The (first) importer into the EU market is by default considered to be the Responsible Person, and has to fulfill all Responsible Person duties and responsibilities. This also includes: taking appropriate action when he has a reason to believe that the product is not safe for use to ensure adequate protection of consumer health and safety; sharing (limited) product information on 3rdparty request; and having an effective cosmetovigilance system in place to track, record, evaluate and implement corrective actions in the case of health related complaints.
We strongly advise our clients to appoint TRC to both perform all the regulatory steps towards EU market readiness, as well as to mandate TRC as the Responsible Person for their products and to manage REACH compliance. In that case you will benefit from clear advantages in terms of efficiency, lead-times, quality and costs. Performing the steps towards regulatory compliance and being the Responsible Person are highly interdependent tasks and responsibilities.
For example, both the safety assessor and the Responsible Person will have to analyze and evaluate your formulations. And in the case of adjustments; updates will have be carried through in the PIF, the regulatory check and safety assessment, the label and claim review, the CPNP notification, and your Responsible Person must be fully informed and approve all adjustments.
The REACH Regulation also applies to cosmetics. Managing REACH compliance requires historical and the most up-to-date raw material and product details that must be in the possession of the Responsible Person. This makes it a natural choice to have your Responsible Person manage REACH compliance for you.
As your Responsible Person, TRC keeps track of all changes in the applicable EU Cosmetics Regulation, and changes initiated by you and your suppliers. We will inform you timely about the impact on your product portfolio, and will advise you on how to stay compliant in the everchanging field of regulations while serving your commercial interests.
The product information file needs to include highly confidential information such as about raw materials, suppliers, formulations and testing results. Information that you do not want to share with your distributors and/or multiple service providers. As your Responsible Person we will store your product information electronically and safe as highly confidential IP information. Where needed, only part of it will be shared by us with authorities in case of urgent requests within the legal term of 48/72 hours.
We successfully guided many EU authority inspections as the Responsible Person for our clients backed by:
- 30+ years of regulatory experience
- 10+ years of experience as a Responsible Person for many products
- 10+ years of experience servicing small sized to global companies
- Our high quality co-developed software