PART 5Amendments relating to products containing, consisting of, or produced from, genetically modified organisms

Amendment of Regulation (EC) No 1829/2003

regulation 14 + 14.—(1) Regulation (EC) No 1829/2003 is amended as follows.

(2) In Article 2, after paragraph 23 insert—

“24.  ‘Register’ means the register of genetically modified food and feed referred to in Article 28.”.

(3) In Article 4(5), omit “renewed,”.

(4) In Article 7—

regulation 14 4 a + (a)in paragraph 3, for “Any authorisation” to “authority and” substitute “Where the appropriate authority determines that there is to be an authorisation in respect of an application, the appropriate authority must specify the date on which the authorisation is to have effect and communicate the determination to the Food Safety Authority, and the authorisation”;

regulation 14 4 b + (b)in paragraph 4—

regulation 14 4 b i + (i)omit the first sentence;

regulation 14 4 b ii + (ii)in the second sentence, after “entered” insert “, by the Food Safety Authority,”.

(5) After Article 9, insert—

“Article 9ASupervision: 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 detection, of the authorised food concerned.

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 10.

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 10.

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 10 based on such information as the Food Safety Authority has which might affect the assessment of the safety of the food concerned or the suitability of the method of detection.

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

(a)the authorisation-holder;

(b)a producer or manufacturer of the food concerned; or

(c)any food business placing on the market the food concerned.”.

(6) In Article 10—

regulation 14 6 a + (a)in paragraph 2, for the third sentence substitute “The appropriate authority must, having regard to the opinion of the Food Safety Authority, determine whether to modify, suspend or revoke the authorisation.”;

regulation 14 6 b + (b)after paragraph 2, insert—

“2A.  Where the appropriate authority determines that an authorisation is to be modified, suspended or revoked, the appropriate authority must specify the date on which the modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the Register accordingly.”;

regulation 14 6 c + (c)after paragraph 3 insert—

“4.  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.

5.  The appropriate authority may prescribe other transitional measures not falling within paragraph 4 in relation to the modification, suspension or revocation of an authorisation.”.

(7) Omit Article 11.

(8) In Article 16(5), omit “renewed,”.

(9) In Article 19—

regulation 14 9 a + (a)in paragraph 3, for “Any authorisation” to “authority and” substitute “Where the appropriate authority determines that there is to be an authorisation in respect of an application, the appropriate authority must specify the date on which the authorisation is to have effect and communicate the determination to the Food Safety Authority, and the authorisation”;

regulation 14 9 b + (b)in paragraph 4—

regulation 14 9 b i + (i)omit the first sentence;

regulation 14 9 b ii + (ii)in the second sentence, after “entered” insert “, by the Food Safety Authority,”.

(10) After Article 21, insert—

“Article 21ASupervision: 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 detection, of the authorised feed concerned.

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 22.

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 22.

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 22 based on such information as the Food Safety Authority has which might affect the assessment of the safety of the feed concerned or the suitability of the method of detection.

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

(a)the authorisation-holder;

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

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

(11) In Article 22—

regulation 14 11 a + (a)in paragraph 2, for the third sentence substitute “The appropriate authority must, having regard to the opinion of the Food Safety Authority, determine whether to modify, suspend or revoke the authorisation.”;

regulation 14 11 b + (b)after paragraph 2, insert—

“2A.  Where the appropriate authority determines that an authorisation is to be modified, suspended or revoked, the appropriate authority must specify the date on which the modification, suspension or revocation is to have effect and communicate the determination to the Food Safety Authority, and the Food Safety Authority must update the Register accordingly.”;

regulation 14 11 c + (c)after paragraph 3 insert—

“4.  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.

5.  The appropriate authority may prescribe other transitional measures not falling within paragraph 4 in relation to the modification, suspension or revocation of an authorisation.”.

(12) Omit Article 23.

(13) In Article 28—

regulation 14 13 a + (a)in paragraph 1—

regulation 14 13 a i + (i)omit “and maintain”; and

regulation 14 13 a ii + (ii)for “hereinafter” substitute “in this Regulation”;

regulation 14 13 b + (b)for paragraph 2, substitute—

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

(14) In Article 44(1), omit “renewal,”.

Amendment of Commission Regulation (EU) No 619/2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material, etc.

regulation 15 + 15.—(1) Commission Regulation (EU) No 619/2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired(1) is amended as follows.

(2) In Article 2—

regulation 15 2 a + (a)in point (b), omit the “and” at the end;

regulation 15 2 b + (b)omit point (c).

Amendment of Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed, etc.

regulation 16 + 16.—(1) Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council, etc.(2), is amended as follows.

(2) In Article 1, in the words before point (a), for “5, 11, 17 and 23” substitute “5 and 17”.

(3) In Article 8—

regulation 16 3 a + (a)in the heading, for “5(3), 11(2), 17(3) and 23(2)” substitute “5(3) and 17(3)”;

regulation 16 3 b + (b)omit paragraph 2.

(4) In Annex III, in section 4 (certified reference material), in the second paragraph, for “throughout the period of validity of the authorisation” substitute “with respect to the authorisation, and whilst the authorisation continues to have effect”.