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The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019

Type Statutory-Instrument

Publication 2019-03-27

Last updated 2025-02-27

State In force

Department King's Printer of Acts of Parliament

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Made: 27th March 2019

Coming into force in accordance with regulation 1(2)

The Secretary of State makes the following Regulations with the consent of the Treasury in exercise of the powers conferred by section 8(1) of, and paragraphs 1 and 7 of Schedule 4 and paragraph 21(b) of Schedule 7 to, the European Union (Withdrawal) Act 2018 .

In accordance with paragraphs 1(1) and 12(1) of Schedule 7 to that Act a draft of these Regulations has been laid before Parliament and approved by a resolution of each House of Parliament.

Citation, commencement and extent

1

(1) These Regulations may be cited as the Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019.

(2) These Regulations come into force on exit day.

(3) Except as provided by paragraph (4), these Regulations extend to England and Wales, Scotland and Northern Ireland.

(4) An amendment or revocation made by Schedule 1 has the same extent as the provision amended or revoked.

Amendments to retained EU law

2

(1) Schedule 1 contains amendments to the following subordinate legislation—

(a) the Health and Safety (Enforcing Authority) Regulations 1998 ;

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) the Dangerous Substances and Explosive Atmospheres Regulations 2002 ;

(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(f) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(g) the Plant Protection Products (Fees and Charges) Regulations 2011 ;

(h) the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013 ;

(i) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(j) the Genetically Modified Organisms (Contained Use) Regulations 2014 ;

(k) the Control of Major Accident Hazards Regulations 2015 ;

(l) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(m) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(n) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(o) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(p) the Health and Safety and Nuclear (Fees) Regulations 2016 .

(2) Schedule 2 contains amendments to the following retained direct EU legislation—

(a) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH);

(b) 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;

(c) Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances;

(d) Commission Regulation (EU) No 545/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products;

(e) Commission Regulation (EU) No 547/2011 of 8 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products;

(f) Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products;

(g) 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;

(h) Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market;

(i) Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market;

(j) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council;

(k) Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council;

(l) Commission Implementing Regulation (EU) No 88/2014 of 31 January 2014 specifying a procedure for the amendment of Annex I to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products;

(m) 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.

(3) Schedule 3 contains amendments to Part 2 of Annex II to the EEA agreement.

Revocation of Commission Regulation (EU) No 440/2010

3

Commission Regulation (EU) No 440/2010 of 21 May 2010 on the fees payable to the European Chemicals Agency pursuant to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures is revoked.

Transitional provision in relation to Regulation (EC) No 1272/2008

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.

Transitional provision in relation to Regulation (EU) No 649/2012

5

Schedule 4 (Savings and transitional arrangements) has effect.

SCHEDULE 1 — AMENDMENTS TO SUBORDINATE LEGISLATION

Health and Safety (Enforcing Authority) Regulations 1998

1

(1) The Health and Safety (Enforcing Authority) Regulations 1998 are amended as follows.

(2) In regulation 2(1), in the definition of “hazardous substance or mixture”, for “laid down” substitute “ as provided for ”.

Health and Safety (Enforcing Authority) Regulations (Northern Ireland) 1999

2

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Control of Substances Hazardous to Health Regulations 2002

3

(1) The Control of Substances Hazardous to Health Regulations 2002 are amended as follows.

(2) In regulation 2(1), in paragraph (a) of the definition of “substance hazardous to health”, for “laid down” substitute “ as provided for ”.

Dangerous Substances and Explosive Atmospheres Regulations 2002

4

(1) The Dangerous Substances and Explosive Atmospheres Regulations 2002 are amended as follows.

(2) In regulation 2, in paragraph (a) of the definition of “dangerous substance”, for “laid down” substitute “ as provided for ”.

Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Dangerous Substances and Explosive Atmospheres Regulations (Northern Ireland) 2003

6

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Plant Protection Products (Fees and Charges) Regulations 2011

7

The Plant Protection Products (Fees and Charges) Regulations 2011 are amended in accordance with paragraphs 8 to 16.

8

(1) Regulation 2(1) is amended as follows.

(2) Omit the definition of “the Directive”.

(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) After the definition of “liability period” insert—

“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;

(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

(4) After the definition of “the MRL Regulation” insert—

“MRL supplementary information requirement” means information requested by a Great Britain competent authority in accordance with Article 14(3) of the MRL Regulation;

(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;

(5) After the definition of “Regulation 1107/2009” insert—

“standalone MRL application” means an application to a Great Britain competent authority which is only for the setting, modification or deletion of a maximum residue level of an active substance;

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”;

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.

(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”.

11

In regulation 6—

(a) for the heading substitute “ Charge for work under the Plant Protection Products (Sustainable Use) Regulations 2012 ”;

(b) for “within the scope of the Directive” substitute “ under the Plant Protection Products (Sustainable Use) Regulations 2012 ”.

12

In regulation 7(2)—

(a) omit “or”;

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

(b) at the end insert “ or regulation 4(2A) and Schedule 3 ”.

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, orregulation 4(2A) and Schedule 3;

14

(1) Schedule 1 is amended as follows.

