Biocides Regulations, 2004

L.N. 294 of 2004

PESTICIDES CONTROL ACT

(CAP. 430)

Biocides Regulations, 2004

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

Pesticides Control Act, the Minister of Rural Affairs and the

Environment, has made the following regulations

The title of these regulations is the Biocides Regulations, 2004, Title and

commencement.

and they 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 biocidal

products not listed under Schedule Two to these regulations;

(ii) on the 15th May, 2004 in relation to biocidal

products listed in Schedule Two to 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.

(1) The scope of these regulations is to provide for the Scope and

applicability.

authorisation and control in relation to dealing, advertising and use of

any biocidal product or any other active substances intended for use in

any biocidal product as specified in the Act.

(2) These regulations shall not apply to those products

which are regulated within the scope of any other provision made by or

under the Act or any other act, in particular

(a)

provisions relating to proprietary medicinal products;

(b) provisions relating to veterinary medicinal products;

(c) provisions relating to veterinary medicinal products and

establishing additional provisions for immunological medicinal

products;

(d) provisions relating to medicinal products and

establishing additional provisions on homeopathic medicinal

products;

(e) provisions relating to veterinary medicinal products and

establishing additional provisions on homeopathic veterinary

medicinal products;

(f) provisions relating to authorisation and supervision of

medicinal products for human and veterinary use;

(g) provisions relating to active implantable medical

devices;

(h)

the provisions concerning medical devices;

(i) provisions concerning food additives authorised for use

in foodstuffs intended for human consumption, relating to

flavourings for use in foodstuffs and to source material for their

production and on food additives other than colours and sweeteners;

(j) provisions relating to material and articles intended to

come into contact with foodstuffs;

(k) provisions laying down the health rules for the

production and placing on the market of raw milk, heat-treated

milk and milk based products;

(l) provisions relating to hygiene and health products

affecting the production and the placing on the market of egg

products;

(m) provisions establishing the health conditions for the

production and the placing on the market of fishery products;

(n) provisions establishing the conditions governing the

preparation, placing on the market and use of medicated

feedingstuffs;

(o) provisions concerning additives in feedingstuffs, on

certain products used in animal nutrition and on the marketing of

straight feedingstuffs;

(p) provisions relating to cosmetic products;

(q) provisions on certain conditions for granting temporary

and limited derogations from specific health rules on the production

and the marketing of certain products of animal origin; and

(r) provisions concerning the placing of plant protection

products on the market.

(3) These regulations shall apply, without prejudice to any

of the following provisions made by or under any other Act or in relation

to measures taken in accordance with the said provisions

(a) provisions relating to restriction on the marketing and

use of certain dangerous substances and preparations;

(b) provisions prohibiting the placing on the market and

use of biocidal products containing certain active substances;

(c) provisions concerning the export and import of certain

dangerous chemicals;

(d) provisions concerning the protection of workers from

the risks related to exposure to chemical, physical and biological

agents at work and on the introduction of measures to encourage

improvements in the safety and health of workers at work; and

(e)

provisions concerning misleading advertising.

(4) The provisions of regulation 35 of these regulations shall

not apply to the carriage of biocidal products by road, sea or air.

(5) The provisions of Part 2 of these regulations shall not

apply in relation to an application for the registration of an active

substance listed in Schedule 3 to these regulations or biocidal products

listed in Schedule 2 to these regulations as the case may be, which

were on the market in Malta on publication of these regulations in the

Government Gazette

Provided that an ad hoc application for the registration of

such active substances or authorisation of a biocidal product as the

case may require, be made to the director in writing as he may establish

in the Gazette

Provided further that any such registration of an active

substance or authorisation of a biocidal product shall be issued by the

Director subject to such terms and conditions as he may deem acceptable

and on condition that the provisions under Part 2 of these regulations

shall be complied within such time as may be stipulated in the

registration or authorisation.

PART ONE

GENERAL PROVISIONS

(1)

In these regulations, unless the context otherwise

requires

“Act” means the Pesticides Control Act;

“advertising” in relation to biocidal products includes any

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

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

products and without prejudice to the generality of the foregoing

in particular includes

(a) the advertising of biocidal 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 of

biocidal 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 Four 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 biocidal 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;

“basic substance” also referred to as commodity substance

means a substance which is listed in Part IB of the Register of

active substances, whose major use is non-pesticidal but which

has some minor use as a biocide either directly or in a product

consisting of the substance and a simple diluents which itself is

not a substance of concern and which is not directly marketed for

this biocidal use. Such substances shall inter alia include the

following

(a)

carbon dioxide;

(b) nitrogen;

(c)

ethanol;

(d) 2-propanol;

(e)

acetic acid;

(f)

kieselguhr;

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

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

of any biocidal product;

“The Department” means the Department responsible for plant

health;

“frame formulations” means the specifications for a group of

biocidal products having the same use and user type, which group

of products must convey the same active substances of the same

specifications, and their compositions must present only variations

from a previously authorised biocidal products which do not affect

the level of risk associated with them and their efficacy and for

such purpose a variation is the allowance of a reduction in the

percentage of the active substance and, or an alteration in

percentage composition of one or more non-active substances and,

or the replacement of one or more pigments, dyes, perfumes by

others presenting the same or a lower risk, and which do not

decrease its efficacy;

“letter of access” means a document, signed by the owner or

owners of relevant data protected under the provisions of these

regulations, which states that this data may be used by the Director

for the purpose of granting an authorisation or for the registration

of a biocidal product in accordance with these regulations;

“low-risk biocidal product” means a biocidal product which

does not contain as active substance any substance of concern,

under the conditions of use, the biocidal product shall pose only a

low risk to humans, animals and the environment;

“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;

“preparation” means mixtures or solutions composed of two

or more substances;

“process-oriented research and development” means the

further development of a substance in the course of which pilot

plant or production trials are used to test the fields of application

of the substance;

“recognised country” means any Member State of the

European Community;

“relevant regulations” means -

The Dangerous Substances (Notification) Regulations,

2001, Legal Notice 318 of 2001,

The Dangerous Substances (Risk Assesment)

