The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019

• Citation: S.I. 2019/758
• Sections: 206

Section 1 Citation, commencement , interpretation and extent

(1) These Regulations may be cited as the REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 and come into force on exit day.

(2) In these Regulations, “ the REACH Regulation ” means Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency.

(3) Regulation 12 and Schedule 10 extend to England and Wales and Scotland.

(4) In Schedule 11—

(a) paragraph 2 extends to England and Wales and Scotland;

(b) paragraph 2A extends to Northern Ireland.

Section 2 Amendment of the REACH Regulation

The REACH Regulation is amended in accordance with regulations 3 to 5.

Section 3 Amendment of Titles 1 to 15

Titles 1 to 15 are amended in accordance with Schedule 1.

Section 4 Transitional provision

The transitional provision in Schedule 2 has effect.

Section 4A Imports from Northern Ireland

The provision in Schedule 2A in respect of imports from Northern Ireland has effect.

Section 5 Amendment of Annexes and Appendices

The Annexes and Appendices are amended in accordance with Schedule 3.

Section 6 Amendment of the Test Methods Regulation

Commission Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is amended in accordance with Schedule 4.

Section 7 Amendment of the Data Regulation

Commission Implementing Regulation (EU) 2016/9 on joint submission of data and data-sharing in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is amended in accordance with Schedule 5.

Section 8 Amendment of the Fees and Charges Regulation

Commission Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is amended in accordance with Schedule 6.

Section 9 Amendment of an authorisation under Article 60(4) of the REACH Regulation

An authorisation under Article 60(4) of the REACH Regulation is amended in accordance with Schedule 7.

Section 10 Revocation of direct retained EU legislation

The Commission Regulations and Commission Decision referred to in Schedule 8 are revoked.

Section 11 Amendment of the EEA agreement

The EEA agreement is amended in accordance with Schedule 9.

Section 12 Amendment of the REACH Enforcement Regulations 2008

The REACH Enforcement Regulations 2008 are amended in accordance with Schedule 10.

Section 13 Amendment and revocation of subordinate legislation

The subordinate legislation referred to in Schedule 11 is amended or revoked as specified.

Section 1 Chapter 1 of Title 1

In Article 1(1), omit “on the internal market”.

Section 2 Chapter 1 of Title 1

(1) Article 2 is amended as follows.

(2) In paragraph 1(a), for “Council Directive 96/29/Euratom” to the end of the point substitute “ retained EU law that transposed Council Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation ; ” .

(3) In paragraph 2, for “Directive 2006/12/EC ” substitute “ Article 3(1) of Directive 2008/98/EC ” .

(4) After paragraph 2, insert—

(2A) For the purposes of this Regulation, “ Directive 2008/98/EC ” means that Directive as last amended by Directive (EU) 2018/851 , and read in accordance with paragraphs 2B and 2C.

(2B) Article 5 is to be read as if—

(a) in paragraph 1, “Member States shall take appropriate measures to ensure that” were omitted;

(b) after paragraph 1 there were inserted—

(1A) Any decision as to whether a substance or object is a by-product must be made—

(a) in accordance with any regulations setting out detailed criteria on the application of the conditions in paragraph 1 to specific substances or objects; and

(b) having regard to any guidance published by the appropriate authority or the appropriate agency for the purposes of this Article.

(c) paragraphs 2 and 3 were omitted.

(2C) Article 6 is to be read as if—

(a) in paragraph 1, “Member States shall take appropriate measures to ensure that” were omitted;

(b) after paragraph 1 there were inserted—

(1A) Any decision as to whether a substance or object has ceased to be waste must be made—

(a) in accordance with any regulations or retained direct EU legislation setting out detailed criteria on the application of the conditions in paragraph 1 to specific types of waste; and

(b) having regard to any guidance published by the appropriate authority or the appropriate agency for the purposes of this Article.

