REACH and Biocides

Regulatorische Studien im Bereich Biozide

Our services in the field of REACH and biocides

To ensure that industrial chemicals do not pose a risk to humans or the environment, chemical substances are authorized in three stages that are governed by the REACh (Registration, Evaluation and Authorization of Chemicals) Regulation.

The authorization of biocides in the EU is governed by a separate biocide regulation. Before biocides can be put on the market, the active ingredients must first be reviewed as part of an EU-wide process and included on a “positive” list (Union-wide list of authorized active ingredients). Only then can the corresponding applications be submitted throughout the EU member states. In Germany, the environmental effects of biocides are also examined by the Federal Environment Agency, which must give its consent before a biocide can be approved.

In both cases, we research and evaluate the chemical, physical, ecotoxicological and toxicological effects of a substance and compile an optimized testing program according to the specific requirements, once we’ve identified any data gaps. We coordinate all activities, create a ready-to-submit dossier and accompany you until the approval process is successfully completed.

Your benefit

You increase the reliability of your planning. On the basis of our research and evaluation of your data, we coordinate and schedule a custom testing program for you. Time and cost savings: We have extensive experience in registration procedures. You gain flexibility – you decide how much or how little we support you in your work, meaning we can either take over entire substance registration or product defense procedures for you, or simply take care of specific tasks. We are recognized by the authorities and can competently answer any questions they might have.

Our strengths

You get all our services – consulting and analytics – from a single source. If necessary, we can work together with other internal and external experts and institutions. We have many years of experience and a wide range of contacts and are very familiar with the legal requirements. Thanks to our participation in committees and industry associations, we are informed about future developments at an early stage.

Services in detail

  • Consulting
  • Determining data requirements
  • Viewing existing data
  • Literature research
  • Identifying data gaps
  • Checking safety data sheets
  • Recommending an intelligent testing strategy (category approach, waiving, read-across, QSAR calculations)
  • Planning and conducting all the necessary studies (PC data, ecotoxicology, environmental behavior and toxicology*)
  • Creating a registration dossier (IUCLID, chemical safety report, etc.)
  • Conducting exposure and risk assessments
  • Submitting the registration dossier
  • Responding to official inquiries
  • Active product defense, even during evaluation and authorization procedures
  • Consortium management

* These tests are conducted by qualified partner institutes.

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