

Cosmetics Consultancy
Advena have been at the forefront of helping businesses adapt to the EU 1223/2009 Cosmetics
Regulation, with cost-effective consultancy support and our EU Responsible Person service.
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. In particular compliance relating to human health, safety and consumer
information.
Working as your EU Responsible Person, Advena’s service includes:
Preparation and compilation of Product Information Files (PIF) as per Article 11 (Cosmetic
Regulation EU 1223/2009).
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.