all times comply with the requirements of these Principles of GEP and with other criteria prescribed by the competent authority;

( d ) an annual report to the competent authority, containing all detailed information necessary to demonstrate compliance with these Principles of GEP;

( e ) claim that the Principles of Good Efficacy Testing Practice have been complied with only in respect of testing services which are carried out in accordance with the requirements of this Schedule and other criteria prescribed by the competent authority;

( f ) not use its compliance with this Schedule in such a manner as to bring the competent authority into disrepute and not make any statement relevant to compliance or non-compliance which the competent authority may reasonably consider to be misleading;

( g ) make it clear in all contracts with its clients that compliance with the Principles of Good Efficacy Testing Practice or test reports generated in accordance with those principles, by themselves in no way constitute or imply product authorization or approval by the competent authority or any other body;

( h ) ensure that no test report nor any part thereof shall be used by them, or be authorized for use by them, for promotional or publicity purposes, if the competent authority considers such use to be misleading; and

( i ) inform immediately the competent authority of any changes bearing on its compliance with the requirements of this Schedule and other criteria affecting the testing facility's capability or scope of activity.

EIGHT SCHEDULE

PART 1

Regulations 25 (3)

PART 2

Regulations 25 (12)

PART 3

Regulations 25 (12)

NINTH SCHEDULE

Regulations 25 (5)

DATA AND INFORMATION REQUIRED IN SUPPORT OF APPLICATIONS FOR AUTHORIZATIONS FOR TRIALS PURPOSES

INTRODUCTION

1

Although the extent of the data and information required to support applications for the authorization of plant protection products for trials purposes is quite limited, the tests and studies reported must satisfy the same standards as to quality, as is required of tests and studies submitted in support of applications for authorization for commercial marketing and use.

2

The information submitted must

2.1

include a technical dossier supplying the information necessary for evaluating the foreseeable immediate risks which the plant protection product may entail for humans, animals and the environment, as well as the information necessary for the identification of potential delayed risks for consumers through dietary exposure, and contain at least the information and results of the studies referred to below;

2.2

where relevant, be generated using test guidelines referred to or described in Annex II or Annex III, or in this Schedule, in the case of studies initiated before the adoption of the modification of those Annexes, or before these Regulations come into effect, as appropriate, the information shall be generated using suitable internationally validated test guidelines or, in the absence thereof, test guidelines accepted by the competent authority;

2.3

in the event of a test guideline being inappropriate or not described, or where another one than those referred to in annex II or III or in this Schedule has been used, include a justification, which is acceptable to the competent authority for the guideline used;

2.4

include, a full description of test guidelines used, except if they are referred to or described in Annex II or III, or in this Schedule, and a full description of any deviations from the guidelines used, including a justification, which is acceptable to the competent authority, for these deviations;

2.5

include a full and unbiased report of the studies conducted as well as a full description of them, or a justification which is acceptable to the competent authority, where

— particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided, or

— it is not scientifically necessary, or technically possible to supply information and data; and

2.6

where relevant, have been generated in accordance with the requirements of Directive 86/609/EEC.

3

Tests and analyses must be conducted in accordance with the principles laid down in Directive 87/18/EEC, where testing is done to obtain data on the properties and/or safety with respect to human or animal health or the environment.

4

The information required must include the proposed classification and labelling of the plant protection product in accordance with relevant Community Directives, as well as the proposed classification and labelling of each novel active substances contained in the plant protection product.

5

Individual study reports must be presented in accordance with the requirements of Part 2 of the Fourth Schedule. Subject to the appropriate clearance or authorization number being quoted, study reports already submitted for plant protection products cleared in accordance with the Regulations of 1994, or authorized in accordance with Regulations 13, 15, or 18, need not be submitted again in support of applications for authorization for trials purposes.

6

The information required must include a summary and overview of the information and study reports submitted. Where particular information, test reports or studies specified are not provided, or have not been submitted previously, the omission must be justified and a reasoned case must be made justifying the granting of an authorization for trials purposes, in the absence of the data concerned. Additional data, not specified hereunder, can be provided in support of applications, where it is of suitable quality, and relates to the risks which the plant protection product may entail for humans, animals and the environment.

7

Authorizations for trials purposes cannot be granted where there are significant gaps in the supporting documentation provided. Decisions as to whether an authorization for trials purposes can be granted where there are minor gaps in the supporting documentation provided, can only be made on a case by case basis. The following general guidance is provided

7.1

in all cases at least that information and data concerning the identity of each active substance, the physical and chemical properties of each active substance, the identity of the plant protection product, the physical and chemical properties of the plant protection product and the acute toxicity of each active substance, must be provided;

7.2

in the case of preparations, which classify as Very Toxic, or Toxic (on the basis of calculations), or which contain substances which are allergic sensitizers, data relating to the acute toxicity of the preparation, must be provided; and

7.3

where the nature of the proposed use is such that a there is a moderate or high risk of residues occurring in food or feed commodities, and where it is not proposed that produce be destroyed, data relating to the short-term toxicity and genotoxicty profile of each active substance, and data on residues at harvest, must be provided.

PART A

Chemical substances

Identity of the applicant

The name and address of the applicant (permanent Community address) must be provided as must the name, position, telephone and telefax number of the appropriate person to contact.

Where, in addition, the applicant has an office, agent or representative within the territory of the state, the name and address of the local office, agent or representative must be provided as must the name, position, telephone and telefax number of the appropriate person to contact.

2

Identity of the active substance(s)

The information provided must be sufficient, to identify with precision each active substance in the plant protection product, to define it in terms of its specification and to characterize it as to its nature. The information and data referred to, unless otherwise specified, are required for all active substances.

2.1

Common name proposed or ISO-accepted, and synonyms

For each active substance in the plant protection product, the ISO common name, or proposed ISO common name, and where relevant, other proposed or accepted common names (synonyms), including the name (title) of the nomenclature authority concerned, must be provided.

2.2

Chemical name (IUPAC and CA nomenclature)

For each active substance in the plant protection product, the chemical name as given in Annex I to the Directive of 1967, or if not included in that Directive, in accordance with both IUPAC and CA nomenclature, must be provided.

2.3

Manufacturer's development code number(s)

For each active substance in the plant protection product, code numbers used to identify the active substances concerned and, where available, to identify formulations containing each of the active substances during development work, must be reported. For each code number reported, the material to which it relates, the period for which it was used, and the Member States or other countries in which it was used, and is being used, must be reported.

2.4

CAS and EEC numbers (if available)

For each active substance in the plant protection product, the Chemical Abstracts, EEC (EINECS or ELINCS), and CIPAC numbers, where they exist, must be reported.

2.5

Molecular and structural formula, molecular mass

The molecular formula, molecular mass and structural formula of each active substance, and where relevant, the structural formula of each stereo and optical isomer present in the active substances concerned, must be provided.

2.6

Manufacturer (name, address, including location of plant)

The name and address of the manufacturer or manufacturers of each active substance must be provided as must the name and address of each manufacturing plant in which the active substances concerned are manufactured. A contact point (preferably a central contact point, to include name, telephone and telefax number) must be provided, with a view to providing updating information and responding to queries arising, regarding manufacturing technology, processes and the quality of technical product (including where relevant, individual batches). Where following authorization for trials purposes, there are changes in the location or number of manufacturers, the information required must again be provided, unless the period of validity of the relevant authorization for trials purposes has expired or it has not been renewed.

2.9

Method of manufacture (synthesis pathway) of active substance

For each active substance in the plant protection product, the method of manufacture, in terms of the identity of the starting materials, the chemical pathways involved, and the identity of by-products and impurities present in the final product, must be provided, for each manufacturing plant. Generally, process engineering information is not required.

Where the information provided relates to a laboratory or pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized, unless the period of validity of the relevant authorization for trials purposes has expired or it has not been renewed.

2.10

Specification of purity of active substance in g/kg or g/l as appropriate

For each active substance in the plant protection product, the minimum content in g/kg of the pure active substance (excluding inactive isomers) in the manufactured material used in production of the formulated product, must be reported.

Where the information provided relates to a laboratory or pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized, if production changes result in a changed specification of purity, unless the period of validity of the relevant authorization for trials purposes has expired or it has not been renewed.

2.11

Identity of isomers, impurities and additives (e.g. stabilizers), together with the structural formula and the content expressed as g/kg

For each active substance in the plant protection product, the maximum content in g/kg of inactive isomers as well as the ratio of the content of isomers/diastereoisomers, where relevant, must be provided. In addition, the maximum content in g/kg of each further component other than additives, including by-products and impurities must be provided. In the case of additives, the content in g/kg must be provided.

For each component, present in quantities of 1 g/kg or more, the following information, where relevant, must be provided

— chemical name according to IUPAC and CA nomenclature;

— ISO common name or proposed common name, if available;

— CAS number, EEC (EINECS or ELINCS) number, and CIPAC number, if available;

— molecular and structural formula;

— molecular mass;

— optical purity and ratio of enantiomorphs; and

— maximum content in g/kg.

Where the manufacturing process is such that impurities and by-products which are particularly undesirable because of their toxicological or environmental properties could be present in an active substance, the content of each such compound must be determined and reported. In such cases, the analytical methods used and the limits of determination, which must be sufficiently low, for each compound of concern, must be reported. Additionally, the following information, where relevant, must be provided

— chemical name according to IUPAC and CA nomenclature;

— ISO common name or proposed common name, if available;

— CAS number, EEC (EINECS or ELINCS) number, and CIPAC number, if available;

— molecular and structural formula;

— molecular mass;

— optical purity and ratio of enantiomorphs; and

— maximum content in g/kg.

Where the information provided does not fully identify a component viz. condensates, detailed information on their composition must be provided for each such component

Where the information provided relates to a laboratory or pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized, if production changes result in a changed specification of purity, unless the period of validity of the relevant authorization for trials purposes has expired or it has not been renewed.

The trade name of components added to active substances, prior to manufacture of formulated product, to preserve stability and facilitate ease of handling, where they are used, must also be provided. Additionally, the following information, where relevant, must be provided for such additives

— chemical name according to IUPAC and CA nomenclature;

— ISO common name or proposed common name, if available;

— CAS number, EEC (EINECS or ELINCS) number, and CIPAC number, if available;

— molecular and structural formula;

— molecular mass;

— optical purity and ratio of enantiomorphs; and

— maximum mean content in g/kg.

For added components, other than active substance and other than impurities resulting from the manufacturing process, the function of the component (additive) must be given

antifoaming agent

buffer

other (specify)

antifreeze

dispersing agent

binder

stabilizer

3

Physical and chemical properties of the active substance(s)

(i)

The information provided, must describe the physical and chemical properties of each active substance included in the plant protection product and together with other relevant information, must serve to characterize them. In particular, the information provided must permit

— physical, chemical, and technical hazards associated with active substances, to be identified;

— classification of active substance as to hazard;

— appropriate restrictions and conditions to be associated with any authorization for trials purposes granted to be selected; and

— appropriate risk and safety phrases to be specified.

The information and data referred to are required for all active substances, except where otherwise specified.

(ii)

The information provided, taken together with that provided for the formulated product, must permit the physical, chemical and technical hazards associated with preparations, to be identified, permit preparations to be classified, and establish that preparations can be used without unnecessary difficulty, and be such that exposure of man, animals, and the environment is minimized, taking account of manner of proposed use.

(iii)

Data and information as to the physical and chemical properties of active substances, are of particular value in predicting their behaviour in the various biological systems of concern, and consequently are of great importance in specifying when particular studies and tests are required, and in the design of such studies.

(iv)

The extent to which active substances comply with relevant FAO specifications, must be stated. Divergences from FAO specifications must be described in detail, and justified.

(v)

In certain specified instances, tests must be conducted using purified active substance of stated specification. In such cases the method(s) of purification employed and their effectiveness must be reported. The purity of such test material, which must be as high as can be achieved using the best available technology, must be reported. A reasoned justification must be provided in cases where the degree of purity achieved is less than 980 g/kg. The justification provided, must demonstrate that all technically feasible and reasonable possibilities for the production of pure active substance have been exhausted.

3.1

Melting point and boiling point

3.1.1

The melting point or where appropriate the freezing or solidification point of purified active substance must be determined and reported according to EEC Method A 1. Measurements should be taken at temperatures up to 360°C.

3.1.2

Where appropriate, the boiling point of purified active substances must be determined and reported according to EEC Method A 2. Measurements should be taken at temperatures up to 360°C.

3.1.3

Where melting point and/or boiling point cannot be determined because of decomposition or sublimation, the temperature at which decomposition or sublimation occurs, must be reported.

3.2

Relative density

In the case of active substances which are liquids or solids, the relative density of the active substance as manufactured and that of purified active substance must be determined and reported according to EEC Method A 3.

3.3

Vapour pressure (in Pa) at 20°C, volatility (e.g. Henry's law constant)

3.3.1

The vapour pressure of purified active substance, determined in accordance with EEC Method A 4, must be reported. Where vapour pressure is less than 10

-5

Pa, the vapour pressure at 20°C may be estimated, using a vapour pressure curve.

3.3.2

In the case of active substances which are solids or liquids, volatility (Henry's law constant) of purified active substance must be calculated from its water solubility and vapour pressure and be reported (in Pa x m

3

x mol

-1

).

3.4

Appearance (physical state, colour and odour; if known)

3.4.1

A description of both the colour, if any, and the physical state of both the active substance as manufactured and of purified active substance, must be provided.

3.4.2

A description of any odour associated with the active substance as manufactured and of purified active substance, noted when handling the materials in laboratories or production plants, must be reported.

3.5

Spectra (UV/VIS, IR, NMR, MS), molecular extinction at relevant wavelengths

3.5.1

The following spectra, including a table of signal characteristics needed for interpretation, must be determined using purified active substance, and be reported ultraviolet/visible (UV/VIS), infrared (IR), nuclear magnetic resonance (NMR), and mass spectra (MS). Molecular extinction at relevant wavelengths, must also be determined and reported. The wavelengths at which UV/VIS molecular extinction occurs are determined and reported must include, where appropriate, a wavelength at the highest absorption value above 290 nm. In the case of active substances which are resolved optical isomers, their optical purity must be measured and reported.

3.5.2

The UV/VIS absorption spectra, IR, NMR and MS spectra, where necessary for the identification of impurities considered to be of toxicological or environmental significance, and molecular extinction at relevant wavelengths, must be determined and reported.

3.6

Solubility in water including effect of pH (4 to 10) on solubility

The water solubility of purified active substances which are not volatile, at 20°C and atmospheric pressure, must be determined in accordance with EEC Method A 6, and be reported. These water solubility determinations must be made in the neutral range (i.e. in purified water in equilibrium with atmospheric carbon dioxide). Where the active substance is capable of forming ions, determinations must also be made in the acidic range (pH 4 to 6) and in the alkaline range (pH 8 to 10), and be reported. Where the stability of the active substance in aqueous media is such that water solubility cannot be determined, a justification based on test data must be provided.

3.7

Solubility in organic solvents

The solubility of active substances, as manufactured, in the following organic solvents at 20°C must be determined and reported — if less than 250 g/kg, the temperature applied must be reported

Aliphatic hydrocarbon

— preferably n-heptane

Aromatic hydrocarbon

— preferably xylene

Halogenated hydrocarbon

— preferably 1,2-dichloroethane

Alcohol

— preferably methanol or isopropyl alcohol

Ketone

— preferably acetone

Ester

— preferably ethyl acetate

If for a particular active substance, one or more of these solvents is unsuitable (e.g. reacts with test material), alternative solvents can be used instead. In such cases, choices made must be justified in terms of their structure and polarity.

3.8

Partition coefficient n-octanol/water including effect of pH (4 to 10)

The n-octanol/water partition coefficient of purified active substance at 20°C, must be determined and reported according to EEC Method A 8. The effect of pH (4 to 10) must be investigated when the substance is acidic or basic as defined by its pKa value (2 for bases).

3.9

Stability in water, hydrolysis rate, photochemical degradation, quantum yield and identity of breakdown product(s), dissociation constant including effect of pH (4 to 9)

3.9.1

The hydrolysis rate of purified active substances (usually radiolabelled active substance,>95% purity), at 20°C, for each of the pH values 4, 7 and 9, under sterile conditions, in the absence of light, must be determined in accordance with EEC Method C 7, and be reported. For substances with a low rate of hydrolysis, the rate can be determined at 50°C, or another appropriate temperature. If degradation is observed at 50°C, degradation rate at another temperature must be determined, and an Arrhenius plot must be constructed to permit an estimate to be made of hydrolysis at 20°C. The identity of hydrolysis products formed and the rate constant observed, must be reported. The estimated DT

50

value must also be reported.

3.9.2

For compounds with a molar decadic absorption coefficient (ε) > 10 (1 x mol

-1

x cm

-1

) at a wavelength λ >290 nm, direct phototransformation in purified water (e.g. distilled water) at 20 to 25°C, of purified active substance, usually radio labelled, using artificial light (intensities and spectral distribution relevant to northern European), under sterile conditions, if necessary using a solubilizer, must be determined and reported. Sensitizers such as acetone must not be used as a co-solvent or solubilizer. The light source must simulate sunlight and be equipped with filters to exclude radiation at wavelengths λ > 290 nm. The identity of breakdown products formed, which at any time during the study are present in quantities> 10% of the active substance added, must be reported. In addition, a mass balance to account for at least 90% of the radioactivity, as well as photochemical halflife must be reported.

3.9.3

Where necessary to investigate direct phototransformation, the quantum yield of direct photodegradation in water must be determined and reported, together with calculations to estimate theoretical lifetime of the active substance in the top layer of aqueous systems and the real lifetime of the substance. The method to be used is that described in the Annex to the FAO Revised Guidelines on Environmental Criteria for the Registration of Pesticides.

3.9.4

Where dissociation in water occurs, the dissociation constant(s) (pKa) of purified active substances, at 20°C, must be determined and reported in accordance with OECD Test Guideline 112. The identity of the dissociated species formed, based on theoretical considerations, must be reported. If the active substance is a salt, the pKa value of the active principle must be given.

3.10

Stability in air, photochemical degradation, identity of breakdown product(s)

An estimation of the photochemical oxidative degradation (indirect phototransformation) of the active substance(s), must be provided.

3.11

Flammability including auto-flammability

3.11.1

The flammability of active substances as manufactured, which are solids, gasses, or are substances which in contact with water or damp air evolve highly flammable gasses, must be determined in accordance with EEC Method A 10, A 11, or A 12, as appropriate, and be reported.

3.11.2

The auto-flammability of active substances as manufactured, determined in accordance with EEC Method A 15, or A 16, as appropriate, must be reported.

3.12

Flash point

The flash point of active substances as manufactured, which have a melting point below 40°C, must be determined in accordance with EEC Method A 9 using a closed cup method, and be reported.

3.13

Explosive properties

The explosive properties of active substances as manufactured, determined in accordance with EEC Method A 14, must be reported, for substances which on theoretical grounds are potentially explosive.

3.14

Oxidizing properties

The oxidizing properties of active substances as manufactured, determined in accordance with EEC Method A 17, must be reported, except where examination of its structural formula, establishes beyond reasonable doubt that the active substance is incapable of reacting exothermically with a combustible material. In such cases, it is sufficient to provide that information as justification for not determining the oxidizing properties of the substance.

4

Further information on the active substance(s)

The intended function of each active substance must be specified from among the following

acaricide

nematicide

algicide

semio chemical

bactericide

plant growth regulator

defoliant

repellant (mammalian, avian,

fungicide

earthworm or insect)

herbicide (selective)

rodenticide

herbicide (non-selective)

talpicide

insecticide

viricide

molluscicide

other (must be specified)

5

Identity of the plant protection product

(i)

The information provided, together with that provided for active substances concerned, must be sufficient to identify with precision, the plant protection product, to define it in terms of its specification and to characterize it as to its nature. The information and data referred to, unless otherwise specified, are required for all plant protection products.

(ii)

The extent to which plant protection products for which authorization is sought, comply with relevant FAO specifications, must be stated. Divergences from FAO specifications must be described in detail, and justified.

5.1

Manufacturer of the preparation and the active substance(s) (names and addresses, etc. including location of plants)

5.1.1

The name and address of the manufacturer of the preparation must be provided as must the name and address of each manufacturing plant in which the preparation is manufactured. A contact point (preferably a central contact point, to include name, telephone and telefax numbers) must be provided for each.

5.2

Trade name or proposed trade name, and manufacturer's development code number of the preparation if appropriate

All former and current trade names and proposed trade names and development code numbers of the preparation as well as current names and numbers must be provided. Where trade names and code numbers referred to, relate to similar but different preparations (possibly obsolete), full details of the differences, must be provided.

5.3

Detailed quantitative and qualitative information on the composition of the preparation (active substance(s), impurities, adjuvants, inert components, etc.)

5.3.1

The content (minimum, mean and maximum in g/kg for solids and in g/kg and g/l at 20°C for liquids) in the preparation, must be provided

— for active substances, in terms both of technical active substance and pure active substance; and

— for each formulant, other than active substances.

In the case of active substances, the salt, ester, anion, or cation concerned, where appropriate, must be specified.

5.3.2

Formulants must where possible, be identified both by their chemical name as given in Annex I to the Directive of 1967, or if not included in that Directive, in accordance with both IUPAC and CA nomenclature. Their ISO common name or proposed common name, where relevant, must be provided. Their structure or structural formula must be provided. For each component of a formulant, the relevant EEC (EINECS or ELINCS) number and CAS number, where they exist, must be provided. Where the information provided does not fully identify a formulant or a component of a formulant, an appropriate specification must be provided. The trade name of both formulants and their components, where they exist, must also be provided.

5.3.3

For formulants, other than active substance, their function must be given

adhesive (sticker)

dye

repellent

antifoaming agent

emetic

safener

antifreeze

emulsifier

solvent

binder

fertiliser

stabiliser

buffer

odourant

synergist

carrier (solid)

perfume

thickener

deodorant

preservative

wetting agent

dispersing agent

propellant

miscellaneous (specify)

5.4

Physical state and nature of the preparation (emulsifiable concentrate, wettable powder, solution etc.)

The type of preparation must be designated according to the coding system contained in Annex 2 to Part 2 of the Fourth Schedule. Where a particular preparation is not defined in that system, a full description of the physical nature and state of the preparation must be provided, together with a proposal for a suitable description of the type of preparation and a proposal for its definition.

5.5

Function (herbicide, insecticide, etc.) of the plant protection product

The intended function, or functions, of the preparation must be specified from among the following

acaricide

nematicide

algicide

semio chemical

bactericide

plant growth regulator

defoliant

repellant (mammalian, avian,

fungicide

earthworm or insect)

herbicide (selective)

rodenticide

herbicide (non-selective)

talpicide

insecticide

viricide

molluscicide

other (must be specified)

6.

Physical and chemical properties of the plant protection product

6.1

Appearance (physical state, colour and odour; if known)

A description of both the colour, if any, and the physical state of the preparation, must be provided.

6.2

Explosivity and oxidizing properties

6.2.1

The explosive properties of preparations, determined in accordance with EEC Method A 14, must be reported, for substances which on theoretical grounds are potentially explosive. Where available thermodynamic information serves to establish beyond reasonable doubt that the preparation is incapable of exothermic reaction, it is sufficient to provide that information as a justification for not determining the explosive properties of the preparation.

6.2.2

The oxidizing properties of preparations, determined in the case of those which are solids, in accordance with EEC Method A 17, must be reported. In other cases, the method used must be justified. The oxidizing properties of preparations need not be determined where it can be shown, without reasonable doubt, on the basis of thermodynamic information, that the preparation is incapable of reacting exothermically with a combustible material. In such cases, it is sufficient to provide that information as justification for not determining the oxidizing properties of the substance.

6.3

Flash point and other indications of flammability or spontaneous ignition

The flash point of liquids which contain flammable organic solvents, must be determined in accordance with EEC Method A 9, and be reported. The flammability of solid preparations and gasses must be determined in accordance with EEC Method A 10, A 11, A 12, as appropriate, and be reported. In addition the auto-flammability of preparations must be determined in accordance with EEC Method A 15 or A16, as appropriate, and be reported.

6.4

Acidity / alkalinity and if necessary pH value

6.4.1

In the case of preparations which are acidic (pH 4) or alkaline (pH 10), their acidity or alkalinity and the pH value must be determined in accordance with CIPAC Method MT 31 and MT 75, as appropriate, and be reported.

6.4.2

Where relevant (if to be applied as an aqueous dilution) the pH of a 1% aqueous dilution, emulsion or dispersion of the preparation, must be determined in accordance with CIPAC Method MT 75, and be reported.

6.5

Viscosity and surface tension

6.5.1

In the case of liquid preparations for ultra low volume application (ULV), the kinematic viscosity of the preparation must be determined in accordance with OECD Test Guideline 114, and be reported.

6.5.2

For non newtonian liquids the viscosity must be determined and reported together with the test conditions.

6.5.3

In the case of liquid preparations, the surface tension of the preparation must be determined in accordance with EEC Method A 5, and be reported.

6.6

Relative density

In the case of preparations which are liquids or solids, the relative density of the preparation must be determined in accordance with EEC Method A 3, and be reported.

6.7

Reactivity towards container materials

The resistance of the proposed packaging material to its contents must be determined and reported.

7.

