Fabian Demicoli

Consultation re Cosmetics (Amendment)

 The Cosmetic Products Regulations needs to be amended due to the publication of the following 2 directives:

1. Commission Directive 2010/3/EU of 1 February 2010 amending, for the purpose of adaptation to technical progress, Annexes III and VI to Council Directive 76/768/EEC concerning cosmetic products.

 

The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion of 15 April 2008 that Ethyl Lauroyl Arginate HCl is safe for the consumers, when used up to a maximum authorised concentration of 0,8 % in soap, anti-dandruff shampoos, and non-spray deodorants. It should therefore be included in Annex III to Directive 76/768/EEC. It was also concluded that it is safe for the consumers, when used up to a maximum authorised concentration of 0,4 % as a preservative in cosmetic products. However, the Committee considered that it should not be used in lip products, oral products and spray due to mucosal and respiratory tract irritation potential. It should therefore be included along with these restrictions in Annex VI to Directive 76/768/EEC.

2. Commission Directive 2010/4/EU of 8 February 2010 amending, for the purpose of adaptation to technical progress, Annex III to Council Directive 76/768/EEC concerning cosmetic products.

Presently, there are two non-oxidative hair dye substances which are provisionally allowed for use in cosmetic products until 31 December 2010 under the restrictions and conditions laid down in Part 2 of Annex III to Directive 76/768/EEC. For these two non-oxidative hair dye substances, HC Orange No 2 and 2-hydroxyethylamino-5-nitroanisole, listed under reference numbers 26 and 29 in Part 2 of Annex III, the SCCS gave its final opinions on their safety. The SCCS recommended maximum authorised concentrations in the finished cosmetic product of 1,0 % for HC Orange No 2 and of 0,2 % for 2- hydroxyethylamino-5-nitroanisole. Therefore, HC Orange No 2 and 2-hydroxyethylamino-5-nitroanisole can be definitively regulated in Part 1 of Annex III. In view of a smooth transition for the marketing of products containing HC Orange No 2 not complying with the labelling requirements laid down in this Directive, it is necessary to provide for appropriate transitional periods.

If this amendment affects you in any way you are kindly asked to submit any comments by 9th April 2010 to the Audrey Anne Anastasi of MSA and for further info call 23952000.

Abigail Mamo-

 

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