Cosmetics: life under the EU Regulation

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1 Cosmetics: life under the EU Regulation CW Briefing, December 2012/January 2013 / Europe Tony Stovold, reporter There are few more suitable venues for a cosmetics workshop than that chosen by the UK Society of Cosmetic Scientists to discuss the practical aspects of implementing the new Cosmetic Products Regulation in October. Boots, headquartered in Nottingham and part of the Alliance Boots group, is the UK s largest retailer of cosmetics and a major manufacturer at the site, best known for the No 7 make-up and skincare range. The presenters included Amanda Isom, technical affairs manager at the UK Cosmetic, Toiletries & Perfumery Association, who discussed the product information file (PIF) which will be the main format in which regulatory-relevant information about cosmetic ingredients and finished products is submitted under the Regulation. Stephen Kirk, scientific advisor to Alliance Boots, assessed the implications of the cosmetic product safety report (CPSR), the single most important part of the PIF, which will replace the cosmetics Directive s safety assessment. And Marie Kennedy, L Oréal s international regulatory affairs manager, explained how the cosmetic products notification portal (CPNP) will be used to notify compliant products and ingredients. The three agreed that the changes introduced by the Regulation are of emphasis and workload rather than fundamental principles. Mr Kirk said the CPSR is now more than an intellectual exercise and you have to write things down. There is an increased amount of documentation and an increased need for a display of reasoning behind it. The Regulation came into force on 11 January 2010, but national notification of products continued under the Directive for two years. We are now half way through the 18-month transition period when notification to national Competent Authorities (CAs) and possibly poison centres under the Directive, or centralised EU notification via the CPNP under the Regulation, can be used. From 11 July 2013, only the Regulation will apply. Some of the Regulation processes look superficially similar to REACH. But there is no role for ECHA and enforcement relies on market surveillance rather than authorisation. The European Commission assumes that cosmetics companies are doing their job properly and there is no reason why they should not, said Ms Kennedy. CW Research Limited, 140B Longden Coleham, Shrewsbury SY3 7DN, United Kingdom. enquiries@chemicalwatch.com Tel: +44(0) Fax: +44(0) UK Company: Registered office: 6 Claremont Buildings, Claremont Bank, Shrewsbury SY1 1RJ

2 All of the information stays with the cosmetics companies, to be handed over to the national CA only when specifically required, and the testing results will generally stay outside the PIF, as an attachment. You should be satisfied that your work is complete in case you are challenged. There would be major consequences for your products if they were not up to scratch, Mr Kirk said. More toxicity studies Getting safety assessments done on products may now take longer, because of the need for more toxicological studies, he added. This has not yet reduced the number of products and ingredients on the market, but it may yet. Certainly, it will add to the time needed to get formulations onto the market. Under article 13 of the Regulation, the manufacturer, importer or their appointed representative is the responsible person who must notify all existing and new cosmetics. They must be based in the EU and have access to the PIF. However, the role is assumed by the distributor if it places a product on the market under its own name or trademark, or modifies a product already on the market in such a way that compliance with the applicable requirements may be affected. Existing products are those that were placed on the EU market before 11 July 2011; new products are those first placed on it afterwards. Old products are those for which the last batch was put on the market between 10 January 2010 and 11 July Product information was already a requirement under the Directive, said Ms Isom. Neither the concept, the scope, nor the principle that one product should be linked to one PIF and lead to one notification have changed. This, Ms Kennedy said, applies equally to product ranges with variations in shade or fragrance, kit products for sequential application, like hair colorants, and gift sets, provided that they not usually sold separately. The required information has been changed by the introduction of the CPSR. Ultimate responsibility for compiling and maintaining the PIF, which must be produced when a cosmetic is placed on the market, remains with the responsible person (RP). The PIF must include: a product description that enables the PIF to be clearly attributed to it. This must contain the exact product name and any unique internal formulation reference and may also contain a product notification reference, any language variations (in product name) and the product function; the CSPR, based on a safety assessment (CPSA) produced before the product is placed on the market; a description of the method of manufacture and, for the first time, a statement of compliance with good manufacturing practices, as referred to in article 8. A third party certificate is not required but the manufacture should state how the process achieves compliance with a relevant harmonised standard, such as the

