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OCCLs: analytical methods, guidance documents and studies

 

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 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 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.
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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.

Find out about all the Market Surveillance Studies in cosmetics:

  • The quality of tooth whiteners and whitening strips was assessed in a Market Surveillance Study carried out by Official Cosmetics Control Laboratories (OCCLs) in 12 European countries and completed in 2018. The findings, based on the testing of 261 samples of tooth whitening products, indicated that a large number of products were non-compliant with European Union or national regulations for cosmetic products: 78% of paint-on (brush-on) whiteners and more than 50% of tray-based tooth whiteners and whitening strips. Non-compliance issues identified concerned the hydrogen peroxide content (higher than permitted), the presence of a CMR substance – those which are carcinogenic, mutagenic or toxic for reproduction – (sodium perborate) and labelling issues. In the study conclusions, the European Network of OCCLs recommended that these products should be more closely monitored by national competent authorities and OCCLs. More detail can be found in the Summary of the Market Surveillance Study on Tooth Whitening Products (published April 2019).

  • 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 of 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. The results of this MSS have been shared with authorities and may be used to establish common guidance values.
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Proficiency testing scheme studies in cosmetics and trainings

When new analytical methods become available, the OCCL Network performs inter-laboratory collaborative studies in order to assess their relevance and validate their suitability and performance. This allows laboratories to become familiar with methodologies that are always robust, fit for purpose and ensure accurate results. PTS studies provide the grounds for the laboratories to build trust in each other’s analytical capacity and validity of results, an essential aspect for avoiding duplication of tasks and streamlining efficiency.

Proficiency testing is a form of external quality control and covers the overall performance of a laboratory. This includes the entire process from reception and storage of samples, to the experimental work in the laboratory, and the interpretation of results. PTS studies within the OCCL Network are co-ordinated by the EDQM; they are an essential tool to demonstrate technical competence and identify scope for technical improvement. 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.

Find out about all the Proficiency Testing Scheme studies in Cosmetics:

  • 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 focus 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 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.
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