TITLE I GENERAL ISSUES

CHAPTER 1 Aim, scope and application

Article 1 Aim and scope

1 . The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances ^F2 ... while enhancing competitiveness and innovation.

2 . This Regulation lays down provisions on substances and [^F1 mixtures^F1] within the meaning of Article 3. These provisions shall apply to the manufacture, placing on the market or use of such substances on their own, in [^F1 mixtures^F1] or in articles and to the placing on the market of [^F1 mixtures^F1] .

3 . This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle.

Article 2 Application

1. This Regulation shall not apply to:

(a) radioactive substances within the scope of [[^F3,F4 assimilated^F4] law that transposed Council Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation^F3] ;

(b) substances, on their own, in a [^F1 mixture^F1] or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;

(c) non-isolated intermediates;

(d) the carriage of dangerous substances and dangerous substances in dangerous [^F1 mixtures^F1] by rail, road, inland waterway, sea or air.

2. Waste as defined in [^F5 Article 3(1) of Directive 2008/98/EC^F5] of the European Parliament and of the Council (26) is not a substance, [^F1 mixture^F1] or article within the meaning of Article 3 of this Regulation.

[^F6 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 [^F7assimilated direct^F7] 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.^F6]

3.[^F8 The Secretary of State^F8] may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a [^F1 mixture^F1] or in an article, where necessary in the interests of defence.

^F9 4.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5. The provisions of Titles II, V, VI and VII shall not apply to the extent that a substance is used:

[^F10 (a)in medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013, or the Human Medicines Regulations 2012;^F10]

(b) in food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:

6. The provisions of Title IV shall not apply to the following [^F1 mixtures^F1] in the finished state, intended for the final user:

[^F15 (a)medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013, or the Human Medicines Regulations 2012;^F15]

[^F16 (b)cosmetic products as defined in Regulation (EC) No 1223/2009 on cosmetic products;^F16]

[^F17 (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;^F17]

(d) food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:

7. The following shall be exempted from Titles II, V and VI:

(a) substances included in Annex IV, as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties;

(b) substances covered by Annex V, as registration is deemed inappropriate or unnecessary for these substances and their exemption from these Titles does not prejudice the objectives of this Regulation;

(c) substances on their own or in [^F1 mixtures^F1] , registered in accordance with Title II, exported [^F21 from Great Britain^F21] by an actor in the supply chain and re-imported [^F22 into Great Britain^F22] by the same or another actor in the same supply chain who shows that:

(d) substances, on their own, in [^F1 mixtures^F1] or in articles, which have been registered in accordance with Title II and which are recovered in [^F23 Great Britain^F23] if:

8 . On-site isolated intermediates and transported isolated intermediates shall be exempted from:

(a) Chapter 1 of Title II, with the exception of Articles 8 and 9; and

(b) Title VII.

9 . The provisions of Titles II and VI shall not apply to polymers.

CHAPTER 2 Definitions and general provision

[^F24Article 2A 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 [^F25 assimilated direct^F25] legislation that was originally made under EU REACH.

Article 2B 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;

• “ 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.^F24]

Article 3 Definitions

For the purposes of this Regulation:

Article 4 General provision

Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users.

[^F45Article 4A The consent requirement _cross-notes

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.^F45]

TITLE II REGISTRATION OF SUBSTANCES

CHAPTER 1 General obligation to register and information requirements

Article 5 No data, no market

Subject to Articles 6, 7 [^F46 and 21^F46] , substances on their own, in [^F1 mixtures^F1] or in articles shall not be manufactured in [^F47 Great Britain^F47] or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required.

Article 6 General obligation to register substances on their own or in [^F1mixtures^F1]

1 . Save where this Regulation provides otherwise, any manufacturer or importer of a substance, either on its own or in one or more [^F1 mixture^F1] (s), in quantities of one tonne or more per year shall submit a registration to the Agency.

2 . For monomers that are used as on-site isolated intermediates or transported isolated intermediates, Articles 17 and 18 shall not apply.

3 . Any manufacturer or importer of a polymer shall submit a registration to the Agency for the monomer substance(s) or any other substance(s), that have not already been registered by an actor up the supply chain, if both the following conditions are met:

( a ) the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s);

( b ) the total quantity of such monomer substance(s) or other substance(s) makes up one tonne or more per year.

4 . A submission for registration shall be accompanied by the fee required in accordance with Title IX.

Article 7 Registration and notification of substances in articles

1. Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met:

(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;

(b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.

A submission for registration shall be accompanied by the fee required in accordance with Title IX.

2. Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met:

(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;

(b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).

3. Paragraph 2 shall not apply where the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal. In such cases, the producer or importer shall supply appropriate instructions to the recipient of the article.

4. The information to be notified shall include the following:

(a) the identity and contact details of the producer or importer as specified in section 1 of Annex VI, with the exception of their own use sites;

(b) the registration number(s) referred to in Article 20(1), if available;

(c) the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI;

(d) the classification of the substance(s) as specified in sections 4.1 and 4.2 of Annex VI;

(e) a brief description of the use(s) of the substance(s) in the article as specified in section 3.5 of Annex VI and of the uses of the article(s);

(f) the tonnage range of the substance(s), such as 1 to 10 tonnes, 10 to 100 tonnes and so on.

5. The Agency may take decisions requiring producers or importers of articles to submit a registration, in accordance with this Title, for any substance in those articles, if all the following conditions are met:

(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;

(b) the Agency has grounds for suspecting that:

(c) the substance is not subject to paragraph 1.

A submission for registration shall be accompanied by the fee required in accordance with Title IX.

6. Paragraphs 1 to 5 shall not apply to substances that have already been registered for that use.

7. [^F48 Paragraphs^F48] 2, 3 and 4 of this Article shall apply six months after a substance is identified in accordance with Article 59(1).

8. [^F49 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.^F49]

Article 8 Only representative of a [^F50non-Great British^F50] manufacturer

1 . A natural or legal person established outside [^F51 Great Britain^F51] who manufactures a substance on its own, in [^F1 mixtures^F1] or in articles, formulates a [^F1 mixture^F1] or produces an article that is imported into [^F51 Great Britain^F51] may by mutual agreement appoint a natural or legal person established in [^F51 Great Britain^F51] to fulfil, as his only representative, the obligations on importers under this Title.

2 . The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 36, shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 31.

3 . If a representative is appointed in accordance with paragraphs 1 and 2, the [^F52 non-Great British^F52] manufacturer shall inform the importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Regulation.

Article 9 Exemption from the general obligation to register for product and process orientated research and development (PPORD)

1 . Articles 5, 6, 7, 17, 18 and 21 shall not apply for [^F53 a five-year exemption period^F53] to a substance manufactured in [^F54 Great Britain^F54] or imported for the purposes of product and process orientated research and development by a manufacturer or importer or producer of articles, by himself or in cooperation with listed customers and in a quantity which is limited to the purpose of product and process orientated research and development.

[^F55 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). ^F55]

2. For the purpose of paragraph 1, the manufacturer or importer or producer of articles shall notify the Agency of the following information:

(a) the identity of the manufacturer or importer or producer of articles as specified in section 1 of Annex VI;

(b) the identity of the substance, as specified in section 2 of Annex VI;

(c) the classification of the substance as specified in section 4 of Annex VI, if any;

(d) the estimated quantity as specified in section 3.1 of Annex VI;

(e) the list of customers referred to in paragraph 1, including their names and addresses.

The notification shall be accompanied by the fee required in accordance with Title IX.

The period set out in paragraph 1 shall begin at receipt of the notification at the Agency.

3. The Agency shall check the completeness of the information supplied by the notifier and Article 20(2) shall apply adapted as necessary. The Agency shall assign a number to the notification and a notification date, which shall be the date of receipt of the notification at the Agency, and shall forthwith communicate that number and date to the manufacturer, or importer, or producer of articles concerned. The Agency shall also communicate this information to the [^F56 appropriate authorities that request it^F56] .

4. The Agency may decide to impose conditions with the aim of ensuring that the substance or the [^F1 mixture^F1] or article in which the substance is incorporated will be handled only by staff of listed customers as referred to in paragraph 2(e) in reasonably controlled conditions, in accordance with the requirements of legislation for the protection of workers and the environment, and will not be made available to the general public at any time either on its own or in a [^F1 mixture^F1] or article and that remaining quantities will be re-collected for disposal after the exemption period.

In such cases, the Agency may ask the notifier to provide additional necessary information.

5. In the absence of any indication to the contrary, the manufacturer or importer of the substance or the producer or importer of articles may manufacture or import the substance or produce or import the articles not earlier than two weeks after the notification.

6. The manufacturer or importer or producer of articles shall comply with any conditions imposed by the Agency in accordance with paragraph 4.

7. The Agency may decide to extend the five-year exemption period by a further maximum of five years or, in the case of substances to be used exclusively in the development of medicinal products for human or veterinary use, or for substances that are not placed on the market, for a further maximum of ten years, upon request if the manufacturer or importer or producer of articles can demonstrate that such an extension is justified by the research and development programme.

8. The Agency shall forthwith communicate any draft decisions to the [^F57 appropriate authorities that request them^F57] .

When taking decisions as provided for in paragraphs 4 and 7, the Agency shall take into account any comments made by [^F58 the appropriate authorities^F58] .

9. The Agency and the [^F59 appropriate authorities^F59] shall always keep confidential the information submitted in accordance with paragraphs 1 to 8.

10. An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraphs 4 and 7 of this Article.

Article 10 Information to be submitted for general registration purposes

A registration required by Article 6 or by Article 7(1) or (5) shall include all the following information:

Article 11 Joint submission of data by multiple registrants

1. When a substance is intended to be manufactured in [^F61 Great Britain^F61] by one or more manufacturers and/or imported by one or more importers, and/or is subject to registration under Article 7, the following shall apply.

Subject to paragraph 3, the information specified in Article 10(a)(iv), (vi), (vii) and (ix), and any relevant indication under Article 10(a)(viii) shall first be submitted by the one registrant acting with the agreement of the other assenting registrant(s) (hereinafter referred to as the lead registrant).

