Royal Decree 349/1988, On 15 April, Which Approves The Reglamentación Of Cosmetic Products.

Original Language Title: Real Decreto 349/1988, de 15 de abril, por el que se aprueba la Reglamentación Técnico-Sanitaria de productos cosméticos.

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

In this sense, law 14/1986 of 25 April, General health, in its preliminary title, article 1.º.1, declared as goal «the regulation of all the actions that allow to give effect to the right to health protection». In its article 40. 2, 5 and 6, concerning the powers of the State says such as the determination of the health requirements of sanitary regulations of food, services or products directly or indirectly related to the use and human consumption; Regulation, authorization, registration or approval, as appropriate, of medicines for human and veterinary use and other products and sanitary articles and those that affect human beings, can pose a risk to the health of the people, as well as regulation and authorization of activities of natural or legal persons engaged in the preparation development and manufacture of the products mentioned.

Similarly, Law 26/1984 of 19 July, General for the defence of consumers and users, in its article 2.º.1.a designates as a basic right of consumers "protection against risks that may affect their health or safety". In particular, articles 3 and 13 ensure the protection of consumers against the risks predictable, determining the obligation to correct information on consumer products. The 4th article 28, 1 and 2, require the contents of the regulatory rules, guarantees of purity, efficacy or safety and liability for damages caused in the use or consumption of goods, which apply to cosmetics.

The Health Foundation Act of 1944, at its base XVI, mentions the cosmetic products. The Spanish food code of 1967 set some of the characteristics that must have cosmetics in its paragraph 5.38.02.

The regulations in force until today, Decree 3339/1968, of 26 December, which regulates cosmetics, has been completely overtaken by great advances in scientific and technical knowledge of cosmetic products; Therefore, in a line of overcoming in the policy of protection of the health of consumers, is necessary the updating of legislation on cosmetic products.

On the other hand, the accession of Spain to the European economic community requires the harmonization of cosmetics with the framework directive of the 76/768 Council Spanish legislation, and its subsequent amendments (directives of the Council 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 , as well as the adaptation of its annexes to technical progress (Commission Directive 82/147, 83/191, 83/341, 83/496, 84/415, 85/391, 86/179 and 86/199), Community legislation which is collected in the present Royal Decree, incorporating it in this way to the legal system of our country.

By virtue, on the proposal of the Minister of health and consumption, heard the sectors affected and the inter-ministerial Commission for food management, according to the Council of State and after deliberation by the Council of Ministers, at its meeting of April 15, 1988, D I S P O N G O: only article.

The Deputy approves Reglamentación of cosmetic products.

ADDITIONAL provisions first.

By order of the Minister of health and Consumer Affairs shall be an Advisory Committee on Cosmetology, composed of representatives of the Administration, affected sectors and professionals of recognized prestige, with advisory functions and technical advice.

The second.

The provisions of this Royal Decree shall apply to cosmetic products which at the entry into force of the same are in application for authorization based on the Decree 3339/1968.

TRANSITIONAL provisions first.

The companies manufacturers and those responsible for the placing on the market shall inform the General Directorate for Pharmacy and medical devices, through the competent authorities in health, within the period of twelve months using global certification, cosmetic products that are traded at the date of entry into force of this provision are in accordance with the specifications contained in the annexes of this Royal Decree.

The second.

1 cosmetic products authorized on the basis of the 1968/3339 Decree will have to adapt to the requirements of this Royal Decree, in accordance with a timetable which the General Directorate for Pharmacy and medical devices shall establish by resolution.

2. the previous adjustment shall also apply to authorized toothpastes which, according to the annexes of this Royal Decree, are classified as cosmetic products.

Third.

Products not covered by the scope of this Royal Decree and that its properties, composition or form of application, however, were considered cosmetics based on the Decree 3339/1968, shall be subject to the special declaration set out in the attached regulations 7th article, as long as there is no specific legislation governing them.

The General Directorate for Pharmacy and medical devices shall resolve any doubts that may arise in the application of this transitional provision.

REPEALING provision one.

From the entry into force of this Royal Decree are repealed the precepts and provisions that are cited: paragraphs 5.38.02 to 5.38.14 of the Decree 2484 / 1967, of 21 September.

3339/1968 Decree, on December 26, in which opposes the present Royal Decree.

The resolution of 1 February 1972 (DGS).

The resolution of October 18, 1983 (DGFM).

Two.

They are also repealed many provisions of equal or lower rank to oppose provisions of this Royal Decree.

FINAL provisions first.

The Ministry of health and Consumer Affairs shall adopt a basic protocol on good manufacturing of cosmetic products, as well as many provisions necessary for the implementation and development of the present Royal Decree and for the updating of the annexes thereto, when established it the rules of the European economic community.

The second.

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

Given in Madrid on April 15, 1988.

JUAN CARLOS R.

The Minister of health and consumption, JULIAN GARCIA VARGAS regulations sanitary about products cosmetics article 1 the present regulation aims to define legal effects to cosmetic products, as well as to determine the sanitary conditions that should qualify, its sanitary control, which met facilities where produced and stored, inspection, violations and, in general , the legal regulation of these products.

TITLE first definitions and exclusions article 2 for the purposes of these regulations, is understood by.

