Post-Market Surveillance
The EU Cosmetics Directive is characterised by a partnership between manufacturer safety responsibility and authorities’ in-market control.
All cosmetic products placed on the EU market must first undergo a thorough safety assessment. Subsequent to this comprehensive safety assessment, companies and competent authorities monitor the actual safety of products on the market.
As a consequence, cosmetic products placed on the EU market have a high standard of safety and quality. Undesirable effects as a result of normal and reasonably foreseeable use of cosmetic products are rare and usually mild.
Any cases of undesirable effects are taken very seriously by the cosmetics industry.
Undesirable events reports
The management of reports of undesirable events can be defined as the activities related to their reporting, assessment, understanding and prevention. For companies, these reports play an important role in the post-marketing surveillance of cosmetic products safety. Provision of such information is covered by the Cosmetics Directive and the 7th Amendment to the Cosmetics Directive:
- Article 7 a (1) (f) of the modified Council Directive 76/768/EEC (Cosmetics Directive), requires that “Existing data on undesirable effects on human health resulting from use of the cosmetic product” shall be easily accessible to the Competent Authorities.
- Directive 2003/15/EC, the 7th Amendment to the Cosmetics Directive, requires in addition that these data shall also be made easily accessible to the public in accordance with article 7a (1) (h) of the modified Directive 76/768/EEC (“Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, Member States shall ensure that the information required under (f) shall be made easily accessible to the public by any appropriate means, including electronic means”).
Colipa Guidelines
In 2005, Colipa issued guidelines on the "Management of undesirable event reports" giving instructions to the cosmetic industry on receiving, handling, evaluation, classification and reporting of undesirable event reports associated with the use of cosmetic products.
Consistent generation of high quality and reliable data demonstrates the high level of product safety and helps the surveillance of cosmetic products placed on the EU market, as well as in the process of safety evaluation.
These guidelines also provide the public and national competent authorities with re-assurance that industry's post-market surveillance data are accurate, credible and respect the protection of privacy of the consumer and healthcare professionals.
Colipa recognizes the intention of some EU Member States to create national “cosmetovigilance” systems, based on an EU-wide model and co-coordinated by the European Commission. Industry is committed to fully playing its role in order to support such a system.