Each registrant shall subsequently submit separately the information specified in Article 10(a)(i), (ii), (iii) and (x), and any relevant indication under Article 10(a)(viii).

The registrants may decide themselves whether to submit the information specified in Article 10(a)(v) and (b) and any relevant indication under Article 10(a)(viii) separately or whether one registrant is to submit this information on behalf of the others.

2. Each registrant need only comply with paragraph 1 for items of information specified in Article 10(a)(iv), (vi), (vii) and (ix) that are required for the purposes of registration within his tonnage band in accordance with Article 12.

3. A registrant may submit the information referred to in Article 10(a)(iv), (vi), (vii) or (ix) separately if:

(a) it would be disproportionately costly for him to submit this information jointly; or

(b) submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or

(c) he disagrees with the lead registrant on the selection of this information.

If points (a), (b) or (c) apply, the registrant shall submit, along with the dossier, an explanation as to why the costs would be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment or the nature of the disagreement, as the case may be.

4. A submission for registration shall be accompanied by the fee required in accordance with Title IX.

Article 12 Information to be submitted depending on tonnage

1 . The technical dossier referred to in Article 10(a) shall include under points (vi) and (vii) of that provision all physicochemical, toxicological and ecotoxicological information that is relevant and available to the registrant and as a minimum the following:

( a ) the information specified in Annex VII for non-phase-in substances, and for phase-in substances meeting one or both of the criteria specified in Annex III, manufactured or imported in quantities of one tonne or more per year per manufacturer or importer;

( b ) the information on physicochemical properties specified in Annex VII, section 7 for phase-in substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer which do not meet either of the criteria specified in Annex III;

( c ) the information specified in Annexes VII and VIII for substances manufactured or imported in quantities of 10 tonnes or more per year per manufacturer or importer;

( d ) the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annex IX for substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer or importer;

( e ) the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annexes IX and X for substances manufactured or imported in quantities of 1 000 tonnes or more per year per manufacturer or importer.

2 . As soon as the quantity of a substance per manufacturer or importer that has already been registered reaches the next tonnage threshold, the manufacturer or importer shall inform the Agency immediately of the additional information he would require under paragraph 1. Article 26(3) and (4) shall apply adapted as necessary.

3 . This Article shall apply to producers of articles adapted as necessary.

Article 13 General requirements for generation of information on intrinsic properties of substances

1. Information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across). Testing in accordance with Annex VIII, Sections 8.6 and 8.7, Annex IX and Annex X may be omitted where justified by information on exposure and implemented risk management measures as specified in Annex XI, section 3.

2. These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved. [^F62 The Secretary of State,^F62] following consultation with relevant stakeholders, shall, as soon as possible, make a proposal, if appropriate, to amend the [^F63 Test Methods Regulation^F63] , and the Annexes of this Regulation, if relevant, so as to replace, reduce or refine animal testing. [^F64 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.^F64]

3. Where tests on substances are required to generate information on intrinsic properties of substances, they shall be conducted in accordance with the test methods laid down in [^F65 the Test Methods Regulation^F65] or in accordance with other international test methods recognised by ^F66 ... the Agency as being appropriate. ^F67 ...

Information on intrinsic properties of substances may be generated in accordance with other test methods provided that the conditions set out in Annex XI are met.

4. Ecotoxicological and toxicological tests and analyses shall be carried out in compliance with the principles of good laboratory practice provided for in [^F68 the Good Laboratory Practice Regulations 1999^F68] or other international standards recognised as being equivalent by ^F69 ... the Agency and with the provisions of [^F70 the Animals (Scientific Procedures) Act 1986^F70] , if applicable.

5. If a substance has already been registered, a new registrant shall be entitled to refer to the study summaries or robust study summaries, for the same substance submitted earlier, provided that he can show that the substance that he is now registering is the same as the one previously registered, including the degree of purity and the nature of impurities, and that the previous registrant(s) have given permission to refer to the full study reports for the purpose of registration.

A new registrant shall not refer to such studies in order to provide the information required in Section 2 of Annex VI.

[^F71 6. In this Article “ Test Methods Regulation ” means Commission Regulation (EU) No 440/2008 . ^F71]

Article 14 Chemical safety report and duty to apply and recommend risk reduction measures

1. [^F72 A^F72] chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter in quantities of 10 tonnes or more per year per registrant.

The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex I for either each substance on its own or in a [^F1 mixture^F1] or in an article or a group of substances.

[^F1 2. A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a mixture if the concentration of the substance in the mixture is less than:

(a) the cut-off value referred to in Article 11, paragraph 3 of Regulation (EC) No 1272/2008;

(b) 0,1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII to this Regulation.^F1]

3. A chemical safety assessment of a substance shall include the following steps:

(a) human health hazard assessment;

(b) physicochemical hazard assessment;

(c) environmental hazard assessment;

(d) persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.

[^F1 4. If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(c) hazard class 4.1;

(d) hazard class 5.1,

or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps:^F1]

(a) exposure assessment including the generation of exposure scenario(s) (or the identification of relevant use and exposure categories if appropriate) and exposure estimation;

(b) risk characterisation.

The exposure scenarios (where appropriate the use and exposure categories), exposure assessment and risk characterisation shall address all identified uses of the registrant.

5. The chemical safety report need not include consideration of the risks to human health from the following end uses:

(a) in food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food (29) ;

(b) in cosmetic products within the scope of [^F73 Regulation (EC) No 1223/2009 on cosmetic products^F73] .

6. Any registrant shall identify and apply the appropriate measures to adequately control the risks identified in the chemical safety assessment, and where suitable, recommend them in the safety data sheets which he supplies in accordance with Article 31.

7. Any registrant required to conduct a chemical safety assessment shall keep his chemical safety report available and up to date.

CHAPTER 2 Substances regarded as being registered

Article 15 Substances in plant protection and biocidal products

[^F74 1. The following are regarded as being registered, and the registration as completed, for manufacture or import for the use as a plant protection product and therefore as fulfilling the requirements of Chapters 1 and 5 of this Title—

(a) active substances manufactured or imported for use in plant protection products only and included in the approvals register in relation to at least one constituent territory;

(b) co-formulants manufactured or imported for use in plant protection products only and not included in the unacceptable co-formulants register in relation to the whole of the UK;

(c) any substance in relation to which the applicant has been notified in accordance with Article 9(3) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market.

1A. In paragraph 1—

(a) in point (a)—

(i) “ approvals register ” means the register maintained in accordance with Article 27A of Regulation (EC) No 1107/2009 ;

(ii) “ constituent territory ” has the meaning given by Article 3A of Regulation (EC) No 1107/2009 ;

(b) in point (b), “ unacceptable co-formulants register ” means the register maintained in accordance with Article 27B of Regulation (EC) No 1107/2009 . ^F74]

[^F75 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.^F75]

Article 16 Duties of ^F76... registrants of substances regarded as being registered

^F77 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. Articles 21, 22 and 25 to [^F78 27^F78] shall not apply to uses of substances regarded as registered according to Article 15.

CHAPTER 3 Obligation to register and information requirements for certain types of isolated intermediates

Article 17 Registration of on-site isolated intermediates

1. Any manufacturer of an on-site isolated intermediate in quantities of one tonne or more per year shall submit a registration to the Agency for the on-site isolated intermediate.

2. A registration for an on-site isolated intermediate shall include all the following information, to the extent that the manufacturer is able to submit it without any additional testing:

(a) the identity of the manufacturer as specified in Section 1 of Annex VI;

(b) the identity of the intermediate as specified in Sections 2.1 to 2.3.4 of Annex VI;

(c) the classification of the intermediate as specified in Section 4 of Annex VI;

(d) any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted;

(e) a brief general description of the use, as specified in Section 3.5 of Annex VI;

(f) details of the risk management measures applied.

Except in cases covered under Article 25(3) [^F79 or Article 27(6)^F79] , the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (d) for the purpose of registration.

The registration shall be accompanied by the fee required in accordance with Title IX.

3. Paragraph 2 shall apply only to on-site isolated intermediates if the manufacturer confirms that the substance is only manufactured and used under strictly controlled conditions in that it is rigorously contained by technical means during its whole lifecycle. Control and procedural technologies shall be used to minimise emission and any resulting exposure.

If these conditions are not fulfilled, the registration shall include the information specified in Article 10.

Article 18 Registration of transported isolated intermediates

1. Any manufacturer or importer of a transported isolated intermediate in quantities of one tonne or more per year shall submit a registration to the Agency for the transported isolated intermediate.

2. A registration for a transported isolated intermediate shall include all the following information:

(a) the identity of the manufacturer or importer as specified in Section 1 of Annex VI;

(b) the identity of the intermediate as specified in Sections 2.1 to 2.3.4 of Annex VI;

(c) the classification of the intermediate as specified in Section 4 of Annex VI;

(d) any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted;

(e) a brief general description of the use, as specified in Section 3.5 of Annex VI;

(f) information on risk management measures applied and recommended to the user in accordance with paragraph 4.

Except in cases covered under Article 25(3) [^F80 or Article 27(6)^F80] , the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (d) for the purpose of registration.

The registration shall be accompanied by the fee required in accordance with Title IX.

3. A registration for a transported isolated intermediate in quantities of more than 1 000 tonnes per year per manufacturer or importer shall include the information specified in Annex VII in addition to the information required under paragraph 2.

For the generation of this information, Article 13 shall apply.

4. Paragraphs 2 and 3 shall apply only to transported isolated intermediates if the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of (an)other substance(s) from that intermediate takes place on other sites under the following strictly controlled conditions:

(a) the substance is rigorously contained by technical means during its whole lifecycle including manufacture, purification, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage;

(b) procedural and control technologies shall be used that minimise emission and any resulting exposure;

(c) only properly trained and authorised personnel handle the substance;

(d) in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered;

(e) in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures;

(f) substance-handling procedures are well documented and strictly supervised by the site operator.

If the conditions listed in the first subparagraph are not fulfilled, the registration shall include the information specified in Article 10.

Article 19 Joint submission of data on isolated intermediates by multiple registrants

1. When an on-site isolated intermediate or transported isolated intermediate is intended to be manufactured in [^F81 Great Britain^F81] by one or more manufacturers and/or imported by one or more importers, the following shall apply.

