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July 14, 2009

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Classified information

The European Union’s new regulations covering the classification, labelling and packaging of chemicals will bring major changes for the industry, so Douglas Leech outlines what they involve.

The dream of global harmonisation (GHS) of the classification, labelling and packaging (CLP) of chemicals, originally conceived by the United Nations, came closer to fruition on 31 December 2008, when the European Union published Regulation (EC) 1272/2008, heralding the introduction of European CLP.1 While the long-term aims of these provisions are welcome – facilitating international trade, reducing costs, and improving the flow of information throughout the chemical supply chain – the new provisions will involve significant changes and costs for industry over a relatively short period of time.

The key dates in the process are: 1 December 2010, when substances must be reclassified and labelled in line with the new global system; and 1 June 2015, when the same process will be applied to mixtures (formerly called preparations).
Each element of the chemical supply chain – manufacturer, importer, downstream user, and distributor – has specific duties under the new provisions, as well as a responsibility to cooperate with other suppliers in respect of the classification, labelling and packaging of substances.

The United Nations has been developing the new system since the Rio Earth Summit in 1992. The Summit’s Agenda 21 included the mandate to create ‘a globally harmonised hazard classification and labelling system, including Safety Data Sheets and easily understood symbols’. 

Under the GHS each hazard class and category is a ‘building block’. The EU will implement the vast majority of the available ‘blocks’ (77 out of 84) and has introduced harmonisation by making the legislation a directly-acting Regulation, so EU member states do not have to pass domestic legislation. Individual countries can simply select which ‘blocks’ they wish to implement.

Thus, the new system implies increased centralisation at EU level through directly-acting regulations and the operations of the European Chemicals Agency (ECHA). The latter is responsible for developing methodologies, tools and technical guidance through REACH Implementation Projects (RIPs). For example, RIP 3.6 has been developing guidance on the classification and labelling under the proposed GHS-based Regulation, and the proposals were discussed at the 16-17 June meeting of the Competent Authority for REACH and Classification And Labelling (CARACAL).

The EU claims it has designed the GHS-based Regulation to dovetail with other European chemical legislation – particularly REACH, which came into force in June 2007.2 The resulting system aims to provide one, global framework for identifying and describing chemical hazards. This framework is complemented by a single system for communicating these hazards through symbols, labels and Safety Data Sheets.

The UK has consolidated all previous amendments to its Chemicals (Hazard Information and Packaging for Supply) Regulations (CHIP) – as well as introducing provisions to enforce the EU CLP Regulation – into CHIP 4 (Statutory Instrument 791/2009), which came into force on 6 April 2009. The UK CHIP Regulations will be repealed when the implementation of the CLP Regulation is complete in June 2015.

Classification
The classification hierarchy used by the new provisions is as follows: Explosive; Gases; Flammable; Other Flammable Materials; Oxidising Substances and Organic Residues; Toxic and Infectious Substances; Radioactive Materials; Corrosives; and Miscellaneous Dangerous Substances. The Regulation also contains more than 7000 translated classifications in the form of Annex VI table 3.1. This, along with table 3.2, replaces the list of substance classifications within the previous Directive’s Annex I, the ‘approved supply list’.

Annex VII of the CLP Regulation incorporates a ‘translation’ table, which can be used to convert classifications under the current Dangerous Substances Directive to new classifications made by applying the GHS criteria. If there is no direct equivalent, the least severe classification is assigned. The supplier has a duty to decide if a more severe classification is required.

The EU has said its intention is to help suppliers or importers of substances and mixtures comply with their obligations under the new Regulation without having to reclassify, as long as the chemical has already been classified under the existing system. However, if a supplier or importer decides not to use the ‘translation’ table they must fully re-evaluate the substance or mixture using the criteria in the Regulation.

The new CLP Regulation therefore creates a substance classification and labelling inventory that will be populated by classifications determined by industry. Much of the information provided on these classifications will be submitted as part of the suppliers’ REACH registration for those substances placed on the market.
The classification of mixtures is a slightly more complex process owing to the fact that they can contain numerous substances of different hazard classes. The regulation provides three alternative methods for the classifier to choose from:
* Test the mixture to determine classification; or
* Read across, as per Article 61; or
* Acute toxicity estimates (ATE), as per Annex I part 3.1.

