In 1988 the process of incorporation into the internal system of the Community acquis on cosmetic products is initiated in Spain. In our country, the free movement of these products in the single European market became a reality, eliminating the previous administrative interventionism, while guaranteeing the health and safety of consumers and users by establishing a series of technical limitations in the composition of cosmetics, as well as the information that should be made available to the authorities and the general public.

This Royal Decree seeks to collect all the regulations on cosmetic products, consisting of the Royal Decrees 349/1988 of 15 April; 475/1991 of 5 April, and 1415/1995 of 4 August, and 15 Ministerial Orders and, at the same time, transposing Council Directive 93 /35/EEC of 14 June amending for the sixth time Council Framework Directive 76 /768/EEC on the approximation of the laws of the Member States relating to cosmetic products, as well as Commission Directives 95 /17/EC, on the exclusion of one or more several ingredients in the list of products for the labelling of cosmetic products, and 97 /18/EC, for which the date from which animal experiments are prohibited for ingredients or combinations of ingredients for cosmetic products is postponed.

This provision is based on the exercise of the powers that Law 14/1986 of 25 April, General of Health, confers, in its Article 40.2, 5 and 6, to the State Administration to determine, respectively, the health requirements of the technical-sanitary regulations of food, services or products directly or indirectly related to human use and consumption; the regulation, authorization, registration and approval, as appropriate, of medicinal products for human and veterinary use and other medical products and articles of those who, by affecting the human being, may pose a risk to the health of the persons; and the regulation and authorization of the activities of natural or legal persons engaged in the preparation, manufacture and manufacture of the products mentioned.

In the same sense, Law 25/1990 of 20 December of the Medicamento, in its additional provision tercera.2, establishes that the Government may determine, among others, cosmetic products whose clinical investigation and use, where appropriate, must be authorized, approved or certified by the State, in view of their special risk or importance to health.

Likewise, Law 26/1984 of 19 July, General for the Defence of Consumers and Users, in Article 2 thereof, points out among the basic rights of consumers protection against risks which may affect their health or safety; Articles 3 and 13 ensure the protection of consumers against foreseeable risks and determines the obligation of correct information on consumer products, respectively; and Articles 4 and 28 (1) and (2) thereof, specifies the content of the regulatory regulations, guarantees of purity, efficacy or safety and liability for damage caused by the use or consumption of products, which are applicable to cosmetics.

On the other hand, the Royal Decree 1907/1996 of 2 August 1996 on advertising and commercial promotion of products, activities or services with intended health purpose, which prohibits any kind of direct or indirect advertising or promotion, massive or individualized, which attribute to cosmetic products properties other than those recognized for such products, according to its special regulations, is prohibited.

Among the novel aspects introduced by this Royal Decree, it is worth noting the information to be provided by those responsible for placing the health authorities on the market for the purpose of rapid and appropriate medical treatment in the event of a nuisance; the obligation to reflect on the labelling the ingredients used in the cosmetic product; the technical memory to be produced by the companies and to keep at the disposal of the health authority; and the prohibition, as from 30 June 2000, to place cosmetic products containing ingredients on the market or combinations of ingredients experienced in animals. It also highlights the possibility for manufacturers to request, for reasons of commercial confidentiality, the exclusion of one or more of the ingredients in the labelling of cosmetic products.

This Royal Decree is issued pursuant to the provisions of Article 149.1.16. ^a of the Constitution, in conjunction with article 40.2, 5 and 6, of Law 14/1986, of 25 April, General of Health, and with the additional provision third of Law 25/1990, of 20 December, of the Medicamento.

Interterritorial Council of the National Health System has issued a favorable report on this Royal Decree and in its preparation have been heard the sectors affected.

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 on October 17, 1997,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object.

This Royal Decree aims to define cosmetic products, to determine the technical-sanitary conditions to be met, their sanitary control, the requirements to be met by the facilities where they are manufactured and the import of products from third countries, the regulation of labelling and advertising, as well as the inspection, the infringements and the penalties.

Article 2. Definitions.

For the purposes of this Royal Decree is understood by:

1. 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 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 1 to this provision are considered as an indicative product.

It is decorative cosmetic products which, by virtue of possessing coloured substances and by their covering power, are applied on different areas of the body, in order to temporarily accentuate their beauty or to mask or conceal various skin imperfections.

It is considered as an indication of decorative cosmetics, those listed in Annex V.

2. Placing on the market: the act of supplying or making available to third parties, for the first time, a cosmetic product whether or not for commercial transactions.

3. Responsible for placing on the market: natural person or legal entity who, having the status of: manufacturer or his agent; person responsible for the manufacture of the cosmetic product; responsible for placing on the Community market of imported cosmetic products, guarantees the suitability of the cosmetic to this Royal Decree.

4. Labelling, packaging and prospectuses: for the purposes of this Royal Decree, it is considered:

(a) Labelling: printed text, attached to the container or the packaging or hanging thereof, containing information and data required for the product.

(b) Recipient: any item or packaging that contains the cosmetic product and is in direct contact with it.

c) Packaging or outer carton: box, case or any other system that contains the container and protects it.

d) Package Leaflet: printed text optionally included inside the packaging, containing additional information and instructions for the use of the cosmetic product.

5. Cosmetic ingredient: any chemical or preparation of synthetic or natural origin; which forms part of the composition of cosmetic products.

Article 3. Exclusions.

Those prepared for the prevention, diagnosis and treatment of diseases, as well as those destined to be ingested, inhaled, injected or implanted in the human body, are excluded from this Royal Decree.

Neither are those prepared for protection against contamination or infection by micro-organisms, fungi or parasites considered to be cosmetic.

CHAPTER lI

Technical-health conditions for cosmetic products

Article 4. General conditions.

1. Cosmetic products placed on the market in the Community shall not be liable to harm human health when they are applied under normal or reasonably foreseeable conditions of use, taking into account, in particular, the presentation of the product, its labelling and any instructions for use and disposal, as well as any other indication or information from the manufacturer or his authorised representative or from any other person responsible for placing the products on the market in the Community.

2. The risks likely to arise from the normal use of cosmetic products, having regard to their nature and the persons to whom they are intended, must be brought to the attention of consumers, by means of instructions and indications for their correct use and appropriate warnings.

However, the presence of such warnings does not exempt from the fulfilment of the other obligations provided for in this provision.

Article 5. Bans.

1. Without prejudice to Article 4, the placing on the market of cosmetic products containing:

(a) The substances listed in Annex II to this Royal Decree.

(b) The substances listed in Annex III, in higher concentrations and under conditions other than those laid down in that Annex.

(c) Colorants not included in Annex IV with the exception of cosmetic products containing colours intended solely for the use of the hair system.

(d) Colorants falling within Annex IV, in higher concentrations and under different conditions than those laid down, with the exception of cosmetic products containing colours intended solely for use in the hair system.

(e) Conservative agents not included in Annex VI.

(f) Conservative agents listed in Annex VI at higher concentrations and under conditions other than those laid down in that Annex.

g) ultraviolet filters not included in Annex VII.

h) ultraviolet filters included in Annex VII in higher concentrations and under conditions other than those laid down in that Annex.

i) Ingredients or combinations of ingredients experienced in animals from 30 June 2000.

j) Any other substance or preparation expressly prohibited by the Ministry of Health and Consumer Affairs in order to ensure the protection of the health or safety of persons.

2. The presence of the remains of substances listed in Annex II shall be tolerated provided that it is technically unavoidable with the correct manufacturing procedures and complies with the provisions of Article 4.

CHAPTER III

Information requirements

Article 6. Technical documentation.

1. The person responsible for placing on the market shall be easily accessible, at the disposal of the competent authorities, at the address specified on the label, in accordance with Article 15 (1) (b), for the purposes of monitoring, the following information:

(a) The qualitative and quantitative formula of the product; in the case of perfuming and perfume compounds, this information shall be limited to the name and number of the compound code and to the identity of the supplier.

(b) The physicochemical and microbiological specifications of the raw materials and the finished product, as well as the criteria of purity and microbiological control of cosmetic products.

(c) The method of manufacture in accordance with the good manufacturing practice provided for by Community law, or by the rules of good manufacturing which are established at the time. The person responsible for the manufacture or the first importation into the Community territory must present an appropriate level of qualification, considering the possession of a university degree or equivalent, in connection with the activity to be carried out, to be sufficient.

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 the case of the same product manufactured in several parts of the Community territory, the manufacturer may choose one of the places of manufacture in which the information is available.

Such a place shall be communicated to the competent authorities, if requested, for control purposes.

(e) The name and address of the qualified persons responsible for the assessment referred to in paragraph (d). These persons must hold a title as defined in Article 1 (a) of Royal Decree 1665/1991 of 25 October 1991 regulating the general system for the recognition of higher education diplomas in the Member States requiring a minimum of three years ' training in the fields of pharmacy, toxicology, dermatology, medicine or an analogous discipline.

(f) Existing data on the undesirable effects on human health caused by the cosmetic product as a result of its use.

(g) Tests demonstrating the effect claimed by the cosmetic product, where the nature of the effect or the product justifies it.

2. The safety assessment for human health referred to in paragraph 1 (d) shall be carried out in accordance with the principles of good laboratory practice laid down in Royal Decree 822/1993 of 28 May 1993 laying down the principles of good laboratory practice and their application in the conduct of non-clinical studies on chemicals and substances.

3. The information referred to in paragraph 1 shall be available at least in the official Spanish language of the State. However, the French or English languages may be accepted in the specialised scientific documentation supporting the technical information. In this case, if there is a reasoned doubt as to the assessment of this information, the official language of the State may be required to provide the information necessary.

Article 7. Registration of the persons responsible for placing on the market.

The person responsible for placing on the market will send a list of the cosmetic products manufactured in Spain and/or imported into Spain, together with the places of manufacture and/or import thereof to the health authorities of the Autonomous Community where its registered office is established, before its marketing on the Community market.

This relationship will be presented in duplicate and one of the copies will be transferred to the Directorate General of Pharmacy and Sanitary Products by the corresponding Autonomous Community.

In the event that the person responsible does not have established his registered office in Spain, this relationship will be sent to the General Directorate of Pharmacy and Health Products.

When a person established in Spain manufactures his products in another Member State of the European Union, he shall communicate the manufacturing sites to the competent authorities of that Community country.

Article 8. Information for medical treatment purposes.

1. With a view to 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 General Directorate of Pharmacy and Health Products, not later than the day when the placing on the market in Spain is effective, the following information:

a) Name of the product.

b) Quantitative Composition. All ingredients shall be linked 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 Commission Decision of 8 May 1996 (OJ 1996 L 132, 1 June 1996) and in its absence, in accordance with the international nomenclature rules permitting its identification.

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

(d) Prospects and in the event that they do not exist or that the particulars required in Article 15, labelling of the container and packaging are not included.

This data will be entered into an envelope, which will be closed.

On the outside of the envelope, the following data must be stated:

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

2. Cosmetic Denomination.

3. Date of presentation.

This envelope, along with a letter that reflects the same data, will be directed to the General Directorate of Pharmacy and Healthcare Products. Paseo del Prado, numbers 18-20, 28014 Madrid.

The copy of the document, sealed by the General Register of the Ministry of Health and Consumer Affairs or by any of the bodies mentioned in Article 38.4 of the Law of Legal Regime of Public Administrations and of the Common Administrative Procedure, will serve as proof of the presentation.

Any change or modification of the data provided shall be communicated, in accordance with the above procedure, with reference to the name of the product, the date of presentation and the name of the person responsible for the information previously provided.

2. Ten years after the information provided for in paragraph 1 of this Article, the person responsible for placing a cosmetic product on the market shall communicate his intention to keep it on the market, as otherwise it shall be deemed to have ceased the placing on the market of the product.

Article 9. Special declarations.

1. The Directorate-General for Pharmacy and Health Products may exceptionally authorize the use in cosmetic products of colorants, preservatives or ultraviolet filters that are not included in the Annexes to this Royal Decree.

In these cases, a special declaration must be presented in which the following data will be displayed:

(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 18.

(c) The number of the authorisation referred to in Article 18.1.

(d) Denomination of the cosmetic product and the category to which it belongs, in accordance with those referred to in Annex 1 or with the classification as the case may be established.

e) Quantitative composition, in descending order, of the concentrations expressed by the INCI denomination or, in its absence, in accordance with the international nomenclature rules that permit identification.

(f) Labelling and prospectuses or, failing that, a sketch of the same in which the texts to be included in the product placed on the market shall 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 foreign cosmetic products, the marketing authorisation or the free-selling certificate issued by the competent authority of the country of origin shall be included, and any further information of that authority may be obtained.

i) Memory of the product which includes the information referred to in Article 6 (1), except paragraph (a).

j) Compliance with a follow-up program that accredits the safety in its use, by the entity that declares it, in accordance with the requirements established by the Directorate General of Pharmacy and Health Products.

k) The justification of the formulation that motivates the special declaration.

