Terms of reference
The Terms of Reference of the European Network of Official Cosmetics Control Laboratories (OCCLs) outline its main objectives, network organisation, membership and quality management system.
Publication of analytical methods
Considering that only few official methods exist in European legislation on cosmetic products for a great number of prohibited or restricted substances, a need for increasing the number of available methods is evident. Following the provisions in Article 12 of Regulation (EC) No 1223/2009 for “reliable and reproducible” methods to be used in cosmetics testing, the European Network of Official Cosmetics Control Laboratories (OCCLs) has developed two analytical methods to support control laboratories in their testing activities: Determination of hydrogen peroxide in cosmetic products and Determination of free formaldehyde in cosmetic products. The OCCL Network activities are coordinated by the EDQM.
Both methods are available in English and can be accessed here: Freepub page
Sunscreen products contain substances that filter or block UV light and many products indicate a so-called “sun protection factor” or “SPF”. The SPF value indicated on sun protection products is established on the basis of in vivo tests on humans or by performing in vitro tests.
Both in vivo and in vitro methods have been used for many years to evaluate SPF. Method harmonisation, in particular for in vitro tests, is on-going. The composition of the formulation, the type (mineral or organic), the photo stability of UV-filter substances when exposed to light and relevant temperatures, physico-chemical incompatibility between filters and other ingredients, product storage, sample preparation, the irradiation process and equipment used greatly influence test results and in vivo/in-vitro correlations. To date, three seminars on this topic have been organised for experts from national authorities and OCCL:
- In June 2011 in Montpellier (France), which was hosted by the Agence nationale de sécurité du médicament et des produits de santé (ANSM)
- In April 2012 in Karlsruhe (Germany), which was hosted by the Chemisches und Veterinäruntersuchungsamt Karlsruhe CVUA
- In April 2014, in Lisbon (Portugal), which was hosted by Portuguese National Authority for Medicines and Health Products (Infarmed).
The presentations focused on analytical developments and approaches to market surveillance on sunscreen products. The participating experts decided to harmonise approaches and further develop methodology.
Official Cosmetics Control Laboratories (OCCLs) check the quality of cosmetic products on the market and support market surveillance activities of the competent authorities. By alerting authorities to products that do not comply with national and European regulations for cosmetic products, OCCLs contribute to consumer health protection.
To foster cross-border collaboration, share technical expertise and enhance quality management in each laboratory in accordance with international standards, the European Network of OCCLs was set up in June 2010 as a result of a survey amongst competent authorities. The EDQM’s long-standing experience with the network of Official Medicines Control Laboratories (OMCLs) has been an asset in the start-up phase.
Network activities include analytical studies, proficiency testing, market surveillance studies (MSS) and training sessions.
Who is involved?
The European Network of national OCCLs was set up on a voluntary basis; more than 30 OCCLs participate in regular network activities, including laboratories in 19 Member States of the European Union. Besides the EU, participation is open to other Council of Europe States having signed the Convention on the Elaboration of a European Pharmacopoeia.
An OCCL is a public institution with a mandate to perform laboratory testing of cosmetic and other products as appropriate, for the purpose of market surveillance. OCCLs are part of an organisational structure under the aegis of the respective Competent Authority.
Market Surveillance Studies in Cosmetics (COS MSS)
In the European Network of OCCLs, Market Surveillance Studies (MSS) are designed as multilateral studies of commercialised cosmetic products of the same type. Products are sampled by the national authorities and checked for compliance with European regulations or, in some cases, for information on trace levels of ubiquitous substances such as metals. The results are shared with national and European authorities.
The quality of cosmetic products that are designed to appeal to children was tested in an MSS completed in 2014. More than one third of the samples was considered non-compliant and several samples contained relevant amounts of nitrosamines, forbidden colorants or lead. A summary on these findings can be obtained here.
In 2011, several countries collected samples of decorative cosmetics (make-up, eye-shadow, eye liner, lip gloss, etc.) to measure the content of certain metals that may give rise to health concerns: antimony, cadmium, chromium, lead, mercury and nickel. Traces of some of these metals may be unavoidable for technical reasons but, in most countries, maximum tolerable limits have not been set. Results of this MSS are shared between authorities and may be used to establish common guidance values.
Proficiency Testing Scheme studies in Cosmetics (COS PTS)
Conducting PTS studies is part of a quality management programme to ensure an appropriate level of performance in the different OCCLs. Participating laboratories in several countries test the same sample for pre-defined parameters following a common test protocol. Results are then evaluated against a set of acceptance criteria according to international standards.
The PTS study programme for 2015 included testing titanium dioxide in sunscreens, fluorides in toothpastes and hydrogen peroxide in tooth whitening products.
The 2014 study programme focussed on testing for formaldehyde released from preservatives and on the determination of UV filters in sunscreens.
The PTS study programme 2012-2013 included the analysis of allergens, diethylene glycol, p-phenylenediamine, phthalates and thioglycolic acid in various cosmetic products.
In 2011, the EDQM initiated a proficiency testing scheme (PTS) for cosmetic products. 16 national laboratories located in Austria, Cyprus, France, Germany, Ireland, the Netherlands, Portugal, Slovenia and Sweden participated in the pilot studies and compared their analytical results obtained for the chemicals formaldehyde and hydroquinone.
The OCCL Network has established close contacts with the European Commission, the Joint Research Centre (JRC) and the European Committee for standardisation (CEN).
In 2014, OCCLs, the JRC and CEN jointly elaborated a common approach for the validation of analytical test methods developed by single laboratories. The resulting Guidelines aim at establishing a common understanding of Regulation (EC) No 1223/2009 and a harmonised testing strategy for cosmetics, using validated analytical methods.