Plant Protection Products Regulations, 2004 (scheduleone)

L.N. 115 of 2004

PESTICIDES CONTROL ACT 2001

(ACT NO. XI OF 2001)

Plant Protection Products Regulations, 2004

IN exercise of the powers conferred by articles 4 and 5 of the

Pesticides Control Act, 2001, the Minister for Rural Affairs and the

Environment, has made the following regulations>-

The title of these regulations is the Plant Protection Products

Regulations 2004, and shall come into force as follows>

(a) the provisions under Part Two

(i) on the expiry of thirty days following the publication

of these regulations in the Gazette in relation to plant

protection products not listed under Schedule One to these

regulations<

(ii) on the first day of May, 2004 in relation to plant

protection products listed in Schedule One of these

regulations< and

(b) on the expiry of thirty days following the publication of

these regulations in the Gazette in relation to all other provisions

of these regulations.

(Regulation 1)

LIST OF PLANT PROTECTION PRODUCTS

Afalon

Linuron

Antracol 70 WP

Propineb 70%

Azuram

Copper oxychloride 40%

Basta F 1

Glufosinate-ammonium 150 gr/l

Bayfidan 50 WP

Triadimenol 5%

Benazim

Carbendazim 50%

Betapal Concentrate

2 naphthylacetic acid

Bolas BT

Bacillus thuringensis

Borial

Iprodione50%

Calypso

Thiacloprid 480 g/l

Chess/Plenum 50 WG

Pymetrozine

Click 50Fl

Terbutilazine 500g/l

Clortosip

Chlorthalonil 75wp and 500 sc

Confidor 200SL

Imidacloprid 200 g/l

Curzate M DF

Mancozeb40% cymoxanil4%

Curzate R

Cymoxanil4.2% copper oxychloride 39.75%

Cymonil

Cymonanil 50g/l chlorthalonil 375g/l

Decis 25 EC

Deltamethrin 25 g/l

Diater 5G

Diazinon 5%

Drago

Cymoxanil 6% mancozeb 70%

Enovit-Methyl FL

Thiophanate-methyl 450g/l

Equation Pro

Cymoxanil30% famoxadone22.5%

Equation System

Famoxadone4% fosetyl aluminium60%

Escartox GB

Metadehyde 4.9%

Etifos M

Chlorpyrifos-methyl 22.5%

Gastrotox E

Metaldeide 5%

House Plant Pest Killer

Pyrethrins

Klinamon

Glyphosate41.5%

Lannate 25 WP

Methomyl25%

Matacar

Exithiazox 24g/l

Match 050 EC

Lufenuron

Mavrik 20EC

Fluvalinate

Mesozin

Metribuzin 35%

Metiosep

Methiocarb 2%

Mibiol

White mineral oil 80%

Micene

Mancozeb 80 wp

Mikal WG

Fosetyl-al+folpet 50 + 25%

Mocap

Ethoprophos 10%

Mospilan 20SP

Acetamiprid 20%

Nemasol

Metam-sodium

Nimrod

Bupirimate

Nustar 20 DF

Flusilazole20%

Oxon Malathion

Malathion 500g/l

Pegasus 250 SC

Diafenthiuron

Previcur N

Propamocarb hci 722 g/l

PY Spray Insect Killer

Pyrethrins

PY SprayGarden Insect

Pyrethrins

Killer

Ramecalce

Copper sulphate 98-99% and hyydrated lime

Ramezeb Blu

Mancozeb 30% copper oxychloride 20%

Ramrod FL

Propachlor 480g/l

Ramrod Flow

Propachlor 43.2%

Rapido Pronto USO

Glyphosate 0.8%

Reglone 40 SL

Diquat

Ridomil Gold MZ 68 WP

Mefenoxam and mancozeb

Rooting Powder

1 naphthylacetic acid

Round Up

Isopropylamine salt of glyphosate 41.7%

Round Up Max

Ammonium salt of glyphostae 78.5%

Score 250 EC

Difenoconazole

Sencor 70 WG

Metribuzin 70%

Sepraform PG

Malathion 5%

Sepralim G

Methaldehyde 5%

Sereno

Fenamidone + mancozeb 10+50%

Sipcaprin 500SC

Prometrine 500g/l

Solfato di Rame

Copper sulphate 98-99%

Staf Off

Aluminium ammonium sulphate

Stuart

Indoxacarb30%

Switch 62.5 WG

Cyprodinil and fludioxonil

Tatoo C

Propamocarb hci +chlorothalonil 375 + 375 g/l

Terfox GR

Foxim 1%

Tersan

Methaldehyde 3% fenitrothion 3%

Thiovit Jet 80 WG

Sulfur

Titus

Rimsulfuron 25%

Topas 100 EC

Penconazole

Trebon

Etophenprox 280g/l

Trigard 75 WP

Cyromazine

Vectra

Bromuconazole 100 g/l

Vertimec 018 EC

Abamectin

Vydate 10l

Oxamyl 10%

Vydate 5g

Oxamyl 5%

ZR20 BLU

Mancozeb 20% rame ossicloruro 20%

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

The scope of these regulations is to provide for the

authorisation and control of the dealing, advertising and use of any

plant protection product or any other active substances intended for

use in any plant protection product as specified in the Act.

PART ONE

GENERAL PROVISIONS

In these regulations, unless the context otherwise requires

“Act” means the Pesticides Control Act, 2001<

“advertising” in relation to plant protection products includes

any form of door-to-door information, canvassing activity or

inducement designed to promote the supply, sale or use of plant

protection products and without prejudice to the generality of the

foregoing in particular includes>

(a) the advertising of plant protection products to the general

public or to persons who may be expected to use or supply these

products<

(b) the provision of inducements to prescribe or supply

plant protection products, by way of a gift, offer or promise of

any benefit or bonus, whether in money or in kind, except when

the intrinsic value of such an inducement is minimal< and

(c) sponsorship of any meeting attended by persons

authorised to deal or who generally use these products>

but shall exclude>

(i) the labelling and the accompanying package leaflets,

which are subject to the provisions of Part Five of these regulations<

(ii) correspondence, even if accompanied by material of a

non-promotional nature, which is in reply to a specific question

about a particular plant protection product< and

(iii) factual, informative, announcement or reference

material relating to pack changes, adverse-effect warnings as

part of general precautions, trade catalogues, price lists and other

material of a similar nature provided that such material does

not include any product claim<

“animal” means an animal belonging to species normally fed

and kept or consumed by man or otherwise considered as beneficial<

“authorised representative” means any person duly authorised

by the Director to act on his behalf for any of the purposes referred

to in these regulations<

“dealing” means any activity in the manufacture, import,

export, transport, storage, distribution, presenting for sale or sale

of any plant protection product<

“Department” means the Department responsible for plant

health<

“high-risk plant protection product” means any plant

protection product classified as toxic or highly toxic product in

accordance with regulation 43 of these regulations<

“manufacturer” means the holder of a manufacturing process

for the manufacturing of a biocidal product<

“manufacturing” shall have the same meaning as is assigned

to it in the Act<

“minor crop” means any crop that is cultivated in Malta except

tomatoes, potatoes or grapes<

“professional user” means any person who is authorised to

act as a professional user in accordance with the regulations<

“recognised country’’ means any member state of the

European Community.

