REACH: The RSC response

REACH has been largely driven by public concern about the effectiveness of current chemicals legislation in protecting our health and environment. Under REACH, enterprises that manufacture or import more than one tonne of a chemical substance per year would be required to register it in a central database. All chemicals produced in quantities greater than 10 tonnes will need a risk assessment and ‘high risk’ chemicals will be restricted to essential uses. 

REACH removes the distinction between ‘new’ and ‘existing’ chemicals listed in the 1981 European Inventory of Existing Commercial Chemical Substances. 

REACH will replace much of the Dangerous Substances Directive (67/548/EEC) for new substances, the Existing Substances Regulation (793/93), the Marketing and Use Directive (76/69/EEC) and the Directive covering Preparations (88/379/EEC). 

The first reading in the European Parliament (EP) of the proposed regulation is scheduled for November 2005. It is expected that the REACH will be agreed and published in June 2007. 

The REACH system

The REACH Regulation shifts the burden of proof from the authorities to industry, which will now have to demonstrate that a chemical can be used safely for a specific use. 

Manufacturers, importers, and, for the first time, downstream users, will have to provide information to enable the end user to manage the risk. 

While the RSC supports the basic principle that all users of chemicals should have access to the necessary information to be able to manage the risks, this should not extend to providing detailed commercially sensitive information that would impact on competitiveness without providing any useful benefit. 

Registering chemicals

Registration is the main element of REACH. Chemicals manufactured or imported in quantities of more than one tonne per year (around 30,000 substances) will need to be registered. This involves providing information on intrinsic properties and hazards and on safe ways of handling the chemical for specified uses. The information required would be proportional to production volumes and the risks posed by a substance. Around 80% of all registered substances are likely to require no further action. 

Evaluation: risk vs hazard

Evaluation of chemicals encompasses several processes within REACH, including the checking of information dossiers of substances to ensure completeness, and substance evaluation by a competent authority. Evaluation is triggered by the volume of the substance imported or manufactured. In addition, evaluation will be needed where there are justified reasons to suspect that a substance poses a risk to human health or the environment. 

It is vitally important that REACH should be based on risk rather than just hazard based. The concept of risk requires an examination of both hazard and exposure levels. This is a better measure, as it takes into account the actual likelihood that an intrinsic hazard associated with a substance will cause actual harm. 

The RSC is concerned that prioritisation by volume will result in an inappropriate use of resources. By focusing on the volume of chemicals produced or imported, the danger exists that effort may be misdirected on high volume but low toxicity substances such as sodium chloride – common table salt, rather than on substances of high concern used in smaller quantities. 

The Commissions view that testing on animals should be minimised is shared by the RSC. Under REACH, organisations would be required to share data in order to reduce animal testing. It would be unethical to require animal testing simply to complete a bureaucratic box ticking exercise. 

The RSC does have concerns about the inappropriate use of non-animal, in silico and in vitro techniques. More work is necessary to develop suitable non-animal models. Although non-validated models might be useful as screening tools, they should not be used for decision making. 

It is important that REACH should only require data that has real value. This is particularly true for ‘existing chemicals’ that have been in use for many years with no apparent adverse effects. Testing thresholds should, where practicable, take account of estimated actual exposure and potential impact. There should also be greater acceptance of scientifically reliable historical data. 

Authorising and restricting use

Authorisation, for specific uses, will be required for about 1,500 substances of very high concern. The European Commission will be responsible for authorisation. 

Substances of very high concern include CMRs (carcinogenic mutagenic or substances toxic to reproduction), PBTs (substances of very high concern that are persistent in the environment, bio accumulative and toxic), vPvBs (very persistent and very bio-accumulative substances) and other substances identified as having serious and irreversible effects to humans and the environment, for example certain endocrine disruptors. 

Where the risks emanating from the use of such a substance are minimal or can be adequately controlled, authorisation would be granted. Under REACH, some substances of very high concern may be subject to restriction. These decisions would be made by the European Chemical Agency, which will be based in Helsinki. It will look at the level of risk, whether the use of the substance was socially and economically important as well as the availability of substitutes. 

Chemical substitution

Chemical substitution is one of many options in the process of reducing risk. Substitution is not a simple process since it is necessary to ensure that the overall risk is reduced and that a decrease in one risk is not overshadowed by the increase in another. Many practical aspects of decision making for substitution will need to be resolved. Effective substitution of a problem chemical by an alternative requires an adequate set of comparative data for the alternative. 

A further problem is that of defining the key hazardous property; chemicals cannot be ranked in order of safety - they have hazard profiles whose ranking differs. Then there is the issue of how different impacts are to be weighted. 

Another difficulty will be agreeing the purpose of substitution i.e. for safety or for sustainability. A safer chemical may be used in larger amounts, use more energy and/or may generate more waste. Finally, the difficult issue of how to assess the cost vs. benefit of substitution will need to be addressed. For example, should substitution be required if it costs £100K to improve safety by 0.01%? 

The RSC opposes any moves to extend mandatory substitution beyond those substances for which risks cannot be adequately controlled. Authorisation provides a sensible mechanism to exert control on hazardous substances and substitution is a desirable endpoint. But decisions on substitution needed to be taken in a holistic manner. 

Chemical diversity

Impact on chemical diversity is a particular concern of the RSC. It is not clear whether authorisation is to be a temporary stay of execution or just a stricter form of control for some chemical substances. If it is the former, this would contribute to a reduction in chemical diversity which could in turn have an impact on innovation. 

There is concern that REACH could lead to useful chemicals being withdrawn unnecessarily due to the high cost of testing, rather than for health, safety or environmental reasons. A similar situation has already resulted from recent EU directives for agricultural products. 60% of active substances have been withdrawn in plant protection products and probably an even larger proportion of active substances in biocide formulations. 

Making REACH workable

Ensuring the Commission produces workable legislation is a key concern of the RSC. To this end, the RSC has made a number of submissions on aspects of REACH to the European Commission, UK Government and to Committees of both Houses of Parliament. The RSC has a representative on the UK Chemical Stakeholders Forum (UKCSF) that advises the UK Government on the REACH Regulation. 

In December 2004, the RSC ran a multi-stakeholder workshop on chemical substitution that was opened by the then Minister of State for Rural Affairs and Local Environmental Quality, the Rt. Hon. Alun Michael MP. More recently the RSC has, at the request of the UKCSF, provided advice on the practicalities of undertaking chemical substitution and on ‘chemicals of equivalent concern’. In June 2005, the RSC hosted a European Chemical Societies (EuChemS) REACH Workshop. 

There will be a continuing need to maintain co-operation between regulators, industry, government and consumers in order to develop and deliver the most positive outcome for REACH.