2019 No. 705

Exiting The European Union
Agriculture
Food

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

Made

Coming into force in accordance with regulation 1

The Secretary of State makes the following Regulations in exercise of the powers conferred by section 8(1) of the European Union (Withdrawal) Act 20181.

In accordance with paragraph 1(1) of Schedule 7 to that Act, a draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament.

As required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety there has been open and transparent public consultation during the preparation of these Regulations.

PART 1Introduction

Citation and commencement1

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.

PART 2Amendment of subordinate legislation

Amendment of the Genetically Modified Food (England) Regulations 2004

2

The Genetically Modified Food (England) Regulations 20042 are amended as follows.

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”.

PART 3Amendment of retained direct EU legislation

Amendment of Regulation (EC) No. 1829/2003

4

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

5

In Article 1—

a

in point (a), omit “internal”;

b

in point (b), omit “Community”.

6

In Article 2, at the end, insert—

17

“Food Safety Authority” means—

a

as regards England, Wales and Northern Ireland, 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

in relation to Northern Ireland, the Northern Ireland devolved authority;

19

“prescribe” means prescribe by regulations;

20

“third country” means a country or state other than the United Kingdom;

21

“public analyst” has the meaning it bears in the Food Safety Act 19903 or, in the case of Northern Ireland, the Food Safety (Northern Ireland) Order 19914;

22

“Northern Ireland devolved authority” means the Department of Health;

23

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

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.”.

8

In Article 4, omit paragraph 6.

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”.

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.

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.

12

In Article 8, omit paragraphs 6 and 8.

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.

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

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”.

16

In Article 12—

a

in the opening words of paragraph 1, for “Community”, substitute “United Kingdom”;

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.

17

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

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.

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.

20

Omit Article 16(6).

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”.

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.

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.

24

In Article 20, omit paragraphs 6 and 8.

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.

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.

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.

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.

29

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

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.

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.

32

In Article 28(1)—

a

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

b

for “Commission”, substitute “appropriate authority”.

33

in Article 29, omit paragraphs 2 and 3.

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.

35

For Article 32, substitute—

Reference laboratory

1

The appropriate authority may appoint 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.

36

Omit Articles 33 and 34.

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

so far as exercisable by the Northern Ireland devolved authority is exercisable by statutory rule for the purposes of the Statutory Rules (Northern Ireland) Order 1979 (SI 1979/1573 (NI 12)) (and not by statutory instrument).

2

For regulations made under this Regulation by the Scottish Ministers, see also section 27 of the Interpretation and Legislative Reform (Scotland) Act 20105 (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, Scottish statutory instrument or statutory rule 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 the National Assembly for Wales;

c

in the case of Scotland, of the Scottish Parliament;

d

in the case of Northern Ireland, being a negative resolution within the meaning given by section 41(6) of the Interpretation Act (Northern Ireland) 19546.

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

of the Northern Ireland devolved authority to make regulations is limited to regulations which apply in relation to Northern Ireland only.

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.

39

Omit Article 45.

40

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

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.

Amendment of Commission Regulation 641/2004

42

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.

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”.

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”.

45

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

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”.

Amendment of Commission Implementing Regulation (EU) 503/2013

47

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.

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.

49

In Article 4(1)(b), for “Union”, substitute “United Kingdom”.

50

In Article 5(3), for “EFSA”, substitute “Food Safety Authority”.

51

In Article 6(2), in both places in which it occurs, for “EFSA”, substitute “Food Safety Authority”.

52

For Article 12, substitute—

1

The Food Safety Authority must monitor the application of this Regulation and the developments in scientific knowledge on replacement, reduction and refinement of animal use in scientific procedures.

2

The Food Safety Authority may review the requirement to perform 90 day feeding studies in rodents with whole genetically modified food or feed (point 1.4.4.1 of Annex 2) on the basis of new scientific information.

