REGULATORY CHEMISTRY & HUMAN HEALTH ASSESSMENT REGULATION SERVICES
The protection of human health is an essential part of the regulations related to all kinds of chemicals. The objective of regulations is to minimize the intentional or unintentional exposure. Hence, regulatory authorities implement complex requirements and assessment schemes to ensure safe use of chemicals.
Auxilife experts design test programs that investigate physico-chemical properties and toxicological effects according to international guidelines.
Our experts propose classification and labelling of chemicals and end-use products based on hazard end points. Connecting potential exposure with hazard endpoints enables our experts to assess the risk for workers, handlers and consumers associated with the use of chemicals.
Auxilife team conducts risk assessments for agrochemicals, biocides, fine chemicals, consumer products, pharmaceuticals (preclinical studies), cosmetics, medical devices, food and feed additives.
Key services
- Data gap analysis and completeness check
- Literature review
- Provide expert statements/reports by developing theoretical rationales and exposure-based waivers for chemicals (TTC and read-across approach)
- Develop and monitor test programs for physical and chemical properties of chemicals and their products
- Develop specifications for chemicals and strategies for chemical equivalence
- Monitor studies on analytical methods for determination of residues in plants, food and feed commodities
- Design, place and monitor toxicological test programs to define hazard endpoints
- Assessment of operator, worker, bystander and resident exposure for plant protection products/ pesticides
- Dietary exposure assessment of residues of plant protection products in food items
- Assessment of safety of food/feed additives and food contact materials
- Assessment of potential endocrine disruptor properties
- Evaluation of relevance of scientific publications
- Prepare dossiers for regulatory submission