Active substances in a biocidal product must be approved within EU to be used. But as long as an active substance is under evaluation, transitional rules apply to the biocidal products containing the substance. On this webpage, you will find information about what applies in Sweden during the transitional period.
The EU Biocidal Products Regulation contains rules governing the transition from national approval to EU rules for biocidal products. According to the transitional measures, Member States may continue to apply their current system or practice for products containing active substances that are under evaluation.
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.
Biocidal products that contains active substances that are not approved, nor under evaluation in the EU review program, may not be sold or used.
In Sweden, authorisation is generally required for a biocidal product that contains active substances that are under evaluation at EU level. However, some product types are exempt from the requirement for authorisation, in accordance with the regulations of the Swedish Chemicals Agency (KIFS 2008: 3) on pesticides, as long as the active substances in the products are evaluated at EU level. Thus, the exempted products may be sold and used in Sweden without being approved.
For products in product types 8, 10, 14, 15, 16, 17, 18, 19, 20 and 21, authorisation 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 sold and used in Sweden without authorisation as long as the active substances are under review in the EU review program.
For product types 2, 9 and 12, the authorisation 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:
For product type 2 authorisation is required for
- products intended for use against microorganisms in chemical toilets
- products against algae and microorganisms in the sea, lakes and watercourses
For product type 9 authorisation is required for
- products against organisms that break down plasticisers in polymerised materials
- products against microorganisms on hides and leather
For product type 12 authorisation is required for
- products intended to be used against slime forming microorganisms in machinery and equipment in the paper and cellulose industry
When a decision of approval is made at EU level for a combination of an active substance and product type, authorisation according to the EU Biocidal Products Regulation is required. An application for authorisation according to the EU Biocidal Products Regulation must be submitted.
If you are going to apply for a national authorisation for a new product, it is important that you contact us well in advance, preferably one year before you submit your application. This is important in order for us to be able to give you the support you need before applying, but also for us to be able to plan our work in a good way.
We recommend that you book a meeting with relevant officers before submitting your application, a so-called pre-submission meeting. During this meeting, we can discuss the process, the data requirements or other issues that are relevant to your application. Such a meeting is free of charge for applying companies.
Contact us via firstname.lastname@example.org
If you want an application for authorisation to be processed by the Swedish Chemicals Agency, you must pay a fee for this.
Once your application has been received by the Swedish Chemicals Agency, you will receive confirmation of this together with advice on which fee you should pay and how you should pay us. You do not pay the fee until after you have received the confirmation letter or invoice. As a rule we only start processing your application once we know that you have paid the correct fee.
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 Swedish Regulation KIFS 2008:3 on pesticides (in Swedish). The rules for labelling biocidal products also apply to biocidal products which are exempt from the authorisation requirement.
Biocidal products that are sold in Sweden must always have instructions for use and label in Swedish, according to the Pesticides Ordinance (2014:425) (in Swedish).
If you manufacture notifiable chemical products in Sweden or import or transfer these into Sweden, you must report such activity to the Swedish Chemicals Agency.
If the annual volume per product is at least 100 kg, you must also report the products and the amounts.
If you are selling biocidal products within the EU, your company, substance or product manufacturer or your substance or product supplier must be registered on the Article 95 List for the relevant product type.This also applies during the transitional period.
If you have had a pesticide authorised, you or the person representing you, must pay an annual fee to cover the duration of the period of authorisation. The annual fee is based on the sales value and shall be paid as of the calendar year following the year when the product was authorised and no later than the end of the calendar year during which the authorisation applies.
If no authorisation is required for the biocidal product during the transitional period, you will pay a chemical charge instead.