53

After Article 13, omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

54

In Annex 1—

a

in Part 1—

i

in paragraph 2, for “European Food Safety Authority (EFSA)”, substitute “Food Safety Authority”;

ii

in paragraph 4(c), for “Union”, substitute “United Kingdom”;

iii

in paragraph 8, in both places in which it occurs, for “Union”, substitute “retained EU”;

b

in Part 2—

i

in paragraph 1.1(b), for “Union”, substitute “United Kingdom”;

ii

in paragraph 1.1(e)(v), for “Union”, substitute “United Kingdom”;

iii

in paragraph 1.1(e)(vi), for “Union”, substitute “United Kingdom”;

iv

in paragraph 7, for “EFSA”, substitute “Food Safety Authority”;

c

in Part 4, in both places in which it occurs, omit “in all official languages of the Union”;

d

in Part 5—

i

for “European Union Reference Laboratory (EURL)”, substitute “reference laboratory”;

ii

for “EURL”, substitute “reference laboratory”;

iii

for “EU Reference laboratory (EURL)”, substitute “reference laboratory”;

iv

omit “These instructions are published on the following webpage: http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm.”;

e

In Part 7—

i

in each place in which it occurs, for “EU”, substitute “United Kingdom”;

ii

in each place in which it occurs, for “Union”, substitute “United Kingdom”;

iii

omit paragraph 1.1(a);

iv

in paragraph 1.8(h), for “EU legislation”, substitute “retained EU law”.

55

In Annex 2—

a

in Section 2—

i

in paragraph 1.1.2(b), for “Union”, substitute “United Kingdom”;

ii

in paragraph 1.3.1, in the seventh subparagraph, omit “in the EFSA scientific opinion ‘Guidance on the selection of comparators for the risk assessment of genetically modified plants and derived food and feed”;

iii

in paragraph 1.3.2.1, in the final subparagraph, for “in the EFSA opinion on ‘Statistical considerations for the safety evaluation of GMOs’”, substitute “from the Food Safety Authority”;

iv

in paragraph 1.3.2.2, in the final subparagraph, for “in the EFSA opinion on ‘Statistical considerations for the safety evaluation of GMOs’”, substitute “from the Food Safety Authority”;

v

in paragraph 1.4.2, for “analogous to that described in the ‘Guidance for submission for food additive evaluations by the EFSA Panel on Food Additives and Nutrient Sources added to Food’ of 16 August 2012” substitute “in accordance with food additives guidance available from the Food Safety Authority”;

vi

in paragraph 1.4.4.1, in the final subparagraph, for “for performing this study is provided in the EFSA Guidance on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed.”, substitute “on conducting repeated dose 90-day oral toxicity study in rodents on whole food and feed is available from the Food Safety Authority”;

vii

in paragraph 1.5, in the final subparagraph, for “in the EFSA scientific opinion on the assessment of the allergenicity of GM plants and micro-organisms and derived food and feed adopted on 30 June 2010.”, substitute “from the Food Safety Authority.”;

viii

in paragraph 1.6.4, in the final subparagraph, for “in the Report of the EFSAGMO Panel Working Group on Animal Feeding Trials.”, substitute “from the Food Safety Authority.”;

ix

in paragraph 2—

aa

in the first subparagraph, omit “in the EU”;

bb

in the second subparagraph, for “EU population”, substitute “population of the United Kingdom and the EU”.

56

In Annex 3—

a

in paragraph 1, at subparagraph 3—

i

for “EU Reference Laboratory (EURL)”, substitute “reference laboratory”;

ii

omit “, assisted by the European Network of GMO Laboratories”;

b

in each place in which it occurs, for “EURL”, substitute “reference laboratory”;

c

in paragraph 3.1, in point C, in subparagraph 4, omit “, and the ENGL”.

Amendment of Commission Decision 2006/197/EC

57

Commission Decision 2006/197/EC authorising the placing on the market of food containing, consisting of, or produced from genetically modified maize line 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

58

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

59

For the heading to Article 5, substitute “Register”.

60

In Article 5, omit “Community”.

61

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2007/305/EC

62

Commission Decision 2007/305/EC on the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its derived products is amended as follows.

63

In Article 1—

a

in the first paragraph for “Union” substitute “United Kingdom”;

b

omit the second paragraph.

64

In Article 3, omit “Community”.