2. Within 90 days, the Directorate-General for Pharmacy and Health Products shall decide on the special declaration submitted. If the product 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 started from the receipt of the required data or tests.

3. The special declaration shall take effect for a maximum period of three years from the date of the favourable pronouncement. The product covered by such a declaration shall be identified on the label in such a way that it differs from other cosmetic products. That period shall be extended if the relevant Community procedure for the inclusion of the substance in any of the Annexes has been initiated, until such time as the decision on the substance has been taken.

4. Any special declaration on which a favourable statement is to be made shall be forwarded to the health authorities of the Autonomous Communities.

5. Whenever the Directorate-General for Pharmacy and Health Products 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 than those referred to in paragraph 1.

6. Any special declaration on which a favourable statement is to be made shall be communicated to the Commission of the European Union within 60 days from the date of delivery.

Article 10. Registration.

The General Directorate of Pharmacy and Health Products will keep up-to-date records with the information provided in compliance with Articles 7, 8 and 9, guaranteeing their confidentiality.

The information on the registration of the persons responsible for placing on the market and the special declarations shall be kept at the disposal of the health authorities of the Autonomous Communities. Information for medical treatment shall be kept at the disposal of the National Institute of Toxicology.

CHAPTER IV

Performances of public administrations

Article 11. Faculty of action.

1. The competent health authorities shall take appropriate measures to ensure that only cosmetic products complying with this Royal Decree are placed on the market.

2. Without prejudice to the actions of other health authorities, the Directorate-General for Pharmacy and Health Products, based on reasons of need or urgency, 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. Any such measure shall be of a provisional nature and shall be immediately notified to the Commission of the European Union and to the competent authorities of the Member States.

3. In any event, if the decision to adopt is to prohibit the marketing of a cosmetic product, it shall be carried out by means of the instruction of the corresponding administrative procedure with an audience of the person concerned, which may manifest its disagreement to the hierarchical superior of the one who issued the resolution by means of the corresponding ordinary appeal within one month, in accordance with the provisions of Articles 114 and following of the Law on the Legal Regime of Public Administrations and the Common Administrative Procedure.

Article 12. Confidentiality.

The competent authorities and the National Institute of Toxicology shall ensure the confidentiality of any information obtained in the performance of their duties.

Article 13. Inspection.

1. The competent public authorities shall carry out periodic inspections to verify compliance with the provisions of this Royal Decree.

2. The authorities of the General Administration of the State and the competent Autonomous Communities shall assist each other for inspection purposes.

Within the Interterritorial Council of the National Health System, appropriate measures will be taken to encourage cooperation and mutual assistance between the state and regional health authorities; specific control programs may also be established with references to the nature, extent, intensity and frequency of the controls to be carried out.

Article 14. Cooperation with the authorities of the Member States.

For the purposes of mutual cooperation referred to in paragraph 5 (12) of Article 1 of Directive 93 /35/EEC, the Directorate-General for Pharmacy and Health Products shall transmit the information requested by the competent authorities of any Member State of the European Union.

Similarly, where it is necessary to collect information on cosmetic products from another Member State, the Directorate-General for Pharmacy and Health Products, it shall request it from the authorities of the Member State concerned.

CHAPTER V

Labeling and Advertising

Article 15. Labelling.

1. The containers and packaging of any cosmetic product placed on the market must bear the following particulars with indelible, easily legible and visible characters:

a) Name of the product.

(b) The name or social name and address or registered office of the manufacturer, or in the case of imported cosmetic products, the name or the social name and the address or registered office of the person responsible for placing on the market of the product established within the territory of the Community. These terms may be abbreviated as long as the abbreviation allows, in general terms, to identify the company.

(c) The nominal content at the time of conditioning, indicated by weight or volume, except for packages containing less than 5 g or less than 5 ml, free samples and single doses; for pre-packaged products, which are normally marketed by unit sets and for which the indication of the weight or volume is not significant, it shall not be necessary to indicate the content, provided that the number of pieces is mentioned in the package. This indication shall not be necessary when it is easy to determine from the outside the number of parts or if the product is normally only marketed by loose units.

(d) The minimum expiry date: the date of minimum expiry of a cosmetic product is the date to which that product, preserved under appropriate conditions, continues to fulfil its initial function and in particular continues to comply with the requirements laid down in Article 4.1.

The minimum expiry date shall be indicated by the words 'use preferably before the end of ...', as follows: either the date itself, or the indication of the place of the labelling where it appears.

In case of need, these particulars shall be supplemented by the indication of the conditions for guaranteeing the indicated duration.

The date will be composed of the indication, in a clear and orderly manner, of the month and year. For cosmetic products whose minimum life exceeds 30 months, the indication of the expiry date shall not be compulsory.

(e) Special precautions for use, and in particular those set out in the column "Conditions of employment and warnings which must be compulsory on the labelling", of Annexes III, IV, VI and VII to be included in the container and packaging, as well as any indications referring to particular precautions to be taken with cosmetic products for professional use, in particular those intended for hairdressers. Where this is not possible in practice, these particulars must be entered in a note, a label, a band or an attached card, which shall be sent to the consumer either by an abbreviated indication or by the symbol of Annex VIII, which must appear on the container and on the packaging.

f) The manufacturing batch number or the reference that permits the identification of the manufacturing. Where this is not possible in practice, due to the small size of cosmetic products, this indication should only appear on the packaging.

g) Country of origin in the case of cosmetic products manufactured outside the Community.

h) The function of the product, except if it appears from its presentation.

i) The list of ingredients by decreasing order of weight at the time of incorporation. This list shall be preceded by the word 'ingredients' or 'ingredients', and may appear only on the packaging. If it is impossible in practice, the ingredients shall be in a note, a label, a band, or an attached card, which shall be sent to the consumer either by 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 quantities strictly indispensable 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. The ingredients of concentration less than 1 per 100 may be mentioned without order after the ingredients of a concentration exceeding 1 per 100. 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 marketed with different shades of colour, the set of colours used in the range may be mentioned, provided that the words "may contain" are added.

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

2. The particulars referred to in paragraphs (d), (e) and (h) of paragraph 1 shall appear at least in the official Spanish language of the State.

3. The particulars referred to in paragraph 1 (a), (b) and (f) may be expressed in the national or official languages of origin, where the product comes from countries in the territory of the Community.

4. The ingredients of the list referred to in paragraph 1 (i) shall be expressed by their name INCI, as set out in the inventory of cosmetic ingredients published in the Official Journal of the European Communities by decision of the Commission of 8 May 1996.

However, when the spelling or consonance of a term of the common nomenclature is significantly removed from an intelligible term by consumers, the Directorate-General for Pharmacy and Health Products may determine the appropriate wording.

5. Those responsible for cosmetic products which are presented without prior packaging or which are packaged at the place of sale at the request of the purchaser or which are pre-packaged for immediate sale, shall have labels or leaflets adjusted to the requirements of paragraph 1 of this Article which shall be attached to or accompany the packaging of the products at the time of delivery to the consumer.

6. In the case of soap and bath pearls, as well as other small products, where due to the size or shape it is impossible to make the indications referred to in paragraph 1 (i) on a label, band, card or note attached, these particulars must appear on a label situated very close to the place where the cosmetic product is offered for sale.

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, prospectuses and advertising of cosmetic products, they shall not attribute to the same characteristics, properties or shares which they do not possess or exceed the cosmetic functions referred to in Article 2, such as curative properties, false claims or misleading claims.

2. Any reference to animal experiments shall clearly indicate whether the experiments carried out relate to the finished product and/or its ingredients.

3. The names of cosmetic products may not lead to confusion with medicinal products, medicinal products or foodstuffs.

4. The packaging and presentation of these products shall be such that they cannot be confused with food or other consumer products in order to avoid health risks.

5. Public administrations in the field of their competences will carry out a control of commercial advertising and propaganda to meet the criteria of veracity in health, limiting everything that may constitute a disservice to the health and will monitor compliance with the provisions of this article.

CHAPTER VI

Confidentiality

Article 17. Confidentiality of ingredients.

1. Cosmetic products on whose labelling, for reasons of commercial confidentiality, may be placed on the market in Spain shall be replaced by the name of one of its ingredients, the registration number granted by a Member State, in accordance with Annex IX.

2. To this end, the Ministry of Health and Consumer Affairs, through the Directorate-General of Pharmacy and Health Products, will recognize the decisions on confidentiality adopted by the authorities of the other Member States, and may request a copy of the file that includes the request for confidentiality and the decision of the competent authority of the Member State that granted the confidentiality. However, after having become aware of this information, the Directorate-General for Pharmacy and Health Products may challenge a decision taken by the competent authority of another Member State, requesting the Commission of the European Union to adopt a decision in accordance with the procedure laid down in Article 10 of Directive 76 /768/EEC.

3. The Directorate-General for Pharmacy and Health Products shall also communicate to the Commission of the European Union and to the other Member States the decisions it takes on the granting or extension of the right to confidentiality, indicating the name or social reason and the address or registered office of the applicants, the names of cosmetic products containing the ingredient for which confidentiality has been granted, and the number of registration granted.

It shall also inform the Commission and the other Member States of their reasoned decisions for refusal or withdrawal of the granting of confidentiality or of refusal of the extension of confidentiality.

4. In the case of decisions on commercial confidentiality, account shall be taken of:

(a) The assessment of safety for human health of the ingredient as used in the finished product (s) taking into account the toxicological profile, the chemical structure and the level of exposure of the ingredient under the conditions specified in paragraphs (d) and (e) of paragraph 1 and Article 6 (2) of this provision.

b) The intended use of the ingredient and, in particular, the different categories of products in which it will be used.

c) The justification for the reasons why confidentiality is requested exceptionally, for example:

1. The fact that the identity of the ingredient or its function in the cosmetic product to be marketed is not described in any publication and is not known for science in its current state.

2. The fact that the information is not yet in the public domain, even if a patent has been applied for the ingredient or its use.

3. The fact that if the information was known it would be easily reproducible to the detriment of the applicant.

The decision granting the right to confidentiality will last for five years and may be extended for justified reasons for a maximum period of three years.

5. The person responsible for placing on the market who wishes to benefit from the exclusion of an ingredient in the labelling of cosmetic products shall be required to document the aspects referred to in paragraph 4 of this Article and shall also provide:

a) The precise identification of the ingredient for which confidentiality is requested, namely:

1. The name INCI, the CAS numbers, EINECS, and Colour Index, the chemical name, the IUPAC name, the name of the European Pharmacopoeia, and the name of the international common nomenclature of the World Health Organization.

2. The name ELINCS and the official number assigned to it in the event of notification under Royal Decree 363/1995 of 10 March, approving the Regulation on new substances and classification, packaging and labelling of dangerous substances, as well as the indication of the granting or refusal of confidentiality on the basis of this Royal Decree.

3. The names and numbers referred to in paragraphs 1. and 2., for example, in the case of certain ingredients of natural origin, shall be given the name of the basic material, the name of the part of the plant or animal used, the names of the ingredients of the ingredient, such as solvents.

(b) If the name of each product containing the ingredient is known and if different names are to be used on the Community market, precise indications on each of them.

If the name of the product is not yet known, it may be reported later, but this communication must be made at least 15 days prior to the marketing.

In case the ingredient is used in several products, it will be sufficient for a single application, provided that these products are clearly indicated to the competent authority.

(c) A declaration specifying whether an application has been submitted to the competent authority of another Member State in relation to the ingredient for which confidentiality is requested and information on the results of that request.

6. The decisions shall relate to a single ingredient, specifying the cosmetic products in which it is to be used on the Community market.

Such decisions shall be taken within a period not exceeding four months from the date of submission of the documentation referred to in paragraphs 4 and 5 of this Article and shall be communicated to the person concerned together with the registration number assigned to the ingredient. This period may be up to two months, when exceptional circumstances are present, informing the person concerned.

7. The refusal of decisions in matters of confidentiality shall be reasoned, and may be brought by the person concerned, the corresponding ordinary appeal within one month in accordance with Articles 114 et seq. of the Law on the Legal Regime of Public Administrations and the Common Administrative Procedure.

8. All modifications to the data provided must be communicated as quickly as possible to the Directorate General of Pharmacy and Health Products. In the case of changes in the name of cosmetic products in which the ingredient is integrated, they must be notified to the Directorate-General for Pharmacy and Health Products at least 15 days before they are placed on the market under their new names.

Depending on the modifications mentioned above or if new elements so require, in particular for imperative reasons of public health, the General Directorate of Pharmacy and Health Products may withdraw the grant of confidentiality. In this case, it shall inform the applicant of its decision within the time limit referred to in paragraph 6 and with the guarantees laid down in paragraph 7 of this Article.

