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

JurisdictionUK Non-devolved
CitationSI 2019/90

2019 No. 90

Exiting The European Union

Environmental Protection

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

Made 17th January 2019

Laid before Parliament 23th January 2019

Coming into force in accordance with regulation 1(2)

The Secretary of State makes these Regulations in exercise of the powers conferred by—

(a) in relation to Part 1, the powers mentioned in paragraphs (b) to (c);

(b) in relation to Part 2, section 2(2) of the European Communities Act 19721;

(c) in relation to Parts 3 and 4, section 8(1) of, and paragraph 21(b) of Schedule 7 to, the European Union (Withdrawal) Act 20182.

The Secretary of State is a Minister designated for the purposes of that subsection in relation to the control and regulation of genetically modified organisms3.

The requirements of paragraph 3(2) of Schedule 7 to the European Union (Withdrawal) Act 2018 (relating to the appropriate Parliamentary procedure for these Regulations) have been satisfied.

1 Introduction

PART 1

Introduction

S-1 Citation and commencement

Citation and commencement

1.—(1) These Regulations may be cited as the Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019.

(2) They come into force—

(a)

(a) as regards this Part and Part 2, 21 days after the day on which these Regulations are laid;

(b)

(b) as regards the remainder, on exit day.

2 Amendments to out of date references

PART 2

Amendments to out of date references

S-2 The Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 1996

The Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 1996

2. In regulation 3(2) of the Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 19964

(a) for sub-paragraph (e) substitute—

“(e)

“(e) consist of, or are included in, a product which is authorised for marketing under—

(iii) in relation to Scotland, the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 20027;”;

(b) after sub-paragraph (e) insert—

“(f)

“(f) are genetically modified organisms which are approved for food or feed use in the United Kingdom.”.

3 Amendments to subordinate legislation relating to withdrawal from the European Union

PART 3

Amendments to subordinate legislation relating to withdrawal from the European Union

S-3 The Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 1996

The Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 1996

3. In regulation 3(2) of the Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 1996—

(a) in sub-paragraph (c), for the words from “for human or veterinary use” to the end substitute “which is authorised for marketing under the Human Medicines Regulations 20128or the Veterinary Medicines Regulations 20139”;

(b) for sub-paragraph (d) substitute—

“(d)

“(d) consist of, or are included in, a product which has marketing consent immediately before exit day under Directive 90/220/EECon the deliberate release into the environment of genetically modified organisms10or Directive 2001/18/ECon the deliberate release into the environment of genetically modified organisms11

(i) which is imported or acquired in accordance with the conditions and limitations on the use of the product specified in the consent, and

(ii) in the case of a consent for genetically modified carnations (Dianthus caryophyllus), where the product is imported or acquired within 10 years of the date on which the consent was issued;”.

4 Amendments to retained direct EU legislation

PART 4

Amendments to retained direct EU legislation

CHAPTER 1

EU Regulations

S-4 Regulation (EC) No 1830/2003 of the European Parliament and of the Council

Regulation (EC) No 1830/2003 of the European Parliament and of the Council

4.—(1) Regulation (EC) No 1830/2003of the European Parliament and of the Council concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms is amended as follows.

(2) In Article 2—

(a)

(a) in paragraph 1, in each place it occurs, for “Community legislation” substitute “retained EU law”;

(b)

(b) in paragraph 2, for the words from “for human” to the end substitute “authorised under the Human Medicines Regulations 2012 or the Veterinary Medicines Regulations 2013”.

(3) In Article 3—

(a)

(a) in paragraph 5, for the words from “Community” to “third country,” substitute “United Kingdom”;

(b)

(b) in paragraph 8, for “Article 6(4) of Directive 2000/13/EC” substitute “Article 2(2)(f) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council”;

(c)

(c) for paragraph 10 substitute—

S-10

10. “Placing on the market” means placing on the market as defined in the specific legislation under which the relevant product is authorised; in other cases, it has the meaning given in the definition of “marketed”—

(a) in England, Wales and Scotland, in section 107(11) of the Environmental Protection Act 199012;

(b) in Northern Ireland, in article 4(11) of the Genetically Modified Organisms (Northern Ireland) Order 199113.”;

(d)

(d) after paragraph 12, insert—

S-13

13. “Competent authority” means—

(a) in England, the Secretary of State;

(b) in Wales, the Welsh Ministers;

(c) in Scotland, the Scottish Ministers;

(d) in Northern Ireland, the Department of Agriculture, Environment and Rural Affairs.”.