Amendment of Commission Decision 2007/306/EC

65

Commission Decision 2007/306/EC on the withdrawal from the market of Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and its derived products is amended as follows.

66

In Article 1—

a

in the first paragraph, for “Union” substitute “United Kingdom”;

b

omit the second paragraph.

67

In Article 3, omit “Community”.

Amendment of Commission Decision 2007/307/EC

68

Commission Decision 2007/307/EC on the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived products is amended as follows.

69

In Article 1(1)—

a

in the first subparagraph, for “Union” substitute “United Kingdom”;

b

omit the second subparagraph.

70

In Article 2 omit “Community”.

Amendment of Commission Decision 2007/692/EC

71

Commission Decision 2007/692/EC authorising the placing on the market of food and feed produced from genetically modified sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

72

For the heading to Article 4, substitute “Register”.

73

In Article 4, omit “Community”.

74

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2007/701/EC

75

Commission Decision 2007/701/EC authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603xMON810 (MON-ØØ6Ø3-6xMON-ØØ81Ø-6) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

76

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

77

For the heading to Article 5, substitute “Register”.

78

In Article 5, omit “Community”.

79

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2007/702/EC

80

Commission Decision 2007/702/EC authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

81

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

82

For the heading to Article 5, substitute “Register”.

83

In Article 5, omit “Community”.

84

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2007/703/EC

85

Commission Decision 2007/703/EC authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507xNK603 (DAS-Ø15Ø7-1xMON-ØØ6Ø3-6) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

86

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

87

For the heading to Article 5, substitute “Register”.

88

In Article 5, omit “Community”.

89

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2008/280/EC

90

Commission Decision 2008/280/EC authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

91

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

92

For the heading to Article 5, substitute “Register”.

93

In Article 5, omit “Community”.

94

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2008/730/EC

95

Commission Decision 2008/730/EC authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean A2704-12 (ACS-GMØØ5-3) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

96

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

97

For the heading to Article 5, substitute “Register”.

98

In Article 5, omit “Community”.

99

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2008/837/EC

100

Commission Decision 2008/837/EC authorising the placing on the market of products containing, consisting of, or produced from genetically modified LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and the Council is amended as follows.

101

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

102

For the heading to Article 5, substitute “Register”.

103

In Article 5, omit “Community”.

104

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2008/933/EC

105

Commission Decision 2008/933/EC authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON89788 (MON-89788-1) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

106

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

107

For the heading to Article 5, substitute “Register”.

108

In Article 5, omit “Community”.

109

In the Annex, in the “NB”, in the final sentence, omit “Community”.

Amendment of Commission Decision 2009/184/EC

110

Commission Decision 2009/184/EC authorising the placing on the market of products containing or produced from genetically modified oilseed rape T45 (ACS-BNØØ8-2) resulting from the commercialisation of this oilseed rape in third countries until 2005 pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

111

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

112

In Article 5(1), for “European Union” substitute “United Kingdom”.

113

In Article 5(3), for “Commission” substitute “Food Safety Authority”.

114

For the heading to Article 6, substitute “Register”.

115

In Article 6, omit “Community”.

116

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2009/813/EC

117

Commission Decision 2009/813/EC authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 89034 (MON-89Ø34-3) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

118

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

119

For the heading to Article 5, substitute “Register”.

120

In Article 5, omit “Community”.

121

In the Annex, in the “NB”, in the final sentence, omit “Community”.

Amendment of Commission Decision 2009/814/EC

122

Commission Decision 2009/814/EC authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 88017 (MON-88Ø17-3) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council authorising the placing on the market of products containing, consisting of, or produced from genetically modified LLCotton25 (ACS-GHØØ1-3) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and the Council is amended as follows.

123

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

124

For the heading to Article 5, substitute “Register”.

125

In Article 5, omit “Community”.

126

In the Annex, in the “NB”, in the final sentence, omit “Community”.

Amendment of Commission Decision 2009/866/EC

127

Commission Decision 2009/866/EC authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MIR604 (SYN-IR6Ø4-5) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

128

In Article 4(2) for “Commission” substitute “Food Safety Authority”.