3 Cen/ISO standard (good manufacturing practice compliance is presumed if this is used). proof of effect, which should, as a minimum, be a summary of any novel or complex claims (such as 24-hour anti-perspirant protection); and data on animal testing conducted by the manufacturer, its agents or suppliers on the product. This should list the test and types of tests related to development or safety, conducted on ingredients or finished products anywhere in the world since 11 September 2004, and for whom they were carried out. PIFs must be produced for both new and existing products, but for discontinued products, they should be generated for information only, until 11 July Manufacturers and other suppliers must keep their files and living data up to date, particularly regarding further animal testing and CPSR information, such as undesirable effects. Little has changed on the location of the PIF, though Ms Isom warned the requirement for it to be readily accessible may vary from country to country. Most member states stipulate 48 to 72 hours. The PIF must be easily understood by the controlling officer (English is generally acceptable). But supporting documents can be in any EU language, which is another good reason to keep them outside the PIF, where they will not need to be translated. Remember: you, as the responsible person, own the PIF, Ms Isom stated. You must not send it out to anyone. A competent authority in your home country may inspect it, but they must keep it confidential and cannot remove it from your premises. Suppliers must now decide, if they have not done so already, if their products are new, existing or old. The PIFs of old products need not be re-done, even if a distributor continues to make them available in some markets. If existing product PIFs already comply with the Regulation, they need not be reproduced, but if not, they should be revised. PIFs for new products must comply with the Regulation. Most of the cosmetic product safety information requirements for the CPSR, which are set out in Annex I Part A of the Regulation, also applied to the PIF under the Directive, said Mr Kirk, but a key difference is that it is no longer enough to assess products based on their international nomenclature of cosmetic ingredients (INCI) names. More documentation is required. This will generally be straightforward for products made entirely in Europe, perhaps less so when ingredients are imported from Asia. There will also be more upstream communication with suppliers, who will know most about microbiological quality, for instance. The safety assessor may not be an expert in the field and will want to see that the formulation passes the preservative efficacy test.

4 Sometimes, too, ingredient suppliers will have to go further still up the chain, notably where traces of Annex II (banned) substances are technically unavoidable. In such cases, firms will have to demonstrate what the effects of these would be, and that the purest possible grade of material has been used. The real buzzword among safety assessors, said Mr Kirk, is the margin of safety (MoS). This is derived by dividing the no observed adverse effect level (Noael) by the systemic exposure dosage (SED). Numerous complications may arise here. Noaels have not been set for many products, so alternative ways of finding toxicity parameters, including read-across, will often be needed. Safety assessors will also consider routes of absorption, considering, for instance, the greater likelihood of lip or oral care products being ingested. The SED, meanwhile, is derived by multiplying the amount applied daily, the contents and 100% assumed dermal absorption (as a worst case scenario) and dividing by a nominal average body weight of 60kg. An MoS above 100 is generally considered safe, but in some cases, a higher MoS might be required. Part B of Annex I CSPR covers the assessment conclusion, label warnings and instructions, and the reasoning behind these. Safety assessors must be qualified medics or pharmacists, or chartered chemists or biologists. Responsible persons must supply four kinds of general information and 11 kinds of product details via the notification portal, said Ms Kennedy. The general information comprises: product name(s), including the trade mark or brand, the product name and specific product name, plus the function, if that is not part of the specific name; children s products, ie if it is intended for children under three; name and address of RP and Contact Person, who are not necessarily the same; this is in case of necessity rather than as a 24/7 hotline; and information on the country of origin and the member state first placing the product on the EU market, for imports only. Two notifications are needed if the same product is made in two locations. We lost that battle, Ms Kennedy remarked. The product details required include stating whether a product contains a nanomaterial or a substance classified as a category 1A or 1B carcinogen, mutagen or reprotoxin. They also cover product categorisation, physical forms, special applications, frame formulations, trigger rules, notification types, original labelling (image and text) and confidentiality. After 18 months of work, it was decided the old system of product categorisation would no longer work because too many changes were needed. There are now three categorisation levels. Level 1 consists of four categories: skin; hair and

5 scalp; nail and cuticle; and oral hygiene products. These are subdivided into 22 level-2 categories, which in turn are subdivided into 82 level-3 categories. Physical forms are a new requirement, Ms Kennedy added. Such forms solid and pressed powders, loose powders, creams/pastes/gels, liquids, foams, sprays and others can be important in terms of toxicological emergency responses. Redefining frame formulations and new trigger rules2 for 18 classes of ingredients were both the result of much labour. Confidentiality on the portal is also a hot topic. The CPNP has a high security level, but remember that all the information will be downloaded into the databases of all the European poison centres Germany alone may have over 300. They probably don t have the same level of security, so you need to be aware of that if you are notifying by full formulation, she said BOX - Cosmetics Regulation key points EC Regulation 223/2009 is applicable from 11 July 2013, when the cosmetics Directive is repealed. However, the provisions which relate to the prohibition and restriction of carcinogenic, mutagenic and reprotoxic (CMR) substances have applied since 1 December A complete ban on the marketing of cosmetics where the final formulation or any of the ingredients have been tested on animals is due to come into effect after 11 March But because validated alternative methods will not be available by this deadline for three toxicological endpoints, the European Commission must decide whether to issue a legislative proposal setting out an alternative course of action possibly a derogation allowing cosmetics containing animal-tested ingredients to be placed on the EU market after the deadline if such animal data were the only data available to prove an ingredient s safety, and the testing was conducted outside the EU. To demonstrate that a cosmetic available on the market is safe, a safety assessment must be performed and be demonstrated through a product safety report. A product safety file, which must include the report, must be available to competent authorities. Before being placed on the market, a cosmetic must be notified to the Commission s product notification portal. To comment on this article, click here: Chemical Watch Forum To sign up for full access to Chemical Watch articles, click here