The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019

• Citation: S.I. 2019/705
• Sections: 480

Section 1 Citation and commencement

These Regulations may be cited as the Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 and come into force on exit day.

Section 2 Amendment of the Genetically Modified Food (England) Regulations 2004

The Genetically Modified Food (England) Regulations 2004 are amended as follows.

Section 3

In the Schedule, in Part 2—

(a) omit the entries in the Table which relate to Article 8.6 of Regulation (EC) No. 1829/2003 ;

(b) in the entry in the second column of the Table which corresponds to the entry in the first column of the Table relating to Article 9.3 of Regulation (EC) No. 1829/2003 , for “Commission”, substitute “ Food Safety Authority ” .

Section 4 Amendment of Regulation (EC) No. 1829/2003

Regulation (EC) No. 1829/2003 of the European Parliament and of the Council on genetically modified food and feed is amended as follows.

Section 5

In Article 1—

(a) in point (a), omit “internal”;

(b) in point (b), omit “Community”.

Section 6

In Article 2, at the end, insert—

(17) “ Food Safety Authority ” means—

(a) as regards England and Wales , the Food Standards Agency;

(b) as regards Scotland, Food Standards Scotland;

(18) “ appropriate authority ” means—

(a) in relation to England, the Secretary of State;

(b) in relation to Wales, the Welsh Ministers;

(c) in relation to Scotland, the Scottish Ministers;

(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(19) “ prescribe ” means prescribe by regulations;

(20) “ third country ” means any country or territory other than the British Islands;

(21) “ public analyst ” has the meaning it bears in the Food Safety Act 1990 ...;

(22) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(23) “ reference laboratory ” means the laboratory appointed by the appropriate authority in accordance with Article 32.

Section 7

For Article 3(2), substitute “ 2. Where necessary, the appropriate authority may prescribe measures designed to amend non-essential elements of this Regulation by supplementing it and determining whether a type of food falls within the scope of this Section. ” .

Section 8

In Article 4, omit paragraph 6.

Section 9

In Article 5—

(a) for paragraph 2, substitute—

(2) The application must be sent to the Food Safety Authority, who must—

(a) acknowledge receipt of the application, and confirm the date of its receipt, in writing to the applicant within 14 days of its receipt;

(b) make the summary of the dossier referred to in paragraph 3(1) available to the public.

(b) in paragraph 6, for “Community”, substitute “ retained EU ” ;

(c) for paragraph 7, substitute—

(7) The appropriate authority, having first consulted the Food Safety Authority, may prescribe rules concerning the preparation and presentation of the application.

(d) in paragraph 8, for “Before the date of application of this Regulation, the Authority shall”, substitute “ The Food Safety Authority must ” .

Section 10

In Article 6—

(a) in paragraph 2, omit “or a national competent authority through the Authority”;

(b) for paragraph 3, substitute—

(3) In order to prepare its opinion, the Food Safety Authority—

(a) must verify that the particulars and documents submitted by the applicant are in accordance with Article 5 and examine whether the food complies with the criteria referred to in Article 4(1);

(b) may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propagating material, the Food Safety Authority must ask a competent authority to carry out the environmental risk assessment;

(c) may ask a public analyst to carry out a safety assessment of the food;

(d) must forward to the reference laboratory referred to in Article 32 the particulars referred to in Article 5(3)(i) and (j). The reference laboratory must test and validate the method of detection and identification proposed by the applicant;

(e) must, in verifying the application of Article 13(2)(a), examine the information and data submitted by the applicant to show that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.

(c) in paragraph 4, for “national competent authority within the meaning of Directive 2001/18/EC , designated by each Member State for this purpose”, substitute “ competent authority designated in accordance with Directive 2001/18/EC ” ;

(d) in paragraph 5(f), omit “Community”;

(e) for paragraph 6, substitute—

(6) The Food Safety Authority must forward its opinion to the appropriate authority and the applicant, including a report describing its assessment of the food and stating the reasons for its opinion and the information on which this opinion is based.

