The Plant Protection Products Regulations 2003

Regulation 26

SCHEDULE 4 TRANSITIONAL PROVISIONS

Application of these Regulations and of the 1986 Regulations to relevant plant protection products

1.  Notwithstanding regulation 3(1) and (2) and subject to the remaining provisions of this Schedule—

(a) these Regulations shall not apply; and

(b) the 1986 Regulations shall continue to apply,

to a relevant plant protection product.

2.  Notwithstanding paragraph 1 above, and subject to paragraphs 3 and 4 below, regulations 1, 2 and 9 and (insofar as they relate to approvals granted under regulation 9) regulations 13(2) and (5) to (8), 14, 17 and 20 to 27 shall apply to a relevant plant protection product.

3.  Regulation 9 shall not apply to a relevant plant protection product to which any of the exemptions provided in regulation 3(2)(a) to (c) and (e) to (j) of the 1986 Regulations applies.

4.  Notwithstanding regulation 27(2), a pesticide approval in respect of a relevant plant protection product given in the form of an experimental permit under regulation 5(a) of the 1986 Regulations which was in force on 13th November 1997 shall continue to be subject to the 1986 Regulations and shall continue in force until the date of expiry of such approval or earlier revocation under those Regulations.

Effect of Annex I decisions on the placing on the market and use of relevant plant protection products which are not approved pesticides

5.  Where in relation to a relevant plant protection product which is not an approved pesticide it is decided under Article 6—

(a) that the relevant active substances of that product should be included in Annex I, or

(b) that any of the relevant active substances of that product should not be included in Annex I,

the placing on the market and use of that product shall become subject to the prohibitions specified in regulation 3(1) and (2).

Effect of a refusal to include an active substance in Annex I on relevant plant protection products which are approved pesticides

6.  Where, in relation to a relevant plant protection product which is an approved pesticide, it has been decided under Article 6 that any of its relevant active substances should not be included in Annex I, the Secretary of State shall notify the pesticide approval holder of that decision and shall take the action described in paragraph 9(1) below.

Effect of a decision to include active substances in Annex I on relevant plant protection products which are approved pesticides

7.—(1) Where, in relation to any relevant plant protection product which is an approved pesticide, it has been decided under Article 6 that its relevant active substances should be included in Annex I, the Secretary of State shall notify the pesticide approval holder of that fact and the pesticide approval holder shall, within such period as the Secretary of State may determine and notify to the pesticide approval holder, provide information to the Secretary of State to show:

(a) that the relevant active substances contained in the plant protection product comply with the conditions of Annex I inclusion; and

(b) that he has access to a dossier satisfying the requirements of Annex II.

(2) After having submitted to the Secretary of State the information required under paragraph (1) above, the pesticide approval holder may continue to place on the market and use the relevant plant protection product until such time as the Secretary of State notifies him of her decision that she is or is not satisfied that the information provided shows that the relevant active substances comply with the conditions of Annex I inclusion and that the approval holder has access to a dossier satisfying the requirements of Annex II.

(3) Where the pesticide approval holder fails to provide adequate information to enable the Secretary of State to reach a decision, the Secretary of State shall notify him of that failure and the pesticide approval holder shall, within such reasonable period as may be specified in the notification, submit further information to the Secretary of State to enable her to reach a decision.

(4) Where the Secretary of State decides that the information provided under paragraph (1) above fails to show that the relevant active substances comply with the conditions of Annex I inclusion or that the approval holder has access to a dossier satisfying the requirements of Annex II she shall take the action described in paragraph 9(1) below.

8.—(1) Where the Secretary of State has determined that the information provided by the approval holder under paragraph 7 above shows that the relevant active substances comply with the conditions of Annex I inclusion and that the approval holder has access to a dossier satisfying the requirements of Annex II she shall notify the pesticide approval holder of that fact and the pesticide approval holder shall, within such period as the Secretary of State may determine and notify to the pesticide approval holder, make an application for an approval of the relevant plant protection product under regulation 5.

(2) The pesticide approval holder may continue to place on the market and use the relevant plant protection product until such time as the Secretary of State notifies him of her decision to grant or refuse an approval under regulation 5.