CHAPTER VII

Manufacturing and import activities

Article 18. Authorization of activities.

1. Natural or legal persons who manufacture cosmetic products or any of their phases, such as packaging, conditioning or labelling, must be authorized in advance to carry out such activities by the Directorate-General of Pharmacy and Health Products.

This authorisation will also be required for importers of cosmetic products from third countries.

2. In order to obtain such authorisation, the persons referred to in paragraph 1 shall meet the following requirements:

(a) Dispose of sufficient personnel and the appropriate qualification to ensure the quality of the cosmetics manufactured and/or imported, as well as the execution of the checks, taking into account the provisions of Article 6.

b) Dispose of a responsible technician with an appropriate level of qualification, considering the possession of a university degree or an equivalent official title, related to the activity to be performed, to be sufficient in this respect, the appointment of which will be communicated to the Directorate General of Pharmacy and Health Products.

c) Dispose of the premises and equipment necessary for the manufacture, control and preservation of the cosmetics that manufacture and/or amount.

For such purposes, you will have differentiated areas, if any:

1. Manufacturing: with the necessary facilities and facilities for the manufacture and packaging of cosmetic products under appropriate hygienic-sanitary conditions.

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

3. Storage: for raw materials, intermediate products and finished products, as well as for packaging and labelling material.

(d) to implement procedures for the production and control of the uniform production of cosmetics and the monitoring of their quality levels by establishing, where appropriate, a quality assurance system.

3. Manufacture, control or storage may be arranged with entities which either have 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. The transfer, extension or substantial modification of the facilities must be authorized in advance at the start of the activities.

5. Where an entity holding an authorisation changes its legal personality, name or social reason, it shall communicate it by attaching the supporting documentation. It will also be communicated to the end of the activities, attaching a relation of the cosmetic products that it commercializes at that moment.

6. 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 any changes or ceases which may occur as set out in paragraphs 1, 4 and 5 respectively of this Article.

CHAPTER VIII

Violations and penalties

Article 19. Infringements.

They will have the consideration of violations of the provisions of this Royal Decree, the actions or omissions provided for in Article 35 of Law 14/1986, of 25 April, General of Health and, where appropriate, in Article 34 of Law 26/1984, of July 19, General for the Defense of Consumers and Users, and specifically those set out in the following article.

The infractions are described as mild, severe and very serious, taking into account the health risk criteria, the amount of the possible benefit obtained, the degree of intentionality, the severity of the health and social changes produced, the generalization of the infringement and the recidivism.

Article 20. Rating of infringements.

1. They are minor infractions:

1. Hinder the inspection by any action or omission that disturbs or delays the work.

2. Failure to comply with the requirements, obligations or prohibitions set out in this Royal Decree, when in accordance with the criteria referred to in the previous article, does not qualify as a serious or very serious fault.

2. These are serious violations:

1. Do not provide the Health Administration with the information contained in Articles 7 and 8 of this Royal Decree, as well as the lack of communication of any modification of the initial information.

2. The lack of agreement between the indications of the labelling of the products and the information provided to the Health Administration under Article 8.

3. Failure to comply with the provisions of Article 9 (3).

4. The omission in the labelling of cosmetic products of any of the particulars provided for in Article 15, or not in the languages and/or in the terms set out in that Article.

5. To make offers, promotions or advertising for cosmetic products which do not conform to the general rules governing these aspects and, in particular, where reference is made to curative properties, false claims or misleading claims.

6. Failure to comply with the provisions of Article 16 (2), (3) and (4).

7. The placing on the market of cosmetic products on the labelling of which are listed as ingredient registration numbers without complying with the conditions laid down in Article 17.

8. The conduct of the activities referred to in Article 18 without the contest of the responsible technician referred to in this Article.

9. To produce cosmetic products under poor technical-health conditions affecting their safety, safety and quality, in breach of the conditions which have been used as a basis for the granting of the authorisation referred to in Article 18.

10. Failure to comply with the provisions of Article 18 (5).

3. These are very serious violations:

1. The placing on the market of cosmetic products which contravene the provisions of Articles 4 or 5.

2. The distortion of the information referred to in Articles 7, 8 and 9 of this provision.

3. The manufacture and/or placing on the market of cosmetic products in which the substances referred to in Article 9 are used without the relevant authorisation.

4. Do not keep at the disposal of the competent health authorities some of the information contained in Article 6.1, or do not express them in the official Spanish language of the State, where it is required.

5. The placing on the market of cosmetic products where they have been the subject of the measures provided for in Article 11.

6. Manufacture, or import cosmetic products without the required authorization, in accordance with Article 18, or to transfer, extend or modify substantially the facilities without the required authorization.

Article 21. Sanctions.

1. The actions or omissions constituting infringements, as provided for in Articles 19 and 20 of this Royal Decree, shall be subject to the appropriate administrative penalties, subject to the instruction of the appropriate procedure, without prejudice to the civil, criminal or other responsibilities that may arise. The procedure for imposing sanctions shall be in accordance with the principles laid down in Title IX of the Law on the Legal Regime of Public Administrations and the Common Administrative Procedure.

2. The offences referred to in Articles 19 and 20 shall be sanctioned in accordance with the graduation laid down in Article 36 of Law 14/1986 of 25 April, General of Health, and, where appropriate, in Article 36 of Law 26/1984 of 19 July, General for the Defence of Consumers and Users.

3. In any event, where health offences are detected, the instructor shall immediately inform the competent health authorities thereof, without prejudice to the adoption of the precautionary measures.

4. The closure or closure of establishments or facilities which do not have the prior authorisations or health records required, or the suspension of their operation until the defects are remedied, or the conditions required for reasons of health, hygiene or safety, shall not be suspended, without prejudice to the sanctioning procedure to be initiated.

Additional disposition first. Basic rule.

The provisions of this Royal Decree have the status of a basic rule according to the provisions of article 149.1.16. of the Constitution, in conjunction with Article 40.2, 5 and 6 of Law 14/1986 of 25 April, General of Health, and with the additional provision of Law 25/1990 of 20 December of the Medication.

Additional provision second. Toothpaste and other products.

1. Dentifrice or similar products and products of hygiene or aesthetics of application in skin or mucous membranes, which, by virtue of their composition, purpose or presentation, the former, and by their mechanism of action or indications, the latter, cannot be included in the field of application of this Royal Decree, and cannot be considered as medicinal products, medical devices or pesticides, shall be subject to a health authorization for placing on the market, establishing a register for that purpose.

2. The authorisation procedure for such products shall, as appropriate, be adjusted as provided for in Article 9 of this Royal Decree. Such authorization shall, however, be valid for 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.

3. These products shall apply to them, as appropriate, the provisions of Articles 4, 11, 12, 13, 16, 18, 19, 20 and 21 of this Royal Decree.

4. The labelling of these products shall be regulated, as appropriate, by Article 15 of this Royal Decree, in addition to the number of health records, and the quantitative composition of the active constituents in their case.

Depending on the nature of each product, the General Directorate of Pharmacy and Health Products may require the inclusion of the particulars or data deemed appropriate for the correct use of the product and the prevention of risks.

5. The Directorate-General for Pharmacy and Health Products may, where the nature of the product so requires, limit its use to certain professional sectors.

Additional provision third. Pharmacy offices.

The cosmetics manufactured by the pharmacy offices for dispensing in the office itself will be in accordance with the provisions of this Royal Decree, with the following exceptions:

(a) The authorisation of activities referred to in Article 18 shall not be required, but the requirements of this Article shall be met. Nor shall it be necessary to discharge in the Register of persons responsible for placing on the market referred to in Article 7.

(b) It shall not be necessary to possess the technical documentation required by Article 6, nor to provide the information for the purposes of medical treatment referred to in Article 8, in the case of cosmetic products made individually and intended for a particular consumer, although documentary evidence of the manufacture of such products shall be recorded by means of the corresponding entries.

These exceptions will not apply in the event that cosmetic products are distributed to other entities or establishments for sale or application to the final consumer.

Additional provision fourth. Agreement on the European Economic Area.

For the purposes of this Royal Decree, the provisions of the Agreement on the European Economic Area shall apply.

Additional provision fifth. Cosmetology Advisory Committee.

For the purposes of this Royal Decree, the Order of 14 February 1996, for which the Advisory Committee on Cosmetology ("Official State Gazette" of 6 March) is constituted, remains in force.

First transient disposition. Time limits for the marketing of cosmetic products.

1. Cosmetic products which do not comply with the provisions of this Royal Decree may not be sold or transferred to the final consumer as from 31 December 1997.

2. By way of derogation from paragraph 1, cosmetic products containing the substance referred to in Annex II, number 416 and cosmetic products containing lithium and calcium hydroxides in higher concentrations or under conditions other than those laid down in Annex III, Part 1, number 15 b and c, may be sold or transferred to the final consumer until 1 July 1998.

Second transient disposition. Deadline for information for medical treatment of products in accordance with Royal Decree 349/1988.

Without prejudice to the provisions of the first transitional provision, those responsible for the products placed on the market under the provisions of Royal Decree 349/1988 of 15 April, approving the Technical-Health Regulations for Cosmetic Products, as amended by Royal Decrees 475/1991 of 5 April, and 1415/1995 of 4 August, will have two years to complete the provisions of Article 8 of this Royal Decree.

Transitional provision third. Time limit for the adequacy of dentifrice and other products.

The products mentioned in the second provision, which are being marketed prior to the entry into force of this Royal Decree, must be adapted to the same, within eighteen months.

Transitional disposition fourth. Application of the rules of methods of analysis for the control of the composition of cosmetic products.

Until the forecasts of the second final provision are developed, the following ministerial orders shall apply, laying down the methods of analysis necessary for the control of the composition of cosmetic products:

a) Order of 28 September 1989 (Official State Gazette of 10 October 1989).

b) Order of 19 October 1990 ("Official State Gazette" of 29).

(c) Order of 17 May 1995 ("Official State Gazette" of 25),

(d) Order of 25 March 1996 ("Official State Gazette" of 12 April).

e) Order of 23 July 1997 (Official State Gazette of 2 August 1997).

Single repeal provision. Regulatory repeal.

1. As from the entry into force of this Royal Decree, the following provisions are hereby repealed:

(a) Decree 3339/1968 of 26 December 1968 on the regulation of cosmetics.

b) Royal Decree 349/1988 of 15 April, approving the Technical-Health Regulations for Cosmetic Products, except for the additional provision which enables the Minister of Health and Consumer Affairs to set up a Cosmetology Advisory Committee.

c) Royal Decree 475/1991 of 5 April 1991 amending Royal Decree 349/1988.

(d) Royal Decree 1415/1995 of 4 August 1995 amending the Technical-Health Regulations for Cosmetic Products, approved by Royal Decree 349/1988 of 15 April

,

2. The following Ministerial Orders are hereby repealed, adapting to technical progress the Annexes to Royal Decree 349/88 of 15 April 1988:

a) Order of 14 March 1989 (Official Gazette of the State of 29).

b) Order of 15 December 1989 ("Official State Gazette" of 22).

c) Order of 19 October 1990 (Official Gazette of the State of 29).

(d) Order of 9 November 1991 ("Official State Gazette" of 19).

(e) Order of 12 March 1993 ("Official State Gazette" of 26).

(f) Order of 10 February 1994 ("Official State Gazette" of 3 March 1994).

(g) Order of 8 June 1995 ("Official State Gazette" of 16).

(h) Order of 25 March 1996 ("Official State Gazette" of 11 April 1996).

i) Order of 23 July 1997 (Official State Gazette of 2 August 1997).

Final disposition first. Regulatory development powers.

The Minister of Health and Consumer Affairs will issue a basic protocol on the correct manufacturing of cosmetic products, as well as how many provisions are necessary for the implementation and development of this Royal Decree and for the updating of its annexes when the regulations of the European Economic Community are established.

Final disposition second. Establishment of criteria of chemical and microbiological quality.

The criteria for the chemical and microbiological quality of cosmetic products will be established by the Order of the Minister for Health and Consumer Affairs, taking into account Community legislation.

In their absence, the analytical methods used or recommended by the National Institute of Consumption and other centers and specialized institutions, national or international, of recognized solvency will be used.

Final disposition third. Modification of the information for medical treatment purposes.

The content of the information referred to in Article 8 may be modified by Order of the Minister for Health and Consumer Affairs, where other systems are equally effective and accepted at Community level.

Final disposition fourth. Modification of a given prohibition date.

By Order of the Minister for Health and Consumer Affairs, the date referred to in Article 5 (i) of this provision may be amended, where the Community rules so provide.

Final disposition fifth. Prohibition on marketing.

Without prejudice to the provisions of the first transitional provision, the placing on the market of cosmetic products which do not comply with the provisions of this Royal Decree shall be prohibited.

