Cosmetic products are defined in Europe as “any substance or mixture intended to be placed in contact with the external parts of the human body … or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours”. They are very often mixtures, and can contain various different ingredients, some of which may be complex multi-constituent natural products (e.g. essential oils). Safety assessments of these products should involve a weight-of-evidence consideration of the toxicology of each individual ingredient, looking at all relevant toxicological endpoints.
We regularly perform hazard and risk assessments of single- and multi-component formulations, so are ideally suited to help in any cosmetic product safety assessment
Specifically, within Europe, cosmetics, toiletries and perfumery products are regulated by cosmetics Regulation (EC) 1223/2009
, which replaced Directive 76/768/EEC
in July 2013. The new legislation is deliberately more robust in nature and is designed to ensure a more thorough compliance with the spirit of the regulation than in the past. As with the Directive, one of the key aims of the Regulation is to ensure that cosmetic products are not placed on the market if they are harmful to health under normal or reasonably foreseeable conditions of use. It is up to the “responsible person” – the cosmetic manufacturer, importer or distributer, or an assigned representative – to ensure that a cosmetic product undergoes a suitable safety assessment. The responsible person should guarantee that a Product Information File (PIF)
is compiled for each cosmetic, and that this PIF includes a Cosmetic Product Safety Report (CPSR)
The CPSR itself consists of Part A – Cosmetic product safety information, and Part B – Cosmetic product safety assessment.
Part A of the CPSR should include toxicological profiles on each ingredient contained in the cosmetic product, as well as other relevant data (e.g. normal and reasonably foreseeable uses, data on exposure, and data on microbiology and stability). Notably, as a result of a March 2013 marketing ban, new animal data cannot be generated specifically for the safety assessment of cosmetics, or cosmetics ingredients, to be marketed in Europe.
The overall assessment of product safety, for Part B of the CPSR, should be performed by a suitably qualified individual “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”, and their credentials should be provided. All bibra senior toxicologists are suitably qualified.
The team of toxicologists at bibra has over 50 years of experience in providing toxicological support to many industrial sectors. We are highly skilled in comprehensively searching the available literature for publically-available toxicological data, and have unique access to our in-house toxicity database, TRACE. We have conducted literally thousands of hazard and risk assessments on a diverse range of substances, including cosmetic ingredients. We have a great deal of experience in filling data gaps using alternative (non-animal) methods such as read-across from structural analogues, (quantitative) structure-activity relationships ((Q)SARs) and also in the use of the Threshold of Toxicological Concern (TTC) approach. In addition, we are familiar with a wide range of consumer product exposure models. All of our senior toxicologists are professionally registered under the UK RSB/BTS and European Registered Toxicologist schemes, and are suitably qualified to complete both parts of the CPSR, as required by the regulation. We can provide high-level input to your product safety report and PIF.
Examples of specific assessments
- CPSR – compilation of a full CPSR (including the weight-of-evidence safety assessment) for a skincare product
- Toxicological profiles – literature searches and (Q)SAR analyses to complete/embellish toxicological profiles on cosmetics ingredients
- Risk assessments of non-EU cosmetics – hazard and risk assessments of various substances marketed in the USA
Recent work in this field
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