Information on the proposed experimental use

7.1

Field of use e.g. field, glasshouse, food or feed storage, home garden

The field of proposed use must be specified from among the following

Crop Protection (Agriculture and Horticulture)

—Field crops, pre-harvest

—Field crops, post-harvest

—Protected crops, pre-harvest

—Protected crops, post-harvest

Forestry —Nursery use

—Crop protection

—Timber protection

Home Garden Use

Household Use

Food and feed storage practice

Non-selective Weed Control —Agriculture and horticulture

—Home garden

—Industrial

—Amenity

Other Amenity Use —Plant protection

—Aquatic weed control

—Algae control

Other (specify)

7.2

Effects on harmful organisms, e.g. contact, inhalation or stomach poison, fungitoxic or fungistatic, etc., systemic or not in plants

3.2.1

The nature of the effects on harmful organisms must be stated

contact action

stomach action

inhalation action

fungitoxic action

fungistatic action

desiccant

reproduction inhibitor

other (must be specified)

3.2.2

Where relevant it must be stated, for each active substance in the preparation, whether or not the active substance is translocated in plants and where relevant whether such translocation is apoplastic, symplastic, or both.

7.3

Details of intended use e.g. types of harmful organisms controlled and/or plants or plant products to be protected

7.3.1

Details of the intended use in terms of crops, groups of crops, plants, or plant products protected, must be provided.

7.3.2

Details of the harmful organisms to be controlled, and where relevant, details of harmful organisms against which protection is afforded, must be provided.

7.3.3

Where relevant, details of other effects to be achieved e.g. sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilization etc., must be provided.

7.4

Proposed application rate

For each method of application and each use, the rate of application per unit treated, in terms of g or kg of both product and active substance, must be provided. Application rates should be expressed in g or kg/hectare for field crops, in g or kg/100 m

2

for glasshouse crops and home garden uses, in g or kg/tonne for treated seed, and in g or kg/unit or unit volume in other cases, as appropriate.

7.5

Concentration of active substance in material used (e.g. in the diluted spray, baits or treated seed)

The content of active substance in g/l of diluted spray material, in g/kg or mg/kg of bait or in g/tonne of treated seed, as appropriate, must be reported.

7.6

Proposed method of application

The method of application proposed must be described fully, indicating the type of equipment to be used, if any, as well as the type and volume of diluent to be used per unit area or volume.

7.7

Number and timing of applications proposed and duration of protection

7.7.1

The maximum number of applications to be used and their timing, must be reported. Where relevant the growth stages of the crop or plants to be protected, and where relevant the development stage of the harmful organism concerned, or their condition, must be indicated. Where possible the interval between applications, in days, must be stated.

7.7.2

Where relevant, the anticipated duration of protection afforded both by each application and by the maximum number of applications to be used, must be indicated.

7.8

Necessary waiting periods or other precautions to avoid Phytotoxic effects on succeeding crops

7.8.1

Where relevant and known, minimum waiting periods between last application and sowing or planting of succeeding crops, which are necessary to avoid phytotoxic effects on succeeding crops, must be stated.

7.8.2

Known limitations on choice of succeeding crops, if any, must be stated.

7.9

Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment

Where relevant, crop destruction, pre-harvest intervals, re-entry periods, withholding periods, or other precautions necessary to minimize the presence of residues in or on crops, plants and plant products, or in treated areas or spaces, with a view to protecting man, livestock or the environment, must be specified

— crop destruction;

— pre-harvest interval (in days) for each relevant crop;

— re-entry period (in days) for livestock, to areas to be grazed;

— re-entry period (in hours or days) for man to crops, buildings or spaces treated;

— withholding period (in days) for animal feedingstuffs;

— waiting period (in days), between application and handling treated produce;

— waiting period (in days), between last application and sowing or planting succeeding crops; or

— other precautions, which must be described.

7.10

Proposed instructions for use

The proposed instructions for use of the preparation, to be followed in the application of the product, must be provided.

8.

Analytical methods

Where use is on a crop or plant product intended for use as food or feed, if residues may occur (moderate or high risk) and the crop or plant product is not to be destroyed, relevant, analytical methods including recovery rates and the limits of determination for residues in treated plants, plant products, foodstuffs and feeding-stuffs, must be provided.

9

Efficacy data

9.1

The data supplied must be sufficient to permit an evaluation to be made of the potential role of the plant protection product, for the uses proposed. In particular it must be possible to establish that on the basis of the information available, it is possible that the product may fulfil its intended purpose, in terms of control of harmful organisms or other intended effects.

9.2

Reports in summary form of preliminary tests (primary biological screening), including glasshouse and field studies, used to assess the biological activity and dose range finding of the plant protection product and of the active substance(s) it contains, must be submitted. Where this information is not available, a reasoned statement of the rational used to suggest that the plant protection product may fulfil its intended purpose, in terms of control of harmful organisms or other intended effects, must be provided.

10.

Toxicological studies

10.1

Acute toxicity

(i)

The studies, data and information to be provided and evaluated, must be sufficient to permit the hazards for humans, following a single exposure to the plant protection product, to be assessed, and in particular to establish, or indicate

— the relationship between dose and morbidity and mortality;

— the toxicity of the active substance relative to other substances;

— the time course and characteristics of poisoning with full details of behaviourial changes and possible gross pathological findings at post-mortem; and

— the relative hazard associated with the different routes of exposure.

(ii)

While the emphasis must be on estimating the toxicity ranges involved, the information generated must also permit the active substance(s) and the preparation to be classified. The information generated through acute toxicity testing is of particular value in assessing hazards likely to arise in accident situations.

(iii)

The vehicle chosen for administration of the test material must be selected such that it is not itself toxic and such that the test substance is bio-available. Where feasible, aqueous solutions are preferred. Other options include solution/suspension in 0.5% carboxymethyl cellulose or solution/suspension in non-polar non-toxic solvents. Where a novel or unusual vehicle is used, the bio-availability of the test substance in the vehicle used must be established and reported —a comparative 7 day test using radiolabelled material with different vehicles.

10.1.1

Oral

10.1.1.1

The acute oral toxicity to the rat of each active substance in the preparation, determined in accordance with the EEC Method B 1 (Fixed Dose Method), must be reported.

10.1.1.2

The acute oral toxicity to the rat of the preparation, determined in accordance with the EEC Method B 1 (Fixed Dose Method), must be reported, except where

— for plant protection products containing one active substance, Article 3.2 of the Directive of 1978 can in principle be invoked; or

— for plant protection products containing more than one active substance, Article 3.3 of the Directive of 1978 can in principle be invoked; and

relevant information and documentation is submitted, or is available to the competent authority, which shows that there are valid grounds for assuming that the classification resulting from the calculation would not vary substantially from that obtainable by biological testing i.e. the composition of the preparation is similar to that of a preparation for which a biological test is available, and the toxicity of the tested preparation is similar to its predicted toxicity, or the composition of the preparation is similar to that of two or more preparations for which biological tests are available, and the toxicity of the tested preparations varies in a consistent manner from their predicted toxicities.

10.1.2

Percutaneous

10.1.2.1

Since knowledge of percutaneous toxicity is necessary for the evaluation of operator hazard and the specification of suitable protective clothing, the acute percutaneous toxicity to rats of each active substance in the preparation, determined in accordance with EEC Method B 3, must be reported. Both local and systemic effects must be investigated.

10.1.2.2

The acute percutaneous toxicity to rats of the preparation, determined in accordance with EEC Method B 3, must be reported. Both local and systemic effects must be investigated. However, testing of the preparation should not be carried out, where

— for plant protection products containing one active substance, Article 3.2 of the Directive of 1978 can in principle be invoked; or

— for plant protection products containing more than one active substance, Article 3.3 of the Directive of 1978 can in principle be invoked; and

relevant information and documentation is submitted, or is available to the competent authority, which shows that there are valid grounds for assuming that the classification resulting from the calculation would not vary substantially from that obtainable by biological testing i.e. the composition of the preparation is similar to that of a preparation for which a biological test is available, and the toxicity of the tested preparation is similar to its predicted toxicity, or the composition of the preparation is similar to that of two or more preparations for which biological tests are available, and the toxicity of the tested preparations varies in a consistent manner from their predicted toxicities.

10.1.3

Inhalation

10.1.3.1

The inhalation hazard of a plant protection product is dependant not only on its toxic properties, physical state, manner of use and where relevant particle size, but also on the vapour pressure and solubility of its components. Accordingly, the inhalation toxicity to rats of each active substance in the preparation, determined in accordance with EEC Method B 2, must be reported where the preparation is

— a gas or liquified gas;

— to be used as a fumigant;

— to be used with fogging equipment;

— to be included in a smoke generating, aerosol or vapour releasing preparation;

— to be included in preparations which are powders containing a significant proportion of particles of diameter1% on a weight basis); or

— to be included in preparations to be applied in a manner which produces a spray, mist or aerosol containing a significant proportion of particles of diameter1% on a weight basis).

10.1.3.2

In addition, in the case of active substances having a vapour pressure> 1 x 10

-2

Pa, and which are to be included in preparations to be used in enclosed spaces such as warehouses or glasshouses, the inhalation toxicity to rats of each such active substance, determined in accordance with EEC Method B 2, must be reported.

10.1.3.3

The inhalation toxicity to rats of the preparation, determined in accordance with EEC Method B 2, must be reported where the preparation is

— a gas or liquified gas;

— a smoke generating formulation or a fumigant;

— a vapour releasing preparation;

— to be used with fogging equipment;

— contains active substance(s) having a vapour pressure>1 x 10

-2

Pa and to be included in preparations to be used in enclosed spaces such as warehouses or glasshouses;

— to be included in a smoke generating, aerosol or vapour releasing preparation;

— to be included in preparations which are powders containing a significant proportion of particles of diameter 1% on a weight basis); or

— to be included in preparations to be applied in a manner which produces a spray, mist or aerosol containing a significant proportion of particles of diameter1% on a weight basis).

10.1.3.4

However, testing of the preparation should not be carried out, where

— for plant protection products containing one active substance, Article 3.2 of the Directive of 1978 can in principle be invoked; or

— for plant protection products containing more than one active substance, Article 3.3 of the Directive of 1978 can in principle be invoked; and

relevant information and documentation is submitted, or is available to the competent authority, which shows that there are valid grounds for assuming that the classification resulting from the calculation would not vary substantially from that obtainable by biological testing i.e. the composition of the preparation is similar to that of a preparation for which a biological test is available, and the toxicity of the tested preparation is similar to its predicted toxicity, or the composition of the preparation is similar to that of two or more preparations for which biological tests are available, and the toxicity of the tested preparations varies in a consistent manner from their predicted toxicities.

10.1.4

Skin and where appropriate eye irritation

10.1.4.1

The possible effects of accidental contamination of skin and eyes, must be investigated, as contact may occur in handling preparations containing the active substance, in either concentrated or dilute form, or in cleaning application equipment.

10.1.4.2

The skin irritancy of each active substance, and of the preparation, determined using a single application to intact skin of rabbits, in accordance with EEC Method B 4, must be reported, except where

— positive results can be predicted on the basis of the acidity or alkalinity of aqueous solutions of the active substance (pH S2 or> 11.5), or on the basis of the acidity or alkalinity of the preparation (pH 2> or11.5), as appropriate;

— no irritation is seen at the limit test dose level in acute percutaneous studies; or

— where the active substance, or preparation, as appropriate, is highly toxic in an acute percutaneous study.

10.1.4.3

Eye irritation tests must not be conducted for active substances or preparations known, or found, to be corrosive. Similarly eye irritation tests must not be conducted for substances or preparation known or found to be skin irritants, unless there is particular reason to believe otherwise. For other active substances contained in the preparation, as well as for the preparation, eye irritancy, determined in accordance with EEC Method B 5, using healthy adult albino rabbits, must be determined and reported, except where it is known, on the basis of other available information that the active substance or preparation, as appropriate, is likely to produce severe effects on the eyes.

10.1.5

Skin sensitization

10.1.5.1

Allergic sensitization, following exposure, occurs in a significant proportion of the human population. The potential of each active substance in the preparation, to provoke skin sensitization reactions, must be assessed in accordance with the EEC Method B 6, using the Guinea-pig Maximization Test (GPMT), and be reported.

10.1.5.2

The potential of preparations which contain an active substance found to provoke skin sensitization reactions, or which contain other components known to lead to such reactions, must be assessed in accordance with the EEC Method B 6, and be reported.

10.2

Short-term toxicity

(i)

Short-term toxicity studies to be submitted and evaluated, must be designed to provide information as to the amount of the active substance that can be tolerated without toxic effects under the conditions of the study. Such studies provide useful data on the risks for those handling and using preparations containing the active substance. In particular, short-term studies provide an essential insight into possible cumulative actions of the active substance, and the risks to workers who may be intensively exposed. In addition short-term studies provide information useful in the design of chronic toxicity studies.

(ii)

The studies, data and information to be provided and evaluated, must be sufficient to permit the hazards for humans, following repeated exposure to the active substance, to be assessed, and in particular to further establish, or indicate

— the relationship between dose and adverse effects;

— toxicity of the active substance relative to other substances;

— target organs, where relevant;

— the time course and characteristics of poisoning with full details of behaviourial changes and possible pathological findings at post-mortem;

— specific toxic effects and pathological changes produced;

— where relevant, the persistence and reversibility of certain toxic effects observed, following discontinuation of dosing;

— where possible, the mode of toxic action; and

— the relative hazard associated with the different routes of exposure.

(iii)

The studies specified are always required in support of applications for authorization for trials purposes where the nature of the proposed use is such that a there is a moderate or high risk of residues occurring in food or feed commodities, and where it is not proposed that produce be destroyed.

10.2.1

Repeated dose oral toxicity (28-day study)

10.2.1.1

Generally, range finding short-term (28 day) studies are an optional requirement. Where conducted they must be reported, since the results can be of particular value in the identification of adaptive responses which can be masked in testing over longer periods. Testing is required where the structure of the active substance (structure activity relationship), or the results of acute toxicity testing, suggest neurotoxic potential.

10.2.1.2

The repeated dose oral toxicity to rats of each active substance in the preparation, following exposure for 28 days, where relevant, must be determined, and reported. The appropriate test guideline is EEC Method B 7.

10.2.2

Oral 90-day study —two species

10.2.2.1

The short-term oral toxicity (90 day) of each active substance in the preparation, to both rat and dog (of defined breed), determined in accordance with the methods specified in Commission Directive 87/302/EEC

34

(Sub-chronic oral toxicity test: 90-day repeated oral dose using rodent species, and Sub-chronic oral toxicity test: 90-day repeated oral dose using non-rodent species), must be reported. Where there is evidence of species differences, and where such data are likely to be of value in extrapolating results obtained to man, a 12 month short-term toxicity study in dogs should be conducted and reported.

10.2.2.2

The number of test animals used in the rat study must, where appropriate, be sufficient to facilitate the determination of the persistence and reversibility of observed effects, following the discontinuation of dosing, as well as to permit observation of delayed effects, if any. Except where it is self evident that effects are persistent and are not reversible, the persistence and reversibility of observed effects, as well as the delayed occurrence of toxic effects, must be reported, unless the effects only occur at doses higher than the potential levels of human exposure, taking account of the appropriate and required margins of safety.

34

O. J. No. L 133/1 30/5/1988.

10.3

Genotoxicity —test strategy to assess gene mutations, chromosomal aberrations and DNA perturbations

(i)

Genotoxicity studies are of value in;

— the prediction of heritable defects;

— the early identification of genotoxic carcinogens; and in

— the elucidation of the mechanism of action of some carcinogens.

(ii)

A sequential, or tiered, approach to testing is specified (Figure 4). To avoid responses that are artifacts of the test system, excessively toxic doses must not be used in either in vitro or in vivo assays for genotoxicity.

(iii)

The studies specified are always required in support of applications for authorization for trials purposes where the nature of the proposed use is such that a there is a moderate or high risk of residues occurring in food or feed commodities, and where it is not proposed that produce be destroyed. Testing can be suspended where on completion of Tier 1 or Tier 2 testing, as appropriate, the results obtained are negative.

10.3.1

Tier 1 In Vitro Testing

10.3.1.1

All in vitro screening tests must be duplicated in separate experiments to confirm the results obtained. Where appropriate, different concentrations of active substance should be investigated in such "repeat" studies. Spurious positive results which are "stress-related" rather than indicative of intrinsic mutagenicity, can result from low pH and high osmolarity in assay systems.

10.3.1.2

Screening studies for gene mutations (base-pair and frame shift) in Salmonella typhimurium, strains TA98, TA100, TA102, TA1535, and TA1537, Escherichia coli WP2 andEscherichia coli WP2 uvrA, conducted in accordance with EEC Methods B 13 and B 14, as appropriate, to include testing in the presence and absence of exogenous metabolic activation, (Figure 4), must be reported.

10.3.1.3

In vitro tests for clastogenicity, to detect structural chromosomal aberrations, using human lymphocytes, conducted in accordance with the EEC Method B 10, must be reported (Figure 4).

10.3.1.4

Since the bacterial gene mutation and the mammalian cytogenetic assays, while efficient, do not detect all compounds with mutagenic potential, further testing for gene mutation in mammalian cells must be conducted, and reported (Figure 4). Tests must be conducted in accordance with the method specified in Commission Directive 87/302/EEC (In vitro mammalian cell gene mutation test) using L5178Y mouse lymphoma cells (TK locus), or other cell lines shown to be as sensitive.

Figure 4

GENOTOXICITY TESTING

Criteria to determine when tests are required

10.3.2

Tier 2 In Vivo Testing, Somatic Cells

10.3.2.1

Where the results of any of the in vivo cytogenetic test is positive, an in vitro test using somatic cells, in accordance with EEC Method B 12, is required (Figure 4). The route of administration, usually oral, must be chosen, to ensure significant absorption in test animals.

10.3.2.2

Where the results of either of the in vitro gene mutation tests are positive, a further test to investigate unscheduled DNA synthesis in rat liver ex vivo, in accordance with the method specified in Commission Directive 87/302/EEC (DNA damage and repair - unscheduled DNA synthesis —mammalian cells in vitro) or a mouse spot test conducted in accordance with the method specified in Commission Directive 87/302/EEC (Mouse spot test), must be reported.

10.3.3

Tier 3 In Vivo Testing, Germ Cells

Where an active substance is found to be genotoxic in vivo in somatic cells, genotoxic potential in germ cells must also be investigated (Figure 4), since not all somatic cell mutagens are germ cell mutagens. Except where use of an alternative method is justified, a dominant lethal assay, conducted in accordance with the method specified in Commission Directive 87/302/EEC (Rodent dominant lethal test), must be reported. The route of administration, usually oral intubation, must be chosen, to ensure significant absorption in test animals.

11

Residues in or on treated products, food or feed

(i)

In principle, the information provided, must be sufficient to permit an evaluation to be made as to the level, nature, and identity of residues, from time of application to harvest, slaughter, or collection, or following storage as appropriate, and as to the decline of such residues, where relevant.

(ii)

In principle, the information provided, must be sufficient to permit an evaluation to be made as to potential exposure, through diet of consumers, to residual traces of active substance and toxicologically significant metabolites, degradation and reaction products. Taken together with relevant and available toxicological information, it must, in principle, be sufficient to permit an evaluation to be made as to

— potential exposure of workers, through contact with dislodgeable residues; and

— the need for crops to be destroyed to preclude consumer exposure to residues; or

— the acceptability of proposed pre-harvest, waiting, withholding and re-entry intervals or periods, or other precautions to protect humans and animals.

(iii)

In practice, where in accordance with the rules relating to Comparability, Extrapolation, Group Tolerances and Data Requirements, as contained in Part 3 of the Fifth Schedule, the proposed use is such that there is a low residue risk (see point 5.4.3 of Part 3 of the Fifth Schedule), it is not necessary that data relating to residues at harvest be generated. However, any available data must nevertheless be provided. Where in accordance with those rules, there is a high or medium residue risk (see points 5.4.1 and 5.4.2 of Part 3 of the Fifth Schedule), data relating to residues at harvest must be provided, unless it is proposed that crops be destroyed prior to harvest, or treated plant products be destroyed to prevent consumption, as appropriate.

11.1

Nature of the residue

11.1.1

In the case of plant protection products cleared in accordance with the Regulations of 1994, authorized in accordance with Regulations 13, 15, or 18, for use on crops used for food or feed, evaluated by the WHO/FAO Joint Meeting on Pesticide Residues (JMPR), or evaluated as part of the first, second or subsequent priority groups for the establishment of a Community MRL, a statement must be provided relating to the

(i) identification of breakdown and reaction products and of metabolites in treated plants or plant products;

(ii) identification of breakdown and reaction products and of metabolites in succeeding crops, where relevant;

(iii) overall material balance for each active substance;

(iv) effects of industrial processing and/or household preparation on the nature and magnitude of residues, where relevant;

(v) results of feeding and metabolism studies in livestock (if residues remain in or on crops or parts of crops used for feed) to permit evaluation of residues in foodstuffs of animal origin; and

(vi) definition of the residue —for each active substance.

11.1.2

In other cases sufficient data must be submitted to identify breakdown and reaction products and metabolites in treated plants or plant products, to establish the effects of industrial processing and/or household preparation on the nature and magnitude of residues, where relevant, and to permit the composition of the residue to be defined.

12.1

Residue levels in treated products, food or feed

12.1.1

Where on the basis of the rules relating to Comparability, Extrapolation, Group Tolerances and Data Requirements, as contained in Part 3 of the Fifth Schedule, the residue levels likely to occur can be estimated on the basis of comparability, the rational and figures used must be provided, together with details of the GAPs used as a basis for the comparison (see Annex 4 of Part 2 of the Fourth Schedule), and the detailed residue data, in summary form, for the crops with which the comparison is made (see Annex 8 of Part 2 of the Fourth Schedule).

12.1.2

In other cases, sufficient residue data from supervised trials in crops, or plant products, for which authorization for trials purposes is sought, must be provided, giving all experimental conditions and details, including residue data concerning the active substance, relevant metabolites and relevant other constituents of the plant protection product, from time of application until harvest, or in the case of post-harvest treatment, breakdown of residues during storage and levels of residues at time of release from storage for marketing.

PART B

Micro-organisms and Viruses

(This part does not apply to GMOs where points come under Directive 90/220/EEC)

Pro Memoria

TENTH SCHEDULE

PART 1

Regulations 26 (2)

PART 2

Regulations 26 (7)

PART 3

Regulations 26 (7)

ELEVENTH SCHEDULE

PART 1

Regulations 27 (1)

PART 2

Regulations 27 (2)

PART 3

Regulations 27 (3)

THIRTEENTH SCHEDULE

Regulations 36 (1)

PART 1

Fees for the consideration of applications for the authorization of plant protection products in accordance with Regulations 13, 15 and 18, and for their renewal in accordance with Regulation 19(1)

Column (1)

Column (2)

£

Each dossier as specified in Regulation 8 (3) (b)

3,500

Each dossier as specified in Regulation 8 (3) (a)

1,250

Each dossier as specified in Regulation 8 (6)

500

PART 2

Regulations 36 (1)

Fees for the consideration of applications for modification of authorization for plant protection products in accordance with Regulation 19 (4)

Column (1)

Category

Column (2)

I

II

£

1,250

500

"Category I"

means a modification in the authorization of a plant protection product involving a major additional use, a major change in the manner of use, or a major formulation change;

"Category II"

means a modification in the authorization of a plant protection product involving a minor additional use, a minor change in the manner of use, or a minor formulation change.

PART 3

Regulations 36 (4)

Annual Fees

£100

Late Annual Fees

£150

Given under my Official Seal, this 12th day of May, 1994

JOE WALSH,

Minister for Agriculture, Food and Forestry

EXPLANATORY NOTE

These Regulations specify the requirements and conditions for the authorization of plant protection products, which must be complied with in relation to their placing on the market and use, in accordance with Council Directive 91/414/EEC as amended, as well as introducing relevant enforcement and financial provisions.

These Regulations also serve to exempt plant protection products which are pesticides regulated in accordance with the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1994 (

S.I. No. 138 of 1994

) from the requirements of those Regulations which require the separate submission of information, data and materials.

TWELFTH SCHEDULE

Regulation 30 (6)

PART 1

Certificate of Result of Analysis.

Laboratory Reference Number............................................................ ............

Sample of............................................................ ............................................................ ....................

received by the designated chemist on............................................................ .............................

from............................................................ ............................................................ .............................

Methods of analysis used............................................................ ..................................................

............................................................ ............................................................ ....................................

This is to certify that the above mentioned sample, which was duty fastened and sealed has been analyzed under the provisions of the European Communities (Authorization, Placing on the Market, Use and Control of Plant Protection Products) Regulations, 1994 (

S.I. No. 139 of 1994

) and the results of the analysis are as follows:—

............................................................ ............................................................ ....................................

This certificate is issued under the European Communities (Authorization, Placing on the Market, Use and Control of Plant Protection Products) Regulations, 1994 (

S.I. No. 139 of 1994

).

Date............................................................ ......

Signed............................................................ ...

Designated Chemist.

PART 2

Regulation 34 (2)

Certificate of Result of Analysis.

Laboratory Reference Number............................................................

Sample of............................................................ ............................................................ ........................

taken at the premises of..........................

on............................................................ ..........

temperature and place of storage............................................................ ..........................................

Date......................................................

Signed............................................................ .......

Authorized Officer

received by the State Chemist on............................................................ .........................................

from............................................................ ............................................................ ...............................

Methods of analysis used............................................................ ....................................................

............................................................ ............................................................ ......................................

This is to certify that the above mentioned sample, which was duly fastened and sealed, has been analyzed under the provisions of the European Communities (Authorization, Placing on the Market, Use and Control of Plant Protection Products) Regulations, 1994 (

S.I. No. 139 of 1994

) and the results of the analysis are as follows:—

............................................................ ............................................................ ......................................

This certificate is issued under the European Communities (Authorization, Placing on the Market, Use and Control of Plant Protection Products) Regulations, 1994 (

S.I. No. 139 of 1994

).

Date............................................................ .....

Signed...........................................................

State Chemist.

ISB SI

Preamble S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994. Open official source

S.I. No. 139 of 1994.

EUROPEAN COMMUNITIES (AUTHORIZATION, PLACING ON THE MARKET, USE AND CONTROL OF PLANT PROTECTION PRODUCTS) REGULATIONS, 1994.