Subject to paragraph 2 of this Article, the information specified in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall first be submitted by one manufacturer or importer acting with the agreement of the other assenting manufacturer(s) or importer(s) (hereinafter referred to as ‘ the lead registrant ’ ).

Each registrant shall subsequently submit separately the information specified in Article 17(2)(a), (b), (e) and (f) and Article 18(2)(a),(b), (e) and (f).

2. A manufacturer or importer may submit the information referred to in Article 17(2)(c) or (d) and Article 18(2)(c) or (d) separately if:

(a) it would be disproportionately costly for him to submit this jointly; or

(b) submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or

(c) he disagrees with the lead registrant on the selection of this information.

If points (a), (b) or (c) apply, the manufacturer or importer shall submit, along with the dossier, an explanation as to why the costs would be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment, or the nature of the disagreement, as the case may be.

3. A submission for registration shall be accompanied by the fee required in accordance with Title IX.

CHAPTER 4 Common provisions for all registrations

Article 20 Duties of the Agency

1. The Agency shall assign a submission number to each registration, which is to be used for all correspondence regarding the registration until the registration is deemed to be complete, and a submission date, which shall be the date of receipt of the registration at the Agency.

2. The Agency shall undertake a completeness check of each registration in order to ascertain that all the elements required under Articles 10 and 12 or under Articles 17 or 18, as well as the registration fee referred to in Article 6(4), Article 7(1) and (5), Article 17(2) or Article 18(2), have been provided. The completeness check shall not include an assessment of the quality or the adequacy of any data or justifications submitted.

The Agency shall undertake the completeness check within three weeks of the submission date^F82 ....

If a registration is incomplete, the Agency shall inform the registrant, before expiry of the three-week ^F83 ... period referred to in the second subparagraph, as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this. The registrant shall complete his registration and submit it to the Agency within the deadline set. The Agency shall confirm the submission date of the further information to the registrant. The Agency shall perform a further completeness check, considering the further information submitted.

The Agency shall reject the registration if the registrant fails to complete his registration within the deadline set. The registration fee shall not be reimbursed in such cases.

3. Once the registration is complete, the Agency shall assign a registration number to the substance concerned and a registration date, which shall be the same as the submission date. The Agency shall without delay communicate the registration number and registration date to the registrant concerned. The registration number shall be used for all subsequent correspondence regarding registration.

4. The Agency shall notify the [^F84 appropriate authorities that request the notification^F84] within 30 days of the submission date, that the following information is available in the Agency database:

(a) the registration dossier together with the submission or registration number;

(b) the submission or registration date;

(c) the result of the completeness check; and

(d) any request for further information and deadline set in accordance with the third subparagraph of paragraph 2.

^F85 ...

^F85 ...

The Agency shall forthwith notify the [^F86 appropriate authorities that request the notification^F86] when any further information submitted by the registrant is available on the Agency database.

5. An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraph 2 of this Article.

6. Where additional information for a particular substance is submitted to the Agency by a new registrant, the Agency shall notify the existing registrants that this information is available on the database for the purposes of Article 22.

Article 21 Manufacturing and import of substances

1 . A registrant may start or continue the manufacture or import of a substance or production or import of an article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the submission date, without prejudice to Article 27(8).

^F87 ...

In the case of an update of a registration according to Article 22 a registrant may continue the manufacture or import of the substance, or the production or import of the article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the update date, without prejudice to Article 27(8).

2 . If the Agency has informed the registrant that he is to submit further information in accordance with the third subparagraph of Article 20(2), the registrant may start the manufacture or import of a substance or production or import of an article if there is no indication to the contrary from the Agency within the three weeks after receipt by the Agency of the further information necessary to complete his registration, without prejudice to Article 27(8).

3 . If a lead registrant submits parts of the registration on behalf of one or more other registrants, as provided for in Articles 11 or 19, any of the other registrants may manufacture or import the substance or produce or import the articles only after the expiry of the time-limit laid down in paragraph 1 or 2 of this Article and provided that there is no indication to the contrary from the Agency in respect of the registration of the lead registrant acting on behalf of the others and his own registration.

Article 22 Further duties of registrants

1. Following registration, a registrant shall be responsible on his own initiative for updating his registration without undue delay with relevant new information and submitting it to the Agency in the following cases:

(a) any change in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address;

(b) any change in the composition of the substance as given in Section 2 of Annex VI;

(c) changes in the annual or total quantities manufactured or imported by him or in the quantities of substances present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture or import;

(d) new identified uses and new uses advised against as in Section 3.7 of Annex VI for which the substance is manufactured or imported;

(e) new knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report;

(f) any change in the classification and labelling of the substance;

(g) any update or amendment of the chemical safety report or Section 5 of Annex VI;

(h) the registrant identifies the need to perform a test listed in Annex IX or Annex X, in which cases a testing proposal shall be developed;

(i) any change in the access granted to information in the registration.

The Agency shall communicate this information to the [^F88 appropriate authorities that request it^F88] .

2. A registrant shall submit to the Agency an update of the registration containing the information required by the decision made in accordance with Articles 40, 41 or 46 or take into account a decision made in accordance with Articles 60 and 73, within the deadline specified in that decision. The Agency shall notify the [^F89 appropriate authorities that request it^F89] that the information is available on its database.

3. The Agency shall undertake a completeness check according to Article 20(2) first and second subparagraphs of each updated registration. In cases where the update is in accordance with Article 12(2) and with paragraph 1(c) of this Article then the Agency shall check the completeness of the information supplied by the registrant and Article 20(2) shall apply adapted as necessary.

4. In cases covered by Articles 11 or 19, each registrant shall submit separately the information specified in paragraph 1(c) of this Article.

5. An update shall be accompanied by the relevant part of the fee required in accordance with Title IX.

CHAPTER 5 Transitional provisions applicable to phase-in substances and notified substances

^F90 Article 23 Specific provisions for phase-in substances

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

Article 24 Notified substances

^F91 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2 . If the quantity of a notified substance manufactured or imported per manufacturer or importer reaches the next tonnage threshold under Article 12, the additional required information corresponding to that tonnage threshold, as well as to all the lower tonnage thresholds, shall be submitted in accordance with Articles 10 and 12, unless it has already been submitted in accordance with those Articles.

TITLE III DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING

CHAPTER 1 Objectives and general rules

Article 25 Objectives and general rules

1. In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort. It is also necessary to take measures limiting duplication of other tests.

2. The sharing and joint submission of information in accordance with this Regulation shall concern technical data and in particular information related to the intrinsic properties of substances. Registrants shall refrain from exchanging information concerning their market behaviour, in particular as regards production capacities, production or sales volumes, import volumes or market shares.

3. Any study summaries or robust study summaries of studies submitted in the framework of a registration under this Regulation [^F92 , or under EU REACH before IP completion day^F92] at least 12 years previously can be used for the purposes of registration by another manufacturer or importer.

CHAPTER 2 [^F93Rules for registrants of substances^F93]

Article 26 Duty to inquire prior to registration

1. Every potential registrant ^F94 ... shall inquire from the Agency whether a registration has already been submitted for the same substance. He shall submit all the following information to the Agency with the inquiry:

(a) his identity as specified in Section 1 of Annex VI, with the exception of the use sites;

(b) the identity of the substance, as specified in Section 2 of Annex VI;

(c) which information requirements would require new studies involving vertebrate animals to be carried out by him;

(d) which information requirements would require other new studies to be carried out by him.

2. If the same substance has previously not been registered, the Agency shall inform the potential registrant accordingly.

3. If [^F95 there is a previous registration of the same substance that is less than 12 years old^F95] , the Agency shall inform the potential registrant without delay of the names and addresses of the previous registrant(s) and of the relevant summaries or robust study summaries, as the case may be, already submitted by them.

[^F96 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.^F96]

Studies involving vertebrate animals shall not be repeated.

The Agency shall simultaneously inform the previous registrants of the name and address of the potential registrant. The available studies shall be shared with the potential registrant in accordance with Article 27.

4. If several potential registrants have made an inquiry in respect of the same substance, the Agency shall inform all potential registrants without delay of the name and address of the other potential registrants.

Article 27 Sharing of existing data in the case of registered substances

1. Where [^F97 there is a previous registration of a substance that is less than 12 years old^F97] as referred to in Article 26(3), the potential registrant:

(a) shall, in the case of information involving tests on vertebrate animals; and

(b) may, in the case of information not involving tests on vertebrate animals,

request from the previous registrant(s) the information he requires with respect to Article 10(a)(vi) and (vii) in order to register.

[^F98 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.^F98]

3. The previous registrant and potential registrant(s) shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way. This may be facilitated by following cost sharing guidance based on those principles which is adopted by the Agency in accordance with Article 77(2)(g). Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements.

4. On agreement on the sharing of the information, the previous registrant shall [^F99 , within two weeks of receipt of payment,^F99] make available to the new registrant the agreed information and shall give the new registrant the permission to refer to the previous registrant's full study report.

[^F100 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).^F100]

6. Within one month from the receipt of the information referred to in paragraph 5, the Agency shall give the potential registrant permission to refer to the information requested by him in his registration dossier, subject to the potential registrant providing, upon request by the Agency, proof that he has paid the previous registrant(s) for that information a share of cost incurred. The previous registrant(s) shall have a claim on the potential registrant for a proportionate share of the cost incurred by him. Calculation of the proportionate share may be facilitated by the guidance adopted by the Agency in accordance with Article 77(2)(g). Provided he makes the full study report available to the potential registrant, the previous registrant(s) shall have a claim on the potential registrant for an equal share of the cost incurred by him, which shall be enforceable in the national courts.

7. An appeal may be brought, in accordance with Articles 91, 92 and 93, against Agency decisions under paragraph 6 of this Article.

8. The registration waiting period in accordance with Article 21(1) for the new registrant shall be extended by a period of four months, if the previous registrant so requests.

