Sr 813.11 Order Of June 5, 2015 On Protection Against Substances And Dangerous Preparations (Chemicals, Chemo Ordinance)

Original Language Title: RS 813.11 Ordonnance du 5 juin 2015 sur la protection contre les substances et les préparations dangereuses (Ordonnance sur les produits chimiques, OChim)

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813.11 order on protection against substances and dangerous preparations (chemicals, chemo Ordinance) of June 5, 2015 (status February 1, 2016) the Swiss federal Council, saw the Act of 15 December 2000 on chemicals (chema), view the art. 26, al. 3, 29, 30 a to 30 d, 38, al. 3, 39, al. 1, 41, al. 3, 44, al. 2 and 3, 46, al. 2 and 3, and 48, al. 2, of the law of 7 October 1983 on the protection of the environment (LPE), view the art. 9, al. 2, let. c, 27, al. 2, and 48, al. 2, of the Federal law of 24 January 1991 on the protection of waters, in pursuance of the Federal law of 6 October 1995 on technical barriers to trade, stop: title 1 provisions general art. 1 scope and field of application this rule order: a. the analysis and assessment of the dangers and risks that substances and preparations can cause for life and human health and the environment; (b) the conditions for the placing on the market of substances and preparations likely to endanger humans or the environment; (c) the use of substances and preparations likely to endanger humans or the environment; d. the treatment by the authorities enforcement data for substances and preparations.

This order applies to biocidal products and their active ingredients as well as plant protection products, to their active substances and their formulants, where refers to the order of 18 May 2005 on biocidal products or order of 12 May 2010 on plant protection products.
This order applies to the substances and radioactive preparations for it no effect due to the radioactivity of these substances and preparations.
Only art. 5 to 7 and 81 of this order apply to cosmetics and as long as it is in the interests of the protection of the environment and the classification or assessment of substances and preparations.
This order does not apply: a. the transport of substances and preparations by road, rail, water, air, road or by conduct. art. 10, al. 1, let. b, is reserved; b. transit under supervision of customs of substances and preparations, provided that these are no treatment or processing; c. to substances and preparations presenting themselves in the form of finished products intended for professional or private users and belonging to the following categories: 1. the foodstuffs within the meaning of art. 3 of the Act of 9 October 1992 on foodstuffs (Ipegs), 2. the drug within the meaning of art. 4, al. 1, let. a, and medical devices within the meaning of art. 4, al. 1, let. b, of the Act of 15 December 2000 on therapeutic products, 3. the feed within the meaning of art. 3, al. 1, of the order of October 26, 2011 pet food;

(d) firearms and ammunition within the meaning of art. 4, al. 1 and 5, of the Act of 20 June 1997 on weapons; e. to substances, preparations and objects considered to be waste within the meaning of art. 7, al. 6, EPA.

Only art. 13 applies to substances and dangerous preparations imported and exported after their labelling change.

SR 813.12 RS 916.161 Erratum on Sept. 8. 2015 (2015 3017 RO).
RS 817.0 SR 812.21 RS 916.307 RS 514.54 art. 2 definitions and law applicable as A precision compared to the chema, means: a. substance: any chemical element and its compounds in the natural state or obtained by a manufacturing process, including any additive necessary to preserve the stability and any impurity as a result of the process being implemented, with the exception of any solvent which may be separated without affecting the stability of the substance or changing its composition; b. manufacturer : 1. any natural or legal person having his domicile, headquarters or a branch in Switzerland and who, as professional or commercial, manufactured, produced or matter substances, preparations or objects, 2 is also deemed manufacturer anyone who procures in Switzerland of substances, preparations or objects and bringing them on a commercial basis, without changing the composition : - under his own name without indication of the name of the OEM - under his own trade name - in a different package from that provided by the original manufacturer, or - for a different use.

3. If a person made in Switzerland a substance, a preparation or an object by a third party, it is deemed manufacturer full if she has his domicile, headquarters or a branch in Switzerland.

In addition, means: a. professional user: 1. any natural or legal person who purchases in Switzerland of substances, preparations or objects to use them for profit, 2 is also renowned professional user:-any natural or legal person who purchases in Switzerland of substances, preparations or objects to use them as part of a training or research purposes - any legal person who purchases in Switzerland of substances, preparations or objects to use them as part of an activity of general interest;

b. private user: any natural person who purchases or uses of substances, preparations or objects for non-profit purposes;

c. Merchant: any physical or moral person who procures in Switzerland of substances, preparations or objects and return them for commercial purposes without changing them;

d. exclusive representative: any natural or legal person authorized by a manufacturer whose domicile or registered office is abroad to notify a substance in Switzerland and representing several importers designated by his care;

e. object: product composed of one or several substances or preparations, which, during manufacture, has a shape, a surface or a specific consistency and whose use is more determined by its physical nature than by its chemical composition; f. existing substance: any substance listed in the European inventory of chemicals marketed on 15 June 1990 (EINECS); g. polymer : substance consisting of molecules characterized by the sequence of one or more types of monomer units: 1. containing a simple weight majority of molecules comprising at least three monomer units linked by Covalent to at least one other monomer unit or other reactive substance, and2. containing a quantity of less than a simple weight majority of molecules of the same molecular weight; these molecules must be distributed over a range of molecular weights, the differences in molecular weight being mainly due to the differences in numbers of monomer units;


h. monomer: substance capable of forming a covalent bonds with a sequence of other molecules similar or not, in the conditions of the relevant training of the polymer reaction for the particular process; i. monomer unit: reacted form of a monomer substance in a polymer; j. produced intermediate: any substance manufactured and used exclusively for chemical transformation processes during which it is transformed into one or more other substances; k. secondary product : any substance that is formed by chemical or biochemical transformation during storage, use or disposal of a substance or a preparation; l. research and development scientific: any activity of scientific experimentation, analysis or chemical research carried out under conditions controlled and bearing on quantities below 1 tonne per year; Mr. research and development activities focus on products and processes : any scientific development related to the development of products or further development of a substance, such what or contained in a preparation or in an object, in which we use a pilot plant or production trials to define the production process or to test the fields of application of the substance; n. summary trial consisting of (robust study summary) : a summary detailed objectives, methods, results and conclusions of a full test report, containing sufficient information to allow an independent assessment of the test and reducing to a minimum the need to take knowledge of the complete test report; o. exposure scenario: all the conditions, including the operating conditions and risk management measures, describing the way in which the substance is manufactured or used during its life-cycle and how the manufacturer controls or would recommend to business users to control exposure of humans and the environment; an exposure scenario may also cover a specific process or, if necessary, several processes or uses; per class of danger: the nature of the physical danger, the danger to human health or the danger to the environment; q. nanomaterial: material containing free particles, in the form of aggregate or agglomerate, with one or more external dimensions between 1 and 100 nanometers or a material having a specific surface in volume more than 60 m/cm. A material is considered to be a nanomaterial is produced intentionally in order to exploit the properties of the external dimensions of its particles or volume specific surface above mentioned. Fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions less than 1 nanometer are considered as nanomaterials.

In addition, the terms defined in a different way in the laws on which this order is based are understood here in the sense of the chema.
Equivalences contained in annex 1, point 1, shall apply for the correct interpretation of expressions used in the regulations (EC) n 1907/2006 (EU-REACH regulation), Regulation (EC) 1272/2008 (CLP - EU Regulation) n and directive 75/324/EEC referred to in this order.
When this order made reference to provisions of the EU-REACH regulation, the EU - CLP regulation or directive 75/324/EEC, which, in turn, refer to other provisions of these legal acts, those other provisions also apply. In this case, the version mentioned in the footnote the al page. 4 if applies, or, in the case of a reference to the annexes of the EU - CLP regulation or the EU-REACH regulation, the version defined in annex 2, c. 1, respectively in annex 4, c. 3, applies. Make exception successive references to the provisions of the EU REACH regulation and the EU - CLP regulation referred to in annex 1, ch. 2; in this case, the provisions referred to in annex 1, c. 2, Swiss apply.
When this order refers to provisions of the EU REACH regulation or regulation EU - CLP which, in turn, refer to other provisions of the law of the EU, Swiss law mentioned in annex 1, point 3, shall apply in place and place of these provisions of the EU.
For the market of substances and preparations whose development is based on the use of genetic resources or traditional knowledge associated with them, the provisions of the Ordinance of 11 December 2015 Nagoya are reserved.

The inventory can be consulted free of charge on the Internet with the European Agency (ECHA) chemicals under: www.echa.europa.eu > chemicals information > EC Inventory European inventory of existing commercial chemical substances (European inventory of marketed chemicals).
Regulation (EC) n 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, evaluation and authorization of chemical substances, as well as the restrictions applicable to these substances (REACH), establishing a European Chemicals Agency, amending directive 1999/45/EC and repealing Regulation (EEC) 793/93 of the Council n and the Regulation (EC) n. 1488/94 the Commission directives 91/155/EEC and directive 76/769/EEC of the Council 93/67/EEC, 93/105/EC and 2000/21/EC of the Commission, OJ L 396 of the 30.12.2006, p. 1; amended lastly by Regulation (EU) 2015/326, JO L 58 of the 3.3.2015, p. 43.
Regulation (EC) n 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 regulations (EC) n 1907/2006, OJ L 353 of 31.12.2008, p. 1. amended lastly by Regulation (EU) 2015/491, OJ L 78 of the 24.3.2015, p. 12.
Directive 75/324/EEC of the Council of 20 May 1975 on the approximation of the laws of the Member States relating to generators aerosol, OJ L 147 of the 9.6.1975, p. 40. amended lastly by directive EU/10/2013, OJ L 77 of the 20.3.2013, p. 20.
RS 451.61 introduced by section 2 of the annex to the O in Nagoya Dec. 11. 2015, in effect since Feb. 1. 2016 (2016 277 RO).

Art. 3 substances and preparations dangerous substances and preparations are deemed dangerous when they meet the classification criteria cited in the technical requirements of annex 2, ch. 1, relating to physical dangers, the dangers to the health, environmental hazards or other dangers;

Art. 4 persistence, bioaccumulation and toxicity are considered persistent, bioaccumulative and toxic (PBT) substances that meet the criteria defined in annex XIII, point 1.1.1 to 1.1.3 of the EU REACH regulation.
Are deemed very persistent and very bioaccumulative (vPvB) substances that meet the criteria defined in annex XIII, point 1.2.1 and 1.2.2 of the EU REACH regulation.

See notes to art. 2, al. 4. Title 2 Chapter 1 Market Conditions control autonomous Section 1 principles art. 5 under autonomous control established by the art. 5 chema and 26 EPA, the manufacturer must assess whether substances or preparations may endanger life or human health or the environment. It must, in accordance with the provisions of this order, classify, package and label substances and preparations therefor; as well as develop exposure scenarios and set a record of safety data concerning them.
In the case of objects containing dangerous substances, substances assessed PBT or vPvB or substances referred to in annex 3, the manufacturer must, under autonomous control established by art. 26 USG, assess whether these substances can endanger the environment or indirectly human being when those items are used as intended or foreseeable use or they are eliminated in accordance with the requirements in this area.
In the case of objects containing the substances referred to in annex 3, the manufacturer must assess whether these substances can endanger human health when those items are used as intended or foreseeable use or they are eliminated in accordance with the requirements in this area.
The manufacturer must collect all available data that meet the obligations referred to in paras. 1 and 2.
Anyone, professional or commercial capacity, important substances, preparations or objects containing dangerous components must have met the obligations referred to in paras. 1 and 2 at the latest before the first delivery to third parties or, in the case of personal use, before the first use.