I, JOE WALSH, Minister for Agriculture, Food and Forestry, in exercise of the powers conferred on me by

section 3

of the

European Communities Act, 1972

(No. 27 of 1972), and for the purpose of giving effect to Council Directive No 91/414/EEC of 15 July 1991

1

, the Corrigendum to Council Directive No. 91/414/EEC , Commission Regulation (EEC) No 3600 of 11 December 1992

3

,and Commission Directive No 93/71/EEC of 27 July 1993

4

, taking account of Council Directive No. 78/631/EEC of 26 June 1978

5

, Council Directive 81/187/EEC of 26 March 1981

6

, and Commission Directive 84/291/EEC of 18 April 1984

7

, and further taking account of Council Directive 67/548/EEC of 27 June 1967

8

, as amended by Council Directive 92/32/EEC of 30 April 1992

9

, hereby make the following Regulations

1 ..

1.

(1) These Regulations may be cited as the European Communities (Authorization, Placing on the Market, Use and Control of Plant Protection Products) Regulations, 1994.

(2) These Regulations shall come into operation on the first day of October 1994.

2

Interpretation.

2.

(1) In these Regulations—

"Annex I" means Annex I to the Directive of 1991, as amended;

"Annex II" (which is set out in Part 1 of the First Schedule) means Annex II to the Directive of 1991, as amended by Commission Directive No 93/71/EEC of 27 July 1993;

1

O.J. No L230/1 19/8/1991

2

O.J. No L170/40 25/6/1992

3

O.J. No L366/10 15/12/1992

4

O.J. No L221/27 31/8/93

5

O.J. No L206/13 29/7/1978

6

O.J. No L 88/29 2/4/1981

7

O.J. No L144/1 30/5/1984

8

O.J. No L196/1 16/8/1967

9

O.J. No L154/1 5/6/1992

"Annex III" (which is set out in Part 2 of the First Schedule) means Annex III to the Directive of 1991, as amended by Commission Directive No 93/71/EEC of 27 July 1993;

"Annex IV" (which is set out in Part 3 of the First Schedule) means Annex IV to the Directive of 1991;

"Annex V" (which is set out in Part 4 of the First Schedule) means Annex V to the Directive of 1991;

"Annex VI" (which is set out in Part 5 of the First Schedule) means Annex VI to the Directive of 1991;

"Annex VII" (which is set out in Part 6 of the First Schedule) means Annex IX to the Directive of 1967 as amended by the Directive of 1992, and adapted by Commission Directive No 91/410/EEC

10

;

"Annex VIII" (which is set out in Part 7 of the First Schedule) means Annex II to the Directive of 1967 as amended by the Directive of 1992, and adapted by Commission Directive No. 93/21/EEC

11

;

"Annex IX" (which is set out in Part 8 of the First Schedule) means Annex III to the Directive of 1967 as amended by the Directive of 1992, and adapted by Commission Directive No. 93/21/EEC;

"Annex X" (which is set out in Part 9 of the First Schedule) means Annex V to the Directive of 1978;

"Annex XI" (which is set out in Part 10 of the First Schedule) means Annex IV to the Directive of 1967 as amended by the Directive of 1992, and adapted by Commission Directive No. 93/21/EEC;

"Annex XII" means Annex XII set out in Part 11 of the First Schedule, which comprises additional safety advice in accordance with Article 16 (5) of the Directive of the Directive of 1991;

"aircraft" includes hovercraft;.

"authorised officer" means an officer of the Minister appointed in writing by the Minister to be an authorised officer for the purpose of these Regulations;

10

O.J. No. L228/68, 17/8/1991.

11

O.J. No. L110/20, 4/5/1993.

"the Commission" means the Commission of the European Communities;

"the competent authority" for the purposes of these Regulations and Commission Regulation No. 3600 of 11 December 1992 is the Pesticide Control Service of the Department of Agriculture, Food and Forestry;

"controlled product" means a product specified by the Minister as such through Orders made pursuant to Regulation 28;

"designated chemist" means an officer of the Minister holding the position of a chemist authorized in writing by the Minister for the purposes of these Regulations;

"the Directive of 1991" means Council Directive No. 91/414/EEC of 15 July 1991

1

;

"the Directive of 1967" means Council Directive 67/548/EEC of 27 June, 1967

8

;

"the Directive of 1978" means Council Directive No. 78/631/EEC of 26 June, 1978

5

, as amended and adapted;

"the Directive of 1992" means Council Directive No. 92/32/EEC of 30 April, 1992

9

, as amended and adapted;

"good agricultural practice" in the use of a plant protection product, means safe use of the plant protection product under actual conditions necessary for its effective action, in accordance with an authorization granted pursuant to these Regulations, encompassing a range of levels of application up to the highest level of use for which an authorization has been granted, applied in a manner which leaves a residue which is the smallest practicable; safe use, in relation to good agricultural practice, means taking into account public and occupational health and environmental considerations; actual conditions of use include any stage in the production, storage, transport and distribution of plants and plant products;

"good plant protection practice" in the use of plant protection products, means their responsible use in accordance with principles defining such use, as set out in the Second Schedule hereto, taking account of the range of authorized products available, the spectrum of harmful organisms occurring, the production, storage, transport and distribution conditions for plants and plant products and alternative means of plant protection available;

1

O.J. No. L230/1 19/8/1991

8

O.J. No. L196/1 16/8/1967

5

O.J. No. L206/13 29/7/1978

9

O.J. No. L154/1 5/6/1992

"Member State" means a Member State of European Communities;

"the Minister" means the Minister for Agriculture, Food and Forestry;

"officially recognized testing facilities and organizations" for the purposes of these Regulations, means testing facilities and organizations which carry out experiments, studies, tests and analyses in accordance with these Regulations;

"officially recognized tests and analyses" for the purposes of these Regulations, means experiments, studies, tests and analyses carried out in accordance with methodologies and to a standard specified from time to time by the competent authority and issued as guideline documentation;

"the Regulations of 1994" means the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1994 (

S.I. No. 138 of 1994

);

"the State Chemist" means the Head of the State Laboratory or a member of the staff of the State Laboratory holding the position of a chemist authorized by the State Chemist in writing to perform functions assigned to the State Chemist under Regulation 34;

"trials permit" means a permit granted under Regulation 26.

(2) In these Regulations, unless otherwise indicated—

(

a

) a reference to a Regulation is a reference to a Regulation of these Regulations,

(

b

) a reference to a paragraph or subparagraph is a reference to a paragraph or subparagraph of the provision in which the reference occurs,

(

c

) a reference to a Schedule is a reference to a Schedule to these Regulations.

(3) A word or expression that is used in the Directive of 1991 or in any other Council or Commission Directive of the European Communities mentioned in these Regulations has, unless the contrary intention appears, the meaning in these Regulations that it has in the Directive concerned.

3

Application

3.

These Regulations apply to any plant protection product which is a plant protection product for the purposes of the Directive of 1991.

4 ..

4.

(1) Subject to paragraphs (2) and (3), the placing on the market and use of a plant protection product in the form in which it is supplied to the user and intended for use as such is hereby prohibited unless the requirements of these Regulations regarding its authorization are complied with.

(2) The placing on the market of a plant protection product in the form in which it is supplied to the user and intended for use as such is hereby prohibited if—

(

a

) the net quantity in any container of such a plant protection product is less than the quantity stated there on in the manner specified in Article 16(1) (

d

) of the Directive of 1991, or

(

b

) the fastenings or containers used to package the plant protection product have been tampered with.

(3) The placing on the market of a plant protection product in the form in which it is supplied to the user and intended for use as such is hereby prohibited unless the annual fees as provided for in Regulation 36 (4) have been paid by the dates specified in accordance with the provisions of that Regulation.

(4) These Regulations shall not apply to—

(

a

) the production, storage or movement of a plant protection product which has not been authorized, where it is intended for use in another Member State and where—

(i) the product is authorized in the other Member State, and

(ii) the provisions of Regulation 30 are complied with.

(5) Regulations 6, 7, 8, 12, 13, 15, 16 and 18 shall not apply to plant protection products authorized for trials purposes in accordance with Regulations 25 and 26.

5

Exemptions from Certain Provisions of the European Communities (Classification, Packaging and Labelling of Pesticides) Regulations, 1994 (

S.I. No 138 of 1994

) and from certain provisions of these Regulations

5.

(1) Plant protection products which are pesticides referred to in paragraph (1) (

a

) of Regulation 3 of the Regulations of 1994, which are classified in accordance with Regulation 5 of those Regulations—

(

a

) are hereby exempted from the provisions of Regulation 6 paragraphs (2) (

a

) and (

b

) and Regulation 18 of those Regulations, and

(

b

) are hereby deemed to comply with the provisions of Regulation 6 paragraph (1) and Regulations 7 and 8 of the Regulations of 1994,

where they have been authorized in accordance with these Regulations.

(2) Plant protection products which are pesticides referred to in paragraph (1) (

a

) of Regulation 3 of the Regulations of 1994 and which are on the market before these Regulations come into effect, may continue to be placed on the market for use in accordance with the Regulations of 1994, until such time as they are authorized in accordance with these Regulations, or are refused such authorization.

(3) Notwithstanding the provisions of Regulations 8, 13 and 18, in the case of a plant protection product which is not on the market before these Regulations come into effect, where the plant protection product is similar to and considered by the competent authority to involve no greater risk for man, animals or for the environment than a plant protection product placed on the market in accordance with the provisions of the Regulations of 1994 and—

(

a

) the record of the studies conducted and the information, documentation and materials referred to in Regulation 6 (2) (

a

) of those Regulations, has not yet been approved, or

(

b

) at least one active substance contained in the plant protection product is contained in a plant protection product cleared in accordance with those Regulations,

permission may be granted by the competent authority on approval of an accurate record of a limited number of studies, information, supporting documentation and materials, as specified from time to time by the competent authority, to market and use such a plant protection product, where application is made in the form set out in the Second Schedule, unless in the case of the plant protection product already on the market, in accordance with Regulation 10, the periods specified in that Regulation have not yet expired for information referred to in Regulation 8 (3) (

a

) and (

b

).

6

Use of Plant Protection Products

6.

(1) The use of a plant protection product other than as specified in paragraph (2), is hereby prohibited.

(2) Plant protection products shall be used—

(

a

) in compliance with the conditions established in accordance with Regulations 13, 15, 18 and 19 and specified on the labelling, as appropriate,

(

b

) in compliance with the conditions established in accordance with Regulation 16, as appropriate,

(

c

) in the case of plant protection products on the market before these Regulations come into effect, 1 October 1994 and pending their authorization in accordance with these Regulations, in compliance with the conditions specified on the labelling, in accordance with the requirements of the Regulations of 1994,

(

d

) in accordance with the Principles of Good Plant Protection Practice as set out in the Third Schedule, and

(

e

) where possible, in accordance with the principles of integrated control.

7

Marketing of Active Substances

7.

(1) Subject to paragraph (2), the placing on the market of active substances is hereby prohibited unless—

(

a

) they are classified, packaged and labelled in accordance with the Directive of 1967, and

(

b

) where the active substance was not on the market 2 years after notification of the Directive of 1991, a dossier has been forwarded to the Member States and the Commission, in accordance with Article 6 of that Directive, with the declaration that the active substance is intended for a use specified in Article 2 (1) of that same Directive.

(2) This Regulation shall not apply to active substances contained in plant protection products intended for use for trials purposes in accordance with Regulations 25 and 26.

8

Application for Authorization

8.

(1) Every application for authorization of a plant protection product intended to be placed on the market, shall be made by or on behalf of the person responsible for first placing it on the market. Every applicant for an authorization shall have a business premises in a Member State. Applications shall be in the form set out in Part 1 of the Fourth Schedule.

(2) Applications, which shall be supported with the documentation specified in paragraph (3) and where relevant, paragraphs (5) (

b

) and (6), shall be in the English language and shall be in the form set out in Part 2 of the Fourth Schedule.

(3) Every application for authorization of a plant protection product, shall be submitted to the competent authority and shall be supported with—

(

a

) a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex III, and

(

b

) for each active substance in the plant protection product, a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex II,

(

c

) samples of the packaging and models, drafts or samples of labelling and leaflets referred to in Regulations 23 and 24,

(

d

) samples of the plant protection product and of each active substance included in it and analytical standards for each such active substance, for impurities and formulants of toxicological or environmental significance, and for transformation products of the active substance included in the residue definition, and

(

e

) the relevant fee in accordance with Regulation 36.

(4) The tests and analyses conducted for the purposes of compiling dossiers referred to in paragraph (3) (

a

), shall be carried out under agricultural, plant health and environmental conditions relevant to use of the plant protection product in question and representative of those prevailing where the product is intended to be used, and shall be officially recognized tests and analyses.

(5) Notwithstanding paragraph (2), and subject to Regulation 10—

(

a

) applicants shall be exempted from supplying the information required under paragraph 3 (

b

), except for that identifying the active substance, if the active substance is already listed in Annex I, taking into account the conditions of inclusion in Annex I, and does not differ significantly in degree of purity and nature of impurities, from the composition registered in the Annex II dossier accompanying the original application, and

(

b

) in the case of a plant protection product already authorized in another Member State, at the request of an applicant, who must substantiate the claim to comparability with documentary evidence, applicants shall be exempted from repeating tests and analyses already carried out in connection with the authorization of the product, to the extent that agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product are comparable in the regions concerned.

(6) Notwithstanding paragraph (2), and subject to Regulation 10, every application for authorization of a plant protection product in accordance with Regulation 13, (2), taking account of the agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product in the regions concerned, shall be supported with a claim as to the comparability of the regions concerned and shall be supported with documentary evidence to support any such claim.

9

Limiting of Testing involving Vertebrate Species

9.

(1) Notwithstanding the provisions of Regulations 8 and 10, applicants for authorization of plant protection products shall, before carrying out experiments involving vertebrate animals, enquire of the competent authority—

(

a

) whether the plant protection product for which an application is to be made is the same as a plant protection product for which authorization has been granted, and

(

b

) as to the name and address of the holder of the authorization.

(2) Where the competent authority is satisfied on the basis of documentary evidence provided that the prospective applicant intends to apply for authorization on his own behalf and that the other information specified in Regulation 8 (3) is available to him or for use on his behalf, it shall provide the name and address of any holder of a previous relevant authorization and shall at the same time inform that holder of the name and address of the applicant.

(3) The holder of a previous authorization and the applicant shall take all reasonable steps to reach agreement on the sharing of information so as to avoid the duplication of testing on vertebrate animals.

(4) Where data is to be submitted with a view to inclusion in Annex I of an active substance already on the market 2 years after notification of the Directive of 1991, the competent authority shall encourage applicants to cooperate in the provision of the requested data, with a view to limiting the duplication of testing on vertebrate animals.

(5) Where application is made for the inclusion in Annex I of an active substance already on the market 2 years after notification of the Directive of 1991, applicants shall take all reasonable steps to reach agreement on—

(

a

) the sharing of relevant data and information, and

(

b

) the submission collectively of all the data and information concerned.

10

Data Protection

10.

(1) Information contained in the dossier referred to in Regulation 8 (3) (

b

) shall not be used to the benefit of other applicants unless—

(

a

) the applicant has agreed with the first applicant that use may be made of such information and the first applicant has submitted written confirmation of such agreement, or

(

b

) 10 years have elapsed from the first inclusion in Annex I of an active substance first placed on the market in the European Communities as a constituent of a plant protection product 2 years after the notification of the Directive of 1991, or

(

c

) 10 years have elapsed from the date of first marketing within the territory of the state of an active substance as a constituent of a plant protection product which was on the market 2 years after the notification of the Directive of 1991, and

5 years have elapsed from the date of decision in the case of further information which is generated specifically for and is necessary—

(i) for first inclusion of an active substance in Annex I, or

(ii) to vary the conditions for, or to maintain, the inclusion of an active substance in Annex I.

(2) Notwithstanding the period of 5 years provided for in paragraph (1), where that period expires before the periods provided for in paragraphs (1) (

b

) and (1) (

c

) the period of 5 years shall be extended so as to expire on the same date as those periods.

(3) Information contained in the dossier referred to in Regulation 8 (3) (

a

) shall not be used to the benefit of other applicants unless—

(

a

) the applicant has agreed with the first applicant that use may be made of such information and the first applicant has submitted written confirmation of such agreement, or

(

b

) 10 years have elapsed from the first authorization or marketing of the plant protection product in any Member State, where authorization follows the inclusion in Annex I of any active substance contained in the product, or

(

c

) 10 years have elapsed from the date of first marketing within the territory of the state of a plant protection product where such marketing precedes inclusion in Annex I of any active substance contained in the product.

(4) The provisions of subparagraphs (1) (

c

), (2) and (3) (

c

) also apply to data and information submitted in accordance with the provisions of the Regulations of 1994.

(5) The competent authority shall inform the Commission of each instance in which an application for authorization of a plant protection product is being considered where they consider an active substance to be listed in Annex I, that has been produced by a person or manufacturing process other than those specified in the dossier on the basis of which the active substance was first included in Annex I.

(6) In each instance referred to in paragraph (5), the competent authority shall transmit to the Commission all data regarding the identity and impurities of the active substance concerned.

11

Confidentiality

11.

(1) An applicant for authorization of a plant protection product, who claims that certain information submitted in accordance with Regulation 8, includes information involving industrial and commercial secrets, may make application for such information to be treated as confidential. Any such application shall identify the information concerned and shall for each such item of information include a statement justifying it being treated as confidential.

(2) Subject to paragraphs (3) and (4) and without prejudice to Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment

12

, the competent authority shall ensure that information referred to in paragraph (1) is treated as confidential where it is accepted by the competent authority that such treatment is warranted.

(3) Confidentiality shall not apply to—

(

a

) the names and content of the active substance or substances and the name of the plant protection product,

(

b

) the name of other substances which are regarded as dangerous under Directives 67/548/EEC and 78/631/EEC,

(

c

) physico-chemical data concerning the active substance and plant protection product,

(

d

) any ways of rendering the active substance or plant protection product harmless,

12

O.J. No. L158/56 23/6/1990

(

e

) a summary of the results of the tests to establish the substance's or product's efficacy and harmlessness to humans, animals, plants and the environment,

(

f

) recommended methods and precautions to reduce handling, storage, transport, fire or other hazards,

(

g

) methods of analysis referred to in Article 4(1)(

c

) and (

d

) and 5(1) of the Directive of 1991,

(

h

) methods of disposal of the product and of its packaging,

(

i

) decontamination procedures to be followed in the case of accidental spillage or leakage, or

(

j

) first aid and medical treatment to be given in the case of injury to persons.

(4) Where applicants subsequently disclose previously confidential information, they shall inform the competent authority accordingly.

12

Consideration of Applications for Authorization of Plant Protection Products and for Inclusion of Active Substances in Annex I

12.

(1) The competent authority shall consider each application received for the authorization of a plant protection product and provided that it has the necessary scientific and technical resources at its disposal, shall inform the applicant within a reasonable period, of its decision as to whether the application has been granted or refused.

(2) In the case of applications involving one or more active substances not on the market in the European Communities as a constituent of a plant protection product 2 years after notification of the Directive of 1991, and not subsequently included in Annex I, the competent authority shall, without undue delay, assess the information provided to determine if the requirements specified in Regulation 8 (3) have been satisfied. For each such application believed to satisfy the requirements of Annex II, the competent authority shall require the applicant to forward the dossier to the competent authorities of the other Member States and to the Commission together with a dossier complying with Annex III on at least one preparation containing that active substance.

(3) Where in accordance with paragraph (2), applicants are required to forward a dossier believed to satisfy the requirements of Annex II and a dossier complying with Annex III on at least one preparation containing the active substance, the competent authority shall, in accordance with Article 6.3, request the Commission to establish whether the dossiers satisfy the requirements of Annex II and Annex III, in accordance with the procedure provided for in that Article.

13

Granting of Authorizations

13.

(1) The competent authority shall not authorize the placing on the market and use of any plant protection product unless—

(

a

) its active substances are listed in Annex I and any conditions laid down therein are fulfilled,

(

b

) following application of the uniform principles as contained in Annex VI, the requirements of Article 4 (1) (

b

), (

c

), (

d

) and (

e

) of the Directive of 1991 are satisfied,

(

c

) maximum residue levels in the agricultural products referred to in the authorization have been provisionally established, and notified to the Commission in accordance with Regulation 22, such maximum residue levels, when adopted pursuant to paragraph (1) of Regulation 28, to remain in force until replaced in accordance with the procedures specified in Article 4 (1) (

f

) of the Directive of 1991, and

(

d

) its packaging and labelling satisfy the provisions of Regulations 23 and 24.

(2) Subject to paragraphs (3) and (4), in the case of a plant protection product already authorised in accordance with the provisions of the Directive of 1991 in another Member State, and where the product contains only active substances included in Annex I, at the request of the applicant, the competent authority, to the extent that Annex VI has been adopted in accordance with Article 23 of the Directive of 1991, shall authorize the placing on the market and use of the product, where it has been established that the agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product are comparable in the regions concerned.

(3) Restrictions on use, necessary in order to avoid exposure of consumers of treated products to risks of dietary contamination in excess of the acceptable daily intake of the residues concerned, and to take account of differences in dietary patterns, shall where appropriate be attached to authorizations granted in accordance with paragraph (2).

(4) With the agreement of the applicant, authorizations granted in accordance with paragraph (2) shall be subject to changes in the conditions of use in order to render, in the regions concerned, any non-comparable agricultural, plant health or environmental (including climatic) conditions irrelevant for the purpose of comparability.

(5) In granting authorizations in accordance with paragraph (1) or Regulation 15 (2), the competent authority shall attach those conditions and restrictions to each authorization, as are necessary and relevant—

(

a

) to ensure compliance with Article 4 (1) (

b

) of the Directive of 1991, and

(

b

) to ensure the maximum residue levels provisionally established in accordance with paragraph (1) (

c

) and Regulation 28 are not exceeded.

(6) Subject to the provisions of Regulation 36, authorizations granted in accordance with this Regulation shall be for fixed periods of 10 years.

14

Refusal to Recognize Comparability

14.

(1) Where the competent authority does not accept that claims as to comparability, with respect to the agricultural, plant health and environmental (including climatic) conditions relevant to use of the product in the regions concerned, made in accordance with Regulation 8 (5) (

b

), are justified, and has required the repetition of one or more tests and analyses, it shall notify the Commission of the grounds on which the repetition of testing or analysis was required.

(2) Where the competent authority does not accept that claims as to comparability, with respect to the agricultural, plant health and environmental (including climatic) conditions relevant to use of the product in the regions concerned, made in accordance with Regulation 13 (2), are justified, and has refused to authorize a plant protection product in accordance with that provision, it shall notify the Commission of the grounds on which the authorization was refused.

(3) Where a decision different from that of the competent authority is made pursuant to Article 10.3 of the Directive of 1991, the competent authority shall without delay accept the tests and analyses or authorize the placing of the plant protection product on the market, subject in the latter case to any terms which the above decision may set.

15

Authorization for Provisional Periods

15.

(1) Notwithstanding the provisions of Regulation 13 (1) (

a

), application may be made in accordance with Regulation 8 for the authorization for a provisional period of the placing on the market and use of a plant protection product containing an active substance not listed in Annex I and not yet available on the market 2 years after the notification of the Directive of 1991.

(2) The competent authority may grant such an authorization for a period not exceeding three years, provided that—

(

a

) following application of Article 6(2) and (3) of the Directive of 1991, it is found that the dossier on the active substance satisfies the requirements of Annexes II and III in relation to the projected uses,

(

b

) the active substance can satisfy the requirements of Article 5 (1) of the Directive of 1991 and that the plant protection product may be expected to satisfy the requirements of Regulation 13 (1) (

b

) and (

c

), and

(

c

) its packaging and labelling satisfy the provisions of Regulations 23 and 24.

(3) The competent authority shall immediately inform the other Member States and the Commission of its assessment of each application considered and of the terms of each authorization granted for a provisional period, giving at least the information provided for in Regulation 22(1).

(4) Notwithstanding the provisions of paragraph (2), where on expiry of the three-year period, a decision has not been taken concerning the inclusion of an active substance in Annex I, a further period of provisional authorization may be granted of a duration consistent with the period ordered in accordance with the final paragraph of Article 8 (1) of the Directive of 1991.

(5) The granting of authorizations for provisional periods shall be subject to the provisions of Regulation 36.

16

Extension of the Field of Application of Authorized Plant Protection Products

16.

(1) Official or scientific bodies involved in agricultural activities or professional agricultural organizations and professional users may request that the field of application of a plant protection product already authorised be extended to purposes other than those covered by the authorization.

(2) Subject to the provisions of paragraph (4), the competent authority shall grant an extension of the field of application of an authorized plant protection product, when it is in the public interest to do so, where—

(

a

) an application for an extension of the field of application of an authorized plant protection product, is made and is in the form set out in Part 1 of the Fifth Schedule,

(

b

) documentation and information, as specified in Part 2 and Part 3 of the Fifth Schedule, to support an extension of the field of application has been submitted by the applicant,

(

c

) the competent authority has established that the conditions referred to in Article 4(1)(

b

)(iii), (iv) and (v) of the Directive of 1991, are satisfied, and

(

d

) the extension of the field of application relates to a use or uses which is or are minor in nature.

(3) The competent authority shall ensure that users are fully and specifically informed as to instructions for use, by means of an addition to the labelling or, failing that, by means of an official publication.

(4) The granting of an extension of the field of application of an authorized plant protection product shall be subject to the provisions of Regulation 36. Each such extension granted shall expire on the same date as the authorization to which it relates.

(5) The provisions of this Regulation shall also apply to plant protection products which are pesticides referred to in Regulation 3 (1) (

a

) of the Regulations of 1994, which have not yet been authorized in accordance with these Regulations and which are placed on the market in accordance with the Regulations of 1994.