Given in Madrid to October 17, 1997.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

JOSE MANUEL ROMAY BECCARIA

ANNEX I

Indicative list by categories of cosmetic products

1. Creams, emulsions, lotions, gels and skin oils.

2. Beauty masks (excluding products from surface abrasion of the skin by chemical).

3. Make-up (liquids, pastes, powders).

4. Make up powders, powders to use after bath and for body hygiene.

5. Toilet soap, deodorant soap.

6. Perfumes, toiletries, waters of colony.

7. Bath and shower products (salts, foams, oils, gels).

8. Depilatories.

9. Deodorants and antiperspirants.

10. Hair products:

Dyes and discolourants.

Products for molding, for degrating and fixing.

Products that help keep the hairstyle.

Cleaning products (lotions, powders, shampoos).

Conditioning products (lotions, lacquers, glitter).

Other hairstyle products.

11. Products for shaving (soaps, foams, lotions).

12. Products for makeup and demakeup of the face and eyes.

13. Products for the lips.

14. Oral and dental care products.

15. Products for nail care and makeup.

16. Products for external intimate care.

17. Solar products.

18. Sunless tanning products.

19. Skin whitening products.

20. Anti-wrinkle products.

ANNEX II (1)

List of banned substances in the composition of cosmetic products

1. 2-acetylamino-5-chlorobenzoxazole.

2. Acetylcholine and its salts.

3. Aceglumato de deanol (a).

(1) The presence of traces of the substances included in this Annex shall be tolerated, where these are technically unavoidable as a result of the application of good manufacturing practice and provided that the fourth article of this Regulation is complied with.

(a) The name of these substances is recommended as an "international common name" for pharmaceutical substances published by the World Health Organization. Geneva 1982.

4. Spironolactone (a).

5. [4-(4-hydroxy-3-iodophenoxy) -3,5-diiodophenyl] acetic acid, [(3, 3 ', 5. triiodothyroacetic) and its salts].

6. Methotrexate (a).

7. Aminocaproic acid (a) and its salts.

8. (a) the salts thereof and the salts thereof.

9. Thyroid acid (a) and its salts.

10. Trichloroacetic acid.

11. 'Aconitum napellus L.' (leaves, roots and preparations).

12. Aconitina (main alkaloid of 'aconitum napellus I.') and its salts.

13. "Adonis vernalis L." And their preparations.

14. Epinephrine (a).

15. Alkaloids of "rauwolfia serpentine" and its salts.

16. Acetylenic alcohols, their esters, oxy-ethers and their salts.

17. Isoprenaline (a).

18. Isothiocyanate of afil.

19. Aloclamide (a) and its salts.

20. Nalorphine (a), its salts and oxy-ethers.

21. Sympathomimetic amines acting on the central nervous system: any substance listed in the first list of medicinal products for which the sale is subject to the medical prescription contained in the resolution. (69) 2 of the Council of Europe.

22. Aminobenzene (aniline), its salts and halogenated halogenated derivatives.

23. Betoxicaine (a) and its salts.

24. Zoxazolamine (a).

25. Procainamide (a), its salts and derivatives.

26. Diaminobiphenyl (benzidine).

27. Tuaminoheptane (a), (aminoheptane), isomers and salts thereof.

28. Octodrin (a) and its salts.

29. 2-amino-1,2-bis (4-methoxyphenyl) ethanol and its salts.

30. 2-amino-4-methylhexane and its salts.

31. 4-aminosalicylic acid and its salts.

32. Arninotoluene, its isomers, salts, halogenated and sulphonated derivatives.

33. Aminoxylenes, their isomers, salts, halogenated and sulphonated derivatives.

34. 9-(3-methyl-2 butenyloxy)-7-h-furo [3,2-g] [1]-benzopyrano-7-one (amidine).

35. 'Ammi majus L.' and preparations thereof.

36. 2,3-dichloro-2-methylbutane (chlorinated amylylene).

37. Androgens and androgenic action substances.

38. Anthracene oil.

39. Antibiotics.

40. Antimony and its compounds.

41. "Apocynum cannabinum L." and its preparations.

42. 5,6,6a, 7-tetrahydro-6-methyl-4h-dibenzo [d, e, g] -10,1 1-diol. quinoline (apomorphine) and its salts.

43. Arsenic and its compounds.

44. "Aropa belladonna 1" and its preparations.

45. Atropine, its salts and derivatives.

46. Barium (sales of) with the exception of:

Sulphate and sulphide under the conditions set out in Annex III (1).

Lacas, pigments or salts prepared from colorants with the reference (3) in Annex IV.

47. Benzene.

48. Benzimidazolone.

49. Benzoacepine and benzodiazepine, its salts and derivatives.

50. Benzoate of (2-methyl-2 butanol) dimethylamine and its salts (amilocaine).

51. Trimethylbenzoyloxypiperidine (benzamine) and its salts.

52. Isocarboxazide (a).

53. Bendroflumetiazide (a) and derivatives.

54. Beryllium and its compounds (glucinium).

55. Bromo.

56. Bretilium tosilate (a).

57. Carbromine (a).

58. Bromysoval (a).

59. Brompheniramine (a) and its salts.

60. Benzylonium bromide (a).

61. Tetrilammonium bromide (a).

62. Bruce.

63. Tetracaine (a) and its salts.

64. Mofebutazone (a).

65. Tolbutamide (a).

66. Carbutamide (a).

67. Phenylbutazone (a).

68. Cadmium and its compounds.

69. 'Vessicatory Cantharis'.

70. Cantaridine.

71. Fenprobamate (a).

72. Nitrated carbazole derivatives.

73. Carbon disulfide.

74. Catalasa.

75. Catherine and her salts.

76. Essence of "chenopodium ambrosioides L."

77. Hydrated chloral.

78. Elemental chlorine.

79. Chlorpropamide (a).

80. Diphenoxylate (a).

81. 2,4-diaminoazobenzene hydrochloride and/or citrate (chrysoidine, hydrochloride and/or citrate).

82. Chlorzoxazone (a).

83. 2-chloro-4-dimethylamino-6-methylpyrimidine (crimidine).

84. Chlorprothixene (a) and its salts.

85. Clofenamide (a).

86. N-bis-(2-chloroethyl) methylamine oxide and its salts (n-mustine oxide).

87. Chlormethin (a) and its salts.

88. Cyclophosphamide (a) and its salts.

89. Manomustine (a) and its salts.

90. Butanilicaine (a) and its salts.

91. Chlormezanone (a).

92. Triparanol (a).

93. 2-(2-p-chlorophenyl-2-phenylacetyl) indane-1,3-dione (chlorophacinone).

94. Chlorphenoxamine (a).

95. Fenaglydol (a).

96. Chloroethane.

97. Salts of chromium, chromic acid and their salts.

98. 'Purpurea Tul', its alkaloids and preparations.

99. 'Conium rnacculatum L.', (fruit, powder and preparations).

100. Glycyclamide (a).

101. Cobalt benzenesulfonate.

102. Colchicine, its salts and derivatives.

103. Colchicoside and its derivatives.

104. 'Colchicum Autumnale L.' and its preparations.

105. Convalatoxin.

106. 'Anamirta cocculus L.' (fruits).

107. "Croton tiglium I" (oil).

108. N-(crotonylamino-4-benzenesulfonyl)-n '-butylurea.

109. Curare and curarins.

110. Synthesis curariants.

111. Cyanhydride acid and its salts.

112. 1-cyclohexyl-3-diethylamino-1 (2-diethyl-amino methyl) phenylpropane and its salts.

113. Cyclomenol (a) and its salts.

114. Sodium hexacyclonate (a).

115. Hexapropimate (a).

116. Dextropropoxyfen (a).

117. 0,0 '-diacetyl-n-allyl-desmethylmorphine.

118. Pipazetate (a) and its salts.

119. (a, β, dibromo-5,5 phenylethyl) -5-methyl hydantoin.

120. Salts of 1,5-bis-(trimethylammonium) pentane (including pentametonium bromide) (a).

121. Azametonium bromide (a).

122. Cyclarbamate (a).

123. Clofenothane.

124. 1,6-bis (trimethylammonium) hexane salts (including hexamethonium bromide).

125. 1,2,-dichloroethane (ethylene chloride).

126. 1,1-dichloroethylene (acetylene chloride).

127. Lisergido (a) and its salts.

128. 3-hydroxy-4-phenyl diethylaminoethyl benzoate and its salts.

129. Cincocainium (a) and its salts.

130. 3-diethylamino propyl cinamate.

131. Thiophosphate of 0,0-diethyl and 0-(4-nitrophenyl) (parathion).

132. Salts of n, n '-bis-(2 diethylaminoethyl) oxamide bis-2-chloroabenyl (among these ambenonium chloride) (a).

133. Methyrilone (a) and its salts.

134. Digitalin and all the heteroxides of the digital.

135. 7 (2,6,-dihydroxy-4-methyl-4-aza-hexyl) theophylline (xantinol).

136. Dioxetedrine (a) and its salts.

137. Piprocurary (a).

138. Propifenazone (a).

139. Tetrabenacin (a) and its salts.

140. Captodiamo (a).

141. Mefeclorazine (a) and its salts.

142. Dimethylamine.

143. 1-dimethylamino-2-dimethylaminomethyl butyl benzoate and its salts.

144. Metapirileno and its salts.

145. Metamfepramone (a) and its salts.

146. Amitriptyline (a) and its salts.

147. Metformide (a) and its salts.

148. Isosorbid dinitrate (a).

149. Dinitrile malonate.

150. Dinitrile succinate.

151. Dinitrophenolic isomers.

152. Improcuona (a).

153. Dimevamide (a) and its salts.

154. Diphenylpyraline (a) and its salts.

155. Sulfinpyrazone (a).

156. Salts of n-(4-amino-4-oxo-3,3-diphenylbutyl)-n, n-diisopropyl-n-methylammonium (including isopropamide iodide) (a).

157. Benacticin (a).

158. Benzatropin (a) and its salts.

159. Cyclizine (a) and its salts.

160. 5,5-diphenyl-4-tetrahydroglioxalinone.

161. Test (a).

162. Bis (n, n-diethylthiocarbamyl) disulfide (disulfiramo) (a).

163. Emetin, its salts and derivatives.

164. Ephedrine and its salts.

165. Oxanamide (a) and derivatives.

166. Eserine or fisostigmine and its salts.

167. Esters of p-aminobenzoic acid (with the free amino group) except those listed in Annex VII (2. part).

168. Esters of choline and methylcholine and their salts.

169. Caramifenium (a).

170. Be p-nitrophenol diethylphosphoric.

171. Metethoheptazine (a) and its salts.

172. Oxopheneridine (a) and its salts.

173. Ethoheptazine (a) and its salts.

174. Methoheptazine (a) and its salts.

175. Methylphenidate (a) and its salts.

176. Doxylminium (a) and its salts.

177. Tolboxane.

178. 4-benzyloxyphenol.

4-methoxyphenol.

4-ethoxyphenol.

179. Paretoxicaine (a) and its salts.

180. Fenozolone (a).

181. Gluteshy (a) and its salts.

182. Ethylene oxide (epoxyethane).

183. Bemegride (a) and its salts.

184. Valnoctamide (a).

185. Haloperidol (a).

186. Parametasone (a).

187. Fluanisone (a).

188. Trifluperidol (a).

189. Fluoresone (a).

190. Fluorouracil (a).

191. Hydrofluoric acid, its salts, complexes and hydroxyfluorides, with the exception of exceptions listed in Annex III (1).

192. Salts of furfuryltrimethylammonium. (Among these the iodide of furtrethronium) (a).

193. Galantamine (a).

194. Gestagens (substances of progestational action).

195. 1,2,3,4,5,6, hexachlorocyclohexane (Hch).

196. 1,2,3,4,10,10 Hexachloro-6,7-epoxy-1,4, 4a, 5,6,7,8,8a Octahydro-1,4,5,8-endoendodimethylenaphthalene (endrin).

197. Hexachloroethane.

198. 1,2,3,4,10,10 hexachloro-1,4, 4a, 5,8,8a hexahydro-1,4,5,8 endo endodimethylenaphthalene. (Isodrin).

199. Hydrazine, hydrastinin and its salts.

200. Hydrazides and their salts.

201. Hydrazine its salts and derivatives.

202. Octamoxin (a) and its salts.

203. Warfarin (a) and its salts.

204. Bis (4-hydroxy-2-coumarinyl) ethyl acetate and acid salts.

205. Metocarbamol (a).

206. Propazilnitrate (a).

207. 1,1-bis-[(4-hydroxy-2-oxo-2h-1 benzopyran) 3-i1] 3-methylthiopropane.