CHAPTER 3 Rules for phase-in-substances

^F101 Article 28 Duty to pre-register for phase-in substances

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

^F101 Article 29 Substance Information Exchange Forums

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

^F101 Article 30 Sharing of data involving tests

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

TITLE IV INFORMATION IN THE SUPPLY CHAIN

Article 31 Requirements for safety data sheets

1. The supplier of a substance or a [^F1 mixture^F1] shall provide the recipient of the substance or [^F1 mixture^F1] with a safety data sheet compiled in accordance with Annex II:

[^F1 (a) where a substance or mixture meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008; or^F1]

(b) where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII; or

(c) where a substance is included in the list established in accordance with Article 59(1) for reasons other than those referred to in points (a) and (b).

2. Any actor in the supply chain who is required, under Articles 14 or 37, to carry out a chemical safety assessment for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment. If the safety data sheet is developed for a [^F1 mixture^F1] and the actor in the supply chain has prepared a chemical safety assessment for that [^F1 mixture^F1] , it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the [^F1 mixture^F1] instead of with the chemical safety report for each substance in the [^F1 mixture^F1] .

[^F1 3. The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a mixture does not meet the criteria for classification as hazardous in accordance with Titles I and II of Regulation (EC) No 1272/2008, but contains:

(a) in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures at least one substance posing human health or environmental hazards; or

(b) in an individual concentration of ≥ 0,1 % by weight for non-gaseous mixtures at least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or

(c) a substance [^F102 in relation to which the law of any part of Great Britain provides^F102] workplace exposure limits.^F1]

[^F1 4. The safety data sheet need not be supplied where hazardous substances or mixtures offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by a downstream user or distributor.^F1]

5. The safety data sheet shall be supplied in [^F103 English and may also be supplied in any other language.^F103]

6. The safety data sheet shall be dated and shall contain the following headings:

7. Any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14 or 37 shall place the relevant exposure scenarios (including use and exposure categories where appropriate) in an annex to the safety data sheet covering identified uses and including specific conditions resulting from the application of Section 3 of Annex XI.

Any downstream user shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses.

Any distributor shall pass on relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for uses for which he has passed on information according to Article 37(2).

[^F1 8. A safety data sheet shall be provided free of charge on paper or electronically no later than the date on which the substance or mixture is first supplied.^F1]

9. Suppliers shall update the safety data sheet without delay on the following occasions:

(a) as soon as new information which may affect the risk management measures, or new information on hazards becomes available;

(b) once an authorisation has been granted or refused;

(c) once a restriction has been imposed.

The new, dated version of the information, identified as ‘Revision: (date)’, shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or [^F1 mixture ^F1] within the preceding 12 months. Any updates following registration shall include the registration number.

^F104 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 32 Duty to communicate information down the supply chain for substances on their own or in [^F1mixtures^F1] for which a safety data sheet is not required

1. Any supplier of a substance on its own or in a [^F1 mixture^F1] who does not have to supply a safety data sheet in accordance with Article 31 shall provide the recipient with the following information:

(a) the registration number(s) referred to in Article 20(3), if available, for any substances for which information is communicated under points (b), (c) or (d) of this paragraph;

(b) if the substance is subject to authorisation and details of any authorisation granted or denied under Title VII in this supply chain;

(c) details of any restriction imposed under Title VIII;

(d) any other available and relevant information about the substance that is necessary to enable appropriate risk management measures to be identified and applied including specific conditions resulting from the application of Section 3 of Annex XI.

2. The information referred to in paragraph 1 shall be communicated free of charge on paper or electronically at the latest at the time of the first delivery of a substance on its own or in a [^F1 mixture^F1] ^F105 ... .

3. Suppliers shall update this information without delay on the following occasions:

(a) as soon as new information which may affect the risk management measures, or new information on hazards becomes available;

(b) once an authorisation has been granted or refused;

(c) once a restriction has been imposed.

In addition, the updated information shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or [^F1 mixture^F1] within the preceding 12 months. Any updates following registration shall include the registration number.

Article 33 Duty to communicate information on substances in articles

1 . Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.

2 . On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.

The relevant information shall be provided, free of charge, within 45 days of receipt of the request.

Article 34 Duty to communicate information on substances and [^F1mixtures^F1] up the supply chain

Any actor in the supply chain of a substance or a [^F1 mixture^F1] shall communicate the following information to the next actor or distributor up the supply chain:

Distributors shall pass on that information to the next actor or distributor up the supply chain.

Article 35 Access to information for workers

Workers and their representatives shall be granted access by their employer to the information provided in accordance with Articles 31 and 32 in relation to substances or [^F1 mixtures^F1] that they use or may be exposed to in the course of their work.

Article 36 Obligation to keep information

1. Each manufacturer, importer, downstream user and distributor shall assemble and keep available all the information he requires to carry out his duties under this Regulation for a period of at least 10 years after he last manufactured, imported, supplied or used the substance or [^F1 mixture^F1] . That manufacturer, importer, downstream user or distributor shall submit this information or make it available without delay upon request ^F106 ... to the Agency [^F107 or to any appropriate authority^F107] , without prejudice to Titles II and VI.

2. In the event of a registrant, downstream user or distributor ceasing activity, or transferring part or all of his operations to a third party, the party responsible for liquidating the registrant, downstream user or distributor's undertaking or assuming responsibility for the placing on the market of the substance or [^F1 mixture^F1] concerned shall be bound by the obligation in paragraph 1 in place of the registrant, downstream user or distributor.

TITLE V DOWNSTREAM USERS

Article 37 Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures

1. A downstream user or distributor may provide information to assist in the preparation of a registration.

2. Any downstream user shall have the right to make a use, as a minimum the brief general description of use, known in writing (on paper or electronically) to the manufacturer, importer, downstream user or distributor who supplies him with a substance on its own or in a [^F1 mixture^F1] with the aim of making this an identified use. In making a use known, he shall provide sufficient information to allow the manufacturer, importer or downstream user who has supplied the substance, to prepare an exposure scenario, or if appropriate a use and exposure category, for his use in the manufacturer, importer or downstream user's chemical safety assessment.

Distributors shall pass on such information to the next actor or distributor up the supply chain. Downstream users in receipt of such information may prepare an exposure scenario for the identified use(s), or pass the information to the next actor up the supply chain.

3. For registered substances, the manufacturer, importer or downstream user shall comply with the obligations laid down in Article 14 either before he next supplies the substance on its own or in a [^F1 mixture^F1] to the downstream user making the request referred to in paragraph 2 of this Article, provided that the request was made at least one month before the supply, or within one month after the request, whichever is the later.

^F108 ...

Where the manufacturer, importer or downstream user, having assessed the use in accordance with Article 14, is unable to include it as an identified use for reasons of protection of human health or the environment, he shall provide the Agency and the downstream user with the reason(s) for that decision in writing without delay and shall not supply downstream user(s) with the substance without including these reason(s) in the information referred to under Articles 31 or 32. The manufacturer or importer shall include this use in Section 3.7 of Annex VI in his update of the registration in accordance with Article 22(1)(d).

4. A downstream user of a substance on its own or in a [^F1 mixture^F1] shall prepare a chemical safety report in accordance with Annex XII for any use outside the conditions described in an exposure scenario or if appropriate a use and exposure category communicated to him in a safety data sheet or for any use his supplier advises against.

A downstream user need not prepare such a chemical safety report in any of the following cases:

(a) a safety data sheet is not required to be communicated with the substance or [^F1 mixture^F1] in accordance with Article 31;

(b) a chemical safety report is not required to be completed by his supplier in accordance with Article 14;

(c) the downstream user uses the substance or [^F1 mixture^F1] in a total quantity of less than one tonne per year;

(d) the downstream user implements or recommends an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to him in the safety data sheet;

(e) the substance is present in a [^F1 mixture^F1] in a concentration lower than any of the concentrations set out in Article 14(2);

(f) the downstream user is using the substance for the purposes of product and process oriented research and development, provided that the risks to human health and the environment are adequately controlled in accordance with the requirements of legislation for the protection of workers and the environment.

5. Any downstream user shall identify, apply and where suitable, recommend, appropriate measures to adequately control risks identified in any of the following:

(a) the safety data sheet(s) supplied to him;

(b) his own chemical safety assessment;

(c) any information on risk management measures supplied to him in accordance with Article 32.

6. Where a downstream user does not prepare a chemical safety report in accordance with paragraph 4(c), he shall consider the use(s) of the substance and identify and apply any appropriate risk management measures needed to ensure that the risks to human health and the environment are adequately controlled. Where necessary, this information shall be included in any safety data sheet prepared by him.

7. Downstream users shall keep their chemical safety report up to date and available.

8. A chemical safety report prepared in accordance with paragraph 4 of this Article need not include consideration of the risks to human health from the end uses set out in Article 14(5).

Article 38 Obligation for downstream users to report information

1 . Before commencing or continuing with a particular use of a substance that has been registered by an actor up the supply chain in accordance with Articles 6 or 18, the downstream user shall report to the Agency the information specified in paragraph 2 of this Article, in the following cases:

( a ) the downstream user has to prepare a chemical safety report in accordance with Article 37(4); or

( b ) the downstream user is relying on the exemptions in Article 37(4)(c) or (f).

2 . The information reported by the downstream user shall include the following:

( a ) his identity and contact details as specified in Section 1.1 of Annex VI;

( b ) the registration number(s) referred to in Article 20(3), if available;

( c ) the identity of the substance(s) as specified in Section 2.1 to 2.3.4 of Annex VI;

( d ) the identity of the manufacturer(s) or the importer(s) or other supplier as specified in Section 1.1 of Annex VI;

( e ) a brief general description of the use(s), as specified in Section 3.5 of Annex VI, and of the conditions of use(s);

( f ) except where the downstream user is relying on the exemption in Article 37(4)(c), a proposal for additional testing on vertebrate animals, where this is considered necessary by the downstream user to complete his chemical safety assessment.

3 . The downstream user shall update this information without delay in the event of a change in the information reported in accordance with paragraph 1.

4 . A downstream user shall report to the Agency if his classification of a substance is different to that of his supplier.

