TITLE I / GENERAL ISSUES

TITLE I

GENERAL ISSUES

Article 1

Purpose and scope

The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by:

harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures;

providing an obligation for:

manufacturers, importers and downstream users to classify substances and mixtures placed on the market;

suppliers to label and package substances and mixtures placed on the market;

manufacturers, producers of articles and importers to classify those substances not placed on the market that are subject to registration or notification under Regulation (EC) No 1907/2006;

providing an obligation for manufacturers and importers of substances to notify the Agency of such classifications and label elements if these have not been submitted to the Agency as part of a registration under Regulation (EC) No 1907/2006;

establishing a list of substances with their harmonised classifications and labelling elements at Community level in Part 3 of Annex VI;

establishing a classification and labelling inventory of substances, which is made up of all notifications, submissions and harmonised classifications and labelling elements referred to in points (c) and (d).

This Regulation shall not apply to the following:

radioactive substances and mixtures within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the danger arising from ionising radiation ( 1 ); 1 1

substances and mixtures which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;

non-isolated intermediates;

substances and mixtures for scientific research and development, which are not placed on the market, provided they are used under controlled conditions in accordance with Community workplace and environmental legislation.

This Regulation shall not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user:

medicinal products as defined in Directive 2001/83/EC;

veterinary medicinal products as defined in Directive 2001/82/EC;

cosmetic products as defined in Directive 76/768/EEC;

medical devices as defined in Directives 90/385/EEC and 93/42/EEC, which are invasive or used in direct physical contact with the human body, and in Directive 98/79/EC;

food or feeding stuffs as defined in Regulation (EC) No 178/2002 including when they are used:

as a food additive in foodstuffs within the scope of Directive 89/107/EEC;

as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC;

as an additive in feeding stuffs within the scope of Regulation (EC) No 1831/2003;

in animal nutrition within the scope of Directive 82/471/EEC.

Article 2

Definitions

For the purpose of this Regulation, the following definitions shall apply:

‘hazard class’ means the nature of the physical, health or environmental hazard;

‘hazard category’ means the division of criteria within each hazard class, specifying hazard severity;

‘hazard pictogram’ means a graphical composition that includes a symbol plus other graphic elements, such as a border, background pattern or colour that is intended to convey specific information on the hazard concerned;

‘signal word’ means a word that indicates the relative level of severity of hazards to alert the reader to a potential hazard; the following two levels are distinguished:

‘Danger’ means a signal word indicating the more severe hazard categories;

‘Warning’ means a signal word indicating the less severe hazard categories;

‘hazard statement’ means a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard;

‘precautionary statement’ means a phrase that describes recommended measure(s) to minimise or prevent adverse effects resulting from exposure to a hazardous substance or mixture due to its use or disposal;

‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

‘mixture’ means a mixture or solution composed of two or more substances;

‘article’ means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;

‘producer of an article’ means any natural or legal person who makes or assembles an article within the Community;

‘polymer’ means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:

a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;

less than a simple weight majority of molecules of the same molecular weight.

In the context of this definition a ‘monomer unit’ means the reacted form of a monomer substance in a polymer;

‘monomer’ means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;

‘registrant’ means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance under Regulation (EC) No 1907/2006;

‘manufacturing’ means production or extraction of substances in the natural state;

‘manufacturer’ means any natural or legal person established within the Community who manufactures a substance within the Community;

‘import’ means the physical introduction into the customs territory of the Community;

‘importer’ means any natural or legal person established within the Community who is responsible for import;

‘placing on the market’ means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market;

‘downstream user’ means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) of Regulation (EC) No 1907/2006 shall be regarded as a downstream user;

‘distributor’ means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties;

‘intermediate’ means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as ‘synthesis’);

‘non-isolated intermediate’ means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;

‘the Agency’ means the European Chemicals Agency established by Regulation (EC) No 1907/2006;

‘competent authority’ means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation;

‘use’ means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation;

‘supplier’ means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture;

‘alloy’ means a metallic material, homogeneous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means; alloys are considered to be mixtures for the purposes of this Regulation;

‘UN RTDG’ means the United Nations Recommendations on the Transport of Dangerous Goods;

‘notifier’ means the manufacturer or the importer, or group of manufacturers or importers notifying to the Agency;

‘scientific research and development’ means any scientific experimentation, analysis or chemical research carried out under controlled conditions;

‘cut-off value’ means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture, above which threshold these shall be taken into account for determining if the substance or the mixture, respectively, shall be classified;

‘concentration limit’ means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture that may trigger classification of the substance or the mixture, respectively;

‘differentiation’ means distinction within hazard classes depending on the route of exposure or the nature of the effects;

‘M-factor’ means a multiplying factor. It is applied to the concentration of a substance classified as hazardous to the aquatic environment acute category 1 or chronic category 1, and is used to derive by the summation method the classification of a mixture in which the substance is present;

‘package’ means the complete product of the packing operation, consisting of the packaging and its contents;

‘packaging’ means one or more receptacles and any other components or materials necessary for the receptacles to perform their containment and other safety functions;

‘intermediate packaging’ means packaging placed between inner packaging, or articles, and outer packaging;

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‘acute toxicity estimates’ means numeric values which are used to classify substances and mixtures in one of four acute toxicity hazard categories based on the oral, dermal or inhalation exposure route;

‘data carrier’ means a linear bar code symbol, a two-dimensional symbol or other automatic identification data capture medium that can be read by a device;

‘refill’ means an operation by which a consumer or a professional user fills packaging with a hazardous substance or mixture offered by a supplier in the course of a commercial activity, whether in return for payment or free of charge;

‘refill station’ means a place where a supplier offers to consumers or professional users hazardous substances or mixtures that can be acquired through refill, either manually or through automatic or semi-automatic equipment.

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Article 3

Hazardous substances and mixtures and specification of hazard classes

A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex.

Where, in Annex I, hazard classes are differentiated on the basis of the route of exposure or the nature of the effects, the substance or mixture shall be classified in accordance with such differentiation.

Article 4

General obligations to classify, label and package

Without prejudice to the requirements of paragraph 1, manufacturers, producers of articles and importers shall classify those substances not placed on the market in accordance with Title II where:

Articles 6, 7(1) or (5), 17 or 18 of Regulation (EC) No 1907/2006 provide for registration of a substance;

Articles 7(2) or 9 of Regulation (EC) No 1907/2006 provide for notification.

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The harmonised classification of that substance shall apply to all its forms or physical states unless an entry in Part 3 of Annex VI specifies that a harmonised classification applies to a specific form or physical state of that substance.

However, where the substance also falls within one or more hazard classes or differentiations or it is in a form or physical state not covered by an entry in Part 3 of Annex VI, its classification in accordance with Title II shall be carried out for those hazard classes, differentiations and forms or physical states.

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