208. Fenadiazole (a).

209. Nitroxoline (a) and its salts.

210. Hyosciamine, its salts and derivatives.

211. "Hyoscamus niger L." (leaves, seeds, powder and preparations).

212. Pemoline (a) and its salts.

213. Iodine.

214. Salts of 1,10-bis (trimethylammonium) decane (including decametonium bromide).

215. "Ipeca uragógna ipecacuanha Baill" and similar species (roots and preparations).

216. N-(2-isopropyl-4-pentenoyl) urea (apronamide).

217. Santonina.

218. "Inflatal lobelina" and preparations.

219. Lobeline (a) and its salts.

220. Barbituric acid, its salts and derivatives.

221. Mercury and its compounds with the exception of those listed in Annex VI (1. part).

222. Mescaline and its salts.

223. Polyacetaldehyde (metaldehido).

224. N, n-2,2 (methoxy-4-allylphenoxy) diethyl acetamide and its salts.

225. Cummetarol (a).

226. Dextromethorphan (a) and its salts.

227. 2-methylaminoheptane and its salts.

228. Isometeptene and its salts (a).

229. Mecamylamine (a).

230. Guaifenesin (a).

231. Dicumarol (a).

232. Phenmethazine (a), its salts and derivatives.

233. Thiamazole (a).

234. (2-methyl-2-methoxy-4-phenyl) -3-4-dihydropyrane coumarin (cyclo-locumanol).

235. Carisoprodol (a).

236. Meprobamate (a).

237. Tefazoline (a) and its salts.

238. Arecoline.

239. Poldine methylsulfate (a).

240. Hydroxycin (a).

241. β-naphthol.

242. α and β naphthylamines and their salts.

243. α, 3 naphthyl-4-hydroxycoumarin.

244. Naphazoline (a) and its salts.

245. Neostigmine and its salts [among these neostigmine bromide (a)].

246. Nicotine and its salts.

247. Amyl nitrites.

248. Metal nitrites with the exception of sodium nitrite.

249. Nitrobenzene.

250. Nitrocoresol and its alkaline salts.

251. Nitrofurantoin (a).

252. Furazolidone (a).

253. Nitroglycerin.

254. Acenocoumarol (a).

255. Alkaline nitroferricyanides (nitroprusiates).

256. Nitrosylbenes, their counterparts and derivatives.

257. Noradrenaline and its salts,

258. Noscapin (a) and its salts.

259. Guanetidine (a) and its salts.

260. Estrogens (substances of estrogenic action).

261. Oleandrina.

262. Chlortalidone (a).

263. Peletierin and its salts.

264. Pentachloroethane.

265. Tetranitrate of pentaerytritile (a).

266. Petricloral (a).

267. Octamylamine (a) and its salts.

268. Picrico acid.

269. Fenacemide (a).

270. Difencloxazine (a).

271. 2-phenyl-1,3-indanedione (phenindione).

272. Ethylfenacemide (a).

273. Femprocoumone (a).

274. Feniramidol.

275. Triamterena (a) and its salts.

276. Tetraethyl pyrophosphate.

277. Tricresyl phosphate.

278. Psilocybin (a).

279. Phosphorus and metal phosphoates.

280. Thalidomide (a) and its salts.

281. 'Physostigma venenosum Balf'.

282. Picrotoxin.

283. Pilocarpine and its salts.

284. 2-benzylacetate of α, piperido-I, (levofacetoperane) and its salts.

285. Pipradrol (a) and its salts.

286. Izaconclonol (a) and its salts.

287. Bietamiverine (a).

288. Butopiprin (a) and its salts.

289. Lead and its compounds with the exception of acetate under the conditions set out in Annex III (1. part no. 55).

290. Coniina.

291. 'Prunus lauro-cerasus L.' (distilled water from the cherry tree).

292. Metirapone (a).

293. Radioactive substances (b).

294. 'Juniperus sabina L.' (leaves, essential oil and preparations).

295. Escopolamine, its salts and derivatives.

296. Gold salts.

297. Selenium and its compounds with the exception of selenium disulfide, under the conditions set out in Annex III (1. part no. 49).

298. 'Solanum nigrum L.' and its preparations.

299. Spartein and its salts.

300. Glucocorticoids.

301. 'Datura stramonium L.' and preparations thereof.

302. Strophantins, strofantidines and derivatives.

303. 'Strophanthus' (species) and preparations thereof.

304. Strychnina and its salts.

305. "Strychnos" (species) and preparations.

306. Narcotic drugs: substances listed in tables i and ii of the Convention on Narcotic Drugs held on 30 March 1961 in New York.

307. Sulfonamides (paraaminobenzenesulfonamide and its derivatives obtained by replacing one or more hydrogen atoms linked to the nitrogen atom) and their salts.

308. Sultiamo.

309. Neodymium and its salts.

310. Thiotepa (a).

311. "Pilocarpus jaborandi Holmes" and its preparations.

312. Telluride and its compounds.

313. Xylometazoline (a) and its salts.

314. Tetrachloroethylene.

315. Carbon tetrachloride.

316. Hexaethyl tetraphosphate.

317. Thallium and its compounds.

318. Glycosides of 'thevitia nerifolia jus'.

319. Ethionamide (a).

320. Phenothiazine (a) and its compounds.

321. Thiourea and derivatives other than those listed in Annex III (1).

322. Mefenesin (a) and its esters.

323. Vaccines, toxins or serums listed in the Annex to the second Council Directive of 20 May 1975 and which refers to the approximation of laws, regulations and administrative provisions relating to proprietary medicinal products. (Official Journal of the European Communities, number L 147 of 9 June 1975, page 13).

324. Tranylcypromine (a) and its salts.

325. Trichloronitromethane.

326. Tribromoethanol (avertin).

327. Trichlormethin (a) and its salts.

328. Tetramine (a).

329. Galamine triethiodide (a).

330. 'Urginea scilla Stern' and preparations thereof.

331. Veratrin and its salts.

332. "Schoenocaulon officinale Lind". (Seeds and preparations).

333. 'Veratrum spp' and preparations thereof.

334. Vinyl chloride (monomer).

(b) The presence of natural radioactive substances from artificial environmental contamination is allowed, provided that such radioactive substances are not enriched before they are used in the manufacture of cosmetic products, and provided that their concentration does not exceed the limits laid down in the Directives laying down the basic standards for the protection of the health of the population and workers, in the face of the dangers arising from ionising radiation (Official Journal of the European Communities, No 11 of 20). of February 1959, page 221/59).

335. Ergocalciferol (a) and colecalciferol (vitamins D2 and D3).

336. Alkaline xanthates and alkoxantates.

337. Yohimbine and its salts.

338. Dimethylsulfoxide (a).

339. Diphenhydramine and its salts.

340. P-butyl tert-phenol.

341. P-butyl tert-pyrocatechin.

342. Dihydrotaquerol (a).

343. Dioxane (1.4 diethylene dioxide).

344. Morpholine and its salts.

345. "Pyrethrum album L." and its preparations.

346. Pyrianisamine maleate.

347. Tripelenamine (a).

348. Ilides tetrachlorosalianilides.

349. Ilides.

350. Ilides tetrabrosemalianilides.

351. Ilides.

352. Bithionol (a).

353. Thiouramic monosulphides.

354. Thiouramic disulfides.

355. Dimethylformamide.

356. Benzylidenacetone.

357. Coniferyl benzoates except for normal quantities contained in natural essences used.

358. Furocoumarins (p. ex. Trioxisalen (a), 8-methoxypsoralene, 5-methoxypsoralene) except for their normal content in the natural essences used.

For sun protection and tanning products, the concentration of furocoumarins must be less than 1 mg/kg.

359. Seed oil of "laurus nobilis L."

360. Safrol except for normal quantities contained in natural oils used and provided that the concentration does not exceed:

100 ppm in the finished product.

50 ppm in products for dental and oral care provided that the safrol does not appear in dentifrices intended especially for children.

361. Iodothymol.

362. 3'ethyl-5 ', 6', 7 ', 8 = tetrahydro-5', 6 ', 8', 8 '-tetramethyl-2'-acetonaphone (1,1,4,4-tetramethyl). 6-ethyl-7-acetyl-1,2,3,4,-tetrahydro-naphthalene) (acetyloethyltetramethyltetraline) (aett).

363. 1,2 diaminobenzene and its salts.

364. 2,4,-diaminotoluene and its salts.

365. Aristoloquic acid and its salts.

366. Chloroform.

367. 2,3,7,8-tetrachlorodibenzo-p-dioxin.

368. 6-acetoxy-2,4-dimethyl-1,3-dioxane (dimethoxy).

369. 2-n-oxide-thiopyridine, sodium salt. (pyrithione sodium).

370. N-trichloromethylthio-4-cyclohexene-1,2-dicarboximide. (Captan).

371. 2,2 'dihydroxy-3,3', 5,5 ', 6,6'-hexachlorodiphenylmethane (hexachlorofen).

372. 6-(1-piperidinyl) -2,4-pyrimidinodiamine-3-oxide (minoxidil) and its salts and derivatives.

373. Strontium and its compounds with the exception of:

Sulfide under the conditions set out in Annex III (1. part).

Chloride under the conditions set out in Annex III (1. part).

Acetate under the conditions set out in Annex III (1. part).

Hydroxide under the conditions set out in Annex III (1. part).

Peroxide under the conditions set out in Annex III (1. part).

Tioglycolate under the conditions set out in Annex III (1).

Lacas, pigments or salts prepared from colorants with the reference (3) in Annex IV.

374. Zirconium and its compounds (with the exception of the compounds listed in Annex III, number 50 (1. part) and the lakes, pigments or zirconium salts of the colours listed in the reference (3) in Annex IV (2. part).

375. Lidocaine.

376. Tirotricin.

377. 3,4 ', 5-tribromosalicyleneilide (tribrominsalan).

378. Species of phytolacca and their preparations.

379. Tretinoin (a) (retinoic acid and its salts).

380. 1-methoxy-2,4-diaminobenzene (2,4-diaminoanisole, C.I. 76050) and its salts.

381. 1-methoxy-2,5-diaminobenzene (2,5-diaminoanisole) and its salts.

382. Colorant C.I. 12140.

383. Colorant C.I. 26105.

384. Colorant C.I. 42555.

Colorant C.I. 42555-1

Colorant C.I. 42555-2

385. Amyl-4-dimethylaminobenzoate (mixture of isomers) [padimato a (a)].

386. Benzoyl peroxide.

387. 2-amino-4-nitrophenol.

388. 2-amino-5-nitrophenol.

389. 11-hydroxy-4-pregnene-3,2-dione and its esters.

390. Colorant C.I. 42640.

391. Colouring matter C.I. 13065.

392. Colorant C.I. 42535. -

393. Colouring matter C.I. 61554.

394. Antiandrogens of steroid structure.

395. Acetonitrile.

396. Tetrizoline (a) and its salts.

397. 8-hydroxyquinoline and its sulphate with the exception of the applications provided for in Part No 51 of Annex III.

398. 2 ,2 '-ditrobispyridine-1,1'-dioxide (addition product with magnesium sulphate trihydrate) (pyrithione disulfide + magnesium sulphate).

399. Colorant C.I. 12075 and its lacquers, pigments and salts.

400. Colouring matter C.I. 45170 and C.I. 45170:1.

401. 1,2-epoxybutane.

402. Colorant C.I. 15585.

403. Pramocaine.

404. 4-ethoxy-m-phenylenediamine and its salts.

405. 2,4-diamino-phenylethanol and its salts.

406. Catecol.

407. Pyrogalol.

408. Nitrosamines.

409. Secondary dialkanolamines.

410. 4-amino-2-nitrophenol.

411. 2-methyl-m-phenylenediamine.

412. 4-tert-butyl-3-methoxy-2,6-dinitrotoluene (ambrexcle).

413. Diisobutylphenoxyethoxyethyldimethylbenzylammonium chloride (benketonium chloride).

414. Cells, tissues or products of human origin.

415. 3,3-bis (4-hydroxyphenyl) phthalide [phenolphthalein (a)]

416. 3 imidazol-4-ylacrylic acid and its ethyl ester (urocanic acid).

417. Tissues and fluids from the brain, the spinal cord and the eyes of cattle, sheep and goats, and the ingredients derived from them.