Regulations 2002, Legal Notice 40 of 2002,

The Dangerous Substances and Preparation

(Restrictions) Regulations 2002, Legal Notice 142 of 2002,

The Dangerous Substances and Preparations

Regulations, 2002, Legal Notice 221 of 2002, and other

regulations as the case may be;

“scientific research and development” means scientific

experimentation, analysis or chemical research carried out under

controlled conditions; it includes the determination of intrinsic

properties, performance and efficacy as well as scientific

investigation related to product development;

“substance” means a chemical element and their compounds

in the natural state or obtained by any production process, including

any additive necessary to preserve the stability of the products and

any impurity deriving from the process used, but excluding any

solvent which may be separated without affecting the stability of

the substance or changing its composition;

“substance of concern” means any substance, other than active

substance, that has an inherent capacity to cause an adverse effect

on humans, animals or the environment and is present or is

produced in a biocidal product in sufficient concentration to create

such an adverse effect. Such a substance, unless there are other

grounds for concern would be normally a substance classified as

dangerous according to the relevant provisions of (Legal Notice

318 of 2001) relating to the classification, packaging and labelling

of dangerous substances and present in the biocidal product at a

concentration leading the product to be regarded as dangerous

within the meaning of the relevant provisions of (Legal Notice

221 of 2002) relating to the classification, packaging and labelling

of dangerous preparations.

PART TWO

AUTHORISATION OF BIOCIDAL PRODUCTS

(1) Without prejudice to the provisions of sub-regulation (8) Registration and

inclusion of an

of this regulation and regulation 5 of these regulations, the Director active substance in

shall register any active substance for an initial period not exceeding The Register of

active substances

ten years

(a) if he has received an application for the registration of

that active substance in such form and such manner and within

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

Gazette;

(b) if he has received a dossier for the active substance

satisfying the requirements of Annex IVA or the requirements of

Annex IIA and, where specified, the relevant parts of Annex IIIA

to Council Directive 98/8/EEC of 16 February 1998 concerning

the placing of biocidal products on the market (Official Journal of

the European Communities, L 123) and as may from time to time

be amended;

(c) if he has received a dossier for at least one biocidal

product containing the active substance in accordance with the

provisions of regulation 17 of these regulations, other than sub-

regulation (2) thereof; and

(d) if he has verified the dossiers and finds them to be in

compliance with the requirements of Annex IVA and Annex IVB

or the requirements of Annex IIA and Annex IIB and, where

relevant, Annexes IIIA and IIIB to Council Directive 98/8/EEC of

16 February 1998 concerning the placing of biocidal products on

the market (Official Journal of the European Communities, L 123)

and as may from time to time be amended.

(2) Notwithstanding the provisions of sub-regulation (4)

of this regulation, the Director shall carry out an evaluation of the above

mentioned dossiers and take a decision whether to include or otherwise

the active substance under the relevant parts of the Register of active

substances, within twelve months of accepting the dossiers

Provided that if, when the dossiers are evaluated, it appears

that further information is necessary for full evaluation to be made, the

receiving Director shall ask that the applicant to submit such information.

The twelve month period shall be suspended from the date of issue of

the Director’s request until the date the information is received.

(3) An active substance shall, in the light of current scientific

and technical knowledge, be included in parts 1, 1A or 1B of the Register

of active substances to these regulations if it may be expected that

(a)

biocidal products containing the active substance;

(b) low-risk biocidal products complying with the definition

in regulation 3 of these regulations;

(c) basic substances complying with the definition in

regulation 3 of these regulations;

will fulfil the conditions laid down in paragraphs (b), (c) and

(d) of sub-regulation (2) of regulation 9 of these regulations, taking

into account, where relevant, cumulative effects from the use of

biocidal products containing the same active substances.

4. (a) The Director shall refuse or remove an entry of an

active substance from parts I and, where relevant from parts IA or IB of

the Register of active substances to these regulations

(i) if the evaluation of the active substance in accordance

with sub-regulation (2) of regulation 4 of these regulations shows

that, under normal conditions of use in any authorised biocidal

product, risks to human beings, animals or the environment still

give rise to concern, and

(ii) if there is another active substance in part I of the

Register of active substances to these regulations for the same

product type which, in the light of scientific or technical knowledge,

presents significantly less risk to health or to the environment.

When such a refusal or removal is considered, an assessment

of an alternative active substance or substances shall take place to

demonstrate that it can be used with similar effect on the target

organism without significant economic and practical disadvantages

for the user and without an increased risk for health or for the

environment.

(b) The Director shall carry out the refusal or

removal of an active substance from part I and, where from

parts IA or IB of the Register of active substances to these

regulations under the following conditions

(i) the chemical diversity of the active substances should

be adequate to minimise occurrence of resistance in the target

organism;

(ii) it should be applied only to active substances which,

when used under normal conditions in authorised biocidal products,

present a significantly different level of risk;

(iii) it should be applied only to active substances used in

products of the same product type; and

(iv) it should be applied only after allowing the possibility,

where necessary, of acquiring experience from use in practice, if it

is not already available.

(5) An active substance shall not be included in part 1A

of the Register of active substances to these regulations if it is classified

according to relevant regulations as

(a)

carcinogenic,

(b) mutagenic,

(c)

toxic for reproduction,

(d) sensitising, or

(e)

is bioaccumulative and does not readily degrade.

(6) Where appropriate, the active substance shall be

registered under part 1A of the Register of active substances to the

concentration ranges between which the substance can be used.

(7) Inclusion of an active substance in parts 1, 1A or 1B of

the Register of active substances, shall where appropriate, be subject

(a)

the requirements on

(i) the minimum degree of purity of the active

substance;

(ii) the nature and maximum content of certain

impurities;

(iii) the product type in which it may be used, manner

and area of use;

(iv) the designation of categories of users (e.g.

industrial, commercial or domestic);

(v) other particular conditions from the evaluation of

the information which has been made available in the context

of these regulations;

(b) the establishment of the following

(i) acceptable operator exposure level (AOEL), as the

case may be required;

(ii) where relevant, an acceptable daily intake for

human beings (ADI) and a maximum residue limit (MRL);

(iii) fate and behaviour in the environment and impact

on non-target organisms.

