The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019

CHAPTER 2 U.K. EU Decisions

Commission Decision 94/730/EC U.K.

7.—(1) Commission Decision 94/730/EC establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6(5) of Council Directive 90/220/EEC is amended as follows.

(2) For Article 1 substitute—

“Article 1 U.K.

1.   Applications for consent to release genetically modified plants for any other purpose than marketing may be made in accordance with the simplified procedures set out in the Annex.”.

(3) Omit Article 2.

(4) The Annex is amended in accordance with paragraphs (5) to (17).

(5) In paragraph 1—

(a) for “notification dossier” substitute “ application ”;

(b) omit “pursuant to Part B of Directive 90/220/EC”.

(6) In paragraph 2, for “A notifier” substitute “ An applicant ”.

(7) For paragraph 3 substitute—

“The information required in the application is that specified in—

1.   in the case of an application to release in England, Schedule 1 to the Genetically Modified Organisms (Deliberate Release) Regulations 2002;

2.   in the case of an application to release in Wales, Schedule 1 to the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002;

3.   in the case of an application to release in Scotland, Schedule 2 to the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002;

4.   in the case of an application to release in Northern Ireland, Schedule 1 to the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003.”.

(8) In paragraph 4—

(a) in the first sentence, for “notification” substitute “ application ”;

(b) omit the second sentence.

(9) In paragraph 5—

(a) for “notification”, in the first and second places it occurs, substitute “ application ”;

(b) omit the words from “, and the appropriate” to the end.

(10) In paragraph 6—

(a) for “A notifier” substitute “ An applicant ”;

(b) for “notification” substitute “ application ”.

(11) In paragraph 6.1—

(a) for “notification”, in both places it occurs, substitute “ application ”;

(b) for “initially notified plants” substitute “ plants contained in the initial application ”;

(c) for “initially notified recipient plant species” substitute “ recipient plant species contained in the initial application ”.

(12) In paragraph 7, in the first sentence, for “notifier” substitute “ applicant ”.

(13) Omit paragraph 7.1.

(14) In paragraph 7.2, for “notifier” substitute “ applicant ”.

(15) In paragraph 7.3—

(a) for “notifier” substitute “ consent holder ”;

(b) for “notification” substitute “ application ”;

(c) for the words from “consent is granted” to the end substitute “ new consent is applied for and granted that does not rely on the simplified procedures provided for in this Decision ”.

(16) In paragraph 8, omit the second sentence.

(17) In paragraph 9—

(a) in the first sentence, for “notifier” substitute “ consent holder ”;

(b) in the second sentence, for “a notification” substitute “ an application ”.

Commencement Information

I1 Reg. 7 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)(b)

Council Decision 2002/812/EC U.K.

8.—(1) Council Decision 2002/812/EC establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products is amended as follows.

(2) For Article 1 substitute—

“Article 1 U.K.

The information format set out in the Annex must be used to summarise applications for consent to market genetically modified organisms, pursuant to—

(a) in relation to England, regulation 16(2)(j) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002;

(b) in relation to Wales, regulation 17(2)(j) of the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002;

(c) in relation to Scotland, regulation 16(2)(j) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002;

F1 (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.

(3) Omit Article 2.

(4) The Annex is amended in accordance with paragraphs (5) to (7).

(5) In the Introduction, in the second paragraph, for “Directive 2001/18/EC” substitute “ retained EU law ”.

(6) In Part 1—

(a) in section A—

(i) in paragraph 1—

(aa) for the heading substitute “ Name of the product to be notified ”;

(bb) omit points (a), (b) and (d);

(ii) in paragraph 2, in each place it occurs, for “notifier” substitute “ applicant ”;

(iii) in paragraph 4, omit points (f) and (h);

(iv) omit paragraphs 5 to 7;

(v) in paragraph 12, for “notifier” substitute “ applicant ”;

(b) in section B—

(i) omit paragraphs 24 and 34;

(ii) in paragraph 41(e), at the end, insert “ of Directive 2001/18/EC ”;

(c) in section D—

(i) in the subheading, for the words “notified under” to the end substitute “ for purposes other than marketing notified to a competent authority in the United Kingdom or to a member State ”;

(ii) in paragraph 8, omit the words from “according to” to the end;

[F2 (iii) in the words after the first paragraph 8, for “the Community” substitute “Great Britain”.]