(2) In paragraph 1—

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

(b) in the table—

(i) in item 4 in the second column, after “application⁽²⁾” omit “⁽³⁾”;

(ii) omit items 5, 5a and 5b;

(iii) in item 11 in the second column, for “for lead zonal re-registration and new product applications” substitute “ to discuss potential product applications ”;

(iv) omit item 12;

(i) omit notes (3), (5) and (6);

(ii) in note (7) for “items 1-5, 10, 11 and 12” substitute “ items 1-4, 10 and 11 ”;

(iii) in note (16) omit “to the United Kingdom to act as lead zonal rapporteur”;

(iv) omit note (17);

(v) in note (18) for “the United Kingdom” substitute “ a United Kingdom competent authority ”.

(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.

Item	Chargeable item	Fee(£)
(1)Application for a parallel trade permit for other than personal use.	(1)Application for a parallel trade permit for other than personal use.	(1)Application for a parallel trade permit for other than personal use.
(2)Verification that the product to be traded is identical to a product authorised in accordance with Regulation 1107/2009.	(2)Verification that the product to be traded is identical to a product authorised in accordance with Regulation 1107/2009.	(2)Verification that the product to be traded is identical to a product authorised in accordance with Regulation 1107/2009.
1	Preliminary consideration of an application to determine whether the application can proceed further	229
2	Parallel trade applications—
	(a) co-ordination of application for a new product or change to an existing product involving parallel trade[^f01000]	728
	(b) parallel trade verification[^f01001]	208
	(c) parallel trade permit for personal use	156

(3) In paragraph 2—

(a) in the heading, for “or synergist” substitute “ , synergist or basic substance ”;

(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”.

(i) in the heading before item 1, for “or synergist” substitute “ , synergist or basic substance ”;

(ii) omit item 2;

(iii) in item 3 for the words in the second column substitute “ Co-ordination of scientific advice and public consultation and finalising the draft assessment report ”;

(iv) in items 7 and 10, for the words in the second column substitute “ Co-ordination of scientific advice and public consultation, and finalising the draft assessment report ”;

(v) in item 12, in the second column, after “synergist,” insert “ basic substance, ”;

(d) in the notes following the table—

(i) omit note (2);

(ii) in note (3)—

(aa) at the beginning insert “ In relation to active substances, safeners or synergists, ”;

(bb) after the first sentence insert “ In relation to basic substances, a full data package comprises the complete dossier (the information referred to in Article 23(3) of Regulation 1107/2009) to support one or more uses of the basic substance. ”;

(cc) in the second sentence after “the product” insert “ or basic substance ”;

(iii) in note (4)—

(aa) omit paragraph (c);

(bb) in paragraph (d) at the beginning insert “ in relation to active substances, safeners or synergists, ”;

(cc) omit paragraph (e);

(dd) in paragraphs (f) and (g), at the beginning insert “ in relation to active substances, safeners or synergists, ”;

(ee) after paragraph (g) insert—

(h) in relation to basic substances, resubmissions (for example where the previous application for approval under Regulation 1107/2009 has been unsuccessful and a new application is made in an attempt to address all the concerns raised from that earlier submission); (i) in relation to basic substances, data to support a change to the conditions of approval of the basic substance.

(iv) for the final sentence substitute—

The evaluation of scientific peer reviewed open literature on the active substance or basic substance and its relevant metabolites will be treated as a partial data package.

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

(4) Omit paragraph 4 (including the table, and the notes following the table, in that paragraph).

15

(1) Schedule 2 is amended as follows.

(2) In the Schedule heading, for “fee” substitute “ fees and standalone MRL application fees ”.

(3) After the Schedule heading insert the paragraph heading “ Fees for import tolerances ”.

(4) The existing content of the Schedule (after the Schedule heading) becomes paragraph 1.

(5) In that paragraph—

(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 the table, before item 1 insert—

A1	Preliminary consideration of an application to determine whether the application can proceed further	229
A2	Co-ordination of applications	1,872

(i) for note (1) substitute—

(1) This category is mainly for active substances not currently approved in respect of the part of Great Britain to which the application relates. In certain cases it may also include active substances still being reviewed if toxicological endpoints have not yet been agreed and accepted in respect of that part of Great Britain.

(ii) in note (2)—

(aa) for “plant protection products” substitute “ active substances ”;

(bb) for “at a European level” substitute “ and accepted in respect of the part of Great Britain to which the application relates ”;

(iii) in note (3)—

(aa) for “plant protection products” substitute “ active substances ”;

(bb) for “at European level” substitute “ and accepted in respect of the part of Great Britain to which the application relates ”;

(iv) after note (3) insert—

Fees for multiple import tolerances for the same active substance are calculated on a modular basis with a charge applied for each crop.

(6) After that paragraph insert—

(2) Fees chargeable by a Great Britain competent authority for standalone MRL applications are in accordance with the following table.

