PART 2Amendments relating to feed additives

Amendment of Regulation (EC) No 1831/2003

regulation 3 + 3.—(1) Regulation (EC) No 1831/2003 is amended as follows.

(2) In Article 2(2), after point (s) insert—

“(t)‘Register’ means the Register of Feed Additives referred to in Article 17.”.

(3) In Article 3(3), omit “Regulation”.

(4) In Article 4(2), omit “renewed,”.

(5) In Article 5(1), for “Regulation authorising” substitute “authorisation concerned in respect of”.

(6) In Article 9—

regulation 3 6 a + (a)in the heading, after “Authorisation” insert “by the appropriate authority”;

regulation 3 6 b + (b)in paragraph 1, in the third sentence, for “The authorisation must be prescribed by the appropriate authority and” substitute “Where the appropriate authority determines that the feed additive is to be authorised, the authorisation”;

regulation 3 6 c + (c)for paragraph 7 substitute—

“7.  Where the appropriate authority determines that a feed additive is, or is not, to be authorised:

(a)in the event of a determination to authorise the feed additive:

(i)the appropriate authority must specify the date on which the authorisation is to have effect; and

(ii)the Food Safety Authority must enter the authorisation, including the elements mentioned in Article 8(4)(b), (c), (d) and (e) and an identification number, in the Register;

(b)the appropriate authority must communicate the determination to the Food Safety Authority.”.

(7) After Article 12, insert—

“Article 12ASupervision: supplementary

1.  This Article applies where the Food Safety Authority receives, or becomes aware of, any information which might affect the assessment of the safety, or the suitability of the method of analysis, of the feed additive.

2.  Where the Food Safety Authority receives, or becomes aware of, information under paragraph 1, the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 13.

3.  The Food Safety Authority may ask a relevant person to provide, within a specified period, such other information as the Food Safety Authority considers necessary for the purposes of deciding whether to issue an opinion under Article 13.

4.  The Food Safety Authority may extend the period of time described in paragraph 3.

5.  Where the Food Safety Authority makes a request under paragraph 3 and the relevant person fails to provide the information requested within the specified period (including any extension of that period), the Food Safety Authority must consider whether it is necessary to issue an opinion under Article 13 based on such information as the Food Safety Authority has which might affect the assessment of the safety, or the suitability of the method of analysis, of the feed additive.

6.  In this Article, “relevant person” means any person who is—

(a)the holder of the authorisation concerned;

(b)a producer or manufacturer of the feed additive concerned; or

(c)any feed business placing on the market, processing or using the feed additive concerned.”.

(8) In Article 13—

regulation 3 8 a + (a)in paragraph 1, in the first sentence, for “or following a request from the appropriate authority, the Food Safety Authority must” substitute “, the Food Safety Authority may, or following a request from the appropriate authority, the Food Safety Authority must,”;

regulation 3 8 b + (b)in paragraphs 2 and 3, in both places, for “in light of” substitute “having regard to”;

regulation 3 8 c + (c)after paragraph 3, insert—

“3A.  The appropriate authority must, in relation to any determination it makes under this Article:

(a)specify the date on which the modification, suspension or revocation is to have effect; and

(b)communicate the determination to the Food Safety Authority.”;

regulation 3 8 d + (d)in paragraph 4—

regulation 3 8 d i + (i)in the words before point (a), for “appropriate authority must, without delay” substitute “Food Safety Authority, without delay after being informed by the appropriate authority, must”;

regulation 3 8 d ii + (ii)omit point (b);

regulation 3 8 e + (e)after paragraph 4 insert—

“4A.  Where the appropriate authority determines that an authorisation of a feed additive is to be modified, suspended or revoked, the Food Safety Authority must update the Register accordingly.”;

regulation 3 8 f + (f)after paragraph 5 insert—

“6.  For the purposes of this Article, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which:

(a)existing stocks of the product concerned, and any products derived from it or containing it, may be placed on the market or used;

(b)the product concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;

(c)the labelling of the product concerned, and any products derived from it or containing it, may continue to be applied.

