The Regulatory Environment
This regulation presents opportunities to biocide producers, including EU wide authorisation for certain groups of biocidal products, product family authorisation for products with similar uses and centralised coordination of authorisation by the European Chemical Agency (ECHA). However, certain restrictions and obligations are imposed, including:
- hazard based exclusion criteria and substitution criteria for active substances and products;
- an increased focus on the presence of nano materials in products;
- regulation of articles treated with biocidal products;
- the requirement to submit data (or demonstrate access to data) for all biocide active substances.
TSGE’s multidisciplinary team of scientists and registration specialists has years of proven experience gaining Annex I listings for biocidal active substances and product authorisations or registrations for biocidal products across the EU.
With a well established reputation in the biocide market, TSGE works with both major chemical companies and small suppliers, targeting services to each company’s specific needs.
Our staff have a wide scope of expertise from working in industry, government organisations and research facilities, to deliver effective guidance and support to achieve timely and successful approvals across a diverse range of active substance and product types.
We believe that proactive project management is essential to ensure that our clients’ needs are identified and met in a timely manner. We provide dedicated project managers who are committed to effective communication and project implementation.
TSGE has invested in and developed a pan-European infrastructure to meet those challenges presented by differing requirements across the Union. The TSGE group has offices in the UK, Ireland, France, Spain, Germany, Slovenia, Slovakia, Poland, Hungary and Romania offering focused, local registration support.
Our success has been achieved based on the understanding that no one individual or organisation can manage the authorisation of a plant protection or biocidal product effectively throughout Europe without local knowledge of procedures, culture and language. Our managers and registration professionals in the regional offices have the necessary regulatory skills and are experienced, approachable and dependable.
Should you wish to discuss any of our services, please contact us.
- Strategic advice & guidance
- Data Gap Analysis (completeness checks)
- Dossier preparation and submission
- Liaison with Regulatory Authorities
- Task Force and Consortia Management
- Preparation of Efficacy Dossiers
- Preparation of Product Labels (CLP & GHS)
- Preparation of MSDSs
- Preparation of expert reports and waivers
- Human health and environmental risk assessments
- Study design and monitoring
- Due diligence audits