1
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force. Ordinance
on Protection against Dangerous Substances and Preparations (Chemicals Ordinance, ChemO) of 18 May 2005 (Status as of 1 December 2014) Please note: this translation does not yet include the amendments of 1.6.2015 The Swiss Federal Council, based on the Chemicals Act of 15 December 2000 (ChemA)1,
on Article 26 paragraph 3, Article 29, Articles 30a-30d, Article 38 paragraph 3, Article 39 paragraph 1, Article 41 paragraph 3, Article 44 paragraphs 2 and 3, Article 46 paragraphs 2 and 3, and Article 48 paragraph 2 of the Federal Act of 7 October 1983 on the Protection of the Environment (EPA)2, and on Article 9 paragraph 2 letter c, Article 27 paragraph 2 and Article 48 paragraph 2 of the Waters Protection Act of 24 January 19913, and in implementation of the Federal Act of 6 October 19954 on Technical Barriers to Trade,5 ordains: Title 1:
General Provisions
Art. 1
Aim and scope
1 This Ordinance regulates: a. the determination and assessment of dangers and risks that substances and preparations may pose to human life and health and to the environment; b. the conditions under which substances and preparations that may endanger people or the environment are placed on the market; c. the handling of substances and preparations that may endanger people or the environment;
AS 2005 2721 1
SR 813.1
2
SR 814.01
3
SR 814.20
4
SR 946.51
5
Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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d. the way in which data relating to substances and preparations is processed by the enforcement authorities.
2 This Ordinance applies to biocidal products and plant protection products insofar as they are referred to in the Ordinance of 18 May 20056 on Biocidal Products or the Ordinance of 18 May 20057 on Plant Protection Products.
3 This Ordinance applies to radioactive substances and preparations, excluding effects attributable to the radioactive nature of these substances and preparations.
4 Only Articles 7-10, 13-15 and 95 apply to cosmetic products8 and only with regard to environmental protection and classification or evaluation in relation to risks to the environment.
5 This Ordinance does not apply to: a. the transport of substances and preparations by road, rail, water, air or pipelines;
b.9 the transit of substances and preparations under customs supervision, provided that this does not involve any processing or transformation;
c. substances and preparations in the form of finished products ready for supply to the final user that fall into the following categories: 1. foodstuffs as defined by Article 3 of the Foodstuffs Act of 9 October
199210,
2. medicinal products as defined by Article 4 paragraph 1 letter a and medical devices as defined by Article 4 paragraph 1 letter b of the Therapeutic Products Act of 15 December 200011, 3. animal feedingstuffs as defined by Article 3 paragraph 1 of the Feedstuffs Ordinance of 26 May 199912; d. weapons as defined by Article 4 paragraph 1 and ammunition as defined by Article 4 paragraph 413 of the Weapons Act of 20 June 199714; e. substances, preparations and objects which are waste according to Article 7 paragraph 6 of the EPA.
6 SR 813.12
7 [AS 2005 3035 4097 5211, 2006 4851, 2007 821 No III 1469 Annex 4 No 54 1843 4541 6291, 2008 2155 4377 Annex 5 No 11 5271, 2009 401 Annex No 3 2845, 2010 2101.
AS 2010 2331 Art. 84]. See today: the Ordinance of 12 May 2010 (SR 916.161).
8
Expression in accordance with No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821). This change has been made throughout the text.
9
Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
10 SR 817.0
11 SR 812.21 12 [AS
1999 1780 2748 Annex 5 No 6, 2001 3294 No II 14, 2002 4065, 2003 4927, 2005 973 2695 No II 19 5555, 2007 4477 No IV 70, 2008 3655 4377 Annex 5 No 14, 2009 2599, 2011 2405. AS 2011 5409 Art. 77]. See today: the Ordinance of 26 Oct. 2011 (SR 916.307).
13 Now: Art. 4 para. 5.
14 SR 514.54
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6 Only Article 49 applies to dangerous substances and preparations that are imported, relabelled and then exported.15
Art. 2
Definitions
1 By way of clarification of the definitions given in the Chemicals Act, in this Ordinance: a.16 substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition; b.17 … c.18 manufacturer means 1. any natural or legal person domiciled in Switzerland or with a registered office or branch in Switzerland, who manufactures, extracts or imports substances, preparations or objects in a professional or commercial capacity.
2. Also deemed to be a manufacturer is any person who obtains substances, preparations or objects in Switzerland and supplies them on a commercial basis, without altering their composition: -
under his own name, without specifying the name of the original manufacturer, under his own trade name,
in packaging other than that intended by the original manufacturer, or
for some other purpose.
3. If a person arranges for the manufacture of a substance, preparation or object in Switzerland by a third party, this person is deemed to be the sole manufacturer if he is domiciled or has a registered office or branch in Switzerland.
2 In addition, in this Ordinance: a.19 object means an article, consisting of one or more substances or preparations, which during production is given a special shape, surface or design
15 Inserted by No I of the Ordinance of 28 Feb. 2007 (AS 2007 821). Amended by No I of the Ordinance of 10 Nov. 2010, in force since 1 Dec. 2010 (AS 2010 5223).
16 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
17 Repealed by No I of the Ordinance of 14 Jan. 2009, with effect from 1 Feb. 2009 (AS 2009 401).
18 Amended by No I of the Ordinance of 28 February 2007, in force since 1 April 2007 (AS 2007 821).
19 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1. Feb. 2009 (AS 2009 401).
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which determines its end use function to a greater degree than does its chemical composition; b.20 existing substance means any substance listed in EINECS21 of 15 June 199022;
c. polymer means a substance consisting of molecules characterised by the sequence of one or more types of monomer units and comprising: 1. a simple weight majority of molecules containing at least three mono-
mer units which are covalently bound to at least one other monomer unit or other reactant and 2.23 less than a simple weight majority of molecules of the same molecular weight; these molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units; cbis.24 monomer means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process; cter.25 monomer unit means the reacted form of a monomer substance in a polymer;
d.26 intermediate means a substance manufactured and used solely for chemical processing during which it is transformed into one or more other substances; e. secondary
product means any substance formed by chemical or biochemical transformation during the storage, use or disposal of a substance or preparation; f.27 … g. sole representative means any natural or legal person that is authorised by a manufacturer whose domicile or registered office is located abroad to notify a substance in Switzerland and represents several importers designated by that manufacturer; 20 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
21 European Inventory of Existing Commercial Chemical Substances.
22 OJ C 146 A of 15.6.1990, p.1, corrected in OJ C 54 of 1.3.2002, p. 13). The EINECS inventory can be consulted free of charge at the Chemicals Notification Authority, CH-3003 Bern; it can also be accessed on the Internet at http://esis.jrc.ec.europa.eu/index.php?PGM=ein.
23 Amended by No I of the Ordinance of 10 Nov. 2010, in force since 1 Dec. 2010 (AS 2010 5223).
24 Inserted by No I of the Ordinance of 10 Nov. 2010, in force since 1 Dec. 2010 (AS 2010 5223).
25 Inserted by No I of the Ordinance of 10 Nov. 2010, in force since 1 Dec. 2010 (AS 2010 5223).
26 Amended by No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821).
27 Repealed by No I of the Ordinance of 7 Nov. 2012, with effect from 1 Dec. 2012 (AS 2012 6103).
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h.28 scientific research and development means any scientific experimentation, analysis or chemical research carried out under controlled conditions and involving quantities of less than 1 tonne per year; i.29 product and process-orientated research and development means any scientific development related to product development or the further development of a substance on its own, in preparations or in objects in the course of which pilot plant or production trials are used to define the production process or test the fields of application of the substance;
j.30 robust study summary means a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study, minimising the need to consult the full study report; k.31 exposure scenario means the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer controls, or recommends customers to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate;
l.32 hazard class means the nature of the physical, health or environmental hazard;
m.33 nanomaterial means a material containing particles in an unbound state or as an aggregate or as an agglomerate, where one or more external dimensions is in the size range 1-100 nm, or a material where the specific surface area by volume is greater than 60 m2/cm3. A material is only considered to be a nanomaterial if it is deliberately produced to utilise the properties arising from the defined external dimensions of the particles it contains, or from the defined surface area by volume of the material. Fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm are considered to be nanomaterials.
3 Any other terms which are used in various senses in the legislation underlying this Ordinance are used here as defined in the Chemicals Act.
28 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
29 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
30 Inserted by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
31 Inserted by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
32 Inserted by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
33 Inserted by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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4
For the correct interpretation of Regulation (EC) No 1907/2006 (REACH Regulation)34 and Regulation (EC) No 1272/2008 (CLP Regulation)35, to which reference is made in this Ordinance, the correspondences specified in Annex 5 apply.36
Art. 3
37
b. preparations
which:
1. are classified exclusively in accordance with Article 10 paragraph 1 and have one of the properties referred to in Articles 4-6 and described in detail in Sections 2-5 of Annex VI to Directive 67/548/EEC39, 2. are classified in accordance with Article 10 paragraph 2 and fulfil the criteria relating to physical hazards, health hazards, environmental hazards or other hazards specified in Parts 2-5 of Annex I to the CLP Regulation.
Art. 4
Hazardous physicochemical properties Preparations which have one of the following properties are deemed to have hazardous physicochemical properties:40 a. explosive: if they may also react exothermically without atmospheric oxygen thereby quickly evolving gases, and, under defined test conditions, detonate, quickly deflagrate or upon heating explode when partially confined; 34 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 Direc-
tives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006, p. 1; last amended by Regulation (EU) No 253/2011, OJ L 69, 16.3.2011, p. 7.
35 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, 31.12.2008, p. 1; last amended by Regulation (EC)
No 286/2011, OJ L 83, 30.3.2011, p. 1.
36 Inserted by No. I of the Ordinance of 14 Jan. 2009 (AS 2009 401). Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
37 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
38 See footnote to Art. 2 para. 4.
39 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, 16.8.1967, p. 1; Last amended by Regulation (EC) No 1272/2008, OJ L 353, 31.12.2008, p. 1.
40 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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b. oxidising: if they give rise to a highly exothermic reaction in contact with other substances, particularly flammable substances; c. extremely flammable: if they have an extremely low flash-point and a low boiling point or, as gases, are flammable in contact with air at ambient temperature and pressure; d. highly
flammable:41 if they: 1. may become hot and finally catch fire in contact with air at ambient temperature without any application of energy, 2. in a solid state, may readily catch fire after brief contact with a source of ignition and continue to burn or to be consumed after removal of the source of ignition, 3. have a very low flash-point, or 4. in contact with water or damp air, evolve extremely flammable gases in dangerous quantities; e. flammable: if they have a low flash-point.
Art. 5
Properties dangerous to health Preparations which have one of the following properties are deemed to have properties dangerous to health:42 a. very toxic: if they cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin in very low quantities;
b. toxic: if they cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin in low quantities; c. harmful: if they can cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin; d. corrosive: if they can, on contact with living tissues, destroy them; e. irritant: if, without being corrosive, they can cause inflammation through immediate, prolonged or repeated contact with the skin or mucous membrane; f.43 sensitising: if they can elicit a reaction of hypersensitisation following inhalation or skin contact such that on further exposure to the preparation characteristic adverse effects are produced;
g. carcinogenic: if they can induce cancer or increase its incidence if they are inhaled or ingested or if they penetrate the skin; 41 Amended by No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821). This change has been made throughout the text.
42 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
43 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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h. mutagenic: if they can induce heritable genetic defects or increase their incidence if they are inhaled or ingested or if they penetrate the skin;
i.
toxic for reproduction: if they can produce, or increase the incidence of, non-heritable adverse effects in the progeny and/or an impairment of male or female reproductive functions or capacity if they are inhaled or ingested or if they penetrate the skin.
Art. 6
44
a45 Persistence, bioaccumulation and toxicity 1. Substances are considered persistent, bioaccumulative and toxic (PBT) if they fulfil the criteria defined in Sections 1.1.1-1.1.3 of Annex XIII to the REACH Regulation46.
2. Substances are considered very persistent and very bioaccumulative (vPvB) if they fulfil the criteria defined in Sections 1.2.1 and 1.2.2 of Annex XIII to the REACH Regulation.
Title 2:
Marketing Requirements Chapter 1: Self-Regulation Section 1: Fundamental Obligations
Art. 7
General provisions47
1 The self-regulation system introduced by Article 5 of the Chemicals Act and Article 26 of the EPA requires manufacturers to assess whether substances or preparations may endanger human life or health or the environment. In accordance with this Ordinance, manufacturers must: a. classify; b. package and;
c. label substances and preparations; d. prepare exposure scenarios and; 44 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
45 Inserted by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401). Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec.
2012 (AS 2012 6103).
46 See footnote to Art. 2 para. 4.
47 Inserted by No I of the Ordinance of 10 Nov. 2010, in force since 1 Dec. 2010 (AS 2010 5223)
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e. compile safety data sheets.48 1bis
and 1ter …49
2 In the case of objects containing dangerous substances, substances rated as PBT or vPvB, or substances listed in Annex 7, self-regulation under Article 26 of the EPA requires manufacturers to assess whether these substances may endanger the environment or indirectly endanger human health when these objects are used as intended, or in a foreseeable manner, or when they are appropriately disposed of.50 2bis In the case of objects containing substances listed in Annex 7, manufacturers must assess whether these substances may endanger human health when these objects are used as intended, or in a foreseeable manner, or when they are appropriately disposed of.51 3 Manufacturers must collect all available data of relevance to the obligations referred to in paragraphs 1 and 2.
4 Any person importing substances, preparations or objects with dangerous constituents in a professional or commercial capacity must comply with the obligations listed under paragraphs 1 and 2 before supplying them to a third party for the first time or, if they are for the importer's own use, before using them for the first time.
a52 Section 2:
Classification of Substances
Art. 8
53
a. Articles 5-15 of the CLP Regulation54; b. Article 4 paragraph 3 of the CLP Regulation, if the Federal Department of Home Affairs (FDHA) has prescribed an official classification in accordance with Article 9; this will be based on Table 3.1 of Part 3 of Annex VI to the CLP Regulation.
48 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
49 Inserted by No I of the Ordinance of 14 Jan. 2009 (AS 2009 401). Repealed by No I of the Ordinance of 10 Nov. 2010, with effect from 1 Dec. 2010 (AS 2010 5223).
50 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103) 51 Inserted by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
52 Inserted by No. I of the Ordinance of 10. Nov. 2010 (AS 2010 5223). Due to the repeal of Art. 56c-56e on 1 Dec. 2012 no longer relevant. A new version will come into force at a later date.
53 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
54 See footnote to Art. 2 para. 4.
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2
Manufacturers obliged to compile a safety data sheet in accordance with Article 52 must additionally classify substances in accordance with: a. the criteria defined in Annex VI to Directive 67/548/EEC55; b. Article 4 paragraph 3 of the CLP Regulation, if the FDHA has prescribed an official classification in accordance with Article 9; this will be based on Table 3.2 of Part 3 of Annex VI to the CLP Regulation.
3 Classification must be based: a. in the case of existing substances: on data collected in accordance with Article 7 paragraph 3;
b. in the case of new substances: on data in the technical dossier as specified in Article 18 paragraph 2 letter b.
Art. 9
Official classification 1 The Federal Department of Home Affairs (FDHA) may prescribe the classification and resultant labelling for certain substances with the agreement of the Federal Department of the Environment, Transport, Energy and Communications (DETEC) and the Federal Department of Economic Affairs, Education and Research (EAER)56. It may declare European classifications to be applicable.
2 The Federal Office of Public Health (FOPH) may, with the agreement of the Federal Office for the Environment (FOEN)57 and the State Secretariat for Economic Affairs (SECO), update the list of European classifications declared to be applicable.
Section 3:
Classification of Preparations
Art. 10
58
1
Manufacturers of preparations must classify these in accordance with Articles 1115.
2
In addition to paragraph 1, they may classify preparations in accordance with the following provisions: a. Articles 5-15 of the CLP Regulation59; or b. Annex VII to the CLP Regulation.
55 See footnote to Art. 3 let. b.
56 The designation of this unit of the Federal Administration was Amended by Art. 16 para.
3 of the Publications Ordinance of 17 Nov. 2004 (SR 170.512.1). This amendment has been made throughout the text.
57 The designation of this unit of the Federal Administration was Amended by Art. 16 para.
3 of the Publications Ordinance of 17 Nov. 2004 (SR 170.512.1). This amendment has been made throughout the text.
58 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
59 See footnote to Art. 2 para. 4.
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Art. 11
Classification with regard to hazardous physical and chemical properties 1 Manufacturers of preparations must classify them with regard to hazardous physicochemical properties on the basis of the criteria laid down in Chapter 2 of Annex VI to Directive 67/548/EEC.
2 The flammability and oxidising properties of gaseous preparations must be evaluated in accordance with Section 9.1.1 of Annex VI to Directive 67/548/EEC.
3 If the composition of a preparation is altered, there is no obligation to determine the physicochemical properties of the altered preparation if it can be assumed, on the basis of the current state of scientific knowledge, that these properties would not lead to any change in the classification.
4 Manufacturers are not required to classify preparations with regard to hazardous physicochemical properties if: a. the preparation is made up exclusively of substances not classified as explosive, oxidising, extremely flammable, highly flammable or flammable; and
b. the preparation itself is highly unlikely to have any of the properties listed in a above.
Art. 12
Classification with regard to properties dangerous to health 1 Manufacturers of preparations must classify them with regard to properties dangerous to health using the calculation method described in Annex II to Directive 1999/45/EC60.61 2 Classification may also be based on test results, provided that: a. it does not relate to carcinogenic, mutagenic or reproductive toxicity properties;
b. it can be demonstrated that the calculation method referred to in paragraph 1 is not appropriate for classifying the preparation; or c. available results of animal tests do not permit correct classification.
