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May 29, 2007

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Within REACH

With the new Registration, Evaluation and Authorisation of Chemicals (REACH) legislation due to come into force this month, Mark Blainey takes a look at the implications for British businesses.

For the past 25 years, European Union chemicals legislation on the control of chemicals in the occupational environment has been split between two main themes: harmonised marketing legislation, and minimum standard occupational legislation.

The former is characterised either by European Union-level decisions on the hazard or risk of a chemical, or that a substance is too dangerous and its use should not be allowed. The latter is covered by EU Directives setting a minimum level of protection for workers, and is based on the requirement for a risk assessment of the chemical by the user.

This changes significantly on 1 June, when the EU’s new REACH (Registration, Evaluation and Authorisation of Chemicals) measures come into force. What makes REACH different from the previous harmonised marketing legislation is that – in addition to providing basic information on hazards – it will provide information on risk management that will enable safe use of a substance.

Chemical world

Chemicals are widely used in the workplace. In 1982 there were 100,000 chemical substances on the market. Of these, it is estimated that 30,000 substances manufactured or imported at or above 1 tonne a year will be registered under REACH. We still know very little about them, and the majority of substances on the market do not carry sufficient information about their human health and environmental effects.1

However, we do know that several hundred different chemicals have been found to cause recognised occupational skin or respiratory diseases.2 In addition, it has been estimated that in 2001, between 18 and 30 per cent of occupational diseases were related to occupational exposure to chemicals.3

Current legislation

The minimum standard Directives 98/24/EC and 2004/37/EC are implemented in Great Britain via the Control of Substances Hazardous to Health Regulations 2002 (COSHH). COSHH applies to substances, or mixtures of substances, classified as dangerous to health, including those with workplace exposure limits, biological agents (bacteria and other micro-organisms), any kind of dust – if its average concentration in the air exceeds the levels specified in COSHH – and any other substance that creates a risk to health.

The main requirements of COSHH are to: assess risks; decide what precautions are needed; prevent or adequately control exposure; ensure that control measures are used and maintained; monitor exposure and carry out appropriate health surveillance; prepare plans and procedures to deal with accidents, incidents and emergencies; and ensure that employees are properly informed, trained and supervised.4 In relation to risk management, a hierarchical set of obligations is clearly set out in Regulation 7: elimination; substitution; exposure reduction; etc.

Assessment

One of the key requirements of REACH is for those who manufacture or import a substance to gather information on its basic hazards and properties. If the substance is manufactured or imported at or above 10 tonnes, a comprehensive risk assessment of the substance must be carried out for its identified uses.

These will be uses identified by the manufacturer/importer, or those that their customers identify. This is called the Chemical Safety Assessment (CSA) and is documented in the Chemical Safety Report (CSR).

The main output of the CSA will be the appropriate risk management measures for a substance with an identified use, or a group of identified uses. If the customer – or ‘downstream user’ in REACH parlance – is concerned about confidentiality, they can use a system of more generic use descriptors to communicate their use to their supplier – or carry out the assessment themselves.

The problem with gathering such information is how best to then communicate it to those who need it. Indeed, risk assessments for the use of chemicals in the workplace, and information on hazards, are generally based on Safety Data Sheets (SDS). While these offer advice on appropriate risk management measures, they are often generic and unhelpful, e.g. ‘wear gloves’ without specifying the material the gloves should be made from.

A number of studies has been carried out on inaccuracies in SDS: one, which examined 150 SDS, found that just 37 per cent included accurate health effects data, with chronic health information being the most inaccurate. Only 47 per cent were accurate regarding personal protective equipment (PPE), or correct occupational exposure limits.4, 5

Even if adequate information is available, there are many other problems with the risk assessment approach, especially where the company lacks the resources, technical expertise, or money to carry it out effectively. The HSE has tried to overcome this via its simple assessment system, COSHH Essentials.6 The scheme has proved to be very successful, but it doesn’t get over the problem of inaccurate or missing information.

REACH will not extensively change the requirements for SDS, although there are changes in detail to enable the enhanced information from the CSA carried out on a substance to be communicated to those who need it.

Exposure scenarios

Another new requirement under REACH is the development of Exposure Scenarios (ES). This forms part of the assessment of a substance (CSA). An ES sets out the risk management measures that ensure a substance is safe for a particular set of operational conditions, and it is attached to the SDS as an Annex.

The European Commission (EC) is currently developing guidance on REACH and on the CSA. One of the results available so far is a sample Exposure Scenario (see table 1). While specific to the textiles industry, it is useful for practitioners to see what kind of information the ES includes. Two questions may arise from this: will the risk management be ‘over the top’ for lower concentrations of the substance? And, will it be appropriate for the other constituents of the preparation in which it is used?

Resolving the first question depends on the delicate balance between the specificity of the identified use, the scope of the ES, and the cost/trouble to produce a larger number of scenarios to cover such possibilities. In the end, it will come down to what the market requires.

In answer to the second question, REACH does not require formulators to produce an exposure scenario for a preparation, but it does allow a CSA to be carried out for the purposes of informing an SDS for that preparation. The formulator therefore has the choice of passing on the ES of all the ingredients, or constructing an ES for the preparation as a whole, the latter being the more market-friendly option. One of the issues still being explored in the aforemetioned guidance work is how to provide better information on preparations.

Authorisation and restrictions

In addition to registration, several other parts of REACH will affect workers’ safety, including its Authorisation and Restrictions procedures. Substances of very high concern, which are included in Annex XIV (a step-wise process to prioritise such substances), will need to be authorised by the European Commission before they are used. Substances where the risk is not adequately controlled, the benefits do not outweigh the risks, or a substitute is available will not be granted an authorisation.7 In addition, a substance that is not adequately controlled, can also be restricted in a similar way to how substances like poly chlorinated biphenyls (PCBs), or asbestos (in Directive 76/769/EEC) are today.