129

For the heading to Article 5 substitute “Register”.

130

In Article 5 omit “Community”.

131

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2010/419/EU

132

Commission Decision 2010/419/EU renewing the authorisation for continued marketing of products containing, consisting of, or produced from genetically modified maize Bt11 (SYN-BTØ11-1), authorising foods and food ingredients containing or consisting of field maize Bt11 (SYN-BTØ11-1) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council and repealing Decision 2004/657/EC is amended as follows.

133

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

134

For the heading to Article 5, substitute “Register”.

135

In Article 5, omit “Community”.

136

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2010/429/EU

137

Commission Decision 2010/429/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 88017 x MON 810 (MON-88Ø17-3 x MON-ØØ81Ø-6) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

138

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

139

For the heading to Article 5, substitute “Register”.

140

In Article 5, omit “Community”.

141

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2011/354/EU

142

Commission Decision 2011/354/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614 (BCS-GHØØ2-5) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

143

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

144

For the heading to Article 5, substitute “Register”.

145

In Article 5, omit “Community”.

146

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2011/366/EU

147

Commission Decision 2011/366/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 89034 × MON 88017 (MON-89Ø34-3xMON-88Ø17-3) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

148

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

149

For the heading to Article 5, substitute “Register”.

150

In Article 5, omit “Community”.

151

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Decision 2011/891/EU

152

Commission Decision 2011/891/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236x3006-210-23 (DAS-24236-5xDAS-21Ø23-5) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

153

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

154

For the heading to Article 5, substitute “Register”.

155

In Article 5, omit “Community”.

156

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision 2012/81/EU

157

Commission Implementing Decision 2012/81/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean A5547-127 (ACS-GMØØ6-4) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

158

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

159

For the heading to Article 5, substitute “Register”.

160

In Article 5, omit “Community”.

161

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision 2012/82/EU

162

Commission Implementing Decision 2012/82/EU as regards the renewal of the authorisation for continued marketing of products containing, consisting of, or produced from genetically modified soybean 40-3-2 (MON-Ø4Ø32-6) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

163

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

164

For the heading to Article 5, substitute “Register”.

165

In Article 5, omit “Community”.

166

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision 2012/83/EU

167

Commission Implementing Decision 2012/83/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87701 (MON-877Ø1-2) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

168

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

169

For the heading to Article 5, substitute “Register”.

170

In Article 5, omit “EU”.

171

In the Annex, in the Note, in the final sentence, omit “EU”.

Amendment of Commission Implementing Decision 2012/84/EU

172

Commission Implementing Decision 2012/84/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 356043 (DP-356Ø43-5) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

173

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

174

For the heading to Article 5, substitute “Register”.

175

In Article 5, omit “EU”.

176

In the Annex, in the Note, in the final sentence, omit “EU”.

Amendment of Commission Implementing Decision 2012/347/EU

177

Commission Implementing Decision 2012/347/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87701 × MON 89788 (MON-877Ø1-2 × MON-89788-1) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

178

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

179

For the heading to Article 5, substitute “Register”.

180

In Article 5, omit “EU”.

181

In the Annex, in the Note, in the final sentence, omit “EU”.

Amendment of Commission Implementing Decision 2012/651/EU

182

Commission Implementing Decision 2012/651/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MIR162 (SYN-IR162-4) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

183

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

184

For the heading to Article 5, substitute “Register”.

185

In Article 5, omit “EU”.

186

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision 2013/327/EU

187

Commission Implementing Decision 2013/327/EU authorising the placing on the market of food containing or consisting of genetically modified oilseed rape Ms8, Rf3 and Ms8 × Rf3, or food and feed produced from those genetically modified organisms pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

188

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

189

For the heading to Article 5, substitute “Register”.

190

In Article 5, omit “Community”.

191

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”.

Amendment of Commission Implementing Decision 2013/648/EU

192

Commission Implementing Decision 2013/649/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON89034 × 1507 × NK603 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

193

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

194

For the heading to Article 5, substitute “Register”.