3 Classification based on test results must be established in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC.
4 If a preparation has been classified both by the calculation method and on the basis of test results, the classification based on test results takes precedence.
5 Where it can be demonstrated that the dangerous effects of a preparation on human health differ from the effects underlying the classification as specified in paragraphs 60 Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 on 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 30.7.1999, p. 1; last amended by Regulation (EC) No 1272/2008, OJ L 353 of 31.12.2008, p. 1. This text can be accessed on the Internet at www.cheminfo.ch.
61 Amended by No I of the Ordinance of 10 Nov. 2010, in force since 1 Dec. 2010 (AS 2010 5223).
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1 and 3, this preparation must be classified according to its effects on human health.
The demonstration must involve: a. epidemiological studies; b. scientifically valid case studies as specified in Annex VI to Directive 67/548/EEC; or
c. statistically backed experience from Switzerland or abroad, such as the assessment of data from poison information units or concerning occupational diseases.
6 If, when a preparation is classified using the calculation method referred to in paragraph 1, it is demonstrated that the properties dangerous to health would be overestimated or underestimated because of interactions between the substances present in the preparation, these interactions must be taken into account in the classification.
Art. 13
Classification with regard to properties dangerous to the environment 1 Manufacturers of preparations must classify them with regard to their properties dangerous to the environment: a. using the calculation method described in Annex III to Directive 1999/45/EC; or
b. on the basis of test results as defined in Article 34, using the criteria laid down in Annex VI to Directive 67/548/EEC.
2 If a preparation has been classified both by the calculation method and on the basis of test results, the classification based on test results takes precedence.
Art. 14
Concentrations requiring substances to be taken into consideration If a preparation is classified using the calculation method, only those constituents dangerous to health or dangerous to the environment that are present in concentrations above the thresholds laid down in Article 3 paragraph 3 of Directive 1999/45/EC need be taken into consideration.
Art. 15
Re-evaluation with regard to properties dangerous to health or the environment 1 Manufacturers of preparations must re-evaluate them when they: a. replace or add a constituent; or b. alter the composition of a preparation, thereby producing the following changes in initial concentrations: 1. in the case of constituents dangerous to health: as specified in Article 6 number 4 first indent of Directive 1999/45/EC, 2. in the case of constituents dangerous to the environment: as specified in Article 7 number 3 first indent of Directive 1999/45/EC.
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2 Re-evaluation is not required when it can be scientifically demonstrated that it would not result in any change to the initial classification.
Chapter 2:
Notification of New Substances and Declaration of New Substances not subject to Notification Requirements Section 1: Notification of New Substances
Art. 16
62
1
Manufacturers of a new substance or their sole representative must notify the new substance to the Notification Authority before placing it on the market for the first time either alone or within a preparation or object from which it may be released under normal or reasonably foreseeable conditions of use.
1bis
If a new substance is contained in a polymer as a monomer or as another substance in the form of monomer units or chemically bound, paragraph 1 applies for the substance as such.63 2
The Notification Authority may require the notification of a substance contained in an object if it has reason to believe that the substance may be released when the object is used.
a64 Relevant quantity of a substance The relevant substance quantities mentioned in Articles 17, 18, 18b, 22, 25, 59, and 60 and in Annex 3 are determined by the following criteria:65 a. if the substance is manufactured within the European Economic Area (EEA): the total quantity manufactured annually in the EEA by a manufacturer, of which a part is supplied to the notifier; b. if the substance is manufactured in Switzerland, the larger of the following quantities: 1. the annual quantity placed on the market in Switzerland, or 2. the largest quantity exported annually to a specific European importer in the EEA;
c. if the substance is manufactured outside Switzerland and the EEA and the notifier imports the substance directly from the country of manufacture: the annual quantity imported into Switzerland; 62 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
63 Inserted by No I of the Ordinance of 10 Nov. 2010, in force since 1 Dec. 2010 (AS 2010 5223).
64 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
65 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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d. if the substance is manufactured outside Switzerland and the EEA and the notifier imports the substance from an EEA member state: the total quantity imported into the EEA annually by an importer, of which a part is supplied to the notifier.
Art. 17
66
2. limited to the quantities required for the said purposes and 3. for a period not exceeding five years; upon justified request, the Notification Authority may in consultation with the assessment authorities extend this period by an additional five or ten years;
e. substances used exclusively as raw materials, active ingredients or additives in foodstuffs, therapeutic products and animal feedingstuffs; f.
substances obtained in Switzerland; g.70 intermediates, provided that they are not monomers; h.71 substances listed in Annex V to the REACH Regulation72.
66 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
67 Amended by No I of the Ordinance of 10 Nov. 2010, in force since 1 Dec. 2010 (AS 2010 5223).
68 Notification of New Substances in accordance with Directive 67/548/EEC on the Classification, Packaging and Labelling of Dangerous Substances. No-Longer Polymer List
Version 3 (EUR 20853 EN/3) 2007. The list can be obtained against payment or consulted free of charge at the Chemicals Notification Authority, CH-3003 Bern; it can also be
accessed on the Internet at www.cheminfo.ch 69 Inserted by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
70 Amended by No I of the Ordinance of 10 Nov. 2010, in force since 1 Dec. 2010 (AS 2010 5223).
71 Inserted by No I of the Ordinance of 10 Nov. 2010 (AS 2010 5223). Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
72 See footnote to Art. 2 para. 4.
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2 If there are reasons to suppose that a given substance that is exempt from notification under paragraph 1 may endanger people or the environment, the Notification Authority shall require the manufacturer to present certain test reports when so requested by an assessment authority. The requirements specified for these test reports must not go beyond those for the technical dossier referred to in Annex 3 number 7 letter a, number 8 letter a and number 9 letter a.
Art. 18
73
2 The notification must contain the following information and documents: a. the decisive substance quantity in accordance with Article 16a together with an indication of which of the requirements (Art. 16a let. a, b, c or d) applies; b. a technical dossier with the following information specified in Annex 3: 1. the identity of the notifier, 2. the identity of the substance, 3. information on manufacture and use, 4. classification and labelling, 5. guidelines for safe use, 6. if applicable, an exposure assessment, 7. robust study summaries with regard to the physical and chemical properties,
8. robust study summaries with regard to the properties dangerous to health,
9. robust study summaries with regard to the properties dangerous to the environment.
c. if the relevant substance quantity in accordance with Article 16a amounts to 10 tonnes per year or more: a chemical safety report in accordance with Article 18a; d. a proposed safety data sheet in the case of dangerous substances or PBT or vPvB substances;
e. all available documents and information on exposure and the substance's harmful effects on people and the environment, unless these are already apparent from the technical dossier described under letter b; 3 Paragraph 2 letter c does not apply to new substances that are placed on the market in the form of preparations if the concentration of the substance is lower than the following levels: 73 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
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a. the concentration limits described in Part B of Annex II or Part B of Annex III to Directive 1999/45/EC;
b. the concentration limits established during the official classification (Art. 9); c. the applicable concentrations established in Article 3 paragraph 3 of Directive 1999/45/EC; or
d. 0.1 % by weight for PBT or vPvB substances.
4
If in the situations listed in Article 16a letter a or d, certain documents specified in paragraph 2 are not available, or if the notifier cannot reasonably be expected to obtain them, the notifier must provide corresponding proof.
5
The Notification Authority may request that the notifier provide test reports that exceed the scope of the technical dossier and that are relevant to the assessment of the substance, provided they are available and the notifier can reasonably be expected to obtain them.
a74 Chemical safety reports The chemical safety report contains the chemical safety assessment in accordance with Annex I to the REACH Regulation75. A chemical safety assessment includes the following steps:76 a. a human health hazard assessment; b. a physicochemical hazard assessment; c. an environmental hazard assessment; d. PBT and vPvB assessment; e.77 if the substance fulfils the criteria specified in Article 14 paragraph 4 of the REACH Regulation: 1. an exposure assessment covering all identified uses, 2. a description of the risks associated with all identified uses.
b78 Substances for which a notification has been submitted in the EU prior to 1 June 2008 1
For substances notified in the EU prior to 1 June 2008, the documents specified in Article 18 paragraph 2 numbers 2-9 may be replaced by the notification submitted in the EU and any updated information together with the corresponding notification number and the risk assessment, if available.
74 Inserted by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
75 See footnote to Art. 2 para. 4.
76 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
77 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
78 Inserted by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
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2
If the decisive substance quantity in accordance with Article 16a exceeds the quantity threshold for which the substance has been notified in the EU, the notification must contain the updated information in accordance with Article 18 paragraph 2 that corresponds to the higher quantity threshold.
3
When a new substance is notified for the first time, the Notification Authority may, in consultation with the assessment authorities, accept a summary of the technical dossier if the notifier demonstrates that: a. the data protection period in the EU has expired; and b. the identity of the substance and the content and identity of the impurities are identical to those for the substance notified in the EU.
Art. 19
79
Use of Data from Previous Notifiers and Data Protection Period
Art. 20
Use of data from previous notifiers 1 The Notification Authority may refer to data from a previous notifier instead of data produced by the notifier if: a. the new notifier proves with a letter of access from a previous notifier that the latter agrees to the Notification Authority consulting its data; or b. the data protection period has expired.
2 The notifier must not refer to data from previous notifiers regarding: a. the identity and purity of the substance and the nature of any impurities; b. action to render the substance harmless.
3 The rules of competition law and intellectual property are not affected by the provisions of this section.
Art. 21
Data protection period 1 The data protection period is 10 years.
2 For data which must be submitted subsequently in accordance with Article 60, the protection period is 5 years. If the data protection period laid down in paragraph 1 has not yet expired, the protection period for data submitted subsequently is extended accordingly.
79 Repealed by No I of the Ordinance of 14 Jan. 2009, with effect from 1 Feb. 2009 (AS 2009 401).
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Art. 22
Mandatory advance enquiries to avoid tests on vertebrates 1 Anyone planning tests on vertebrates for notification purposes must contact the Notification Authority in writing to enquire whether data from such tests is already available (Art. 12 of the Chemicals Act).
2 This enquiry must contain information on: a. the identity of the substance in accordance with Article 18 paragraph 2 letter b number 2;
b. the decisive substance quantity of the substance in accordance with Article 16a.80
Art. 23
Use of data from previous tests with vertebrates 1 If the Notification Authority already has adequate data from previous tests with vertebrates, it shall inform the notifier of the extent to which further tests on vertebrates are unnecessary for the purposes of the notification.
2 If the data is derived from vertebrate tests of previous notifiers and if the protection period for this data has not yet expired, the Notification Authority shall proceed as follows: a. It shall provide the previous notifiers with information on: 1. which parts of their data it intends to use for the benefit of the new notifier,
2. the address of the new notifier; b. It shall inform the new notifier of the addresses of the previous notifiers.
3 Within 30 days, the previous notifiers may object to the immediate use of their data and apply for a delay in the use of the data.
4 If no application for a delay is received, the Notification Authority shall order the use of the data.
5 If an application for a delay is received, the Notification Authority shall order: a. which parts of the data of the previous notifiers are to be used, b. that notification of the substance is to be delayed by the period which would be required by the notifier to supply his own data.
6 At the request of the new notifier, the Notification Authority shall draw up summaries of the data used; this does not prejudice the provisions on confidential data specified in Article 85.
80 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
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Art. 24
Previous notifiers' entitlement to remuneration for data from tests on vertebrates 1 The previous notifiers shall be entitled to fair remuneration from the new notifier for the use of their data from tests on vertebrates protected in accordance with Article 21. 2 If the notifiers cannot reach agreement on remuneration within 6 months, the Notification Authority, at the request of one notifier, shall decide on the amount of the remuneration, taking the following factors in particular into account: a. the costs incurred in obtaining the test results; b. the remaining period of protection for the data concerned; c. the number of entitled notifiers.
3 The previous notifiers may request the Notification Authority to prohibit the placing of the substance on the market until the new notifier has paid them the remuneration.
Section 3:
Declaration of New Substances for Product and Process-orientated Research and Development81
Art. 25
82
Art. 26
Form and content of the declaration 1 The declaration must be submitted in quadruplicate. The accompanying letter must be written in an official language and submitted on paper. The information and documents may be written in English instead of in an official language and may be submitted on electronic media instead of on paper.
2 The declaration must contain the following information and documents: a. the name and address of the manufacturer; b. the name and address of the foreign manufacturer if the manufacturer has imported the substance; 81 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
82 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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c. essential data relating to the identity of the substance; d. the intended uses; e. the amount of the substance that the manufacturer intends to place on the market each year in Switzerland; f.
proposed classification and labelling; g. the research programme and a list of the people to whom the substance is to be supplied;
h.83 a proposed safety data sheet in the case of dangerous substances or PBT or vPvB substances.
3 …84
Section 4:
Procedure for Notification and Declaration
Art. 27
Confirmation of receipt and forwarding of the documents 1 The Notification Authority shall confirm to the manufacturer or the sole representative the date on which the notification or declaration was received.
2 If the documents are not obviously incomplete, the Notification Authority shall forward them to the assessment authorities.
Art. 28
Review of the notification or declaration 1
The assessment authorities, within their area of competence, shall assess whether: a.85 the submission is complete or if not, whether the reasons given by the notifier are valid;
a. the data is scientifically plausible; b. the test reports are based on tests meeting the requirements laid down in Article 34.
2 The assessment authorities shall report the results of their review to the Notification Authority.
Art. 29
Additions to the documents 1 If the Notification Authority discovers that the documents are obviously incomplete, it must inform the manufacturer or sole representative accordingly without delay.
83 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
84 Repealed by No I of the Ordinance of 14 Jan. 2009, with effect from 1 Feb. 2009 (AS 2009 401).
85 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
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2 If an assessment authority discovers that the documents are incomplete or inaccurate, or that further data or tests are required to assess the dangers associated with the substance in question, it shall inform the Notification Authority accordingly. The Notification Authority shall ask the manufacturer or sole representative to submit additions or corrections.
2bis
If a robust study summary in accordance with Article 18 paragraph 2 letter b numbers 7-9 does not permit an independent assessment of a specific test, the Notification Authority may request the full study report.86 3 The Notification Authority shall confirm to the manufacturer or the sole representative the date on which the additions and corrections were received.
Art. 30
Acceptance of the notification or declaration With the agreement of the assessment authorities, the Notification Authority shall order the acceptance of the notification or declaration if the review has shown that the notification or declaration documents are complete and adequate for assessment of the dangers and risks associated with the substance in question.
Section 5:
Authorisation to Place Substances on the Market
Art. 31
Placing substances subject to notification requirements on the market 1 Substances subject to notification requirements may be placed on the market if: a. the Notification Authority has accepted their notification; or b. 60 days have elapsed since the confirmed date of receipt of the notification and of any additions or corrections required thereafter, without the Notification Authority having issued any response.
2 The period referred to in paragraph 1 letter b shall be reduced to 30 days if the notifier has submitted official confirmation that the substance was notified in the EU before 1 June 2008 and that the notification has been accepted.87
Art. 32
Placing substances subject to declaration requirements on the market Substances subject to declaration requirements may be placed on the market if: a. the Notification Authority has accepted their declaration; or b. 30 days have elapsed since the confirmed date of receipt of the declaration and of any additions or corrections required thereafter, without the Notification Authority having issued any response.
86 Inserted by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
87 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
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Chapter 3: Requirements for Tests
Art. 33
Principle
1 Manufacturers must ensure that the conduct of the tests, test methods and assessment of test results are in accordance with the current state of scientific and technical knowledge.
2 The FDHA, DETEC and the EAER may regulate technical details in their respective areas of competence.
Art. 34
88
1 Tests designed to determine the properties of substances and preparations must be carried out in accordance with: a.89 the test methods defined in Regulation (EC) No. 440/200890; or b. the Guidelines for the Testing of Chemicals drawn up by the Organisation for Economic Cooperation and Development (OECD) of August 200791 (OECD Guidelines for the Testing of Chemicals).
2 Other test methods may be used if: a. no method is specified in paragraph 1; b. the manufacturer can show that a specified method for determining a given physicochemical property is not suitable; or c.92 the method is recognised in the EU in accordance with Article 13 paragraph 3 of the REACH Regulation93.
3 If other test methods are used, the manufacturer must show that these methods: a. produce valid results; and b. take due account of animal protection in the case of tests on animals.
4 Non-clinical tests designed to determine properties that are dangerous to health or the environment must be carried out in accordance with the principles of Good 88 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
89 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
90 Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),
OJ L 142 of 31.5.2008, p. 1; last amended by Regulation (EU) No 640/2012, OJ L 193, 20.7.2012, p. 1.
91 OECD Guidelines for the Testing of Chemicals, August 2007. This text can be accessed on the Internet at www.cheminfo.ch 92 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
93 See footnote to Art. 2 para. 4.
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Laboratory Practice (GLP) specified in the Ordinance of 18 May 200594 on Good Laboratory Practice.
5 If certain tests do not comply with GLP principles or do not comply with them fully, the person submitting the test reports must state the reasons. The Notification Authority shall decide whether to accept these test results after consulting the assessment authorities.
Chapter 4: Packaging and Labelling95 Section 1:96 Packaging and Labelling of Dangerous Substances
a Packaging Manufacturers making available or supplying dangerous substances to third parties must package them in accordance with Article 35 of the CLP Regulation97.
b Labelling 1 Manufacturers making available or supplying dangerous substances to third parties must label them in accordance with Article 17 paragraph 1, Article 18 with the exception of the last sentence of paragraph 2, Articles 19-23, Article 25 paragraphs 1, 3, 4 and 6, Articles 26-28, Article 29 paragraphs 1-4, Article 31, Article 32 paragraphs 1-5 and Article 33 of the CLP Regulation98.
