The
Cosmetic Regulation (EC) No. 1223/2009 sets strict requirements for cosmetic product safety. It mandates the designation of a
Responsible Person (RP) within the EU and the appointment of a Safety Assessor who evaluates the safety of each product before it reaches the market.
The
responsible person has the freedom to select a safety assessor based on their qualifications, experience, and expertise. However, the responsible person also bears full responsibility for this choice. A properly conducted s
afety assessment is essential for ensuring product compliance and protecting consumers.
According to Article 10 of the Regulation:
"In order to demonstrate that a cosmetic product complies with Article 3, the
responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a
safety assessment."
- Understand formulation science, including raw materials, ingredient functions, interactions, and product stability, as well as microbiological risks.
- Identify potential borderline product classifications (e.g., differentiating between cosmetics, pharmaceuticals, or biocides).
- Analyze the toxicological profile of each ingredient and assess its safety in combination with other ingredients.
- Evaluate exposure scenarios based on real-world product use.
- Ensure compliance with EU safety standards and stay updated on evolving scientific research.
Safety Assessor's Qualifications
According to Regulation (EC) N° 1223/2009, the safety assessor is defined as
"a person in possession of 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 recognized as equivalent by a Member State" (Art. 10).
To fulfill the role of a Safety Assessor, individuals must possess a degree from an accredited university in one of the following crucial fields:
- Pharmacy
- Toxicology
- Medicine
- Chemistry or Biochemistry (if toxicology is covered)
- Other similar scientific disciplines
The degree must include both theoretical and practical components, ensuring that the assessor is well-equipped with the essential knowledge and skills in toxicology, risk assessment, and cosmetic safety to protect consumer health and safety.
Experience in the Cosmetic Industry
In addition to formal education, practical experience in the cosmetic industry is crucial for a Safety Assessor. Hands-on experience in formulation, research and development, and conducting
safety assessments is essential for evaluating ingredient interactions, interpreting toxicological data, and understanding the real-world behavior of cosmetic products.
Industry experience ensures that the Safety Assessor is familiar with the latest scientific advancements, formulation challenges, and regulatory changes that could affect product safety. This expertise is necessary for making informed and reliable
safety assessments.
Some institutions offer short courses (5-7 days or even a few weeks) or online certifications in
cosmetic safety assessment. However, these are not sufficient to qualify as a Safety Assessor under EU law.
The CJEU case C-13/17 (
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:62017CJ0013) clarified this further by stating that:
- A short course cannot be considered equivalent to a formal university degree.
- Member States must recognize foreign diplomas if they meet the required standards but are not obliged to accept non-university courses as equivalent.
- Safety Assessor must have a proper education in toxicology, and some Member States require assessors to prove formal education in both toxicology and biochemistry.
While short courses may provide a basic introduction to regulatory requirements, they cannot replace the need for formal education and hands-on experience in evaluating
cosmetic ingredients, understanding formulation interactions, and
interpreting toxicological data.
If you are looking for a cosmetic product safety assessor,
contact us.
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