The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020

• Citation: S.I. 2020/1567
• Sections: 113

Section 1 Citation, commencement and extent

(1) These Regulations may be cited as the Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020.

(2) These Regulations come into force immediately before IP completion day.

(3) Any amendment made by these Regulations has the same extent as the provision amended.

Section 2 Interpretation

In these Regulations, “the 2019 Regulations” means the Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 .

Section 3 Amendment of the 2019 Regulations

The 2019 Regulations are amended in accordance with regulations 4 to 10.

Section 4 Amendment of regulation 2 of the 2019 Regulations

In regulation 2 of the 2019 Regulations (Amendments to retained EU law), in paragraph (1) (domestic subordinate legislation corrected by the 2019 Regulations) omit the following—

(a) sub-paragraph (b) (the Health and Safety (Enforcing Authority) Regulations (Northern Ireland) 1999);

(b) sub-paragraph (e) (the Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003);

(c) sub-paragraph (f) (the Dangerous Substances and Explosive Atmospheres Regulations (Northern Ireland) 2003);

(d) sub-paragraph (i) (the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013);

(e) sub-paragraph (l) (the Explosives (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2015);

(f) sub-paragraph (m) (the Biocidal Products (Fees and Charges) Regulations (Northern Ireland) 2015);

(g) sub-paragraph (n) (the Control of Major Accident Hazards Regulations (Northern Ireland) 2015);

(h) sub-paragraph (o) (the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015).

Section 5 Amendment of regulation 4 of the 2019 Regulations

For regulation 4 of the 2019 Regulations (Transitional provision in relation to Regulation (EC) No 1272/2008 ) substitute—

Revocation of Commission Delegated Regulation (EU) No 492/2014

(4) Commission Delegated Regulation (EU) No 492/2014 of 7 March 2014 supplementing Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the rules for the renewal of authorisations of biocidal products subject to mutual recognition is revoked.

Section 6 Amendment of regulation 5 of the 2019 Regulations

For regulation 5 of the 2019 Regulations (Transitional provision in relation to Regulation (EU) No 649/2012), substitute—

Savings and transitional arrangements

(5) Schedule 4 (Savings and transitional arrangements) has effect.

Section 7 Amendment of Schedule 1 to the 2019 Regulations

Schedule 1 to the 2019 Regulations (Amendments to subordinate legislation) is amended in accordance with Schedule 1.

Section 8 Amendment of Schedule 2 to the 2019 Regulations

Schedule 2 to the 2019 Regulations (Amendments to retained direct EU legislation) is amended in accordance with Schedule 2.

Section 9 Amendment of Schedule 3 to the 2019 Regulations

Schedule 3 to the 2019 Regulations (Amendments to Annex II to the EEA Agreement) is amended in accordance with Schedule 3.

Section 10 Insertion of Schedule 4 into the 2019 Regulations

After Schedule 3 to the 2019 Regulations, insert a new Schedule 4 (Savings, transitional and consequential provision), as provided for in Schedule 4.

Section 1 Amendment of Schedule 1 to the 2019 Regulations

Schedule 1 to the 2019 Regulations (Amendments to subordinate legislation) is amended in accordance with paragraphs 2 to 24.

Section 2 Amendments relating to the Health and Safety (Enforcing Authority) Regulations (Northern Ireland) 1999

Omit paragraph 2 and the heading above it.

Section 3 Amendments relating to the Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003

Omit paragraph 5 and the heading above it.

Section 4 Amendments relating to the Dangerous Substances and Explosive Atmospheres Regulations (Northern Ireland) 2003

Omit paragraph 6 and the heading above it.

Section 5 Amendments relating to the Plant Protection Products (Fees and Charges) Regulations 2011 (“the PPP Fees and Charges Regulations”)

(1) Paragraph 8 (amendment of regulation 2(1) of the PPP Fees and Charges Regulations ) is amended as follows.

