Regulation (EC) No 1223/2009 on cosmetic products establishes strict requirements for the safety of cosmetic products placed on the European Union market. It requires each cosmetic product to have a designated
Responsible Person (RP) established within the EU. Before a cosmetic product is placed on the market, the Responsible Person must ensure that its safety has been assessed by a suitably qualified Safety Assessor and that a
Cosmetic Product Safety Report (CPSR) has been prepared.
The Responsible Person is free to select a Safety Assessor based on their qualifications, experience and expertise. At the same time, the Responsible Person is responsible for the choice made and for engaging an appropriately qualified and competent assessor. A properly conducted
safety assessment is essential for product compliance and consumer protection.
Under Article 10(1) of the Regulation:
Before placing a cosmetic product on the market, the Responsible Person must ensure that the product has undergone a
safety assessment based on the relevant information and that a Cosmetic Product Safety Report has been prepared in accordance with Annex I of Regulation (EC) No 1223/2009.
- Understand cosmetic formulation science, including raw materials, ingredient functions, interactions, product stability and relevant microbiological risks.
- Identify potential borderline product classifications, including the distinction between cosmetic products, medicinal products and biocidal products.
- Analyse the toxicological profile of each ingredient and assess its safety within the finished formulation, taking into account relevant exposure data and potential interactions.
- Assess exposure scenarios based on the normal and reasonably foreseeable use of the product.
- Keep up to date with relevant regulatory requirements and current scientific knowledge relating to cosmetic product safety assessment.
Regulation (EC) No 1223/2009 establishes formal qualification requirements for the person carrying out the cosmetic product safety assessment.
Under Article 10(2), the safety assessment must be carried out by a person holding a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.
The Regulation identifies the following fields of study, while also allowing for similar disciplines and qualifications recognised as equivalent by a Member State:
- Pharmacy
- Toxicology
- Medicine
- Other similar scientific disciplines, subject to the applicable qualification requirements and recognition of equivalence where necessary.
The required education must combine theoretical knowledge with practical training. The Safety Assessor must have an appropriate scientific foundation for evaluating toxicological data, understanding the human body and its relevant biological responses, and assessing the physical and chemical properties of substances used in cosmetic products. These competencies are essential for a scientifically sound safety assessment and a high level of consumer health protection.
In addition to the required formal qualifications, relevant practical experience in the cosmetic industry is highly valuable for a Cosmetic Product Safety Assessor. Experience in formulation, research and development, ingredient evaluation and the preparation of
safety assessments contributes to a better understanding of ingredient interactions, the interpretation of toxicological data and the behaviour of finished cosmetic products under normal and reasonably foreseeable conditions of use.
Relevant professional experience, combined with continuous scientific and regulatory development, helps the Safety Assessor understand formulation challenges, apply scientific knowledge and recognise regulatory requirements that may affect product safety. This expertise supports well-founded and reliable
safety assessments.
Various institutions offer short courses, workshops and online certificates in
cosmetic safety assessment. Although such training may provide useful additional knowledge, a short course or certificate does not, by itself, establish that an individual meets the formal qualification requirements of Article 10(2) of Regulation (EC) No 1223/2009.
Based on the judgment of the Court of Justice of the European Union in Case C-13/17 (
read the judgment), the following practical conclusions can be drawn:
- A short professional course or certificate does not, by itself, demonstrate that the formal qualification requirements for a Safety Assessor have been met. When determining whether education is equivalent, its level, content, and the relevant theoretical and practical knowledge required to competently assess cosmetic product safety are decisive.
- A Member State may recognise certain education as equivalent, but this does not mean that every private or non-university professional course is automatically considered equivalent. The recognised qualification must provide relevant knowledge comparable to that obtained through appropriate studies in pharmacy, toxicology or medicine, while ensuring a high level of protection of human health.
- The appropriate qualification of a Safety Assessor must be based on relevant scientific education that provides the knowledge necessary to assess the safety of both cosmetic ingredients and finished products, including knowledge of the human body and its pathologies, as well as the physical and chemical properties of substances used in cosmetic products.
Although short courses may provide a basic introduction to regulatory requirements, they cannot replace appropriate formal education and practical experience in evaluating
cosmetic ingredients, understanding formulation interactions and interpreting toxicological data.