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)

[X1 Article 61 U.K. Review of authorisations

1. Authorisations granted in accordance with Article 60 shall be regarded as valid until the [F1Secretary 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 .

[F2The 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 [F3Secretary 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.

[F4Any 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 [F5Secretary 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 [F5Secretary 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 [F5Secretary of State] may suspend the authorisation pending the review, taking into account the principle of proportionality.

[F6Where 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 F7 ... is not met, the authorisations granted for the use of the substance concerned may be reviewed.

5. If the [F8river basin] environmental objectives F9 ... 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 [F10Secretary of State] shall withdraw the authorisation for that use.

[F117. 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.] ]