(7) In Part 2—

(a) in section A—

(i) in paragraph 1—

(aa) for the heading substitute “ Name of the product to be notified ”;

(bb) omit points (a), (b) and (d);

(ii) in paragraph 3, omit points (e) and (i);

(iii) omit paragraphs 4 to 6;

[F3 (b) in section B, in paragraph 13, for “the Member State(s)” substitute “Great Britain”;]

(c) in section C—

(i) in paragraph 32—

(aa) in the subheading, for the words from “notified under” to the end substitute “ for purposes other than marketing notified to a competent authority in the United Kingdom or of a member State by the same applicant ”;

(bb) in point (c), omit the words from “(submitted to” to the end;

(ii) in paragraph 33, in the subheading—

[F4 (aa) for “the Community” substitute “Great Britain”;]

(bb) for “notifier” substitute “ applicant ”.

Textual Amendments

F1 Words in reg. 8(2) omitted (31.12.2020 immediately before IP completion day) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 5(2)

F2 Reg. 8(6)(c)(iii) substituted (31.12.2020 immediately before IP completion day) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 5(3)

F3 Reg. 8(7)(b) substituted (31.12.2020 immediately before IP completion day) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 5(4)(a)

F4 Reg. 8(7)(c)(ii)(aa) substituted (31.12.2020 immediately before IP completion day) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 5(4)(b)

Commencement Information

I2 Reg. 8 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)(b)

Council Decision 2002/813/EC U.K.

9.—(1) Council Decision 2002/813/EC establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market is amended as follows.

(2) For Article 1 substitute—

“Article 1 U.K.

1.   The Summary Notification Information Format set out in the Annex must be used for the purpose of summarising an application for consent to release genetically modified organisms, pursuant to—

(a) in relation to England, regulation 11(1)(d) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002;

(b) in relation to Wales, regulation 12(1)(d) of the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002;

(c) in relation to Scotland, regulation 11(1)(d) of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002;

(d) in relation to Northern Ireland, regulation 11(1)(d) of the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003.

2.   In this Decision, “constituent nation” means England, Wales, Scotland or Northern Ireland, as the case may be.”.

(3) Omit Article 2.

(4) The Annex is amended in accordance with paragraphs (5) to (7).

(5) In the Introduction section—

(a) omit the first paragraph;

(b) in the sixth and eighth paragraphs, for the words from “to the competent authority” to the end substitute “ in the full application for consent to release ”.

(6) In Part 1—

(a) in the heading, omit the words from “in accordance” to the end;

(b) in section A—

(i) omit paragraph 1(a);

(ii) in paragraph 4—

(aa) in the heading, for the words from “elsewhere in” to “Article 6(1))” substitute “ in any other constituent nation of the United Kingdom to that for which the application has been made ”;

(bb) in the second row of the table, for “insert the country code(s)” substitute “ state the [F5 constituent nations] concerned ”;

(iii) in paragraph 5—

(aa) in the heading, for “Community” substitute “United Kingdom;

(bb) for the second row of the table substitute—

“If yes, state the [F5 constituent nations] concerned”;

(iv) in paragraph 6—

(aa) in the heading, for “Community” substitute “ United Kingdom ”;

(bb) for the second row of the table substitute—

“If yes, state the [F5 constituent nations] concerned”;

(c) in section B—

(i) in paragraph 3—

(aa) in point (a), for “country where the notification is made” substitute “ United Kingdom ”;

(bb) in point (b), for “other EC countries” substitute “ member States ”;

(cc) in points (c) and (d), for “country where the notification is made” substitute “ United Kingdom ”;

(ii) in paragraph 6, omit “Community”;

(d) in section D, in paragraph 4, in the heading—

(i) omit “Community”;

(ii) for “Directive 90/679/EEC on” substitute “ those relating to ”;

(e) in section E, in paragraph 3(b), at the end, insert “ of Directive 2001/18/EC ”.

(7) In Part 2—

(a) in section A—

(i) in paragraph 3—

(aa) in the heading, for the words from “elsewhere, inside” to “Article 6(1)” substitute “ in any other constituent nation nation of the United Kingdom to that for which the application has been made,”;

(bb) in the second row of the table, for “insert the country code(s)” substitute “ state the [F6 constituent nations] concerned”;

(ii) in paragraph 4—

(aa) in the heading, for “, inside or outside the Community” substitute “ in the United Kingdom ”;

(bb) in the second row of the table, for “notification number” substitute “ state the [F6 constituent nations] concerned ”.

