in force 2014-04-25 MODIFIED+124 −207§
Amended by Regulation (EU) No 334/2014 32014R0334
applies from: unchanged
Sources disagree — the text comparison and the amending act's instructions found this change; the EU's own amendment metadata does not list it. All are shown; none is overruled.
The definition of biocidal product family was rewritten from a single descriptive sentence into a four-point list, requiring similar uses, the same active substances, similar composition with specified variations, and similar levels of risk and efficacy.
The earlier version described the active substances as having the same specifications and the variations as not adversely affecting risk or significantly reducing efficacy, wording that no longer appears in the revised point (s).
Cited: Art. 3, v1 · Art. 3, v2
text before / after
02012R0528-20130923 → 02012R0528-20140425
Article 3
Definitions
1. For the purposes of this Regulation, the following definitions shall apply:
(a) 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, … 750 unchanged words … one of the product-types specified in Annex V;
(r) single biocidal product means a biocidal product with no intended variations as to the percentage of the active or non-active substances it contains;
(s) biocidal product family means a group of biocidal products having having:
(i) similar uses, the active substances of which have uses;
(ii) the same specifications, active substances;
(iii) similar composition with specified variations; and presenting specified variations in their composition which do not adversely affect the level (iv) similar levels of risk or significantly reduce the efficacy of the products; and efficacy;
(t) 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 … 582 unchanged words … 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.