The European Union (EU) and the United Kingdom (UK) have regulations in place for cosmetics to ensure that they are safe for consumers to use. One of the key requirements under these regulations is the appointment of a Responsible Person (RP) for cosmetics. In this article, we will discuss what an RP is, their duties, why they are important, the risks of not having one, and concrete cases where RPs have been penalized or in contact with consumers.
What is a Responsible Person according to EU and UK cosmetic regulations?
An RP is a natural or legal capable person who is designated by a cosmetic product manufacturer, importer, or distributor to be responsible for ensuring the safety of the cosmetic product they place on the market. The RP should have access to all relevant information about the cosmetic product, including the manufacturing process, formulation, and safety assessments.
In the EU, the RP is required under the Cosmetics Regulation (EC) No 1223/2009. In the UK, the RP is required under the Cosmetic Products Enforcement Regulations 2013. Both regulations require that the RP be established within the EU or UK, respectively. The name and address of the RP need to appear on the product label, so the RP can be contacted by both Authorities and consumers if needed.
What are the duties of a Responsible Person?
The duties of a Responsible Person are specified in the Cosmetics Regulation and the Cosmetic Products Enforcement Regulations. The main duties include:
1. Ensuring that the cosmetic product complies with all applicable regulations, including GMP;
2. Ensuring that the cosmetic product has undergone a safety assessment by a qualified professional;
3. Ensuring that the cosmetic product is labelled correctly with all necessary information, including ingredients, warnings, and instructions for use
4. Maintaining documentation of the safety assessment and product information for at least 10 years after the product is placed on the market, updated in case of any regulatory/toxicological evolution, undesirable effects raised by consumers, formula update, or any relevant change
5. Cooperating with authorities in the event of a product recall or safety concern.
What are the risks of not having a Responsible Person?
The risks of not having an RP are significant. First, cosmetic products that do not meet regulatory requirements may be removed from the market, resulting in financial losses for manufacturers, importers, and distributors. Secondly, if a cosmetic product is found to be unsafe, it may cause harm to consumers, resulting in legal action and reputational damage for those involved in the product's manufacture, import, or distribution.
There have been several cases in recent years where an RP has been penalized by authorities for failing to comply with regulatory requirements:
In 2019, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) fined an RP £14,000 for selling a cosmetic product that contained a prohibited substance.
Another case involved a company based in the UK that was fined £40,000 by the MHRA for failing to appoint an RP for its cosmetic products. The company had also failed to ensure that its cosmetic products were safe and compliant with regulatory requirements.
The RP may be in contact with consumers in the event of a product recall or safety concern. In 2020, a well-known cosmetic brand issued a voluntary recall of one of its products after it was found to contain high levels of a potentially harmful substance. The Responsible Person for the product issued a statement informing consumers of the recall and providing instructions on how to return the product for a refund.
Another case involves a UK-based distributor of cosmetic products that issued a voluntary recall of a facial mask product in 2021 after it was found to contain a potential allergen not declared on the product label. The Responsible Person for the product contacted consumers who had purchased the product to inform them of the recall and to provide instructions on how to return the product for a refund.
The appointment of an RP is a legal requirement under EU and UK cosmetic regulations. CIRS offers this service for both regions and is capable of playing this crucial role in ensuring the safety of cosmetic products, ensuring compliance with regulatory requirements, and maintaining consumer confidence in the industry. We can represent your brand to the Authorities, manage the audits/inspections and defend your product’s compliance.
Failure to appoint an RP or to comply with regulatory requirements can result in financial losses, legal action, and reputational damage. On the other hand, effective communication with consumers in the event of a product recall or safety concern can help to maintain consumer trust in the industry.