PART TWO

AUTHORISATION OF PLANT PROTECTION PRODUCTS

(1) No person shall promote or deal with any active substance

registered in accordance with regulation 5 of these regulations or any

plant protection product unless the product has been authorised by the

Director in accordance with regulations 6 of these regulations.

(2) No person shall place a plant protection product on the

market in Malta unless he is in possession of an authorisation issued to

him in accordance with regulation 6 of these regulations.

(1) The Director shall register any active substance if he has

received>

(a) an application for the registration of that active substance

in such form and such manner and within such timeframe the

Director may from time to time require by Notice in the Gazette<

and

(b) a dossier describing the properties of the active substance

in accordance with Annex II to Council Directive 91#414#EEC of

15 July 1991 concerning the placing of plant protection products

on the market (Official Journal of the European Communities, L

230) and its subsequent amendments.

(2) Registered active substances shall be classified by the

Director, on the basis of information submitted to him in accordance

with sub-regulation (1) above and after taking into consideration the

opinion of the Pesticides Control Board, under any one or more of the

following categories>

(a) an active substance that may be incorporated in a plant

protection product for placing on the market>

Provided that the Director is satisfied that>

(i) such an active substance is suitable for the intended

purpose< and

(ii) such an active substance does not cause any

unacceptable harmful effect on the user through expected handling

or application of the active substance< and

(iii) residues resulting from the use of such an active

substance that could be found in plant products are safe for

consumption by human beings or animals< and

(iv) the dispersal or any residue of such active substance in

the environment through normal use does not result in unacceptable

effects on the environment, including beneficial organisms or

biodiversity.

(b) an active substance that may not be incorporated in a

plant protection product for placing on the market>

Provided that the Director is satisfied that such an active substance

is not in conformity with any of the provisions of sub-paragraph (i) to

(iv) of the provisions to paragraph (a) of this sub-regulation<

(c) an active substance that may only be incorporated in a

high-risk plant protection product for placing on the market>

Provided that the Director is satisfied that such an active substance

is in conformity with all provisions of sub-paragraph (i) to (iv) of the

provisions to paragraph (a) of this sub-regulation but requires use by a

professional user.

(1) The Director shall authorise the placing on the market Granting of an

authorisation to

of any plant protection product if he has>

place a plant

protection product

on the market.

(a) received an application for the issue of an authorisation

in accordance with regulation 14 of these regulations< and

(b) received a product dossier in accordance with regulation

14 and Annex III to Council Directive 91#414#EEC of 15 July 1991

concerning the placing of plant protection products on the market

(Official Journal of the European Communities, L 230) and its

subsequent amendments< and

(c) established that the provisions of sub-regulation (2) of

this regulation are satisfied.

(2) Prior to the issue of an authorisation in accordance

with sub-regulation (1) above, the Director shall, on the basis of

information supplied to him by the applicant, be satisfied that>

(a) all the active substances contained within the plant

protection product are listed in the register of active substances

and classified as an active substance that may be incorporated in

any plant protection product or as an active substance that may be

incorporated in a high risk plant protection product>

Provided that if the active substance is still pending a decision on

its classification, the Director may issue an authorisation pending a final

decision on the classification of the active substance<

(b) the nature and quality of all the active substances

contained within the plant protection product can be determined

by appropriate methods>

Provided that the methods referred to in Annex II to Council

Directive 91#414#EEC of 15 July 1991 concerning the placing of plant

protection products on the market (Official Journal of the European

Communities, L 230) and its subsequent amendments shall be considered

as appropriate methods.

(c) any significant toxic or ecologically harmful impurities

contained within the plant protection product can be determined

by appropriate methods>

Provided that the methods referred to in Annex III to Council

Directive 91#414#EEC of 15 July 1991 concerning the placing of plant

protection products on the market (Official Journal of the European

Communities, L 230) and its subsequent amendments shall be considered

as appropriate methods<

(d) residues in soil, water, plant or plant products that may

result from its authorised use can be determined using appropriate

methods>

Provided that the methods referred to in Annex III to Council

Directive 91#414#EEC of 15 July 1991 concerning the placing of plant

protection products on the market (Official Journal of the European

Communities, L 230) and its subsequent amendments shall be considered

as appropriate methods<

(e) the maximum residue level of any active substance or

related substance that may result from the authorised use is deemed

to be safe and is less or equal to the maximum residue limit that,

may be in force from time to time in accordance with any provisions

made by or under the Act<

(f) the physical and chemical properties of the plant

protection product are acceptable for the intended use and storage

of the plant protection product<

(g) the plant protection product>

(i) is sufficiently effective for the control of harmful

organisms identified in the product dossier<

(ii) has no unacceptable effect on plant material or plant

products<

(iii) does not cause unnecessary suffering or pain to

vertebrates<

(iv) has no direct or indirect harmful effect on human

or animal health if consumed through drinking water, food

or feed<

(v) has no unacceptable influence on the environment

when considering, as a minimum, its distribution in the

environment, its ability to contaminate drinking water or

groundwater, or its impact on beneficial plant or animal

species<

(h) the packaging and labelling requirements detailed in Part

Five of these regulations are satisfied>

Provided that the plant protection product may have different

specifications and characteristics for the labelling and packaging of

different pack sizes.

(3) In establishing compliance with the provisions of sub-

regulation (1) of this regulation the Director shall, where this is relevant,

follow the guidelines specified in Annex VI to Council Directive

91#414#EEC as established by Council Directive 97#57#EC of 22

September 1997 establishing Annex VI to Directive 91#414#EEC

concerning the placing of plant protection products on the market

(Official Journal L 265) and its subsequent amendments.

(4) Any test or analysis carried out by or on behalf of the

Department for the purpose of ensuring that any requirement listed in

sub-regulation (1) of this regulation is satisfied, shall>

(a) be conducted by a person recognised by the Department

to be competent for the carrying out of such test or analysis<

(b) be carried out under relevant and representative Maltese

agricultural, plant health and environmental conditions.