(f) for paragraph 7, substitute—

(7) The Food Safety Authority must make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Food Safety Authority within 30 days from such publication.

Section 11

For Article 7, substitute—

(1) Within three months after receiving the opinion of the Food Safety Authority, the appropriate authority must determine, taking account of the opinion of the Food Safety Authority, any relevant provisions of retained EU law, and other legitimate factors relevant to the matter under consideration, the decision to be taken in respect of the application.

(2) Where the decision is not in accordance with the opinion of the Food Safety Authority, the appropriate authority must provide an explanation for the differences.

(3) For applications which are authorised, the terms of the authorisation must be prescribed by the appropriate authority and must include—

(a) the particulars referred to in Article 6(5);

(b) the name of the authorisation holder;

(c) where appropriate, the unique identifier attributed to the GMO as referred to in the Regulation (EC) No 1830/2003 .

(4) The authorisation granted in accordance with the procedure referred to in this Regulation is valid for 10 years and is renewable in accordance with Article 11. The authorised food must be entered in the Register referred to in Article 28. Each entry in the Register must mention the date of authorisation and must include the particulars referred to in paragraph 3.

(5) The authorisation under this Section is without prejudice to other provisions of retained EU law governing the use and placing on the market of substances which may only be used if they are included in a list of substances registered or authorised to the exclusion of others.

(6) References made in parts A and D of Directive 2001/18/EC to GMOs authorised under part C of that Directive shall be considered as applying equally to GMOs authorised under this Regulation.

Section 12

In Article 8, omit paragraphs 6 and 8.

Section 13

In Article 9—

(a) in paragraph 1, for “Commission”, substitute “ Food Safety Authority ” ;

(b) in paragraph 3, in both places in which it occurs, for “Commission”, substitute “ Food Safety Authority ” ;

(c) for paragraph 4, substitute—

(4) The Food Safety Authority must make the information supplied by the applicant available to the appropriate authority without delay.

Section 14

In Article 10, for subparagraphs 1 and 2, substitute—

(1) On its own initiative, the Food Safety Authority may, or following a request from the appropriate authority, must, issue an opinion on whether an authorisation for a product referred to in Article 3(1) still meets the conditions set by this Regulation. It shall immediately transmit this opinion to the appropriate authority and the authorisation-holder. The Food Safety Authority must make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Food Safety Authority within 30 days from such publication.

(2) The appropriate authority must examine the opinion of the Food Safety Authority as soon as possible. Any appropriate measures must be taken in accordance with Article 34. If appropriate, the appropriate authority may prescribe modifications to, a suspension of, or revocation of, an authorisation

Section 15

In Article 11—

(a) in paragraph 1, for “Commission”, substitute “ appropriate authority ” ;

(b) for paragraph 5, substitute—

(5) The appropriate authority, having first consulted the Food Safety Authority, may make provision for the application of this Article, by prescribing provisions concerning the preparation and the presentation of the application.

(c) in paragraph 6, for “Authority”, substitute “ Food Safety Authority ” .

Section 16

In Article 12—

(a) in the opening words of paragraph 1, for “Community” substitute “ Great Britain ” ;

(b) for paragraph 4, substitute—

(4) The appropriate authority may prescribe amendments to non-essential elements of this Regulation by supplementing it and establishing lower thresholds, in particular in respect of foods containing or consisting of GMOs, or taking account of advances in science and technology.

Section 17

In Article 13, in paragraph 1, for “Community”, substitute “ retained EU ” .

Section 18

For Article 14, substitute—

The appropriate authority may prescribe the following measures designed to amend non-essential elements of this Regulation by supplementing it—

(a) the measures necessary for operators to satisfy the competent authorities as referred to in Article 12(3);

(b) the measures necessary for operators to comply with the labelling requirements set out in Article 13;

(c) measures concerning the information to be given by mass caterers providing food to the final consumer. In order to take account of the specific situation of mass caterers, such measures may provide for adaptation of the requirements set out in Article 13(1)(e); and

(d) measures to facilitate the uniform application of Article 13.

