The Plant Protection Products (Scotland) Regulations 2005

Citation, commencement and extent S

1.—(1) These Regulations may be cited as the Plant Protection Products (Scotland) Regulations 2005 and shall come into force on 1st July 2005.

(2) These Regulations extend to Scotland only.

Commencement Information

I1 Reg. 1 in force at 1.7.2005, see reg. 1(1)

Interpretation S

2.—(1) In these Regulations, except where the context otherwise requires–

“the 1985 Act” means the Food and Environment Protection Act 1985(1);

“active substance” means any substance or micro-organism, including a virus, having general or specific action against harmful organisms or on plants, parts of plants or plant products;

“animals” means animals belonging to species normally fed and kept or consumed by humans;

“approval” in relation to a plant protection product means an administrative act under these Regulations by which the Scottish Ministers, following an application submitted by an applicant, approve the placing on the market or use of that plant protection product in the whole or any part of Scotland, and “approved” shall be construed accordingly;

“the Commission” means the Commission of the European Communities;

“contravenes” includes “fails to comply with”;

[F1 “the Directive” means Council Directive 91/414/EEC concerning the placing of plant protection products on the market, as amended–

(a)

by the instruments listed in Part I of Schedule 1 to these Regulations;

(b)

from 1st January 2007, by the instrument listed in Part II of Schedule 1 to these Regulations;

(c)

from 1st February 2007, by the instruments listed in Part III of Schedule 1 to these Regulations;

(d)

from 1st April 2007, by the instruments listed in Part IV of Schedule 1 to these Regulations;

(e)

from 1st August 2007, by the instrument listed in Part V of Schedule 1 to these Regulations;

(f)

from 1st November 2007, by the instrument listed in Part VI of Schedule 1 to these Regulations;

(g)

from 1st December 2007, by the instrument listed in Part VII of Schedule 1 to these Regulations; and

(h)

from 1st February 2008, by the instrument listed in Part VIII of Schedule 1 to these Regulations.]

“EEA State” means a member State, Norway, Iceland or Liechtenstein;

“the environment” means water, air, land, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms;

“equivalent provision” means any provision in any other Regulations made for the purposes of implementing the Directive, extending to any part of the United Kingdom, which has equivalent effect to a specified provision in these Regulations;

“harmful organisms” means pests of plants or plant products belonging to the animal or plant kingdom, viruses, bacteria and mycoplasmas and other pathogens;

“integrated control” means the rational application of a combination of biological, biotechnological, chemical, cultural or plant-breeding measures whereby the use of chemical plant protection products is limited to the minimum strictly necessary to maintain harmful organisms below levels above which economically unacceptable damage or loss would occur;

“International Organization for Standardization” means the institution of that name founded in 1947 and currently having its headquarters at 1 Rue de Varembé, CP 56, 1211 Geneva 20, Switzerland;

“International Union of Pure and Applied Chemistry” means the institution of that name founded in 1919 and currently having its headquarters at 104 T.W. Alexander Drive, Building 19, Research Triangle Park, NC 27709, USA;

“new active substance” means an active substance which is not an old active substance;

“old active substance” means an active substance which was on the market–

(a)

in the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia, and Slovakia, on or before 1st May 2004;

(b)

in Austria, Finland, Iceland, Norway, Sweden and Liechtenstein, on or before 1st July 1994;

(c)

in any other EEA State, on or before 26th July 1993;

“placing on the market” means any supply, whether in return for payment or not, within Scotland, including importation into Scotland otherwise than from an EEA State, other than a supply for storage followed by consignment otherwise than to an EEA State or disposal, and “place on the market” shall be construed accordingly;

“plants” means live plants and live parts of plants including fresh fruit and seeds;

“plant products” means products derived from plants in the unprocessed state or having undergone only simple preparation such as milling, drying or pressing, but excludes plants themselves;

“plant protection product” means an active substance or a preparation containing one or more active substances, put up in the form in which it is supplied to the user, intended to–

(a)

protect plants or plant products against all harmful organisms or prevent the action of such organisms;

(b)

influence (for example, as a growth regulator) the life processes of plants, otherwise than as a nutrient;

(c)

preserve plant products, in so far as such active substances or preparations are not subject to provisions of Community law on preservatives;

(d)

destroy undesired plants; or

(e)

destroy parts of plants or check or prevent the undesired growth of plants;

“preparation” means a mixture or solution composed of two or more substances, of which at least one is an active substance, and which is intended for use as a plant protection product;

“the 1986 Regulations” means the Control of Pesticides Regulations 1986(2);

“the relevant competent authorities” means the authorities appointed in the member States, other than the United Kingdom, for the purpose of carrying out the duties of a competent authority under the Directive;

“residue” in relation to a plant protection product means one or more substances present in or on plants or products of plant origin, edible animal products or elsewhere in the environment and resulting from the use of that plant protection product, and includes its metabolites and products resulting from its degradation or reaction;

“substance” means any chemical element and its compounds, as they occur naturally or by manufacture, and includes any impurity inevitably resulting from the manufacturing process,

and other terms used in these Regulations and in the Directive shall have the same meaning as in the Directive.

