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Why designate a Responsible Person ?

What does Article 4 of the Cosmetics Regulations say

Article 4 of the Cosmetic Regulations states that only cosmetic products for which a Responsible Person has been designated can be placed on the market. In other words, a Responsible Person is essential for the sale of your cosmetics.

Who can be a Responsible Person?

For each cosmetic product placed on the European market, a Responsible Person must be designated. The Responsible Person can be the manufacturer, the importer or even the distributor or any other person established in the European Union.
They must ensure compliance with the provisions of the regulations in respect of the cosmetic product(s) they are placing on the market.

What are their responsibilities and obligations?

The Responsible Person has numerous obligations and responsibilities. They must ensure that the cosmetic product for which they are responsible complies with Regulation 1223/2009 and its amendments.
In other words, they are primarily responsible for:

  • Ensuring that the cosmetic product they represent is safe for human health
  • Ensuring that the cosmetic product they represent complies with the Cosmetics Regulations obligations
  • Being the first point of contact for the competent authorities in the Member States
  • Informing the competent authorities in the Member States (in particular if the cosmetic product poses a risk to human health)
  • Cooperating with the competent authorities in the Member States
  • Reporting Serious Adverse Reactions (SARs) to the competent authority in the Member State where the SAR was recorded.
  • Identifying the supply chain (distributors)
  • Communicating information to the public: qualitative and quantitative product formula, quantitative information on potentially hazardous substances, fragrance compositions, desirable and undesirable effects etc.

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