According to European Regulation EC 1223/2009 (Article 4.1), “Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market.” This regulation can be the cause of much confusion when it comes to appointing or working with a fitting importer in the cosmetic products field. For example, its setting out of the mandatory obligation for manufacturers to designate a European Responsible Person – a body whose duties would otherwise fall to the (potentially uninitiated) importer – can raise many questions surrounding the effectivity of importers as regulatory representatives. We will, in this post, address some of those questions.
As stated above (and as originally laid out in EC 1223/2009: “For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market.”), the importer is automatically allocated the position of Responsible Person when introducing a new product to the European market. This can have many problematic consequences:
I. Area of Expertise
In many cases a importer is a purely commercial entity. That is, an entity that is specialized in commercial matters – rather than compliance or regulatory ones. While this is beneficial in terms of driving sales, it can often lead to large lapses in compliance and regulatory standards and practices. As a commercial entity, keeping constantly up to date on compliance standards in all 31 EEA countries (including the provision and confidentiality of their clients’ Product Information File) can be lower on their list of priorities.
II. Notification
It is the duty of the Responsible Person tocomplete the premarket notification and answer any questions from Competent Authorities. Should any unforeseen circumstances arise between the manufacturer and the importer (for example through a conflict of interest, or unfavourable treatment in regards another manufacturer the importer may be working with) that would lead to the termination of their contract, the entire notification process (including the reprinting of packages and notification of products) would need to be restarted from the first step with a new Responsible Person.
III. Confidentiality
As the Responsible Person, the importer is responsible for the handling and dissemination of all information required in the Product Information File (PIF). This includes product formulas, methods of manufacturing, animal testing data and research, compliance information, and proof of the claimed effect of the product. When working with a commercial entity which may being working in tandem with a series of manufacturers being distributed to one market, serious questions regarding the proper procedures surrounding information flow can arise.
IV. Conflicts of Interest
As mentioned above, it is sometimes the case that an importerwill work with many clients within the one market. This can often lead to the development of a hierarchical situation amongst manufacturers which can cause conflicts within the market (for example in terms of expansion, prioritisation, or effective lobbying by other manufacturers). As such, neutrality can sometimes be difficult for importers.
As is evident, there are many, many pitfalls of working only with an importer as a Responsible Person. That is why it is strongly advisable to delegate such responsibilities to a professional, neutral third-party with experience in the industry. This is where the European Responsible Person comes into effect. It is the job of the Responsible Person to act in the best interest of the manufacturer at all times and to respond to any question, remark, or crisis brought forth by any EU Authorities or Anti-Toxic center – regardless of any bias or inherent commercial stake in the market. Along with helping to avoid some of the danger areas outlined above, just some of the Responsible Person’s duties can include:
- Notifying and updating the Cosmetic Product Notification Portal (CPNP)
- Ensuring compliance with regulatory
- Product safety reports
- Good Manufacturing Practices
- Preparing and distributing the Product Information File
- Providing information and documentation to demonstrate conformity as requested by competent and national authorities
- Enacting immediate corrective measures or withdrawal/recall (where appropriate) in case of non-conformities
Located only minutes from the EU Commission in Brussels, in the heart of Europe, Obelis’ regulatory Experts are perfectly located – with all the relevant knowledge and expertise – to guide you through every step of the notification and compliance process and help get your products onto the European market in the most efficient and secure way possible. Feel free to contact us today for more information or a free quote.