Similar to plant protection products, biocidal products (BP) are a specific (use) group of chemicals, which are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria for example, through the properties of the active substances contained in the BP. The Biocidal Product Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of BP. For Luxembourg, further rules are defined in the Loi du 4 septembre 2015.
Article 69 BPR (partly referring to Art. 22 BPR) specifies that biocidal products have to be classified, packaged and labelled in accordance with the CLP Regulation (Article 17 CLP) and to contain additional BP specific label elements.
BP specific label elements
In addition to the CLP label parts, the following elements are required for BP (Article 69 BPR):
- Trade name of the biocidal product;
- Name and address of the authorisation holder and authorisation number;
- Identity and concentration of every active substance;
- Nanomaterials contained in the product, if any, and any specific related risks (and following each reference to nanomaterials, the word ‘nano’ in brackets);
- Details of likely direct or indirect adverse side effects and any directions for first aid measures*;
- Information on any specific danger to the environment particularly concerning protection of non-target organisms and the avoidance of a contamination of water*;
- Type of formulation*;
- Uses for which the biocidal product is authorised;
- Categories of users to which the biocidal product is restricted;
- Directions for use, frequency of application and dose rate, for each authorised use*;
- Where applicable, the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product or between application and the next use of the treated product, or the next potential entry of humans or animals to the area where the biocidal product has been used, including particulars concerning decontamination methods and measures and duration of necessary ventilation periods of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use and transport*;
- Conditions of storage (Art. 22 BPR);
- Directions for the safe disposal and, where relevant, any prohibition on the reuse of packaging*;
- Formulation batch number or designation and the expiry date relevant to normal conditions of storage*;
- If accompanied by a leaflet (see below), the sentence ‘Read attached instructions before use’ and, where applicable, warnings for vulnerable groups should be included.
The different label elements are shown below in a generic label:
* The amount of information on the label of a BP can be quite substantial. Therefore, if the space available on the package is too small, the elements marked with an asterisk in the list above can be indicated on a separate leaflet accompanying the package.
Treated articles according to BPR
For so-called treated article (unless it has a primary biocidal function), Article 58(3) BPR defines different label requirements:
- A statement that the treated article incorporates BP;
- Where substantiated, the biocidal property attributed to the treated article;
- The name of all active substances contained in the BP (alternative chemical name according to Article 24 CLP can be used instead);
- The name of all nanomaterials contained in the BP (the word ‘nano’ in brackets);
- Any relevant instructions for use, including any precautions to be taken because of the biocidal products with which a treated article was treated or which it incorporates.
Article 3(l) BPR defines: “‘treated article’ means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products”. It is different from the article definition applicable under REACH and CLP, i.e. a product considered a substance or a mixture under REACH and CLP may be considered a (treated) article under BPR.