Item	Category	Fee (£)
1	Preliminary consideration of an application to determine whether the application can proceed further	229
2	Co-ordination of applications	1,872
3	Full human health description⁽¹⁾	16,224
4	Metabolism and residues evaluation⁽²⁾	6,760
5	Residues evaluation⁽³⁾	2,028

Notes (1) This category is mainly for active substances not currently approved in respect of the part of Great Britain to which the application relates. In certain cases it may also include active substances still being reviewed if toxicological endpoints have not yet been agreed and accepted in respect of that part of Great Britain. (2) This category is for active substances where toxicological endpoints have already been agreed and accepted in respect of the part of Great Britain to which the application relates but the residue definition has only been established for crop groups unrelated to the intended use. (3) This category is for active substances where relevant toxicological endpoints and residue definition have already been agreed and accepted in respect of the part of Great Britain to which the application relates. Fees for multiple standalone applications for the same active substance are calculated on a modular basis with a charge applied for each crop or combination of maximum residue levels.

16

After Schedule 2 insert—

SCHEDULE 3 Fees chargeable by a Great Britain competent authority for the evaluation of supplementary information provided in accordance with Article 14(3) of the MRL Regulation are in accordance with the following table.

Item	Category	Fee (£)
1	Preliminary consideration of application to determine whether the application can proceed further	229
2	Co-ordination of applications	1,872
3	Simple reasoned case⁽¹⁾	416
4	Analytical method⁽²⁾	416
5	Toxicology⁽³⁾	3,120
6	Metabolism and residues evaluation⁽⁴⁾	6,760
7	Residues evaluation⁽⁵⁾	2,028

Notes (1) This category is for an MRL supplementary information requirement to provide additional information on aspects of the data already evaluated or to provide evidence of the commercial availability of standards for MRL compliance. (2) This category is for an MRL supplementary information requirement to provide an analytical method for MRL compliance. (3) This category is for an MRL supplementary information requirement to address the toxicological relevance of a metabolite identified in plants or products of animal origin. (4) This category is for an MRL supplementary information requirement to address plant or livestock metabolism or any other nature of residue study. (5) This category is for an MRL supplementary information requirement to provide additional residue trials or any other magnitude of residue study including monitoring data. Fees for multiple submissions to address MRL supplementary information for the same active substance are calculated on a modular basis with a charge applied for each MRL supplementary information requirement. Large or novel studies to address MRL supplementary information requirements will incur an additional fee, as a multiple of the original fee, if significant extra work is required over and above the usual level for the module in question.

Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013

17

The Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013 are amended in accordance with paragraphs 18 to 29.

18

In regulation 4(1)—

(a) in the definition of “the Biocides Regulation”, for “Annexes I to IV” substitute “ Annexes II to IV ”;

(b) omit the definition of “the Commission”;

(d) after the definition of “devolved administration” insert—

“Devolved Authority” means— (a) the Scottish Ministers, or (b) the Welsh Ministers... (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .;

(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;

(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;

19

In regulation 6(1) omit “of Article 43”.

20

For regulation 7 substitute—

(7) (1) For the purposes of the PIC Regulation, the Designated National Authority is— (a) in England, Scotland and Wales, the Great Britain Executive; (b) in Northern Ireland, the Northern Ireland Executive. (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. (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.

21

In regulation 8—

(a) in paragraph (2) omit “or Member State”;

(b) for paragraph (4) substitute—

(4) The duties referred to in paragraph (3) are those contained in Articles 6(1), 7(1), 13(1) and (2)(b), 20(1), 26(1), 29(1), 31(1), 50(2), 54(1) and (2), 59(2), 62(1), 63(1), (2) and (3), 64(2), 71(3), 79, 93 and 95(1) of the Biocides Regulation.

22

In regulation 13—

(a) for paragraph (1) substitute—

(1) In this regulation, “essential use active substance” means an active substance in respect of which the Secretary of State or a Devolved Authority has granted a derogation for essential use under Article 22 of the Review Regulation.

(b) in paragraph (5)(c), for “Commission” substitute “ Secretary of State or Devolved Authority ”;

(c) in paragraph (6), for “Commission makes a decision or adopts a regulation” substitute “ Secretary of State or Devolved Authority issues a decision ”.

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);

(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)”;

(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”.

24

In regulation 17, for “Member State” substitute “ Secretary of State ”.

25

In regulation 21—

(a) for the heading, substitute “ Duties on the Designated National Authority and the Secretary of State ”;

(b) for “a designated national authority or the Member State” substitute “ the Designated National Authority or the Secretary of State ”.

26

In regulation 30(1)—

(a) in sub-paragraph (a), omit “or”;

(b) omit sub-paragraph (b).

27

In regulation 38 omit paragraph (2).

28

In Schedule 2—

(a) in paragraph 1, in the definition of “Plant protection product”, after “91/414/EEC” insert “ as it had effect immediately before exit day ”;

(b) after paragraph 10 insert—

(11) For the purposes of regulation 13 of these Regulations, essential use derogations granted by the Commission before exit day (under either Regulation 1062/2014 or its predecessor Regulation 1451/2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market) are deemed to have been granted by the Secretary of State subject to the same terms and conditions.