(c) in paragraph 2—

(i) the first subparagraph were omitted;

(ii) in the second subparagraph, for “Those detailed criteria” there were substituted “Any detailed criteria set out in guidance as referred to in paragraph 1A”;

(iii) the third and fourth subparagraphs were omitted;

(d) paragraph 3 were omitted;

(e) in paragraph 4—

(i) in the first subparagraph—

(aa) in the first sentence, for the words from the beginning to “Member State”, there were substituted “Where criteria have not been set out as referred to in paragraph 1A(a), the appropriate agency”;

(bb) the second sentence were omitted;

(ii) in the second subparagraph—

(aa) for “Member States” there were substituted “The appropriate agency”;

(bb) “by competent authorities” were omitted.

(2D) In paragraphs 2B and 2C, “appropriate agency” means—

(a) the Environment Agency, in relation to England;

(b) the Natural Resources Body for Wales, in relation to Wales;

(c) the Scottish Environment Protection Agency, in relation to Scotland.

(5) In paragraph 3, for “Member States” substitute “ The Secretary of State ” .

(6) Omit paragraph 4.

(7) In paragraph 5—

(a) for point (a) substitute—

(a) in medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013 , or the Human Medicines Regulations 2012 ;

(b) for point (b)(i) substitute—

(i) as a food additive in foodstuffs as defined by Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;

(c) for point (b)(ii) substitute—

(ii) as a flavouring in foodstuffs within the scope of Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods or Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No 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;

(d) for point (b)(iv) substitute—

(iv) in animal nutrition within the scope of Article 2(1) of Regulation (EC) No 767/2009 .

(8) In paragraph 6—

(a) for point (a) substitute—

(a) medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013, or the Human Medicines Regulations 2012;

(b) for point (b) substitute—

(b) cosmetic products as defined in Regulation (EC) No 1223/2009 on cosmetic products;

(c) for point (c) substitute—

(c) medical devices which are invasive or used in direct physical contact with the human body in so far as legislation relating to the classification and labelling of dangerous substances and mixtures applies to them which ensures the same level of information provision and protection as Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures;

(d) for point (d)(i) and (ii) substitute—

(i) as a food additive in foodstuffs as defined by Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;

(ii) as a flavouring in foodstuffs within the scope of Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods or Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No 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;

(e) for point (d)(iv) substitute—

(iv) in animal nutrition within the scope of Article 2(1) of Regulation (EC) No 767/2009 .

(9) In paragraph 7(c)—

(a) for “from the Community” substitute “ from Great Britain ” ;

(b) for “into the Community” substitute “ into Great Britain ” .

(10) In paragraph 7(d), for “ the Community ” substitute “ Great Britain ” .

Section 3 Chapter 2 of Title 1

In Chapter 2 of Title 1, before Article 3 insert—

The Agency

(1) The functions and powers of the Agency under the REACH legislation are to be functions and powers of the HSE.

Accordingly, any reference to the Agency in the REACH legislation must be read as meaning the HSE.

(2) The general incidental powers of the HSE are to be exercisable for the purpose of carrying out the functions of the Agency under the REACH legislation.

But that does not limit the powers which the HSE has under the REACH legislation.

(3) The non-REACH functions of the HSE are not limited by the functions of the Agency under the REACH legislation.

Accordingly, the HSE is not prevented from carrying out non-REACH functions in relation to a matter just because any of the functions of the Agency under the REACH legislation is also exercisable, or has been exercised, in relation to that matter.

(4) The power of the Secretary of State under section 12(2)(a) of HASWA 1974 to give directions (as read with section 12(4) of HASWA 1974) is to be exercisable with respect to the functions of the Agency under the REACH legislation.

The Secretary of State may not give any such directions with regard to the enforcement of the REACH legislation in any particular case.

The Secretary of State must consider any request made by any of the other appropriate authorities for the Secretary of State to give a direction by virtue of this paragraph.

The function of giving directions by virtue of this section is subject to the consent requirement in Article 4A (whether or not there has been a request under the previous subparagraph).

