Redebel Regulatory Affairs Biocides

National registration – Transitional Period

We offer a global registration service for your biocide product for the whole of Europe, complying with the national legislation in each country.

The experience acquired in this area for over fifteen years and collaboration with local trustworthy partners allow us to offer a full registration strategy based on national requirements and your available data. We can also advise you on specific national features to be considered (distributor registrations, labelling, notification to poison centres, etc.).

Active substance

Support in building your project to list a new active substance (a.s. inclusion in Annex 1) from the preparation of the application to its approval, including the introduction to Article 95, preparation and participation in pre-submission meetings with the authorities, technical equivalence, negotiation of data sharing and preparation of its renewal application.

Our team prepares the active substance and representative product application adhering to the latest requirements and technical guidelines to ensure full compliance while anticipating all potential issues.

Drafting of all different sections (including risk assessments for representative uses and risk characterisation according to CLP): identity and mode of action, physico-chemical aspects, analytical methods, toxicology, environmental fate, ecotoxicology, residue (if necessary) and efficacy.

Submission of the active substance and representative product application to the relevant authorities in the proper format on R4BP3.

Efficient monitoring of the evaluation process and interactions with relevant authorities.Our job does not end when the file is submitted, our experts guide you through the different phases of drafting, submission and evaluation of your active substance approval application.

RRA is at the heart of the deliberation process that will enable you to find the best strategy and achieve your goal.

Product & biocidal product family

• Simplified authorisation procedure The so-called simplified authorisation procedure (Art. 25 of the BPR) gives faster access to the market if a product contains a low-risk active substance listed in Annex 1 of the BPR. The product containing this substance should prove its effectiveness and should contain no substance of concern nor be classified under the CLP Regulation.
• Product and product family dossiers including several Product Types The status of the active substance and the type of product targeted will determine the procedure to be adopted to obtain the authorisation to place your biocidal product on the market. The assessment authorities are becoming increasingly precise in their requirements and the recent introduction of new technical guides for building product families forces applicants to rationalise their portfolio and family projects. RRA offers a step-by-step approach to secure each pillar of this family guidance, from composition (backbone) to the similarity of risks and effectiveness (core assessment).
• National procedure or EU dossier – mutual recognition Whether your business is national or European, RRA will support every application that you need by advising you on appropriate submission strategies. Preparing and attending pre-submission meetings is a very important step when preparing a file as assessment, testing and file constitution approaches can be shared with the authorities before the submission itself.
• Maintaining authorisations - Administrative changes/minor/major/renewal It is frequently necessary during the lifetime of an authorisation to change it, for example by adding commercial descriptions or uses, changing an authorisation holder, etc. Authorisations also have to be renewed every seven or ten years depending on the type of product. RRA will guide you throughout this process, as the requirements can change and new rules apply when renewing authorisations.
• UFI – PCN Our services can also submit the declarations to the poison centres as per the new procedures in UFI format (Art. 45 and Annex VIII of the CLP Regulation). The limit date for professional products is 2021 and 2024 for industrial products.
• Consortium, task force and data sharing Should you wish to share the efforts within a Consortium to prepare your product files whilst protecting your marketing strategy, you should be able to find an RRA Consortium designed for you!

RRA manages consortiums and task forces for scientific research and test protocol development projects.

Our wealth of experience for your dossier

RRA assists and advises you from the Data Gap Analysis phase up to submission of files on R4BP3.

We pay special attention to preparing the pre-submission meeting and advance support documents.

Monitoring studies from requests for quotations to scientific review of reports including discussions with laboratories on developing protocols.

It is occasionally necessary to develop specific trials to highlight the effectiveness of a product or refine the risk of exposure. RRA has developed expertise in this area by supporting companies in creating their own test protocols.

Our (eco)toxicology experts calculate the exposures, assess the qualitative and quantitative risks and suggest refinements based on appropriate models and their experience to obtain acceptable risks.
Review of intended CLP classification.
Analysis of components in a formulation to identify the substances showing endocrine disrupting properties.

RRA drafts all documents in a file in house: PAR – SPC – IUCLID – Labelling – Supporting documents.

Bibliographical searches take place as per the guidance in EFSA document 2011; 9(2):2092 mainly when the risks have to be refined or a test, (eco)toxicological profile comparison or effectiveness needs to be justified.

Throughout the many years involved in these regulations, our teams have managed to develop solid and constructive relations with the various competent European authorities and we bring these advantages to your project.

Specific strategy and media

We pay special attention to understanding your expectations and personalise our scientific and regulatory supports in line with your product portfolio.

Before preparing the file, our teams will guide you especially in identifying and analysing all possible strategic options to choose the best submission models, file types, partners, laboratories and assessment authorities.

Once the file has been submitted, RRA monitors the authorisation requests in progress until authorisation is granted, in particular when additional information is requested, comments are made by the applicant when the assessment has been completed or during the BPC peer review, when the applicant is invited to defend his case.

RRA also offers highly personalised supports specific to the challenges of its customers (SME or multi-national), for we know that exhaustive regulatory watch can require a huge amount of energy. For this reason, we can set up a regulatory watch appropriate to your situation and product portfolio.

Negotiating sharing of data with third parties; we offer this interim support guaranteeing confidentially, mainly in a data room context.

Ancillary legislation

• Plant protection products Regulation (EC) 1107/2009 – see our PPP page
• Detergents (EC) 648/2004
• Medical devices (UE) 2017/745 & veterinary medicinal products (EC) 2019/6
• Cosmetics (EC) 1223/2009