17

Information on Potentially Harmful Effects

17.

(1) Those to whom an authorization has been granted and those to whom an extension of the field of application has been granted in accordance with Regulation 16, shall immediately notify the competent authority of all new information on the potentially dangerous effects of any plant protection product, or of residues of an active substance, on human or animal health or on ground water, or their potentially dangerous effects on the environment.

(2) The competent authority shall require the parties concerned to immediately notify the information provided in accordance with paragraph (1) to the other Member States and to the Commission.

18

Authorization of Plant Protection Products Containing Active Substances on the Market Prior to 25 July 1993, Pending a Decision concerning their inclusion in Annex I

18.

(1) Subject to the provisions of paragraph (4) and Regulation 19 (7), during the period to 24 July 2003, applications may be made to the competent authority for authorization of plant protection products in accordance with Regulation 8 for products containing active substances not listed in Annex I that are already on the market 2 years after the notification of the Directive of 1991.

(2) Pending the review of such active substances in accordance with Article 8 (2) of the Directive of 1991, such applications shall be examined by the competent authority, which shall decide thereon within a reasonable period, provided that it has the necessary scientific and technical resources at its disposal.

(3) In deciding on applications made in accordance with paragraph (1), the competent authority shall not authorize the placing on the market and use of any plant protection product unless—

(

a

) following application of the uniform principles as contained in Annex VI, the requirements of Article 4 (1) (

b

), (

c

), (

d

) and (

e

) of the Directive of 1991 are satisfied,

(

b

) maximum residue levels in the agricultural products referred to in the authorization have been provisionally established, and notified to the Commission in accordance with Regulation 22, such maximum residue levels, when adopted pursuant to 28 (1), to remain in force until replaced in accordance with the procedures specified in Article 4 (1)

(f)

of the Directive of 1991, and

(

c

) its packaging and labelling satisfy the provisions of Regulations 23 and 24.

(4) Subject to the provisions of Regulation 36, an authorization granted in accordance with this Regulation shall be for a fixed period of 10 years.

19

Renewal, Review, Amendment and Cancellation of Authorizations and Extensions of the field of Application of Authorized Plant Protection Products

19.

(1) Subject to the provisions of paragraph (12), where an application is made for the renewal of an authorization in the form set out in Part 1 of the Sixth Schedule, and is supported with the documentation specified in Regulation 8 (3) and where relevant, the documentation specified in Regulation 8 (5) (

b

), the authorization shall be renewed where the competent authority has verified that the requirements of Regulation 13 (1) are still satisfied. Renewal shall be granted for the period necessary for such verification, where an application for such renewal has been made.

(2) Subject to the provisions of paragraph (12), where an application is made for the renewal of an extension of the field of application of an authorization in the form set out in Part 2 of the Sixth Schedule, and is supported with the documentation specified in Regulation 16 (2) (

b

), an extension shall be renewed where the competent authority has verified that the requirements of Regulation 16 (2) are still satisfied. Renewal shall be granted for the period necessary for such verification, where an application for such renewal has been made.

(3) An authorization may be reviewed at any time specified by the competent authority, if there are indications that any of the requirements provided for in Regulation 13(1) are no longer being satisfied. In such a case the competent authority shall require the holder of the authorization concerned, or party to whom an extension of the field of application was granted in accordance with Regulation 16, to submit further information necessary for the review at a time to be specified by the competent authority. The authorization shall, where necessary, be extended for the periods necessary to provide such further information and to complete the review.

(4) Where an application is made by the holder of an authorization for its modification in the form set out in Part 3 of the Sixth Schedule and is supported with a statement as to the reasons therefor and with the documentation specified in Regulation 8 (3), subject to the provisions of paragraph (12), an amendment to the authorization shall be granted where the competent authority has verified that the requirements of Regulation 13(1), Regulation 15 (2) and Regulation 18 (2), as appropriate, are still satisfied.

(5) Where an application is made by the holder of an authorization for its cancellation in the form set out in Part 4 of the Sixth Schedule and is supported with a statement as to the reasons therefor, the competent authority shall cancel the authorization.

(6) Without prejudice to decisions taken pursuant to Regulation 13 (2), authorizations shall be

(

a

) cancelled if it is established that—

(i) the requirements for obtaining the authorization are not, or are no longer, satisfied, or

(ii) false or misleading particulars were supplied concerning the facts on the basis of which the authorization was granted; or

(

b

) modified if it is established that on the basis of developments in scientific and technical knowledge the manner of use and amounts used can be modified.

(7) Following the evaluation of a dossier as provided for in Article 6 (3) of the Directive of 1991 the competent authority, within 6 months of the completion of the evaluation concerned, shall—

(

a

) where it has been decided that the active substance does not satisfy the requirements specified in Article 5(1) of the Directive of 1991, cancel any authorization granted in accordance with Regulations 13 or 15 (2) for plant protection products containing the active substance, and

(

b

) where it has been decided to include the active substance in Annex I of the Directive of 1991, modify any authorization granted in accordance with Regulations 13 and 15 (2) and modify any extension of the field of application of any authorization granted in accordance with Regulation 16, for each plant protection product containing the active substance, such that the conditions and restrictions associated with inclusion of the active substance in Annex I are complied with.

(8) Following the review of an active substance in accordance with Article 8 (2) of the Directive of 1991, the competent authority shall—

(

a

) within 6 months of the completion of each such review, where a decision is taken not to include an active substance in Annex I,

(i) in the case of a pesticide referred to in Regulation 3 (1) (

a

) of the Regulations of 1994, which is a plant protection product and which contains the active substance, cancel each notification, clearance and permission to market granted in accordance with the Regulations of 1994, for the each product concerned, and

(ii) cancel each authorization granted in accordance with Regulation 18 and each permission granted in accordance with Regulation 5 (3), for each plant protection product containing the substance;

(

b

) within 6 months of the completion of each such review, where a decision is taken to include an active substance in Annex I,

(i) in the case of a pesticide referred to in Regulation 3 (1) (

a

) of the Regulations of 1994, which is a plant protection product and which contains the active substance,

— cancel each relevant notification, clearance and permission to market granted in accordance with those Regulations, for each product concerned, where in accordance with Regulation 10, information referred to in Regulation 8 (3), may not be used to support its authorization, unless the information concerned is provided in accordance with subparagraph (

c

),

— modify each notification, clearance and permission to market granted in accordance with those Regulations, for each product concerned, such that the conditions and restrictions associated with inclusion of the active substance in Annex I are complied with,

(ii) in the case of an authorization granted in accordance with Regulation 18 and a permission granted in accordance with Regulation 5 (3), for a plant protection product containing the active substance,

— cancel the authorization or permission to market, as appropriate, where in accordance with Regulation 10, information referred to in Regulation 8 (3), may not be used to support the authorization or permission, unless the information concerned is provided in accordance with subparagraph (

c

),

— modify the authorization or permission to market for each product concerned, such that the conditions and restrictions associated with inclusion of the active substance in Annex I are complied with; and

(

c

) where a decision is taken to include an active substance in Annex I,

(i) require persons marketing a pesticide referred to in Regulation 3 (1) of the Regulations of 1994, which is a plant protection product and which contains the active substance, to make application for its authorization in accordance with these Regulations, at a time specified by the competent authority,

(ii) in the case of a permission granted in accordance with Regulation 5 (3), for a plant protection product containing the active substance, require persons marketing the product concerned to make application for its authorization in accordance with these Regulations, at a time specified by the competent authority,

(iii) in cases referred to in subparagraphs (

i

) and (ii), subject to the provisions of paragraph (12), examine, and authorize or not each plant protection product concerned in accordance with these Regulations, within a period of 2 years following the receipt of a complete application,

(iv) in cases referred to in subparagraphs (

i

) and (ii), where complete applications are not received by the dates specified, refuse authorization for each plant protection product concerned, unless

— it is established that the necessary supporting documentation is being generated, or

— access to such documentation is being negotiated.

(9) Where the competent authority has valid reasons to consider that a plant protection product which it has authorized or is bound to authorize in accordance with Regulation 13(1) or (2) or Regulation 15 (2), constitutes a risk to human or animal health or the environment, it shall provisionally restrict or prohibit the use and/or sale of that product. In such instances, the competent authority shall immediately inform the Commission and the other Member States of such action and provide reasons for its decision.

(10) Where an authorization is cancelled in accordance with this Regulation, the competent authority shall immediately inform the holder of the authorization of the cancellation. Without prejudice to decisions taken and periods provided for in any decision under Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances

13

, as last amended by Directive 90/533/EEC

14

, or the consequences of decisions taken pursuant to Article 6(1) or Article 8(1) or (2) of the Directive of 1991, notwithstanding the provisions of this Regulation, or the provisions of Regulations 4, 6 and 31, the competent authority may grant a period of grace for the disposal, storage, placing on the market and use of existing stocks, of a length in accordance with the reason for the withdrawal.

(11) In the case of a plant protection product for which some or all uses are cancelled or modified pursuant to the provisions of paragraph (8), notwithstanding the provisions of this Regulation, or of Regulations 4, 6 and 31, an authorised officer acting on behalf of the Minister, may, by a notice in writing given to the owner or person in apparent charge or control, permit the controlled placing on the market or use of existing stocks of the plant protection product, subject to such conditions as he may specify in order to minimize any unacceptable risk to man, animals or the environment that might arise from such use.

(12) The consideration of applications for the renewal of an authorization in accordance with paragraph (1), for the renewal of an extension of the field of application of an authorization in accordance with paragraph (2), for the modification of an authorization in accordance with paragraph (4) and for authorization in accordance with paragraph (8) (

c

), shall be subject to the provisions of Regulation 36.

13

O.J. No. L33/36 8/2/1979

14

O.J. No. L296/63 27/10/1990

(13) Authorizations granted in accordance with these Regulations shall be cancelled where there has been a failure to comply with the provisions of Regulation 36 (4).

20

Emergency Authorizations

20.

(1) Notwithstanding the provisions of Regulations 13, 15 and 18, the competent authority may authorize for a period not exceeding 120 days the placing on the market of plant protection products not complying with the provisions of Regulations 13, 15 or 18 for limited and controlled use if such a measure appears necessary because of an unforeseeable danger which cannot be contained by other means.

(2) Where authorizations are granted in accordance with paragraph (1), the competent authority shall immediately inform the other Member States and the Commission of its action.

21

Files on Applications

21.

(1) The competent authority shall ensure that a file is compiled on each application for authorization of a plant protection product in accordance with Regulations 13, 15 and 18, and on each application for extension in the field of application of an authorized plant protection product in accordance with Regulation 16.

(2) Each file shall contain at least—

(

a

) a copy of the application,

(

b

) a record of the administrative decisions taken by the competent authority concerning the application,

(

c

) a record of the administrative decisions taken by the competent authority concerning the particulars and documentation provided for in accordance with Regulation 8 (3), and

(

d

) a summary of the particulars and documentation provided for in accordance with Regulation 8 (3), (5) (

b

) and (6).

(3) The competent authority shall on request make available to the competent authorities of other Member States and to the Commission the files provided for in paragraph (1), and shall supply to them on request all information necessary for full comprehension of applications, and shall, where requested, ensure that applicants provide a copy of the technical documentation specified in Regulation 8 (3) (

a

).

22

Information Exchange

22.

(1) Within a period of one month at the end of each quarter, the competent authority shall inform the competent authorities of the other Member States and the Commission in writing of any plant protection product authorized or for which an authorization has been cancelled, in accordance with the provisions of these Regulations, indicating at least—

(

a

) the name or business name of the holder of the authorization,

(

b

) the trade name of the plant protection product,

(

c

) the type of preparation,

(

d

) the name and amount of each active substance which it contains,

(

e

) the use or uses for which it is or was intended,

(

f

) the maximum residue levels provisionally established where they have not already been set by Community rules,

(

g

) where relevant, the reasons for cancellation of an authorization, and

(

h

) the dossier needed for the evaluation of the maximum residue levels provisionally established.

(2) The competent authority shall draw up an annual list of the plant protection products authorized in its territory and shall communicate that list to the competent authorities of the other Member States and to the Commission.

23

Packaging

23.

(1) The packaging of plant protection products authorized in accordance with these Regulations, together with the fastenings and containers used in such packaging and the materials constituting such packaging or fastenings shall comply with the requirements of Article 5(1) of the Directive of 1978, whether or not they are pesticide preparations which are dangerous for the purposes of the Directive of 1978.

(2) Where the packaging of a plant protection product to which these Regulations apply includes an inner liner, except where the liner is used as a seal to protect rodenticide baits, or is a water soluble sachet contained in a sealed foil sachet, it shall not be detachable from the rest of the packaging unless it itself complies with the requirements of paragraph (1).

(3) In addition to complying with paragraph (1)—

(

a

) packages containing a plant protection product to which these Regulations apply shall be closed with a distinctive seal in such a way that when the package is opened for the first time the seal is irreparably damaged, and

(

b

) containers having a capacity not exceeding three litres shall have childproof fastenings designed in accordance with Annex VII where the plant protection product—

(i) is intended for domestic or garden use, and

(ii) is a pesticide preparation which is a dangerous pesticide for the purposes of the Directive of 1978.

24

Labelling

24.

(1) The packaging of plant protection products authorized in accordance with these Regulations, or labels attached to packaging, shall comply with the requirements of paragraph (2) as to labelling.

(2) Subject to the provisions of paragraph (3), the following information shall be stated clearly and in an indelible form on all packaging which is packaging mentioned in Regulation 23 (1), or on a label on or attached to such packaging in the Irish language or in the English language or in both the Irish and English languages

(

a

) the trade name or designation of the plant protection product;

(

b

) the name and address of the holder of the authorization and the authorization number of the plant protection product and, if different, the name and address of the person responsible for the final packaging and labelling or for the final labelling of the plant protection product on the market;

(

c

) the name of each active substance as given in the list contained in Annex I to the Directive of 1967, if not included therein, its ISO common name. If the latter is not available, the active substance shall be designated by its chemical designation according to IUPAC rules;

(

d

) the amount of each active substance so contained expressed—

(i) for pesticides which are solids, aerosols, volatile liquids (maximum boiling point 50°C) or viscous liquids (lower limit 1 Pas at 20°C), as a percentage by weight,

(ii) for other liquids, as a percentage by weight and in grams per litre at 20°C,

(iii) for gases, as a percentage by volume, and

(iv) for acids, their amides, esters and salts, on an acid equivalent basis;

(

e

) the net quantity of plant protection product given in legal units of measurements;

(

f

) the formulation batch number or some means of identifying it;

(

g

) the particulars required under Article 6 of the Directive of 1978—

(i) the name as given in the list contained in Annex I to the Directive of 1967, of each very toxic, toxic, harmful or corrosive substance, excluding active substances, contained in the plant protection product, in concentrations of more than 0.2 percent in the case of very toxic and toxic substances, 5 percent in the case of harmful substances and 5 percent in the case of corrosive substances,

(ii) the symbols and indications as specified in Annex VIII,

(iii) phrases indicating the nature of the special risks referred to in Article 6 (2)(

h

) of the Directive of 1978, selected from among those contained in Annex IX and specified by the competent authority,

(iv) phrases providing safety advice concerning the use of the plant protection product, selected by the competent authority from those contained in Annexes X and XI, and

(v) for plant protection products classified in accordance with Regulation 5 of the Regulations of 1994, as being very toxic, toxic or harmful, a statement that the packaging must not be re-used for any purpose, except in the case of containers which are specifically designed for re-use, recharging or refilling by the manufacturer or distributor;

(

h

) first-aid information for use in the event of accidental exposure or ingestion;

(

i

) the nature of any special risks for humans, animals or the environment, by means of standard phrases selected as appropriate from those given in Annex IV;

(

j

) safety precautions for the protection of humans, animals or the environment, in the form of standard phrases selected as appropriate from those given in Annex V;

(

k

) in accordance with Article 16 (5) of the Directive of 1991, additional phrases deemed necessary for the protection of human beings, animals or the environment, where appropriate selected from those set out in Annex XII;

(

l

) the type of action of the plant protection product (e.g. insecticide, growth regulator, herbicide, etc);

(

m

) the type of preparation (e.g. wettable powder, emulsifiable concentrate, etc);

(

n

) the uses for which the plant protection product has been authorized and any specific agricultural, plant health and environmental conditions under which the product may be used or should not be used;

(

o

) directions for use and the dose rate, expressed in metric units, for each use provided for under the terms of the authorization;

(

p

) where necessary, the safety interval for each use between application and—

(i) sowing or planting of the crop to be protected,

(ii) sowing or planting of succeeding crops,

(iii) access by humans or animals,

(iv) harvesting,

(v) use or consumption;

(

q

) particulars of possible phytotoxicity, varietal susceptibility, and any other direct or indirect adverse side effects on plants or products of plant origin together with the intervals to be observed between application and sowing or planting of—

(i) the crop in question, or

(ii) subsequent crops;

(

r

) if accompanied by a leaflet, as provided for in paragraph 3, the sentence

Read accompanying instructions before use;

(

s

) directions for safe disposal of the plant protection product and of the packaging;

(

t

) the expiry date relevant to normal conditions of storage where the shelf life of the product is limited to less than two years;

(

u

) where relevant, the category or categories of users to which supply and use is restricted; and

(

v

) the authorization number, or permission to market number, as appropriate, of the plant protection product.

(3) Notwithstanding the provisions of paragraph (2), the information specified in subparagraphs (

o

), (

p

) and (

q

) of paragraph (2) may be included on a separate leaflet accompanying the package if the space available on the package is too small. Such a leaflet shall be regarded as part of the label for the purposes of these Regulations.

(4) Labels and packaging of plant protection products shall not bear indications such as

non-toxic, harmless,

or other similar indication. However, information to the effect that the plant protection product may be used when bees or other non-target species are active, or when crops or weeds are in flower or other such phrases to protect bees or other non-target species may be given on the label, if the authorization relates explicitly to use during the season for bees or other specified organisms and presents minimal hazard to them.

(5) The competent authority shall notify the competent authorities of the other Member States and the Commission of each additional phrase specified and the reasons for its specification.

25

Authorization for Trials Purposes

25.

(1) The placing on the market for use in experiments and tests, of a plant protection product to which these Regulations apply, and use of such a product in experiments and tests, other than in accordance with the provisions of Regulation 26, where—

(

a

) the testing or experimentation is for research or development purposes, and

(

b

) the tests or experiments concerned involve any release into the environment of an unauthorized plant protection product, or of an authorized plant protection product for an unauthorized use,

are hereby prohibited unless the requirements of this Regulation, in relation to authorization for trial purposes, are complied with, and the experiments and tests are carried out in compliance with the requirements specified in the Seventh Schedule, or in compliance with Irish/European Standard IS/EN 45001.

(2) The provisions of this Regulation, in relation to authorization of plant protection products for trials purposes, shall not apply to experiments or tests covered by Part B of Council Directive No. 90/220/EEC of 23 April 1990.

15.

(3) Every application for authorization of a plant protection product for trials purposes, shall be made by or on behalf of the person responsible for, or on whose behalf, the research and development is to be conducted, subject to the person concerned having an office in a Member State, and shall be in the form set out in Part 1 of the Eight Schedule.

(4) Applications for authorization of a plant protection product for trials purposes, which shall be supported with the documentation specified in paragraph (5), shall be in the English language.

(5) Every application for authorization of a plant protection product for trials purposes, shall be submitted to the competent authority at least 45 days before the date on which it is intended that the experiments or tests commence, and shall be supported with a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in the Ninth Schedule.

(6) The tests and analyses conducted for the purposes of compiling dossiers referred to in paragraph (5), shall be carried out under agricultural, plant health and environmental conditions relevant to use of the plant protection product in question and representative of those prevailing where the product is intended to be used, and to the extent that they are carried out in the territory of the state, shall be officially recognized tests and analyses.

(7) Notwithstanding paragraph (5), and subject to Regulation 10, applicants shall be exempted from supplying the information relevant to the active substance, except for that identifying the active substance, if—

15

O.J. No. L117/15 8/5/1990

(

a

) it is already listed in Annex I, taking into account the conditions of inclusion in Annex 1, and does not differ significantly in degree of purity and nature of impurities, from the composition registered in the relevant Annex II dossier supporting the inclusion of the active substance in Annex I,

(

b

) a plant protection product containing the active substance is authorized for a provisional period in accordance with Regulation 15,

(

c

) a plant protection product containing the active substance is authorized in accordance with Regulation 18, or

(

d

) a plant protection product containing the active substance has been cleared in accordance with the Regulations of 1994.

(8) The competent authority shall examine every application received for the authorization of a plant protection product for trials purposes, and shall decide there on within a reasonable period, provided that it has the necessary scientific and technical resources at its disposal.

(9) The competent authority shall not authorize the placing on the market and use of any plant protection product for trials purposes unless it is satisfied that when used in accordance with the conditions and restrictions specified pursuant to paragraphs (10) and (11), it has no harmful effect on human or animal health and no unacceptable influence on the environment.

(10) Restrictions on use, necessary in order to avoid harmful effects on human or animal health that may arise—

(

a

) through exposure of consumers of treated products to risks of dietary contamination—

(i) in excess of the Acceptable Daily Intake level (ADI) of the residues concerned, or

(ii) due to residues for which the health risks associated with exposure have yet to be established, and

(

b

) through direct exposure of workers and bystanders—

(i) in excess of the Acceptable Operator Exposure Level (AOEL) for the active substance or substances concerned, or

(ii) due to exposure to active substances for which the health risks associated with exposure have yet to be established,

shall, where appropriate, be attached to authorizations granted in accordance with paragraph (8).

(11) In granting authorizations for trials purposes in accordance with paragraph (8), the competent authority shall attach any further conditions and restrictions to each such authorization, as are necessary and relevant to avoid any harmful effect on human or animal health and any unacceptable influence on the environment, to include—

(

a

) particular packaging and labelling requirements,

(

b

) restrictions as to the quantity that may be placed on the market and used for trials purposes,

(

c

) restrictions as to the area or areas that may be treated, and

(

d

) conditions necessary to ensure that the use for trials purposes is controlled and subject to official supervision.

(12) Subject to the provisions of Regulation 36, authorizations for trials purposes—

(

a

) shall be for fixed periods of 12 months,

(

b

) shall be varied as to any conditions and restrictions attached, where application for such variation is made in the form set out in Part 2 of the Eight Schedule, and the competent authority is satisfied that the provisions of paragraph (9) will be complied with under the changed conditions or restrictions, and

(

c

) may be renewed for further fixed periods of 12 months, where application for such renewal is made in the form set out in Part 3 of the Eight Schedule.

(13) Experiments and tests conducted in accordance with the conditions and restrictions specified in an authorization for trials purposes, are hereby deemed to have been conducted by officially recognized testing facilities or organizations, for the purposes of these Regulations.

26

Trials Permits

26.

(1) Subject to paragraph (2), and notwithstanding the provisions of Regulation 25, a "trials permit" shall be granted by the competent authority to a person, organization or official body involved in research or development, for specified premises and sites, to conduct tests and experiments using plant protection products for which for authorization for trials purposes has not been granted, or using authorized plant protection products for a use not yet authorised, where—

(

a

) application is made by the person, organization or official body, in the form set out in Part 1 of the Tenth Schedule, and

(

b

) the competent authority is satisfied that the requirements specified in paragraph (3) are satisfied.

(2) A person, organization or official body, that holds a trials permit is hereby exempted from the provisions of Regulation 25, in relation to tests and experiments which comply with the requirements of paragraph (6), where they are conducted in accordance with the conditions and restrictions of the trials permit specified pursuant to paragraphs (4) and (5).

(3) A trials permit shall not be granted for particular premises or sites, unless the applicant—

(

a

) owns, or has exclusive control of premises or sites suitable for conducting trials and experiments,

(

b

) owns, or has available, equipment and other facilities, necessary for conducting trials and experiments, at each such premises or site, and

(

c

) holds, or an employee of his holds, appropriate professional qualifications.

(4) Each trials permit granted shall be subject to the condition that—

(

a

) tests and experiments conducted in accordance with the trials permit shall be carried out in compliance with the requirements specified in the Seventh Schedule,

(

b

) unless the tests and experiments are conducted by an organization or laboratory accredited in accordance with Irish/European Standards IS/EN 45002 and 45003 by the Irish Laboratory Accreditation Board to carry out such tests and experiments in accordance with Irish/European Standard IS/EN 45001.

(5) Each trials permit granted shall be subject to conditions and restrictions such that the use of plant protection products in tests and experiments conducted in accordance with the trials permit has no harmful effect on human or animal health and no unacceptable influence on the environment. The conditions and restrictions specified for each trials permit shall—

(

a

) restrict its validity to the premises, site or sites specified in the trials permit,

(

b

) restrict its validity to tests and experiments conducted under the direct supervision of the professionally qualified personnel specified in the trials permit, and

(

c

) be conditional on an authorization for trials purposes being obtained, in accordance with Regulation 25, in each instance in which trials or experiments other than those conforming to the requirements of paragraph (6) are to be conducted.

(6) A trials permits shall not be valid for tests and experiments involving plant protection products unless—

(

a

) the conditions and manner of use are encompassed by an existing authorization for a plant protection product containing the same active substance or substances,

(

b

) use is restricted to crops other than food or feed crops,

(

c

) the nature of the use or of the active substance is such that residues at harvest are precluded, or

(

d

) food, feed and forage crops are destroyed by burning or burying to preclude consumption by humans or animals.

(7) Subject to the provisions of Regulation 36, a trials permit granted—

(

a

) shall be for fixed periods of 12 months,

(

b

) may be varied as to any conditions and restrictions attached, where application for such variation is made in the form set out in Part 2 of the Tenth Schedule, and the competent authority is satisfied that the provisions of paragraph (3) will be complied with under the changed conditions or restrictions, and

(

c

) may be renewed for a further fixed periods of 12 months, where application for such renewal is made in the form set out in Part 3 of the Tenth Schedule.

