International Regulatory Support:
Europe - Other Services

Other (food contact, animal and human health, personal care, toy safety and surfactants)

A honey bee studied for chemical exposure effects on endocrine systemTSGE advises companies on the general framework of legislation for food contact materials as laid out in EC Regulation 1935/2004. Our consultants assess exposure and risk associated with migration into food, and can monitor migration and other studies associated with threshold limits.

Our team of scientists also assist in interpreting and understanding the requirements for animal health products under Directive 2001/82 and can manage the environmental aspects for medicinal products for human health under Directive 2001/83/EC. TSGE’s consultants prepare complete or partial dossiers, conduct quality, safety and efficacy reports, complete risk assessments and monitor studies for the registration of products. We also provide strategy guidance to effectively obtain a company’s national and/or European registration.

In addition, TSGE provides guidance for registering surfactants as regulated in the EU. Our consultants are actively engaged in supporting companies wishing to place new, or amend existing, cosmetic or personal care products in the EU. We prepare Technical Information Files (TIFs) and Product Information Requirements (PIRs) as well as new ingredients for safety evaluation by the Scientific Committee on Consumer Products (SCCP).

Chemical ingredient assessment on personal care products and cosmeticsOur consultants are also able to help guide companies through the regulatory requirements of the revised Toys Safety Directive (2009/48/EC). Our toxicologists and product chemists conduct assessments of the manufacture, chemical composition and use of a product. TSGE’s scientists construct appropriate exposure scenarios and models, perform toxicological and chemical risk assessments, and provide companies with relevant classification and labeling information.

Additional services include providing technical advice to contract laboratories. As an independent consultancy, TSGE has extensive experience in placing and monitoring studies at appropriate testing facilities. We are able to identify areas where testing may be required to satisfy safety concerns and recommend suitable testing strategies. We can also support companies by offering in-house training on a wide range of EU regulatory topics.
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