2
In addition to paragraph 1, the labelling must meet the following requirements: a. The name, address and telephone number of the manufacturer are to be included. In the case of substances imported from an EEA member state and not intended for supply to the general public, the manufacturer's name may be replaced by the name of the person specified in Article 17 paragraph 1 letter a of the CLP Regulation.
b. The labelling must be written in at least two official languages. With the agreement of individual professional final users, a substance for supply to these final users may be labelled in only one official language or in English.
3
If further labelling elements are required in order to comply with other legislation, these are to be included in the section for supplemental information in accordance with Article 25 of the CLP Regulation.
94 SR 813.112.1 95 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
96 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
97 See footnote to Art. 2 para. 4.
98 See footnote to Art. 2 para. 4.
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4
Where the name in the IUPAC nomenclature99 exceeds 100 characters, another name may be used, provided that the notification in accordance with Article 64 includes both the name set out in the IUPAC nomenclature and the other name used.
c Exemptions from labelling requirements 1
The Notification Authority may in consultation with the assessment authorities permit labelling in only one official language for certain substances or groups of substances in cases where labelling in accordance with Article 34b is not possible because packages are too small or otherwise unsuitable.
2
It shall issue a ruling or a general ruling in response to a justified request.
3
It shall maintain a list of exemptions granted and make this accessible to the public.
d Labelling of dangerous substances for export 1
Any person exporting dangerous substances must label them at least with the following information, taking into account the relevant international standards: a. name of the manufacturer; b. chemical name or trade name; c. labels showing the hazards to humans and the environment and the appropriate protective measures.
2
The labelling must be worded in a language accepted by the importing country.
Section 2:
Packaging and Labelling of Preparations100
e101 General provisions
1
Manufacturers making available or supplying preparations to third parties must package and label them in accordance with the following provisions: a. Articles 35-50, if they are classified exclusively in accordance with Article 10 paragraph 1. Article 34d applies mutatis mutandis;
b. Articles
34a-34d, mutatis mutandis, if they are classified in accordance with Article 10 paragraph 2.
2
Double labelling in accordance with paragraph 1 letters a and b is not permissible.
99 Chemical
nomenclature
of
the International Union of Pure and Applied Chemistry (IUPAC): www.iupac.org 100 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
101 Inserted by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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Art. 35
Characteristics of packaging 1 Packaging must be constructed in such a way that the dangerous preparations contained therein do not present any risk to people or the environment during storage or transport.102 2 In particular, packaging must meet the following requirements: a. it must be so designed and constructed that its contents cannot escape; b. it must not be damaged by the contents; c. it must not form harmful or dangerous compounds with the contents; d. it must safely withstand the normal stresses and strains of handling; in particular, any fastenings must not loosen.
3 The requirements specified in paragraphs 1 and 2 are deemed to be met if the packaging complies with the regulations concerning transport by post, rail, road, air, water and pipelines.103
Art. 36
Design of packaging
Packaging of dangerous preparations sold to the general public must be designed so as not to:104 a. attract or arouse the curiosity of children; b. mislead consumers; c. lead to confusion with packaging containing foodstuffs, cosmetic products, therapeutic products or animal feedingstuffs.
Art. 37
Special provisions
1 Containers for preparations sold to the general public must be fitted with childresistant fastenings if the preparation: a. is labelled as toxic or corrosive; b. is labelled as harmful, with the risk phrase R 65; this does not apply to aerosols or containers with a sealed spray attachment;
c. has a methanol (CAS No.105 67-56-1) content equal to or greater than 3 per cent or a dichloromethane (CAS No. 75-09-2) content equal to or greater than 1 per cent.106 102 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
103 Amended by No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821).
104 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
105 Number assigned by the Chemical Abstracts Service (CAS) to facilitate the identification of substances: www.cas.org 106 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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2 Containers for preparations sold to the general public must carry a tactile warning of danger if the preparation is labelled as toxic, harmful, corrosive, extremely flammable or highly flammable. This does not apply to aerosols labelled only as extremely flammable or highly flammable.107 3 The technical properties of the child-resistant fastenings and tactile warnings of danger must comply with Annex IX to Directive 67/548/EEC.
4 Aerosol dispensers not covered by the Foodstuffs Act of 9 October 1992108 are subject both to the packaging provisions of this Ordinance and to Articles 1 and 2 of, and points 2.1, 2.4, 3, 4, 5 and 6 of the Annex to Directive 75/324/EEC109.110
Art. 38
Exemptions
Articles 35 to 37 do not apply to explosives or pyrotechnic devices within the meaning of the Explosives Act of 25 March 1977111, with the exception of pyrotechnic devices designed to produce toxic gases, smoke or dusts.
Art. 39
112
c. the fill quantity, in the case of preparations made available to the general public;
d. the danger symbols and indications of danger in accordance with Annex 1 number 1;
e. the R-phrases in accordance with Annex 1 number 2, indicating special risks;
f. the S-phrases in accordance with Annex 1 number 3, providing safety advice;
107 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
108 SR 817.0 109 Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers, OJ L 147 of 9.6.1975, p. 40; last amended by Directive 2008/47/EC, OJ L 96 of 9.4.2008, p. 15. This text can be accessed on the Internet at www.cheminfo.ch
110 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
111 SR 941.41 112 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
113 See footnote to Art. 12 para. 1.
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g. the chemical name of the dangerous substances in a preparation in accordance with Annex 1 number 4;
Art. 40
114
Manufacturers of preparations may use an alternative chemical name for a substance:
a. if they demonstrate that disclosing the name of the substance on the label or in the safety data sheet would put the confidential nature of their business, in particular their intellectual property rights, at risk; and b. if the substance meets the criteria specified in Section 1.4 of Annex I to the CLP Regulation117.
2
The alternative chemical name shall be a name that identifies the most important functional groups or serves as an alternative designation.
3
Manufacturers wishing to use an alternative chemical name must make a request in writing to the Notification Authority.
4
The use of an alternative chemical name may be requested for a preparation: a. in a specific composition; b. with a specific trade name or a specific designation; and c. reserved for certain uses.
5
Authorisation to use an alternative chemical name is granted to the manufacturer and is non-transferable.
Art. 44
Requests to use an alternative chemical name118 1
Requests to use an alternative chemical name must contain:119 a. the manufacturer's name, address and telephone number; 114 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
115 Repealed by No I of the Ordinance of 14 Jan. 2009, with effect from 1 Feb. 2009 (AS 2009 401).
116 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
117 See footnote to Art. 2 para. 4.
118 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
119 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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b. the following information relating to the substances whose identity is to remain confidential on the label: 1. the chemical name, 2. the CAS number, 3. the
EC
number;
c. the alternative name of the substance; d. the reasons for the request; e. the trade name or designation of the preparation; f. the information on the constituents in accordance with the provisions relating to the safety data sheet;
g. the classification of the preparation; h. the labelling of the preparation; i.
the intended uses of the preparation; j.
the physical state; k. if applicable, the safety data sheet.
2 The Notification Authority shall decide on the request in agreement with the assessment authorities.
Art. 45
120
Art. 46
Optional labelling
1 Manufacturers may provide further indications of dangers to the environment and information on protective measures, as shown in Annex 1 number 7, on the packaging of preparations or objects.121 2 If Annex 1 number 7 requires a specific pictogram to be used, manufacturers must not use a different pictogram unless they can demonstrate that it is in common international use.
Art. 47
Implementation of labelling 1 Labelling information must appear on each package or on a label that is firmly affixed to the packaging. It must be written in at least two official languages and be clearly visible, legible and durable.122 120 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
121 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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1bis …123 2 The details of implementation are based on the provisions of Annex 1 number 6.
3 With the agreement of individual professional final users, a preparation for supply to these final users may be labelled in only one official language or in English.124
Art. 48
125
2 In the case of a single package, the danger symbols and indications of danger may be omitted provided that the labelling requirements specified in paragraph 1 letter a are met. This does not apply, in the case of preparations, to the danger symbol N and the indication of danger "dangerous for the environment" if they do not appear in this form on the label.
a126 Derogations from the labelling requirements127 1
The Notification Authority may, after consultation with the assessment authorities, permit derogations from the labelling requirements for certain preparations or groups of preparations and allow these not to be labelled or to be labelled in some other suitable form: a. if the packages are too small or otherwise unsuitable for labelling in accordance with Articles 39 to 47; or
b. if the preparations are supplied in such small quantities that that they pose no risk to humans or the environment.128 2
The Notification Authority shall issue a ruling or a general ruling in response to a justified application.
122 Amended by No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821).
123 Inserted by No I of the Ordinance of 28 Feb. 2007 (AS 2007 821). Repealed by No I of the Ordinance of 14 Jan. 2009, with effect from 1 Feb. 2009 (AS 2009 401).
124 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
125 Amended by No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821).
126 Inserted by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
127 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
128 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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3
The Notification Authority shall maintain a list of the derogations that have been permitted and make it available to the public.
Art. 49
129
Art. 50
130
Exemptions
1 Articles 39 to 49 do not apply to explosives or pyrotechnic devices (Art. 38), with the exception of pyrotechnic devices designed to produce toxic gases, smoke or dusts.
2 Article 39 does not apply to the following dangerous preparations provided that, in the form in which they are placed on the market, they do not represent a danger either to human health as a result of inhalation, ingestion or skin contact, or to water bodies:131 a. metals in massive form, b. alloys, c. preparations containing polymers or elastomers.
3 Preparations classified as harmful on the basis of an aspiration hazard need not be labelled as harmful with R 65 when placed on the market in aerosol containers or in containers fitted with a sealed spray attachment.132 Chapter 4a: Exposure Scenarios and Safety Data Sheet133 Section 1:134 Exposure Scenarios
a 1 The manufacturer of an existing substance that fulfils the criteria specified in Article 14 paragraph 4 of the REACH Regulation135 and is supplied as such to third parties in a total quantity of 10 tonnes per year or more must prepare an exposure scenario for each identified use of the substance.
2
Any person who obtains a substance for which exposure scenarios have been prepared and supplies it to third parties on a commercial basis in quantities of 129 Repealed by No I of the Ordinance of 7 Nov. 2012, with effect from 1 Dec. 2012 (AS 2012 6103).
130 Amended by No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821).
131 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
132 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
133 Inserted by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
134 Inserted by No. I of the Ordinance of 14 Jan. 2009 (AS 2009 401). Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
135 See footnote to Art. 2 para. 4.
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1 tonne per year or more as a substance or in a preparation for a use not described in the safety data sheet must prepare an exposure scenario for this use.
3
Paragraph 2 does not apply in cases where: a. the exposure scenario for the new use would exclusively cover conditions described in an exposure scenario included in the safety data sheet; b. the substance is present in the preparation in a concentration below the limits referred to in Article 18 paragraph 3; c. the substance is used for purposes of product and process-orientated research and development.
4
The exposure scenarios must be prepared in accordance with the provisions of Section 5.1 of Annex I to the REACH Regulation136.
Section 2:
Safety Data Sheet137
Art. 51
Purpose Safety data sheets are designed to enable people handling substances or preparations in a professional or commercial capacity to take the measures required for health protection, occupational safety and environmental protection.
Art. 52
138
e.140 preparations containing at least one PBT or vPvB substance in an individual concentration of
0.1 per cent by weight; 136 See footnote to Art. 2 para. 4.
137 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
138 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
139 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
140 Amended by No I of the Ordinance of 10 Nov. 2010, in force since 1 Dec. 2010 (AS 2010 5223).
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f.141 preparations containing at least one substance listed in Annex 7 in an individual concentration of
0.1 per cent by weight; g.142 preparations containing at least one substance for which a workplace exposure limit has been laid down in Directives 2000/39/EC143, 2006/15/EC144 or 2009/161/EU145.
Art. 53
146
2
For the information to be provided in accordance with points 1, 7, 8, 13 and 15 of the two versions of Annex II to the REACH Regulation referred to in paragraph 1, the correspondences specified in Annex 5 must be taken into account.
3
The exposure scenarios included in the chemical safety report (Art. 18a) or prepared in accordance with Article 50a must be attached to the safety data sheet.
4
The classification must be indicated in the safety data sheet as follows: a. in the case of substances: the classification both in accordance with Article 8 paragraph 1 and in accordance with Article 8 paragraph 2; 141 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
142 Inserted by No I of the Ordinance of 10 Nov. 2010, in force since 1 Dec. 2010 (AS 2010 5223).
143 Commission Directive 2000/39/EC of 8 June 2000 establishing a first list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work, OJ L 142 of 16.6.2000, p. 47; last amended by Directive 2009/161/EU, OJ L 338 of 19.12.2009, p. 87.
This text can be accessed on the Internet at www.cheminfo.ch 144 Commission Directive 2006/15/EC of 7 February 2006 establishing a second list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC and amending Directives 91/322/EEC and 2000/39/EC; OJ L 38 of 9.2.2006, p. 36. This text can be accessed on the Internet at www.cheminfo.ch 145 Commission Directive 2009/161/EU of 17 December 2009 establishing a third list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC and amending Commission Directive 2000/39/EC, OJ L 338 of 19.12.2009, p. 87. This text can be accessed on the Internet at www.cheminfo.ch 146 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
147 Commission Regulation (EU) No 453/2010 of 20 May 2010 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), OJ L 133 of 31.5.2010, p. 1.
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b. in the case of preparations labelled according to Article 34e paragraph 1 letter b: the classification both in accordance with Article 10 paragraph 1 and in accordance with Article 10 paragraph 2 for the preparation and the constituents to be specified.
5 The FDHA may, in consultation with DETEC and the EAER, define the technical expertise required for the compilation of safety data sheets.
Art. 54
148
2 The safety data sheet must be provided: a. when supplying a substance or a preparation as defined in Article 52 letters a-c: at the latest at the time it is first supplied, and if requested with other deliveries; b. when supplying a preparation as defined in Article 52 letters d-g: on request.
3 In the case of substances and preparations supplied via a retail outlet, the safety data sheet must be provided if this is requested by a professional or commercial customer.
4 Safety data sheets must be provided as follows: a. free of charge; b. in the official languages requested by the customer or, by mutual agreement, in another language; the annex to the safety data sheet may be written in English; c. on paper or in electronic form; the safety data sheet is to be provided on paper if this is requested by the customer.
Art. 55
149
1 If important new information on a substance or preparation becomes available, the manufacturer must update the safety data sheet without delay.
2
The supplier must make the updated safety data sheet available to all professional or commercial customers supplied with the substance or preparation concerned within the previous twelve months.
3 Paragraph 2 does not apply to safety data sheets provided through retail outlets.
148 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
149 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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Art. 56
Obligation to retain safety data sheets Professional or commercial customers are required to retain the safety data sheet for as long as the substance or preparation in question continues to be handled at their workplace.
a150
b-56e151 Title 3:
Obligations after Placing on the Market Chapter 1:
Taking Account of new Information Relevant to Assessment, Classification and Labelling
Art. 57
Reassessment of substances, preparations and objects Manufacturers must reassess or further assess substances, preparations and objects containing dangerous constituents and reclassify them where necessary if: a. they are to be supplied for different purposes; b. they are to be used in a different way; c. they are to be used in much larger quantities than before; d. variations arise in the nature and quantity of impurities, which could have adverse effects on human health or the environment; e. the evaluation of the risks they pose to human health or the environment needs to be modified in the light of practical experience, new data or new information.
Art. 58
Updating and retention of documents 1 Manufacturers are required to update documents continuously with new information relevant to health and the environment for as long as they continue to supply the substance, preparation or object containing dangerous constituents.
2 They must retain or ensure the availability of the main documents used in the assessment and classification, together with the results of the assessment and classification, for at least ten years after the products are last placed on the market. They must retain samples and specimens for as long as their condition allows them to be analysed.
150 Inserted by No I of the Ordinance of 14 Jan. 2009 (AS 2009 401). Repealed by No I of the Ordinance of 10 Nov. 2010, with effect from 1 Dec. 2010 (AS 2010 5223).
151 Inserted by No I of the Ordinance of 14 Jan. 2009 (AS 2009 401). Repealed by No I of the Ordinance of 7 Nov. 2012, with effect from 1 Dec. 2012 (AS 2012 6103).
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Chapter 2:
Updated Information and Additional Test Reports on new Substances
Art. 59
Updated information
1 Notifiers must inform the Notification Authority in writing without delay if: a. the details referred to in Article 18 paragraph 2 letter b numbers 1-6 or Article 26 paragraph 2 change;
b. the relevant substance quantity in accordance with Article 16a is likely to have reached one of the thresholds laid down in Article 60 paragraph 1; in this case, the notifier shall specify which tests it intends to conduct in order to produce the additional information specified in Article 60 paragraph 1; c. the decisive substance quantity in accordance with Article 16a has increased or decreased by a factor of more than two compared with the quantity last notified; d. new information comes to their attention regarding the effects of the substance on human health or the environment;
e. they place the substance on the market for a new use or become aware that this substance is being used for purposes other than those indicated to the Notification Authority; f.
they compile, or have compiled for them, test reports going beyond the technical dossier referred to in Article 18 paragraph 2 letter b for the substance in question; g. they are able to obtain other test reports going beyond the technical dossier referred to in Article 18 paragraph 2 letter b.152 2 Sole representatives must ensure that they have access to updated data, particularly as regards the quantities of substances imported annually by the importers they represent.
3 Importers represented by a sole representative for notification of a new substance must inform that representative annually of the imported quantities of the substance concerned.
Art. 60
153
153 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
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a. for quantities of 10 tonnes per year or more: the information mentioned in Annex 3 number 8 letter b and number 9 letter b and a chemical safety report in accordance with Article 18a; b. for quantities of 100 tonnes per year or more: the information mentioned in Annex 3 number 7 letter b, number 8 letter c and number 9 letter c and a chemical safety report in accordance with Article 18a; c. for quantities of 1,000 tonnes per year or more: the information mentioned in Annex 3 number 8 letter d and number 9 letter d and a chemical safety report in accordance with Article 18a.
