The Royal Decree 1599/1997 of 17 October, which regulates cosmetic products, has brought into force 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.

By successive rules, the corresponding Commission directives have been incorporated which were amended by the Framework Directive 76 /768/EEC.

Directive 2003 /15/EC of the European Parliament and of the Council of 27 February 2003 amending the Framework Directive provides for major innovations in the regulation of cosmetic products, which requires carry out its transposition by means of this royal decree amending, in turn, Royal Decree 1599/1997 of 17 October.

One of the novelties introduced by the directive is the obligation to systematically use alternative methods for animal testing for the safety assessment of cosmetic products or their ingredients. or combinations of ingredients. In this regard, Directive 2003 /15/EC adapts the rules on cosmetic products to the Protocol on the protection and welfare of animals annexed to the Treaty establishing the European Community by the Treaty of Amsterdam, which stipulates that the Community and Member States shall take full account of animal welfare requirements in the application of Community policies and in particular in the area of the internal market.

The directive also lays down provisions on the prohibition of substances classified as carcinogenic, mutagenic or toxic to reproduction, as well as measures aimed at achieving maximum protection and information consumers of cosmetic products.

The provisions of the aforementioned Directive concerning the indication of the time limit for the use of cosmetic products once opened by the consumer have been incorporated into the Spanish legal order through the Royal Decree 2131/2004, of 29 October, amending Royal Decree 1599/1997 of 17 October on cosmetic products, which is why this royal decree completes the transposition of Directive 2003 /15/EC.

Moreover, and apart from the transposition of Directive 2003 /15/EC, it has been considered appropriate to make further amendments to Royal Decree 1599/1997 of 17 October, in order to clarify and update its content, The most significant is the procedure for the authorization of installations.

In the elaboration of this royal decree, the sectors affected have been consulted.

This royal decree is issued in accordance with the provisions of Article 149.1.16. of the Constitution and of the provisions of Article 40.2, 5 and 6 of Law 14/1986 of 25 April, General of Health, and in the additional provision Third of Law 25/1990, of 20 December, of the Medicamento. In its virtue, on a proposal from the Minister for Health and Consumer Affairs, with the prior approval of the Minister of Public Administration, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 25 February 2005,

DISPONGO:

Single item. Amendment of Royal Decree 1599/1997 of 17 October on cosmetic products.

Royal Decree 1599/1997 of 17 October on cosmetic products is amended as follows:

One. Article 2 is worded as follows:

" Article 2. Definitions.

For the purposes of this royal decree, it is understood by:

(a) Cosmetic product: any substance or preparation intended to be brought into contact with the various superficial parts of the human body (epidermis, hair and hair system, nails, lips and external genital organs) or with the teeth and mouth mucous membranes, for the sole or main purpose of cleaning, perfuming, modifying their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.

The preparations listed in Annex I are considered as an indicative product.

These are decorative cosmetic products which, because they possess coloured substances and their covering power, are applied on different areas of the body to temporarily accentuate their beauty or to mask or conceal different skin imperfections.

For example, the decorative cosmetics listed in Annex V. are considered as indicative.

(b) Market: the act of providing or making available to third parties, for the first time, a cosmetic product, whether or not for commercial transactions.

(c) Manufacturer: it is considered a manufacturer of a cosmetic product which is listed as such on the labelling of the product, irrespective of whether the manufacturing activities are carried out materially by the product or are entrusted to it third parties.

(d) Responsible for placing on the Community market for imported cosmetic products: the one which appears as such on the labelling of the cosmetic product manufactured outside the European Union and markets it within the Community market. It must be based in a country of the European Union.

(e) President: he who, without appearing on the labelling of the product as a manufacturer or as responsible for placing imported cosmetic products on the Community market, performs on behalf of them certain actions required by the regulations.

(f) Responsible for placing on the market: a natural person or legal entity who, as a manufacturer, representative or responsible for placing on the Community market of imported cosmetic products, ensures compliance from the cosmetic to this royal decree. It must be based in a country of the European Union.

g) Labelling, packaging and prospectuses: it is considered:

1. Labelling: the printed text, attached to the container or the packaging or hanging from them, and containing information and mandatory data of the product.

2. Contain: any item or container that contains the cosmetic product and is in direct contact with it.

3. Packaging or outer carton: box or any other system that contains the container and protects it.

4. Prospecto: printed text optionally included inside the packaging, containing additional information and instructions for the use of the cosmetic product.

