The European Commission has finally published the draft legislation for its proposed new chemical policy.

The European Commission has finally published the draft legislation for its proposed new chemical policy. Elizabeth Willcocks looks at the response the draft has generated. 

Good things come to those who wait. Or so it is said. The European Commission certainly made the chemical industry wait for the draft regulations underpinning its proposed new chemical policy, outlined in the 2001 White Paper entitled Strategy for a future chemicals policy (see Chem. Br., January 2002, p.35). 

Since publishing the White Paper, the Commission has been working towards establishing the details of the policy. En route, it has postponed the deadline for publication of the draft legislation more than once. To say that the delay has been frustrating is an understatement, and rumours earlier this year that the Commission was at last going to publish the draft legislation were met with a great deal of scepticism. However, the leak turned out to be correct and, after two years of waiting, the 1200-page document was finally published online on 7 May. 

Now that the draft regulations have arrived, how have they been received? As one might expect, reactions to the draft legislation have been mixed. Certainly, the chemical industry did not expect to be 100 per cent happy with it - industry representatives are seriously concerned about the impacts of implementing the new policy. Environmental NGOs (non-governmental organisations), on the other hand, feel that the proposals do not go far enough. 

In the beginning... 
 When the Commission published its White Paper in 2001, it made clear its concerns about what it described as a general lack of knowledge about the potential hazards posed by many chemicals. The commission’s proposed solution was to evaluate the safety of all chemicals, and restrict or prohibit the use of certain ones. 

At the heart of the proposed new chemical policy - which was intended to replace some 40 pieces of existing chemical legislation - was the Reach (registration, evaluation and authorisation of chemicals) system. Under Reach, the responsibility for testing the safety of chemicals, including both new and existing substances, passes from the authorities to the manufacturers. 

For its part, the European chemical industry’s response has been that it is keen to take on this responsibility, and it supports a change in the current chemical legislation. ’We want this regulation to happen’, insists Judith Hackitt, director general of the Chemical Industries Association (CIA). ’The current legislation has not delivered what it was expected to’, she adds. But the chemical industry only wants legislation if the Commission can get it right - if it will lead to an effective and practical system that works for everybody concerned. 

Getting it right 
So what would be the consequences of getting the new regulations wrong? Among the chemical industry’s main concerns about the proposed legislation are: the costs associated with implementing the legislation; whether the legislation would hamper innovation in the industry; the effect of the regulations on SMEs; and the possible migration of chemical businesses outside the EU. 

The French Union of Chemical Industries, together with the French Ministry for Ecology and Sustainable Development and the ministries of economy and finance, commissioned a study, carried out by Mercer Management Consulting, which claimed that the new regulations could cost the French economy up to €50.000m (ca ?35.000) over 10 years. A similar German study predicted that the legislation would lead to significant job losses and a fall of up to 6.4 per cent in growth for the German economy. Hackitt says that it would be foolish not to heed the warnings of these two studies. 

In contrast to the French and German studies, an independent study by the UK firm Risk and Policy Analysts, on behalf of the Commission, estimated that the direct costs of implementing the new policy would be ca €4000m over 10 years. The Commission claims that this represents only a very small fraction of the European chemical industry’s turnover, but, according to Hackitt, the Commission’s argument misses the point. ’It is the competitiveness [of the European chemical industry] versus Asia, the US and the Far East that matters’, she insists. 

The draft legislation 
The 1200-page document outlining the draft legislation has been almost two years in the making. During this period, both the chemical industry and environmental pressure groups have lobbied intensively to ensure that their concerns about the proposals in the White Paper were heard. And is either side now happy? The answer is a resounding no. 

The NGOs feel that the legislation does not go far enough. A joint statement from the European Environment Bureau, Friends of the Earth, Greenpeace and the World Wide Fund for Nature accused the Commission of accepting conditions set by industry that have led to a ’weakening of the public health and environmental objectives of the reform’. 

The CIA believes that the proposed legislation presents too much bureaucracy, despite the Commission’s claim that it made a ’determined effort to avoid unnecessary bureaucracy’. Hackitt argues that ’if it takes 1200 pages to describe the process, the alarm bells should start ringing’. 