Section 2 Classification of substances and preparations art. 6 classification of substances the manufacturer must classify the substances according to the art. 5, 7 to 13 and 15 from the EU - CLP regulation.
If a classification harmonised for a substance is fixed in annex VI of the EU - CLP regulation, in the version set out in Schedule 2, section 1 of this order, the manufacturer must also classify this substance according to art. 4, al. 3, the EU - CLP regulation.
The classification should be based:

a. for existing substances: the data collected under art. 5, al. 4; (b) for the new substances: the data of the technical dossier to the senses of the art. 27, al. 2, let. b. the federal Department of Home (Affairs FDHA) may, in agreement with the federal Department of the economy, training and research (Davis) and with the federal Department of the environment, transport, energy and communications (DETEC), prescribe a classification of certain classes of danger of a substance defined as well as the corresponding labelling, when annex VI of the EU - CLP regulation in the version prescribed in annex 2 , ch. 1, contains no classification harmonised substance for these hazard classes.

See notes to art. 2, al. 4 art. 7 classification of preparations the manufacturer must classify preparations according to the art. 6-15 of the EU - CLP regulation.

See notes to art. 2, al. 4 section 3 packaging and labelling of substances and preparations art. 8 packaging manufacturer who makes available to third parties or shall give to third parties of substances or of preparations dangerous must pack them according to art. the EU - CLP regulation 35.

See notes to art. 2, al. 4 art. 9 packaging of aerosol generators of aerosol generators that do not fall under the Ipegs are governed, in addition to the provisions of this order, by the art. 1 and 2, and by ch. 2.1, 2.3, 3, 4, 5 and 6 of the annex to directive 75/324/EEC.

RS 817.0 see notes to art. 2, al. 4 art. 10 labelling the manufacturer who makes available to third parties or shall give to third parties of substances or of preparations dangerous is to label them in accordance with the following provisions: a. art. 17, al. 1: 18, except al. 2, last sentence, 19 to 23, 25, al. 1, 3 and 4, 26 to 28, 29, al. 1 to 4, 31, 32, al. 1 to 5 and 33 of regulation EU - CLP; b. rules on the labelling of the outer packagings, inner packagings and unique packaging according to art. 33, the EU - CLP regulation.

The preparations with specific hazards, referred to in art. 4, al. 7, the EU - CLP regulation, extra must be labelled in accordance with art. 25, al. 6, the EU - CLP regulation.
In addition to the al. 1 and 2, the labelling must meet the following requirements: a. include the name, address and phone of the manufacturer number. When the substance or preparation is imported from a Member State of the European economic area (EEA) and it is not intended to be delivered to a private user, the name of the manufacturer may be replaced by the name of the person responsible for the placing on the market in the EEA; b. be formulated in at least two official languages. a substance can be labeled in one official language or for delivery to a business user in agreement with the English.

The elements of labelling as a result of the requirements of other legislative acts must be placed in the section reserved for the additional information referred to in art. 25 the EU - CLP regulation.
When the name of a substance IUPAC nomenclature exceeds 100 characters, a different name may be used, provided that the communication according to art. 49 understands both the name in the IUPAC nomenclature and the name used.
The requirements of para. 1 are considered to be fulfilled when the inner packagings are labeled before or immediately after the removal of the outer packaging. Packaging and labelling responsibility to the manufacturer.

See notes to art. 2, al. 4. system for naming chemical substances developed by the International Union of pure and applied chemistry (IUPAC): www.iupac.ch.

Art. 11 labeling of spray cans of aerosol generators that do not fall under the LDAI are governed, in addition to the provisions of this order, by the art. 1, 2 and 8, al. 1A, c. 1.8, 1.9 and 1.10, the introductory provision of the No. 2, and by points 2.2 and 2.3 of the annex to directive 75/324/EEC.
Aerosol generators which are not dangerous in the sense of art. 3 must contain the name and address of the manufacturer. In the case of import of spray cans from a Member State of the EEA, it is possible to replace the name of the manufacturer by the name of the personneresponsable of the placing on the market in the EEA.

RS 817.0 see art note. 2, al. 4 art. 12 derogations from the labelling conditions the body of notification may, in agreement with the evaluation bodies, grant derogations in terms of labelling for certain substances or preparations or certain groups of substances or preparations and allow the absence of labelling or labeling another form appropriate when: a. the packaging is too small or otherwise ill-suited to labelling in accordance with art. 10; (b) the substance or preparation is so small that there is no risk for human being, nor to the environment by its dangerous properties. OUC. the substance or preparation does not fall within the scope of the EU - CLP regulation.

It shall issue a decision on duly motivated request or shall issue a general ruling.
It establishes a list of the exceptions and posts it on its website.

See notes to art. 2, al. 4 art. 13 labelling of substances and preparations dangerous for export any person who exports of substances or dangerous preparations must label them taking into account critical regarding international standards and including at least the following: a. the name of the manufacturer; b. the chemical name or trade name; c. the dangers to humans and the environment as well as the corresponding protection measures.

The language of labelling must be consistent with the practice of the country of importation.

Art. 14 use of an alternative chemical name the manufacturer of preparation can be used an alternative to a substance chemical name: a. If he proves that the disclosure of the name of a substance on the label or safety data sheet presents a risk to the confidentiality of his professional activity, in particular for its intellectual property rights; ETB. If the substance meets the criteria referred to in annex I, section 1.4, the EU - CLP regulation in the version defined in annex 2, Chapter 1.

The alternative chemical name is a name expressing the major functional groups or a replacement name.
The manufacturer wishing to use an alternative chemical name must file a written application with the body of notification.
The use of a chemical name of replacement of a substance may be required for preparation: a. whose composition is given; b. a trade name or designation given; reserved for given purposes etc.

Permission to use an alternative chemical name is granted to the manufacturer and is not transferable.
Authorization for the use of an alternative chemical name is not necessary in the 6 years following the notification of a new substance. Subsequently, it must either use the chemical designation referred to in art. 18, al. 2, the EU - CLP regulation, or file an application for the use of an alternative chemical name.

See notes to art. 2, al. 4 art. 15 request for use of an alternative chemical name the request for use of a chemical name of replacement of a substance in a preparation must be written in one of the official languages or in English and presented in electronic format requested by the body of notification. The cover letter should be written in an official language.
The application must include: a. the name, address and telephone number of the manufacturer; b. data on substances whose identity must remain confidential to labelling: 1. the chemical designation, 2 the number set by the Chemical Abstract service (case n), 3. the n CE;

c. the replacement name; (d) the reasons justifying the request; e. the name commercial or the designation of the preparation; (f) the composition of the preparation in accordance with the provisions on the safety data sheet g. the classification of the preparation h. labelling of the preparation; i. intended uses; j. physical preparation; k. as appropriate the safety data sheet.

Notification body shall decide on the request, in accordance with the evaluation bodies.

The case n can be consulted free of charge on the Internet with ECHA under: www.echa.europa.eu > chemicals information > EC Inventory Section 4 exposure Scenarios and security for the substances and preparations Art. data sheet 16 obligation to establish an exposure scenario the manufacturer of an existing substance meets the criteria of art. 14, al. 4, the EU REACH regulation and delivery to a third party as such in total quantity equal to or greater than 10 tonnes per year, is required to prepare an exposure scenario for each identified substance use.

One who obtains a substance for which the exposure scenarios have been established and provide it to third parties on a commercial basis, as such or in a preparation, in amount equal or greater than one tonne per year, for a use not described in the safety data sheet, must establish an exposure for this use scenario.
The al. 2 does not apply when: a. the exposure for the new use scenario includes exclusively the conditions described in the exposure scenario for the form of safety data; (b) the substance is present in the preparation in lower concentration to the limits referred to in art. 27, al. 3; or listen to me. the substance is used for research and development purposes focus on products and processes.

See notes to art. 2, al. 4 art. 17 requirements for the establishment of an exposure scenario of exposure scenarios must be established in accordance with the provisions of annex I, section 5.1, the EU REACH regulation.

See notes to art. 2, al. 4 art. 18 purpose of the safety data sheet safety data sheet aims to educate users and traders so that they can take the measures that are necessary in terms of the protection of health, safety at work and environmental protection.

Art. 19 duty to establish a safety data sheet in the cases provided for in art. 21, the manufacturer is required to establish and provide a safety data sheet for: a. substances and dangerous preparations; b. substances PBT or vPvB; c. the substances set out in Schedule 3; d. preparations that are not dangerous in the sense of art. 3. and that contain at least one of the following: 1. a substance dangerous to health or to the environment in an individual concentration of ≥ 1.0% weight for non-gaseous preparations and ≥ 0.2% volume for gaseous preparations, 2. a substance PBT or vPvB in individual ≥ 0.1% weight concentration, 3. a substance set out in Schedule 3 in an individual ≥ 0.1% weight concentration 4. a substance for which the directives 2000/39/EC, 2006/15/EC or 2009/161/EU set a value limit of occupational exposure.

Directive 2000/39/EC of the Commission of 8 June 2000 on the establishment of values limits occupational exposure of indicative in application of directive 98/24/EC of the Council on the protection of the health and safety of workers from the risks related to chemical agents at the workplace, OJ L 142 of the 16.6.2000 p. 47; amended lastly by directive 2009/161/EU, OJ L 338 of the 19.12.2009, p. 87.
Directive 2006/15/EC of the Commission of 7 February 2006 establishing a second list of values indicative occupational exposure limits in application of the Council directive 98/24/EC and amending directives 91/322/EEC and 2000/39/EC, OJ L 38 of the 9.2.2006, p. 36.
2009/161/EU Commission directive of 17 December 2009 establishing a third list of values indicative occupational exposure limits in application of the Council directive 98/24/EC and amending directive 2000/39/EC of the Commission, OJ L 338 of the 19.12.2009, p. 87.

Art. 20 requirements for the establishment of the safety data sheet safety data sheet must be established in accordance with the technical requirements of annex 2, Chapter 3.
The exposure scenarios based on art. 16 or contained in the safety report chemical (art. 28) must be attached to the form of safety data. sections 1, 7, 8 and 13 information from the safety data sheet must correspond to the uses listed in the exposure scenarios.
DFI may, in agreement with the Davis and DETEC, define the professional qualifications required for the preparation of safety data sheets.

Art. 21 duty to provide a safety data sheet any individual who gives commercial substances or preparations referred to in art. 19-Professional users or dealers must provide a current safety data sheet. In the retail sector, the safety data sheet must be provided upon request.
The safety data sheet must be provided: a. for the substances and preparations within the meaning of art. 19, let. a to c: no later than upon first delivery and, on request, during subsequent remissions; b. for preparations within the meaning of art. 19, let. d g: on request at time of delivery.

The safety data sheet must be provided: a. free; (b) in the official languages required by the professional user or merchant or, in agreement between the two parties, in another language; the annex to the safety data sheet may be made in English; c. in printed or electronic form; at the request of the professional user or merchant, the safety data sheet must be provided in printed form.

Art. 22 update of the safety data sheet the manufacturer shall update the safety data sheet without delay in the event of significant new information on the substance or preparation.
The presenter must provide the data sheet updated security for business users and traders which he gave during the last twelve months the substance or preparation concerned.
The al. 2 does not apply when the safety data sheet has been provided through the retail industry.

Art. 23 obligation to keep the safety data sheet professional user or merchant is required to keep the safety data sheet a long time he uses the substance or preparation concerned.

Chapter 2 Notification and declaration of new substances Section 1 Notification of new substances art. 24 duty to notify the manufacturer of a new substance or his representative must notify the said new substance to the body of notification before his first placing on the market: a. as such; (b) in a preparation; OUC. in an object which the new substance is intended to be released under normal or reasonably foreseeable operating conditions.

When a new substance is contained in a polymer, in the form of monomer or monomer units or as a substance chemically related para. 1 applies to the substance itself.
The body of notification may require notification of a new substance contained in an object, when he has reason to suspect that the substance can be released under the conditions of use of the object.

