The Cosmetic Products (Safety) Regulations 2008

Requests for confidentiality U.K.

21.—(1) A responsible person who for reasons of trade secrecy wishes not to include one or more cosmetic ingredients in the list of cosmetic ingredients referred to in regulation 12(2) shall submit a request to that effect to the competent authority.

(2) In this regulation “applicant” means a responsible person who submits a request for confidentiality.

(3) The applicant shall ensure that—

(a) the request for confidentiality includes the particulars laid down in Part 1 of Schedule 9; and

(b) any amendments to the particulars provided for in sub-paragraph (a) are communicated as quickly as possible to the competent authority and, in particular, that all changes to the names of cosmetic products containing the cosmetic ingredient in respect of which confidentiality is or has been sought, are communicated to the competent authority at least 15 days before those cosmetic products are supplied under their new names.

(4) Within four months of the receipt of a request for confidentiality in respect of which the requirements of paragraph (3)(a) are satisfied, the competent authority shall examine the request and inform the applicant in writing of its decision.

(5) If the competent authority decides to grant its approval to the applicant's request it shall, in notifying the applicant of its decision, in accordance with paragraph (4), also notify the applicant of the registration number which will replace the cosmetic ingredient in question in the list referred to in regulation 12(2), the said number to be allocated to the product in accordance with the procedure provided for in Part 2 of Schedule 9.

(6) If the competent authority refuses to grant its approval to the applicant's request it shall, in its notification of this refusal, include a statement of the reasons for refusal and a clear explanation of appeals procedures and their time limits.

(7) In exceptional cases the competent authority may inform the applicant in writing that a period of two months in addition to the four-month period referred to in paragraph (4) is required for the examination of the request.

(8) A decision granting confidentiality shall be valid for a period of five years.

(9) An applicant may, by submitting a reasoned request to the competent authority, request that the period of confidentiality referred to in paragraph (8) be extended.

(10) In the event of a reasoned request being submitted in accordance with paragraph (9), the competent authority shall deal with the request in accordance with paragraphs (4), (5) and (6).

(11) Any extension of the period of confidentiality shall not exceed three years.

(12) The competent authority may withdraw its approval to an applicant's request for confidentiality if it considers this appropriate taking into account—

(a) any amendments to the particulars provided for in paragraph (3)(a) which are communicated to it in accordance with paragraph (3)(b); and

(b) any new information which comes to its attention which makes it imperative, particularly for compelling reasons of public health, for it to so act,

and in withdrawing its approval the competent authority shall comply with the provisions of paragraphs (4), (6) and (7).