1 cosmetic product: any substance or prepared to be put in contact with the different parts of the surface of the human body (epidermis, hair and hairy system, lips, nails, genitalia with the teeth and the mucous membranes of the oral cavity or external,), with the sole intended purpose or primary purpose of cleaning them, perfuming them or protecting them, to keep them in good condition, change their appearance and correcting body odours.

They are considered cosmetics preparations listed in annex I to this regulation.

They are decorative cosmetic products which, by virtue of owning colored substances and for its covering, are applied to different parts of the body, in order to temporarily enhance your beauty or mask or conceal various skin anaesthetic.

2. communication: Action that is put in knowledge of the General Directorate for Pharmacy and medical devices, on DGFPS, in the terms provided for in this Royal Decree, the information required in these regulations.

3. placing on the market: Act supply or third parties having a cosmetic product, whether or not for commercial transactions.

4. responsible for the placing on the market: person physical or entity jurdicia which, boasting the status of manufacturer, importer or owner of a products cosmetic, presents, on its own behalf or through third party legal representation, administrative communication or the special declaration, if necessary, for the purposes of its placing on the market.

5 tags, packaging and leaflets: for the purposes of these regulations, it is considered: to) label: text printed, attached to the container or packaging or by hanging them, containing information and mandatory product data.

(b) packaging: any element or container that contains the cosmetic product, and is in direct contact with him.

(c) packaging or outer packaging. Box, case, or any other system that contains the container, and protects it.

(d) leaflet: printed text, optionally included within the outer packaging, containing information and instructions for use of the cosmetic product.

Article 3 are excluded from these regulations those preparations intended for the prevention, diagnosis and cure of diseases, as well as those intended to be ingested, inhaled, injected or implanted in the human body.

Title II sanitary conditions of cosmetic products article 4th


1 cosmetic products placed on the market available to consumers will not involve risk to the health or safety as they are used in the conditions laid down for its use.

2. risks which foreseeably may arise from the normal use of cosmetic products, taking account of its nature and of persons to which van intended, should be placed on prior knowledge of consumers through manual and instructions for correct use and appropriate warnings.

Article 5 without prejudice to provisions of article 4th, prohibited putting on the market of cosmetic products containing: 1. substances covered by Annex II to this Reglamentación.

2. the substances included in annex III (part I) and annex IV (part one), in higher concentrations and conditions different from those laid down in those annexes.

3. not included in the annexes IIl dyes and IV.

4. dye falling in annexes III and IV in higher concentrations and conditions other than the stipulated therein.

5 UV filters not included in annex V.

6. UV filters in higher concentrations and conditions different from those laid down in annex V.

7 preservatives not included in annex VI.

8 preservatives in higher concentrations and conditions different from those laid down in annex VI.

9. any other substance or prepared expressly prohibited by the Ministry of health and consumption, 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 must be communicated no later than the day that is made effective. To do this, the person responsible for the placing on the market must submit forms established, completed at the official Spanish language of the State. They shall bear at least the following information: a) the name or business name and address or registered office of the manufacturer and the person responsible for the placing on the market of the cosmetic product.

(b) complete identification and qualification of the responsible technician referred to in article 16.

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

(d) name of the cosmetic product and the category to which it belongs, in accordance with those referred to in annex I or with the classification which in your case is established.

(e) qualitative composition of its components active, in descending order of their concentrations, expressed with the international common denomination (DCI), where it exists, or, in their absence, in accordance with the international nomenclature rules that allow your identification.

In the case of solid soaps, perfume, Cologne and toilet water, qualitative formula will refer only to the vehicle, preservatives and colorants employees.

(f) quantitative composition of the components referred to in the preceding paragraph which will be presented in a single sealed envelope to ensure its confidentiality.

(g) labels, packaging and leaflets or, failing that, a sketch of them which will include texts contained in the product put on the market.

(h) net contents at the time of packaging, in accordance with the maximum levels and the designated volumes, where appropriate, by the legislation in force.

(i) certificate of having carried out the necessary tests to verify the safety of the cosmetic product.

((j) certificate of having carried out the necessary checks to verify the quality of the cosmetic product, k) in the case of cosmetic products not marketed in the European economic community will include, in addition, marketing authorization or the free sale certificate issued by the competent authority of the country of origin, being able to obtain any additional information from the authority.

2 the documentation referred to in the previous number shall be submitted to the competent health administration at copy duplicate, except as provided for in paragraph 1, f). This Administration immediately sent one of these copies together with the aforementioned sealed envelope to the DGFPS.

3. the technical documentation on the basis which presents the certificate of safety may be experimental or literature.

The previous 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 manufacturer or person responsible for the placing on the market for verification by the administration.

4. the communication concerning cosmetic products imported from third countries and cosmetic products placed on the market from another Member country of the European economic community, with the exceptions that are provided for in this regulation, shall be made upon presentation of the documentation directly on the DGFPS.

Chapter II statements special article 7th 1. The DGFPS may authorise exceptional employment in conservative cosmetic colorants, agents products or UV filters that are not included in the annexes to this regulation.

In such cases, shall provide a special declaration that meets the terms indicating the article except sections i) and j), whose requirements shall be replaced by the following: 1 justification of its safety with the necessary toxicological tests, scientific-technical and analytical in accordance with nature and the intended use of that product, through presentation of a memory.

2nd fulfillment of a monitoring programme that certifies safety in its use by the Entidd that declares them, in accordance with the requirements established by the DGFPS.