2 After receiving the information specified in Article 59 paragraph 1 letter b, the Notification Authority shall in accordance with Article 23 inform the notifier of the data that it already holds.
3 If the risks associated with a given substance cannot be adequately evaluated, the Notification Authority shall, if so requested by an assessment authority, require the notifier to submit additional information or carry out additional tests relating to the substance or its transformation products.
4 The Notification Authority, after consulting the notifier and with the agreement of the assessment authorities, shall draw up a timetable for carrying out the additional tests.
5 If the notifier fails to submit the additional test reports by the specified deadline, the Notification Authority may arrange for the required tests to be carried out at the notifier's expense and, if necessary, prohibit the notifier from continuing to place the relevant substance on the market.
Chapter 3: Obligation to Register
Art. 61
154
155 Repealed by No I of the Ordinance of 7 Nov. 2012, with effect from 1 Dec. 2012 (AS 2012 6103).
156 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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a. the manufacturer's name and address; b. the name of the person responsible for placing the substance or preparation on the market in the EEA in accordance with Article 10 point 2.2 of Directive 1999/45/EC157 or Article 17 paragraph 1 letter a of the CLP Regulation158, if the manufacturer's identity is not mentioned on the label; c. in the case of substances: 1. the chemical name according to Article 18 paragraph 2 letters a-d of the CLP Regulation,
2. the CAS number, 3. the EC
number,
4. the classification and labelling; 5. the intended uses, 6. in the case of substances dangerous to the environment: the quantity likely to be placed on the market annually according to one of the following categories: less than 1 tonne, 1-10 tonnes, 10-100 tonnes, more than 100 tonnes, 7. in the case of nanomaterials: the composition, particle form and mean particle size and, where available, the number size distribution, specific surface area by volume, crystal structure, aggregation status, surface coating and surface functionalisation, 8. an indication of whether the substance is considered to be PBT or vPvB,
9. the chemical safety report available in the EEA, provided the manufacturer can reasonably be expected to obtain it;
d. in the case of preparations: 1. the trade name, 2. data relating to the constituents in accordance with the provisions concerning the safety data sheet,
3. the classification and labelling, 4. the intended uses, 5. the physical state.
6. in the case of preparations dangerous to the environment: the quantity likely to be placed on the market annually according to one of the following categories: less than 1 tonne, 1-10 tonnes, 10-100 tonnes, more than 100 tonnes, 7. in the case of preparations containing nanomaterials: the composition of the nanomaterials, the particle form and mean particle size and, where available, the number size distribution, specific surface area by volume, crystal structure, aggregation status, surface coating and surface functionalisation.
157 See footnote to Art. 12 para. 1.
158 See footnote to Art. 2 para. 4.
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Art. 65
159
Art. 66
161
Art. 67
162
1 Any modifications to the data referred to in Articles 64 and 65 must be reported within 3 months.
2 If the quantity of substances and preparations dangerous to the environment actually supplied in a year is outside the registered category of quantities placed on the market, the quantity placed on the market in the previous year must be reported by 31 March of the following year in accordance with the categories specified in Article 64 letter c number 6 and letter d number 6.
Art. 68
163
Art. 69
Exemptions from the obligation to register The registration requirements specified in this Chapter do not apply to: a.164 …
159 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
160 See footnote to Art. 12 para. 1.
161 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
162 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
163 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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b. intermediates; c.165 substances and preparations which are placed on the market solely for purposes of analysis, research or education, or which are subject to research and development;
d.166 substances and preparations used exclusively for foodstuffs, therapeutic products or animal feedingstuffs; e. fertilisers which require authorisation from the Federal Office for Agriculture (FOAG) or have to be notified to the FOAG under the Fertiliser Ordinance of 10 January 2001167;
f.168 explosives and pyrotechnic devices which require authorisation under the Explosives Ordinance of 27 November 2000169; g.170 substances obtained in Switzerland; h.171 preparations obtained in Switzerland and supplied in packaging other than that intended by the original manufacturer, provided that: 1. the trade name, composition and intended use are unchanged, and 2. the name of the original manufacturer is also indicated; i.172 gas mixtures consisting exclusively of registered gases; j.173 non-dangerous preparations in packages containing no more than 200 ml, if they are manufactured in Switzerland and supplied directly to final users by the manufacturer; k.174 preparations placed on the market in quantities of less than 100 kg per year and intended exclusively for professional users.
164 Repealed by No I of the Ordinance of 7 Nov. 2012, with effect from 1 Dec. 2012 (AS 2012 6103).
165 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
166 Amended by No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821).
167 SR
916.171
168 Inserted by No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821).
169 SR
941.411
170 Inserted by No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821).
171 Inserted by No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821).
172 Inserted by No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821).
173 Inserted by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
174 Inserted by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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Title 4:
Handling of Substances, Preparations and Objects Chapter 1: General Provisions
Art. 70
Taking account of the information provided by the manufacturer 1 Substances, preparations and objects may be promoted, offered or supplied professionally or commercially only for the uses and methods of disposal stated by the manufacturer.
2 The advice and instructions given on the package and in the safety data sheet must be taken into account.
Art. 71
Environmental release 1 Substances and preparations may be released directly into the environment only to the extent that is necessary for the intended use.
2 To this end, users must: a. use equipment allowing correct and accurate application; b. take steps to prevent substances and preparations, as far as possible, from entering surrounding areas or water bodies; c. take steps to ensure that, as far as possible, animals, plants, their biocoenoses and habitats are not threatened.
3 Preparations may be released directly into the environment only for the uses specified by the manufacturer.
Art. 72
Storage 1 When substances and preparations are stored, the advice and instructions given on the package and, if applicable, in the safety data sheet must be taken into account.
2 Dangerous substances and preparations and their containers must be protected against hazardous impacts, especially those of a mechanical nature.
3 Dangerous substances and preparations must be clearly identifiable and kept separate from other goods. No foodstuffs, animal feedstuffs or therapeutic products may be kept in the immediate vicinity.
4 Paragraphs 1 to 3 also apply to objects from which substances or preparations are released in quantities that may endanger human health or the environment.
5 Substances and preparations that may react dangerously with each other must be stored separately.
6 Dangerous substances and preparations that are not commercially supplied may only be filled and stored in containers meeting the following requirements: a. the packaging must not be capable of being confused with packaging containing foodstuffs, cosmetics, therapeutic products or feedstuffs;
b. the name of the substance or preparation must be given in the labelling; and
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c. the construction of the packaging must comply with the requirements of Article 35.175
Art. 73
176
Art. 74
Chemicals contact person 1 Companies and educational establishments must notify the cantonal enforcement authorities of their chemicals contact person, to be appointed under Article 25 paragraph 2 of the Chemicals Act.
2 The FDHA sets down the rules for mandatory notification in accordance with paragraph 1; it defines the form and content of the notification.
3 It defines the requirements that the chemicals contact person must meet, particularly with regard to technical qualifications and operational responsibilities.
Art. 75
177
1 Advertising for substances, preparations and objects must not give a misleading impression as to the risks posed to human health and the environment or as to their environmental acceptability, and must not encourage inappropriate or illegitimate use or disposal.
2 Terms such as "degradable", "environmentally harmless", "environment-friendly" and "water-friendly" may be used in advertising only if the properties thus described are at the same time explained in more detail. 3 Anyone who advertises dangerous substances or preparations that the general
public can purchase without seeing the labelling beforehand must indicate their hazardous properties in a comprehensible and clearly legible or audible manner.
4
Paragraph 3 also applies to preparations labelled in accordance with number 5 of Annex 1 to this Ordinance or Article 25 paragraph 6 of the CLP Regulation178.
5
Substances and preparations are not to be promoted for uses for which they must not be placed on the market.
175 Inserted by No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821).
176 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
177 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
178 See footnote to Art. 2 para. 4.
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Chapter 2:
Handling of Dangerous Substances and Preparations in Groups 1 and 2179
Art. 76
180
2
Dangerous substances and preparations are deemed to belong to Group 2: a. if their labelling in accordance with the CLP Regulation contains at least one element specified in number 1.2 of Annex 6 to this Ordinance; or b. if they are not yet labelled in accordance with the CLP Regulation and their labelling contains at least one element specified in number 2.2 of Annex 6 to this Ordinance.
Art. 77
182 Storage 1 For the storage of substances or preparations in Groups 1 and 2, Article 72 applies.
2 Anyone storing substances or preparations in Groups 1 and 2 must ensure that they are not accessible to unauthorised persons.
3 Substances and preparations in Groups 1 and 2 which are not commercially supplied may only be filled and stored in containers if these are labelled with the appropriate danger symbols or hazard pictograms.
Art. 78183 Exclusion of self-service 1
Substances and preparations in Group 2 which are intended for the general public must not be offered on a self-service basis.
2 Paragraph 1 does not apply to motor fuels.
179 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
180 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
181 See footnote to Art. 2 para. 4.
182 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
183 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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Art. 79184 Supply restrictions
1 Substances and preparations in Group 1 must not be supplied to the general public.
2 Substances and preparations in Groups 1 and 2 may be commercially supplied only to adults.
3 Paragraph 2 does not apply to legal minors who have to handle these substances or preparations in a professional or commercial capacity.
4 Paragraphs 1 and 2 do not apply to motor fuels.
Art. 80185 Special obligations with regard to supply 1 Anyone who commercially supplies a substance or preparation in Group 1 must inform the purchaser expressly of the precautions required and the correct method of disposal.
2 Anyone who commercially supplies a substance or preparation in Group 2 to the general public must inform the purchaser in an appropriate manner, at the time of supply, of the precautions required and the correct method of disposal.
3 Substances and preparations may be supplied in accordance with paragraph 2 only to persons who can be assumed by the supplier to be capable of sound judgement and able to comply with the duty of care under Article 8 of the Chemicals Act and the requirements set out in Article 28 of the EPA.
4 The obligations specified in paragraphs 1 and 2 do not apply to the supply of motor fuels.
Art. 81
Knowledge required to supply 1
Special knowledge is required by anyone who, in a commercial capacity: a. supplies substances and preparations in Group 1 to professional final users; b. supplies substances and preparations in Group 2 to the general public.186 2 The FDHA may regulate: a. how the knowledge requirements are to be met; in this connection, it takes into account professional training and experience; b. the content, duration and organisation of courses for people seeking to acquire such knowledge.
3 Article 11 of the Chemical Risk Reduction Ordinance of 18 May 2005187 (ORRChem) applies mutatis mutandis188.
184 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
185 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
186 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
187 SR
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4
Paragraph 1 does not apply to motor fuels.189
Art. 82
190
2 The police must inform the cantonal authority responsible for enforcing this Ordinance as well as the Federal Office of Police.
3
Anyone who erroneously places on the market a substance or a preparation in Group 1 or 2 must immediately inform the cantonal authority responsible for enforcing this Ordinance and provide the following information: a. all the data required for precise identification of the substance or preparation;
b. a comprehensive description of the danger which the substance or preparation may pose;
c. all the available information as to the source from which the substance or preparation was obtained and, if the substance or preparation has not been supplied directly to users, to whom the substance or preparation has been supplied; d. the measures taken to avert any danger, such as warnings, suspension of sales, withdrawal from the market or recall.
4 The cantonal authority must decide whether the public needs to be warned of any danger.
Art. 83191 Samples Substances and preparations in Groups 1 and 2 may be provided for promotional purposes only to professional or commercial users.
Art. 83
a192 Substances and preparations intended for self-defence 1
For the handling of substances and preparations intended for self-defence, Article 77, Article 79 paragraphs 2 and 3, Article 80 paragraphs 2 and 3, Article 81 paragraph 1 letter b, Article 82 paragraphs 3 and 4 and Article 83 apply mutatis mutandis.193
188 Inserted by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
189 Inserted by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
190 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
191 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
192 Inserted by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
193 Revised with effect from 15 Jan. 2013 (AS 2013 201).
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2
Substances and preparations intended for self-defence must not be offered on a self-service basis.
Chapter 3:194 Handling of Substances of Very High Concern
b List of substances of very high concern 1
Substances referred to in Article 57 of the REACH Regulation195 are deemed to be of very high concern if they are included in Annex 7 (candidate list).
2
The FOEN shall decide, in consultation with the FOPH and SECO, whether a candidate list substance listed in Annex XIV to the REACH Regulation is to be included in Annex 1.17 to the ORRChem196.
c Objects containing substances of very high concern 1
Anyone who commercially supplies an object containing a substance of very high concern in a concentration greater than 0.1 % by weight must provide the customer with the following information: a. the name of the substance concerned; b. all the information required to allow safe use of the object, insofar as this is available to the supplier.
2
This information must be provided free of charge: a. to professional or commercial customers: without being so requested; b. to private customers: on request within 45 days.
Title 5:
Data Processing Art. 84 Register of products
1 The Notification Authority shall maintain a register of substances and preparations that fall within the scope of the following Ordinances: a. this Ordinance; b. the ORRChem197; c. the Biocidal Products Ordinance of 18 May 2005198; d. the Plant Protection Products Ordinance of 18 May 2005199.
194 Inserted by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
195 See footnote to Art. 2 para. 4.
196 SR
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197 SR
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198 SR
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2 The register is compiled on the basis of data: a. that has been collected or produced by a Swiss authority under one of the ordinances cited in paragraph 1; b. that is made available by foreign authorities or by international organisations.
Art. 85 Confidential data
1 The enforcement authorities shall treat data as confidential when an interest in its confidentiality is worthy of protection, unless there is an overriding public interest in its disclosure.
2 The Notification Authority shall designate the confidential data in consultation with the assessment authorities. It shall designate it before sending it on to the competent cantonal or federal authorities cited in Article 87 paragraph 2.
3 In particular, the interest in maintaining commercial/manufacturing secrecy, including information on the full composition of a substance or preparation and the quantities placed on the market, shall be deemed worthy of protection.
4 If the Notification Authority discovers that data deemed to be confidential has subsequently been disclosed by lawful means, this data shall no longer be treated as confidential.
5 The following are not deemed confidential under any circumstances: a. the trade name; b. the name and address of the person subject to notification, declaration or registration requirements; c. the physicochemical properties defined in Annexes VII A, VII B, VII C and VII D to Directive 67/548/EEC; d. procedures for proper disposal, for possible recycling or reuse, and for other ways of rendering materials harmless; e. the summary of results of toxicological and ecotoxicological tests; f.
the degree of purity of a substance and the identity of the impurities and additives that are relevant for classification; g. recommendations regarding precautions during use and emergency measures in the event of an accident; h. information that appears in the safety data sheet; i.
suitable analytical methods for determining the exposure of human beings and presence in the environment.
199 [AS
2005 3035 4097 5211, 2006 4851, 2007 821 No. III 1469 Annex 4 No. 54 1843 4541 6291, 2008 2155 4377 Annex 5 No. 11 5271, 2009 401 Annex No. 3 2845, 2010 2101.
AS 2010 2331 Art. 84]. See now the Ordinance of 12 May 2010 (SR 916.161).
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6 The Notification Authority and assessment authorities may allow public access to data in the register of products which is not deemed confidential under any circumstances.
Art. 86 Data to be passed on to the Notification Authority and the assessment authorities The following data concerning substances, preparations and objects must be passed on to the Notification Authority and the assessment authorities if requested and if necessary for enforcement of this Ordinance: a. data collected by the FOAG under: 1. the Fertilisers Ordinance of 10 January 2001200, 2. the Animal Feedstuffs Ordinance of 26 May 1999201, 3. the Plant Protection Products Ordinance of 18 May 2005202; b.203 data on contaminants and constituents in foodstuffs and on substances in articles of daily use collected by the FOPH and by the Federal Food Safety and Veterinary Office under the Foodstuffs Ordinance of 1 March 1995204;
c.205 data collected by the Federal Customs Administration from customs declarations;
d. data collected by SECO, by the Swiss National Accident Insurance Fund (SUVA) or by cantonal employment inspectorates under legislation on the protection of workers; e. data collected by the poisons information centre (Art. 91); f. data collected by examining bodies under Article 12 paragraph 3 of the ORRChem206;
g. data collected by cantons in connection with the enforcement of this Ordinance or of other legislation governing the protection of human health or the environment against substances, preparations or objects.
200 SR
916.171
201 [AS
1999 1780 2748 Annex 5 No. 6, 2001 3294 No. II 14, 2002 4065, 2003 4927, 2005 973 2695 No. II 19 5555, 2007 4477 No. IV 70, 2008 3655 4377 Annex 5 No. 14, 2009 2599, 2011 2405]. See now the Ordinance of 26 Oct. 2011 (SR 916.307).
202 [AS
2005 3035 4097 5211, 2006 4851, 2007 821 No. III 1469 Annex 4 No. 54 1843 4541 6291, 2008 2155 4377 Annex 5 No. 11 5271, 2009 401 Annex No. 3 2845, 2010 2101.
AS 2010 2331 Art. 84]. See now the Ordinance of 12 May 2010 (SR 916.161).
203 Amended by No I 3 of the Ordinance of 4 Sept. 2013 (Reorganisation in the field of Food Safety and Veterinary Medicine), in force since 1 Jan. 2014 (AS 2013 3041).
204 [AS
1995 1491, 1996 1211, 1997 292 1145 1198 Art. 24, 1998 108, 1999 303 No I 8 1848, 2002 573, 2003 4915 No II, 2004 457 3035 3065 No II 1, 2005 1057 1063 2695 No II 15. AS 2005 5451 Annex 2 No I 1]. See the Foodstuffs and Utility Articles Ordinance of 23 Nov. 2005 (SR 817.02).
