The Spanish Constitution, in its articles 43 and 51, ensures the protection of public health and the defense and security of consumers and users.

In this sense, Law 14/1986 of 25 April, General of Health, in its preliminary title, article 1. ° .1, declares as objective " the regulation of all actions that allow to make effective the right to the protection of the health. " In Article 40 thereof. 2, 5 and 6, when dealing with the powers of the State, indicates the determination of the health requirements of the Technical-Health Regulations of food, services or products directly or indirectly related to the use and consumption Human and veterinary medicinal products for human and veterinary use and for other medical devices and medical devices and for those which may pose a risk to the human being, as appropriate, of medicinal products for human and veterinary use and of other medical devices and medical devices. the health of the people, as well as the regulation and authorization of the activities of the natural or legal persons engaged in the preparation, manufacture and manufacture of the products mentioned.

Similarly, Law 26/1984, of 19 July, General for the Defence of Consumers and Users, in Article 2 of the Law of 19 July 1984, states as the basic right of consumers " protection against risks which may affect their health or security ". In particular, Articles 3 and 13 ensure the protection of consumers against foreseeable risks by determining the obligation of correct information on consumer products. Article 4 (1) and (2) specify 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.

The Health Bases Act of 1944, in its base XVI, mentions cosmetic products. The Spanish Food Code of 1967 set out some of the characteristics of cosmetics in paragraph 5.38.02.

The regulations in force until today, Decree 3339/1968, of 26 December, which regulate cosmetics, have been completely overcome by the great advances made in the scientific and technical knowledge of the products This is why, in a line of improvement in the policy of consumer health protection, the updating of the legislation on cosmetic products is necessary.

Moreover, the accession of Spain to the European Economic Community requires the harmonization of Spanish cosmetics legislation with Council Framework Directive 76/768 and subsequent amendments (Directives of the European Communities, Council Directive 79/661, 82/368, 83/574) concerning the approximation of the laws, regulations and administrative provisions relating to the competition, labelling and packaging of cosmetic products and the adjustments to their Annexes to technical progress (Commission Directives 82/147, 83/191, 83/341, 83/496, 84/415, 85/391, 86/179 and 86/199), Community legislation contained in this Royal Decree, incorporating it in this way into the Legal Order of our country.

In its virtue, on the proposal of the Minister of Health and Consumer Affairs, the affected sectors and the Inter-Ministerial Commission for Food Management, in agreement with the Council of State and after deliberation of the Council of Ministers, at their meeting on 15 April 1988,

D I S P O N G O:

Single item.

The attached Technical-Health Regulations for cosmetic products are approved.

ADDITIONAL PROVISIONS

First.

By Order of the Minister of Health and Consumer Affairs, a Cosmetology Advisory Committee will be set up by representatives of the Administration, the sectors affected and professionals of recognized prestige, with functions consulting and technical advice.

Second.

The provisions of this Royal Decree shall apply to cosmetic products which, at the entry into force of this Decree, are in the process of being approved on the basis of Decree 3339/1968.

TRANSIENT PROVISIONS

First.

The manufacturers and those responsible for placing on the market shall communicate to the Directorate-General for Pharmacy and Health Products, through the competent Sanitary Administrations, within 12 months, by means of the global certification, that cosmetic products that are marketing at the date of entry into force of this provision comply with the specifications contained in the Annexes to this Royal Decree.

Second.

1. The cosmetic products authorized under Decree 3339/1968 must be in accordance with the requirements of this Royal Decree, according to a timetable which the Directorate General of Pharmacy and Health Products will establish by means of Resolution.

2. The above adequacy shall also apply to authorised dentifrices which, in accordance with the Annexes to this Royal Decree, are classified as cosmetic products.

Third.

Products not covered by this Royal Decree and which, however, by their properties, composition or form of application, were considered cosmetic on the basis of Decree 3339/1968, will be subject to the Special Declaration provided for in Article 7. of the attached Regulations, until such time as there is no specific regulation to regulate them.

The General Directorate of Pharmacy and Health Products will resolve any doubts that may arise in the application of this transitional provision.

REPEAL PROVISION

One.

As of the entry into force of this Royal Decree, the precepts and provisions cited are repealed:

Paragraphs 5.38.02 to 5.38.14 of Decree 2484/1967 of 21 September.

Decree 3339/1968 of December 26, in which you oppose this Royal Decree.

The Resolution of 1 February 1972 (DGS).