3rd having a concrete indication that will be presented in the Special Declaration and identified according to set the DGFPS to differentiate them from the rest of the products.

2. in the period of sixty days the DGFPS shall pronounce on the special declaration filed. If this does not allow an adequate sanitary evaluation of the product, will be required to the declarant data or tests; in this case will begin to have a further period of sixty days from the receipt of data or trials required.

3. the special declaration shall take effect for a maximum period of three years from the date of the favorable ruling.

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

5. any special declaration which justifiably favorable ruling will be communicated to the Commission of the EEC within a period of sixty days.

Chapter III rules common article 8 the DGFPS ensure the confidentiality of the data that have such character through the provisions and instructions. The DGFPS itself or at the request of the corresponding health administration may proceed to the opening of the envelope referred to in paragraph f) item 6 for reasons of risk to the health or safety of persons, adopting measures that apply in your case.

Article 9th the criteria of microbiological and chemical quality of cosmetic products, as well as their analytical methods, shall be established by order of the Minister of health and consumption, taking into account Community legislation and hearing the seems of the Advisory Committee on Cosmetology.

Failing that, will be preferably used analytical methods used or recommended by the Institute of health "Carlos III" and other centers and institutes specialized, national, or international, of recognized solvency.

Article 10.

1. in the event of cessation of the manufacture or marketing of a cosmetic product, the entity must notify the DGFPS by means of the procedure laid down in article 6.2 or 6.4, as appropriate, keeping all the technical documentation relating to the product for a period of five years.

2. the provisions of the previous number will be done in the DGFPS for products of chapter II.

Article 11.

Without prejudice to the actions that apply to other health authorities; the DGFPS based on justified reasons may prohibit the placing on the market, order the withdrawal or impose special conditions of cosmetic control to any products which, even meeting the requirements laid down in this regulation, present a risk to the health and safety of persons in the normal or foreseeable conditions of use.

Any of these measures will be provisional and of them shall be informed immediately to the competent authorities of the Member States and the Commission of the EEC. In any case, if the decision that adopted is derived from the cancellation of a cosmetic product, this will be made by the instruction of the corresponding administrative proceedings with the interested audience.

Article 12.

1. any modification of the data included in the communication or statement shall communicate 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 your manager must manifest its intention to keep it in the same.

Article 13.

The DGFPS will keep updated a registration which shall contain written down all communications and special statements of cosmetic products.

Title IV labelling article 14.


1 the labelling of the packaging and the packaging of any product cosmetic job market must bear at least in the official Spanish language of the State, with easily legible, visible and indelible characters, the following information: a) name of the product. Internationally accepted or common nomenclatures may include.

((b) origin or source, in the case of cosmetic products imported from non-Community countries, c) nominal NET content at the time of packaging, expressed in units S.I., 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 containing, in case of multiple container.

(d) the date of minimum durability which, for the purposes of this regulation, the date up to which said product, stored under appropriate conditions, continues fulfilling its initial function and in special provisions of article 4th date of minimum durability shall be indicated by the mention «use preferably before the end of... "followed, either the date or an indication of the place of the labelling containing that date.

The date shall consist of the indication of the month and the year, clearly and in this order.

These terms will be supplemented if necessary with indication of the conditions that must be met to ensure the indicated duration.

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

(e) conditions of employment if the product requires it and especially which are specified in the annexes to this Regulation as the 'conditions of employment and to take precautions that should be mandatory on the labelling', which should not appear in tags.

If for justified reasons of space, arising from the small size of the product, this is not possible, the conditions of employment must be given on the outer packaging or on the leaflet, then appearing on the container defined in article 2.º5, b, a mention indicating that concerned employment conditions are detailed in the outer packaging or , where appropriate, in the package leaflet.

2 in addition, shall include the following entries, which may be expressed in their languages of origin when the product comes from EU countries: a) name or corporate name and address or seat of the manufacturer or responsible for the placing on the market established within the European economic community. Those responsible for the placing on the market of products coming from third countries, must be indicated in addition to the name or corporate name, their domicile or headquarters in the Spanish territory.

These mentions may be abbreviated provided its abbreviation identifies, in general terms, the company.

(b) batch number of manufacture or reference that will allow their identification.

When the small size of any cosmetic product does not permit their inclusion in the labelling of the packaging, this data should be mandatory in the outer packaging.

3 multiple packaging labels and presentations containing different cosmetic products of the same company, must meet the same requirements as individual containers.

Article 15.

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

2. the names of cosmetic products may not give rise to confusion with drugs, pharmaceutical or food products.

3. the packaging and presentation of these products must be such that may not lend itself to confusion with other consumer products, in order to avoid health risks.

4 Ei cosmetic product will indicate the qualitative and quantitative formula of substances whose presence is announced in the name of the product, or in advertising.

Title V technical responsible for article 16.

1. the manufacture, control, storage, as well as imports from non-Community countries of cosmetic products, will take place under the supervision and responsibility of a technician in profession related activity required for these processes, effects of guaranteeing the characteristics and composition of the product, as well as its safety.

2. the company shall notify the DGFPS, by means of the procedure laid down in article 6, 2, the appointment of the technician. Where this ceases, the company shall inform the appointment of a replacement within the period of one month.

Title VI installations article 17.

1. the companies manufacturers and those responsible for the placing on the market of cosmetic products must have facilities authorized by the corresponding license to operate in Spain. This requirement shall not be enforceable with respect to cosmetic products placed on the market from another Member country of the European economic community.