Section 19

In Article 15, for paragraph 2, substitute—

(2) Where necessary, the appropriate authority may prescribe measures designed to amend non-essential elements of this Regulation by supplementing it and determining whether a type of feed falls within the scope of this Section.

Section 20

Omit Article 16(6).

Section 21

In Article 17—

(a) for paragraphs 1 and 2, substitute—

(1) To obtain the authorisation referred to in Article 16(2), an application must be submitted in accordance with the following provisions.

(2) The application must be sent to the Food Safety Authority, who must—.

(a) acknowledge receipt of the application, and confirm the date of its receipt, in writing to the applicant within 14 days of its receipt;

(b) make the summary of the dossier referred to in paragraph 3(1) available to the public.

(b) in paragraph 6, for “Community”, substitute “ retained EU ” ;

(c) for paragraph 7, substitute—

(7) The appropriate authority, having first consulted the Food Safety Authority, may prescribe rules concerning the preparation and presentation of the application.

(d) in paragraph 8, for “Before the date of application of this Regulation, the Authority shall”, substitute “ The Food Safety Authority must ” .

Section 22

In Article 18—

(a) in paragraph 2, omit “or a national competent authority through the Authority”;

(b) for paragraph 3, substitute—

(3) In order to prepare its opinion, the Food Safety Authority—

(a) must verify that the particulars and documents submitted by the applicant are in accordance with Article 17 and examine whether the food complies with the criteria referred to in Article 16(1);

(b) may ask a competent authority designated in accordance with Article 4 of Directive 2001/18/EC to carry out an environmental risk assessment; however, if the application concerns GMOs to be used as seeds or other plant-propagating material, the Food Safety Authority must ask a competent authority to carry out the environmental risk assessment;

(c) may ask a public analyst to carry out a safety assessment of the feed;

(d) must forward to the reference laboratory the particulars referred to in Article 17(3)(i) and (j). The reference laboratory must test and validate the method of detection and identification proposed by the applicant;

(e) must, in verifying the application of Article 25(2)(c), examine the information and data submitted by the applicant to show that the characteristics of the feed are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics.

(c) in paragraph 4, for “the national competent authority within the meaning of Directive 2001/18/EC , designated by each Member State for this purpose”, substitute “ the competent authority designated in accordance with Directive 2001/18/EC ” ;

(d) in paragraph 5(f), omit “Community”;

(e) for paragraph 6, substitute—

(6) The Food Safety Authority must forward its opinion to the appropriate authority and the applicant, including a report describing its assessment of the feed and stating the reasons for its opinion and the information on which this opinion is based.

(f) for paragraph 7, substitute—

(7) The Food Safety Authority must make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Food Safety Authority within 30 days from such publication.

Section 23

For Article 19, substitute —

(1) Within three months after receiving the opinion of the Food Safety Authority, the appropriate authority must determine, taking account of the opinion of the Food Safety Authority, any relevant provisions of retained EU law, and other legitimate factors relevant to the matter under consideration, the decision to be taken in respect of the application.

(2) Where the decision is not in accordance with the opinion of the Food Safety Authority, the appropriate authority must provide an explanation for the differences.

(3) For applications which are authorised, the terms of the authorisation must be prescribed by the appropriate authority and must include—

(a) the particulars referred to in Article 18(5);

(b) the name of the authorisation-holder;

(c) where appropriate, the unique identifier attributed to the GMO as referred to in Regulation (EC) No. 1830/2003 .

(4) The authorisation granted in accordance with the procedure referred to in this Regulation is valid for 10 years and is renewable in accordance with Article 23. The authorised feed must be entered in the Register referred to in Article 28. Each entry in the Register must mention the date of authorisation and must include the particulars referred to in paragraph 3.

(5) The authorisation under this Section is without prejudice to other provisions of retained EU law governing the use and placing on the market of substances which may only be used if they are included in a list of substances registered or authorised to the exclusion of others.

(6) References made in parts A and D of Directive 2001/18/EC to GMOs authorised under part C of that Directive shall be considered as applying equally to GMOs authorised under this Regulation.