(5) The applicant shall, as soon as practicable, notify the

Department in writing of any change in the information supplied to the

Department in the application or dossier and shall provide the

Department with all the evidence that may be deemed necessary to

support any identified change.

(6) Any authorisation issued in accordance with this

regulation may be subject to any such>

(a) condition relating to the storage, distribution or use of

the plant protection product as the Director may deem necessary

for the purpose of protecting the health of persons coming into

contact with the product<

(b) restriction in use in order to avoid the exposure of any

consumer of any treated produce or product to a risk of dietary

contamination that exceeds the acceptable daily intake of the plant

protection product residue.

(7) The Director shall determine the application within a

reasonable time not exceeding 90 working days from the date of receipt

of an application>

Provided that such time shall be suspended until all the relevant

information is received.

(1) Any authorisation for a plant protection product issued Information found

in an authorisation.

in accordance with regulation 6 of these regulations shall, as a minimum,

(a) the product trade name<

(b) the chemical name and Chemical Abstracts Service

registry number of any active substance contained in the product

formulation<

(c) the approved product formulation<

(d) the classification of the plant protection product as a

high risk plant protection product or otherwise<

(e) the application rates and instructions for use for each

plant or plant produce on which the plant protection product is

being authorised for use<

(f) the approved labelling and packaging including any

advisory phrases or directions that may be related to the storage or

use of the product<

(g) any condition that may be attached to the granting of

the authorisation<

(h) the name and contact details of the holder of the

authorisation<

(i) the authorisation number<

(j) the term of validity of the authorisation< and

(k) any other specification that the Director may deem

necessary.

Any authorisation issued by the Director in accordance with Duration of validity

of an authorisation.

regulation 6 of these regulations shall be valid for such period not

exceeding ten years as may be specified in the authorisation>

Provided that the Director may extend the validity of any such

authorisation upon the submission of an application for its renewal

submitted to him in accordance with regulation 11 of these regulations

and if he is satisfied that the conditions established by regulation 6 of

these regulations are still being complied with.

(1) If the Director suspects that any of the conditions

established by regulation 6 of these regulations is no longer satisfied,

the Director>

(a) shall require the holder of the authorisation to submit

such further information as may be necessary to establish

compliance with the provisions of regulation 6 of these regulations

or such other information as may be reasonably required<

(b) may carry out any review or test that he deems necessary<

(c) may suspend the authorisation in accordance with

regulation 10 of these regulations.

(1) Any authorisation issued in accordance with regulation

6 of these regulations may be suspended or revoked by the Director if it

is established that>

(a) any information or particular supporting the application

for an authorisation was incorrect, false or misleading< or

(b) any requirement as detailed in regulation 6 of these

regulations is no longer satisfied< or

(c) the applicant for authorisation requests that the Director

revokes the authorisation to place on the market, deal or use a

plant protection product in Malta< or

(d) the plant protection product is no longer satisfactory in

the performance of the function or functions for which it was

originally intended as detailed in the plant protection product

dossier< or

(e) new scientific information or data indicates that the

introduction into Malta, the marketing or the use of a plant

protection product presents a previously unknown risk or unknown

risks, which are considered to be unacceptable.

(2) Where the Director suspends or revokes an

authorisation, he shall notify the holder of the authorisation in writing

of such suspension or revocation with detailed reasons on which such a

decision was based and shall publish such suspension or revocation by

notice in the Gazette.

(3) Notwithstanding the provisions of sub-regulation (1)

of this regulation, where the Director is satisfied that the circumstances

of the case may so require he may suspend an authorisation, until he

carries out such verifications that may be required. Such verifications

shall be carried out without any unnecessary delay.

(1) On the expiry of an authorisation, the Director shall Renewal of an

authorisation.

renew the authorisation if>

(a) he has received an application for renewal in such form

and such manner and within such time as the Director may, from

time to time require by notice in the Gazette<

(b) he is satisfied that the conditions detailed in regulation

6 of these regulations are still being complied with>

Provided that the Director may request the applicant to provide

any additional information as he may deem necessary prior to the renewal

or otherwise of the authorisation>

Provided further that any renewal of any authorisation may be

subject to any condition as the Director may deem appropriate.

(2) Where an application for renewal in accordance with

sub-regulation (1) of this regulation has been submitted to the Director,

the validity of the authorisation granted in accordance with regulation

6 of these regulations shall be deemed to continue to have effect until

such time as the Director has determined the application for renewal.

(1) Without prejudice to the provisions of regulation 9 of Modification of an

authorisation.

these regulations, the Director may, upon the written request of the

holder of the authorisation, modify an authorisation to place a plant

protection product on the market in Malta>

Provided that the Director is satisfied that such modification is

justified and appropriate, and where relevant, reflects current scientific

opinion.

(2) Without prejudice to the provisions of regulation 10

of these regulations, the Director may modify the original authorisation

if he considers that any condition on which the authorisation was based

in accordance with regulation 6 of these regulations has been

substantially changed.

(3) Any request for a modification to the authorisation in

accordance with sub-regulation (1) of this regulation shall be made by

the holder of the authorisation on such form and such manner and within

such time as the Director may, from time to time require by notice in

the Gazette.

(1) Without prejudice to any other provision made by or

under the Act, it shall be the duty of any person holding an authorisation

granted to him in accordance with regulation 6 of these regulations to>

(a) keep such records and for such time as the Director may,

from time to time require by notice in the Gazette, to be kept and

the period that they are to be preserved or maintained by the holder

of the authorisation<

(b) to draw up annually and to submit to the Director by not

later than February of each year, a report of the quantity of each

plant protection product or active substance placed on the market

during the previous calendar year<

(c) inform the Director in writing, as soon as practicable,

of any change in any information provided to the Director for the

granting of an authorisation<

(d) inform the Director, as soon as practicable, of any

adverse effect on the user through the use or exposure to the product

that may have been brought to his attention<

(e) inform the Director, as soon as practicable, of any

unexpected adverse effect on the environment or the ecosystem as

a result of the use, dispersal, dumping, disposal or otherwise of

the plant protection product<

(f) inform the Director, as soon as practicable, of any

unexpected adverse effect on any human being or animal

consuming any plant or plant product having any residue related

to the plant protection product<

(g) allow the Director or his authorised representative access

to the land or premises at any reasonable time< and

(h) comply with any provision made by or under the Act.

(1) An application for the granting of an authorisation for

the placing on the market in Malta of a plant protection product shall be

submitted to the Director in Maltese or English language together with

a product dossier prepared in accordance with Annex III to Council

Directive 91#414#EEC of 15 July 1991 concerning the placing of plant

protection products on the market (Official Journal of the European

Communities, L 230) and its subsequent amendments>

Provided that, the Director may from time to time by notice in the

Gazette establish the organisation and content of the application form

that is to be submitted by an applicant.

