Whitepaper Author: Dr Chris Brennan EurChemCSci CChem MRSC EUROTOX Registered Toxicologist Intertek Date: May 2013 Understanding the EU Cosmetic Regulation and attaining compliance Understanding the EU Cosmetic Products Regulation and Attaining Compliance. Introduction The Cosmetics Regulation 1223/2009 will replace the existing Cosmetics Directive 76/768/EEC on 11 July 2013. It is important for all stakeholders in the cosmetics industry to understand the requirements of this Regulation and ensure that the requirements are met. But how did the need for regulation of cosmetics and careful scrutiny of these products develop? The evolution of the EU Cosmetic Regulation has its origins in the early 1970s when several tragedies involving the accidental inclusion of the organochlorine disinfectant, hexachlorophene, in baby products led to several deaths. At the time this disinfectant active was also widely used in adult cosmetic products such as soaps and facial cleansers. In 1972, a manufacturing incident in France led to the inclusion hexachlorophene in a talc product which resulted in a poisoning epidemic with the injury of 208 children and the tragic death of 361. Subsequently, in July 1976, a seminal event for the EU cosmetic products industry was held with the introduction of Council Directive 76/768/EEC for the safety of cosmetic products. It’s aim was to define the safety criteria to which cosmetic products must conform and to prescribe rules for their labelling and packaging. Over thirty years later on 22nd December 2009, the directive was recast as the Cosmetic Products Regulation (EC) No. 1223/2009, which entered into force on 11th January 2010 and will take full effect from 11th July 20132. Intertek Health & Beauty Product Services www.intertek.com/cosmetics Understanding the EU Cosmetic Regulation and attaining compliance. Page 2 Regulatory Drivers Responsible Person The main driver for change has been simplification. The definition of a “responsible person” (RP) was With simplification there is the potential to improve less well defined under the Directive, and is now product safety and reduce costs for businesses, much improved under the Regulation. By default legal uncertainties and inconsistencies to avoid the the manufacturer or importer assumes the identity divergence in national transposition. A Commission of the “responsible person”. The distributor within Directive has to be transposed into the national the EEA could also be the responsible person, if law of each Member States. After 30 years, the places a cosmetic product on the market under Cosmetics Directive consisted of the core text with his own name or trademark or modifies a product seven amendments and more than 40 technical already placed on the market in a way which may adaptations. It also included 27 national legal affect its compliance. Alternatively a person or frameworks and 3,500 pages of legal text. Hence authorized representative within the EEA who is the move towards a single piece of legislation which appointed by the manufacturer or importer to act is instantly and directly enforced across the whole as their responsible person, could be used. The 27 EU Member States, along with Norway, Iceland mandate request and acceptance to appoint an and Liechtenstein under the European Economic authorized representative shall both be in writing. Area (EEA) Agreement. Regulation Recast - The Highlights The obligations of a responsible person are detailed The recast has brought clarification with regard in Articles 4 and 5. Some of these are listed as to the definition of ‘responsible person’, Good follows: Manufacturing Practice (GMP) and safety reporting. • Ensure overall safety and compliance of the It will assist in implementing consistency across cosmetic product the EEA with regard to notification, allowing for a central commission to be developed. Notification, • Notify their products to the central commission labelling, definition and safety assessment will be using the notification portal necessary for nanomaterials. Substances classified • Ensure the product information file is current as carcinogenic, mutagenic or toxic for reproduction and complete are prohibited and will be reviewed by the Scientific Committee on Consumer Safety (SCCS) before use • Ensure a safety assessment is completed. is granted. • Comply with Good Manufacturing Practice New criteria will be developed for product claims. • Ensure compliance to the Regulation of any The responsible person will be clearer in their animal testing objectives and responsibilities to list corrective actions in the event of noncompliance or following • Maintain accurate and compliant labelling. reports of serious undesirable effects from the • Ensure claims are substantiated cosmetic product. • Notify the presence of any nanomaterials. The definition of a cosmetic product has not really changed under the Regulation, except for some • Identify the supply chain and immediate minor editorial changes. As defined, a ‘cosmetic distributors product’ means any substance or mixture intended • Co-operate with the competent authorities to be placed in contact with the external parts of (CA) the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth • Monitor compliance with the Regulation and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, • Manage any reported incidents of undesirable perfuming them, changing their appearance, effects and serious undesirable effects protecting them or keeping them in good condition or correcting body odours. Intertek Health & Beauty Product Services www.intertek.com/cosmetics Understanding the EU Cosmetic Regulation and attaining compliance. Page 3 The Product Information File Guidance3; putting into legal text what should fundamentally already have been considered in the The Regulation (EC) No 1223/2009 has introduced safety assessment. changes to the existing PIF; however, the majority of the content remains the same as the current These considerations shall be accompanied Directive. The product information file is now by the cosmetic safety report in the product defined by the following components; a description information file and include the results of of the cosmetic product, description of the method microbiological specifications and preservative of manufacture and compliance with GMP, proof challenge testing, purity specification of the raw of effect and data on any animal tests completed materials and packaging and also packaging after September 2004, and of course, the cosmetic material compatibility; these shall be provided at product safety report (CPSR) which will include the time of the safety assessment. In addition, Part A, safety information and Part B, the cosmetic clear understanding of the product usage under product safety assessment. The PIF still also needs to normal and reasonably foreseeable conditions is be held accessible at the address on the packaging. expected with exposure scenarios to the cosmetic This simply means that the PIF must be available to product and its ingredients. This exposure data the enforcing authorities from the address specified must include site of use, area, amount, frequency on the product label, and that address alone. The and/or duration, intended use, target population PIF does not need to be held physically at that (e.g. children, pregnant woman, those with skin address and can be accessed electronically. It can conditions). The assessment must also include any even be held outside of the EEA depending on other information supporting the safe use of the issues of confidentiality agreements between the RP product (e.g. existing studies on human volunteers). and their suppliers; nevertheless, the CA should be Crucially, the toxicological profile of the substances able to gain access and receive it within typically 72 in the cosmetic product now includes specific hours. This address can only be within the EEA. reference to nanomaterials. Margins of safety shall also be assessed and discussed where relevant. It is noteworthy that the requirements of the Further guidance to Annex I is expected to be Regulation’s PIF shall also apply to those products published before the deadline in July 2013. A draft notified under the current Directive. This means that of this is currently available and the final version not for all cosmetic products approved for supply under expected to change significantly from this4. the old Directive, the PIF may need to be updated with additional information before 11th July 2013, Guidance is already available for labelling, role of so there is no chance to beat the deadline! the responsible person and the product information file (PIF). This is available on the Cosmetics Europe website. Safety Assessments for Cosmetic Products The cosmetic product safety assessment was Good Manufacturing Practice introduced as part of the 6th amendment to the Cosmetic Products Directive. This allowed the Good Manufacturing Practice (GMP) has always experienced assessor to identify any potential been a mandatory requirement under The Directive, problems with a cosmetic formulation taking into and remains so under the Regulation. The main account the foreseeable use and the information difference is the reference to the harmonised provided in the product information file (PIF). The standard, EN ISO 22716:2007 and its presumption Directive lacks clarity on the prerequisites for the of conformity to the Regulation’s GMP