Textual Amendments

F5 Words in reg. 9(6)(b) substituted (31.12.2020 immediately before IP completion day) by The Animal Health and Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1229), regs. 1(3), 5(2); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in reg. 9(7)(a) substituted (31.12.2020 immediately before IP completion day) by The Animal Health and Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1229), regs. 1(3), 5(2); 2020 c. 1, Sch. 5 para. 1(1)

Commencement Information

I3 Reg. 9 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)(b)

Commission Decision 2003/701/EC U.K.

10.—(1) Commission Decision 2003/701/EC establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market is amended as follows.

(2) For Article 1 substitute—

“Article 1 U.K.

1.   The results of a release of genetically modified higher plants (GMHP) undertaken pursuant to a consent granted—

(a) in relation to England, pursuant to regulation 21 of the Genetically Modified Organisms (Deliberate Release) Regulations 2002,

(b) in relation to Wales, pursuant to regulation 22 of the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002,

(c) in relation to Scotland, pursuant to regulation 21 of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002,

(d) in relation to Northern Ireland, pursuant to regulation 21 of the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003,

must be presented to the relevant competent authority by the consent holder using the format set out in the Annex to this Decision, hereinafter “the report format”.

2.   In this Decision, “constituent nation” means England, Wales, Scotland or Northern Ireland, as the case may be.”.

(3) In Article 2, for “notification” substitute “ consent ”.

(4) In Article 3—

(a) in paragraph 1—

(i) for “notification” substitute “ consent ”;

(ii) for “notifier” substitute “ consent holder ”;

[F7 (aa) in paragraph 2, for “notification” substitute “ consent ”]

(b) F8 ... omit paragraph 4.

(5) In Article 4, for “notifier” substitute “ consent holder ”.

(6) Omit Article 5.

(7) In the Annex—

(a) in the first heading, omit “in accordance with Article 10 of Directive 2001/18/EC”;

(b) omit paragraphs 1.1 and 1.2;

(c) in paragraph 4.1—

(i) in the first sentence, for “under Community legislation(s)” substitute “ in the United Kingdom ”;

(ii) in the second sentence, for “country(ies) of notification” substitute “ constituent nations of the United Kingdom in which the product is intended to be marketed ”;

(d) in paragraph 6.1.7, in point (b), in the first sentence, for the words from “measures according” to “2001/18/EC)” substitute “ emergency measures ”;

(e) in paragraph 6.4.3, omit the footnote;

(f) in the words after paragraph 7, in the first sentence, omit “in accordance with Article 25 of Directive 2001/18/EC”.

Textual Amendments

F7 Reg. 10(4)(aa) inserted (31.12.2020 immediately before IP completion day) by The Animal Health and Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1229), regs. 1(3), 5(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in reg. 10(4)(b) omitted (31.12.2020 immediately before IP completion day) by virtue of The Animal Health and Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1229), regs. 1(3), 5(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

Commencement Information

I4 Reg. 10 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)(b)

Commission Decision 2009/770/EC U.K.

11.—(1) Commission Decision 2009/770/EC establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council is amended as follows.

(2) For Article 1 substitute—

“Article 1 U.K.

1.   This Decision concerns the reporting of monitoring results in respect of genetically modified organisms authorised for marketing under Regulation (EC) No 1829/2003 of the European Parliament and of the Council, or any decision in respect of genetically modified organisms authorised for marketing pursuant to the following legislation—

(a) the Genetically Modified Organisms (Deliberate Release) Regulations 2002;

(b) the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002;

(c) the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002;

F9 (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.   Holders of authorisations or consents to market genetically modified organisms must use the formats set out in the Annexes to this Decision to report the results of their required monitoring activities.”.

(3) Omit Article 2.

(4) Annex 1 is amended in accordance with paragraphs (5) to (9).

(5) In the first subheading, omit the words from “in accordance” to the end.

(6) Omit paragraphs 1.2 and 1.3.

(7) Appendix 2 is amended in accordance with paragraphs (8) and (9).

(8) In section B, omit the first two paragraphs.

(9) In section C—

(a) omit section C.1;

(b) in section C.2—

(i) omit the heading;

(ii) in the paragraph before paragraph 1—

(aa) omit the second sentence;

(bb) in the third sentence, for “A non-confidential” substitute “ Where confidential data does arise, it should be provided in a separate Annex, with a verifiable justification for confidentiality, and a non-confidential ”;

(iii) in paragraph 1, in the first subparagraph, omit “within the EU,”;

(iv) in paragraph 3.1.1, in point (c), for “each Member State” substitute “ [F10 Great Britain] ”;

(v) in paragraph 3.1.2, in point (b), for “Member States where the surveillance network is active” substitute “ whether the surveillance network is active, ”;

[F11 (vi) in paragraph 3.1.3, in the first subparagraph, for “the Community” substitute “Great Britain”.]