The Resolution of 18 October 1983 (DGFM).

Two.

Likewise, how many provisions of equal or lower rank are repealed with the provisions of this Royal Decree.

FINAL PROVISIONS

First.

The Ministry 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.

Second.

This Royal Decree shall enter into force three months after its publication in the "Official Gazette of the State", without prejudice to the provisions of the first provision.

Given in Madrid to April 15, 1988.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

JULIAN GARCIA VARGAS

TECHNICAL-HEALTH REGULATIONS ON COSMETIC PRODUCTS

Article 1. º

the purpose of this Regulation is to define, for legal purposes, cosmetic products, as well as to determine the technical and health conditions to be met, their health control, the requirements to be met by the facilities for the production and storage, inspection, infringements and, in general, the legal order of the products concerned.

TITLE FIRST

Definitions and exclusions

Article 2. º

For the purposes of this Regulation, it 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, lips, nails, external genital organs, or with teeth and mucous membranes of the Oral cavity), with the exclusive purpose or main purpose of cleaning, perfuming or protecting them, to keep them in good condition, modify their appearance and correct the body odours.

The preparations listed in Annex I to this Regulation are considered as cosmetic products.

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 inaesticisms.

2. Communication: Action for which the Directorate-General of Pharmacy and Health Products is brought to the attention, hereinafter DGFPS, in the terms provided for in this Royal Decree, the information required in this Regulation.

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

4. Responsible for placing on the market: Natural person or legal entity who, having the status of manufacturer, importer or owner of a cosmetic product, presents, in his own name or through legal representation of the third, the administrative communication or the special declaration, where appropriate, for the purpose of placing it on the market.

5. Labels, packaging and leaflets: For the purposes of this Regulation, it is considered:

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

b) Envase: Any element or container that contains the cosmetic product and is in direct contact with it.

c) Cartonage or outer carton. Box, case or any other system that contains the package and protects it.

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

Item 3.

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

TITLE II

Technical-health conditions for cosmetic products

Article 4. º

1. Cosmetic products placed on the market at the disposal of consumers shall not entail a risk to health or safety when they are used under the conditions laid down for their use.

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

Article 5.

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

1. The substances listed in Annex II to this Technical-Health Regulation.

2. The substances listed in Annex III (first part) and Annex IV (first part), in higher concentrations and under conditions other than those laid down in those Annexes.

3. Colours not included in Annexes IIl and IV.

4. Colouring matters in Annexes III and IV in higher concentrations and under conditions other than those laid down therein.

5. Ultraviolet filters not included in Annex V.

6. Ultraviolet filters in higher concentrations and under conditions other than those laid down in Annex V.

7. Conservative agents not included in Annex VI.

8. Conservative agents at higher concentrations and under conditions other than those laid down in Annex VI.

9. 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.

TITLE III

CHAPTER FIRST

Communication

Article 6.

1. The placing on the market of a cosmetic product shall be communicated not later than the day on which it is made effective. To this end, the person responsible for placing the market on the market must present the forms to be established, duly completed in the official Spanish language of the State. The following data shall be included in them:

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

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

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

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

(e) Qualitative composition of its active constituents, in descending order of their concentrations, expressed with the International Non-proprietary Name (INN), where it exists, or, failing that, in accordance with the rules of nomenclature international to permit identification.

In the case of solid soaps, perfumes, cologne and toilet waters, the qualitative formula will refer only to the vehicle, conservative agents and colorants used.

f) Quantitative composition of the components referred to in the previous paragraph, which shall be presented in a single lacquered envelope to ensure its confidentiality.

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

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

i) Certificate of having carried out the necessary tests to check the safety of the cosmetic product.

j) Certificate of having carried out the necessary checks to check the quality of the cosmetic product,

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

2. The documentation referred to in the preceding number shall be submitted to the competent health authority in duplicate, except as provided for in paragraph 1 (f). This Administration shall immediately forward one of these copies together with the lacquered reference to the DGFPS.

3. The technical documentation on the basis of which the safety certificate is presented may be experimental or bibliographic.

The above documentation, together with the analytical methods and tests referred to in paragraph (j) of this Article, shall be kept at the registered office of the Company which is the manufacturer or responsible for the placing on the market. the market for verification by the Administration.

4. The communication concerning cosmetic products imported from third countries and the cosmetic products placed on the market from another Member State of the European Economic Community, with the exceptions provided for in this Directive. Regulations shall be made by submitting the relevant documentation directly to the DGFPS.

