The Biocidal Products Regulation provides for a simpler and cheaper authorisation procedure for less harmful biocidal products
Under the new Biocidal Products Regulation (BPR) less harmful biocidal products may be made available on the market faster and cheaper than traditional products.
A biocidal product can take a short cut to the market if all the active substances contained in the product appear in Annex I and the product is effective and contains no substance of concern and no nano materials and if personal protective equipment is not required. Lactic acid and lavender oil are among the active substances included in Annex I of the Regulation.
Click here to see more the application procedure
The simplified authorisation procedure in brief
A simplified authorisation procedure aims to encourage the use of biocidal products that are less harmful for the environment, human and animal health.
To be eligible for the simplified authorisation procedure a biocidal product must comply with all of the following conditions:
- all the active substances contained in the biocidal product appear in Annex I of the BPR and comply with the specified restrictions
- the biocidal product does not contain any substance of concern
- the biocidal product does not contain any nanomaterials
- the biocidal product is sufficiently effective
- the handling of the biocidal product and its intended use do not require personal protective equipment
If all of these conditions are met, the applicant seeking authorisation should submit an application to ECHA through R4BP 3 indicating which Member State competent authority will evaluate the application.
Where a simplified authorisation is granted, the biocidal product may be made available on the market in other Member States without the need for mutual recognition. The authorisation holder, however, needs to notify each relevant Member State 30 days before placing the product on its territory. This notification is done in R4BP 3.
The application procedure for simplified authorisation of a biocidal product is similar to the procedure for national product authorisation except for the different data requirements. Applicants need to submit a draft summary of biocidal product characteristics, relevant efficacy data and any other relevant information demonstrating that the product meets the conditions for a simplified authorisation procedure.
Applications are submitted through R4BP 3 to ECHA in the form of a IUCLID file.
Under the simplified authorisation procedure for biocidal products according to the BPR a company may submit an application for a product to the EU pointing out a single Member State as the evaluating competent authority.
The authorisation given is valid for the whole of the EU without the need for mutual recognition. However, the authorities of each relevant Member State must be notified 30 days in advance of the placing on the market of the biocidal product in question in that Member State and the biocidal product must be labelled in the official language or languages of that Member State (in Denmark the label should thus be in Danish).
This will easie the burden on the companies since they will no longer need to apply for mutual recognition of these less harmful biocidal products following their authorisation in a single EU Member State.
Eligibility for the simplified authorisation procedure
An application for authorisation of a biocidal product may be made under the simplified authorisation procedure if all the following conditions are met:
• All the active substances contained in the biocidal product appear in Annex I of the Regulation and satisfy any restriction specified in that Annex.
• The biocidal product does not contain substances of concern.
• The biocidal product does not contain nanomaterials.
• The biocidal product is sufficiently effective.
• The handling of the biocidal product and its intended use do not require personal protective equipment.
How to apply for authorisation under the simplified procedure:
• The applicant must mustcontact the Member State authority which he would prefer to evaluate the application. The written confirmation from that authority and the application must then be submitted to the Register for Biocidal Products (R4BP) for processing.
• The evaluation fee must be paid within 30 days. After that, the authority must carry out the evaluation within 90 days.
• If the evaluating authority considers that the application is incomplete, the applicant will have 90 days to add the additional information to the application, after which the authority will complete the evaluation within the following 90 days.
• If your active substance does not appear in Annex I, and you believe it should be included, you can find advice in this guidance document on the simplified procedure and Annex I. [LINK til dokument]
Please note that a fee depending on the type of application will be charged by the authorities about to process your application. This may be the Danish EPA, ECHA and/or relevant authorities of other EU Member States.
Read more about the danish fees here.
Be cautious when labelling your product
After authorisation product marketing and labelling may not be misleading. Indications such as 'low-risk biocidal product', 'non-toxic', 'harmless', 'natural', 'eco-friendly', 'animal-friendly' or the like are not allowed. The rules are detailed in Article 69(2) of the BPR