(5) In this Article—“ general incidental powers ” means the powers which the HSE has under—

(a) section 13 of HASWA 1974, and

(b) Schedule 2 to HASWA 1974;

“ HASWA 1974 ” means the Health and Safety at Work etc. Act 1974 ;“ HSE ” means the Health and Safety Executive;“ non-REACH function ” means any function which arises otherwise than under the REACH legislation;“ REACH legislation ” means—

(a) this Regulation,

(b) any instrument made under this Regulation, and

(c) any retained direct EU legislation that was originally made under EU REACH.

Advice from Environment Agency or other environmental regulators to Agency

(1) The Agency must comply with paragraph 2 when exercising—

(a) its functions under—

(i) Article 7(5),

(ii) Article 9(4), (7) and (8),

(iii) Article 21,

(iv) Articles 40(1) and (3), 41(1), (3) and (5), 42(1), 43, 44, 45, 46(1) and (3), 48, 49, 51 and 52,

(v) Articles 58(3) and (4) and 59(1), (2), (3), (6) and (7),

(vi) Article 64(1), (3), (4), (5) and (6),

(vii) Articles 69, 70 and 71, and

(b) any of its other functions under this Regulation,

if, and to the extent that, the exercise of the function involves consideration of any relevant environmental issues.

(2) The Agency must—

(a) obtain the advice of the Environment Agency before exercising the function concerned, and

(b) use the advice obtained when exercising the function concerned.

(3) Whenever the advice of the Environment Agency is sought by the Agency under this Article, the Environment Agency must collaborate with the other environmental regulators when formulating the advice.

(4) If, as part of a collaboration under paragraph 3, one of the other environmental regulators gives advice to the Environment Agency, the Environment Agency must pass that advice on to the Agency if that other environmental regulator requires it to do so.

(5) In this Article—“ other environmental regulator ” means—

(a) in relation to Wales, the Natural Resources Body for Wales;

(b) in relation to Scotland, the Scottish Environment Protection Agency;

(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“ relevant environmental issue ” means—

(a) exposure of the environment to chemicals;

(b) exposure of humans to chemicals in the environment;

(c) assessment of the potential effect of chemicals on the environment;

(d) measures aimed at controlling the release of chemicals into the environment.

Section 4 Chapter 2 of Title 1

(1) Article 3 is amended as follows.

(2) Before paragraph 1 insert—

(A1) EU REACH: means Regulation (EC) No 1907/2006 of the European Parliament and of the Council as it has effect in EU law;

(A2) appropriate authority: means—

(a) the Secretary of State, in relation to England;

(b) the Scottish Ministers, in relation to Scotland;

(c) the Welsh Ministers, in relation to Wales;

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

. . .

(3) In paragraph 4, for “ the Community ” substitute “ Great Britain ” .

(4) In paragraph 9, for “ the Community ”, in both places it occurs, substitute “ Great Britain ” .

(5) In paragraph 10, for “ the customs territory of the Community” substitute “ Great Britain ” .

(5A) After paragraph 10, insert—

(10A) protected NI import: has the meaning given by Article 139A(2);

(10B) qualifying Northern Ireland good: has the meaning given to it from time to time in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.

(6) In paragraphs 11, 13 and 14, for “ the Community ” substitute “ Great Britain ” .

(7) For paragraph 18 substitute—

(18) Agency: see Article 2A;

(18A) ECHA: means the European Chemicals Agency established under EU REACH;

(8) Omit paragraph 19.

(9) In paragraph 20, in points (b) and (c)—

(a) for “Community” substitute “European Community” ;

(b) for “the entry into force of this Regulation” substitute “1 June 2007” .

(10) In paragraph 21, for “has been” substitute “was” .

(11) In paragraph 36, at the end insert—

and, in its application for the purposes of this paragraph, the Annex to that Recommendation has effect with the following modifications—

(a) in Article 2(1)—

(i) the reference to EUR 50 million has effect as a reference to £43.650 million;

(ii) the reference to EUR 43 million has effect as a reference to £37.539 million;

(b) in Article 2(2) the reference to EUR 10 million has effect as a reference to £8.730 million;

(c) in Article 2(3) the reference to EUR 2 million has effect as a reference to £1.746 million;

(d) in Article 3(2)—

(i) in point (a), the reference to EUR 1,250,000 has effect as a reference to £1,091,250;

(ii) in point (d), the reference to EUR 10 million has effect as a reference to £8.730 million.

