Biocides

Product Authorisation

The BPR requires suppliers of biocidal products to seek positive permission, in the form of an authorisation, in order to place such products on the market in an EU Member State. A biocidal product is defined under Article 3(1)(a) of the Biocidal Products Regulation as:

‘Any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,

Any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

A treated article that has a primary biocidal function shall be considered a biocidal product’

This definition means that the Regulation applies to not only substances and mixtures placed on the market and exhibiting a biocidal function (such a disinfectant); but also those that are generated in-situ (such as chlorine dioxide) and their precursors (such as sodium chlorite and hydrochloric acid) if placed on the market for this purpose.

The final sentence in the definition brings articles, as defined under the REACH Regulation, treated with biocidal products into scope, but only where that treatment confers a primary biocidal function on the article. 

Article 17(1) states that a biocidal product shall not be made available on the market or used unless authorised in accordance with the BPR. Applications may be for:

  • a National authorisation, which allows making available on the market and use in an individual Member State; or
  • a Union authorisation which allows the authorisation to be recognised throughout the EU.

Where a national authorisation has been granted in one Member State, authorisation within other Member States may be obtained through a process of mutual recognition. It is also possible to obtain an authorisation for both a single product or, in cases where a number of similar products are placed on the market, a product family. The authorisation, if granted will last for a maximum of ten years.

Transitional arrangements

Following the implementation of the Biocidal Products Directive in 1998 an EU-wide list of ‘existing active substances’ was produced, and the properties of these substances has been under assessment since. This review program of active substances, although originally intended to be concluded much sooner, is now scheduled to run until 2024.

As, under the BPR, biocidal products cannot be placed upon the market unless the active substances have been approved, and approval of all existing active substances is not going to be completed until 2024, an unintended market freeze would have been the consequence for certain products unless transitional measures were in place. These measures, detailed under Articles 89-93 of the BPR, allow biocidal products containing an active substance which is still under review to continue to be made available on the market provided applications for their authorisation are submitted no later than the date of approval of the last active substance for that product type. If no application for authorisation is made, the biocidal product shall no longer be made available on the market with effect from 180 days after this date, whilst disposal and use of existing stocks may continue until 365 days after this date.

The authorisation of any biocidal products granted in accordance with the Biocidal Products Directive remains valid until the expiry date of the authorisation. However in the case of applications submitted under the BPD for which the evaluation has not yet been completed the applicant may be required to submit further information.

Finally, there are some biocidal products which fall under the scope of the BPR but were not under the scope of the BPD, such as those generated from devices when no precursors are placed on the market. For such products, available on the market on 1 September 2013 and where existing active substance approval has already been granted, an application for authorisation should have been submitted by 1 September 2017.