Safety within REACH regulations

The Control of Substances Hazardous to Health (COSHH) Regulations brought about a radical change to health and safety management when they were introduced in 1989. They shook people out of the complacency into which they had been lulled by previous legislation, such as the Health and Safety at Work Act 1974, which urged employers to look after their workers, without offering any tools for doing so. It also offered get-out clauses, stating that employers would only have to keep staff safe ‘so far as reasonably practicable’.

COSHH, on the other hand, introduced the requirement for proactive risk assessment,1 and as it was updated over the following 13 years, it emphasised the importance of substituting hazardous substances with safe ones as a means of controlling chemical hazards. Of course, COSHH literature has always made it clear that if a chemical did not have an occupational exposure limit, one should not assume that it was safe for use – the absence of a limit might simply mean that there was no information available because the chemical had not yet been tested.

Under COSHH, it has generally been up to public authorities rather than manufacturers and importers, to show that a substance was potentially hazardous.

New ground

There is no doubt that in the absence of COSHH, there would have been a lot more reported occupational diseases of the lungs and skin, as well as cancers, but it is also true that COSHH has not been a complete success. According to the European Trade Union Confederation (ETUC), one in three occupational diseases is due to chemicals, and in the EU, three million days are lost each year due to occupational skin diseases.2 The incidence of asthma, skin diseases and cancers is still very high across the EU, and this is due, at least in part, to exposure to chemicals in the workplace.

It was in this context that in October 2003, the European Commission adopted a proposal for a new EU regulatory framework for the Registration, Evaluation and Authorisation of Chemicals (REACH).3 At a time when investment in chemical industries in the EU is falling behind that of Japan and the US, REACH is the chemicals part of the policy that underlies the Lisbon strategy aimed at turning the EU into “the most competitive and dynamic knowledge-based economy in the world, capable of sustainable economic growth with more and better jobs, greater social cohesion and respect for the environment” by the year 2010.4

REACH’s scope

In its aim to fulfil these requirements, REACH is going further than the existing regulations such as COSHH, in that it aims to deliver in all three pillars of the EU’s sustainable development policy, which are economic (industrial competitiveness), social (protection of human health and jobs) and environmental. It also puts the responsibility for establishing the safety of chemicals onto manufacturers and importers, rather than public bodies. It will replace more than 40 existing directives and regulations.5

REACH will apply to all chemicals produced in large quantities. In 1981, there were 100,106 existing chemicals, and since then, around 3,000 new ones have been introduced into the market. It is anticipated that REACH will apply to around 30,000 of these chemicals.

The main element of REACH is registration. This will require all the chemicals manufactured or imported in quantities greater than one tonne per year (per manufacturer or importer) to be registered on a central database. This will include information on the properties, uses and safe ways of handling the chemicals, much as is required under the current COSHH and Chemicals (Hazard Information and Packing for Supply) Regulations. This information will be passed down the supply chain so that all those who use these chemicals in their industrial processes will be fully aware of any risks.

The database will be managed by the new European Chemicals Agency, and it is expected that 80% of the chemicals registered will require no further action. A period of 11 years will be allowed for the registration dossiers to be completed, although carcinogens, mutagens and substances toxic for reproduction (CMRs) will have to be registered within the first three years after REACH comes into force. Any of the 30,000 substances unregistered at the end of the 11 years will not be allowed to be manufactured or imported into the EU.

The next element of REACH – evaluation – will allow the competent authority in each member state to scrutinise the registration dossiers presented by manufacturers or importers. At this stage, the authority will be able to ask for further information about risks that may be presented to health or the environment. Where more than one manufacturer or importer is using the same chemical, the competent authority or central agency will be able to require that information is compared and shared. It is hoped that one positive result of this will be a reduction in the need for animal experiments.

Substances of high concern, such as CMR and other chemicals identified as having serious and irreversible effects on human health or the environment, will require authorisation – the next component of REACH – for particular uses. The European Commission will decide whether or not to authorise on the basis of whether risks can be adequately controlled, whether the use of the substance is economically and socially important and whether there are substitutes available. Any restrictions placed will apply throughout the European Union.