(4) In Article 4—

(a)

(a) in paragraph 1(b), omit “in accordance with Article 8”;

(b)

(b) in paragraphs 5, 6 and 7, for “Community legislation” substitute “retained EU law”;

(c)

(c) in paragraph 8, for “, 24 or 47” substitute “or 24”.

(5) In Article 5—

(a)

(a) in paragraph 3, for “Community legislation” substitute “retained EU law”;

(b)

(b) in paragraph 4, for “, 24 or 47” substitute “or 24”.

(6) In Article 6, for “Community” substitute “other”.

(7) Omit Article 7.

(8) In Article 9—

(a)

(a) in paragraph 1, for “Member States” substitute “The competent authorities”;

(b)

(b) omit paragraph 3.

(9) Omit Articles 11 and 12.

(10) After Article 13, omit the words from “This Regulation” to “Member States.”.

S-5 Regulation (EC) No 1946/2003 of the European Parliament and of the Council

Regulation (EC) No 1946/2003 of the European Parliament and of the Council

5.—(1) Regulation (EC) No 1946/2003of the European Parliament and of the Council on transboundary movements of genetically modified organisms is amended as follows.

(2) In Article 1, omit the following—

(a)

(a) “and without prejudice to the provisions of Directive 2001/18/EC,”;

(b)

(b) “common”;

(c)

(c) “on behalf of the Community”.

(3) In Article 3—

(a)

(a) in paragraph 10(a), for the words from “customs territory” to the end substitute “United Kingdom of GMOs”;

(b)

(b) in paragraph 11, for “Community from a Party within the Community” substitute “United Kingdom by a United Kingdom exporter”;

(c)

(c) in paragraph 12, for “customs territory of the Community”, in both places it occurs, substitute “United Kingdom”;

(d)

(d) in paragraph 14, omit “, excluding intentional movements between Parties within the Community”;

(e)

(e) for paragraph 19 substitute—

S-19

19. “competent authority”, in relation to performing the administrative functions required by the Protocol, means—

(a) in England, the Secretary of State;

(b) in Wales, the Welsh Ministers;

(c) in Scotland, the Scottish Ministers;

(d) in Northern Ireland, the Department of Agriculture, Environment and Rural Affairs;”;

(f)

(f) for paragraph 20 substitute—

S-20

20. “focal point” means the Secretary of State, who has been designated as the United Kingdom’s entity to be responsible on its behalf for liaising with the Secretariat;”;

(g)

(g) after paragraph 21, insert—

S-22

22. “constituent nation” means England, Wales, Scotland or Northern Ireland, as the case may be;

S-23

23. “relevant authority” means any of the competent authorities, together with the Food Standards Agency, the Health and Safety Executive, the Medicines and Healthcare products Regulatory Agency or other agencies as the case may be and as appropriate in the circumstances.”.

(4) In Article 5—

(a)

(a) in paragraph 2, in the first sentence, for the words from “, to the Member State” to the end substitute “and to the competent authority for any constituent nation in which the exporter is based”;

(b)

(b) in paragraph 5, for “Commission and the Member States” substitute “focal point”.

(5) In Article 6—

(a)

(a) in the heading, for “Party of export” substitute “competent authority”;

(b)

(b) in the first paragraph, for the words “of the Member State” to the end substitute “for any constituent nation in which the exporter is based”;

(c)

(c) in the second paragraph—

(i) for “Commission” substitute “competent authority for any constituent nation in which the exporter is based”;

(ii) for “the Community rules” substitute “retained EU law”.

(6) In Article 9—

(a)

(a) in paragraph 1—

(i) in the first subparagraph—

(aa) for the words from “Commission on behalf of” to “made the decision” substitute “focal point”;

(bb) for “, Community or use within a Member State,” substitute “United Kingdom”;

(ii) for the second subparagraph substitute—

“This paragraph does not apply to decisions to grant a consent for the deliberate release of a GMO taken, pursuant to—

(a)

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

(b)

(b) in Scotland, regulation 21 of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002,

(c)

(c) in Wales, regulation 22 of the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002,

(d)

(d) in Northern Ireland, regulation 21 of the...

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