Regulatory risk assessment

We assess the potential risks from chemicals to human health and the environment

Regulations and thematic areas

We can assist you in risk assessment and authorization of your product.

 

Plant protection products

Scientific and strategic assistance in the assessment and authorization of plant-protecting active substances and plant protection products, right up to dossier preparation and defense.

Biocides

Scientific and strategic assistance in the assessment and authorization of biocides (active ingredients, biocidal products and product families), from strategy development to dossier preparation and defense.

Industrial chemicals

Risk assessment and authorization of industrial chemicals under REACH (European chemicals regulation), from strategy development via classification and labeling to dossier submission and defense.

Further areas of regulatory support

Cosmetics

Scientific and regulatory support in the assessment and authorization of cosmetic products and perfumes, right up to the issuance of an IFRA statement.

Food and feed products

Risk assessment and authorization of ingredients, additives, novel foods, contact materials and processing aids, and evaluation of health claims and allergies.

Overview of our services

© Fraunhofer ITEM, Ralf Mohr
Potential risks from a chemical substance to human health and the environment must be assessed, before the substance can be approved for commercialization.

We offer our clients the studies and services required to assess the potential risks from chemicals to human health and the environment and to register these substances for the intended use. These include industrial chemicals, biocides, food additives, and human and veterinary medicinal products. In close cooperation with our clients, we compile the data required for registration according to current legislation.

We can assist you!

  • Counseling and support: We provide comprehensive consulting and collaborate with you to develop a registration strategy tailored to your situation.
  • Data collection: In cooperation with you, we determine whether the available data are sufficient (data gap analysis), what data are available, what additional studies are necessary, and we check whether there is further information publicly available about your substances and products (literature review). We develop testing strategies and commission required experimental studies (analytics, physico-chemical and ecological/toxicological characterization, efficacy testing).
  • Risk assessment: We identify potential hazards of your substances and products and of all additives, residues and metabolites. In addition to evaluating the exposure and emission, we assess the endocrine-disrupting and PBT (persistence, bioaccumulation and toxicity) properties of your chemicals and perform risk assessment. The assessment can be documented in the form of an expert report.
  • Dossier preparation: We prepare the complete registration dossier including exposure and risk assessment in compliance with regulatory requirements, chemical safety report (CSR), and expert statements.
  • Communication with the authorities: On your behalf, we keep close contact with the competent authorities, so as to generate custom-tailored and accepted solutions for your substances and products.

Your benefits

You benefit from synergies between experimental toxicology, analytical methods, and regulatory knowledge.

We act as interface between clients and regulatory authorities, participate in panels, and collaborate with scientific organizations.

We have our own toxicological databases, which we can customize, whenever needed.

Your contact for regulatory issues, risk assessment and authorization of chemical substances

Ariane Zwintscher

Contact Press / Media

Ariane Zwintscher

Head of Department of Regulatory Issues

Phone +49 511 5350-312