5 . Except where a downstream user is relying on the exemption in Article 37(4)(c), reporting in accordance with paragraphs 1 to 4 of this Article shall not be required in respect of a substance, on its own or in a [^F1 mixture^F1] , used by the downstream user in quantities of less than one tonne per year for that particular use.

Article 39 Application of downstream user obligations

1 . Downstream users shall be required to comply with the requirements of Article 37 at the latest 12 months after receiving a registration number communicated to them by their suppliers in a safety data sheet.

2 . Downstream users shall be required to comply with the requirements of Article 38 at the latest six months after receiving a registration number communicated to them by their suppliers in a safety data sheet.

TITLE VI EVALUATION

CHAPTER 1 Dossier evaluation

Article 40 Examination of testing proposals

[^F1 1 . The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances above 100 tonnes per year with uses resulting in widespread and diffuse exposure, provided they fulfil the criteria for any of the following hazard classes or categories set out in Annex I of Regulation (EC) No 1272/2008:

( a ) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

( b ) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

( c ) hazard class 4.1;

( d ) hazard class 5.1.^F1]

2 . Information relating to testing proposals involving tests on vertebrate animals shall be published on the Agency website. The Agency shall publish on its website the name of the substance, the hazard end-point for which vertebrate testing is proposed, and the date by which any third party information is required. It shall invite third parties to submit, using the format provided by the Agency, scientifically valid information and studies that address the relevant substance and hazard end-point, addressed by the testing proposal, within 45 days of the date of publication. All such scientifically valid information and studies received shall be taken into account by the Agency in preparing its decision in accordance with paragraph 3.

3 . On the basis of the examination under paragraph 1, the Agency shall draft one of the following decisions and that decision shall be taken in accordance with the procedure laid down in Articles 50 and 51:

( a ) a decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline for submission of the study summary, or the robust study summary if required by Annex I;

( b ) a decision in accordance with point (a), but modifying the conditions under which the test is to be carried out;

( c ) a decision in accordance with points (a), (b) or (d) but requiring registrant(s) or downstream user(s) to carry out one or more additional tests in cases of non-compliance of the testing proposal with Annexes IX, X and XI;

( d ) a decision rejecting the testing proposal;

( e ) a decision in accordance with points (a), (b) or (c), if several registrants or downstream users of the same substance have submitted proposals for the same test, giving them the opportunity to reach an agreement on who will perform the test on behalf of all of them and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users, as appropriate, to perform the test on behalf of all of them.

4 . The registrant or downstream user shall submit the information required to the Agency by the deadline set.

Article 41 Compliance check of registrations

1. The Agency may examine any registration in order to verify any of the following:

(a) that the information in the technical dossier(s) submitted pursuant to Article 10 complies with the requirements of Articles 10, 12 and 13 and with Annexes III and VI to X;

(b) that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes VII to X and with the general rules set out in Annex XI;

(c) that any required chemical safety assessment and chemical safety report comply with the requirements of Annex I and that the proposed risk management measures are adequate;

(d) that any explanation(s) submitted in accordance with Article 11(3) or Article 19(2) have an objective basis.

2. The list of dossiers being checked for compliance by the Agency shall be made available to [^F109 the appropriate authorities that request it^F109] .

3. On the basis of an examination made pursuant to paragraph 1, the Agency may, within 12 months of the start of the compliance check, prepare a draft decision requiring the registrant(s) to submit any information needed to bring the registration(s) into compliance with the relevant information requirements and specifying adequate time limits for the submission of further information. Such a decision shall be taken in accordance with the procedure laid down in Articles 50 and 51.

4. The registrant shall submit the information required to the Agency by the deadline set.

5.[^F110 The registration dossiers selected by the Agency for compliance checking must include—

(a)until 27 October 2027, not less than 20% of the registration dossiers received by the Agency for substances referred to in Article 127P(4B)(a);

(b)until 27 October 2030, not less than 20% of the registration dossiers received by the Agency for substances referred to in Article 127P(4B)(b);

(c)until 27 October 2035, not less than 20% of the registration dossiers received by the Agency for substances referred to in Article 127P(4B)(c).^F110]

[^F111 In this paragraph, references to registration dossiers do not include the dossiers referred to in Article 127B(9).^F111]

^F1126.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[^F113 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.^F113]

Article 42 Check of information submitted and follow-up to dossier evaluation

1. The Agency shall examine any information submitted in consequence of a decision taken under Articles 40 or 41, and draft any appropriate decisions in accordance with these Articles, if necessary.

2. Once the dossier evaluation is completed, the Agency shall notify the [^F114 appropriate authorities that request the notification^F114] of the information obtained and any conclusions made. ^F115 ... The Agency shall use the information obtained from this evaluation for the purposes of Article 44.

Article 43 Procedure and time periods for examination of testing proposals

1. In the case of non phase-in substances, the Agency shall prepare a draft decision in accordance with Article 40(3) within 180 days of receiving a registration or downstream user report containing a testing proposal.

2. In the case of phase-in substances, the Agency shall prepare the draft decisions in accordance with Article 40(3):

^F116 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F116 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c) by 1 June [^F117 2023^F117] for any registrations containing testing proposals received [^F118 by ECHA^F118] by 1 June 2018.

3. The list of registration dossiers being evaluated under Article 40 shall be made available to [^F119 appropriate authorities that request it^F119] .

CHAPTER 2 Substance evaluation

Article 44 Criteria for substance evaluation

1. [^F120 The^F120] Agency shall in cooperation with the [^F121 appropriate authorities^F121] develop criteria for prioritising substances with a view to further evaluation. Prioritisation shall be on a risk-based approach. The criteria shall consider:

(a) hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;

(b) exposure information;

(c) tonnage, including aggregated tonnage from the registrations submitted by several registrants.

2. The Agency shall use the criteria in paragraph 1 for the purpose of compiling a draft ^F122 ... rolling action plan which shall cover a period of three years and shall specify substances to be evaluated each year. Substances shall be included if there are grounds for considering (either on the basis of a dossier evaluation carried out by the Agency or on the basis of any other appropriate source, including information in the registration dossier) that a given substance constitutes a risk to human health or the environment. [^F123 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.^F123]

^F124 ...

Article 45 [^F125Evaluation of substances on the rolling action plan^F125]

1. The Agency shall be responsible for ^F126 ... ensuring that substances on the ^F127 ... rolling action plan are evaluated. ^F128 ...

^F129 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F129 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F129 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F129 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 46 Requests for further information and check of information submitted

1. If the [^F130 Agency^F130] considers that further information is required, including, if appropriate, information not required in Annexes VII to X, it shall prepare a draft decision, stating reasons, requiring the registrant(s) to submit the further information and setting a deadline for its submission. A draft decision shall be prepared within 12 months of the publication of the ^F131 ... rolling action plan on the Agency's website for substances to be evaluated that year. The decision shall be taken in accordance with the procedure laid down in Articles 50 and 52.

2. The registrant shall submit the information required to the Agency by the deadline set.

3. The [^F132 Agency^F132] shall examine any information submitted, and shall draft any appropriate decisions in accordance with this Article, if necessary, within 12 months of the information being submitted.

4. The [^F133 Agency^F133] shall finish its evaluation activities within 12 months of the start of the evaluation of the substance or within 12 months of the information being submitted under paragraph 2 ^F134 .... If this deadline is exceeded, the evaluation shall be deemed to be finished.

Article 47 Coherence with other activities

1. An evaluation of a substance shall be based on all relevant information submitted on that particular substance and on any previous evaluation under this Title. Where information on intrinsic properties of a substance has been generated by reference to structurally related substance(s), the evaluation may also cover these related substances. In cases where a decision on an evaluation has been previously taken in accordance with Article 51 or Article 52, any draft decision requiring further information under Article 46 may be justified only by a change of circumstances or acquired knowledge.

^F135 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[^F136 Article 48 Follow-up to substance evaluation

Once the substance evaluation has been completed, the Agency must consider how to use the information obtained from this evaluation for the purposes of Article 59(3) and Article 69(4). The Agency must inform the appropriate authorities and the registrant of its conclusions as to whether or how to use the information obtained.^F136]

CHAPTER 3 Evaluation of intermediates

Article 49 Further information on on-site isolated intermediates

For on-site isolated intermediates that are used in strictly controlled conditions, neither dossier nor substance evaluation shall apply. However, where the [^F137 Agency^F137] considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, it may:

[^F138 Where the appropriate authority in relation to the part of Great Britain where the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, that appropriate authority may request the Agency to take the steps set out in points (a) and (b) of the first paragraph.

The Agency must inform the appropriate authorities that request them of the results of an assessment under this Article.^F138]

CHAPTER 4 Common provisions

Article 50 Registrants' and downstream users' rights

1. The Agency shall notify any draft decision under Articles 40, 41 or 46 to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt. If the concerned registrant(s) or downstream user(s) wish to comment, they shall provide their comments to the Agency. ^F139 ...

2. If a registrant has ceased the manufacture or import of the substance, or the production or import of an article, or the downstream user the use, he shall inform the Agency of this fact with the consequence that the registered volume in his registration, if appropriate, shall be put to zero and no further information may be requested with respect to that substance, unless the registrant notifies the restart of the manufacture or import of the substance or the production or import of the article, or the downstream user notifies the restart of the use. The Agency shall inform the [^F140 appropriate authorities that request it, when a registrant has informed the Agency in accordance with this paragraph^F140] .

3. The registrant may cease the manufacture or import of the substance or the production or import of the article, or the downstream user the use, upon receipt of the draft decision. In such cases, the registrant, or downstream user, shall inform the Agency of this fact with the consequence that his registration, or report, shall no longer be valid, and no further information may be requested with respect to that substance, unless he submits a new registration or report. The Agency shall inform the [^F141 appropriate authorities that request it, when a registrant has informed the Agency in accordance with this paragraph^F141] .

4. Notwithstanding paragraphs 2 and 3, further information may be required in accordance with Article 46 in either or both of the following cases:

(a) where the [^F142 Agency^F142] prepares a dossier in accordance with Annex XV concluding that there is a potential long-term risk to human health or the environment justifying the need for further information;

(b) where the exposure to the substance manufactured or imported by the registrant(s), or to the substance in the article produced or imported by the registrant(s), or to the substance used by the downstream user(s) contributes significantly to that risk.

