Why can’t my Safety Assessor act as Responsible Person?
The role of the Responsible Person is an absolutely pivotal one in the compliance and European Market distribution process. Many questions have arisen surrounding who or what bodies may perform the functions of the Responsible Person. The most important thing to know, at any stage, is that according to EU Cosmetics Regulation (Regulation (EC) No. 1223/2009): “Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market”. With this in mind, it is clear that the role of the Responsible Person is one to be taken seriously, and appointments should not be made lightly – especially not to organised bodies which may have limited industry knowledge or experience, or may have a role/skillset of their own already.
One such body that often arises when calling into question who should take on the role of the Responsible Person is the Safety Assessor. Firstly, it is important to note that while some aspects of safety are certainly within the remit or the Responsible Person; the Responsible Person’s role is a legislative matter and has many other aspects to it outside the realm of safety. As such, an overwhelming proportion of the duties attributed to the Responsible Person fall largely outside the remit and skillset of the Safety Assessor.
While there are some duties which may well be manageable for a Safety Assessor, including:
- Safety (according to Article 3 of Regulation 1123/2009)
- Good Manufacturing Practices (Article 8)
- Safety assessment (Article 10)
Many of the duties required of the Responsible Person may not be possible for the Safety Assessor to carry out effectively, these include:
- Completion of the Product Information File (Article 11) and making available of the file to the relevant Competent Authorities
- Sampling and analysis (Article 12)
- Market Notification, and CPNP notification (Article 13)
- Restrictions for substances listed in the Annexes (Article 14)
- Restrictions on CMR Substances (Article 15)
- Nanomaterials (Article 16)
- Traces of prohibited substances (Article 17)
- Animal Testing (Article 18)
- Labelling (Article 19)
- Product Claims (Article 20)
- Making information accessible to the public (Article 21)
- Communication of serious undesirable effects (Article 23)
- Information on substances and raw materials (Article 24)
Secondly, it has to be stressed that the main role of the Safety Assessor is to complete Safety Assessment including all the necessary tests being completed according to the EU protocol, whilst the role of Responsible Person is to verify them. There is an obvious conflict of interest arising if the RP and Safety Assessor is one and the same person. For that reason, it is not possible for any Safety Assessor to be appointed as the Responsible Person – both entities have to remain separate in the EU Compliance process.
Located minutes from the EU Commission in Brussels, our regulatory experts and consultants have the knowledge and expertise to guide you through each step of the Responsible Person appointment process, as well as the compliance process in general. Contact us today for advice, a free quote, or to get more information on the role of the Responsible Person.