Key Benefits:
The Prime Minister,
On the report of the Minister of Health and Social Welfare,
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the legislation of member States on cosmetic products, as last amended by the Directive 2003/15/EC of the European Parliament and the Council of 27 February 2003;
Considering the Public Health Code;
Considering the opinion of the National Consumer Council of 15 June 2004;
The State Council (Social Section) heard,
Decrete:
Section R. 5131-2 of the Public Health Code is amended as follows:
I. - At the 4th of this article:
1° In the first sentence, after the words: "the chemical structure and the level of exposure", the words are inserted: "and the specific characteristics of exposure of the bodily areas on which the product will be applied or the population to which it is intended".
2° After the last sentence, the following sentence is inserted: "; a specific assessment of cosmetic products intended for children under three years of age and cosmetic products intended exclusively for external intimate hygiene is carried out; "
II. - It is inserted after 8° a 9° as follows:
« 9° Data on animal experiments conducted by the manufacturer, its agents or suppliers concerning the development or evaluation of the safety of the product or its ingredients, including any animal experiments conducted to meet the legislative or regulatory requirements of non-EU countries. »
Section R. 5131-4 of the Public Health Code is amended as follows:
I. - At the 4th of this article:
1° After the words: "the date consists of the indication, in clear and in order, of the month and of the year," the words are inserted: "or of the day, of the month and of the year";
2° After the sentence: "; for cosmetic products whose minimum durability exceeds thirty months, the indication of the durability date is not obligatory;" the phrases are added: "However, with regard to these products, the mentions are supplemented by the indication of the duration of use allowed after opening without damage to the consumer; this information is indicated by the symbol set by decree of ministers responsible for health and consumption, followed by the duration of use (expressed in months and/or years); "
II. - In the first paragraph of the 8th article:
1° The phrase: "; perfumes and fragrant compositions are mentioned by the word "parfum or "arôme ;" is replaced by the phrase: "; perfumes and aromatic compositions and their raw materials are mentioned by the word "parfum or "arôma ; "
2° Between the words "fragrant or arôma ;" and the words " ; the ingredients in concentration less than 1%" is inserted the sentence: "However, the presence of substances required under the provisions relating to "other limitations and requirements set out in the order set out in 2° of section R. 5131-3 is indicated in the list, regardless of their function in the product; "
3° In the phrase: "provided to add the words: "may contain or mention "+/-", the word "mark" is replaced by the word " symbol".
III. - The second paragraph of the 8th article is as follows:
"The ingredients mentioned in the 8° shall be declared under their common name established by the competent bodies of the European Commission or, if not, their chemical name, their CTFA name, their denomination in the European Pharmacopoeia, their international common name of the World Health Organization (WHO), their numbers Einecs, IUPAC, CAS and colour index. »
Section R. 5131-5 of the Public Health Code is replaced by the following:
"Art. R. 5131-5. - I. - The manufacturer or the person responsible for placing on the community market the cosmetic product may not report, on the packaging of the product, or on any document, notice, label, tape or card accompanying this product or referring to it, the absence of experiments made on animals only if the manufacturer and its suppliers have not conducted or commissioned such experiments for the finished cosmetic product, or its prototype »
II. - For the purposes of this article, the following means:
(a) "cosmetic product finishes the cosmetic product in its final formulation as it is put on the market at the disposal of the final consumer or its prototype;
b) "prototype a first model or drawing that has not been produced in batches and from which the finished cosmetic product is copied or is the subject of a final development. »
The 3rd of section R. 5131-6 of the Public Health Code is amended as follows:
"After the words: "fragrant compositions, are added the words: "and aromatic. »
Manufacturers or their representatives, or persons on whose behalf cosmetic products are manufactured, or those responsible for placing on the market cosmetic products imported for the first time from a non-member State of the European Community or not a party to the agreement on the European Economic Area shall apply the provisions of the 4th of Article R. 5131-4 relating to the period of use authorized after opening and of the 8th of Article
The Minister of State, Minister of Economy, Finance and Industry, the Minister of Health and Social Welfare, the Minister Delegate for Industry and the Minister Delegate for Small and Medium Enterprises, Trade, Crafts, Professionals and Consumer Affairs are responsible, each with regard to the execution of this Order, which will be published in the Official Journal of the French Republic.
Done in Paris, November 17, 2004.
Jean-Pierre Raffarin
By the Prime Minister:
Minister of Health
and Social Welfare
Philippe Douste-Blazy
Minister of State, Minister of Economy,
finance and industry,
Nicolas Sarkozy
Minister Delegate to Industry,
Patrick Devedjian
Minister Delegate
small and medium-sized enterprises,
trade, crafts,
liberal professions
and consumption,
Christian Jacob
