Commentaries: Art. 2

By way of clarification of the definitions given in the ChemA, in this Ordinance: a. biocidal products means: 1. substances, preparations or objects, in the form in which they are supplied to the user, consisting of, containing or generating one or more active substances, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on, any harmful organism by any means other than mere physical or mechanical action, 2. substances or preparations generated from substances or preparations which are not themselves biocidal products as defined in number 1, and which are intended for the purpose for which biocidal products as defined in number 1 are intended; b. product type means one of the categories of biocidal products specified in Annex 10; c. manufacturer means any natural or legal person who, by way of profession or trade, manufactures or extracts substances or preparations.
In addition, in this Ordinance: a. substance of concern means a 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, unless there are other grounds for concern, would be, in particular:¹ 1. a substance classified as dangerous or that meets the criteria to be classified as such according to Article 2 paragraph 2 in conjunction with Annex VI Numbers 2–5 of Directive 67/548/EEC², and that is present in the biocidal product at a concentration leading the product to be classified as dangerous within the meaning of Article 1 paragraph 2 in conjunction with Articles 5, 6 and 7 of Directive 1999/45/EC³, 2. a substance classified as hazardous or that meets the criteria to be classified as such according to Article 2 paragraph 2 in conjunction with Parts 2–5 of Annex I to Regulation (EC) No 1272/2008 (CLP Regulation)⁴, 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, or 3.⁵ a substance which meets the criteria for being a persistent organic pollutant (POP) under Regulation (EC) No 850/2004⁶, or which meets the criteria for being persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) in accordance with Annex XIII to Regulation (EC) No 1907/2006 (REACH Regulation)⁷; b. biocidal product family means a group of biocidal products having the following properties in common: 1. similar uses, 2. the same active substances, 3. similar composition with specified variations, 4. similar level of risk, 5. similar efficacy; c. harmful organism means an organism, including pathogenic agents, which has an unwanted presence or a detrimental effect on humans or their activities, on products they use or produce, or on animals or the environment; d. microorganisms means microbiological entities, especially bacteria, algae, fungi, protozoa, viruses and viroids; cell cultures, prions and biologically active genetic material are also included in this category; e. letter of access means a document, signed by the person authorised to use protected data, which states that the data may be used by the Notification Authority and, if necessary, by the competent authority of a state party for the purpose of granting an authorisation of a biocidal product; f. 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; g. new active substance means an active substance of a biocidal product which is not an existing active substance; h. active substance which is a candidate for substitution means an active substance which meets the criteria specified in Article 10 paragraph 1 of Regulation (EU) No 528/2012⁸; i. 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; j⁹ treated article means a substance, preparation or object which does not have a primary biocidal function, but which has been treated with, or intentionally incorporates, one or more biocidal products; k. national authorisation means an authorisation granted by the competent authority of an EU or EFTA Member State for the placing on the market of a biocidal product in its territory; l. Union authorisation means an authorisation granted by the European Commission for the placing on the market of a biocidal product in the territory of the EU; m. 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 are in the size range 1–100 nm; fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm are deemed to be nanomaterials; in addition, for nanomaterials, the following definitions apply: 1. particle means a minute piece of matter with defined physical boundaries, 2. 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, 3. aggregate means a particle comprising strongly bound or fused particles; n. technical equivalence means similarity, as regards the chemical composition and hazard profile, between 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 or manufacturing location, and the substance from the reference source in respect of which the initial risk assessment was carried out; o. vulnerable groups means persons needing specific consideration when assessing the acute and chronic health effects of biocidal products; these include pregnant and breastfeeding women, the unborn, infants and children, the elderly, and workers and other persons subject to high exposure to biocidal products over the long term.
The following terms are to be understood as defined in Article 2 of the Chemicals Ordinance of 18 May 2005¹⁰(ChemO):
1. substance;
2. object;
3. product and process-orientated research and development;
4. scientific research and development.
The correspondence of expressions between Regulation (EU) No 528/2012 and this Ordinance set out in Annex 3 Number 1 applies.¹¹ 4bis. Where reference is made in this Ordinance to provisions of Regulation (EU) No 528/ 2012 which themselves refer to other provisions of EU law, the Swiss law in Annex 3 Number 2 applies instead of that EU law.¹²
Any other terms which are used in various senses in the legislation underlying this Ordinance are used here as defined in the ChemA.

Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). ↩
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, OJ L 196 of 16 August 1967, p. 1; last amended by Directive 2013/21/EU, OJ L 158 of 10 June 2013, p. 240. ↩
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, OJ L 200 of 30 July 1999, p. 1; last amended by Directive 2013/21/EU, OJ L 158 of 10 June 2013, p. 240. ↩
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006, OJ L 353 of 31 December 2008, p. 1; last amended by Regulation (EU) No 944/2013, OJ L 261 of 3 October 2013, p. 5. ↩
Amended by No I of the O of 15 Nov. 2023, in force since 1 Jan. 2024 (AS 2023 709). ↩
Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC, OJ. L 158 of 30.4.2004, p. 7, last amended by Regulation (EU) No 519/2012, OJ L 159 of 20 June 2012, p. 1. ↩
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396 of 30 December 2006, p. 1; last amended by Regulation (EU) No 474/2014, OJ L 136 of 9 May 2014, p. 19. ↩
See footnote to Art. 1b para. 3. ↩
Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). ↩
[AS 2005 2721; 2007 821; 2009 401,805; 2010 5223; 2011 5227; 2012 6103,6659; 2013 201,2673,3041No I 3; 2014 2073Annex 11 No 1,3857.AS 2015 1903Art. 91]. See now: the O of 5 June 2015 (SR 813.11 ). ↩
Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). ↩
Inserted by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). ↩

Art. 2

Footnotes