Art. 25 decisive substance quantity the decisive quantity of substance to be considered for the values referred to in art. 27, 31, 34, 46, 47 and annex 4 shall be as follows: a. If the substance is manufactured in the EEA: the total quantity produced per year in the EEA by a manufacturer whose part of the production is supplied to the notifier; (b) if the substance is manufactured in Switzerland, the highest amount between: 1 quantity placed on the market a year in Switzerland or 2. the largest quantity exported annually to EEA for an importer determined having its seat in the EEA;

c. If the substance is manufactured out of Switzerland and outside the EEA and that the Notifier is importing the substance directly from that country: the quantity imported per year in Switzerland; d. If the substance is manufactured out of Switzerland and outside the EEA and that notifying importing the substance of a country member of the EEA: total quantity imported per year in the EEA by an importer part of which is provided to the notifier.

Art. 26 exceptions notification is not required: a. for polymers and substances contained in monomer units or related chemically to the polymer in a concentration of less than 2% weight; (b) for the substances on the list of the No-Longer Polymer (list NLP); (c) for substances placed on the market in quantities less than 1 tonne per year; d. for substances placed on the market by a manufacturer : 1 exclusively for purposes of research and development activities focus on products and processes, 2. in quantities strictly limited to these purposes, et3. more than five years; on justified request, the body of notification may, in agreement with the evaluation bodies, extend that period by a period of five or ten years;

e. for substances that are exclusively used as raw materials, active or additives in food, principles the therapeutic products and animal feed; f. substances acquired in Switzerland; g. for intermediate products, unless they are monomers; h substances for substances defined in annex V of the regulation EU-REACH; i. to substances that have already been notified and exported by a manufacturer and new imported by the same manufacturer or another manufacturer in the same supply chain, subject to be able to demonstrate: 1 that it is of the same substance, 2 that he has provided a record of data security in accordance with art. 20 for the substance exported, insofar as this is required by art. 19.


If there is reason to assume that a given substance, not subject to notification under para. 1, could endanger humans or the environment, the receiving agency notifications requires the manufacturer, at the request of a review body, the presentation of test reports. For these test reports, it is not possible to require the data beyond those required for the technical file referred to in annex 4, no. 8, let. a, 9, let. a, and 10, let. a. dangerous substances, PBT and vPvB not subject to notification according to para. 1, let. a to c, are subject to the obligation to communicate art. 48. the NLP list can be found for free on the Internet with ECHA under: www.echa.europa.eu > chemicals information > EC Inventory and information on chemicals > registered substances > registered substances information.
See notes to art. 2, al. 4 art. 27 form and content of notification notification must be written in one of the official languages or in English and presented in electronic format requested by the body of notification. The cover letter should be written in an official language.
It must include the data and the following documents: a. an indication of the significant amount of substance defined in art. 25 stating the case (art. 25, let a, b, c or d) applicable; (b) a technical dossier containing information following and specified in annex 4: 1. the identity of the notifier, 2. the identity of the substance, 3. information on the manufacture and use, 4. the classification and labelling, 5. safe usage tips, 6. the assessment of exposure, 7. summaries of consistent testing and other data related to the physico-chemical properties, 8. summaries of consistent testing referring to properties dangerous to health, 9. consistent test summaries referring to the dangerous properties for the environment;

c. when the decisive quantity of substance defined in art. 25 equal or exceed 10 tons per year: a chemical safety report referred to in art. 28; (d) a proposal of data security in the case of dangerous substances or PBT or vPvB;. e all documents and available information on exposure and the harmful effects of the substance on the human being and the environment insofar as these aspects are not already addressed in the technical file referred to in the let. b. the al. 2, let. c, does not apply to new substances placed on the market in the form of preparation, if the concentration of the substance is less than the following levels: a. the cut-off value referred to in art. 11, al. 3, of the regulation EU - CLP; forgotten the source. 0.1% weight if the substance is PBT or vPvB.

If, in the situations referred to in art. 25, let. a or d, certain documents required to the al. 2 are not available or if the notifier may not be obtained on reasonable terms, it must provide proof.
The body of notification may require the notifier test reports beyond technical and record relevant to the assessment of the substance, provided that they are available and that it is possible to obtain them on reasonable terms.

See notes to art. 2, al. 4 art. 28 report on chemical safety chemical safety report contains the assessment of the chemical safety established in accordance with the provisions of annex I of the EU REACH regulation. Chemical safety assessment contains: a. an assessment of the hazards to human health; b. a physicochemical hazard assessment; c. an assessment of dangers for the environment; d. an assessment of PBT and vPvB; e. characters when the substance meets the criteria of art. 14, al. 4, of the EU REACH regulation: 1. an exposure assessment covering all of the identified uses, 2. a risk characterization carrying on all the identified uses.

See notes to art. 2, al. 4 section 2 use records of previous and duration of protection of data article notifiers 29 use data of previous notifiers notification body renounce data of the notifier and uses data from a notifier precedent: a. when the notifier produces a letter of access of a notifier precedent showing that he agrees to what the body of notification refers to its data; forgotten the source. When the term of data protection has expired.

The notifier cannot in no case refer to the data of one Notifier precedent regarding: a. the identity, purity and impurities of a substance identity; b. neutralization opportunities specific to this substance. The provisions of this section are without prejudice to the rules of the law of competition and intellectual property law.

Art. 30 term of protection of data data are protected for 10 years.
The data submitted later under art. 47 are protected for five years. If the term of protection referred to in para. 1 has not yet expired at the end of these five years, the protection of data submitted later is extended.

Art. 31 duty to file a request for tests on vertebrate animals before tests on vertebrate animals for the purposes of submitting a notification, the notifier must apply in writing to the receiving agency notifications if there is already data from such trials (art. 12 chema).
The request must include: a. data on the identity of the substance in accordance with art. 27, al. 2, let. b, c. 2; (b) data on the significant amount of substance according to art. 25 art. 32 use of the results of previous tests on vertebrate animals if the notification body has sufficient results from previous tests on vertebrate animals, it signals to the notifier to what extent these data to avoid new tests on vertebrate animals for the proposed notification.
If these results from tests carried out by previous notifiers, and these data is still protected, the body of notification takes the following measures: a. communicate to previous notifiers: 1. the data he intends to use for the benefit of the new notifier, and2. the address of the new notifier;

b. shall inform the new notifier address of previous notifiers.

Previous notifiers may oppose the immediate use of their data within 30 days and ask that these data access be postponed.
If no request is made, the notification shall a decision validating the re-use of data.
If a report is filed, the notification shall a decision setting: a. data from previous notifiers that he hears reuse; b. the report hitting the notification of substance, equivalent to the time that would put the new notifier for its own results.

The notification body establishes, at the request of the new notifier, a summary of the results used; the provisions on the confidential data to the senses of the art. 73 are reserved.

Art. 33 compensation of the previous notifiers for the re-use of their test results on the previous notifiers vertebrae are entitled to fair compensation on the part of the new notifier for the re-use of the results of tests on vertebrate animals when these data are still protected under art. 30. If the notifiers fail to a compensation agreement in a span of six months, the notification shall, on request of one of the notifiers, a decision fixing the amount of compensation. It takes into account in particular the following factors: a. expenditures on the acquisition of the test results; (b) the duration of protection for remaining data referred; c. the number of notifiers who is entitled to compensation.

The previous notifiers may request the body of notification to prohibit the placing on the market of the substance until the new applicant has paid them compensation.

Section 3 Declaration of new substances for purposes of research and development activities focus on products and processes art. 34 obligation to declare before first placed on the market, the manufacturer of a new substance not subject to notification under art. 26, al. 1, let. d, or his representative, is required to declare to the body of the substance, as such notification or contained in a preparation or in an object of which the substance is intended to be released under normal or reasonably foreseeable operating conditions when the amount determining according to art. 25 equals or exceeds 1 tonne per year.

Art. 35 form and content of the declaration the declaration must be written in one of the official languages or in English and presented in electronic format requested by the body of notification. The cover letter should be written in an official language.
It must include the data and the following documents:

a. the name and address of the manufacturer; b. the name and address of the foreign manufacturer if the substance is imported; c. the essential data concerning the identity of the substance; (d) the intended use; e. the annual substance that the manufacturer intends to put on the market in Switzerland; (f) the classification and labelling provided; g. the research program and a list of people to which it is planned to deliver the substance; h. a proposal of data sheet of security in the case of a dangerous substance or PBT or vPvB.

The body of notification may require the manufacturer or the exclusive representative test reports relevant to the assessment of the substance, as far they are available and that it is possible to obtain them on reasonable terms.

Section 4 Procedure applicable to notifications and declarations art. 36 confirmation of reception and transmission of the body of notification record confirms to the manufacturer or to the exclusive representative of receipt of the notification or declaration.
If the file notification or declaration does not obvious shortcomings, the notification body transmits to assessment bodies.

Art. 37 review notification or declaration assessment bodies check in their area of expertise: a. If the file is complete or, otherwise, if the reasons given by the notifier are valid; b. If data are scientifically plausible; c. If test reports are based on tests meets the requirements set out in art. 43. If a review body finds, during the review of the notification dossier, that the substance presents a particular risk to human health or the environment, due to his dangerousness of its properties, its likely use or quantity placed on the market, it can conduct a targeted risk assessment prior to the acceptance of the notification.
Assessment bodies transmit the results of their review to the body of notification.

Art. 38 supplements and corrigenda, if notification body notes that the present record of patent gaps, it signals immediately to the manufacturer or to the exclusive representative.
If a review body finds gaps in the record, or mistakes, or that data or additional tests are necessary for the assessment of hazards and risks associated with the substance in question, it shall communicate it to the body of notification. This requires the manufacturer or the exclusive representative complete or correct his file accordingly.
When a summary of test consisting of referred to in art. 27, al. 2, let. b, c. 7-9, does not allow an independent assessment of a given trial, the body of notification may require the complete test report.
The body of notification confirms to the manufacturer or to the exclusive representative the date of receipt of the add-ins or corrigenda.

Art. 39 acceptance notification or declaration in accordance with the review bodies, the receiving agency notifications accepts a decision notice or the statement if, after review, file is complete and sufficient for the assessment of hazards and risks associated with the substance in question.
In the event of a targeted risk assessment, decision includes the prescribed measures for risk reduction.

Section 5 the art market authorisation 40 placing on the market of substances subject to notification a substance subject to notification may be placed on the market: a. If the notification body agreed its notification by decision; forgotten the source. If the body of notification has not issued notice within 60 days after the confirmed date of receipt of the notification and, where appropriate, supplements or corrections required after the fact.

Art. 41 placing on the market of substances subject to a substance subject to declaration statement can be placed on the market: a. If the notification body accepted his statement by decision; forgotten the source. If the body of notification has not issued notice within 30 days after the confirmed date of receipt of the declaration and, if necessary, supplements or corrections required after the fact.

Chapter 3 requirements for testing art. 42 principles the manufacturer must ensure that the tests required for the estimation of the dangers and risks represented by the substances and preparations, the test methods and evaluation of test results correspond to the State of scientific and technical knowledge.
The DFI, the Davis and DETEC can define technical terms in their respective fields.

Art. 43 requirements the tests to determine the properties of substances and preparations must be made according to the technical requirements of annex 2, no. 2 test methods.
Other test methods may be applied if: a. no method is prescribed in accordance with para. 1; b. the manufacturer can demonstrate that a prescribed method is not adequate to determine a physicochemical property given; or listen to me. the method is recognized in the EU in accordance with art. 13, al. 3, of the EU REACH regulation.

Other test methods are applied, the manufacturer shall demonstrate: a. that these methods deliver valid results. ETB. These methods take duly into account the protection of animals in the case of testing on animals.

