Regulatory compliance for chemical, cosmetic and biocidal products.
COSMETICS
Cosmetic regulation and safety assessment
Services
Alchemy Compliance can advise on most aspects of marketing cosmetic products.
We can write the safety assessment for your cosmetic product. The process involves researching the ingredients for hazardous properties using databases, literature data, and structure–activity relationships, and determining safe levels, according to industry benchmarks or regulatory limits. We estimate exposures according to EU guidance, and provide margins of safety where appropriate. We can also advise on non-animal testing strategies to ensure the safety of the product.
As well as safety advisor, we can act as co-ordinator of the Technical Information File [TIF; sometime called the Product Information Package (PIP)]. This involves compiling information on all the safety aspects of the cosmetic product, including manufacturing processes, stability, microbiological data, physico-chemical data, test data, and the safety evaluation.
With a broad experience in chemical supply legislation (notification, classification, risk assessment, etc.), and regulatory chemistry and toxicology we are also able to produce dossiers to support inclusion of colouring agents, preservatives, and UV filters in Annexes IV, VI and VII of the Cosmetics directive. We can advise on testing strategies and laboratories to conduct studies, and liaise with authorities to expedite the application.
Alchemy Compliance can register finished cosmetic products with appropriate national authorities and poison information centres, particularly in the UK, France, Sweden, and Germany.
Finally, we can also provide labelling advice, including INCI names.
Further information
Cosmetic legislation and the product safety assessment
Cosmetic legislation in Europe is based on the Cosmetics Directive (CD; 76/768/EC, as amended). This has been transcribed in the UK into the Cosmetic Products (Safety) Regulations 1996. Its two key objectives are:
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Ensuring a high level of protection for consumers of cosmetic product
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Allows the free circulation of safe cosmetic products within the EU
Unlike other chemical products (new industrial chemicals, biocides, medicines, etc.), the CD achieves this aim without a pre-market procedure (authorisation, registration, or notification), although there are provisions (Article 7.4) for informing the authority of the place of manufacture, or importation, and some national requirements to file the composition with Poison Information Centres. Instead, a competent person, the safety assessor, must perform a safety assessment for each finished cosmetic product before it is placed on the EU market.
The safety assessment is part of a package of information, the TIF (or PIP), which the manufacturer or importer must keep up-to-date and available for inspection by the Authorities. The content of the TIF is as follows:
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Composition of the cosmetic product
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Physico-chemical and microbiological specifications of raw materials and finished product
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Method of manufacture
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Cosmetic safety assessment, and details of the safety assessor
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Existing data on the undesirable effects on human health (eg from customer complaints)
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Proof of the effect (only for certain products, such as sunscreens)
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Data on animal testing performed by the manufacturer, his agents, or suppliers relating to the development or safety evaluation of the product or its ingredients
Data on undesirable effects, the qualitative composition, and the amount of dangerous ingredients (according to 67/54/EEC) in the cosmetic product should available to the public on request.
The cosmetic safety assessment has to be carried out by a suitably qualified person, such as a chartered toxicologist, dermatologist, or chemist. The safety assessment uses available test reports, literature data, structure–activity relationships, and regulatory texts to determine safe levels of cosmetic ingredients in a new formulation. Human data such as patch test, and in vitro tests can provide additional re-assurance of safety, required by the CD. Combined with exposure values for particular types of cosmetic use, this risk assessment process can give margins of safety for individual components and an overall conclusion regarding the safety of the new cosmetic product.
In current cosmetic legislation, colouring agents (with the exception of hair dyes) (Annex IV), preservatives (Annex VI), and sunscreens (Annex VII) can only be used in cosmetic formulations if they are listed in the Annexes and used according to the conditions given therein. All other ingredients may be used, unless specifically banned or restricted according to Annexes II and III.
To get a new colouring agent, preservative, or UV filter listed on the Annexes, the applicant requires a dossier with substantial toxicology data. Guidance for the testing is given in a document published by the Scientific Committee on Consumer Products (SCCP). The applicant can submit the data to the SCCP via the cosmetics trade association, COLIPA. It is not clear how the safety of these substances will be assessed after the pending ban on the use of animals for the testing of cosmetic ingredients comes into force.
The 7th Amendment to the CD contains several provisions regarding the testing on animals of both cosmetic ingredients and finished products. Such testing has been very controversial, and the industry has long recognised the need to move to in vitro techniques, when such techniques have been validated to international standards. The validation process has been slow. Animal testing of finished cosmetic products (and marketing of products thus tested) has been prohibited from the date of implementation of the 7th Amendment (2003/15/EC) into national legislation (latest Sep 2004). Animal tests for ingredients will be phased out as alternative come on line, with target dates being set according to the current state of the art for various tests. For acute tests the target date is 2009, and for repeat-dose animal testing, for which there no obvious alternatives, the target year is 2013. Many commentators doubt that non-animal tests will be validated for regulated purposes in time, certainly for the more complicated repeat-dose endpoints.
Cosmetic ingredients that are supplied in the EU, and are not part of a finished cosmetic product, are subject to the same legislation as industrial chemicals. Therefore, cosmetic ingredients that are new chemicals (those not listed on EINECS) are subject to notification requirements (under 67/548/EC), even if their sole use is in cosmetic products. However, new chemicals that are marketed only in finished cosmetic products would not be subject to notification, presumably because that use has been assessed for risk in the cosmetic safety assessment.
Fragrance ingredients
Fragrances are regulated as industrial chemicals, but there is a separate code of practice (CoP) issued by the International Fragrance Association (IFRA). Interestingly, copyright laws usually apply only to visual or aural works, and fragrance formulations cannot generally be protected this way, so that the industry is often highly secretive about the composition of its products. This can cause problems in hazard communication and safety assessment of cosmetics, but interested parties may be able to obtain limited composition information by signing confidentiality ingredients. Otherwise the fragrance supplier should provide a certificate (IFRA certificate) indicating the maximum recommended concentration of the fragrance compound for the type of product under consideration.
For existing fragrances, the CoP advocates a safety evaluation of the substance before marketing occurs. The evaluation follows guidelines given in a published paper (Regulatory Toxicology and Pharmacology, 2000, 31, 166-181). The paper takes a holistic approach based on structure–activity relationships, literature data, tonnage data, and likely exposure to determine appropriate testing. In vitro alternatives should be considered where properly validated test exist.
The use of fragrance ingredient has come under the spotlight, owing to their ability to cause allergic reactions in sensitive individuals. This has led to an amendment of Annex III of the CD, so that cosmetic products containing any one of the 26 allergens (listed in Directive 2003/15/EC) should include the name of the allergen on the product ingredients list. Common fragrance ingredients subject to this provision are citral, eugenol, geraniol, linalool, citronellol, and d-limonene. This will help consumers to avoid products containing fragrance ingredients to which they are sensitive.
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