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Regulatory & compliance

The Regulatory Company

Service Description

Cosmetic products in the EU are strictly regulated. They are governed by the harmonized EU legislation, EU Cosmetics Regulation 1223/2009. The EU Cosmetics Regulation defines requirements related to among others: responsibility / liability, product safety, centralized cosmetics notification (registration), product dossier content, product labeling and consumer information, cosmetovigilance, etc. The main aspect of the regulatory compliance of cosmetic products in the EU is that it is the responsibility of the manufacturer or importer (the so called "Responsible Person") to ensure that the cosmetic products meet all requirements of the Cosmetics Regulation. The Responsible Person is liable for: Availability and correct content of the product dossier (Product Information File) Safety assessment of cosmetic products (conducted by a qualified safety assessor) Notification (registration) of the products to the competent authority Providing the relevant information to the Poison Centers Correct consumer information and product labeling Cosmetovigilance (Post-marketing surveillance of health-related undesirable effects, possibly due to the use of cosmetic products)

Details

  • SegmentPersonal care
  • ApplicationsMake up, Skin care

Specialized in

EU regulation
Product information files (PIF)
REACH
Classification and labelling (CLP)
Responsible person
GHS

Sample work

CompanyLogo

  • Company nameThe Regulatory Company
  • Legal nameThe Regulatory Company
  • HeadquartersThe Hague, Netherlands
  • DescriptionWe aim to guarantee product safety and compliance in a rapidly developing context. We act with in dept toxicological and regulatory knowledge, and pursue an effective and efficient way of working. We are convinced we have to do so in cooperation with regulators, authorities, producers, distributors, brand-owners, service providers and other stakeholders. To add the highest possible value we contribute in the entire product lifecycle from an information management, regulatory and toxicological perspective, by offering and executing complete services, in close and involved partnership with our clients. We place customers first, work fully digital making use of the latest available technology, are well informed and our experts can be contacted easily and directly.