The non-clinical tests to determine properties dangerous to health or the environment must be carried out in accordance with the principles of good laboratory practice (GLP) pursuant to the order of 18 May 2005 on good laboratory practices.
If some tests fail, or do not fully respect the principles of GLP, the person submitting the test reports shall justify this. The body of notification decides, in accordance with the evaluation bodies, if he accepts the test results.

See notes to art. 2, al. 4 RS 813.112.1 title 3 Obligations of the subsequent manufacturer to market Chapter 1 taking into account of new key facts for the assessment, classification and labelling art. 44 reassessment of substances, preparations and objects the manufacturer must carry out a new assessment of substances, preparations and objects containing dangerous components, or complete their assessment and, if necessary, proceed to their reclassification, repackaging and re-labeling: a. when they are intended to be handed over to other purposes; b. when they are intended to be used in another way; c. when they are intended to be used in higher amounts; d. when differences in nature and the amount of impurities can adversely affect the risks to humans or the environment; e. when the risks they represent for human beings or the environment must be reassessed in the light of practice, new information, or new acquis.

Art. 45 maintenance and conservation of the assessment the manufacturer documentation is required to update and supplement the assessment file based on the new information critical to human health and the environment, as long as it brings to market the substance, preparation or article containing hazardous components.
He is required to keep or to keep available the main documents used in the assessment and classification, including the corresponding results for at least 10 years after the last market. He must keep the samples and specimens as long as their State allows an assessment.

Chapter 2 information and additional test reports on new substances art. 46 additional information the Notifier is required to inform without delay and in writing the body of notification: a. If the data referred to in art. 27, al. 2, let. b, c. 1 to 6, or art. 35, al. 2, change; (b) if the decisive quantity of substance according to art. 25 reached in all likelihood one of the quantitative thresholds laid down in art. 47, al. 1; in this case, the notifier shows the tests that he plans to get the additional data referred to in art. 47, al. 1; c. If the decisive quantity according to art. 25 has more than doubled or more than cut in half compared to the amount notified in last place; d. If he has knowledge of new facts regarding the effects of the substance on man or the environment; e. If he puts the substance on the market for a new use or that he has knowledge of the fact that this substance is used for other purposes than what it has given to the body of notification; f. If he establishes or establish, for the substance in question, test reports go beyond the technical file referred to in art. 27, al. 2, let. b; g. If it is able to obtain, under reasonable conditions, other reports of trials beyond the technical file referred to in art. 27, al. 2, let. b.


Additional information according to para. 1 must be written in one of the official languages or in English and presented in electronic format requested by the body of notification. The cover letter should be written in an official language.
The exclusive representative must ensure that up-to-date, particularly with regard to the amounts of substance imported annually by the importers that it represents.
Importers subrogated to an exclusive representative for the notification of a new substance should inform it of the amount of substance imported annually.

Art. 47 information to be submitted depending on the quantities the Notifier is required to submit to the receiving agency notifications the following additional data, the critical amount of substance according to art. 25: a. equal amount or greater than 10 tonnes per year: the information referred to in annex 4, no. 9, let. b, and. 10, let. b, as well as a report on chemical safety referred to in art. 28; b. quantity equal to or greater than 100 tonnes per year: the information referred to in annex 4, no. 8, let. b, 9, let. c, and 10, let. c, as well as a report on chemical safety referred to in art. 28; c. amount equal to or greater than 1000 tonnes per year: the information referred to in annex 4, no. 9, let. d, and 10, let. d, as well as a report on chemical safety referred to in art. 28. after receipt of the information referred to in art. 46, al. 1, let. b, the body of notification, in application of art. 32, inform the notifier of already available data.
If the dangers associated with a given substance cannot be evaluated sufficiently, the body of notification requires the notifier at the request of a review body, information or additional tests for the substance concerned or its secondary products.
The body of notification, after consultation of the notifier and in agreement with the evaluation bodies, establishes a timetable for conducting additional tests.
If the notifier fails to present timely reports of additional testing, the body of notification may have carried out the tests required at the expense of the notifier and, if necessary, prohibit it to bring to market the substance considered.

Chapter 3 Obligation to communicate art. 48 substances and preparations subject to communication the manufacturer must provide to the body of notification the substances and preparations referred to in art. 19, regardless of the requirement of establishing a safety data sheet, within a period of three months after the first placing on the market.

Art. 49 communication communication content must contain the following information: a. the name and address of the manufacturer; b. the name of the person responsible for placing on the market in the EEA, as defined in art 17, al. 1, let. a, of the EU - CLP regulation if the labelling does not mention the identity of the manufacturer; (c) for substances: 1. the chemical designation within the meaning of art. 18, al. 2, let. a to d, EU - CLP regulation, 2. the n case, 3. the n CE, 4. the classification and labelling, 5. the intended use, 6. for substances dangerous for the environment: the annual amount that is expected to put on the market according to the following categories: less than 1 ton of 1 to 10 tonnes, from 10 to 100 tonnes over 100 tonnes, 7 for Nanomaterials: the composition of the nanomaterial shape particles and their average size and, when this information is available grain size distribution, specific surface in volume, the Crystal structure, the State of aggregation, the surface coating and the surface Functionalization, 8. the indication of whether the substance is deemed to be PBT or vPvB, 9. the report on chemical safety available in the EEA, provided that the manufacturer can get it on reasonable terms;

d. for preparations: 1. the trade name, 2. data relating to components, in accordance with the provisions applying to the plug safety data, 3. the classification and labelling, 4. the intended use, 5. the physical condition, 6. for preparations dangerous for the environment: the annual amount that is expected to put on the market according to the following categories: less than 1 ton from 1 to 10 tonnes, 10-100 tonnes, 100 ton, 7. for preparations that contain nanomaterials: the composition of nanomaterials, the shape of the particles and their average size and, when this information is available, grain size distribution, specific surface volume, crystal structure, the State of aggregation, the surface coating and Functionalization of surface.

See notes to art. 2, al. 4 art. 50 communication extended for dangerous preparations accessible to private users, please call the complete composition to the body of notification. Components that are not dangerous in the sense of art. 3 may be designated by a name expressing the major functional groups or by a replacement name obtained in accordance with art. 15 art. 51 form of communication with the wider communication communication and extended communication must be sent: a. electronic format requested by the body of notification; (b) in an official language or in English.

Art. 52 changes changes in the data referred to in art. 49 and 50 shall be communicated within three months.
If, in the case of substances and preparations dangerous for the environment, the annual quantity actually delivered does not meet the previously announced quantitative category, it is necessary to communicate, until March 31 of the following year, the actually delivered quantity during the preceding year, broken down by the categories set out in art. 49, let. c, c. 6, and d, Chapter 6.

Art. 53 alternative forms of disclosure that the obligation to communicate the preparations in accordance with art. 48 is considered filled when a request for use of an alternative chemical name has been filed (art. 15) and the body of notification has required information to art. 49, let. a, b and d, and, where appropriate, to the art. 50 art. 54 exceptions to the obligation to communicate are not subject to the regime of communication within the meaning of this chapter: a. intermediate products, with the exception of new substances in the form of monomers; (b) substances and preparations placed on the market exclusively for purposes of analysis, research, teaching or subject themselves to an activity of research and development; (c) substances and preparations used exclusively for food , therapeutic products or the animal feed; d. fertilisers which must be authorized by the federal Office for agriculture (FOAG) or announced at the FOAG, under the Ordinance of 10 January 2001 fertilizers; e. explosives and pyrotechnic devices which are subject to authorization according to the order of 27 November 2000 on explosives; f. substances acquired in Switzerland; g. the preparations developed in Switzerland and delivered in a package that is different from that expected by the original manufacturer, provided that: 1. the trade name, composition and intended use are not modified, and que2. the name of the original manufacturer is also mentioned;

h. gas mixtures made up exclusively of gas was the subject of a communication; i. preparations that are not dangerous in the sense of art. 3 and packaged in packages not exceeding 200 ml, when they are manufactured in Switzerland and handed over directly by the manufacturer to the professional or private user; j. preparations placed on the market in quantities less than 100 kg per year and exclusively intended for professional users.

RS 916.171 RS 941.411 Title 4 rules of conduct when using the substances, preparations and objects Chapter 1 provisions general art. 55 observation of the data of the manufacturer the substances, preparations and objects cannot, as professional or commercial, to be an advertising promotion, of a sale or a discount for the uses and the elimination methods provided by the manufacturer.
The instructions on the packaging, labelling, and safety data sheet must be taken into account.

Art. 56 dispersion in the environment any direct dispersion of substances or preparations in the environment must be limited to the strict necessary compared to the intended use.
To this end, there is: a. to use devices allowing consistent and specific employment; (b) to take all necessary measures so that substances fail unnecessarily in the vicinity or in the water; etc to take all necessary measures for the animals, the plants, their communities and their biotopes are not threatened unnecessarily.

The direct scattering of preparations in the environment is admitted only for the uses intended by the manufacturer.

Art. 57 storage it should be to store substances and preparations taking into account the indications on the packaging, the labelling and, where appropriate, on the safety data sheet.

Substances and dangerous preparations as well as their containers must be protected against any dangerous deterioration, especially mechanical.
Substances and dangerous preparations should be stored clear and orderly, away from other goods. All nearby storage of food, animal feed or therapeutic products is prohibited.
The al. 1 to 3 also apply to objects releasing substances or preparations in quantities that could endanger humans or the environment.
Substances and preparations likely to interact causing dangerous reactions should be stored separately from each other.
Substances and dangerous preparations cannot be transferred and stored in containers comply with the following requirements: a. they should not be confused with packaging of food, cosmetics, therapeutic products or pet food; (b) the name of the substance or preparation must appear on the labelling of the container; c. they must conform to the requirements of art. 35, al. 1 and 3, of the EU - CLP Regulation; (d) they must not have a form or an aesthetic that is likely to attract or encourage the curiosity of children.

See the notes to the art. 2, al. 4 art. 58 specific obligations related to the delivery of substances and preparations any person who puts on a commercial basis a substance or a preparation and who must provide a safety data sheet, must know and be able to interpret the content of the safety data sheet.

Art. 59 contact person for chemicals companies and educational institutions must announce to the cantonal enforcement authorities the name of the contact person for chemicals under art. 25, al. 2, chema.
The DFI regulates the obligation to announce the para. 1. it sets the form and the content of the ad.
It specifies requirements that the contact person for the chemical products must meet, including with regard to the qualifications required both the technical manager.

Art. 60 advertising the advertising of substances, preparations and objects must not create an erroneous impression about the nature of the dangers they represent to human beings and the environment or their environmental compatibility, and should suggest neither use nor a consistent or abusive removal.
Terms such as 'degradable', "ecologically harmless", "environmentally friendly" and "harmless for waters" cannot be used in advertising only if they are simultaneously explained.
Any person who is advertising for substances or preparations dangerous private user has the possibility to buy without having previously seen labelling must indicate their dangerous properties of understandable and clearly readable or audible manner.
The al. 3 apply also to preparations labelled according to art. 25, al. 6, the EU - CLP regulation.
The substances and preparations cannot be an advertising promotion for a use for which they can be placed on the market.

See notes to art. 2, al. 4 Chapter 2 use of substances and preparations of groups 1 and 2 art. 61 substances and preparations of groups 1 and 2 means substances and preparations in Group 1, substances and preparations: a. which labelling according to EU - regulation mentions at least one item listed in annex 5, point 1.1 of the present order; forgotten the source. who are not yet labelled according to EU - regulation and labelling mentions at least an element listed in annex 5, ch. 2.1, of this order.

