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October 24, 2007

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Sweet harmony

With a new system intended to harmonise the global classification, labelling and packaging of chemicals due to come into force next year, Mark Blainey examines the changes that this will bring to existing legislation.

The European Community recognised the need to establish a framework to allow for the control of chemical substances as far back as the 1960s. This led to the adoption of Council Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances.1 In the subsequent 40 years, this framework has been considerably enlarged, including the adoption of Directive 1999/45/EC on the classification, packaging and labelling of preparations.2

In the UK, the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 (CHIP) implement these EC Directives.3 CHIP requires the classification (hazard determination) of a substance or a preparation, and the communication of it, in the form of a label and a Safety Data Sheet (SDS).

The Control of Substances Hazardous to Health (COSHH) Regulations define a substance hazardous to health as a substance or a preparation, among others, as listed in Part I of the approved supply list, as dangerous for supply.4 The indication of danger specified for the substance is designated as: very toxic; toxic; harmful; corrosive; or irritant.

The main requirements of COSHH are to assess the risks of a substance, and decide what precautions are needed to prevent, or adequately control, exposure. In doing so, it sets out that risk assessments mustconsider information on health effects provided by the supplier, including information contained in any relevant SDS. For this reason, the information provided through the requirements of CHIP is vital in ensuring chemical safety.

All change

The current system for assigning classifications and hazard communication has changed, following the European Commission’s adoption of a proposal for a new regulation on Classification, Labelling and Packaging of substances and mixtures (CLAP).5 If the European Commission and Parliament can agree on its final content in time, the new legislation will come into force at the same time as the main REACH provisions (i.e. June 2008).

The main drivers behind this change are two-fold. Firstly, the regulation will implement the Globally Harmonised System (GHS) for classification and labelling. Secondly, it will streamline and update the two existing Directives.6

The need for harmony

Over the last 30 years, a number of different systems for the classification of chemicals has been developed around the world. This has led to different health, safety and environmental information being available for the same chemical, depending on its country of origin.

In 1992, the UN Conference on Environment and Development (UNCED), in Rio de Janeiro, identified the harmonisation of classification and labelling systems for chemicals as one of its action programmes. In December 2002, the GHS was agreed, and was formally adopted by the UN Economic and Social Council (ECOSOC) in July 2003.

However, at present, the author knows that only New Zealand has implemented the system – although Japan, Brazil and several other countries have plans to implement it soon.

Classification criteria

The CHIP and GHS classification systems are very similar. They cover the same structural elements, and both result in labels and SDS. In addition, the GHS covers nearly all hazards currently covered by the EU system, with similar – or equivalent – classification criteria.

However, there are differences, the main one relating to the classification of dangerous and non-dangerous chemicals. The GHS system uses a system of hazard class (the nature of the physical, health, or environmental hazard) and hazard category (according to severity), and while the EU system comprises 15 categories of danger, the GHS system comprises 27 hazard classes.

With more than 20 other EU laws currently referencing classification criteria, and often using the concept of classified as ‘dangerous’, this is an issue that needs to be addressed.

On a more detailed level, the test methods for GHS classification criteria for physico-chemical hazards are based on the ‘UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria’, and are therefore very different from the current EU system for supply and use. As a result of changes to these criteria, there will be major changes to the classification of physico-chemical hazards.

With regard to health hazards, GHS has no comparable classifications to the current EU ‘R-phrases’: R37 (respiratory sensitisation); R65 (aspiration hazards); or for the so-called ‘other toxicological properties’, which are only assigned if the substance is classified for another hazard (except for an equivalent to R64 ‘may cause harm to breast-fed babies’).

In addition, GHS has greater separation of acute toxic effects and systemic toxicity (Target Organ Systemic Toxicity: single and repeat dose). For some hazard classes, the GHS exhibits a more differentiated structure than the EU system (e.g. for acute toxicity there are five classes, as opposed to the EU system, which has three – very toxic, toxic and harmful).