(2) In these Regulations–

(a) any reference to a numbered Article shall be construed as a reference to the Article so numbered in the Directive; and

(b) any reference to a numbered Annex shall be construed as a reference to the Annex so numbered of the Directive.

(3) A reference in these Regulations to anything done in writing or produced in written form includes a reference to an electronic communication, as defined in the Electronic Communications Act 2000(3), which has been recorded and is consequently capable of being reproduced.

Textual Amendments

F1 Words in reg. 2(1) substituted (22.12.2006) by The Plant Protection Products (Scotland) Amendment (No. 3) Regulations 2006 (revoked) 2006 (S.S.I. 2006/576), regs. 1, 3

Commencement Information

I2 Reg. 2 in force at 1.7.2005, see reg. 1(1)

Prohibitions S

3.—(1) No person shall place on the market any plant protection product unless–

(a) it has been approved under regulation 5, 7, 8 or 11 or an equivalent provision; and

(b) it is placed on the market in accordance with any requirement or condition which is specified in the approval.

(2) No person shall use any plant protection product unless–

(a) it has been approved under regulation 5, 7, 8 or 11 or an equivalent provision;

(b) it is used in accordance with any requirement or condition which is–

(i) specified in the approval or in any extension of use granted under regulation 10 or an equivalent provision; or

(ii) required by the approval or extension of use to be on the labelling;

(c) it is used in accordance with the principles of good plant protection practice; and

(d) whenever possible, it is used in accordance with the principles of integrated control.

(3) No person shall place on the market any new active substance unless–

(a) that active substance is included in Annex I; or

(b) an application–

(i) has been granted for the inclusion of that active substance in Annex I; or

(ii) has been made for the inclusion of that active substance in Annex I but has not yet been decided in accordance with the procedure in Article 19.

(4) Paragraphs (1), (2) and (3) above shall not apply to any plant protection product or active substance which is approved under regulation 9 or an equivalent provision.

(5) Nothing in this regulation shall impede the production, storage or movement within Scotland of a plant protection product intended for use in an EEA State other than the United Kingdom, provided that–

(a) the product is authorised by the competent authority of that EEA State for use in that EEA State; and

(b) the inspection requirements laid down by that EEA State in order to ensure compliance with Article 3(1) are satisfied.

(6) Any person who contravenes or causes or permits any person to contravene paragraphs (1), (2)(a) or (b) or (3) above shall be guilty of an offence.

Commencement Information

I3 Reg. 3 in force at 1.7.2005, see reg. 1(1)

Applications concerning active substances S

4.—(1) Any person who applies for the inclusion of a new active substance in Annex I shall submit to the Scottish Ministers, the relevant competent authorities and the Commission a dossier which satisfies the requirements of Annex II, a declaration that the active substance is intended for use in a plant protection product, and a dossier complying with Annex III on at least one preparation containing that active substance.

(2) Where any active substance has been included in Annex I, any person may make an application for variation of the conditions subject to which the active substance was included.

(3) Any person who applies under paragraph (2) above shall submit the application to the Scottish Ministers, the relevant competent authorities and the Commission.

(4) This regulation applies to any person whose principal place of business in Great Britain is situated in Scotland.

Commencement Information

I4 Reg. 4 in force at 1.7.2005, see reg. 1(1)

Standard approvals S

5.—(1) Subject to the following provisions of this regulation and to regulation 6, the Scottish Ministers may approve, for a period not exceeding ten years, the placing on the market and use of any plant protection product.

(2) The Scottish Ministers may renew an approval granted under this regulation after verification that the requirements of regulation 6(2) to (7) continue to be satisfied.

(3) Where an application for renewal of an approval granted under this regulation has been made, the Scottish Ministers may renew the approval for a provisional period while they undertake the verification mentioned in paragraph (2) above.

(4) Without prejudice to regulation 11, an applicant for approval of a plant protection product under this regulation shall submit with the application–

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

(b) for each active substance in the plant protection product, a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex II except to the extent that the applicant is exempted from doing so by paragraph (5) below.

(5) Without prejudice to regulation 15(1) to (4), an applicant for approval of a plant protection product under this regulation shall be exempted from supplying the information required under paragraph (4)(b) above (except for that identifying the active substance) if the active substance–

(a) is already included in Annex I at the time of the application, there being taken into account the conditions of that inclusion; and

(b) does not differ significantly in degree of purity and nature of impurities from the composition registered in the dossier accompanying the original application for inclusion of the active substance in Annex I.

(6) An approval granted under this regulation shall specify the requirements and conditions relating to the placing on the market and use of the product and such requirements and conditions shall include all those necessary to ensure that the requirements in regulation 6(3)(a) to (e) are satisfied.

(7) Any person who contravenes or causes or permits any person to contravene any requirement or condition of an approval granted under this regulation shall be guilty of an offence.