The procedure in Articles 69 to 73 shall apply mutatis mutandis .

[^F143 Article 51 Adoption of decisions under dossier evaluation

1. This Article applies where the Agency has notified its draft decision in accordance with Article 40 or 41.

2. If the Agency receives no comments from the registrant or downstream user, the Agency must make its decision in the version notified under paragraph 1.

3. If the Agency receives any comments from the registrant or downstream user, the Agency must—

(a) take the comments into account, and

(b) make its decision (whether that is to make the decision in the version notified or vary the decision notified).

4. The Agency must notify the registrant or downstream user and the appropriate authorities of the decision made under paragraph 2 or 3.

5. An appeal may be brought, in accordance with Articles 91, 92 and 93 against a decision made under paragraph 2 or 3.^F143]

[^F144 Article 52 Adoption of decisions under substance evaluation

1. This Article applies where the Agency has circulated its draft decision in accordance with Article 46.

2. If the Agency receives no comments from the registrant or the downstream user, the Agency must make its decision in the version circulated under paragraph 1.

3. If the Agency receives any comments from the registrant or the downstream user, the Agency must—

(a) take the comments into account, and

(b) make its decision (whether that is to make the decision in the version circulated or vary the decision circulated).

4. The Agency must notify the registrant or the downstream user, and the appropriate authorities, of the decision made under paragraph 2 or 3.

5. An appeal may be brought, in accordance with Articles 91, 92 and 93 against a decision made under paragraph 2 or 3.^F144]

Article 53 Cost sharing for tests without an agreement between registrants and/or downstream users

1 . Where registrants or downstream users are required to perform a test as a result of a decision taken under this Title, those registrants or downstream users shall make every effort to reach an agreement as to who is to carry it out on behalf of the other registrants or downstream users and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users to perform the test on behalf of all of them.

2 . If a registrant or downstream user performs a test on behalf of others, they shall all share the cost of that study equally.

3 . In the case referred to in paragraph 1, the registrant or downstream user who performs the test shall provide each of the others concerned with a copy of the full study report.

4 . The person performing and submitting the study shall have a claim against the others accordingly. Any person concerned shall be able to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provide security for that amount or fails to hand over a copy of the full study report of the study performed. All claims shall be enforceable in the national courts. Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration order.

Article 54 Publication of information on evaluation

By 28 February of each year, the Agency shall publish on its website a report on the progress made over the previous calendar year towards discharging the obligations incumbent upon it in relation to evaluation. This report shall include, in particular, recommendations to potential registrants in order to improve the quality of future registrations.

TITLE VII AUTHORISATION

CHAPTER 1 Authorisation requirement

Article 55 Aim of authorisation and considerations for substitution

The aim of this Title is to ensure the good functioning of the [^F145 market in Great Britain^F145] while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.

Article 56 General provisions

1. A manufacturer, importer or downstream user shall not place a substance on the market for a use or use it himself if that substance is included in Annex XIV, unless:

(a) the use(s) of that substance on its own or in a [^F1 mixture^F1] or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been authorised in accordance with Articles 60 to 64; or

(b) the use(s) of that substance on its own or in a [^F1 mixture^F1] or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been exempted from the authorisation requirement in Annex XIV itself in accordance with Article 58(2); or

(c) the date referred to in Article 58(1)(c)(i) has not been reached; or

(d) the date referred to in Article 58(1)(c)(i) has been reached and he made an application 18 months before that date but a decision on the application for authorisation has not yet been taken; or

(e) in cases where the substance is placed on the market, authorisation for that use has been granted to his immediate downstream user.

2. A downstream user may use a substance meeting the criteria set out in paragraph 1 provided that the use is in accordance with the conditions of an authorisation granted to an actor up his supply chain for that use.

3. Paragraphs 1 and 2 shall not apply to the use of substances in scientific research and development. Annex XIV shall specify if paragraphs 1 and 2 apply to product and process orientated research and development as well as the maximum quantity exempted.

4. Paragraphs 1 and 2 shall not apply to the following uses of substances:

(a) uses in plant protection products within the scope of [^F146 Regulation (EC) No 1107/2009^F146] ;

(b) uses in biocidal products within the scope of [^F147 Regulation (EU) No 528/2012^F147] ;

(c) use as motor fuels covered by [^F148 the Motor Fuel (Composition and Content) Regulations 1999^F148] ;

(d) uses as fuel in mobile or fixed combustion plants of mineral oil products and use as fuels in closed systems.

5. In the case of substances that are subject to authorisation only because they meet the criteria in Article 57(a), (b) or (c) or because they are identified in accordance with Article 57(f) only because of hazards to human health, paragraphs 1 and 2 of this Article shall not apply to the following uses:

(a) uses in cosmetic products within the scope of [^F149 Regulation (EC) No 1223/2009^F149] ;

(b) uses in food contact materials within the scope of Regulation (EC) No 1935/2004.

6. Paragraphs 1 and 2 shall not apply to the use of substances when they are present in [^F1 mixtures^F1] :

(a) for substances referred to in Article 57(d), (e) and (f), below a concentration limit of 0,1 % weight by weight (w/w);

[^F1 (b) for all other substances, below the values specified in Article 11(3) of Regulation (EC) No 1272/2008 which result in the classification of the mixture as hazardous.^F1]

Article 57 Substances to be included in Annex XIV

The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:

Article 58 Inclusion of substances in Annex XIV

1. [^F150 The Secretary of State may, by regulations, include in Annex 14 substances referred to in Article 57. The regulations must specify for each substance:^F150]

(a) the identity of the substance as specified in Section 2 of Annex VI;

(b) the intrinsic property (properties) of the substance referred to in Article 57;

(c) transitional arrangements:

(d) review periods for certain uses, if appropriate;

(e) uses or categories of uses exempted from the authorisation requirement, if any, and conditions for such exemptions, if any.

2. Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific ^F151 ... legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled. In the establishment of such exemptions, account shall be taken, in particular, of the proportionality of risk to human health and the environment related to the nature of the substance, such as where the risk is modified by the physical form.

3. Prior to a decision to include substances in Annex XIV, the Agency shall ^F152 ... recommend priority substances to be included specifying for each substance the items set out in paragraph 1. Priority shall normally be given to substances with:

(a) PBT or vPvB properties; or

(b) wide dispersive use; or

(c) high volumes.

The number of substances included in Annex XIV and the dates specified under paragraph 1 shall also take account of the Agency's capacity to handle applications in the time provided for. The Agency shall make its first recommendation of priority substances to be included in Annex XIV [^F153 within 12 months of IP completion day^F153] . The Agency shall make further recommendations at least every second year with a view to including further substances in Annex XIV.

4. Before the Agency sends its recommendation to the [^F154 appropriate authorities^F154] it shall make it publicly available on its website, clearly indicating the date of publication, taking into account Articles 118 and 119 on access to information. The Agency shall invite all interested parties to submit comments within three months of the date of publication, in particular on uses which should be exempt from the authorisation requirement.

The Agency shall update its recommendation, taking into account the comments received.

5. Subject to paragraph 6, after inclusion of a substance in Annex XIV, this substance shall not be subjected to new restrictions under the procedure outlined in Title VIII covering the risks to human health or the environment from the use of the substance on its own, in a [^F1 mixture^F1] or incorporation of a substance in an article arising from the intrinsic properties specified in Annex XIV.

6. A substance listed in Annex XIV may be subjected to new restrictions under the procedure outlined in Title VIII covering the risks to human health or the environment from the presence of the substance in (an) article(s).

7. Substances for which all uses have been prohibited under Title VIII or by other ^F155 ... legislation shall not be included in Annex XIV or shall be removed from it.

[^F156 8. The Secretary of State may, by regulations, remove from Annex 14 substances which as a result of new information no longer meet the criteria of Article 57.^F156]

[^F157 9. Regulations under paragraph 1 or 8 are to be made by statutory instrument; and a statutory instrument containing regulations under paragraph 1 or 8 is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under paragraph 1 or 8 is subject to the consent requirement in Article 4A.^F157]

Article 59 Identification of substances referred to in Article 57

1. The procedure set out in paragraphs 2 to 10 of this Article shall apply for the purpose of identifying substances meeting the criteria referred to in Article 57 and establishing a candidate list for eventual inclusion in Annex XIV. The Agency shall indicate, within this list, the substances that are on its work programme according to Article 83(3)(e).

[^F158 1A. The Agency must include in its candidate list every substance that is included in ECHA's candidate list under Article 59(1) of EU REACH immediately before IP completion day.^F158]

2. [^F159 An appropriate authority^F159] may ask the Agency to prepare a dossier in accordance with relevant Sections of Annex XV for substances which in its opinion meet the criteria set out in Article 57. [^F1 The dossier may be limited, if appropriate, to a reference to an entry in [^F160 the GB mandatory classification and labelling list^F160] .^F1] The Agency shall make this dossier available to the [^F161 appropriate authorities^F161] .

3. [^F162 The Agency^F162] may prepare a dossier in accordance with Annex XV for substances which in its opinion meet the criteria set out in Article 57 ^F163 .... [^F1 The dossier may be limited, if appropriate, to a reference to an entry in [^F164 the GB mandatory classification and labelling list^F164] .^F1] The Agency shall make this dossier available [^F165 to the appropriate authorities^F165] .

4. The Agency shall publish on its website a notice that an Annex XV dossier has been prepared for a substance. The Agency shall invite all interested parties to submit comments within a specified deadline to the Agency.

^F166 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6. If the Agency does not receive ^F167 ... any comments, it shall include this substance on the list referred to in paragraph 1. The Agency may include this substance in its recommendations under Article 58(3).

7. When comments are ^F168 ... received, the Agency [^F169 must consider the comments and make a decision on the identification of the substance within 45 days of the deadline specified in paragraph 4^F169] .

^F170 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F170 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10. The Agency shall publish and update the list referred to in paragraph 1 on its website without delay after a decision on inclusion of a substance has been taken.