2 such facilities shall meet the following requirements: to) have a technician in accordance with the provisions of article 16.

b) having different, where appropriate, areas: manufacturing. With the facilities and resources necessary for the preparation and packaging of cosmetic products in adequate hygienic conditions.

Control. With the media, equipment, laboratory supplies, reagents and patterns necessary to ensure the quality of raw materials, intermediates and finished products, as well as the material of packaging and labelling.

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

(c) the realization of the analysis and testing of cosmetic products quality control may enter into with centers or control laboratories previously approved by a DGFPS.

Article 18.

1. the operating license shall be granted on presentation of the following documents: 1 duly completed and signed by the manufacturer or the person responsible of the implementation in the market and by the technician referred to in article 16.

2. descriptive report of the installation and the same plane in which will be clearly specified areas destined to the manufacture, control and storage.

3 kinds of cosmetic products which they intend to develop in accordance with the categories set out in annex I or in the classification which, if any, is established.

4th appointment of the technical responsible along with a copy of his academic title duly authenticated by the Centro universitario, notary or corresponding official school, 5 the importing entities will accompany the documentation attesting that the owner or company manufacturer is legally established in the country of origin.

(6 Las entities that have agreed the accomplishment of analysis and testing of quality control with centres or laboratories which referred to article 17.2, c), will be presented, also copy the corresponding contract.

2. in the light of the documentation submitted, after the corresponding inspection visit to the installation, will be granted, if you leave it running and corresponding identification code will be assigned.

Article 19.

In the event that the person responsible for the placing on the market make the manufacture of cosmetic products with one or more other entities, these facilities should also have license to operate.

Article 20.

1. the transfer, expansion or substantial modification of the facilities referred to in article 17 shall be regarded as new installation.

2. when an assignee of an authorized facility changes its legal status, name, or your company name it shall attach supporting documentation. The cessation of activities, attaching a list of cosmetic products which have reported or declared at that time will be also communicated.

Title VII inspection article 21.

The competent public administrations shall carry out periodic inspections to verify compliance with the provisions of this regulation.

Title VIII violations and sanctions article 22.

1. minor offences are: 1 simple irregularity in compliance with the technical regulations, as well as offences committed by simple negligence always alteration or health risk arising out little entity and without direct public health significance.

2nd that, due to the criteria referred to in this article, deserve the rating of mild, or not appropriate qualification as very serious or serious misdemeanors.

2. serious breaches are: 1 the lack of checks and precautions required in the activity of the cosmetic product installations.

2. non-compliance with specific requirements who ask us where the DGFPS, whenever they occur for the first time.

3rd resistance to supply data, provide information or provide collaboration health authorities or their agents.

4th developing cosmetic products in poor sanitary conditions that affect their safety, food safety and quality.

5 move, extend, or substantially modify facilities where they are manufactured, packaged or stored cosmetic products without the mandatory license to operate.

6 manufacture, package, store or import cosmetic products without the competition of the technician referred to in article 16.


7th make offers, promotions or advertising of cosmetic products which do not conform to the General rules governing these aspects and especially when they make mention of healing properties, false claims or that misleading.

8th which are concurrent with other minor offences, or have served to facilitate or cover up his Commission.

9th who, owing to the elements referred to in this article deserve serious qualification or not appropriate qualification as minor or serious misdemeanors.

10. the recidivism in the Committee on minor offences in the past three months.

3 are very serious infringements: 1 which occur in a conscious and deliberate way whenever they cause serious damage.

2nd breach reiterated IOS specific requirements that the sanitary authorities.

3rd the negative absolute to provide information or provide collaboration for health inspection services, thus coma resistance, coercion, threats, retaliation, contempt or any other form of pressure on health authorities or their agents.

4th the refusal to supply when required the technical documentation referred to in article 10.

5 sell or keep on the market cosmetic products which have been subject to withdrawal order interim or final.

6 the placing on the market of cosmetic products which are contrary to the provisions of the article 5 7th the placing on the market of cosmetic products without having made communications or obtained the authorization referred to in articles 6 and 7th, 12.

((8th distortions of data communicated or declared as well as the lack of any document, on the basis to which paragraphs certifications have been issued i) and j) item 6 9th manufacture or store cosmetic products in facilities that do not meet the mandatory license to operate.

10 modify the composition of the cosmetic product, or any data that article 14 requires the labelling without prior communication.

11. the infringements which are concurrent with other serious health violations or have served to facilitate or cover up his Commission.

12 which, because of the elements referred to in this article and its degree of concurrence, deserve the rating of very serious or not appropriate qualification as minor or serious misdemeanors.

13. the recidivism in the Commission of serious offences in the past five years.

Article 23.

Violations of the provisions of this Royal Decree shall be administrative sanctions that correspond, prior examination of the appropriate case, without prejudice to responsibilities civil, criminal or other who could attend.

If damage production are several people, they will respond jointly and severally to the handicapped.

Article 24.

1 violations typified in article 22 of this Regulation shall be punished with a fine according to the following ranking: to) minor offences, up to 500,000 pesetas.

(b) serious offences, from 500.001 to 2,500,000 pesetas, can exceed this amount up to five times the value of the products subject to infringement.

(c) very serious offences, from 2.500.001 to 100,000,000 pesetas, can exceed this amount up to five times the value of the products subject to the infringement.

