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Definitions glossary - English

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S

Term Definition
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2- it has not been the subject of any non-approval decision or the last non-approval decision concerning it was repealed

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