(8) The inclusion of an active substance the Register of

active substances to these regulations of an active substance shall be

restricted to those product types listed in Schedule One to these

(9) Following the decision by the competent authority of

a recognised country to include or not to include an active substance in

Annex I, IA or IB to Council Directive 98/8/EEC of 16 February 1998

concerning the placing of biocidal products on the market (Official

Journal of the European Communities, L 123) as may from time to time

be amended, the Director shall amend the relevant parts of the Register

of active substances whereby Annex 1 shall correspond to Part1 , Annex

1A shall correspond to Part 1A and Annex 1B shall correspond to Part

1B to these regulations to reflect such decisions

(1) The Director shall renew the registration of an active Renewal of

registration of an

substance in parts I, IA or IB of the Register of active substances to active substance.

these regulations for periods not exceeding ten years 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; and

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

4 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 registration 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 registration granted in accordance with regulation 4

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

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

(1) Where the Director suspects that any of the conditions Review of

registration of an

established by regulation 4 of these regulations for the inclusion or active substance.

renewal of inclusion of an active substance in part I, IA or IB of the

Register of active substances to these regulations is no longer satisfied,

he

(a) shall require the applicant to submit any further

information necessary to establish compliance with the provisions

of regulation 4 of these regulations;

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

(c) may remove an active substance from parts I, IA or IB

of the Register of active substances to these regulations in

accordance with regulation 4 of these regulations.

(2) The Director shall, where necessary, grant renewal

of inclusion of an active substance from parts I, IA or IB of the Register

of active substances to these regulations in accordance with regulation

4 of these regulations for the minimum period necessary to complete a

review.

Where in the consideration of an application for renewal in

terms of regulation 5 of these regulations or in a review carried out

during the currency of a registration in terms of Regulation 6 of these

regulations. It is decided that an active substance shall be removed from

Part1 and where relevant from Part 1A or 1B because of any of the

conditions described in sub-regulation 4 are no longer being complied

with. Such a decision shall be notified to the applicant or the Registration

holder as the case may be and the removal shall take effect immediately

after six months from the date of such notification.

(1) Subject to the provisions of Regulation 4 of these

regulations the Director shall authorise the placing on the market in

Malta of any active substance that is intended for use in biocidal products

if

(a) he has received an application submitted in such form

and such manner and within such a time as he may from time to

time, require by notice in the Gazette

Provided that the applicant shall have a permanent office in

Malta or a recognised country,

(b) in the case where the active substance is listed in

Schedule 3 or was not on the market locally or a recognised country

before 14 May 2000, a dossier has been submitted, which is in

accordance with the requirements of sub-regulation (1) of

regulation 4 of these regulations or in accordance with similar

requirements in a recognised country and is accompanied by the

declaration that the active substance is intended for inclusion in a

biocidal product

Provided that the requirement of this sub-regulation shall not

apply to substances for use in accordance with the provisions of

regulation 37 of these regulations, and

(c) he has established that the active substance complies with

the provisions of relevant regulations regarding the classification,

packaging and labelling of dangerous substances.

(2) Provisions of regulation 4 of these regulations mutatis

mutandis shall apply to an authorisation under this regulation.

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

authorisation to

of any biocidal product if he has

place a biocidal

product on the

market.

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

in accordance with regulation 17 of these regulations;

(b) received a product dossier in accordance with regulation

17 of these regulations; and

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

hereof are complied with.

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

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

information supplied to him by the applicant, be satisfied that

(a) the active substance is included in Part I or IA of the

Register of active substances

Provided that if the active substance is still pending its

registration, the Director may issue an authorisation pending a final

decision on the registration of the active substance;

(b) it is established, in the light of current scientific and

technical knowledge, and is shown from appraisal of the biocidal

product dossier, according to the common principles for the

evaluation of dossiers as laid down in Annex VI to Council

Directive 98/8/EEC of 16 February 1998 concerning the placing

of biocidal products on the market (Official Journal of the European

Communities, L 123) as may from time to time be amended that,

when used as authorised and having regard to

- all normal conditions under which the biocidal

product may be used,

-

how the material treated with it may be used,

- the consequences from use and disposal, the biocidal

product

(i)

is sufficiently effective;

(ii) has no unacceptable effects on the target

organisms, such as unacceptable resistance or cross-

resistance or unnecessary suffering and pain for

vertebrates;

(iii) has no unacceptable effects itself or as a result

of its residues, on human or animal health, directly or

indirectly (e.g. thorough drinking water, food or feed,

indoor air or consequences in the place of work) or on

surface water and groundwater;

(iv) has no unacceptable effect itself, or as a result

of its residues, on the environment having particular

regard to the following considerations

- its fate and distribution in the environment;

particularly contamination of surface water (including

estuarian and seawater), ground water and drinking water,

-

its impact on non-target organisms;

(c) the nature and quantity of its active substance and, where

appropriate, any toxicologically or ecotoxicologically significant

impurities and co-formulants, and its residues of toxicological or

environmental significance, which result from authorised uses, can

be determined according to the relevant requirements in Annexes

IIA, IIB, IIIA, IIIB, IVA, or IVB to Council Directive /EEC of 16

February 1998 concerning the placing of biocidal products on the

market (Official Journal of the European Communities, L 123)

and as may from time to time be amended;

(d) its physical and chemical properties have been

determined and deemed acceptable for purposes of the appropriate

use, storage and transport of the product; and

(e) the packaging and labelling requirements detailed in Part

Four of these regulations are complied with

Provided that biocidal product may have different

specifications and characteristics for the labelling and packaging

of different pack sizes.

(3) A biocidal product classified under the relevant

regulations as toxic, very toxic or as a category 1 or 2 carcinogen, or as

a category 1 or 2 mutagen or classified as toxic for reproduction category

1 or 2 shall not be authorised for marketing, or use by the general public.

(4) Authorisations under these regulations may be subject

to such terms and conditions as the director may deem necessary, in

relation to

(i) marketing and use of the biocidal product and,

(ii) other requirement under any other legislation.

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

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

Director in the application or dossier and shall provide him with all the

evidence that may be deemed necessary to support any identified change.

