Which biocidal products are allowed on the market?
The principal rule that applies in Sweden is that all biocidal products must be authorised for placing on the market or for use. However, there are transitional measures which allows for exceptions under certain conditions.
The active substances to be used in biocidal products are evaluated at an EU-level in a review programme. After evaluation of an active substance, an EU-common decision is made about the approval or non-approval of that active substance for a specific product type. If a biocidal product contains only EU approved active substances for the specific product type, that biocidal product needs to be authorised in accordance with the EU Biocidal Products Regulation. But for other biocidal products, it depends on which active substances they contain and what product type they belong to, if approval is currently required in Sweden.
In order to simplify a suitable assessment of exposure and risk to health and the environment as a result of biocidal product use, the European Commission has determined specific product types of biocidal products. The assessment can thus be made to suit the intended area of use for each biocidal product. According to the EU Biocidal Products Regulation, there are 22 specific product types of biocidal products.
Which products must have an authorisation?
The principal rule is that biocidal products need authorisation in order to be placed on the market or to be used, but different rules apply depending on which active substance(s) that are in the product. Active substances in biocidal products are divided into two categories; new substances and existing substances. Existing active substances are those that were already on the market on 14 May 2000 while new active substances are those introduced after that date.
Active substances that are classified as existing active substances are evaluated through a special EU Review Programme. They may be used in biocidal products of a specified product type, in accordance with current national rules and practice, for as long as the evaluation is in progress. Current practice in Sweden means that some products need to be authorised in order to be sold and used while others do not. The Swedish rules during transition are described in more detail below.
New active substances may only be made available on the EU market before the substance has been authorised if the biocidal product has been granted temporary national authorisation in accordance with Article 55 (2) of the EU Biocidal Products Regulation.
If a product only contains active substances in Annex I of the EU Biocidal Products Regulation and meets the conditions of article 25 of the same regulation, you may apply for authorisation according to a simplified procedure. Read more about simplified authorisation procedure for biocidal products.
If a biocidal product contains an active substance which is not supported in the review program within the correct product type, the product is not allowed to be sold or used.
You can find active biocidal substances and their status in a database at the European Chemicals Agency ECHA's website.
If you want to apply for an authorisation of a biocidal product you can follow our application guidance.
Swedish rules about transition to EU regulations
Not all active substances-product type combinations have yet been decided on within EU. As long as the active substance is being evaluated, so-called transitional measures apply to the biocidal products that contain the substance. This is to give manufacturers and distributors time to adapt to the EU rules. During the transitional period, Member States may continue to apply their national rules to products containing active substances under evaluation.
In Sweden authorisation is generally required for biocidal products that contain active substances under evaluation at EU level, but certain product types are exempted from the authorisation requirement during the evaluation process of the active substance. The exempted products may thus be sold and used without being authorised.
Transitional rules apply to biocidal products that contain:
- active substances that are part of the EU review programme for the relevant product type
- active substances that are still under review by EU as well as active substances that are approved in accordance with the EU Biocidal Products Regulation for the relevant product type.
The national rules for authorisation apply for these kinds of products. Some product types are exempt from authorisation requirements in accordance with the Swedish Chemicals Agency’s regulations (KIFS 2008:3) on pesticides.
For products in product types 8, 10, 14, 15, 16, 17, 18, 19, 20 and 21, approval in accordance with Swedish regulations is required during the review of the active substances in the EU review program.
Products in product types 1, 3, 4, 5, 6, 7, 11, 13 and 22 may be placed on the market and used in Sweden without approval as long as the active substances are under review in the EU review program.
For product types 2, 9 and 12, the approval requirement according to Swedish regulation applies only to certain types of products, as long as the active substances are under review in the EU review program:
- products intended for use against microorganisms in chemical toilets
- products against algae and microorganisms in the sea, lakes and watercourses
- products against organisms that break down plasticisers in polymerised materials
- products against microorganisms on hides and leather
- products intended to be used against slime forming microorganisms in machinery and equipment in the paper and cellulose industry
After a decision is made in the EU review programme for a combination of active substance and product type, the following rules apply according to the EU Biocidal Products Regulation.
If the product contains only one active substance
For biocidal products that contains only one active substance, the approval requirement will apply as of the date of approval of the active substance in the product. The holder of a biocidal product must submit an application for its authorisation no later than the date of approval of the substance in order to be able to market and sell that product on the EU market. If the product already exists on the Swedish market (either with a Swedish national authorisation or under exemption from national authorisation) and no application for authorisation has been filed by this date, the product may be put on the market during 180 days after the date of approval of the substance. Products which are already on the market may be used 365 days after the same date.
If the biocidal product belongs to several product types it is only necessary to apply for national authorisation when the active substance contained in it has been approved for all relevant product types before the deadline of the last approved.
If the product contains more than one active substance
For a biocidal product that contains more than one active substance for the same product type, the application for national authorisation must be submitted no later than the date of approval of the last approved active substance for that product type. If the biocidal product belongs to several product types it is only necessary to apply for authorisation when the active substances contained in it have been approved for all relevant product types before the deadline of the last approved substance.
If the product already exists on the Swedish market (either with a Swedish national authorisation or under exemption from national authorisation) and no application for authorisation has been filed by this date, the product may be placed on the market during 180 days after the date of approval of the substance. Products which are already on the market may be used 365 days after the same date.
Rules governing the labelling of biocidal products
Rules for classification and labelling in the CLP Regulation also apply to biocidal products. In addition to the CLP regulation, rules for labelling of biocidal products are given in the EU Biocidal Products Regulation and in the Swedish regulation KIFS 2008:3 on pesticides (in Swedish).
Biocidal products that are marketed in Sweden must always have instructions for use and label in Swedish, according to the Pesticides Ordinance (2014:425) (in Swedish).
Authorised products also need to be marked with information about the active substance(s), product registration number and user classification on the label.
Special rules for certain biocidal products
Special rules apply for certain kinds of biocidal products. See an overview here.