What to do if an active substance is included in Annex I

For biocidal products whose active substances have been approved an application for authorisation or renewed authorisation must be submitted in accordance with the principles of the Biocidal Products Directive. This applies to existing products on the Danish market and to new products – that is, products which were not on the market before the active substance was included in Annex I of the Biocidal Products Directive.

An active substance is approved when a decision has been made about inclusion in the “positive list”, Annex I of the Biocidal Products Directive for one or more product groups.

The situation is different in relations to application deadlines and the right to place a product on the market depending on whether we are dealing with an existing product or a new product.

Existing products on the market

This group consists of product types/application categories which were not subject for authorisation by the old Danish rules and of products which already have an authorisation by the old Danish rules. None of these products can continue on the market under the previous conditions.

Application deadlines

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).

The deadline for submission of an application is the date of the formal inclusion of the active ingredient in Annex I for one or more product types. This means two years after the decision date. If a product contains several active substances, the deadline of the product follows the date of the active substance which was the last to be included.

A product can be marketed on the Danish market until the Danish Environmental Protection Agency has completed the evaluation of the application.

Consequences, if you do not apply on time

If you do not submit you application on time your product is illegal and imports, production and sales must cease six months after the application deadline. This applies even if an existing authorisation has not expired. In Denmark, sales in subsequent links in the retail chain, storage and use of the product must cease not later than two years after the application deadline.  This applies both to the use of products stocked by consumers and to products that are used for production purposes.

Further reading

Deadlines for submission of product applications can be found in the inclusion directives on the EU-Commission web site and in Annex 1 of the Danish Statutory Order on the use of chemical substances and mixtures in pesticides and biocides.

New products on the Danish market

New products, meaning products that were not on the market before the inclusion of the active substance in Annex I, cannot be placed on the market in Denmark until they have been authorised by the Danish Environmental Protection Agency in accordance with the principles of the Biocidal Products Directive.

Application deadlines

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).

Products which are new to the market and products which contain the included active substance and which are otherwise within the relevant product type can apply from the date the formal inclusion takes effect. This means approximately two years after the decision date and unlimited in the time hereafter. If a product contains several active substances, the deadline of the product follows the date of the active substance that was the last to be included.