Substances and preparations in Group 2, substances and preparations means: a. which labelling according to EU - regulation mentions at least one item listed in annex 5, point 1.2 of this order; forgotten the source. which are not yet labelled according to EU - regulation and labelling mentions at least one item listed in annex 5, ch. 2.2 of this order.

See notes to art. 2, al. 4 art. 62 storage art. 57 applies to substances and preparations storage groups 1 and 2.
Anyone who stores substances or preparations of groups 1 and 2 must ensure that they are inaccessible to unauthorized persons.
Substances and preparations of groups 1 and 2 cannot be moved and kept in containers labeled by symbols of danger or of adequate hazard pictograms.

Art. 63 exclusion of self-service selling the substances and preparations of Group 2 for private users are excluded from the self-service.
The prohibition within the meaning of para. 1 does not apply to motor fuels.

Art. 64 restrictions on delivery the substances and preparations of the Group 1 cannot be delivered on a commercial basis, to private users.
Substances and preparations of groups 1 and 2 can be delivered on a commercial basis, to people with the exercise of civil rights.
Substances and preparations of groups 1 and 2 can be given to minors, insofar as the latter are capable of forming and use of such substances or preparations as part of their training or professional or commercial.
Restrictions on delivery of the al. 1 and 2 do not apply to motor fuels.

Art. 65 specific obligations related to delivery any person who, on a commercial basis, recovering a substance or a preparation of Group 1 to a business user or to a trader must inform him specifically, ceremony, necessary protection and measures compliant with the elimination mode.
Any person who, on a commercial basis, recovering a substance or a preparation of Group 2 in a private user must inform him specifically, ceremony, necessary protection and measures compliant with the elimination mode.
Substances and preparations referred to in para. 2 may be delivered to the user as if handing can reasonably admit that it is capable of discernment and that it is able to satisfy the duty of care provided by art. 8 chema as well as to the provisions of art. 28 APR.
The obligations referred to in paras. 1 and 2 are not for the delivery of fuel to engine.

Art. 66 technical knowledge required for delivery must have technical knowledge who, on a commercial basis, recovering: a. substances or preparations for Group 1 to a person who procures them for business purposes without putting them on the market in a different form; (b) substances or preparations in Group 2 to a private user.

The DFI can adjust: a. the criteria, taking into account the professional training and professional experience; b. the material, the duration and terms of courses to acquire the technical knowledge required.

The art. 10 and 11 of the Ordinance of 18 May 2005 on the reduction of the risks related to chemical products (ORRChem) apply by analogy.
The al. 1 apply not to the delivery of fuel to engine.

SR 814.81 art. 67 theft, loss, put on the market by mistake in case of theft or loss of substances or preparations in Group 1, the victim of the theft, or the person who suffered the loss is required to immediately notify the police.
The police inform the cantonal authority responsible for applying this order as well as the federal Office of police.
One who puts on the market a substance or a preparation in groups 1 or 2 by mistake, is required to immediately notify the cantonal authority responsible for applying this order and to communicate: a. all information allowing identification says of the substance or preparation; b. a full description of the risk posed by the substance or preparation; (c) all available information on the identity of the person who gave him the substance or preparation and the people to which he delivered; (d) the measures taken to prevent risk, such warnings, the interruption of the sale, the withdrawal from the market or recall.

The cantonal authority decides the relevance with a warning against any potential danger and its form.

Art. 68 samples the substances and preparations in groups 1 and 2 may be released for advertising purposes to professional users and merchants.

Art. 69 substances and preparations intended for self-defence art. 62, 64, al. 2 and 3, 65, al. 2 and 3, 66 al. 1, let. b, 67, al. 3 and 4, and 68 apply by analogy to the use of substances and preparations intended for self-defence.
Substances and preparations intended for self-defence are excluded from sale in self-service.

Chapter 3 use of substances of very high concern art. 70 list of very high concern substances substances according to art. 57 the EU REACH regulation are deemed to be very high concern when they are included in annex 3 (candidate list).

The federal Office for the environment (FOEN) Decides, in accordance with the federal Office of health public (FOPH) and the Secretariat of State for the economy (SECO), if a substance from the list of candidate listed in annex XIV of the EU REACH regulation should be resumed at annex the ORRChem 1.17.

See notes to art. 2, al. 4 SR 814.81 art. Any person who, on a commercial basis, recovering an object containing extremely worrisome substance with a concentration above 0.1% weight 71 objects containing very high concern substances must provide the following information: a. the name of the substance; (b) all the necessary information available to it to allow the use of the object safely.

It must provide this information for free: a. spontaneously to the professional user and merchant; (b) on request and within a period of 45 days to the private user.

Title 5 processing of data art. 72 product register the notification body shall keep a register of substances and preparations that are covered by the following legislative acts: a. this order; b. the ORRChem; c. the order of 18 May 2005 on products biocides; (d) the order of 12 May 2010 on plant protection products.

The register is based on the data: a. that have been collected or processed by a Swiss authority in any of the orders referred to in para. 1; b. that are transmitted by foreign authorities or international agencies.

SR 814.81 SR 813.12 SR 916.161 art. 73 confidential enforcement authorities process confidential data when maintaining secrecy interest worthy of protection, unless overriding public interest requires dissemination.
The body of notification defines, in agreement with the evaluation bodies, confidential personal data. He sets them before sending them to federal or cantonal authorities competent under art. 75, al. 2. is deemed worthy of protection in particular interest to the guarantee of confidentiality of business and the secret of manufacturing, including details of the full composition and quantities placed on the market.
If the notification body learns that deemed confidential data have been also disclosed legally, they lose their confidential character.
Are certainly not deemed confidential: a. the trade description; (b) the name and address of the person subject to the obligation to notify, report or communicate; c. the physicochemical properties; d. consistent elimination processes, recycling opportunities and the possibilities of circumvention; e. summary results of the toxicological and ecotoxicological; f. the degree of purity of the substance under review and the identity of impurities and additives determinative for classification; g. recommendations bearing on the precautions and emergency accident; h. the information on the safety data sheet; i. analytical methods to determine the risk of exposure to humans and the risk of dispersion in the environment.

The body of notification and assessment bodies can publish the data appearing in the register of products and are certainly not deemed confidential.

Art. 74 transmission of data to the body of notification and assessment if bodies required the execution of this order, the body of notification or assessment bodies may request the following data on substances, preparations and objects: a. data collected by the FOAG in application of: 1. the Ordinance of 10 January 2001 on fertilizers 2. the order of October 26, 2011 on the feed, 3. order of 12 May 2010 on plant protection products;

(b) data on foreign substances and components present in food as well as the substances present in the everyday objects, collected by the federal Office of food safety and Veterinary Affairs in accordance with the order of 23 November 2005 on the provision of food and everyday objects; c. data collected by Federal Customs through customs declarations; d. the data collected by the SECO by the Swiss National Fund for insurance; accident (NAC) or by the cantonal inspectorates of labour in application of the legislation on the protection of workers (e) data collected by the toxicological information centre (art. 79); f. data collected by the bodies responsible for examinations and licences within the meaning of art. 12, al. 3, ORRChem; g. data collected by the cantons in application of this order or any other legislation governing the protection of human beings or the environment against the risks associated with the substances, preparations and objects.

RS 916.171 RS 916.307 RS 916.161 RS 817.02 SR 814.81 art. 75 data exchange the body of notification and assessment bodies Exchange each other, insofar as the exercise of their duties so requires, the data they collect or do collect pursuant to this order or any other legislation governing the protection of human beings or the environment against the risks associated with the substances, preparations and objects. They may set up for this purpose of the automated access procedures.
They put at the disposal of the cantonal and federal authorities responsible for enforcement of legislation governing the protection of humans and the environment against the risks associated with the substances, preparations and objects, the data necessary for the performance of their duties.
They can make available, through procedures of access automated, the authorities mentioned below, manufacturers and data on the substances or preparations that they have placed on the market, if these data are required to carry out, namely: a. the Customs authorities; b. to the authorities referred to in para. 2; c. to toxicological information centre (art. 79).

In special cases, they can pass to the cantonal or federal services that are not referred to in para. 2 data relating to substances, preparations and objects, insofar as the exercise of their duties so requires.
If it's confidential data relating to the composition of a preparation, data exchanges set out in paras. 2, 3 and 4 are admitted only if these data are required by a criminal prosecution authority, if it comes to answering questions of a medical nature, especially in an emergency, or if it comes to ward off a danger directly threatening the life and the human health or the environment.
The cantons inform the FOPH about the results of surveys and analyses on the quality of local ambient air and transmit the data they have in this regard.

Art. 76 transmission of data to foreign authorities and international bodies the body of notification and assessment bodies can transmit non-confidential data to the authorities and foreign institutions.
They can transmit confidential data: a. when required by international agreements or decisions emanating from international organizations; forgotten the source. When necessary to deal with a danger directly threatening the life and the human health or the environment.

Title 6 enforcement Chapter 1 Confederation Section 1 Organization art. 77 notification body and Executive Committee the body of notification is attached administratively to the FOPH.
The body of notification is subject to an Executive Committee composed of the directors of the following offices: a. FOPH; b. FOAG c. FOEN; d. SECO.

The Executive Committee has for tasks and skills: a. appoint the body of notification management; (b) to define the strategy of the notification body; c. to consult and amend the budget of the body of notification.

The Executive Committee decides unanimously.

Art. 78 evaluation bodies assessment bodies are: a. The FOPH for aspects falling under the protection of life and human health; b. the FOEN for aspects falling within the protection of the environment and, indirectly, to be human; c. SECO, for aspects falling under the protection of workers.

Art. 79 Center of toxicological information toxicological information center provided by art. 30 chema is the Tox Info Switzerland.
The FOPH concludes with the Tox Info Switzerland an agreement establishing the amount of the compensation for the services it provides pursuant to art. 30, al. 2, chema.

Section 2 reconsideration of existing substances art. 80. the assessment authorities can review an existing substance: a. If it represents a particular risk to life or human health or to the environment of the quantities manufactured or placed on the market, the fact of his dangerousness, its secondary products or waste; forgotten the source. If it is the subject of an international program of revaluation.


In the case of review of an existing substance, the body of notification requires, at the request of a review body, the following of all manufacturers involved: a. the name and address of the manufacturer and, in the case of import, the name and address of the foreign manufacturer; b. all documents used in the analysis and setting the properties of the substance; c. the known uses; (d) the quantities marketed by each manufacturer; e. the registration file submitted to the European Agency for chemical products, as far as it is available and the manufacturer to get it on reasonable terms.

At the request of a review body, the body of notification requires one of the manufacturers of clarifications or additional analysis. The cost to the latter are supported jointly by all the manufacturers concerned.

Section 3 audit of autonomous control and supervision art. 81 independent control check check assessment bodies, in their respective areas, referring to substances, preparations and objects: a. assessment and the classification; (b) the information contained in the safety data sheet.

They can load the body of notification: a. check the composition and physicochemical properties of substances, preparations and objects; b. to ask the cantonal enforcement authorities to take samples.

If there is reason to suppose that the assessment or classification are lacking or that they have not been carried out properly, the body of notification requires the manufacturer concerned, at the request of an evaluation body: a. all documents used to assessing or establishing the dangerous properties of the substance; b. where appropriate, the safety data sheet.

At the request of a review body, the body of notification requires the manufacturer conduct testing or additional assessments if clues to assume: a. that a substance or a preparation and its secondary products or waste can endanger humans or the environment; b. an object, its secondary products or waste can endanger the environment.

Moreover, the enforcement authorities exercise the powers attributed to them by art. 42 chema and, in case of danger for the environment, art. 41 chema.
If a manufacturer does not comply with an official decision, the notification body forbade him, at the request of a review body to continue delivery of substances, preparations or objects concerned.
Regarding cosmetics as well as raw materials and additives intended exclusively for them, to take measures shall be the competent service in the area. The collaboration of the FOEN is governed by arts. 62A and 62B of the Act of 21 March 1997 on the Organization of Government and administration.

