OCCLs: analytical methods
Analytical methods and guidance documents
Market surveillance of cosmetic products in Europe can be a challenge due to the great variety of products, and substances to be investigated and the diversity of matrices. Only a few official methods are available in European legislation for detecting prohibited or restricted substances in cosmetic products. In line with its mission of supporting the analytic competence of laboratories across Europe, the EDQM strives to further increase the access to harmonised test protocols that have been suitably validated and have appropriate reproducibility.
Determination of polar N-nitrosamines in cosmetic products
The European Network of Official Cosmetics Control Laboratories (OCCLs) has validated an analytical method for the determination of polar N-nitrosamines in cosmetic products. A detailed description of the method using liquid chromatography coupled to mass spectrometry can be downloaded for FREE from the EDQM Freepub website. Work is underway within the network to validate an analytical method for the determination of non-polar N-nitrosamines in cosmetic products for future publication.
Determination of free formaldehyde in cosmetic products
Following the provisions in Article 12 of European Union 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 validated an analytical method for the determination of free formaldehyde in cosmetic products. A detailed description of the method using liquid chromatography can be downloaded for FREE online.
Determination of hydrogen peroxide in cosmetic products
Following the provisions in Article 12 of European Union 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 validated an analytical method for the determination of hydrogen peroxide present in or released by tooth whitening or bleaching products. A detailed description of the method using liquid chromatography can be downloaded for FREE online.
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, five seminars on this topic have been organised for experts from national authorities and OCCL:
- 2019 Strasbourg (France), hosted by the EDQM
- 2016 Nicosia (Cyprus), hosted by the State General Laboratory of Cyprus (SGL)
- 2014 Lisbon (Portugal), hosted by the Autoridade Nacional do Medicamento e Produtos de Saúde (Infarmed)
- 2012 Karlsruhe (Germany), hosted by the Chemisches und Veterinäruntersuchungsamt Karlsruhe (CVUA)
- 2011 Montpellier (France), hosted by the Agence nationale de sécurité du médicament et des produits de santé (ANSM)
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.
The European Committee CD-P-COS is currently focusing on ensuring participation of national OCCLs in its pan-European network and is expanding further its database of test results for childcare and children cosmetics.
An OCCL is a public institution tasked with performing laboratory testing of cosmetics for the purpose of market surveillance. More than 50 OCCLs participate in the OCCL Network. Participation is open to member states which are Parties to the Convention on the Elaboration of a European Pharmacopoeia of the Council of Europe and to observers/observer states.
Network membership is open to publicly funded, independent laboratories, which have implemented a quality management system as laid down in ISO/IEC 17025:2017 (or equivalent), and have suitable rules in place for sub-contracting certain types of work.
Official Cosmetics Control Laboratories in eligible member states may join the Network.
Official observers of the European Pharmacopoeia are also invited to participate in Network activities such as coordinated market surveillance studies, proficiency testing and different types of expert meetings.
To enquire about membership and projects, contact the OCCL Network Secretariat.