Union authorisation – a convenient approach to marketing biocidal products across the EU
Want to place a biocidal product on the EU market without having to apply for country-specific national authorisations? Union authorisation may provide the answer.
Union authorisation offers the convenience of a single dossier submission to ECHA (European Chemicals Agency) and evaluation by one Member State (MS), enabling companies to market biocidal products throughout the European Union (EU), Norway, Iceland and Switzerland.
Applications are possible for most products, with the exception of biocidal products containing active substances subject to the exclusion criteria, as well as those in Product Types 14 (rodenticides), 15 (avicides), 17 (piscicides), 20 (other vertebrates) and 21 (antifouling).
So, if you need help evaluating if Union authorisation is the right choice for your company, or if you’re struggling to decide which MS to submit your evaluation to, please do get in touch via the form below.
How TSG can help
TSG Consulting is proud to have supported clients with successful Union authorisations for single biocidal products and product families based on propan-2-ol as well as ongoing applications with products based on actives such as hydrogen peroxide, peracetic acid and sodium hypochlorite. This practical experience, gained across the entire lifecycle of Union authorisation submissions, enables us to provide the strategic support and guidance required in getting a biocidal product to market.
Our experienced consultants can help:
- Evaluate if Union authorisation is the right choice for your company based on market area needs and sales. We will compare the costs of Union authorisation versus National authorisation and mutual recognition to help identify the most cost-effective route forward
- Identify the preferred MS to evaluate an application, as well as assist with contacting them
- Prepare for the pre-submission to ECHA as well as the pre-submission meeting with the chosen evaluating MS. We can also be on hand during this meeting to provide support and guidance
- Explain the process, expected timeline and costs of the whole procedure upfront, so that you are well informed and as prepared as possible from the start
In addition to Union authorisations, TSG’s team of consultants has many years of experience working in the biocides area, from active substance applications to gaining product registrations throughout the EU for a wide range of products and use areas. We are very familiar with the requirements for all the various applications types and have extensive experience of using ECHA web-based tools such as R4BP and IUCLID, which are mandatory for submitting applications to the EU Authorities. We can help with biocidal product dossier preparation and submission, provide strategic advice on your product range (single product or product family), assist with the commissioning and monitoring of studies and provide guidance on label claims and data packages.