EU Cosmetic Directive

Key words Teratogenicity testing. Cosmetics, Cosmetic ingredients, EU Cosmetic Directive... 

This is currently a hot topic in the EU, evident by the recent ban on the testing of cosmetic products on animals under the EU Cosmetics Directive [105]. In vitro cell cultures usually originate from a live animal so, ultimately, some animal sacrifice is necessary. Some synthetic systems do exist, such as serru-permeable membranes to model tissue passive transport. 

Kaluzhny Y, Kandarova H, Hayden P, Kubilus J, D Argembeau-Thornton L, Klausner M (2011) Development of the EpiOcular(TM) eye irritation test for hazard identification and labelling of eye irritating chemicals in response to the requirements of the EU cosmetics directive and REACH legislation. Altern Lab Anim 39 339-364... 

The EU Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, known as the EU Cosmetics Directive, was adopted on... 

In recent years the EU Cosmetics Directive has become the model of modem cosmetic regnlations worldwide, representing a dynamic legislation that allows for continuous adaptation to technical progress, leading to relevant restrictions and/or warnings and to rapid inclusion of new regulated molecules (e.g. preservatives, colours, UV filters). 

Annex 1 of the EU Cosmetics Directive contains a non-exhaustive, illustrative list of the products to be considered as cosmetics within the meaning of the definition in Article 1, which are shown below... 

Safety of cosmetics and consumer protection are primarily addressed in Article 2 of the EU Cosmetics Directive, A cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account in particular, of the product s presentation, its labelling, any instructions for its use and disposal as well as any other indication or information provided by the manufacturer or his authorized agent or by any other person responsible for placing the product on the Community market. The provision of such warnings shall not, in any event, exempt any person from compliance with the other requirements laid down in this Directive . 

The manufacturer, the first importer into the EU or the responsible person for placing a product on the market has the primary responsibility to ensure compliance with the requirements of the EU Cosmetics Directive and, of course, the safety of cosmetics. The EU Cosmetics Directive does not require information on the safety of cosmetics to be submitted to Member State competent authorities before a product is placed on the market, however The manufacturer or his agent, or the person to whose order a cosmetic product is manufactured, or the person responsible for placing imported cosmetic products on the Community market, shall notify the competent authority of the Member State of the place of manufacture or of the initial importation of the address of the place of manufacture or of initial importation into the Community of the cosmetic product before the latter are placed on the Community market (Article 7a.4). 

Ingredients are regulated according to the Annexes of the EU Cosmetics Directive with some discrepancies however, a local scientific body, the Camara T6cnica de Cosmdticos (CATEC—Technical Group on Cosmetics) may introduce different restrictions or bans. 

Basically, the KS A authorities consider Annex 1 to the EU Cosmetics Directive an illustrative list of cosmetics. Conversely to the EU law, perfumery products based on ethanol are classified according to the essential oil content as follows ... 

Banned, restricted and regulated ingredient lists are based on the relevant annexes to the EU Cosmetics Directive. In compliance with Islamic law, cosmetics shall contain no pork, pork fat or pork derivatives, ethanol must be denatured and should not exceed 90%, containers containing ethanol should not exceed 250 ml and a non-ronovable pump is mandatory. 

The definition of a cosmetic is referable to that outlined in the EU Cosmetics Directive, but they are divided into two categories common cosmetics (skin care, make-up, hair care, fragrances) and special-function cosmetics (e.g. anti-perspirants, hair dyes, sunscreens). 

Making reference to the EU Cosmetics Directive, various positive and negative lists control the use of cosmetic ingredients. 

A new draft cosmetic regulations is currently under discussion at the Rnssian Parliament, the Duma. These technical regulations will greatly harmonize with the EU Cosmetics Directive and will introduce, among other issues, post-marketing control by government and a reduced registration system. 

The definition of a cosmetic product is close to the EU Cosmetics Directive one, with the following appendix Cosmetics have a local action on healthy skin and appendages, on mucous membranes, on the external genital organs, or on the teeth. Ingredients contained in cosmetics if absorbed must not exert an internal action . The illustrative list of cosmetics in the Swiss ordinance is referable to the Annex 1 of the EU Cosmetics Directive (Ddpartement f6d6ral de Tintdrieur, 2005). 

Ingredients are basically allowed, restricted or banned according to the annexes of the EU Cosmetics Directive but some discrepancies are in force (i.e. restrictions for alpha-hydroxy acids or AHAs, essential oils, arbutin, etc.) (Ddpartement fdddral de fintdrieur, 2004). To date Switzerland is the only country in Western Europe imposing a tax on the volatile organic compounds (VOCs) content of cosmetics. 

Labelling is also in line with the provisions of the EU Cosmetics Directive and must be in at least one the official languages, except warnings that must be in all official languages. 

