When to apply
As a producer, importer or distributor of biocidal products, it is currently possible for several situations to be applicable. Your product may already be on the Danish market, either with a requirement for authorisation or temporarily without a requirement for authorisation. You may also be in the process of introducing a new product to the market which is not currently subject to a re-quirement for authorisation, but which will have to be authorised in the future.
Enterprises will be covered by the new authorisation scheme as the EU approves or rejects the active substances with regard to one or more of the 23 product types that the legislation distinguishes between. The EU is progressing with this task.
An active substance can now fall within four categories with different consequences for the enterprises concerned:
1. The active substance has been approved (included) for one or more product-types
Products with the specific active substance must be authorised in accordance with the new rules. This applies both to products that are already on the Danish market and to new products. Active substances that the EU approves are included in a "positive list", Annex I to the Biocidal Products Directive.
2) The active substance has been refused (not included) for one or more product-types.
Products containing the specific active substance must be phased out within a short period of time. Active substances that are no longer permitted are placed on a "negative list" ("non-inclusion list").
3 ) The active substance is under evaluation by the EU.
During a transitional period, products with active substances that are under evaluation may continue to be marketed in accor-dance with the Danish rules. This will apply until the EU has evaluated the active substances in the products, and either included them in Annex I as approved active substances or refused their inclusion.
4) The active substance is new within the EU.
Applications may not be submitted for products with new active substances that are not covered by the EU's review programme until the active substance has been evaluated and approved within the EU.
It is not possible to say in advance exactly when the EU will approve or refuse an active substance. Enterprises are therefore required, and obliged, to monitor developments in the active substances that can remain on the market, those that are on the way out and those that are still in the process of being evaluated.