Biocides regulation


Find the best strategy for your products

 

 


1- REGULATORY DIAGNOSIS

Before putting your dossier together, EcoMundo carries out an accurate regulatory diagnosis in order to draw up an action plan with a view to ensuring the compliance of your biocidal product (BP).

This diagnosis includes:

  • Analysis of active substances (have they been approved?, do they already exist?) contained in your biocidal products,
  • Identification of the most suitable type of MA dossier for your biocidal products out of the 3 main authorisation groups (long-term, transitional and provisional) described in the EU Biocides Regulation 528/2012.

Bonus:

  • You will be guided step-by-step through the entire process of ensuring the compliance of your BP
  • Possible creation of BP families (cost optimisation)
 


2- CREATING AND SUBMITTING MARKETING AUTHORISATION DOSSIERS

Our specialists will guide you from the creation to the submission of your Marketing Authorisation (MA) application:

  • Determine the size of your business, and validate it with ECHA
  • Complete the toxicological and ecotoxicological “data gap” that must be provided (read-accross strategy, QSAR, etc.)
  • Help with the collection of relevant data: analytics, efficiency, toxicology, ecotoxicology, residue analysis, etc.
  • Draw-up the scientific argument
  • Create the dossier in IUCID 6 format
  • Submit the dossier via R4BP

EcoMundo will represent you and look after your interests:

  • before ECHA and the BPC (Biocidal Product Committee)
  • within task forces
  • before data owners to negotiate LoA costs
  • before the assessing Member State to confirm authorisation of the application and manage interactions in the event that additional information is requested

Bonus:

  • Use of advanced software tools (SDS Factory) to calculate the CLP hazard classification of your Biocidal Products
  • Direct interaction with the national evaluating competent authorities (eCA)
  • Guaranteed anonymity until the application is submitted, thereby simplifying interactions and ensuring the success of negotiations
  • 100% of the MA applications submitted by our experts have been validated!


3- CREATION OF A BIOCIDES CONSORTIUM

Creating or joining a biocides consortium involves submitting a Marketing Authorisation application to various authorities. There are considerable advantages to this approach:

  • Reduction of the costs associated with submitting the application to the competent authorities,
  • Optimisation of resources involved in carrying out tests,
  • Sharing of technical and regulatory work involved in putting the dossier together.

Bonus:

  • EcoMundo handles all the activities related to the creation and/or management of a biocides consortium
  • Our experts manage the interface with other members of the consortium
  • The confidentiality of your information is guaranteed
 


1- REGULATORY DIAGNOSIS

Before putting the dossier together, EcoMundo carries out an accurate regulatory diagnosis and draws up an action plan in order to ensure the compliance of your biocidal Active Substances (AS).

This diagnosis includes the analysis of active substances (have they been approved?, do they already exist?) before identifying which procedure will best meet your requirements: technical equivalence or approval application for a new Active Substance. Our experts will guide you and draw up their strategic recommendations (optimisation of costs, simplification of regulatory procedures, etc.).

 

Bonus:

  • Risk pre-assessment: EcoMundo's specialists anticipate the acceptance of a product’s intended use even if the Active Substance is under examination.
 


2- DOSSIER FOR A NEW BIOCIDAL ACTIVE SUBSTANCE

Dossiers for a new Active Substance (AS) are put together for each biocidal product type (PT) in question. They include physico-chemical, toxicological and ecotoxicological data and the effectiveness of the AS. They also undergo an assessment of the risk to human health and the environment.

EcoMundo assists you in creating your new AS dossiers before sending your dossier to a national evaluating Competent Authority (eCA) which then submits the application to ECHA. The agency gives an initial opinion concerning the approval of the AS in the European Union. The European Commission then makes the final decision on whether or not to approve the AS for the given PT.

EcoMundo also puts together your dossiers for the renewal of your approval of SA.

 

Bonus:

  • Comprehensive monitoring of your dossiers and optimisation of costs related to tests (data gap)
  • Personalised support: our experts deal directly with the eCA. This facilitates the process and ensures your regulatory compliance.
 


3- INCLUSION ON THE LIST OF APPROVED SUPPLIERS

According to Article 95 of the EU Biocides Regulation, every manufacturer of an existing AS (whether it has already been approved or is under examination) for a given type of product must be registered on the list of approved suppliers in order to comply with the regulation.

Our specialists will support you when purchasing the Letter of Access (LoA) and submitting your application to validate your registration on the list of approved suppliers.

 

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