Introduction: Responsible Person versus Importer
By law (European Cosmetics Regulation EC No 1223/2009 Art. 4-5), every cosmetic product placed on the European Union market must be legally represented by a Responsible Person which can be a legal or a natural person and has to be based in the European Union. The Responsible Person ensures compliance with all legal requirements established by the European Cosmetics Regulation.
If you are a cosmetic brand and do not have an office in the European Union, one option could be to open one, and hire people to be your Responsible Person, however, this could be very expensive and very difficult to organize from outside the European Union.
Another option would be to turn to your importer (or your distributor) as he has this physical presence and hence could act as the Responsible Person of your products. This would seem the ideal option. Yet most importers are not willing to take on this role for three main reasons:
- Lack of qualifications: in order to represent and defend your brand, to perform regulatory monitoring and to guarantee the compliance of your product, the Responsible Person must be an expert in regulatory and legal affairs, toxicology, chemistry and pharmaceutical sciences.
- Lack of language & communication skills: in order to manage interactions with customers and with the 27 National Competent Authorities in the 24 official languages, the Responsible Person requires strong language and communication skills.
- Time investment: as described in more detail below, the Responsible Person has a wide range of tasks to perform, which represents a significant investment of time that most importers are unwilling to make.
Most importers are marketing and sales specialists with little to no interest in diversifying beyond their core activities.
Another layer of complexity appeared in the last months with the Brexit situation: In order to sell cosmetic products in the UK, it is now mandatory to have a Responsible Person with offices based in the country. If you sell both in the EU and in the UK, you need to ensure that your Responsible Person is present on both territories. Whereas you could rely on one single physical location anywhere in the EU or the UK before the Brexit.
Therefore, it’s strongly advised to hire an independent, qualified Responsible Person able to embrace the full scope of its mission before starting any commercial discussions with European importers and distributors.
The Role of a Responsible Person
Finding the right Responsible Person is not always easy. Many companies may claim to be qualified for this function but only a very small fraction of them can realistically take on this role. This business partner must be able to complete the following tasks:
- Protect your brand against compliance issues.
- Assist you with legal questions related to the European Cosmetics Regulation.
- Answer all questions from National Competent Authorities (27 EU Member States + United Kingdom)
- Manage all inspections of cosmetic product decided by the Supervisory Competent Authorities.
- Keep a close eye on regulatory developments and changes and keep you up to date by providing assessments that detail in depth the impact this may have on your products.
- Handle all cosmetovigilance issues (undesirable effects) by following-up with the consumers and ensuring the best course of action.
- Maintain all cosmetic product files.
Criteria to Verify When Selecting a Responsible Person
In order to fulfill this role, a Responsible Person must have specific strengths. Several criteria should always be verified before selecting your Responsible Person.
A Responsible Person unable to fulfill even just one of these criteria is likely to produce poor results, which in turn could result in terrible consequences for your brand: market withdrawal of one, several or all products, criminal & severe financial consequences*, loss of reputation, etc.
Here is a suggestion of criteria that a company should consider:
- Technical proficiency:
– Answering the specific questions asked by the Competent Authorities or the cosmetic brands would be impossible without in-depth knowledge in regulatory affairs, toxicology and chemistry. Regulatory experts with at least 5 years of relevant professional experience in the cosmetic industry and toxicologists legally qualified as “Safety Assessor” (PhD level) are considered to be a prerequisite for example.
– The management of special issues with the Authorities requires a deep knowledge but also a good practice of legal affairs applied to the cosmetic industry.
– The proper management of undesirable effects with consumers requires not only years of experience but also being highly skilled in pharmaceuticals sciences.
- Communication talent:
– The European Union has 24 official languages and many inspectors of the National Competent Authorities will only communicate in their native language with the Responsible Person. The ability to understand questions of the Authorities is key and being able to answer in the same language is an effective way to show good will and facilitate the successful resolution of legal issues.
– In case of a legal, regulatory and/or safety issue, it is an important part of the Responsible Person’s role to defend at best your brand’s interests. Beyond scientific and regulatory arguments, the Responsible Person must be an excellent communicator with a strong capability to build trust with the Competent Authorities, convince them and negotiate compromises as advantageous as possible you.
