Expertise Réglementaire et Toxicologique
Depuis 2014
Regulatory and Toxicological Expertise
Since 2014
Our aim is to assist you in the creation of innovative and effective products which are in line with european regulation, and safe for both human health and the environment.
Toxicological profile of the ingredients
The Product Information File (PIF) encloses the toxicological profile of substances contained in the cosmetic product for all relevant toxicological endpoints. Emphasis is put on the assessment of the local toxicity (eye and skin irritation), dermal sensitization and, in case of UV absorption, photo-induced toxicity.
Particular consideration shall be given to any possible impacts on the toxicological profile arising from :
- particle size, including nanomaterials
- levels of impurity contained in active substances
- interaction between substances
The non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in Good Manufacturing Practice (GMP), shall be permitted provided that such presence is in conformity with Article 3 of regulation (EC) n°1223/2009.
In the event of serious doubt regarding the safety of any substance contained in cosmetic products, the competent authority of a Member State in which a product containing such a substance is made available on the market may by reasoned request require the responsible person to submit a list of all cosmetic products for which he is responsible and which contain this substance.
ERTC drafts the PIF in its entirety (part A and part B) : the PIF contains the toxicological profile of the ingredients used together in the frame formulation of your cosmetic products.
ERTC offers numerous solutions customized to your requirements, whether you don't have the required knowledge or don't have the required qualifications to legally place your products on the market.
Contact us in order to know the terms of our services.