New Biocides Review Programme Regulation enters into force
The new Commission delegated regulation identifies the active substance and product-type combinations in the Review Programme. The regulation describes processes for changing the participating company/ies and allows new active substance and product-type combinations to be added in specific cases.
Helsinki, 30 October 2014 – The new work programme for the systematic examination of all existing active substances contained in biocidal products enters into force on 30 October 2014. This new regulation updates the on-going review programme to fit the processes of the Biocidal Products Regulation and allows new active-substance/product-type combinations to be included in specific cases.
Key aspects of the regulation include:
- Listing the active substance/product-type combinations currently in the Review Programme;
- Listing the active substance/product-type combinations not currently supported by at least one participant;
- Defining Member States deadlines for submitting their assessments of the active substances in order to finalise the Review Programme by 2024 (as set in the amended Biocidal Products Regulation);
- Detailing the procedure for joining and replacing participants supporting active substance/product-type combinations;
- Defining the specific cases where active substance/product-type combinations can be added to the Review Programme. A specific case for example is when the substance benefitted from a derogation for food and feed under the old Review Programme regulation. Deadlines apply for declaring an interest to notify an addition of an active substance/product-type combination;
- Clarifying that nano forms of active substances require notification within 12 months in order to remain in the Review Programme. This requirement applies to all active substances except silver absorbed on silicon dioxide (as a nanomaterial in the form of a stable aggregate with primary particles in the nanoscale) (CAS 68909-20-6) and silicon dioxide (as a nanomaterial formed by aggregates and agglomerates) (No CAS available), as these two substances are already included as nanomaterials in the Review Programme.
Biocidal products that contain active substances that are included in the Review Programme can be made available and used subject to national laws until 3 years after the date of approval of the last active substance / product-type combination in the product.
The active substance / product-type combinations included in the Review Programme but not currently supported by a participating company are listed in part 2 of Annex II of the new regulation. Companies interested in supporting those active substances are invited to prepare their notifications. They will have to be made within one year of entering into force of the regulation.