ANNEX III

FIRST PART

LIST OF SUBSTANCES THAT CANNOT CONTAIN COSMETIC PRODUCTS AT HIGHER CONCENTRATIONS AND UNDER CONDITIONS OTHER THAN THOSE ESTABLISHED

number	Substance	Restrictions			Terms of employment and warnings, which must be compulsorily listed on the
		field and/or use	Maximum Concentration on finished product	Other limitations and
	b	c	d	e	f
1	ACID BORIC	a) Talc.	-5%	a) Do not use in care products for children under three years of age.	a) Do not use for care of children under three years of age.
		b) Bucal care products.	-0.5%
		c) Other products.	-3%
2a	TIOGLYCOLIC ACID AND ITS SALTS	a) Hair curly and curly products		a) b) c)	a)
		-General Usage.	-8% ready for use pH 7 to 9.5.	The employment mode text must include the following phrases mandatory: -Avoid eye contact. -In case of contact with the eyes, wash them immediately and abundantly with water and consult with a specialist.	-Contains salts of thioglycolic acid. -Follow the mode of employment. -Stay out of reach of children. -Reserved for professionals.
		-Professional use.	-11% ready for use pH 7 to 9., 5
		b) Depilatories. c) Other hair treatment products intended to be cleared after application	-5% ready for use pH 7 to 12.7. -2% ready for use pH 7 to 9.5	-Using suitable gloves (only for a) and c))	b) and c) -Contains salts of thioglycolic acid. -Follow the mode of employment. -Stay out of reach of children.
			The above percentages are calculated in tioglycolic acid.
2b	THIOGLYCOLIC ACID ESTERS	Products for curly and curly hair.		The employment mode text must necessarily include the following phrases:	-Contains esters of thioglycolic acid. -Follow the mode of employment. -Stay out of reach of children.
				-You can cause an allergic reaction. -Avoid contact with your eyes.
		-General usage.	-8% ready for use pH 6 to 9.5.	-In case of contact with the eyes, wash them immediately and abundantly with water and consult with a specialist.
				-Use appropriate gloves.
		-Professional use.	-11% ready for use pH 6 to 9.5.		-Reserved to professionals.
			The above percentages are calculated in tioglycolic acid.
3	OXALIC ACID, ESTERS AND ALKALINE SALTS	Capillaries	-5%		-Reserved to professionals.
4	AMMONIA		-6% calculated in NH2.		-Contains ammonia (only when the concentration is greater than 2%)
5	TOSYLCHLORAMIDE SODIUM		-0.2%
6	a) Dentifrics	-5%
		b) Other uses.	-3%
7	METHYLENE CHLORIDE		-35% (in case of mixing with 1,1,1, trichloroethane, total concentration cannot exceed 35%)	-Maximum impurities content 0.2%
	8	DIAMINOBENZENE (META, PARA), ITS N-SUBSTITUTED DERIVATIVES, AND THEIR SALTS, AND THE ORTHO DIAMINOBENZENE DERIVATIVES. N-SUBSTITUTED (1)	Hair oxidation colorants. a) General usage.	-6% calculated on free base		a)-Can cause allergic reaction. -Contains diaminobenzenes. -Do not use to dye eyebrows and eyelashes.
		b) Professional use.			b)-Reserved for professionals. -Use appropriate gloves. -Contains diaminobenzenes. -It can cause an allergic reaction.
9	DIAMINOTOLUENES, THEIR N-SUBSTITUTED DERIVATIVES AND THEIR SALTS(1) EXCEPT FOR THE 364 NUMBER OF ANNEX II	HAIR OXIDATION COLORANTS.	-10% calculated on free base
		a) General usage			a)-It can cause allergic reaction. -Contains diaminotoluenes. -Do not use to dye eyebrows and eyelashes.
		b) Professional use			b)-Reserved to professionals. -Use appropriate gloves. -Contains diaminotoluenes. -It can cause an allergic reaction.
	DIAMINOPHENOLS (1)	Hair oxidation colorants.	-10% calculated on free base
		a) General usage.			a)-You can cause allergic reaction. -Contains diaminophenols. -Do not use to dye eyebrows and eyelashes.
		b) Professional use.			b)-Reserved for professionals. -Use appropriate gloves. -Contains diaminophenols. -May cause allergic reaction.
11	DICTIONARY		-0.5%		-Contains dichlorophene.
12	OXYGENATED WATER AND OTHER COMPOUNDS OR MIXTURES THAT RELEASE OXYGENATED WATER, INCLUDING OXYGENATED WATER CARBAMIDE AND ZINC PEROXIDE	a) Prepared for capillary treatments. b) Ready for skin hygiene. c) Ready to tighten nails. d) Products for oral hygiene.	-12% of H2 OR2 (40 volumes) present or detached. -4% of H2 OR2 present or detached. -2% of H2 OR2 present or detached. -0.1% of H2 OR2 present or detached		a)-Use appropriate gloves. a), b), and c) -Contains oxygenated water -Avoid eye contact. -In case of contact with the eyes, wash them immediately and abundantly with water.
13	FORMALDEHYDE	Preparing to Tighten Nails	-5% expressed in formaldehyde		-Protect the cuticles with a fat substance. -Contains formaldehyde (2).
14	HYDROQUINONE(3)	a) Oxidation coloring for hair dyeing.	-2%		a)
		1. General use.			1. -Do not use to dye eyebrows and eyelashes. -In case of eye contact, wash them immediately and abundantly with water. -Contains hydroquinone.
		2. Professional use.			2. -Reserved for professionals. -Contains hydroquinone. -In case of contact with the eyes, wash them immediately and abundantly with water.
		b) Localized skin agent.	-2%		b)
					-Contains hydroquinone.
					-Avoid eye contact.
					-Apply only on small surfaces.
					-In case of irritation the use is suspended.
					-Do not use in children under 12 years old.
15a	POTASSIUM HYDROXIDE OR SODIUM HYDROXIDE	a) Solvent of nail cuticles.	a) 5% by weight (4).		a)-Contains alkaline agent. -Avoid contact with your eyes. Danger of blindness. -Stay out of reach of children.
		b) Hair smoothing products.	b)		b)
		1. General use.	1. 2% by weight (4).		1. -Contains alkaline agent. -Avoid contact with your eyes. Danger of blindness. -Stay out of reach of children.
		2. Professional use.	2. 4.5% by weight (4).		2. -Reserved for professionals. -Avoid contact with your eyes. Danger of blindness.
		c) pH Regulator -Depilatories.	c) Up to pH 12.7.		c)-Stay out of reach of children. -Avoid contact with your eyes.
		d) Other uses as a pH regulator.	d) Up To pH 11
15b	LITHIUM HYDROXIDE.	a) Hair smoothing products.
		1. General use.	1. 2% by weight (4).		1. -Contains alkaline agent. -Avoid eye contact. Danger of blindness. -Stay out of reach of children.
		2. Professional use.	2. 4.5% by weight (4).		2. -Reserved for professionals. -Avoid contact with your eyes. Danger of blindness.
		b) Other uses.
15c	CALCIUM HYDROXIDE.	a) Products for hair smoothing with two components, calcium hydroxide and a guanidine salt.	7% by weight of calcium hydroxide.		-Contains alkaline agent. -Avoid contact with your eyes. -Stay out of reach of children. -Danger of blindness.
		b) Other uses
16	α-NAFTOL	Capillaries	0.5%		Contains α-naphthol
	17	SODIUM NITRITE	Corrosion inhibitor.	0.2%	Do not use secondary and/or tertiary amines or other substances that form nitrosamines.
18	NITROMETANO	Corrosion inhibitor.	0.3%
19	PHENOL AND ITS ALKALINE SALTS	Soap and shampoos.	1% calculated in phenol.		Contains phenol.
21	QUININA AND ITS SALES	a) Champus.	a) 0.5% expressed in base quinine.
		b) Capillaries	b) 0.2% expressed in base quinine.
22	RESORCIN (3)	a) Hair oxidation colorant.	a) 5%		a)
		1. General Use			1. -Contains resorcin. -Clear the hair well after the application. -Do not use to dye eyebrows or eyelashes. -In case of contact with the eyes, wash them immediately and abundantly with water.
		2. Professional use.			2. -Reserved for professionals. -Contains resorcin. -In case of contact with the eyes, wash them immediately and abundantly with water.
		b) Capillaries and shampoos.	b) 0.5%		b)-Contains resorption.
23	ALKALINE SULPHIDES	a) Depilatories.	a) 2% expressed in sulphur pH 12.7.		a)-Stay out of the reach of children. -Avoid contact with your eyes.
	ALKALINE EARTH SULPHIDES	b) Depilatories.	a) 6% expressed in sulphur pH 12.7.		b)-Stay out of reach of children. -Avoid eye
24	WATER-SOLUBLE ZINC SALTS EXCEPT ZINC ZINC AND PYRITHIONE		1% expressed in zinc.
25	CINC SULFOFENATE	Deodorants, antiperspirants, and astringent lotions.	6% expressed as% of anhydrous matter		-Avoid eye contact.
26	AMMONIUM MONOFLUOROPHOSPHATE	Products for oral hygiene.	0.15% expressed in fluoride. In the case of a mixture with other fluorinated compounds authorised in this Annex, the maximum concentration shall be 0,15% expressed in fluorine.		-Contains ammonium monofluorophosphate.
27	SODIUM MONOFLUOROPHOSPHATE	Idem.	Idem.		-Contains sodium monofluorophosphate.
28	POTASSIUM MONOFLUOROPHOSPHATE	Idem.	Idem.		-Contains potassium monofluorophosphate.
29	CALCIUM MONOFLUOROPHOSPHATE	Idem.	Idem.		-Contains calcium monofluorophosphate.
30	CALCIUM FLUORIDE	Products for oral hygiene	0.15% expressed in fluoride. In case of mixing with other fluorinated compounds, authorised in this Annex, the maximum concentration shall be 0,15% expressed in fluoride		-Contains calcium fluoride.
31	SODIUM FLUORIDE	Idem.	Idem.		-Contains sodium fluoride.
32	POTASSIUM FLUORIDE	Idem.	Idem.		-Contains potassium fluoride.
33	AMMONIUM FLUORIDE	Idem.	Idem.		-Contains ammonium fluoride.
34	ALUMINUM FLUORIDE	Idem.	Idem.		-Contains aluminum fluoride.
35	STANNOUS FLUORIDE	Idem.	Idem.		-Contains stannous fluoride.
	CETILAMINE HYDROFLUORIDE (HEXADECIMAL HYDROFLUORIDE)	Idem.	Idem.		-Contains cetylamine hydrofluoride
37	BIS-(HYDROXYETHYL) AMINOPROPYL-N-HYDROXYETHYL-OCTA-DECYLAMINE	Idem.	Idem.		-Contains bis-(hydroxyethyl)-aminopropyl-N-hydroxyethyl-octa-decylamine dihydrofluoride
38	DIHYDROFLUORIDE OF N, N', N ' -TRI (POLYOXYETHYL EN) -N-HEXADE-CIL-PROPYLENEDIAMINE	Products for oral hygiene.	0.15% expressed in fluoride. In the case of a mixture with other fluorinated compounds authorised in this Annex, the maximum concentration shall be 0,15% expressed in fluorine.		-Contains N, N ', N'-trl (polyoxyethylen) -N-hexadecimal-propylenediamine
	39	octadecenyl amine	Iofm.	Idem.		-Contains octadecenyl amine hydrofluoride.
40	SODIUM SILICOFLUORIDE	Idem.	Idem.		-Contains sodium silicofluoride.
41	POTASSIUM SILICOFLUORIDE	Idem.	Idem.		-Contains potassium silicofluoride
42	AMMONIUM SILICOFLUORIDE	Idem.	Idem.		-Contains ammonium silicofluoride
43	MAGNESIUM SILICOFLUORIDE	Idem.	Idem.		-Contains magnesium silicofluoride
44	1,3-DIHYDROXIMETHYL -2-TIONAIMIDAZOLIDINE	a) Capillaries for Capillaries.	Up to 2%	a) Forbidden in aerosols	-Contains 1,3-dihydroximethyl-2-tionaimidazolidin
		b) A nail care preparations.	Up to 2%	b) The pH must be less than 4.
45	BENZYL ALCOHOL	Solventes, perfumes, and perfuming compounds.
46	6-METHYLCOUMARIN	Products for oral hygiene	0.003%
47		IOFM.	0.15% expressed in fluoride. In case of mixing with other fluorinated compounds, authorized in this Annex, the maximum concentration will be 0.15% expressed in fluoride		-Contains nicomethanol fluorhydrate
48	SILVER NITRATE	Only for products intended for the colouring of eyebrows and eyelashes.	4%		-Contains silver nitrate. -In case of contact with the eyes immediately and abundantly wash with water
49	SELENIUM DISULFIDE	Champus anticaspa.	1%		-Contains selenium disulfide. -Avoid contact with your eyes and damaged skin.
50	ALUMINUM AND ZIRCONIUM CHLORIDE HYDROXIDES2 Zr (OH) and CI2 AND ITS GLYCINE COMPLEX	Antiperspirants.	20% of aluminium hydroxide and anhydrous zirconium. 5.4% expressed in zirconium.	1. The ratio between the numbers of aluminium and zirconium atoms must be comprised between 2 and 10. 2. The ratio between the numbers of the atoms (Al + Zr) and chlorine must be between 0.9 and 2.1. 3. Prohibited in aerosols.	-Do not apply on irritated or damaged skin.
51	8-HYDROXYQUINOLINE AND ITS SULFATE	H2 stabilizing agent OR2 in preparations for capillaries intended to be cleared.	0.3% calculated on base.
		oxygenated water stabilizing agent in preparations for hair treatments that are not removed with water.	0.3% calculated on base.
52	METHYL ALCOHOL	Desnaturalizer for ethyl and isopropyl alcohols	5% calculated as% of ethyl and isopropyl alcohols
53	ETIDRONIC ACID AND ITS SALTS (1-HYDROXYETHYLIDENE-DI-PHOSPHONIC ACID AND ITS SALTS)	a) Hair Care Products.	1.5% expressed in etidronic acid.
		b) Soap	0.2% expressed in etidronic acid.
54	PHENOXYPROPANOL	Only for cleared products. Banned in oral hygiene products.	2.0%	As a conservative agent, see Annex VI, Part No. 43
55	LEAD ACETATE	Only hair dye	0.6% (expressed in lead).		-Stay out of the reach of children. -Avoid contact with your eyes. -Wash your hands thoroughly after your application. -Contains lead acetate. -Do not use to dye eyebrows, tabs, and moustache. -In case of skin irritation, suspend the use.
56	MAGNESIUM FLUORIDE	Oral hygiene products.	0.15% calculated in fluoride. If mixed with other fluorinated compounds, authorized in this Annex, the maximum fluoride concentration remains 0.15%		-Contains magnesium
57	STRONTIUM CHLORIDE (HEXAHYDRATE)	Dentriphics.	3.5% expressed in strontium. In the case of a mixture with other strontium compounds authorised by this Annex, the maximum strontium concentration is fixed at 3,5%.		-Contains strontium chloride. -Your use in children is discouraged.
58	STRONTIUM ACETATE (SEMI-HYDRATED)	Dentriphic.	3.5% expressed in strontium. In case of mixing with other strontium compounds authorised by this Annex, the maximum strontium concentration is fixed at 3.5%		-Contains strontium acetate. -Your use in children is discouraged.
59	TALCO: HYDRATED MAGNESIUM SILICATE	a) Spray products for children under three years of age. b) Other products			a) Keep section of the child's nose and mouth.
60	FATTY ACID DIALKANOLAMIDES.		Maximum content of dialkanotamine: 0.5%.	-Do not use with nitrous agents. -Maximum content of dialkanolamine: 5% (affects raw materials). -Maximum content of N-nitrosodialkanolamines: 50 ug/Kg. -Keep in containers that do not contain nitrites.
61	MONOALKANOLAMINES.		Maximum content of dialkanolamine: 0.5%.	-Do not use with nitrous agents. -Minimum Purity 99%. -Maximum content of secondary alkanolamines: 5% (affects raw materials). -Maximum content of N-nitrosodialkanolamines: 50 ug/kg. -Keep in containers that do not contain nitrites.
62	TRIALKANOLAMINES	a) Products that do not require clarification. b) Other products.	a) 2.5%	a) b): -Do not use with nitrosating agents. -Minimum Purity 99%. -Maximum content of secondary alkaloamines: 0.5% (affects raw materials). -Maximum content of N-nitrosodialkanolamines: 50 ug/kg. -Keep in containers that do not contain nitrites.
63	STRONTIUM HYDROXIDE	pH regulator in depilatory products	3.5% expressed in strontium maximum pH 12.7		-Keep out of the reach of children. -Avoid eye contact.
64	STRONTIUM PEROXIDE	Hair care products, intended to be cleared after application. Professional use	4.5% expressed in strontium in the product prepared for use	All products must meet hydrogen peroxide emission requirements	-Avoid eye contact. -Immediately match your eyes if the product comes into contact with them. -Professional use. -Use appropriate gloves.

