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Eurofins Biocidal Services: EAS Reg Ag

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Friday, December 5, 2014

Today, we are happy to introduce our Group Biocidal Services and feature an interview with Nick Jarvis our regulatory manager for Biocides.

**On 3rd February 2015, Nick will be presenting at TSGE Forum's 3rd Annual European Regulatory Conference on Biocides at the Sheraton Airport Hotel, Brussels**

The EU Directive on Biocidal Products (98/8/EC) came into force on May 14, 2000 with the intention both to harmonise the EU internal market for biocides and to ensure a high level of protection for humans and the environment. The Biocidal Products Directive (BPD) was repealed on September 1, 2013 and replaced with the Biocidal Products Regulation (Regulation (EU) No 528/2012)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) Our team of regulatory managers and product safety experts have extensive experience of negotiating with regulatory authorities, providing regulatory advice and stewardship of dossiers through the evaluation process.

We cover all of the disciplines needed to successfully compile and submit dossiers for new and existing active substances and formulations. In addition we are able to cover a full range of GLP and efficacy testing services as part of a complete registration solution for biocidal products.

Here, Nick Jarvis,our manager for Biocides addresses some important issues relating to the BPR regulation:

The BPR regulation has been in place since September 1st 2013. What are the main changes compared to the former directive.

The BPR introduces a number of new aspects to the legislation governing biocidal products, including:

  • Introduction of centralized authorizations by the European Chemicals Agency (ECHA)
  • Additional requirements for treated articles (both manufactured in and imported into the EU)
  • Introduction of an Approved Supplier list for all active substances made available within the EU
  • Modification of the definition of a biocidal product to include in-situ generated products
  • Facilities for authorization of biocidal product families
  • Requirements for mandatory vertebrate data sharing
  • Introduction of a simplified authorization procedure for certain active substances
  • Option of a Union Authorization for certain products with similar use patterns throughout the EU
  • Hazard based exclusion and substitution criteria
  • IUCLID format for active substance and product dossiers

Can you give some more information on Union registrations?

The BPR has provided the opportunity to have biocidal product authorized on Union level with the idea to market throughout Europe. For new active substances Union registration is available from September 1, 2013 whereas existing substances will be available depending on product type up to 2020.

In practice, the usefulness of Union authorisation will have to be carefully considered taking into account the marketing areas for the product and comparing all the costs for the Union authorisation with the costs for mutual recognition.

How do you see the timelines developing for the active substance review and how does this influence the product registrations?

The objective of ECHA is to streamline the progression of the review program of active substances to finish it before the new deadline of 2024.

This will require companies to be more aware of the progress of active substances of interest through the review program so they are ready to react for product authorisation when the substances are approved.

How would you handle a Biocidal Product Registration?

Due to the diversity of products encompassed within the Biocides legislation there is no one answer to this, every use will have to be considered individually.

Generally companies will need to ensure that they are obtaining the active substance from an approved source and that they have suitable access to all the relevant active substance data (through a Letter of Access from the supplier) and that they allow adequate time for generation of shelf life data. It will also be necessary to have robust efficacy data to support the label claims being made.

The introduction of the Biocidal Product Family concept will allow options to streamline the registration process for some products (specifically, products within the wood preservative group and the disinfectant group will be able to make considerable use of this option) and when groups of similar products are being supported this option should be given serious consideration.

If you have any questions you would like to put to Nick and the biocides team, please contact them here.