Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilShow full title

[X1 Article 60 U.K. Granting of authorisations

1. The [F1 Secretary of State] shall be responsible for taking decisions on applications for authorisations in accordance with this Title. [F2 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.]

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 [F3 Agency 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 [F4 Secretary 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 [F4 Secretary of State] shall not consider the risks to human health arising from the use of a substance in a [F5 relevant 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 [F6 the 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 [F7 Secretary 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);

(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. ]

Editorial Information

X1 Substituted by Corrigendum to 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 (Official Journal of the European Union L 396 of 30 December 2006).

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)