Technical Equivalence will be one of the next challenges for the Biocides Industry
Technical Equivalence must be demonstrated at product authorisation stage if the source of the active substance is different from the reference source. Getting an alternative source recognised as technically equivalent is not an easy and straightforward process. Decisions by ECHA on technical equivalence are subject to review by the Board of Appeal.
This webinar provided a regulatory and legal overview of this complex matter and identified the steps to a successful Technical Equivalence application and strategic considerations on remedies available. It covered the following points:
- When is it needed?
- Required information
- Tier I or Tier II?
- Timelines
- Legal remedies
Speakers:
- Darren Abrahams, Steptoe & Johnson is a partner, English barrister, and Avocat at the Brussels Bar. He focuses his practice on EU regulatory requirements and the related commercial issues in the environment, chemicals, and life sciences area. He is well-known for (1) litigation work before the Court of Justice of the EU, the EU General Court, and BoA of ECHA in the chemicals regulation (REACH & agrochemicals) and environmental areas; and (2) product defence & product approvals work (biocides, agrochemicals, and biotech).
- Nathalie Hanon, CEHTRA holds an engineering degree in natural sciences from the Gembloux Agricultural University (Belgium). She has nearly 20 years’ experience in regulatory affairs and among her numerous activities in the field, she worked for 12 years in the Biocide Industry. She has recently become a consultant at CEHTRA where she will be able to put her wide experience and background to the service of Industry.
- Eléonore Mullier, Steptoe & Johnson is resident in Steptoe’s Brussels office and specializes in EU regulatory law and litigation. She advises clients on regulatory compliance, product defence, and litigation strategies in the field of environmental law, as well as related support on contracts and negotiations. She has broad and in-depth REACH experience: registration and data sharing, authorization, dossier and substance evaluation, intermediates, restrictions, emerging issues (e.g. nanotechnology and EDCs), and enforcement. Eléonore regularly represents clients before the EU Court of Justice and the ECHA Board of Appeal; national and EU regulatory authorities. She also assists clients in data sharing negotiations and related disputes and litigation.