Citation, commencement, extent and interpretation

1.—(1) These Regulations may be cited as the Chemicals (Health and Safety) (Amendment, Consequential and Transitional Provision) Regulations 2026 and come into force on the 21st day after the day on which they are made.

(2) These Regulations extend to England and Wales and Scotland.

(3) In these Regulations—

“ GB BPR ” means of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products( Regulation (EU) No 528/2012 3 );

“ GB CLP ” 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/EC , and amending Regulation (EC) No 1907/2006 ( 4 );

“ GB PIC ” means of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (recast)( Regulation (EU) No 649/2012 5 ).

Revocations, replacements and alternative provision

2. The Schedule makes provision for revocation, replacement and the making of alternative provision, and consequential amendments, in respect of provisions of—

(a)GB CLP (Part 1 of the Schedule);

(b)GB BPR (Part 2 of the Schedule);

(c)GB PIC (Part 3 of the Schedule).

Transitional provision

3.—(1) The changes made by paragraphs 1(7) to (10) and 3 of the Schedule do not apply in relation to—

(a)an opinion referred to in paragraph 1 of Article 37 of GB CLP as that Article was in force immediately before commencement day and which was published by the Committee for Risk Assessment of the European Chemicals Agency before commencement day;

(b)a proposal referred to in paragraph 2 or 3 of Article 37A of GB CLP as that Article was in force immediately before commencement day and which was received by or produced by the Agency(6) before commencement day.

(2) In this regulation, “ commencement day ” means the day on which these Regulations come into force.

Regulation 2

SCHEDULE

PART 1 Provision in respect of GB CLP

1.—(1) GB CLP is amended as follows.

(2) In Article 1, paragraph 1 (purpose), omit subparagraph (e).

(3) In Article 2 (definitions), omit paragraph 39.

(4) In Article 10 (concentration limits and M-factors in the GB notification database), omit paragraph 5.

(5) In Article 18, paragraph 2 (product identifiers)—

(a)omit subparagraph (b);

(b) in subparagraph (c), omit “nor the GB notification database”.

(6) In the heading to Title V, omit “and the GB notification database”.

(7) In Article 36 (mandatory classification and labelling of substances) , in paragraphs 1, 2 and 3, omit “or Article 37A”.

(8) For Articles 37 and 37A substitute—

Article 37 Procedure for mandatory classification and labelling

1. This Article applies in relation to a substance(7) which is the subject of a proposal for a new or revised classification and labelling requirement and, where appropriate, specific concentration limits(8) or M-factors(9).

2. In this Article—

“fast-track proposal” means a proposal from a territory (including the European Union) or state authority which in the opinion of the Agency(10)—

“GHS” means the United Nations Globally Harmonised System of Classification and Labelling of Chemicals, as revised from time to time(11);

“proposal” means a proposal referred to in paragraph 1;

“state authority” means an authority or organisation which acts for a territory;

“work plan” means the plan published and maintained by the Agency in accordance with paragraph 3.

3. The Agency must publish, keep under review and in the event of change publish an updated version of a work plan for its evaluation of proposals, and must identify any fast-track proposals for inclusion in the work plan, having particular regard to the provisions of Article 36. The Agency must consult the Devolved Authorities(12) when—

(a)producing;

(b)reviewing;

(c)making any material changes to,

the work plan.

4. Paragraph 5 of this Article applies to fast-track proposals, and paragraphs 6 to 9 apply to other proposals.

5. In respect of each fast-track proposal—

(a)the Agency must publish a technical report on the proposal in accordance with the Agency’s work plan;

(b)where the Agency considers that it is appropriate to recommend that a new or revised mandatory classification and labelling requirement is imposed, the Agency must within 12 months of the publication by the Agency of the technical report submit a recommendation to the Secretary of State concerning the proposal;

(c)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);

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

(e)within 1 month of the Secretary of State notifying the Agency of a decision in accordance with subparagraph (c)(iv), the Agency must update the GB mandatory classification and labelling list(13) accordingly, making clear the date from when any new or revised classification and labelling requirement must be complied with.

6. Proposals referred to in this paragraph are not fast-track proposals, and a proposal under subparagraph (a) or (b) must comply with the requirements specified in paragraph 8—

(a)a proposal may be produced by the Agency or submitted to the Agency by a competent authority(14);

(b)subject to paragraph 7, a manufacturer(15), importer(16) or downstream user(17) of a substance may submit a proposal in relation to a substance to the Agency 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;

(c)subject to paragraph 7, a manufacturer, importer or downstream user of a substance 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.