2. inside of the limits in the previous administrative sanctioning body graduate fines according to the criteria of risk to health, amount of benefit earned, degree of intentionality and seriousness of social or health alteration produced.

3. the disciplinary procedure shall comply with provisions of articles 133 to 137, both inclusive, of the law on administrative procedure. The competent administration is established in law 26/1984 of July 19, and 14/1986 of 25 April, and, where appropriate, in the Royal Decree 1945 / 1983, of June 22.

In any case, when they are detected breaches of health, organ instructor will immediate notice thereof to the competent health authorities, without prejudice to the adoption of appropriate precautionary measures.

Article 25.

1. in cases of very serious offences, may agree, by the Council of Ministers or by the corresponding body of the autonomous communities which they have competence to do so, the temporary closure of the establishment or installation for a maximum period of five years. In such a case, shall apply as provided for in article 57.4 of the law 8/1980 of 10 March, which approves eI status of workers.

2. the authority with corresponding address record may agree, as an accessory sanction the confiscation product.

3 in the event that there is, or is reasonably suspected the existence of a risk of imminent and extraordinary par health, the health authority may adopt the preventive measures referred to in article 26 of the law 14/1986 of 25 April, with the intended scope in that article.

Annex I indicative list by category of cosmetic creams, emulsions, lotions, gels and oils for the skin.

Masks of beauty (with the exception of products surface abrasion of the skin through a chemical).

Makeup (liquids, pastes, powders).

Powder makeup, powders for use after bath and body hygiene.

Toilet SOAP, deodorant SOAP.

Perfumes, Eau de toilette, Cologne water...

Products for bath and shower (salts, foams, oils, gels).

Depilatories.

Antiperspirant deodorants.

Hair products.

Dyes and bleaches.

Products for moulding, relaxer and fix.

Products that help to keep the hairstyle.

(Lotions, powders, shampoos) cleaning products.

Conditioning products (lotions, lacquers, glitter).

Other styling products.

Products (soaps, foams, lotions) shaving.

Products for make-up and make-up from the face and eyes.

Products for the lips.

Oral and dental care products.

Products for care and nail make-up.

Products for external intimate care.

Solar products.

Products for tanning without sun.

Skin whitening products.

Anti-wrinkle products.

Annex II list of substances banned in the composition of cosmetic products 1. 2-acetilamino-5-clorobenzoxazol.

2 acetylcholine and its salts.

3. deanol Aceglumato (a).

4 spironolactone (a).

5 acid [4-(4-hidroxi-3-yodofenoxi)-3,5-diyodefenil] acetic, [(ácido 3,3',5-triyodotiroacético) and its salts].

6 methotrexate (a).

7 Aminocaproic acid (a) and its salts.

8. Cincofeno (a), its salts, derivatives and salts of derivatives.

9. acid tiropropico (a) and its salts.

10 trichloroacetic acid.

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

12. aconitine (principal alkaloid of «Aconitum napellus L») and its salts.

13 «adonis versalis l.» and its preparations.

14 epinephrine (a).

15 «Rauwolfia serpentina» alkaloids and their salts.

16 acetylenic alcohols, their esters, oxi-ethers and its salts.

17 Isoprenaline (a).

18. allyl lsotiocianato.

19 Aloclamida (a) and its salts.

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

21 amines sympathomimetic that Act on the central nervous system: any substance contained in the first list of medicinal products the sale of which is subject to the prescription contained in resolution A. P. (69) 2 of the Council of Europe.

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

23 Betoxicaina (a) and its salts.

24 Zoxazolamine (a).

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

26 Diaminobifenilo (benzidine).

27. Tuaminoheptane (a) (aminoheptano), their isomers and their salts.

28 Octodrina (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 acid 4-aminosalicylic and its salts.

32 Aminotolueno, their isomers, salts, halogenated and sulphonated.

33 Aminoxilenos, their isomers, salts, halogenated and sulphonated.

34. 9-(3 - methyl - 2-buteniloxi)-7-H-furo[3,2-g][1]-benzopirano-7-ona (amidine).

35 ' Ammi majus L» and its preparations.

36. 2, 3-Dichloro-2-methylbutane (clone amileno).

37 androgens and androgenic action substances.

38. anthracene oil.

39. antibiotics, with the exception of those included in annex IV.

40 antimony and its compounds.

41 ' Apocynum cannabinum «L» and their preparations. "

42. 5,6,6a,7-tetrahidro-6-metil-4h-dibenzo [de, g] - 10, 11-diolquinolina (apomorphine) and its salts.

43. arsenic and its compounds.

44 «atropa Belladonna L.» and its preparations.

45. atropine, its salts and derivatives.

46. with the exception of barium salts: sulphate and sulphide under the conditions laid down in annex III (part one).

Lacquers, pigments or salts prepared from dyes listed with the reference (3) in the list of annex III (second part) and the reference (1) in annex IV (part II).

47. benzene.

48. Bencimidazolona.

49 Benzoacepina benzodiazepine, its salts and derivatives.

50 (2-methyl-2-butanol) benzoate Dimethylamine and its salts (aminolocaina).

51 Trimetilbenzoiloxipiperidina (benzamina) and its salts.

52 isocarboxazid (a).

53. Bendroflumethiazide (a) and derivatives.

54. beryllium and its compounds (glucinium).

55. bromine.

