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REACH-Consulting

We offer the following services in the field of REACH-Consulting:

  • Data gap analysis
  • Literature research
  • Development of test strategies
  • Assessment and implementation of waiving and weight-of-evidence options
  • Read-across strategies and entries and justification documents
  • Entry of robust study summaries in the dossier (IUCLID)
  • Dossier improvement
  • Inquiry/PPORD dossiers
  • REACH IT
  • QSAR calculations
  • Classification according to CLP VO
  • PBT-assessment
  • PNEC derivative
  • Exposure estimation based on PhysChem and Efate data
  • Risk Assessment (CSA)
  • Enquiries/Negotiations with authorities
  • Training courses/Overview Presentations (on request)
  • Newsletter on regulatory changes (on request)
  • Additional services on request

An optimized registration and testing strategy is essential for the successful registration of industrial chemicals and biocides. Data requirements are subject to constant and dynamic change. We always keep our customers informed about the latest requirements and novelties in the regulatory environment, e.g.:

  • Polymers under REACH
  • Generic risk assessment (GRA)
  • CLP Revision
  • MAF (mixture assessment factor)
  • Nanomaterials

For you, this means our team of experts from various disciplines researches and evaluates the chemical, physical, ecotoxicological and toxicological effects of a substance and, after identifying the data gaps, puts together an optimized test program in accordance with the requirements. We coordinate all activities, prepare a dossier ready for submission and support you until the authorization is successfully completed.

How can we help you?

Specifications:

Your benefits from our direct laboratory access

We rely on short distances and combine our consulting services directly with the laboratory teams, in which regulatory studies on substance properties (physicochemical and environmental fate tests (LINK)) as well as on ecotoxicity (ecotoxicological material tests (LINK)) are carried out.

In the case of studies that we cannot carry out in-house, we support you in your search for reliable contract laboratories, obtain offers and accompany your project in study monitoring. We have been involved in REACH from the very beginning and can also draw on a wealth of experience and cooperation with numerous testing institutes.

Your benefits from our consulting

Our experts will be happy to help you with any questions you may have and guide you through the complicated registration process. Based on an extensive literature review, we carry out a detailed data gap analysis for you. Each data gap analysis is based on the specific dossier requirements, which depend on the tonnage band of the substance and the possible status as an intermediate product. Based on this, we develop an optimal, i.e. robust and at the same time cost-saving registration strategy for you.

We have built up the relevant expertise to be able to carry out high-quality risk assessments (CSA) and are familiar with various higher tier tools (e.g. ART, Riskofderm, ConsExpo). Even for difficult substances, we can meet today’s demanding REACH approval and restriction requirements and prepare a compliant chemical safety report (CSR). In the case of demanding substances or intermediate products that are only used under strictly controlled conditions (SCC) and are subject to rigorous containment (RCC), we help with the preparation of the appropriate documentation.

Close collaboration with our customers and also within our teams is not only a matter of course for us, but also a necessary prerequisite for ensuring scientific integrity and regulatory compliance.

Other customers have already been able to benefit from REACH-Consulting and received customized solutions even for difficult substances, complex issues and special topics such as ‘alternative chemical name request’ or commenting on ECHA draft decisions.

Do you have a request? Feel free to contact us!

 

Contact

Dr. Thomas Sadler
Dr. Thomas Sadler

Contact

Catharina Julia Seel

Q18

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