CHAPTER II

Special Statements

Item 7.

1. The DGFPS may exceptionally authorise the use in cosmetic products of colours, preservatives or ultraviolet filters which are not included in the Annexes to this Regulation.

In these cases, a special declaration must be submitted that complies with the terms of the article except for paragraphs (i) and (j), the requirements of which shall be replaced by the following:

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

2. º Compliance with a follow-up program that accredits the safety in its use by the Entity that declares them, according to the requirements that the DGFPS establishes.

3. Have a specific indication that will be detailed in the special declaration and will be identified as determined by the DGFPS to differentiate them from the rest of the products.

2. Within 60 days the DGFPS shall give its opinion on the special declaration submitted. If it does not allow an adequate health assessment of the product, the declarant shall be required to provide the necessary data or tests; in this case, a new period of 60 days shall be counted from the receipt of the data or tests. required.

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

4. Whenever the DGFPS considers it necessary for the protection of the health and safety of persons, the special declaration system may be applied to any cosmetic product containing other substances other than those specified in the Directive. paragraph 1.

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

CHAPTER III

Common rules

Article 8. º

The DGFPS shall ensure the confidentiality of the data that has such a character by the necessary provisions and instructions. The DGFPS by itself or at the request of the relevant Health Administration may proceed to the opening of the envelope referred to in Article 6 (f) for reasons of risk to the health or safety of persons, taking the measures that are appropriate for you to do so.

Article 9. º

The criteria for the chemical and microbiological quality of cosmetic products, as well as their analytical methods, will be laid down by the Order of the Minister for Health and Consumer Affairs, taking into account Community legislation and hearing the of the Advisory Committee on Cosmetology.

In default, the analytical methods used or recommended by the "Carlos III" Health Institute and other specialized, national or international Centers and Institutes of recognized solvency will be used.

Article 10.

1. In the event of cessation of the manufacture or placing on the market of a cosmetic product, the Responsible Entity shall communicate it to the DGFPS by means of the procedure provided for in Articles 6.2 or 6.4, as appropriate, retaining all documentation the product for a period of five years.

2. The provisions of the preceding number shall be made directly in the DGFPS for the products of Chapter II.

Article 11.

Without prejudice to actions corresponding to other Sanitary Administrations; the DGFPS based on justified reasons may prohibit the placing on the market, order the withdrawal or subject to special conditions of control of any cosmetic products which, while complying with the requirements laid down in this Regulation, present a risk to the health and safety of persons under normal or foreseeable conditions of use.

Any of these measures shall be of a provisional nature and shall be immediately reported to the Commission of the EEC and to the competent authorities of the Member States. In any event, if the decision to be taken results in the cancellation of a cosmetic product, the cosmetic product shall be carried out by means of the instruction in the relevant administrative file with the person concerned.

Article 12.

1. Any modification of the data included in the communication or declaration shall be communicated as soon as possible.

2. Every five years from the date on which the placing on the market of a cosmetic product has been communicated, the person responsible shall state his intention to maintain the cosmetic product on the market.

Article 13.

The DGFPS will keep an updated book-record in which all communications and special declarations of cosmetic products will be recorded.

TITLE IV

Tagged

Article 14.

1. The labelling of the packaging and the cartonage of any cosmetic product placed on the market must appear, at least, in the official Spanish language of the State, with indelible, visible and easily legible characters, the following data:

a) Name of the product. Internationally accepted or commonly used nomenclatures may be included.

(b) Origin or provenance, in the case of cosmetic products imported from non-Community countries,

(c) Net nominal content at the time of packaging, expressed in S.I. units, in the case of products with a weight or volume equal to or greater than 5 g or 5 ml and the number of copies it contains, in the case of multiple packaging.

(d) The date of minimum duration which, for the purposes of this Regulation, is the date to which the said product, preserved under appropriate conditions, continues to fulfil its initial function and in particular as established in the Article 4. º

The date of minimum duration shall be indicated by the words "use preferably before the end of ..." followed either by the date or an indication of the place of the labelling in which that date is given.

The date will be composed of the month and year indication, clearly and in this order.

These entries shall be completed if necessary with the indication of the conditions to be met to ensure the duration indicated.

The indication of the date of duration shall not be mandatory for cosmetic products whose minimum duration exceeds 30 months.

