Dr. Matteo Zanotti Russo – Angel Consulting
In less than two weeks I attended two very high level conferences:
the CRCC in Brussels and the Cosmetica Italia Information Day in Milan. In both events the effects of Brexit have been investigated, which will take place within a few months. The hopes for last-minute changes are unrealistic, partly because the experts have shown us that there would be no more technical times for a change of course. Brexit is something done, at least for the cosmetics industry, and all the companies have been invited to organize themselves as if Brexit were already operational.
What will happen in practice? And when?
By the end of March 2019 UK will be issued rules that will fully reflect the current European standards. So, at least at first, we can get an idea of the British cosmetic regulatory scenario, then of course, as an independent state, the UK government can decide whether to maintain alignment with the cosmetics legislation in force in the EU or move away from our model for follow the American FDA approach, or make your own independent frame. It is not possible to know now what the developments will be, but common sense suggests that if they are there they will be gradual and in the medium term.
We therefore have the certainty that at the end of March 2019 a virtual wall will rise, and every cosmetic product on the UK market will have a Responsible Person UK on the label, while in Europe every product with Responsible Person present in UK will have to refer to a Responsible Person located in Europe. At the same time, the “non-visible” part, such as the CPNP (and a “UK”) must appear, and above all a Product Information File (PIF) – UK identical to the “EU” model, except for Safety Assessment, to be carried out by a “UK” Safety Assessor.
I am not sure that everyone has understood that the day after the entry into force of Brexit products in the UK will already have to be “UK” and vice versa products from UK on the European market will have to comply with EU rules that exclude the recognition of the UK. I’m not sure everyone has understood that there will not be an adoption time. The products with Responsible Person “UK” on a shelf in EU will be outlawed.
Considering the importance of the British market in cosmetic products, I think of the amount of actions necessary to ensure the continuity of marketing and the compliance of products on the UK and EU markets, which from April 2019 will be two separate and distinct markets. By monitoring the flow of information requests and the Brexit keywords for cosmetics, I believe that many companies are underestimating the practical consequences of what will happen, certainly, within 5 months.
What to do?
The first step is certainly a “check up”: it is essential to make a “mapping” of its products on the market, so as to evaluate the flow of products to the UK or from the UK to Europe. For cosmetics manufacturers, it is also necessary to consider that the flows of raw and semifinished materials will also be subject to new customs regulations and different duties. But the secret of success, as in all regulatory aspects, is always: timing. Studying a correct strategy and putting it into practice takes time, and in my opinion who should start worrying only today about the consequences of Brexit would be in serious delay.
The greatest risk is certainly the blocking of the market, but also the possible recourse to extemporaneous solutions involves considerable risks. In this case, the possibility of having to appoint a “last-minute” Responsible Person may occur, perhaps using the local Distributor, a practice that is certainly legal but always strongly discouraged. We must not forget that the Responsible Person is not simply an “address to put on the label”, as some people still believe. The EU Responsible Person, but in the same way the UK Responsible Person, is the “focal point” of the cosmetic product, that is the entity that guarantees compliance with the law, it manages the fundamental points that must be able to control and above all it must be able to demonstrate this control to the authorities. The key terms that must characterize the Responsible Person are “capacity” and “responsibility”. It is important to remember that the companies that today sell in all the countries of the EU from March 29th 2019 to 11.00 must have two entities, and the products present at that moment in the two markets must be both suitable and adequate.
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