Biocides

All biocidal products, which are used to protect against harmful organisms like pests or bacteria, require an authorisation before they can be placed on the EU market, and the active substances contained in that biocidal product must be previously approved to ensure a high level of protection for humans and the environment.

The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012), applicable from 1 September 2013 and repealing the Biocidal Products Directive (Directive 98/8/EC) aims to harmonise the market at Union level; simplify the approval of active substances and authorisation of biocidal products and promotes the reduction of animal testing by introducing mandatory data sharing obligations and encouraging the use of alternative testing methods.

The approval of active substances takes place at Union level under the remit of ECHA and the subsequent authorisation of the biocidal products at Member State level that can be extended to other Member States by mutual recognition. The new regulation also provides applicants with the possibility of a new type of authorisation at Union level (Union authorisation).

Our Services

DERAC has previous experience in reviewing or developing environmental risk assessment for active substances registered for PTs 1, 2, 3, 4, 5, 6, 8, 11, 12, 14, 18 and 21 biocidal products.

DERAC understanding of environmental sciences, industrial processes and regulatory authorities expectations enables to make the best use of existing information, to ensure that testing programmes are appropriate and to provide convicing justifications to the authorities.

DERAC offers its main and specific skills in support of BPR compliance with many aspects of the BPR requirements.

Active substance approval and Biocidal products authorisation (environmental sections)

New active substances, national authorisation (including mutual recognition) and Union authorisation of Biocidal Products application dossiers

Search for and assessment of existing data (relevance and reliability)
Determination of the registration strategy including alternative methods
Determination of the testing strategy and generation of experimental and in-silico missing data
Preparation of technical dossier in IUCLID format including Classification and PBT assessment and aid in submitting via the Register for Biocidal Products (R4BP).
Scientific representation within the consortium and at BPC working group meetings
Negotiations with the authorities (Member States and ECHA)
Environmental and toxicological profile of candidates for substitution for comparative assessment

Our experience

As regulatory authorities (European Chemicals Bureau)

Involvement in the review program of active substance: Technical Completness Check, Technical meetings preparation and co-chairing, review of Competent Authorities decision.
Participation to the organisation of scientific and technical workshop
Development of new exposure assessment guidance

As an applicant for industry (manufacturer)

Review and comments on draft CAR for PT12, PT2 and PT6
Update of exposure assessment for PT11 and PT12 to show negligeable exposure
Preparation of active substance IUCLID dossier
Comparative assessment
Developement of a defense strategy for an active substance proposed for a non approval by the Rapporteur Member State (non Annex I inclusion) including meeting with the competent authorities to stop the clock and launch an highier tier test to assess degradation pathways, in-deep review of the CAR, drafting of statement papers to highlight inconsistencies in the environmental risk assessment and comments in the commenting table.