Section 5

After Article 4 insert—

The consent requirement

(1) Where any provision of this Regulation states that a function is subject to the consent requirement in this Article, the function may be exercised in a particular instance only if the person exercising it has obtained the consent or consents (if any) required by paragraphs 2 to 4.

(2) The consent of the Scottish Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 54 of the Scotland Act 1998 ), whether or not the exercise of the function also relates to a part of Great Britain other than Scotland.

(3) The consent of the Welsh Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006 ) whether or not the exercise of the function also relates to a part of Great Britain other than Wales.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 6 Chapter 1 of Title 2

In Article 5—

(a) for “, 21 and 23” substitute “ and 21 ” ;

(b) for “ the Community ” substitute “ Great Britain ” .

Section 7 Chapter 1 of Title 2

(1) Article 7 is amended as follows.

(2) In paragraph 7, for “From 1 June 2011 paragraphs” substitute “ Paragraphs ” .

(3) For paragraph 8 substitute—

(8) Any measures for the implementation of paragraphs 1 to 7 shall be adopted by regulations made by the Secretary of State. Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under this paragraph is subject to the consent requirement in Article 4A.

Section 8

(1) Article 8 is amended as follows.

(2) In the heading, for “non-Community” substitute “ non-Great British ” .

(3) In paragraph 1, for “ the Community ”, in each place it occurs, substitute “ Great Britain ” .

(4) In paragraph 3, for “non-Community” substitute “ non-Great British ” .

Section 9

(1) Article 9 is amended as follows.

(2) In paragraph 1—

(a) for “a period of five years” substitute “ a five-year exemption period ” ;

(b) for “ the Community ” substitute “ Great Britain ” .

(3) After paragraph 1, insert—

(1A) In paragraph 1 “ five-year exemption period ” means a period of five years beginning when Articles 5, 6, 7, 17, 18 and 21 would otherwise apply to the substance (if it were not manufactured or imported as mentioned in paragraph 1).

(4) In paragraph 3, in the final sentence, for “competent authority of the Member State(s) concerned” substitute “ appropriate authorities that request it ” .

(5) In paragraph 8—

(a) in the first subparagraph, for the words from “competent” to the end substitute “ appropriate authorities that request them ” ;

(b) in the second subparagraph, for “such competent authorities” substitute “ the appropriate authorities ” .

(6) In paragraph 9, for “competent authorities of the Member States concerned” substitute “ appropriate authorities ” .

Section 10

In Article 10(a), in the final subparagraph, for “, Article 27(6) or Article 30(3)” substitute “ or Article 27(6) ” .

Section 11

In Article 11(1), for “ the Community ” substitute “ Great Britain ” .

Section 12

(1) Article 13 is amended as follows.

(2) In paragraph 2—

(a) in the second sentence—

(i) for “The Commission,” substitute “ The Secretary of State, ” ;

(ii) for “Commission Regulation on test methods adopted in accordance with the procedure referred to in Article 133(4)” substitute “ Test Methods Regulation ” ;

(b) for the third sentence substitute—

Amendments to the Test Methods Regulation may be made by regulations made by the Secretary of State. Amendments to the Annexes of this Regulation may be made by regulations made by the Secretary of State. Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament. The functions of making regulations under this paragraph are subject to the consent requirement in Article 4A.

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

(a) in the first sentence—

(i) for “a Commission Regulation” substitute “ the Test Methods Regulation ” ;

(ii) omit “the Commission or”;

(b) omit the second sentence.

(4) In paragraph 4—

(a) for “Directive 2004/10/EC ” substitute “ the Good Laboratory Practice Regulations 1999 ” ;

(b) omit “the Commission or”;

(c) for “Directive 86/609/EC ” substitute “ the Animals (Scientific Procedures) Act 1986 ” .

