October 29, 2003

new EU chemical policy (REACH) unveiled

New regulations that will tighten up the testing of manufactured chemicals have been announced today in Brussels.

Professor David Taylor, Royal Society of Chemistry, said:

“I welcome the new proposal from the Commission as the next step in the continuing debate on an appropriate method of chemicals control policy in Europe.

“The basic principles on which REACH is based are agreed by all parties, the difficulties lie in finding an appropriate regulatory framework that allows European Citizens to continue to benefit from the products produced by the application of the chemical sciences whilst protecting human health and the environment.

“The new proposal represents a major improvement on the earlier draft particularly in its clarification of the chemical safety report.

“The Royal Society of Chemistry is still concerned at the inadequacy of priority setting in the proposal. This will require large amounts of data to be generated quickly for substances like common salt, washing soda and alcohol, simply because they are manufactured at more than 1000 tonnes per year, whereas potentially more harmful substances, produced at between 1-10 tonnes, may not be registered for a further 10 years. This represents both an unnecessary use of resources and a lack of precaution.”

Dr Jennifer Dandrea, Scientific Officer at the Fund for the Replacement Of Animals in Medical Experiments (FRAME), said:

“We’re delighted that the EC is committed to use of alternative methods wherever possible and that data sharing will be mandatory to minimize duplicate testing. It’s vital that animal testing should only be the very last resort.

“We’re also pleased that many of our concerns were echoed in the submissions made to the EC consultation exercise, and that there will be a single, new, Chemicals Agency to implement REACH. But we are disappointed that REACH will rely solely on production volume as a measure of toxicity rather than on other measures, such as bioavailability.”

Peter Frier, Government Chemist Programme Manager at Laboratory of the Government Chemist (LGC), said:

“Adoption of the new EU Chemicals legislation has been long awaited and the serious task of implementation now begins. Previous chemical legislation was poorly resourced and difficult to enforce, and the concern is that REACH will go the same way.

“A lot of emphasis has been placed on toxicity effects during the debate over legislation, but the fact is that exposure assessment is in most cases the weakest part of any risk estimate. At least REACH will force more research on how to monitor these exposure levels more effectively.”

LGC has been advising the government on what support measures should be put in place to help industry meet the new registration system proposed by REACH.

Prof Gary Coleman, Deputy Director of Chemical Hazards and Poisons Division of the Health Protection Agency, said:

“The Health Protection Agency welcomes the principles underpinning the European Commission’s REACH initiative. This is a promising first step on the route to setting up the first ever European system for assessing the health risks from chemical products. It now needs to be implemented in such a way as to make a significant improvement in the protection of human health and the environment.”

Dr Stuart Dobson of the Natural Environment Research Council , said:

“The new REACH proposals finally provide a practical approach to chemical regulation which should bring all information on hazards into the public arena and allow informed involvement of all stakeholders. Whilst ambitious in scope, the proposals give the opportunity for industry, regulators and independent scientists to work together to repair loss of public confidence in all three. These proposals have resulted from widespread consultation and represent a position supportable by stakeholders from industry through environmental pressure groups. The work involved is of global significance – chemical risk is not simply a European problem. However, REACH should improve European cooperation in the worldwide attempts to make chemical risk assessment both transparent and harmonised.”

Dr Dobson is a member of the UK Chemicals Stakeholder Forum, a member of the UK Advisory Committee on Hazardous Substances, and Chair of the Risk Assessment Steering Group of the International Programme on Chemical Safety.

Professor David Slater, Professor of Sustainable Chemical Engineering, Manchester University, and Fellow of the Institution of Chemical Engineers, said:

“The European Commission has to put a system in place that actually works. The current proposals have at least consulted with stakeholders and tried to do this. The chemical industry needs to understand that “No action” is not an option. And wider society needs to know what chemicals we are being exposed to, or at least be confident that somebody does and is in a position to do something if necessary – preferably before there are clear medical indications in the population!

“The industry, however, is quite right in questioning the process and its cost benefit justification. A typical submission protocol for a new substance can involve preparing some 40 CD’s of information.

“The proposal for a new independent agency to take all these decisions could result in even less transparency than the current committees. This is particularly the case where there appear to be no published, or agreed, criteria, for what is an acceptable level of safety. Swedish and Greek interpretations for example, could be widely different.

“This system will only be as good as the people and institutions responsible for its implementation and enforcement.”

Dr Neville Reed, Director of Communication Services at the Royal Society of Chemistry, said:

“Quite rightly the EU proposals set high safety standards to be met. Of concern is the retrospective and indiscriminate nature of the required testing regime. Rather than using a shotgun approach, it would be better to prioritise the chemicals to be tested in terms of highest risk and look at these first.

“Failure to go about this in a sensible way will have a dramatic effect on the UK. The chemicals sector is a UK success story. It has an annual turnover of ca £50 billion; employs 235,000 people; supports several hundred thousand additional jobs throughout the economy; contributes 2% of GDP; contributes in excess of £5 billion annually to balance of payments; and pays [with employees] a further £5 billion (including tax, national insurances and business rates) annually to government and local authorities. Faced with an indiscriminate testing regime for chemicals, many of which are known to be safe, many companies may decide to relocate their businesses outside of the UK and the EU. We would then have to import the chemicals, giving a double whammy on our economy: loss of economic activity and costs of imports. And moving this industrial sector out of the EU will hamper the Lisbon EU Council objective to make Europe the most competitive and knowledge based-based economy by 2010′ which means increasing the average R&D investment level to rise from 1.9% of GDP to 3.0% of GDP by 2010.

“Some would like all chemicals removed from our daily lives. To do so would remove medicines, clothes, buildings, transport, food, sources of heat and general sustenance for our everyday way of life. The aim is a safe sustainable environment for us all and a sensible chemical testing regime has a key part to play in ensuring this. We are made of chemicals, as is everything around us. Removing all chemicals from our lives, as some would argue for, is naïve, nonsense and for neverland.”