SR 172.010 art. 82 monitoring in the context of national defence in the case covered by national defence, notification body shall verify, in agreement with the evaluation bodies, upon compliance with the provisions of this order.

Art. At the request of the receiving agency 83 monitoring import and export Customs offices control notifications, if the substances, preparations or objects are consistent with the provisions of this order.
Assessment bodies may request the body of notification to submit a request under para. 1. If there is presumption of infringement, customs offices are empowered to confiscate the goods at the border and to call on other enforcement authorities mentioned in this order. These are the necessary steps and stop action.

Section 4 Adaptation of the technical requirements and the list of candidate art. 84. in agreement with the SECO and the FOEN, the FOPH fits the following annexes: a. Appendix 2: 1. by defining the critical version of the annexes to the regulation EU - CLP, 2. taking into account the changes to the guidelines of the Organization for cooperation and development (OECD) for the testing of chemicals and by defining the critical version of the Regulation (EC) n 440/2008 and the manual of tests and criteria of the UN recommendations on the transport of dangerous goods, 3. by defining the critical version of annex II of the regulation EU-REACH;

b. Annex 3: it takes into account the changes of the "list of substances identified for inclusion in annex XIV of Regulation (EC) n 1907/2006" referred to in art. 59, al. 1, of the regulation EU-REACH;
c. Annex 4: it takes into account the amendments of the annexes III and VII to XI of the EU REACH regulation.

See the notes to the art. 2, al. 4 Regulation (EC) n 440/2008 of 30 May 2008 Commission establishing methods of testing in accordance with the Regulation (EC) n 1907/2006 of the European Parliament and of the Council concerning the registration, evaluation and authorization of chemical substances, as well as the restrictions applicable to these substances (REACH), OJ L 142 of the 31.5.2008, p. 1; amended lastly by Regulation (EU) n 900/2014, OJ L 247 of the 21.8.2014, p. 1.
The manual, 5th revised edition, 2013, can be accessed for free on the site of the United Nations at the following address: www.unece.org/fileadmin/DAM/trans/danger/publi/manual/Rev5/French/ST-SG-AC10-11-Rev5-FR.pdf see note on art. 2, al. 4 section 5 Delegation of tasks and skills at the third art. 85. the competent federal services may delegate to corporations under public law or private individuals all or part of tasks and powers conferred on them by this order.
What provisions on the protection of health, they cannot delegate that: a. the audit of self-regulation; b. the assessment the review of notifications and of information; c. information within the meaning of art activities. 28 chema; (d) the estimation of the risks within the meaning of art. 16 chema.

Section 6 fees art. 86. the plan and the calculation of fees for administrative acts to which the federal enforcement authorities conduct under this order are governed by the Ordinance of 18 May 2005 on the fees in application of the legislation on chemicals.

RS 813.153.1 Chapter 2 Cantons Section 1 controls later art. 87 tasks for the cantonal enforcement authorities the cantonal enforcement authorities control by sampling the substances, preparations and objects placed on the market.
As part of these controls, check: a. that the obligation to notify, to declare or to report (art. 24, 34, 48, 52, 53) and additional information (art. 46) provisions are respected; b. that the packaging comply with the provisions applicable in this area (arts. 8 and 9);. c the labelling complies with the provisions applicable in this area (art. 10-13); (d) the requirements on the provision , updating and preservation of security (art. 21 to 23) data sheets are respected and that the information contained in the safety data sheets are not obviously incorrect e. that the requirements on advertising (art. 60) and samples (art. 68) are met; (f) the obligation to provide information during the delivery of an object containing extremely worrisome substance (art. 71) is respected.

Art. 88 collaboration between cantonal and federal enforcement authorities the authority prompt notifications, on its own initiative or at the request of a review body, the cantonal enforcement authorities to conduct target testing of substances, preparations or objects, especially under art. 81, al. 1. the cantonal enforcement authorities take samples at the request of the body of notification.
If the controls give rise to major challenges, the authority which carried out the review informs the body of notification as well as the competent cantonal authorities in making decisions under art. 89. in the case of a well-founded suspicion of incorrect classification, the authority which carried out the review inform the body of notification.

Art. 89 decisions of the cantonal authorities of performance if the check shows offences against the provisions referred to in art. 87, al. 2, and 88, al. 1, the authority of the canton in which the offending person has his domicile or head office shall adopt the measures to take.

Section 2 monitoring the use and encouragement of behaviors needed art. 90. the cantonal enforcement authorities monitor compliance with the provisions governing the use of chemicals (art. 55 to 59, 61 to 67 and 69). Art. 25, al. 1, 2 sentence, chema, shall apply by analogy.
The cantons encourage behaviours EFVs.

Chapter 7 final provisions 1 repeal and amendment of other acts art. 91 repeal of another act the order of 18 May 2005 on chemicals is repealed.


[RO 2005 2721, 2007 821, 2009 401 805, 2010 5223, 2011 5227, 6103 2012, 2013 201 3041 c. I 3, 2014 2073 annex 11 c 1 3857.]

Art. 92 amendment of other acts the amendment of other acts is set in annex 6.

Chapter 2 provisions transitional art. 93. for preparations labelled and packaged before the entry into force of this order, in accordance with the art. 35 to 50 of the Ordinance of 18 May 2005 on chemicals, the following transitional provisions shall apply: a. they may be handed over until May 31, 2017, if a data security within the meaning of art. 19 of this order has been established and a communication in the sense of art. 48 of this order was made; If it's liquid textile detergents intended for private and packed in water-soluble packaging, users who do not meet the requirements of the Regulation (EU) n 1297/2014, they cannot be given until December 31, 2015; b. double labelling according to the art. 35 to 50 of the Ordinance of 18 May 2005 on chemicals and according to art. 10 of this order is not allowed; (c) the provisions of Title 4 of this order apply to the use of these preparations.

Generators of aerosol labeled and packaged before the entry into force of this order, that do not fall under the Ipegs and who do not meet the requirements of art. 9 and 11, can be submitted until May 31, 2017.
If a preparation labeled before the entry into force of this order, in accordance with art. 39 to 50 of the order of 18 May 2005 on chemicals in its December 1, 2012, is poured from its original packaging to smaller packages, unless the composition or the intended use be changed, until May 31, 2017, it can be delivered also in these smaller packages with the old labelling.
The manufacturer must meet the obligation referred to in art until June 1, 2018. 16 to develop scenarios of exposure for substances placed on the market in total quantity of 10 to 100 tonnes per year.

[RO 2005 2721, 2007 821, 2009 401 805, 2010 5223, 2011 5227, 6103 2012, 2013 201 3041 c. I 3, 2014 2073 annex 11 c 1 3857.]
Regulation (EU) n 1297/2014 the Commission of 5 December 2014 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) no 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, the 6.12.2014 OJ L 350, p. 1.
RS 817.0 Chapter 3 entry into force art. 94. this order comes into force on July 1, 2015.

Annex 1 (art. 2, para. 4, 5 and 6) equivalence of expressions and the right applicable 1 in order to correctly interpret the expressions contained in the EU-REACH regulation, the EU - CLP regulation and directive 75/324/EEC referred to in the present order, take into account the following equivalencies: EU Switzerland a. Expressions in french: manufacturer, supplier, importer, manufacturer according to art downstream user. 2, al. 1, let. b the market placed on the market pursuant to art. 4, al. 1, let. i, chema, mixture preparation article intermediate product intermediary object according to art. 2, al. 2, let. d consumer private user official advisory body Tox Info Switzerland (art. 79) b.Expressions enallemand: manufacturer, supplier, importer, nachgeschalteter users Herstellerin nach Artikel 2 presentation 1 brief b Inverkehrbringen Inverkehrbringen nach Artikel 4 presentation 1 brief i ChemG Gemisch Zubereitung Erzeugnis Gegenstand Zwischenprodukt Zwischenprodukt nach Artikel 2 about 2 brief j Verbraucher private Verwenderin public Beratungsstelle Tox Info Switzerland (Art. 79) c.Expressions enitalien : Fabbricante, fornitore, importatore, details a valle Fabbricante I sensi dell'articolo 2 capoverso 1 lettera b Immissione sul mercato Immissione sul mercato I sensi dell 'articolo 4 capoverso 1 lettera i LPChim Miscela Preparato Articolo Oggetto Sostanza intermedia Prodotto intermedio have sensi dell' articolo 2 capoverso 2 lettera j Consumator details privato Organismo di consulenza ufficiale Tox Info Switzerland (art. 79) 2 when this order refers to provisions of the EU REACH regulation or the EU - CLP regulation which, in turn, refer to one of the following provisions of these legal acts, the following provisions of Swiss law apply instead: provision of the EU REACH regulation or the EU - regulation law Swiss art. 13 of EU-reach art. 43, al. 2 of this order art. 31 of EU-reach art. 20 of this order art. 59 of the EU REACH Regulation Annex 3 to this order art. 17, al. 2, of the EU - regulation art. 10, al. 3, let. b, of the present order art. 23, let. e, of the EU - regulation legislation on explosives art. the EU - regulation art 24. 14 of this order 3 when this order refers to provisions of the EU REACH regulation or regulation EU - CLP, which, in turn, refer to other provisions of the EU law, the following Swiss law shall apply instead: right European Swiss law directive 86/609/EEC of the Council of 24 November 1986 on the approximation of legislation regulatory and administrative provisions of the Member States relating to the protection of animals used for experimental purposes or for other scientific purposes, OJ L 358 of the 18.12.1986, p. 1 Federal law of December 16, 2005, on the protection of animals Regulation (EU) No. 528/2012 of the Parliament and the Council of May 22, 2012, about the availability on the market and use of biocidal products , OJ L 167 of 27.6.2012, p. 1 order of 18 May 2005 on biocides Regulation (EC) n. 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing on the market of plant protection products and repealing directives 79/117/EEC and 91/414/EEC of the Council, OJ L 309 of 24.11.2009, p. 1 order of 12 May 2010 on plant protection products regulations for transport of goods dangerous provisions governing the postal, railway, road, air, waterway and transport driving decision of the Commission, of the 12 juillet1995, relating to the creation of a Scientific Committee for occupational exposure limits to chemical agents, OJ L 188 of the 9.8.1995, p. 14 art. 50, al. 3, of the Ordinance of 19 December 1983 on the accident prevention directive 98/24/EC of the Council of 7 April 998 regarding the protection of health and safety of workers against the risks associated with chemical agents in the workplace, JO L 131 of the 5.5.1998, p. 11 legislation on the protection of workers directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers against risks related to exposure to carcinogenic or mutagenic agents at work OJ L 158 of the 30.4.2004, p. 50 legislation on the protection of workers national occupational exposure limits list the NAC securities exposure limits at work directive 89/686/EEC of the Council positions, of December 21, 1989, concerning the approximation of the laws of Member States relating to personal protective equipment , OJ L 399 of 30.12.1989, p. 18 order of 19 May 2010 on the security of products directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain directives, JO L 312 of the 22.11.2008, p. 3 order of 4 December 2015 on the waste and order of 22 June 2005 on the movement of waste regulation (EC) n 1005/2009 of the European Parliament and of the Council of 16 September 2009 on to substances that Deplete the ozone layer, OJ L 286 of the 31.10.2009, p. 1 Annex 1.4 ORRChem Regulation (EC) No. 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending directive 79/117/EEC, OJ L 158 of the 30.4.2004, p.7 annexes 1.1, 1.9 and 1.16 ORRChem Regulation (EU) No. 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning exports and imports of goods chemical dangerous, OJ L 201 of the 27.7.2012, p. 60 order peak on November 10, 2004 directive 2012/18/EU of the European Parliament and of the Council of July 4, 2012, about control of the dangers associated with major accidents involving dangerous substances, amending and repealing directive 96/82/EC of the Council, OJ L 197 of the 24.7.2012, per 1 order of February 27, 1991 on major accidents directive 80/181/EEC of the Council , December 20, 1979, concerning the approximation of the laws of the Member States relating to units of measurement and repealing directive 71/354/EEC, OJ L 39 of the 15.2.1980, p. 40 law of June 17, 2011 on metrology and orders are related in the field of the weights and measures regulations (EC) No. 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents OJ L 104 of the 8.4.2004, p. 1 annexes 2.1 and 2.2 ORRChem update according to section 3 of annex 6 to the O from 4 dec. 2015 on waste, in force since Jan. 1. 2016 (2015 5699 RO).
See notes to art. 2, al. 4. see note on art. 2, al. 4. see note on art. 2, al. 4 RS RS RS 916.161 RS 832.30 813.12 455

The list of values workstations exposure limits can be downloaded on the website of the NAC: www.suva.ch > Prevention > job > occupational medicine > 'Exposure limit values to the workstations' RS 930.111 RS 814.600 RS 814.610 SR 814.81 RS 814.82 RS 814.012 RS 941.20 State February 1, 2016 Schedule 2 (art. 2, para. 5, 3, 6, al. 2 and 4) , 14, al. 1, let. b, 20, al. 1, 43, al. 1, and 84, let. (a) list technical key 1 requirements technical requirements for the classification, labelling and packaging of substances and preparations annexes I to VII of the EU - CLP Regulation apply for the classification, labelling and packaging of substances and preparations.

