By Royal Decree 349/1988 of 15 April, the current Technical-Health Regulations for Cosmetic Products were approved, thus adapting the regulatory regulations for these products to the current state of knowledge In addition, the Commission's proposal for a Directive on the approximation of the laws of the Member States relating to the approximation of the laws of the Member States relating to the approximation of the laws of the Member States relating to:

Subsequently, Royal Decree 349/1988 has been amended by Royal Decree 475/1991 of 15 April 1991 transposing Directive 88/667 and, in accordance with the provision provided for in its first provision, by seven Ministerial orders, all in transposition of Community Directives on the adaptation to technical progress of the Framework Directive on Cosmetic Products, 76/768.

At the present time, following the indications of the Court of Justice of the EEC and in order to achieve full adaptation to Community law, a change in the Regulations is introduced by this Royal Decree Cosmetic Products-Healthcare which, by removing superfluous formalities for the marketing of cosmetic products in Spain, maintains the need to provide the necessary information to the national authorities for the protection of the (a) health, taking into account the possibility offered by Article 7.3 of Directive 76/768.

To this end, the present Royal Decree, in which the sectors concerned have been heard, has deleted the "communication of the placing on the market of a cosmetic product", maintaining only the obligation that the responsible for the placing on the market of any cosmetic product report to the Health Administration on the name of the product, its quantitative composition, its physical-chemical constants and a description of the products and a copy of the package leaflet, carton or package.

In its virtue, on the proposal of the Minister of Health and Consumer Affairs, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of August 4, 1995,

D I S P O N G O:

Single item.

The Technical-Health Regulations on Cosmetic Products, approved by Royal Decree 349/1988 of 15 April, are amended in the following terms:

1. Article 2 (2) is replaced by the following:

" Information: action for which the General Directorate of Pharmacy and Sanitary Products, hereinafter D.G.F.P.S., is brought to the attention, in the terms provided for in this Royal Decree, the information required in the present Regulation. '

2. Article 2 (4) is replaced by the following:

" Responsible for placing on the market: natural person or legal entity who, having the status of manufacturer, importer or owner of a cosmetic product, guarantees the adequacy of the product to the Regulation technical-health. "

3. Title III 'Communication' is replaced as a heading in the first chapter of 'Information'.

4. Article 6 is worded as follows:

" 1. The person responsible for placing a cosmetic product on the market shall provide the health administration, not later than the day on which the placing on the market is effective, with the following information:

a) Name of the product.

b) Quantitative Composition. All ingredients in descending order of concentration shall be related, expressed in accordance with the rules of international nomenclature which permit their identification. The composition will be presented in a closed envelope to ensure its confidentiality.

c) Physical-chemical constants that may be relevant for medical treatment purposes.

(d) Prospects and, if they do not exist or which do not appear in it, the particulars required in Article 14, cartons or packages.

2. The information referred to in the preceding paragraph shall be addressed to the competent authority of the corresponding Autonomous Community, who shall immediately forward this information to the D.G.F.P.S.

In the case of cosmetic products placed on the market from another Member State of the European Union, this information shall be addressed to the Autonomous Community in which the first marketing is carried out. If this first marketing is carried out in several Autonomous Communities at the same time, the information shall be sent to the competent body of any of them. The Autonomous Community shall immediately transfer this information to the D.G.F.P.S.

3. By way of derogation from the above point, in the case of cosmetic products imported from third countries, the information shall be addressed directly to the D.G.F.P.S.

4. Any modification of the information submitted shall be communicated in accordance with paragraphs 2 and 3 of this Article.

5. The D.G.F.P.S. shall establish, in coordination with the corresponding bodies of the Autonomous Communities, models of official forms to facilitate the presentation of such information. "

5. Article 7 is worded as follows:

" 1. The D.G.F.P.S. may exceptionally authorize the use in cosmetic products of colorants, preservatives or ultraviolet filters which are not included in the Annexes to this Regulation.

In these cases, a special declaration must be submitted, showing the following data:

(a) The name or social reason and the address or registered office of the manufacturer and the person responsible for placing the cosmetic product on the market.

