Regulatory & Toxicology
Global expertise, personal touch
Regulatory & Toxicology
Launching a cosmetic product on the market is nowadays becoming a real challenge, from a safety and regulatory point of view.
Being aware of major constraints at an early stage of product development is one of the main keys to success for any brand.Our international regulation and safety assessment expert teams are involved in the major study groups and discussions led by authorities therefore supporting your projects during all the stages with the latest regulatory updates.
From the first formulation steps to the registration in countries, audit of the cosmetic dossier, signature of the safety report, and management of cosmetovigilance throughout the product's entire lifecycle.
The team is composed of Eurotox Toxicologists who have a strong industrial background and extensive expertise in complex products such as products for babies and pregnant women, and those containing essential oils. Our experts work closely with all relevant departments in the field of product safety to ensure an optimal coordination; for example in vitro testing, microbiology and tolerance studies.
All stages of the evaluation process are in line with the European Cosmetics Regulation (EC) No 1223/2009, Article 3:
"A cosmetic product made available on the market is safe for human health when used Under normal or reasonably foreseeable conditions of use".
In an increasingly demanding regulatory environment, Eurofins offers you personalised support for your cosmetic product compliance procedures.
- Regulatory Affairs
- Creation of Material Safety Data Sheets (MSDS)
- Notification / Declaration / Registration of raw materials and products
- Creation, audits, diagnostics of Technical Files
- Regulatory compliance of communication supports
- Label check (regulatory label check & claim substantiation)
- Safety Assessment
- Medical devices expertise
- Toxicological profile of raw material & ingredients
- Analysis of toxicological risk of a formula / product
- Expertise: formula analysis and tests recommendation by an expert before product launch or clinical testing
- Safety assessment according to the Regulation (EC) N° 1223/2009 of the European parliament and council by a safety assessor Eurotox
- Risk assessment of packaging materials
- Toxicological watch
- Cosmetovigilance: advice, action plans and support to be compliant with local authorities
- Claim Assessment
According to Regulation (EU) No 655/2013 product claims of cosmetic products serve mainly to inform end users about the characteristics and qualities of the products. Those claims are essential ways of differentiating between products. They also contribute to stimulating innovation and fostering competition.
- Common Criteria for Cosmetics claims: Legal compliance, Truthfulness and Evidential support (Studies, etc.), Honesty and fairness
- Special criteria – (Claims that require further guidance): Health-related claims (e.g. “clinically tested”, “Hypoallergenic”, etc.), “Natural”,“Bio”, “organic”…
- Claims in the Cosmetics Directive:
- Cosmetic Products Regulation (EC) No 1223/2009 has extended requirements
- Calculation of Naturalness Index
- Creation of a COSMOS file for raw materials and finished products
- Scientific Advice / Technical Support
- On request, on site or at our premises
- Support during product lifecycle: development, launch, post-marketing
- Design of tailor-made protocols
- Choice of raw materials
- Selection of tests