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[X1 TITLE XII U.K. INFORMATION

Article 117 U.K. Reporting

F1 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. Every five years, the Agency shall submit to the [F2appropriate authorities] a report on the operation of this Regulation. The Agency shall include in its report [F3sections on evaluation and enforcement,] information on the joint submission of information in accordance with Article 11 and an overview of the explanations given for submitting information separately.

The first report shall be submitted by [F41 April 2022] .

3. Every three years the Agency, in accordance with the objective of promoting non-animal testing methods, shall submit to the [F5appropriate authorities] a report on the status of implementation and use of non-animal test methods and testing strategies used to generate information on intrinsic properties and for risk assessment to meet the requirements of this Regulation.

The first report shall be submitted by [F61 April 2022] .

4. Every five years, the [F7Secretary of State, in cooperation with the other appropriate authorities, must] publish a general report on:

(a) the experience acquired with the operation of this Regulation, including the information referred to in paragraphs 1, 2 and 3 and;

(b) the amount and distribution of funding made available by the [F8appropriate authorities] for the development and evaluation of alternative test methods.

The first report shall be published by [F91 April 2023] .

Textual Amendments

Article 118 U.K. Access to information

F10 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests of the concerned person:

(a) details of the full composition of a [F11mixture] ;

(b) without prejudice to Article 7(6) and Article 64(2), the precise use, function or application of a substance or [F11mixture] , including information about its precise use as an intermediate;

(c) the precise tonnage of the substance or [F11mixture] manufactured or placed on the market;

(d) links between a manufacturer or importer and his distributors or downstream users.

Where urgent action is essential to protect human health, safety or the environment, such as emergency situations, the Agency may disclose the information referred to in this paragraph.

3. The [F12Agency] shall adopt the practical arrangements for F13 ... appeals or remedies necessary for reviewing a partial or full rejection of a confidentiality request F14 ....

F15 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 119 U.K. Electronic public access

1 . The following information held by the Agency on substances whether on their own, in [F11mixtures] or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e):

[F11(a) without prejudice to paragraph 2(f) and (g) of this Article, the name in the IUPAC nomenclature for substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

(b) if applicable, the name of the substance as given in EINECS;

(c) the classification and labelling of the substance;

(d) physicochemical data concerning the substance and on pathways and environmental fate;

(e) the result of each toxicological and ecotoxicological study;

(f) any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) established in accordance with Annex I;

(g) the guidance on safe use provided in accordance with Sections 4 and 5 of Annex VI;

(h) analytical methods if requested in accordance with Annexes IX or X which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans.

2. The following information on substances whether on their own, in [F11mixtures] or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e) except where a party submitting the information submits a justification in accordance with Article 10(a)(xi), accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned:

(a) if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous;

(b) the total tonnage band (i.e. 1 to 10 tonnes, 10 to 100 tonnes, 100 to 1 000 tonnes or over 1 000 tonnes) within which a particular substance has been registered;

(c) the study summaries or robust study summaries of the information referred to in paragraph 1(d) and (e);

( d ) information, other than that listed in paragraph 1, contained in the safety data sheet;

(e) the trade name(s) of the substance;

[F11(f) subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for non-phase-in substances referred to in paragraph 1(a) of this Article for a period of six years;]

[F11 subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for substances referred to in paragraph 1(a) of this Article that are only used as one or more of the following:]

(i)

as an intermediate;

(ii)

in scientific research and development;

(iii)

in product and process orientated research and development.

Textual Amendments

Article 120 U.K. Cooperation with [F16other] countries and international organisations

Notwithstanding Articles 118 and 119, information received by the Agency under this Regulation may be disclosed to any government or national authority of [F17another country or an international organisation in accordance with an agreement concluded between the United Kingdom and the other country or international organisation,] provided that both the following conditions are met:

(a)

the purpose of the agreement is cooperation on the implementation or management of legislation concerning chemicals covered by this Regulation;

(b)

the [F18other country or international organisation concerned] protects the confidential information as mutually agreed.]

Textual Amendments

Editorial Information