(2) After sub-paragraph (2) insert—

(2A) After the definition of “authorisation holder”, insert—

“Great Britain competent authorities” means—

in relation to England, the Secretary of State;

in relation to Wales, the Welsh Ministers;

in relation to Scotland, the Scottish Ministers;

(2B) In the definition of “import tolerance”, after “has” insert “, in relation to Great Britain,”;

(3) In sub-paragraph (3), for the definition of “MRL compliance” being inserted by that sub-paragraph substitute—

“MRL compliance” means, in relation to products placed on the market in Great Britain, compliance with the requirements of Article 18 of the MRL Regulation;

(4) After sub-paragraph (3) insert—

(3A) For the definition of “the MRL Regulation” substitute—

“the MRL Regulation” means—

in relation to Great Britain, Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ;

in relation to Northern Ireland, Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC as it has effect in EU law

(5) In sub-paragraph (4), in the definition of “MRL supplementary information requirement” being inserted by that sub-paragraph, after “requested” insert “by a Great Britain competent authority”.

(6) After sub-paragraph (4) insert—

(4A) After the definition of “nominated sales representative”, insert—

“Northern Ireland competent authority” means the Department of Agriculture, Environment and Rural Affairs;

(4B) For the definition of “Regulation 1107/2009” substitute—

“Regulation 1107/2009” means—

in relation to Great Britain, Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market, as last amended by Regulation (EU) 2019/1009 of the European Parliament and of the Council;

in relation to Northern Ireland, Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market, as last amended by Regulation (EU) 2019/1009 of the European Parliament and of the Council as it has effect in EU law;

(7) In sub-paragraph (5), in the definition of “standalone MRL application” being inserted by that sub-paragraph, after “application” insert “to a Great Britain competent authority”.

Section 6 Amendments relating to the Plant Protection Products (Fees and Charges) Regulations 2011 (“the PPP Fees and Charges Regulations”)

For paragraph 9 (omission of regulation 3 of the PPP Fees and Charges Regulations), substitute—

(9) Regulation 3 is amended as follows—

(a) for the heading, substitute “Functions in Article 74(1) of Regulation 1107/2009: Northern Ireland”;

(b) in paragraph (1)—

(i) omit “of the Member State”;

(ii) for “United Kingdom competent authorities” substitute “Northern Ireland competent authority”;

(c) omit paragraph (2).

Section 7 Amendments relating to the Plant Protection Products (Fees and Charges) Regulations 2011 (“the PPP Fees and Charges Regulations”)

For paragraph 10 (amendment of regulation 4 of the PPP Fees and Charges Regulations) substitute—

(10) Regulation 4 is amended as follows—

(a) in paragraph 1—

(i) omit sub-paragraph (b);

(ii) at the end, after “in accordance with” insert “paragraphs 1 and 3 respectively of”;

(b) after paragraph 1, insert—

(1A) A Great Britain competent authority may charge fees for work carried out within the scope of Regulation 1107/2009 which relates to evaluating applications made to it for the approval of active substances, safeners, synergists or basic substances, and such fees are payable in accordance with paragraph 2 of Schedule 1.

(1B) The Northern Ireland competent authority may charge fees for work carried out within the scope of Regulation 1107/2009 which relates to evaluating parallel trade applications made to it and such fees are payable in accordance with paragraph 1A of Schedule 1.

(c) in paragraph 2—

(i) for “United Kingdom” substitute “Great Britain”;

(ii) after “applications for import tolerances” insert “and standalone MRL applications”;

(d) after paragraph 2, insert—

(2A) A Great Britain competent authority may charge fees for the evaluation of supplementary information provided in accordance with Article 14(3) of the MRL Regulation and such fees are payable in accordance with Schedule 3.

(e) in paragraph (4), for “a United Kingdom” substitute “the relevant”;

(f) in paragraph (5), for “A United Kingdom” substitute “The relevant”;

(g) in paragraph (7), for “a United Kingdom” substitute “the relevant”.

Section 8 Amendments relating to the Plant Protection Products (Fees and Charges) Regulations 2011 (“the PPP Fees and Charges Regulations”)

In paragraph 12 (amendment of regulation 7(2) of the PPP Fees and Charges Regulations), after paragraph (a) insert—

(aa) for “under regulation 4(1)” substitute “under regulations 4(1), 4(1A) or 4(1B)”;

Section 9 Amendments relating to the Plant Protection Products (Fees and Charges) Regulations 2011 (“the PPP Fees and Charges Regulations”)

For paragraph 13 (amendment of regulation 8(6) of the PPP Fees and Charges Regulations), substitute—

(13) In regulation 8(6), for the definition of “total costs incurred” substitute—

“total costs incurred” means the costs referred to in regulations 5 and 6, excluding any costs in respect of which a fee is payable under—

regulations 4(1), 4(1A) or 4(1B) and Schedule 1,

regulation 4(2) and Schedule 2, or

regulation 4(2A) and Schedule 3;

Section 10 Amendments relating to the Plant Protection Products (Fees and Charges) Regulations 2011 (“the PPP Fees and Charges Regulations”)

(1) Paragraph 14 (amendment of Schedule 1 to the PPP Fees and Charges Regulations) is amended as follows.