(8) Experiments and tests conducted in accordance with the conditions and restrictions associated with a trials permit, are hereby deemed to have been conducted by officially recognized testing facilities or organizations, for the purposes of these Regulations.

27

Notification of Imports and Exports

27.

(1) Unless exempted in accordance with the provisions of paragraph (2), where a person proposes to import into the State a plant protection product to which these Regulations apply, three days notice of the intended importation shall be given in writing, in the form set out in Part 1 of the Eleventh Schedule, to the competent authority on behalf of the importer specifying—

(

a

) the brand name of the plant protection product,

(

b

) the port, airport or other place at which it is expected that the plant protection product shall be landed or otherwise brought into the State,

(

c

) the date on which the plant protection product is expected to be so transferred into the State,

(

d

) the number of packs which the relevant consignment comprises (if it comprises more than one),

(

e

) the pack size (given by reference to volume or weight) of the consignment or, in case the consignment comprises more than one pack size, the pack size (so given) of each such pack, and

(

f

) in the case of a plant protection product being imported into the State, the destination to which the pesticide is consigned or, in lieu thereof, an address at which the plant protection product may be examined, sampled, tested or inspected pursuant to Regulation 30 (1).

(2) Where satisfied that plant protection products imported and intended for use in the territory of the State, in the first instance following importation, will be transferred to nominated warehouse or storage facilities, the competent authority may grant an exemption from the requirements of paragraph (1) to particular importers, where

(

a

) the importer has provided the address of each premises at which plant protection products concerned will be stored following importation, prior to supply or sale,

(

b

) the importer notifies on an annual basis, details of all imports to the competent authority, in the form set out in Part 2 of the Eleventh Schedule, such notification to be provided by 31 January each year in relation to imports during the previous year.

(3) Where a plant protection product to which these Regulations apply, is exported out of the State, the exporter shall notify on an annual basis details of the export to the competent authority, in the form set out in Part 3 of the Eleventh Schedule, such notification to be provided by 31 January each year in relation to exports during the previous year.

28

Provisional Maximum Residue Levels

28.

(1) The Minister may from time to time specify the maximum levels of residues of plant protection products which may be contained in specified controlled products.

(2) The maximum levels of residues of plant protection products specified in accordance with paragraph (1) shall be those established by the competent authority pursuant to subparagraph (1) (

c

) of Regulation 13, subparagraph (2) (

b

) of Regulation 15 or subparagraph (2) (

b

) of Regulation 18 and shall remain in force until—

(

a

) replaced by maximum levels subsequently specified to give effect to provisional maximum levels established by the Community in accordance with Article 4 (1) (

f

) of the Directive of 1991, or

(

b

) replaced by maximum levels established pursuant to Directive 76/895/EEC

16

, Directive 86/362/EEC

17

, Directive 86/363/EEC

18

, Directive 90/642/EEC

19

, Directive or 91/132/EEC

20

, amending Directive 74/63/EEC

21

.

29 ..

29.

(1) A person shall not place on the market any controlled product if—

(

a

) the product contains within it or on it a residue of a plant protection product, and

(

b

) the level of such residue exceeds the maximum specified in relation to the controlled product in accordance with Regulation 28(1).

(2) A person who contravenes the provisions of paragraph (1) shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000 or imprisonment for a term not exceeding 6 months or to both.

30

Inspections, Sampling, Tests and Examinations

30.

(1) Subject to paragraph (5), an authorised officer may at any reasonable time enter—

(

a

) any place or premises in which he has reasonable grounds for believing that—

16

O.J. No. L340/26, 9/12/1976

17

O.J. No. L221/36, 7/8/1986

18

O.J. No. L221/43, 7/8/1986

19

O.J. No. L350/71, 14/12/1990

20

O.J. No. L66/16, 13/3/1991

21

O.J. No. L38/31, 11/2/1974

(i) a plant protection product is being manufactured, placed on the market, stored or used, or

(ii) a controlled product is being produced, placed on the market, processed, stored or used,

(

b

) any railway wagon, vehicle, ship, vessel, aircraft, container or other thing in which he has reasonable grounds for believing that a plant protection product or a controlled product is being either transported, stored or used, or

(

c

) any premises in which he has reasonable grounds for believing that there are any books, documents or records relating to any business whose activities consist of or include—

(i) the manufacture, placing on the market, storage, transport or use of a plant protection product, or

(ii) the production, putting into circulation, processing or storage of any controlled product,

and there or at any other place—

(iii) make such examinations, tests and inspections, and

(iv) take samples in accordance with the methods described in the manual on the development and use of FAO specifications for plant protection products (Food and Agriculture Organization of the United Nations, FAO Plant Production and Protection Paper 85, Fourth Revised Edition), of any plant protection product which he finds in the course of his inspection and which he believes is or may be a plant protection product to which these Regulations apply, and

(v) take samples in accordance with Commission Directive 79/700/EEC of 24 July 1979

22

, or the Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, recommended method of sampling for the determination of Pesticide Residues (Food and Agriculture Organisation of the United Nations CAC/PR5-1984), where relevant, and in accordance with other internationally accepted procedures in other cases, of any plant, plant product, soil, compost, or take samples from or of any other thing, which he finds in the course of an inspection and which he believes may have been treated or contaminated with a plant protection product to which the Regulations apply,

22

O.J. No. L207/26 15/8/1979

as he may consider appropriate and provided the quantity which a sample taken pursuant to this Regulation comprises is reasonable.

(2) A person who has in any place, on any premises or in any railway wagon, vehicle, ship, vessel, aircraft, container or other thing a plant protection product to which these Regulations apply, or a controlled product, shall at all reasonable times—

(

a

) afford to an authorised officer such facilities and assistance as are reasonably necessary for an inspection and for the taking of samples pursuant to this Regulation,

(

b

) give an authorised officer any information which he may reasonably require regarding the purchase, importation, storage, transportation, sale, supply or use of any such plant protection product or regarding the production, purchase, importation, processing, transport, storage, sale, supply or use of any controlled product, which is within the person's knowledge or procurement,

(

c

) produce to an authorised officer any document relating to the raw materials used in the formulation of any plant protection product or relating to the production of any controlled product which the authorised officer may reasonably require and when produced permit the officer to inspect and take extracts from the document.

(3) In addition to the foregoing any person who carries on the business of manufacturing, formulating, packaging, processing or marketing a plant protection product for the purposes of the Directive of 1991 shall—

(

a

) keep records of all transactions regarding the plant protection product,

(

b

) produce at the request of an authorised officer any records, books or other documents relating to such business which are in his possession or under his control,

(

c

) permit such an officer to inspect and take extracts from such records, books or other documents and give to the officer any information which is within his knowledge or under his control and which such officer may reasonably require in relation to any entries therein,

(

d

) afford to any such an officer such facilities and assistance as are reasonably necessary for inspecting the stock of any plant protection product on any premises on which such person carries on such a business,

(

e

) give to such an officer any information he may reasonably require in relation to such transactions, including, in particular, information which he may reasonably require regarding any plant protection product specified by him.

(4) Where a sample is taken pursuant to this Regulation, the authorised officer concerned shall—

(

a

) divide the sample into 3 parts, each of which he shall seal and mark,

(

b

) give one part thereof to a designated chemist for analysis in accordance with paragraph (5),

(

c

) leave with, or send by registered post to, the defendant or his agent, a second part thereof, and

(

d

) retain the remaining part thereof for possible analysis by the State Chemist in accordance with Regulation 34.

(5) Where a designated chemist receives a sample from an authorized officer in pursuance of these Regulations, he shall make analyses thereof in accordance with—

(

a

) the Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, Recommendations for Methods of Analysis of Pesticide Residues (Food and Agriculture Organisation of the United Nations CAC/PR 8-1989), as updated from time to time, or the method included as part of the documentation approved in accordance with Regulation 8, as appropriate, and the Codex Guidelines on Good Practice in Pesticide Residue Analysis (Food and Agriculture Organisation of the United Nations CAC/PR 7-1984), in the case of residues in controlled products, and

(

b

) the relevant CIPAC method (Collaborative International Pesticides Analytical Council Limited, Handbook Volume I, IA, IB, IC, and D), or the method included as part of the documentation approved in accordance with Regulation 8, as appropriate, in other cases.

(6) (

a

) In any proceedings for an offence under these Regulations, the result of any test, examination or analysis of, or any report on, a sample taken pursuant to this Regulation shall not be adduced unless, before the proceedings were instituted, one of the parts into which the sample was divided (as required by paragraph (4)) was left with, or sent by registered post to, the defendant or his agent.

(

b

) In any proceedings for an offence under these Regulations, evidence of the presence of a plant protection product to which the Regulations apply, in or on equipment capable of use for application of the pesticide, shall be evidence, until the contrary is proved, of the use of the plant protection product by the owner or person in possession of the equipment.

(

c

) In any proceedings for an offence under these Regulations, evidence of the presence of a residue of a plant protection product to which the Regulations apply, in or on agricultural produce, in soil or compost or in or on surfaces or other materials which may have been treated with or exposed to the plant protection product, shall be evidence, until the contrary is proved, of the use of the plant protection product by the owner, occupier or person in possession, as the case may be.

(

d

) In any proceedings for an offence under these Regulations, a certificate in the form set out in Part 1 of the Twelfth Schedule showing the results of an analysis shall, until the contrary is shown, be sufficient evidence of the facts certified to therein in relation to—

(i) the presence in a plant protection product of any active substance, impurity or formulating ingredient, and the level of any such presence, or

(ii) the presence of a residue of a plant protection product and the level of such residues in any controlled product, and

a document purporting to be such a certificate shall be deemed, until the contrary is shown, to be such a certificate.

(

e

) In any proceedings for an offence under these Regulations, each of the documents referred to in subparagraphs (1) (

c

) (iv) and (v), and in subparagraphs (5) (

a

) and (

b

) may be proved by a production of a copy thereof purporting to have been published in the Official Journal of European Communities, by the Food and Agriculture Organization of the United Nations, by the Collaborative International Pesticides Analytical Council Limited, or by the production of the document describing the method, certified by the officer-in-charge of the competent authority as being part of the documentation submitted in accordance with Regulation 8, as appropriate.

(

f

) For the purpose of these Regulations, the presence of a plant protection product, to which these Regulations apply, on any premises (including any stores) where the business of marketing such a plant protection product is carried on, shall, until the contrary is shown, be sufficient evidence that the plant protection product in question is or was being placed on the market by the owner and by the occupier of such premises.

(7) If any person—

(

a

) tampers with any plant protection product so as to procure that any sample of it taken pursuant to these Regulations does not correctly represent the plant protection product,

(

b

) tampers with any controlled product so as to procure that any sample of it taken pursuant to these Regulations does not correctly represent the product sampled, or

(

c

) tampers or interferes with any sample taken pursuant to these Regulations,

he shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000 or to imprisonment for a term not exceeding 6 months or to both.

(8) An authorised officer shall be furnished with a certificate of his appointment as an authorised officer and when exercising any power conferred on him by these Regulations shall, if requested by any person affected, produce the certificate to that person.

(9) A designated chemist shall be furnished with a warrant of his appointment by the Minister to carry out analyses as required by these Regulations.

31

Seizure, Retention, Removal and Disposal

31.

(1) An authorised officer may seize and retain, or seize, remove and retain any plant protection product which he believes is a plant protection product to which these Regulations apply or any controlled product to which these Regulations apply and in relation to which the authorised officer has reasonable grounds for suspecting that there is or has been a failure to comply with any provision of these Regulations.

(2) An authorised officer may by a notice in writing given to the owner or to the person in apparent charge or control of a plant protection product or controlled product which has been seized under this Regulation—

(

a

) require things specified in the notice to be done in relation to the plant protection product or controlled product before it is released by an authorised officer,

(

b

) in the case of a plant protection product, either—

(i) require the disposal of the plant protection product by the person to whom the notice is given, in a manner specified in the notice and at the expense of the owner, or

(ii) indicate the authorised officer's intention of disposing of the plant protection product at the expense of the owner,

such disposal to be, in either case, such as will prevent the said plant protection product from being placed on the market or used, and

(

c

) in the case of a controlled product require the disposal of the product by the owner, or person in apparent charge or control of the product, in a manner and within a time specified in the notice and at the expense of the owner, such disposal to be such as will prevent the product being used for human or animal consumption,

and in case a notice given under this paragraph requires specified things to be done in relation to a plant protection product or controlled product, the authorised officer shall retain control of the plant protection product or controlled product to which the notice relates until the requirements of the notice have been complied with.

(3) Where a notice is given under this Regulation, a person shall not, without the consent of the authorised officer by whom the notice was given sell, move, dispose of or otherwise interfere with the plant protection product or controlled product in any way pending compliance with the requirements of the notice.

(4) Any person who is aggrieved by a notice given under paragraph (2), in relation to a plant protection product, which either requires the plant protection product to which it relates to be disposed of or indicates an intention to dispose of such a plant protection product may, not later than the expiration of a period of seven days beginning on the date of the notice, appeal against the notice to the District Court in the District Court District in which the notice has been served.

(5) Disposal of a plant protection product pursuant to a notice given under paragraph (2) shall not take place until—

(

a

) the period during which an appeal under paragraph (4) may be taken against the notice has expired, or

(

b

) an appeal under that paragraph is determined or withdrawn.

(6) (

a

) Where an appeal is made to the District Court under paragraph (4), that court, if it is satisfied that—

(i) the plant protection product to which the relevant notice under this Regulation relates is one to which Regulation 3 applies, and

(ii) if the plant protection product was released, it might be placed on the market or used for purposes not authorised in accordance with these Regulations, and

(iii) there has been a failure to comply with the provisions of these Regulations—

shall order that the plant protection product be disposed of in the manner specified in the notice, or in such other manner as may be specified in the court's order and which, in the opinion of the court, will prevent the plant protection product from being used or placed on the market.

(

b

) Where an order made by the District Court under this paragraph requires the plant protection product to which it relates to be disposed of by an authorised officer, the cost of such disposal shall be recoverable by the Minister as a simple contract debt in any court of competent jurisdiction from the person who was either the owner or in apparent charge or control of the product at the time of its seizure under this Regulation.

(7) Notwithstanding paragraph (2) and the requirements of these Regulations in relation to plant protection products, the method of disposal specified in a notice given under paragraph (2) may include its use subject to such conditions as the authorized officer may specify in the notice, provided that the officer is not aware of any apparent risk to man or the environment by such use.

(8) In the case of a notice given under paragraph (2) which indicates an intention to dispose of a plant protection product, the ownership of such a plant protection product shall, in the absence of an appeal by the owner against the notice to the District Court, vest in the Minister on the expiration of a period of 7 days beginning on the date of the notice. In the event of an appeal by the owner against the notice to the District Court, ownership of the plant protection product shall vest in the Minister if the court makes an order under paragraph (5) which requires the plant protection product to be disposed of by an authorised officer.

(9) In the case of a notice under paragraph (2) which requires the disposal at the expense of the owner of a plant protection product which has been seized under this Regulation and where there has been a failure to pay, the cost of such disposal shall be recoverable by the Minister as a simple contract debt in any court of competent jurisdiction from the person who was either the owner or in apparent charge or control of the plant protection product at the time of its seizure under this Regulation.

(10) Where there has been failure to comply with a requirement of a notice given under paragraph (2) with respect to a controlled product, an authorised officer who in pursuance of this Regulation has seized any controlled product may, on giving notice in writing to the owner, or the person in apparent charge or control of such product of his intention to do so, apply to the District Court in the District Court district in which the notice has been served for an order directing that the controlled product be disposed of (by destruction or otherwise) in a manner, specified in the order, that will prevent its being used for human or animal consumption.

(11) Where an application is made under paragraph (10) to the District Court for an order directing the disposal of a controlled product, the Court, if it is satisfied that—

(i) the controlled product to which the notice relates contains within it or on it a residue of a plant protection product in excess of the maximum specified in relation to that product in accordance with Regulation 28,

(ii) if such product were released, it might be put into circulation contrary to Regulation 29, and

(iii) such product if consumed would constitute a danger to human or animal health,

shall order that the product be disposed of (by destruction or otherwise) in a manner, specified in the order, that will prevent its being used for human or animal consumption.

(12) Where an order is made by the District Court under paragraph (11), the order may provide that the controlled product to which it relates shall be disposed of in the manner specified in the notice given under paragraph (2), or in such other manner as may be specified in the Court's order and which, in the opinion of the Court, will prevent the product being used for human or animal consumption.

(13) Where an order made by the District Court under paragraph (11) requires that a product to which it relates be disposed of by an authorised officer, the cost of disposing of the relevant product pursuant to and in accordance with the order shall be recoverable by the Minister as a simple contract debt in any court of competent jurisdiction from the person who was either the owner, or in apparent charge or control of the product, at the time it was seized.

32

General Offenses

32.

(1) A person who contravenes Regulation 4, 6 or 7 shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000, to imprisonment for a term not exceeding 6 months, or to both.

(2) A person who —

(

a

) fails to comply with the requirements of Regulations 7, 8, 9, 17, 23, 24, 25 (1), 26 (4) and (5), 27, 30 (2) and (3), or 31 (3), or

(

b

) who obstructs or interferes with an authorised officer in the course of exercising a power conferred on him by Regulations 30, 31 or 37, or

(

c

) who in the context of Regulation 8, 11 (1), 16 (2) (

b

), 17, 19 (3), 25 (5), 26 (2) (

a

) or 27, submits false or misleading information, or who gives false information when requested to provide information under Regulation 37,

shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,000, to imprisonment for a term not exceeding six months, or to both.

33

Prosecutions and Specific Rules of Evidence

33.

(1) An offence under these Regulations may be prosecuted by the Minister.

(2) In proceedings for an offence under Regulation 32(1) it shall be a defence for the defendant to prove that the plant protection product to which the offence relates, was either in stock or purchased by him during the twelve month period following—

(

a

) its authorization in accordance with these Regulations, or

(

b

) the date of its clearance in accordance with the provisions of the Regulations of 1994, if purchased prior to the date of implementation of these Regulations.

34

Referee Analyses

34.

(1) Where an appeal is made to the District Court concerning the results of any analysis made under Regulation 30 (5), the third part of the sample shall, if the defendant so requests, be analyzed by the State Chemist.

(2) The State Chemist shall in making an analysis comply with the methods of analysis that apply in the particular case as specified in Regulation 30 (5) and issue a certificate in the form set out in Part 2 of the Twelfth Schedule to the defendant and to the designated chemist concerned.

35 ..

35.

The defendant shall be liable for the cost of the analysis carried out by the State Chemist under Regulation 34 in the event that the results of that analysis confirm that there has been a breach of these Regulations.

36

Fees

36.

(1) The consideration of every application for the authorization of a plant protection product, for the renewal or modification of an authorization granted, for an extension in the field of use of an authorized plant protection product, for the renewal of an extension granted, for the authorization of a plant protection product for trials purposes, for the renewal or variation in the conditions or restrictions of such an authorization, for a trials permit, for the renewal or variation in the conditions or restrictions of a trials permit, for the inclusion of an active substance in Annex I, or for the modification of the conditions or restrictions associated with any such inclusion, shall be subject to the payment of the following fees at the times specified, that is to say—

(

a

) in the case of an application for authorization of a plant protection product in accordance with Regulation 13, 15, or 18, for inclusion of an active substance in Annex I in accordance with Article 6 of the Directive, or for a modification of the conditions or restrictions associated with any such inclusion, the fee, or fees as appropriate, set out in column (2) of Part 1 of the Thirteenth Schedule, payable to the Minister in respect of the evaluation of the dossiers set out in column (1) of the said Part 1;

(

b

) in the case of an application for the renewal of an authorization in accordance with Regulation 19 (1), the fee, or fees as appropriate, set out in column (2) of Part 1 of the Thirteenth Schedule, payable to the Minister in respect of the evaluation of the dossiers set out in column (1) of the said Part 1;

(

c

) in the case of an application for the modification of an authorization in accordance with Regulation 19 (4), the fee, or fees as appropriate, set out in column (2) of Part 2 of the Thirteenth Schedule, payable to the Minister in respect of the each such modification in relation to a category set out in column (1) of the said Part 2;

(

d

) an initial fee of £100 payable to the Minister shall accompany each application for the authorization of a plant protection product or for the renewal or modification of an authorisation, which payment shall be offset against the fees mentioned in subparagraphs (

a

), (

b

) and (

c

) (evaluation of each application shall not be undertaken until the balance of the relevant fee is paid);

(

e

) a fee of £150 shall be payable to the Minister in each case where an application is made for a minor amendment to the packaging and labelling or to the documentation, information and materials submitted in accordance with Regulation 8 (3), where it is considered no hazard evaluation or evaluation of the performance of the plant protection product is involved or required, which fee shall not be offset against the fees mentioned in subparagraphs (

a

), (

b

) and (

c

);

(

f

) a fee of £500 shall be payable to the Minister in each case where an application is made for a permission to market in accordance with Regulation 5 (3), which fee shall not be offset against the fees mentioned in subparagraphs (

a

), (

b

) and (

c

);

(

g

) a fee of £200 shall be payable to the Minister in each case where an application is made for an extension in field of use of an authorized plant protection product, in accordance with Regulation 16, which fee shall not be offset against the fees mentioned in subparagraphs (

a

), (

b

) and (

c

); and

(

h

) a fee of £100 shall be payable to the Minister in each case where an application is made for the renewal of an extension in field of use of an authorized plant protection product, in accordance with Regulation 19 (2), which fee shall not be offset against the fees mentioned in subparagraphs (

a

), (

b

) and (

c

).

(2) (

a

) The consideration of every application for the authorization of a plant protection product for trials purposes in accordance with the provisions of Regulation 25 shall be subject to the payment of a fee of £250 payable to the Minister.

(

b

) The renewal of an authorization of a plant protection product for trials purposes in accordance with the provisions of Regulation 25 shall be subject to the payment of a fee of £50 payable to the Minister.

(

c

) The variation of the conditions or restrictions of an authorization of a plant protection product for trials purposes in accordance with the provisions of Regulation 25 shall be subject to the payment of a fee of £50 payable to the Minister.

(3) (

a

) The consideration of every application for a trials permit in accordance with the provisions of Regulation 26 shall be subject to the payment of a fee of £1,000 payable to the Minister.

(

b

) The renewal of a trials permit in accordance with the provisions of Regulation 26 shall be subject to the payment of a fee of £250 payable to the Minister.

(

c

) The variation of the conditions or restrictions of a trials permit in accordance with the provisions of Regulation 26 shall be subject to the payment of a fee of £250 payable to the Minister.

(4) Authorization of a plant protection product in accordance with the requirements of these Regulations shall be revoked if, in the case such plant protection product continues to be placed on the market or used, there is a failure to pay the annual renewal fee set out in Part 3 of the Thirteenth Schedule, within 30 days of the fee falling due, but renewal of authorization of a plant protection product may be granted where application is made more than 30 days but not more than 60 days after the renewal fell due on payment to the Minister of the late annual renewal fee set out in Part 3 of the Thirteenth Schedule.

(5) In the case of a plant protection product already on the market at the time of the commencement of these Regulations, the Minister may reduce the fee payable under paragraph (1), on a request being made to him in that behalf, where he is satisfied that the wholesale sales of the plant protection product during the previous 12 month period did not exceed 50 times the fee payable to the Minister in accordance with paragraph (1).

(6) In the case of a plant protection product which is being placed on the market for the first time, the Minister may refund part of the fee payable in accordance with paragraph (1), on a request being made to him in that behalf, where he is satisfied that the wholesale sales of the plant protection product during the 12 month period following the date of its authorization in accordance with Regulation 13, 15 or 18, did not exceed 50 times the fee payable to the Minister in accordance with paragraph (1).

(7) In the case of an application for the authorization of a plant protection product for trials purposes, the fee payable under paragraph (2) may be reduced by the Minister on a request being made to him in that behalf where the potential area of use is limited to a specialised area or specialised areas of use.

(8) A fee payable under these Regulations may be recovered by the Minister as a simple contract debt in any court of competent jurisdiction.

37 ..

37.

A person who makes a claim for a reduction or a refund of fees in accordance with paragraphs Regulation 36 (5), (6) or (7) shall, at all reasonable times—

(

a

) produce, at the request of an authorised officer, any records, books or other documents which are in his possession or under his control which substantiate such a claim,

(

b

) permit the officer to inspect and take extracts from such records, books or other documents and give to the officer any information which is within his knowledge or under his control and which such officer may reasonably require for the purpose of verifying the claim,

(

c

) afford to such an officer such facilities and assistance as are reasonably necessary for inspecting the stock of the relevant plant protection product if the officer considers such inspection is necessary for the purpose of verifying the claim.

FIRST SCHEDULE

Part 1

Annex II

(Annex II to the Directive of 1991, as amended by Commission Directive No 93/71/EEC of 27 July 1993)

REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE INCLUSION OF AN ACTIVE SUBSTANCE IN ANNEX I

Introduction

The information required shall

1.1

Include a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the substance may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below;

1.2

where relevant, be generated using test guidelines referred to or described in this Annex, in the case of studies initiated before the adoption of the modification of this Annex, the information shall be generated using suitable internationally or nationally validated test guidelines or, in the absence thereof, test guidelines accepted by the competent authority;

1.3

in the event of a test guideline being inappropriate or not described, or where another one than those referred to in this annex has been used, include a justification, which is acceptable to the competent authority for the guideline used;

1.4

include, when required by the competent authority, a full description of test guidelines used, except if they are referred to or described in this Annex, and a full description of any deviations from them including a justification, which is acceptable to the competent authority, for these deviations;

1.5

include a full and unbiased report of the studies conducted as well as a full description of them or a justification, which is acceptable to the competent authority where

— particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided, or

— it is not scientifically necessary, or technically possible to supply information and data;

1.6

where relevant, have been generated in accordance with the requirements of Directive 86/609/EEC23, of 24 November 1986, on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes.

