CHAPTER II

AUTHORISATION, USE, MONITORING AND TRANSITIONAL MEASURES APPLICABLE FOR FEED ADDITIVES

Status of existing products
Article 10
1
By way of derogation from Article 3, a feed additive which has been placed on the market pursuant to Directive 70/524/EEC and urea and derivatives, an amino acid, salt of an amino acid or analogous substance, which was listed in points 2.1, 3 and 4 of the Annex to Directive 82/471/EEC, may be placed on the market and used in accordance with the conditions specified in Directives 70/524/EEC or 82/471/EEC and their implementing measures, including in particular specific labelling provisions concerning compound feed and feed materials, provided that the following conditions are met:
a
within one year of the entry into force of this Regulation, persons first placing the feed additive on the market or any other interested parties shall notify this fact to the Commission. At the same time, the particulars mentioned in Article 7(3)(a), (b) and (c) shall be directly sent to the Authority;
b
within one year of the notification mentioned under (a), the Authority shall, after verification that all the information required has been submitted, notify the Commission that it has received the information required under this Article. The products concerned shall be entered in the Register. Each entry in the Register shall mention the date on which the product concerned was first entered in the Register and, where applicable, the expiry date of the existing authorisation.
2
An application shall be submitted in accordance with Article 7, at the latest one year before the expiry date of the authorisation given pursuant to Directive 70/524/EEC for additives with a limited authorisation period, and within a maximum of seven years after the entry into force of this Regulation for additives authorised without a time limit or pursuant to Directive 82/471/EEC. A detailed calendar listing in order of priority the different classes of additives to be re-evaluated may be adopted in accordance with the procedure referred to in Article 22(2). The Authority shall be consulted in drawing up the list.
3
Products entered in the Register shall be subject to the provisions of this Regulation, in particular Articles 8, 9, 12, 13, 14 and 16, which without prejudice to specific conditions concerning the labelling, placing on the market and use of each substance pursuant to paragraph 1, shall apply to such products as if they had been authorised pursuant to Article 9.
4
In the case of authorisations not issued to a specific holder, any person who imports or manufactures the products referred to in this Article or any other interested party may submit the information as referred to in paragraph 1 or the application as referred to in paragraph 2 to the Commission.
5
Where the notification and accompanying particulars referred to in paragraph 1(a) are not supplied within the period specified or are found to be incorrect, or where an application is not submitted as required by paragraph 2 within the period specified, the appropriate authority may prescribe that—
a
the additives concerned must be withdrawn from the market;
b
that, for a limited period of time, existing stocks of the product may remain, or continue to be placed, on the market.
6
Where, for reasons beyond the control of the applicant, no decision is taken on the renewal of an authorisation before its expiry date, the period of authorisation of the product shall automatically be extended until the appropriate authority takes a decision. The appropriate authority shall inform the applicant of this extension of the authorisation.
7
By way of derogation from Article 3, substances, micro-organisms and preparations used in the Community as silage additives at the date referred to in Article 26(2), may be placed on the market and used provided that points (a) and (b) of paragraph 1 and paragraph 2 are complied with. Paragraphs 3 and 4 shall apply accordingly. For these substances, the deadline for application as referred to in paragraph 2 shall be seven years after the entry into force of this Regulation.
Art. 10(5) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 18(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 10(6) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 18(b); 2020 c. 1, Sch. 5 para. 1(1)