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In many cases, substances are subject to harmonised classification in European Union according to Regulation (EC) No 1272/2008 (CLP), while mixtures should be self-classified by supplier (manufacturer, importer).
The procedure for classifying mixtures is a stepwise approach based on a hierarchy principle and depends on the type and amount of available data/information.
| 1) | If valid test data are available for the whole mixture, they have a priority to be used to determine classification. |
| 2) | Bridging principles are used if the mixture itself has not been tested to determine its hazardous properties, but there are sufficient data on similar tested mixtures to adequately characterise the hazards of the mixture. |
| 3) | If above approaches can not be applied, classification of a mixture is based on classification and concentration of its ingredients. |
Classifications are calculated for mixtures at physical states: gas. liquid and solid (Annex I, 1.0 of CLP).
| − | Gas means a substance (or mixture) which: (i) at 50 oC has a vapour pressure greater than 300 kPa (absolute); or (ii) is completely gaseous at 20 oC at a standard pressure of 101.3 kPa. |
| − | Liquid means a substance or mixture which: (i) at 50 oC has a vapour pressure of not more than 300 kPa (3 bar); (ii) is not completely gaseous at 20 oC and at a standard pressure of 101.3 kPa; and (iii) which has a melting point or initial melting point of 20 oC or less at a standard pressure of 101.3 kPa. |
| − | Solid means a substance or mixture which does not meet the definitions of liquid or gas. |
Classifications of following mixtures are not calculated.
According to Article 1 of Regulation (EC) no 1272/2008 (CLP) below mentioned substances and mixtures are exempted from the requirements of the CLP Regulation as a whole:
| ● | 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
;
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 dangers arising from ionizing radiation (OJ L 159, 29.6.1996, p. 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; |
| ● | waste as defined in Directive 2006/12/EC
;
Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste (OJ L 114, 27.4.2006, p. 9). |
| ● | Member States may allow for exemptions in specific cases for certain substances or mixtures, where necessary in the interests of defence; |
| ● | certain 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
;
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). | |
| − veterinary medicinal products as defined in Directive 2001/82/EC
;
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1). | |
| − cosmetic products as defined in Directive 76/768/EEC
;
Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ L 262, 27.9.1976, p. 169). | |
| − 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
;
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17). Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1). |
|
| − food or feeding stuffs as defined in Regulation 178/2002
, including when they are used as food additives 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) 1831/2003
, and in animal nutrition within the scope of Directive 82/471/EEC
.
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (OJ L 40, 11.2.1989, p. 27). 1999/217/EC: Commission Decision of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996 (OJ L 84, 27.3.1999, p. 1). Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29). Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (OJ L 213, 21.7.1982, p. 8). |
For mixtures, classification their physical hazards should be based on the results of tests carried out on the mixtures themselves. If such results are not available, the most careful way would be transfer physical hazards of all ingredients to the mixture. Obviously, this may lead to the overestimated classification, but in case of the absence of data for the mixture itself it looks like a reasonable approach. In turn, if no ingredient of a mixture is classified resulted from physical properties (explosive, flammable, oxidizing etc.) it is obvious that the mixture will also not be classified as hazardous for these categories.
For this reason this Online Mixture Classification Calculator does not calculate classification for physical hazards (see Guidance on the Application of the CLP Criteria, section 1.1.6.2 ).
The Calculator classifies mixtures for health and environmental hazards. Classification categories, cut-off values (Article 2(31) to CLP), concentration limits (Article 2(32) to CLP) like specific concentration limits (SCLs) and generic concentration limits (GCLs), M-factors (Article 2(34) to CLP), mixture's pH, Acute Toxicity Estimate points (ATEs) are taken into account.
Table 3 of Annex VI to CLP contains list of harmonised classification and labelling of hazardous substances. The table includes following information required for classification of mixtures: Hazard Classes, Category Codes, Hazard statement Codes, Specific Concentration Limits, M-factors and ATEs (Acute Toxicity Estimate points).
Manufacturers and importers are required to notify European Chemical Agency (ECHA) of the classification and labelling of hazardous substances placed on the European Economic Area (EEA) market and of substances subject to registration in accordance with the REACH Regulation. In case if there is no substance of your interest in Table 3 of Annex VI to CLP the other source of information on substance's classification is a database on ECHA's webpage where you may find also self-classified substances based on notification and registration dossiers.