Commencement Information

I5 Reg. 5 in force at 1.7.2005, see reg. 1(1)

General requirements for granting standard approvals S

6.—(1) The Scottish Ministers shall not approve a plant protection product under regulation 5 unless the requirements set out in paragraphs (2) to (7) below are satisfied in relation to it.

(2) The active substances of the plant protection product shall have been included in Annex I at the time the approval is granted and any conditions laid down in that Annex shall have been fulfilled.

(3) Having regard to current scientific and technical knowledge and upon the appraisal of the dossier submitted for the approval of the product, it shall have been established (pursuant to the uniform principles provided for in Annex VI) that, when used in accordance with regulation 3(2) and having regard to all normal conditions under which it may be used and the consequences of its use, the plant protection product–

(a) is sufficiently effective;

(b) has no unacceptable effects on plants or plant products;

(c) does not cause unnecessary suffering and pain to vertebrates which are to be controlled;

(d) has no harmful effect directly or indirectly on human or animal health (for example, through drinking water, food or feed) or on ground water;

(e) has no unacceptable influence on the environment, having particular regard to–

(i) its fate and distribution in the environment, particularly contamination of water (including drinking water and ground water); and

(ii) its impact on non target species; and

(f) can be used in such a way that any provisional maximum residue levels determined by the Scottish Ministers under paragraph (7) below or by the Commission under Article 4(1)(f) are not exceeded.

(4) The Scottish Ministers, pursuant to the uniform principles provided for in Annex VI, shall have determined the nature and quantity of the active substances of the plant protection product and, where appropriate, any toxicologically or ecotoxicologically significant impurities and co formulants, applying methods which, until harmonised methods have been adopted under Article 4(1)(c), they have determined are appropriate.

(5) The Scottish Ministers, pursuant to the uniform principles provided for in Annex VI, shall have determined the residues of the plant protection product, resulting from approved uses, which are of toxicological or environmental significance, by applying appropriate methods in general use.

(6) The Scottish Ministers, pursuant to the uniform principles provided for in Annex VI, shall have determined the physical and chemical properties of the plant protection product and shall have adjudged them to be acceptable for the purposes of the appropriate use and storage of the product.

(7) The Scottish Ministers shall have determined provisional maximum residue levels for the agricultural products referred to in the approval and shall have notified them to the Commission.

(8) The Scottish Ministers shall ensure that compliance with the requirements set out in paragraphs (2) to (7) above is achieved by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product and representative of those prevailing where the product is intended to be used.

Commencement Information

I6 Reg. 6 in force at 1.7.2005, see reg. 1(1)

Provisional approvals S

7.—(1) The Scottish Ministers may, to enable a gradual assessment to be made of the properties of new active substances and to make it easier for new preparations to be made available for use in agriculture, approve, for a provisional period not exceeding three years, the placing on the market and use of any plant protection product containing a new active substance which is not included in Annex I, provided that the conditions specified in paragraph (2) below are satisfied.

(2) The conditions mentioned in paragraph (1) above are–

(a) a dossier on the active substance has been submitted in accordance with regulation 4(1) and satisfies the requirements of Annexes II and III in relation to the projected uses; and

(b) the Scottish Ministers have established that the active substance can satisfy the requirements of Article 5(1) and that the plant protection product may be expected to satisfy the requirements of regulation 6(3) to (7).

(3) When the conditions specified in paragraph (2) above have been satisfied the Scottish Ministers shall immediately inform the relevant competent authorities and the Commission of their assessment of the dossier and of the terms of the approval, giving at least the information provided for in Article 12(1).

(4) If, following the examination provided for in Article 6(3) of a dossier submitted under regulation 4(1), it is decided, in accordance with the procedure laid down in Article 19, that the active substance does not satisfy the requirements specified in Article 5(1), the Scottish Ministers shall withdraw the provisional approval.

(5) Before the expiry of an approval under paragraph (1) above and at the request of the approval holder, the Scottish Ministers may, subject to Article 8(1), extend that approval.

(6) The Scottish Ministers shall ensure that compliance with the requirements set out in regulation 6(2) to (7) is achieved by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product and representative of those prevailing where the product is intended to be used in Scotland.

(7) An approval granted under this regulation shall specify the requirements and conditions relating to the placing on the market and use of the product and such requirements and conditions shall include at least all those necessary to ensure that the requirements set out in regulation 6(3)(a) to (e) are satisfied.

(8) Any person who contravenes or causes or permits any person to contravene any requirement or condition of an approval granted under this regulation shall be guilty of an offence.

Commencement Information

I7 Reg. 7 in force at 1.7.2005, see reg. 1(1)

Emergency approvals S

8.—(1) For the purpose of addressing a danger falling within Article 8(4), the Scottish Ministers may approve, for a period not exceeding 120 days, the placing on the market and use of any plant protection product not complying with regulation 6 for a limited and controlled use.

(2) An approval granted under this regulation shall specify the requirements and conditions relating to the placing on the market and use of the product.

(3) Any person who contravenes or causes or permits any person to contravene any requirement or condition of an approval granted under this regulation shall be guilty of an offence.

