Article 138 ReviewX1

United Kingdom

F1Within 18 months of IP completion day , the F2Secretary 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. F3 ... When carrying out the review the Secretary 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;

( F4d )

the views of any appropriate authority.

On the basis of these reviews, the Secretary of State may, if appropriate, F5formulate proposals to extend this obligation.

The Secretary of State may F6formulate 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.

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 Secretary of State may F7formulate 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).

F8 4.

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F9Within 18 months of IP completion day , the Secretary 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 Secretary of State may, if appropriate, F10formulate proposals to extend that obligation.

In accordance with the objective of promoting non-animal testing and the replacement, reduction or refinement of animal testing required under this Regulation, the Secretary of State shall review the testing requirements of Section 8.7 of Annex VIII by F11within 18 months of IP completion day .

F12The 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.