56. bretylium Tosylate (a).

57 Carbromal (a).

58 Bromisoval (a).

59. Brompheniramine (a) and its salts.

60 benzilonio bromide (a).

61 tetrilamonio bromide (a).

62 brucine.

63. tetracaine (a) and its salts.

64 Mofebutazona (a).

65 tolbutamide (a).

66 Carbutamide (a).

67 Phenylbutazone (a).

68. cadmium and its compounds.

69 «Cantharis vesicatoria".

70 Cantharidin.

71 Fenprobamato (a).


72. Nitrated derivatives of the carbazole.

73. carbon disulphide.

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 hydrochloride or citrate of 2, 4-diaminoazobenceno (chrysoidine, hydrochloride and/or citrate).

82 Chlorzoxazone (a).

83 2-cloro-4-dimetilamino-6-metilpidimidina (crimidina).

84 Clorprotixeno (a) and its salts.

85 Clofenamida (a).

86 n-oxide of bis-(2-chloroethylphosphonic) methylamine and its salts (n-mustine oxide).

87 mechlorethamine (a) and its salts.

88. cyclophosphamide (a) and its salts.

89 Manomustina (a) and its salts.

90 Butanilicaina (a) and its salts.

91 Chlormezanone (a).

92 Triparanol (a).

93 2-(2-p-clorofenil-2-fenilacetil) indan-1, 3-Dione (chlorophacinone).

94 Clorfenoxamina (a).

95 Fenaglicodol (a).

96. Clroetano.

97 salts of chromium, chromic acid salts.

98 «Claviceps purpurea tul», its alkaloids and preparations.

99 "Conium maculatum L» (fruit, powder and preparations).

100 Gliciclamida (a).

101. cobalt Benzenesulphonate.

102. colchicine, its salts and derivatives.

103 Colchicosido and their derivatives, 104. Colchicum Autumnale L and its preparations.

105. Convalatoxina.

106. Anamirta Cocculus L (fruits).

107. Croton Tiglium L (oil).

108 N-(Crotonilamino-4-Bencenosulfonil)-N'-Butilurea 109. Curare and curaminas.

110 Curarizantes of synthesis.

111 hydrocyanic acid and its salts.

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

113 Ciclomenol (a) and its salts.

114. sodium Hexaciclonato (a).

115 Hexapropimato (a).

116 Dextropropoxyphene (a).

117. 0, 0' - diacetyl-N-allyl-desmetilmorfina.

118 Pipazetato (a) and its salts.

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

120 1 salts, 5-bis-(trimethylammonium) pentane (between these pentametonio bromide (a).)

121 azametonio bromide (a).

122 Ciclarbamato (a).

123 Clofenotane.

124 sales 1, 6-bis (trimethylammonium) hexane (among these haxametonio bromide).

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

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

127 Lisérgido (a) and its salts.

128 - 3-Hydroxy-4-dietilaminoetilo phenyl benzoate and its salts.

129 Cincocaino (a) and its salts.

130 3-diethylamino propyl Cinnamate.

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

132 salts of N, N' - bis-(2-dietilaminoetil) oxamida bis-2 - clorobencilo (between these ambenonium chloride) (a).

133 Metipirilona (a) and its salts.

134 Digitalis and all the heteroxidos of the digital.

(135 7-(2,6-dihidroxi-4-metil-4-aza-hexil) theophylline (niacinate).

136 Dioxetedrina (a) and its salts.

137 Piprocurano (a).

138 Propyphenazone (a).

139. Tetrabenazine (a) and its salts.

140 Captodiano (a).

141 Mefeclorazina (a) and its salts.

142. Dimethylamine.

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

144. Methapyrilene and its salts.

143 Metamfepramona (a) and its salts.

146. amitriptyline (a) and its salts.

147. metformin (a) and its salts.

148. Isosorbide dinitrate (a).

149. dinitrilo malonate.

150 dinitrilo succinate.

151 isomers dinitrofenolicos.

152 Improcuona (a).

153 Dimevamida (a) and its salts.

154 Difenilpiralina (a) and its salts.

155 Sulfinpyrazone (a).

156. N-(4-amino-4-oxo-3,3-difenilbutilo)-N,N-diisopropil-N-metilamonio salts (among these isopropamida iodide) (a).

157 Benacticina (a).

158 Benztropine (a) and its salts.

159. cyclizine (a) and its salts.

160. 5, 5-diphenyl-4-tetrahidroglioxalinona.

161 Probenecid (a).

162 disulfide bis (N, N-dietiltiocarbamilo) (disulfiram) (a).

163. Emetine, its salts and derivatives.

164. ephedrine and its salts.

165 Oxanamida (a) and derivatives.

166. Eserine or Physostigmine and its salts.

167 esters of P-aminobenzoic acid (with the free amino group). Except those that appear collected in annex V (2nd part).

168 esters of Hill and the metilcolina and its salts.

169 Caramifenio (a).

170 Ester dietilfosforico of P-nitrophenol.

171 Metetoheptazina (a) and its salts.

172 Oxofeneridina (a) and its salts.

173 Etoheptazina (a) and its salts.

174 Metoheptazina (a) and its salts.

175 methylphenidate (a) and its salts.

176 Doxilminio (a) and its salts.

177. Tolboxano.

178. 4-Benziloxifenol. 4-Methoxyphenol. 4-Etoxifenol.