205 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
206 SR
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Art. 87 Exchange of information and data 1 The Notification Authority and assessment authorities must, insofar as is required for the performance of their duties, make available to each other the data that they have collected or have had collected on their behalf under this Ordinance or any other legislation governing the protection of human health or the environment against substances, preparations or objects. To this end, they may establish automated retrieval procedures.
2 The Notification Authority and assessment authorities must make available to the cantonal and federal authorities responsible for enforcing legislation governing the protection of human health or the environment against substances, preparations or objects the data necessary for the performance of their duties. To this end, they may establish automated retrieval procedures.
2bis
The Notification Authority may make data concerning manufacturers and the substances or preparations that they have placed on the market accessible to the authorities listed below, if these authorities require the data in order to perform their duties: a. the assessment authorities; b. the customs authorities; c. the cantonal authorities specified in paragraph 2; d. the poisons information centre (Art. 91).207 3 The Notification Authority and assessment authorities may, in special cases, pass on data relating to substances, preparations and objects to bodies other than those cited in paragraph 2, if these bodies require the data in order to perform their duties.
4 Confidential data relating to the composition of preparations may only be passed on under paragraphs 2, 2bis and 3 if this is required by a criminal prosecution authority or if the data serves to answer medical queries, particularly in cases of emergency or to prevent an imminent danger to human life or health or to the environment.208 5 The cantons must inform the Notification Authority of the results of surveys and analyses regarding the quality of indoor air and pass on available data on indoor air to the Notification Authority.
Art. 88
Passing-on of data to other countries and to international organisations 1 The Notification Authority and assessment authorities may pass on data that is not confidential to foreign authorities and institutions, and to international organisations.
2 They may pass on confidential data if: 207 Inserted by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
208 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
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a. this is required by international agreements or decisions of international organisations; or
b. it is necessary to prevent an imminent danger to human life or health or to the environment.
Title 6:
Enforcement
Chapter 1: Confederation Section 1: Organisation
Art. 89 Notification Authority and steering committee 1 The Notification Authority is administratively attached to the FOPH.
2 A steering committee is appointed for the Notification Authority. It is composed of the directors of the following federal offices: a. FOPH; b. FOAG; c. FOEN; d. SECO.
3 The steering committee has the following duties and powers: a. appointing the management of the Notification Authority; b. defining the strategy of the Notification Authority; c. inspection and application rights concerning the budget of the Notification Authority.
4 The steering committee makes decisions by consensus.
Art. 90 Assessment authorities
The assessment authorities are: a. the FOPH, for matters concerning the protection of human life and health; b. the FOEN, for matters concerning the protection of the environment and indirect protection of human beings;
c. SECO, for matters concerning the protection of workers.
Art. 91 Poisons information centre 1 The poisons information centre established by Article 30 of ChemA is the Swiss Toxicological Information Centre in Zurich (STIZ).
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2 The FOPH shall enter into an agreement with the STIZ setting the amount of remuneration that it receives for the services it provides under Article 30 paragraph 2 of ChemA.209 Art. 92 Expert Committee for Chemicals 1 The FDHA may, in consultation with DETEC and the EAER, appoint an Expert Committee for Chemicals.
2 The Expert Committee for Chemicals shall be composed of specialists from federal and cantonal bodies, from the fields of science, business and consumer protection and from interested groups.
3 It shall advise the federal departments on fundamental questions of legislation and enforcement concerning substances and preparations and is authorised to put forward proposals. It may call in external experts for consultation.
Art. 93210 Section 2:
Review of Existing Substances
Art. 94
1 The assessment authorities may review any existing substances which: a. represent a particular risk to human life or health or to the environment, owing to the quantities manufactured or placed on the market or owing to their dangerous nature or the dangerous nature of their secondary products or wastes; or
b. are included in an international existing substances programme.
2 If an existing substance is to be reviewed, the Notification Authority, at the request of an assessment authority, shall require all the manufacturers concerned to provide the following information: a. the name and address of the manufacturer, and the name and address of the foreign manufacturer if the manufacturer imports the substance; b. all documents used in assessing and establishing the hazardous properties of the substance;
c. the known uses; d. information on the quantities placed on the market by the manufacturers.
209 Amended by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
210 Repealed by No I 7.2 of the Ordinance of 9 Nov. 2011 (Review of Extra-Parliamentary Commissions), with effect from 1 Jan. 2012 (AS 2011 5227).
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e.211 the registration dossier that was submitted to the European Chemicals Agency, provided it is available and the notifier can reasonably be expected to obtain it.
3 If requested by an assessment authority, the Notification Authority shall request one of the manufacturers to carry out investigations or studies. The costs incurred by the manufacturer shall be borne jointly by all the manufacturers concerned.
Section 3:
Review of Self-Regulation and Monitoring
Art. 95
Review of self-regulation 1 The assessment authorities must review, in their area of competence, for substances, preparations and objects: a. the assessment and classification; b. the information that appears in the safety data sheet.
2 They may instruct the Notification Authority: a. to verify the composition and the physicochemical properties of substances, preparations and objects; b. to ask cantonal enforcement authorities to take samples.
3 If there is reason to suppose that the assessment or classification has not been carried out or has not been carried out correctly, the Notification Authority, at the request of an assessment authority, must require the manufacturer concerned to provide: a. all the documents used in establishing the hazardous properties or in the assessment;
b. the safety data sheet, if appropriate.
4 At the request of an assessment authority, the Notification Authority must require the manufacturer to perform tests or additional assessments if there are indications that: a. substances or preparations and their secondary products or wastes may endanger human health or the environment;
b. objects, their secondary products or their wastes may endanger the environment.
5 Moreover, the enforcement authorities have the powers assigned to them by Article 42 of the Chemicals Act and, in the case of a danger to the environment, also Article 41 of the Chemicals Act.
211 Inserted by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
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6 If a manufacturer does not comply with an official order, the Notification Authority must, if so requested by an assessment authority, prohibit it from continuing to supply the substances, preparations or objects concerned.
7 As regards cosmetic products, and raw materials and additives intended exclusively for these products, the body responsible for these products must order the necessary measures. The participation of the FOEN is governed by Articles 62a and 62b of the Federal Act of 21 March 1997212 on the Organisation of the Government and the Administration.
Art. 96 Monitoring with regard to national defence In matters concerning national defence, the Notification Authority must examine, in consultation with the assessment authorities, whether the provisions of this Ordinance are being respected.
Art. 97 Monitoring of imports and exports 1 Customs offices must check, at the request of the Notification Authority, whether substances, preparations or objects comply with the provisions of this Ordinance.213 2 The assessment authorities may call upon the Notification Authority to submit a request as defined in paragraph 1.
3 In cases of suspected infringement, the customs offices are authorised to detain goods at the border and call in the other enforcement authorities in accordance with this Ordinance. These authorities must carry out further investigations and take the necessary measures.214 Section 3a:215Adaptations to EU legislation
Art. 97
a In consultation with the FOEN and SECO, the FOPH shall adapt Annex 7, taking account of any amendments to the candidate list for eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006 referred to in Article 59 paragraph 1 of the REACH Regulation216.
212 SR
172.010
213 Amended by Annex 4 No 41 of the Customs Ordinance of 1 Nov. 2006, in force since 1 May 2007 (AS 2007 1469).
214 Amended by Annex 4 No 41 of the Customs Ordinance of 1 Nov. 2006, in force since 1 May 2007 (AS 2007 1469).
215 Inserted by No. I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401). Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec.
2012 (AS 2012 6103).
216 See footnote to Art. 2 para. 4.
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Section 4:
Delegation of Duties and Powers to Third Parties
Art. 98
1 The competent federal bodies may delegate to appropriate public corporations or private persons all or some of the duties and powers assigned to them by this Ordinance.
2 To the extent that enforcement of health protection is concerned, delegation is limited to the following: a. review of self-regulation; b. assessment as part of a review of notification and updated information; c. provision of information under Article 28 of the Chemicals Act; d. risk assessment under Article 16 of the Chemicals Act.
Section 5:
Charges
Art. 99
The obligation to pay charges and the calculation of charges for administrative
actions by the federal enforcement authorities in accordance with this Ordinance is based on the Chemical Charges Ordinance of 18 May 2005217.
Chapter 2: Cantons Section 1: Further Inspection
Art. 100
Duties of the cantonal enforcement authorities 1 By means of random sampling, the cantonal enforcement authorities must inspect substances, preparations and objects placed on the market.
2 Within the framework of these inspections, the cantonal enforcement authorities must verify: a. that the notification, declaration and registration requirements (Articles 16, 25, 61, 67 and 68) and the provisions governing updated information (Art. 59) have been respected; b. that packaging conforms to the provisions on packaging (Articles 34a and 34e-37);
c. that labelling conforms to the provisions on labelling (Articles 34b, 39-50 and Annex 1);
217 SR
813.153.1
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d. that the requirements concerning the provision, updating and retention of the safety data sheet (Articles 54-56) are being complied with and that the information in the safety data sheet is not obviously incorrect; e. that the provisions on advertising (Art. 75) and samples (Art. 83) are being respected.
f.
that the requirement to provide information when supplying objects containing substances of very high concern (Art. 83c) has been complied with.218 Art. 101 Cooperation between the cantonal and federal enforcement authorities 1 The Notification Authority must, on its own initiative or at the request of an assessment authority, instruct the cantonal enforcement authorities to inspect certain substances, preparations or objects, especially in accordance with Article 95 paragraph 1.
2 The cantonal enforcement authorities must collect samples at the request of the Notification Authority.
3 If the inspections identify serious concerns, the authority that performed the inspections must inform the Notification Authority and the authorities responsible for orders under Article 102.
4 If there are grounds for suspecting incorrect classification, the authority that performed the inspections must inform the Notification Authority.
Art. 102219 Orders of cantonal enforcement authorities If the inspection reveals infringements of the provisions referred to in Article 100 paragraph 2 and Article 101 paragraph 1, the competent authority of the canton in which the infringing party is domiciled or has its registered office must order the measures which need to be taken.
Section 2:
Monitoring of Handling and Promotion of Environmentally Sound Practices
Art. 103 1 The cantonal enforcement authorities must monitor compliance with the specific
provisions relating to handling (Articles 70-74 and 76-82). Article 25 paragraph 1 second sentence of the Chemicals Act applies accordingly.
2 The cantons must promote environmentally sound practices.
218 Amended by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
219 Amended by No I of the Ordinance of 28 Feb. 2007, in force since 1 April 2007 (AS 2007 821).
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Title 7:
Final Provisions Chapter 1: Transitional Provisions Art. 104-109220
Art. 110
Knowledge required to supply and chemicals contact person The FDHA, in consultation with DETEC and the EAER, shall issue the transitional provisions on: a. the requirements concerning knowledge required for the supply of particularly dangerous substances and preparations;
b. the requirements concerning the chemicals contact person.
a221
b222 Transitional provisions concerning the Amendment of 14 January 2009
1
and 2…223
3
The manufacturer must comply with the requirements of Article 50a relating to the preparation of exposure scenarios by: a.224 … b. 1 June 2013 for substances that are placed on the market in quantities of 100 tonnes per year or more; c. 1 June 2018 for substances that are placed on the market in quantities of 10 tonnes per year or more.
c225 Transitional provisions concerning the Amendment of 10 November 2010
1
Substances that have been packaged and labelled in accordance with Articles 3550 before 1 December 2012 may:
a. be placed on the market by the manufacturer until 30 November 2013; 220 Repealed by No I of the Ordinance of 14 Jan. 2009, with effect from 1 Feb. 2009 (AS 2009 401).
221 Inserted by No I of the Ordinance of 28 Feb. 2007 (AS 2007 821). Repealed by No I of the Ordinance of 10 Nov. 2010, with effect from 1 Dec. 2010 (AS 2010 5223).
222 Inserted by No I of the Ordinance of 14 Jan. 2009, in force since 1 Feb. 2009 (AS 2009 401).
223 Repealed by No I of the Ordinance of 7 Nov. 2012, with effect from 1 Dec. 2012 (AS 2012 6103).
224 Repealed by No I of the Ordinance of 7 Nov. 2012, with effect from 1 Dec. 2012 (AS 2012 6103).
225 Inserted by No I of the Ordinance of 10 Nov. 2010, in force since 1 Dec. 2010 (AS 2010 5223).
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b. be supplied to final users until 30 November 2014.
2
Preparations that have been packaged and labelled in accordance with Articles 3550 before 1 June 2015 may:
a.226 … b. be supplied to final users until 31 May 2017.
3
…227
d228 Transitional provisions concerning the Amendment of 7 November 2012
1
Where changes to packaging or labelling are required by the Amendment of 7 November 2012, substances that have been packaged and labelled according to the provisions of the CLP Regulation as last amended by Regulation (EC) No 790/2009229 may: a. be placed on the market by the manufacturer until 30 November 2013; b. be supplied to final users until 30 November 2014.
2
Preparations referred to in Article 10 paragraph 2 may be classified according to the provisions of the CLP Regulation as specified in paragraph 1 until 31 May 2015.
3
Preparations that have been packaged and labelled according to the provisions of the CLP Regulation as specified in paragraph 1 may: a.230 … b. be supplied to final users until 31 May 2017.
4
Requests to use an alternative chemical name in accordance with Article 44 may be submitted in accordance with Article 15 of Directive 1999/45/EC231 until 31 May 2015.
5
In the case of substances and preparations for which a safety data sheet has been compiled under existing law, the manufacturer must comply with the obligations specified in Article 53 paragraph 1 by 30 November 2014.
226 Repealed by Annex 11 No 1 of the Ordinance of 20 June 2014, with effect from 15 July 2014 (AS 2014 2073).
227 Repealed by No I of the Ordinance of 7 Nov. 2012, with effect from 1 Dec. 2012 (AS 2012 6103).
228 Inserted by No I of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
229 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, 31.12.2008, p. 1; last amended by Regulation (EC)
No 790/2009, OJ L 235, 5.9.2009, p. 1.
230 Repealed by Annex 11 No 1 of the Ordinance of 20 June 2014, with effect from 15 July 2014 (AS 2014 2073).
231 See footnote to Art. 12 para. 1.
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6
In the case of preparations that were placed on the market before 1 December 2012 and were not subject to registration requirements, the manufacturer must comply with the obligations specified in Article 61 by 30 November 2013.
7
Substances and preparations as specified in Article 78 paragraph 1 which were placed on the market before 1 December 2012 and for which self-service is now prohibited on account of one of the following labelling elements may continue to be offered on a self-service basis until 30 November 2013: a. EUH029, EUH031 or EUH032 in accordance with Annex 6 number 1.2 letter f; or
b. R29, R31 or R32 in accordance with Annex 6 number 2.2 letter f.
Chapter 2: Commencement
Art. 111
This Ordinance comes into force on 1 August 2005.
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Annex 1232
(Art. 39, Art. 40, Art. 46, Art. 47 para. 2, Art. 100 para. 2 let. c) Labelling of preparations 1
Dangers
1.1
Danger symbols and indications of danger 1 The following danger symbols and indications of danger must be used for labelling of dangerous preparations: E O F+
Explosive Oxidising Extremely flammable
F N T+
Highly flammable
Dangerous for the environment Very toxic
T Xn
C
Toxic Harmful
Corrosive
232 Amended by No II para. 1 of the Ordinance of 28 Feb. 2007 (AS 2007 821). Revised by No II para. 1 of the Ordinance of 14 Jan. 2009 (AS 2009 401), of 10 Nov. 2010 (AS 2010 5223), and of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
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Xi
Irritant 2 The symbols must be printed in black on an orange-yellow background.
1.2
Assignment of danger symbols and indications of danger 1 Dangerous preparations must be labelled with the appropriate danger symbols and indications of danger according to their classification.
2 If the manufacturer's classification requires more than one danger symbol for a preparation, the following applies: a. if labelling with the T+ or T danger symbol is required, the Xn, Xi and C symbols are optional; b. if labelling with the C danger symbol is required, the Xn and Xi symbols are optional;
c. if labelling with the E danger symbol is required, the F, F+ and O symbols are optional;
d. if labelling with the Xn danger symbol is required, the Xi symbol is optional.
2 Special
Risks
2.1 R-phrases R 1 Explosive when dry.
R 2
Risk of explosion by shock, friction, fire or other sources of ignition.
R 3
Extreme risk of explosion by shock, friction, fire or other sources of ignition.
R 4
Forms very sensitive explosive metallic compounds.
R 5
Heating may cause an explosion.
R 6
Explosive with or without contact with air.
R 7
May cause fire.
R 8
Contact with combustible material may cause fire.
R 9
Explosive when mixed with combustible material.
R 10 Flammable.
R 11 Highly flammable.
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R 12 Extremely flammable.
R 14 Reacts violently with water.
R 15 Contact with water liberates extremely flammable gases.
R 16 Explosive when mixed with oxidising substances.
R 17 Spontaneously flammable in air.
R 18 In use, may form flammable/explosive vapour-air mixture.
R 19 May form explosive peroxides.
R 20 Harmful by inhalation.
R 21 Harmful in contact with skin.
R 22 Harmful if swallowed.
R 23 Toxic by inhalation.
R 24 Toxic in contact with skin.
R 25 Toxic if swallowed.
R 26 Very toxic by inhalation.
R 27 Very toxic in contact with skin.
R 28 Very toxic if swallowed.
R 29 Contact with water liberates toxic gas.
R 30 Can become highly flammable in use.
R 31 Contact with acids liberates toxic gas.
R 32 Contact with acids liberates very toxic gas.
R 33 Danger of cumulative effects.
R 34 Causes burns.
R 35 Causes severe burns.
R 36 Irritating to eyes.
R 37 Irritating to respiratory system.
R 38 Irritating to skin.
R 39 Danger of very serious irreversible effects.
R 40 Limited evidence of a carcinogenic effect.
R 41 Risk of serious damage to eyes.