Responsibility

The problem with current legislation is that the onus on testing has largely placed the responsibility for researching and determining risk at the feet of public authorities. As a result, it has often been difficult to identify risks, and where they have been established, action has often been slow to follow. Furthermore, because legislation has not been uniform across the EU, it has been easier at times for manufacturers in member states to undercut competitors’ costs due to less stringent legislation.

REACH, on the other hand, will require the manufacturers and importers to determine risk, and the centralisation of the system will mean both uniform requirements across the 25 countries, and the standardisation and sharing of information. Funding will also be set aside for innovation and research and development, especially in the search for safer alternatives. Most of all, it is hoped that a REACH label on a chemical will be seen as evidence to users outside the EU that it has gone through rigorous testing, that the information provided with it is reliable, and that the requirements for the protection of human health and the environment have been properly addressed.

As one would expect with such major new regulations, there are some potential downsides to the introduction of REACH. First, some small- to medium-sized employers may well find the cost of researching and producing dossiers for REACH to be so high that they simply shut down production. This could have an impact on other industries which, for their processes, depend upon the ready availability of that particular chemical.

It would be even worse if competing manufacturers in countries outside the EU, such as Japan or the US, tried to force their products into the EU without meeting the stringent requirements of REACH. Similar tactics have been tried in the past – for example, when Canada tried to force the EU to reverse its ban on asbestos in a bid to protect its own mining industry. And the US used the World Trade Organisation to try to overturn a ban on genetically modified products. In globalised economies, a regulation such as REACH would be unworkable if it allowed non-EU manufacturers to undermine and undercut EU industry.

Second, some pesticides, pharmaceuticals and cosmetics will not be covered by REACH, because they are subject to other regulations. Many pesticides have been linked to cancers and neurological conditions, and pesticides, along with hormone-mimicking chemicals, are increasingly found in drinking water, breast milk and farm products.6 It would be ironic if they were allowed to continue to harm human health and the environment while some less toxic substances were driven out of production and use.

The European Commission estimates that the thousands of deaths avoided each year by the introduction of REACH will result in a saving of €50bn (£35bn) over 30 years8. But in the end, the success of REACH will be measured by the degree of success it achieves in its stated aims, which are: “To improve protection of human health and the environment from the hazards of chemicals and enhance the competitiveness of the EU chemicals industry.”7

Bashyr Aziz is senior lecturer at the School of Health, University of Wolverhampton

References
1 Aziz, B (1998) Where Next? The Future of COSHH. Journal of Occupational Health, Safety and Environment. Vol 2,
Issue 8. Aug 1998, p.20-24.
2 Grgoire, D (2005) REACH: Getting The Balance Right Between Competitiveness and Health. HESA Newsletter,
No. 28, p.4-6, October.
3 http://europa.eu.int/comm/environment/chemicals/whitepaper.htm
4 European Commission (2003) Chemicals: Commission Presents Proposal To Modernise EU Legislation.
No.67/03, October 29. http://www.eurunion.org/news/press/2003/2003067A.htm.
5 In March 2000 at the European Council meeting in Lisbon, the EU set itself “a new strategic goal for the next decade.” http://www.etuc.org/r/206
6 Friends of the Earth (1995): Drinking water figures mask concern. http://www.foe.co.uk/resource/press_releases/19950706149543.html, 6 july 1998.
7 European Commission (2003) as above.
8 Pickvance, S (Unpublished) The Impact of REACH on Future Skin and Respiratory Disease. School of Health and Related Research, University of Sheffield

How will REACH affect occupational health practice?

REACH is likely to have an important impact on occupational health practice. First, the preparation of dossiers is likely to require input on control measures in the workplace. It is important to note that the registration of a substance will specify the applications and uses to which the registration applies. So if an organisation wishes to use the substance in a different process, it may well have to produce its own dossier. An occupational health service will have to look at the use of the chemical within its own organisation, and also in relation to its use, handling, storage and disposal by downstream users.

Second, just as REACH will go beyond the health and safety limitations of COSHH into the public health arena of protection of human health and the environment, so will it ground occupational health nursing into the public health arena defined in the Specialist Community Public Health Nursing register of the Nursing and Midwifery Council. Under REACH, the occupational health service will have to look well beyond its responsibility to its employer or purchaser’s workforce.

Third, as safety data sheets are updated and standardised across the EU, occupational health professionals will have to review their systems for health surveillance, hygiene, personal protective equipment and health promotion.

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