(6) The Director shall, upon request by the applicant, or on

his own initiative, and where relevant, establish a frame-formulation

and communicate it to the applicant when issuing an authorisation for a

particular biocidal product.

(7) Where a frame formulation has been established, an

application for the Authorisation of a biocidal product to which the

frame formulation refers, a second subsequent application shall be

subject to the provisions of Regulation 17 and 46.

(8) Any application received by the director under this

regulation shall be determined by him within a reasonable time not

exceeding 60 working days from the date of receipt of an application

Provided that such time may be suspended until the relevant

information is received.

(9) The Director may authorise temporarily, for a period

not exceeding 120 days, the placing on the market of biocidal products

that are not authorised in accordance with these regulations, for a limited

and controlled use if such a measure appears necessary because of

unforeseen danger which cannot be contained by other means.

(1) Any authorisation for a biocidal product issued in Information found

accordance with regulation 9 of these regulations shall, as a minimum, in an authorisation.

specify

(a)

the biocidal 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 biocidal product as a low risk

biocidal product or otherwise;

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

biocidal product being authorised;

(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 conditions 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

regulation 9 of these regulations shall be valid for a period not exceeding

a period of ten years from the date of first or renewed inclusion of its

active substance in Part I or IA of the Register of active substances for

the product type.

Provided that the Director may extend the validity of any such

authorisation upon the submission of an application for the renewal of

the authorisation submitted to him in accordance with regulation 14 of

these regulations and the Director is satisfied that the conditions

established by regulation 9 of these regulations are being complied with.

Where the Director suspects that any of the conditions

established by regulation 9 of these regulations is no longer satisfied,

(a) shall require the applicant for authorisation or the holder

of the authorisation granted in accordance with regulation 9 of

these regulations to submit any further information necessary to

establish compliance with the provisions of regulation 9 of these

regulations;

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

(c) may suspend or revoke the authorisation in accordance

with regulation 13 of these regulations; and

(d) if, after having suspended the authorisation and after

carrying out the necessary verifications he establishes that the

conditions of regulation 9 of these regulations are being complied

with, he may extend the validity of an authorisation for the period

equivalent to the time needed for the Director to complete its

verification.

(1) Any authorisation issued in accordance with regulation Suspension or

9 of these regulations may be suspended or revoked by the Director if it revocation of an

authorisation.

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 sub-regulation (2) of

regulation 9 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

biocidal product in Malta; or

(d) the biocidal product is no longer satisfactory in the

performance of the function or functions for which it was originally

intended as detailed in the biocidal product dossier; or

(e) new scientific information or data indicates that the

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

product presents a previously unknown risk or unknown risks which

are considered to be unacceptable; or

the active substance is no longer included in Parts 1 or 1A of

the Register of active substances as required by paragraph (a) of

sub-regulation (2) of regulation 9 of these regulations.

(2) (a) Where the Director suspends or revokes an

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

of such a decision also providing the holder of the authorisation with

detailed reasons on which such a decision was based and shall publish

a notice in the Gazette announcing such suspension or revocation.

(b) In the case of a revocation the Director may specify that

the commencement of any such revocation shall take effect within

a reasonable time for the disposal or for the storage, marketing

and use of existing stocks, and this period shall be of a length that

reflects the reason for the revocation.

(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 such manner and with such a time as the Director may, from

time to time require by Notice in the Gazette; and

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

9 of these regulations are still being complied with

Provided that the Director may request the applicant to

provide any additional information 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

9 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 12 of

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

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

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 regulation 13 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 9 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.

(4) Where a proposed modification of an authorisation

(a) concerns an extension of uses, the Director shall extend

the authorisation subject to the particular conditions placed on the

active substance listed in Parts I or IA of the Register of active

substances to these regulations;

(b) involves changes to the particular conditions placed on

the active substance listed in Parts I or IA of the Register of active

substances, such changes can be made only after evaluation of the

active substance, with regard to the proposed changes, in

accordance with the procedures laid down in regulation 17 of these

regulations.

Without prejudice to any provision made by or under the Obligations of the

holder of an

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

granted to him in accordance with regulation 9 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;

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

of any change to any information supplied to the Director for the

granting of the authorisation, in particular

(i) changes in the source or composition of the active

substance;

(ii) changes in composition of a biocidal product;

(iii) development of resistance of the target harmful

organisms;

(iv) changes of an administrative nature or other

aspects, such as the nature of the packaging;

(c) inform the Director in writing, 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;

(d) 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 biocidal product;

(e) allow the Director or his authorised representative with

access to the land or premises at any reasonable time; and

(f)

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 biocidal product shall be

submitted to the Director in Maltese or English together with a dossier

or a letter of access for the biocidal product satisfying, in the light of

current scientific and technical knowledge, the requirements set out in

Annex IIB and, where specified, the relevant parts of Annex IIIB to

Council Directive 98/8/EEC of 16 February 1998 concerning the placing

of biocidal products on the market (Official Journal of the European

Communities, L 123) and as may from time to time be amended, and

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) By way of derogation from sub-regulation (1) above, a

dossier submitted to the Director in relation to the granting of an

authorisation of a low-risk biocidal product shall comprise the following

data

(a) applicant

(i)

name and address,

(ii) manufacturers of the biocidal product and the active

substances, (names and addresses including location of

manufacturer of the active substances)

(iii) where appropriate, a letter of access to any relevant

data needed;

(b) identity of the biocidal product

(i)

trade name,

(ii) full composition of the biocidal product,

(iii) physical and chemical properties as referred to in

paragraph (d) of sub-regulation (2) of regulation 9 of these

regulations;

(c)

intended uses

(i) product type (as listed in Schedule one to these

regulations) and field of use,

(ii) category of users,

(iii)

method of use;

(d) efficacy data;

(e)

analytical methods;

(f) classification, packaging and labelling, including a draft

label, according to Part Four of these regulations;

(g) safety data sheet prepared in accordance with the national

provisions relating to the classification, packaging and labelling

of dangerous substances.

(3) Only applications submitted by a person having a

permanent office in Malta or a recognised country shall be considered

for authorisation.

