Plant protection products that are chemical products or consist of micro-organisms must be labelled in accordance with two different regulations: the EU Plant Protection Products Regulation with its associated labelling regulation and the EU CLP Regulation.
Labelling under the EU Plant Protection Products Regulation
All chemical plant protection products and those consisting of micro-organisms must be labelled in accordance with the EU Plant Protection Products Regulation. This means among others that the requirements in the labelling regulation for plant protection products must be fulfilled. Annex I of the labelling regulation states the information that must be included in the labelling of a plant protection product. This includes among others information about the authorised areas of use, conditions of use and dose rate. The information in the labelling also included in the decision of the Swedish Chemicals Agency for an authorisation of a plant protection product must be in accordance with the decision. The products shall be clearly and indelibly labelled.
Some of the information may be stated on a leaflet accompanying the package if the space available on the package is too small. Such a leaflet should be regarded as part of the label.
The user shall always comply with the conditions specified in the labelling.
Amendment of conditions in the authorisation
If the conditions of use are amended, the new conditions apply for products placed on the market by the authorisation holder from the day the decision enters into force. There is no obligation in the regulations to re-label products that are already on the market.
It is the preliminary assessment of the Swedish Chemicals Agency that it is the authorisation holder who is responsible for the labelling and that it complies with the requirements in the EU Plant Protection Products Regulation. In case the authorisation holder wishes to re-label products already placed on the market, we therefore recommend that the company itself effects the re-labelling since incorrect labelling may entail criminal liability. If new labels are sent out it is important to ensure that the products remains correctly labelled.
Hazard labelling under the CLP Regulation
As with all chemical products, plant protection products that are authorised under the EU Plant Protection Products Regulation must be classified, packaged and labelled in accordance with the CLP Regulation. This means that a plant protection product shall be labelled according to the CLP Regulation as well as the EU Plant Protection Products Regulation and its associated labelling regulation. CLP labelling must inform the user of the product about the product's hazardous properties and how the user is to protect his or her health and the environment when using it.
The content of the labelling
In order for a plant protection product to be sold or transferred in Sweden, the labelling must be in Swedish.
The brochure "The labelling of plant protection products" states which information must be included in the labelling, and gives illustrations of different forms of labelling.
Labelling of nematodes, insects and arachnids
Since the 1st of July 2016 the Swedish Environmental Agency approves the organisms that may be used in plant protection products and an authorisation of the product is therefore no longer needed.
Biological pesticides that consist of nematodes, insects and arachnids and that have a product authorisation decided already before the 1st of June 2016 shall still be labelled in accordance with national regulations and include the information stated in Appendix 1 of the Swedish Chemical Agency's Pesticides Regulations (KIFS 2008:3).