OUR SERVICES AND TRAINING RELATED TO THE REGULATION OF BIOCIDAL PRODUCTS (BPR)

Since the advent of the Biocidal Products Regulation (BPR), the consultants of ATOUT BIOCIDES (a service of ATOUT CHIMIE) support you on all regulatory aspects, but also related to efficacy, toxicology and ecotoxicology.

THE REGULATION OF BIOCIDAL PRODUCTS

The BPR (Regulation (EU) No 528/2012) concerns the placing on the market and the use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms, such as than harmful animals and bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the market for biocidal products in the EU, while ensuring a high level of protection of human health and the environment.

 

our services

ATOUT BIOCIDES accompanies you on any service within the framework of the BPR. Our experience is mainly based on the marketing authorization applications (AMM) that we managed as a service provider ("case owner"), and our mastery of the complementary REACH and CLP regulations is an asset to ensure the best expertise in all aspects of the files.

 

> APPROVAL AND AUTHORIZATION

  • Application for approval of an active substance
  • Application for marketing authorization (AMM) for biocidal products
  • National AMM procedure of Union for the same biocidal product "SAME" or simplified, parallel and provisional trade
  • Mutual recognition in sequence and simultaneous (RMS)
  • Summary of Product Characteristics (SPC)
  • Development of a Family of Biocidal Products (BPF)
  • Inclusion in the list of approved suppliers (article 95)

 

> PERSONALIZED SUPPORT

  • Inter and intra company training on biocidal regulation and the use of IUCLID 6, SPC Editor, R4BP 4
  • Transitional marketing authorization application (AMM) (national regulations, before the approval of the active substance)
  • Labeling and advertising validation, claim and border products
  • Compiling your data under IUCLID 6
  • Development of a Summary of Product Characteristics (SPC)
  • Follow-up of files with the authorities (ANSES, ECHA, etc.)
  • HELPDESK - vacation of regulatory expert and toxicologists and ecotoxicologists

 

Strategy

  • Strategic diagnosis with a view to a marketing authorization for a biocidal product
  • Intra / inter-company training
  • Marketing: regulatory cost, budget, deadlines and deadlines
  • Effectiveness of active substances
  • Letter of access costs and budget
  • Compliance of approved suppliers
  • Efficacy of biocidal products
  • Rationalization of portfolios and optimization of ranges of biocidal products
  • Gap analysis of a "Data Gap" file and test strategy

 

RISK ASSESSMENT, EXPERTISE (ECO) TOXICOLOGY

  • During product development and from the early stages of R&D
  • As part of approval / authorization requests (AMM)
  • Writing in standardized ECHA "Competent Authority Report, CAR" and "Product Assessment Report, PAR" formats
  • Preliminary risk assessment of biocidal products for human health and the environment Search for an Endocrine
  • Disruptor potential of active substances and co-formulants (screening)
  • Prediction of mixed or “cocktail” effects, analysis of toxicological interactions, synergies and potentiation of effects
  • Analysis of environmental fate, metabolites, degradation by-products and residues

 

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