Regulation (EU) No 528/2012

means a substance or a micro-organism that has an action on or against harmful organisms;

means an amendment of an existing authorisation of a purely administrative nature involving no change to the properties or efficacy of the biocidal product or biocidal product family;

means a means of promoting the sale or use of biocidal products by printed, electronic or other media;

means the European Chemicals Agency established by Regulation (EC) No 1907/2006;

means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components,

means a particle comprising strongly bound or fused particles;

means national authorisation, Union authorisation or authorisation in accordance with Article 26;

means the person established within the Union who is responsible for the placing on the market of a biocidal product in a particular Member State or in the Union and specified in the authorisation;

means A treated article that has a primary biocidal function shall be considered a biocidal product.

means a group of biocidal products having:

means a substance which was on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development;

means an organism, including pathogenic agents, which has an unwanted presence or a detrimental effect on humans, their activities or the products they use or produce, on animals or the environment;

means an original document, signed by the data owner or its representative, which states that the data may be used for the benefit of a third party by competent authorities, the Agency, or the Commission for the purposes of this Regulation;

means an amendment of an existing authorisation which is neither an administrative change nor a minor change;

means any supply of a biocidal product or of a treated article for distribution or use in the course of a commercial activity, whether in return for payment or free of charge;

means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, algae, protozoa and microscopic parasitic helminths;

means an amendment of an existing authorisation that is not of a purely administrative nature and requires only a limited re-assessment of the properties or efficacy of the biocidal product or biocidal product family;

means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm.

means an administrative act by which the competent authority of a Member State authorises the making available on the market and the use of a biocidal product or a biocidal product family in its territory or in a part thereof;

means a substance which was not on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development;

means a minute piece of matter with defined physical boundaries,

means the first making available on the market of a biocidal product or of a treated article;

means any substance falling within the definition of point (b) of Article 3(2) of Regulation (EC) No 1333/2008 or point (h) of Article 2(2) of Regulation (EC) No 1831/2003;

means one of the product-types specified in Annex V;

means a substance present in or on products of plant or animal origin, water resources, drinking water, food, feed or elsewhere in the environment and resulting from the use of a biocidal product, including such a substance’s metabolites, breakdown or reaction products;

means a biocidal product with no intended variations as to the percentage of the active or non-active substances it contains;

means any substance, other than the active substance, which has an inherent capacity to cause an adverse effect, immediately or in the more distant future, on humans, in particular vulnerable groups, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect.

means sufficiently well-developed according to internationally agreed test development criteria.

means similarity, as regards the chemical composition and hazard profile, of a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source in respect of which the initial risk assessment was carried out, as established in Article 54;

means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products;

means an administrative act by which the Commission authorises the making available on the market and the use of a biocidal product or a biocidal product family in the territory of the Union or in a part thereof;

means all operations carried out with a biocidal product, including storage, handling, mixing and application, except any such operation carried out with a view to exporting the biocidal product or the treated article outside the Union;

means persons needing specific consideration when assessing the acute and chronic health effects of biocidal products.