Contract manufacturing and safety assessment of a cosmetic product – The «person in charge»the marketing of a cosmetic product as defined in the Regulation 1223/2009 is the body responsible for ensuring that, prior to its marketing, a dossier containing information on its safety, and that it be assessed by an expert. This responsibility lies neither with the designer nor with the manufacturer. Where third parties are involved, they must provide all safety information to the «responsible person». Should this person not have the scientific and technical knowledge where necessary, it is advisable to consult a security adviser.
Contract manufacturing and the person responsible: what does the Regulation say?
In the Regulation 1223/2009 on cosmetic products, in the Article 4, the «Responsible Person» (a natural or legal person) is defined as the person who will ensure compliance with the relevant requirements set out in these Regulations. In the Article 5, their obligations are set out.
Before continuing, it should be made clear that the Regulation is defined as «manufacturer»as« "any natural or legal person who manufactures a product, or who commissions the design or manufacture of a product, and who markets that product under their own name or trade mark«. Consequently, the «manufacturer« need not necessarily be the person who manufactures the product, nor must the »person who manufactures it« be the »manufacturer«. In fact, the concept of »manufacturer« is more closely linked to the »responsible person’ than to the industrial producer of a cosmetic product.”.
The Regulation makes it very clear that, for every cosmetic product placed on the market, «the responsible person» shall ensure compliance with the safety requirements set out in the Article 3. That is why, in the Article 10 It states: «The person responsible shall ensure that a safety assessment has been carried out on the basis of the relevant information, and that a report on the safety of the cosmetic product is drawn up in accordance with Annex 1«. Furthermore, Article 10 also states that the «person responsible» shall ensure that the safety assessment takes into account:
- (a) systematic, advance exposure to specific ingredients in the final formulation
- (b) the use of an appropriate approach to the strength of the evidence in order to examine data from all available sources
- (c) updating the information with any relevant data generated once the product has been placed on the market.
Responsible person, brand, manufacturer and safety requirements
It is clear, then, that the commitment to the the safety of a cosmetic product lies entirely and solely with the «person in charge«, which must ensure that certain information relating to its security is collected and updated, and that it is properly assessed.
If the «responsible person» is the same person who designs, manufactures and markets the product under their own name or brand, given their experience and involvement in the design and development of cosmetic products, they should have the technical knowledge and of the information about your safety, and for this reason, it should be able to ensure that it is properly assessed in accordance with the requirements of Part B (cosmetic product safety assessment). The same applies to contract manufacturing: that is, to cases where the «responsible person» designs, develops and markets the cosmetic product under their own name or trade mark, and, for technical, logistical or commercial reasons, contracts out its manufacture to a third party.
What happens if the «responsible person» is not the manufacturer?
However, there may be cases where the «responsible person» merely markets the cosmetic product under their name or brand, without being involved in either its design or development. Furthermore, they may not possess the full technical knowledge required to assess whether an evaluation meets the aforementioned requirements (a), (b) and (c). An example might be a sports brand that markets a cosmetic product under its own name or brand. In this case, the sports brand, as the «responsible person», must also ensure that information on the product’s safety is gathered and that it is subjected to an assessment. If the «responsible person» is not technically qualified to manage the aforementioned assessment, in order to ensure the safety of the cosmetic product, they should consult a qualified person, who in many cases may be the person who designed, developed and manufactured the product.
If a cosmetic product is designed and manufactured by a third party, given the responsibility that the Regulation places on the «person responsible» for placing it on the market under their name or trade mark, that person must have free access to all information about his safety (Part A, Annex I) and its correct assessment. The confidentiality The dissemination of this information must always be governed by agreements between the parties and must never involve restricting access to it.
Conclusions on contract manufacturing and the safety assessment of a cosmetic product
Given the complexity of the issue, if the «person responsible» for placing a cosmetic product manufactured by a third party on the market has scientific or technical doubts, in order to take full responsibility for its safety, it is advisable that they consult a security adviser.
In view of all the above, in accordance with the Regulation 1223/2009 With regard to cosmetic products, the responsibility for gathering the relevant information to support the safety of a cosmetic product and for its evaluation lies solely with the «responsible person», who shall provide the necessary resources to ensure that this is carried out. And, where necessary, shall ensure that this is carried out by means of the expert advice. Through a very robust contractual agreement with the party that designed, developed and manufactured the cosmetic product. .
For further information on the safety assessment of a cosmetic product and contract manufacturing, do not hesitate to contact us. We specialise in the safety assessment of cosmetic products.
- The Expert opinion It was drafted in 2012 for the former GTF M. Camps website. This coincided with a period of uncertainty regarding the interpretation of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. To this day, these issues remain of great relevance to the cosmetics sector.