June 2023: BIORIUS International Information Letter 006: Clarification regarding the definition of a Responsible Person in USA

Responsible Person in USA: in our previous article regarding the Modernization of the Cosmetic Regulation Act, we informed you that a responsible person must be designated for each cosmetic product made available on the market.

The Responsible Person must:

• Ensure that the product is safe
• Take care of the cosmetovigilance cases including :
  • Receipt of Adverse Reactions and Severe Adverse Reactions
  • Reporting of Severe Adverse Reactions to the FDA
  • Allow competent authorities to access cosmetovigilance reports
  • Allow competent authorities to access information on fragrances and flavorings in case of a Severe Adverse Reaction
  • Include a contact person, address etc. on the label to receive consumer complaints
• Notify cosmetic products and:
  • Perform the annual renewal of this notification
  • Perform an update of the notification in case of modifications
• Ensure that allergens appear accurately on the label (list to be published by the FDA)
• In case of inspection, provide with evidence regarding the safety of the products to the authorities within a reasonable time and in a reasonable manner
• Recall/withdrawal of products at the request of the authorities

On beginning of June, FDA gave more information regarding the location of the responsible person:

• The responsible person is the entity that places products on the market. The responsible person does not need to be on U.S. territory.
• The contact for adverse reaction reporting is listed on the product label. This contact must have a full address, telephone number or e-mail contact in the USA.

In case of the responsible person is not located on U.S. territory, an US agent must be designated.

The US Agent must be mentioned in the establishment registration. He needs to reside in the USA and be available 24 hours a day for questions, health issues, and controls or inspections. The agent will not be responsible for products nor for sanitary matters. However, he facilitates communications with competent authorities.

We hope that this will be of help and stay at your disposal for any questions related to this topic. Should you have any question, please, feel free to contact your CRM (Customer Relationship Manager) or contact us directly: info@biorius.com. We will keep you updated on future developments regarding this topic.

Thanks to Pierre Verachten for writing this article.