Commencement Information

I8 Reg. 8 in force at 1.7.2005, see reg. 1(1)

Approvals for research and development S

9.—(1) No person shall carry out any experiment or test for research or development purposes involving the release into the environment of a plant protection product which has not been approved under regulation 5, 7, 8 or 11 unless an approval for trial purposes has been granted by the Scottish Ministers under this regulation in respect of that product.

(2) Subject to paragraph (3) below, any person who wishes to obtain an approval under this regulation shall submit an application to the Scottish Ministers before the commencement of the experiment or test, together with a dossier containing all the available information, so as to permit an assessment to be made of possible effects on human or animal health or the possible impact on the environment.

(3) Paragraph (2) above shall not apply if the Scottish Ministers have granted the applicant the right to undertake certain experiments and tests and have determined the conditions under which the experiments and tests have to be undertaken.

(4) An approval granted under this regulation shall specify the requirements and conditions relating to the release into the environment of the product, which shall include a specification of the controlled conditions for carrying out the test, the quantities and area or location in respect of which the approval shall apply and any conditions imposed under paragraph (5) below.

(5) If the proposed experiments or tests referred to in paragraph (1) above are liable to have harmful effects on human or animal health or to have an unacceptably adverse influence on the environment, the Scottish Ministers may either prohibit them or permit them subject to such conditions as they consider necessary to prevent those consequences.

(6) This regulation shall not apply to experiments or tests covered by Part B of Council Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms(4) as amended(5).

(7) Any person who contravenes or causes or permits any person to contravene–

(a) paragraph (1) above; or

(b) any requirement or condition of an approval granted under this regulation,

shall be guilty of an offence.

Commencement Information

I9 Reg. 9 in force at 1.7.2005, see reg. 1(1)

Extensions of approved use S

10.—(1) Official or scientific bodies involved in agricultural activities or professional agricultural organisations and professional users may apply to the Scottish Ministers for the approved use of a plant protection product in Scotland to be extended to purposes other than those for which the approval of that product was granted.

(2) The Scottish Ministers shall grant an extension of the approved use of a plant protection product when they consider that it is in the public interest and if–

(a) the documentation and information to support the extension have been submitted by the applicant for extension;

(b) the Scottish Ministers have established that the requirements referred to in regulation 6(3)(c), (d) and (e) are satisfied;

(c) the intended use is minor in nature; and

(d) users are fully and specifically informed as to instructions for use.

(3) An extension of use granted under this regulation shall be for such a period, not extending beyond the expiry of the period for the approved use of the plant protection product, as may be specified in the extension and shall specify the requirements and conditions relating to the extended use of the product.

(4) Any person who contravenes or causes or permits any person to contravene any requirement or condition of an extension of use granted under this regulation shall be guilty of an offence.

Commencement Information

I10 Reg. 10 in force at 1.7.2005, see reg. 1(1)

Mutual recognition of approvals S

11.—(1) Where–

(a) a plant protection product has been authorised under the Directive to be placed on the market and used in another EEA State; and

(b) all the active substances contained in that plant protection product are included in Annex I,

any person may apply to the Scottish Ministers for approval of that plant protection product under this regulation.

(2) An applicant for an approval under this regulation must substantiate the comparability requirement with documentary evidence.

(3) To the extent that they are satisfied that the comparability requirement is met, the Scottish Ministers shall not require the repetition of tests and analyses already carried out in connection with the authorisation of the plant protection product in that other EEA State and shall grant the application.

(4) An approval granted under this regulation may specify conditions resulting from the implementation of other measures in accordance with Community law, relating to the conditions for distribution and use of plant protection products intended to protect the health of the distributors, users and workers concerned.

(5) An approval granted under this regulation may also specify conditions by way of restrictions on use which arise from differences in dietary patterns and are necessary in order to avoid exposure of consumers of treated products to the risks of dietary contamination in excess of the acceptable daily intake of the residues concerned.

(6) An approval granted under this regulation may, with the agreement of the applicant, specify modifications in the requirements or conditions of use subject to which the plant protection product was authorised in order to render any non comparable agricultural, plant health or environmental (including climatic) conditions irrelevant for the purpose of satisfying the comparability requirement.

(7) Any person who contravenes or causes or permits any person to contravene any requirement or condition of an approval granted under this regulation shall be guilty of an offence.

(8) In this regulation “the comparability requirement” means the requirement that the agricultural, plant health and environmental (including climatic) conditions relevant to the use of the plant protection product in the EEA State in which it has been authorised to be placed on the market and used must be comparable to those in the United Kingdom.

Commencement Information

I11 Reg. 11 in force at 1.7.2005, see reg. 1(1)

Provisional restrictions and prohibitions S

12.—(1) Where the Scottish Ministers reasonably consider that a product which they have approved, or are required to approve, under regulation 11 constitutes a risk to human or animal health or the environment, they may provisionally restrict or prohibit its sale or use in Scotland and shall immediately notify the holder of the approval or the applicant (as the case may be), the relevant competent authorities and the Commission of such action, giving reasons for the decision.

(2) A provisional restriction or prohibition under paragraph (1) above shall survive so long as its survival is consistent with Article 11(2).