The classification of preparations in both systems is structurally similar in terms of available methods, i.e. testing of mixtures, conclusions drawn from similar mixtures, and calculation methods based on the ingredients of mixtures. However, more preparations (mixtures) are likely to be classified under the

new system because of changes in the relevant cut-off values.

For environmental hazards there is a clear division in GHS of aquatic toxicity, into ‘acute’ aquatic toxicity and ‘chronic’ aquatic toxicity.

With regard to hazard communication, the main differences are in the appearance of some hazard symbols, and in the introduction of a hazard pictogram, which consists of the hazard symbol, and other graphic elements. The indication of danger, and the specification of R-phrases of the EU system will vanish; in their place, the structurally-corresponding elements of signal word and hazard statement will be introduced by the GHS.

Directive development

A simple replacement of the current scheme by the GHS would result in the loss of protection in some areas, and this has been avoided. As well as introducing the changes required by GHS, the Commission is taking the opportunity to combine and update elements of the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC).

In developing the Directives, these key principles have been followed:

– to maintain (or enhance) the existing standard of protection;

– to be as close as possible to the existing EU scheme; and

– to facilitate implementation by the industries concerned.

The main issues the Commission had to solve were the length and structure of the transitional period for application of the different requirements, and the fate of the current list of harmonised classification and labelling, as listed in Annex 1 of Directive 67/548. As a result, the Commission has recommended a transition time of three years for substances, and a further four and a half years for mixtures. As far as Annex 1 is concerned, it was decided to be completely update it.

A missed opportunity?

In developing the new system of classification and hazard communication an attempt was also made to improve the comprehensibility of information for workers and consumers. One of the annexes to the GSH provides a methodology to test comprehensibility.

However, has an opportunity been missed? Several studies have shown that the following elements are the most important in establishing comprehensibility and compliance:7, 8

– safety information should be expressed as definitive, rather than probable hazard e.g. ‘smoking kills’ rather than ‘smoking can kill’;

– information should be expressed as personal instructions; and

– information should be located within the directions for use;

In addition, it has been found that the first two of these points (the linguistic expression) have a stronger effect than the last (location of the information).

The panel above shows a comparison of the new elements of GHS and Directive 67/548/EEC and it’s immediately obvious the above points above have not been taken into account. Risk phrases/hazard phrases are probabilistic rather than definitive, and the safety/precautionary phrases are not personal instructions. Also, the safety/precautionary phrases are located on a separate part of the label, rather than incorporated within the directions for use.

In this case the desire to maintain scientific correctness (i.e. any carcinogen only may cause cancer), and to maintain a system as close as possible to the existing one, has meant that the opportunity to design a system that really focuses on comprehension and compliance, has been missed.

Effect on REACH

The new regulation will also affect REACH, which currently uses Directive 67/548/EEC’s classification regime. The following elements will be affected by implementation of the new CLAP Regulation, and need to be updated:9

– Registration –the classification of the substance is part of the information that needs to be registered. Certain classifiable hazards need to be registered early (e.g. category 1 and 2 carcinogens, mutagens, and substances toxic to reproduction) and for the Chemical Safety Assessment, the presence of a classifiable hazard is used as a trigger for when an exposure assessment also has to be carried out;

– A Safety Data Sheet is required for classified substances/preparations, and for non-classified preparations containing 1 per cent or more of a dangerous substance;

– The classifications of all marketed substances should be notified to the European Chemicals Agency, three years after entry. The Agency will make them publicly available;

– Authorisation – the classification of a substance defines when it is subject to authorisation, i.e. category 1 and 2 carcinogens, mutagens and substances toxic to reproduction;

– Restrictions – category 1 and 2 substances (see above) will be subject to restrictions for consumer use.

In addition, the classification and labelling inventory (Title XI) will be moved to the new regulation, and deleted completely from REACH.

In this regard, an addition to the procedure under REACH has been made: a company will now be able to suggest a harmonised classification for a substance not currently in the list of harmonised classifications (Annex VI of the CLAP Regulation). In REACH, only a Member State Competent Authority could propose a harmonised classification.