23

O.J. No. L358/1,18/12/1986

2.1

Tests and analyses must be conducted in accordance with the principles laid down in Directive 87/18/EEC24 of 18 December 1986, on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances, where testing is done to obtain data on the properties and/or safety with respect of human or animal health or the environment.

2.2

Notwithstanding the provisions of 2.1, during the period to 31 December 1999, tests and analyses done to obtain data on the properties and/or safety with respect to honeybees and beneficial arthropods other than bees may have been conducted by officially recognized testing facilities or organisations, in accordance with the principles laid down in the Sixth Schedule, or in compliance with Irish/European Standard IS/EN 45001, where they are conducted within the territory of the state, and in accordance with the requirements of points 2.2 and 2.3 of the introduction to Annex III to Directive 93/71/EEC, where they are conducted outside the territory of the state.

PART A

Chemical substances

1

Identity of the active substance

The information provided must be sufficient to identify with precision each active substance, to define it in terms of its specification and to characterize it as to its nature. The information and data referred to, unless otherwise specified, are required for all active substances.

1.1

Applicant (name, address, etc.)

The name and address of the applicant (permanent community address) must be provided as must the name, position, telephone and telefax number of the appropriate person to contact.

Where, in addition, the applicant has an office, agent or representative in the territory of the State, the name and address of the local office, agent or representative must be provided, as must the name, position, telephone and telefax number of the appropriate person to contact.

1.2

Manufacturer (name, address, including location of plant)

The name and address of the manufacturer or manufacturers of the active substance must be provided as must the name and address of each manufacturing plant in which the active substance is manufactured. A contact point (preferably a central contact point, to include name, telephone and telefax number) must be provided, with a view to providing updating information and responding to queries arising, regarding manufacturing technology, processes and the quality of product (including where relevant, individual batches). Where following inclusion of the active substance in Annex I, there are changes in the location or number of manufacturers, the information required must again be notified to the Commission and the Member States.

24

O.J. No. L15/3, 17/01/1987

1.3

Common name proposed or ISO-accepted, and synonyms

The ISO common name, or proposed ISO common name and where relevant, other proposed or accepted common names (synonyms), including the name (title) of the nomenclature authority concerned, must be provided.

1.4

Chemical name (IUPAC and CA) nomenclature

The chemical name as given in Annex I to the Directive of 1967, or, if not included in that Directive, in accordance with both IUPAC and CA nomenclature, must be provided.

1.5

Manufacturer's development code number(s)

Code numbers used to identify the active substance and, where available, formulations containing the active substance, during development work, must be reported. For each code number reported, the material to which it relates, the period for which it was used, and the Member States or other countries in which it was used and is being used, must be stated.

1.6

CAS, EEC and CIPAC numbers (if available)

Chemical Abstracts, EEC (EINECS or ELINCS), and CIPAC numbers, where they exist, must be reported.

1.7

Molecular and structural formula, molecular mass

The molecular formula, molecular mass and structural formula of the active substance, and where relevant, the structural formula of each stereo and optical isomer present in the active substance, must be provided.

1.8

Method of manufacture (synthesis pathway) of the active substances

The method of manufacturer, in terms of the identity of the starting materials, the chemical pathways involved, and the identity of by-products and impurities present in the final product, must be provided, for each manufacturing plant. Generally process engineering information is not required.

Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized.

1.9

Specification of purity of the active substance in g/kg

The minimum content in g/kg of pure active substance (excluding inactive isomers) in the manufactured material used for production of formulated products, must be reported.

Where the information provided relates to a pilot plant production system, the information required must again be provided to the Commission and the Member States once industrial scale production methods and procedures have stabilized, if production changes result in a changed specification of purity.

1.10

Identity of isomers, impurities and additives (e.g. stabilizers), together with the structural formula and the content expressed as g/kg

The maximum content in g/kg of inactive isomers as well as the ratio of the content of isomers/diastereoisomers, where relevant, must be provided. In addition, the maximum content in g/kg of each further component other than additives, including by-products, and impurities, must be provided. In the case of additives the content in g/kg must be provided.

For each component, present in quantities of 1 g/kg or more, the following information, where relevant, must be provided—

— chemical name according to IUPAC and CA nomenclature;

— ISO common name or proposed common name if available;

— CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available;

— molecular and structural formula;

— molecular mass; and

— maximum content in g/kg.

Where the manufacturing process is such that impurities and by-products which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties could be present in the active substance, the content of each such compound must be determined and reported. In such cases, the analytical methods used and the limits of determination, which must be sufficiently low, for each compound of concern, must be reported. Additionally the following information, where relevant, must be provided—

— chemical name according to IUPAC and CA nomenclature;

— ISO common name or proposed common name if available;

— CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available;

— molecular and structural formula;

— molecular mass; and

— maximum content in g/kg.

Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilised, if the production changes result in a changed specification of purity.

Where the information provided does not fully identify a component viz. condensates, detailed information on the composition must be provided for each such component. The trade name of components added to the active substance, prior to manufacture of formulated product, to preserve stability and facilitate ease of handling, where they are used, must also be provided. Additionally the following information, where relevant, must be provided for such additives—

— chemical name according to IUPAC and CA nomenclature;

— ISO common name or proposed common name if available;

— CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available;

— molecular and structural formula;

— molecular mass; and

— maximum content in g/kg.

For added components, other than active substances and other than impurities resulting from the manufacturing process, the function of the component (additive) must be given—

antifoaming agent

buffer

antifreeze

dispersing agent

binder

stabiliser

other (specify)

1.11

Analytical profile of batches

Representative samples of the active substance must be analyzed for content of pure active substance, inactive isomers, impurities and additives, as appropriate. The analytical results reported must include quantitative data, in terms of g/kg content, for all components present in quantities of more than 1 g/kg and typically should account for at least 98% of the material analyzed. The actual content of components which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties, must be determined and reported. Data reported must include the results of the analysis of individual samples and a summary of that data, to show the minimum or maximum and typical content of each relevant component, as appropriate.

Where an active substance is produced in different plants this information must be provided for each of the plants separately.

In addition, where available and relevant, samples of the active substance produced in laboratory scale or pilot production systems, must be analyzed, if such material was used in generating toxicological or ecotoxicological data.

2

Physical and chemical properties of the active substance

(i) The information provided, must describe they physical and chemical properties of active substances and together with other relevant information, must serve to characterize them. In particular, the information provided must permit—

— physical, chemical, and technical hazards associated with active substances, to be identified;

— classification of active substance as to hazard;

— appropriate restrictions and conditions to be associated with inclusions in Annex I to be selected; and

— appropriate risk and safety phrases to be specified.

The information and data referred to are required for all active substances, except where otherwise specified.

(ii) The information provided, taken together with that provided for relevant preparations, must permit the physical, chemical and technical hazards associated with preparations, to be identified, permit preparations to be classified, and demonstrate that preparations can be used without unnecessary difficulty, and be such that exposure of man, animals, and the environment is minimized, taking account of manner of use.

(iii) The extent to which active substances for which inclusion in Annex I is sought, comply with relevant FAO specifications, must be stated. Divergences from FAO specifications must be described in detail, and justified.

(iv) In certain specified instances, tests must be conducted using purified active substance of stated specification. In such cases the principles of the method(s) of purification used must be reported. The purity of such test material, which must be as high as can be achieved using the best available technology, must be reported. A reasoned justification must be provided in cases where the degree of purity achieved is less than 980 g/kg. Such justification must demonstrate that all technically feasible and reasonable possibilities for the production of the pure active substance have been exhausted.

2.1

Melting point and boiling point

2.1.1

The melting point or where appropriate the freezing or solidification point of purified active substance must be determined in accordance with EEC Method A 1 and be reported. Measurements should be taken up to 360°C.

2.1.2

Where appropriate, the boiling point of purified active substances must be determined in accordance with EEC Method A 2 and be reported. Measurements should be taken up to 360°C.

2.1.3

Where melting point and/or boiling point cannot be determined because of decomposition or sublimation, the temperature at which decomposition or sublimation occurs, must be reported.

2.2

Relative density

In the case of active substances which are liquids or solids, the relative density of the purified active substance must be determined in accordance with EEC Method A3 and be reported.

2.3

Vapour pressure (In Pa), volatility (e.g. Henry's law constant)

2.3.1

The vapour pressure of purified activie substance must be determined in accordance with EEC Method A4 and be reported. Where vapour pressure is less than 10

-5

Pa, the vapour pressure at 20 or 25°C may be estimated using a vapour pressure curve.

2.3.2

In the case of activie substnaces which are solids or liquids, volatility (Henry's law constant) of purified active substance must be determined or calculated from its water solubility and vapour pressure and be reported (in PA x m

3

x mol

-1

).

2.4

Appearances (physical state, colour and odour; if known)

2.4.1

A description of both the colour, if any, and the physical state of both the active substance as manufactured and the purified active substance, must be provided.

2.4.2

A description of any odour associated with the active substance as manufactured and with the purified active substance, noted when handling the materials in laboratories or production plants, must be reported.

2.5

Spectra (UV/VIS, IR, NMR, MS), molecular extinction at relevant wavelengths

2.5.1

The following spectra including a table of signal characteristics needed for interpretation must be determined and reported: Ultraviolet/Visible (UV/VIS), infrared (IR), nuclear magnetic resonance (NMR), and mass spectra (MS) of purified active substance. Molecular extinction at relevant wavelengths, must be determined and reported. The wavelengths at which UV/visible molecular extinction occurs are to be determined and reported and must include, where appropriate, a wavelength at the highest absorption value above 290 nm.

In the case of active substances which are resolved optical isomers their optical purity must be measured and reported.

2.5.2

The UV/visible absorption spectra, IR, NMR and MS spectra, where necessary for the identification of impurities considered to be of toxicological, ecotoxicological or environmental significance, must be determined and reported.

2.6

Solubility in water including effect of pH (4 to 10) on solubility

The water solubility of purified active substances under atmospheric pressure must be determined in accordance with EEC Method A 6 and be reported. These water solubility determinations must be made in the neutral range (i.e. in distilled water in equilibrium with atmospheric carbon dioxide). Where the active substance is capable of forming ions, determinations must also be made in the acidic range (pH 4 to 6) and in the alkaline range (pH 8 to 10), and be reported. Where the stability of the active substances in aqueous media is such that water solubility cannot be determined, a justification based on test data must be provided.

2.7

Solubility in organic solvents

The solubility of active substances, as manufactured, in the following organic solvents at 15 to 25°C must be determined and reported if less than 250 g/kg; the temperature applied must be specified

Aliphatic hydrocarbon

—preferably n-heptane

Aromatic hydrocarbon

—preferably xylene

Halogenated hydrocarbon

—preferably 1, 2-dichlorethane

Alcohol

—preferably methanol or isopropyl acetone

Ketone

—preferably acetone

Ester

—preferably ethyl acetate

If for a particular active substance, one or more of these solvents is unsuitable (e.g. reacts with test material), alternative solvents can be used instead. In such cases, choices made must be justified in terms of their structure and polarity.

2.8

Partition co-efficient n-octanol/ water including effect of pH (4 to 10)

The n-octanol/water partition coefficient of purified active substance must be determined in accordance with EEC Method A 8 and be reported. The effect of pH (4 to 10) must be investigated when the substance is acidic or basic as defined by its pka value ( 2 for bases).

2.9

Stability in water, hydrolysis rate, photochemical degradation, quantum yield and identity of breakdown product(s), dissociation constant including effect of pH (4 to 9)

2.9.1

The hydrolysis rate of purified active substances (usually radiolabelled active substance,> 95% purity), for each of the pH values 4, 7 and 9, under sterile conditions, in the absence of light, must be determined in accordance with EEC Method C 7 and be reported. For substances with a low rate of hydrolysis, the rate can be determined at 50°C, or another appropriate temperature. If degradation is observed at 50°C, degradation rate at another temperature must be determined, and an Arrhenius plot must be constructed to permit an estimate to be made of hydrolysis products formed and the rate constant observed, must be reported. The estimated DT

50

value must also be reported.

2.9.2

For compounds with a molar (decadic) absorption coefficient (ε) > 10 (1 x x mol

-1 x

xcm

-1

) at a wavelength λ > 290 nm, direct phototransformation in purified (e.g. distilled) water at 20 to 25°C, of purified active substance usually radio labelled using artificial light under sterile conditions, if necessary using a solubilizer, must be determined and reported. Sensitizers such as acetone must not be used as a co-solvent or solubilizer. The light source must simulate sunlight and be equipped with filters to exclude radiation at wavelengths λ > 10% of the active substance added, a mass balance to account for at least 90% of the applied radioactivity, as well as photochemical halflife must be reported.

2.9.3

Where necessary to investigate direct phototransformation, the quantum yield of direct photodegradation in water must be determined and reported, together with calculations to estimate theoretical lifetime of the active substance in the top layer of aqueous systems and the real lifetime of the substance. The method to be used is described in the Annex to the FAO Revised Guidelines on Environmental Criteria for the Registration of Pesticides.

2.9.4

Where dissociation in water occurs, the dissociation constants(s) (pKa values) of purified active substances must be determined in accordance with OECD Test Guideline 112 and be reported. The identity of the dissociated species formed, based on theoretical considerations, must be reported. If the active substance is a salt, the pKa value of the active principle must be given.

2.10

Stability in air, photochemical degradation, identity of breakdown product(s)

An estimation of the photochemical oxidative degradation (indirect phototransformation) of the active substance(s), must be submitted.

2.11

Flammability including auto-flammability

2.11.1

The flammability of active substances as manufactured, which are solids, gases, or are substances which evolve highly flammable gases, must be determined in accordance with EEC Methods A 10, A 11 or A 12, as appropriate, and be reported.

2.11.2

The auto-flammability of active substances as manufactured must be determined in accordance with EEC Method A 15 or A 16, as appropriate, and/or, where necessary, according to the UN-Bowes-Cameron-Cage-Test (UN-Recommendations on the Transport of Dangerous Goods, Chapter 14, Nr. 14.3.4), and be reported.

2.12

Flash point

The flash point of active substances as manufactured with a melting point below 40°C, must be determined in accordance with EEC Method A 9 and be reported; only closed cup methods should be used.

2.13

Explosive properties

The explosive properties of active substances as manufactured, must be determined in accordance with EEC Method A 14, where appropriate, and be reported.

2.14

Surface tension

The surface tension of active substances must be determined in accordance EEC Method A 5 and be reported.

2.15

Oxidizing properties

The oxidizing properties of active substances as manufactured, must be determined in accordance with EEC Method A 17 and be reported, except where examination of their structural formulae, establish beyond reasonable doubt that the active substance concerned is incapable of reacting exothermically with a combustible material. In such cases, it is sufficient to provide that information as justification for not determining the oxidizing properties of the substance.

3

Further information on the active substance

(i) The information provided must describe the intended purposes for which preparations containing the active substance are used, or are to be used and the dose and manner of their use or proposed use.

(ii) The information provided must specify the normal methods and precautions to be followed, in the handling, storage and transport of the active substance.

(iii) The studies, data and information submitted, together with other relevant studies, data and information, must both specify and justify the methods and precautions to be followed in the event of fire. The possible products of combustion in the event of fire should be estimated, based on the chemical structure and the chemical and physical properties of the active substance.

(iv) The studies, data and information submitted, together with other relevant studies, data and information, must demonstrate the suitability of measures proposed for use in emergency situations.

(v) The information and data referred to are required for all active substances, except where otherwise specified.

3.1

Function, e.g. fungicide, herbicide, insecticide, repellant, growth regulator

The function must be specified from among the following

acaricide

plant growth regulator

bactericide

repellant

fungicide

rodenticide

herbicide

semio-chemicals

insecticide

talpicide

molluscicide

viricide

nematicide

other (must be specified)

3.2

Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach poison, fungitoxic or fungistatic, etc. systemic or not in plants

3.2.1

The nature of the effects on harmful organisms must be stated

contact action

stomach action

inhalation action

fungitoxic action

fungistatic action

desiccant

reproduction inhibitor

other (must be specified)

3.2.2

It must be stated whether or not the active substance is translocated in plants and where relevant whether such translocation is apoplastic, symplastic or both.

3.3

Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening

The field(s) of use, existing and proposed, for preparations containing the active substance must be specified from among the following

Field use

— Agriculture

— Horticulture

— Forestry

— Viticulture

Protected crops

Amenity

Weed control on non-cultivated areas

Home gardening

House plants

Plant products storage practice

Other (specify)

3.4

Harmful organisms controlled and crops or products protected or treated

3.4.1

Details of existing and the intended use in terms of crops, groups of crops, plants, or plant products treated and where relevant protected, must be provided.

3.4.2

Where relevant, details of harmful organisms against which protection is afforded, must be provided.

3.4.3

Where relevant, effects achieved e.g. sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilization etc., must be reported.

3.5

Mode of action

3.5.1

To the extent that it has been elucidated, a statement must be provided as to the mode of action of the active substance in terms, where relevant, of the biochemical and physiological mechanism(s) and biochemical pathway(s) involved. Where available, the results of relevant experimental studies must be reported.

3.5.2

Where it is known that to exert its intended effect, the active substance must be converted to a metabolite or degradation product following application or use of preparations containing it, the following information, cross referenced to and drawing on information provided in the context of paragraphs 5.6, 5.11, 6.1, 6.2, 6.8, 7.1, 7.2 and 9, where relevant, must be provided for the active metabolite or degradation product—

— chemical name according to IUPAC and CA nomenclature;

— ISO common name or proposed common name;

— CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available;

— empirical and structural formula; and

— molecular mass.

3.5.3

Available information relating to the formation of active metabolites and degradation products, must be provided, to include —

— the processes, mechanisms and reactions involved;

— kinetic and other data concerning the rate of conversion and if known the rate limiting step; and

— environmental and other factors effecting the rate and extent of conversion.

3.6

Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies

Where available information on possible occurrence of the development of resistance or cross-resistance must be provided.

3.7

Recommended methods and precautions concerning handling, storage, transport or fire

A Safety Data Sheet in accordance with Article 27 of the Directive of 1967 must be provided for all active substances.

3.8

Procedures for destruction or decontamination

3.8.1

Controlled incineration

In many cases the preferred or sole means to safely dispose of active substances, contaminated materials, or contaminated packaging, is through controlled incineration in a licensed incinerator. Where the content of halogens of the active substance is greater than 60%, the pyrolytic behaviour of the active substance under controlled conditions (including, where relevant, supply of oxygen and residence time), at 800°C and the content of polyhalogenated dibenzo-p-dioxins and dibenzo-furans in the products of pyrolysis must be reported. The applicant must provide detailed instructions for safe disposal.

3.8.2

Others

Other methods to dispose of the active substance, contaminated packaging and contaminated materials, where proposed, must be fully described. Data must be provided for such methods, to establish their effectiveness and safety.

3.9

Emergence measures in case of an accident

Procedures for the decontamination of water in case of an accident must be provided.

4

Analytical methods

4.1

Analytical methods for the determination of pure active substance and, where appropriate, for relevant breakdown products, isomers and impurities of the active substance and additives (e.g. stabilizers)

4.2

Analytical methods including recovery rates and the limits of determination for residues in, and where relevant on, the following

4.2.1

Treated plants, plant products, foodstuffs, feeding stuffs

4.2.2

Soil

4.2.3

Water (including drinking water)

4.2.4

Air

4.2.5

Animal and human body fluids and tissues

5

Toxicological and metabolism studies on the active substance

5.1

Acute toxicity

5.1.1

Oral

5.1.2

Percutaneous

5.1.3

Inhalation

5.1.4

Intraperitoneal

5.1.5

Skin and where appropriate eye irritation

5.1.6

Skin sensitization

5.2

Short-term toxicity

5.2.1

Oral cumulative toxicity (28-day study)

5.2.2

Oral administration — two species, one rodent (preferably rat) and one non-rodent, usually 90-day study

5.2.3

Other routes (inhalation, percutaneous as appropriate)

5.3

Chronic toxicity

5.3.1

Oral long-term toxicity and carcinogenicity (rat and other mammalian species) — other routes as appropriate

5.4

Mutagenicity — test battery to assess gene mutations, chromosomal aberrations and DNA perturbations

5.5

Reproductive toxicity

5.5.1

Teratogenicity studies — rabbit and one rodent species, oral and when appropriate percutaneous

5.5.2

Multi-generation studies in mammals (at least two generations)

5.6

Metabolism studies in mammals

5.6.1

Absorption, distribution and excretion studies — following both oral and percutaneous administration

5.6.2

Elucidation of metabolic pathways

5.7

Neurotoxicity studies — including where appropriate delayed neurotoxicity tests in adult hens

5.8

Supplementary studies

5.8.1

Toxic effects of metabolites from treated plants in cases where different from those identified in animal studies

5.8.2

Any mechanistic studies needed to clarify effects reported in toxicity studies

5.9

Toxic effects on livestock and pets

5.10

Medical data

5.10.1

Medical surveillance on manufacturing plant personnel

5.10.2

Direct observation, e.g. clinical cases and poisoning incidents

5.10.3

Health records, both from industry and agriculture

5.10.4

Observations on exposure of the general population and epidemiological studies if appropriate

5.10.5

Diagnosis of poisoning (determination of active substance, metabolites), specific signs of poisoning, clinical tests

5.10.6

Sensitization/allergenicity observations

5.10.7

Proposed treatment: first aid measures, antidotes, medical treatment

5.10.8

Prognosis of expected effects of poisoning

5.11

Summary of mammalian toxicology and conclusion (including no observable adverse effect level (NOAEL), no observable effect level (NOEL), acceptable daily intake (ADI). Overall evaluation with regard to all toxicological data, and other information concerning the active substance

6

Residues in or on treated products, food and feed

6.1

Identification of breakdown and reaction products and of metabolites in treated plants or products

6.2

Behaviour of residue of the active substance and its metabolites from the time of application until harvest or out-loading of stored products — uptake and distribution in, and where relevant on, plants, kinetics of disappearance, binding to plant constituents, etc.

6.3

Overall material balance for the active substance. Sufficient residue data from supervised trials to demonstrate that residues likely to arise from the proposed treatments would not be or concern for human and animal health

6.4

Estimation of the potential and actual exposure through diet and other means, such as residue monitoring data for products in the distribution chain, or such as data concerning exposure via air, water, etc.

6.5

Feeding and metabolism studies in livestock (if residues remain in or on crops or parts of crops used for feed) to permit evaluation of residues in foodstuffs of animal origin

6.6

Effects of industrial processing and/or household preparation on the nature and magnitude of residues

6.7

Summary and evaluation of residue behaviour resulting from data submitted pursuant to points 6.1 to 6.6

7

Fate and behaviour in the environment

7.1

Fate and behaviour in soil

7.1.1

Rate and route of degradation (to 90 per cent degradation) including identification of the processes involved and identification of metabolites and breakdown products in at least three soil types under appropriate conditions

7.1.2

Adsorption and desorption in at least three soil types and where relevant adsorption and desorption of metabolites and breakdown products

7.1.3

Mobility in at least three soil types and where relevant mobility of metabolites and breakdown products

7.1.4

Extent and nature of bound residues

7.2

Fate and behaviour in water and air

7.2.1

Rate and route of degradation in aquatic systems — biodegradation, hydrolysis, photolysis (as far as not covered by point 2.8), including identification of metabolites and breakdown products

7.2.2

Adsorption and desorption in water (sedimentation) and where relevant adsorption and desorption of metabolites and breakdown products

7.2.3

Rate and route of degradation in air (for fumigants and other volatile active substances) (as far as not covered by point 2.9)

8

Ecotoxicological studies on the active substance

8.1

Effects on birds

8.1.1

Acute oral toxicity

8.1.2

Short-term toxicity — eight-day dietary study in at least one species (other than chicken)

8.1.3

Effects on reproduction

8.2

Effects on aquatic organisms

8.2.1

Acute toxicity to fish

8.2.2

Chronic toxicity to fish

8.2.3

Effects on fish reproduction and growth rate

8.2.4

Bioaccumulation in fish

8.2.5

Acute toxicity for Daphnia magna

8.2.6

Daphnia magna reproduction and growth rate

8.2.7

Effects on algal growth

8.3

Effects on other non-target organisms

8.3.1

Acute toxicity to honeybees and other beneficial arthropods (e.g. predators)

8.3.2

Toxicity to earthworms and to other soil non-target macro-organisms

8.3.3

Effects on soil non-target micro organisms

8.3.4

Effects on other non-target organisms (flora and fauna) believed to be at risk

8.3.5

Effects on biological methods for sewage treatment

9

Summary and evaluation of points 7 and 8

10

Proposals including justification for the proposals for the classification and labelling of the active substance according to Council Directive 67/548/EEC

— Hazard symbol(s)

— Indications of danger

— Risk phrases

— Safety phrases

11

A dossier as referred to in Annex III, part A, for a representative plant protection product

PART B

Micro-organisms and viruses

(this part does not apply to GMOs where points come under Directive 90/220/EEC)

1

Identity of the organism

1.1

Applicant (name, address, etc.)