(2) In sub-paragraph (2)—

(a) paragraph (a) becomes paragraph (b), and paragraph (b) becomes paragraph (c);

(b) above the paragraph re-numbered as paragraph (b), insert—

(a) in the first sentence, after “product-related applications” insert “to a United Kingdom competent authority”;

(3) After sub-paragraph (2) insert—

(2A) After paragraph 1, insert—

(1A) Fees for parallel trade applications to the Northern Ireland competent authority are in accordance with the following table, and each item is charged cumulatively.

Application for a parallel trade permit for other than personal use.

Verification that the product to be traded is identical to a product authorised in accordance with Regulation 1107/2009.

(4) In sub-paragraph (3), for paragraph (b) substitute—

(b) in the first sentence—

(i) after “The fees” insert “chargeable by a Great Britain competent authority”;

(ii) for “or synergist” substitute “, synergist or basic substance”.

(5) After sub-paragraph (3) insert—

(3A) In paragraph 3, after “organisation” insert “by a United Kingdom competent authority”.

Section 11 Amendments relating to the Plant Protection Products (Fees and Charges) Regulations 2011 (“the PPP Fees and Charges Regulations”)

(1) Paragraph 15 (amendment of Schedule 2 to the PPP Fees and Charges Regulations) is amended as follows.

(2) In sub-paragraph (5)—

(a) for paragraph (a) substitute—

(a) in the first sentence, for the words from the start to “product-related applications” substitute “Fees chargeable by a Great Britain competent authority for import tolerances”;

(b) in paragraph (c)—

(i) in paragraph (i), in the note (1) which that paragraph substitutes, in both places it occurs, for “the United Kingdom” substitute “Great Britain”;

(ii) in paragraphs (ii)(bb) and (iii)(bb), for “the United Kingdom” substitute “Great Britain”.

(3) In sub-paragraph (6)—

(a) in the new paragraph 2 which that sub-paragraph inserts, in the sentence above the table, after “Fees” insert “chargeable by a Great Britain competent authority”;

(b) in the notes which follow the new paragraph 2 which that sub-paragraph inserts, in each place it occurs, for “the United Kingdom” substitute “Great Britain”.

Section 12 Amendments relating to the Plant Protection Products (Fees and Charges) Regulations 2011 (“the PPP Fees and Charges Regulations”)

In paragraph 16 (insertion of Schedule 3 to the PPP Fees and Charges Regulations), in the new Schedule 3 which that paragraph inserts, in the heading and in the sentence above the table, after “Fees” insert “chargeable by a Great Britain competent authority”.

Section 13 Amendments relating to the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013

In paragraph 18—

(a) in sub-paragraph (c), for “the United Kingdom” substitute “Great Britain”;

(b) in sub-paragraph (d), in the new definition of “Devolved Authority” which that sub-paragraph inserts—

(i) at the end of paragraph (a), insert “or”;

(ii) at the end of paragraph (b), omit “, or”;

(iii) omit paragraph (c);

(c) for sub-paragraph (e) substitute—

(e) for the definition of “the PIC Regulation”, substitute—

“the PIC Regulation” means—

in relation to Great Britain, Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals, of which Annexes II, IV and VI are to be read as amended from time to time;

in relation to Northern Ireland, Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals as it has effect in EU law;

(d) after paragraph (e) insert—

(f) after the definition of “the PIC Regulation” insert—

“the Review Regulation” means Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council

Section 14 Amendments relating to the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013

In paragraph 20—

(a) for the new regulation 7(2) which that paragraph inserts, substitute—

(2) In accordance with Article 18 of the PIC Regulation, the Designated National Authority is responsible for controlling the export and import of the following chemicals—

(a) in relation to Great Britain, the chemicals listed in Parts 1, 2 and 3 of the GB PIC list;

(b) in relation to Northern Ireland, the chemicals listed in Annex I to the PIC Regulation;

(b) for the new paragraph 7(3) which that paragraph inserts, substitute—

(3) In paragraph (2), “the GB PIC list” means the list established and maintained in accordance with Articles 7 and 23 of the PIC Regulation.

