The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019

Substitution of Article 13 U.K.

13.  For Article 13 (notification) substitute—

“Article 13 U.K. Notification

1.   Before placing a cosmetic product on the market, the responsible person must submit by electronic means the following information to the Secretary of State—

(a) the category of cosmetic product and its name or names, enabling its specific identification;

(b) the name of the responsible person;

(c) the address at which the product information file in respect of the cosmetic product is kept;

(d) the contact details of a natural person to contact in the case of urgency;

(e) where applicable, the following information—

(i) presence of substances in the form of nanomaterials;

(ii) the identification including the chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes 2 to 6 to this Regulation; and

(iii) the reasonably foreseeable exposure conditions;

(f) the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as [F1 CMR substances of category 1A or 1B] under Regulation (EC) No 1272/2008;

(g) the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties.

2.   When a cosmetic product is placed on the market, the responsible person must notify to the Secretary of State the original labelling and, where reasonably legible, a photograph of the corresponding packaging

3.   Paragraph 4 applies in relation to a cosmetic product where prior to [F2 IP completion day]—

(a) the cosmetic product has been supplied on the market of the United Kingdom or the market of any EEA state for distribution, consumption or use in the course of a commercial activity (whether in return for payment or free of charge); and

(b) a responsible person designated under Article 4 of the EU Regulation (pre-exit) has complied with Article 13 of that Regulation in relation to that product.

4.   Where this paragraph applies—

(a) if the cosmetic product is placed on the market at any time before the expiry of the transitory period, subject to subparagraph (b), paragraphs 1 and 2 are to have effect as if they required the information specified in those paragraphs before the end of the transitory period;

(b) paragraph 1 is to be treated as being satisfied in respect of the cosmetic product and paragraph 2 does not apply in respect of that product where—

(i) before the expiry of the transitory period, the responsible person for the cosmetic product submits to the Secretary of State by electronic means the information set out in points (a) to (d) and (g) of paragraph 1; and

(ii) when submitting that information, the responsible person at the same time gives notice confirming the matters set out in paragraph 3 in relation to the cosmetic product;

(c) if at any time a request is made to the responsible person by the Secretary of State in accordance with paragraphs 5 and 6, the responsible person must comply with the request within the period specified in the request.

5.   Where the Secretary of State considers it necessary for the purposes of reducing a risk to human health, the Secretary of State may request that a responsible person submits the information referred to in paragraph 1(e) to (f) in relation to a cosmetic product to which paragraph 4 applies.

6.   When making a request under paragraph 5 the Secretary of State must specify a period—

(a) within which the responsible person must respond; and

(b) which is reasonable and commensurate with the nature of the risk presented by the product.

7.   The Secretary of State must make the following information available in relation to a cosmetic product to all other competent authorities—

(a) the information referred to in paragraph 1(a) to (f); and

(b) the information referred to in paragraph 2.

8.   Competent authorities may only use the information referred to in paragraph 7 for the purposes of market surveillance, market analysis, evaluation and consumer information in the context of Articles 25 to 27.

9.   The Secretary of State must without delay make the following information available to poison centres or similar bodies established in the United Kingdom—

(a) the information referred to in paragraph 1; and

(b) the information referred to in paragraph 2

10.   Those poison centres and similar bodies may only use that information for the purposes of medical treatment.

11.   Where any information provided under this Article in relation to a cosmetic product changes, the responsible person must provide an update by electronic means to the Secretary of State without delay.”.

Textual Amendments

F1 Words in Sch. 34 para. 13 substituted (31.12.2020 immediately before IP completion day) by The Product Safety, Metrology and Mutual Recognition Agreement (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1246), regs. 1(3), 8(b); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Sch. 34 para. 13 substituted (31.12.2020 immediately before IP completion day) by The Product Safety and Metrology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/852), regs. 2(2), 4(2), Sch. 1 para. 1(t)(iv)

Commencement Information

I1 Sch. 34 para. 13 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1