Article 5a of the EU Cosmetics Directive (Council Directive 76/768/CEE), established a deadline on 14 December 1994 for the Commission to compile an inventory of ingredients employed in cosmetic products, which should be updated periodically. It must contain information on the identity of each ingredient, its function in the cosmetic product, and any restriction and condition of use and/or warning which must be printed on the label. In addition, the same article, defines cosmetic ingredient as any chemical substance or preparation of synthetic or natural origin, except for perfume and aromatic compositions, used in the composition of cosmetic products . Nevertheless, according to Article 6.1, the impurities in the raw materials used are not considered as ingredients, nor are the subsidiary technical materials used in the preparation but not present in the final product or the materials used in strictly necessary quantities as solvents or as carriers for perfume and aromatic compositions. 

The lists that reflect regulatory aspects in the EU framework are, as already mentioned in Section 1.1, the different annexes of the EU Cosmetics Directive, where Annex II is a negative list of over 1200 substances (or families of substances) that are banned for use in the composition of cosmetic products. Annex III gives over 150 ingredients which cosmetic products may only contain subject to the restrictions and conditions established therein. Finally, Annexes IV, VI and VII are positive lists of over 150 colouring agents. 

Nevertheless, according to Article 8a of the EU Cosmetics Directive, ( ) a Member State may authorize the use within its territory of other substances not contained in the lists of substances allowed, for certain cosmetic products specified in its national authorization (...) . In this case, the authorization must not exceed a maximum period of three years, and the Monber State must carry out an official check on cosmetic products containing the substance or preparation, which it has authorized. Moreover, cosmetic products containing the new authorized substance or preparation must bear a distinctive indication, which will be defined in the authorization. 

In the event of perfume and aromatic compositions and their raw materials, they have to be referred to by the word perfume or aroma. However, the presence of aromatic substances, for which there is a special mention according to Annex III of the EU Cosmetics Directive, must be declared in the labelling list irrespective of their function in the product. This is the case of the 26 potentially allergenic fragrance compounds, which according to the above mentioned annex must be indicated when their content in the finished product is higher than 0.001% in leave-on products and 0.01% in rinse-off products. 

Despite the concessions regarding trade secrecy, for control purposes and according to Article 7a of the EU Cosmetics Directive, the manufacturer, agent or person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product on the Community market, must have readily available, among other documents, the qualitative and quantitative composition of the product on request by the competent authorities of the Member States concerned at the address specified on the product label. 

These substances must not be found in the finished product, except as traces. Indeed, according to the Article 4.2 of the EU Cosmetics Directive, the presence of... 

These substances may not be used in cosmetic products, except subject to the restrictions and conditions laid down by the different legislations (e.g. EU Cosmetics Directive Annex III). The restrictions may concern maximum concentrations, pH limits in the finished product, warning labels or purity criteria, depending on the product in which they are formulated. Eor example, see Table 2.1.1 for the restrictions specific to thioglycohc acid and its salts in the EU Cosmetics Directive Annex HI. 

A specific case concerns the 26 potentially allergenic fragrance ingredients hsted in EU Cosmetics Directive Annex III these substances must be shown on the ingredient list on the label if their content in the final product exceeds 0.001% in leave-on cosmetics and 0.01% in rinse-off cosmetics. 

However, the positive lists may also concern functions which are considered to correspond to a cosmetic in the EU, but whose ingredients are considered as active ingredients of over-the-counter (OTC) drugs in the US, quasi-drugs in Japan, functional cosmetics in Korea or medicated products in Taiwan (see Section 1.1). Only substances included on a specific positive list are allowed for the function concerned in the country issuing the list. However, a substance that is not included in a specific positive list (e.g. a preservative not listed in EU Cosmetics Directive Annex VI) may nevertheless be used in a cosmetic insofar as it is used for a function other than that taken into account in the positive list concerned (preservation in this example). 

Restrictions on thioglycolic acid and its salts according to EU Cosmetics Directive Annex III... 

For its part, COLIPA, in collaboration with the Institute for Reference Materials and Measurements (IRMM), the Rome Istituto Superiore di Sanith (ISS), the Tuscany Regional Health Authorities (ARPAT) and the University of Siena (Italy), has published a compilation of analytical methods aimed specifically at cosmetic products (Anselmi et al., 2004). These methods are intended to identify and quantitatively determine the substances listed in the various annexes of the EU Cosmetics Directive. Although most of these methods are not official , they do, at least, exist. 

Asian countries in which cosmetic regulations concerning substances have been based on the EU Cosmetics Directive will be considered later on. These are countries such as China and India, and also the Association of South East Asia Nations (ASEAN) which integers other 10 Asian countries. 

Banned substances Annex 4 of Notification 93-57 + Notification 2003-23 List fairly similar to EU Cosmetics Directive Annex II... 

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