– When interacting with a consumer in the context of a cosmetovigilance issue, it is also key to be able to show empathy and act as an ambassador of the cosmetic brand. The objective is to re-establish consumer confidence in the cosmetic brand while addressing the safety issue.
– When a legal, regulatory and/or safety issue is identified by the Competent Authorities or simply when a random verification is operated, responsiveness is key: accurate answers should always be provided within one business day and suitable technical evidence submitted without delay. Any exception to this rule could be interpreted as a lack of dedication, seriousness and good will of the Responsible Person, which may lead to unwanted consequences for your brand.
– In addition to a timely follow-up of legal issues, the Responsible Person should adopt a proactive and solution-oriented approach offering in good faith workable proposals to the Competent Authorities.
– The responsiveness criterion outlined above is somehow linked to the capacities of the Responsible Person. Small teams, for example, cannot do much when serious issues arise. An explosive reactivity, prone to show good will to the Competent Authorities and likely to leave the inspectors with a good impression, is an absolutely necessity. Small Responsible Persons, only made of a few regulatory experts and toxicologists (likely overwhelmed by their normal workload), may result in poor performances in case of a problem.
– To ensure a proper follow-up of all issues, it is preferable that the Responsible Person has an Account Management team in which project managers overseeing and verifying that questions are properly answered and in a timely manner.
– The role of the Responsible Person is to protect your interests. Serious Responsible Persons rarely fail in their mission, but this important matter is not worth taking the risk: what happens if something does go wrong? In such a situation, the Responsible Person should be able to assume its financial responsibilities: indemnify the cosmetic brand if necessary, pay fines to the Authorities, and so on. This worst-case scenario should be kept in mind and it is strongly advisable to select a bigger company with good financial capacities and, it goes without saying, an excellent reputation.
– Beyond this, you should also ensure that the selected Responsible Person is covered by a good insurance plan. Cover of one million euros per legal case and per year seems to be an absolute minimum.
- Presence in the UK: Last but not least, when choosing the right Responsible Person you should also take into consideration the fact that the United Kingdom has left the European Union, with the transition period coming to an end on December 31st, 2020. Following this deadline, every cosmetic brand that wants to place its products on the British market will be asked to have a UK based Responsible Person. Therefore, only Responsible Persons having at least two offices (one in the EU and one in the UK) will be able to cover the whole of Europe in the near future. More information on the Brexit situation.
How does BIORIUS fit into these Selection Criteria?
BIORIUS has over eleven years of experience as a Responsible Person, with offices in Belgium (headquarters), France (2 offices), Luxembourg, South Korea and the United Kingdom. With over 50 employees, including 6 Account Managers and more than 30 experts specializing in legal and regulatory affairs, toxicology, chemistry and pharmaceutical sciences; BIORIUS possesses the necessary capacities and knowledge to fulfill its role in the best way possible.
BIORIUS is also proud to have a long withstanding and excellent relationship with the National Competent Authorities and its Supervisory Competent Authorities (Belgium Ministry of Health) and can voice the interests of its numerous clients in Dutch, English, French, German, Greek, Italian, Korean, Portuguese, Spanish and Turkish.
Today, BIORIUS is the Responsible Person for over more than 10,000 cosmetic products and is exceptionally robust and effective in its function. However, even the best companies may encounter a bump in the road from time to time, therefore BIORIUS is covered by an insurance plan of five million euros per legal case and per year. This is because BIORIUS thinks big and is part of the reason why it has been able to build and maintain strong, long lasting working relationships with several big corporations.
BIORIUS competitors have been objectively screened internally with the analysis leading to the following comparison between BIORIUS and the market average:
*Examples of financial penalties
|Ireland||Prison sentence||Financial penalty|
|Safety issue||Up to 3 years||Up to 100.000 €|
|Regulatory issue||Up to 3 years||Up to 100.000 €|
|Italy||Prison sentence||Financial penalty|
|Safety issue||1 to 5 years||Up to 100.000 €|
|Regulatory issue||–||Up to 5.000 €|
|United Kingdom||Prison sentence||Financial penalty|
|Safety issue||Up to 1 year||Up to 20.000 £|
|Regulatory issue||Up to 1 year||Up to 20.000 £|