Article 16Nanomaterials

1

The provisions of this Article do not apply to nanomaterials used as colourants, UV-filters or preservatives that are regulated under Article 14.

2

A cosmetic product containing nanomaterials must be notified in accordance with paragraph 3.

3

To meet the requirements of paragraph 2, the information set out in paragraph 4 must be submitted by electronic means—

a

to the Secretary of State;

b

by the responsible person; and

c

at least six months prior to the cosmetic product being placed on the market.

4

The information referred to in paragraph 3 must contain—

a

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

b

the specification of the nanomaterial including size of particles and chemical properties;

c

an estimate of the quantity of nanomaterials contained in cosmetic products intended to be placed on the market per year;

d

except where paragraph 13 applies, the toxicological profile of the nanomaterial;

e

the safety data of the nanomaterial relating to the category of cosmetic product, as used in such products;

f

the reasonably foreseeable exposure conditions.

5

Paragraph 6 applies in relation to a cosmetic product containing nanomaterials where prior to F1IP 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 16 of that Regulation in relation to that product.

6

Where this paragraph applies—

a

if the cosmetic product containing nanomaterials is placed on the market at any time before the expiry of the transitory period, subject to subparagraph (b) paragraphs 2 and 3 are to have effect as if they required the information specified in paragraph 4 before the end of the transitory period; and

b

paragraphs 2 and 3 are to be treated as being satisfied in respect of the cosmetic product where—

i

before the end 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 paragraph 4; and

ii

when submitting that information, the responsible person at the same time gives notice confirming the matters set out in paragraph 5 in relation to the cosmetic product;

c

if at any time a request is made to the responsible person by a competent authority in accordance with paragraphs 9 and 10, the responsible person must comply with the request within the period specified in the request.

7

Paragraph 8 applies in relation to a cosmetic product containing nanomaterials where—

a

prior to F1IP completion day a responsible person designated under Article 4 of the EU Regulation (pre-exit) has complied with the requirements of Article 16 of that Regulation in relation to that product; and

b

the period between the day on which F1IP completion day falls and the day on which the person designated under Article 4 of the EU Regulation (pre-exit) complied with Article 16 of that Regulation is less than six months.

8

Where this paragraph applies—

a

paragraphs 2 and 3 are to be treated as being satisfied where—

i

a period of 7 months has elapsed between the day on which the responsible person designated under Article 4 of the EU Regulation (pre-exit) complied with Article 16 of that Regulation and the day on which the responsible person places the cosmetic product on the market;

ii

before the expiry of the transitory period, the responsible person for that cosmetic product submits to the Secretary of State the information set out in paragraph 4; and

iii

when submitting that information, the responsible person at the same time gives notice confirming the matters set out in paragraph 7; and

b

if at any time a request is made to the responsible person by a competent authority in accordance with paragraphs 9 and 10, the responsible person must comply with the request within the period specified in the request.

9

Where a competent authority has concerns regarding the safety of a nanomaterial, the competent authority may request that a responsible person submits the following information to the competent authority—

a

which nanomaterials are used in a cosmetic product; and

b

the reasonably foreseeable exposure conditions.

10

When a competent authority makes a request under paragraph 9, the competent authority must specify a period—

a

within which the responsible person must respond; and

b

which is reasonable and commensurate with the nature of the concerns held by the competent authority.

11

Where paragraph 12 applies, the information set out in paragraph 4 may be provided by the person designated in accordance with that paragraph on behalf of the responsible person.

12

This paragraph applies where—

a

the responsible person designates another person by written mandate to meet the notification requirements under this Article in respect of a cosmetic product on that responsible person's behalf (“the designated person”);

b

the designated person accepts the designation in writing; and

c

the responsible person informs the Secretary of State of the name and address of that designated person.

13

The Secretary of State may provide a reference for the toxicological profile and that reference may be provided in the place of the information referred to in paragraph 4(d)