(4) The dossiers under this regulation shall include a

detailed and full description of the studies conducted and of the methods

used or a literature reference to those methods. The information in the

dossiers shall be sufficient for an evaluation to be made of the effects

and properties referred to in sub-regulation (2) of regulation 9 of these

regulations. It shall be submitted to the Director in the form of technical

dossiers, containing the information and results of the studies referred

to in Annexes IIB and, where specified, the relevant parts of Annexes

IIIB to Council Directive 98/8/EEC of 16 February 1998 concerning

the placing of biocidal products on the market (Official Journal of the

European Communities, L 123) and as may from time to time be

amended.

(5) Information which is not necessary owing to the nature

of the biocidal product or of its proposed uses need not be supplied.

The same applies where it is not scientifically necessary or technically

possible to supply the information. In such cases, a justification,

acceptable to the Director must be submitted. Such a justification may

be the existence of a frame-formulation that the applicant has the right

to access.

(6) If the evaluation of the dossier shows that further

information, including data and results from further testing, is necessary

to evaluate the risks of the biocidal product, the Director shall ask the

applicant to submit such information. The time period for the evaluation

of the dossier shall commence from the provision of such information.

(7) The name of an active substance must be given as

registered in the list contained and provided in the relevant regulations

relating to the classification, packaging and labelling of dangerous

substances or, if the name is not included therein, the active substance

must be given its International Standards Organisation (ISO) common

name. If the latter is not available, the substance must be designated by

its chemical designation according to International Union of Pure and

Applied Chemistry (IUPAC) rules.

(8) Tests must be conducted according to the methods

described in the relevant regulations relating to the classification,

packaging and labelling of dangerous substances. When a method is

inappropriate or not described, other methods used should be justified,

whenever possible, be internationally recognised. Such tests where

appropriate must be conducted in accordance with the relevant provisions

of the Animal Welfare Act (Cap 439) regarding the protection of animals

used for experimental and other scientific purposes and in any case

texts shall comply with the relevant provisions relating to the principles

of Good Laboratory Practice (GLP).

(9) Without prejudice to the provisions of sub-regulation 8

of this regulation the need to conduct any test shall be decided by the

Director on a case-by-case basis, taking into account, among other

factors, the need to minimise testing on vertebrate animals.

(10) The Director may require that samples of the preparation

and of its ingredients shall be provided. In addition to the application

for the granting of an authorisation to this regulation an applicant shall

submit such samples of the biocidal product, of its ingredients and

models or drafts of the packaging, labelling and leaflets as the Director

may require

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

product record for each biocidal product for which an application for

the granting of an authorisation has been submitted in accordance with

these regulations.

(2) Each record shall as a minimum contain

(a) a copy of the application submitted to the Director by

the applicant;

(b) a record of the administrative decisions taken by the

Director concerning the application and concerning the dossiers

submitted in accordance of sub-regulation (1) of regulation 17 of

these regulations, with a summary of the latter; and

(c) any other document or information submitted,

considered or used during the course of evaluating the application

and the dossier.

(1) The Director shall keep and maintain, subject to the Registers to be kept

and maintained.

provisions of sub-regulation 7 of regulation 4 of these regulations, a

register of active and basic substances referred to as ‘The register of

active substances’ for biocidal products which shall be divided into 3

parts Part1, Part 1A and Part 1B. Part 1 shall contain a list of active

substances which may be contained in biocidal products; Part 1A shall

contain a list of active substances which may be contained in low risk

biocidal products; Part 1B shall contain a list basic substances.

(2) Such 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/s;

(d) the Chemical Abstracts Service (CAS) registry number

of each active substance;

(e) the classification of the active substance in accordance

with the provisions of sub-regulation (1) of regulation 4 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; and

(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 biocidal

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

(a)

the authorisation number of the biocidal product;

(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 biocidal product is to be placed

on the market in Malta;

(e) the name, Chemical Abstracts Service registry number

and percentage of all active substances contained within the

formulation;

(f) whether the product is a low risk biocidal product or

otherwise;

(g)

the name and contact details of the authorisation holder;

and

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

time, establish.

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

active and basic substances contained in the register established under

regulation 19 of these regulations and such publication shall

(a) be issued at least once annually and prior to the 1st day

of February;

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

(i) the common name and Chemical Abstracts Service

registry number of the active or basic substance;

(ii) the classification of the active or basic 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 or

basic 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 issued under sub-regulation (1) of

this regulation.

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

biocidal products authorised for marketing or use in Malta and such

publication shall

(a) be issued at least once annually and prior to the 1st day

of February;

(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 low risk biocidal product

or otherwise;

(v) the authorisation number of the product.

(2) Whenever an authorisation has been issued in relation

to a biocidal product the Director shall, by notice in the Gazette publish

in relation to such biocidal product, the information specified in

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

be deemed to amend the list of biocidal products issued under

subregulation (1) of this regulation.

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

practicable, specify the biocidal product for which the authorisation

has been suspended or revoked and such publication shall be deemed to

amend the list of biocidal products issued under sub-regulation (1) of

this regulation.

(1) For the purposes of these regulations, and without Recognition of

prejudice to the provisions of regulation 46 of these regulations the equivalent

standards.

Director may deem that a biocidal product or an active substance that is

intended for inclusion in a biocidal product satisfies the conditions of

these regulations, 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 9 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

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

treated in accordance with this sub-regulation;

(b) the applicant provides suitable evidence as to the

authenticity of the authorisation issued by a recognised country to

the satisfaction of the Director;

(c) tests and analysis were carried out under circumstances

of use, such as climate or breeding period of the target species,

relevant to the use of the biocidal 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 analyses 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 circumstances of use, such as climate

or breeding period of the target species in the regions concerned,

irrelevant for the purposes of comparability.

Where following any test or analysis carried out as referred

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

tests or analyses establish that the product does not satisfy the

conditions established in these regulations in all respects, the

Director shall issue the authorisation subject to

(i) adjustment of conditions referred to in paragraphs

(e), (f), (h), (j) and (l) of sub-regulation (3) of regulation 35

of these regulations to render irrelevant any non-comparable

circumstances for the purposes of comparability; and

(ii) any other such restriction as he may deem

appropriate.