CHAPTER 2 Granting of authorisations

Article 60 Granting of authorisations

1. The [^F171 Secretary of State^F171] shall be responsible for taking decisions on applications for authorisations in accordance with this Title. [^F172 That responsibility of the Secretary of State is subject to the provisions of this Title which make the exercise of certain functions subject to the consent requirement in Article 4A.^F172]

2. Without prejudice to paragraph 3, an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with Section 6.4 of Annex I and as documented in the applicant's chemical safety report, taking into account the opinion of the [^F173 Agency so far as the opinion relates to the elements^F173] referred to in Article 64(4)(a). When granting the authorisation, and in any conditions imposed therein, the [^F174 Secretary of State^F174] shall take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the time of the decision.

The [^F174 Secretary of State^F174] shall not consider the risks to human health arising from the use of a substance in a [^F175 relevant medical device^F175] .

3. Paragraph 2 shall not apply to:

(a) substances meeting the criteria in Article 57(a), (b), (c) or (f) for which it is not possible to determine a threshold in accordance with Section 6.4 of Annex I;

(b) substances meeting the criteria in Article 57(d) or (e);

(c) substances identified under Article 57(f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties.

4. If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account [^F176 the elements^F176] referred to in Article 64(4)(a) and (b):

(a) the risk posed by the uses of the substance, including the appropriateness and effectiveness of the risk management measures proposed;

(b) the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties;

(c) the analysis of the alternatives submitted by the applicant under Article 62(4)(e) or any substitution plan submitted by the applicant under Article 62(4)(f), and any third party contributions submitted under Article 64(2);

(d) available information on the risks to human health or the environment of any alternative substances or technologies.

5. When assessing whether suitable alternative substances or technologies are available, all relevant aspects shall be taken into account by the [^F177 Secretary of State^F177] , including:

(a) whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures;

(b) the technical and economic feasibility of alternatives for the applicant.

6. A use shall not be authorised if this would constitute a relaxation of a restriction set out in Annex XVII.

7. An authorisation shall be granted only if the application is made in conformity with the requirements of Article 62.

8. Authorisations shall be subject to a time-limited review without prejudice to any decision on a future review period and shall normally be subject to conditions, including monitoring. The duration of the time-limited review for any authorisation shall be determined on a case-by-case basis taking into account all relevant information including the elements listed in paragraph 4(a) to (d), as appropriate.

9. The authorisation shall specify:

(a) the person(s) to whom the authorisation is granted;

(b) the identity of the substance(s);

(c) the use(s) for which the authorisation is granted;

(d) any conditions under which the authorisation is granted;

(e) the time-limited review period;

(f) any monitoring arrangement.

10. Notwithstanding any conditions of an authorisation, the holder shall ensure that the exposure is reduced to as low a level as is technically and practically possible.

Article 61 Review of authorisations

1. Authorisations granted in accordance with Article 60 shall be regarded as valid until the [^F178 Secretary of State^F178] decides to amend or withdraw the authorisation in the context of a review, provided that the holder of the authorisation submits a review report at least 18 months before the expiry of the time-limited review period. Rather than re-submitting all elements of the original application for the current authorisation, the holder of an authorisation may submit only the number of the current authorisation, subject to the second, third and fourth subparagraphs.

A holder of an authorisation granted in accordance with Article 60 shall submit an update of the analysis of alternatives referred to in Article 62(4)(e), including information about any relevant research and development activities by the applicant, if appropriate, and any substitution plan submitted under Article 62(4)(f). If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account the elements in Article 60(5), he shall submit a substitution plan, including a timetable for proposed actions by the applicant. If the holder cannot demonstrate that the risk is adequately controlled, he shall also submit an update of the socio-economic analysis contained in the original application.

If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report.

If any other elements of the original application have changed, he shall also submit updates of these element(s).

When any updated information is submitted in accordance with this paragraph, any decision to amend or withdraw the authorisation in the context of the review shall be taken in accordance with the procedure referred to in Article 64 applied mutatis mutandis .

[^F179 The function of deciding under this paragraph whether to amend or withdraw the authorisation is subject to the consent requirement in Article 4A.^F179]

2. Authorisations may be reviewed at any time if:

(a) the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio-economic impact; or

(b) new information on possible substitutes becomes available.

The [^F180 Secretary of State^F180] shall set a reasonable deadline by which the holder(s) of the authorisation may submit further information necessary for the review and indicate by when it will take a decision in accordance with Article 64.

[^F181 Any of the other appropriate authorities may request the Secretary of State to carry out a review of an authorisation under this paragraph.^F181]

3.In its review decision the [^F182 Secretary of State^F182] may, if circumstances have changed and taking into account the principle of proportionality, amend or withdraw the authorisation, if under the changed circumstances it would not have been granted or if suitable alternatives in accordance with Article 60(5) become available. In the latter case the [^F182 Secretary of State^F182] shall require the holder of the authorisation to present a substitution plan if he has not already done so as part of his application or update.

In cases where there is a serious and immediate risk for human health or the environment, the [^F182 Secretary of State^F182] may suspend the authorisation pending the review, taking into account the principle of proportionality.

[^F183 Where the Secretary of State is carrying out a review of an authorisation under this paragraph, any of the other appropriate authorities may request the Secretary of State to suspend the authorisation while the review is being carried out.

The function of deciding under the first subparagraph whether to amend or withdraw the authorisation, and the function of deciding under the second subparagraph whether to suspend the authorisation, are subject to the consent requirement in Article 4A.^F183]

4. If an environmental quality standard ^F184... is not met, the authorisations granted for the use of the substance concerned may be reviewed.

5. If the [^F185 river basin^F185] environmental objectives ^F186... are not met, the authorisations granted for the use of the substance concerned in the relevant river basin may be reviewed.

6. If a use of a substance is subsequently prohibited or otherwise restricted in Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants (30), the [^F187 Secretary of State^F187] shall withdraw the authorisation for that use.

[^F188 7.In this Article—

(a) “ environmental quality standard ” means the set of requirements which must be fulfilled at a given time in relation to a given environment or particular part thereof, as set out in [^F189 assimilated ^F189] law;

(c) “ river basin district in Scotland ” means an area designated as a river basin district by order under section 4(1) of the Water Environment and Water Services (Scotland) Act 2003 ;

(d) “ river basin environmental objectives ” means—

(i)in relation to the Northumbria River Basin District, the environmental objectives referred to in the WFD Regulations as applied by regulation 5 of the Water Environment (Water Framework Directive) (Northumbria River Basin District) Regulations 2003;

(ii)in relation to the Solway Tweed River Basin District, the environmental objectives as defined in regulation 2 of the Water Environment (Water Framework Directive) (Solway Tweed River Basin District) Regulations 2004;

(iii)in relation to any other river basin district within the meaning of the WFD Regulations, the environmental objectives referred to in those Regulations;

(iv)in relation to a river basin district in Scotland, the environmental objectives set under section 9(1)(a) of the Water Environment and Water Services (Scotland) Act 2003;

(e) “ the WFD Regulations ” means the Water Environment (Water Framework Directive) (England and Wales) Regulations 2017 . ^F188]

Article 62 Applications for authorisations

1. An application for an authorisation shall be made to the Agency.

2. Applications for authorisation may be made by the manufacturer(s), importer(s) and/or downstream user(s) of the substance. Applications may be made by one or several persons.

3. Applications may be made for one or several substances, that meet the definition of a group of substances in Section 1.5 of Annex XI, and for one or several uses. Applications may be made for the applicant's own use(s) and/or for uses for which he intends to place the substance on the market.

4. An application for authorisation shall include the following information:

(a) the identity of the substance(s), as referred to in Section 2 of Annex VI;

(b) the name and contact details of the person or persons making the application;

(c) a request for authorisation, specifying for which use(s) the authorisation is sought and covering the use of the substance in [^F1 mixtures^F1] and/or the incorporation of the substance in articles, where this is relevant;

(d) unless already submitted as part of the registration, a chemical safety report in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIV;

(e) an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution and including, if appropriate information about any relevant research and development activities by the applicant;

(f) where the analysis referred to in point (e) shows that suitable alternatives are available, taking into account the elements in Article 60(5), a substitution plan including a timetable for proposed actions by the applicant.

5. The application may include:

(a) a socio-economic analysis conducted in accordance with Annex XVI;

(b) a justification for not considering risks to human health and the environment arising either from:

(i)emissions of a substance from an installation for which a permit [^F190 to carry out an activity referred to in Annex I to Directive 2010/75/EU was granted in accordance with [^F191 assimilated^F191] law^F190] ; or

[^F192 (ii)discharges of a substance from a point source governed by [^F193 assimilated^F193] law that transposed the requirement for prior regulation referred to in Article 11(3)(g) of Directive 2000/60/EC and Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy.^F192]

6 . The application shall not include the risks to human health arising from the use of a substance in a [^F194 relevant medical device^F194] .

7 . An application for an authorisation shall be accompanied by the fee required in accordance with Title IX.

Article 63 Subsequent applications for authorisation

1 . If an application has been made for a use of a substance, a subsequent applicant may refer to the appropriate parts of the previous application submitted in accordance with Article 62(4)(d), (e) and (f) and (5)(a), provided that the subsequent applicant has permission from the previous applicant to refer to these parts of the application.

2 . If an authorisation has been granted for a use of a substance, a subsequent applicant may refer to the appropriate parts of the previous application submitted in accordance with Article 62(4)(d), (e) and (f) and (5)(a), provided that the subsequent applicant has permission from the holder of the authorisation to refer to these parts of the application.

3 . Before referring to any previous application in accordance with paragraphs 1 and 2, the subsequent applicant shall update the information of the original application as necessary.

Article 64 Procedure for authorisation decisions

1. The Agency shall acknowledge the date of receipt of the application. [^F195 The Agency must give its draft opinion within ten months of the date of receipt of the application^F195] .

2. The Agency shall make available on its web-site broad information on uses, taking into account Articles 118 and 119 on access to information, for which applications have been received and for reviews of authorisations, with a deadline by which information on alternative substances or technologies may be submitted by interested third parties.