(e) Special conditions of employment if the product so requires and in particular those specified in the Annexes to this Regulation as ' conditions of employment and precautions to be taken which must be compulsory in the labelling ", which must not appear on hanging labels.

If for justified reasons of space, resulting from the reduced size of the product, this is not possible, the particular conditions of use must be included in the outer packaging or in the package leaflet, then the package defined in Article 2 (5) (b), a statement indicating that the above conditions of employment are detailed in the outer packaging or, where appropriate, the package leaflet.

2. In addition, the following entries must be included which may be expressed in their official languages of origin when the product comes from Community countries:

(a) Name or social name and address or registered office of the manufacturer or responsible for placing on the market, established within the European Economic Community. Those responsible for placing products from third countries on the market must indicate in addition to the name or social reason, their registered office or registered office in the Spanish territory.

These terms may be abbreviated as long as their abbreviation allows, in general terms, to identify the Company.

b) Number of manufacturing batch or reference that permits identification.

When the reduced size of a cosmetic product does not allow inclusion on the label of the package, this data must be included in the outer packaging.

3. Multiple packaging labels and presentations containing different cosmetic products from the same company shall meet the same requirements as those for individual packaging.

Article 15.

1. Without prejudice to the provisions of the rules governing advertising, the text, names, marks, images and other signs, graphics or not, appearing on labels, packaging and leaflets and on the advertising of cosmetic products, attribute to the same characteristics or properties that they do not own.

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

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

4. The cosmetic product shall indicate the qualitative and quantitative formula of the substances whose presence is announced in the name of the product or in its advertising.

TITLE V

Responsible Technician

Article 16.

1. The manufacture, control, storage, as well as the importation from non-Community countries of cosmetic products, will be carried out under the supervision and responsibility of a Technician entitled in profession related to the precise activity such processes, for the purpose of ensuring the characteristics and composition of the product, as well as its safety.

2. The Company shall communicate to the DGFPS, by means of the procedure provided for in Article 6, 2, the appointment of the Technical Officer. In the event that the latter ceases, the Company shall report the appointment of a replacement within one month.

TITLE VI

Installations

Article 17.

1. Manufacturers and those responsible for the placing on the market of cosmetic products must have in Spain facilities authorized by the corresponding operating licence. This requirement shall not be required in respect of cosmetic products placed on the market from another Member State of the European Economic Community.

2. Those facilities shall meet the following requirements:

a) Having a Technical Officer responsible in accordance with the provisions of Article 16.

b) Counting with differentiated areas, if any, of:

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

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.

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

c) The analysis and testing of quality control of cosmetic products may be arranged with control centres or laboratories previously approved by DGFPS.

Article 18.

1. The operating licence may be granted on presentation of the following documentation:

1. Application duly completed and signed by the manufacturer or the person responsible for placing on the market and by the Technician referred to in Article 16.

2. The installation and plane of the description of the installation in which the areas for manufacturing, control and storage are clearly specified.

3. Classes of cosmetic products intended to be drawn up in accordance with the categories set out in Annex I or in the classification which, where appropriate, is established.

4. Appointment of the Responsible Technician together with a copy of his or her academic degree duly authenticated by the University Centre, Notary or the appropriate official College,

5. The importing Entities will accompany the documentation that proves that the owner or the manufacturer is legally established in the country of origin.

6. The entities that have agreed to carry out analysis and tests of quality control with Centers or laboratories referred to in Article 17.2, c), shall submit, in addition, a copy of the corresponding contract.

2. In the light of the documentation submitted, prior to the appropriate inspection visit to the facility, it shall be granted, if the operating licence and the corresponding identification code is assigned.

Article 19.

In the event that the person responsible for placing on the market is aware of the production of cosmetic products with other entities or other entities, the facilities of these entities must also be licensed for operation.

Article 20.

1. The transfer, extension or substantial modification of the facilities referred to in Article 17 shall be considered as a new facility.

2. Where an Entity holding an approved installation changes its legal personality, the name or its social reason shall communicate it by attaching the supporting documentation. The cessation of activities shall also be communicated, including a list of cosmetic products which are communicated or declared at that time.

TITLE VII

Inspection

Article 21.

Competent Public Administrations shall carry out periodic inspections to verify compliance with the provisions of this Regulation.

TITLE VIII

Violations and penalties

Article 22.

