S.I. No. 11/1984 - European Communities (Cosmetic Products) Regulations, 1984.


The Minister for Health, in exercise of the powers conferred on him by section 3 of the European Communities Act, 1972 (No. 27 of 1972), hereby makes the following Regulations:—

1. These Regulations may be cited as the European Communities (Cosmetic Products) Regulations, 1984.

2. The European Communities (Cosmetic Products) Regulations 1979 and 1982 ( S.I. No. 402 of 1979 and S.I. No. 341 of 1982 ) are hereby revoked.

3. (1) In these Regulations:—

"the Council Directive" means Council Directive 76/768/EEC 1 as amended by Council Directives 79/661/EEC 2, 82/368/EEC 3 and 83/574/EEC 4 and by Commission Directives 82/147/EEC 5 , 83/191/EEC 6, 83/341/EEC 7 and 83/496/EEC 8;

1Official Journal of the European Communities, No. L262 27/9/76 (pages 169-200).

2Official Journal of the European Communities, No. L192 31/7/79 (page 35).

3Official Journal of the European Communities, No. L167 15/6/82 (pages 1-32).

4Official Journal of the European Communities, No. L332 28/11/83 (pages 38-42).

5Official Journal of the European Communities, No. L63 6/3/82 (page 26).

6Official Journal of the European Communities, No. L109 26/4/83 (pages 25-27).

7Official Journal of the European Communities, No. L188 13/7/83 (page 15).

8Official Journal of the European Communities, No. L275 8/10/83 (pages 20-21).

"the Minister" means the Minister for Health;

"sale" includes offering or keeping for sale.

(2) In these Regulations words and phrases shall have the same meaning as in the Council Directive.

(3) In these Regulations every reference to an article shall, except where otherwise indicated, be construed as a reference to an article contained in these Regulations and any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article.

4. These Regulations shall not apply to the cosmetic products specified in sub-article (3) of article 1 of the Council Directive.

5. (1) Subject to the provisions of these Regulations a cosmetic product shall not be placed on the market:—

(a) unless it fulfils the provisions of article 2 of the Council Directive;

(b) if it contains any substance specified in paragraph (a) of article 4 (1) of the Council Directive;

(c) if, in the case of a cosmetic product intended for application in the vicinity of the eyes, on the lips, in the oral cavity or to the external genital organs, it contains any colouring agent other than one specified in paragraph (d) of article 4 (1) of the Council Directive;

(d) if it contains any preservative other than one specified in paragraph (f) of article 4 (1) of the Council Directive;

(e) if it contains any UV filter other than one specified in paragraph (h) of article 4 (1) of the Council Directive;

(f) if it contains any substance, colouring agent, preservative or UV filter specified in paragraph (b), (d), (f) or (h) of article 4 (1) of the Council Directive otherwise than in accordance with the conditions therein laid down;

(g) unless its packaging, container or label bears the information specified in paragraph (a), (b) (c), (d) and (e) of article 6 (1) of the Council Directive and the information specified in the said paragraphs (b), (c) and (d) is expressed in the Irish or the English language;

(h) if the wording, use of names, trade marks, images or other signs, figurative or otherwise, employed in the labelling, presentation for sale or advertising of the product suggests a characteristic which the product in question does not possess.

(2) With effect from the 1st day of January, 1988 a cosmetic product shall not be sold by retail or otherwise supplied to a consumer unless it complies with the provisions of this article relating to the placing of cosmetic products on the market.

(3) Without prejudice to sub-article (1) (a), the provisions of sub-article (1) (b) shall not apply to the presence in cosmetic products of traces of any of the substances to which the said sub-article refers where such presence is technically unavoidable in the context of good manufacturing practice.

(4) (a) The requirements of this article set out in sub-article (1) (d) and in relation to cosmetic products containing preservatives specified in paragraph (f) of article 4 (1) of the Council Directive the requirements of this article set out in sub-article (1) (f), shall not have effect until the 1st day of January, 1986.

(b) The requirements of this article set out in sub-article (1) (c), (d) and (f) in relation to cosmetic products containing, in accordance with the conditions laid down in article 5 of the Council Directive, any substance, colouring agent or preservative specified in the said article 5, shall not have affect until the 1st day of January, 1986.

(c) The requirements of this article set out in sub-article (1) (e) and in relation to cosmetic products containing UV filters specified in paragraph (h) of article 4 (1) of the Council Directive the requirements of this article set out in sub-article (1) (f), shall not have effect until the 1st day of January, 1987.

(d) The requirements of this article set out in sub-article (1) (e) and (f) in relation to cosmetic products containing, in accordance with the conditions laid down in article 5 of the Council Directive, any UV filter specified in the said article 5, shall not have effect until the 1st day of January, 1989.

6. (1) Notwithstanding the provisions of article 5 (1) (b), (c), (d), (e) and (f) and subject to sub-articles (2), (3) and (4) the Minister may grant, to any person who applies in the form and manner required by him, an authorisation to place a cosmetic product on the market containing a substance not otherwise permitted by virtue of these Regulations.

