Key Benefits:
Royal Decree 1599/1997 of 17 October 1997 on cosmetic products, compiled in a single text all the legislation in force in this field and incorporated into the Spanish legal order Council Directive 76 /768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products and their subsequent amendments.
In order to incorporate the new Community directives, the aforementioned royal decree was subsequently amended by Royal Decree 2131/2004 of 29 October, and by Royal Decree 209/2005 of 25 February, as well as by successive orders that have modified their attachments.
The Scientific Committee on Consumer Products (CCPC), subsequently replaced by the Scientific Committee on Consumer Safety (SCCS), concluded that Ethyl Lauroyl Arginate HCl (INCI) is safe for consumers if they are to be is used with a maximum authorised concentration of 0.8% in soaps, anti-cancer shampoos and non-aerosol deodorants (spray). It is therefore appropriate to include it in Annex III to Directive 76 /768/EEC.
In the same opinion, the SCCP came to the conclusion that Ethyl Lauroyl Arginate HCl (INCI) is safe for consumers if it is used with a maximum authorised concentration of 0,4% as a preservative in cosmetic products, Although it should not be used in labial products, oral products or sprays (sprays), due to its potential for irritation to mucous membranes and airways. It is therefore appropriate to include it with these restrictions in Annex VI to Directive 76 /768/EEC.
It was therefore appropriate to amend Directive 76 /768/EEC, which has been carried out with the approval of Commission Directive 2010 /3/EU of 1 February amending Annexes III and VI to the Directive. Council Directive 76 /768/EEC on cosmetic products for the purposes of adapting to technical progress, the provisions of which are transposed into national law by means of this order, and for which further changes must be made to the Annexes III and VI to Royal Decree 1599/1997 of 17 October.
In the processing of this order, the Consumer and Users ' Council has been informed preceptively, and the sectors affected have been heard.
This order is made in use of the enablement conferred by the final provision of Royal Decree 1599/1997 of 17 October, which empowers the holder of the Ministry of Health and Social Policy to update the its annexes when it is established by Community legislation.
In its virtue, I have:
Single item. Amendment of Annexes III and VI to Royal Decree 1599/1997 of 17 October on cosmetic products.
1. In the first part of Annex III to Royal Decree 1599/1997 of 17 October 1997 on cosmetic products, the following order number is added:
|
No. | Substance | Restrictions | Employment conditions and warnings | ||
|---|---|---|---|---|---|
|
Field | Maximum authorized concentration | Other limitations | |||
|
| b | c | d |
f | f |
|
207 | N2-dodecanoyl-L-argininate hydrochloride. | a) soaps. | 0.8% | For other purposes other than inhibition of the growth of microorganisms in the product. The presentation of the product must demonstrate these purposes. |
|
(*) For use as a preservative, see Annex VI, Part One, No. 58. "
2. In the first part of Annex VI to Royal Decree 1599/1997 of 17 October 1997 on cosmetic products, the following order number is added:
|
No. | Substance | Maximum Authorized Concentration |
Limitations and Requirements | Employment Conditions |
|---|---|---|---|---|
| to | b | c | d | |
|
" 58 | N2 hydrochloride-dodecanoyl-L-argininate | 0.4% | Do not use in lip products, mouth products, or sprays. |
|
(**) With uses other than use as a preservative, see Annex III, Part One, No. 207. "
Single transient arrangement. Time limit for sale or transfer.
As of March 1, 2011, cosmetic products that do not comply with this order may not be sold or transferred to the final consumer.
Final disposition first. Incorporation of European Union law.
By this order, the Commission Directive 2010 /3/EU of 1 February amending Annexes III and VI to Council Directive 76 /768/EEC on products is incorporated into the internal legal order. cosmetics to adapt to technical progress.
Final disposition second. Entry into force.
This order shall enter into force on the day following that of its publication in the "Official State Gazette".
Madrid, July 23, 2010. -Minister of Health and Social Policy, Trinidad Jiménez García-Herrera.
