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Definitions glossary - English

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Term Definition
National authorisation

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.

New active substance

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-oriented research and development

Non-approval decision

The decision not to approve a substance/product type combination in accordance with Article 9(1), point b) of Regulation (EU) No 528/2012 or Article 89(1), third subparagraph of the same Regulation, or not to include it in Annex I or IA to Directive 98/8/EC.

Placing on the market

The first making available on the market of a biocidal product or of a treated article.

Product family

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 product

Product type

A comprehensive list of twenty-two product types, including an indicative set of descriptions for each type, published in Annex V to Regulation (EU) No 528/2012. Four groups are represented: Group 1: Disinfectants and general biocidal products (PT1 to 5), Group 2: Preservatives (PT6 to 13), Group 3: Pest control products (PT14 to 19), Group 4: Other biocidal products (PT20 to 22).

Residues

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.

Single biocidal product

A biocidal product with no intended variations as to the percentage of the active or non-active substances it contains.

Substance of concern

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

Substance/product type combination

A substance/product type combination listed in Annex II that fulfils the following conditions: 1- it has not been the subject of any of the following acts: - a directive relating to inclusion in Annex I or IA of Directive 98/8/EC; - a regulation establishing that it has been approved under Article 89(1), third subparagraph, of Regulation (EU) No 528/2012; 2- it has not been the subject of any non-approval decision or the last non-approval decision concerning it was repealed

Technical equivalence

The 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 of Regulation (EU) No 528/2012.

Transitional period

The transitional regime is defined by Article 89 of Regulation (EU) No 528/2012: it is the period of time during which the making available on the market and use of biocidal products are governed by the national provisions in force in each Member State, pending approval of all the active substances they contain at Community level. Certain product types are subject to national approvals. For more information, see the Regulations - Transitional period section.

Treated article

Any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.

Union authorisation

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.

Use

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

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