(h) Cosmetic ingredient: any chemical or preparation of synthetic or natural origin, which forms part of the composition of cosmetic products. "

Two. Article 5 (1) (i) shall be worded as follows:

" (i) Substances classified as carcinogenic, mutagenic or toxic to reproduction of categories 1, 2 and 3 of Annex I to the Regulation on the notification of new substances and classification, packaging and labelling of dangerous substances, approved by Royal Decree 363/1995 of 10 March. This prohibition shall be carried out by the inclusion of the relevant substances in Annex II. However, a substance classified in category 3 may be used in cosmetic products if it has been evaluated by the Scientific Committee for Consumer Products, which is considered acceptable for use in cosmetic products and included in the annexes of this royal decree. "

Three. Paragraphs 3 and 4 are added to Article 5, with the following wording:

" 3. Without prejudice to the general conditions resulting from Article 4, it shall be prohibited:

(a) The placing on the market of cosmetic products whose final formulation, in order to meet the requirements of this royal decree, has been subjected to animal testing by using a different method of a method alternative after it has been validated and adopted at the level of the European Union, taking due account of the evolution of validation within the OECD.

b) The placing on the market of cosmetic products containing ingredients or combinations of ingredients which, in order to comply with the requirements of this royal decree, have been the subject of animal testing by the use of a different method of an alternative method after it has been validated and adopted at European Union level, taking due account of the evolution of validation within the OECD.

c) The performance of tests on finished cosmetic products, to meet the requirements of this royal decree.

d) Testing in animal ingredients or combinations of ingredients, to meet the requirements of this royal decree, as at the later date when such tests are to be replaced by one or more validated alternative methods referred to in Annex V to the Regulation on the notification of new substances and the classification, packaging and labelling of dangerous substances, approved by Royal Decree 363/1995 of 10 March, or Annex IX to this royal decree.

With regard to paragraphs (a), (b) and (d), the period of implementation shall be in accordance with the schedules submitted by the European Commission to Parliament and the Council, in compliance with Articles 1.2 and 4 bis.2 of the Directive. 2003 /15/EC of the European Parliament and of the Council of 27 February 2003 and shall be limited to a maximum of six years from 11 March 2003.

In relation to the toxicity tests for repeated administration, toxicity to reproductive and toxicocytic function, for which there are still no alternatives under study, the period of application of the (a) and (b) of this paragraph shall be in accordance with the schedules submitted by the European Commission to the Parliament and the Council, in compliance with Articles 1.2 and 4 bis.2 of Directive 2003 /15/EC, and shall be limited to a maximum of 10 years from 11 March 2003.

In exceptional circumstances where there are serious doubts about the safety of a cosmetic ingredient, the Spanish Agency for Medicines and Health Products may request the European Commission to authorise a derogation from the provisions of this paragraph. The request shall contain an assessment of the situation and identify the relevant measures. For these purposes, exceptional circumstances shall be considered only if:

1. The use of the ingredient is widespread and cannot be replaced by another ingredient capable of performing a similar function.

2. The specific problem for human health is explained and the need for animal testing is justified, all supported by a detailed research protocol proposed as a basis for evaluation.

4. For the purposes of paragraph 3, the following definitions shall

:

(a) Finished Cosmetic Product: the cosmetic product in the final formulation in which it is to be placed on the market and made available to the final consumer, or its prototype.

b) Prototype: a first model or design not produced in series and from which the finished cosmetic product is finally developed or copied. "

Four. Article 6 (1) (d) is worded as follows, and a paragraph (h) is added with the following wording:

" (d) The assessment of safety for human health of the finished product. For this purpose, the manufacturer shall take into account the general toxicological profile of the ingredients, their chemical structure and their level of exposure. In particular, it shall take into account the specific exposure characteristics of the areas on which the product or population to which the product is intended to apply. A specific assessment of cosmetic products intended for use in children under three years of age and of cosmetic products intended exclusively for external intimate hygiene shall be carried out.

In the case of the same product manufactured in several places in the Community territory, the manufacturer may choose one of the manufacturing sites in which such information is available.

Such a place shall be communicated to the competent authorities, if requested, for the purposes of control. In this case the information must be easily accessible. "

" (h) Information on animal experiments carried out by the manufacturer, his agents or his suppliers in connection with the preparation or assessment of the safety of the product or its ingredients, including any animal experiment carried out to meet the legislative or regulatory requirements of non-EU Member States. "

Five. A paragraph 4 is added to Article 6 with the following wording:

" 4. Citizens may be informed of the information referred to in paragraphs (a) and (f) of paragraph 1, without prejudice to the protection of trade secrets and intellectual property rights, as provided for in Article 15.7. For these purposes, the person responsible for placing on the market shall have systems for the registration and management of consumer consultations, at the disposal of the competent authorities.

The quantitative information to be made available to consumers as regards the provisions of paragraph 1 (a) shall be limited to the dangerous substances listed in the Regulation on the notification of substances. new and classification, packaging and labelling of dangerous substances, approved by Royal Decree 363/1995 of 10 March.

As for the information referred to in paragraph 1.f), the person responsible for placing a cosmetic product on the market shall have a system of registration and management of the adverse effects produced.