Section 15 Amendments relating to the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013

In paragraph 21(b), in the new paragraph (4) which that paragraph substitutes, for “the second subparagraph of 89(3)” substitute “79”.

Section 16 Amendments relating to the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013

In paragraph 22(a), in the new paragraph (1) which it inserts, for the words from “Article 22” to the end substitute “Article 22 of the Review Regulation”.

Section 17 Amendments relating to the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013

For paragraph 23 substitute—

(23)

(1) Regulation 14 is amended as follows.

(2) In paragraph (1)—

(a) for “paragraphs (3) and (4)” substitute “paragraph (4)”;

(b) at the end insert “or the Review Regulation listed in paragraph (2A)”.

(3) In paragraph (2)—

(a) at the start, for “The decisions” substitute “In relation to the Biocides Regulation, the decisions”;

(b) above paragraph (a) insert—

(za) to prohibit or amend the terms and conditions under which a biocidal product may be made available on the market under Article 17A(2);

(c) omit sub-paragraphs (f), (g), (k) and (l);

(d) before sub-paragraph (m) insert—

(la) to reject an application due to non-payment of fees under Article 54(3);

(lb) to establish technical equivalence under Article 54(4);

(lc) to reject an application for failure to provide additional information under Article 54(5);

(e) after paragraph (n) insert—

(na) to give a prospective applicant data under Article 63(3);

(nb) to refuse a request under Article 63(3) where every effort has not been made to reach an agreement;

(f) after paragraph (o) insert—

(oa) to allow a subsequent applicant to refer to data previously provided by P under Article 64(1);

(4) After paragraph (2) insert—

(2A) In relation to the Review Regulation, the decision referred to in paragraph 9(1) is a decision to reject a notification made under Articles 14(2) or 16(5).

(5) Omit paragraph (3).

(6) In paragraph (4)—

(a) in sub-paragraph (a)—

(i) for “(g)” substitute “(e)”;

(ii) after “(j)” insert “(la), (lc),”;

(b) in sub-paragraph (b) omit “and 2(l)”;

(c) in sub-paragraph (d) omit “, (k)”;

(d) after sub-paragraph (d) insert—

(e) in relation to paragraph (2)(za), the decision relates to a notification by P, or someone on behalf of P”;

(f) in relation to paragraph (2A), the decision relates to a notification by P, or by someone on behalf of P.

(7) In paragraph (7), for “Commission or another competent authority” substitute “Secretary of State or a Devolved Authority”.

Section 18 Amendments relating to the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013

Omit paragraphs 30 to 39, and the heading above paragraph 30.

Section 19 Amendments relating to the Genetically Modified Organisms (Contained Use) Regulations 2014

In paragraph 40(3), in the new regulation 33A which that paragraph inserts, in both places it occurs, for “exit day” substitute “IP completion day”.

Section 20 Amendments relating to the Control of Major Accident Hazards Regulations 2015

In paragraph 41(2), for “UK” substitute “GB”.

Section 21 Amendments relating to the Explosives (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2015

Omit paragraph 42 and the heading above it.

Section 22 Amendments relating to the Biocidal Products (Fees and Charges) Regulations (Northern Ireland) 2015

Omit paragraph 43 and the heading above it.

Section 23 Amendments relating to the Control of Major Accident Hazards Regulations (Northern Ireland) 2015

Omit paragraph 44 and the heading above it.

Section 24 Amendments relating to the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015

Omit paragraph 45 and the heading above it.

Section 1

Schedule 2 to the 2019 Regulations (Amendments to retained direct EU legislation) is amended in accordance with paragraphs 2 to 72.

Section 2 Amendments relating to Regulation (EC) No 1907/2006 (“the REACH Regulation”)

In the following paragraphs, in each place it occurs, for “UK” substitute “GB”—

(a) paragraph 2 (amendment of Article 3 of the REACH Regulation);

(b) paragraph 3 (amendment of Article 15 of the REACH Regulation);

(c) paragraph 4 (amendment of Article 59 of the REACH Regulation);

(d) paragraph 5 (amendment of Annex I to the REACH Regulation);

(e) paragraph 6 (amendment of Annex II to the REACH Regulation);

(f) paragraph 7 (amendment of Annex XVII to the REACH Regulation);

(g) paragraph 8 (amendment of the foreword to Appendices 1 to 6 to the REACH Regulation);

(h) paragraph 10 (amendment of Appendix 2 to the REACH Regulation).