195

In Article 5, omit “EU”.

196

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision 2013/649/EU

197

Commission Implementing Decision 2013/649/EU authorising the placing on the market of pollen produced from maize MON 810 (MON-ØØ81Ø-6) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

198

For the heading to Article 4, substitute “Register”.

199

In Article 4, omit “Community”.

200

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision 2013/650/EU

201

Commission Implementing Decision 2013/650/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified (GM) maize MON 89034 × 1507 × MON88017 × 59122 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7), four related GM maizes combining three different single GM events (MON89034 × 1507 × MON88017 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3), MON89034 × 1507 × 59122 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7), MON89034 × MON88017 × 59122 (MON-89Ø34-3 × MON-88Ø17-3 × DAS-59122-7), 1507 × MON 88017 × 59122 (DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7)) and four related GM maizes combining two different single GM events (MON89034 × 1507 (MON-89Ø34-3 × DAS-Ø15Ø7-1), MON89034 × 59122 (MON-89Ø34-3 × DAS-59122-7), 1507 × MON88017 (DAS-Ø15Ø7-1 × MON-88Ø17-3), MON 88017 × 59122 (MON-88Ø17-3 × DAS-59122-7)) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

202

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

203

For the heading to Article 5, substitute “Register”.

204

In Article 5, omit “EU”.

205

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/683

206

Commission Implementing Decision (EU) 2015/683 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87460 (MON 8746Ø-4) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

207

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

208

For the heading to Article 5, substitute “Register”.

209

In Article 5, omit “EU”.

210

In the Annex—

a

in point (f), omit “EU”;

b

in point (h), omit “EU”.

Amendment of Commission Implementing Decision (EU) 2015/684

211

Commission Implementing Decision (EU) 2015/684 authorising the placing on the market of genetically modified maize NK603 (MON-ØØ6Ø3-6) and renewing the existing maize NK603 (MON-ØØ6Ø3-6) products, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council is amended as follows.

212

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

213

For the heading to Article 5, substitute “Register”.

214

In Article 5, omit “EU”.

215

In the Annex—

a

in point (f), omit “EU”;

b

in point (h), omit “EU”.

Amendment of Commission Implementing Decision (EU) 2015/685

216

Commission Implementing Decision (EU) 2015/685 authorising the placing on the market of genetically modified cotton MON 15985 (MON-15985-7) products pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

217

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

218

For the heading to Article 5, substitute “Register”.

219

In Article 5, omit “Community”.

220

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/686

221

Commission Implementing Decision (EU) 2015/686 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87769 (MON-87769-7) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

222

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

223

In Article 5(2), for “Commission” substitute “Food Safety Authority”.

224

For the heading to Article 6, substitute “Register”.

225

In Article 6, omit “Community”.

226

In the Annex—

a

in point (g)(1)(i), for “European Union” substitute “United Kingdom”;

b

in point (g)(1)(ii), for “Member State” substitute “the United Kingdom”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/687

227

Commission Implementing Decision (EU) 2015/687 authorising the placing on the market of products containing, consisting of, or produced from genetically modified oilseed rape MON 88302 (MON-883Ø2-9) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

228

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

229

For the heading to Article 5, substitute “Register”.

230

In Article 5, omit “Community”.

231

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/688

232

Commission Implementing Decision (EU) 2015/688 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton MON 88913 (MON-88913-8) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

233

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

234

For the heading to Article 5, substitute “Register”.

235

In Article 5, omit “Community”.

236

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/689

237

Commission Implementing Decision (EU) 2015/689 renewing the authorisation for existing genetically modified cotton MON 531 (MON-ØØ531-6) products pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

238

For the heading to Article 4, substitute “Register”.

239

In Article 4, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/690

240

Commission Implementing Decision (EU) 2015/690 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB614xLLCotton25 (BCS-GHØØ2-5xACS-GHØØ1-3) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

241

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

242

For the heading to Article 5, substitute “Register”.

243

In Article 5, omit “Community”.

244

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/691

245

Commission Implementing Decision (EU) 2015/691 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean BPS-CV127-9 (BPS-CV127-9) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

246

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

247

For the heading to Article 5, substitute “Register”.

