We provide a complete service for you as the Responsible Person

Who is the Responsible Person?
 

If you intend  to launch cosmetic products throughout the EU,

you need a “Responsible Person” for your products in the EU market.

Since 2013 according to the European Cosmetic Regulation EU 1223/2009, 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 European Cosmetic Regulation EU 1223/2009, particularly compliance relating to human health, safety and consumer information.
 

“Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market. In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community”.
 

The importer or manufacturer outside the EU should select a company, established within the EU community as the Responsible Person, who will be responsible for legal obligations in respect of the Cosmetic Regulation, including safety assessments, maintenance of product files and registration

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Danima`s service as Responsible Person includes:
 

• Ensuring that your products are complied with EU regulation EU 1223/2009

• Providing EU address

• 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.

• Providing an  immediate response to local and competent authorities in the Netherlands  and to any referral from an EU Member of States.

• Reporting any serious or undesirable effects to competent national authorities.

• Vigilance and Complaint reporting to the EU commission. Guidance on corrective actions and product recalls (Article 23).