(2) Only applications submitted by a person having a

permanent office in Malta or in a recognised country shall be considered

for authorisation.

(1) The Director shall draw up, keep and maintain a separate Plant protection

product file.

file for each plant protection product for which an application for the

granting of an authorisation has been submitted in accordance with these

regulations.

(2) Each file shall as a minimum contain>

(a) a copy of the application and dossier submitted to the

Director by the applicant< and

(b) a copy of the authorisation, or if this has not been issued,

a copy of the letter informing the applicant of such a decision< and

(c) any other document or information submitted,

considered or used during the course of evaluating the application.

(1) The Director shall keep and maintain a register of active Registers to be kept

and maintained.

substances for plant protection products.

(2) Such a register shall, as a minimum, contain the

following information>

(a) a reference number for the entry in the register<

(b) the date of registration<

(c) the common name of the active substance<

(d) the Chemical Abstracts Service registry number of the

active substance<

(e) the classification of the active substance in accordance

with the provisions of sub-regulation (2) of regulation 5 of these

regulations or whether such classification is still pending<

(f) the date on which a decision on the classification was

made and a track record of any subsequent change in the

classification of the active substance<

(g) any other information the Director may, from time to

time, require by notice in the Gazette.

(3) The Director shall also keep a register of plant

protection products which shall, as a minimum, contain the following

information>

(a) a reference number for the entry in the register<

(b) the date of issue of the current authorisation and a track

record of any subsequent issue or otherwise of an authorisation<

(c) the date on which the current term of authorisation will

expire<

(d) the name by which the plant protection product is to be

placed on the market in Malta<

(e) the name and Chemical Abstracts Service registry

number of all active substances contained within the formulation<

(f) whether the product is a high risk plant protection product

or otherwise<

(g) the name and contact details of the authorisation holder<

(h) any other information the Director may, from time to

time, establish.

(1) The Director shall publish in the Gazette a list of all

active substances registered in Malta and such publication shall>

(a) be issued at least once annually prior to the first day of

February of each year<

(b) contain, as a minimum, the following information>

(i) the common name and Chemical Abstracts Service

registry number of the active substance< and

(ii) the classification of the active substance or an

indication that the classification of the active substance is still

pending.

(2) Whenever a new active substance has been entered in

the register of active substances or the classification of the active

substance has changed, the Director shall, by notice in the Gazette,

publish in relation to such active substance, the information specified

in paragraph (b) of the foregoing sub-regulation and such publication

shall be deemed to amend the list of active substances for plant protection

products issued under sub-regulation (1) of this regulation.

(1) The Director shall publish in the Gazette a list of all Publication of

authorised plant

plant protection products authorised for marketing or use in Malta and protection products.

such publication shall>

(a) be issued at least once annually and prior to the first day

of February of each year<

(b) contain, as a minimum, the following information>

(i) the name by which the product is to be placed on

the market in Malta<

(ii) the active substance and concentration<

(iii) the name and postal address of the holder of the

authorisation<

(iv) whether the product is a high-risk plant protection

product or otherwise<

(v) the authorisation number of the product.

(2) Whenever an authorisation has been issued in relation

to a plant protection product the Director shall, by notice in the Gazette

publish in relation to such plant protection product, the information

specified in paragraph (b) of the foregoing sub-regulation and such

publication shall be deemed to amend the list of plant protection products

issued under sub-regulation (1) of this regulation.

(3) The Director shall by notice in the Gazette, as soon as

practicable, specify the plant protection product for which the

authorisation has been suspended or revoked and such publication shall

be deemed to amend the list of plant protection products issued under

sub-regulation (1) of this regulation.

(1) The Director may deem that a plant protection product

satisfies the conditions of these regulations in relation to an authorisation,

if in relation to such product, an authorisation has been issued by a

recognised country.

(2) For the purposes of the issue of an authorisation in

accordance with regulation 6 of these regulations the Director shall not

require that tests and analysis already carried out by a recognised country

be repeated for the purposes of issuing an authorisation provided that

the conditions shall be deemed to be satisfied as aforesaid and if>

(a) the applicant makes a request for the application to be

treated in accordance with this regulation<

(b) the applicant provides suitable evidence as to the

authenticity of the authorisation issued by the recognised country

to the satisfaction of the Director<

(c) tests and analysis were carried out under agricultural,

plant health and environmental conditions relevant to the use of

the plant protection product that are comparable to those existent

in Malta.

(3) Where any test or analysis required for authorisation

under these regulations has not been carried out under conditions as are

referred to in paragraph (c) of sub-regulation (2) of this regulation, the

Director may require that>

(a) the applicant carries out such tests or analysis in

accordance with conditions existing in Malta<

(b) if the applicant so requests, the authorisation shall be

issued subject to such conditions that may be required in order to

render any non-comparable agricultural, plant health or

environmental conditions in the regions concerned, irrelevant for

the purposes of comparability.

(4) Where following any test or analysis carried out as

referred in sub-regulation (3) of this regulation, it is established that>

(a) the product satisfies the conditions established under

these regulations, the Director shall not subject the authorisation

to any restriction in use< and if

(b) the tests or analysis establish that the product does not

satisfy the conditions established in these regulations in all respects,

the Director shall issue the authorisation subject to any such

restriction as may be appropriate.

(1) The Director may authorise the use of an abridged Abridged

authorisation

authorisation process in relation to a plant protection product that is process and

identical to another product already authorised for placing on the market requirements

plant protection

in Malta and if such product is placed on the market in a recognised products already

authorised in Malta

country.

and in a recognised

country.

(2) For the purposes of this regulation, “identical” means

that the product is manufactured by the same or an associated company

or under license of such company and, that the formulation of the product

and any of its active substances are the same.

(3) An application for an authorisation for the placing on

the market of a plant protection product in accordance with the provisions

of this regulation shall contain, as a minimum, the following information>

(a) the trade name of the product to be imported<

(b) the authorisation number of the imported product<

(c) the original label of the imported product and an official

translation of it in the Maltese and English languages<

(d) the trade name of the reference product<

(e) the authorisation number of the reference product<

(f) the trade name with which the product will be marketed

in Malta<

(g) the proposed draft label of the product to be marketed

in Malta<

(h) a sample of the product as it will be marketed in Malta<

(i) a sample of the package as it will be marketed in Malta<

and

(j) any other additional information as the Director may

deem necessary to establish that the conditions specified in this

regulation are satisfied.

(4) In establishing whether the conditions of sub-

regulation (1) of this regulation are satisfied, the Director may consult

with the competent authority of the recognised country in which the

plant protection product has been authorised to be placed on the market.