(1) These substances may be used alone or mixtures thereof in quantity such that the sum of the "relative ratios" of each of the substances does not exceed the unit.

It is called "relative ratio" to the ratio of the concentration of a substance to the maximum concentration allowed for that substance.

(2) Only if the concentration is greater than 0,05%.

(3) These substances may be used alone or mixed with each other, in such a quantity that the sum of the "relative ratios" of all of them does not exceed the figure 2.

It is called "relative ratio" to the ratio of the concentration of a substance to the maximum concentration allowed for that substance.

(4) The amount of potassium, sodium or lithium hydroxide is expressed by weight of sodium hydroxide. In the case of mixtures, the sum should not exceed the limits laid down in column (d).

SECOND PART

LIST OF SUBSTANCES PROVISIONALLY ADMITTED

number	Substance	Restrictions			Terms of employment and warnings that must be mandatory on the label	Admitted
		application and/or usage	Maximum authorized concentration on finished product	Other limitations and
	b	c	d	e	f	g

ANNEX IV

FIRST PART

LIST OF COLORANTS THAT MAY CONTAIN COSMETIC PRODUCTS (1)

APPLICATION FIELD

Column 1: Colorants admitted to all cosmetic products.

Column 2: Colorants admitted to all cosmetic products except those applied close to the eyes, and more specifically in eye makeup and demakeup products.

Column 3: Colorants admitted only in cosmetic products that are not intended to contact the mucous membranes.

Column 4: Colorants admitted only to cosmetic products intended to be briefly contacted with the skin.

Number of the index index

or denomination

red

123

18.820

42,045

42,735

red

74,260

77,288

172

77,947

orange

white

Coloration	Application field				Other limitations and requirements
	1	2	3	4
10.006	green				X
10.020	green
				X				11,680
	11,680	yellow			X
11.710	yellow			X
						orange
orange	orange
					X
	12.085 (3	red	X				3% maximum in finished product.
12.120	red				X
12.150	red	X
12,370	red				X
12.420	red				X
	12.480	brown
	x
		yellow	yellow				X	13,015
	X							14,270
orange	X				E 103
	14,700	red	X	X
		red	X				E 122
14,815	red	X				E 125
	15,510 (3)	orange		X
X
	15,580	red	X				15,620
		red	X				3% in finished product.
15,800	red			X
15,850 (3)	red	X
	red	X
15,880	red	X
	15,980	orange	X				E 111
	15,985 (3)	yellow	X				E 110
	16,035	red	X
16,185	red	X
			X
16.255 (3)	red
red	X				E 124
16,290	red	X					17.200 (3)	red	X
	18.050	red		red		red			X
18.130	red				X
18,690	yellow					X
		red				X
yellow				X
	18.965	yellow	X
	19.140 (3)	yellow	X				E 102
					X	Maximum 5 ppm content in 3.3 -dimethylbenzidine in the colorant.
20.170	orange			X
20,470	black				X
21,100	yellow				X	Maximum content of 5 ppm in 3-3 dimethylbenzidine in the colorant.
21.108	yellow				X	Maximum content of 5 ppm in 3.3-dichloro benzidine in the colorant.
21,230	yellow			X
24,790	red				X
26,100	red			X		purity criteria: Aniline 0.2% 2-naphthol 0.2% 4-aminoazobenzene 0.1% 1-(felinazo-2-2naphthol 3% 1-[(2-phenylazo) phenyl) azo] -2-naphthalenol 2%
					X
	black	X				E 152
	28,440	black	X				E 151
40215	orange				X
orange		X
		orange	X
			X
	40,850	orange	X
blue			X
		blue	X				E 131
42,053	green			X
42,080	blue				X
	X
42.100	green		green					X
	42.170	green				X
42,510	violet			X				42,520
	42,520	violet				X	5 ppm maximum on finished product
blue			X
44,045	blue			X			44,090
	X		X						45,100
red				X
	45,190
	45.220
red
		X						6% maximum in finished product.
45,370 (3)	orange	X				Maximum content of 1% in fluorescein and 2% in monobromofluorescein.
45,380 (3)	red	X				Idem.
45,396	orange	X				When used for the lips, the colorant is supported only in the form of free acid with a maximum concetation of 1%.
45,405	red		X			Maximum content of 1% in fluorescein and 2% in monobromofluorescein.
45.410 (3)	red	X				Idem.
45.425	red	X				Maximum content of 1% in fluorescein and 3% in monoiodofluorescein.
45.430 (3)	red	X				E 127 Idem.
47,000	yellow			X
47.005	yellow	X				E 104
50.325	violet				X
50.420	black			X
51,319	violet
			red	X
	59.040	green			X		60,724
					X	X	X
		x
		violet				X
	61,565	green	X
61,570	green	X						61,585
									X
							X
69,800						E 130
		X	X
			73,000	blue
73,000	blue
			X																73.360
X
	73.385	violet	X	X	x	x
							X
73,915	red				X		blue
							X
	X	X
	74.180					X
green		X
	X						orange		75.120	orange						75.125
yellow	X							75.130
orange	X				75.135
	75.135
yellow	X	x	X					75.170
	X
75,300	yellow	X					red
red				X				E 120
75,810	green	X				E 140 and E 141
77,000						77,002
	X			X
	X
		blue
			X
		X	77,120						white
	X
		X						E 170
77,231	white	X					77,266
		black	X
			X
	77.268:1			X			E 153
green	X				Exempt chromate ion.
77,289	green	X				Exempt chromate ion.
77,346	green	X
	77,400	brown	X
77,480	brown	X				E 175
77.489	orange	X				E 172
77.491	red	X
	X					E 172
		black						77,510
	X						cyanide-ion Exempt.
77,713	white	X
77.427	violet	X
77,745	red	X
77,820						77,891
	X		X
	X
	Lactoflavin	yellow	X				E 101
Carme	brown	X
X				E 160 C
beetroot, betanine	red						Autotians
red	X
white
	blue	blue	blue	blue				X
	bromoresol	green				X
acid 195	red			X

(1) Lacas or salts of these dyes containing substances whose use is not prohibited in Annex II are also permitted.

(2) Colours, the number of which is accompanied by the letter E, in accordance with the provisions of the EEC Directive of 1,962 on food additives and colouring matters, must comply with the purity conditions laid down therein. These colours are still subject to the general criteria of Annex II to the Directive of 1962 to colouring matters even if the E number has been deleted from that Directive.

(3) Lacas, pigments or salts of Barium, Strontium and Zirconium, insoluble, of these dyes are also admitted. They must comply with the insolubility test provided for in Article 8 of the EEC Directive of 1,962 on food additives and colouring matters.

SECOND PART

LIST OF PROVISIONALLY SUPPORTED COLORANTS THAT CAN CONTAIN COSMETIC PRODUCTS ⁽¹⁾

APPLICATION FIELD

Column 1: Colorants admitted to all cosmetic products.

Column 2: Colorants admitted to all cosmetic products, except those that apply near the eyes, and more specifically in makeup products and eye demakeup.

Column 3: Colorants admitted only in cosmetic products that are not intended to contact the mucous membranes.

Column 4: Colorants admitted only to cosmetic products intended to be briefly contacted with the skin.

Number of the index index

or denomination

Coloration	Application field				Other limitations and requirements	Admitted
	1	2	3	4

(1) Lacas or salts of these dyes containing substances whose use is not prohibited in Annex II are also permitted.

(2) Colours, the number of which is accompanied by the letter E, in accordance with the provisions of the EEC Directive of 1962 concerning food additives and colouring matters, must comply with the purity conditions laid down therein. These colours are still subject to the general criteria of Annex III to the 1962 Directive on colouring matters even if the E number has been deleted from that Directive.

ANNEX V

INDICATIVE LIST OF DECORATIVE COSMETIC PRODUCTS

Lip makeup.

Eyelid Shadow.

Coloring.

Pencil of eyes.

Fluid Makeup.

Makeup powder.

Tab Mask.

Nail Polish.

ANNEX VI

LIST OF CONSERVATIVE AGENTS THAT CAN CONTAIN COSMETIC PRODUCTS

PREAMBLE

1. Conservative agents are the substances that are added as ingredients to cosmetic products mainly to inhibit the development of microorganisms in these products.

2. In concentrations other than those provided for in this Annex, substances bearing the symbol (+) may also be added to cosmetic products for other specific purposes derived from the presentation of the product, e.g. as deodorant in soaps, or anti-cancer agents in shampoos.

3. Other substances used in the formulation of cosmetic products may also possess antimicrobial properties and may in this way contribute to the preservation of products, such as numerous essential oils and certain alcohols. These substances are not listed in this Annex.

4. In this list it is understood by:

Sales: the salts of cations sodium, potassium, calcium, magnesium, ammonium and ethane foils; of chloride anions, bromide, sulphate, and acetate.

Esters: methyl, ethyl, propyl, iso-propyl, butyl, isobutyl and phenyl esters.