R 42 May cause sensitisation by inhalation.
R 43 May cause sensitisation by skin contact.
R 44 Risk of explosion if heated under confinement.
R 45 May cause cancer.
R 46 May cause heritable genetic damage.
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R 48 Danger of serious damage to health by prolonged exposure.
R 49 May cause cancer by inhalation.
R 50 Very toxic to aquatic organisms.
R 51 Toxic to aquatic organisms.
R 52 Harmful to aquatic organisms.
R 53 May cause long-term adverse effects in the aquatic environment.
R 54 Toxic to flora.
R 55 Toxic to fauna.
R 56 Toxic to soil organisms.
R 57 Toxic to bees.
R 58 May cause long-term adverse effects in the environment.
R 59 Dangerous for the ozone layer.
R 60 May impair fertility.
R 61 May cause harm to the unborn child.
R 62 Possible risk of impaired fertility.
R 63 Possible risk of harm to the unborn child.
R 64 May cause harm to breastfed babies.
R 65 Harmful: may cause lung damage if swallowed.
R 66 Repeated exposure may cause skin dryness or cracking.
R 67 Vapours may cause drowsiness and dizziness.
R 68 Possible risk of irreversible effects.
2.2 Combined R-phrases
R 14/15
Reacts violently with water, liberating extremely flammable gases.
R 15/29
Contact with water liberates toxic, extremely flammable gases.
R 20/21
Harmful by inhalation and in contact with skin.
R 20/22
Harmful by inhalation and if swallowed.
R 20/21/22
Harmful by inhalation, in contact with skin and if swallowed.
R 21/22
Harmful in contact with skin and if swallowed.
R 23/24
Toxic by inhalation and in contact with skin.
R 23/25
Toxic by inhalation and if swallowed.
R 23/24/25
Toxic by inhalation, in contact with skin and if swallowed.
R 24/25
Toxic in contact with skin and if swallowed.
R 26/27
Very toxic by inhalation and in contact with skin.
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R 26/28
Very toxic by inhalation and if swallowed.
R 26/27/28
Very toxic by inhalation, in contact with skin and if swallowed.
R 27/28
Very toxic in contact with skin and if swallowed.
R 36/37
Irritating to eyes and respiratory system.
R 36/38
Irritating to eyes and skin.
R 36/37/38
Irritating to eyes, respiratory system and skin.
R 37/38
Irritating to respiratory system and skin.
R 39/23
Toxic: danger of very serious irreversible effects through inhalation.
R 39/24
Toxic: danger of very serious irreversible effects in contact with skin.
R 39/25
Toxic: danger of very serious irreversible effects if swallowed.
R 39/23/24
Toxic: danger of very serious irreversible effects through inhalation and in contact with skin.
R 39/23/25
Toxic: danger of very serious irreversible effects through inhalation and if swallowed.
R 39/24/25
Toxic: danger of very serious irreversible effects in contact with skin and if swallowed.
R 39/23/24/25 Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.
R 39/26
Very toxic: danger of very serious irreversible effects through inhalation.
R 39/27
Very toxic: danger of very serious irreversible effects in contact with skin.
R 39/28
Very toxic: danger of very serious irreversible effects if swallowed.
R 39/26/27
Very toxic: danger of very serious irreversible effects through inhalation and in contact with skin.
R 39/26/28
Very toxic: danger of very serious irreversible effects through inhalation and if swallowed.
R 39/27/28
Very toxic: danger of very serious irreversible effects in contact with skin and if swallowed.
R 39/26/27/28 Very toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed.
R 42/43
May cause sensitisation by inhalation and skin contact.
R 48/20
Harmful: danger of serious damage to health by prolonged exposure through inhalation.
R 48/21
Harmful: danger of serious damage to health by prolonged exposure in contact with skin.
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R 48/22
Harmful: danger of serious damage to health by prolonged exposure if swallowed.
R 48/20/21
Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin.
R 48/20/22
Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed.
R 48/21/22
Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed.
R 48/20/21/22 Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed.
R 48/23
Toxic: danger of serious damage to health by prolonged exposure through inhalation.
R 48/24
Toxic: danger of serious damage to health by prolonged exposure in contact with skin.
R 48/25
Toxic: danger of serious damage to health by prolonged exposure if swallowed.
R 48/23/24
Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin.
R 48/23/25
Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed.
R 48/24/25
Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed.
R 48/23/24/25 Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed.
R 50/53
Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
R 51/53
Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
R 52/53
Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
R 68/20
Harmful: possible risk of irreversible effects through inhalation.
R 68/21
Harmful: possible risk of irreversible effects in contact with skin.
R 68/22
Harmful: possible risk of irreversible effects if swallowed.
R 68/20/21
Harmful: possible risk of irreversible effects through inhalation and in contact with skin.
R 68/20/22
Harmful: possible risk of irreversible effects through inhalation and if swallowed.
R 68/21/22
Harmful: possible risk of irreversible effects in contact with skin and if swallowed.
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R 68/20/21/22 Harmful: possible risk of irreversible effects through inhalation, in contact with skin and if swallowed.
2.3
Assignment of R-phrases 1 Dangerous preparations must be labelled with the appropriate R-phrases according to their classification.
2 As a general rule, no more than six R-phrases are to be used. However, each dangerous property of a classified preparation must be indicated by at least one R-phrase drawing attention to the principal hazard. Combined R-phrases are regarded as single R-phrases.
2.4
Choice of R-phrases 1 … 2 R-phrases must be assigned according to the following criteria and priorities: a. Dangers to health: 1. R-phrases corresponding to the category of danger illustrated by a symbol. In certain cases the R-phrases must be adopted according to the tables in Part B of Annex II to Directive 1999/45/EC. More specifically, the R-phrases of the constituents which are responsible for the assignment of the preparation to a danger category must appear on the label,
2. R-phrases corresponding to other categories of danger which have been attributed to the constituents but which are not illustrated by a symbol; b. Dangers arising from physicochemical properties: 1. R-phrases corresponding to the category of danger illustrated by a symbol. More specifically, the R-phrases of the constituents which are responsible for the assignment of the preparation to a danger category must appear on the label,
2. R-phrases corresponding to other categories of danger which have been attributed to the constituents but which are not illustrated by a symbol; 3. The R-phrases R 11 and R 12 need not be indicated where they repeat the wording of the indication of danger used with a symbol; c. Dangers for the environment: 1. R-phrases corresponding to the category "dangerous for the environment",
2. Where the R-phrase R 50 has been assigned in addition to a combined R-phrase R 51/53 or R 52/53 or to the R-phrase R 53 alone, the combined R-phrase R 50/53 must be used.
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2.5 Exemptions 1 …
2 It is not necessary to indicate the appropriate R-phrases for preparations that are placed on the market in packages containing not more than 125 ml and which: a. are classified as highly flammable, oxidising or irritant, without the R-phrase "Risk of serious damage to eyes" (R 41); or b. are classified as dangerous for the environment and assigned the N symbol.
3 When the labelling includes the symbols F or F+, the R-phrases R 11 or R 12 do not have to be indicated.
3 Safety
Advice
3.1 S-phrases S 1 Keep locked up.
S 2
Keep out of the reach of children.
S 3
Keep in a cool place.
S 4
Keep away from living quarters.
S 5
Keep contents under… (appropriate liquid to be specified by the manufacturer).
S 6
Keep contents under… (inert gas to be specified by the manufacturer).
S 7
Keep container tightly closed.
S 8
Keep container dry.
S 9
Keep container in a well-ventilated place.
S 12 Do not keep the container sealed.
S 13 Keep away from food, drink and animal feedingstuffs.
S 14 Keep away from… (incompatible materials to be indicated by the manufacturer).
S 15 Keep away from heat.
S 16 Keep away from sources of ignition - No smoking.
S 17 Keep away from combustible material.
S 18 Handle and open container with care.
S 20 When using do not eat or drink.
S 21 When using do not smoke.
S 22 Do not breathe dust. S 23 Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer).
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S 24 Avoid contact with skin.
S 25 Avoid contact with eyes.
S 26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S 27 Take off immediately all contaminated clothing.
S 28 After contact with skin, wash immediately with plenty of… (to be specified by the manufacturer).
S 29 Do not empty into drains.
S 30 Never add water to this product.
S 33 Take precautionary measures against static discharges.
S 35 This material and its container must be disposed of in a safe way.
S 36 Wear suitable protective clothing.
S 37 Wear suitable gloves.
S 38 In case of insufficient ventilation, wear suitable respiratory equipment.
S 39 Wear eye/face protection.
S 40 To clean the floor and all objects contaminated by this material, use… (to be specified by the manufacturer).
S 41 In case of fire and/or explosion do not breathe fumes.
S 42 During fumigation/spraying wear suitable respiratory equipment (appropriate wording to be specified by the manufacturer).
S 43 In case of fire, use… (type of fire-fighting equipment to be specified by the manufacturer. If water increases the risk, add: "Never use water").
S 45 In case of accident or if you feel unwell, seek medical advice immediately.
(Show the label where possible).
S 46 If swallowed, seek medical advice immediately and show this container or label.
S 47 Keep at temperature not exceeding… °C (to be specified by the manufacturer).
S 48 Keep wet with… (appropriate material to be specified by the manufacturer).
S 49 Keep only in the original container.
S 50 Do not mix with… (to be specified by the manufacturer).
S 51 Use only in well-ventilated areas.
S 52 Not recommended for interior use on large surface areas.
S 53 Avoid exposure - obtain special instructions before use.
S 56 Dispose of this material and its container at hazardous or special waste collection point.
S 57 Use appropriate containment to avoid environmental contamination.
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S 59 Refer to manufacturer/supplier for information on recovery/recycling.
S 60 This material and its container must be disposed of as hazardous waste.
S 61 Avoid release to the environment. Refer to special instructions/safety data sheet.
S 62 If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label.
S 63 In case of accident by inhalation: remove casualty to fresh air and keep at rest.
S 64 If swallowed, rinse mouth with water (only if the person is conscious).
3.2 Combined S-phrases
S 1/2
Keep locked up and out of the reach of children.
S 3/7
Keep container tightly closed in a cool place.
S 3/9/14
Keep in a cool, well-ventilated place away from… (incompatible materials to be indicated by the manufacturer).
S 3/9/14/49
Keep only in the original container in a cool, well-ventilated place away from… (incompatible materials to be indicated by the manufacturer).
S 3/9/49
Keep only in the original container in a cool, well-ventilated place.
S 3/14
Keep in a cool place away from… (incompatible materials to be indicated by the manufacturer).
S 7/8
Keep container tightly closed and dry.
S 7/9
Keep container tightly closed and in a well-ventilated place.
S 7/47
Keep container tightly closed and at temperature not exceeding… °C (to be specified by the manufacturer).
S 20/21
When using do not eat, drink or smoke.
S 24/25
Avoid contact with skin and eyes.
S 27/28
After contact with skin, take off immediately all contaminated clothing and wash immediately with plenty of… (to be specified by the manufacturer).
S 29/35
Do not empty into drains; waste and containers must be disposed of in a safe way.
S 29/56
Do not empty into drains; dispose of this material and its container at hazardous or special waste collection point.
S 36/37
Wear suitable protective clothing and gloves.
S 36/37/39
Wear suitable protective clothing, gloves and eye/face protection.
S 36/39
Wear suitable protective clothing and eye/face protection.
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S 37/39
Wear suitable protective clothing, gloves and eye/face protection.
S 47/49
Keep only in the original container at temperature not exceeding … °C (to be specified by the manufacturer).
3.3
Assignment of S-phrases 1 Dangerous preparations must be labelled with the appropriate S-phrases according to their classification. The choice of S-phrases is based on Section 6 of Annex VI to Directive 67/548/EEC233.
2 As a general rule, no more than six S-phrases are to be used. Combined S-phrases are regarded as single phrases.
3 An S-phrase concerning disposal of the preparation must be used, unless it is clear that disposal of the preparation or its container does not present a danger for human health or the environment.
4 With regard to dangerous preparations that are sold to the general public, the following applies: a. The S-phrases S 1, S 2 and S 45 are obligatory for all very toxic, toxic and corrosive preparations.
b. The S-phrase S 2 is obligatory for all dangerous preparations other than those referred to under letter a, except for those that are only classified as dangerous to the environment.
c. The S-phrase S 46 is obligatory for all preparations referred to under letter b unless there is no reason to fear any danger from swallowing, particularly by children.
5 The choice of S-phrases must take account of the intended use and the foreseeable conditions of use.
6 S-phrases must be chosen in such a way as to avoid any redundancy or ambiguity.
7 If, for technical reasons, the S-phrases cannot appear on the label or on the packaging, they may be supplied separately as written information.
3.4 Exemptions 1 …
2 It is not necessary to indicate the appropriate S-phrases for preparations that are placed on the market in packages containing not more than 125 ml and which: a. are classified as highly flammable, flammable, oxidising or irritant, without the R-phrase "Risk of serious damage to eyes" (R 41); or b. are classified as dangerous to the environment.
233 See footnote to Art. 3 let. b.
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4
Declaration of Dangerous Substances in Preparations 1 As a general rule, no more than four dangerous substances responsible for the main dangerous properties of a preparation need to be indicated.
2 In all cases, it is necessary to indicate dangerous substances that have led to the preparation being classified as follows: a. carcinogenic; b. mutagenic; c. toxic to reproduction; d. very toxic, toxic or harmful, when the effects of a single exposure are not lethal;
e. toxic or harmful, when the effects of repeated or prolonged exposure are severe;
f.
sensitising.
3 Without prejudice to paragraph 2, it is not necessary to indicate dangerous substances that have led to the preparation being classified as follows: a. explosive; b. oxidising; c. extremely flammable; d. highly flammable; e. flammable; f.
irritant;
g. dangerous to the environment.
4 As regards preparations assigned the danger symbol T+, T or Xn, only those substances with the symbol T+, T or Xn need to be taken into account, subject to paragraph 3, whose concentration is equal to or exceeds the following lowest limit (Xn limit): a. the Xn limit established during official classification; b. if no limit has been established as defined in paragraph a: the Xn limit according to Part B of Annex II to Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999234 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (Directive 1999/45/EC).
5 As regards preparations assigned the danger symbol C, only those substances with the symbol C need to be taken into account, subject to paragraph 3, whose concentration is equal to or exceeds the following lowest limit (Xi limit): 234 OJ L 200, 30.7.1999, p. 1, last amended by Directive 2006/8/EC (OJ L 19, 24.1.2006, p. 12).
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a. the limit established during official classification; b. the Xi limit according to Part B of Annex II to Directive 1999/45/EC.
5
Provisions relating to Preparations with Special Risks 5.1 Cyanoacrylate-based adhesives
1 Cyanoacrylate-based adhesives must be labelled as follows: "Cyanoacrylate.
Danger. Bonds skin and eyes in seconds. Keep out of the reach of children." 2 Appropriate advice on safety must accompany the package.
5.2 Preparations containing
isocyanates
Preparations containing isocyanates (as monomers, oligomers, prepolymers, etc. or as mixtures thereof) must be labelled as follows: "Contains isocyanates. See information supplied by the manufacturer." 5.3
Preparations containing epoxy constituents with an average molecular weight 700
Preparations containing epoxy constituents with an average molecular weight ≤ 700 must be labelled as follows: "Contains epoxy constituents. See information supplied by the manufacturer." 5.4 Preparations which
contain
active
chlorine
Preparations containing more than 1% of active chlorine which are sold to the general public must be labelled as follows: "Warning! Do not use together with other products. May release dangerous gases (chlorine)." 5.5
Preparations containing cadmium (alloys) and intended to be used for brazing or soldering Preparations containing cadmium (alloys) and intended to be used for brazing or soldering must be labelled as follows: "Warning! Contains cadmium. Dangerous fumes are formed during use. See information supplied by the manufacturer. Comply with the safety instructions." 5.6 Preparations available
as
aerosols
1
Aerosol dispensers not covered by the Foodstuffs Act of 9 October 1992235 are subject both to the provisions of this Ordinance and to Articles 1, 2, 8 paragraph 1a, 235 SR 817.0
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the introductory provision of point 2 and points 2.2 and 2.3 of the Annex to Directive 75/324/EEC236.
2
In the case of aerosol dispensers not deemed to be dangerous under Article 3 of this Ordinance, the manufacturer's name and address must be indicated. If the aerosol dispenser is imported from an EEA member state, the manufacturer's name may be replaced by the name of the person responsible for placing it on the market in the EEA, as specified in Article 10 point 2.2 of Directive 1999/45/EC237.
5.7
Preparations not classified as sensitising but containing at least one substance classified as sensitising Preparations not classified as sensitising but containing at least one substance classified as sensitising and being present in a concentration equal to or greater than 0.1% or in a concentration equal to or greater than that specified for the substance in the official classification (Art. 9) must be labelled as follows: "Contains (name of sensitising substance). May produce an allergic reaction." 5.8
Liquid preparations containing halogenated hydrocarbons Preparations which show no flashpoint or a flashpoint higher than 55°C and contain a halogenated hydrocarbon and more than 5% flammable or highly flammable substances must be labelled as follows, as appropriate: "Can become flammable in use" or "Can become highly flammable in use".
5.9
Preparations not classified as dangerous but containing at least one dangerous substance and not sold to the general public Preparations not classified as dangerous but containing at least one dangerous substance and which are not sold to the general public must be labelled as follows: "Safety data sheet available for professional users on request".
5.10 Preparations containing a substance assigned R-phrase R 67
1 Preparations containing a substance assigned R-phrase R 67 in a total concentration equal to or greater than 15% must be labelled with R-phrase R 67.
2 The labelling specified in paragraph 1 is not required if: a. R-phrase R 20, R 23, R 26, R 68/20, R 39/23 or R 39/26 is assigned to the preparation; or
b. the package does not contain more than 125 ml.