(5) If the Director is not fully satisfied that the product is

identical, he may carry out such chemical or other analysis of the product

with the aim of establishing its identicality.

(6) Any authorisation issued in accordance with this

regulation shall be valid for a maximum period of three years from the

date of issue and shall, unless previously revoked, be renewable on

application by the holder made at least three months before expiry of

the validity period.

(7) The Director shall determine the application within a

reasonable time not exceeding 45 working days from the date of receipt

of an application>

Provided that such time may be suspended until all the relevant

information is received.

PART THREE

HIGH RISK PLANT PROTECTION PRODUCTS AND

PROFESSIONAL USERS

(1) Any plant protection product that contains any active

protection products.

substance classified as an active substance that may only be incorporated

in a high-risk plant protection product for placing on the market in

accordance with the provisions of paragraph (c) of sub-regulation (2)

of regulation 5 of these regulations shall be designated as a high-risk

plant protection product.

(2) A high-risk plant protection product may only be used

by a professional user appointed in accordance with regulation 23 of

these regulations.

(3) Dealers in high-risk plant protection products shall

only provide, sell or otherwise supply high-risk plant protection

products to another authorised dealer or to a professional user.

(1) The Director may, from time to time by notice in

the Gazette, establish the records that must be kept and maintained

in respect of high risk plant protection products by any dealer

authorised in accordance with these regulations>

Provided that as a minimum, such records shall include the

following details>

(a) the name of the high risk plant protection product being

dealt or otherwise handled by the dealer<

(b) the quantities and batch number of the high risk plant

protection product being dealt or otherwise handled by the dealer<

and

(c) details to identify from where and when he has obtained

the plant protection product and to whom he has sold the product.

(1) No person shall use or allow to be used any plant Professional users.

protection product that is designated as a high-risk plant protection

product unless the user is authorised as a professional user in accordance

with the provisions of these regulations.

(2) Any person wishing to qualify as a professional user

shall attend a course of instruction regarding the safe use and handling

of a high risk plant protection product>

Provided that such course is recognised by the Director for the

purpose of appointing a professional user in accordance with this

regulation.

(3) On successful completion of a course of instruction in

accordance with sub-regulation (2) above, the Director shall, upon

receipt of a written application and proof of the successful completion

of the course of instruction, authorise the successful candidate to act as

a professional user>

Provided that such authorisation shall specify the high risk plant

protection product or class, group or category of high risk plant

protection products the professional user is authorised to procure and

use>

Provided further that the plant protection products stated have

been covered by type and content of the course of instruction.

(4) Any authorisation issued in accordance with sub-

regulation (3) of this regulation may be subject to any such condition or

conditions that the Director may deem necessary for satisfying the

provisions made by or under of the Act during the course of business of

the professional user.

(5) If a professional user has been convicted of an offence

against any of these regulations, the Director shall revoke the

authorisation to act as a professional user.

Duration of validity

Any authorisation issued by the Director in accordance with

sub-regulation (3) of regulation 23 of these regulations shall be valid

for such period not exceeding two years as may be specified in the

authorisation>

Provided that the Director may extend the validity of any such

authorisation upon the submission of an application for its renewal

submitted to him in accordance with regulation 25 of these regulations

and if he is satisfied that the conditions established by regulation 23 of

these regulations are still being complied with.

(1) On the expiry of an authorisation, the Director shall

renew the authorisation if>

(a) he has received an application for renewal in such form

and in such manner and within such time as the Director may from

time to time require by notice in the Gazette<

(b) he is satisfied that the conditions detailed in regulation

23 of these regulations are still being complied with>

Provided that the Director may request the applicant to provide

additional information as he may deem necessary prior to the renewal

or otherwise of the authorisation>

Provided further that any renewal of any authorisation may be

subject to any condition as the Director may deem appropriate.

(2) Where an application for renewal in accordance with

sub-regulation (1) of this regulation has been submitted to the Director,

the validity of the authorisation granted in accordance with regulation

23 of these regulations shall be deemed to continue to have effect until

such time as the Director has determined the application for renewal.

(1) Any authorisation issued in accordance with regulation

23 of these regulations may be suspended or revoked by the Director if

it is established that>

(a) any information or particular supporting the application

for an authorisation was incorrect, false or misleading< or

(b) any requirement as detailed in regulation 23 of these

regulations is no longer satisfied< or

(c) the holder of the authorisation requests that the Director

revokes the authorisation>

(2) Where the Director suspends or revokes an

authorisation, he shall notify the holder of the authorisation in writing

of such suspension or revocation with detailed reasons on which such a

decision was based and shall inform authorised dealers in plant protection

products or active substances of such suspension or revocation.

(1) The Director may, upon the written request of the holder Modification

authorisation.

of the authorisation, and if he is satisfied that such modification is

justified, modify an authorisation to act as a professional user.

(2) Any request for a modification to the authorisation in

accordance with sub-regulation (1) of this regulation shall be made by

the holder of the authorisation on such form and such manner and within

such time as the Director may, from time to time require by notice in

the Gazette.

(1) The Director may, from time to time by notice in the Records to be kept

and maintained by a

Gazette, establish the records that must be kept and maintained in respect professional user.

of high risk plant protection products by any professional user authorised

in accordance with these regulations.

(2) Such records shall in respect of high risk plant

protection products procured by the professional user include>

(a) the name of the high risk plant protection product<

(b) the quantities and batch number of the high risk plant

protection product procured<

(c) details to identify the place from where and the date on

which he has procured the product.

(3) In respect of high risk plant protection products used

by the professional user, the following records shall also be kept>

(a) the name of the high risk plant protection product<

(b) the quantities and batch number of the high risk plant

protection product being used in a particular instance<

(c) details to identify the location or crop on which the

product was used<

(d) the date on which the product was applied in the

particular location.

A professional user shall ensure that he takes all necessary

and indicated precautions in order to minimise the risk of unwanted

effects to humans, animals and the environment that may result from

the use or disposal of the plant protection product or its packaging.

(1) The Director shall publish annually in the Gazette a list

of all persons authorised to act as professional users in accordance with

the provisions of these regulations.

(2) Such list shall contain the following information>

(a) the name, surname and postal address of the professional

user<

(b) the high risk plant protection products covered by the

authorisation<

(c) the date and validity of the authorisation.

PART FOUR

DEALING IN PLANT PROTECTION PRODUCTS

No person shall deal or dispose of any>

(a) active substance unless this is registered in accordance

with regulation 5 of these regulations,

(b) plant protection product unless this is authorised for

placing on the market in Malta in accordance with regulation 6 of

these regulations,

unless he is in possession of an authorisation to deal in active substances

or plant protection products granted to him in accordance with regulation

32 of these regulations.

