Special National Assessment Frameworks for Biocides

The Danish Environmental protection Agency utilizes special assessment frameworks in some areas. These assessment frameworks are based on previous Danish regulation or practice, or special protection cnsicerations

In relation to the approval of biocide product the Danish Environmental Protection Agency utilizes the following special Danish assessment frameworks:

Product for the control of rats and mice

The assessment framework ensures that the approved cases are in accordance with the Danish EPA regulation for rat control and the framework takes particular account of the risk of anticoagulant agents to predators and birds.

The reason for the existance of special Danish assessment principles is that in two Danish research repotrs from 2010 and 2015 in Denmark, the spread of poison to predators and birds thateat rats that have eaten rat poison has been demonstrated. Restrictions have been set nationally for the use of the substances in order to reduce the risk of poisoning other animals by now allowing preventive use or use in the open country (article 37(1)(a)). The assessment principlesalso ensure compliance with the authorization requirements of the executive order on rats (rottebekendtgørelsen), such that the products may only be used by persons who have received traning in rat control (article 37 (1)(c)). The assessment framework was last updated in 2018

Read the guidance on assessment and approval of chemical control agents for rats and mice (Danish).

Antifouling paint for yachts

Antifounling paint products are currently being assessed according to the rules Biocide Regulation, and until they are approved by the Danish EPA the products are regulated based on the executive order on antifouling. The assessment framework ensures that the upcoming approvals are in accordance with the executive order on antifouling, and it describes which of the EU-harmonised scenarios are deemed relevant for Danish waters. According to the executive orer on antifouling, substances are not approved for use on leisure boats which are predominantly used in fresh water, as well as substances for use on leisure boats under 200 kg which are used in salt water and do not have a fixed space in certain harbours. The restrictions have been laid down in the executive order on antifouling for many years and are done for the sake of the aquatic environment (article 37(1)(b)).

Read Guidance on the assessment and approval of antifouling agents (Danish)

Mosquito repellents/Repellents for use on people

In certain cases, the Danish EPA will add a restriction to the approval, so that it is not permitted to use the product on children under 2 years of age.

executive order on biocides, a risk assessment is made in accordance with the executive order on biocides, and a possible age restriction is determined based on the risk assessment.

In the case of approvals under the executive order on pesticides and biocides, a restriction will be generally set so that the product may not be used on children under  years 2 years of age.

The principle in the assessment framework is justified by the fact that, as a starting point, a quantitative risk assessment is not made for approvals under the executive order on pesticides and biocides. And based on a precautionary principle, mosquito repellents are not generally approved for use on children under 2 years of age.

If the applicant should want the product approved for children under 2 years of age, it is the applicant's responsibility to provide documentation that the use is safe, this can include providing calculaitons for the risk assessment.

Insecticides (risk assessment for bees)

The assessment principles describe the method used for risk assessment for bees when approving insecticides until harmonized principles are drawn up in the EU.

The rationale for the special Danish assessment principles is a desire to protect bees and other non-target insects from insecticides. The principles set restrictions on the approval of certain insecticides that pose a particular risk to bees and are used outdoors. The purpose is to prevent bees and other non-target insects from coming into contact with the products (Article 37(1)(c)). The national principles are necessary, as there is still no EU harmonized guidance on how the risk assessment of insecticides for bees should be carried out. The preparation of an EU-harmonised guide has begun. The national principles were introduced in 2017-2018.

Wood Preservatives

The Danish EPA only approves selected parts of the indoor use of wood preservatives. In buildings where people stay for longer periods of time, including homes, office buildings and workplaces, indoor use is only approved for places where people generally only occasionally and briefly come into contact with the product.

It covers e.g. roof constructions, skunk rooms and joists in basements and under the floor construction. Products are also approved for indoor use in churches etc., other buildings worthy of preservation as well as buildings where people do not work or stay for a long time at a time, and here the approved use also includes preservation-worthy or protected furnishings in these buildings. The Danish EPA does not approve the private use of wood preservatives indoors (Article 37(1)(c)).

National practice for indoor approval of wood preservatives was introduced in 1998-2000 and was last revised in 2021 (Article 37(1)(b)). The practice is based on a desire to avoid unnecessary exposure of people as well as an assessment that wood preservatives are assessed as not normally being necessary indoors where people come into contact with the product (Article 37(1)(e)).

In addition, only industrial treatment of wood against termites for wood for export is approved (Article 37(1)(e)).

Renewal of PT8 products.

Other application of Article 37

In addition, the Danish Environmental Protection Agency can choose to use Article 37 by, for example, not approving uses to combat pests that do not exist in Denmark (Article 37(1)(e)).

Insecticides with long-acting pyrethroids

The Danish EPA does not approve products with long-acting pyrethroids for use in stables, poultry houses, greenhouses or the like. This has been a national practice for 40 years, where the purpose is to maintain the sensitivity of the housefly population in Denmark to both short- and long-acting pyrethroids.

The reason for this is that the use of long-acting pyrethroids for pest control in stables, poultry houses, greenhouses or the like will lead to a strong and rapid selection of pyrethroid resistance in houseflies, whereby short-acting pyrethroids will no longer be fast and effective in controlling houseflies. The restriction is made with reference to the protection of animal health (Article 37(1)(c)).

Approved insecticides with long-acting pyrethroids must also, regardless of use, be labeled with the phrase "Do not use in stables, poultry houses, greenhouses and the like".