Biocidal products

What is a biocidal product?

A biocidal product is defined in the Environmental Code (1998:808) as a chemical or biological pesticide which is intended to prevent or control animals, plants or micro-organisms, including viruses, causing harm or inconvenience to human health or damage to property.

There are 23 different types of biocidal products, see table below. For fuller descriptions of these different product types, see Appendix 9 of the Swedish Chemical Agency´s Pesticides Regulations (KIFS 2008:3).

Which biocidal products require authorisation?

The main rule in Sweden is that all biocidal products must be authorised to be placed and used on the Swedish market. However, today some products are currently exempted from the requirement for authorisation, see table below. These exemptions will cease to apply once Sweden has transposed the Biocidal Products Directive into Swedish law. The Biocidal Products Directive stipulates that all biocidal products placed on the market in the EU must be authorised by 14 May 2014.

One condition for authorisation of a biocidal product, or for using the exemption from the requirement for authorisation, is that the active substances in the biocidal product are among the substances included in the EU work programme for existing substances. It is therefore important to find out whether the active substances in a product are included in the programme.

Step 1 – Search for the active substance in Annex II to Regulation (EC) No 1451/2007 (substances that will be evaluated). Take note that the substance must have been notified in the product type to which the biocidal product belongs.
Step 2 – If the active substance in the product is included in Annex II, look at the web site of the European Commission/Biocides if there is a Commission decision to allow or not allow the substance for use in biocidal products. The decision makes it clear what applies to products containing the substance. The decision is included in Annex I, IA or IB to the Biocidal Products Directive.

If a product contains an active substance that is not included in Annex II, or if there is a decision that the substance is not allowed to be used in biocidal products, the biocidal product is not allowed to be placed on the Swedish market. This also applies to products which at the present situation are exempted from the requirement for authorisation.

These products may, nevertheless, be offered for sale and transferred until 31 December 2010 and used until 31 December 2011.

For choice of application for a biocidal product, see the page Choice of application. Forms and information on how to apply for a product authorisation are found on the pages for the different applications and on the page Guidance. Note that there are also rules for the products currently exempted from the requirement for authorisation.

Product types
Main group	Product type	Description
Disinfectants and general biocidal products	1 *	Human hygiene biocidal products
	2 **	Private area and public health area disinfectants and other biocidal products
	3 *	Veterinary hygiene biocidal products
	4 *	Food and feed area disinfectants
	5 *	Drinking water disinfectants
Preservatives	6 *	In-can preservatives
	7 *	Film preservatives
	8	Wood preservatives
	9 **	Fibre, leather, rubber and polymerised materials preservatives
	10	Masonry preservatives
	11 *	Preservatives for liquid-cooling and processing systems
	12 **	Slimicides
	13 *	Metalworking-fluid preservatives
Pest control	14	Rodenticides
	15	Avicides
	16	Molluscicides
	17	Piscicides
	18	Insecticides, acaricides and products to control other arthropods
	19 ***	Repellents and attractants
Other biocidal products	20 *	Preservatives for food or feedstocks
	21	Antifouling products
	22 *	Embalming and taxidermist fluids
	23	Control of other vertebrates
* For these product authorisation is not required at present (see Chapter 4, Section 4, KIFS 2008:3). Authorisation will be required for these exempted products to the extent they are included in Annexes I, IA or IB of the Biocidal Products Directive, 98/8/EC.
** For some of these products authorisation is required at present (see Chapter 4, Section 4 a-e, KIFS 2008:3).
*** Authorisation is not required for products where the active substances consist only of food or feed (see Chapter 4, Section 4a KIFS 2008:3). The requirement that the active substance in the biocidal product must be included in the EU word programme is not applicable for this exemption.
For other products authorisation is required.