2 test methods related to the properties of the substances and preparations the tests to determine the properties of the substances and preparations must be made: a. According to the test methods defined in Regulation (EC) n 440/2008; forgotten the source. According to the guidelines of the OECD for the testing of chemicals (OECD Guidelines for the Testings of Chemicals) in their version of July 28, 2015, ouc according to test methods of the manual of tests and criteria of the UN recommendations on the transport of dangerous goods.

3 requirements 3.1 safety data sheet safety data sheet must meet the requirements of annex II of the EU REACH regulation.
3.2 equivalency of Schedule 1 must be taken into consideration for the information to be provided according to annex II, sections 1, 7, 8, 13 and 15, of the EU REACH regulation.

4 transitional provisions 4.1 preparations, packaged and labelled before the entry into force of this order which do not meet the requirements of the Regulation (EU) n 286/2011 (2 adaptation of EU - regulation to technical progress [ATP]), can be submitted until May 31, 2017.
4.2 the substances and preparations, packaged and labelled before the entry into force of this order, that do not the requirements of the Regulation (EU) n 487/2013 [4 ATP] and annex I to Regulation (EU) n 944/2013 [5 ATP], can be given as follows: a. substances: until November 30, 2016; b. preparations: until May 31, 2017.

4.3 the substance 'pitch, coal tar, high-temp. (n CE 266-028-2) as well as preparations containing them, including classification and labelling do not meet the requirements of the Regulation (EU) n 944/2013, may be released until March 31, 2016.
4.4 the substances which are listed in the Regulation (EU) n 605/2014 [6 ATP] as well as preparations containing them, including classification and labelling do not meet the requirements of the regulation, may be released until December 31, 2015.
4.5 textile liquid detergents intended for private and packed in water-soluble packaging, users who do not meet the requirements of the Regulation (EU) n 1297/2014 can be submitted until 31 December 2015.

5 transitional provisions of the amendment of 2 November 2015 5.1 substances and preparations whose German labelling does not meet the requirements of the EU - CLP regulation according to the corrigendum of April 10, 2015, may be submitted until 10 October 2016.
5.2 substances which are listed in the Regulation (EU) 2015/1221 (ATP 7), as well as preparations containing them, including the classification and labelling do not meet the requirements of the regulation, may be released until December 31, 2016.
5.3 for the substances and preparations for which a safety data sheet has been established according to the old law prior to the entry into force of the amendment of 2 November 2015, a data sheet of annex II of the EU REACH regulation security should be established at the latest by 1 June 2017.

Update according to section I of the O of the FOPH from 2 nov. 2015, in effect since Dec. 1. 2015 (2015 4429 RO).
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 regulations (EC) No. 1907/2006, OJ L 353 of 31.12.2008, p. 1; amended lastly by Regulation (EC) 2015/1221, OJ L 197 of 25.7.2015, p. 10.
Regulation (EC) n 440/2008 of the Commission of 30 May 2008 establishing methods of testing in accordance with the Regulation (EC) n 1907/2006 of the European Parliament and of the Council concerning the registration, evaluation and authorization of chemical substances, as well as the restrictions applicable to these substances (REACH), OJ L 142 of the 31.5.2008, p. 1; amended lastly by Regulation (EU) n 900/2014, OJ L 247 of the 21.8.2014, p. 1.
The guidelines of the OECD for the testing of chemicals may be consulted free of charge at the following address: www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals_chem_guide_pkg-en the manual, 5th revised edition, 2013, can be accessed for free on the site of the United Nations at the following address: www.unece.org/fileadmin/DAM/trans/danger/publi/manual/Rev5/French/ST-SG-AC10-11-Rev5-FR.pdf Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration evaluation and authorization of chemical substances, as well as the restrictions applicable to these substances (REACH), establishing a European Chemicals Agency, amending directive 1999/45/EC and repealing Regulation (EEC) No 793/93 of the Council and Regulation (EC) No 1488/94 the Commission directives 91/155/EEC and directive 76/769/EEC of the Council 93/67/EEC, 93/105/EC and 2000/21/EC of the Commission, OJ L 396 of the 30.12.2006, p. 1; amended lastly by Regulation (EU) No. 2015/830, JO L 132 of the 29.5.2015, p. 8.
Regulation (EU) n 286/2011 Commission March 10, 2011 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) n 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, version of the OJ L 83 of the 30.3.2011, p. 1.
Regulation (EU) n 487/2013 the Commission on 8 may 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) n 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, version of the OJ L 149 of the 1.6.2013, p. 1.
Regulation (EU) n 944/2013 the Commission on 2 October 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) n 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, version of the 3.10.2013 JO L 261, p. 1.
Regulation (EU) n 605/2014 the Commission of 5 June 2014 amending, for the purposes of additions of hazard statements and precautionary statements in the Croatian language and for the purposes of its adaptation to scientific and technical progress, Regulation (EC) n 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures version of the OJ L 167 of the 6.6.2014, p. 1.
Regulation (EU) n 1297/2014 the Commission of 5 December 2014 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) n 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, version of the OJ L 350 of the 6.12.2014, p. 1.
Corrigendum to 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, modi-based and repealing directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No. 1907/2006. OJ L 94 of the 10.4.2015, p. 9 of the German version.
Regulation (EU) 2015/1221 Commission July 24, 2015, amending regulations (EC) no 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures for the purposes of its adaptation to scientific and technical progress, version of the OJ L 197 of the 25.7.2015, p. 10.

Status as of February 1, 2016 annex 3 (art. 70, para. 1 and 84, let. b) list of very high concern substances ('candidate list') this list has been updated last on 1 September 2015 and includes 163 substances.

Name of the substance information substance No. CE No. case reason for inclusion in the 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 esters for reproduction 1, 2-Benzenedicarboxylic acid, di-C6-10-alkyl; 1, 2-Benzenedicarboxylic acid, mixed decyl and hexyl and protection diesters with ≥0.3% of dihexyl phthalate (EC No. 201-559-5) 271-094-0, 272-013-1 68515-51-5;
68648-93-1 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 health 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-triazinane-2,4,6-trione (TGIC) 219-514-3 2451-62-9 Mutagenic 1,3,5-tris[(2S 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione and (a-TGIC) 423-400-0 59653-74-6 Mutagenic 1-bromopropane (n-other bromide) 203-445-0 106-94-5 Toxic for reproduction 1-Methyl-2-pyrrolidone 212 - 828 - 1 872 - 50 - 4 Toxic for reproduction 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) 247-384-8 25973-55-1 PBT and vPvB 2-benzotriazol-2-yl-4 , 6-di-tert-butylphenol (UV-320) 223-346-6 3846-71-7 PBT and vPvB 2,2' - dichloro-4, 4' - methylenedianiline 202-918-9 101 - 14 - 4 2 Carcinogenic, 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-hexylphtalate 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOWRY) 239-622-4 15571-58-1 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 UVCBS substances, polymers counterparts and 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]dimethylammonium 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)

219-943-6

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 Carcinogenic 101-80-4;
Mutagenic 4-Aminoazobenzene 200 - 453 - 6 60 - 09 - 3 Carcinogenic 4-methyl-m-phenylenediamine (toluene-2, 4-diamine) 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 UVCBS-and well-defined substances which include any of the individual 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 UVCBS - and well-defined substances, polymers and counterparts, which include any of the individual isomers and/or combinations thereof] Equivalent level of concern having probable serious effects to the environment 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1 3 - dioxane [1] 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] covering any of the individual stereoisomers of [1] and [2] or any combination thereof - vPvB 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, 257-175-3 basic 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, chromic acid and dichromic acid of Oligomers.

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 Paraffins international) 287-476-5 85535-84-8 PBT and vPvB 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, gold 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 micrometers (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 (PFOA) 223-320-4 3825-26-1 Toxic for reproduction;
PBT Anthracene 120-12-7 204-371-1 PBT Anthracene oil 292-602-7 90640-80-5 Carcinogenic [1], PBT and vPvB Anthracene oil, anthracene paste 292-603-2 Carcinogenic 90640-81-6 [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

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
Equivalent level of concern having probable serious effects to the environment

Bis (2-methoxyethyl) ether

203-924-4

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;
vPvB 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;
Equivalent level of concern having probable serious effects to human health 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 fluoride 232-222-0 7790-79-6 Carcinogenic, Mutagenic, Toxic for reproduction and Equivalent level of concern having probable serious effects to human health Cadmium oxide 215-146-2 19-1306-0 Carcinogenic.
Equivalent level of concern having probable serious effects to human health Cadmium sulphate 233-331-6 10124-36-4;
31119-53-6 Carcinogenic, Mutagenic, Toxic for reproduction and Equivalent level of concern having probable serious effects to human health Cadmium useless 215-147-8 1306-23-6 Carcinogenic.
Equivalent level of concern having probable serious effects to human health 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 Cobalt (II) diacetate 200-755-8 71-48-7 Carcinogenic and toxic for reproduction Cobalt (II) 233-402-1 understood 10141-05-6 Carcinogenic and toxic for reproduction Cobalt (II) 233-334-2 sulphate 10124-43-3 Carcinogenic and toxic for reproduction Cyclohexane-1 2 - dicarboxylic anhydride [1], cis-cyclohexane-1, 2-dicarboxylic anhydride [2], trans-cyclohexane-1, 2-dicarboxylic anhydride [3] The individual cis - [2] and trans - [3] isomer substances and all possible combinations of the cis - and trans-isomers [1] are covered by this entry 201-604-9;
236-086-3;
238-009-9 85-42-7;
13149-00-3;
14166 21-3 Equivalent level of concern having probable serious effects to human health arsenic pentoxide 215-116-9 1303-28-2 Carcinogenic arsenic trioxide 215-481-4 1327-53-3 Carcinogenic Diazene-1, 2-dicarboxamide (C, it-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; 201-861-7 88-85-7 Toxic for reproduction Dioxobis (stearato) 235-702-8 trilead 12578-12-0 Toxic for reproduction Dipentyl phthalate (DPP) 205-017-9 131 - 18-0 Toxic for reproduction 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate soda) (C.I. Direct Red 28) 209-358-4 573 - 58 - 0 Carcinogenic Disodium 4-amino-3-[[4'-[(2,4-diaminophenyl)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, 215-540-4 State 1303-96-4 / 1330-43-4 / 12179-04-3 Toxic for reproduction


