Regulatory Studies

Regulatorische Studien im Bereich Pflanzenschutz

Our services in the field of regulatory studies

We offer the full range of regulatory studies for industrial chemicals, biocides and pesticides under GLP conditions. These include, among others, testing of physicochemical data of active ingredients, identity testing, ecotoxicological studies, and validation of analytical methods along national and international guidelines and requirements.

This means that you receive an optimized test program according to the requirements resulting from the evaluation of the substance. The corresponding regulatory studies complement the consulting and dossier preparation within the registration and testing strategy.

This means for you the successful registration of industrial chemicals, biocides, and plant protection products.

Service description

REACH regulatory studies / industrial chemicals

Industrial chemicals, pharmaceutical starting products, polymers
We offer the following tests that are listed in Directive 440/2008/EC for the registration of chemicals in accordance with the REACH Regulation:

  • Physiochemical tests or identity/sameness checks
  • Ecotoxicological tests
Regulatory studies for crop protection products

We offer the following tests required as per the Commission Directive 91/414, Annex II and Annex III for the registration of crop protection products:

  • Physiochemical data of active ingredients(EU, OECD, OPPTS guidelines)
  • Identity screening (NMR, IR, UV, mass spectroscopy)
  • Analytical profile of various batches (five-batch analysis)
  • Determining the technical characteristics of formulations (CIPAC methods)
  • Stability tests for active ingredients and formulations (Gifap No. 17, OPPTS, CIPAC)
  • Validation of analytical methods (HPLC, HPLC-MS, HPLC-MS-MS, GC, GC-MS) in accordance with SANCO and OPPTS requirements
  • Ecotoxicological analyses(EU, OECD, OPPTS guidelines)
Regulatory studies for biocides

We offer the following tests required as per the Commission Directive 98/8, Annex II and III for the registration of biocides:

  • Physiochemical data of active ingredients (EU, OECD, OPPTS guidelines)
  • Identity screening (NMR, chromatography, IR, UV, MS)
  • Additional tests stipulated by the “Technical guidance document in support of directive 98/8”
  • Validation of analytical methods (HPLC, HPLC-MS, HPLC-MS-MS, GC, GC-MS) in accordance with SANCO and OPPTS requirements
  • Ecotoxicological analyses (EU, OECD, OPPTS guidelines)

The authorization of biocides in the EU is regulated by a Biocides Regulation. Before biocides can be placed on the market, the active substances of the biocidal products must be reviewed in an EU-wide procedure and included on a "positive" list (Union list of approved active substances). Only then may corresponding applications for approval be submitted in the EU member states. In Germany, the Federal Environment Agency also reviews the environmental effects of biocides and must give its approval prior to registration.

An optimal registration and testing strategy is essential for the successful registration of industrial chemicals and biocides.

If the performance of regulatory studies can be avoided for scientific or technical reasons within the strategy, CURRENTA Analytics offers the development of appropriate concepts, such as read-across and weight-of-evidence approaches. For studies that we cannot perform in-house, we will support you in finding reliable contract laboratories, obtain quotations and accompany your project in study monitoring.

Your benefit from our regulatory studies

The successful registration of industrial chemicals, biocides, and plant protection products - you can fulfil the REACH authorisation and restriction requirements or the biocides regulation even with difficult substances with the help of our services.

Application examples

Other customers benefited e.g. from high-quality risk assessments (CSA) to meet permitting and restriction requirements.

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