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CLASSIFICATION

Classification under CLP Regulation - Our services

Alchemy Compliance has extensive experience in the classification of chemical substances according to EU criteria. We can advise whether a substance has a mandatory classification, according to Annex VI of Regulation 1272/2008, or requires self-classification using available data, such as study reports, literature searches, and structure–activity relationships.

Manufacturers, distributors, and importers of chemical products are obliged to make themselves aware of the relevant and accessible data concerning their hazardous properties. Alchemy Compliance can fulfil this obligation on your behalf, through literature searching.

This also fulfils the ‘due diligence’ requirement, which is a defence in any proceedings.

Alchemy Compliance can also classify preparations, either from test data, or by calculation according to the CLP Regulation (1272/2008) (calculation method).

Further information

What is the CLP Regulation?

Classification is the process of codifying hazard information into fixed categories (eg flammable, toxic, dangerous for the environment) and statements (eg irritating to skin, possible risk of harm to the unborn child), according to the criteria given in the specified legislation and guidance.

The older European system for classification and labeling of substances is Directive 67/548/EEC (the Dangerous Substances Directive; DSD), Annex VI, as amended. The criteria for classification of mixtures are given in the EU Directive 99/45/EC (Dangerous Preparations Directive; DPD).

The more recent Classification, Labeling and Packaging Regulation (CLP; EC Regulation 1272/2008) covers both substances and mixtures, and gradually supersedes the above Directives, according to the transition periods given in Articles 55 and 56. As a Regulation, CLP came into force directly in the Member States and ensures a higher degree of harmonization.

Industry had to classify, label and package substances according to the CLP Regulation at the latest by 1 December 2010. From 1 December 2010 to 1 June 2015, substances should be also classified according to the DSD. Mixtures must be classified according to the DPD before 1 June 2015 and according to the CLP after 1 June 2015. Suppliers may choose to classify, label and package according to the CLP before 2015, but must also still classify according the DPD.

There is also a two year grace period for products that are placed on the market before the classification deadlines, but are in circulation after the deadline, to be packaged and labeled according to the DSD/DPD scheme.

How does the CLP Regulation help?

REACH and the CLP Regulation helps industry form harmonized classifications for their substances and formulations by creating much greater transparency than offered in the prior classification system.

This is achieved through a classification and labeling inventory (CLP Regulation, Title V). The majority of substances are self-classified, which means that the classification is determined by suppliers, usually in collaboration with other manufacturer/importers through the REACH SIEF.

The Commission will provide harmonized, mandatory classifications for substances classified for the specific hazards of carcinogenicity, mutagenicity, toxic for reproduction, and respiratory sensitization.

Mandatory classifications for certain substances are given in the CLP Regulation, Annex VI, Table 3.1. For those hazards listed for a particular chemical, the stated classification is mandatory. Suppliers are required to check the data, and classify for hazard classes not covered in the Annex VI entry (see Art 4.3).

Where do I get data from for classification?

REACH specifies a tonnage-dependent strategy for generating data on substances. REACH Annexes VII to X cover physico-chemical, toxicological and ecotoxicological properties, often referred to as ‘endpoints’. Most of this data is expected to be generated through conventional testing.

Where testing under REACH does not prescribe information, for example toxicological information for phase-in substances of 1 to 10 tonnes, then it is possible to use other information for purposes of classification, such as available data from the literature, structure–activity relationships (SAR), or data from humans (eg epidemiology).

Principles of classification of substances

Classification of substances according to test data

The principles of classification are similar for the DSD/DPD scheme and the CLP Regulation. Once the data is available from the various sources, it is compared with criteria given in the legislation.

Once new testing or other data is available for a substance, it is necessary check whether the substance, and formulations in which it is used, require a new classification, and therefore a new label and safety data sheet.

The CLP Regulation and guidance gives instructions on how the convert the physico-chemical, toxicological and ecotoxicological data into the classification (hazard classes plus hazard phrases), and then the labelling elements as follows:

• Hazard classes (flammable liquid, skin corrosion/irritation, hazardous to the aquatic environment, etc)
• Signal word
• Pictograms (red-bordered square-set-on-point, with symbol inside)
• Hazard phrases (H-phrases; eg H302: Harmful if swallowed)
• Precautionary phrases (P-phrases; eg P270: Do not eat, drink or smoke when using this product)

Each hazard class and category is associated with specific H-phrases prescribed in the CLP Regulation. Normally, all H-phrases should be given on the label. The P-phrases are assigned according to guidance and the judgement of the supplier. A maximum of only six P-phrases should appear on the label. Guidance on labelling by hazard class can be found on in the ECHA document, Guidance on Labelling and Packaging in Accordance with Regulation (EC) No 1272/2008.