The first option is usually impracticable owing to the sheer level of testing required, and the cost of compliance. The tests are the same as those required for registration under REACH. The third option, acute toxicity estimates, requires more information and is labour-intensive. It requires a different skill set and the services of a toxicologist. This method is generally assumed to be an accurate calculation method but, at present, the level of information and data available to guarantee an accurate calculation is not readily to hand. However, this process will become easier as REACH gathers pace.

Labelling
In labelling terms, the provisions introduce two ‘signal words’: Danger designates more serious hazard categories; Warning is used for less severe hazard categories. The first stage of the labelling matrix is below:
* Name, address, and telephone number of supplier;    
* Any relevant signal words;
* Nominal quantity of substance or    mixture in package;    
* Any relevant hazard statements;
* Product identifiers (name, CAS number, etc.);    
* Any relevant precautionary statements;
* Any relevant hazard pictograms;
* Any supplementary information.

The regulation does not specify a label format, just a set of label elements that must be included.

With regard to substances and mixtures sold to the general public the existing provisions (i.e. in the Dangerous Substances and Dangerous Preparations Regulations) for Tactile Warnings of Danger (TDW) and Child-Resistant Closures and Fastenings (CRC/CRF) have been retained in the new Regulation. The only change is to align the current applicable hazard classes to correspond with the new designations under CLP. Details of these requirements can be found in Article 35 and Annex II, Sections 3.1 & 3.2, of the Regulation.

Packaging
The CLP Regulation retains the existing level of basic features with which packaging for supply to the general public market should comply. First and foremost, it should be designed and constructed so that its contents cannot escape; the packaging must be compatible with the contents; it must be able to withstand the stress and strains of handling; it should not attract the attention of children; or mislead consumers.
In addition, its fastenings should not loosen during handling and it should be capable of being refastened repeatedly without leakage.

However, CLP also introduces special rules pertaining to the labelling of outer, inner and single packaging (see Article 33). These rules allow for the removal of duplicate information when packages are labelled in accordance with both CLP and transport regulations. The rules are as follows:
* Where a package consists of an outer and an inner packaging, together with any intermediate packaging, and the outer packaging meets labelling provisions in accordance with the rules on the transport of dangerous goods, the inner and any intermediate packaging shall be labelled in accordance with the CLP Regulation. The outer packaging may also be labelled in accordance with the Regulation. Where the hazard pictogram(s) required by this Regulation relate to the same hazard, as in the rules for the transport of dangerous goods, the hazard pictogram(s) required by this Regulation need not appear on the outer packaging.

* Where the outer packaging of a package is not required to meet labelling provisions in accordance with rules on the transport of dangerous goods, both the outer and any inner packaging, including any intermediate packaging, shall be labelled in accordance with the CLP Regulation. However, if the outer packaging permits the inner or intermediate packaging labelling to be clearly seen, the outer packaging need not be labelled.
* Single packages that meet the labelling provisions in accordance with the rules on the transport of dangerous goods shall be labelled both in accordance with the latter and the CLP Regulation. Where the hazard pictogram(s) required by the CLP Regulation relate to the same hazard, as in rules on the transport of dangerous goods, the hazard pictogram(s) required by this Regulation need not appear.

Conclusion
Organisations should investigate the implications to their business of the new Regulation before they run out of time. They should begin by:
* Determining what they sell – substances, mixtures, or both?
* Determine what markets or sectors they operate in;
* Determine what demands are being made by customers and/or suppliers;
* Develop a business plan and strategy to:
   – aid allocation of resources (time and staff);
   – prepare budgets;
   – investigate options;
   – minimise surprises; and
   – manage business impacts.

References
1    http://ec.europa.eu/enterprise/reach/ghs/index_en.htm
2    For previous SHP features on REACH, please see Mark Blainey’s articles ‘Within REACH‘ (June 2007) and ‘Sweet harmony‘ (November 2007)
Further Information
    Health & Safety Executive – www.hse.gov.uk/ghs/index.htm

Douglas Leech is technical manager at the Chemical Business Association.

 

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