Labelling of biocidal products
Biocidal products must be labelled in accordance with various regulations. Both the EU Biocidal Products Regulation and the EU CLP Regulation applies. For biological and chemical biocidal products that are authorised according to national legislation or exempted from the authorisation requirements, national regulation apply along with the CLP Regulation. For biocidal products that are authorised according to the EU Biocidal Products Regulation, this Regulation applies for labelling along with the CLP Regulation.
Labelling following the EU Biocidal Products Regulation
EU-authorised biocidal products released on the market must be labelled in accordance with the EU Biocidal Products Regulation. Article 69 provides a list of the information that must be included on the labelling. This often refers to details concerning the conditions of use, dosage and further directions. The company that holds the product authorisation must ensure that the labelling details correspond with the conditions of use issued by the Swedish Chemicals Agency or other competent authority.
Directions for use are part of the labelling of biocidal products for which the company is responsible. Directions for use must contain all the important information needed for the correct use of the substance. The user is also responsible for following the information in the substance’s directions for use.
Labelling following national regulations
National regulations must be followed for the labelling of Biocidal products that have not yet been authorised following the EU Biocidal Products Regulation, or for which provisional regulations between the older and new regulations apply. Specific labelling regulations for biocidal products can be found in the Swedish Chemicals Agency Regulations (4 Chap 6§ and Annex 2 to KIFS 2008:3) Pesticides.
Regulations for labelling biological biocidal products are stipulated in the Regulation (2014:425) about pesticides and the Swedish Chemicals Agency Regulations (4 Chap 6§ and Annex 2 to KIFS 2008:3) Pesticides.
Hazard labelling following the CLP Regulation
Just as all other chemical products, biocidal products must be classified, packaged and labelled following the CLP Regulation. Labelling in accordance with the Regulation applies in addition to the labelling requirements stipulated in the EU Biocidal Products Regulation. Labelling following CLP must provide the product user with information of its hazardous properties and how the user must protect their health and the environment when using the product.
It is the responsibility of the holder of the product authorisation to ensure that the product is classified, packaged and labelled correctly.
Information in e-commerce
According to the CLP- and Biocidal Products Regulation, there are requirements that certain information should be included in advertising, for example when marketing a product via the internet.
If you sell biocidal products via the internet, you must inform customers about the product's hazardous properties on the website where the product is marketed. This gives customers information about the hazard of the product before the purchase. In addition, the advertisement must include a demand to use the biocidal product safely and that the user should read the information on the packaging before use.
Expressions that may lead to underestimation of the hazard of the product can not be mentioned in the advertisement. Examples of such expressions are "natural", "environmentally friendly" or similar.
For the product to be sold or released in Sweden, biocidal product labelling must be in Swedish.
An authorised pesticide have a four-digit registration number on the packaging. The registration number is the same as the number in the Swedish Chemicals Agency Pesticides Register. Packaging must also be labelled with an authorisation class and information about the active substance(s) in the product. These details must correspond with the information in the decision for authorisation.
The Swedish Chemicals Agency Pesticides Register can be searched and contains information for all pesticides currently and previously authorised in Sweden. It is possible to search the product name, registration number or area of use in the Register.
Guidance for first aid instructions
EU member states have developed a harmonised guidance document on which first aid instructions are to be included in the labelling of biocidal products, during product approval. This guidance document can be helpful when companies develop draft labels for their biocidal products.
Temporary rules for disinfectants
The Swedish Chemicals Agency has decided on temporary regulations that provide exemptions from the language requirements that labelling and safety data sheets should be in Swedish for certain disinfectants. The exemption applies to hand and surface disinfectants that are to be used professionally. The exception does not apply to products to be used by private individuals. Danish, English or Norwegian are now also accepted, instead of Swedish. However, information about the active substance, its concentration and the intended use of the product must still be provided in Swedish in some way. But the information does not need to be on the packaging, it can be provided on a separate information sheet or otherwise. The regulations apply until 15 March 2021. Read more about the temporary rules for disinfectants (In Swedish).
Regulations for labelling biocidal products
Pesticides Ordinance (2014:425) (In Swedish)