29

In Schedule 3, in paragraph 7, omit sub-paragraphs (c) and (d).

Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013

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Genetically Modified Organisms (Contained Use) Regulations 2014

40

(1) The Genetically Modified Organisms (Contained Use) Regulations 2014 are amended as follows.

(2) In regulation 3(2)—

(a) in sub-paragraph (a) omit paragraph (iii);

(b) in sub-paragraph (b), for paragraph (i) substitute—

(i) a medicinal product for veterinary use marketed in accordance with the Veterinary Medicines Regulations 2013 ;

(3) After regulation 33 insert—

(33A) (1) Subject to paragraphs (2) and (3), these Regulations do not apply to any activity which is covered by a written consent given by a competent authority of an EEA State in accordance with Article 15(3), 17(6) or 18(2) of Directive (EC) No 2001/18 of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms . (2) The written consent referred to in paragraph (1) must be valid immediately before IP completion day. (3) Any activity covered by the consent referred to in paragraph (1) must be conducted in accordance with any obligations, conditions or limitations attached to that consent. (4) Subject to paragraphs (5) and (6), these Regulations do not apply to any genetically modified organisms which are cultured, stored, transported, destroyed, disposed of or used, where such organisms are, or are contained in, a medicinal product for human or veterinary use marketed in accordance with an authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. (5) The marketing authorisation referred to in paragraph (4) must be valid immediately before IP completion day. (6) Any marketing authorisation referred to in paragraph (4) must be conducted in accordance with any obligations, conditions, restrictions, requirements or limitations attached to that authorisation.

(4) In Schedule 3, in paragraph 3 for sub-paragraph (d) substitute—

(d) consideration of relevant legislation, including legislation on the protection of workers from risks related to exposure to biological agents at work, other classification schemes referring to plant and animal pathogens, and other international and national classification schemes for genetically modified micro-organisms;

Control of Major Accident Hazards Regulations 2015

41

(1) The Control of Major Accident Hazards Regulations 2015 are amended as follows.

(2) In regulation 2(1), in the definition of “the CLP Regulation”, for “Annex VI, Part 3 Table 3.1” substitute “ the GB mandatory classification and labelling list established under Article 38A (which for the purposes of these Regulations is deemed to be part of Regulation (EC) No. 1272/2008) ”.

Explosives (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2015

42

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Biocidal Products (Fees and Charges) Regulations (Northern Ireland) 2015

43

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Control of Major Accident Hazards Regulations (Northern Ireland) 2015

44

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015

45

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Health and Safety and Nuclear (Fees) Regulations 2016

46

(1) The Health and Safety and Nuclear (Fees) Regulations 2016 are amended as follows.

(2) In regulation 21—

(a) omit paragraph (1);

(b) for paragraph (2) substitute—

(2) Each competent authority must charge fees for— (a) work it carries out within the scope of the Biocides Regulation which relates to the activities listed in column 1 of Schedule 15; (b) work it carries out in order to evaluate an application for a change to an authorised product under Regulation 354/2013; (c) work it carries out in order to determine an application to be a participant for the review of an active substance/product-type combination under Article 17 of Regulation 1062/2014; and (d) work it carries out in order to evaluate an application under regulation 13 of the 2013 Biocidal Products and Chemicals Regulations.

“Regulation 354/2013” means Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council; and “Regulation 1062/2014” 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.

(3) After regulation 21 insert—

(21A) (1) The Agency may charge fees for work it carries out within the scope of the CLP Regulation which relates to the activities listed in column 1 of Schedule 16. (2) Any fee payable under paragraph (1) must be calculated in accordance with paragraphs (3) to (9). (3) Where a fee is payable under paragraph (1), the Agency must prepare and send to the person referred to in column 2 of Schedule 16 (“the applicant”) an estimate of the fee, which will be at least £5000. (4) The applicant must pay the Agency the amount of that estimate within 30 days of its issue. (5) Upon completion of the work, the Agency must prepare a detailed statement of the work carried out and of the cost incurred by the Agency or any person acting on its behalf in carrying out that work. (6) If the cost referred to in paragraph (5) is greater than the amount estimated in accordance with paragraph (3), the Agency must notify the amount of the difference to the applicant who must pay the amount of the difference, which will be the final fee payable, without delay. (7) If the cost referred to in paragraph (5) is less than the amount estimated in accordance with paragraph (3), the fee must be adjusted accordingly and the amount of the difference must be paid without delay by the Agency to the applicant. (8) Subject to paragraph (9), in estimating or stating the cost of carrying out any work, the Agency must determine that cost by reference to the daily rate per person specified in column 3 of Schedule 16 that corresponds to the activity listed in column 1. (9) The daily rate per person must be adjusted pro rata for a period worked of less than 7.4 hours on any one day by— (a) dividing the daily rate by 14.8 to create a half-hourly rate; and (b) multiplying that figure by the number of half hours worked, rounded up or down to the nearest half hour. (10) Any unpaid fees may be recovered by the Agency as a civil debt. (11) For the purposes of this regulation and Schedule 16 “the 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. (12) Expressions used in the CLP Regulation which are also used in this regulation or Schedule 16 have the same meaning in these Regulations as they have in the CLP Regulation.

