1.For the purposes of this Directive the following definitions shall apply:
(a)Biocidal products
Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.
An exhaustive list of 23 product types with an indicative set of descriptions within each type is given in Annex V.
(b)Low-risk biocidal product
A biocidal product which contains as active substance(s) only one or more of those listed in Annex I A and which does not contain any substance(s) of concern.
Under the conditions of use, the biocidal product shall pose only a low risk to humans, animals and the environment.
(c)Basic substance
A substance which is listed in Annex I B, whose major use is non-pesticidal but which has some minor use as a biocide either directly or in a product consisting of the substance and a simple diluent which itself is not a substance of concern and which is not directly marketed for this biocidal use.
The substances, which could potentially enter Annex IB in accordance with the procedure laid down in Articles 10 and 11, are inter alia the following:
(c)carbon dioxide,
nitrogen,
ethanol,
2-propanol,
acetic acid,
kieselguhr.
(d)Active substance
A substance or micro-organism including a virus or a fungus having general or specific action on or against harmful organisms.
(e)Substance of concern
Any substance, other than the active substance, which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to create such an effect.
Such a substance, unless there are other grounds for concern, would be normally a substance classified as dangerous according to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(1), and present in the biocidal product at a concentration leading the product to be regarded as dangerous within the meaning of Article 3 of Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(2).
(f)Harmful organism
Any organism which has an unwanted presence or a detrimental effect for humans, their activities or the products they use or produce, or for animals or for the environment.
(g)Residues
One or more of the substances present in a biocidal product which remains as a result of its use including the metabolites of such substances and products resulting from their degradation or reaction.
(h)Placing on the market
Any supply, whether in return for payment or free of charge, or subsequent storage other than storage followed by consignment from the customs territory of the Community or disposal. Importation of a biocidal product into the customs territory of the Community shall be deemed to constitute placing on the market for the purposes of this Directive.
(i)Authorisation
An administrative act by which the competent authority of a Member State authorises, following an application submitted by an applicant, the placing on the market of a biocidal product in its territory or in a part thereof.
(j)Frame-formulation
Specifications for a group of biocidal products having the same use and user type.
This group of products must contain the same active substances of the same specifications, and their compositions must present only variations from a previously authorised biocidal product which do not affect the level of risk associated with them and their efficacy.
In this context, a variation is the allowance of a reduction in the percentage of the active substance and/or an alteration in percentage composition of one or more non-active substances and/or the replacement of one or more pigments, dyes, perfumes by others presenting the same or a lower risk, and which do not decrease its efficacy.
(k)Registration
An administrative act by which the competent authority of a Member State, following an application submitted by an applicant, after verification that the dossier meets the relevant requirements of this Directive, allows the placing on the market of a low-risk biocidal product in its territory or in a part thereof.
(l)Letter of access
A document, signed by the owner or owners of relevant data protected under the provisions of this Directive, which states that these data may be used by the competent authority for the purpose of granting an authorisation or a registration of a biocidal product under this Directive.
2.For the purposes of this Directive the definitions for:
(a)substance,
(b)preparation,
(c)scientific research and development,
(d)process-orientated research and development
laid down in Article 2 of Council Directive 67/548/EEC shall apply.
OJ 196, 16.8.1967. Directive as last amended by Directive 94/69/EC (OJ L 381, 31.12.1994, p. 1).