Application for EU authorisation of a biocidal product
Applicants wishing to apply for EU authorisation must submit an application to the European Chemicals Agency (ECHA).
The Biocidal Products Regulation (BPR) introduces the possibility to have certain biocidal products authorised at Union level. This will allow companies to place their biocidal products on the market throughout the entire Union, without the need to obtain a specific national authorisation.
New active substances
A product containing new active substances, also in combination with existing active substances, is eligible for Union authorisation from 1 September 2013.
Existing active substances
For biocidal products containing only existing active substances, Union authorisation will be available in three different 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 to the remaining product-types 7, 8, 9, 10, 11, 12, 16 and 22.
The list of biocidal products with Union authorisation will be published on the ECHA website.
The application process is a little different for applications for EU authorisation:
- Prior to submitting a full application, the applicant must submit a summary of the biocidal product characteristics (SPC) to ECHA. The purpose of submitting this summary is to offer ECHA the opportunity to evaluate whether the biocidal product of the applicant falls within the scope of the BPR and whether it will have similar conditions of use across the Union.
- Hereafter, the applicant must submit an application via the R4BP to ECHA, including a confirmation that the biocidal product will have similar conditions of use across the Union. In addition, the application must specify the name of the authority of the Member State that the applicant proposes should evaluate the application. For Danish companies, it will usually be the Danish EPA. However, a company is allowed to submit the application to the authorities of another EU Member State. The application to R4BP must also be accompanied by written confirmation from this authority that it agrees to process the application.
- Once the application processing fees has been paid to ECHA and the evaluating authority, the latter will start processing the application.
- The evaluating authority will process the application if the application complies with the formal requirements.
The authority may spend up to 1 year evaluating the application and will then pass it on to ECHA which may spend up to 180 days preparing an opinion, based on which the European Commission will make a final decision.
A fee will be charged by both ECHA and the evaluating authority and processing of the application. Additionally, ECHA will charge an annual fee while the authorisation is in force.
Read more about the Danish fees here
Click here to see the ECHA fees
ECHA has published a manual in which you will be guided through the application process and information about what important deadlines to consider
Read more on Dossier submission for union authorisation
Read more about the evaluation process
Template: Product Assessment Report (PAR) Union Authorisation (May 2016)