7. Paragraph 6(b) and (c) does not apply to manufacturers, importers or downstream users of substances established in Northern Ireland who supply qualifying Northern Ireland goods directly to Great Britain.

8. A proposal—

(a)under paragraph 6(a) or (b) 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;

(b)under paragraph 6(b) which concerns the mandatory classification and labelling of a substance in accordance with Article 36(3) must additionally be accompanied by the relevant fee as determined by the Agency.

9. For each proposal which is not a fast-track proposal—

(a)within 12 months of the proposal being received 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;

(b)within 6 months of publishing the technical report (which may in exceptional circumstances be extended to 12 months), the Agency must publish an opinion on the proposal;

(c)where the Agency considers that it is appropriate to recommend that a new or revised mandatory classification and labelling requirement is imposed, the Agency must within 12 months of the opinion being published submit a recommendation to the Secretary of State to give effect to the opinion;

(d)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 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);

(e)the Secretary of State’s functions under subparagraph (d)(i) and (iii) are subject to the consent requirement in Article 53B;

(f)within one month of the Secretary of State notifying the Agency of a decision in accordance with subparagraph (d)(iv), 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.”.

(9) In Article 38 (content of opinions and decisions for mandatory classification and labelling)—

(a)omit paragraph A1;

(b) in paragraph 1, for “Article 37A” substitute “Article 37 must specify the reasons for the opinion, and” ;

(c) in paragraph 2, omit “or Article 37A”.

(10) In Article 38A, omit “and Article 37A”.

(11) Omit Chapter 2 (GB notification database) of Title V.

(12) In Annex I (classification and labelling requirements), in point 1.1.2.2.2 (cut-off values)—

(a)in paragraph (a)—

(i) in subparagraph (i), omit “either” and “or in the GB notification database referred to in Article 42”;

(ii)in subparagraph (ii)—

(aa) omit “either” in both places where it occurs;

(bb) omit “or in the GB notification database referred to in Article 42”; and

(cc) omit “or in the GB notification database” where those words appear for the second time;

(iii) in subparagraph (iii), omit “either” and “or in the GB notification database referred to in Article 42”;

(iv) in subparagraph (iv), omit “either” and “or in the GB notification database referred to in Article 42”;

(b)in paragraph (b)—

(i) in subparagraph (i), omit “either” and “or in the GB notification database referred to in Article 42”;

(ii) in subparagraph (ii), omit “either” and “or in the GB notification database referred to in Article 42”.

(13) In Annex VI (mandatory classification and labelling for certain hazardous substances)—

(a)in Table 1.1, omit footnote (a);

(b)omit points 1.1.3 to 1.1.3.2 (technical notes on entries).

2.—(1) 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 and repealing Directive 1999/45/EC and Council Regulation (EEC) No 793/93 as well as Council Directive Commission Regulation (EC) No 1488/9476/769/EEC and Commission Directives 91/155/ EEC, 93/67/EEC, 93/105/EC and 2000/21/EC(18) is amended as follows.

(2) In Article 3 (definitions), omit paragraph 43.

(3) In Annex II (requirements for compilation of safety data sheets), point 3.2.1, paragraph (a), omit subparagraphs (iv) and (vi).

3.—(1) The Health and Safety and Nuclear (Fees) Regulations 2022(19) are amended as follows.

(2) In Schedule 16 (fees under GB CLP) , for “sub paragraph (1) of paragraph 3 of Article 37A” substitute “subparagraph (b) of paragraph 6 of Article 37” .

PART 2 Provision in respect of GB BPR

4.—(1) GB BPR is amended as follows.

(2) In Article 14 (evaluation of applications for renewal), for paragraph 5 substitute—

“5. Where, for reasons beyond the control of the applicant, the approval of the active substance(20) is likely to expire before a decision has been taken on its renewal the Secretary of State shall issue a decision postponing the expiry date of approval for a period sufficient to enable the competent authority to examine the application.

By way of derogation from the preceding provisions of this paragraph and from Articles 4(1), 10(4) and 12(3), where—

(a)the expiry date of the approval of any active substance falls on or after 23 June 2026 but no later than 30 July 2031; and

(b)an application for renewal of that approval, made in accordance with Article 13, has been received,

the expiry date of that approval will automatically be 31 July 2031 without the need for a decision; but if before 31 July 2031 the Secretary of State issues a decision on that approval, the expiry date shall instead be that specified in that decision.”.

