What is all the fuss about regulating cosmetic products? Why do they need to be so carefully scrutinised? The beginning of the EU cosmetic products regulation harks back to the 1970s when several incidents involving the deaths of children from the accidental inclusion of the organochlorine disinfectant, hexachlorophene, in baby products which, at the time, was also used widely in adult cosmetic products such as soaps and facial cleansers.
In 1972, a manufacturing incident in France led to the inclusion of hexachlorophene in a talc which caused a poisoning epidemic resulting in the injury of 208 children and the tragic death of 36. Subsequently, on 27 July 1976, there was a seminal event for the EU cosmetic products industry with the introduction of Council Directive 76/768/EEC for the safety of cosmetic products. Its 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 22 December 2009, the directive was recast as the Cosmetic Products Regulation (EC) No. 1223/2009, which entered into force on 11 January 2010 and takes full effect from 11 July 2013. The main driver for change has been simplification, to strengthen product safety and reduce costs for businesses, removing legal uncertainties and inconsistencies to avoid the divergence in national transposition. A Commission Directive has to be transposed into the national law of each Member State. After 30 years, the Cosmetics Directive consisted of the core text with seven amendments and more than 40 technical adaptations. It also included 27 national legal frameworks and 3,500 pages of legal text. Hence the move towards a single piece of legislation which is instantly and directly enforced across the whole 27 EU Member States, along with Norway, Iceland and Liechtenstein under the European Economic Area (EEA) Agreement.
Cosmetic Products Regulation recast – highlights
The recast has given improvement and clarification especially in regards to the ‘responsible person’ definition, Good Manufacturing Practice (GMP), and safety reporting. It will implement consistency across the EEA with regards to notification, allowing for a central commission to be developed. Notification, labelling, definition and safety assessment will be necessary for nanomaterials. Substances classified as carcinogenic, mutagenic or toxic for reproduction are prohibited and will be reviewed by the Scientific Committee on Consumer Safety (SCCS) before use is granted. New criteria will be developed for product claims. The responsible person will be clearer in their objectives and responsibilities to list corrective actions in the event of non-compliance or following reports of serious undesirable effects from the cosmetic product. The definition of a cosmetic product has not really changed under the Regulation, except for some minor editorial changes. As defined, a ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) 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 or keeping them in good condition or correcting body odours.
The definition of a ‘responsible person’ (RP) was less well defined under the Directive, and is now much improved under the Regulation. By default the manufacturer or importer assumes the identity of the ‘responsible person’. The distributor within the EEA could also be the responsible person, if he places a cosmetic product on the market under his own name or trademark or modifies a product already placed on the market in a way which may affect its compliance. Alternatively a person or authorised representative within the EEA who is appointed by the manufacturer or importer to act as their responsible person, could be used. The mandate request and acceptance to appoint an authorised representative shall both be in writing. The obligations of a responsible person are detailed in Articles 4 and 5. Some of these are listed as follows:
• Ensure overall safety and compliance of the cosmetic product. • Notify their products to the central commission using the notification portal. • Ensure the product information file is current and complete. • Ensure a safety assessment is completed. • Comply with Good Manufacturing Practice. • Ensure compliance to the Regulation of any animal testing. • Maintain accurate and compliant labelling. • Ensure claims are substantiated. • Notify the presence of any nanomaterials. • Identify the supply chain and immediate distributors. • Co-operate with the competent authorities (CA). • Monitor compliance with the Regulation. • Manage any reported incidents of undesirable effects and serious undesirable effects.
The Product Information File
The Regulation (EC) No 1223/2009 has introduced changes to the existing PIF; however, the majority of the content remains the same as the current Directive. The product information file is now defined by the following components; a description of the cosmetic product, description of the method of manufacture and compliance with GMP, proof of effect and data on any animal tests completed after September 2004, and of course, the cosmetic product safety report (CPSR) which will include Part A, safety information, and Part B, the cosmetic product safety assessment. The PIF still also needs to be held accessible at the address on the packaging. This simply means that the PIF must be available to the enforcing authorities from the address specified on the product label, and that address alone. The PIF does not need to be held physically at that address and can be accessed electronically. It can even be held outside of the EEA depending on issues of confidentiality agreements between the RP and their suppliers; nevertheless, the CA should be able to gain access and receive it typically within 72 hours. This address can only be within the EEA. It is noteworthy that the requirements of the Regulation’s PIF shall also apply to those products notified under the current Directive. This means that for all cosmetic products approved for supply under the old Directive, the PIF may need to be updated with additional information before 11 July 2013, so there is no chance to beat the deadline!