The Ministry of Health and Consumer Affairs shall establish the appropriate procedure to ensure that the consumer receives the information referred to in this paragraph. "

Six. The second paragraph of Article 7 is worded as follows:

" This relationship will be presented in duplicate and one of the copies will be transferred to the Spanish Agency for Medicines and Sanitary Products by the corresponding autonomous community. In the same way, the changes affecting the data provided in relation to the provisions of this Article shall be communicated.

This information may be submitted electronically through the computer system of the Spanish Agency for Medicines and Health Products. "

Seven. Article 8 is worded as follows:

" Article 8. Information for medical treatment purposes.

1. In order to provide rapid and appropriate medical treatment in the event of a nuisance, the person responsible for placing a cosmetic product on the market must provide the Spanish Agency for Medicines and Health Products, not later than the the day when the placing on the market in Spain is effective, the following information:

a) The product name, which will include the product name and mark. The specific name can match the product function.

b) Quantitative Composition. All ingredients shall be related in order of decreasing concentration, in accordance with the International Nomenclature of Cosmetic Ingredients (hereinafter INCI), which is contained in the Inventory of cosmetic ingredients, adopted by the Decision 96 /335/EC of the Commission of 8 May 1996 and, in its absence, in accordance with the rules of the international nomenclature permitting their identification.

(c) physico-chemical constants that may be relevant for the purpose of medical treatment and product description.

(d) Prospects and, if they do not exist or where the particulars required by Article 15, labelling of the container and packaging do not appear in them.

This data will be entered into an envelope that, together with a paper that reflects the same data, will be directed to the Spanish Agency for Medicines and Health Products. Calle de Alcala n. º 56, 28071 Madrid. On the outside of the envelope, the following data shall be recorded:

1. The name and address of the person responsible for placing on the market.

2. The product name, which will include the product name and brand name.

3. Date of presentation in the Administration record.

The copy of the document, sealed by the General Register of the Spanish Agency for Medicinal Products and Sanitary Products or by any of the organs mentioned in Article 38.4 of Law 30/1992, of 26 November, of Regime Legal of the Public Administrations and of the Common Administrative Procedure, will serve as proof of the presentation.

In the case of a change in the name of the product, new information shall be submitted for the purpose of medical treatment, indicating its new name and the date of submission of the information to which it replaces.

In the event of a change of responsibility for placing on the market, the new person responsible will present new information for medical treatment purposes. The initial product responsible shall communicate the cancellation of the first information for the purposes of medical treatment and shall be responsible for the product as long as it continues on the market.

When other changes occur, quantitative composition, framework formula, physico-chemical constants, prospects or labelling, change of contact person or of their data, will be communicated by reference to the information presented above, and the name of the product, the date of submission of the information in the Administration's register and the name of the person responsible for the information.

2. 10 years after the information referred to in paragraph 1 has been provided, the person responsible for placing a cosmetic product on the market shall communicate his intention to keep it on the market, since otherwise it shall be deemed to be The product has ceased to be marketed.

3. This information may be submitted electronically through the computer system of the Spanish Agency for Medicines and Health Products.

4. The person responsible for placing the market on the market may replace the information referred to in paragraph 1 (b) with the reference to the corresponding framework formula, in accordance with a system of arrangements which is equally effective and accepted at Community level, which will in any case include a contact person.

If the person responsible for placing on the market chooses to provide the reference to the framework formula, he may also replace the presentation of the information referred to in paragraph 1 (d) with all the information contained in the labelling that fully identifies the product and the data for a permanent contact person, with knowledge of the Spanish language. This information shall allow the Toxicological Information Service and the health authorities to identify the product concerned and to specify how much data is necessary for the purposes of this Article.

If the person responsible for placing on the market chooses to provide the framework formulas but does not have permanent contact staff with knowledge of the Spanish language, he will not be able to dispense with the information indicated in the paragraph 1.d). "

Eight. Article 9 (2) is worded as follows:

" 2. The Spanish Agency for Medicines and Health Products will have to rule on the special declaration submitted within the time limits laid down in Law 30/1992, of 26 November, of the Legal Regime of the Public Administrations and of the Common Administrative Procedure. If the documentation submitted does not permit, in the case of the Administration, an appropriate assessment of the product and the declarant is required for the submission of tests, documents and other necessary evidence, the time limit for the shall be suspended until its receipt. The procedure shall also be suspended when the declarant is required to address deficiencies in the documentation submitted, up to completion by the declarant. "

Nine. Article 11 (2) and (3) are worded as follows:

" 2. Without prejudice to the actions of other health authorities and to the actions taken in accordance with Article 26 of Law 14/1986 of 25 April, General Health, the Spanish Agency for Medicinal Products and Products Health care, based on justified reasons, may prohibit the placing on the market, order the withdrawal or subject to special conditions any cosmetic product which, while complying with the requirements laid down in this royal decree, presents a risk to the health and safety of persons under normal or foreseeable conditions of use. The Spanish Agency for Medicinal Products and Sanitary Products shall immediately inform the health authorities of the autonomous communities, the European Commission and the competent authorities of the Member States.

