In the field of cosmetic products, appointing a Responsible Person is a mandatory part of introducing any product to the European Market. As the Cosmetic Regulation EC 1223/2009 states: “only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market” (Article 4.1).
Non-European companies cannot fulfil this role themselves, therefore they have to delegate this regulatory burden to another party. Many of them decide to work with one of their European distributors as Responsible Person. We must stress that this strategy is really risky and there are numerous long-term factors to take into consideration while choosing a Responsible Person:
I. Areas of Expertise
The role and required competencies of the Responsible Person are quite specific. They must be proficient in EU Regulations and must possess enough regulatory expertise to answer any queries or questions from Competent Authorities. Most regular distributors (operating in a purely commercial capacity) may not be able to do that. The main regulatory roles of RP include:
- Notification: Completing pre-market Notification in the Cosmetic Product Notification Portal (CPNP), along with answering any questions posed by relevant Competent Authorities about products put on the EU market.
- Compliance: The RP is also responsible for all compliance process throughout the entire lifetime of a product on the market– including completing the Product Information File (PIF) and updating it regularly if there are any changes made to the product.
- Safety Assessment & Testing: Responsible Person has to make sure that all necessary testing has been completed and validate/double check its results
- Good Manufacturing Processes: The RP must ensure all Good Manufacturing Processes are adhered to.
II. Conflicts of Interest/ Impartiality
As alluded to above, in many cases, a distributor’s main motivation may be of a commercial nature. While this is not a largely negative factor, it can often lead to conflicts of interest when the distributor works with more than one manufacturer, for example, in terms of expansion, prioritisation, or effective lobbying by other manufacturers. This can lead to issues surrounding the level of impartiality required of a Responsible Person.
III. Confidentiality
Similar to conflicts of interest and impartiality, confidentiality can sometimes too be an issue when improper consideration is given to assigning a generic distributor as Responsible Person when working with many clients in one market. For manufacturers located outside of the European Union, it is mandatory for the Responsible Person to hold a copy of the manufacturer’s Product Information File on their premises. The PIF includes information on product formulas, methods of manufacturing, testing data and research, compliance information, and proof of the claimed effect of the product. For this to be viable, the manufacturer must place a lot of trust in their chosen distributor and be sure all information is being treated with the upmost level of confidentiality.
It is for these reasons, along with many others, it’s strongly advisable for manufacturers to designate a neutral third-party as a Responsible Person – one with extensive experience and a strong reputation in the industry. It is the duty of the Responsible Person to act in the best interests of the manufacturer at all times and take care of all their compliance and regulatory interests inside the European Union.
Obelis’ team of expert regulatory consultants are perfectly placed only minutes from the EU Commission in Brussels and have all the required knowledge and industry experience to ensure each step of the manufacturing to market process is carried out with professional care. To find out more about Obelis’ Responsible Person services, or to get a free quote, contact us today.