5. In all finished products containing formaldehyde or substances of this Annex which release formaldehyde, the words 'contains formaldehyde' must be included in the conditioning material, provided that the concentration of formaldehyde in the finished product exceeds 0,05%.

FIRST PART

LIST OF SUPPORTED CONSERVATIVE AGENTS

34

Number	Substance	Maximum Authorized Concentration	Limits and Requirements	Terms of employment and warnings that must be compulsorily
	b	c	d
1	BENZOIC ACID ITS SALTS AND ITS ESTERS (+)	0.5% (acid)
2	PROPIONIC ACID AND ITS SALTS (+)	2% (acid)
	3	SALICYLIC ACID AND ITS SALTS (+)	0.5% (acid)	Do not use in preparations intended for children under 3 years, except for shampoos.	Do not use for care of children under 3 years of age. (1)
4	SORBID ACID AND ITS SALTS (+)	0.60% (acid)
5	FORMALDEHYDE AND PARAFORMALDEHYDE	-0.2%% (except for oral care). -0.1% (for oral care). Concentrations expressed in free formaldehyde	Forbidden in aerosols (sprays).
7	O-PHENYLPHENOL AND ITS SALTS (+)	0.2% expressed in phenol.
8	CCN SALES OF 1-OXI-2-THIOLPYRIDINE (CCN PIRITIONA) (+).	0.5%	-Authorized in the cleared products (2). -Prohibited in oral care products.
9	INORGANIC (+)	0.2% (expressed on SO2 free)
	10	SODIUM IODATE	0.1%	Only for the cleared products.
11	1,1,1-TRICHLORO-2,2-METHYLPROPANOL (2-CHLOROBUTANOL)	0.5%	Prohibited in aerosols (sprays).	Contains chlorobutanol
12	P-HYDROXYBENZOIC ACID, ITS SALTS AND ESTERS (+).	-0.4%% (acid) for an ester. -0.8%% (acid) for ester mixtures
13	DEHYDROACETIC ACID AND ITS SALTS	0.6% (acid).	Forbidden in sprays (sprays).
14	FORMIC ACID AND ITS SODIO (+) SAL (+)	0.5% (expressed as acid)
	1.6-DI-N-(AMIDINO-2-BROMOPHENOXY) HEXANO. (DIBROMOHEXAMIDINE) AND ITS SALTS (INCLUDING ISETHIONATE)	0.1%
16	SODIUM ETHYLMERCURY (THIOMERSAL) TIOSALICILATE	0.007% (in Hg). In the case of a mixture with other mercury salts authorised in this Regulation, the maximum concentration of Hg remains fixed at 0.007%.	Only for makeup products and eye demakeup.	Contains sodium ethylmercury thiosalicilate
17	PHENYLMERCURY AND ITS SALTS (COMPRISED OF BORATE)	0.007% (in Hg). In the case of a mixture with other mercury salts authorised in this Regulation, the maximum concentration of Hg remains fixed at 0.007%.	Only for makeup products and eye demakeup.	Contains phenylmercuric
18	UNDECENICO ACID AND ITS SALES (+)	0.2% (acid)
19	5-AMINO-1,3-BIS-(2-ETHYL-HEXYL) -5-METHYL-PERHI-DROPYRIMIDINE (+) (HEXETIDINE)	0.1%
20	5-BROMO-5-NITRO-1,3 DIOXANO	0.1%	-Only for cleared products. -Avoid the formation of nitrosamines.
21	2-BROMO-2-NITRO-1,3 PROPANEDIOL (BRONOPOL)	0.1%	Avoid the formation of nitrosamines.
22	ALCOHOL 2.4-DICHLOROBENZYL (+)	0.15%.
23	3,4,4 '-TRICHLOROCARBANILI DA (+) (TRICLOCARBAN)	0.2%	purity criteria: 3-3' -4-4 '-Tetrachloroazobenzene benzene < ppm 3-3' -4-4 '-Tetrachloroazoxybenzene <1ppm.
24	PARACHLOROMETACRESOL (+)	0.2%	Forbidden in products intended to contact mucous membranes.
25	2,4,4 '-TRICHLORO-2'-HYDROXYDIPHENYLETHER. (+) (TRICLOSAN)	0.3%
26	PARACHLOROMETAXILENOL (+)	0.5%
27	IMIDAZOLIDINYLUREA (+)	0.6%
28	POLYHEXAMETHYLENE BIGUANIDE (HYDROCHLORIDE DE) (+)	0.3%
29	2-PHENOXIETHANOL (+)	1.0%
30	HEXAMETHYLENETRAMINE (+) (METHENAMINE)	0.15%
31	1-(3-CHLOROALIL) CHLORIDE -3,5,7- TRIAZA-1-AZONIA-ADAMANTANO	0.2%
32	1-IMIDAZOLYL-1-(4-CHLOROPHENOXY) 3,3-DIMETHYL-2-BUTANONE (+)	0.5%
33	%	%
	1,0%	1.0%	%
	35		35	1-HYDROXY-4-METHYL-6 (2,4, 4-TRIMETHYLPENTYL) 2-PYRIDON AND ITS MONOETHANOLAMINE SALT (+)	1.0% 0.5%	-For clarified products. -For other products.
36	1,2-DIBROMO-2,4-DICYANOBUTAN	0.1%	Do not use in sunscreen products with a concentration greater than 0.025%.
37	3,3 '-DIBROMO-5,5'-DICHLORO-2,2 '-DIHYDROXYDIPHENYLMETHANE (+)	0.1%
38	ISOPROPYLMETACRESOL	0.1%
39	5-CHLORO-2-METHYL-3,4-ISOTHIAZOLONE-+ 2-METHYL-3,4-ISOTHIAZOLONE + MAGNESIUM CHLORIDE AND MAGNESIUM NITRATE.	0.0015% Of a mixture in the ratio 3: 1 of 5-chloro-2-methyl-3,4-isothiazolone and 2-methyl-3,4-isothiazolone.
40	2-BENZYL-4-CHLOROPHENOL (CHLOROFEN)	0.2%
41	CHLORACETAMIDE	0.3%		Contains chloracetamide
		BIS-(P-CHLOROPHENYLDIGUANIDE) -1,6-HEXANE (+): ACETATE GLUCONATE AND HYDROCHLORIDE (CHLORHEXIDINE)	0.3% expressed in chlorhexidine.
43	PHENOXYPROPANOL	1.0%	Only for cleared products.
44	ALKYL (C12 C22) TRIMETHYL AMMONIUM, BROMIDE, (+)	0.1%
45	4,4-DIMETHYL-1,3-OXAZOLIDINE	0.1%	The pH of the finished product will not be less than 6.
46	N-(HYDROXYMETHYL) N-(1,3 DIHYDROXIMETHYL-2,5-DIOXO-4-IMIDAZOLIDINIL) N' (HYDROXYMETHYL) UREA.	0.5%
47	1.6-DI (AMIDINOPHENOXY)-N-HEXANE (HEXAMIDINE AND ITS SALTS (INCLUDING ISETHIONATE AND P. HYDROXYBENZOATO) (+)	0.1%
48	GLUTARALDEHYDE (1,5-PENTANODIAL)	0.1%	Prohibited in aerosols (sprays)	Contains glutaraldehyde (when the concentration of glutaraldehyde in the finished product exceeds 0.05%)
49	7-ETHYLBICYCLO OXAZOLIDINE	0.3%	Forbidden in the oral hygiene products and in the products destined for the mucous membranes.
50	3-(P-CHLOROPHENOXY)-PROPAN-1,2 DIOL (CHLORFENESIN)	0.3%
51	SODIUM HYDROXYMETHYLAMINACETATE (SODIUM HYDROXYMETHYLGLYCINATE)
	52	SILVER CHLORIDE DEPOSITED ON TITANIUM DIOXIDE	0.004% calculated as AgCl	20% AgCl (p/p) on TIO2. Prohibited in products for children under three years of age in oral hygiene products and in products intended to be applied around the eyes or on the lips.

⁽¹⁾ Only products that could be used for care of children under the age of 3 and remain in prolonged contact with the skin.

⁽²⁾ Clear products are meant to be rinsed after application.

SECOND PART

LIST OF PROVISIONALLY SUPPORTED CONSERVATIVE AGENTS

Number	Substance	Maximum Authorized Concentration	Limits and Requirements	Terms of employment and warnings that must be mandatory on the label	Admitted
to	b	c	d	e	f
16	ALKYL (C8-C18) DIMETHYLBENZYL AMMONIUM, (+) (BENZALKONIUM, BROMIDE CHLORIDE, SACCHARINATE DE)	0.1%			30.6.97
21	BENZILHEMIFORMAL	0.03%	Only for products intended to be cleared after application.		30.6.97
29	3-IODO-2 PROPINILBUTYL CARBAMATE	0.1			30.6.97

ANNEX VII

LIST OF ULTRAVIOLET FILTERS THAT CAN CONTAIN COSMETIC PRODUCTS

For the purposes of this Royal Decree, ultraviolet filters are defined as substances which, contained in the cosmetic products of sun protection, are specifically intended to filter certain radiation to protect the skin from its harmful effects.

These filters may be added to other cosmetic products within the limits and in compliance with the conditions set out in this Annex.

This list does not include ultraviolet filters that are only used to protect cosmetic products from ultraviolet radiation.

FIRST PART

LIST OF ULTRAVIOLET FILTERS THAT CAN CONTAIN COSMETIC PRODUCTS

NUMBER	SUBSTANCES	MAXIMUM AUTHORIZED CONCENTRATION	LIMITS AND REQUIREMENTS	EMPLOYMENT CONDITIONS AND WARNINGS THAT MUST BE COMPULSORILY LISTED
TO	B	C	d
1	4-AMINOBENZOIC Acid	5%
2	METHYL SULFATE AND N, N, N-TRIMETHYL-4-[(2-OXO-3 BORMILIDEN) -METHYL]-ANILINA	6%
3	HOMEALATO	10%
4	OXIBENZONA	10%		Contains oxybenzone (1)
6	2-PHENYL-5-BENZIMIDAZOLE SULFONIC ACID AND ITS POTASSIUM, SODIUM, AND TRIETHANOLAMINE SALTS	8% (Expressed on Acid)
7	3-3 '-(1,4-PHENYLENE DIMETHYLIDINE) BIS [ACID 7.7 DIMETHYL-2-OXO-BICYCLO (2,2, 1) HEPTANE 1-METHANE SULFONIC] AND ITS SALTS	10% (expressed in acid)
	1-(4-TERT-BUTYL-PHENYL)-3-(4-METHOXYPHENYL) PROPANE-1,3-DIONE.	5%
9	ACID (2-OXO-3-BORNILIDENO) 4-TOLUENSULFONIC AND ITS SALTS	6% (Expressed on Acid)
10		10% (acid-expressed)
	11	N-[(2-OXOBORN-3-YLIDENE) METHYL] BENZYL] ACRYLAMIDE	6%		6%

(1) The indication shall not be required if the concentration is equal to or less than 0,5% and if the substance is used only to protect the product.

SECOND PART

LIST OF ULTRAVIOLET FILTERS THAT CAN PROVISIONALLY CONTAIN COSMETIC PRODUCTS

17

29

Number	Substance	Maximum Authorized Concentration	Limits and Requirements	Terms of employment and warnings that must be mandatory on the label	Admitted
to	b	c	d	e	f
2	ETHOXYLATED 4-AMINOBENZOIC ACID	10%			30.6.97
5		8%			30.6.97
	5%	5%			30.6.97
12	AMYL 4-METHOXYCINNAMATE (ISOMER MIXTURE)	10%			30.6.97
13	4-ETHYLHEXYL 4-METOXYCINNAMATE					17
17	5% expressed as acid)			30.6.97
25	3-(4-METHYLBENZYLIDENEN-2-BORNANONE)	6%			30.6.97
	26	3-BENZYLIDENEN-2-BORNANONE	6%			30.6.97
4-ISOPROPYL benzyl	4%			30.6.97
	32	2,4,6, -TRIANILINE-P-(CARBO-2 ' -ETHYLHEXYLPOXI) 1,3, 5-TRIAZINE	5%			30.6.97

ANNEX VIII

CONSUMER REFERRAL TOKEN TO INGREDIENT LIST

ANNEX IX

MODALITIES FOR GRANTING THE REGISTRATION NUMBER REFERRED TO IN ARTICLE 17

1. The registration number referred to in Article 17 consists of 7 figures, the first two of which correspond to the year of the granting of confidentiality, the two following the code assigned to each Member State, in accordance with paragraph 2 below, and the last three assigned by the competent authority.

2. Each Member State shall have the following codes:

01 France 06 United Kingdom 11 Spain

02 Belgium 07 Ireland 12 Portugal

03 Netherlands 08 Denmark 13 Finland

04 Germany 09 Luxembourg 14 Austria

05 Italy 10 Greece 15 Sweden