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

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[X1 CHAPTER 2 U.K. Granting of authorisations

Article 60 U.K. Granting of authorisations

1. The [F1Secretary of State] shall be responsible for taking decisions on applications for authorisations in accordance with this Title. [F2That 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.]

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 [F3Agency so far as the opinion relates to the elements] referred to in Article 64(4)(a). When granting the authorisation, and in any conditions imposed therein, the [F4Secretary of State] 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 [F4Secretary of State] shall not consider the risks to human health arising from the use of a substance in a [F5relevant medical device] .

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 [F6the elements] 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 [F7Secretary of State] , 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);

(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.

Textual Amendments

F1 Words in Art. 60(1) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 47(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 60(1) inserted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 47(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 60(2) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 47(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 60(2) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 47(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 60(2) substituted (30.9.2021) by The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 4

F6 Words in Art. 60(4) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 47(4); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 60(5) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 47(5); 2020 c. 1, Sch. 5 para. 1(1)

Article 61 U.K. Review of authorisations

1. Authorisations granted in accordance with Article 60 shall be regarded as valid until the [F8Secretary of State] 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 .

[F9The function of deciding under this paragraph whether to amend or withdraw the authorisation is subject to the consent requirement in Article 4A.]

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 [F10Secretary of State] 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.

[F11Any of the other appropriate authorities may request the Secretary of State to carry out a review of an authorisation under this paragraph.]

3. In its review decision the [F12Secretary of State] 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 [F12Secretary of State] 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 [F12Secretary of State] may suspend the authorisation pending the review, taking into account the principle of proportionality.

[F13Where 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.]

4. If an environmental quality standard F14 ... is not met, the authorisations granted for the use of the substance concerned may be reviewed.

5. If the [F15river basin] environmental objectives F16 ... 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 (1) , the [F17Secretary of State] shall withdraw the authorisation for that use.

[F187. 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 retained EU 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.]

Textual Amendments

F8 Words in Art. 61(1) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 48(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Art. 61(1) inserted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 48(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in Art. 61(2) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 48(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in Art. 61(2) inserted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 48(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F12 Words in Art. 61(3) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 48(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Art. 61(3) inserted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 48(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F14 Words in Art. 61(4) omitted (31.12.2020) by virtue of The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 48(5); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in Art. 61(5) inserted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 48(6)(a); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Art. 61(5) omitted (31.12.2020) by virtue of The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 48(6)(b); 2020 c. 1, Sch. 5 para. 1(1)

F17 Words in Art. 61(6) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 48(7); 2020 c. 1, Sch. 5 para. 1(1)

F18 Art. 61(7) inserted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 48(8) (as amended by S.I. 2020/1577, regs. 1(1)(b), 4(23)); 2020 c. 1, Sch. 5 para. 1(1)

Article 62 U.K. 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 [F19mixtures] 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 [F20to carry out an activity referred to in Annex I to Directive 2010/75/EU was granted in accordance with retained EU law] ; or

[F21(ii) discharges of a substance from a point source governed by retained EU 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.]

6 . The application shall not include the risks to human health arising from the use of a substance in a [F22relevant medical device] .

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

Textual Amendments

F19Substituted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).

F20 Words in Art. 62(5)(b)(i) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 49(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F21 Art. 62(5)(b)(ii) substituted (31.12.2020) by The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758), reg. 1(1), Sch. 1 para. 49(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

F22 Words in Art. 62(6) substituted (30.9.2021) by The REACH etc. (Amendment) Regulations 2021 (S.I. 2021/904), regs. 1(2), 5

Article 63 U.K. 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 U.K. Procedure for authorisation decisions

1. The Agency shall acknowledge the date of receipt of the application. [F23The Agency must give its draft opinion within ten months of the date of receipt of the application] .

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.

[F24 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.]

[F253A. 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.]

4. The draft [F26opinion] shall include the following elements:

(a) F27 ... 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) F28 ... 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 [F29its draft opinion] 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 [F30its final opinion to the appropriate authorities] 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 [F31Agency] shall consider the comments and adopt [F32its] final [F33opinion] 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 [F33opinion] , with the written argumentation attached, to the [F34appropriate authorities] and the applicant.

6. The Agency shall determine in accordance with Articles 118 and 119 which parts of its [F35opinion] 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.

[F36 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.]

9. Summaries of the [F37decisions of the Secretary of State] , including the authorisation number and the reasons for the decision, in particular where suitable alternatives exist, shall be published [F38by the Secretary of State] and shall be made publicly available in a database established and kept up to date by the Agency.