OBLIGATIONS FOR DISTRIBUTORS

Distributors must comply with a number of obligations regarding placing a cosmetic product on the market and must cooperate with the Responsible Person and the authorities whenever necessary. These obligations include:

1. Checking transport and storage conditions

Distributors must ensure that storage and transport conditions are fully compliant with the cosmetics regulations.

2. Checking the labelling, language, and date of minimum durability

• Before any cosmetic product is placed on the market, distributors must ensure that:
  The label displays the name (or company) and address of the Responsible Person as well as the batch number and a list of ingredients contained in the product.
• The product includes a supplementary document (label, strip, card or enclosed leaflet) which provides:
  • The precautions for use
  • A list of ingredients where there is insufficient space on the packaging
  • A label next to small products: soaps, bath pearls etc.
• The information on the label is written in French.
• The label shows a minimum durability date and certifies that it has not expired.

3. Refraining from selling a product that does not comply with cosmetics regulations

If the distributor observes that a product does not comply with the cosmetics regulation requirements, they must refrain from selling the product.

4. Obligations in case of non-compliance with cosmetics regulations

• The distributor must:
• Take corrective action, withdraw or recall the product.
• Immediately inform the Responsible Person as well as the country’s competent authorities (the ANSM and DGCCRF for France) if the product poses a risk to human health: they should provide specific details on actions undertaken to avoid any health risk for consumers.

FYI: how should the ANSM and DGCCRF be informed?

• For the ANSM, contact their Direction de la Surveillance (DS or Monitoring Authority) directly at cosmetovigilance@ansm.sante.fr
• Reports falling within the competence of the DGCCRF, are processed by the DD(CS)PP or the DIECCTE in accordance with the order of 9 September 2004.

5. Informing the ANSM in the event of an SAE (Serious Adverse Event)

If an SAE has been recorded and recognised in the country where a product is marketed, the distributor must immediately contact the country’s competent authorities, i.e. the ANSM in France (at the following address: cosmetovigilance@ansm.sante.fr ) and provide them with:

• The list of SAEs the distributor is aware of or can be assumed to be aware of.
• The name of the product so that it can be identified.
• Corrective measures and actions taken, if any.

6. Cooperating with Member States when requested

In France, distributors must cooperate with the ANSM and DGCCRF when these organisations ask them to:

• Put measures in place to eliminate the risks associated with a given product placed on the market. In order to do this, distributors must provide information and documentation that proves the product’s compliance with the requirements related to labelling, language, and date of minimum durability.
• Identify the distributor or Responsible Person who supplied the product and the distributors to whom they supplied the product, in order to identify the supply chain and traceability of the product. This obligation applies for a period of 3 years from the date on which the batch of products was made available to the distributor.

7. Notifying the European Commission before a cosmetic product is offered for sale in another Member State

Before a product already on the market in one member state, is offered for sale in another member state, the distributor must translate all elements of the product’s labelling in order to comply with national law. The European Commission must be notified of this information electronically.

8. Notifying the Responsible Person if the cosmetic product is taken off the market and subsequently re-introduced

Where a cosmetic product has been placed on the market before 11 July 2013, but then withdrawn as from that date, the distributor must provide the Responsible Person with certain information should they reintroduce the product into a Member State after this date.