(5) At the end insert—

(6) In this Article “ Test Methods Regulation ” means Commission Regulation (EU) No 440/2008.

Section 13

(1) Article 14 is amended as follows.

(2) In paragraph 1, for “without prejudice to Article 4 of Directive 98/24/EC , a” substitute “ A ” .

(3) In paragraph 5(b), for “Directive 76/768/EEC ” substitute “ Regulation (EC) No 1223/2009 on cosmetic products ” .

Section 14 Chapter 2 of Title 2

(1) Article 16 is amended as follows.

(2) In the heading, omit “the Commission, the Agency and”.

(3) Omit paragraph 1.

(4) In paragraph 2, for “28” substitute “ 27 ” .

Section 15 Chapter 3 of Title 2

In Articles 17(2) and 18(2), in the second subparagraph, for “, Article 27(6) or Article 30(3)” substitute “ or Article 27(6) ” .

Section 16 Chapter 3 of Title 2

In Article 19(1), for “ the Community ” substitute “ Great Britain ” .

Section 17 Chapter 4 of Title 2

(1) Article 20 is amended as follows.

(2) In paragraph 2—

(a) in the second subparagraph, omit the words from “, or within” to the end;

(b) in the third subparagraph, in the first sentence, omit “or three-month”.

(3) In paragraph 4—

(a) in the first subparagraph, for “competent authority of the relevant Member State” substitute “ appropriate authorities that request the notification ” ;

(b) omit the second and third subparagraphs;

(c) in the fourth subparagraph, for “competent authority of the relevant Member State(s)” substitute “ appropriate authorities that request the notification ” .

Section 18 Chapter 4 of Title 2

In Article 21(1), omit the second subparagraph.

Section 19

(1) Article 22 is amended as follows.

(2) In the following provisions, for “competent authority of the relevant Member State” substitute “ appropriate authorities that request it ”

(a) paragraph 1, the final subparagraph;

(b) paragraph 2, the final sentence.

Section 20 Chapter 5 of Title 2

Omit Article 23.

Section 21 Chapter 5 of Title 2

In Article 24, omit paragraph 1.

Section 22 Chapter 1 of Title 3

In Article 25(3), after “this Regulation” insert “, or under EU REACH before IP completion day ” .

Section 23 Chapter 2 of Title 3

For the title of Chapter 2 substitute “ Rules for registrants of substances ” .

Section 24 Chapter 2 of Title 3

(1) Article 26 is amended as follows.

(2) In paragraph 1, omit “of a non-phase-in substance, or potential registrant of a phase-in substance who has not pre-registered in accordance with Article 28,”.

(3) In paragraph 3—

(a) in the first subparagraph, for “the same substance has previously been registered less than 12 years earlier” substitute “ there is a previous registration of the same substance that is less than 12 years old ” ;

(b) after the first subparagraph, insert—

A registration of a substance is less than 12 years old if—

(a) in a case where the registration came into existence under Article 127A, the existing EU registration (as defined in Article 127D) began less than 12 years before the potential registrant's enquiry to the Agency;

(b) in any other case, the registration under this Regulation began less than 12 years before the potential registrant's enquiry to the Agency.

Section 25

(1) Article 27 is amended as follows.

(2) In paragraph 1, for “a substance has previously been registered less than 12 years earlier” substitute “ there is a previous registration of a substance that is less than 12 years old ” .

(3) For paragraph 2 substitute—

(2) Within one month of a request for information being made according to paragraph 1, the owner of the study shall provide proof of the cost of the information to the potential registrant(s) requesting it. The potential and the previous registrant(s) as referred to in paragraph 1 shall make every effort to reach an agreement on the sharing of the information requested by the potential registrant(s) with respect to Article 10(a)(vi) and (vii). Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of the arbitration order.

(4) In paragraph 4, after “the previous registrant shall” insert “ , within two weeks of receipt of payment, ” .

