EU evaluation of active substances
Since 2004, the EU has been working on the evaluation of active substances with respect to their future role as ingredients of biocidal products. This is being done on the basis of the information submitted by the active substance applicants during the period 2004-2008. The EU evaluates only those substances for which enterprises have submitted applications. Active substances for which no application has been submitted may no longer be used within the EU.
After approval by the EU, active substances are included in a "positive list", Annex I to the Biocidal Products Directive. It takes approximately two years from the date of the EU decision that an active substance should be included in the positive list (the decision date) for the formal approval to take effect (the formal inclusion date).
Active substances that are no longer permitted are added to a "negative list" (non-inclusion list).
The EU's review programme
The EU's review programme comprises a schedule for the review of active substance types. This schedule takes the form of phases established by review regulations.
Only biocidal products containing active substances that have been evaluated or that are under evaluation in accordance with the Biocidal Products Directive can be sold and used in the EU market. Other products have been phased out.
The active substances are evaluated in the EU according to the product-types in which they are used. The legislation distin-guishes between 23 product-types, and each active substance is either approved or refused for one or more of the 23 product-types. Once an active substance has been approved by the EU for a product-type, it can be used in all products of that type.
Read more about the product-types here
In order for the substances to be reviewed, the authorities must prepare an assessment report which refers to, summarises and evaluates the collective documentation for the substance concerned. The substances are distributed so that each Member State is responsible for evaluating a number of substances. The assessment reports form the basis for the decision concerning EU approval.