Regulatory & toxicology
The cosmetic and pharmaceutical industries are subject to strict rules that vary from place to place and are constantly evolving. To ensure full product compliance, we stay abreast of all such regulatory developments.
Ensuring the compliance of ingredients with regulations, for all specialized markets and at all stages, from innovation to commercialization is a prerequisite for all market players. This compliance is essential to guarantee safety for humans and the environment.
Ingredients are first of all chemicals: we strive to follow continuously the chemical regulations in an international complex landscape to ensure compliance of our manufactures and exportations such as REACh in Europe which controls chemical substances and guarantees the preservation of the environment and safety of use for workers in direct contact with the ingredient.
We sell ingredients for dedicated markets: pharmaceuticals and cosmetics. Each application has its own rules and regulations which may vary according to geographical areas.
As we exclusively serve those markets, our dedicated team of regulatory experts provide solid operational support to our customers during all phases of project development.
We constantly monitor legislation and pharmacopoeias to ensure our ingredients remain in compliance. Gattefossé products come with all the guarantees they need for registration in our customers’ regions to accelerate market release.
To help our customers to comply with their own obligations, we provide for each ingredient extensive and regularly updated documentary support compiling all the data and specifications required for its evaluation such as:
- DMFs in the USA or Canada, Bundling Reviews in China for our pharmaceutical ingredients and their respective Letters of Authorization
- Wide range of certificates to help our customers to state the compliance of their formula
- NMPA submission codes of our cosmetic portfolio ingredients in China according to the new CSAR regulation
Developing safe ingredients for workers, formulators and end users is our priority. Toxicological evaluation is performed at all stages of the research and development process of new ingredients taking into consideration of our customers desires not to use animal tests for any purposes.
Labels commitment
Regulation compliance is a prerequisite, but additional guarantees may be required by customers to select their ingredients. We engage in natural and organic standards to develop and offer ingredients obtained from organic cultivated plants and green chemistry compliant processes.
In our portfolio, we offer ingredients certified or approved according to COSMOS, NaTrue or NSF/ANSI 305 standards.
Proactive approach to industry regulatory changes
Our membership of several professional associations —and regular participation in their workshops— allows us to closely monitor the shifting international regulatory landscape for the cosmetic and pharmaceutical industries. Through this anticipatory and collaborative approach, we actively contribute to the establishment of new guidelines and prepare for the impact these regulatory developments may have on our business and that of our customers.
For cosmetics, Gattefossé is affiliated with:
- The European Federation for Cosmetic Ingredients (EFfCI),
- ASPA-INGRECOS (French section of the cosmetic ingredients suppliers),
- France Chimie.
For pharmaceuticals, we are members of:
- The International Pharmaceutical Excipients Council (IPEC),
- The European Oleochemicals and Allied Products Group (APAG),
- The French Society of pharmaceutical sciences and technologies (SFSTP).
- The European Pharmacopoeia Group of Experts