Section 3 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

In paragraph 13 (amendment of Article 1 of the CLP Regulation )—

(a) in sub-paragraph (2)(c), for “UK” substitute “GB”;

(b) in sub-paragraph (2)(d)—

(i) for “UK” substitute “GB”;

(ii) for “exit day” substitute “IP completion day”;

(c) in sub-paragraph (3)(a), omit “and the Ionising Radiations Regulations (Northern Ireland) 2017”.

Section 4 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

For paragraph 14 (amendment of Article 2 of the CLP Regulation) substitute—

(14) In Article 2—

(a) for point 10 (definition of “producer of an article”), substitute—

(10) “producer of an article” means any natural or legal person—

(a) who makes or assembles an article within Great Britain;

(b) who makes or assembles an article within Northern Ireland which is a qualifying Northern Ireland good and which is placed directly on the market in Great Britain;

(b) for point 15 (definition of “manufacturer”) substitute—

(15) “manufacturer” means any natural or legal person—

(a) established in Great Britain, who manufactures a substance within Great Britain”;

(b) established in Northern Ireland, who manufactures a substance which is a qualifying Northern Ireland good and which is placed directly on the market in Great Britain;

(c) for point 16 (definition of “import”) substitute—

(16) “import” means the physical introduction into Great Britain, except where the goods are qualifying Northern Ireland goods;

(d) for point 17 (definition of “importer”) substitute—

(17) “importer” means any natural or legal person established within Great Britain who is responsible for import;

(e) in point 19 (definition of “downstream user”), for “within the Community” substitute “within Great Britain, or within Northern Ireland in the case of qualifying Northern Ireland goods which are placed directly on the market in Great Britain”;

(f) in point 20 (definition of “distributor”), for “within the Community” substitute “within Great Britain, or within Northern Ireland in the case of qualifying Northern Ireland goods which are placed directly on the market in Great Britain”;

(g) in point 23 (definition of “the Agency”), for the words from “European Chemicals Agency” to the end substitute “Health and Safety Executive”;

(h) in point 24 (definition of “competent authority”), for “established by the Member States to carry out the obligations arising from this Regulation” substitute “appointed to carry out the obligations arising from this Regulation by the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013”;

(i) after point 37 (definition of “intermediate packaging”) insert—

(38) “GB mandatory classification and labelling list” means the list of mandatory classification and labelling requirements of substances and groups of substances established and maintained in accordance with Article 38A;

(39) “GB notification database” means the database established in accordance with Article 42;

(40) “European Chemicals Agency” means the Agency established by Article 75 of Regulation (EC) No 1907/2006 as it has effect in EU law;

(41) “EU CLP Regulation” means Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EEC , and amending Regulation (EC) No 1907/2006 , as it has effect in EU law;

(42) “Devolved Authority” means—

(a) the Scottish Ministers, or

(b) the Welsh Ministers;

(43) “qualifying Northern Ireland goods” has the meaning given by regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.

Section 5 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

For paragraph 15 (amendment of Article 4 of the CLP Regulation) substitute—

(15) In Article 4—

(a) in paragraph 3—

(i) in the first subparagraph—

(aa) for “harmonised” substitute “mandatory”;

(bb) for “Part 3 of Annex VI” substitute “the GB mandatory classification and labelling list”;

(ii) in the second subparagraph, for “Part 3 of Annex VI” substitute “the GB mandatory classification and labelling list”;

(b) in paragraph 5, after “distributors” insert “who are established within Great Britain”;

(c) in paragraph 6, after “downstream users” insert “who are established within Great Britain”.

Section 6 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

In the following paragraphs, in each place it occurs, for “UK” substitute “GB”—

(a) paragraph 17 (amendment of Article 10 of the CLP Regulation);

(b) paragraph 18 (amendment of Article 15 of the CLP Regulation);

(c) paragraph 21 (amendment of Article 18 of the CLP Regulation);

(d) paragraph 22 (amendment of Article 21 of the CLP Regulation);

(e) paragraph 24 (amendment of Article 25 of the CLP Regulation);

(f) paragraph 25 (amendment of Article 26 of the CLP Regulation);

(g) paragraph 30 (amendment of the heading for Title V of the CLP Regulation);

(h) paragraph 32 (amendment of Article 36 of the CLP Regulation).