236 See footnote to Art. 37 para. 4.
237 See footnote to Art. 12 para. 1.
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5.11 Dangerous preparations available to the general public 1 Dangerous preparations sold to the general public must be labelled with S-phrases
in accordance with number 3.3.
2 Where it is physically impossible to give instructions on the package itself, preparations classified as toxic (T) or corrosive (C) must be accompanied by precise and easily understandable instructions for use including, if applicable, instructions for the destruction of the empty package. The instructions must be written in at least two official languages.
5.12 Dangerous preparations intended for use by spraying Dangerous preparations intended for use by spraying must be labelled with S-phrase
S 23, accompanied by S-phrases S 38 or S 51.
5.13 Preparations containing a substance assigned R-phrase R 33 When a preparation contains a substance assigned R-phrase R 33, it must be labelled
with R-phrase R 33 if this substance is present in a concentration equal to or higher than 1%, unless different concentration limits are set in the official classification (Art. 9).
5.14 Preparations containing a substance assigned R-phrase R 64 When a preparation contains a substance assigned R-phrase R 64, it must be labelled
with R-phrase R 64 if this substance is present in a concentration equal to or higher than 1%, unless different concentration limits are set in the official classification (Art. 9).
6 Label 1 The label must be affixed to the packaging in such a way that the information can
be read horizontally when the package is set down normally.
2 The dimensions of the label must be as follows: Capacity of the package Dimensions (in mm)
not exceeding 3 litres if possible at least 52 74
greater than 3 litres but not exceeding 50 litres at least 74
105
greater than 50 litres but not exceeding 500 litres at least 105
148
greater than 500 litres at least 148
210
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3 The label must contain only the information stipulated in this Ordinance for labelling, as well as any additional information regarding hygiene and safety which may be applicable.
4 Each symbol must cover at least one-tenth of the surface area of the label but must not be less than 1 cm2.
5 A label is not required if the information specified in Articles 39-46 is clearly shown on each package.
6 The colour and presentation of the label or, in the case of paragraph 5, of the package must be such that the danger symbol and its background stand out clearly from it.
7 In the case of mobile gas cylinders, the requirements relating to labelling are deemed to have been met if these cylinders comply with the relevant stipulations in Annex VI to Directive 67/548/EEC.
7 Optional
Labelling
7.1
Indications of dangers for the environment Number
Pictogram
Examples of wording 7.1.1
Toxic to bees
Do not spray before or during flowering.
Do not treat plants affected by greenfly.
Take care when plants nearby are in full bloom or are interspersed with flowering weeds.
Do not use in wind.
7.1.2
Dangerous for groundwater Use prohibited in groundwater protection zones S (S 1, S 2 and S 3) of drinking water wells.
Do not spread on fallow or temporarily fallow land.
Do not use in karstic regions, or on porous soils.
Do not use on railways.
Storage prohibited in groundwater protection zones S (S 1, S 2 and S 3) of drinking water wells.
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7.2
Information on protective measures Number
Pictogram
Examples of wording 7.2.1
Domestic waste
May be disposed of with domestic waste.
7.2.2
Hazardous waste
Hand in to …(company) as hazardous waste.
Return to point of sale as hazardous waste.
Return to toxic waste collection point as hazardous waste.
Hand in to used oil collection point as hazardous waste.
Note: the label must clearly indicate the recommended method of disposal. 7.2.3
Not to be disposed of via drains Do not empty into the sink or the toilet, but dispose of with domestic waste.
Do not empty into the sink or the toilet, but return to point of sale or waste collection point.
Note: the label must clearly indicate the recommended method of disposal.
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Annex 2238
(Art. 53)
238 Repealed by No. II para. 2 of the Ordinance of 7 Nov. 2012, with effect from 1 Dec. 2012 (AS 2012 6103).
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Annex 3239
(Art. 16a, Art. 17 para. 2, Art. 18 para. 2 let. b and Art. 60 para. 1) Technical Dossier General Provisions 1 The information in the technical dossier may be submitted in a form approved by the European Chemicals Agency. In this case, certain expressions may differ from those used in this Annex.
2
The information required under numbers 6-9 depends on the decisive substance quantity in accordance with Article 16a.
1 General
Notifier
Information
1
The notifier's identity must be provided, specifically: a. name, address, telephone number and e-mail address; b. a contact person; c. if applicable, the location of the notifier's production sites; 2
In addition, if the notifier is the sole representative, the following information is required:
a. foreign manufacturer's name and address; b. location of the production sites; c. authorisation from the foreign manufacturer stating that it appointed the notifier as its sole representative;
d. names and addresses of the importers represented; e. the quantities of a substance that each importer intends to import annually.
2
Identification of the Substance The following information on the substance must be provided: a. data specified in Section 2 of Annex VI to the REACH Regulation240; b. in the case of nanomaterials: data on the composition and, where available, the surface coating and surface functionalisation.
239 Inserted by No II para. 3 of the Ordinance of 14 Jan. 2009 (AS 2009 401 1135). Revised by No II para. 1 of the Ordinance of 10 Nov. 2010 (AS 2010 5223) and of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
240 See footnote to Art. 2 para. 4.
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3
Information on Manufacture and Use The following information must be provided: a. the estimated overall quantity to be placed on the market by the notifier in the calendar year of the notification; b. the quantities for the notifier's own use; c. the form or physical state in which the substance is made available; d. a brief description of the identified use(s).
e. information on waste quantities and composition of waste resulting from manufacture of the substance, the use in objects and identified uses; f.
uses advised against (Section 1.2 of the safety data sheet).
4
Classification and Labelling The following must be indicated: a. the classification of the substance according to Article 8 paragraph 1 of this Ordinance for all hazard classes and categories of the CLP Regulation241; if no classification has been given for a hazard class or differentiation of a hazard class, the reasons are to be provided; b. the labelling of the substance in accordance with Article 34b; c. any specific concentration limits resulting from the application of Article 10 of the CLP Regulation.
5 Guidance
on
Safe
Use
The following information, which must be consistent with that in the safety data sheet, where such a safety data sheet is required in accordance with Article 52, must be stated: a. first-aid measures (safety data sheet, No. 4); b. fire-fighting measures (safety data sheet, No. 5); c. accidental release measures (safety data sheet, No. 6); d. handling and storage (safety data sheet, No. 7); e. transport information (safety data sheet, No. 14); f.
exposure controls/personal protection (safety data sheet, No. 8); g. stability and reactivity (safety data sheet, No. 10); h. disposal considerations. Information on recycling and methods of disposal for industry and for the public (safety data sheet, No. 13).
241 See footnote to Art. 2 para. 4.
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6
Information on Exposure (1-10 tonnes per year) For substances with a decisive quantity according to Article 16a of between 1 and 10 tonnes per year, the following information on exposure must be provided: a. main use categories: 1. industrial
use,
2. professional
use,
3. consumer
use;
b. specification for industrial and professional use: 1. use in a closed system, 2. use resulting in inclusion into or onto matrix, 3. non-dispersive use,
4 dispersive
use;
c. significant routes of exposure: 1. human exposure: oral, dermal and inhalatory, 2. environmental exposure: water, air, solid waste and soil, 3. pattern of exposure: accidental/infrequent, occasional or continuous/ frequent.
7
Information on Physicochemical Properties The following information must be provided: a. for decisive quantities according to Article 16a of 1 tonne per year or more: 1. robust study summaries with regard to the information specified in Section 7 of Annex VII to the REACH Regulation242,
2. in the case of nanomaterials: the particle form and mean particle size and, where available, the number size distribution, specific surface area by volume and aggregation status; b. for decisive quantities according to Article 16a of 100 tonnes per year or more: in addition to the information required by letter a, robust study summaries with regard to the information specified in Section 7 of Annex IX to the REACH Regulation.
8 Toxicological Information
Robust study summaries must be provided with regard to the following information: a. for quantities of 1 tonne per year or more: the information specified in Section 8 of Annex VII to the REACH Regulation243;
242 See footnote to Art. 2 para. 4.
243 See footnote to Art. 2 para. 4.
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b. for quantities of 10 tonnes per year or more: in addition to the information required by letter a, the information specified in Section 8 of Annex VIII to the REACH Regulation; c. for quantities of 100 tonnes per year or more: in addition to the information required by letters a and b, the information specified in Section 8 of Annex IX to the REACH Regulation; d for quantities of 1,000 tonnes per year or more: in addition to the information required by letters a-c, the information specified in Section 8 of Annex X to the REACH Regulation.
9 Exotoxicological Information
Robust study summaries must be provided with regard to the following information: a. for quantities of 1 tonne per year or more: the information specified in Section 9 of Annex VII to the REACH Regulation244;
b. for quantities of 10 tonnes per year or more: in addition to the information required by letter a, the information specified in Section 9 of Annex VIII to the REACH Regulation; c. for quantities of 100 tonnes per year or more: in addition to the information required by letters a and b, the information specified in Section 9 of Annex IX to the REACH Regulation; d for quantities of 1,000 tonnes per year or more: in addition to the information required by letters a-c, the information specified in Section 9 of Annex X to the REACH Regulation.
10
Omission of certain Tests Certain tests specified in numbers 7-9 may be omitted if, according to the criteria specified in Annex XI to the REACH Regulation245: a. testing does not appear scientifically necessary; b. testing is technically not possible; c. the exposure assessment makes it possible for certain tests to be omitted.
244 See footnote to Art. 2 para. 4.
245 See footnote to Art. 2 para. 4.
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Annex 4246
246 Inserted by No II para. 3 of the Ordinance of 14 Jan. 2009 (AS 2009 401). Repealed by No. II para. 2 of the Ordinance of 7 Nov. 2012, with effect from 1 Dec. 2012 (AS 2012 6103).
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Annex 5247
(Art. 2 para. 4)
Correspondences between expressions, legislation and individual provisions For the correct interpretation of the REACH Regulation248 and the CLP Regulation249, to which reference is made in this Ordinance, the following correspondences between expressions, legislation and individual provisions apply: 1 Equivalent
expressions
Terms used in the EU Terms used in Switzerland Manufacturer, supplier, importer, downstream user Manufacturer as defined by Article 2 paragraph 1 letter c Placing on the market Placing on the market as defined by Article 4 paragraph 1 letter i ChemA Mixture Preparation Article Object Intermediate Intermediate as defined by Article 2 paragraph 2 letter d Where a chemical safety report is required If exposure scenarios must be attached to the safety data sheet Official advisory body Swiss Toxicological Information Centre (Art. 91) 2
Swiss provisions corresponding to EU legislation cited in the REACH Regulation and in the CLP Regulation and to individual EU provisions
EU legislation and individual provisions Swiss legislation and individual provisions Directive 86/609/EEC
Animal Protection Act of 16 December 2005250 Directive 98/8/EC
Biocidal Products Ordinance of 18 May 2005251 247 Inserted by No. II para. 3 of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103).
248 See footnote to Art. 2 para. 4.
249 See footnote to Art. 2 para. 4.
250 SR
455
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EU legislation and individual provisions Swiss legislation and individual provisions Directive 91/414/EEC
Plant Protection Products Ordinance of 12 May 2010252 Rules on the transport of dangerous goods Regulations concerning transport by post, rail, road, air, water and pipelines Decision 95/320/EC
Art. 50 para. 3 of the Ordinance of 19 December 1983253 on Accident Prevention Directive 98/24/EC
Legislation on the protection of workers Directive 2004/37/EC
Legislation on the protection of workers National occupational exposure limit values List of occupational exposure limit values published by SUVA254 Directive 89/686/EEC
Ordinance of 19 May 2010255 on Product Safety Directive 2008/98/EC
Technical Ordinance of 10 December 1990256 on Wastes and Ordinance of 22 June 2005257 on the Movement of Wastes Regulation (EC) No 2037/2000 Annex 1.4 ORRChem258
Regulation (EC) No 850/2004 Annexes 1.1, 1.9 and 1.16 ORRChem Regulation (EC) No 689/2008 PIC Ordinance of 10 November 2004259 Directive 96/82/EC
Major Accidents Ordinance of 27 February 1991260 Art. 13 of the REACH Regulation261 Art. 34 para. 2
Art. 31 of the REACH Regulation Art. 53
Art. 59 of the REACH Regulation Annex 7
Art. 24 of the CLP Regulation262 Art.
43
251 SR
813.12
252 SR
916.161
253 SR
832.30
254 The list of Swiss occupational exposure limit values is available online at www.suva.ch/waswo/1903.d (German) and www.suva.ch/waswo/1903.f (French) 255 SR
930.111
256 SR
814.600
257 SR
814.610
258 SR
814.81
259 SR
814.82
260 SR
814.012
261 See footnote to Art. 2 para. 4.
262 See footnote to Art. 2 para. 4.
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Annex 6263
(Art. 76)
Substances and preparations in Groups 1 and 2 1
Substances and preparations labelled in accordance with the CLP Regulation264 1.1 Group
1
a.
in conjunction with (H300)265: Fatal if swallowed, or H310: Fatal in contact with skin, or H330: Fatal if inhaled, or combinations of the above hazard statements b.
c. Substances and preparations labelled as follows in accordance with Annex 1.10 ORRChem:
in conjunction with H340: May cause genetic defects, or H350: May (if inhaled) cause cancer, or H360: May damage fertility or the unborn child 263 Inserted by No. II para. 3 of the Ordinance of 7 Nov. 2012, in force since 1 Dec. 2012 (AS 2012 6103). Revised by Annex 11 No 1 of the Ordinance of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
264 See footnote to Art. 2 para. 4.
265 Need not appear in the labelling (used for codification of hazard statements).
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1.2 Group
2
a.
in conjunction with H301: Toxic if swallowed, or H311: Toxic in contact with skin, or H331: Toxic if inhaled, or combinations of the above hazard statements b.
in conjunction with H370: Causes damage to organs, or H372: Causes damage to organs through prolonged or repeated exposure c.
in conjunction with H314: Causes severe skin burns and eye damage d. Containers with a content of more than 1 kg labelled as follows: in conjunction with
H410: Very toxic to aquatic life with long lasting effects e.
in conjunction with H250: Catches fire spontaneously if exposed to air, or H260: In contact with water releases flammable gases which may ignite spontaneously, or H261: In contact with water releases flammable gases f.
EUH006: Explosive with or without contact with air, or EUH019: May form explosive peroxides, or EUH029: Contact with water liberates toxic gas, or EUH032: Contact with acids liberates very toxic gas g. Substances and preparations that can release chlorine gas, labelled as follows: EUH031: Contact with acids liberates toxic gas
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2
Substances and preparations not yet labelled in accordance with the CLP Regulation266 2.1 Group
1
a.
in conjunction with R28: Very toxic if swallowed, or R27: Very toxic in contact with skin, or R26: Very toxic by inhalation, or combinations of the above R phrases b.
c. Substances and preparations labelled as follows in accordance with Annex 1.10 ORRChem:
in conjunction with R46: May cause heritable genetic damage, or R45: May cause cancer, or R49: May cause cancer by inhalation, or R60: May impair fertility, or R61: May cause harm to the unborn child 2.2 Group
2
a.
in conjunction with R25: Toxic if swallowed, or R24: Toxic in contact with skin, or R23: Toxic by inhalation, or combinations of the above R phrases b.
in conjunction with R39: Danger of very serious irreversible effects, or R48: Danger of serious damage to health by prolonged exposure c.
in conjunction with R35: Causes severe burns, or R34: Causes burns 266 See footnote to Art. 2 para. 4.
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d. Containers with a content of more than 1 kg labelled as follows: in conjunction with
R50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment e.
in conjunction with R17: Spontaneously flammable in air, or R15: Contact with water liberates extremely flammable gases f.
R6: Explosive with or without contact with air, or R19: May form explosive peroxides, or R29: Contact with water liberates toxic gas, or R32: Contact with acids liberates very toxic gas g. Substances and preparations that can release chlorine gas, labelled as follows: EUH031: Contact with acids liberates toxic gas
87
Annex 7267
(Art. 7 para. 2 and 2bis, 52 let. c and f, 83b para. 1 and 97a) List of substances of very high concern (candidate list) This list was last revised on 1 September 2014 and contains 154 substances.
Name of substance
Additional information on the substance EC No
CAS No
Reason for inclusion on list 1,2,3-Trichloropropane 202-486-1
96-18-4
Carcinogenic and toxic for reproduction 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich 276-158-1
71888-89-6
Toxic
for
reproduction
1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters 271-084-6
68515-42-4
Toxic
for
reproduction
1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear
271-093-5
68515-50-4
Toxic
for
reproduction
1,2-Benzenedicarboxylic acid, dipentylester, branched and linear
284-032-2
84777-06-0
Toxic
for
reproduction
1,2-bis(2-methoxyethoxy)ethane (TEGDME; triglyme)
203-977-3
112-49-2
Toxic
for
reproduction
1,2-dichloroethane 203-458-1 107-06-2
Carcinogenic
1,2-Diethoxyethane
211-076-1
629-14-1
Toxic
for
reproduction
1,2-dimethoxyethane; ethylene glycol dimethyl ether (EGDME)
203-794-9
110-71-4
Toxic
for
reproduction
1,3,5-Tris(oxiran-2-ylmethyl)-1,3,5-triazinane2,4,6-trione (TGIC)
219-514-3 2451-62-9 Mutagenic 1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]-1,3,5triazine-2,4,6-(1H,3H,5H)-trione (β-TGIC)
423-400-0
59653-74-6
Mutagenic
1-bromopropane (n-propyl bromide) 203-445-0
106-94-5
Toxic
for
reproduction
1-Methyl-2-pyrrolidone 212-828-1
872-50-4
Toxic
for
reproduction
267 Inserted by No. II para. 3 of the Ordinance of 7 Nov. 2012 (AS 2012 6103). Amended by No I of the FOPH Ordinance of 17 Nov. 2014, in force since 1 Dec.