179 Paretoxicaina (a) and its salts.

180 Fenozolona (a).

181. Glutethimide (a) and its salts.

182 (epoxietano) ethylene oxide.

183 Bemegrida (a) and its salts.

184 Valnoctamida (a).

185 Haloperidol (a).

186 Paramethasone (a).

187 Fluanisona (a).

188 Trifluperidol (a).

189 Fluoresona (a).

190 fluorouracil (a).

191 acid hydrofluoric, its salts, complexes and hidroxifluoruros exceptions listed in annex III (1st part).

192. furfuriltrimetilamonio salts (among these furtretonio iodide (a).)

193 Galantamine (a).

194 gestagens (action progestational substances).

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

196 1,2,3,4,10,10 hexacloro-6, 7-epoxi - 1, 4, 4a, 5, 6, 7, 8, 8a-octahydro-1, 4, 5, 8-endo-endodimetilennaftaleno (endrin).

197 hexachloroethane.

198 1,2,3,4,10,10 hexacloro-1, 4, 4a, 5, 8, 8a hexahydro-I, 4, 5, 8-endo-endodimetilennaftaleno (isodrina).

199. Hydrastine, hidrastinina and its salts.

200 Hydrazines 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-cumarinil) ethyl acetate and salts of the acid.

205 Methocarbamol (a).

206 Propatilnitrato (a).

(207. 1,1-bis-[(4-hidroxi-2-oxo-2H-lbenzopirano) 3-IL] 3-metiltiopropano.

208 Fenadiazol (a).

209 Nitroxolina (a) and its salts.

210. hyoscyamine, its salts and derivatives.

211. «Hyosciamus Níger L-» (leaves, seeds, powder and preparations).

212. pemoline (a) and its salts.

213 iodine.

214 sales of 1, 10-bis (trimethylammonium) Dean (among these the decamethonium brumuro).

215 «Ipecac Uragoga Ipecacuaha Baill» and similar species (roots and preparations).

216 n-(2-isopropyl-4-pentenoil) urea (apronalida).

217. santonina.

218 ' lobelia Inflata L' and preparations.

219 Lobeline (a) and its salts.

220 acid barbiturate, its salts and derivatives.

221 mercury and its compounds except those included in annex VI (1st part).

222 mescaline and its salts.

223 poliacetaldehido (Metaldehyde).

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

225 Cumetarol (a).

226. dextromethorphan (a) and its salts.

227 2-metilamineheptano and its salts.

228 Mucate and its salts (a).

229 Mecamylamine (a).

230 Guaifenesin (a).

231 Dicoumarol (a).

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

233 Tiamazol (a).

234. (2-metil-2-metoxi-4-fenil)-3-4-dihidropirano coumarin (cycle-cumarol).

235 Carisoprodol (a).

236 meprobamate (a).

237 Tefazolina (a) and its salts.

238 Arecoline.

239. poidina Metilsulfato (a).

240 Hydroxyzine (a).

241 β-naphthol.

242 α and β naftilaminas and its salts.

243 α, 3 naphthyl-4-hydroxycoumarin.

244. Naphazoline (a) and its salts.

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

246. nicotine and its salts.

247. Amyl nitrites.

248. metallic nitrites with the exception of sodium nitrite.

249 nitrobenzene.

250 Nitrocresol and its alkaline salts.

251 nitrofurantoin (a).

252 Furanzolidona (a).

253. Nitrocliclerina.

254 Acenocoumarol (a).

255. alkali Nitroferricianuros (nitroprusiatos).

256 Nitrostilbenos, counterparts and derivatives.

257. noradrenaline and its salts.

258. Noscapine (a) and its salts.

259. Guanethidine (a) and its salts.

260 estrogens (estrogenic action substances).

261 Oleandrin.

262 Chlorthalidone (a).

263 Peletierina and its salts.

264 Pentachloroethane.

265 Pentaerythritol tetranitrate rosinate (a).

266 Petricloral (a).

267 Octamilamina (a) and its salts.

268 picric acid.

269 Phenacemide (a).

270 Difencloxazina (a).

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

272 Etilfenacemida (a).

273 Femprocoumona (a).

274. Feniramidol.

275. triamterene (a) and its salts.

276. tetraethyl pyrophosphate.

277. tricresilo phosphate.

278 psilocybin (a).

279 phosphorus and metal phosphides, 280. Thalidomide (a) and its salts.

281 «Venenosum venenosum balf».

282. Picrotoxina.

283. pilocarpine and its salts.

284 2-bencilacetatato of α, piperidilo-L, (levofacetoperano) and its salts.

285 Pipradol (a) and its salts.

286 Azaciclonol (a) and its salts.

287 Bietamiverina (a).

288 Butopiprina (a) and its salts.

289. lead and its compounds with the exception of the acetate in the conditions laid down in annex IV (part one).

290 Coniine.

291 ' Prunus lauro-cerasus L» (laurel cherry distilled water).

292 Metyrapone (a).

293 substances radioactive (l).

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

295 scopolamine, its salts and derivatives.

296. Gold salts.

297. selenium and its compounds with the exception of disulfide selenium, in the conditions laid down in annex III (first part, number 49).

298 «Solarium nigrum L» and its preparations.

299. sparteine and its salts.

300 glucocorticoids.

301 "datura stramonium L» and its preparations.

302 Strophanthins, estrofantidinas and derivatives.

303 «Strophanthus"(species) and its preparations.

