Cosmetic ingredients restriction

Phenylmercuric acetate is no longer permitted to be used as a pesticide in the USA. It is, however, included in the FDA Inactive Ingredients Guide (ophthalmic preparations), and is also included in nonparenteral medicines licensed in the UK. In France, a maximum concentration of 0.01% is permitted for use in pharmaceuticals. The use of phenylmercuric acetate in cosmetics is restricted in the UK see Phenylmercuric Nitrate. Included in the Canadian List of Acceptable Non-medicinal Ingredients (however, there must be no other suitable preservatives available). 

Cosmetic manufacturers may use essentially any raw material as a cosmetic ingredient insofar as it is not considered as only a drug active ingredient, and market the product without approval. The law regulates only colour additives specifically approved for cosmetics and a few prohibited and restricted ingredients (e.g. bithionol, mercury compounds, vinyl chloride, halogenated salicylanilides). Cosmetics should not be contaminated with nitrosamines, 1,4-dioxane and pesticide residues, whose potential presence is regularly checked by the FDA (see Section 2.1). 

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. 

In most cases, skin moisturizers are intended to keep the skin in a good condition, and are therefore considered as cosmetic/hygienic products and must comply with the legislation for these products. The manufacturer is in principle responsible for the safety of each product. However, in addition, the legislation in many countries may restrict the use of certain ingredients, and demand specific documentation of ingredients and the final product. 

Restrictions on the use of a given ingredient are identified. Restrictions are set out in the Directive itself or in the IFRA (International Fragrance Association) code of practice. These restrictions may take the form of a quantitative limitation (expressed as a percentage of the final product or as a concentration for application to the skin), or the ingredient may have to meet certain specifications or may only be used in conjunction with certain specified ingredients. These substances are marked with one asterisk for IFRA restrictions or with two asterisks for restrictions in the Cosmetic Products Directive. 

The EU Commission has implemented the above-mentioned SCCNFP opinions in the 7th Amendment of the Cosmetic Directive 76/768/EC (2003/15/EC) by adding the following restrictions [limitations and requiranents (for labeling)] to 26 fragrance substances in Annex III, Part 1 The presence of the substance must be indicated in the list of ingredients referred to in Article 6(l)(g) when its concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products. ... 

Currently, the presence of hydroxycitronellal and isoeugenol needs to be labeled in the final cosmetic product according to Annex III, Part 1 of the Cosmetic Directive (Entries 72 and 73, respectively). However, in the future, restrictions to these fragrance ingredients may be proposed, because the Commission is considering a maximum concentration of 1.0% of hydroxycitronellal and of 0.02% of cis- and trani -isoeugenol (or their sum) in finished cosmetic products (except oral care products). DG Enterprise has asked SCCP its opinion whether they consider these concentrations to be safe for... 

On the other hand, the European regulation also prohibits and restricts the amount used of more than 50 fragrance substances, like some extracts or synthetic musks, in cosmetic products. Other substances related to fragrances, such as phthalate esters, commonly known as phthalates, which have been used as solvents and vehicles for fragrance ingredients, are also restricted as a consequence of their undesirable side effects. 

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