(4) In Schedule 15, for the table substitute—

1Activity	2Fee per person per day worked
(a) Validation of an application for approval of an active substance	£465
(b) Evaluation of an application to approve an active substance	£465
(c) Evaluation of an application to renew an active substance approval	£465
(d) Validation of an application to amend the conditions of approval of an active substance	£465
(e) Evaluation of an application to amend the conditions of approval of an active substance	£465
(f) Work relating to a request for inclusion of an active substance in the Simplified Active Substance List made on behalf of an economic operator	£465
(g) Validation of an application to amend the conditions of inclusion of an active substance in the Simplified Active Substance List	£465
(h) Evaluation of an application to amend the conditions of inclusion of an active substance in the Simplified Active Substance List	£465
(i) Meetings with applicants and prospective applicants	£465
(j) Evaluation of an application to authorise a biocidal product under the simplified procedure	£409
(k) Validation of an application for a national authorisation of a biocidal product	£409
(l) Evaluation of an application for a national authorisation of a biocidal product	£409
(m) Evaluation of an application to renew a national authorisation of a biocidal product	£409
(n) Determination of an application to amend an existing biocidal product authorisation	£409
(o) Evaluation of an application for an emergency use permit	£409
(p) Assessment of an application to be included in the list of suppliers maintained under Article 95 of the Biocides Regulation	£465
(q) Determination of a request that information on an active substance or product is not made publicly available	£465
(r) Determination of the classification of a proposed change to an authorised product in accordance with Regulation 354/2013	£409
(s) Determination of an application to be a participant for the review of an active substance/product-type combination under Article 17 of Regulation 1062/2014	£465
(t) Assessment of technical equivalence	£465
(u) Evaluation of an application under regulation 13 of the 2013 Biocidal Products and Chemicals Regulations	£409

(5) After Schedule 15 insert—

SCHEDULE 16

1Activity	2Person by whom fee is payable	3Fee
Consideration of a proposal submitted under sub paragraph (1) of paragraph 3 of Article 37A	Person submitting the application	£465

SCHEDULE 2 — AMENDMENTS TO RETAINED DIRECT EU LEGISLATION

Regulation (EC) No 1907/2006

1

Commission Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC is amended in accordance with paragraphs 2 to 11.

2

In Article 3, after paragraph 41 insert—

(42) GB mandatory classification and labelling list: the list of mandatory classification and labelling requirements of substances and groups of substances established and maintained in accordance with Article 38A of Regulation (EC) No 1272/2008. (43) GB notification database: the database established in accordance with Article 42 of Regulation (EC) No 1272/2008.

3

In Article 15, for paragraph 2 substitute—

(2) Active substances manufactured or imported for use in biocidal products only and included either in the GB List or the Simplified Active Substance List defined in Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products or Annex II of 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, subject to the transitional measures detailed in Article 89 of Regulation (EU) No 528/2012, shall be regarded as being registered and the registration as completed for manufacture or import for the use in a biocidal product and therefore as fulfilling the requirements of Chapters 1 and 5 of this Title.

4

In Article 59, in paragraphs 2 and 3, for “Part 3 of Annex VI to Regulation (EC) No 1272/2008” substitute “ the GB mandatory classification and labelling list ”.

5

In Annex I—

(a) in point 1.3.1, for “Part 3 of Annex VI to Regulation (EC) No 1272/2008” substitute “ the GB mandatory classification and labelling list ”;

(b) in point 3.2.1, for “Part 3 of Annex VI to Regulation (EC) No 1272/2008” substitute “ the GB mandatory classification and labelling list ”.

6

In Annex II—

(a) in point 3.2.1(a)(ii) and (iii), for “Part 3 of Annex VI to Regulation (EC) No 1272/2008” substitute “ the GB mandatory classification and labelling list ”;

(b) in point 3.2.1(a)(iv) and (vi), for “classification and labelling inventory” substitute “ GB notification database ”.

7

In Annex XVII—

(a) in entries 28 to 30 of the table (certain substances that are carcinogens, cell mutagens or toxic to reproduction)—

(i) for “Part 3 of Annex VI to Regulation (EC) No 1272/2008” wherever it occurs substitute “ the GB mandatory classification and labelling list ”;

(ii) omit “(Table 3.1)” and “(Table 3.2)” wherever they occur;

(b) in entry 40 of the table (certain flammable substances etc.), in the first column, for “Part 3 of Annex VI to Regulation (EC) No 1272/2008” substitute “ the GB mandatory classification and labelling list ”.

8

(1) The foreword to Appendices 1 to 6 is amended as follows.

(2) In the first paragraph of the section headed “substances”, for “Part 3 of Annex VI” to the end of the paragraph substitute “ the GB mandatory classification and labelling list ”.

(3) In the section headed “entries for groups of substances”—

(a) for “Part 3 of Annex VI to Regulation (EC) No 1272/2008” wherever it occurs substitute “ the GB mandatory classification and labelling list ”;

(b) in the second paragraph, for “elsewhere in Annex VI to Regulation (EC) No 1272/2008” substitute “ elsewhere in the GB mandatory classification and labelling list ”.