304. strychnine and its salts.

305 «Strychnos» (species) and preparations.

306. narcotics: Those substances listed in tables I and II of the Convention on narcotic drugs, held on March 30, 1961, in New York.

307. sulphonamides (paraaminobencenosulfonamida and its derivatives obtained by substitution of one or more hydrogen atoms bound to the nitrogen Atom) and its salts.

308. Sultiamo.

309. neodymium and its salts.

310 ThioTEPA (a).

311 «Pilocarpus jaburandi holmes» and its preparations.

312. tellurium and its compounds.

313. Xylometazoline (a) and its salts.

314 tetrachloroethylene.

315. carbon tetrachloride.


316. hexaetilo TETRAPHOSPHATE.

317. thallium and its compounds.

318 «thevitia nerifolia juss» glycosides.

319 Ethionamide (a).

320. phenothiazine (a) and its compounds.

321 thiourea and derivatives, with the exception of those listed in annex III (part one).

322 Mefenesina (a) and its esters.

323. vaccines, toxins or serums listed in the annex to the second Council directive of 20 May 1975 and which concerns 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 Tribromoetanol (avertina).

327 Triclormetina (a) and its salts.

328 Tetramina (a).

329. Gallamine triethiodide of (a).

330 «Urginea scillia stern» and its preparations.

331 veratridine and its salts.

332 «Schoenocaulon officinale lind». (Seeds and preparations).

333 «Veratrum spp.» and its preparations.

334 vinyl chloride (monomer).

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

336 xanthates alkaline and alkilxantatos.

337. yohimbine and its salts.

338. dimethyl sulfoxide (a).

339. diphenhydramine and its salts.

340 p-butyl tert-phenol.

341 p-butyl tert-pirocatequina.

342 Dihydrotachysterol (a).

343 dioxane (1,4-diethylene dioxide).

344. Morpholine and its salts.

345 «Pyrethrum album L ' and its preparations.

346 pirianisamina maleate.

347 Tripelennamine (a).

348 Tetraclorosalicilanilidas.

349. Diclorosalicilanilidas.

350 Tetrabromosalicilanilidas except impurities of the tribromosalicilanilida according to the criteria laid down in annex IV (part one).

351 Dibromosalicitanilidas except impurities of the tribromosalicilanilida according to the criteria laid down in annex IV (part one).

352 Bithionol (a).

353 monosulfuros tiouramicos.

354. tiouramicos Disulfides.

355. Dimethylformamide.

356 Benzylideneacetone.

357. benzoates of coniferilo except normal amounts contained in natural essences used.

358 Furocoumarins among these: Trioxisalen (a) and 8-metoxipsoraleno except normal amounts contained in natural essences used.

359 seeds oil of «Laura L nobilis».

360 safrole except for normal amounts contained in natural oils and provided that the concentration does not exceed: 100 PPM in the particular product.

50 PPM in products for dental care oral, provided that safrole is not displayed in toothpastes intended especially for children.

361. Yodotimol.

(362-3'-etil-5',6,7',8'-tetrahidro-5',6',8',8'-tetrametil-2'-acetonaftona(1,1,4,4-tetrametil-6-etil-7-acetil-1,2,3,4-tetrahidronaftaleno) (Acetiloetiltetramietiltetralina) (AETT).

363. 1, 2-diaminobenceno and its salts.

364. 2, 4-diaminotolueno and its salts.

365 acid aristolochic and its salts.

366 chloroform.

367. 2, 3,7,8-tetracolorodibenzo-P-dioxifla.

368 6-acetoxi-2,4-dimetil-1,3-dioxano (dimetoxano).

369. 2-n-oxide-tiopiridino, sodium salt. (Sodium Pyrithione).

370. N-triclorometitio-4-ciclobexano-1,2-dicarboximida. (Capture), 371. 2, 2' - dihydroxy-3, 3', 5, 5 ', 6, 6' - hexaclorodifenilmetano (bexaclorofeno).

372 6-(1-piperidinil)-2,4-pirimidinodiamina-3-oxido (minoxidil) and its salts and derivatives.

373 strontium and its compounds, with the exception of: sulphide under the conditions laid down in annex III (part one).

Chloride in the conditions laid down in annex IV (part one).

Lacquers, pigments or salts prepared from dyes listed with the reference (3) in the list of annex III (second part) and the reference (1) in annex IV (second part).

374 zirconium and its compounds [with the exception of complexes related to number 50 in annex III (first part), and lacquers, pigments or salts of zirconium dyes listed with the reference (3) of annex III (second part) and the reference (1) in annex IV (part II)].

375 lidocaine.

376 Tyrothricin.

The presence of traces of substances included in this annex, will be tolerated when these are technically unavoidable consequences of the implementation of good laboratory practices, provided the article 4th of this regulation are met.

(a) the name of its substances is recommended as «International Nonproprietary name» for pharmaceutical substances issued by the World Health Organization. Geneva, 1982.

(1) it admits the presence of natural radioactive substances from artificial environmental pollutions, provided that the radioactive substances are not enriched prior to use in the manufacture of cosmetic products, and provided that the concentration does not exceed the limits laid down in the directives which set the basic rules for the protection of the health of the population and of workers , against the dangers arising from ionising radiation. ("Official Journal of the European communities number 11, on February 20, 1959, pages 221/59).

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