(10) Annex 2 is amended in accordance with paragraphs (11) to (14).

(11) In the first subheading, omit the words from “in accordance” to the end.

(12) Omit paragraphs 1.2 and 1.3.

(13) In paragraph 3—

[F12 (a) for “the Community”, in each place it occurs, substitute “Great Britain”;]

(b) omit paragraph 3.1.2;

(c) in paragraph 3.1.3, for “tables 3.1.1 and 3.1.2” substitute “ table 3.1.1 ”;

(d) in paragraph 3.3.2, in the table—

(i) omit the first column;

(ii) in the heading of the second column, insert at the end “ in [F13 Great Britain] ”.

(14) Appendix 2 is amended in accordance with paragraphs (15) and (16).

(15) In section B, omit the first two paragraphs.

(16) In section C—

(a) omit subsection C.1;

(b) in subsection C.2—

(i) omit the heading;

(ii) in the paragraph before paragraph 1—

(aa) omit the second sentence;

(bb) in the third sentence, for “A non-confidential” substitute “ Where confidential data does arise, it should be provided in a separate Annex, with a verifiable justification for confidentiality, and a non-confidential ”;

(c) in paragraph 1—

(i) in the first subparagraph, omit “within the EU,”;

(ii) omit the second subparagraph;

(d) in paragraph 3—

[F14 (i) for “the Community”, in each place it occurs, substitute “Great Britain”;]

(ii) in paragraph 3.1.2—

(aa) omit the heading;

(bb) in the first sentence, for “Tables 3.1.1 and 3.1.2” substitute “ Table 3.1.1 ”;

(cc) omit points (b) and (c);

(dd) in point (d), at the end, insert “ into [F15 Great Britain] ”;

(iii) in paragraph 3.1.3—

(aa) in the heading, for “tables 3.1.1 and 3.1.2” substitute “ table 3.1.1 ”;

(bb) for “years and”, in the first place it occurs, substitute “ years, ”;

(cc) for “change,” substitute “ change and ”;

(dd) omit the words from “as well as” to the end;

(iv) in paragraph 3.2.2, in point (b), for “Member States where the surveillance network is active” substitute “ whether the surveillance network is active, ”;

(v) in paragraph 3.3.2, in point (b), for “Member State/the Community” substitute “ United Kingdom ”.

Textual Amendments

F9 Words in reg. 11(2) omitted (31.12.2020 immediately before IP completion day) by virtue of The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 6(2)

F10 Words in reg. 11(9)(b)(iv) substituted (31.12.2020 immediately before IP completion day) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 6(3)(a)

F11 Reg. 11(9)(b)(vi) substituted (31.12.2020 immediately before IP completion day) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 6(3)(b)

F12 Reg. 11(13)(a) substituted (31.12.2020 immediately before IP completion day) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 6(4)(a)

F13 Words in reg. 11(13)(d)(ii) substituted (31.12.2020 immediately before IP completion day) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 6(4)(b)

F14 Reg. 11(16)(d)(i) substituted (31.12.2020 immediately before IP completion day) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 6(5)(a)

F15 Words in reg. 11(16)(d)(ii)(dd) substituted (31.12.2020 immediately before IP completion day) by The Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1421), reg. 1(4), Sch. para. 6(5)(b)

Commencement Information

I5 Reg. 11 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)(b)

Commission Implementing Decision (EU) 2016/321 U.K.

12.—(1) Commission Implementing Decision (EU) 2016/321 adjusting the geographical scope of the authorisation for cultivation of genetically modified maize (Zea mays L.) MON 810 (MON- ØØ81Ø-6) is amended as follows.

(2) In Article 1, for the words from “the territories” to the end substitute “ Wales, Scotland and Northern Ireland ”.

(3) For Article 2 substitute—

“Article 2 U.K.

The information set out in this Decision must be entered—

(a) in Wales, in the register maintained under the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002;

(b) in Scotland, in the register maintained under the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002;

(c) in Northern Ireland, in the register maintained under the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003.”.

(4) Omit Article 3.

(5) Omit the Annex.

Commencement Information

I6 Reg. 12 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)(b)