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[X1 TITLE XV U.K. F1... FINAL PROVISIONS

F2 Article 128 U.K. Free movement

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[F3 Article 129 U.K. Safeguard clause

1. An appropriate authority may impose an appropriate provisional restriction in respect of a substance if that authority—

(a) has justifiable grounds for believing that urgent action is essential to protect human health or the environment in respect of the substance, on its own, in a mixture or in an article, even if satisfying the requirements of this Regulation, and

(b) has competence to impose the provisional restriction.

2. If an appropriate authority imposes a provisional restriction in accordance with paragraph 1, it must—

(a) immediately inform the Agency and the other appropriate authorities, giving reasons for its decision and submitting the scientific or technical information on which the provisional restriction is based, and

(b) within three months of its decision, request the Agency to initiate the procedure under Article 69.

3. When a decision has been reached under Article 73 (as part of the procedure under Article 69) the appropriate authority must revoke the provisional measure.

4. In this Article “ restriction ” means a restriction on the placing on the market or use of a substance.

5. The Secretary of State has competence to impose a provisional restriction if, or to the extent that, the exercise of that function to impose that restriction—

(a) relates to England;

(b) relates to Scotland and is not within devolved competence (within the meaning of section 54 of the Scotland Act 1998);

(c) relates to Wales and is not within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).

6. The Scottish Ministers have competence to impose a provisional restriction if, or to the extent that, the exercise of that function to impose that restriction is within devolved competence (within the meaning of section 54 of the Scotland Act 1998).

7. The Welsh Ministers have competence to impose a provisional restriction if, or to the extent that, the exercise of that function to impose that restriction is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).]

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Article 130 U.K. Statement of reasons for decisions

The [F4appropriate authorities and] the Agency F5... shall state the reasons for all decisions they take under this Regulation.

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[F6 Article 131 U.K. Amendments to the Annexes

1. The Secretary of State may, by regulations, make such amendments of the Annexes as the Secretary of State considers appropriate.

The Secretary of State must consider any request made by any of the other appropriate authorities for amendments of the Annexes to be made.

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

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

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[F7 Article 132 U.K. Implementing legislation

1. The Secretary of State may, by regulations, make such provision as the Secretary of State considers appropriate for putting the provisions of this Regulation efficiently into effect.

The Secretary of State must consider any request made by any of the other appropriate authorities for such provision to be made.

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

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

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[F8Article 132A U.K. Regulations under this Regulation

Any power to make regulations under this Regulation includes power to make supplementary, incidental, consequential, transitional, transitory or saving provision.]

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F9 Article 133 U.K. Committee procedure

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F9 Article 134 U.K. Preparation of establishment of the Agency

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F9 Article 135 U.K. Transitional measures regarding notified substances

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F9 Article 136 U.K. Transitional measures regarding existing substances

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F9 Article 137 U.K. Transitional measures regarding restrictions

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Article 138 U.K. Review

1. [F10Within 18 months of IP completion day] , the [F11Secretary of State] shall carry out a review to assess whether or not to extend the application of the obligation to perform a chemical safety assessment and to document it in a chemical safety report to substances not covered by this obligation because they are not subject to registration or subject to registration but manufactured or imported in quantities of less than 10 tonnes per year. F12 ... When carrying out the review the [F11Secretary of State] shall take into account all relevant factors, including:

(a) the costs for manufacturers and importers of drawing up the chemical safety reports;

(b) the distribution of costs between actors in the supply chain and the downstream user;

(c) the benefits for human health and the environment;

[F13(d) the views of any appropriate authority.]

On the basis of these reviews, the [F11Secretary of State] may, if appropriate, [F14formulate] proposals to extend this obligation.

2. The [F11Secretary of State] may [F15formulate] proposals as soon as a practicable and cost-efficient way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established, and after publishing a report on the following:

(a) the risks posed by polymers in comparison with other substances;

(b) the need, if any, to register certain types of polymer, taking account of competitiveness and innovation on the one hand and the protection of human health and the environment on the other.

3. The report, referred to in Article 117(4), on the experience acquired with the operation of this Regulation shall include a review of the requirements relating to registration of substances manufactured or imported only in quantities starting at one tonne but less than 10 tonnes per year per manufacturer or importer. On the basis of that review, the [F11Secretary of State] may [F16formulate] proposals to modify the information requirements for substances manufactured or imported in quantities of one tonne or more up to 10 tonnes per year per manufacturer or importer, taking into account the latest developments, for example in relation to alternative testing and (quantitative) structure-activity relationships ((Q)SARs).

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8. [F18Within 18 months of IP completion day] , the [F11Secretary of State] shall carry out a review to assess whether or not to extend the scope of Article 33 to cover other dangerous substances, taking into account the practical experience in implementing that Article. On the basis of that review, the [F11Secretary of State] may, if appropriate, [F19formulate] proposals to extend that obligation.

9. In accordance with the objective of promoting non-animal testing and the replacement, reduction or refinement of animal testing required under this Regulation, the [F11Secretary of State] shall review the testing requirements of Section 8.7 of Annex VIII by [F20within 18 months of IP completion day] .

[F21The Secretary of State may, by regulations, amend Annex 8 if the Secretary of State considers that it is appropriate to do so on the basis of this review, while ensuring a high level of protection of health and the environment.

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 Article is subject to the consent requirement in Article 4A.]

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Article 139 U.K. Repeals

Directive 91/155/EEC shall be repealed.

Directives 93/105/EC and 2000/21/EC and Regulations (EEC) No 793/93 and (EC) No 1488/94 shall be repealed with effect from 1 June 2008 .

Directive 93/67/EEC shall be repealed with effect from 1 August 2008 .

Directive 76/769/EEC shall be repealed with effect from 1 June 2009 .

References to the repealed acts shall be construed as references to this Regulation. ]

F22 Article 140 U.K. Amendment of Directive 1999/45/EC

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F23 Article 141 U.K. Entry into force and application

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Editorial Information

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