[^F196 3. In preparing its opinion, the Agency must first check that the application includes all the information specified in Article 62 that is relevant to its remit. If necessary, the Agency must request additional information to bring the application into conformity with the requirements of Article 62. The Agency may, if it deems it necessary, require the applicant or request third parties to submit, within a specified time period, additional information on possible alternative substances or technologies. The Agency, and any scientific adviser providing the Agency with scientific knowledge and advice in relation to the opinion, must take into account any information submitted by third parties.^F196]

[^F197 3A. In paragraph 3 “ scientific adviser ” means a person who the Agency has commissioned (in compliance with the duty imposed by Article 77(A1)) to provide it with scientific knowledge and advice. ^F197]

4. The draft [^F198 opinion^F198] shall include the following elements:

(a) ^F199 ... An assessment of the risk to human health and/or the environment arising from the use(s) of the substance, including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives;

(b) ^F200 ... An assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance as described in the application, when an application is made in accordance with Article 62 and of any third party contributions submitted under paragraph 2 of this Article.

5. The Agency shall send [^F201 its draft opinion^F201] to the applicant by the end of the deadline set out in paragraph 1. Within one month of receipt of the draft opinion, the applicant may provide written notice that he wishes to comment. The draft opinion shall be deemed to have been received seven days after the Agency has sent it.

If the applicant does not wish to comment, the Agency shall send [^F202 its final opinion to the appropriate authorities^F202] and the applicant, within 15 days of the end of the period within which the applicant may comment or within 15 days of receipt of notice from the applicant that he does not intend to comment.

If the applicant wishes to comment, he shall send his written argumentation to the Agency within two months of the receipt of the draft opinion. The [^F203 Agency^F203] shall consider the comments and adopt [^F204 its^F204] final [^F205 opinion^F205] within two months of receipt of the written argumentation, taking this argumentation into account where appropriate. Within a further 15 days the Agency shall send the [^F205 opinion^F205] , with the written argumentation attached, to the [^F206 appropriate authorities^F206] and the applicant.

6. The Agency shall determine in accordance with Articles 118 and 119 which parts of its [^F207 opinion^F207] and parts of any attachments thereto should be made publicly available on its website.

7. In cases covered by Article 63(1), the Agency shall treat the applications together, provided the deadlines for the first application can be met.

[^F208 8. The Secretary of State must make a decision granting or refusing the authorisation within six months of receipt of the opinion from the Agency.

The function in this paragraph of deciding whether to grant or refuse the authorisation is subject to the consent requirement in Article 4A.^F208]

9. Summaries of the [^F209 decisions of the Secretary of State^F209] , including the authorisation number and the reasons for the decision, in particular where suitable alternatives exist, shall be published [^F210 by the Secretary of State^F210] and shall be made publicly available in a database established and kept up to date by the Agency.

10. In cases covered by Article 63(2), the deadline set out in paragraph 1 of this Article shall be shortened to five months.

CHAPTER 3 Authorisations in the supply chain

Article 65 Obligation of holders of authorisations

Holders of an authorisation, as well as downstream users referred to in Article 56(2) including the substances in a [^F1 mixture^F1] , shall include the authorisation number on the label before they place the substance or a [^F1 mixture^F1] containing the substance on the market for an authorised use ^F211 .... This shall be done without delay once the authorisation number has been made publicly available in accordance with Article 64(9).

Article 66 Downstream users

1. Downstream users using a substance in accordance with Article 56(2) shall notify the Agency within three months of the first supply of the substance.

2. The Agency shall establish and keep up to date a register of downstream users who have made a notification in accordance with paragraph 1. The Agency shall grant access to this register to the [^F212 appropriate authorities^F212] .

TITLE VIII RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, [^F1MIXTURES^F1] AND ARTICLES

CHAPTER 1 General issues

Article 67 General provisions

1. A substance on its own, in a [^F1 mixture^F1] or in an article, for which Annex XVII contains a restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction. This shall not apply to the manufacture, placing on the market or use of a substance in scientific research and development. Annex XVII shall specify if the restriction shall not apply to product and process orientated research and development, as well as the maximum quantity exempted.

2. Paragraph 1 shall not apply to the use of substances in cosmetic products, as defined by [^F213 Regulation 1223/2009^F213] , with regard to restrictions addressing the risks to human health within the scope of that [^F214 Regulation^F214] .

^F215 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER 2 Restrictions process

Article 68 Introducing new and amending current restrictions

1. When there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, ^F216 ... Annex XVII shall be amended [^F217 by regulations made by the Secretary of State which provide for the adoption of new restrictions or the amendment of^F217] current restrictions in Annex XVII, for the manufacture, use or placing on the market of substances on their own, in [^F1 mixtures^F1] or in articles, pursuant to the procedure set out in Articles 69 to 73. [^F218 In exercising the power to make regulations under this paragraph, the Secretary of State^F218] shall take into account the socio-economic impact of the restriction, including the availability of alternatives.

The first subparagraph shall not apply to the use of a substance as an on-site isolated intermediate.

[^F1 2. For a substance on its own, in a mixture or in an article which meets the criteria for classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B, and could be used by consumers [^F219 the Secretary of State may propose restrictions. The function of proposing restrictions is subject to the consent requirement in Article 4A. The Secretary of State may, by regulations, amend Annex 17 to give effect to a proposed restriction.^F219] Articles 69 to 73 shall not apply.^F1]

[^F220 3. Regulations under paragraph 2 of this Article are to be made by statutory instrument; and a statutory instrument containing regulations made under paragraph 2 of this Article is subject to annulment in pursuance of a resolution of either House of Parliament.

The function of making regulations under paragraph 2 of this Article is subject to the consent requirement in Article 4A.^F220]

Article 69 Preparation of a proposal

1. If [^F221 an appropriate authority^F221] considers that the manufacture, placing on the market or use of a substance on its own, in a [^F1 mixture^F1] or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed, it shall ask the Agency to prepare a dossier which conforms to the requirements of Annex XV.

2. After the date referred to in Article 58(1)(c)(i) for a substance listed in Annex XIV, the Agency shall consider whether the use of that substance in articles poses a risk to human health or the environment that is not adequately controlled. If the Agency considers that the risk is not adequately controlled, it shall prepare a dossier which conforms to the requirements of Annex XV.

3. Within 12 months of the receipt of the request from [^F222 an appropriate authority^F222] in paragraph 1 and if this dossier demonstrates that action ^F223 ... is necessary, beyond any measures already in place, the Agency shall suggest restrictions, in order to initiate the restrictions process.

[^F224 4. If the Agency considers that the manufacture, placing on the market or use of a substance on its own, in a mixture or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed, the Agency must prepare a dossier which conforms to the requirements and format of the relevant sections of Annex 15. If this dossier demonstrates that action is necessary, beyond any measures already in place, the Agency must initiate the restrictions process and must inform those who submitted a registration for that substance.

The Agency must refer to any dossier, chemical safety report or risk assessment submitted to it under this Regulation. The Agency must also refer to any relevant risk assessment submitted for other regulatory purposes. To this end other public bodies carrying out a similar task must provide information to the Agency on request.^F224]

[^F225 5. The Agency must maintain a list of substances for which a dossier conforming to the requirements of Annex 15 is planned or underway for the purposes of a proposed restriction.^F225]

[^F226 5A. The Agency or an appropriate authority may propose the re-examination of an existing restriction listed in Annex 17.

If the Agency is proposing the re-examination, it must notify the appropriate authorities of the proposal. If an appropriate authority is proposing a re-examination, it must notify the Agency and the other appropriate authorities of the proposal. Where a re-examination is proposed (by the Agency or an appropriate authority), the Secretary of State must decide, on the basis of evidence presented by whoever proposed the re-examination, whether the re-examination should take place. That function of deciding whether the re-examination should take place is subject to the consent requirement in Article 4A. If the Secretary of State decides that the re-examination should take place, the Agency must carry out the re-examination.^F226]

6. Without prejudice to Articles 118 and 119, the Agency shall make publicly available on its website all dossiers conforming with Annex XV including the restrictions suggested pursuant to paragraphs 3 and 4 of this Article without delay, clearly indicating the date of publication. The Agency shall invite all interested parties to submit individually or jointly within six months of the date of publication:

(a) comments on dossiers and the suggested restrictions;

(b) a socio-economic analysis, or information which can contribute to one, of the suggested restrictions, examining the advantages and drawbacks of the proposed restrictions. It shall conform to the requirements in Annex XVI.

Article 70 Agency opinion: [^F227risk assessment^F227]

Within nine months of the date of publication referred to in Article 69(6), the [^F228 Agency^F228] shall formulate an opinion as to whether the suggested restrictions are appropriate in reducing the risk to human health and/or the environment, based on its consideration of the relevant parts of the dossier. This opinion shall take account of the [^F229 dossier^F229] , and the views of interested parties referred to in Article 69(6)(a).

Article 71 Agency opinion: [^F230socio-economic analysis^F230]

1. Within 12 months of the date of publication referred to in Article 69(6), the [^F231 Agency^F231] shall formulate an opinion on the suggested restrictions, based on its consideration of the relevant parts of the dossier and the socio-economic impact. It shall prepare a draft opinion on the suggested restrictions and on the related socio-economic impact, taking account of the analyses or information according to Article 69(6)(b), if there are any. The Agency shall publish the draft opinion on its website without delay. The Agency shall invite interested parties to give their comments on the draft opinion no later than 60 days from the publication of that draft opinion.

2. The [^F232 Agency^F232] shall without delay adopt its opinion, taking into account where appropriate further comments received by the deadline set. This opinion shall take account of the comments and socio-economic analyses of interested parties submitted under Article 69(6)(b) and under paragraph 1 of this Article.

^F233 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 72 Submission of an opinion to the [^F234appropriate authorities^F234]

1. The Agency shall submit to the [^F235 appropriate authorities^F235] without delay [^F236 its opinions on risk assessment and socio-economic analysis^F236] on restrictions suggested for substances on their own, in [^F1 mixtures^F1] or in articles. If [^F237 the Agency does^F237] not formulate an opinion by the deadline set in Article 70 and Article 71(1) the Agency shall inform the [^F238 appropriate authorities^F238] accordingly, stating the reasons.