Biocides
The spectra team is well experienced with the regulatory processes of active substance and biocidal product authorisations under BPR (Regulation (EU) No 528/2012). You profit from our expertise with applications for
- active substance authorisation
- technical equivalence of active substances
- Article 95 listing
- single products
- biocidal product families (BPF)
- national authorisations
- mutual recognition
- Union authorisation
BPR requirements and processes can be overwhelming. spectra is the reliable partner at your side and accompanies you through the entire BPR process:
from the very start ...
- thorough data gap analysis based on BPR Annexes II or III, including development of read-across and waiving strategies
- setting up of biocidal product family (BPF) concepts
- development of test strategies for physico-chemical properties and efficacy
- study monitoring
- assessment of (eco)toxicological hazards
- check of classification and labelling according to CLP (Regulation (EC) No 1272/2008)
- check for substances of concern (SoCs) or co-formulants with potential endocrine disrupting (EDs) properties in your biocidal products
- literature search for relevant data (e.g. in the context of ED assessment)
- preliminary exposure and risk assessments for human health (HHRA, including livestock exposure and dietary risk assessment) based on up-to-date exposure models (ConsExpo, Advanced REACH Tool, TNsG models, RiskofDerm) and relevant ECHA guidance (Biocides Exposure Methodology, HEAdHoc Recommendations, HEEG Opinions)
- preliminary exposure and risk assessments for the environment (ERA) based on up-to-date exposure models (EUSES, Simple Treat, FOCUS PEARL) and emission scenario documents (ESDs)
- development of refinement strategies for risk assessments (e.g. exposure studies for Tier-3 assessment)
- preparation of and participation in pre-submission meetings with competent authorities
- preparation of draft summary of product characteristics (SPC) for pre-submission consultation for Union authorisations
... through dossier preparation ...
- preparation of study summaries in IUCLID and PAR (product assessment report) or DRAR (draft risk assessment report)
- preparation of exposure and risk assessments for human health (including livestock exposure and dietary risk assessment) and environment and reporting in the PAR format
- elaboration of expert statements (e.g. regarding dermal absorption, classification & labelling etc.)
- elaboration of read-across statements and waiving strategies (e.g. regarding physico-chemical or (eco)toxicological properties and efficacy data)
- preparation of (Q)SARs (e.g. regarding (eco)toxicological properties, ED characteristics)
- support in preparation of comparative assessment for active substances which are candidates for substitution
- preparation of the summary of product characteristics (SPC) using the ECHA SPC Editor
- submission and follow-up of your application via R4BP (register for biocidal products, maintained by ECHA)
... and defence phase ...
- support in answering requests from the evaluating competent authority (eCA) or ECHA
- preparation of and participation in post-submission meetings with the eCA
- support with e-consultation processes
- support in the commenting phase of national authorisations or in the process of mutual recognition as well as Union authorisations or active substance authorisations (response to comments (RCOM) tables)
- participation in working group meetings and meetings of the biocidal product committee (BPC) of ECHA
- timely support in processing ad-hoc follow-up tasks
- assistance with organising timely translations of the SPC