(4) In the section headed “Index number”, for “Part 3 of Annex VI to Regulation (EC) No 1272/2008” substitute “ the GB mandatory classification and labelling list ”.

(5) In Note A, for “Part 3 of Annex VI to that Regulation” substitute “ the GB mandatory classification and labelling list ”.

(6) In Note D, for “Part 3 of Annex VI to Regulation (EC) No 1272/2008” substitute “ the GB mandatory classification and labelling list ”.

9

In the heading of Appendix 1 omit “(Table 3.1)” and “(Table 3.2)”.

10

(1) Appendix 2 is amended as follows.

(2) In the heading omit “(Table 3.1)” and “(Table 3.2)”.

(3) In the entry for “chromium (VI) compounds”, for “Annex VI to Regulation (EC) No 1272/2008” substitute “ the GB mandatory classification and labelling list ”.

(4) In the entry for “benzidine based azo dyes”, for “Annex VI to Regulation (EC) No 1272/2008” substitute “ the GB mandatory classification and labelling list ”.

(5) In the entry for “o-Dianisidine based azo dyes”, for “Annex VI to Regulation (EC) No 1272/2008” substitute “ the GB mandatory classification and labelling list ”.

(6) In the entry for “o-Tolidine based dyes”, for “Annex VI to Regulation (EC) No 1272/2008” substitute “ the GB mandatory classification and labelling list ”.

11

In the headings of Appendices 3, 4, 5 and 6, omit “(Table 3.1)” and “(Table 3.2)”.

Regulation (EC) No 1272/2008

12

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 is amended in accordance with paragraphs 13 to 57.

13

(1) Article 1 is amended as follows.

(2) In paragraph 1—

(a) in the first sentence, omit “as well as the free movement of substances, mixtures and articles as referred to in Article 4(8)”;

(b) in point (a), for “harmonising” substitute “ establishing ”;

(c) in point (d), for “harmonised classifications and labelling elements at Community level in Part 3 of Annex VI” substitute “ mandatory classifications and labelling elements in the GB mandatory classification and labelling list ”;

(d) in point (e), for “classification and labelling inventory of substances, which is made up of all notifications, submissions and harmonised classification and labelling elements referred to in points (c) and (d)” substitute “ GB notification database of substances notified to the Agency after IP completion day ”.

(3) In paragraph 2—

(a) in point (a), for “Council Directive 96/29/Euratom of 13 May 1996” substitute “ the Ionising Radiations Regulations 2017 ... ”;

(b) in point (d), omit “Community”.

(4) In paragraph 3, for “Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006” substitute “ Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 ”.

(5) Omit paragraph 4.

(6) In paragraph 5—

(a) in point (a), for “Directive 2001/83/EC” substitute “ the Human Medicines Regulations 2012 ”;

(b) in point (b), for “Directive 2001/82/EC” substitute “ the Veterinary Medicines Regulations 2013 ”;

(c) in point (c), for “Directive 76/768/EEC” substitute “ Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products ”;

(d) for point (d), substitute—

(d) medical devices as defined in the Medical Devices Regulations 2002 which are invasive or used in direct physical contact with the human body, and in vitro diagnostic medical devices, as defined in the same regulations.

(e) in point (e)—

(i) in paragraph (i), for “Directive 89/107/EEC” substitute “ Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives ”;

(ii) in paragraph (ii), for “Directive 88/388/EEC and Decision 1999/217/EC” substitute “ Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods or Commission implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Regulation 1999/217/EC ”;

(iii) in paragraph (iv), for “Directive 82/471/EEC” substitute “ Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed ”.

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;

(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.

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”;

16

In Article 7, in paragraph 1, for “within the meaning of Directive 86/609/EEC” substitute “ to which the Animals (Scientific Procedures) Act 1986 applies ”.

17

In Article 10—

(a) in paragraph 3, for “harmonised” substitute “ mandatory ” and for “Part 3 of Annex VI” substitute “ the GB mandatory classification and labelling list ”;

(b) in paragraph 4—

(i) in the first subparagraph, for “harmonised” substitute “ mandatory ” and 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 ”;

18

In Article 15—

(a) in paragraph 4, for “harmonised” substitute “ mandatory ” and for “Part 3 of Annex VI” substitute “ the GB mandatory classification and labelling list ”;

(b) in paragraph 5, for “Directive 91/414/EEC or Directive 98/8/EC” substitute “ Regulation (EC) No 1107/2009 or Regulation (EC) No 528/2012 ”, and for “Directives” substitute “ Regulations ”.

19

Omit Article 16.

20

In Article 17, in paragraph 2—

(a) in the first subparagraph, for “the official language(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise” substitute “ English ”;

(b) in the second subparagraph, for “those required by the Member States” substitute “ English ”.

