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Order Sco/3089/2007, Of 19 October, That Amending Annexes Iii, Iv And Vi Of The Real Decree 1599 / 1997, Of October 17, On Cosmetic Products.

Original Language Title: ORDEN SCO/3089/2007, de 19 de octubre, por la que se modifican los anexos III, IV y VI del Real Decreto 1599/1997, de 17 de octubre, sobre productos cosméticos.

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Royal Decree 1599/1997 of 17 October 1997 on cosmetic products, compiled in a single text all the existing legislation on this subject, adapting it to Community legislation, in particular Directive 76 /768/EEC of the European Parliament and of the Council. Council of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. With this purpose of adaptation, this royal decree has subsequently been amended by Royal Decree 2131/2004 of 29 October, and Royal Decree 209/2005 of 25 February, and the Orders of 4 June 1998, of 26 April 1999, of 3 August 2000 and Orders SCO/249/2003, SCO/1448/2003, SCO/2592/2004, SCO/3664/2004, SCO/544/2005, SCO/3691/2005, SCO/747/2006, SCO/1730 /2006, SCO/3283/2006, SCO/504/2007, SCO/1929/2007 and SCO/2614/2007 have also amended their Annexes.

Commission Directives 2007 /17/EC of 22 March 2007 amending Council Directive 76 /768/EEC on cosmetic products for the purposes of adapting Annexes III and VI thereto to technical progress and Commission Directive 2007 /22/EC, COMMISSION DIRECTIVE of 17 April 2007 amending Council Directive 76 /768/EEC on cosmetic products for the purposes of adapting Annexes IV and VI to technical progress requires their incorporation into the internal legal system by means of the transposition that approves this provision, which introduces new changes to the annexes to the Royal Decree 1599/1997 of 17 October.

This order is issued in accordance with the provisions of the final provision of Royal Decree 1599/1997 of 17 October 1997.

By virtue,

DISPONGO:

Article first. Amendment of Annexes III, IV and VI to Royal Decree 1599/1997 of 17 October on cosmetic products.

Annexes III, IV and VI to Royal Decree 1599/1997 of 17 October on cosmetic products are amended as follows:

One. The following reference numbers are added in the first part of Annex III:

Number

Substance

Restrictions

Conditions of employment and warnings that must be mandatory on the

Field application and/or use

Maximum concentration on finished product

Other limitations and

b

c

d

e

f

" 98

Acid salicylic.

(CAS number 69-72-7).

(as a preservative, see Annex VI, Part 1, Number 3).

a) Hair products that are cleared.

b) Other products.

a) 3.0%

b) 2.0%

Do not use in products intended for children under three years of age, except for shampoos.

For other purposes other than inhibiting the growth of microorganisms in the product. The presentation of the product must show these other purposes.

Not to use for the care of children under the age of three years.

(Only in the case of products that may be used for care of children under three years of age and who remain in prolonged contact with the skin.

99

Inorganic sulfites and bisulphites.

(as a preservative, see Annex VI, 1st part, number 9).

a) Oxidative Hair Dyes.

b) Hair Smoothing Products.

c) Facial Self-tanning.

d) Other auto-tanners.

a) 0.67% expressed in free SO2.

b) 6.7% expressed in free SO2.

c) 0.45% expressed in free SO2.

d) 0.40% expressed in free SO2.

For other purposes other than inhibiting the growth of microorganisms in the product. The presentation of the product must demonstrate these other purposes.

100

Triclocarban crow.

(CAS number 101-20-2).

(as a preservative, see Annex VI, Part 1, number 23).

Products that are clarify.

1.5%

purity criteria:

to a

for controlling the growth of micro-

. in the product. The presentation of the product must demonstrate these other purposes.

101

zinc piritionate.

(CAS number 13463-41-7).

(as a preservative, see Annex VI, Part 1, number 8).

Products for hair that are not cleared.

0.1%

Con other purposes other than inhibition of the growth of micro-organisms in the product. The presentation of the product must show these other purposes. "

Two. In Part 1 of Annex IV, the colouring agent CI 45425 is deleted.

Three. The first part of Annex VI is amended as follows:

a) In column b, the symbol (+) is deleted from reference numbers 1, 2, 4, 7, 12, 14, 18, 19, 21, 22, 24, 25, 26, 27, 28, 29, 30, 32, 33, 35, 37, 42 and 47.

b) In column b, the symbol (+) is added to the reference numbers 5 and 43.

c) The reference number 10 is deleted.

d) The reference number 36 is deleted.

e) The reference number 1 is replaced by the following:

Number

Substance

Maximum Authorized Concentration

Limits and Requirements

Conditions of employment and warnings that must be mandatory on the

a

b

c

d

" 1

Benzoic acid (CAS number 65-85-0) and its sodium salt (number CAS 532-32-1).

Products that are cleared, except for oral hygiene products: 2.5% (acid).

Products for oral hygiene: 1.7% (acid).

Products that do not clear: 0.5% (acid).

 

1 bis

Benzoic acid sales other than those included in the order number 1 and esters of benzoic acid.

0.5% (acid). "

f) The reference number 8 is replaced by the following:

Number

Substance

Maximum Authorized Concentration

Limits and Requirements

Conditions of employment and warnings that must be mandatory on the

a

b

c

d

" 8

zinc (+) piritionate (+)

(CAS number 13463-41-7).

Hair products: 1.0%

Other products: 0.5%

Products only that are cleared.

Do not use in products for oral hygiene.

g) The reference number 56 is replaced by the following:

Number

Substance

Maximum Authorized Concentration

Limits and Requirements

Conditions of employment and warnings that must be mandatory on the

a

b

c

d

" 56

Yodopropynil butylcarbamate (IPBC).

a) products that are cleared: 0.02%.

b) products that do not clear up: 0.01%, except in deodorants and antiperspirants: 0.0075%.

Not to be used in products for oral hygiene and care of the lips.

a) It should not be used in preparations for children under 3 years of age, except for bathroom products, shower gel and shampoo.

b)

-Not to be used in body lotions and creams (products intended to be applied in large body extensions).

-Not to be used in children's preparations under 3 years.

a) " Not to be used in children under 3 years "(only in case of products, other than bath products, shower gel and shampoo, which could be used in children under 3 years).

b)" Not to be used in children under 3 years " (only in case of products that could be used with children under the age of 3). "

Article 2. Time to market.

1. From 23 March 2008 cosmetic products which do not comply with the provisions of Article 1 (a), (b), (d), (e) and (f) may not be placed on the market.

2. From 18 October 2008 cosmetic products which do not comply with the provisions of Article 1 (2) and (c) and (c) and (g) may not be placed on the market.

Article 3. Time limit for sale or transfer.

1. From 23 June 2008, cosmetic products which do not comply with the provisions of Article 1 (a), (b), (d), (e) and (f) may not be sold or transferred to the final consumer.

2. From 18 April 2009, cosmetic products which do not comply with the provisions of Article 1 (2) and (c) and (g) shall not be sold or transferred to the final consumer.

Final disposition first. Incorporation of European Union law.

By this order, Commission Directives 2007 /17/EC of 22 March 2007 amending Council Directive 76 /768/EEC on cosmetic products to adapt their requirements are incorporated into the internal legal order. Annexes III and VI to technical progress and Commission 2007 /22/EC of 17 April 2007 amending Council Directive 76 /768/EEC on cosmetic products to adapt Annexes IV and VI 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, 19 October 2007.-The Minister of Health and Consumer Affairs, Bernat Soria Escoms.