(1) Subject to the provisions relating to the conditions for

distribution and use of biocidal products under this or any other

legislation, the Director may authorise the use of an abridged

authorisation process in relation to a biocidal product that is identical to

another product already authorised for placing on the market in Malta

or in relation to a biocidal product which is placed on the market in a

recognised country

(2) For the purposes of sub-regulation 1 of this regulation,

“identical biocidal products” 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 its active substances are the

same.

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

the market of a biocidal product in accordance with the provisions of

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

(a) a summary of the dossier as required sub-regulation (1) of

regulation 17 of these regulations and Section X of Annex IIB to

Council Directive 98/8/EEC of 16 February 1998 concerning the

placing of biocidal products on the market (Official Journal of the

European Communities, L 123) and as may from time to time be

amended, and a certified copy of the first authorisation granted;

and in the case of low-risk biocidal products, the data requirements

of sub-regulation (2) of regulation 17 of these regulations, except

for the efficacy data for which a summary shall suffice;

(b) the trade name of the product to be imported;

(c)

the authorisation number of the imported product;

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

translation of it in the Maltese and English languages;

(e)

the trade name of the reference product;

(f)

the authorisation number of the reference product;

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

in Malta;

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

in Malta;

(i)

a sample of the product as it will be marketed in Malta;

(j)

a sample of the package as it will be marketed in Malta;

and

(k) any other additional information as the Director may

deem necessary for establishing that the conditions specified in

this regulation are satisfied

Provided that the active substance of the biocidal product

is included in Parts I or IA of the Register of active substances and

conforms to the requirements thereof.

(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 biocidal

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 (3) years from

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

application by the holder made at least three (3) 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

Provided further that the Director may refuse the granting

of an authorisation according to this regulation in the following

circumstances

(a) for product types 15, 17 and 23 listed in Schedule One

to these regulations if such limitation can be justified and does not

jeopardise the purposes of these regulations;

(b) in accordance with the provisions of regulation 4 of these

regulations, the Director establishes that the target species is not

present in harmful quantities;

(c) in accordance with the provisions of regulation 4 of these

regulations, the Director establishes that there is unacceptable

tolerance or resistance of the target organism to the biocidal product.

Notwithstanding any of the provisions under this part, the

Director shall on application thereof authorise the placing on the market

of a basic substance for biocidal purposes provided that such substance

is listed under Part 1B in the register of active substances

PART THREE

DEALING IN BIOCIDAL PRODUCTS

(1) No person shall deal in any

Authorisation to

deal in biocidal

products and their

(a) active substance unless this is authorised in accordance

active substances.

with these regulations;

(b) biocidal product unless this is authorised for placing on

the market in Malta in accordance with these regulations;

(2) No person shall deal in any active substance or biocidal

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

substances or biocidal products granted to him in accordance with

regulation 26 of these regulations.

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

authorisation to

deal in biocidal products or active substances shall be made in writing deal.

to the Director and shall contain such information, and accompanied

by such documents, samples and other material as the director may

(2) Any application shall contain as a minimum the

following requirements

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

substances and biocidal 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 the director;

(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 the person who will be effectively

responsible for carrying out the activity;

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

biocidal product, the name of the biocidal 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 period of time; not exceeding 45 working days from the

date of receipt of an application

(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 requisite and where any such request has been made,

the provision of sub-regulation (3) 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

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.

Duration of validity

Any authorisation issued by the Director in accordance with

regulation 26 of these regulations shall be valid for such a period not

exceeding three (3) 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 of

the authorisation submitted to him in accordance with regulation 30 of

these regulations and if he is satisfied that the conditions established by

regulation 26 of these regulations are still being complied with.

Without prejudice to regulation 29 of these regulations, and

if the Director suspects that any of the conditions established by

regulation 25 of these regulations is no longer satisfied, the Director

(a) shall require the applicant for authorisation or the holder

of the authorisation to submit further information necessary to

establish compliance with the provisions of regulation 26 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

29 of these regulations.

(1) Any authorisation issued in accordance with regulation Suspension or

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

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 25 of these

regulations is no longer satisfied; or

(c) the applicant for authorisation requests that the Director

revokes the authorisation to deal in biocidal products or active

substances; or

(d) if 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 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

26 of these regulations are still being complied with

Provided that the Director may request the applicant for

any additional information 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 as the director may deem appropriate

(1) Without prejudice to the provisions of regulation 28 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 regulation 29 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 25 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 in such form and in such manner and

within such a 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 26 of these regulations to

(a) keep such records 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

to be kept for different types of dealing activities;

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

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 that he may require; and

(e)

comply with the provisions made by or under the Act.

(2) To the extent that may be applicable a person holding

an authorisation under regulation 25 of these regulations shall exercise

general supervision over his employees and shall, before requiring or

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

product

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

handling and application of biocides;

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

otherwise prescribed, is understood and complied with; and

(c) ensure that such workers wear suitable protective

clothing provided by him.

(3) Where a person holding an authorisation of biocidal

products has even the slightest suspicion that any biocidal product has

caused any poisoning, he shall immediately notify the appropriate health

authority.

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

authorised dealers

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 person authorised to deal in biocidal products shall Notification of entry

into Malta.

notify the Director of any consignment of any authorised biocidal

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 biocidal

product or active substance shall as a minimum include the following

information

(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; and

(e)

the date and place of bringing into Malta.

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

biocidal product in any manner whatsoever unless such advertising has biocidal products.

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 biocidal product.

(3) The Director shall authorise the advertising of a

biocidal 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 that is

false or otherwise misleading;

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

product for any purpose or circumstance or instruction other than

those specified by the authorisation for the biocidal product issued

in accordance with regulation 9 of these regulations;

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

that claims or implies the absolute safety of the biocidal product

and in particular shall not include any of the statements ‘low-risk

biocidal product’ or ‘non-toxic’ or ‘harmless’ or any similar

statement.

(g) the advertising contains the statement ‘Use biocides

safely. Always read the label and product information before use’

(4) In any authorised advertising the word biocide may be

replaced by an accurate description of the product type referred to in

Schedule 1 to these regulations.