3. Decisions to be taken in accordance with the above paragraph shall be of a provisional nature and for that purpose the corresponding administrative procedure shall be instructed in accordance with Law No 30/1992 of 26 November 1992. Legal framework for public administrations and the common administrative procedure. Against the decision to terminate the procedure, the procedure shall be brought before the Court of Justice in accordance with Article 114 of Law No 30/1992 of 26 November 1992. '

Ten. A paragraph 3 is added to Article 13, with the following wording:

" 3. For the control of products, the competent health authorities may enter into agreements, agreements or contracts with public or private undertakings. In such cases, the health authorities shall ensure the confidentiality of the information obtained. "

Once. Article 15 (1) (i) shall be worded as follows:

" i) The list of ingredients in descending order of weight at the time of incorporation. This list shall be preceded by the word 'ingredients' or 'ingredients'. Where it is impossible in practice, the ingredients shall appear in a note, a label, a band or an attached card, which shall be sent to the consumer either by means of an abbreviated indication or by the symbol of Annex VIII which must appear on the packaging.

However, no ingredients will be considered:

1. ° The impurities contained in the raw materials used.

2. ° The subsidiary technical substances used during manufacture, but which are no longer in the finished product.

3. The substances used in the strictly indispensable quantities as solvents or supports of the perfuming and aromatic compounds.

The perfuming and aromatic compounds, as well as their raw materials, will be mentioned with the word "perfume" or "parfum" and "aroma", respectively. However, the presence of substances the indication of which is mandatory in the column 'Other limitations and requirements' of Annex III shall be indicated on the list irrespective of their function in the product.

The ingredients of less than one percent concentration may be mentioned without order after those with a concentration higher than that percentage. Colours may be mentioned without any order after the other ingredients, by means of the number of the 'Colour Index' or the name given in Annex IV.

For decorative cosmetic products placed on the market with different shades of colour, the set of colours used in the range may be mentioned, provided that the words "may contain" or the symbol " + /-.

The manufacturer may, for reasons of commercial confidentiality, request the exclusion of one or more ingredients from that list, in accordance with Article 17. "

Twelve. The first subparagraph of Article 15 (4) is worded as follows:

" The ingredients in the list referred to in paragraph 1 (i) shall be expressed by their name INCI, as set out in the inventory of cosmetic ingredients adopted by decision of the European Commission and, in their absence, of an agreement with the rules of international nomenclature permitting their identification. "

Thirteen. A paragraph 7 is added to Article 15, with the following wording:

" 7. For the purposes of Article 6.4, the person responsible for placing the market on the market may include a consumer service telephone and/or an e-mail address, a website or any other information on the label. the company where consumers can be directed to obtain such information. "

Fourteen. Article 16 is worded as follows:

" Article 16. Advertising.

1. Without prejudice to the provisions of the rules governing advertising, the text, names, marks, images and other signs, graphics or not, which appear on the labelling, prospects and advertising of cosmetic products shall not be attributed to: such characteristics, properties or actions which do not possess or exceed the cosmetic functions referred to in Article 2, such as curative properties, false claims or misleading claims.

2. The person responsible for placing the cosmetic product on the market may only mention on the packaging of the product, or in any document, label, label, ring or collarete accompanying or referring to the product, which has not been experienced in animals, where neither the manufacturer nor his suppliers have carried out or commissioned experiments on animals of the finished product, their prototype or any of the ingredients that make up or have used any ingredient which has been experienced by third parties to develop new cosmetic products. For these purposes, the Ministry of Health and Consumer Affairs shall publish the guidelines to be adopted in the Community framework.

3. The names of cosmetic products may not be the same, similar or misleading with medicinal products, proprietary medicinal products, medical devices, biocidal products or foodstuffs, nor shall they refer to the names of pathologies.

4. The form, appearance, colour, smell, presentation or labelling of cosmetic products or their packaging, as well as the images and allusions made in advertising, shall be such that they cannot cause confusion with food or other products of consumption, in order to avoid risks to the health or safety of consumers.

5. The presentation of the articles intended for use in the bathroom and normally with wet hands should not be made in glass containers or any other material that is easily broken by hitting and causing cuts or injuries.

6. Public administrations, in the field of their competences, will carry out commercial advertising and propaganda monitoring to meet the criteria of accuracy in health, and limit all that may constitute a harm to it, as well as in what is affecting animal experimentation, and will monitor compliance with what is stated in this article.

The Spanish Agency for Medicinal Products and Sanitary Products shall monitor compliance with this Article and may adopt the measures provided for in Article 11. "

Fifteen. Paragraphs 6, 7 and 8 of Article 17 are worded as follows:

" 6. The decisions shall relate to a single ingredient, and the cosmetic products in which it is to be used on the Community market shall be specified. Such decisions shall be taken within the time limits laid down in Law No 30/1992 of 26 November 1992 on the legal system of public administrations and the common administrative procedure and shall be communicated to the person concerned together with the registration number. assigned to the ingredient.

