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Guideline on Safety assessment of cosmetic products 1. Introduction
The purpose of the guideline The purpose of this guideline is to describe the expectations of the authorities regarding volume and extent of specification of easily accessible information on cosmetic products. At the same time recommendations are given for a practical procedure for collecting and preparing product information/dossier covering the individual products. Further, applicable literature is indicated. Thus the guideline should contribute to the effort of preparing uniform cosmetic dossiers at the individual producer. Jette Rud Larsen, Danish Toxicology Centre, has prepared the present guideline for The Danish Agency of Environmental Protection. The project has been followed by a steering group, which has contributed with good and constructive advice. The steering group consisted of: Anette Espersen, The Consumer Council, until the autumn of 1998 In the spring of 2000 Chapter 2.7 regarding proof of claimed effects was supplemented and a synopsis of the scientific basis is enclosed as Annex 3 to these guidelines. At this time Annette Orloff, The Danish Agency of Environmental Protection became co-ordinator of the guideline. 1.1 BackgroundBackground Based on the Chemical Substances and Products Act The Danish Agency of Environmental Protection has issued a number of orders with the object of preventing health risks and environmental hazards in connection with production, storage, use and removal of chemical substances and products. One of these statutory orders is the Order of Cosmetic Products (1), which comprises the marketing of cosmetic products. The order has been prepared on the basis of the regulations of the EEC Cosmetics Directive from 1976 incorporating amendments and approximations (2). This guideline describes the requirements of § 32 in the Order of Cosmetic Products, which is based on the requirements of Article 7a in The Cosmetics Directive. This means that corresponding requirements are laid down in the other Member States. 1.2 LegislationLegislation In § 9 of the Order of Cosmetic Products it is stipulated that cosmetic products, which are put on the market within the Community must not cause damage to human health when used under normal conditions. In substantiation of the safety of the products specific information according to §32 of the Order about all cosmetic products, which are placed on the Community market, must be available. According to the Order of Cosmetic Products the following applies: § 32. The manufacturer or his agent or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product on the Community market shall for control purposes keep the following information readily accessible to the competent authorities of the Member State concerned at the address specified on the label in accordance with § 17. The required information is mentioned in technical Notes for Guidance from the Scientific Committee for Cosmetic Products and Non-Food Products (SCCNFP) (3). A further description can be found in Chapter 2 of this guideline. Further, the person responsible for the marketing of a cosmetic product in Denmark must have appropriate professional qualifications or experience in accordance with Danish legislation and common practice. If the address stated on the product is Danish, The Danish Agency of Environmental Protection is the competent authority, which should make an application to the company in question, whether it concerns control in Denmark or in another Member State. A great amount of the cosmetic products marketed in Denmark carry an address of a company in another Member State. If the Danish Agency of Environmental Protection wants to examine such a product more closely, the Danish Agency of Environmental Protection must make an application to the competent authority in the country of the address stated, and ask the authority to assess the relevant information. Correspondingly, the authorities in other Member States must contact the Danish Agency of Environmental Protection, if they want an assessment of the information in a dossier in this country. Product information only has to be available in one Member State. Where more company addresses are stated on the label the address where the dossier is kept could be underlined. If the product is manufactured in other Member States, the manufacturer may choose one single address where the information is available. Further, it will be possible that the product information in practice will be available in the head quarters, technical departments, or administrative departments etc., even if these are separated from the actual place of manufacture. If the Danish Agency of Environmental Protection requests that the information is made available, the information must be obtainable at the address mentioned in § 17. Sub-contractor manufacture and information In case of sub-contractor manufacture the name and address of the sub-contractor will not appear from the package. On the contrary, the name and address (country) of the company which ordered the production and which is marketing the product will appear from the package. Thus, a Danish company whose address is stated on a cosmetic product must - whether the product is marketed in Denmark or in another Member State - make sure that any foreign sub-contractor is able to supply product information according to the directives of this guideline. 1.3 Elaboration and submission of informationLanguage of information and confidentiality Product information/dossier must be prepared in a language, which is easily understood by the Danish authorities. The Danish Agency of Environmental Protection will accept to receive information in Danish or in English. Consequently, it is important to secure those foreign contractors or sub-contractors are able to submit information in these languages. As a starting point the Danish Agency of Environmental Protection will demand that the requested information is sent to the Danish Agency of Environmental Protection. It should, however, be emphasised that the Danish Agency of Environmental Protection, will typically not demand an entire dossier on a cosmetic product. It will rather be a matter of specific questions regarding selected parts of the dossier. The information can be delivered either on paper or electronically, and must be available to the Danish Agency of Environmental Protection within 48 hours. Consequently, it will be the exception to the rule if the Danish Agency of Environmental Protection will pay a visit the company in order to go over the dossier to choose the sections of which they want a copy. The Danish Agency of Environmental Protection will treat the information confidentially. Annex 1 to this guideline contains a proposal for a checklist for obtaining information on cosmetics. Further, Annex 2 contains a list of literature with proposals for works of reference suitable for collecting information for the preparation of the general toxicological profile of the ingredients. Annex 3 is a synopsis of the scientific basis for efficacy testing of cosmetic products. |