Section 24

In Article 20, omit paragraphs 6 and 8.

Section 25

In Article 21—

(a) in paragraph 1, for “Commission”, substitute “ Food Safety Authority ” ;

(b) in paragraph 3, in both places in which it occurs, for “Commission”, substitute “ Food Safety Authority ” ;

(c) for paragraph 4, substitute—

(4) The Food Safety Authority must make the information supplied by the applicant available to the appropriate authority without delay.

Section 26

In Article 22, for subparagraphs 1 and 2, substitute—

(1) On its own initiative, the Food Safety Authority may, or following a request from the appropriate authority, must, issue an opinion on whether an authorisation for a product referred to in Article 15(1) still meets the conditions set by this Regulation. It shall immediately transmit this opinion to the appropriate authority and the authorisation-holder. The Food Safety Authority must make its opinion public, after deletion of any information identified as confidential in accordance with Article 30 of this Regulation. The public may make comments to the Food Safety Authority within 30 days from such publication.

(2) The appropriate authority must examine the opinion of the Food Safety Authority as soon as possible. Any appropriate measures shall be taken in accordance with Article 34. If appropriate, the appropriate authority may prescribe modifications to, a suspension of, or revocation of, an authorisation.

Section 27

In Article 23—

(a) in paragraph 1, for “Commission”, substitute “ appropriate authority ” ;

(b) for paragraph 5, substitute—

(5) The appropriate authority, having first consulted the Food Safety Authority, may make provision for the application of this Article, by prescribing provisions concerning the preparation and the presentation of the application.

Section 28

For Article 24(4), substitute—

(4) The appropriate authority may prescribe amendments to non-essential elements of this Regulation by supplementing it and establishing lower thresholds, in particular in respect of feed containing or consisting of GMOs, or taking account of advances in science and technology.

Section 29

In Article 25(1), for “Community”, substitute “ retained EU ” .

Section 30

For Article 26, substitute—

The appropriate authority may prescribe the following measures designed to amend non-essential elements of this Regulation by supplementing it—

(a) measures necessary for operators to satisfy the competent authorities as referred to in Article 24(3);

(b) measures necessary for operators to comply with the labelling requirements set out in Article 25;

(c) measures to facilitate the uniform application of Article 25.

Section 31

For Article 27, substitute—

(1) Where a product is likely to be used as both food and feed, a single application under Articles 5 and 17 must be submitted and must give rise to a single opinion from the Food Safety Authority and a single decision of the appropriate authority.

(2) The Food Safety Authority must consider whether the application for authorisation of a product should be submitted as a single application for authorisation as both food and feed and advise the appropriate authority accordingly.

Section 32

In Article 28(1)—

(a) omit “Community” in both places in which it occurs (including the heading);

(b) for “Commission”, substitute “ appropriate authority ” .

Section 33

in Article 29, omit paragraphs 2 and 3.

Section 34

In Article 30—

(a) in paragraph 2, for “Commission”, substitute “ Food Safety Authority ” ;

(b) for paragraph 4, substitute—

(4) Notwithstanding paragraph 2, the Food Safety Authority must on request supply the appropriate authority with all information in its possession.

(c) for paragraph 6, substitute—

(6) The appropriate authority and the Food Safety Authority must take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.

(d) for paragraph 7, substitute—

(7) If an applicant withdraws or has withdrawn an application, the Food Safety Authority and the appropriate authority must respect the confidentiality of commercial and industrial information, including research and development information, as well as any information in respect of which a claim of confidentiality is disputed.

Section 35

For Article 32, substitute—

Reference laboratory

(1) The appropriate authority may designate in accordance with Article 100 of Regulation (EU) 2017/625 a reference laboratory to perform the duties and tasks set out in the Annex.

(2) Applicants for authorisation of genetically modified food and feed shall contribute to supporting the costs of the duties and tasks of the reference laboratory.

(3) The contributions from applicants shall not exceed the costs incurred in carrying out the validation of detection methods.