Commencement Information

I12 Reg. 12 in force at 1.7.2005, see reg. 1(1)

Applications, reviews, revocations and modifications S

13.—(1) An application for approval of a plant protection product under regulation 5, 7, 8 or 11 shall be made to the Scottish Ministers by or on behalf of the person responsible for first placing it on the market in Scotland.

(2) For the purpose of any application for an approval under these Regulations or for an extension of use under regulation 10–

(a) the applicant shall have a permanent office in an EEA State;

(b) the applicant’s principal place of business in Great Britain shall be situated in Scotland;

(c) the application shall be in English;

(d) samples of the preparation and of its ingredients shall be provided if requested by the Scottish Ministers.

(3) The Scottish Ministers may review an approval granted under regulation 5 or 7 or an extension of use granted under regulation 10 if there are indications that any of the relevant requirements are no longer satisfied.

(4) When reviewing an approval or extension of use under paragraph (3) above the Scottish Ministers may require the holder of the approval or extension of use to submit further information necessary for the review and the approval or extension of use may, where necessary, be extended for the period necessary to provide the further information and complete the review.

(5) Without prejudice to any decision already taken pursuant to regulation 11, the Scottish Ministers, in relation to any approval granted under these Regulations or extension of use granted under regulation 10–

(a) shall revoke the approval or extension of use if it is established that–

(i) the requirements for obtaining the approval or extension of use are not or are no longer satisfied; or

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

(b) may revoke the approval or extension of use if it is established that any requirement or condition which is–

(i) specified in the approval or extension of use; or

(ii) required by the approval or extension of use to be on the labelling,

is not or is no longer satisfied;

(c) may revoke the approval or extension of use at the request of the holder of the approval or the extension of use, who shall state the reasons for such a request.

(6) Where the Scottish Ministers revoke an approval or extension of use under paragraph (5) above, they shall immediately inform the holder of the approval or extension of use of the revocation and may grant a period of grace for the disposal, storage, placing on the market and use of existing stocks, of a length commensurate with the reason for the revocation, without prejudice to any period provided for by a decision taken under Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances(6) as amended(7) or to Article 6(1) or 8(1) or (2).

(7) Without prejudice to any decision already taken pursuant to regulation 11 and subject to paragraph (8) below, the Scottish Ministers, in relation to any approval granted under these Regulations or extension of use granted under regulation 10–

(a) shall modify the approval or extension of use if it is established that on the basis of developments in scientific and technical knowledge the manner of use and amounts used can be modified;

(b) may modify the approval or extension of use at the request of the holder of the approval or the extension of use, who shall state the reasons for such a request.

(8) The Scottish Ministers may modify an approval or an extension of use under paragraph (7) above if it is established that the relevant requirements continue to be satisfied.

(9) Before revoking an approval or extension of use under paragraph (5)(a) or (b) above, or modifying an approval or extension of use under paragraph (7)(a) above, the Scottish Ministers shall notify the holder of the approval or extension of use of their intention to revoke or modify the approval or extension of use (and of their grounds for doing so) and shall allow the holder such opportunity (if any) to make representations as the Scottish Ministers shall consider reasonable having regard to the reason why they think the revocation or modification is required.

(10) Where, in the case of a revocation or modification referred to in paragraph (9) above, the Scottish Ministers do not allow any opportunity to make representations, they shall notify the holder in question as soon as is reasonably practicable of their grounds for not allowing it.

(11) In this regulation “the relevant requirements” means–

(a) in the case of an approval granted under regulation 5, the requirements of regulation 6(2) to (7);

(b) in the case of an approval granted under regulation 7, the requirements of regulation 6(3) to (7);

(c) in the case of an extension of use granted under regulation 10, the requirements of regulation 6(3)(c), (d) and (e).

Commencement Information

I13 Reg. 13 in force at 1.7.2005, see reg. 1(1)

Notification of information on potentially dangerous effects S

14.—(1) The holder of any approval of a plant protection product granted under these Regulations or the holder of any extension of use of a plant protection product granted under regulation 10 shall immediately notify the Scottish Ministers, the relevant competent authorities and the Commission of all new information on the potentially dangerous effects of that plant protection product, or of residues of an active substance contained in that plant protection product, on human or animal health, ground water or the environment.

(2) Any person who contravenes or causes or permits any person to contravene paragraph (1) above shall be guilty of an offence.

Commencement Information

I14 Reg. 14 in force at 1.7.2005, see reg. 1(1)

Data protection S

15.—(1) Subject to paragraph (2) below, the Scottish Ministers shall not make use of any information provided in accordance with Annex II by an applicant for approval of a plant protection product under regulation 5 or 7 for the benefit of any other applicant for approval of a plant protection product under regulation 5 or 7.

(2) The Scottish Ministers may make use of such information in the circumstances provided for in Article 13(3).

(3) Subject to paragraph (4) below, the Scottish Ministers shall not make use of any information provided in accordance with Annex III by an applicant for approval of a plant protection product under regulation 5 or 7 for the benefit of any other applicant for approval of a plant protection product under regulation 5 or 7.

