Authorisation of same biocidal products
You can apply for authorisation of a biocidal product that is identical to one that has already been authorised in Sweden following the EU Biocidal Products Regulation, or for which an application for authorisation has been submitted. This means that authorisation can be granted based on the product examination of a reference product.
Application for authorisation of same biocidal product
If you are applying for authorisation of two or more biocidal products with the same properties, authorisation may be issued based on one product description. One of the products will then become a reference product once an application for authorisation or a mutual recognition has been submitted. The other products will then be regarded as “same products”.
It is also possible to apply for authorisation for same biocidal product if a biocidal product with the same properties has already been authorised in accordance with the EU Biocidal Products Regulation. In such cases, the product that has already been authorised is known as the “reference product”. The application is to be submitted to the EU country that evaluated the reference product.
In both cases, the same biocidal and reference products may only differ in properties that could be subject to changes to administrative conditions, for example they might have different names and holders.
For examples of what are classed as changes to administrative conditions, see Implementing Regulation (EU) No. 354/2013 on changes of biocidal products External link..
To be able to apply for authorisation of same biocidal product, you must have permission to use all the documents that form the basis of the application for the reference product. Submit application via R4BP3 External link..
Conditions and decisions for same biocidal products
Authorisation conditions will be based on the examination conducted for the reference product. However, when approved, the same biocidal product will be given a different registration number to the reference product. It will also be possible to change or revoke the authorisation of the same biocidal product, regardless of the reference product’s authorisation.
When applying for renewal of authorisation, the products will be treated independently. In case of renewal of the product authorisation, your product will not be automatically included in the renewed authorisation of the reference product, and you must apply for a renewed authorisation of your product.
Changes to the regulation
Following requests from industry and other actors, the regulation for the authorisation of same biocidal products has been changed. The change means that it is now possible to apply for national authorisation for same biocidal product, even if the reference product has been authorised by the EU. The change entered into force on 1 November 2016.
With the changes to the regulations, it will also be possible to apply for authorisation for same biocidal products when the reference product is an individual biocidal product within a biocidal product family.
The ECHA register of biocides (R4BP) has been updated to enable these new types of application.
Read more about authorisation of same biocidal products on the ECHA website External link.
The consolidated Implementing Regulation (EU) 414/2013 External link.