7. An appeal against the refusal of confidentiality may be brought, in accordance with Article 114 of Law 30/1992, of 26 November.

8. All modifications to the data provided must be communicated as quickly as possible to the Spanish Agency for Medicines and Health Products. In the case of changes in the name of the cosmetic products in which the ingredient is integrated, they shall be notified to the Spanish Agency for Medicinal Products and Health Products at least 15 days prior to their placing on the market under their new conditions. names.

Depending on the modifications mentioned above or if new elements so require, in particular for imperative reasons of public health, the Spanish Agency for Medicines and Health Products may withdraw by resolution reasons for the granting of confidentiality. This decision may be brought before the Court of Justice in accordance with Article 114 of Law No 30/1992 of 26 November 1992. '

Sixteen. Article 18 is worded as follows:

" Article 18. Authorization of activities.

1. Natural or legal persons who perform materially the manufacture of cosmetic products or any of their stages, such as control, conditioning, packaging or labelling, on national territory, must be authorised by the Agency in advance. Spanish Medicines and Healthcare products.

This authorisation will also be required for importers of cosmetic products from non-EU countries.

In order to obtain this authorization, the natural or legal person who develops the activity will ask for the Spanish Agency for Medicines and Health Products, which will decide on the application within the time limits. established in Law 30/1992, of 26 November, of the Legal Regime of Public Administrations and of the Common Administrative Procedure.

If the documentation submitted does not permit an adequate assessment of the activities, the applicant shall be required for the submission of documents and other necessary elements of judgment; The time limit for the resolution shall be suspended until the date of receipt of the decision. The procedure shall also be suspended when the applicant is required to address deficiencies in the documentation submitted, up to completion by the applicant.

Examines the documentation submitted with the application, the Spanish Agency for Medicines and Health Products will request an inspection report on the conditions in which the companies intend to carry out the activities (a) in this paragraph, and shall order the inspections of the premises of such undertakings to be deemed necessary for such purposes. Since the requested report is decisive for the content of the decision to be taken, your request shall suspend the maximum period of time for the resolution for the time between the request for the report and its receipt, in accordance with the established in Law 30/1992, of 26 November, of the Legal Regime of Public Administrations and of the Common Administrative Procedure.

The authorizations will have a maximum validity period of five years. After that period, the revalidation shall be requested, at least three months before the expiry of the period for which it was granted. In the case of revalidation, the revalidation may be granted after verifying the Administration that the necessary requirements to be re-authorized are met.

For the procedure of modification of the authorization, it will be, in everything that is applicable, to the provisions of this article.

2. In order to obtain prior authorization from the Spanish Agency for Medicines and Health Products for the activities provided for in this article, the natural or legal persons who request it must meet the following requirements:

(a) Dispose of a responsible technician with an appropriate qualification, which monitors the manufacturing and/or import of cosmetics and ensures that the products comply with the requirements of the current regulations. For the purposes of assessing the suitability of the responsible technician, the possession of a university degree or equivalent official title, relating to the activities to be carried out, the appointment of which shall be communicated to the Spanish Agency for Medicines and Health Products.

(b) Dispose of an organisational structure capable of ensuring the quality of cosmetics manufactured and/or imported, as well as the execution of the checks carried out, taking into account the provisions of Article 6.

(c) Dispose of sufficient facilities, procedures, equipment and personnel with adequate qualifications for the manufacture, control and preservation of cosmetic products which manufacture and/or import. Such facilities shall have differentiated areas to develop, where appropriate, the following activities:

1. Manufacturing: with the facilities and means necessary for the manufacture and conditioning of the products under appropriate sanitary sanitary conditions.

2. Control: with the facilities, means, equipment, laboratory tools, reagents and patterns necessary to ensure the quality of the raw materials, intermediate products and finished products, as well as that of the material packaging.

3. Storage: for raw materials, intermediate products, finished products, and conditioning material.

d) Dispose and apply written work procedures where the functioning of each of the company's activities is collected, both in the technical aspects of processing and analytical procedures and in the control of quality levels, as well as in product traceability, documentary archiving and product monitoring on the market, through the establishment, where appropriate, of a quality assurance system.

3. Any stage of manufacture and, in the case of importers, control and storage may be made with entities which either possess the authorization referred to in this Article or are included in the processing of the authorisation of the holding company. In all cases, the undertakings concerned shall be referred to in the authorization documents.

4. Any modification of the ends provided for in the authorization, such as the transfer of facilities, the subcontracting of activities with new companies that do not have authorization of activities, the extensions of the facilities, the Inspection and authorisation shall be required in respect of the establishment of manufacturing lines for products of different categories or the substantial restructuring or redistribution of the zones in respect of the original authorisation. of the Spanish Agency for Medicines and Health Products.