248

In Article 5, omit “Community”.

249

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/693

250

Commission Implementing Decision (EU) 2015/693 renewing the authorisation for existing genetically modified cotton MON 1445 (MON-Ø1445-2) products pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

251

For the heading to Article 4, substitute “Register”.

252

In Article 4, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/695

253

Commission Implementing Decision (EU) 2015/695 renewing the authorisation for existing genetically modified cotton MON 531 x MON 1445 (MON-ØØ531-6 x MON-Ø1445-2) products and authorising the placing on the market of cottonseed oil produced from genetically modified cotton MON 531 x MON 1445 (MON-ØØ531-6 x MON-Ø1445-2) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

254

For the heading to Article 4, substitute “Register”.

255

In Article 4, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/696

256

Commission Implementing Decision (EU) 2015/696 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON87705 (MON-877Ø5-6) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

257

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

258

In Article 5(2), for “Commission” substitute “Food Safety Authority”.

259

For the heading to Article 6, substitute “Register”.

260

In Article 6, omit “Community”.

261

In the Annex—

a

in point (g)(1)(i), for “European Union” substitute “United Kingdom”;

b

in point (g)(1)(ii), for “Member State” substitute “the United Kingdom”;

c

in the final sentence, in the Note, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/697

262

Commission Implementing Decision (EU) 2015/697 authorising the placing on the market of genetically modified maize T25 (ACS-ZMØØ3-2) and renewing the existing maize T25 (ACS-ZMØØ3-2) products, pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

263

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

264

For the heading to Article 5, substitute “Register”.

265

In Article 5, omit “Community”.

266

In the Annex—

a

in point (f), omit “EU”;

b

in point (h), omit “EU”.

Amendment of Commission Implementing Decision (EU) 2015/698

267

Commission Implementing Decision (EU) 2015/698 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 (DP-3Ø5423-1) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

268

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

269

In Article 5(2), for “Commission” substitute “Food Safety Authority”.

270

For the heading to Article 6, substitute “Register”.

271

In Article 6, omit “Community”.

272

In the Annex—

a

in point (g)(1)(i), for “European Union” substitute “United Kingdom”;

b

in point (g)(1)(ii), for “Member State” substitute “the United Kingdom”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/699

273

Commission Implementing Decision (EU) 2015/699 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton T304-40 (BCS-GHØØ4-7) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

274

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

275

For the heading to Article 5, substitute “Register”.

276

In Article 5, omit “Community”.

277

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/700

278

Commission Implementing Decision (EU) 2015/700 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON87708 (MON-877Ø8-9) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

279

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

280

For the heading to Article 5, substitute “Register”.

281

In Article 5, omit “Community”.

282

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/701

283

Commission Implementing Decision (EU) 2015/701 authorising the placing on the market of food containing or consisting of genetically modified oilseed rape GT73, or food and feed produced from that genetically modified organism pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

284

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

285

For the heading to Article 5, substitute “Register”.

286

In Article 5, omit “Community”.

287

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/2279

288

Commission Implementing Decision (EU) 2015/2279 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603 × T25 (MON-ØØ6Ø3-6 × ACS-ZMØØ3-2) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

289

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

290

For the heading to Article 5, substitute “Register”.

291

In Article 5, omit “Community”.

292

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2015/2281

293

Commission Implementing Decision (EU) 2015/2281 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 (MON-87427-7) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

294

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

295

For the heading to Article 5, substitute “Register”.

296

In Article 5, omit “Community”.

297

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”;

c

in the note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2016/1215

298

Commission Implementing Decision (EU) 2016/1215 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 (MST-FGØ72-2) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

299

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

300

For the heading to Article 5, substitute “Register”.

301

In Article 5, omit “Community”.

302

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2016/1216

303

Commission Implementing Decision (EU) 2016/1216 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87708 × MON 89788 (MON-877Ø8-9 × MON-89788-1) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

304

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

305

For the heading to Article 5, substitute “Register”.

306

In Article 5, omit “Community”.