(5) For paragraph 5 substitute—

(5) If the previous registrant as referred to in paragraph 1 refuses to provide either proof of the cost of that study or the study itself to a potential registrant, or there is failure to reach an agreement referred to in paragraph 4, the potential registrant(s) shall inform the Agency and the previous registrant(s) thereof at the earliest one month after receipt, from the Agency, of the name and address of the previous registrant(s).

Section 26 Chapter 3 of Title 3

Omit Articles 28 to 30.

Section 27

(1) Article 31 is amended as follows.

(2) In paragraph 3(c), for “for which there are Community” substitute “ in relation to which the law of any part of Great Britain provides ” .

(3) In paragraph 5, for the words from “an official language” to the end substitute “ English and may also be supplied in any other language. ”

(4) Omit paragraph 10.

Section 28

In Article 32(2), omit “after 1 June 2007”.

Section 29

In Article 36(1)—

(a) omit “to any competent authority of the Member State in which he is established or”;

(b) after “Agency” insert “ or to any appropriate authority ” .

Section 30 Title 5

In Article 37(3), omit the second subparagraph.

Section 31 Chapter 1 of Title 6

(1) Article 41 is amended as follows.

(2) In paragraph 2, for “Member States competent authorities” substitute “ the appropriate authorities that request it ” .

(3) In paragraph 5(c), omit “Community”.

(4) Omit paragraph 6.

(5) For paragraph 7 substitute—

(7) The Secretary of State may, by regulations, make provision to modify the effect of paragraph 5 by—

(a) modifying the percentage of dossiers to be selected;

(b) modifying the criteria which determine the dossiers to which priority is to be given.

Regulations under this paragraph may amend paragraph 5.

The Secretary of State must consult the Agency before making regulations under this paragraph.

Regulations under this paragraph are to be made by statutory instrument; and a statutory instrument containing regulations under this paragraph is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under this paragraph is subject to the consent requirement in Article 4A.

Section 32 Chapter 1 of Title 6

In Article 42(2)—

(a) in the first sentence, for “Commission and the competent authorities of the Member States” substitute “ appropriate authorities that request the notification ” ;

(b) omit the second sentence.

Section 33

(1) Article 43 is amended as follows.

(2) In paragraph 2—

(a) omit points (a) and (b);

(b) in point (c)—

(i) for “2022” substitute “ 2023 ” ;

(ii) after “received” insert “ by ECHA ” .

(3) In paragraph 3, for “Member States” substitute “ appropriate authorities that request it ” .

Section 34 Chapter 2 of Title 6

(1) Article 44 is amended as follows.

(2) In the first sentence of paragraph 1—

(a) for “In order to ensure a harmonised approach, the” substitute “ The ” ;

(b) for “Member States” substitute “ appropriate authorities ” .

(3) In paragraph 2—

(a) in the first subparagraph—

(i) in the first sentence omit “Community”;

(ii) for the last two sentences substitute—

The Agency must submit its draft rolling action plan to the appropriate authorities within 12 months of IP completion day and give the appropriate authorities the opportunity to comment on it. The Agency must submit a draft annual update to its rolling action plan by 31 May in each subsequent year and give the appropriate authorities the opportunity to comment on it. The Agency must adopt a final rolling annual action plan for each year (after taking account of any comments made on the draft by the appropriate authorities) and must publish it on its website.

(b) omit the last subparagraph.

Section 35 Chapter 2 of Title 6

(1) Article 45 is amended as follows.

(2) For the heading substitute “ Evaluation of substances on the rolling action plan ” .

(3) In paragraph 1—

(a) in the first sentence omit—

(i) “coordinating the substance evaluation process and”;

(ii) “Community”;

(b) omit the last two sentences.

(4) Omit paragraphs 2 to 5.

Section 36

(1) Article 46 is amended as follows.

(2) In paragraph 1—

(a) in the first sentence for “competent authority” substitute “ Agency ” ;

(b) in the second sentence, omit “Community”.

(3) In paragraph 3, for “competent authority” substitute “ Agency ” .

(4) In paragraph 4, in the first sentence—

(a) for “competent authority” substitute “ Agency ” ;

(b) omit “, and notify the Agency accordingly”.