Regulation (EC) No 1223/2009 requires any company selling cosmetic products in the European market to designate a Responsible Person. This obligation, essential to ensure product compliance and safety, requires particular attention when drafting mandate or service agreements. A rigorous approach is necessary to secure the parties' commitments and anticipate legal risks.

1. Who Can Be Designated as the Responsible Person?

The Responsible Person may be the manufacturer established in the European Union, the importer, the distributor, or a third-party representative. The Regulation stipulates that this designation must be formalized in a written agreement, clearly specifying the scope of responsibilities assumed.

Contractual Consideration:

The mandate agreement must unambiguously define the respective obligations of the parties and the allocation of responsibilities (Article 4 of the Regulation), particularly concerning regulatory dossier management and communication with competent authorities.

2. Legal Obligations of the Responsible Person

The Responsible Person must ensure the product's compliance with the Regulation's requirements, particularly regarding safety, labeling, and notification.

Key obligations include:

• Ensuring product safety (safety assessment and compliance report, Annex I);

• Maintaining the Product Information File (PIF) for 10 years (Article 11);

• Notifying the product via the CPNP portal (Article 13);

• Reporting serious adverse effects to national authorities (Article 23);

• Verifying labeling (e.g., "[nano]" designation, claims) and ensuring no animal testing.

These obligations require close coordination with the manufacturer or importer, which must be formalized in the contract.

Contractual Considerations:

The Regulation's annexes are frequently updated (e.g., lists of prohibited substances). Mandate agreements should include specific clauses governing access to technical data, updates in case of regulatory changes, and procedures for reporting adverse effects. Additionally, provisions on liability limitations and insurance coverage are recommended to mitigate risks related to potential non-compliance.

3. Risks and Best Practices in Mandate Agreements

The complexity of regulatory requirements, particularly concerning nanomaterials and claims, underscores the need for precise drafting of mandate and service agreements. Parties should anticipate potential disputes, such as post-market non-compliance or legislative changes affecting product commercialization. For example, rapid response mechanisms in case of inspections should be established.

Special attention should be paid to confidentiality clauses, contract duration, and termination terms to ensure a smooth transition in case of a change in the Responsible Person. Finally, including technical annexes detailing regulated substances and required evidence for claims is a best practice to strengthen legal security.

Additionally, in case of contract termination, provisions should ensure a seamless transfer of responsibilities and address the status of remaining stock.

Conclusion

The designation of a Responsible Person is a crucial step in the commercialization of cosmetic products in the European Union. Meticulous contract drafting helps secure relationships between parties and ensures compliance with legal obligations.

Companies are advised to seek specialized legal guidance to tailor contracts to their specific needs and regulatory developments.

Keywords: Cosmetic Responsible Person, Regulation 1223/2009, EU compliance, mandate agreement, cosmetic product safety, cosmetic labeling, nanomaterials, CPNP, cosmetic claims.

This article is for informational purposes only and does not constitute legal advice.