BIOCIDES

biocides lab

BIOCIDES

In the EU, biocidal products can only be placed in the market once they have been approved by the competent authorities of the Member States in which they will be marketed.

From September 2013, the placing on the market and use of biocidal products is regulated by The Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012), which will repeal the Biocidal Products Directive (Directive 98/8/EC) with a transitional period for certain provisions.

Per BPR, obtaining an authorisation to place a product in the market is a two-step process:

  1. Approval of the active substance/product-type combination at EU level
  2. Approval of the biocidal product, either at EU level (union authorisations) or at Member State level (national authorisations)

Biocidal products containing active substances in the Review Programme are still subject to national laws within the transitional period. They can be made available on the market and used (if compliant with national laws) pending the final decision on the approval of the active substance and until the specific given deadline.

Following approval of the respective active substance/product type combination(s) and in order to maintain such products on the market within the transitional period, an application for authorisation under BPR needs to be submitted.

Biocidal Products containing new active substances that are still under assessment may also be allowed on the market where a provisional authorisation is granted.

Biocides

REGULATORY SERVICES:

Our team of experts can help you navigate this complex scenario for your products, in one or all the steps of the process:

  1. Authorisation Strategy & Timelines

We can devise the best strategy to place your products in the market while ensuring their timely application and compliance.

  1. Transitional period:
    • Assessment of National Requirements
    • Preparation and submission of any necessary Notifications / Registrations / Renewals according to the specific requirements
  2. BPR Active substance authorisation
    • Notifications
    • Inquiries
    • Applications for approval of the active substance
    • Active substance Review Programme evaluations
    • 95 inclusion
    • Annex I inclusion
    • Technical equivalence
    • Chemical similarity
    • Renewals
    • Technical dossier [links to 5 below]
  1. BPR Product authorisation
    • Union or National authorisations
    • National authorisations
      • single product(s)
      • product family
    • Mutual recognition in parallel or in sequence
    • Same biocidal product applications in parallel or in sequence
    • Simplified authorisations (where applicable)
    • Minor/major changes, product merges, parallel trade
    • Technical dossier [links to 5 below]
  2. Technical Dossier
    • Pre-submission meetings with ECHA & evaluating Competent Authorities (eCA)
    • Data collection and evaluation (including bibliographic research)
    • Data gap analysis and Intelligent Testing Strategy (ITS)
      • Laboratory contracts and Study monitoring
      • Data waiving justifications
      • QSAR modelling
      • Read-across approaches
    • Risk assessment [link]
    • Endocrine Disruptor assessments [link]
    • Technical documents (IUCLID dossier, PAR draft, SPC)
    • R4BP3 submission
    • Post-submission assistance and communication with Regulatory Authorities
  3. Auditing services [link]
    • Portfolio status evaluation
    • Regulatory and legal advice

 

MANAGEMENT SERVICES

Consortium Management 

Task Force Management 

Data Sharing Negotiations 

Brexit 

RESEARCH & DEVELOPMENT SERVICES

  • Protocol development for the adaptation of legal requirements with product specific technical properties and discussion with the authorities (i.e. tests to justify less restrictive classifications for a specific formulation or formulation type)
  • Protocol development – efficacy Semi-field/Field tests
  • Monitoring data (i.e. collection of real data from public pools)

 

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