April 28, 2021
Responsible Person (RP)
Responsible Person is essential element of compliance for cosmetic products.
According to EU Cosmetics Regulation (Regulation (EC) No. 1223/2009), “Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market”.
Clearly, the role of the Responsible Person must be taken seriously, as there are many obligations that the RP has regarding the safety, good manufacturing practice, being a link between the manufacturer and safety assessor, keeping Product information file, notifying the products on the CPNP, ensuring compliant labelling, etc.
Manufacturers are often wondering about the difference between Responsible Person and Safety Assessors.
Many duties fall on the Responsible Person, such as:
- Safety (according to Article 3 of Regulation 1123/2009)
- Good Manufacturing Practices (Article 8)
- Safety assessment (Article 10)
- Completion of the Product Information File (Article 11) and making available of the file to the relevant Competent Authorities
- Sampling and analysis (Article 12)
- Market Notification, and CPNP notification (Article 13)
- Restrictions for substances listed in the Annexes (Article 14)
- Restrictions on CMR Substances (Article 15)
- Nanomaterials (Article 16)
- Traces of prohibited substances (Article 17)
- Animal Testing (Article 18)
- Labelling (Article 19)
- Product Claims (Article 20)
- Making information accessible to the public (Article 21)
- Communication of serious undesirable effects (Article 23)
- Information on substances and raw materials (Article 24)
Furthermore, the RP must ensure that the PIF comprehends all the necessary documentation in order to meet the requirements set by Regulation 1223/2009. It is also a task of the RP to ensure artwork and claims on the packaging comply with the law and that the language of the PIF is easily understandable by the Competent Authorities. Lastly, the RP must keep the PIF updated at the address specified on the label for 10 years after the last batch was placed on the market.
Safety Assessor (SA)
The main role of the Safety Assessor is to perform the Safety Assessment report for each product.
The Safety Report is identified in Annex I of the EC 1223/2009. It is one of the essential elements when building the Product Information File. In a simplified manner, we can look at this report as to a theoretical toxicological evaluation of the safety of the respective product.
The Safety Report always includes two parts:
- Part A: Safety Information
- Part B: Safety Assessment
Part A: Safety Information
The Safety Information, identified in the Annex I of the Regulation, is Part A of the Safety Report within the Product Information File of a cosmetic product.
The Safety Information includes, among others:
- The quantitative and qualitative composition of the cosmetic product;
- The physical-chemical characteristics, microbiological specifications and stability of the cosmetic product;
- The physical-chemical characteristics, microbiological and toxicological specifications of the raw materials;
- The impurities, traces, information about the packaging material;
- Normal and reasonably foreseeable use of the cosmetic product;
- Exposure to the cosmetic product and substances;
Part B: EU Safety Assessment
The Safety Assessment, identified in the Annex I of the Regulation, is Part B of the Safety Report within the Product Information File of a cosmetic product. The Safety Assessment includes but is not limited to:
- Statement on the safety of the cosmetic product in relation to Article 3;
- Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1) (d);
- Explanation of the scientific reasoning leading to the assessment conclusion which is to be based on the possible interactions of the substances contained in the cosmetic product and also on the Safety Information documentation;
- Justification of the consideration and non-consideration of the raw materials’ toxicological profiles;
- Consideration of the impact of the stability on the safety of the cosmetic product;
- Assessor’s credentials and approval (name and address, proof of qualification, date and signature).
The safety assessment is to be completed by the “Safety Assessor”, a qualified person with a European degree in pharmacy, medicine, toxicology or a related discipline. When the qualification degree diploma is not obtained from a European University, the Safety Assessor must have it recognized by the appointed national bodies within one of the EU Member States.
Lastly, a special safety assessment needs to be issued in case the products are:
- Intended for use on children under 3 years old.