PART FOUR

LABELLING AND PACKAGING OF BIOCIDAL PRODUCTS

(1) Biocidal products shall be classified and packaged in

accordance with the provisions relating to classification and packaging

of relevant regulations.

(2) Biocidal products shall be classified labelled and packaged

in accordance with the provisions relating to packaging and labelling

of relevant regulations. Labels shall not be misleading or give an

exaggerated impression of the product. Subject to the provisions of these

regulations, the label must show clearly and indelibly the following

(a) the identity of every active substance and its

concentration in metric units;

(b) the authorisation number allocated to the biocidal

product by the Director;

(c) the type of preparation contained within the product (e.g.

liquid concentrates, granules, powders, solids, etc.);

(d) the uses for which the biocidal product is authorised

(e.g. wood preservation, disinfection, surface biocide, anti-fouling,

etc.);

(e) directions for use and the dose rate, expressed in metric

units, for each use provided for under the terms of the authorisation;

(f) particulars of likely direct or indirect adverse side effects

and any directions for first aid;

(g) if accompanied by a leaflet, the sentence ‘Read attached

instructions before use’;

(h) directions for safe disposal of the biocidal product and

its packaging, including, where relevant, any prohibition on reuse

of packaging;

(i) the formulation batch number or designation and the

expiry date relevant to normal conditions of storage;

(j) the period of time needed for the biocidal effect, the

interval to be observed between applications of the biocidal product

or between application and the next use of the product treated, or

the next access by man or animals to the area where the biocidal

product has been used, including particulars concerning

decontamination means and measures and duration of necessary

ventilation of treated areas; particulars for adequate cleaning of

equipment; particulars concerning precautionary measures during

use, storage and transport (e.g. personal protective clothing and

equipment, measures for protection against fire, covering of

furniture, removal of food and feedingstuff and directions to prevent

animals from being exposed);

and where applicable

(k) restricitions to the use of biocidal products;

(l) information on any specific danger to the environment

particularly concerning protection of non-target organisms and

avoidance of contamination of water;

(3) Information detailed in paragraphs (a), (b), (d) and where

applicable (g) and (k) of this sub-regulation shall always be carried on

the label of the product. Information detailed in paragraphs (c), (e), (f),

(h), (i), (j) and (l) of this sub-regulation may be carried elsewhere on

the packaging or on an accompanying leaflet integral to the packaging.

Such information shall be regarded as label information for the purposes

of these regulations.

(4) In the case of microbiological biocidal products,

labelling shall also comply with the provisions made by or under the

Occupational Health and Safety Act relating to the protection of workers

from risks related to exposure to biological agents at work.

(5) It is prohibited for a label of a biocidal product to contain

the statement ‘low-risk biocidal product’ or ‘non-toxic’ or ‘harmless’

or any similar phrase.

(6) Where a biocidal product identified as an insecticide,

acaricide, rodenticide, avicide or molluscicide is authorised under these

regulations is subject to the provisions of relevant regulations, the

Director may permit changes to the packaging and labelling of that

product in so far as these do not conflict with the conditions of the

authorisation issued under these regulations.

(7) The label shall be resistant to exposure to normal

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

shall remain clear and legible throughout the expected product shelf-

life.

The packaging, including any material constituting the

immediate container, any outer packaging or any fastening device of

any biocidal product, shall as a minimum, satisfy the following

requirements

(a) be designed and constructed so that its contents cannot

disperse or leak in the environment during storage, transport,

handling or otherwise of the container other than for the purpose

of use or safe disposal;

(b) packaging shall be designed in a manner to minimise the

likelihood for food, drink or feeding stuff;

(c) not be susceptible to degradation through its contact or

exposure to its contents and shall be stable under normal conditions

of storage, handling or use;

(d) shall not be liable to form harmful or dangerous

compounds through the chemical interaction with any of its

contents; and

(e) be sealed in such a way that such a seal is irreparably

damaged when the packaging is opened for the first time.

(f) In the case of biocidal products which may be mistaken

for food, drink or feeding stuff shall contain components to

discourage their consumption.

PART FIVE

RESEARCH AND DEVELOPMENT

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

the Act, the Director may, upon receiving a written request for the issue experimentation,

research or testing.

of an authorisation for a biocidal product or active substance for the

purpose 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 biocidal product

or any active substance intended exclusively for use in a biocidal product.

(2) An unauthorised biocidal product or an active substance

for exclusive use in a biocidal product may not be placed on the market

for the purpose of any experiment or test which may involve or result in

release to the environment unless the Director has assessed the complete

record and issued an authorisation. Such authorisation shall limit the

quantities to be used and areas to be treated as the director may deem fit

to impose. Provided that such an authorisation shall not be required if

the director has granted the pertson concerned the right to undertake

such experiments and tests under the conditions of the authorisation

issued for such research and development.

(3) 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 necessary information that may be deemed necessary to establish

and define

(a) the biocidal 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

biocidal 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 biocidal product or active substance and that these are suitable

for use in such purpose;

(d) any procedure, precaution and any 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 biocidal product

or active substance;

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

contamination, release or spread of the biocidal product or active

substance;

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

and made available upon request to any authorised representative

and the minimum period for which these 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 biocidal product or active

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

after use;

(k) any other conditions or additional information as the

Director may reasonably require from the applicant in writing.

(4) 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, in the case of scientific research and

development, the persons concerned draw up and maintain written

records detailing the identity of the biocidal product or active

substance, labelling data, quantities supplied and the names and

addresses of those persons receiving the biocidal product or active

substance and compile a complete record containing all available

data on possible effects on human or animal health or impact on

the environment. This information shall, if requested, be made

available to the Director;

(c) be satisfied that, in the case of process-oriented research

and development, the complete record referred to in paragraph (b)

of this sub-regulation is submitted to him and where the process

oriented research & development is carried out in a recognised

country such complete record shall also be submitted to the

Competent Authority of such recognised country;

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

appropriate and safe;

(e) be satisfied that the test, research or experimentation

does not involve, or result in, release into the environment unless

he has assessed the available data and issued an authorisation for

the purpose which limits the quantities to be used and the areas to

be treated

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

the expertise or capability to safely handle the biocidal product or

active substance that is being authorised for use in the

experimentation, research or testing;

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

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

employees or representatives; and

(h) the premises, equipment, procedures and contingency

plans are suitable and appropriate.