Section 7 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

For paragraph 33 (amendment of Article 37 of the CLP Regulation) substitute—

(33) For Article 37 substitute—

Article 37 Procedure for mandatory classification and labelling where the EU Risk Assessment Committee publishes an opinion

(1) This Article applies in relation to a substance—

(a) on which the Committee for Risk Assessment of the European Chemicals Agency (“the Committee”) publishes an opinion under Article 37(4) of the EU CLP Regulation on or after IP completion day, or

(b) on which the Committee has published an opinion under Article 37(4) of the EU CLP Regulation before IP completion day, but which has not, as at IP completion day, been included in Part 3 of Annex VI of the EU CLP Regulation.

(2) Within 6 months of the publication of the Committee’s opinion, the Agency must publish a technical report on the Committee’s opinion.

(3) Within 12 months of the publication by the Agency of the technical report, the Agency must publish its own opinion.

(4) Where the Agency’s opinion recommends aligning with the Committee’s opinion that there should be a change—

(a) within 12 months of the publication of its opinion, the Agency must—

(i) submit a recommendation to the Secretary of State to give effect to the classification and labelling requirement set out in the Agency’s opinion, and

(ii) send a copy of that recommendation to the Devolved Authorities;

(b) within 3 months of the recommendation being submitted by the Agency, the Secretary of State must—

(i) decide whether to accept the recommendation;

(ii) publish that decision, together with reasons for the decision;

(iii) where the decision referred to in paragraph (i) is to accept the recommendation, specify (alongside the decision and the reasons for the decision) the date from when any new or revised classification and labelling requirement must be complied with;

(iv) notify the Agency of the decision and details referred to in paragraphs (ii) and (iii);

(c) the Secretary of State’s functions under paragraph (b)(i) and (iii) are subject to the consent requirement in Article 53B;

(d) within one month of the Secretary of State notifying the Agency of a decision in accordance with paragraph (b)(iv), the Agency must update the GB mandatory classification and labelling list accordingly, making clear the date from when the new or revised classification and labelling requirement must be complied with.

(5) Where the Agency’s opinion does not recommend aligning with the Committee’s opinion the Agency may produce a proposal under paragraph 2 of Article 37A for a new or revised mandatory classification and labelling requirement.

Section 8 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

For paragraph 34 (insertion of Article 37A of the CLP Regulation) substitute—

(34) After Article 37 insert—

Article 37A Procedure for mandatory classification and labelling of substances where Article 37(1) does not apply

(1) This Article—

(a) applies in relation to substances to which Article 37(1) does not apply;

(b) does not apply to manufacturers, importers or downstream users established in Northern Ireland who supply qualifying Northern Ireland goods directly to Great Britain.

(2)

(1) The Agency may produce a proposal for a new or revised mandatory classification and labelling requirement and, where appropriate, specific concentration limits or M-factors.

(2) A competent authority may submit to the Agency a proposal for a new or revised mandatory classification and labelling requirement and, where appropriate, specific concentration limits or M-factors.

(3) A proposal under subparagraphs (1) or (2) must follow the format set out in Part 2 of Annex VI and must contain the relevant information provided for in Part 1 of Annex VI.

(3)

(1) A manufacturer, importer or downstream user of a substance may submit to the Agency a proposal for a mandatory classification and labelling of that substance and, where appropriate, specific concentration limits or M-factors, where there is no entry in the GB mandatory classification and labelling list for such substance in relation to the hazard class or differentiation covered by that proposal;

(2) A manufacturer, importer or downstream user who has new information which may lead to a change of the mandatory classification and labelling elements of a substance in the GB mandatory classification and labelling list must submit a proposal to the Agency for a revised classification.

(3) A proposal under subparagraph (1) must follow the format set out in Part 2 of Annex VI and must contain the relevant information provided for in Part 1 of Annex VI.

(4) Where a proposal under subparagraph (1) concerns the mandatory classification and labelling of a substance in accordance with Article 36(3), it must be accompanied by a fee.

(4) Within 12 months of a proposal being received by or produced by the Agency, during which time the parties concerned must be given an opportunity to comment, the Agency must publish a technical report on the proposal.

(5) Within 6 months of publishing the technical report, the Agency must publish an opinion on the proposal.