1. They are minor infractions:

1. The simple irregularity in the observance of the technical-health regulations, as well as the infractions committed by the simple negligence provided that the alteration or health risk produced out of little entity and without Direct relevance to public health.

2. The ones that, by reason of the criteria mentioned in this article, deserve the qualification of mild, or do not proceed their qualification as serious or very serious faults.

2. These are serious violations:

1. The lack of controls and precautions required in the activities of the cosmetic products ' facilities.

2. The non-compliance with the specific requirements that the DGFPS will formulate in its case, as long as they occur for the first time.

3. The resistance to providing data, providing information or collaborating with the Health Authorities or their Agents.

4. Develop cosmetic products in poor technical-sanitary conditions that affect their safety, safety and quality.

5. To move, extend or substantially modify the facilities where the cosmetic products are manufactured, packaged or stored without the required operating license.

6. " Manufacture, packaging, storing or importing cosmetic products without the contest of the responsible technician referred to in Article 16.

7. Make offers, promotions or advertising of cosmetic products that do not conform to the general rules that regulate these aspects and especially when in them mention of curative properties, false claims or that they fail.

8. º Those that are concurrent with other minor infractions, or have served to facilitate or cover up their commission.

9. º. Those that are considered to be serious or are not classified as minor or very serious due to the elements referred to in this article.

10. The recidivism in the commission of minor infractions in the last three months.

3. These are very serious violations:

1. º That are realized in a conscious and deliberate manner as long as they cause severe damage.

2. The repeated non-compliance of Ios specific requirements to be formulated by the Health Authorities.

3. The absolute refusal to provide information or to provide collaboration to health inspection services, thereby comatose resistance, coercion, threats, retaliation, contempt or any other form of pressure exerted on the Health Authorities or their Agents.

4. The refusal to supply when the technical documentation referred to in Article 10 is required.

5. º Sell or keep on the market cosmetic products that have been the subject of a precautionary or definitive withdrawal order.

6. The placing on the market of cosmetic products that contravene the provisions of Article 5.

7. The placing on the market of cosmetic products without having carried out the communications or obtained the authorization referred to in Articles 6, 7, 7 and 12.

8. The distortion of the data communicated or declared as well as the lack of any document, on the basis of which the certifications of paragraphs (i) and (j) of Article 6 have been issued.

9. Make or store cosmetic products in facilities that do not have the required operating license.

10. Modify the composition of the cosmetic product or any of the data required by Article 14 on the labelling without prior communication.

11. Violations that are concurrent with other serious health violations or have served to facilitate or cover up your commission.

12. Those who, by reason of the elements referred to in this Article and of their degree of concurrency, deserve the qualification of very serious or do not proceed with their qualification as minor or serious faults.

13. Recidivism in the commission of serious misconduct in the last five years.

Article 23.

The infringements of the provisions of this Royal Decree shall be subject to the administrative penalties which correspond, subject to the instruction of the appropriate file, without prejudice to the civil, criminal or other responsibilities. order that they may attend.

If multiple people are involved in the production of the damages, they will respond in solidarity to the injured.

Article 24.

1. The offences referred to in Article 22 of this Regulation shall be punishable by fine according to the following graduation:

a) Minor infractions, up to 500,000 pesetas.

(b) Serious infractions, from 500,001 to 2,500,000 pesetas, and may exceed that amount until the value of the products being infringed is reached.

c) Very serious infractions, ranging from 2,500,001 to 100,000,000 pesetas, being able to exceed that amount until reaching the fivefold of the value of the products that are the object of the infringement.

2. Within the limits established in the previous number, the administrative organ sanctioning the fines according to the health risk criteria, the amount of the benefit obtained, the degree of intentionality and the severity of the alteration. social or health produced.

3. The sanctioning procedure shall be in accordance with Articles 133 to 137, inclusive of the Administrative Procedure Act. The competent authority is the one that is established by Law 14/1986 of 25 April and 26/1984 of 19 July, and, where appropriate, Royal Decree 1945/1983 of 22 June.

In any event, where health offences are detected, the instructor shall immediately give the competent Sanitary Authorities an immediate account thereof, without prejudice to the adoption of the precautionary measures. from.

Article 25.

1. In the case of very serious infringements, the temporary closure of the establishment or installation may be agreed by the Council of Ministers or by the relevant body of the Autonomous Communities which have the competence to do so. maximum of five years. In such a case, the provisions of Article 57.4 of Law 8/1980 of 10 March of 10 March, approving the Staff Regulations of Workers, shall apply.