One of the potential problems that has been raised regarding the relationship between REACH and current worker protection legislation is how to manage carcinogenic or mutagenic substances. Whereas under the original EC proposal for REACH such substances could be authorised if the applicant demonstrated that they were adequately controlled (i.e. with no mandatory substitution), this was seemingly not consistent with Article 4 of Directive 2004/37/EC, where substitution is the first control measure that should be considered. However, the final version of REACH has clarified that for such substances where a no-effect threshold cannot be determined, a substance cannot get authorisation just because of adequate control.

Most carcinogens and mutagens will therefore fall into the authorisation route, where the availability of substitutes, as well as socio-economic factors, will determine if an authorisation is granted. Furthermore, companies will have to deliver an analysis of substitutes, and third parties will be asked for information on available substitutes with their application. So, this can be seen as making Directive 2004/37/EC more enforceable.

Even if a substance is given authorisation because of adequate control, at the first and subsequent reviews of that authorisation, the availability and suitability of substitutes will be taken into account when considering whether or not to amend or withdraw the authorisation.

Implications for practitioners

What will all this mean for safety practitioners at the coalface? Will REACH be a help, or a hindrance? Well, the implications are manifold and will, of course, depend on the nature of the business. If the company manufactures or imports substances at, or over 1 tonne a year it will need to be registered with a certain amount of information.

Generally, the higher the tonnage, the greater the information requirements, and the shorter the deadline to register. However, REACH will also affect those who use substances in preparations, or incorporate them into products for downstream users. They do not have to register their substances, but they will need to make sure the substances they use are covered by their supplier’s Exposure Scenario. If they are not, they have two choices: either identify their use to the supplier (who will then incorporate that use into their CSA, and ensure an ES covers it); or develop an ES themselves. This latter option is more attractive if the company wants to keep their use secret from their supplier.

Act now

REACH is not a panacea for all problems related to chemicals. It does not cover substances manufactured or imported below 1 tonne. Even substances manufactured or imported from 1 to 10 tonnes will only have sufficient information if they are priority substances.

There is no requirement to conduct a CSA for preparations, and it will not cover the effects of mixed exposures, nor process-generated risks. In that sense, it will not replace Directive 98/24/EC, which covers these areas.

Having said that, it will provide essential information on the 30,000 substances about which we know very little today. It is a holistic approach to providing information and managing chemicals, which will help protect the health of workers, and the environment – and that is definitely a good thing.

Planning for REACH

– Inventorise your substances and their uses. Assess current difficulties in chemical risk management.

– Study guidance developed http://ecb.jrc.it/REACH

– Develop business plans for the future.

– Communicate with suppliers and customers in the supply chain regarding your expectations. Develop partnerships. Discuss how to meet their needs and yours.

– Develop exposure scenarios if necessary.

References

1 Allanou, R, Hansen, B, and van der Bilt, Y (1999): ‘Public Availability of Data on EU High Production Volume Chemicals’, European Chemicals Bureau, available at:

http://ecb.jrc.it/existing-chemicals

2 European Commission (2003): ‘Work and health in the EU, a statistical portrait – data 1994-2002′, Eurostat

3 European Commission (2004): ‘Occupational diseases in Europe in 2001′, Statistics in focus, population and social conditions, number 15, Eurostat

4 Evans, M (1999): ‘Inaccuracies in safety data sheets 1999′, Health

Directorate PD/7/1

5 Klop, PW, Williams, PL, Burtan, RC (1995): ‘Assessment of the accuracy of material safety data sheets’, American Industrial Hygiene Association Journal 56:178–183

6 http://www.coshh-essentials.org.uk

7 In REACH-speak, safe means either ‘adequately controlled’ according to Section 6.4 of Annex I, or minimised, according to Section 6.5 of Annex I

References to Directives and other source material

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 Regulation (EEC) 793/93 of 23 March on the evaluation and control of existing chemical substances OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

3 Council Directive 76/769/EEC of 27 July 1976 on the on the approximation of laws, regulations and administrative provisions relating to restrictions on the marketing and use of certain dangerous substances and preparations OJ L 262, 27.9.1976, p. 201. Directive as last amended by Directive 2005/90/EC of the European Parliament and of the Council (OJ L 33, 4.2.2006, p. 28).

4 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work OJ L 158, 30.4.2004, p. 50. Corrected in OJ L 229, 29.6.2004, p. 23

5 Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work OJ L 131, 5.5.1998, p. 11 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC OJ L369 vol 49 p 1-849 available at http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML

6 R. Allanou, B. Hansen and Y. van der Bilt, ‘Public Availability of Data on EU High Production Volume Chemicals’ (European Chemicals Bureau, 1999); available at: http://ecb.jrc.it/existing-chemicals/.

7 Work and health in the EU, a statistical portrait. Data 1994-2002. Eurostat. European Commission 2003.

8 Occupational diseases in Europe in 200. Statistics in focus, population and social conditions, no 15, Eurostat, 2004.

9 Kogevinas et al. Estimation of the burden of occupational cancer in Europe – study financed by Europe against cancer 1998.

10 In REACH speak safe means either adequately controlled according to Section 6.4 of Annex I or minimised according to Section 6.5 of Annex I.

11 Carcinogens, Mutagens and substances toxic to Reproduction (CMR), substances with peristant, bioaccumulative and toxic (PBT) or very Persistent very Bioaccumulative (vPvB) properties or substances with an equivalent level of concern.

 

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