21

In Article 18, in paragraph 2—

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

(b) in point (b), for “Part 3 of Annex VI” substitute “ the GB mandatory classification and labelling list ” and for “classification and labelling inventory” substitute “ GB notification database ”;

(c) in point (c), for “Part 3 of Annex VI nor the classification and labelling inventory” substitute “ the GB mandatory classification and labelling list nor the GB notification database ”.

22

In Article 21, in paragraph 3, for “Part 3 of Annex VI” substitute “ the GB mandatory classification and labelling list ”.

23

In Article 24—

(a) in paragraph 2—

(i) for “referred to in Article 111 of Regulation (EC) No 1907/2006 and shall” substitute “ specified by the Agency. The Agency may require the request to ”;

(ii) omit the second subparagraph;

(b) for paragraph 4, substitute—

(4) If the Agency does not accept the request, the manufacturer, importer or downstream user may ask the Agency to review its decision.

(d) in paragraph 6, for “practical arrangements referred to in Article 118(3) of Regulation (EC) No 1907/2006 shall apply”, substitute “ manufacturer, importer or downstream user may ask the Agency to review the withdrawal or amendment. ”

24

In Article 25—

(a) in paragraph 1, in the third subparagraph, for “Part 3 of Annex VI” substitute “ the GB mandatory classification and labelling list ”;

(b) in paragraph 2, in the first subparagraph, for “Directive 91/414/EEC” substitute “ Regulation (EC) No 1107/2009 ”.

25

In Article 26, in paragraph 2, in the second subparagraph, for “Part 3 of Annex VI” substitute “ the GB mandatory classification and labelling list ”.

26

In Article 29—

(a) in paragraph 1, omit “in the languages of the Member State in which the substance or mixture is placed on the market”;

(b) in paragraph 5, for “Commission” substitute “ Secretary of State or a Devolved Authority ”.

27

In Article 30, in paragraph 3—

(a) for “Directives 91/414/EEC or 98/8/EC” substitute “ Regulation (EC) No 1107/2009 or Regulation (EC) No 528/2012 ”;

(b) for “Directives” substitute “ Regulations ”.

28

In Article 32—

(a) in paragraphs 2 and 3, after “language” in each place it occurs, insert “ ,where languages other than English are used ”;

(b) in paragraph 6, for “Community Acts” substitute “ retained EU law ”.

29

Omit Article 34.

30

For the heading of Title V substitute “ MANDATORY CLASSIFICATION AND LABELLING OF SUBSTANCES AND THE GB NOTIFICATION DATABASE ”.

31

For the heading of Chapter 1 in Title V substitute “ Establishing mandatory classification of substances ”.

32

In Article 36—

(a) in the heading, for “Harmonisation of” substitute “ Mandatory ”.

(b) in paragraph 1—

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

(ii) after “Article 37” insert “ or Article 37A ”;

(i) for “Directive 91/414/EEC or Directive 98/8/EC” substitute “ Regulation (EC) No 1107/2009 or Regulation (EC) No 528/2012 ”;

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

(iii) after “Article 37” insert “ or Article 37A ”;

(iv) omit “paragraphs 1, 4, 5 and 6”;

(d) in paragraph 3—

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

(ii) after “classification and labelling”, insert “ requirement ”;

(iii) after “Article 37” insert “ or Article 37A ”;

(iv) for “Annex VI”, substitute “ the GB mandatory classification and labelling list ”;

(v) omit “at Community level”.

33

For Article 37 substitute—

(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.

34

After Article 37 insert—

(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.

35

In Article 38—

(a) in the heading, for “harmonised” substitute “ mandatory ” and for “Part 3 of Annex VI” substitute “ the GB mandatory classification and labelling list ”;

(b) before paragraph 1, insert a new paragraph—

(A1) Any opinion of the Agency referred to in Article 37 must specify the reasons for the opinion.

(c) in paragraph 1, for “referred to in Article 37(4) and any decision according to Article 37(5)” substitute “ of the Agency referred to in Article 37A ”;

(d) for paragraph 2, substitute—

(2) When making publicly available an opinion or a decision as referred to in Article 37 or Article 37A, the Agency must not publish any information in relation to which paragraph 3 applies.

(e) after paragraph 2, insert—

(3) This paragraph applies to information which has been made available to the Agency in relation to which a person has submitted a justification, accepted by the Agency as valid, as to why publication of the information is potentially harmful to the commercial interests of that person or any other person.

36

After Article 38, insert—

The Agency must establish, maintain and publish electronically a list (to be called “the GB mandatory classification and labelling list”) of all the mandatory classifications and accompanying labelling requirements made by the Secretary of State in accordance with Article 37 and Article 37A.

37

For the heading to Chapter 2 substitute “ GB notification database ”.

38

In Article 39 in point (b), omit “or Directive 1999/45/EC”.

39

In Article 40, in paragraph 1—

(a) in the first subparagraph, for “inventory” substitute “ GB notification database ”;

(b) in the second subparagraph, in the first sentence, after “notifier” insert “ or has been notified before IP completion day to the European Chemicals Agency under Article 40 of Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures. ”;

(c) in the third subparagraph, for “pursuant to Article 111 of Regulation (EC) No 1907/2006, substitute “ by the Agency ”.

