Definitions

1. For the purposes of this Regulation, the following definitions shall apply:

‘biocidal product’ means

any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,

any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

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

‘micro-organism’ 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;

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

‘existing active substance’ 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;

‘new active substance’ 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;

‘substance of concern’ 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.

Such a substance would, unless there are other grounds for concern, normally be:

a substance classified as dangerous or that meets the criteria to be classified as dangerous according to Directive 67/548/EEC, and that is present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Articles 5, 6 and 7 of Directive 1999/45/EC, or

a substance classified as hazardous or that meets the criteria for classification as hazardous according to Regulation (EC) No 1272/2008, and that is present in the biocidal product at a concentration leading the product to be regarded as hazardous within the meaning of that Regulation,

a substance which meets the criteria for being a persistent organic pollutant (POP) under Regulation (EC) No 850/2004, or which meets the criteria for being persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) in accordance with Annex XIII to Regulation (EC) No 1907/2006;

‘harmful organism’ 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;

‘residue’ 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;

‘making available on the market’ 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;

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

‘use’ 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;

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

‘national authorisation’ 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;

‘Union authorisation’ 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;

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

‘authorisation holder’ 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;

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

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

‘biocidal product family’ means a group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products;

‘letter of access’ 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;

‘food’ and ‘feed’ mean food as defined in Article 2 of Regulation (EC) No 178/2002 and feed as defined in Article 3(4) of that Regulation;

‘processing aid’ 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;

‘technical equivalence’ 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;

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

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

‘nanomaterial’ 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.

Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.

For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:

‘particle’ means a minute piece of matter with defined physical boundaries,

‘agglomerate’ 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,

‘aggregate’ means a particle comprising strongly bound or fused particles;

‘administrative change’ 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;

‘minor change’ 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;

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

‘vulnerable groups’ means persons needing specific consideration when assessing the acute and chronic health effects of biocidal products. These include pregnant and nursing women, the unborn, infants and children, the elderly and, when subject to high exposure to biocidal products over the long term, workers and residents;

‘small and medium-sized enterprises’ or ‘SMEs’ means small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises ( 40 ) .

2. For the purposes of this Regulation, the definitions laid down in Article 3 of Regulation (EC) No 1907/2006 shall apply for the following terms:

‘substance’;

‘mixture’;

‘article’;

‘product and process-orientated research and development’;

‘scientific research and development’.

3. The Commission may, at the request of a Member State, decide, by means of implementing acts, whether a substance is a nanomaterial, having regard in particular to Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial ( 41 ) , and whether a specific product or group of products is a biocidal product or a treated article or neither. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).

4. The Commission shall be empowered to adopt delegated acts in accordance with Article 83 in order to adapt the definition of nanomaterial set out in point (z) of paragraph 1 of this Article in view of technical and scientific progress and taking into account the Recommendation 2011/696/EU.

CHAPTER II

APPROVAL OF ACTIVE SUBSTANCES

REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 May 2012 concerning the making available on the market and use of biocidal products ANNEX I ANNEX II ANNEX III ANNEX IV ANNEX V ANNEX VI ANNEX VII