(3) Where the pesticide approval holder fails to provide adequate information to enable the Secretary of State to consider the application, the Secretary of State shall notify him of that failure and the pesticide approval holder shall, within such reasonable period as may be specified in the notification, submit further information to the Secretary of State to enable her to consider the application.

Revocation of pesticide approval

9.—(1) The Secretary of State shall, at the same time as she notifies a pesticide approval holder of a decision mentioned in paragraph 6, 7(4) or 8(2) above, revoke the pesticide approval.

(2) The Secretary of State may, if any pesticide approval holder fails to comply with a notification given under paragraph 7(1) or (3) or 8(1) or (3) above, revoke the pesticide approval.

(3) Where the Secretary of State revokes a pesticide approval under sub-paragraph (1) or (2) above, she may revoke that approval—

(a) completely;

(b) in the manner specified in sub-paragraph (4) below; or

(c) in the manner specified in sub-paragraph (5) below.

(4) When revoking an approval in the manner mentioned in paragraph (b) of sub-paragraph (3) above, the Secretary of State shall—

(a) subject to sub-paragraph (b) below, revoke that approval in so far as it authorises the advertisement, sale, storage, supply and use of that product; and

(b) in the form of a provisional approval granted under regulation 5 of the 1986 Regulations for a period not exceeding one year commencing with the date of that revocation, authorise—

(i) the storage of that product by any person; and

(ii) the advertisement, sale, supply and use of that product by any person other than the pesticide approval holder or the pesticide approval holder’s employees or agents.

(5) When revoking an approval in the manner mentioned in paragraph (c) of sub-paragraph (3) above, the Secretary of State shall—

(a) subject to sub-paragraphs (b) and (c) below, revoke that approval in so far as it authorises the advertisement, sale, supply, storage and use of that product;

(b) in the form of a provisional approval granted under regulation 5 of the 1986 Regulations for a period not exceeding one year commencing with the date of that revocation, authorise the advertisement, sale, storage, supply and use of that product by any person; and

(c) in the form of a provisional approval granted under regulation 5 of the 1986 Regulations for a period, not exceeding one year following the end of the period of provisional approval granted under sub-paragraph (b) above, authorise—

(i) the storage of that product by any person; and

(ii) the advertisement, sale, supply and use of that product by any person other than the pesticide approval holder or the pesticide approval holder’s employees or agents.

Effect of revocation on the placing on the market and use of the product

10.—(1) Where the Secretary of State has revoked a pesticide approval in relation to any plant protection product under paragraph 9(1) or (2) above completely, the placing on the market and use of that product shall become subject to the prohibitions specified in regulation 3(1) and (2) forthwith.

(2) Where the Secretary of State has revoked a pesticide approval in relation to any plant protection product in the manner specified in paragraph 9(4) above, the placing on the market and use of that product shall become subject to the prohibitions specified in regulation 3(1) and (2) on the expiry of the period of the provisional approval granted under paragraph 9(4)(b) above.

(3) Where the Secretary of State has revoked a pesticide approval in relation to any plant protection product in the manner specified in paragraph 9(5) above, the placing on the market and use of that product shall become subject to the prohibitions specified in regulation 3(1) and (2) on the expiry of the period of the provisional approval granted under paragraph 9(5)(c) above.

Notifications

11.  Any notification given by the Secretary of State under this Schedule shall be in writing.

Interpretation

12.  For the purposes of this Schedule—

“approved pesticide” means a pesticide which is the subject of a pesticide approval;

“pesticide approval” means approval of a pesticide given under regulation 5 of the 1986 Regulations;

“pesticide approval holder” means any person who holds a current pesticide approval;

“relevant active substance” means an active substance contained in a relevant plant protection product which is an approved pesticide;

“relevant plant protection product” means any plant protection product—

(a)

which is a pesticide, or substance, preparation or organism prepared or used for any of the purposes mentioned in regulation 3(1)(b) of the 1986 Regulations, and

(b)

at least one of whose active ingredients is an old active substance; and

“active ingredient”, “advertisement”, “organism”, “pesticide”, “preparation”, “sale”, “storage”, “substance”, “supply” and “use” have the same meanings as in the 1986 Regulations.