(2) An authorisation granted under sub-article (1) shall be limited in duration to a maximum period of three years and shall be subject to such conditions as the Minister may specify and, in particular, to conditions:—

(a) specifying the cosmetic product or class of cosmetic product in which the said substance may be used and

(b) specifying a distinctive indication which the said cosmetic product or class of cosmetic product must bear.

(3) The period specified in an authorisation for the purpose of sub-article (2) shall be extended until a decision is made following a request pursuant to paragraph 3 of article 8 (a) of the Council Directive, for the inclusion of the substance to which the authorisation relates in a list of permitted substances.

(4) There shall be paid to the Minister a fee of £300 in respect of each application for an authorisation under sub-article (1).

7. A person who contravenes any provision of article 5, or any condition attached to an authorisation granted under article 6, shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £500 and, in the case of a continuing offence, to a further fine not exceeding £50 for each day on which the offence is continued.

8. (1) Subject to sub-article (2), these Regulations may be enforced by officers of the Minister and by health boards and their officers.

(2) The provisions of article 5 (1) (g) (in so far as they relate to compliance with article 6 (1) (b) of the Council Directive) and of article 5 (1) (h) shall be enforced by officers of the Minister for Industry, Trade, Commerce and Tourism.

9. For the purpose of ascertaining whether or not there is or has been a contravention of article 5, an officer specified in article 8 (with, in the case of an officer of the Minister, a written authorisation of the Minister, in the case of an officer of the Minister for Industry, Trade, Commerce and Tourism, a written authorisation of the Minister for Industry, Trade, Commerce and Tourism and in the case of an officer of a health board, a written authorisation of the board) may, at all reasonable times—

(1) enter any premises where cosmetic products are manufactured, stored, sold or offered or kept for sale; and

(2) inspect and take (without payment) samples of any cosmetic product which is manufactured, stored, sold or offered or kept for sale at such premises, for test, examination or analysis.

10. The official testing of cosmetic products by, or under the direction of, any of the persons specified in article 11 (1) shall be carried out in accordance with the methods described in the Commission Directives 80/1335/EEC 9, 82/434/EEC 10 and 83/514/EEC 11, in so far as such methods are applicable.

9Official Journal of the European Communities, No. L383 31/12/80 (pages 27-46).

10Official Journal of the European Communities, No. L185 30/6/82 (pages 1-28).

11Official Journal of the European Communities, No. L291 24/10/83 (pages 9-46).

11. (1) In any proceedings for an offence under article 7 a certificate signed by—

(a) the State Chemist, or

(b) a public analyst appointed under section 10 of the Sale of Food and Drugs Act, 1875, or

(c) a chemist or analyst appointed by the Minister for that purpose

stating the result of any test, examination or analysis of a sample shall, with regard to that sample, be evidence for all purposes of such result.

(2) The certificate referred to in sub-article (1) shall be in the form set out in the Schedule to these Regulations

SCHEDULE

EUROPEAN COMMUNITIES (COSMETIC PRODUCTS) REGULATIONS, 1984

( S.I. No. 11 of 1984 )

Certificate Stating Results of Test, Examination or Analysis

This Certificate is issued by me, the undersigned, for the purpose of article 11 of the European Communities (Cosmetic Products) Regulations, 1984 being (1) ............................................................ ..................

I hereby certify that I received on the .......................... day of ............................................................ .....................

19 ............................. from (2) ................................................ of ............................................................ ........................

a sample of (3) .............................. for test, examination and analysis, which was undamaged, duly sealed and marked (4) ............................................................ ............................................................ .........................................

I further certify that the said sample has been tested, examined and analysed by me or under my direction and that the results are as follows:— (5)

Signature .........................................................

Date ............................................................ ...

Address ...........................................................

...........................................................

(1) Here insert official title of analyst.

(2) Here insert the name of the sampling officer or agent who submitted the sample for analysis.

(3) Here insert the name or description of the product.

(4) Here insert the distinguishing mark on the sample and the date of sampling shown thereon.

(5) Here insert the relevant results as appropriate.

GIVEN under the Official Seal of the Minister for Health this 18th day of January, 1984.

BARRY DESMOND,

Minister for Health.

EXPLANATORY NOTE.

The purpose of these Regulations is to give statutory effect in this country to the requirements of the various EEC Directives relating to cosmetic products referred to in the Regulations.

The effect of the Regulations is to prohibit the placing on the market of cosmetic products which, under normal conditions of use, are liable to cause damage to human health. The presence in cosmetic products of certain listed substances is either prohibited absolutely or permitted subject to certain restrictions and conditions of use. Positive lists of colouring agents, anti-microbial preservatives and ultraviolet sunscreen filters are established which, subject to compliance with any prescribed restrictions or conditions of use, are permitted to be used.

Certain requirements in regard to labelling are also laid down and the use of words, names, trade marks, images or other signs either in the labelling, presentation for sale or advertising of cosmetic products is prohibited where such suggests a characteristic which the product in question does not possess.

While the main provisions of the Regulations come into effect immediately, those relating to preservatives and UV filters do not come into effect until 1 January, 1986 and 1 January, 1987 respectively.

With effect from the 1 January, 1988 cosmetic products not complying with these Regulations may not be sold by retail or otherwise supplied to consumers.