Other methods of classification under the CLP Regulation

Around 3400 substances under the DSD (Directive 67/548/EEC) had a mandatory classification (Annex I of DSD). These classifications were agreed at EU level, and have been taken without modification into the new CLP Regulation as Annex VI, Table 3.2. These substances also appear in Annex VI, Table 3.1 with the new classifications. The substance classification are harmonised and should be used unless there is good reason (ie to ensure safety) to deviate from them. However, because the criteria under the DSD and the CLP differ, particularly for acute oral toxicity (see here) and STOT RE, the harmonised classifications are sometimes flagged as being the minimum classification, so that a more severe classification can be applied if the supplier has information that would support this.

The Regulation also contains a conversion table (Annex VII, Table 1.1), which allows in most cases to interconvert between a classification under the DSD/DPD and a classification under the CLP Regulation, for both substances and mixtures. However, because of the differences between the criteria, there are instances where no conversion is possible, particularly for flammable and explosive substances. This Table is a useful rough guide, but using the data and the criteria is the more reliable approach.

Classification of mixtures

Physico-chemical properties

Testing of mixtures is not mandated under REACH, which deals only with substances (ingredients). Testing of mixtures for purposes of classification can be very useful for reasons of product stewardship and ensuring safe use of the product.

Testing of mixtures is particularly appropriate for hazardous physico-chemical properties, such as flammability, oxidising properties, and explosivity, where at least one ingredient possesses the property. For such hazards, there is no simple threshold limit that allows classification of the mixture from the amount of hazardous ingredient it contains. If a mixture is suspected of possessing the hazardous property, then it is recommended to perform a suitable test to decide on the correct classification.

Testing is also useful for general physico-chemical properties, such as melting point (or range), density, surface tension, and vapour pressure. It is less useful for properties where the ingredients of the mixture separate and express their individual values, for example for the water solubility or partition coefficient.

Toxicological properties

Toxicological testing of mixtures is rarely carried out for purposes of REACH. This is because of animal welfare concerns, and the strict ethical code under which EU laboratories operate. Testing of mixtures is considered to be unethical because there are many more mixtures than substances, and it is therefore more effective to test substances, and calculate the classification of the mixture from its composition. A justification for toxicological testing of mixtures would therefore be if there was reason to expect the calculation method was inappropriate, for example if one component increased skin absorption of another and thereby increased the potential risk. Where testing data of mixtures is available, the results override classification by other means.

Testing is not usually allowed only in order to remove an unwanted classification produced by the calculation principles outlined below.

If only one ingredient of a mixture is classified, then the mixture can classified by direct comparison of the concentration of the hazardous ingredient with the generic threshold limits for particular hazard classes, as given in the appropriate Section of Annex I, or any specific concentration limit given in Table 3.2, Annex VI, of the CLP Regulation.

For acute toxicity, the CLP Regulation introduced Acute Toxicity Estimates (ATEs; these are equivalent to LD50s in most cases) rather than concentration threshold limits. The ATE of a mixture can be calculated from the ATE of the ingredients according to the Equation in CLP Annex I, Part 3.1.3.

A detailed description of how to classify mixtures with two or more ingredients with hazardous properties can be complicated, but generally effects are regarded as additive, so the concentration of ingredients with classification in a particular hazard class are summed and compared to the threshold limits to decide whether the product is classified.

Ecotoxicological properties

Ecotoxicological properties of mixtures are handled in a similar way to toxicological properties (see above). It is unusual to test mixtures for aquatic toxicity; although the principle of aquatic testing of mixtures is sound, fish (but not Daphnia or algae) are protected under animal welfare legislation, and also analytical work necessary for ecotoxicological testing is difficult for mixtures. Where testing of mixtures for ecotoxicity has been done, the data take precedence over other methods of classification.

Testing of mixtures for biodegradation, hydrolysis, and soil adsorption are very rare, since these are considered properties of the individual components, which act independently within the test system. For example, if one were to test the ready biodegradability of a mixture comprising 90% readily biodegradable substance, and 10% non-biodegradable substance, then the result might well be that the mixture was ‘readily biodegradable’ masking the fact that the mixture contains significant amounts of non-biodegradable ingredient.

As with toxicological properties, the CLP Regulation contains harmonised classifications (Annex VI, Table 3.1 of CLP Regulation). Instead of specific concentration limits, for ecotoxicology the CLP Regulation introduces the Multipying Factor (M-factor), which is a parameter used in calculating the classification of mixtures. As the toxicity of a substance increases, so does the M-factor (see Annex I, Table 4.1.3 of the CLP Regulation). The higher M-factor increases the likelihood that a mixture containing the substance will also be classified, according to the calculations given in (see Annex I, Table 4.1.2 of the CLP Regulation).

As with toxicological properties, the CLP Regulation contains harmonised classifications (Annex VI, Table 3.1 of CLP Regulation). Instead of specific concentration limits, for ecotoxicology the CLP Regulation introduces the Multipying Factor (M-factor), which is a parameter used in calculating the classification of mixtures. As the toxicity of a substance increases, so does the M-factor (see Annex I, Table 4.1.3 of the CLP Regulation). The higher M-factor increases the likelihood that a mixture containing the substance will also be classified, according to the calculations given in Annex I, Table 4.1.2 of the CLP Regulation.

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