307

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2016/1217

308

Commission Implementing Decision (EU) 2016/1217 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87705 × MON 89788 (MON-877Ø5-6 × MON-89788-1) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

309

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

310

In Article 5(2), for “Commission” substitute “Food Safety Authority”.

311

For the heading to Article 6, substitute “Register”.

312

In Article 6, omit “Community”.

313

In the Annex—

a

in point (f), omit “Community”;

b

in point (g)(1)(i), for “European Union” substitute “United Kingdom”;

c

in point (g)(1)(ii), for “Member State” substitute “the United Kingdom”;

d

in point (h), omit “Community”;

e

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2016/1685

314

Commission Implementing Decision (EU) 2016/185 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × MIR162 × MIR604 × GA21, and genetically modified maizes combining two or three of the events Bt11, MIR162, MIR604 and GA21, and repealing Decisions 2010/426/EU, 2011/892/EU, 2011/893/EU and 2011/894/EU is amended as follows.

315

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

316

In Article 5(2), for “Commission” substitute “Food Safety Authority”.

317

For the heading to Article 6, substitute “Register”.

318

In Article 6, omit “Community”.

319

In the Annex—

a

in point (f), omit “Community”;

b

in point (g)(1), for “Commission” substitute “Food Safety Authority”;

c

in point (h), omit “Community”;

d

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2017/1208

320

Commission Implementing Decision (EU) 2017/1208 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB119 (BCS-GHØØ5-8) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council on genetically modified food and feed is amended as follows.

321

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

322

For the heading to Article 5, substitute “Register”.

323

In Article 5, omit “Community”.

324

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2017/1209

325

Commission Implementing Decision (EU) 2017/1209 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × 59122 × MIR604 × 1507 × GA21, and genetically modified maize combining two, three or four of the events Bt11, 59122, MIR604, 1507 and GA21 pursuant to Regulation (EC) No. 1829/2003 of the European parliament and of the Council on genetically modified food and feed is amended as follows.

326

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

327

In Article 5(2), for “Commission” substitute “Food Safety Authority”.

328

For the heading to Article 6, substitute “Register”.

329

In Article 6, omit “Community”.

330

In the Annex—

a

in point (f), omit “Community”;

b

in point (g)(1), for “Commission” substitute “Food Safety Authority”;

c

in point (h), omit “Community”;

d

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2017/1211

331

Commission Implementing Decision (EU) 2017/1211 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913 (DAS-24236-5 × DAS-21Ø23-5 × MON-88913-8) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

332

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

333

For the heading to Article 5, substitute “Register”.

334

In Article 5, omit “Community”.

335

In the Annex, in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2017/1212

336

Commission Implementing Decision (EU) 2017/1212 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize DAS-40278-9, pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and the Council is amended as follows.

337

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

338

For the heading to Article 5, substitute “Register”.

339

In Article 5, omit “Community”.

340

In the Annex—

a

in point (f), omit “Community”;

b

in point (g), omit “Community”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2017/2448

341

Commission Implementing Decision (EU) 2017/2448 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 × 40-3-2 (DP-3Ø5423-1 × MON-Ø4Ø32-6) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council on genetically modified food and feed is amended as follows.

342

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

343

In Article 5(2), for “Commission”, substitute “Food Safety Authority”.

344

For the heading to Article 6, substitute “Register”.

345

In Article 6, omit “Community”.

346

In the Annex—

a

in point (f), omit “Community”;

b

in point (g)(1)(i), for “European Union” substitute “United Kingdom”;

c

in point (g)(1)(ii), for “Member State” substitute “the United Kingdom”;

d

in point (h), omit “Community”;

e

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2017/2449

347

Commission Implementing Decision (EU) 2017/2449 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-68416-4, pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council on genetically modified food and feed is amended as follows.

348

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

349

For the heading to Article 6, substitute “Register”.

350

In Article 6, omit “Community”.

351

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2017/2450

352

Commission Implementing Decision (EU) 2017/2450 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-44406-6, pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council on genetically modified food and feed is amended as follows.

353

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

354

For the heading to Article 6, substitute “Register”.

