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EU Responsible Person Service

Appoint Advena as your EU Responsible Person and benefit from our experience of being at the forefront of helping businesses adapt to the EU 1223/2009 Cosmetics Regulation.

With the introduction of the European Cosmetic Regulation EU 1223/2009 in 2013, came the requirement for a ‘Responsible Person’ established within the European Union (EU) to be designated for each product placed on the market. The ‘Responsible Person’ must ensure compliance of the products with the rules set out in the Cosmetic Regulation, particularly compliance relating to human health, safety and consumer information.

The importer or those outside the EU can by ‘written mandate’ select a person, already established within the EU community as the Responsible Person, who will carry out all of their legal obligations in respect of the new Cosmetic Regulation, including safety assessments, maintenance of product files and registration.

Working as your Responsible Person, Advena’s service includes:

  • Preparation and compilation of Product Information Files (PIF) as per Article 11 (Cosmetic Regulation EU 1223/2009). To include regulatory assistance with labelling requirements, restricted substances and claims.
  • Provide Safety Assessments to ensure compliance as per Article 10 (Cosmetic Regulations EU 1223/2009) via the use of one of our external registered qualified partners.
  • Registration of your cosmetic products via the EU Commissions Cosmetic Products Notification Portal (CPNP) system to include notifications of nano-materials (Article 16) or substances classified as carcinogenic, mutagenic or toxic for reproduction (Article 15) used.
  • Vigilance and Complaint reporting to the EU commission. Guidance on corrective actions and product recalls (Article 23).
  • Guidance on Good Manufacturing Practice (GMP) or ISO 22716 compliance.

Clients also receive regulatory reports by email, helping to keep you up-to-date with the ever-changing regulations and standards.

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