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CEHTRA - Consultancy for Environmental & Human Toxicology and Risk AssessmentCEHTRA help with your Biocides dossiers under BPR
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CEHTRA help with your Biocides dossiers under BPR CEHTRA can help you with any aspect of biocides whether under the Directive or in regard to the impact of the new Regulation on your business.

Biocide regulation: a challenging maze

The new Biocidal Products Regulation (EU) No 528/2012 (BPR) took over from Directive 98/8/EC on the 1st September 2013. Regulation of biocidal products was first introduced in 2000 to harmonise the data requirements and evaluation procedure for both active substances and biocidal products across the EU.

With the introduction of the BPR companies have to contend with changes in not only the data requirements for active substances and biocidal products, but also changes in application and evaluation schemes for approvals and authorisations along with new requirements for treated articles. In addition, they have to ensure their products qualify as an “existing” biocidal product under existing National schemes in order to remain on the market during the transition to EU regulation.

There is no global harmonisation of biocidal product regulation with many countries not differentiating certain EU product types from general industrial chemicals.

CEHTRA's services: your solution

We can help you with any aspect of biocidal product approvals:

  • Preparation of active substance and biocidal product authorisations and registrations, including mutual recognition under the EU scheme;
  • Development of Biocidal Product Families;
  • National registration of biocidal products;
  • Obtaining approved active substance supplier status;
  • Negotiations with Authorities;
  • CLP classification of substances and products;
  • Product safety and risk assessments;
  • (Q)SAR and classification of products using calculation methods;
  • Dossier preparation in IUCLID format and aid in submitting via R4BP;
  • EU Representation;
  • Data gap analysis, data evaluation (reliability and acceptance), data-sharing and compensation;
  • Labelling and reporting requirements for treated articles;
  • Socio-economic analysis (SEA) for comparative assessment;
  • Independent expert witness/representative at BPC Working Group Meetings
  • Project management and study monitoring;
  • Advice on scope in relation to REACH and other legislation;
  • Global product compliance.

CEHTRA’s experience: proof of our commitment

CEHTRA’s consultants have been involved in the preparation of over 30 active substance Annex I inclusion dossiers and the submission of biocidal products through the BPD process and under National schemes. Our wide experience in supporting active substances and biocidal products is your best guarantee.

Case Study: CEHTRA worked with a client to obtain a BPR authorisation of a biocidal product containing a PBT/CMR substance. Non-authorisation of the product would have resulted in the loss of revenue totaling several million Euros. Using scenario mapping to forecast alternative outcomes CEHTRA developed an authorisation strategy, identified relevant in-house data to support the strategy and participated in construction of the Socio-Economic Analysis.  
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®Cehtra • March 2018