355

In Article 6, omit “Community”.

356

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2017/2451

357

Commission Implementing Decision (EU) 2017/2451 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 × A5547-127, pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council on genetically modified food and feed is amended as follows.

358

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

359

For the heading to Article 6, substitute “Register”.

360

In Article 6, omit “Community”.

361

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2017/2452

362

Commission Implementing Decision (EU) 2017/2452 renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

363

In Article 5(2), for “Commission” substitute “Food Safety Authority”.

364

For the heading to Article 6, substitute “Register”.

365

In Article 6, omit “Community”.

366

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2017/2453

367

Commission Implementing Decision (EU) 2017/2453 of 21 December 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified oilseed rapes MON 88302 × Ms8 × Rf3 (MON-883Ø2-9 × ACSBNØØ5-8 × ACS-BNØØ3-6), MON 88302 × Ms8 (MON-883Ø2-9 × ACSBNØØ5-8) and MON 88302 × Rf3 (MON-883Ø2-9 × ACS-BNØØ3-6) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council on genetically modified food and feed is amended as follows.

368

In Article 5(2), for “Commission” substitute “Food Safety Authority”.

369

For the heading to Article 6, substitute “Register”.

370

In Article 6, omit “Community”.

371

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2018/1109

372

Commission Implementing Decision (EU) 2018/1109 renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

373

In Article 5(2), for “Commission” substitute “Food Safety Authority”.

374

For the heading to Article 6, substitute “Register”.

375

In Article 6, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2018/1110

376

Commission Implementing Decision (EU) 2018/1110 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 × 59122 × MON 810 × NK603, and genetically modified maize combining two or three of the single events 1507, 59122, MON 810 and NK603, and repealing Decisions 2009/815/EC, 2010/428/EU and 2010/432/EU is amended as follows.

377

In Article 5(2), for “Commission” substitute “Food Safety Authority”.

378

For the heading to Article 6, substitute “Register”.

379

In Article 6, omit “Community”;

380

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2018/1111

381

Commission Implementing Decision (EU) 2018/1111 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 × NK603 (MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6) and genetically modified maize combining two of the events MON 87427, MON 89034 and NK603, and repealing Decision 2010/420/EU is amended as follows.

382

In Article 4(2), for “Commission” substitute “Food Safety Authority”.

383

For the heading to Article 6, substitute “Register”.

384

In Article 6, omit “Community”.

385

In the Annex—

a

in point (f), omit “Community”;

b

in point (h), omit “Community”;

c

in the Note, in the final sentence, omit “Community”.

Amendment of Commission Implementing Decision (EU) 2018/1112

386

Commission Implementing Decision (EU) 2018/1112 renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No. 1829/2003 of the European Parliament and of the Council is amended as follows.

387

In Article 5(2), for “Commission” substitute “Food Safety Authority”.

388

For the heading to Article 6, substitute “Register”.

389

In Article 6, omit “Community”.

PART 4Revocation of retained direct EU legislation

Revocation of Commission Regulation (EC) No. 1981/2006390

Commission Regulation (EC) No. 1981/2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No. 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms is revoked.

Signed by authority of the Secretary of State for Health and Social Care.

Stephen HammondMinister of State,Department of Health and Social Care
EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations are made in exercise of the powers conferred by section 8(1) of the European Union (Withdrawal) Act 2018 (c.16) in order to address failures of retained EU law to operate effectively and other deficiencies arising from the withdrawal of the United Kingdom from the European Union. In particular, the Regulations address the deficiency specified in section 8(2)(b) of that Act, namely the conferral of functions by retained EU law on, or in relation to, EU entities which no longer have functions in that respect under EU law in relation to the United Kingdom.

These Regulations make amendments to legislation relating to the safety of genetically modified food and animal feed. Part 2 amends subordinate legislation in England. Part 3 amends retained direct EU legislation for the whole of the United Kingdom. Part 4 revokes retained direct EU legislation for the whole of the United Kingdom.

An impact assessment has not been produced for this instrument as no, or no significant, impact on the public, private or voluntary sector is foreseen.