(4) The Scottish Ministers may make use of such information in the circumstances provided for in Article 13(4).

(5) The Scottish Ministers, following examination of an application for approval of a plant protection product under regulation 5 or 7, shall inform the Commission of instances where they consider that an active substance as included in Annex I has been produced by a person or manufacturing process other than those specified in the dossier on the basis of which that active substance was first included in Annex I and shall transmit to the Commission all relevant information regarding the identity and impurities of that active substance.

Commencement Information

I15 Reg. 15 in force at 1.7.2005, see reg. 1(1)

Duplication of experiments S

16.—(1) Notwithstanding regulation 5(4), and without prejudice to regulation 11, where an active substance has been included in Annex I–

(a) any person who intends to apply for approval under regulation 5 or 7 of a plant protection product containing that substance, and who intends to use that plant protection product in an experiment involving vertebrate animals, shall enquire of the Scottish Ministers–

(i) whether approval has already been granted for that plant protection product and, if so,

(ii) as to the name and address of any holder of a previous or existing approval,

and shall supply evidence that they intend to apply for approval on their own behalf and that the other information specified in regulation 5(4) is available;

(b) the Scottish Ministers, if satisfied that that person intends to make such an application, shall provide that person with the name and address of the holder or holders of previous or existing approvals and at the same time inform the holders of those approvals of the name and address of that person.

(2) The holder or holders of previous approvals and the person intending to make the application shall take all reasonable steps to reach agreement on the sharing of information so as to avoid the duplication of testing on vertebrate animals.

(3) Where a person requests any information with a view to inclusion of an old active substance in Annex I, the Scottish Ministers shall encourage holders of such information to co operate in the provision of the requested information, with a view to limiting the duplication of testing on vertebrate animals.

(4) Where a person who intends to apply for approval of a plant protection product and holders of previous approvals of the same product cannot reach an agreement on the sharing of information, the Scottish Ministers may direct that person and holders of previous approvals located within Scotland to share the information with a view to avoiding duplicative testing on vertebrate animals and determine both the procedure for utilising information and the reasonable balance of the interests of the parties concerned.

(5) Any person who–

(a) fails to make enquiries as required in paragraph (1)(a) above; or

(b) fails to comply with a direction made by the Scottish Ministers under paragraph (4) above,

shall be guilty of an offence.

(6) Any person who causes or permits any person to–

(a) fail to make enquiries as required in paragraph (1)(a) above; or

(b) fail to comply with a direction made by the Scottish Ministers under paragraph (4) above,

shall be guilty of an offence.

Commencement Information

I16 Reg. 16 in force at 1.7.2005, see reg. 1(1)

Confidentiality S

17.—(1) Subject to paragraphs (2) and (4) below, where an applicant for the inclusion of an active substance in Annex I or an applicant for approval of a plant protection product so requests, the Scottish Ministers shall treat any information submitted by that applicant as confidential to the extent that in the opinion of the Scottish Ministers that information contains industrial or commercial secrets.

(2) The Scottish Ministers shall not treat as confidential the information specified in Schedule 2 and, once the application has been granted, the Scottish Ministers may make that information available to any person for inspection.

(3) If subsequent to the request mentioned in paragraph (1) above the applicant discloses any information which is confidential by virtue of this regulation, the applicant shall inform the Scottish Ministers accordingly.

(4) This regulation–

(a) is without prejudice to the provisions of the Environmental Information (Scotland) Regulations 2004(8); and

(b) does not prohibit the provision, to any authority responsible for exercising any function under any equivalent provision, of information which the Scottish Ministers consider will assist the authority in exercising it.

Commencement Information

I17 Reg. 17 in force at 1.7.2005, see reg. 1(1)

Packaging S

18.—(1) No person shall place on the market a plant protection product unless the packaging of that product satisfies the following requirements–

(a) the packaging must be so designed and constructed that its contents cannot escape (unless special safety devices are required);

(b) the materials constituting the packaging and fastenings must not be susceptible to attack by the contents, or liable to form harmful or dangerous compounds with the contents;

(c) the packaging and fastenings must be strong and solid throughout so as to ensure that they will not come apart and will safely withstand normal handling; and

(d) containers with fastening devices must be so designed that the container can be repeatedly refastened so that the contents cannot escape.

(2) Any person who contravenes or causes or permits any person to contravene paragraph (1) above shall be guilty of an offence.

Commencement Information

I18 Reg. 18 in force at 1.7.2005, see reg. 1(1)

Labelling S

19.—(1) No person shall place on the market a plant protection product unless–

(a) the labelling of the packaging in which the product is contained satisfies the requirements of paragraphs 1 to 6 of Schedule 3; and

(b) that person has complied with any requirement imposed by the Scottish Ministers under paragraph 7 of that Schedule.

(2) Any person who contravenes or causes or permits any person to contravene paragraph (1) above shall be guilty of an offence.

