On the 10th of July 2018, the Commission published its 12th Report to the European Parliament and to the Council on the development, validation and legal acceptance of methods alternative to animal testing in the field of cosmetics for the period 2015-2017.
The report informs the Parliament and the Council about the compliance with this ban by economic operators in the EU and the impacts of the animal testing and marketing bans.
It also provides an update on progress in the development, validation and legal acceptance of methods alternative to animal testing.
The Commission confirmed that compliance with the EU norms on animal testing was mainly verified through checks by the competent national authorities on cosmetic products’ Product Information Files (PIFs), which must be kept by the Responsible Person for every cosmetic placed on the EU market. National Authorities carried out monitoring activities and checks during regular inspections on cosmetic products as part of general control activities.
Member States identified as main issue the fact of PIFs being incomplete with regard to data on animal testing and noted a correlation between the size of the operator (SMEs) and the problem of incomplete information on animal testing in the PIF.
Progress in the development, validation and acceptance of methods alternative to animal testing in the EU
Significant work is being done to develop the so called ‘integrated approaches to testing and assessment’ (IATAs) which include in vitro technologies, bioinformatics and computational toxicology.
This work has led to a substantial progress in the development, validation and regulatory acceptance of alternative methods for skin irritation/corrosion, serious eye damage/eye irritation and skin sensitisation but important gaps remain in the field of more complex human health effects (endpoints) such as acute and chronic systemic toxicity.
Progress at International Level
The Commission plays an active role at OECD level in the regulatory acceptance of alternative methods and their international adoption. In pursuance of a globally harmonised safety assessment of chemicals, the OECD updates on a regular basis the set of Test Guidelines to keep pace with progress in science and countries’ regulatory needs. From 2016 to 2017, 24 new and updated test guidelines were approved. Four of these guidelines were based on in vitro methods on skin sensitisation, skin corrosion and endocrine disruption.
At the same time, the International Cooperation on Cosmetics Regulation Steering Committee has endorsed some principles for an integrated strategy for the risk assessment of cosmetics ingredients incorporating ‘new approach methodologies’.
If you wish to know more about the requirements to comply with the EU animal testing ban, do not hesitate to contact us. Obelis Expert Consultants, with nearly 30 years of experience with EU regulatory affairs, will gladly answer your questions.