Hackitt and the CIA are also concerned that introducing the legislation as it currently stands could force a mass migration of not only the chemical industry, but also large sections of the manufacturing industry, out of Europe. ’A molecule in the EU is the same elsewhere’, says Hackitt. Chemical manufacturers want cost effectiveness, and it takes very little to tip the competitive balance, she adds. 

The Commission is so far unclear on how products that are imported from outside the EU will be policed. NGOs have accused the Commission of ’failing to provide proper protection from chemicals in imported products’. The CIA also shares this concern: ’If we fail to preserve the wealth creation of manufacturing, we will only shift the problem’, Hackitt notes. 

Reach is still at the core of the legislation, but the Commission has moved away from its proposals in the White Paper of testing all chemicals produced in quantities of over 1.t pa per manufacturer, has relaxed the rules for certain substances. In particular, polymers with molecular weight greater than 10.kDa will be excluded. The testing requirements for intermediates, according to the proposals, will be scaled into four categories depending on the potential exposure risk. For example, intermediates that don’t leave a particular site will be excluded, but those that are freely traded will be treated like other substances. This should give the industry something to be happy about - the number of substances likely to qualify for testing is about 30,000, compared with earlier estimates of up to 170,000. 

The European chemical industry was not the only industry waiting in anticipation for the Commission’s draft regulations. Prior to the draft document’s publication, Charles Ford, head of the US mission to the EU, talked about some of the US concerns over the forthcoming legislation. The legislation may not be fully consistent with the EU’s World Trade Organisation obligations, he said. The US is also concerned about whether the EU has the resources to cope with such an extensive set of regulations. ’It could make Europe the most expensive place to launch a chemical - but this could increase activity in the US’, Ford admitted. 

The way forward 
So what happens now? The draft legislation will be subject to an ongoing consultation process. The deadline given for online stakeholder responses to the document was 10 July, by which time the European Parliament will be in recess. With the European Parliament elections due in 2004, it could be another year before the draft legislation gets even its first reading in Parliament. One thing is certain - the wait for a new EU chemical policy is far from over. 

Source: Chemistry in Britain

The RSC’s view

As Chemistry in Britain went to press, the RSC was busy compiling its response to the draft legislation to be submitted to the Commission by the 10 July deadline. Over the past two years, the RSC has raised a number of concerns about the proposed new chemical policy. The RSC says that:  

  • In principle it would welcome a single harmonised regime for assessing and controlling the effects of chemicals on health and the environment, but the current EU system is fragmented and cumbersome.
  • The regime should, where appropriate, be compatible with other international initiatives and minimise duplication.
  • The regime should be based on risk. Chemicals should not be banned on the basis of intrinsic hazards alone.
  • The regime should not inhibit innovation. Innovation is essential to achieving sustainable development. Chemistry should be seen primarily as part of the ’solution’ to sustainable development rather than as part of the problem.
  • The regime should only require data that have real value. This is particularly true for ’existing chemicals’ that have been in use for many years with no apparent adverse effects.
  • Testing on animals should be minimised. It would be unethical to require animal testing simply to complete a bureaucratic box-ticking exercise.
  • The regime should attempt to ensure that any chemicals that are withdrawn are those that are least desirable for health, safety or environmental reasons. It should attempt to ensure that the ’best’ or ’safest’ substances are not withdrawn simply because they generate insufficient profit to cover the cost of testing.
  • Testing thresholds should, where practical, take account of estimated exposure and potential impact. Production levels can be a poor indicator of potential harm.
  • Testing should be carried out by approved laboratories in accordance with approved methods and quality control systems. However, the regime should allow use of historic data that may have been produced in other ways if it is judged to be reliable.
  • The regime should be flexible enough to adapt to developments in toxicology, eg resulting from the fast developing area of genomic science.
  • The regime should be transparent. Transparency is one way in which public confidence in chemistry and chemicals may be improved.
  • The detail provided in the safety data sheets should be proportional to risk. Current safety data sheets can be alarming, especially for small scale users such as school laboratories. Safety data sheets should enable precautions to fit the scale of use.
  • There appears to be some doubt as to how the legislation will apply to academic research.