(6) In exceptional circumstances, the 6 month time limit referred to in paragraph 5 may be extended to 12 months.

(7) Where the Agency considers that it is appropriate to recommend that a new or revised mandatory classification and labelling requirement is imposed, within 12 months of the opinion being published, the Agency must—

(a) submit a recommendation to the Secretary of State to give effect to the opinion, and

(b) send a copy of that recommendation to each of the Devolved Authorities.

(8)

(1) Within 3 months of the recommendation being submitted by the Agency, the Secretary of State must—

(a) decide whether to accept the recommendation;

(b) publish that decision, together with reasons for the decision;

(c) where the decision referred to in paragraph (b) is to accept the recommendation, specify (alongside the decision and the reasons for the decision) the date from when any new or revised classification and labelling requirement must be complied with;

(d) notify the Agency of the decision and details referred to in paragraphs (b) and (c).

(2) The Secretary of State’s functions under subparagraphs (1)(a) and (c) are subject to the consent requirement in Article 53B.

(9) Within one month of the Secretary of State notifying the Agency of a decision in accordance with paragraph 8(d), the Agency must update the GB mandatory classification and labelling list accordingly, making clear the date from when any new or revised classification and labelling requirement must be complied with.

Section 9 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

In the following paragraphs, in each place it occurs (including in new provisions being inserted and headings), for “UK” substitute “GB”—

(a) paragraph 35 (amendment of Article 38 of the CLP Regulation);

(b) paragraph 36 (insertion of Article 38A into the CLP Regulation);

(c) paragraph 37 (amendment of the heading for Chapter 2 of the CLP Regulation);

Section 10 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

In paragraph 39 (amendment of Article 40 of the CLP Regulation)—

(a) in sub-paragraph (a), for “UK” substitute “GB”;

(b) in sub-paragraph (b), for “exit day” substitute “IP completion day”.

Section 11 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

In paragraph 40 (amendment of Article 41 of the CLP Regulation), for “UK” substitute “GB”.

Section 12 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

In paragraph 41 (amendment of Article 42 of the CLP Regulation)—

(a) in each place it occurs (including in the amendment to the heading), for “UK” substitute “GB”;

(b) in point (e), for “37(3)(b) and Article 37A(6)” substitute “37(4)(b) and Article 37A(8)”.

Section 13 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

In paragraph 45 (amendment of Article 45 of the CLP Regulation)—

(a) in sub-paragraph (b), in the new paragraph 1A which it inserts, for “Scotland, Wales or Northern Ireland” substitute “Scotland or Wales”;

(b) for paragraph (d) substitute—

(d) for paragraph 4 substitute—

(4) The Secretary of State may by regulations specify the information relating to emergency health response and preventative measures required for the purposes of this Article, following consultation with relevant stakeholders as referred to in paragraph 5.

(5) Before making regulations, the Secretary of State must consult—

(a) the body or bodies appointed under paragraph 1,

(b) any person or body who the Secretary of State considers is representative of importers, if any,

(c) any person or body who the Secretary of State considers is representative of downstream users, if any, and

(d) any other person who the Secretary of State considers appropriate.

(6) The Secretary of State’s regulation-making function under paragraph 4 is subject to the consent requirement in Article 53B.

Section 14 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

For paragraph 48 (amendment of Article 49 of the CLP Regulation) substitute—

(48) In Article 49—

(a) in paragraph 3—

(i) in the first subparagraph, for “competent authority or the enforcement authorities of a Member State in which a supplier is established” substitute “competent authorities, enforcing authorities”;

(ii) in the second subparagraph, after “authority” insert “in question”;

(b) after paragraph 3 insert—

(4) For the purposes of this Article, “enforcing authorities” has the meaning given by regulation 18 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013.

Section 15 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

In paragraph 51 (amendment of Article 52 of the CLP Regulation), in the new Article 52 which it substitutes—

(a) in paragraph 1(b), for “paragraphs 6 to 10” substitute “paragraphs 6 to 8”;

(b) omit paragraph 6(d) (and the semicolon before it);

(c) omit paragraphs 9 and 10.

Section 16 Amendments relating to Regulation (EC) No 1272/2008 (“the CLP Regulation”)

In paragraph 53 (insertion of Articles 53A and 53B into the CLP Regulation), in the new Article 53B which that paragraph inserts, omit paragraphs 4 to 7.