French competent authority Agence Nationale de Sécurité de Médicament et des Produits de Santé ban breast implants linked to anaplastic large cell lymphoma.
News
What kind of testing do I need to do to register my cosmetics in the EU?
Find out what tests and other compliance factors may affect your cosmetic products under EU Cosmetics Regulation EC 1223/2009. Our EU experts are here to help.
Food Supplements Services launch!
Obelis launch consultancy and regulatory services for EU food supplements controlled by European directive 2002/46/EC.
Obelis new interdepartmental organization
Obelis announces re-organisation of departmental structure in ongoing expansion for greater skill development and improved career path transparency.
New Benefits with Obelis Monthly Plans
Obelis expands monthly plan offering to include greater round-the-clock client support and EU regulatory consulting scope.
Consequences of Non-Compliance
Full adherence to all compliance-related matters is a hugely important part of introducing a product to the European Market – or indeed maintaining its position there. Each category of CE Marking certifiable product has its own set of regulations or directives, from medical devices to personal protective equipment to toys, and electromagnetic devices to construction products and motor vehicles.
RA/QA The European Commission updates the restrictions in Cosmetic Products for: Phenylene Bis-Diphenyltriazine; 2-Chloro-p-Phenylenediamine; Climbazole
Read more about the new restrictions on phenylene bis-diphenyltriazine, 2-chloro-p-phenylenediamine and climbazole in cosmetics products on the European market.
Can Safety Assessment be done in a lab outside of the EU?
The Safety Assessment procedure is an important part of the cosmetics compliance process. Find out if this can be done in a lab outside the EU.
‘Free from’ claims – clarification of application
Danish authorities ask for clarification on processes for 'free from' claims for cosmetics products on the European market.
Biocompatibility: MDR and EN ISO 10993-1:2018
What does the new standard on Medical Device Regulation say.