EU Responsible Person
As clearly indicated by the EC 1223/2009, designating a Responsible Person is a mandatory requirement.
“Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24” (Art.5, p.1).
The RP is responsible to ensure that all the obligations related to product conformity have been carried out prior to placing the product onto the European Market and then to act as the Cosmeto-Vigilance contact point in Europe towards the cosmetic product responsible for.
In supporting any brand owners in gaining EU Compliance, a professional EU Responsible Person should act as a consultant providing:
- Formula verification- review for restricted, prohibited ingredients, etc.
- Support collecting, verifying and compiling documentation required for the Product Information File
- Creation and validation of the Product Information File
- Verification of Safety Testing
- Identification of missing Safety Testing & EU Accepted Protocols
- Guidance on labeling and language requirements
- Advice on claims & proper substantiation
- Guidance on compliance with the No Animal Testing, GMP, CMR
- Pre-Market Notification
Once products have been registered (notified), the EU Responsible Person should also provide:
- Ongoing Regulatory updates & EU Market Consultancy
- Post-Marketing Surveillance: reporting of Serious Undesirable Effects (SUE), support regarding any EU Competent Authority requests, corrective measures,
- Immediate corrective measures, withdrawal/recall if appropriate in case of non-compliance.
- Immediate information to competent authorities (CA) and other economic operators in case of risk to protection of human health.
- Provide information and documentation to demonstrate conformity as per requests by national authorities. Keep the PIF readily accessible to the Competent Authorities for a period of 10 years after the last batch was placed on the market.
- Scope & Classification
- The Regulation: EC 1223/2009
- Product Information File
- Good Manufacturing Practices
- Cosmetic Product Safety Report (CPSR) - Part A & B
- Mandatory Safety Testing
- EU Labeling
- Pre-Market Notification: Cosmetic Product Notification Portal (CPNP)
- Post-Market Surveillance
- Risks of Non-Compliance
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