Commencement Information

I19 Reg. 19 in force at 1.7.2005, see reg. 1(1)

Seizure and disposal of plant protection products S

20.—(1) Where there has been a contravention of any prohibition, requirement or condition imposed by or under these Regulations or an equivalent provision in relation to a plant protection product, the Scottish Ministers shall have the power–

(a) to seize or dispose of the plant protection product or require the holder of any approval relating to the plant protection product, or any other person appearing to the Scottish Ministers to be the owner or the person in charge of the plant protection product, to dispose of it;

(b) to seize or dispose of anything treated with the plant protection product or require any person appearing to the Scottish Ministers to be the owner or the person in charge of anything so treated to dispose of it; or

(c) to require the holder of any approval relating to the plant protection product, or any other person appearing to the Scottish Ministers to be the owner or the person in charge of the plant protection product, to take such remedial action as appears to the Scottish Ministers to be necessary as a result of the contravention including, where it appears to be necessary as a result of the contravention, recovery of the plant protection product from the market in Scotland.

(2) If any plant protection product has been imported into Scotland in contravention of these Regulations, the Scottish Ministers may, by notice in writing served on the person appearing to the Scottish Ministers to be the owner, the importer or the person in charge of the product, require that it shall be exported from Scotland within such period as the Scottish Ministers reasonably may determine.

(3) Any person who contravenes or causes or permits any person to contravene any requirement imposed under this regulation shall be guilty of an offence.

Commencement Information

I20 Reg. 20 in force at 1.7.2005, see reg. 1(1)

General offences S

21.—(1) Where in relation to an application for an approval under these Regulations, an application for an extension of use under regulation 10 or a requirement or condition specified in such an approval or extension of use, any person–

(a) makes a statement which that person knows to be false in a material particular;

(b) recklessly makes a statement which is false in a material particular; or

(c) intentionally fails to disclose any material particular,

that person shall be guilty of an offence.

(2) Where in relation to an application for an approval under these Regulations, an application for an extension of use under regulation 10 or a requirement or condition specified in such an approval or extension of use, any person causes or permits any person–

(a) to make a statement which the former knows to be false in a material particular;

(b) recklessly to make a statement which is false in a material particular; or

(c) intentionally to fail to disclose any material particular,

that person shall be guilty of an offence.

(3) Any person who–

(a) intentionally obstructs an officer in the performance of any functions of that officer under regulation 24;

(b) fails to comply with a requirement made or direction given by an officer in the performance of the functions of that officer under regulation 24; or

(c) in purporting to give information required by an officer for the performance of any of the functions of that officer under regulation 24–

(i) makes a statement which that person knows to be false in a material particular;

(ii) recklessly makes a statement which is false in a material particular; or

(iii) intentionally fails to disclose any material particular;

shall be guilty of an offence.

(4) In this regulation “officer” shall have the same meaning as provided for in paragraph 1(c) of Schedule 2 to the 1985 Act, as read with regulation 24.

Commencement Information

I21 Reg. 21 in force at 1.7.2005, see reg. 1(1)

Penalties S

22.—(1) A person guilty of an offence under regulation 3(6), 5(7), 7(8), 8(3), 9(7), 10(4), 11(7), 18(2), 19(2), 20(3) or 21(1) or (2) shall be liable–

(a) on summary conviction, to a fine of an amount not exceeding the statutory maximum; and

(b) on conviction on indictment, to a fine.

(2) A person guilty of an offence under regulation 14(2), 16(5) or (6) or 21(3) shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale.

(3) Where an offence under these Regulations which has been committed by a body corporate is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a director, manager, secretary or other similar officer of the body corporate, or any person who was purporting to act in any such capacity, that person as well as the body corporate shall be guilty of that offence and be liable to be proceeded against and punished accordingly.

(4) Where the affairs of a body corporate are managed by its members, paragraph (3) above shall apply in relation to the acts and defaults of a member in connection with the functions of management of that member as if that member were a director of the body corporate.

(5) In paragraphs (3) and (4) above references to a “body corporate” include references to a partnership and, in relation to such partnership, any reference to a director or other officer of a body corporate is a reference to a partner.

(6) Proceedings for any offence under these Regulations may be taken, and the offence may for the purposes of the jurisdiction of the court to try the offences be treated as having been committed, in any place in Scotland.

(7) It shall be a defence in proceedings for an offence under section 7(b) of the Protection of Animals (Scotland) Act 1912(9) (which restricts the placing on land of poison and poisonous substances) for the person charged to show that they acted in accordance with an approval granted under these Regulations and, where appropriate, an extension of use granted under regulation 10.

Commencement Information

I22 Reg. 22 in force at 1.7.2005, see reg. 1(1)

General defence of due diligence S

23.—(1) In any proceedings for an offence under these Regulations it shall be a defence for the person charged to prove that they took all reasonable precautions and exercised all due diligence to avoid the commission of the offence.

(2) Without prejudice to the generality of paragraph (1) above, a person is to be taken to have established the defence provided by that paragraph if that person proves–

(a) that they acted under instructions given by the employer of that person; or

(b) that they acted in reliance on information supplied by another person without any reason to suppose that the information was false or misleading,

and in either case that they took all such steps as were reasonably open to them to ensure that no offence would be committed.