5. The change in the legal personality, the name or the social reason of the holder, the technician responsible or the hiring of any activity with other authorized companies shall be considered a substantial modification of the activity, subject to the authorisation of the Spanish Agency for Medicines and Health Products.

6. The cessation of the activities involving the interest of the authorized undertaking in not continuing the maintenance of the conditions of the authorization and, consequently, the renunciation of the authorization must be communicated to the Spanish Agency of Medicines and Sanitary products by any means that permit their constancy, and shall attach a relation of the cosmetic products that they manufacture and/or amount at that time. The Spanish Agency for Medicinal Products and Sanitary Products will accept the waiver, in accordance with the provisions of Article 91 of Law 30/1992, of 26 November, of the Legal Regime of Public Administrations and of the Procedure. Common Administrative.

7. Any authorisation may be reviewed at any time, revoked or suspended. As regards the procedure, the provisions of Law 30/1992, of 26 November, of the Legal Regime of Public Administrations and of the Common Administrative Procedure will be provided. The decision to terminate these proceedings may be brought before the Court of Appeal in accordance with that law.

8. An authorisation shall be revoked if it is established that the conditions under which it was granted are not fulfilled or the information under which the authorisation was granted is found to contain false or misleading elements.

9. The health authorities of the autonomous communities shall be duly informed of the authorisations of activities granted to natural or legal persons located in their territory, and of modifications, revocations, resignations and revalidations that may occur as set out in the preceding paragraphs. "

seventeen. A paragraph 7 is added to Article 20 (3), with the following wording:

" 7. The placing on the market of cosmetic products manufactured in installations which do not have the authorisation provided for in Article 18. '

Eighteen. The additional second provision is worded as follows:

" Additional Disposition Second. Personal hygiene products.

1. Personal hygiene products shall mean all substances or preparations which, without the legal consideration of cosmetics, biocidal products, medical devices or medicinal products, are intended to be applied on the skin, teeth or mucous membranes of the human body for the purpose of hygiene or aesthetics, or to neutralize or eliminate ectoparasites, such as dentifrices, esthetic products, pediculics, vaginal moisturizers, anal cleaners in the case of hemorrhoids, products for massage sports, nasal cleaners or eye cleaners, or any other products which can be qualified as such.

2.

the following definitions shall apply:

(a) Denthrifics: substances or preparations which are applied in the oral mucosa and/or teeth which, by their indications, composition or form of presentation, cannot be considered as cosmetic, such as toothpaste, collutories, dental bleaches, chewing gum or tablets for oral hygiene or hyperfluorinated products for professional use or any other product which may be qualified as such.

(b) Aesthetic products: application products on the skin, which do not have the legal status of cosmetics, medicinal products or medical devices by their composition, indications, mechanism of action, application or duration, such as, where appropriate, tattoos for tattoos, micropigments or preparations for permanent and semi-permanent makeup, skin abrasion masks, chemical or transdermal patches, or any other product which may be labelled as such.

3. The products referred to in this additional provision shall be subject to a marketing authorization granted by the Spanish Agency for Medicinal Products and Sanitary Products, which shall be entered in the register which it has set.

4. The procedure for the authorisation of such products shall, as appropriate, be adjusted as provided for in Article 9. Such authorisation shall, however, be valid for a period of five years and may be revalidated at the request of the person responsible for placing on the market in the last six months of its validity.

5. The Spanish Agency for Medicinal Products and Sanitary Products may require the tests, data or tests it deems necessary for the toxicological evaluation of the product, as an extension of the safety assessment for established human health. in Article 6 (d).

6. The products referred to above shall apply to them, as appropriate, the provisions of Articles 4, 11, 12, 13, 16, 18, 19, 20 and 21.

7. The labelling of these products shall be regulated, as appropriate, by Article 15, which shall also include the number of health records and the quantitative composition of the active constituents where appropriate.

Depending on the nature of each product, the Spanish Agency for Medicinal Products and Sanitary Products may require the inclusion in the labelling of the particulars or data deemed appropriate for the correct use of the product. product and risk prevention.

8. The Spanish Agency for Medicines and Health Products may, where the nature of the product so requires, limit its use to certain professional sectors.

9. The Spanish Agency for Medicinal Products and Sanitary Products shall decide on the inclusion of a given product in that register, depending on its specific characteristics.

10. Manufacturers and/or importers of such products shall be specifically authorised to carry out manufacturing and/or import activities for such products, which shall be reflected in the relevant authorisation of activities, except the pharmacy offices that produce these products for dispensing in the office itself. "

nineteen. A sixth additional provision is added, with the following wording:

" Additional disposal sixth. Information to the European Commission.