Downstream legislation

More than 20 pieces of so-called ‘downstream’ legislation currently refer to classification and labelling, either directly or indirectly.10 The effects of the new CLAP Regulation on this legislation, if any, will be mainly due to an increased number of classified substances and mixtures.

This means additional chemical agents are likely to be classified, and the downstream legislation will apply to more products. For example, COSHH will apply to more hazardous chemical agents than is currently the case.

However, one more potentially important effect of the CLAP Regulation is that it may lead to an increased number of classified substances and mixtures, which would then be covered by the Seveso II Directive. As a result, an additional number of companies could become lower- or even upper-tier establishments.

Cost implications

The European Commission has assessed the costs and benefits of the new system to European industry.11 It is worth noting here that the protection level to health and the environment is not expected to change. Furthermore, the main benefits are assessed as being trade-related cost savings, leading to more trade with countries outside the EU.

The Commission has estimated costs of approximately £526 million against these trade-related benefits. It is hoped that the new regulation will ultimately overcome the one-off costs of the implementation; as long as a smooth transition from the current system maintains the current high level of environment and health protection, and minimises the burden for companies.

Implications for practitioners

The implications for safety practitioners will, of course, depend on what duties their company has under the new legislation. Suppliers of substances and mixtures will have to apply the new system and re-label their products. This will also have an effect on Safety Data Sheets, which must incorporate the new information. Time will be allowed for this work to be carried out, but it may need to be factored into business plans now. Customers may also need to be educated to be prepared for the new system.

Users of substances and mixtures will have to be aware of the changes and incorporate them into their safety management systems. Substances and mixtures that haven’t been classified in the past may now have a hazard label, and may need to be assessed under COSHH, with appropriate risk management steps taken.

In addition, hazard labels will look different. A number of the symbols will not have been seen before by the workforce, and are not intuitively understandable. This will probably mean updating training for staff to recognise the new labels, and the hazards they represent.

The new CLAP Regulation has been adopted by the Commission and is currently being debated by Member States in the European Parliament. In the UK, the HSE has responsibility for the classification measures, and it is taking the lead for the negotiations and eventual implementation.12

References

1 Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances OJ 196, 16.8.1967, p 1 Directive as last amended by Commission Directive 2004/73/EC (OJ L 152, 30.4.2004, p 1) Corrected in OJ L 216, 16.6.2004, p 3

2 Council Directive 1999/45/EC of 31 May 1999 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations OJ L 200, 30.7.1999, p 1 Directive as last amended by Commission Directive 2006/8/EC (OJ L 19, 24.1.2006, p 12)

3 More information can be found at: http://www.hse.gov.uk/chip/index.htm

4 HSE (2002): ‘COSHH : a brief guide to the Regulations’, HSE books

5 Proposal for a Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 (COM(2007) 355 final) – available from: http://ec.europa.eu/enterprise/reach/ghs_en.htm.

6 More information is available at: http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html

7 HSE (2001): ‘The effectiveness of labelling of pesticides’, Contract Research Report 390/2001

8 Frantz, J.P. (1993): ‘Effect of location and presentation format on attention to and compliance with warnings and instructions’, J Saf Res 24(3) p 131-154

9 Blainey, M.A. (2007): ‘Within REACH’, SHP, June 2007 p 47-49

10 European Commission Staff Working Document: Accompanying document to the Proposal for a Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006: Impact Assessment, available from http://ec.europa.eu/enterprise/reach/docs/ghs/ghs_ia_en.pdf

11 Commission Services (2006): ‘Analysis of the Potential Effects of the Proposed GHS Regulation on its EU Downstream Legislation’ pp 155-176 available from: http://ec.europa.eu/e
terprise/reach/docs/ghs/ghs_sc_study_final_110806.pdf

12 see link below

http://www.hse.gov.uk/ghs/index.htm

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