40

In Article 41, for “inventory” in both places it occurs, substitute “ GB notification database ”.

41

In Article 42—

(a) in the heading, for “classification and labelling inventory” substitute “ GB notification database ”;

(b) in paragraph 1—

(i) in the first subparagraph, for “a classification and labelling inventory in the form of a database” substitute “ a database, (to be called “the GB notification database”) ”;

(ii) in the second subparagraph, for “inventory, as well as information submitted as part of registrations under Regulation (EC) No 1907/2006”, substitute “ GB notification database ”;

(iii) for the third subparagraph, substitute—

Information in the GB notification database which corresponds to the information referred to in Article 38(1) is to be made publicly accessible by the Agency except where Article 38(3) applies to that information.

(d) in paragraph 3, in the first subparagraph—

(i) for point (a), substitute—

(a) whether in respect of the entry, there is mandatory classification and labelling by inclusion in the GB mandatory classification and labelling list;

(ii) omit points (b), (c) and (d);

(e) in paragraph 3, in the second subparagraph, for “37(5)” substitute “ 37(4)(b) and Article 37A(8) ”.

42

For the heading to Title VI, substitute “ HELPDESK AND APPOINTMENT OF BODIES ”.

43

Omit Article 43.

44

In Article 44, for “Member States shall establish national helpdesks” substitute “ The Agency must establish a helpdesk ”.

45

In Article 45—

(a) in paragraph 1, for “Member States” substitute “ The Secretary of State in relation to England, and the Devolved Authorities in relation to their respective countries ”;

(b) after paragraph 1, insert—

(1A) The Secretary of State may carry out the function set out in paragraph 1 in relation to Scotland or Wales, if the Devolved Authority in question has consented to the Secretary of State exercising that function.

(c) in paragraph 2, in point (b), for “Member State” substitute “ Secretary of State or the relevant Devolved Authority ”;

(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.

46

Omit Articles 46 and 47.

47

In Article 48, in paragraph 2, in the second subparagraph, for “Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997” substitute “ the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013 ”.

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.

49

In Article 50—

(a) omit paragraph 1;

(b) in paragraph 2—

(i) omit “Secretariat of the”;

(ii) in point (b), for “helpdesks” substitute “ helpdesk ” and omit “by Member States”.

50

Omit Article 51.

51

For Article 52 substitute—

(1) The Secretary of State or a Devolved Authority may take appropriate provisional measures in respect of a substance or mixture if they— (a) have justifiable grounds for believing that the substance or mixture, although satisfying the requirements of this Regulation, constitutes a serious risk to human health or the environment due to reasons of classification, labelling or packaging; and (b) have competence to take the provisional measures, within the meaning of paragraphs 6 to 8. (2) A provisional measure taken by a Devolved Authority applies only in relation to the territory in relation to which it has competence. (3) Where the Secretary of State takes a provisional measure, the Secretary of State must immediately inform the Devolved Authorities, giving the reasons for the decision. Where a Devolved Authority takes a provisional measure, it must immediately inform the other Devolved Authorities and the Secretary of State, giving the reasons for the decision. (4) Within 90 days of a provisional measure being taken— (a) in the case of a provisional measure relating to classification or labelling of a substance— (i) where the Secretary of State took the measure, the Secretary of State must request the Agency to produce a proposal for a new or revised mandatory classification and labelling requirement under Article 37A(2), (ii) where a Devolved Authority took the measure, the Competent Authority for that country must request the Agency to produce a proposal for a new or revised mandatory classification and labelling requirement under Article 37A(2); (b) in the case of a provisional measure that falls within the scope of Article 53— (i) where the Secretary of State took the measure, the Secretary of State must decide whether or not to make the measure permanent by making regulations under Article 53, (ii) where a Devolved Authority took the measure, it must decide whether or not to request the Secretary of State to make the measure permanent by making regulations under Article 53. (5) The taker of the provisional measure must revoke that measure, when— (a) in the case of a provisional measure relating to the classification or labelling of a substance, the Secretary of State makes a decision under Article 37A; (b) in the case of a provisional measure that falls within the scope of Article 53— (i) where paragraph 4(b)(i) of this Article applies, the Secretary of State either decides not to make the measure permanent or makes regulations under Article 53 to make the measure permanent, or (ii) where paragraph 4(b)(ii) of this Article applies, the Devolved Authority decides not to request the Secretary of State to make the measure permanent. (6) The Secretary of State has competence to take a provisional measure if, or to the extent that, the exercise of the function to take that measure— (a) relates to England; (b) relates to Scotland and is not within devolved competence (within the meaning of section 54 of the Scotland Act 1998 ); (c) relates to Wales and is not within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006 ) ... (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (7) The Scottish Ministers have competence to take a provisional measure if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 54 of the Scotland Act 1998). (8) The Welsh Ministers have competence to take a provisional measure if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006). (9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

52

In Article 53—

(a) for “Commission may” substitute “ Secretary of State may by regulations ”;

(b) omit the second and third sentences.

53

After Article 53, insert—

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