(1) Any application for the granting of an authorisation to Application

authorisation to

deal in plant protection products or active substances shall be made in deal.

writing to the Director and shall contain such information, documents,

samples and other material as provided by or under the Act>

(2) Any application shall as a minimum satisfy the

following requirements>

(a) the nature of any activity related to the dealing of plant

protection products the applicant wishes to undertake<

(b) the place where such activity is to take place, and suitable

information, documentation and evidence as may be required in

order to show that such place is suitable and sufficient for that

purpose<

(c) evidence to show that the place where such activity is to

take place has the necessary equipment and control facilities as

may be required by or under the Act<

(d) evidence to show that the health and safety of staff shall

be protected and ensured at all times<

(e) the name and postal address and any other contact details

of the applicant<

(f) the name of at least one person who is qualified to ensure

that the activity complies with any provisions made by or under

the Act at all times, and that persons under his charge have the

necessary skills required to carry out the tasks assigned to them>

Provided that any person who has successfully completed any

course recognised by the Director as sufficient for the purposes of this

paragraph shall be considered to be qualified for the purposes of this

paragraph of this sub-regulation<

(g) any other information, documentation or evidence as

may be required by the Director or by any provision made by or

under the Act< and,

(h) in the case of an application for the manufacture of a

plant protection product, the name of the plant protection product

and any formulation which is to be, or intended to be manufactured,

assembled or in any way modified including details of the type

and concentration of any active substance to be found within the

formulation.

(3) The Director shall determine the application within a

reasonable time< not exceeding 45 working days from the date of receipt

of an application>

Provided that such time shall be suspended until all the relevant

information is received.

(4) Where an application has been made to the Director

for the granting of an authorisation to deal in accordance with this

regulation, the Director may, before determining the application, request

the applicant to submit such further information relating to the

application as he may consider necessary and where any such request

has been made, the provision of sub-regulation (2) of this regulation

shall be suspended until the additional information has been submitted.

(5) Any authorisation issued in accordance with this

regulation shall be made in writing and be subject to any such condition

that the Director may deem necessary so that the business of dealing

shall be carried out in accordance with the provisions made by or under

the Act.

Any authorisation issued by the Director in accordance with

Duration of validity

regulation 32 of these regulations shall be valid for such period not

exceeding three years as may be specified in the authorisation>

Provided that the Director may extend the validity of any such

authorisation upon the submission of an application for its renewal to

him in accordance with regulation 36 of these regulations and if he is

satisfied that the conditions established by regulation 32 of these

regulations are still being complied with.

Without prejudice to regulation 35 of these regulations, and

if the Director suspects that any of the conditions established by

regulation 32 of these regulations is no longer satisfied, the Director>

(a) shall require the holder of the authorisation to submit

such further information as may be necessary to establish

compliance with the provisions of regulation 32 of these regulations

or such other information as may be reasonably required<

(b) may carry out any inspection, review or test that he

deems necessary<

(c) may suspend the authorisation in accordance with

regulation 35 of these regulations.

(1) Any authorisation issued in accordance with regulation Suspension

revocation of

32 of these regulations may be suspended or revoked by the Director if authorisation.

it is established that>

(a) any information or particular supporting the application

for an authorisation was incorrect, false or misleading< or

(b) any requirement as detailed in regulation 32 of these

regulations is no longer satisfied< or

(c) the applicant for authorisation requests that the Director

revokes the authorisation to deal in plant protection products or

active substances< or

(d) the activity is being carried out in contravention to any

provision made by or under the Act.

(2) Where the Director suspends or revokes an

authorisation, he shall notify the holder of the authorisation in writing

of such suspension or revocation also providing reasons on which such

a decision was based.

On the expiry of an authorisation, the Director shall renew Renewal of an

authorisation.

the authorisation if>

(a) he has received an application for renewal in such form

and in such manner and with such a time as the Director may,

from time to time require by notice in the Gazette<

(b) he is satisfied that the conditions detailed in regulation

32 of these regulations are still being complied with>

Provided that the Director may request the applicant to provide

additional information as he may deem necessary prior to the renewal

or otherwise of the authorisation>

Provided further that any renewal of any authorisation may be

subject to any such condition as the Director may deem appropriate.

(1) Without prejudice to the provisions of regulation 34 of Modification of an

authorisation.

these regulations, the Director may, upon the written request of the

holder of the authorisation, modify an authorisation to carry out a dealing

activity if the Director is satisfied that such modification is justified

and appropriate, and where relevant, reflects current scientific opinion.

(2) Without prejudice to the provisions of regulation 35

of these regulations, the Director may modify the original authorisation

if he considers that any condition on which the authorisation was based

in accordance with regulation 32 of these regulations has been

substantially altered.

(3) Any request for a modification to the authorisation in

accordance with sub-regulation (1) of this regulation shall be made by

the holder of the authorisation on such form and in such manner and

within such time as the Director may, from time to time require by

notice in the Gazette.

Without prejudice to any other provision made by or under

the Act, it shall be the duty of any person holding an authorisation granted

to him in accordance with regulation 32 of these regulations to>

(a) keep such records and in such manner as the Director

may from time to time establish by Notice in the Gazette>

Provided that the Director may establish different records for

different types of dealing activities<

(b) inform the Director in writing and as soon as practicable,

of any change in any information provided to the Director for the

granting of the authorisation<

(c) allow the Director or his authorised representative access

to the land or premises where dealing is carried out at any

reasonable time<

(d) make available to the Director or his authorised

representative such records which he may require< and

(e) comply with any provision made by or under the Act.

(1) The Director shall publish annually in the Gazette a list

Publication of list of

of all persons authorised to act as dealers in accordance with the

provisions of these regulations.

(2) Such list shall contain the following information>

(a) the name, surname and postal address of the authorised

dealer<

(b) the postal address of any premises used by the dealer

for the purposes of carrying out his business<

(c) the date and validity of the authorisation.

(1) Any supplier of plant protection products shall exercise Additional duties of

authorised dealers.

general supervision over his employees and shall, before requiring or

permitting any of such employees to handle or to apply any plant

protection product>

(a) provide such employees with proper training in the safe

handling and application of plant protection products<

(b) ensure that any safety precaution set out in the label, or

otherwise prescribed, is understood and complied with<

(c) ensure that such workers wear suitable protective

clothing provided by him.

(2) Where a supplier of plant protection products has even

the slightest suspicion that any plant protection product has caused any

poisoning, he shall immediately notify the appropriate health authority.