(3) If in any case the defence provided by paragraph (1) above involves an allegation that the commission of the offence was due to an act or omission by another person, other than the giving of instructions to the person charged with the offence by the employer of that person, or to reliance on information supplied by another person, the person charged shall not, without leave of the court, be entitled to rely on that defence unless within a period ending seven clear days before the trial diet, that person has served on the prosecutor a notice giving such information identifying or assisting in the identification of that other person as was then in the possession of that person.

Commencement Information

I23 Reg. 23 in force at 1.7.2005, see reg. 1(1)

Enforcement S

24.—(1) Section 19 of, and paragraphs 1(c), 2 and 4 to 9 of Schedule 2 to, the 1985 Act (enforcement powers) shall have effect for the purposes of these Regulations as they have effect for the purpose of that Act and as if–

(a) any reference in that section, or in those paragraphs, to that Act or a Part of it were a reference to these Regulations;

(b) any reference in that section to a pesticide were a reference to a plant protection product; and

(c) any reference in that section to an offence under section 16(12)(a) of that Act were a reference to an offence to which this regulation applies.

(2) This regulation applies to any offence under regulation 3(6), 5(7), 7(8), 8(3), 9(7), 10(4), 11(7), 14(2), 16(5) or (6), 18(2), 19(2) or 20(3).

Commencement Information

I24 Reg. 24 in force at 1.7.2005, see reg. 1(1)

Service of documents S

25.—(1) Any document required or authorised under these Regulations to be served by the Scottish Ministers on any person may be served–

(a) by delivering it to that person or by leaving it at the proper address of that person or by sending it by post to that person at that address;

(b) if the person is a body corporate, by serving it in accordance with sub-paragraph (a) above on the secretary of that body; or

(c) if the person is a partnership, by serving it in accordance with sub-paragraph (a) above on a partner or a person having control or management of the partnership business.

(2) For the purpose of this regulation and section 7 (which relates to the service of documents by post) of the Interpretation Act 1978(10) in its application to this regulation, the proper address of any person on whom a document is to be served shall be the last known address of that person, except that–

(a) in the case of service on a body corporate or its secretary, it shall be the address of the registered or principal office of the body; or

(b) in the case of service on a partnership or a partner or a person having the control or management of a partnership business, it shall be the address of the principal office of the partnership,

and for the purpose of this paragraph the principal office of a company registered outside Scotland or of a partnership carrying on business outside Scotland includes its principal office within Scotland.

(3) If a person to be served under these Regulations with any document has specified to the Scottish Ministers an address within Great Britain other than the proper address of that person (as determined under paragraph (2) above) as the one at which that person or someone on behalf of that person will accept documents of the same description as that document, that address shall also be treated as the proper address of that person for the purposes of this regulation and for the purposes of section 7 of the Interpretation Act 1978 in its application to this regulation.

(4) In this regulation “secretary”, in relation to a local authority within the meaning of the Local Government (Scotland) Act 1973(11), means the proper officer within the meaning of that Act.

Commencement Information

I25 Reg. 25 in force at 1.7.2005, see reg. 1(1)

Agency arrangements S

26.—(1) The Scottish Ministers may arrange, with the agreement of the United Kingdom Ministers, for any of their functions under or for the purposes of these Regulations or the Directive to be exercised on their behalf by a Minister of the Crown.

(2) An arrangement under this regulation in respect of any function may include provisions for any fees and payments and levies payable under any enactment to any part of the Scottish Administration in respect of that function to be collected by a Minister of the Crown or Government Department on behalf of that part of the Scottish Administration.

(3) An arrangement under this regulation shall be in writing and be signed by, or on behalf of, the Scottish Ministers and the UK Ministers and such an arrangement may be subject to such conditions (including conditions as to the costs and charge for costs) as may be agreed.

Commencement Information

I26 Reg. 26 in force at 1.7.2005, see reg. 1(1)

Transitional provisions S

27.  Schedule 4 shall have effect.

Commencement Information

I27 Reg. 27 in force at 1.7.2005, see reg. 1(1)

Disapplication S

28.—(1) The 1986 Regulations shall not apply to any plant protection product the placing on the market and use of which are, or under Schedule 4 have become, subject to the prohibitions specified in regulation 3(1) and (2).

(2) The 1986 Regulations shall not apply to any plant protection product which is approved under regulation 9 of these Regulations.

(3) The Farm and Garden Chemicals Regulations 1971(12) shall not apply to any plant protection product to the extent that regulation 19 applies to it.

Commencement Information

I28 Reg. 28 in force at 1.7.2005, see reg. 1(1)

Revocation S

29.  The Plant Protection Products (Scotland) Regulations 2003(13) and the Plant Protection Products (Scotland) Amendment Regulations 2004(14) are hereby revoked.

Commencement Information

I29 Reg. 29 in force at 1.7.2005, see reg. 1(1)

ROSS FINNIE

A member of the Scottish Executive

St Andrew’s House, Edinburgh

8th June 2005