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Order Sas/2062/2010 Of 23 July For Amending Annexes Ii And Iii Of The Royal Decree 1599 / 1997, Of October 17, On Cosmetic Products.

Original Language Title: Orden SAS/2062/2010, de 23 de julio, por la que se modifican los anexos II y III del Real Decreto 1599/1997, de 17 de octubre, sobre productos cosméticos.

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TEXT

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.

Currently, verbena oil (Lippia citriodora Kunth) cannot be used as a fragrance ingredient, due to its sensitising potential. This prohibition was decided on the basis of an opinion of the Scientific Committee on Cosmetic Products and Non-Food Products for the Consumer (SCCNFP), which is currently replaced by the Scientific Committee on Consumer Safety. (CCSC).

In a subsequent opinion, the Scientific Committee on Consumer Safety (SCCS) concluded that the absolute verbena obtained from Lippia citriodora Kunth could be used provided that its content in the products Finished cosmetics not exceeding 0,2%. It is therefore appropriate to include verbena absolute (Lippia citriodora Kunth), with the corresponding restriction, in Part 1 of Annex III to Directive 76 /768/EEC and to amend Annex II.

Directive 2008 /42/EC of 3 April 2008 amending Council Directive 76 /768/EEC on cosmetic products, in order to adapt Annexes II and III to technical progress, includes in Annex III, Part II, Annex III to Directive 2008 /42/EC of the European Parliament and of the Council 1, of Directive 76 /768/EEC several allyl esters containing allyl alcohol as impurity. The substance allyl phenethyl ether may also contain allyl alcohol as impurity. The SCCNFP issued an opinion recommending that 0,1% of allyl alcohol should not be exceeded as an impurity, in the light of which, for reasons of consistency, it is appropriate to amend Part 1 of Annex III to Directive 76 /768/EEC, including this substance, as well as the corresponding restriction.

The group of substances Terpene terpenoids sinpine is currently listed in Part 1 of Annex III to Directive 76 /768/EEC. However, the word "sinpine" is a commercial name, so it should be deleted from the name of that group of substances.

It was therefore appropriate to amend Directive 76 /768/EEC, which has been carried out with the approval of Commission Directive 2009 /164/EU of 22 December 2009 amending Annexes II and III to Directive 76 /768/EEC, 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 further changes to the Annexes II and III of 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 II and III to Royal Decree 1599/1997 of 17 October on cosmetic products.

1. Annex II to Royal Decree 1599/1997 of 17 October 1997 on cosmetic products is hereby amended as follows:

'Reference number 448' Verbena oil (Lippia citriodora Kunth) (CAS No 8024-12-2), in use as a fragrance ingredient 'is replaced by' Essential oils of verbena (Lippia citriodora Kunth) and other derivatives of the absolute (CAS number 8024-12-2), in its use as a fragrance ingredient '.'

2. The first part of Annex III to Royal Decree 1599/1997 of 17 October on cosmetic products is hereby amended as follows:

a) After order number 151, the following entry is inserted:

No.

Substance

Restrictions

Employment conditions and warnings
to be entered obligatorily
on the

Field
application and/or use

Maximum authorized concentration in the finished cosmetic product

Other limitations and requirements

c

d

e

e

Table_head"> f

" 1515a

Allyl phenethyl ether
CAS No. 14289-65-7
N. CE 238-212-2

The level of free allyl alcohol in the ether should be less than 0.1 %. "

b) New order number 206 is added:

N.
order

Substance

Restrictions

Employment Conditions
and warnings
to be entered obligatorily
on the

Field
application
and/or use

Maximum authorized concentration
in the finished cosmetic product

Other limitations
and requirements

b

c

d

and

f

206

Verbena Absolute (Lippia citriodora Kunth.)
CAS 8024-12-2

0.2%. "

(c) In column "b" of order number 130, the words "Terpene terpenoids sinpine" are replaced by "Terpenes and terpenoids".

Single transient arrangement. Time limit for placing on the market and placing on the market.

From February 15, 2011, cosmetic products that do not conform to the requirements of this order cannot be placed on the market.

From August 15, 2011, cosmetic products that do not conform to the requirements of this order may not be sold or transferred to the final consumer.

Final disposition first. Incorporation of European Union law.

By this order, Commission Directive 2009 /164/EU of 22 December 2009 amending Annexes II and III to Directive 76 /768/EEC on products to be incorporated into the internal legal order cosmetics, to adapt them 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.