(4) The appropriate authority may prescribe—

(a) measures for implementing this Article and the Annex; and

(b) measures designed to amend non-essential elements of this Regulation and adapting the Annex.

Section 36

Omit Article 33.

Section 36A

In Article 34—

(a) after “opinion of the”, insert “ Food Safety ” ;

(b) omit “and 54”.

Section 37

For Article 35, substitute—

Regulations and devolved powers

(1) Any power to make regulations under this Regulation—

(a) so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;

(b) so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument;

(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) For regulations made under this Regulation by the Scottish Ministers, see also section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 (Scottish statutory instruments).

(3) Any power to make regulations under this Regulation includes power—

(a) to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business); and

(b) to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.

(4) Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation shall be subject to annulment in pursuance of a resolution—

(a) in the case of England, of either House of Parliament;

(b) in the case of Wales, of Senedd Cymru ;

(c) in the case of Scotland, of the Scottish Parliament;

(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) In this Regulation, any power—

(a) of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;

(b) of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;

(c) of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only;

(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 38

For Article 36, substitute—

(1) Any decision taken under, or failure to exercise, the powers vested in the Food Safety Authority by this Regulation may be reviewed by the appropriate authority on its own initiative or in response to a request from any person directly and individually concerned.

(2) To this effect a request shall be submitted to the appropriate authority within two months from the day on which the party concerned became aware of the act or omission in question.

(3) The appropriate authority must take a decision within two months requiring, if appropriate, the Food Safety Authority to withdraw its decision or to remedy its failure to act.

Section 38A

In Article 44, for “Commission” substitute “ Food Safety Authority ” in each place it occurs.

Section 39

Omit Article 45.

Section 40

After Article 49, omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

Section 41

In the Annex—

(a) in the Title, omit “Community”;

(b) omit paragraphs 1 and 2;

(c) in paragraph 3—

(i) in the opening words, omit “Community”

(ii) omit points (a) and (b);

(d) for paragraph 4, substitute—

(4) The reference laboratory must help to resolve disputes concerning the results of the duties and tasks outlined in this Annex.

Section 42 Amendment of Commission Regulation 641/2004

Commission Regulation 641/2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation is amended as follows.

Section 43

In Article 2—

(a) in paragraph 1, for “European Food Safety Authority (the Authority)”, substitute “ Food Safety Authority ” ;

(b) in paragraph 4, for “Commission”, substitute “ appropriate authority ” .

Section 44

In Article 3—

(a) in paragraph 1(a), omit “taking into account Council Decision 2002/811/EC ”;

(b) in paragraph 1(d), omit “in all official Community languages”.

Section 45

After Article 20, omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

Section 46

In Annex 1—

(a) in point 1.A, omit “Community”;

(b) in point 1.B, for “have been compiled by the European Network of GMO Laboratories (ENGL)”, substitute “ are set out ” ;

(c) in point 1.C, omit “established under Regulation (EC) No 1829/2003 and assisted by ENGL,”;

(d) in point 1.F, omit “, together with ENGL,”;

(e) in point 1.G, omit “, assisted by ENGL,”;

(f) in point 2.B, for “ENGL”, substitute “ RL ” ;

(g) in point 3.A—

(i) for “ENGL”, substitute “ RL ” ;

(ii) omit “, together with ENGL,”;

(h) in each place in which it occurs, for “CRL”, substitute “ RL ” .

Section 47 Amendment of Commission Implementing Regulation (EU) 503/2013

Commission Implementing Regulation (EU) 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 and amending Commission Regulations (EC) No. 641/2004 and (EC) No. 1981/2006 is amended as follows.

Section 48

For Article 3(6), substitute—

(6) When studies have been already submitted to the Food Safety Authority for the purposes of an application and, where relevant, to the extent that they may be used by the applicant in accordance with Article 31 of Regulation (EC) No. 1829/2003 , a reference to such studies and the results of the Food Safety Authority's assessment may, with the agreement of the Food Safety Authority, be made in the framework of another application.