Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

Article 20 Classification, packaging and labelling of biocidal products

1. Biocidal products shall be classified in accordance with the provisions relating to classification in Directive 88/379/EEC.

2. Biocidal products shall be packaged in accordance with Article 6 of Directive 88/379/EEC. In addition:

(a) products which may be mistaken for food, drink or feedingstuff shall be packaged to minimize the likelihood of such a mistake being made;

(b) products available to the general public which may be mistaken for food, drink or feedingstuff shall contain components to discourage their consumption.

3. Biocidal products shall be labelled in accordance with the provisions relating to labelling in Directive 88/379/EEC. Labels shall not be misleading or give an exaggerated impression of the product and, in any case, not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or similar indications. In addition, the label must show clearly and indelibly the following:

(a) the identity of every active substance and its concentration in metric units;

(b) the authorisation number allocated to the biocidal product by the competent authority;

(c) the type of preparation (e.g. liquid concentrates, granules, powders, solids, etc.);

(d) the uses for which the biocidal product is authorised (e.g. wood preservation, disinfection, surface biocide, anti-fouling, etc.);

(e) directions for use and the dose rate, expressed in metric units, for each use provided for under the terms of the authorisation;

(f) particulars of likely direct or indirect adverse side effects and any directions for first aid;

(g) if accompanied by a leaflet, the - sentence ‘Read attached instructions before use’;

(h) directions for safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on reuse of packaging;

(i) the formulation batch number or designation and the expiry date relevant to normal conditions of storage;

(j) 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 product treated, or the next access by man or animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use, storage and transport (e.g. personal protective clothing and equipment, measures for protection against fire, covering of furniture, removal of food and feedingstuff and directions to prevent animals from being exposed);

and where applicable:

(k) the categories of users to which the biocidal product is restricted;

(l) information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water;

(m) for microbiological biocidal products, labelling requirements according to Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work(1).

Member States shall require that items 3(a), (b), (d) and where applicable (g) and (k) always be carried on the label of the product.

Member States shall permit items 3(c), (e), (f), (h), (i), (j) and (1) to be carried elsewhere on the packaging or on an accompanying leaflet integral to the packaging. These items of information shall be regarded as label information for the purposes of this Directive.

4. Where a biocidal product identified as insecticide, acaricide, rodenticide, avicide or molluscicide is authorised pursuant to this Directive and is also subject to classification, packaging and labelling according to Council Directive 78/63 I/EEC of 26 June 1978 on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides)(2) by virtue of other Community provisions, Member States shall permit changes to the packaging and labelling of that product which may be required as a consequence of those provisions in so far as they do not conflict with the conditions of an authorisation issued under this Directive.

5. Member States may require the provision of samples, models or drafts of the packaging, labelling and leaflets.

6. Member States shall make the placing of biocidal products on the market in their territories subject to them being labelled in their national language or languages.

(1)

OJ L 374, 31.12.1990, p. 1. Directive as last amended by Directive 95/30/EC (OJ L 155, 6.7.1995, p. 5).

(2)

OJ L 206, 29.7.1978, p. 13. Directive as last amended by Directive 92/32/EEC (OJ L 154, 5.6.1992, p. 1).