(1) Any person authorised to deal in plant protection Notification of entry

into Malta.

products shall notify the Director of any consignment of any authorised

plant protection product or active substance he brings into Malta.

(2) Such notice shall be submitted in such form and in

such manner and within such time as the Director may from time to

time require by Notice in the Gazette.

(3) The information supplied in relation to a plant

protection product or active substance shall include the following as a

minimum>

(a) the name of the product and the batch number<

(b)

the authorisation number<

(c) the country of origin<

(d) the quantity of the consignment<

(e) the date and place of bringing into Malta.

(1) No person shall advertise or cause to be advertised any Advertising of plant

plant protection product in any manner whatsoever unless such production

products.

advertising has been authorised by the Director.

(2) The Director shall, from time to time by notice in the

Gazette, establish the form, content, manner and time for the submission

of an application for the issue of an authorisation for the advertising of

a plant protection product.

(3) The Director shall authorise the advertising of a plant

protection product if>

(a) he has received an application in accordance with sub-

regulation (2) of this regulation<

(b) he is satisfied that the advertising sufficiently represents

the content and conditions of the authorisation<

(c) the advertising does not make use of any statement which

cannot be technically proven<

(d) the advertising does not include any statement which is

false or otherwise misleading<

(e) the advertising does not encourage the use of the plant

protection product for any purpose or circumstance or instruction

other than that specified by the authorisation for the plant protection

product issued in accordance with regulation 6 of these regulations<

(f) the advertising does not contain any wording or statement

which claims or implies the absolute safety of the plant protection

product and in particular shall not include any of the words

“harmless” or “non-toxic” or any similar phrase unless such words

are used within a context to give information regarding the

properties of the product<

(g) the advertising contains a suitable warning against the

improper use of the product and shall encourage the use of the

plant protection product in accordance with the instructions found

on the label or packaging.

PART FIVE

LABELLING AND PACKAGING OF PLANT PROTECTION

PRODUCTS

(1) The labelling of any plant protection product must show

clearly and indelibly>

(a) the trade name of the plant protection product<

(b) the name and postal address of the holder of the

authorisation and the authorisation number of the plant protection

product and, if different, the name and postal address of the person

responsible for the final packaging and labelling or for the final

labelling of the plant protection product<

(c) the name of each active substance as registered in Malta

and amount of each active substance as a percentage of the product

formulation<

(d) the net quantity of the plant protection product or active

substance found in the package<

(e) the formulation batch number or some other standard

means of identifying the individual batch<

(f) the nature of any special risks for human beings, animals

or the environment<

(g) any safety precautions for the protection of human

beings, animals or the environment,

(h) the mode of action of the plant protection product <

(i) the type of preparation found within the container or

package<

(j) the use or uses for which the plant protection product

has been authorised

(k) the corresponding directions for use and the

recommended or permitted dose rate, expressed in metric units for

each use described in paragraph (j) above<

(l) any specific agricultural, plant health or environmental

condition under which the plant protection product may or may

not be used<

(m) where necessary the safety interval between the last

application of the plant protection product and>

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

(ii) sowing or planting of succeeding crops< or

(iii) entry by human beings or domestic animals in the

area where the product has been applied< or

(iv) produce harvesting< or

(v) the use, offering for sale or consumption of the crop,

produce or plant material< or

(vi) the application of another plant protection product

in the same area or on the same plant, crop<

(n) details of possible undesired phytotoxicity or varietal

susceptibility or any other direct or indirect effect on any plant or

product of plant origin<

(o) the following words in both English and Maltese

languages, “Read accompanying instructions before use” and “Aqra

t-tag_rif mal-prodott qabel ma tu_a_”, if the product is accompanied

by a leaflet in accordance with sub-regulation (2) of this regulation<

(p) directions for the safe disposal of the plant protection

product or its packaging<

(q) the expiry date of the product stored under

recommendation conditions for storage<

(r)

the recommended conditions for storage< and

(s) it shall be in compliance with any provision made by or

under any other act regarding the labelling of dangerous substances

or products.

(2) Where there is insufficient space on the product

package to insert all the labelling requirements detailed in sub-regulation

(1) above, the information relating to paragraphs (k), (m) and (n) of

sub-regulation (1) above shall be indicated on a separate leaflet

accompanying the package and such a leaflet shall be regarded as part

of the label for the purposes of these regulations.

(3) It is prohibited for a label of a plant protection product

to contain the statement “Non-toxic” or “Harmless” or any similar phrase

unless such words are used within the context to give information

regarding the properties of the product.

(4) The wording, phrasing and presentation of any label

of any plant protection product shall be such as to promote the proper

and safe use of the product.

(5) The label shall be resistant to exposure under normal

conditions of storage, handling or use and shall ensure that its contents

will remain clear and legible throughout the expected product shelf-

life.

(6) The labels shall be printed in the Maltese and English

languages.

(1) The packaging, including any material constituting the Packaging of a plant

protection product.

immediate container, any outer packaging or any fastening device of

any plant protection product, shall as a minimum, satisfy the following

requirements>

(a) it shall be designed and constructed so that its contents

cannot disperse or leak in the environment during storage, transport,

handling or any other manner of the container other than for the

purpose of use or safe disposal<

(b) it shall not be susceptible to degradation through its

contact or exposure to any of its contents and shall be stable under

normal conditions of storage, handling or use<

(c) it shall not be liable to form any harmful or dangerous

compound through the chemical interaction with any of its contents<

(d) it shall be sealed in such a way that the seal will be

irreparably damaged when the packaging is opened for the first

time.

PART SIX

RESEARCH AND DEVELOPMENT

(1) Without prejudice to the provisions made by or under Authorisation for

experimentation,

the Act, the Director may, upon receiving a written request for the issue research or testing.

of an authorisation for the purposes of research and development in

accordance with this regulation, authorise in writing, for a specific period

of time, to keep, use, manipulate, study or otherwise experiment upon

any plant protection product or any active substance.