The Ministry of Health and Consumer Affairs will forward to the European Commission data on the number and types of tests carried out on animals with cosmetic products. For these purposes, it shall annually collect this information from those responsible for the placing on the market of cosmetic products. "

Twenty. The following order numbers are added in Annex III, Part One, 'List of substances which cannot contain cosmetic products at higher concentrations and under conditions other than those laid down':

Number	Substance	Restrictions			Conditions of employment and warnings that must be mandatory on the label
		Scope application and/or usage	Maximum concentration on finished product	Other limitations and demands
	b	c	d	e	f
67	amyl Cinamal (CAS No 122-40-7)			The presence of the substance must be indicated in the list of ingredients to be made reference in Article 15 (i) where the concentration exceeds: -0,001% in products not to be rinsed. -0,01% in the products to be rinsed.
68					-0,001% in products which are not rinse. -0.01% on products to be rinsed.
		cinnamic Alcohol (CAS No 104-54-1)			The presence of the substance must be indicated in the list of ingredients referred to in the article 15.i) when its concentration exceeds: -0,001% in products which are not rinse. -0.01% on products to be rinsed.
70	Citral (CAS No 5392-40-5)			The the presence of the substance must be indicated in the list of ingredients referred to in Article 15 (i) when the substance is concentration exceeds: -0.001% in products that should not be rinsed. -0.01% in products to be rinsed.
71	Eugenol (CAS No 97-53-0)			The presence of the substance must indicate in the list of ingredients referred to in Article 15 (i) where their concentration exceeds: -0,001% in products not to be rinsed. -0,01% in products to be rinsed.
72	Hydroxicronelal (CAS No 107-75-5)			The presence of the substance must be indicated in the list of ingredients referred to in Article 15.i) when its concentration exceeds: -the 0.001% in the products that should not be rinsed. -0.01% in the products to be rinsed.
73	Isoeugenol (CAS No 97-54-1)			The presence of the substance must be indicated in the list of ingredients referred to in Article 15 (i) where their concentration exceeds: -0,001% in products not to be rinsed. -0,01% in products to be rinsed.
74	amilcinamyl alcohol (CAS No 101-85-9)			The presence of the substance must be indicated in the list of ingredients referred to in Article 15.i) when its concentration exceeds:-0,001% in the products not to be rinsed.-0,01% in products to be rinsed.
		75	(CAS No 118-58-1)			The presence of the substance must be indicated in the list of ingredients referred to in the article 15.i) when its concentration exceeds: -0,001% in products which are not rinse. -0.01% on products to be rinsed.
76				The the presence of the substance must be indicated in the list of ingredients referred to in Article 15 (i) when the substance is concentration exceeds: -0.001% in products that should not be rinsed. -0.01% in products to be rinsed.
77	Cumarina (CAS No 91-64-5)			The presence of the substance be indicated in the list of ingredients referred to in Article 15 (i) where their concentration exceeds: -0,001% in products not to be rinsed. - 0.01% on products to be rinsed.
78	Geraniol (CAS No 106-24-1)			The presence of the substance must be indicated in the list of ingredients referred to in Article 15.i) when its concentration exceeds: -the 0.001% in the products that should not be rinsed. -0.01% in the products to be rinsed.
79	hydroxymethyl-pentylcyclohexex-enocarbaldehido (CAS No 31906-04-4)			The presence of the substance must be indicated in the list of ingredients referred to in Article 15.i) when its concentration exceeds: -0,001% in the products that should not be rinsed. -0,01% in the products to be rinsing.
80	4-methoxybenzyl alcohol (CAS No 105-13-5)			The presence of the substance must be indicated in the list of ingredients to be referred to in Article 15.i) where its concentration exceeds: -0,001% for products that should not be rinsed. -0.01% on products to be rinsed.
81	Benzyl Cinamate (CAS No 103-41-3)			-0,001% in products not to be rinsed. -0,01% in the products to be rinsed.
82	Farnesol (CAS No 4602-84-0)			-0,001% in products which are not rinse. -0.01% on products to be rinsed.
83	2-(4-tert-butylbenzyl) propionaldehyde (CAS No 80-54-6)			The presence of the substance must be indicated in the list of ingredients to be refers to Article 15 (i) where its concentration exceeds: -0,001% in products which must not be rinsed. -0,01% in the products to be rinsed.
84	Linalol (CAS No 78-70-6)			-0,001% in products which are not rinse. -0.01% on products to be rinsed.
	85	benzyl Benzoate (CAS No 120-51-4)			The presence of the substance must be indicated in the list of ingredients referred to in the article 15.i) when its concentration exceeds: -0,001% in products which are not rinse. -0.01% on products to be rinsed.
86				The the presence of the substance must be indicated in the list of ingredients referred to in Article 15 (i) when the substance is concentration exceeds: -0.001% in products that should not be rinsed. -0.01% in products to be rinsed.
87	a-hexilcinamaldehyde (CAS No 101-86-0)			The presence of the substance shall be indicated in the list of ingredients referred to in Article 15 (i) where its concentration exceeds: -0,001% in products not to be rinsed.
88	(CAS No 5989-27-5)			The presence of the substance must be indicated in the list of ingredients referred to in Article 15.i) when its concentration exceeds: -the 0.001% in the products that should not be rinsed. -0.01% in the products to be rinsed.
89	Heptine methyl carbonate (CAS No 111-12-6)			The presence of the substance must be indicated in the list of ingredients referred to in Article 15 (i) where their concentration exceeds: -0,001% in products not to be rinsed. -0,01% in products to be rinsed.
90	3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl) -3-buten-2-one (CAS No 127-51-5)			The presence of the substance must be indicated in the list of ingredients referred to in Article 15.i) when its concentration exceeds: -0.001% in products that should not be rinsed.
91	Evernia prunastri, extract (CAS No 90028-68-5)			-0.001% in products that should not be rinsed. -0.01% in products to be rinsed.
92	Evernia furfuracea, extract (CAS No 90028-67-4)			The the presence of the substance must be indicated in the list of ingredients referred to in Article 15 (i) where the concentration exceeds: -0,001% in the products not to be rinsed.

