.svg-1.png)
The compliance and safety of each cosmetic product has to be monitored and continuously managed with all relevant information readily available for competent authorities.
TRC will do so as your Responsible Person (RP) in the EU/UK, and your US Agent/compliance partner in the USA.
The EU/UK Responsible Person must ensure continued compliance, be in possession of the full product dossier including the cosmetic product safety report (CPSR), notify products in CPNP/SCPN, and be at the disposal of the authorities for inspection and monitoring at all times. Inspections will always take place at the address of the Responsible Person.
The EU manufacturer or the (first) importer into the EU market is by default considered to be the Responsible Person, and has to fulfil all Responsible Person duties and responsibilities. With TRC as the Responsible Person these responsibilities are delegated to TRC by a written mandate.
RP responsibilities include: 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 3rd party 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 you to appoint TRC as your safety assessor to perform all the regulatory steps towards EU/UK market readiness, and to mandate TRC as your Responsible Person for your 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 US Agent/compliance partner, we provide services for Non-US and US based companies. As your US Agent we service as your domestic contact in communication between the FDA and the (Non-US based) manufacturing facility. We will register your facility, and enter and manage your brand listings for the brands with product sales in the USA.
As your compliance partner, before we start with your product listings, we will look into your product details. Depending on your needs and the contracted TRC services, we will list your products after a basic product review and label check, or we will first perform full product regulatory compliance and safety assessment services.
As your compliance partner, TRC keeps track of all changes in the applicable cosmetics regulations, 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 ever changing 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 compliance partner we will store your highly confidential IP information electronically and safe.
Only information that is rightfully requested will be shared by us with competent authorities. We will do so within the legal term of 48/72 hours in the case of urgent requests.
We successfully guided many authority inspections as the Responsible Person for our clients backed by:
- 30+ years of regulatory experience
- 15+ years of experience servicing small sized to global companies
- 10+ years of experience as a Responsible Person for many products
- Our high quality co-developed PRIMS software
