Compliance and safety for the supply of chemical products
CLASSIFICATION
Classification and labelling of substances and mixtures according the Dangerous Substances Directive (67/548/EEC) and Dangerous Preparations Directive (99/45/EC) - 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 Dangerous Preparations Directive (99/45/EC).
Further information
Classification
Until the provision of the CLP Regulation take over, classification of chemical substances and mixtures is based on two major pieces of European legislation:
- For substances: Directive 67/548/EEC, known as the Dangerous Substances Directive (DSD). Labelling and packaging of substances has been superseded by the CLP Regulation since December 2010, although suppliers must continue to classify substances according to the DSD until June 2015.
- For mixtures: Directive 99/45/EC, known as the Dangerous Preparations Directive (DPD). The system of classification described in the CLP Regulation will be mandatory for mixtures from June 2015, although suppliers may bring in CLP labelling and packaging earlier. Suppliers need to classify mixture according to both DPD and CLP until June 2015.
As Directives, 67/548/EEC and 99/45/EC were transposed into national legislation before they become effective. In the UK, they were transposed as the CHIP [Chemicals (Hazard Information and Packaging for Supply)] Regulations, administered by the Health and Safety Executive (HSE).
The European Directives and the associated parts of the CHIP Regulations will be superseded by EC Regulation 1272/2008 (CLP Regulation), but their provisions will continue for now according to the transitional arrangements described in the CLP Regulation. Note that a Regulation, in contrast to a Directive, is directly effective in all EU Member States, so the CLP Regulation is not transposed into UK legislation. The transition period ends 1 June 2015, and until that date an understanding of the DSD/DPD classification system is important.
The backbone of the DSD/DPD system is the classification of dangerous chemicals into one or more of 15 categories of danger: explosive, oxidising, extremely flammable, highly flammable, flammable, very toxic, toxic, harmful, corrosive, irritant, sensitising, carcinogenic, mutagenic, toxic for reproduction, and dangerous for the environment.
For substances, the DSD labelling and packaging is obsolete, but suppliers must still classify substances according to the DSD, and the classification should be recorded in Section 3 of the SDS for hazardous ingredients.
Mandatory classifications for certain substances are given in the CLP Regulation, Annex VI, Table 3.2. This Table is a transposition of Annex I of the DSD, so the latter has now been repealed.
For substances without a mandatory classification, suppliers have to determine the appropriate symbols and warnings for their chemicals (self-classification), according to the criteria in the labelling guide (UK Approved Classification and Labelling Guide, or Annex VI of 67/548/EEC), which gives instructions on how the convert the physico-chemical, toxicological and ecotoxicological data into:
- Categories of danger (flammable, toxic, irritant, etc)
- Hazard symbols (eg skull and crossbones for toxic substances)
- Risk phrases (eg R25 toxic if swallowed)
- Safety phrases (eg S22 do not breath dust)
Each category of danger is associated with risk phrases ‘R-phrases’ (e.g. R20 harmful by inhalation). Once the classification is determined, the safety phrases ‘S-phrases’ (eg wear suitable gloves) can be assigned, and the specific hazard information is communicated to the recipient of the chemical through both safety data sheets (SDSs), and appropriate labelling.
Mixtures
Mixtures (called preparations in earlier legislation), are defined as deliberate mixtures of substances, and constitute by far the greatest proportion of supplied chemicals. It is possible for some direct testing of mixtures, especially for physical properties, but there are often practical or ethical difficulties associated with the testing for toxicological or ecological hazards.
Mixtures are therefore usually classified for such hazards from information on the classification and percentages of their ingredients, according to the so-called calculation method. This may involve simple threshold values (either generic values given in the DPD, or specific values given in the CLP Regulation, Annex VI), or more complex calculation if there are several hazardous components. If the preparation is classified as dangerous, its packaging needs to carry labelling, and the supplier is obligated to provide a safety data sheet.
There are generic exemptions from classification for mixtures that contain dangerous substances at low levels, eg very toxic or toxic substances at less than 0.1%, or harmful, corrosive or irritant substances below 1%. Specific limits for certain chemicals are given in the CLP Regulation, and these take precedence over generic limits.
Explosivity, flammability, and related properties do not have to be considered in mixtures if none of the ingredients possesses such properties.
The calculation method is recommended for toxicological endpoints that require vertebrate animal testing (eg acute toxicity), although the results from testing, if available, take precedence over those derived from calculations for purposes of classification. Some specific health effects (mutagenicity, carcinogenicity, and toxic for reproduction), and environmental effects (biodegradation and bioaccumulation potential) can only be evaluated by the calculation method.
Labelling issues
The supplier must label the container with the following information:
- Trade name of mixture
- Supplier (name, full address, and telephone number)
- Symbols and indications of danger
- Risk and Safety phrases
- For mixtures, the names of some hazardous ingredients (see DPD, Article 10.2.3)
- For mixture sold to the public, the nominal quantity (unless specified elsewhere on the packaging)
Mixtures containing low concentrations of sensitising substances may require special labelling. The scheme generally requires that mixtures containing greater than 1% of a skin sensitiser is labelled with the R43 phrase, ‘May cause sensitisation by skin contact.’ However, if such a substance is present at 0.1 to 1%, DPD requires the labelling phrase, ‘Contains (name of sensitising substance). May produce an allergic reaction.’ Some preservative and fragrance substances fall into this category and may impact additional labelling of consumer products.
There are further special labelling requirements for other types of product, such as aerosols, isocyanates, and epoxy compounds.
The final aspect is packaging, which ensures that the dangerous chemical is delivered in appropriate containers, for example having a child-resistant closure or a tactile warning of danger for certain substances that are supplied to the public.
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