2. The authority to which the file is to be resolved may agree, as a sanction to the confiscation of the product.

3. In the event that there is or is reasonably suspected the existence of an imminent and extraordinary risk to health, the Health Authority may adopt the preventive measures referred to in Article 26 of Law 14/1986 of 25 April 1986, with the scope provided for in that Article.

ANNEX I

Indicative list by categories of cosmetic products

Creams, emulsions, lotions, gels and skin oils.

Beauty masks (excluding skin surface abrasion products by chemical).

Make-up (liquids, pastes, powders).

Makeup powders, powders to use after bath and for body hygiene.

Toilet soap, deodorant soap.

Perfumes, toiletries, colony waters ...

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

Depilatories.

Antiperspirant deodorants.

Capillaries.

Dyes and discolourants.

Products for molding, degrating, and fixing.

Products that help keep the hairstyle.

Cleaning products (lotions, powders, shampoos).

Conditioning products (lotions, lacquers, glitter).

Other hairstyle products.

shaving products (soaps, foams, lotions).

Products for makeup and demakeup of the face and eyes.

Products for the lips.

Products for oral and dental care.

Products for nail care and makeup.

External care products.

Solar products.

Sunless tanning products.

Skin whitening products.

Anti-wrinkle products.

ANNEX II

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).

4. Spironolactone (a).

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

6. Methotrexate (a).

7. Aminocaproic acid (a) and its salts.

8. Cincopene (a), its salts, derivatives 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 L') and its salts.

13. "Adonis versalis 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. Allyl isothiocyanate.

19. Alloclamide (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 Resolution A. P. (69) 2 of the Council of Europe.

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

23. Betoxicaine (a) and its salts.

24. Zoxazolamine (a).

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

26. Diaminobiphenyl (benzidine).

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

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. Aminotoluene, 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]-benzopyran-7-one (amidine).

35. 'Ammi majus L' and its preparations.

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

37. Androgens and androgenic action substances.

38. Anthracene oil.

39. Antibiotics, with the exception of those listed in Annex IV.

40. Antimony and its compounds.

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

42. 5,6,6a, 7-tetrahydro-6-methyl-4h-dibenzo [of, g] -10,11-diolquinoline (apomorphine) and its salts.

43. Arsenic and its compounds.

44. 'Aropa Belladonna L.' and its preparations.

45. Atropine, its salts and derivatives.

46. Barium salts with the exception of:

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

Lacas, pigments or salts prepared from colorants with reference (3) in the list in Annex III (Part 2) and with the reference (1) in Annex IV (Part Two).

47. Benzene.

48. Benzimidazolone.

49. Benzoacepine benzodiazepine, its salts and derivatives.

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

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. Bromyoval (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. "vesicatory Cantharis".

70. Cantaridine.

71. Fenprobamate (a).

72. Nitrated carbazole derivatives.

73. Carbon disulfide.

74. Catalase.

75. Cefelina and its 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-methyldimidine (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) indano-1,3-dione (chlorophacinone).

94. Chlorphenoxamine (a).

95. Fenaglydol (a).

96. Clroethane.

97. Chromium salts, chromic acid and salts thereof.

98. 'Tul purpurea claviceps', their alkaloids and preparations.

99. "Conium maculatum 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 L (oil).

108. N-(Crotonylamino-4-Benzenesulfonyl) -N ' -Butilurea

109. Curare and curamines.

110. Synthesis curariants.

111. Hydrocyanic 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 haxametonium 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. Cincocaino (a) and its salts.

130. 3-diethylamino propyl cinnamate.

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

132. Salts of N, N '-bis-(2 diethylaminoethyl) oxamide bis-2-chlorobenzyl (including ambononium chloride) (a).

133. Methypiricanvas (a) and its salts.

134. Digitalin and all the heteroxides of digital.

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

136. Dioxetedrine (a) and its salts.

137. Piprocuran (a).

138. Propifenazone (a).

139. Tetrabenacin (a) and its salts.

140. Captodian (a).

141. Mefeclorazine (a) and its salts.

142. Dimethylamine.

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

144. Metapirileno and its salts.

143. Metamfepramone (a) and its salts.

146. Amitriptyline (a) and its salts.

147. Metformin (a) and its salts.

148. Isosorbide 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. Tested (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. P-aminobenzoic acid esters (with the free amino group). Except for those listed in Annex V (2. part).