(2) Such request shall be submitted in such form and in

such manner and within such time as the Director may, from time to

time require by notice in the Gazette and shall, as a minimum contain

all the deemed information to establish and define>

(a) the plant protection product or active substance and the

maximum quantities that are to be used or released during the course

of such experimentation, research or testing<

(b) the chemical, physical and biological properties of the

plant protection product or active substance as determined by

scientifically acceptable and validated laboratory testing including

a dossier containing all the available data to permit an assessment

to be made on the possible effects on human or animal health or

the possible impact on the environment<

(c) the premises, equipment, conditions and procedures to

be used for purposes of experimentation, research or testing using

the plant protection product or active substance and that these are

suitable for use in such purpose<

(d) any procedure, precaution and any other matter that the

Director may consider necessary to be undertaken during such test,

research or experiment<

(e) the procedures and precautions to be taken when any

human being, animal, plant or the environment or any other object

is, or may come in contact with or exposed to any plant protection

product or active substance<

(f) the details of all contingency plans in case of any

contamination, release or spread of the plant protection product or

active substance<

(g) the minimum records that are to be kept, maintained

and made available upon request to the Director or his authorised

representative and the minimum period for which such records

are to be kept<

(h) the name and related qualifications or expertise of the

applicant, the person responsible for undertaking the test, research

or experiment and, where relevant any person which may be

engaged in such undertaking<

(i) the contact details of the applicant<

(j) the details on how the plant protection product or active

substance or any other test material is to be disposed or destroyed

after use<

(k) any other condition or additional information as the

Director may reasonably require in writing.

(3) In granting an authorisation in accordance with this

regulation the Director shall>

(a) take into consideration the result of any inspection or

any test carried out by an authorised representative in order to

verify or establish any of the information outlined in sub-regulation

(2) of this regulation<

(b) be satisfied that the test, research or experimentation is

appropriate and safe<

(c) be satisfied that the authorised person has at his disposal

the expertise or capability to safely handle the plant protection

product or active substance that is being authorised for use in the

experimentation, research or testing<

(d) be satisfied that all the necessary precautions shall be

taken at all times by the authorised person or, where relevant, his

employees or representatives<

(e) the premises, equipment, procedures and contingency

plans are suitable and appropriate.

(4) An application submitted under this regulation shall

be in such form and in such manner and within such time as the Director

may from time to time require by notice in the Gazette.

(5) The authorisation under this regulation may be issued

in relation to testing or experimentation in relation for any plant

protection product or active substance whether such plant protection

product or active substance is authorised or otherwise.

Any authorisation issued by the Director in accordance with Duration of validity

of an authorisation.

regulation 45 of these regulations shall be valid for such period not

exceeding two years as may be specified in the authorisation>

Provided that the Director may extend the validity of any such

authorisation upon the submission of an application for its renewal

submitted to him in accordance with regulation 50 of these regulations.

The holder of an authorisation issued by the Director in

accordance with regulation 45 of these regulations shall take all the

necessary steps and measures to ensure that the conditions of such an

authorisation are complied with at all times.

The Director shall not issue an authorisation in accordance

with regulation 45 of these regulations if he has>

(a) any reasonable doubt to believe that the information

contained in the application may be false, inaccurate or of a

misleading nature<

(b) reason to believe that the risks to human beings, animals

or the environment outweigh the potential benefits that will be

derived from the experimentation, research or testing.

The holder of an authorisation shall immediately notify the

Director of any change in any information submitted for the issue of an

authorisation under this Part.

(1) On the expiry of an authorisation, the Director shall

renew the authorisation if>

(a) he has received an application for renewal in such form

and in such manner and within such time as the Director may from

time to time require by notice in the Gazette<

(b) he is satisfied that the conditions detailed in regulation

45 of these regulations are still being complied with>

Provided that the Director may request the applicant to provide

additional information as he may deem necessary prior to the renewal

or otherwise of the authorisation>

Provided further that any renewal of any authorisation may be

subject to any condition as the Director may deem appropriate.

(2) Where an application for renewal in accordance with

sub-regulation (1) of this regulation has been submitted to the Director,

the validity of the authorisation granted in accordance with regulation

45 of these regulations shall be deemed to continue to have effect until

such time as the Director has determined the application for renewal.

(1) Any authorisation issued in accordance with regulation Suspension

revocation of an

45 of these regulations may be suspended or revoked by the Director if authorisation for

experimentation etc.

it is established that>

(a) any information or particular supporting the application

for an authorisation was incorrect, false or misleading< or

(b) any requirement as detailed in regulation 45 of these

regulations is no longer satisfied< or

(c) the holder of the authorisation requests that the Director

revokes the authorisation>

(2) Where the Director suspends or revokes an

authorisation, he shall notify the holder of the authorisation in writing

of such suspension or revocation with detailed reasons on which such a

decision was based and shall inform authorised dealers in plant protection

products or active substances of such suspension or revocation.

(1) The Director may, upon the written request of the holder Modification of an

authorisation for

of the authorisation, and if he is satisfied that such modification is experimentation etc.

justified, modify an authorisation issued in accordance with regulation

45. (2) Any request for a modification to the authorisation in

accordance with sub-regulation (1) of this regulation shall be made by

the holder of the authorisation on such form and such manner and within

such time as the Director may, from time to time require by notice in

the Gazette.

PART SEVEN

MISCELLANEOUS

Where any provision of these regulations provides that the Fees.

Director may issue or grant any authorisation or may carry out any

verification, test, analysis or any other activity in relation to the issue,

renewal or maintenance of such authorisation, the Director may request

the payment of such fees as may be required to cover the costs and

expenses of such services as may be prescribed.

(1) Notwithstanding any other provision of law relating to Confidentiality.

the freedom of access to information on the environment, the following

information shall not be treated as confidential>

(a) information that is essential in order to satisfy the

labelling requirements established by regulation 43 of these

regulations<

(b) physico-chemical data concerning the active substance

and plant protection product<

(c) any method or system that may be used for rendering

the active substance or plant protection product harmless including

antidotes and means for treating human or animal poisoning or

injury as a result of exposure to the product or active substance<

(d) a summary of any results of the test or tests to establish

the safety, efficacy and harmlessness of an active substance or

plant protection product to human beings, animals, plants and the

environment<

(e) recommended methods and precautions to reduce any

hazard that may result or may be associated with the handling,

storage, transport, disposal or use<

(f) any method of analysis referred to in paragraphs (b), (c)

and (d) of sub-regulation (2) of regulation 6 of these regulations<

(g) any method of disposal for the plant protection product

or active substance or its packaging<

(h) any decontamination procedure to be followed in the

case of an accidental spillage or leakage.

(2) Subject to the provisions of sub-regulation (1) of this

regulation, the Director shall, on the request of the holder of an

authorisation, treat any information submitted to him in relation to any

provision of these regulations which is of industrial or commercial nature

as confidential.

(3) In circumstances where sub-regulation (2) of this

regulation applies, the holder of an authorisation shall inform the Director

of any disclosure by himself or his representative of any such confidential

information to any other person.

It shall be the duty of any employer who has an authorisation

under these regulations to take the necessary measures to ensure that

the activities made under the authorisation do not present any hazard to

the health of his employees and for such purposes he shall provide such

medical supervision as may be appropriate.

The Importation, Sale and Use of Pesticides Regulation, 1967

are hereby repealed.