Regulatory compliance for chemical, cosmetic and biocidal products.
CHEMICALS
Supply Classification according to current EU criteria
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 1 (of 67/548/EEC; known in the UK as the Approved Supply List), or requires self-classification using available data, such as study reports, literature searches, and structure–activity relationships.
Manufacturers, distributors, and importers of dangerous substances that appear in EINECS are obliged to make themselves aware of the relevant and accessible data concerning the properties of their products. Alchemy Compliance can fulfil this obligation on your behalf, through literature searching and structure–activity relationships. This also fulfils the ‘due diligence’ requirement (Regulation 15 of UK CHIP legislation), which is a defence in any proceedings for an offence in contravention of the provisions of UK CHIP Regulations.
Alchemy Compliance can also classify preparations, either from test data, or by calculation according to the Dangerous Preparations Directive (99/45/EC) (so-called conventional method).
The EU provisions for classification and labelling apply to industrial chemical and biocides.
Further information
Classification
The CHIP [Chemicals (Hazard Information and Packaging for Supply)] Regulations, administered by the Health and Safety Executive (HSE), govern the supply, manufacture, import and/or distribution of dangerous chemicals in the UK. Such Regulations, first introduced in the UK in 1993, have been regularly updated to keep up with amendments to the parent European Directives (67/548/EEC, the Dangerous Substances Directive; 99/45/EC, the Dangerous Preparations Directive). The most recent update, ‘CHIP3’, was a consolidation of the existing CHIP regulations, plus the implementation of several major new initiatives, particularly the environmental classification of preparations.
CHIP comprises 19 Regulations, including:
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Scope of the Regulations, including exemptions (number 3)
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Details of the Approved Supply List (ASL) (number 4). The ASL implements Annex I of 67/548/EEC, as amended and adapted. The ASL contains the following hazard communication information approved at EC level: names, index number, CAS number, classification, labelling data, EC number, concentration limits for preparations
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Classification criteria of substances and preparations dangerous for supply (number 5)
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Safety data sheets for substances and preparations dangerous for supply (number 6)
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Packaging and labelling of substances and preparations dangerous for supply (numbers 8 and 9)
The backbone of the CHIP regulations is the classification of dangerous chemicals into one or more of 15 categories: explosive, oxidising, extremely flammable, highly flammable, flammable, very toxic, toxic, harmful, corrosive, irritant, sensitisation, carcinogenicity, mutagenicity, toxicity for reproduction, and dangerous for the environment.
For new substances, and other substances not on the ASL (particularly ‘exsiting substance’, ie those on EINECS), suppliers have to determine the appropriate symbols and warnings for their chemicals (self-classification). The labelling guide (UK Approved Classification and labelling guide, or EU 2001/59/EC) gives instructions on how the convert the physico-chemical, toxicological and ecotoxicological data into:
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Categories of danger (flammable, toxic, irritant, etc)
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Hazard symbol (eg skull and crossbones for toxic substances)
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Risk phrases (eg R25 toxic if swallowed)
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Safety phrases (eg S22 do not breath dust)
Each category of danger is associated with risk phrases ‘R-phrases’ (e.g. 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. The final aspect in CHIP is packaging, which ensures that the dangerous chemical is delivered in appropriate containers. As an example having the child-resistant closures or a tactile warning of dangers for certain substances that are supplied to the public.
Preparations
Preparations, defined as mixtures of substances, constitute by far the greatest proportion of supplied chemicals. There is some provision for testing the toxicity of the preparations directly, but there may be practical difficulties associated with the required methodology. Preparations are therefore usually classified from information on the classification and percentages of their components, according to the conventional method. This may involve simple threshold values, or more complex calculation if there are several hazardous components. If the preparation is classified, its packaging needs to carry labelling, and the supplier is obligated to a safety data sheet.
Suppliers classify dangerous preparations according to the EU Directive 99/45/EEC (the Dangerous Preparations Directive), which is enacted in the UK as part of CHIP. Dangerous preparations contain at least one dangerous substance. There are general exemptions from classification for preparations containing dangerous substances at low levels, eg very toxic or toxic substances at less than 0.1%, or harmful, corrosive or irritant substances below 1%. Limits for specific chemicals are sometimes given in the ASL and these take precedence over generic limits given in CHIP.
Explosivity, flammability, and related properties do not have to be considered in preparations if none of the constituents possesses such properties.
The conventional method is preferred over testing of the preparation for endpoints (eg acute toxicity) that require animal testing, although the results from testing take precedence over those derived from calculations. Some specific health effects (mutagenicity, carcinogenicity, and toxic for reproduction), and environmental effects (biodegradation and bioaccumulation potential) can only be evaluated by the conventional method.
Labelling issues
The supplier must label the container with the following information:
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Substance name
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Supplier
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Symbols and indication of danger
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Risk and Safety phrases
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For substances, the EC number
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For substances appearing in the ASL, the words EC label
Preparations containing low concentrations of sensitising substances may require labelling. The scheme requires generally that preparations containing greater than 1% of a skin sensitiser is also labelled with the R43 phrase, ‘May cause sensitisation by skin contact.’ If such a substance is present at 0.1 to 1%, CHIP 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.
New substances with less than base-set testing are additionally labelled with the phrase: Caution – substance not yet fully tested. This labelling is not applicable to existing substances.
There are further specific labelling requirements for certain substances, such as isocyanates, epoxy compounds, and isocyanate adhesives.
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