Safety assessments for cosmetic products
The cosmetic product safety assessment was introduced as part of the 6th amendment to the Cosmetic Products Directive. This allowed the experienced assessor to identify any potential problems with a cosmetic formulation taking into account the foreseeable use and the information provided in the product information file (PIF). The Directive lacks clarity on the pre-requisites for the cosmetic product safety assessment, such that the new Regulation now introduces some of the general requirements from the SCCS Notes of Guidance; putting into legal text what should fundamentally already have been considered in the safety assessment. These considerations shall be accompanied by the cosmetic safety report in the product information file and include the results of microbiological specifications and preservative challenge testing, purity specification of the raw materials and packaging and also packaging material compatibility; these shall be provided at the time of the safety assessment. In addition, clear understanding of the product usage under normal and reasonably foreseeable conditions is expected with exposure scenarios to the cosmetic product and its ingredients. This exposure data must include site of use, area, amount, frequency and/or duration, intended use, target population (e.g. children, pregnant women, those with skin conditions). The assessment must also include any other information supporting the safe use of the product (e.g. existing studies on human volunteers). Crucially, the toxicological profile of the substances in the cosmetic product now includes specific reference to nanomaterials. Margins of safety shall also be assessed and discussed where relevant within the assessment. Cosmetics Europe, formerly known as Colipa, the European Cosmetic Products Association, will publish further guidance in 2012. Guidance is already available for labelling and the product information file (PIF).
Good Manufacturing Practice
Good Manufacturing Practice (GMP) has always been a mandatory requirement under The Directive, and remains so under the Regulation. The main difference is the reference to the harmonised standard, EN ISO 22716:2007 and its presumption of conformity to the Regulation’s GMP requirements offered by compliance. Although EN ISO 22716 is not a mandatory standard, but your GMP system shall at least be equivalent to it.
Marking and labelling requirements
There are no major changes to the labelling requirements under the Regulation; however, a new egg timer symbol has been included for use alongside the best before date and there is clearer guidance on when dates of durability are not required, when irrelevant to the product type, e.g. for aerosols.
One major change employed under the new Regulation is the notification requirement. A new electronic notification portal has been set up and went live on 1 January 2012. The intention is to harmonise the procedure for notifying the intention to supply cosmetics in the EEA through to a centralised commission and ensuring cosmetic products can be traced back to the responsible person. As part of the notification procedure, poisons centres will be automatically included in the notification process. The following information must be included in the notification:
• Category of cosmetic product. • Name/address of responsible person where the PIF held. • Contact details of physical person to contact in case of necessity. • Country of origin, if imported. • Member State where product is first put on the market • Presence of nanomaterials (separate notification also required). • Name/CAS No of each substance classified as CMR category 1A or 1B. • Frame formulation (Cosmetics Europe to revise the frame formulations). • Original labelling and photograph of the packaging.• Poisons centres now included in the notification process and disseminated to the appropriate bodies by the Commission.
Undesirable Effects and Serious Undesirable Effects
There is a now a new requirement to report any serious undesirable effects. While it was a requirement that any undesirable adverse effects were included in the product information file, there are now also obligations on the responsible person and distributor to communicate any serious undesirable effects to the competent authority and to list corrective measures.
Under Article 20, the new Regulation also tightens up product claims. Highlights include:
• The labelling, making available on the market and advertising of cosmetic products, text, names, trade names, pictures and figurative and other signs shall not be used to imply that these products have characteristics or functions which they do not have. • Commission shall adopt a list of common criteria for claims.
It is intended that common criteria will be developed, such that cosmetic product claims should meet the following:
• Legal compliance. • Truthfulness.• Evidence support. • Honesty. • Fairness. • Allow informed decisions.
It is likely these criteria will be published as a Commission Decision (and therefore law). Consequently, manufacturers will need to be conscious of the claims they choose to make either on the product itself or in commercial advertising and ensure these can be substantiated. Claims denigrating competitors or ingredients that have an otherwise safe history of use will also be scrutinised as will claims stating that the product does not contain specific ingredients that are already prohibited according to law. There is a great deal of work ahead of the cosmetics industry to ensure practices and procedures are aligned, the cosmetic product information is readily available to the safety assessor, the product information file is updated and the marketing departments are fully versed. Do not be alarmed, there is help available to do this.
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