1.2

Manufacturer (name, address, including location of plant)

1.3

Common name or alternative and superseded names

1.4

Taxonomic name and strain for bacteria, protozoa and fungi, indication whether it is a stock variant or a mutant strain; for viruses the taxonomic designation of the agent, serotype, strain or mutant

1.5

Collection and culture reference number where the culture is deposited

1.6

The appropriate test procedures and criteria used for identification (e.g. morphology, biochemistry, serology)

1.7

Composition — microbiological purity, nature, identity, properties, content of any impurities and extraneous organisms

2

Biological properties of the organism

2.1

Target organism. Pathogenicity or kind of antagonism to host, infective dose, transmissibility and information on mode of action

2.2

History of the organism and its uses. Natural occurrence and geographical distribution

2.3

Host specificity range and effects on species other than the target harmful organism including species most closely related to the target species — to include infectivity, pathogenicity and transmissibility

2.4

Infectivity and physical stability when used according to the proposed method. Effect of temperature, exposure to air radiation, etc. Persistence under the likely environmental conditions of use

2.5

Whether the organism is closely related to a plant pathogen or to a pathogen of a vertebrate species or a non-target invertebrate species

2.6

Laboratory evidence of genetic stability (i.e. mutation rate) under environmental conditions of proposed use

2.7

Presence, absence or production of toxins as well as their nature, identity, chemical structure (if appropriate) and stability

3

Further information on the organism

3.1

Function, e.g. fungicide, herbicide, insecticide, repellant, growth regulator

3.2

Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach poison, fungitoxic or fungistatic, etc. systemic or not in plants

3.3

Field of use envisaged, e.g. field, glasshouse, food or feed storage, home garden

3.4

Where necessary, in the light of the test results, any specific agricultural, plant health or environmental conditions under which the active substance may or may not be used

3.5

Harmful organisms controlled and crops or products protected or treated

3.6

Method of production with descriptions of the techniques used to ensure a uniform product and of assay methods for its standardization. In the case of a mutant, detailed information should be provided on its production and isolation, together with all known differences between the mutant and the parent wild strains.

3.7

Methods to prevent loss of virulence of seed stock

3.8

Recommended methods and precautions concerning handling, storage, transport or fire

3.9

Possibility of rendering the organism uninfective

4

Analytical methods

4.1

Methods for establishing the identity and purity of seed stock from which batches are produced and results obtained, including information on variability

4.2

Methods to show microbiological purity of the final product and showing that contaminants have been controlled to an acceptable level, results obtained and information on variability

4.3

Methods used to show that there are no human or other mammalian pathogens as contaminants in the active agent, including in the case of protozoa and fungi, the effects of temperature (35°C and other relevant temperatures)

4.4

Methods to determine viable and non-viable (e.g. toxins) residues in or on treated products, foodstuffs, feeding stuffs, animal and human body fluids and tissues, soil, water and air, where relevant

5

Toxicological, pathogenicity and infectivity studies

5.1

Bacteria, fungi, protozoa and mycoplasma

5.1.1

Toxicity and/or pathogenicity and infectivity

5.1.1.1

Oral single dose

5.1.1.2

In cases where a single dose is not appropriate to assess pathogenicity, a set of range-finding texts must be carried out to reveal highly toxic agents and infectivity

5.1.1.3

Percutaneous single dose

5.1.1.4

Inhalation single dose

5.1.1.5

Intraperitoneal single dose

5.1.1.6

Skin and, where necessary, eye irritation

5.1.1.7

Skin sensitization

5.1.2

Short-term toxicity (90 days exposure)

5.1.2.1

Oral administration

5.1.2.2

Other routes (inhalation, percutaneous as appropriate)

5.1.3

Supplementary toxicological and/or pathogenicity and infectivity studies

5.1.3.1

Oral long-term toxicity and carcinogenicity

5.1.3.2

Mutagenicity — (tests as referred to under point 5.4 of part A)

5.1.3.3

Teratogenicity studies

5.1.3.4

Multi-generation study in mammals (at least two generations)

5.1.3.5

Metabolic studies — absorption, distribution and excretion in mammals including elucidation of metabolic pathways

5.1.3.6

Neurotoxicity studies, including where appropriate delayed neurotoxicity tests in adult hens

5.1.3.7

Immunotoxicity, e.g. allergenicity

5.1.3.8

Pathogenicity and infectivity under immunosuppression

5.2

Viruses, viroids

5.2.1

Acute toxicity and/or pathogenicity and infectivity

Data as outlined under point 5.1.1 and cell culture studies using purified infective virus and primary cell cultures of mammalian, avian and fish cells

5.2.2

Short-term toxicity

Data as outlined under point 5.1.2 and tests for infectivity carried out by bio-assay or on a suitable cell culture at least seven days after the last administration to the test animals

5.2.3

Supplementary toxicological and/or pathogenicity and infectivity studies as outlined under point 5.1.3.

5.3

Toxic effects on livestock and pets

5.4

Medical data

5.4.1

Medical surveillance on manufacturing plant personnel

5.4.2

Health records, both from industry and agriculture

5.4.3

Observations on exposure of the general population and epidemiological data, if appropriate

5.4.4

Diagnosis of poisoning, specific signs of poisoning, clinical tests, if appropriate

5.4.5

Sensitization/allergenicity observations, if appropriate

5.4.6

Proposed treatment: first aid measures, antidotes, medical treatment, if appropriate

5.4.7

Prognosis of expected effects of poisoning, if appropriate

5.5

Summary of mammalian toxicology and conclusions (including NOAEL, NOEL and ADI, if appropriate). Overall evaluation with regard to all toxicological pathogenicity and infectivity data, and infectivity and other information concerning the active substance

6

Residues in or on treated products, food and feed

6.1

Identification of viable and non-viable (e.g. toxins) residues in or on treated plants or products, the viable residue by culture or bio-assay and the non-viable by appropriate techniques

6.2

Likelihood of multiplication of the active substance in or on crops or food together with a report on any effect on food quality

6.3

In cases where residues of toxins remain in or on an edible plant product, data as outlined under points 4.2.1 and 6 of part A are required

6.4

Summary and evaluation of residue behaviour resulting from data submitted under points 6.1 to 6.3

7

Fate and behaviour to the environment

7.1

Spread, mobility, multiplication and persistence in air, water, soil

7.2

Information concerning possible fate in food chains

7.3

In cases where toxins are produced, data as outlined under part A, point 7 are required, where relevant

8

Ecotoxicological studies

8.1

Birds — acute oral toxicity and/or pathogenicity and infectivity

8.2

Fish — acute toxicity and/or pathogenicity and infectivity

8.3

Toxicity — Daphnia magna (if appropriate)

8.4

Effects on algal growth

8.5

Important parasites and predators of target species; acute toxicity and/or pathogenicity and infectivity

8.6

Honey bees: acute toxicity and/or pathogenicity and infectivity

8.7

Earthworms: acute toxicity and/or pathogenicity and infectivity

8.8

Other non-target organisms believed to be at risk: acute toxicity and/or pathogenicity and infectivity

8.9

Extent of indirect contamination on adjacent non-target crops, wild plants, soil and water

8.10

Effects on other flora and fauna

8.11

In cases where toxins are produced, data as outlined under Part A, points 8.1.2, 8.1.3, 8.2.2, 8.2.3, 8.2.4, 8.2.5, 8.2.6, 8.2.7 and 8.3.3 are required, where relevant

9

Summary and evaluation of points 7 and 8

10

Proposals including justification of the proposals for the classification and labelling of the active substance in accordance with Directive 67/548/EEC

— Hazard symbol(s)

— Indications of danger

— Risk phrases

— Safety phrases

11

A dossier referred to in Annex III, part B, for a representative plant protection product

Part 2

Annex III

(Annex III to the Directive of 1991, as amended by Commission Directive No 93/71/EEC of 27 July 1993)

REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE AUTHORIZATION OF A PLANT PROTECTION PRODUCT

INTRODUCTION

The information required shall

1.1

include a technical dossier supplying the information necessary for evaluating efficacy and the foreseeable risks, whether immediate or delayed, which the plant protection product may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below;

1.2

where relevant, be generated using test guidelines referred to or described in this Annex; in the case of studies initiated before the adoption of the modification of this Annex, the information shall be generated using suitable internationally or nationally validated test guidelines or, in the absence thereof, test guidelines accepted by the competent authority;

1.3

in the event of a test guideline being inappropriate or not described, or where another one than those referred to in this annex has been used, include a justification, which is acceptable to the competent authority for the gidelines used;

1.4

include, a full description of test guidelines used, except if they are referred to or described in this Annex, and a full description of any deviations from them including a justification, which is acceptable to the competent authority, for these deviations;

1.5

include a full and unbiased report of the studies conducted as well as a full description of them or a justification, which is acceptable to the competent authority where

— particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided, or

— it is not scientifically necessary, or technically possible to supply information and data.

1.6

where relevant, have been generated in accordance with the requirements of Directive 86/609/EEC.

2.1

Tests and analyses must be conducted in accordance with the principles laid down in Directive 87/18/EEC, where testing is done to obtain data on the properties and/or safety with respect to human health or the environment.

2.2

Tests and analyses, required under the provisions of section 6 points 6.2 to 6.6 of this annex, shall, where they are conducted outside the territory of the state, be conducted by official or officially recognized testing facilities or organisations in the Member State concerned, which satisfy at least the requirements specified in points 2.2 and 2.3 of the introduction to Annex III to Directive 93/71/EEC.

2.3

Tests and analyses, required under the provisions of section 6 points 6.2 to 6.6 of this annex, shall, where they are conducted within the territory of the state, be conducted in accordance with the Principles of Good Experimental Practice set out in the Sixth Schedule, or in compliance with Irish/European Standard IS/EN 45001 and in accordance with the authorization for trials or trials permit concerned.

2.4

Notwithstanding the provisions of point 2.1, during the period to 31 December 1999, tests and analyses done to obtain data on the properties and/or safety with respect to honeybees and beneficial arthropods other than bees may have been conducted by officially recognized testing facilities or organisations, in accordance with the principles laid down in the Sixth Schedule, or in compliance with Irish/European Standard IS/EN 45001, where they are conducted within the territory of the state, and in accordance with the requirements of points 2.2 and 2.3 of the introduction to Annex III to Directive 93/71/EEC, where they are conducted outside the territory of the state.

3

The information required shall include the proposed classification and labelling of the plant protection product in accordance with relevant Community Directives.

4

In individual cases it may be necessary to require certain information as provided for in Annex II, Part A, for formulants. Before such information will be required and before possibly new studies have to be performed, all information on the formulant, made available to the competent authority, shall be considered, in particular when

— the use of the formulant is permitted in food, animal feeding stuffs, medicines or cosmetics in accordance with Community legislation; or

— a safety data sheet has been submitted for the formulant in accordance with Council Directive 67/548/EEC of 27 June 1967, on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.

PART A

Chemical preparations

1

Identity of the plant protection product

The information provided, taken together with that provided for the active substance(s), must be sufficient to identify preparations, with precision, and to define them in terms of their specification and nature. The information and data referred to, unless otherwise specified, are required for all plant protection products.

1.1

Applicant (name and address, etc.)

The name and address of the applicant (permanent community address) must be provided as must the name, position, telephone and telefax number of the appropriate person to contact.

Where, in addition, the applicant has an office, agent or representative in the territory of the State, the name and address of the local office, agent or representative should be provided, as should the name, position, telephone and telefax number of the appropriate person to contact.

1.2

Manufacturer of the preparation and the active substance(s) (names and addresses, etc. including location of plants)

The name and address of the manufacturer of the preparation and of each active substance in the preparation must be provided as must the name and address of each manufacturing plant in which the preparation and active substance are manufactured. A contact point (preferably a central contact point, to include name, telephone and telefax numbers) must be provided for each.

If the active substance originates from a manufacturer from which data according to Annex II had not been submitted previously, a statement of purity and detailed information on the impurities as required in Annex II must be provided.

1.3

Trade name or proposed trade name, and manufacturer's development code number of the preparation if appropriate

All former and current trade names and proposed trade names and development code numbers of the preparation as well as the current names and numbers must be provided. Where trade names and code numbers referred to, relate to similar but different preparations (possibly obsolete), full details of the differences, must be provided. (The proposed trade name may not give rise to confusion with the trade name of plant protection products already authorized).

1.4

Detailed quantitative and qualitative information on the composition of the preparation (active substance(s), and formulant (s)

1.4.1

For preparations the following information must be reported—

— the content of both technical active substance(s) and pure active substance(s); and

— the content of formulants,

The concentrations must be expressed in terms as provided for in Article 6(2) of the Directive of 197.

1.4.2

For active substances their ISO common names or proposed ISO common names and their CIPAC numbers, and, where available, the EEC (EINECS or ELINCS) numbers must be provided. Where relevant it must be stated which salt, ester, anion or cation is present.

1.4.3

Formulants must where possible, be identified both by their chemical name as given in Annex I to the Directive of 1967, or, if not included in that Directive, in accordance with both IUPAC and CA nomenclature. Their structure or structural formula must be provided. For each component of formulants the relevant EEC (EINECS or ELINCS) number and CAS number where they exist, must be provided. Where the information provided does not fully identify a formulant, an appropriate specification must be provided. The trade name of formulants, where they exist, must also be provided.

1.4.4

For formulants the function must be given

adhesive (sticker)

preservative

antifoaming agent

odourant

antifreeze

perfume

binder

propellant

buffer

repellent

carrier

safener

deodorant

solvent

dispersing agent

stabiliser

dye

synergist

emetic

thickener

emulsifier

wetting agent

fertilizer

miscellaneous (specify)

1.5

Physical state and nature of the preparation (emulsifiable concentrate, wettable powder, solution etc.)

1.5.1

The type and code of preparation must be designated in accordance with Annex 2 to Part 2 of the Fourth Schedule.

Where a particular preparation is not defined precisely in that Annex, a full description of the physical nature and state of the preparation must be provided, together with a proposal for a suitable description of the type of preparation and a proposal for its definition.

1.6

Function (herbicide, insecticide, etc.)

The function must be specified from among the following

acaricide

plant growth regulator

bactericide

repellant

fungicide

rodenticide

herbicide

semio-chemicals

insecticide

talpicide

molluscicide

viricide

nematicide

other (must be specified)

2

Physical, chemical and technical properties of the plant protection product

The extent to which plant protection products for which authorization is sought, comply with relevant FAO specifications as agreed by the Group of Experts on Pesticide Specifications, of the FAO Panel of Experts on Pesticide Specifications, Registration Requirements and Application Standards, must be stated. Divergences from FAO specifications must be described in detail, and justified.

2.1

Appearance (colour and odour)

A description of both the colour and odour, if any, and the physical state of the preparation, must be provided.

2.2

Explosivity and oxidizing properties

2.2.1

The explosive properties of preparations must be determined in accordance with EEC Method A 14 and be reported. Where available thermodynamic information establishes beyond reasonable doubt, that the preparation is incapable of exothermic reaction, it is sufficient to provide that information as a justification for not determining the explosive properties of the preparation.

2.2.2

The oxidizing properties of preparations which are solids, must be determined in accordance with EEC Method A 17 and be reported. For other preparations the method used must be justified. Oxidizing properties do not have to be determined if it can be shown without reasonable doubt, on the basis of thermodynamic information, that the preparation is incapable of reacting exothermically with combustible materials.

2.3

Flash point and other indications of flammability or spontaneous ignition

The flash point of liquids which contain flammable solvents, must be determined in accordance with EEC Method A 9 and be reported. The flammability of solid preparations and gasses must be determined in accordance with EEC Method A 10, A 11 or A 12, as appropriate, and be reported. The auto-flammability of preparations, determined in accordance with EEC Method A 15 or A 16 as appropriate, and/or, where necessary, in accordance with the UN-Bowes-Cameron-Cage-Test (UN-Recommendations on the Transport of Dangerous Goods, Chapter 14, Nr. l4.3.4), must be reported.

2.4

Acidity/alkalinity and if necessary pH value

2.4.1

In the case of preparations which are acidic (pH10) the acidity or alkalinity and the pH value must be determined in accordance with CIPAC Method MT31 and MT75 respectively, and be reported.

2.4.2

Where relevant (if to be applied as aqueous dilution) the pH of a 1% aqueous dilution, emulsion or dispersion of the preparation, must be determined in accordance with CIPAC Method MT75 and be reported.

2.5

Viscosity and surface tension

2.5.1

In the case of liquid preparations for Ultra Low Volume use (ULV) the kinematic viscosity must be determined in accordance with OECD Test Guideline 14 and be reported.

2.5.2

For non newtonian liquids the viscosity must be determined and reported together with the test conditions.

2.5.3

In the case of liquid preparations the surface tension must be determined in accordance with EEC Method A 5 and be reported,

2.6

Relative density and bulk density

2.6.1

The relative density of liquid preparations must be determined in accordance with EEC Method A 3 and be reported.

2.6.2

The bulk (tap) density of preparations which are powders or granules, must be determined in accordance with CIPAC Methods MT33, MT159 or MT169, as appropriate, and be reported.

2.7

Storage stability — stability and shelf-life. Effects of light, temperature and humidity on technical characteristics of the plant protection product

2.7.1

The stability of the preparation after storage for 14 days at 54°C must be determined in accordance with CIPAC Method MT46 and be reported. Other storage times and/or temperatures may be needed (e.g. 8 weeks at 40°C or 12 weeks at 35°C or 18 weeks at 30°C) if the preparation is heat sensitive.

If the active substance content after the heat stability test has decreased by more than 5% of the initial determined content, the minimum content must be declared and information on the degradation products must be supplied.

2.7.2

Additionally in the case of liquid preparations, the effect of low temperatures on stability, must be determined in accordance with CIPAC Methods MT39, MT48, MT51 or MT54, as appropriate, and be reported.

2.7.3

The shelf life of the preparation at ambient temperatures must be reported. Where shelf life is less than two years, the shelf life in months, with appropriate temperature specifications, must be reported. Useful information relating to such testing is contained in GIFAP Monograph No 17.

2.8

Technical characteristics of the plant protection product

The technical characteristics of the preparation must be determined to permit a decision to be made as to its acceptability.

2.8.1

Wettability

The wettability of solid preparations which are diluted for use (e.g. wettable powders, water soluble powders, water soluble granules and water dispersible granules), must be determined in accordance with CIPAC Method MT53.3 and be reported.

2.8.2

Persistent foaming

The persistence of foaming of preparations to be diluted with water, must be determined in accordance with CIPAC Method MT47 must be reported.

2.8.3

Suspensibility and suspension stability

2.8.3.1

The suspensibility of water dispersible products (e.g. wettable powders, water dispersible granules, suspension concentrates) must be determined in accordance with CIPAC Method MT15, MT161 or MT168, as appropriate and be reported.

2.8.3.2

The spontaneity or dispersibility of water dispersible products (e.g. suspension concentrates and water dispersible granules) must be determined in accordance with CIPAC Methods MT160 or MT174, as appropriate, and be reported.

2.8.4

Dilution stability

The dilution stability of water soluble products must be determined in accordance with CIPAC Method MT41 and be reported.

2.8.5

Dry sieve test and wet sieve test

In order to ensure that dustable powders have a suitable particle size distribution for ease of application, a dry sieve test must be conducted in accordance with CIPAC Method MT59.1 and be reported.

In the case of water dispersible products, a wet sieve test must be conducted in accordance with CIPAC Method MT59.3 or MT167, as appropriate, must be reported.

2.8.6

Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules)

2.8.6.1

The size distribution of particles in the case of powders, must be determined in accordance with OECD Method 110 and be reported.

The nominal size range of granules for direct application must be determined in accordance with CIPAC MT58.3 and for water dispersible granules and in accordance with CIPAC MT170, and be reported.

2.8.6.2

The dust content of granular preparations, must be determined in accordance with CIPAC Method MT171 and be reported. If relevant for operator exposure the particle size of dust must be determined in accordance with OECD Method 110 and be reported.

2.8.6.3

The friability and attrition characteristics of granules, must be determined and reported once internationally agreed methods are available. Where relevant data are available they must be reported together with details of the method used.

2.8.7

Emulsifiability, Re-emulsifiability, emulsion stability

2.8.7.1

The emulsifiability, emulsion stability and re-emulsifiability of preparations which form emulsions, must be determined in accordance with CIPAC Methods MT36 or MT173, as appropriate, and be reported.

2.8.7.2

The stability of dilute emulsions and of preparations which are emulsions, must be determined in accordance with CIPAC Method MT20 or MT173, as appropriate, and be reported.

2.8.8

Flowability, pourability (rinsability) and dustability

2.8.8.1

The flowability of granular preparations must be determined in accordance with CIPAC Method MT172 and be reported.

2.8.8.2

The pourability (including rinsed residue) of suspensions (e.g. suspension concentrates, suspo-emulsions), must be determined in accordance with CIPAC Method MT148 and be reported.

2.8.8.3

The dustability of dustable powders following accelerated storage as specified in paragraph 2.7.1 must be determined in accordance with CIPAC Method MT34 or another suitable method and be reported.

2.9

Physical and chemical compatibility with other products including plant protection products with which its use is to be authorized

2.9.1

The physical compatibility of tank mixes must be determined using in-house test methods and be reported. A practical test is an acceptable alternative.

2.9.2

The chemical compatibility of tank mixes must be determined and reported except where examination of the individual properties of the preparations establishes beyond reasonable doubt that there is no possibility of reaction taking place. In such cases it is sufficient to provide that information as justification for not determining chemical compatibility.

2.10

Adherence and distribution to seeds

In the case of preparations for seed treatment, both distribution and adhesion must be investigated and reported; in the case of distribution in accordance with CIPAC Method MT175.

2.1.1

Summary and evaluation of data presented under points 2.1 to 2.10

3

Data on application

3.1

Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening

The field(s) of use, existing and proposed, for preparations containing the active substance must be specified from among the following

Field use

— Agriculture

— Horticulture

— Forestry

— Viticulture

Protected crops

Amenity

Weed control on non-cultivated areas

Home gardening

House plants

Plant products storage practice

Other (specify)

3.2

Effects on harmful organisms, e.g. contact, inhalation or stomach poison, fungitoxic or fungistatic, etc., systemic or not in plants

3.2.1

The nature of the effects on harmful organisms must be stated

contact action

stomach action

inhalation action

fungitoxic action

fungistatic action

desiccant

reproduction inhibitor

other (must be specified)

It must be stated whether or not the active substance is translocated in plants and where relevant whether such translocation is apoplastic, symplastic or both.

3.3

Details of intended use e.g. types of harmful organisms controlled and/or plants or plant products to be protected

Details of the intended use must be provided.

Where relevant, effects achieved e.g. sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilization etc. must be reported.

3.4

Application rate

For each method of application and each use, the rate of application per unit (ha, m , m

3

) treated, in terms of g or kg of both preparation and active substance, must be provided.

Application rates shall normally be expressed in g or kg/ha or in kg/m

3

and where appropriate in g or kg/tonne; for protected crops and home gardening use rates shall be expressed in g or kg/100mor g or kg/m

3

.

3.5

Concentration of active substance in material used (e.g. in the diluted spray, baits or treated seed)

The content of active substance shall be reported, as appropriate, in g/l, g/kg, mg/kg or in g/tonne.

3.6

Method of application

The method of application proposed must be described fully, indicating the type of equipment to be used, if any, as well as the type and volume of diluent to be used per unit of area or volume.

3.7

Number and timing of applications and duration of protection

The maximum number of applications to be used and their timing, must be reported. Where relevant the growth stages of the crop or plants to be protected and the development stages of the harmful organisms, must be indicated. Where possible the interval between applications, in days, must be stated.

The duration of protection afforded both by each application and by the maximum number of applications to be used, must be indicated.

3.8

Necessary waiting periods or other precautions to avoid Phytotoxic effects on succeeding crops

Where relevant, minimum waiting periods between last application and sowing or planting of succeeding crops, which are necessary to avoid phytotoxic effects on succeeding crops, must be stated, and follow from the data provided under paragraph 6.6.

Limitations on choice of succeeding crops, if any, must be stated.

3.9

Proposed instructions for use

The proposed instructions for use of the preparation, to be printed on labels and leaflets, must be provided.

4

Further information on the plant protection product

4.1

Packaging (type, materials, size etc.), compatibility of the preparation with proposed packaging materials

4.1.1

Packaging to be used must be fully described and specified in terms of the materials used, manner of construction (e.g. extruded, welded etc.), size and capacity, size of opening, type of closure and seals. It must be designed in accordance with the criteria and guidelines specified in the FAO "Guidelines for the Packaging of Pesticides".

4.1.2

The suitability of the packaging, including closures, in terms of its strength, leakproofness and resistance to normal transport and handling, must be determined in accordance with ADR Methods 3552, 3553, 3560, 3554, 3555, 3556 and 3558, or ADR methods for intermediate bulk containers, as appropriate, and where child resistant closures are required, in accordance with ISO Standard 8317, and be reported.

4.1.3

The resistance of the packaging material to its contents must be determined in accordance with GIFAP Monograph no. 17, and be reported.

4.2

Procedures for cleaning application equipment

Cleaning procedures for both application equipment and protective clothing must be described in detail. The effectiveness of the cleaning procedure, must be fully investigated and reported.

4.3

Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment

The information provided must follow from and be supported by the data provided for the active substance(s) and that provided under sections 7 and 8.

4.3.1

Where relevant, pre-harvest intervals, re-entry periods or withholding periods necessary to minimize the presence of residues in or on crops, plants and plant products, or in or on treated areas or spaces, with a view to protecting man or livestock, must be specified e.g.

— pre-harvest interval (in days) for each relevant crop;

— re-entry period (in days) for livestock, to areas to be grazed;

— re-entry period (in hours or days) for man to crops, buildings or spaces treated;

— withholding period (in days) for animal feedingstuffs;

— waiting period (in days), between application and handling treated products; or

— waiting period (in days), between last application and sowing or planting succeeding crops.

4.3.2

Where necessary, in the light of test results, information on any specific agricultural, plant health or environmental conditions under which the preparation may or may not be used, must be provided.

