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

... until authorisation of your biocidal product or active substance!