Twenty-one. The current Annex IX becomes Annex X.

Twenty-two. The new Annex IX is called the "List of validated alternative methods for animal testing".

First transient disposition. Adequacy of the authorisations for the manufacture and/or import of cosmetic products or of any of their phases such as control, packaging, conditioning or labelling, prior to the entry into force of Royal Decree 1599/1997 of 17 October 1997, on cosmetic products.

1. Holders of authorizations for the manufacture and/or import of cosmetic products or of any of its phases such as control, conditioning, packaging or labelling, authorized prior to the entry into force of Royal Decree 1599/1997, of On 17 October, on cosmetic products, which have not been subject to new authorization after that date, they must revalidate their authorization to prove the adequacy of the current regulations. For these purposes, they will present the documentation supporting the fulfilment of the requirements established in this royal decree before the Spanish Agency for Medicines and Health Products, which, once the adequacy has been verified, will issue a document proving the said extremes. For the purposes of validity and duration of this document, the provisions of Article 18.1 of Royal Decree 1599/1997 of 17 October 1997 on cosmetic products shall be subject to the provisions of this document.

2. After the period of 24 months after the entry into force of this royal decree without having presented the evidence of conformity as referred to in the previous paragraph, the Administration will proceed with its own initiative to leave no such authorizations.

Second transient disposition. Deadline for the adequacy of cosmetic products to the provisions of this royal decree.

As of 11 March 2005, cosmetic products which do not comply with the provisions of paragraph 12 of the Single Article shall not be placed on the market.

Transitional provision third. Repeal of the ban on marketing cosmetics with ingredients or combinations of ingredients experienced in animals.

Since 1 July 2002, the content of Article 5 (1) (i) of Royal Decree 1599/1997 of 17 October 1997 on cosmetic products concerning the placing on the market of cosmetic products containing ingredients or combinations of ingredients experienced in animals, in the wording preceding this royal decree, as amended by the Order of 3 August 2000, without affecting the application, as from 11 March 2005 of the new subparagraph (i) of the said order Article 5.1 concerning the use in cosmetic products of carcinogenic, mutagenic or toxic substances for playback.

Transitional disposition fourth. Ordered products.

The ordered products included in the second provision of Royal Decree 1599/1997 of 17 October 1997 on cosmetic products, regulated by Royal Decree 3349/1983 of 30 November 1983, on the Technical-sanitary regulations for the manufacture, placing on the market and use of pesticides and their subsequent modifications, must be adapted to what is established in this royal decree, within 18 months from the date of their entry into

By way of derogation from the preceding paragraph, products authorised in accordance with the above rules may continue to be placed on the market during the period of validity of their authorisation.

The facilities in which these products are manufactured and/or imported must also have specific health authorization for these activities, issued by the Spanish Agency for Medicines and Health Products, as established in this royal decree, within 18 months, from its entry into force.

By way of derogation from the above paragraph, undertakings may continue to carry out the activities authorised during their period of validity.

Single repeal provision. Regulatory repeal.

As many rules of equal or lower rank are repealed, they are opposed to what was established in this royal decree.

Final disposition first. Basic character and competence title.

This royal decree has the status of a basic rule and is dictated under the protection of article 149.1.16. of the Constitution and in accordance with the provisions of article 40.2.5 and 6 of Law 14/1986 of 25 April, General of Health, and in the third provision of Law 25/1990, of 20 December, of the Medication.

Final disposition second. Faculty of development.

The Minister of Health and Consumer Affairs is empowered to issue, within the scope of his powers, the necessary provisions for the implementation and development of this royal decree, as well as for the updating of its annexes to progress. technical, when the rules of the European Union are laid down.

Final disposition third. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, 25 February 2005.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

ELENA SALGADO MENDEZ