168. Esters of choline and methylcholine and their salts.

169. Caramifenium (a).

170. Diethylphosphoric ester of P-nitrophenol.

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. part).

192. Salts of furfuryltrimethylammonium (including furtrethonium iodide (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-endo-endodimethylenaphthalene (endrin).

197. Hexachloroethane.

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

199. Hydrazine, hydrazinin and its salts.

200. Hydrazine and its 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-lbenzopyran) 3-YL] 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. Pemolina (a) and its salts.

213. Iodine.

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

215. "Ipeca Uragia Ipecacuaha Baill" and similar species (roots and preparations).

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

217. Santonina.

218. "Lobelia Inflata L" 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. Mescalina and its salts.

223. Polyacetaldehyde (metaldehido).

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

225. Cummetarol (a).

226. Dextromethorphan (a) and its salts.

227. 2-methylaminoheptane and its salts.

228. Isometepteno and its salts (a).

229. Mecamylamine (a).

230. Guaifenesina (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-coumarol).

235. Carisoprodol (a).

236. Meprobamate (a).

237. Tefazoline (a) and its salts.

238. Arecoline.

239. Poidine 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. Nitroresol and its alkaline salts.

251. Nitrofurantoin (a).

252. Furanzolidone (a).

253. Nitroclyllerine.

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. Pentaerythrityl tetranitrate (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-benzylacetatate of α, piperido-L, (levofacetoperane) and its salts.

285. Pipradol (a) and its salts.

286. Azacyclonol (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 laid down in Annex IV (first part).

290. Coniina.

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

292. Metirapone (a).

293. Radioactive substances (l).

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 (Part 1, No 49).

298. "Solarium nigrum L" and its preparations.

299. Spartein and its salts.

300. Glucocorticoids.

301. "Datura stramonium L" and its preparations.

302. Strophantins, strofantidines and derivatives.

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

304. Strychnina and its salts.

305. "Strychnos" (species) and preparations.

306. Narcotic drugs: Those substances listed in Tables I and II of the Convention on Narcotic Drugs held on March 30, 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 jaburandi holmes' and their 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, with the exception of those listed in Annex III (first part).

322. Mefenesin (a) and its esters.

323. Vaccines, toxins or serums listed in the Annex to the second Council Directive of 20 May 1975 concerning the approximation of laws, regulations and administrative provisions relating to proprietary medicinal products. (Official Journal of the European Communities No 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 trietiodide (a).

330. 'Urginea scillia stern' and its preparations.

331. Veratrin and its salts.

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

333. 'Veratrum spp' and its preparations.

334. Vinyl chloride (monomer).

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. Dihydroacquiessterol (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. Tetrabromosalifilyilides other than impurities of tribromosalilide ilide according to the criteria set out in Annex IV (first part).

351. Dibromosalitanilides other than impurities of tribromosalifilide ilide according to the criteria set out in Annex IV (first part).

352. Bitionol (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 between these: Trioxisalen (a) and 8-methoxypsoralene, except for normal amounts contained in natural essences used.

359. "Laura Nobilis L" seed oil.

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

100 PPM on the given product.

50 PPM in dental and oral care products, 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-tetrahydronaphthalene) (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-dioxifla.

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

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

370. N-trichloromethitio-4-cyclohexane-1,2-dicarboximide. (Captan),

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

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 (first part).

Chloride under the conditions set out in Annex IV (first part).

Lacas, pigments or salts prepared from colorants listed in the list in Annex III (Part Two) and with the reference (1) in Annex IV (Part Two).

374. Zirconium and its compounds (with the exception of the compounds listed in Annex III, number 50 (first part), and lacquers, pigments or zirconium salts of the colours listed in Annex III (Part Two) and with the reference reference (1) in Annex IV (second part)).

375. Lidocaine.

376. Thyrotricin.

The presence of traces of the substances included in this Annex shall be tolerated, where these are technically unavoidable as consequences of the application of good laboratory practice and provided that the Article 4. of this Regulation.

(a) The name of their substances is recommended as the "International Denomination" for pharmaceutical substances published by the World Health Organization. Geneva, 1982.

(1) The presence of natural radioactive substances from artificial environmental contamination is allowed, provided that such radioactive substances are not enriched before use in the manufacture of (a) cosmetic products, 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 the ionising radiation. (Official Journal of the European Communities No 11 of 20 February 1959, pages 221/59)