Does your biocidal product now fall under the scope of the Biocidal Products Regulation?
By 1 September 2016, companies should apply for the approval of active substances in biocidal products that were outside the scope under the previous directive but now fall within the scope of the Biocidal Products Regulation.
Helsinki, 10 May 2016 – This deadline concerns two groups:
- Active substances in food contact materials for surface action. Example: antimicrobial substances used on plastic chopping boards to give them an antimicrobial surface (product-type 4, disinfection of material which may have contact with food);
- In situ generated active substances* with precursors that were not in the scope of the directive because they were not placed on the market, or because no claim was made that these precursors could be used for a biocidal purpose. Example: ozone generated from oxygen from the air (product-type 5, disinfection of drinking water).
Companies should submit a dossier on the active substance to ECHA through R4BP 3.
If an application is not made by the deadline, the biocidal product may only be placed on the EU market until 1 September 2017.
The obligation applies only to active substances that were available on the EU market or used in biocidal products on 1 September 2013 when the Biocidal Products Regulation entered into application.
* A biocidal active substance is called ‘in situ generated' if it is generated from another substance (called a 'precursor') at the place of use. Under the Biocidal Products Regulation, the potential risks of both the precursor and the substance it generates are to be evaluated.
Article 93 of the Biocidal Products Regulation (BPR) specifies the transitional measures for biocidal products which were not covered by the scope of the Biocidal Products Directive (Directive 98/8/EC) but now fall within the scope of the BPR. A Member State may continue to make such biocidal products available on the market if an application for approval of the active substance for the relevant product-type is submitted by 1 September 2016.