(3) In Article 55 (derogation from requirements), for paragraph 1 substitute—

“1. By way of derogation from Articles 17 and 19, the competent authority may permit, for a period not exceeding 180 days, the making available on the market(21) or use(22) of a biocidal product(23) that does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use under the supervision of the competent authority, if such a measure is necessary because of a danger to public health, animal health or the environment that cannot be contained by other means. On receipt of a reasoned request from the competent authority, the Secretary of State or a Devolved Authority(24) shall issue a decision, with or without conditions, on whether the action taken may be extended—

(a)in any case, for a period not exceeding 550 days; or

(b)where the continued need for use of the biocidal product is not likely to be temporary, until the biocidal product is authorised,

if they have competence to exercise the derogation within the meaning in paragraphs 4 to 7.

1A. A decision under paragraph 1(b) extending the action taken until the biocidal product is authorised may specify deadlines by which applications to approve the active substances that the biocidal product contains, consists of or generates, or to authorise the biocidal product, must be submitted.

1B. The competent authority may cancel the derogation at any time if—

(a)no applications to approve the active substances that the biocidal product contains, consists of or generates, or to authorise the biocidal product, are received by any deadline specified under paragraph 1A for such an application;

(b)any application received is rejected by the competent authority;

(c)a non-approval decision is taken on any active substance that the biocidal product contains, consists of or generates;

(d)a decision is taken not to authorise the biocidal product;

(e)the criteria for exercising the derogation are no longer met;

(f)there is any other reason which appears to the competent authority to make cancellation necessary or appropriate.

1C. If a derogation is cancelled in accordance with paragraph 1B, the competent authority may grant a period of grace not exceeding—

(a)180 days for making the biocidal product available on the market; and

(b)an additional 180 days for the use of existing stocks of the biocidal product.

1D. Where a decision was issued by the Secretary of State or a Devolved Authority under paragraph 1 before 23 June 2026 extending the action taken for a period extending beyond that date, the Secretary of State or Devolved Authority may further extend the action taken in accordance with paragraph 1(b) and with paragraph 1A, provided that—

(a)the original period of extension has not yet expired; and

(b)the criteria for exercising the derogation and any conditions for its validity continue to be fulfilled.”.

(4) In Article 60 (data protection periods), for paragraph 2 substitute—

“2. The protection period for data submitted with a view to the approval of an existing active substance shall end 10 years from the first day of the month following the date of adoption of a decision in accordance with Article 9(1), Article 28(1) or Article 89(5), or where relevant with Article 9(1), Article 28(1), Article 89(1) or Article 90(2) of 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(25) as it had effect immediately before IP completion day, on the approval of the relevant active substance for the particular product-type.

The protection period for data submitted with a view to the approval of a new active substance shall end 15 years from the first day of the month following the date of adoption of a decision in accordance with Article 9(1) or Article 28(1), or where relevant with Article 9(1), Article 28(1) or Article 90(2) of 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 as it had effect immediately before IP completion day, on the approval of the relevant active substance for the particular product-type.

The protection period for new data submitted with a view to the renewal or review of the approval of an active substance shall end five years from the first day of the month following the date of the adoption of a decision in accordance with Article 14(4) or Article 15(3) concerning the renewal or the review.”.

PART 3 Provision in respect of GB PIC

5.—(1) GB PIC is amended as follows.

(2) In Article 2 (scope), in paragraph 3, omit the second subparagraph (beginning “Notwithstanding”).

(3) In Article 7 (chemicals to be included in the GB PIC list)—

(a) in the heading, for “Regulation (EC) No. 850/2004 ” substitute “ Regulation (EU) 2019/1021 ” ( 26 );

(b) in paragraphs 1 and 2, for “Secretary of State” substitute “Designated National Authority” ( 27 );

(c) in subparagraph d of paragraph 1 and in subparagraph d of paragraph 2, for “Regulation (EC) No. 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants” substitute “ Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants” .

(4) In Article 14 (obligations in respect of export of chemicals), in paragraph 7—

(a) in the first subparagraph, omit “, subject to the second subparagraph,”;

(b) omit the final two subparagraphs (respectively beginning “In the case of chemicals listed in Part 3” and “When deciding on”).

(5) In Article 19 (further obligations of exporters), omit paragraph 2.

(6) In Article 23 (updating the GB PIC list)—

(a)in paragraph 1—

(i) for “Secretary of State” substitute “Designated National Authority” ;

(ii) for “the GB PIC list” substitute “Parts 1 to 3 of the GB PIC list” ;

(b) in paragraphs 3 and 5, for “Secretary of State” substitute “Designated National Authority” .