S.I. No. 213/1998:

EUROPEAN COMMUNITIES (COSMETIC PRODUCTS) (AMENDMENT) REGULATIONS, 1998.

EUROPEAN COMMUNITIES (COSMETIC PRODUCTS) (AMENDMENT) REGULATIONS, 1998.

The Minister for Health and Children 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) (Amendment) Regulations, 1998.

2. These Regulations shall be construed as one with the European Communities (Cosmetic Products) Regulations, 1997 ( S.I. No. 87 of 1997 ) and may be cited with those Regulations as the European Communities (Cosmetic Products) Regulations, 1997 and 1998.

3. (1) In these Regulations "the Principal Regulations" mean the European Communities (Cosmetic Products) Regulations, 1997.

(2) In these Regulations, unless the context otherwise indicates, any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations or, as the case may be, to a Schedule thereto, and likewise any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article.

4. The Principal Regulations are hereby amended:--

(a) by the addition to the definition of "the Principal Directive", contained in Article 4(1), of the references "97/18/EC⁴⁰", "97/45/EC⁴¹" and "98/16/EC⁴²";

(b) by the substitution in Article 7(1)(f) of the "30th June, 2000" for the date specified therein;

⁴⁰97/18/EC -- Official Journal of the European Communities, No. L114, 1/5/97 (pages 43-44) (Postponing the date after which animal tests are prohibited).

⁴¹97/45/EC -- Official Journal of the European Communities, No. L196, 24/7/97 (pages 77-78) (Twenty first Commission Directive).

⁴²98/16/EC -- Official Journal of the European Communities, No. L77, 14/3/98 (pages 44-45) (Twenty second Commission Directive).

(c) by the insertion in Article 20, immediately after the reference "95/32/EC", of the reference "96/45/EC⁴³.

⁴³96/45/EC -- Official Journal of the European Communities, No. L213, 22/8/96 (pages 8-15) (Methods of analysis).

5. The Schedules to the Principal Regulations are hereby amended in the manner set out in the Schedule herein.

6. (1) As from the 1st July, 1998, for the substances set out in the Schedule, neither manufacturers nor importers established in the Community shall place on the market cosmetic products which do not comply with the requirements of the Schedule. However, paragraph 1(c) of the Schedule shall apply from the date of the signing of these regulations.

(2) Cosmetic products containing the substances set out in the Schedule shall not be sold or otherwise supplied to the consumer after the 30th June, 1999.

SCHEDULE

1. Schedule 2 to the Principal Regulations is amended as follows:--

(a) The following new entry is added:--

"420. Crude and refined coal tars.".

(b) The following entry is deleted:--

"415. Diisobutylphenoxyethoxyethyl-dimethylbenzylammonium chloride; (Benz ethonium chloride).".

(c) The entries numbered 95, 368 and 419 are substituted as follows:--

"95. Phenaglycodol (INN).".

"368. 2, 6-Dimethyl-1, 3-dioxan-4-yl acetate; (Dimethoxane).".

"419. "specified risk materials" being:

(a) the skull, including the brain, eyes, tonsils and spinal cord of:

--bovine animals aged over 12 months,

--ovine and caprine animals which are aged over 12 months or have a permanent incissor tooth erupted through the gum;

(b) the spleens of ovine and caprine animals and the ingredients derived therefrom.

However, tallow derivatives may be used in cosmetic products provided that the following methods have been used and strictly certified by the producer of such derivatives:

--Transesterification or hydrolysis at not less than 200°C, 40 bars (40,000 hPa) for 20 minutes (glycerol and fatty acids and esters),

--Saponification with sodium hydroxide 12M (glycerol and soap):

--Batch process at 95°C for 3 hours, or

--Continuous process at 140°C, 2 bars (2000 hPa) for 8 minutes or equivalent conditions.".

2. The following new entry is added to Part 1 of Schedule 6 to the Principal Regulations:--

3. The dates referred to in Column f of Part 2 of Schedule 6 to the Principal Regulations, in respect of the substances having the reference numbers 16, 21, and 29 respectively, are in each case replaced by the "30.06.1998".

4. The following new entry is added to Part 1 of Schedule 7 to the Principal Regulations:--

5. Part 2 of Schedule 7 to the Principal Regulations is amended as follows:--

(a) the substance having the reference number 13 is hereby deleted; and

(b) the dates referred to in Column f, in respect of the substances having the reference numbers 2, 5, 6, 12, 17, 25, 26, 29 and 32 respectively, are in each case replaced by the "30.06.1998".

GIVEN under the Official Seal of the Minister for Health and Children, this 26th day of June, 1998.

BRIAN COWEN,

Minister for Health and Children.

EXPLANATORY NOTE.

These regulations amend the European Communities (Cosmetic Products) Regulations 1997. The regulations update the law in relation to the manufacture, marketing and sale of cosmetic products by the transposition of the 7th Commission Directive 96/45/EC, Commission Directive 97/18/EC, the 21st Commission Directive 97/45/EC, and the 22nd Commission Directive 98/16/EC (references above).