The Product Safety, Metrology and Mutual Recognition Agreement (Amendment) (EU Exit) Regulations 2019

Amendments to Schedule 34 U.K.

8.  In Schedule 34—

(a) in paragraph 3(h)—

(i) after the inserted point (v) insert—

“(va) ‘CMR’ means carcinogenic, mutagenic or toxic for reproduction;”;

(ii) after the inserted point (y) insert—

“(ya) ‘historic animal testing data’ means data from any animal testing that was carried out before the date on which such testing was prohibited in accordance with Article 18 of the EU Regulation (pre-exit);”;

(b) in paragraph 13, in the inserted Article 13(1)(f) for “carcinogenic” to “1B” substitute “ CMR substances of category 1A or 1B ”;

(c) in paragraph 15, in the inserted Article 15—

(i) for paragraph 1, substitute—

“1.   A cosmetic product must not contain a substance classified as a CMR substance of category 1A, 1B or 2 under Regulation (EC) No 1272/2008, unless the substance is included in any of Annexes 3 to 6.”;

(ii) for paragraph 2, substitute—

“2.   Where a CMR substance of category 1A or 1B is permitted for use in cosmetic products, specific labelling in order to avoid misuse of the cosmetic product must be provided in accordance with Article 3 of this Regulation, taking into account possible risks linked to the presence of hazardous substances and the routes of exposure.”;

(d) in paragraph 17, in the substituted Article 18—

(i) at the beginning of paragraph 1 insert “ Except as provided in paragraph 1A, ”;

(ii) after paragraph 1 insert—

“1A.   Paragraph 1 does not prevent the use of historic animal testing data in order to meet the requirements of this Regulation.”;

(e) in paragraph 27—

(i) in the inserted Article 30, for paragraphs 3 to 7 substitute—

“3.   Where the conditions in paragraph 4 are met, the Secretary of State may by regulations amend Article 16(1) to extend the provisions of Article 16 to nanomaterials used as colourants, UV-filters or preservatives that are regulated under Article 14.

4.   The conditions referred to in paragraph 3 are that the Secretary of State considers that it is necessary to do so in view of—

(a) safety concerns raised by a competent authority; or

(b) scientific or technical evidence that there are safety concerns relating to colourants, UV filters or preservatives regulated under Article 14.

5.   The Secretary of State may amend Article 14(1)(c) to extend its scope to hair colouring products.”;

(ii) in the inserted Article 31, at the end insert—

“(f) Annex 2 to add a substance classified as a CMR substance of category 1A, 1B or 2 under Regulation (EC) No 1272/2008;

(g) Annexes 3 to 6—

(i) to allow a substance classified as a CMR substance of category 2 under Regulation (EC) No 1272/2008 to be used in cosmetic products where the Secretary of State considers that there is sufficient scientific evidence that the substance is safe for use in cosmetic products;

(ii) to allow a substance classified as a CMR substance of category 1A or 1B under Regulation (EC) No 1272/2008 to be used in cosmetic products where the conditions in point (h) are met;

(iii) to make provision as to labelling in order to implement Article 15(2);

(h) the conditions referred to in point (g)(ii) are that—

(i) the CMR substance complies with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety;

(ii) an analysis of alternative substances has been undertaken and concluded that there are no suitable alternative substances available;

(iii) an application to the Secretary of State is made for a particular use of the product category with a known exposure;

(iv) the Secretary of State considers that there is sufficient scientific evidence that the CMR substance has been evaluated and found safe for use in cosmetic products; and

(v) the evaluation referred to in point (iv) took into account exposure to the product and overall exposure to the CMR substance from other sources, particularly for vulnerable population groups”.

Commencement Information

I1 Reg. 8 in force at 31.12.2020 in force immediately before IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(3)