Any product placed on the EU and UK market that falls under classification of cosmetic products is subject to Cosmetic Regulation 1223, 2009. One of the main principles of this regulation is attributing a Responsible Person (RP) to each product that is being placed on the market. But who can be the responsible person? Based on Article 4, Reg 1223,2009 “A Responsible Person is a natural (i.e. an individual) or legal person (i.e. a company) established within the European Union who shall ensure compliance with the relevant obligations set out in the Cosmetics Regulation”.
The name and address of the Responsible Person should be printed both on the container and packaging of each cosmetic product. But is it just a traceable address without any other responsibilities?
The Responsible Persons shall ensure compliance with Article 3 (safety), Article 8 (GMP), Article 10 (safety assessment and if the safety assessor is duly qualified), Article 11 (PIF), Article 12 (sampling and analysis), Article 13 (notification on the EU portal/CPNP), Article 14 (restrictions for substances listed in the Annexes), Article 15 (substances classified as CMR substances), Article 16 (nanomaterials), Article 17 (traces of prohibited substances), Article 18 (animal testing), Article 19(1)(2) and (5) (labelling), Article 20 (If there is substantiation for product’s claims), Article 21 (access to information for the public), Article 23 (communication of serious undesirable effects) and Article 24 (information on substances).
Considering the above list, it is truly fair to state that the RP is a BIG responsibility that can affect a brand’s identity. Hence, it is not just an address on your label. While choosing the RP for your brand, the criteria that should be taken in account are:
Is the company just selling an address or has it got the expertise inside the company to be able to look after your brands for all the responsibilities stated above?
Does the company have toxicologist/safety assessors in house to update your safety assessment in case of requirement of updating your safety report?
Is the company trustworthy and does it have a physical address and not just a post box?
Does the company know how to provide you with post market surveillance and fully support your brand?
Considering the Brexit and requirement for UK and EU RP, the expertise of a Responsible Company is more important than ever. The company should have a team of experts in house to ensure your compliance and with a physical address in the EU/UK should be able to respond with agility on any Undesirable and Serious undesirable effects.
If you want to discuss further for answering the above questions, please do drop us an email or give us a call....
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About the author:
Bio: Dr Mojgan Moddaresi (PhD, PharmD, CBiol, FRSB, MBTS, MSCS)
Mojgan (known as Dr M) is the managing director of Personal Care regulatory Ltd. She has been graduated as the first PhD in cosmetic science from London college of Fashion (in collaboration with Kings’ College, London). She has over 20 years of multi-disciplinary experience in cosmetic, pharmaceutical and biopharma industries. She is a Chartered biologist, Fellow of Royal Society of Biology, a member of British Toxicology society and UK Society of Cosmetic Scientists.