(5) 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.

Provided that the Director may, before determining the

application, request the applicant to submit such further information

relating to the application as he may consider appropriate.

(6) The authorisation under this regulation may be issued

in relation to testing or experimentation for any biocidal product or

active substance whether such biocidal product or active substance is

authorised or otherwise.

Duration of validity

Any authorisation issued by the Director in accordance with

regulation 38 of these regulations shall be valid for such period not

exceeding 2 years as may be specified the Director but shall never exceed

a maximum validity period of two years

Provided that the Director may extend the validity of any such

authorisation upon the submission of an application for the renewal

submitted to him in accordance with regulation 43 of these regulations.

The holder of an authorisation issued by the Director in

accordance with regulation 38 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 38 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 issued by the Director in

accordance with regulation 38 of these regulations shall immediately

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

of the 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

38 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.

(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

38 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 or

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

authorisation for

it is established that

experimentation etc.

(a) any information or particular supporting the application

for an authorisation was incorrect, false or misleading; or

(b) any requirement as detailed in regulation 38 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 in writing the holder of the authorisation of such

suspension or revocation with detailed reasons on which such a decision

was based.

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

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

38 of these regulations.

(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 in such form and such manner and within

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

the Gazette.

PART SIX

MISCELLANEOUS

(1) In any case where any information has been submitted to

the director in relation to any application under these regulations, the

applicant may request the director to treat any information so submitted

to him to be treated as confidential being of an industrial or commercial

nature. In submitting such a request the applicant shall substantiate his

demand.

(2) The director may, if he deems such a request to be

justified allow such information to be treated as confidential. In such a

case the holder of an authorisation necessary shall inform the Director

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

information to any other person.

(3) Notwithstanding the provision of sub regulation 1 of

these regulations the following information shall after the issue of an

authorisation, not be treated as confidential

(a)

the name and postal address of the applicant;

(b) the name and postal address of the biocidal product

manufacturer;

(c) the name and postal address of the active substance

manufacturer;

(d) the names and content of the active substance or

substances in the biocidal product and the name of the biocidal

product;

(e) the names of other substances which are regarded as

dangerous within the meaning of the provisions of relevant

regulations relating to the classification, packaging and labelling

of dangerous substances which contribute to the classification of

the product;

(f) physical and chemical data concerning the active

substance and biocidal product;

(g) any ways of rendering the active substance or biocidal

product harmless;

(h) a summary of the results of the tests required pursuant

to regulation 17 of these regulations to establish the substance’s or

product’s efficacy and effects on humans, animals and the

environment and, where applicable, its ability to promote

resistance;

(i) recommended methods and precautions to reduce

dangers from handling, storage, transport and use as well as from

fire or other hazards;

(j)

safety data sheets;

(k) methods of analysis referred to in paragraph (c) of sub-

regulation (2) of regulation 9 of these regulations;

(l)

methods of disposal of the product and of its packaging;

(m) procedures to be followed and measures to be taken in

the case of spillage or leakage; and

(n) first aid and medical advice to be given in the case of

injury to persons.

(1) Where an application has been made for the registration Use of data held by

of an active substance, which has already been registered by another the

other applicants.

applicant in terms of regulation 4 of these regulations. Information in

relation to the first applicant should not be disclosed for the benefit of

the second or subsequent applicant

(a) unless the second or subsequent applicant has the written

agreement in the form of a letter of access of the first applicant

that use may be made of such information, or

(b) in the case of any information submitted for a registration

of an active substance made under paragraph (b) of subregulation

1 of regulation 8 of these regulations, before the lapse of 15 years

from the date of first inclusion in part 1 or 1A in the register of

active substances, or

(c) in the case of an active substance already on the market

on May 14, 2000 for a period of 10 years from the date of entry

of an active substance into Parts I or IA of the Register of active

substances to these regulations for information submitted for the

first time in support of the first inclusion in Parts I or IA of the

Register of active substances of either the active substance or an

additional product type for that active substance,

(d) in the case of any further information submitted for the

first time for any of the following

(i) variation of the requirements of the entry on Parts I

or IA of the Register of active substances;

(ii) maintenance of the entry of Parts I or IA of the

Register of active substances for a period of five years from

the date of decision following receipt of further information

unless the five-year period expires before the period provided

for in paragraphs (b) and (c) of this sub-regulation, in which

case the period of five years shall be extended so as to expire

on the same date as those periods.

(2) Where an application has been made for the authorisation

of a biocidal product, which has already been registered by another

applicant in terms of regulation 9 of these regulations. Information in

relation to the first applicant should not be disclosed for the benefit of

the second or subsequent applicant

It shall not be made use of the information referred to in

regulation 17 of these regulations, for the benefit of a second or

subsequent applicant

(a) unless the second or subsequent applicant has the written

agreement in the form of a letter of access of the first applicant

that use may be made of such information; or

(b) in the case of a biocidal product containing an active

substance not on the market on May 14, 2000 for a period of 10

years from the date of first authorisation or;

(c) in the case of a biocidal product containing an active

substance already on the market on May 14, 2000, for a period of

10 years from the date of entry of an active substance onto Parts I

or IA of the Register of active substances, for information which

is submitted for the first time in support of the inclusion in Parts I

or IA of the Register of active substances either of the active

substance or of an additional product type for that active substance;

(d) in the case of any data submitted for the first time for

either of the following

(i) variation of the conditions of authorisation of a

biocidal product;

(ii) submission of data necessary to maintain entry of

an active substance onto Parts I or IA of the Register of active

substances for a period of five years from the date of first

receipt of further information, unless the five-year period

expires before the period in paragraphs (b) and (c) of this

sub-regulation, in which case the period of five years shall be

extended so as to expire on the same date as those periods.

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) Every other provision of law made from or under this Deletions and

Safeguards

Act that regulates these regulations in a different manner shall be deleted

upon the expiry of thirty days upon the publication of these regulations

in the Gazette.

(2) Without prejudice, such deletions shall be made to

anything made or omitted under the provisions made before that date.

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