7.  The appropriate authority may prescribe other transitional measures not falling within paragraph 6 in relation to the modification, suspension or revocation of an authorisation.”.

(9) Omit Article 14.

(10) In Article 15—

regulation 3 10 a + (a)the existing paragraph is renumbered as paragraph 1;

regulation 3 10 b + (b)in paragraph 1, as so renumbered, omit the second sentence;

regulation 3 10 c + (c)after paragraph 1, insert—

“2.  The appropriate authority may withdraw a provisional authorisation given under paragraph 1.

3.  Where the appropriate authority determines that a provisional authorisation is to be withdrawn, the appropriate authority may specify, in relation to the withdrawal of a provisional authorisation, a period of time, or different periods of time, within which:

(a)existing stocks of the product concerned, and any products derived from it or containing it, may be placed on the market or used;

(b)the product concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;

(c)the labelling of the product concerned, and any products derived from it or containing it, may continue to be applied.

4.  The appropriate authority may prescribe other transitional measures not falling within paragraph 3 in relation to the withdrawal of a provisional authorisation.

5.  Where the appropriate authority determines that a feed additive is, or is not, to be provisionally authorised (including a determination to withdraw a provisional authorisation), the appropriate authority must communicate the determination to the Food Safety Authority and:

(a)in the event of a determination to provisionally authorise a feed additive:

(i)the provisional authorisation must, to the extent that it is possible to do so, include information equivalent to that which must be included for an authorisation under Article 9(1);

(ii)the appropriate authority must specify the date on which the provisional authorisation is to have effect; and

(iii)the Food Safety Authority must enter the provisional authorisation, including the information mentioned in paragraph (i), in the Register;

(b)in the event of a determination to withdraw a provisional authorisation:

(i)the appropriate authority must specify the date on which the withdrawal is to have effect; and

(ii)the Food Safety Authority must update the Register accordingly.”.

(11) In Article 17, for paragraph 2 substitute—

“2.  The Food Safety Authority must make the Register available to the public.”.

(12) In Annex IV, in paragraph 1, omit “Regulation”.

Amendment of Commission Regulation (EC) No 378/2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives

regulation 4 + 4.—(1) Commission Regulation (EC) No 378/2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives(1) is amended as follows.

(2) In Article 3(3), in the first subparagraph—

regulation 4 2 a + (a)for “valid for the entire period of” substitute “for”;

regulation 4 2 b + (b)for “those expired” substitute “any that expire”.

(3) In Article 5(4), omit point (c).

(4) In Annex IV, omit paragraph 5.

Amendment of Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives

regulation 5 + 5.—(1) Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives(2) is amended as follows.

(2) In Annex I, in the application form, in the first part, omit “Renewal of a feed additive authorisation (Article 14 of Regulation (EC) No 1831/2003)” and the corresponding checkbox.

(3) In Annex II—

regulation 5 3 a + (a)in the first paragraph (general aspects)—

regulation 5 3 a i + (i)at the end of the second indent, insert “or”;

regulation 5 3 a ii + (ii)at the end of the third indent, omit “, or”;

regulation 5 3 a iii + (iii)omit the fourth indent (“a renewal of the authorisation of a feed additive”);

regulation 5 3 b + (b)in section 5 (post-market monitoring plan), in the fourth paragraph, omit “, preferably during the latter part of the period of authorisation”.

(4) In Annex III—

regulation 5 4 a + (a)in the text before part 1 (technological additives), in the second paragraph (list of the specific requirements for establishing dossiers for:), omit “(10) Renewal of authorisations”;

regulation 5 4 b + (b)in part 2 (sensory additives), in point 2.2.3.1., in paragraph (2), omit “(following by analogy Regulation (EU) No 872/2012)”;

regulation 5 4 c + (c)omit part 10 (renewal of authorisations).