4.4

Recommended methods and precautions concerning: handling, storage, transport or fire

The recommended methods and precautions concerning handling procedures (detailed) for the storage, at both warehouse and user level of plant protection products, for their transport and in the event of fire must be provided, Where available, information on combustion products must be provided. The risks likely to arise and the methods and procedures to minimize the hazards arising, must be specified. Procedures to preclude or minimize the generation of waste or leftovers must be provided.

Where relevant, assessment must be conducted in accordance with ISO-TR 9122.

Where relevant, the nature and characteristics of protective clothing and equipment proposed must be reported. The data provided must be sufficient to permit an evaluation to be made of the suitability and effectiveness of the protective clothing under realistic conditions of use (e.g. field or glasshouse circumstances).

4.5

Emergency measures in the case of an accident

Whether arising during transport, storage or use, detailed procedures to be followed in the event of an emergency, must be provided, and include procedures for—

— containment of spillages;

— decontamination of areas, vehicles and buildings;

— disposal of damaged packaging, adsorbents and other materials;

— protection of emergency workers and bystanders; and

— first aid measures.

4.6

Procedures for destruction or decontamination of the plant protection product and its packaging

Procedures for destruction and decontamination must be developed for both small quantities (user level) and large quantities (warehouse level). The procedures must be consistent with provisions in place relating to the disposal of waste and of toxic waste. The means of disposal proposed should be without unacceptable influence on the environment and be the most cost effective and practical means of disposal feasible.

4.6.1

Possibility of neutralization

Neutralization procedures (e.g. by reaction with alkali to form less toxic compounds) for use in the event of accidental spillages, must where they are feasible, be described. The products produced after neutralization should be identified (through analysis or on the basis of theoretical considerations)and be reported.

4.6.2

Controlled incineration

In many cases the preferred or sole means to safely dispose of active substances as well as plant protection products containing them, contaminated materials, or contaminated packaging, is through controlled incineration in a licensed incinerator.

Where the content of halogens of the active substance(s) in the preparation is greater than 60%, the pyrolytic behaviour of the active substance under controlled conditions (including, where relevant, supply of oxygen and residence time), at 800°C and the content of polyhalogenated dibenzo-p-dioxins and dibenzo-furans in the products of pyrolysis must be reported. The applicant must provide detailed instructions for safe disposal.

4.6.3

Others

Other methods to dispose of plant protection products, packaging and contaminated materials, where proposed, must be fully described. Data must be provided for such methods, to establish their effectiveness and safety.

5

Analytical methods

5.1

Analytical methods for determining the composition of the plant protection product

5.2

In so far as not covered by Annex II, Part A, point 4.2, analytical methods including recovery rates and the limits of determination for residues and where relevant on, the following;

5.2.1

Treated plants, plant products, foodstuffs, feeding-stuffs

5.2.2

Soil

5.2.3

Water (including drinking water)

5.2.4

Air

5.2.5

Animal and human body fluids and tissues

6

Efficacy data

General

The data supplied must be sufficient to permit an evaluation of the plant protection product to be made. In particular it must be possible to evaluate the nature and extent of benefits that accrue following use of the preparation, where they exist in comparison to suitable reference products and damage thresholds, and to define its conditions of use.

The number of trials to be conducted and reported depends mainly on factors such as the extent to which the properties of the active substance(s) it contains are known and on the range of conditions that arise, including variability in plant health conditions, climatic differences, the range of agricultural practices, the uniformity of the crops, the mode of application, the type of harmful organism and the type of plant protection product.

Sufficient data must be generated and submitted to confirm that patterns determined hold for the regions and the range of conditions, likely to be encountered in the regions concerned, for which its use is to be recommended. Where an applicant claims that tests in one or more of the proposed regions of use are unnecessary because conditions are comparable with those in other regions where tests have been carried out, the applicant must substantiate the claim for comparability with documentary evidence.

In order to assess seasonal differences, if any, sufficient data must be generated and submitted to confirm the performance of the plant protection products in each agronomically and climatically different region for each particular crop (or commodity)/ harmful organism combination. Normally trials on effectiveness or phytotoxicity, where relevant, in at least two growing seasons must be reported.

If in the opinion of the applicant the trials from the first season adequately confirm the validity of claims made on the basis of extrapolation of results from other crops, commodities or situations or from tests with closely similar preparations, a justification, which is acceptable to the competent authority for not carrying out a second seasons's work must be provided. Conversely, where, because of climatic or plant health conditions or other reasons, the data obtained in any particular season are of limited value for the assessment of performance, trials in one or more further seasons must be conducted and reported.

6.1

Preliminary tests

Reports in summary form of preliminary tests, including glasshouse and field studies, used to assess the biological activity and dose range finding of the plant protection product and of the active substance(s) it contains, must be submitted when requested by the competent authority. These reports will provide additional information for the competent authority when it evaluates the plant protection product. Where this information is not submitted a justification which is acceptable to the competent authority must be provided.

6.2

Testing effectiveness

Aim of the tests

The tests shall provide sufficient data to permit an evaluation of the level, duration and consistency of control or protection or other intended effects of the plant protection product in comparison to suitable reference products, where they exist.

Test conditions

Normally a trial consists of three components: test product, reference product and untreated control.

The performance of the plant protection product must be investigated in relation to suitable reference products, where they exist. A suitable reference product is defined as an authorized plant protection product which has proved to have a sufficient performance in practice under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use. In general, formulation type, effects on the harmful organisms, working spectrum and method of application should be close to those of the tested plant protection product.

Plant protection products must be tested in circumstances where the target harmful organism has been shown to have been present at a level causing or known to cause adverse effects (yield, quality, operational benefit) on an unprotected crop or area or on plants or plant products which have not been treated or where the harmful organism is present at such a level that an evaluation of the plant protection product can be made.

Trials to provide data on plant protection products for control of harmful organisms must show the level of control of the species of harmful organisms concerned or of species representative of groups for which claims are made. Trials must include the different stages of growth or life cycle of the harmful species, where this is relevant and the different strains or races, where these are likely to show different degrees of susceptibility.

Similarly, trials to provide data on plant protection products which are plant growth regulators, must show the level of effects on the species to be treated, and include investigation of differences in the response of a representative sample of the range of cultivars on which its use is proposed.

In order to clarify the dose response, dose rates lower than the recommended one must be included in some trials in order to enable to assess whether the recommended rate is the minimum necessary to achieve the desired effect.

The duration of the effects of treatment must be investigated in relation to the control of the target organism or effect on the treated plants or plant products, as appropriate. When more than one application is recommended, trials must be reported which establish the duration of the effects of an application, the number of applications necessary and the desired intervals between them.

Evidence must be submitted to show that the dose, timing and method of application recommended give adequate control, protection or have the intended effect in the range of circumstances likely to be encountered in practical use.

Unless there are clear indications that the performance of the plant protection product is unlikely to be affected to a significant degree by environmental factors, such as temperature or rain, an investigation of the effects of such factors on performance must be carried out and reported, particularly where it is known that the performance of chemically related products is so affected.

Where proposed label claims include recommendations for the use of the plant protection product with other plant protection product(s) or adjuvant(s) information on the performance of the mixture must be provided.

Test guideline

Trials must be designed to investigate specified issues, to minimize the effects of random variation between different parts of each site and to enable statistical analysis to be applied to results amenable to such analysis. The design, analysis and reporting of trials must be in accordance with European and Mediterranean Plant Protection Organisation (EPPO) guidelines 152 and 181. The report shall include a detailed and critical assessment of the data.

When conducted within the territory of the state, the trials must be carried out in accordance with specific EPPO guidelines, where available. When conducted within the territory of another Member State, the trials must be carried out in accordance with specific EPPO guidelines, where available or when the Member State concerned so requires, in accordance with guidelines satisfying at least the requirements of the corresponding EPPO guidelines.

A statistical analysis of results amenable to such analysis must be carried out; where necessary the test guideline used must be adapted to enable such analysis.

6.3

Information on the occurrence or possible occurrence of the development of resistance

Laboratory data and where it exists, field information relating to the occurrence and development of resistance or cross-resistance in populations of harmful organisms to the active substance(s), or to related active substances, must be provided. Where such information is not directly relevant to the uses for which authorization is sought or to be renewed (different species of harmful organism or different crops), it must, if available, nevertheless be provided, as it may provide an indication of the likelihood of resistance developing in the target population.

Where there is evidence or information to suggest that, in commercial use, the development of resistance is likely, evidence must be generated and submitted as to the sensitivity of the population of the harmful organism concerned to the plant protection product. In such cases a management strategy designed to minimize the likelihood of resistance of cross-resistance developing in target species must be provided.

6.4

Effects on the yield of treated plants or plant products in terms of quantity and/or quality

6.4.1

Effects on the quality of plants or plant products

Aim of the tests

The tests shall provide sufficient data to permit an evaluation of the possible occurrence of taint or odour or other quality aspects of plants or plant products after treatment with the plant protection product.

Circumstances in which required

The possibility of the occurrence of taint or odour in food crops must be investigated and be reported where

— the nature of the product or its use is such that a risk of occurrence of taint or odour might be expected, or

— other products based on the same or a closely similar active substance have been shown to present a risk of occurrence of taint or odour.

The effects of plant protection products on other quality aspects of treated plants or plant products must be investigated and reported where

— the nature of the plant protection product or its use could have an adverse influence on other quality aspects (for example in the case of use of plant growth regulators close to harvest), or

— other products based on the same or a closely similar active substance have been shown to have an adverse influence on the quality.

Testing should be conducted initially on the main crops on which the plant protection product is to be used, at twice the normal rates of application and using, where relevant, the main methods of processing, where effects are observed it is necessary to perform testing at the normal rate of application.

The extent of investigation necessary on other crops will depend on their degree of similarity to the main crops already tested, the quantity and quality of data available on those main crops and how far the manner of use of the plant protection product and methods of processing the crops, if relevant, are similar. it is generally sufficient to perform the test with the main formulation type to be authorized.

6.4.2

Effects on transformation processes

Aim of the tests

The tests shall provide sufficient data to permit an evaluation of the possible occurrence of adverse effects after treatment with the plant protection product on transformation processes or on the quality of their products.

Circumstances in which required

When the treated plants or plant products are normally intended for use in transformation process such as wine making, brewing or bread making and when at harvest significant residues are present, the possibility of the occurrence of adverse effects must be investigated and reported where

— there are indications that the use of the plant protection product could have an influence on the processes involved (for example in the case of use of plant growth regulators or fungicides close to harvest), or

— other products based on the same or a closely similar active substance have been shown to have an adverse influence on these processes or its products.

It is generally sufficient to perform the test with the main formulation type to be authorized.

6.4.3

Effects on the yield of treated plants or plant products

Aim of the tests

The tests shall provide sufficient data to permit an evaluation of the performance of the plant protection product and of the possible occurrence of yield reduction or loss in storage of treated plants or plant products.

Circumstances in which required

The effects of plant protection products on the yield or yield components of treated plants or plant products must be determined where relevant. When treated plants or plant products are likely to be stored the effect on the yield after storage, including data on storage life must be determined where relevant.

This information will normally be available from the tests required under the provisions of point 6.2.

6.5

Phytotoxicity to target plants (including different cultivars), or to target plant products

Aim of the tests

The tests shall provide sufficient data to permit an evaluation of the performance of the plant protection product and of the possible occurrence of phytotoxicity after treatment with the plant protection product.

Circumstances in which required

For herbicides and for other plant protection products for which adverse effects, however transitory, are seen during the trials, performed in accordance to point 6.2, the margins of selectivity on target crops must be established, using twice the recommended rate of application. Where serious phytotoxic effects are seen, an intermediate application rate must also be investigated.

Where adverse effects occur, but are claimed to be unimportant in comparison with the benefits of use or to be transient, evidence to support this claim is required. If necessary yield measurements must be submitted.

The safety of a plant protection product to the main cultivars of the main crops for which it is recommended must be demonstrated, including effects of crop growth stage, vigour, and other factors which may influence susceptibility to damage or injury.

The extent of investigation necessary on other crops will depend on their degree of similarity to the main crops already tested, the quantity and quality of data available on those main crops and how far the manner of use of the plant protection product, if relevant, is similar. It is generally sufficient to perform the test with the main formulation type to be authorized.

Where proposed label claims include recommendations for the use of the plant protection product with other plant protection product(s) or adjuvant(s), the provision of the previous paragraphs apply for the mixture.

Test guideline

Observations concerning phytotoxicity must be recorded and reported in the tests provided for under point 6.2.

Where phytotoxic effects are seen, they must be accurately assessed and recorded in accordance with EPPO Guideline 135, where testing is conducted within the territory of the state. When conducted within the territory of another Member State, the trials must be carried out in accordance with EPPO Guideline 135, or when the Member State concerned so requires, in accordance with guidelines satisfying at least the requirements of EPPO Guideline 135.

A statistical analysis of results amenable to such analysis must be carried out, where necessary the test guideline used must be adapted to enable such analysis.

6.6

Observations on undesirable or unintended side-effects e.g. on beneficial and other non-target organisms, on succeeding crops, other plants or parts of treated plants used for propagating purposes (e.g. seeds, cuttings, runners)

6.6.1

Impact on succeeding crops

Aim of the information required

Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on succeeding crops.

Circumstances in which required

Where data, generated in accordance with section 9, point 9.1, shows that significant residues of the active substance, its metabolites or degradation products, which have or may have biological activity on succeeding crops, remain in soil or in plant materials, such as straw or organic material up to sowing or planting time of possible succeeding crops, observations must be submitted on effects on the normal range of succeeding crops.

6.6.2

Impact on other plants, including adjacent crops

Aim of the information required

Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on other plants, including adjacent crops.

Circumstances in which required

Observations must be submitted on adverse effects on other plants, including the normal range of adjacent crops, when there are indications that the plant protection product could affect these plants via vapour drift.

6.6.3

Impact on treated plants or plant products to be used for propagation

Aim of the information required

Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on plants or plant products to be used for propagation.

Circumstances in which required

Observations must be submitted on the impact of plant protection products on plant parts used for propagation except where the proposed uses preclude use on crops intended for production of seeds, cuttings, runners or tubers for planting, as appropriate

(i) For seeds — viability, germination and vigour

(ii) Cuttings — rooting and growth rates

(iii) Runners — establishment and growth rates

(iv) Tubers — sprouting and normal growth

Test guideline

For seeds testing shall be done according to ISTA methods

25

.

6.6.4

Effects on beneficial and other non-target organisms

Any effects, positive or negative, on the incidence of other harmful organisms, observed in the tests performed in accordance with the requirements of this section, shall be reported. Any observed environmental effects must also be reported, especially effects on wildlife and/or beneficial organisms.

6.7

Summary and evaluation of data presented under 6.1 to 6.6

A summary of all data and information provided under points 6.1 to 6.6 must be provided, together with a detailed and a critical assessment of the data, with particular reference to the benefits that the plant protection product offers, adverse effects that do or may arise and measures necessary to avoid or minimize adverse effects.

7

Toxicological studies

7.1

Acute toxicity

7.1.1

Oral

7.1.2

Percutaneous

7.1.3

Inhalation

7.1.4

Skin and, where relevant, eye irritation

25

International Rules for Seed Testing, 1985. Proceedings of the International Seed Testing Association, Seed Science and Technology, Volume 13, Number 2,1985.

7.1.5

Skin sensitization

7.1.6

Where appropriate, acute dermal toxicity, skin and eye irritation for combinations of plant protection products for which authorization is sought for use in such combinations

7.2

Operator exposure

7.2.1

Dermal absorption

7.2.2

Likely operator exposure under field conditions, including where relevant quantitative analysis of operator exposure

7.2.3

Available toxicological data relating to non-active substances

8

Residues in or on treated products, food and feed

8.1

Data from supervised trials in crops, food or feeding stuffs, for which authorized use is sought, giving all experimental conditions and details, including residue data concerning the active substance, relevant metabolites and relevant other constituents of the plant protection product, from time of application until harvest, or in the case of post-harvest treatment, breakdown of residues during storage and levels of residues at time of release from storage for marketing. Data should be available for the range of climatic and agronomic conditions likely to be encountered in the proposed area of use.

8.2

Effects of industrial processing and/or household preparation on the nature and magnitude of residues

8.3

Effects on taint, odour, taste or other quality aspects due to residues in or on fresh or processed products

8.4

Estimation of residues in products of animal origin resulting from ingestion of feeding stuffs or resulting from contact with bedding, on the basis of residue data referred to in point 8.1 and studies in livestock referred to in Annex II, Part A, point 6.5

8.5

Residue data in succeeding or rotational crops where presence of residues might be expected

8.6

Proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses

8.7

Proposed maximum residue levels (MRLs) and justification of the acceptability of these residues

8.8

Summary and evaluation of the residue behaviour on the basis of the data submitted under points 8.1 to 8.7

9

Fate and behaviour in the environment

The information provided must, where relevant, include that referred to in Annex II, part A. point 7, and

9.1

Testing for distribution and dissipation in soil

9.2

Testing for distribution and dissipation in water

G

9.3

Testing for distribution and dissipation in air

10

Ecotoxicological studies

10.1

Effects on birds

10.1.1

Acute oral toxicity

10.1.2

Supervised trials to assess risks to avian species under field conditions

10.1.3

If appropriate, studies on acceptance of bait, granules, or treated seeds by birds

10.2

Effects on aquatic organisms

10.2.1

Acute toxicity to fish

10.2.2

Acute toxicity to Daphnia magna

10.2.3

Overspray study (if toxic to fish or other aquatic organisms and persistent in water) to assess risks to aquatic organisms under field conditions

10.2.4

In case of application in/at surface waters

10.2.4.1

Particular studies with fish and other aquatic organisms

10.2.4.2

Residue data in fish concerning the active substance and including toxicologically relevant metabolites

10.2.5

The studies referred to in Annex II, Part A, points 8.2.2, 8.2.3, 8.2.4, 8.2.6, and 8.2.7 may be required for particular plant protection products

10.3

Effects on other non-target organisms

10.3.1

Effects on terrestrial vertebrates other than birds

10.3.2

Toxicity to honey-bees

10.3.3

Toxicity to foraging bees under field conditions

10.3.4

Effects on beneficial arthropods other than bees

10.3.5

Effects on earthworms and other soil non-target macro-organisms, believed to be at risk

10.3.6

Effects on soil non-target micro-organisms

10.3.7

Available data from biological primary screening in summary form

11

Summary and evaluation of points 9 and 10

12

Further information

12.1

Information on authorization in other countries

12.2

Information on established maximum residue limits (MRL) in other countries

12.3

Proposals including justification for the classification and labelling proposed in accordance with Directive 67/548/EEC and Directive 78/631/EEC

— Hazard symbol(s)

— Indication of danger

— Risk phrases

— Safety phrases

12.4

Proposals for risk and safety phrases in accordance with Article 15(1), (g) and (h) and proposed label

12.5

Specimens of proposed packaging

PART B

Preparations of micro-organisms or viruses

(this part does not apply to GMOs where points come under Directive 90/220/EEC)

1

Identity of the plant protection product

1.1

Applicant (name, address, etc.)

1.2

Manufacturer of the preparation and the active agent(s) (names, addresses, etc., including location of plants)

1.3

Trade name or proposed trade name and manufacturer's development code number for the plant protection product, if appropriate

1.4

Detailed quantitative and qualitative information on the composition of the plant protection product (active organism(s), insert components, extraneous organisms, etc.)

1.5

Physical state and nature of the plant protection product (emulsifiable concentrate, wettable powder, etc.)

1.6

Use category (insecticide, fungicide, etc.)

2

Technical properties of the plant protection product

2.1

Appearance (colour and odour)

2.2

Storage stability — stability and shelf-life. Effects of temperature, method of packaging and storage, etc. on retention of biological activity

2.3

Methods for establishing storage and shelf-life stability

2.4

Technical characteristics of the preparation

2.4.1

Wettability

2.4.2

Persistent foaming

2.4.3

Suspensibility and suspension stability

2.4.4

Wet sieve test and dry sieve test

2.4.5

Particle size distribution, content of dust/fines, attrition and friability

2.4.6

In the case of granules, sieve test and indications of weight distribution of the granules, at least of the fraction with particle sizes bigger than 1 mm

2.4.7

Content of active substance in or on bait particles, granules, or treated seed

2.4.8

Emulsifiability, re-emulsifiability, emulsion stability

2.4.9

Flowability, pourability and dustability

2.5

Physical and chemical compatibility with other products including plant protection products with which its use is to be authorized

2.6

Wetting, adherence and distribution to target plants

3

Data on applications

3.1

Field of use, e.g. field, glasshouse, food or feed storage, home garden

3.2

Details of intended use, e.g. types of harmful organism controlled and/or plants or plant products to be protected

3.3

Application rate

3.4

Where necessary, in the light of the test results, any specific agricultural, plant health and/or environmental conditions under which the product may or may not be used

3.5

Concentration of active substance in material used (e.g. % concentration in the diluted spray)

3.6

Method of application

3.7

Number and timing of application

3.8

Phytopathogenicity

3.9

Proposed instructions for use

4

Further information on the preparation

4.1

Packaging (type, materials, size, etc.), compatibility of the preparation with proposed packaging materials

4.2

Procedures for cleaning applications equipment

4.3

Re-entry periods, necessary waiting periods or other precautions to protect humans and animals

4.4

Recommended methods and precautions concerning handling, storage, transport

4.5

Emergency measures in case of an accident

4.6

Procedures for destruction of decontamination of the plant protection product and its packaging

5

Analytical methods

5.1

Analytical methods for determining the composition of the plant protection product

5.2

Methods for determining residues in or on treated plants or in or on plant products (e.g. biotest)

5.3

Methods used to show microbiological purity of the plant protection product

5.4

Methods used to show the plant protection product to be free from any human and other mammalian pathogens or, if need be, from honey-bee pathogens

5.5

Techniques used to ensure a uniform product and assay methods for its standardization

6

Efficacy data

6.1

Preliminary range-finding tests

6.2

Field experimentation

6.3

Information on the possible occurrence of the development of resistance

6.4

Effects on the quality and where appropriate on the yield of treated plants or effects on the quality of treated plant products

6.5

Phytotoxicity to target plants (including different cultivars), or to target plant products

6.6

Observations concerning undesirable or unintended side-effects, e.g. on beneficial and other non-target organisms, on succeeding crops, other plants or parts of treated plants used for propagation purposes (e.g. seeds, cuttings, runners)

6.7

Summary and evaluation of data presented under points 6.1 to 6.6

7

Toxicity and/or pathogenicity and infectivity studies

7.1

Oral single dose

7.2

Percutaneous single dose

7.3

Inhalation

7.4

Skin and where relevant eye irritation

7.5

Skin sensitization

7.6

Available toxicological data relating to non-active substances

7.7

Operator exposure

7.7.1

Percutaneous absorption

7.7.2

Likely operator exposure under field conditions, including where relevant quantitative analysis of operator exposure

8

Residues in or on treated products, food and feed

8.1

Residue data concerning the active substance including data from supervised trials in crops, food or feeding stuffs for which authorization for use is sought, giving all experimental conditions and details. Data should be available for the range of different climatic and agronomic conditions encountered in the proposed area of use. It is also necessary to identify viable and non-viable residues in treated crops

8.2

Effects of industrial processing and/or household preparation on the nature and magnitude of residues, if appropriate

8.3

Effects on taint, odour, taste or other quality aspects due to residues on or in fresh or processed products, if appropriate

8.4

Residue data in products of animal origin resulting from ingestion of feeding stuffs or contact with bedding, if appropriate

8.5

Residue data in succeeding or rotational crops where presence of residues might be expected

8.6

Proposed pre-harvest intervals for envisaged uses or withholding periods, or storage periods, in the case of post-harvest uses

8.7

Proposed maximum residue levels (MRLs) and the justification of the acceptability of these levels (for toxins), if appropriate

8.8

Summary and evaluation of the residue behaviour on the basis of the data submitted under points 8.1 to 8.7

9

Fate and behaviour in the environment

9.1

In cases where toxins are produced, data as outlined under Part A, point 9 are required, if appropriate

10

Ecotoxicological studies

10.1

Effects on aquatic organisms

10.1.1

Fish

10.1.2

Studies in Daphnia magna and in species closely related to the target organisms

10.1.3

Studies in aquatic micro-organisms

10.2

Effects on beneficial and other non-target organisms

10.2.1

Effects on honey-bees, if appropriate

10.2.2

Effects on other beneficial organisms

10.2.3

Effects on earthworms

10.2.4

Effects on other soil fauna

10.2.5

Effects on other non-target organisms believed to be at risk

10.2.6

Effects on soil microflora

11

Summary and evaluation of points 9 and 10

12

Further information

12.1

Information on authorization in other countries

12.2

Information on established maximum residue limits (MRLs) in other countries

12.3

Proposals including justification for the classification and labelling proposed in accordance with Directives 67/548/EEC and 78/631/EEC

— Hazard symbol(s)

— Indication of danger

— Risk phrases

— Safety phrases

12.4

Proposals for risk and safety phrases in accordance with Article 15(1)(g) and (h) and proposed label

12.5

Specimens of proposed packaging

Part 3

Annex IV

(Annex IV to the Directive of 1991)

Pro Memoria

Part 4

Annex V

Annex V to the Directive of 1991)

Pro Memoria

Part 5

Annex VI

(Annex VI to the Directive of 1991)

Pro Memoria

Part 6

Annex VII

(Annex IX to Council Directive 67/548/EEC as amended by the Directive of 1992 and adapted by Commission Directive 91/410/EEC)

PROVISIONS RELATING TO CHILD-PROOF FASTENINGS

1.

Re-closable packages

Child-proof fastenings used on re-closable packages shall comply with ISO Standard 8317 (1 July 1989 edition) relating to Child-resistant packages — Requirements and methods of testing for re-closable packages adopted by the International Standard Organization (ISO).

2.

Non-re-closable packages

(pro memoria)

3.

Notes

S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994.

Table of Provisions (12)

Statutory Text (12 Articles)

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