2014 (AS 2014 3857)
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Name of substance
Additional information on the substance EC No
CAS No
Reason for inclusion on list 2,2'-dichloro-4,4'-methylenedianiline 202-918-9
101-14-4
Carcinogenic
2,4-Dinitrotoluene 204-450-0 121-14-2
Carcinogenic
2-Ethoxyethanol 203-804-1 110-80-5
Toxic
for
reproduction
2-Ethoxyethyl acetate 203-839-2
111-15-9
Toxic for reproduction 2-Methoxyaniline; o-Anisidine 201-963-1
90-04-0
Carcinogenic
2-Methoxyethanol 203-713-7 109-86-4
Toxic
for
reproduction
3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine 421-150-7
143860-04-2
Toxic for reproduction 4-(1,1,3,3-tetramethylbutyl)phenol 205-426-2
140-66-9
Equivalent level of concern having probable serious effects to the environment
4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated covering well-defined substances and UVCB substances, polymers and homologues
Equivalent level of concern having probable serious effects to the environment
4,4'-Diaminodiphenylmethane (MDA) 202-974-4
101-77-9
Carcinogenic
4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol
with ≥ 0.1 % of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2) 209-218-2 561-41-1 Carcinogenic 4,4'-bis(dimethylamino)benzophenone (Michler's ketone)
202-027-5
90-94-8
Carcinogenic
[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylam-
monium chloride (C.I. Basic Violet 3) with ≥ 0.1 % of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2) 208-953-6 548-62-9 Carcinogenic [4-[[4-anilino-1-naphthyl][4-(dimethylamino) phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride (C.I. Basic Blue 26) with ≥ 0.1 % of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2) 19-943-6 2580-56-5 Carcinogenic 4,4'-methylenedi-o-toluidine 212-658-8
838-88-0
Carcinogenic
4,4'-oxydianiline and its salts 202-977-0
101-80-4
Carcinogenic
4-Aminoazobenzene
200-453-6
60-09-3
Carcinogenic
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Name of substance
Additional information on the substance EC No
CAS No
Reason for inclusion on list 4-methyl-m-phenylenediamine (toluene-2,4diamine)
202-453-1
95-80-7
Carcinogenic
4-Nonylphenol, branched and linear substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the indi-
vidual isomers or a combination thereof
Equivalent level of concern having probable serious effects to the environment
4-Nonylphenol, branched and linear, ethoxylated substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the
individual isomers and/or combinations thereof]
Equivalent level of concern having probable serious effects to the environment
5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 201-329-4
81-15-2
vPvB
6-methoxy-m-toluidine (p-cresidine) 204-419-1
120-71-8
Carcinogenic
Acetic acid, lead salt, basic 257-175-3
51404-69-4
Toxic
for
reproduction
Acids generated from chromium trioxide and their oligomers. Names of the acids and their oligomers: Chromic acid, Dichromic acid, Oligomers of chromic acid and dichromic acid.
231-801-5,
236-881-5
7738-94-5,
13530-68-2
Carcinogenic
Acrylamide
201-173-7
79-06-1
Carcinogenic and mutagenic Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) 287-476-5
85535-84-8
PBT
and
vPvB
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Name of substance
Additional information on the substance EC No
CAS No
Reason for inclusion on list Aluminosilicate Refractory Ceramic Fibres are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.2 of 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, and fulfil the two following conditions: a) Al2O3 and SiO2
are present within the following concentration ranges:Al2O3: 43.5-47 % w/w, and SiO2: 49.5-53.5 % w/w, or Al2O3: 45.5-50.5 % w/w, and SiO2: 48.5-54 % w/w,b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres
(µm).
- Extracted
from
Index no.:
650-017-00-8
Carcinogenic
Ammonium dichromate 232-143-1 7789-09-5 Carcinogenic, mutagenic and toxic for reproduction
Ammonium pentadecafluorooctanoate (APFO) 223-320-4
3825-26-1
Toxic
for
reproduction
Anthracene
204-371-1
120-12-7
PBT
Anthracene oil
292-602-7
90640-80-5
Carcinogenic[1], PBT and vPvB Anthracene oil, anthracene paste 292-603-2
90640-81-6 Carcinogenic[2], mutagenic[3], PBT and vPvB
Anthracene oil, anthracene paste, anthracene fraction
295-275-9
91995-15-2
Carcinogenic[2], mutagenic[3], PBT and vPvB
Anthracene oil, anthracene paste,distn. lights 295-278-5
91995-17-4
Carcinogenic[2], mutagenic[3], PBT and vPvB
Chemicals Ordinance 91
813.11
Name of substance
Additional information on the substance EC No
CAS No
Reason for inclusion on list Anthracene oil, anthracene-low 292-604-8
90640-82-7 Carcinogenic[2], mutagenic[3], PBT and vPvB
Arsenic acid
231-901-9
7778-39-4
Carcinogenic
Benzyl butyl phthalate (BBP) 201-622-7
85-68-7
Toxic
for
reproduction
Biphenyl-4-ylamine
202-177-1
92-67-1
Carcinogenic
Bis (2-ethylhexyl)phthalate (DEHP) 204-211-0
117-81-7
Toxic
for
reproduction
Bis (2-methoxyethyl) ether 03-924-4
111-96-6
Toxic
for
reproduction
Bis (2-methoxyethyl) phthalate 204-212-6
117-82-8
Toxic
for
reproduction
Bis (pentabromophenyl) ether (decabromodiphenyl ether; DecaBDE)
214-604-9 1163-19-5 PBT Bis(tributyltin)oxide (TBTO) 200-268-0
56-35-9
PBT
Boric acid
233-139-2/
234-343-4
10043-35-3/
11113-50-1
Toxic for reproduction Cadmium
231-152-8
7440-43-9
Carcinogenic
Cadmium chloride
233-296-7 10108-64-2 Carcinogenic, Mutagenic, Toxic for reproduction and Equivalent level of concern having probable serious effects to human health Cadmium oxide
215-146-2
1306-19-0
Carcinogenic
Cadmium sulphide 215-147-8 1306-23-6
Carcinogenic
Calcium arsenate
231-904-5
7778-44-1
Carcinogenic
Chromium trioxide
215-607-8
1333-82-0
Carcinogenic and mutagenic Cobalt dichloride
231-589-4
7646-79-9
Carcinogenic and toxic for reproduction Cobalt(II) carbonate
208-169-4
513-79-1
Carcinogenic and toxic for reproduction
Chemicals
92
813.11
Name of substance
Additional information on the substance EC No
CAS No
Reason for inclusion on list Cobalt(II) diacetate
200-755-8
71-48-7
Carcinogenic and toxic for reproduction Cobalt(II) dinitrate
233-402-1
10141-05-6
Carcinogenic and toxic for reproduction Cobalt(II) sulphate 233-334-2 10124-43-3
Carcinogenic and toxic for reproduction Diarsenic pentaoxide
215-116-9
1303-28-2
Carcinogenic
Diarsenic trioxide
215-481-4
1327-53-3
Carcinogenic
Diazene-1,2-dicarboxamide (C,C'azodi(formamide))
204-650-8
123-77-3
Equivalent level of concern having probable serious effects to human health Diboron trioxide
215-125-8
1303-86-2
Toxic for reproduction Dibutyl phthalate (DBP) 201-557-4
84-74-2
Toxic
for
reproduction
Dibutyltin dichloride (DBTC) 211-670-0
683-18-1
Toxic
for
reproduction
Dichromium tris(chromate) 246-356-2
24613-89-6
Carcinogenic
Diethyl sulphate 200-589-6 64-67-5
Carcinogenic; Mutagenic Dihexyl phthalate
201-559-5
84-75-3
Toxic for reproduction Diisobutyl phthalate
201-553-2
84-69-5
Toxic
for
reproduction
Diisopentylphthalate 210-088-4
605-50-5
Toxic
for
reproduction
Dimethyl sulphate 201-058-1 77-78-1
Carcinogenic
Dinoseb (6-sec-butyl-2,4-dinitrophenol) 201-861-7
88-85-7
Toxic
for
reproduction
Dioxobis(stearato)trilead 235-702-8
12578-12-0
Toxic
for
reproduction
Disodium 3,3'-[[1,1'-biphenyl]-4,4'diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate)
(C.I. Direct Red 28) 209-358-4
573-58-0
Carcinogenic
Disodium 4-amino-3-[[4'-[(2,4diaminophenyl)azo][1,1'-biphenyl]-4-yl]azo] -5-
hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate (C.I. Direct Black 38) 217-710-3 1937-37-7 Carcinogenic Disodium tetraborate, anhydrous 215-540-4
1303-96-4/
1330-43-4/
12179-04-3
Toxic for reproduction
Chemicals Ordinance 93
813.11
Name of substance
Additional information on the substance EC No
CAS No
Reason for inclusion on list Dipentyl phthalate (DPP) 205-017-9
131-18-0
Toxic
for
reproduction
Fatty acids, C16-18, lead salts 292-966-7
91031-62-8
Toxic for reproduction Formaldehyde, oligomeric reaction products with aniline
500-036-1
25214-70-4
Carcinogenic
Formamide
200-842-0
75-12-7
Toxic
for
reproduction
Furan
203-727-3
110-00-9
Carcinogenic
Henicosafluoroundecanoic acid 218-165-4
2058-94-8
vPvB
Heptacosafluorotetradecanoic acid 206-803-4
376-06-7
vPvB
Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified: Alpha-hexabromocyclododecane Beta-hexabromocyclododecane Gamma-hexabromocyclododecane 247-148-4 and
221-695-9
25637-99-4
3194-55-6
(134237-50-6)
(134237-51-7)
(134237-52-8)
PBT
Hexahydromethylphthalic anhydride [1], Hexahydro-4-methylphthalic anhydride [2], Hexahydro-1-methylphthalic anhydride [3], Hexahydro-3-methylphthalic anhydride [4] The individual isomers [2], [3] and [4] (including their cis- and transstereo isomeric forms) and all
possible combinations of the isomers [1] are covered by this entry
247-094-1, 243-072-0, 256-356-4, 260-566-1 25550-51-0, 9438-60-9, 48122-14-1, 7110-29-9 Equivalent level of concern having probable serious effects to human health Hydrazine
206-114-9
302-01-2/
7803-57-8
Carcinogenic
Imidazolidine-2-thione (2-imidazoline-2-thiol) 202-506-9
96-45-7
Toxic
for
reproduction
Lead bis(tetrafluoroborate) 237-486-0
13814-96-5
Toxic
for
reproduction
Lead chromate
231-846-0
7758-97-6
Carcinogenic and toxic for reproduction Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 235-759-9
12656-85-8
Carcinogenic and toxic for reproduction Lead cyanamidate 244-073-9 20837-86-9
Toxic
for
reproduction
Lead di(acetate)
206-104-4
301-04-2
Toxic for reproduction Lead diazide, Lead azide 236-542-1
13424-46-9
Toxic for reproduction
Chemicals
94
813.11
Name of substance
Additional information on the substance EC No
CAS No
Reason for inclusion on list Lead dinitrate
233-245-9
10099-74-8
Toxic for reproduction Lead dipicrate
229-335-2
6477-64-1
Toxic
for
reproduction
Lead hydrogen arsenate 232-064-2
7784-40-9
Carcinogenic and toxic for reproduction Lead monoxide (lead oxide) 215-267-0
1317-36-8
Toxic
for
reproduction
Lead oxide sulfate
234-853-7
12036-76-9
Toxic for reproduction Lead styphnate
239-290-0
15245-44-0
Toxic
for
reproduction
Lead sulfochromate yellow (C.I. Pigment Yellow 34)
215-693-7 1344-37-2 Carcinogenic and toxic for reproduction Lead titanium trioxide 235-038-9
12060-00-3
Toxic for reproduction Lead titanium zirconium oxide 235-727-4
12626-81-2
Toxic for reproduction Lead(II) bis(methanesulfonate) 401-750-5
17570-76-2
Toxic
for
reproduction
Methoxyacetic acid
210-894-6
625-45-6
Toxic
for
reproduction
Methyloxirane (Propylene oxide) 200-879-2
75-56-9
Carcinogenic; Mutagenic N,N,N',N'-tetramethyl-4,4'-methylenedianiline (Michler's base)
202-959-2
101-61-1
Carcinogenic
N,N-dimethylacetamide 204-826-4
127-19-5
Toxic
for
reproduction
N,N-dimethylformamide 200-679-5
68-12-2
Toxic
for
reproduction
N-methylacetamide
201-182-6
79-16-3
Toxic
for
reproduction
N-pentyl-isopentylphthalate 776297-69-9
Toxic for reproduction o-aminoazotoluene 202-591-2 97-56-3
Carcinogenic
Orange lead (lead tetroxide) 215-235-6
1314-41-6
Toxic
for
reproduction
o-Toluidine
202-429-0
95-53-4
Carcinogenic
Pentacosafluorotridecanoic acid 276-745-2
72629-94-8
vPvB
Pentadecafluorooctanoic acid (PFOA) 206-397-9
335-67-1
Toxic
for
reproduction
Pentalead tetraoxide sulphate 235-067-7
12065-90-6
Toxic
for
reproduction
Pentazinc chromate octahydroxide 256-418-0
49663-84-5
Carcinogenic
Chemicals Ordinance 95
813.11
Name of substance
Additional information on the substance EC No
CAS No
Reason for inclusion on list Phenolphthalein 201-004-7 77-09-8
Carcinogenic
[Phthalato(2-)]dioxotrilead 273-688-5
69011-06-9
Toxic
for
reproduction
Pitch, coal tar, high temp.
266-028-2
65996-93-2
Carcinogenic, PBT and vPvB Potassium chromate
232-140-5
7789-00-6
Carcinogenic and mutagenic Potassium dichromate
231-906-6
7778-50-9 Carcinogenic, mutagenic and toxic for reproduction
Potassium hydroxyoctaoxodizincatedichromate 234-329-8
11103-86-9
Carcinogenic
Pyrochlore, antimony lead yellow 232-382-1
8012-00-8
Toxic
for
reproduction
Silicic acid (H2Si2O5), barium salt (1:1), lead-doped with lead (Pb) content above the applicable generic concentration limit for 'toxicity for reproduction' Repr. 1A (CLP) or category 1 (DSD); the substance is a member of the group entry of lead compounds, with index number 082-
001-00-6 in Regulation (EC) No 1272/2008
272-271-5 68784-75-8 Toxic for
reproduction
Silicic acid, lead salt 234-363-3
11120-22-2
Toxic for reproduction Sodium chromate
231-889-5 7775-11-3 Carcinogenic, mutagenic and toxic for reproduction
Sodium dichromate
234-190-3
7789-12-0/
10588-01-9
Carcinogenic, mutagenic and toxic for reproduction
Sodium perborate; perboric acid, sodium; salt 239-172-9;
234-390-0
- Toxic
for
reproduction
Sodium peroxometaborate 231-556-4
7632-04-4
Toxic
for
reproduction
Strontium chromate
232-142-6
7789-06-2
Carcinogenic
Sulfurous acid, lead salt, dibasic 263-467-1
62229-08-7
Toxic
for
reproduction
Tetraboron disodium heptaoxide, hydrate 235-541-3
12267-73-1
Toxic
for
reproduction
Tetraethyllead
201-075-4
78-00-2
Toxic
for
reproduction
Chemicals
96
813.11
Name of substance
Additional information on the substance EC No
CAS No
Reason for inclusion on list Tetralead trioxide sulphate 235-380-9
12202-17-4
Toxic
for
reproduction
Trichloroethylene 201-167-4 79-01-6
Carcinogenic
Tricosafluorododecanoic acid 206-203-2
307-55-1
vPvB
Triethyl arsenate
427-700-2
15606-95-8
Carcinogenic
Trilead bis(carbonate)dihydroxide 215-290-6
1319-46-6
Toxic
for
reproduction
Trilead diarsenate
222-979-5
3687-31-8
Carcinogenic and toxic for reproduction Trilead dioxide phosphonate 235-252-2
12141-20-7
Toxic
for
reproduction
Tris(2-chloroethyl)phosphate 204-118-5
115-96-8
Toxic
for
reproduction
Trixylyl phosphate
246-677-8
25155-23-1
Toxic for reproduction Zirconia Aluminosilicate Refractory Ceramic Fibres
are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.2 of 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, and fulfil the two following conditions: a) Al2O3, SiO2 and
ZrO2 are present within the following concentration ranges: Al2O3:
35-36 % w/w, and SiO2: 47.5-50 % w/w, and ZrO2: 15-17 % w/w, b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres
(µm).
- Extracted
from
Index no.
650-017-00-8
Carcinogenic
α,α-Bis[4-(dimethylamino)phenyl]-4(phenylamino)naphthalene-1-methanol
(C.I. Solvent Blue 4) with ≥ 0.1 % of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2) 229-851-8 6786-83-0 Carcinogenic
Chemicals Ordinance 97
813.11
Name of substance
Additional information on the substance EC No
CAS No
Reason for inclusion on list [*]
The EC number includes both anhydrous and hydrated forms of a substance and consequently the entries cover both these forms. The CAS number included may be for the anhydrous form only, and therefore the CAS number shown does not always describe the entry accurately.
[1]
The substance does not meet the criteria for identification as a carcinogen in situations where it contains less than 0.005 % (w/w) benzo[a]pyrene (EINECS No 200-028-5) [2]
The substance does not meet the criteria for identification as a carcinogen in situations where it contains less than 0.005 % (w/w) benzo[a]pyrene (EINECS No 200-028-5) and less than 0.1 % w/w benzene (EINECS No 200-753-7).]
Chemicals
98
813.11