EU Responsible Person: What does it mean?
Whether you are a company intending to establish your Cosmetic products in the European Union (EU) market or whether you are already working within the community, you have certainly heard about the Responsible Person figure.
So, who is, in fact, the Responsible Person?
You probably would say that it is a person who is highly responsible, which is true, of course, because it takes a lot of responsibility to do this job, but the role of Responsible Person goes far beyond that.
This concept was introduced by the EU Cosmetics Regulation 1223/2009, which defines the Responsible Person as a legal (i.e. a company) or natural (i.e. an individual) person designated within the EU who shall ensure compliance with the relevant obligations set out in the Regulation for each cosmetic product placed on the market.
So, who may be the Responsible Person?
There are four scenarios from which a Responsible Person can be appointed:
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- If the cosmetic product is manufactured within the EU, and not subsequently exported and imported back, the manufacturer is the Responsible Person by default, as it is based on the EU.
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- If the cosmetic product is manufactured outside the EU, then the manufacturer cannot assume this role as it is not based on the EU, and, therefore, the importer established within the EU will act as Responsible Person.
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- Alternatively, the manufacturer or the importer within the EU may also transfer this responsibility to a third party based on the EU, like a consultancy company, by a written mandate. However, there must be a written acceptance to this assignment by the third party, as well.
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- If a distributor modifies a cosmetic product in a way that compromises its compliance with the legislation and/or markets a cosmetic product under its name or trademark, then it takes the role of Responsible Person.
Well, one thing is clear, for cosmetic products placed in the EU, the nominated Responsible Person must always be based within the EU. By the way, it is not new that the UK left the EU which had a great impact on the Responsible Person field. What do we know? For cosmetics placed on the EU market, Responsible Persons based in the UK are no longer recognized by the EU. Conversely, EU-based Responsible Persons cannot be in charge of cosmetics being introduced in the UK market. Thus, companies who wish to place cosmetic products in the UK will need to appoint a UK-based Responsible Person.
What if a company continues to operate in both markets? Well, in this case, two different Responsible Persons shall be appointed, one for each market, even if there are no differences in the product composition, labelling, claims, etc., in order to be compliant with the Regulation. Confusing enough? We agree, but, at least, responsibilities don’t change. And what are these responsibilities? Let’s take a look.
The obligations of the Responsible Person are described in Article 5 of the Regulation:
"Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1), (2) and (5), as well as Articles 20, 21, 23 and 24.” (EU Regulation 1223/2009, Article 5.1.)”
Simply just by the number of articles, you can already see that it is not an easy task but we will try to outline this part.
In short, the Responsible Person must ensure compliance with Good Manufacturing Practices (GMP), held the Product Information File (PIF) which includes the Cosmetic Product Safety Report (CPSR) and keep it up to date, be in compliance with labelling and claims requirements, notify the cosmetic product through the Cosmetic Product Notification Portal (CPNP), cooperate with the competent authorities, in order to communicate any identified undesirable effect or non- conformity and be always able to demonstrate that the cosmetic product complies with all the regulatory requirements. In the end, the main duty of the Responsible Person is to guarantee a high level of consumer safety by ensuring the safety of the cosmetic product.
As you can see, the Responsible Person role implies a lot of work and heavy responsibility, since you must keep the cosmetic product under surveillance for ten years following the market entry.
At Cosmedesk we have noticed the required effort and amount of responsibility over the shoulders of Responsible Persons, so we decided to build a tool to help them.
Our solution offers you the possibility to manage all your cosmetic products, from the ingredients’ creation to the generation of the required regulatory documents, helping you to perform the label review, handle ingredients restrictions, and to keep all the documents organized during the product life cycle.
