Product Information File & Cosmetic Product Safety Report

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1 Product Information File & Cosmetic Product Safety Report October 2015

2 Compliance with Cosmetic Regulation EC No. 1223/2009 Product Information File and Cosmetic Product Safety Report Regulation EC No. 1223/2009, which governs the composition, labelling and packaging of cosmetic products, came fully into force in July It replaced the previous Cosmetics Directive 76/768/EEC. Among the changes to the earlier legislation was a re-structuring of the Product Information File (PIF), and the introduction of a much expanded Cosmetic Product Safety Report (CPSR), to be held as part of the PIF. Enforcement: In the UK, Trading Standards are the Competent Authority, with legal powers of enforcement over the Cosmetics Regulation. Under the enforcement regulations they are required to carry out market surveillance, and have the power to inspect the PIF for any cosmetic product on the market. When requested, the Responsible Person must make a PIF available to Trading Standards in a reasonable time. Penalties for non-compliance can lead to fines of up to 20,000, imprisonment up to 12 months, or both. There follows a summary of the requirements of both the PIF and CPSR, with more detailed notes below. PRODUCT INFORMATION FILE (PIF) A description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product Cosmetic Product Safety Report A description of the method of manufacturing and a statement on compliance with good manufacturing practice Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product Data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries COSMETIC PRODUCT SAFETY REPORT (CPSR) Part A: Cosmetic Product Safety Information 1. Quantitative and qualitative composition 2. Physical/chemical characteristics and stability 3. Microbiological quality 4. Impurities, traces, information about the packaging material 5. Normal and reasonably foreseeable use 6. Exposure to the product 7. Exposure to the ingredients 8. Toxicological profile of the ingredients 9. Undesirable and serious undesirable effects 10. Other relevant information Part B: Cosmetic Product Safety Assessment 1. Safety Assessment Conclusion 2. Assessors recommended warnings and instructions of use 3. Reasoning 4. Safety assessor's credentials and sign-off

3 Description of the Cosmetic Product This should allow anyone reading the PIF to clearly connect it to the cosmetic product as placed on the market. It should be as clear and full as possible, and include the brand name, product name, bulk and/or formula code or any other relevant product identifier/s. Cosmetic Product Safety Report The CPSR is an expert report by an experienced and qualified professional. Part A of the CPSR pulls together all the information required by the safety assessor to identify the risks and assess if the cosmetic product is safe for human health under its intended purpose. This typically includes formulation, finished product and microbiological specifications, results of preservative efficacy (challenge) test and stability tests, and any previously reported adverse effects. The safety assessor will include historical data on the toxicological profiles of the raw materials and their exposure levels, depending on the type of product and target market. Part B is the safety assessment itself. It includes a conclusion that the product is safe (or otherwise) under the terms of the Cosmetics Regulation. The conclusion is backed up by the safety assessor's reasoning, based on the information provided in Part A. The safety assessor will indicate any mandatory warnings that may be required on the product label, and also suggest additional warnings where relevant. Finally there will be a summary of the safety assessor's qualifications and experience. Qualifications and Experience of the Safety Assessor: The CPSR shall be carried out "by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State". In addition there is an intensive week-long training course run in the Toxicology Department of Vrije University in Brussels. It is most obviously in the responsible person's interest that the safety assessment should be independent, sound and supportable. Substantial experience of carrying out toxicological safety assessments on finished cosmetic products, in addition to formal qualifications, is fundamental for this function to be adequately fulfilled. Method of Manufacture A brief summary of the method of manufacture is all that is required here. This should include a bulk material code which can be cross-referenced to more detailed production documentation held internally by the product manufacturer. Good Manufacturing Practices (GMP) Indication that the manufacture of the cosmetic product complies with Good Manufacturing Practices (GMP). The minimum to demonstrate compliance is a basic statement in the PIF. However while external certification is not mandatory, the best and most responsible way of confirming compliance is third party certification to GMP standard ISO

4 The highest standards of GMP are essential for putting safe and effective products on the market. Failure to have these standards in place can lead to product recall and excessive premiums for liability insurance. For more information on GMP please see separate bulletin, "Good Manufacturing Practices". Proof of Effect Claimed The PIF should contain supporting information or at least a short summary of the technical support for the claimed effects. The level of information depends on the type of claims made. Ingredient claims are typically supported by raw material suppliers own clinical trial results. Product claims are supported by test results on the finished product (for example SPF or 24 hour hydration tests). Data on Animal Testing While not explicitly required, it is normal for this section to include a statement that no animal testing has been carried out on the product or its ingredients by the responsible person or their representatives. On testing in third countries, the scope of this requirement should be interpreted taking into account the information that cosmetic companies can be aware of or can reasonably be expected to obtain. Responsibility, Location and Access to the PIF It is the responsibility of the Responsible Person to ensure that a PIF is compiled before a cosmetic product is placed on the market anywhere in the EU. The PIF does not necessarily need to be physically held by the responsible person, but must be readily accessible through the address on the product label. If more than one address is included on the label, the address where the PIF is made available should be underlined. If requested the PIF must be available within a reasonable time for inspection by the Competent Authorities. (For example Trading Standards in the UK). "A reasonable time" is not defined, but in practice is up to 72 hours from the time the request is received. Retention Period The PIF must be retained for ten years after the last batch of product was placed on the market.

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