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Agroscience Services >> Regulatory Affairs >> Biocide Services

Biocide Services

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The Biocidal Products Directive has been in force since May 2000 and introduced a regulatory framework for biocidal products placed on the European Union market. The Biocidal Products Directive defined the 23 product types covered by the legislation.

The Biocidal Product Types are divided into four main groups:

  • Group 1: Disinfectants and General Biocides
  • Group 2: Preservatives
  • Group 3: Pest Control
  • Group 4: Other Biocides

The directive introduced a review process for all existing biocidal active substances which allows products to remain on the market whilst the review program is on-going and prior to receiving Annex I inclusion. During this review period the relevant existing national legislation in the countries where the biocidal product is marketed remains in force.

The Biocidal Products Directive (BPD) was repealed on September 1, 2013 and replaced with the Biocidal Products Regulation (Regulation (EU) No 528/2012)

The review of active substances submitted under the BPD continues under the BPR, which maintains the two step process of approving the active substance before products containing the active substance become eligible for authorisation.

For suppliers of biocidal products to benefit from the transitional phase and maintain continuity of supply, biocidal products must usually be registered under existing national schemes prior to inclusion of the active substance onto the Union list (previously Annex I).

In conjunction with Eurofins Biolab, we can offer a full range of GLP and efficacy testing services as part of a complete registration solution for your biocidal product

Regulatory AG

Our Biocides registration services include:

  • Full service provider for product authorisation under Directive 98/8/EC and Regulation 528/2012
  • Assistance and dossier preparation for national authorisation under the transitional arrangements
  • Advice on registration and testing strategies
  • Scientific review & legislative verification of existing data
  • Assistance in defining product families/frame formulations
  • Classification and labelling in accordance with Directive 1999/45/EC and Regulation (EC) No 1272/2008
  • Preparation of full risk assessments including all relevant exposure modelling
  • Compilation & submission of complete registration dossiers
  • Support in negotiations with regulatory authorities
  • Co-ordination and monitoring of in-house and external studies
  • Post submission support
  • A full service provider for Inclusion on the Union list of approved biocidal active substances (previously Annex I of directive 98/8/EC)

Please contact us for further details and download our Biocides brochure for information

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