Fatty acids, C16-18, lead salts 292-966-7 91031-62-8 Toxic for reproduction Formaldehyde, reaction products with aniline 500-036-1 oligomeric 25214-70-4 Carcinogenic Formamide 200-842-0 75-12-7 Toxic for reproduction Furan 203-727-3 110-00-9 Carcinogenic Henicosafluoroundecanoic acid 4-165-218 2058-94-8 vPvB Heptacosafluorotetradecanoic 206-803-4 376 acid - 06 - 7 vPvB Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified: Alpha-hexabromocyclododecane hexabromocyclododecane Beta 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 trans- stereo 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 Lead understood 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, no, no-tetramethyl-4, 4' - methylenedianiline (Michler's base) 202-959-2 101 - 61 - Carcinogenic 1, N, N-dimethylacetamide 204-826-4 127-19-5 Toxic for reproduction N, N-dimethylformamide 200-679-5 68-12-2 Toxic for breeding N-methylacetamide 201-182-6 79-16-3 Toxic for reproduction N-pentyl-isopentylphthalate-776297-69-9 Toxic for reproduction o-aminoazotoluene Carcinogenic Orange lead (lead tetroxide) 202-591-2-97-56-3 215-235-6-1314-41-6 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;
PBT Pentalead tetraoxide sulphate 235-067-7 12065-90-6 Toxic for reproduction Pentazinc chromate octahydroxide 256-418-0 49663-84-5 Carcinogenic 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 Carcinogenic 65996-93-2, 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 reaction of 2-hexylphtalate mass 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-hexylphtalate 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3 5-dithia-4-stannatetradecanoate (reaction mass of DOWRY and MOTE) - Toxic for reproduction Silicic acid (H2Si2O5), barium salt (1:1), lead-windows with lead (Pb) content above the applicable generic concentration limit for ' toxicity for reproduction' representative. 1 has (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 5-271-272 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

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 micrometers (µm).

-Extracted from Index No..
650-017-00-8 a,a-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol Carcinogenic (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 [*] The EC number includes both State and hydrated forms of a substance and consequently the entries cover both these forms. The case number may be included for the State form only, and therefore the case 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).]

Update according to the erratum on Sept. 8. 2015 (2015 3017 RO) and section I of the O of the FOPH from 2 nov. 2015, in effect since Dec. 1. 2015 (2015 4429 RO).

State on 1 February 2016 Schedule 4 (art. 2, para. 5, 25, 26, para. 2, 27, al. 2, let. b, 47, para. 1 and 84, let. c) 1 General information 1.1 technical file the technical file information can be submitted in a form accepted by the European Chemicals Agency. In this case, certain expressions may be different from those mentioned in this annex.
1.2 the information required in points 7 to 10 depend on decisive substance quantity pursuant to art. 25 2 General information on the notifier 1.1 it is necessary to indicate the identity of the notifier, in particular: a. its name, address, telephone number and e-mail address; b. contact person; (c) where applicable, the geographical location of production sites of the notifier;

1.2 in addition, if the Notifier is exclusive representative, it is necessary to provide: a. the name and address of the foreign manufacturer; b. the location of production sites; c. a power of Attorney from the foreign manufacturer attesting that he has designated the notifier as exclusive representative; (d) the names and addresses of the importers represented; e. the annual quantities that each importer intends to import.

3 identification of the substance it is necessary to provide the following information on the substance: a. the data in accordance with annex VI, section 2, of the EU REACH Regulation; (b) for Nanomaterials: data on the composition and the case may be, to the surface coating and Functionalization of surface.

4 information on the manufacture and usage there is need to provide the following information:

a. the total amount that the notifier intends to put on the market during the calendar year of notification; (b) the amount used for his own uses; c. the form or physical state under which the substance is provided; d. a succinct description of the identified uses; e. data on waste quantities and composition of waste resulting from the manufacture of the substance use in objects and identified uses; f. deprecated uses (section 1.2 of the safety data sheet).

5 classification and labelling there are be indicated: a. the classification of the substance in accordance with art. 6, al. 1, for all classes and categories of danger of the EU - CLP regulation; If no classification is given for a hazard class or differentiation of a hazard class, you should indicate the reasons; b. labelling of the substance according to the provisions of art. 10; c. any specific concentration resulting from the application of the art limits. 10 the EU - CLP regulation.

6 tips for safe use there to indicate the following information, which must be consistent with those appearing on the safety data sheet, in case it is required according to art. 19: a. first aid (point 4 of the safety data sheet); b. measures of firefighting (ch. 5 of the safety data sheet); c. measures to be taken in case of accidental release (ch. 6 of the safety data sheet); d. handling and storage (ch. 7 of the safety data sheet); e. information relating to the transport (No. 14 of the safety data sheet); f. exposure controls and personal protection) section 8 of the safety data sheet); g. stability and reactivity (No. 10 of the safety data sheet); h. disposal considerations. Information on recycling and methods of disposal for professional and private users (ch. 13 of the safety data sheet).

7 information on exposure (1-10 tonnes per year) for the substances which the decisive quantity according to art. 25 is between 1 and 10 tonnes per year, it is necessary to provide the following information on the exhibition: a. main use categories: 1. professional use, commercial use 2, 3 use private;

b. specifications for professional and commercial use: 1. use in a closed system, 2 use inclusion in or on a matrix, 3 non-dispersive use, 4 dispersive use;

c. important exposure routes: 1. human exposure: oral, cutaneous and inhalation, 2 exhibition of the environment: water, air, solid waste and soil, 3 exhibition plan: accidental/little common, occasional or continuous / frequent.

8 information on the physicochemical properties it is necessary to provide the following information: a. for determining amounts under art. 25 equal to or greater than 1 tonne per year: 1. summaries of trials consistent on the information referred to in annex VII, section 7, of the EU REACH regulation, 2. for Nanomaterials: the shape of the particles and their medium size, as well as, where such information is available, grain size distribution, volume specific surface and the State of aggregation;

b. for the decisive quantities according to art. 25 equal to or greater than 100 tonnes per year: in addition to the information required by the let. a, summaries of trials consistent on the information referred to in annex IX, section 7, of the EU REACH regulation.

9 toxicological information there is to provide summaries of consistent testing for the following information: a. for amounts equal or exceeding 1 tonne per year: the information referred to in annex VII, section 8, of the EU REACH Regulation; (b) for equal amounts or exceeding 10 tonnes per year: in addition to the information required by the let. a, the information referred to in annex VIII, section 8, of the EU REACH Regulation; (c) for equal amounts or exceeding 100 tonnes per year: in addition to the information required by the let. a and b, the information referred to in annex IX, section 8, of the EU REACH regulation; d. for equal amounts or exceeding 1000 tons per year: in addition to the information required by the let. a to c, the information referred to in annex X, section 8, of the EU REACH regulation.

10 ecotoxicological information there is to provide summaries of consistent testing for the following information: a. for amounts equal or exceeding 1 tonne per year: the information referred to in annex VII, section 9, of the EU REACH Regulation; (b) for equal amounts or exceeding 10 tonnes per year: in addition to the information required by the let. a, the information referred to in annex VIII, section 9, of the EU REACH Regulation; (c) for equal amounts or exceeding 100 tonnes per year: in addition to the information required by the let. a and b, the information referred to in annex IX, section 9, of the EU REACH regulation; d for amounts equal or exceeding 1000 tonnes per year: in addition to the information required by the let. a to c, the information referred to in annex X, section 9, of the EU REACH regulation.

11 possibility to waive some tests it is possible to waive some of the tests mentioned in points 8 to 10 when, in application of the criteria set out in annex XI of the EU REACH regulation: a. the trials do not appear as necessary from the scientific point of view; b. trials are technically impossible; c. the exposure assessment allows to waive certain tests.

Regulation (EC) n 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, evaluation and authorization of chemical substances, and the restrictions applicable to these substances (REACH), establishing a European Chemicals Agency, amending directive 1999/45/EC and repealing Regulation (EEC) n 793/93 of the Council and Regulation (EC) n. 1488/94 the Commission directives 91/155/EEC and directive 76/769/EEC of the Council 93/67/EEC, 93/105/EC and 2000/21/EC of the Commission, OJ L 396 of the 30.12.2006, p. 1; amended lastly by Regulation (EU) 2015/326, JO L 58 of the 3.3.2015, p. 43.
See notes to annex 2, Chapter 1.

Status as of February 1, 2016 annex 5 (art. 61) Substances and preparations of groups 1 and 2 1 Substances and preparations labelled according to EU - regulation 1.1 group 1a.

in relation to H300: deadly if swallowed, or H310: fatal by skin contact, or H330: deadly by inhalation, or combination of references to dangers above.

b. c.

Substances and preparations according to annex 1.10 ORRChem labelled with: in relation to h340′s: can induce genetic abnormalities, or H350: may cause cancer (by inhalation), or H360: can adversely affect fertility or fetal 1.2 Group 2a.

in relation to H301: toxic if swallowed, or H311: toxic by skin contact, or H331: toxic by inhalation, or combination of references to dangers above.

b. in relation to H370: proven risk of serious effects for the organs, or H372: risk proven serious effects for the bodies following repeated exposures or prolonged exposure.

c. in connection with H314: causes Burns of skin and eye damage.

d. more than a kilo container labeled with: in relation to H410: very toxic to aquatic organisms, adverse effects long term.

e. in connection with H250: spontaneously ignites in contact air, or H260: off to contact the water of flammable gases which may ignite spontaneously, or H261: off to contact the water of flammable gases.

f. H230: can explode even in the absence of air, or H231: can explode even in the absence of air to a pressure and/or high temperature (s) or EUH019: may form explosive peroxides, or EUH029: contact water, give off toxic gases, or EUH031: at the touch of an acid, gives off a poisonous gas, or EUH032: at the touch of an acid, gives off a very toxic gas.

2 substances and preparations which are not yet labeled according to EU - regulation 2.1 group 1a.

in relation to R28: very toxic if swallowed, or R27: very toxic in contact with the skin, or R26: very toxic by inhalation, or combination of R-phrases above.

b. c.

Substances and preparations according to annex 1.10 ORRChem labelled with: in relation to R46: may cause hereditary genetic alterations, or R45: may cause cancer, or R49: may cause cancer by inhalation, or R60: can impair fertility, or R61: risk during pregnancy of harm to the child.

2.2 Group 2a.

in relation to R25: toxic if swallowed, or R24: toxic in contact with the skin, or R23: toxic by inhalation, or combination of R-phrases above.

b. in connection with R39: danger of very serious irreversible effects, or R48: risk of serious effects for the health in the case of prolonged exposure.

c. in relation to R35: causes severe burns, or R34: causes burns.

d. more than a kilo container labeled with: in relation to R50/53: very toxic to aquatic organisms, may cause harmful effects in the long term to the aquatic environment.

e. in connection with R17: spontaneously flammable in air, or

R15: contact the water, out of extremely flammable gases.

f. R6: Danger of explosion in contact or without contact with air, or R19: may form explosive peroxides, or R29: contact water, give off toxic gases, or A31: in contact with an acid, gives off a poisonous gas, or R32: at the touch of an acid, gives off a very toxic gas.

See notes to art. 2, al. 4. the number of the H sentence has no need to appear on the label.
SR 814.81 number R-phrase didn't need to appear on the label.

Status as of February 1, 2016 annex 6 (art. 92) amendment of other acts...

Mod. can be found at the RO 2015 1903.

Status as of February 1, 2016

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