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Article related to: biocides
How to get EU-wide authorisation for a biocidal product
Do you want to market your biocidal product in all EU countries or in a number of them? The Biocidal Products Regulation introduces a new concept of Union authorisation. Once the Union authorisation has been granted for a biocidal product, the authorisation applies to the entire Union market. You can apply for Union authorisation both for a single biocidal product or a product family with similar conditions of use across the EU.
The steps below will guide you in applying for Union authorisation. Before getting started, remember that the following products are excluded from Union authorisation:
- Products containing substances that fulfil the exclusion criteria, e.g. substances that are classified as carcinogenic, mutagenic or toxic for reproduction. The complete list of exclusion criteria can be found in Article 5 of the Biocidal Products Regulation.
- Product-types 14, 15, 17 and 20, covering e.g. products to control rodents, birds, fish and other vertebrates.
- Product-type 21 covering antifouling products.
Step 1 – Check when the Union authorisation can be granted for your product
If your product contains new active substances, alone or in combination with existing active substances, you can apply for Union authorisation now.
For products containing existing active substances, Union authorisation can be granted in three stages, depending on the product-type:
- From 1 September 2013 for product-types 1, 3, 4, 5, 18 and 19.
- From 1 January 2017 for product-types 2, 6 and 13.
- From 1 January 2020 onwards for the remaining product-types.
Considering that the evaluation of the application can take up to 18 months, the application can be submitted earlier than the dates listed above. However, the decision on the Union authorisation will only be given on or after the dates indicated above.
Step 2 – Prepare your application
The purpose of pre-submission is to confirm that the product falls within the scope of the Biocidal Products Regulation, it has similar conditions of use across the Union and that you have identified the appropriate product-type for your product.
Contact ECHA Helpdesk for further information and feedback related to pre-submission well before you plan to submit your Union authorisation application. Only after you have received ECHA's feedback on your pre-submission, can you submit your application in IUCLID format through R4BP 3, the online submission tool.
Pre-submision is also briefly described in the Biocides Submission Manual 4a: Biocidal Products Part A, Initial submissions
Step 3 - Create a IUCLID 5 dossier
1. Include all required information
The information requirements for a biocidal product are listed in Annex III of the Biocidal Products Regulation.
More details are given in the Guidance for information requirements.
2. Create IUCLID dossier
The Biocides Submission Manual 4a: Biocidal Products Part A, Initial submissions provides you with a checklist of elements that need to be included in the substance and product datasets of your IUCLID dossier.
If you need more instructions on how to create and build a IUCLID 5 dossier, you should also have a look at:
- BPR dossier creation/IUCLID Quick Guide
- Biocides Submission Manual 1: Using IUCLID for biocide applications
- The video tutorial Creation of a biocidal product dossier with IUCLID
Step 4 - Submit and follow-up your application
1. Use R4BP 3 to submit your application
Remember to upload your IUCLID 5 file to your application. The Union authorisation application wizard in R4BP 3 will guide you through the submission steps. A checklist for Union authorisation can be found in the Biocides Submission Manual 4a: Biocidal Products Part A, Initial submissions.
If you are not familiar with R4BP 3 yet, have a look at the Biocides Submission Manual 2: Using R4BP 3 for biocide applications to get useful information on the basic functions of the software.
2. Remember to follow up your application in R4BP 3
All important information related to your application will be communicated to you through R4BP 3. Therefore, it is essential to keep checking your account after you have submitted your application.
- In the Events history tab of the case, you can monitor how your application goes through the different stages of the process and which steps have been completed so far.
- To complete your application you need to pay the invoice that you receive through R4BP 3. More information related to invoicing and R4PB 3 can be found in the Biocides Submission Manual 5: Invoicing in R4BP 3.
- All fees related to Union authorisation are explained in Table I of Annex II of the BPR Fee Regulation (Commission Implementing Regulation (EU) No 564/2013).
- Any requests for additional information related to your application will be sent to you through R4BP 3 during the evaluation process.
Step 5 – After the Biocidal Products Committee has given its opinion
Once the Biocidal Products Committee has given its opinion on your biocidal product, you have 30 days to prepare and submit the summary of product characteristics (SPC) in all the official languages of the Union to ECHA. The European Commission can only grant the authorisation after they have received all translated SPCs from ECHA.
- Guidance on biocides legislation
- Biocides Submission Manuals
- IUCLID 5 support documents
- ECHA's YouTube channel with video tutorials
- Supporting document templates for biocides applications
Infograph: Steps that you need to take when applying for union authorisation.
Text by Päivi Jokiniemi
Top image: Fotolia
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