(b) Full identification and certification of the responsible technician referred to in Article 16.

c) The operating license number of the installation of the person responsible for placing on the market or the manufacturer.

(d) Denomination of the cosmetic product and the category to which it belongs, in accordance with those referred to in Annex I or with the classification as the case may be established.

e) Quantitative composition, in order of decreasing concentrations, expressed in accordance with the international nomenclature rules that permit identification.

(f) Labels, packaging and leaflets or, failing that, a sketch of the same in which the texts appearing on the market are to be included.

g) Net content at the time of packaging, in accordance with the maximum levels and the volumes indicated, where applicable, by the legislation in force.

h) In the case of cosmetic products not placed on the market in the European Union, the marketing authorisation or the free-selling certificate issued by the competent authority of the country of origin shall also be included; any further information of that authority may be obtained.

i) Justification of its safety with the necessary toxicological, scientific-technical and analytical tests according to the nature and the intended use for that product, through the presentation of a memory.

j) Compliance with a follow-up program that accredits the safety in its use, by the entity that declares them, in accordance with the requirements established by the D.G.F.P.S.

k) The documentation that justifies a specific indication that will be identified according to the D.G.F.P.S., to differentiate them from the rest of the cosmetic products.

2. Within 90 days, the D.G.F.P.S. shall decide on the special declaration submitted. If it does not allow an adequate health assessment of the product, the declarant shall be required to provide the necessary data or tests; in this case, a new period of 90 days shall be counted from the receipt of the data or tests. required.

3. The special declaration shall take effect for a maximum period of five years from the date of the favourable pronouncement.

4. Whenever the D.G.F.P.S. deems it necessary for the protection of the health and safety of persons, the special declaration system may be applied to any cosmetic product containing other substances other than those mentioned in the Annex. paragraph 1.

5. Any special declaration on which a favourable statement is to be made shall be communicated to the Commission of the European Union within a period of 60 days. '

6. Article 8. is replaced by:

"The competent health authorities shall ensure the confidentiality of the information provided."

7. Article 10 shall be deleted.

8. Article 12 shall be deleted.

9. Article 13 is replaced by:

" The D.G.F.P.S. shall keep up to date a record in which the information referred to in Article 6 and the special declarations of cosmetic products shall be recorded. Such registration shall be kept at the disposal of the health authorities of the CCAA and the National Institute of Toxicology. "

10. In Article 15 (1), a second paragraph is added with the following content:

"Nor may they refer to actions, indications and forms of non-cosmetic application of a cosmetic, in accordance with the definition of Article 2., or to those excluded from this Regulation by Article 3."

11. Article 15 (4) shall be deleted.

12. Article 17 (1) is worded as follows:

" The manufacturers located in Spain and those responsible for the placing on the market of cosmetic products from third countries, will have to count in Spain with facilities authorized by the corresponding Operating Health License. '

13. Article 20 (2) is worded as follows:

" 2. Where an entity holding an approved installation changes its legal personality, name or social reason, it shall communicate it by attaching the supporting documentation. The cessation of activities shall also be communicated, together with a list of cosmetic products which it places on the market at that time. "

14. Article 22 (3) (4) shall be deleted.

15. Article 22 (3), number 7 is replaced by the following:

"The placing on the market of cosmetic products without having provided the health authorities with the information referred to in Article 6 or without obtaining the authorisation referred to in Article 7."

16. Article 22 (3) (3) is replaced by the following:

"The distortion of the information referred to in Articles 6 and 7 of this Regulation."

Additional disposition first.

dentifrice products or similar hygienic products which, by their composition, destination and indications cannot be included within the scope of the Technical-Health Regulations of Cosmetic Products, will be the subject of a Health authorisation for marketing. The procedures for the application and resolution of the authorisation shall be carried out, as appropriate, in accordance with the provisions of Article 7. of this Regulation.

Additional provision second.

This Royal Decree is of a basic nature and is dictated by the provisions of Article 149.1.16.

Single end disposition.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given in Palma de Mallorca to August 4, 1995.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

MARIA ANGELES AMADOR MILLAN