The heart of the matter

26 May 2003 00:00  [Source: ICB]

Wallstrom: many of the chemicals in use today are expected to pose no concern

As part of its continuing coverage of the controversial new chemicals policy for Europe, ECN is pleased to publish this contribution from environment commissioner Margot Wallstrom. She sets out the key motivations for the proposals and argues they will bring benefits in terms of health, innovation and public perception of the chemical industry

Most ECN readers will have followed the lively discussion on the new European Union chemicals policy, from the publication of our White Paper in 2001, to the development of different position papers, to the draft legislation, which is now on the Internet for consultation*. The idea is to invite comments from stakeholders so we can fine tune the draft proposal and ensure it is workable.

The constructive dialogue between the European Commission, national and regional authorities and different stakeholders has been vital in bringing this important reform forwards. We have invested heavily in striking the right balance between the interests of the citizens and the environment on the one hand, and the competitiveness of a very important sector of European industry on the other.

The new chemicals policy is a test case for the principle of sustainable development. To be sustainable, any policy has to reconcile economic, social and environmental concerns. Achieving this balance is particularly important in the case of chemicals, where the stakes are so high on all three sides.

There has been a lot of discussion about the different aspects of Reach, including costs, benefits, animal testing, intermediates, polymers, authorisation, substitution, data sharing, labelling, definitions, imports and exports.There has been so much discussion from so many angles that it is possible some may have lost sight of the most important point. It is time that European citizens get the high level of protection for environment and health that they have the right to expect. This is why we need a new strategy for chemicals management. The current regulatory system is not working well and cannot ensure the safety of the chemicals we use.

Chemical safety can sound abstract. Many EU citizens are not even aware of the large volumes of chemicals used in everyday life, let alone the potential risks. But when problems do become evident, it can be too late.

Not long ago I received a letter from a paediatrician who was very concerned. She was often finding, she wrote, that young boys she examined had been born with abnormalities of the reproductive organs. She said that this defect was much more common now than a few decades ago. She believed that hormone-disrupting substances might be the cause of this defect. Her frustration was clear from her letter. Of course, the boys will get the surgery they need to repair the abnormalities as far as possible. But if certain chemical substances are causing the problem, we can expect these defects to become increasingly widespread, unless we take action.

Substances that have accumulated in our bodies or in the environment are there to stay. Our children get their first dose when they are still in the womb. A new-born baby girl may have her father's eyes and her mother's nose but she will also have a cocktail of synthetic chemicals in her bloodstream that she has inherited from our modern way of life.

There is no getting away from this. Even animals in remote areas like the Arctic and at the bottom of the sea carry synthetic substances that accumulate in their bodies. Does this tie in with sustainable development?

Some effects of chemicals have been more researched than others. We have lists of chemicals likely to cause cancer, irritate skin, cause respiratory problems or that may be harmful for other reasons. Whenever risks are known, there are ways of reducing them.

The problem today is that so few of the chemicals on the market have been properly assessed. Of the high-production volume chemicals tested as many as 70% turned out to be dangerous. So if we do not even know the risks, how can we manage these substances properly?

Why are we in this situation today? There are two main reasons for this:

- The legislative system - now 20 years old - is inefficient, slow and does not guarantee enough protection; and

- There is an artificial divide between old and new chemicals. The tens of thousands of substances that were on the market in 1981 can be used without any testing, while the requirements for getting a new substance introduced are very strict (testing from 10kg) and the whole responsibility for assessment lies with the public authorities.

So it is easier to keep using an old untested and potentially harmful substance, than to try to develop or introduce a new and safer alternative. This stifles innovation.

These are some of the concerns that have led us to introduce Reach. It will radically change the way that chemicals are managed in our society. The EU chemicals industry will shoulder the responsibility for chemicals safety, and will have to demonstrate that their chemicals are being used safely. This is in line with corporate responsibility.

Reach entails the registration, evaluation and authorisation of chemicals. Registration will give industries the opportunity to show that they know what they are doing when dealing with chemicals. Chemicals produced or imported in volumes of at least 1 tonne/ year by a particular manufacturer or importer will have to be registered in a central database.

The public will have access to the non-confidential parts of this information. When chemicals are sold to downstream users, the relevant safety information must also be passed on. This will help to enhance the reputation of the industry as a transparent and responsible sector.

Five main types of information will be required: properties, intended uses, likely exposure scenarios, potential risks to human health and the environment, and how these risks are to be managed.

Many of the chemicals in use today are expected to pose no concern, and for these there will be no need for further examination beyond registration. We estimate that this will be the case for around 80% of substances.

For substances that are produced in high volumes - more than 100 tonne/year - there will be compulsory evaluation by EU member states to avoid unnecessary animal testing and to ensure that tests meet the right standards. A priority evaluation procedure can be used to check the quality of registration dossiers and to look particularly at substances of concern.

Authorisation is for substances of very high concern. Use-specific authorisation will be required in order to use or import substances in this category. We are talking about the inherent properties of substances: they may be carcinogenic, mutagenic, toxic for reproduction, bio-accumulative, persistent, etc. By having these undergo the strictest control, we are sending a clear message: look for and develop safer alternatives. The principles behind this whole proposal are precaution and substitution.

Finally, as a safety net, it will also be possible to impose restrictions at EU level on any substance that poses unacceptable risks - or on the manufacture, marketing or particular uses of that substance.

For intermediates, it makes sense to exempt non-isolated intermediates, and to adjust requirements for other categories of intermediates to their degree of exposure. Similarly, potentially hazardous polymers will have limited registration requirements, while non-hazardous ones will be exempt.

Reach has been designed to promote innovation of new and safer substances. In order to help the industry draw the benefits from the new requirements, we have agreed to exempt substances that are manufactured for product and process-oriented research and development from registration for five years, with the possibility of renewal for a further maximum of five years.

I am fully aware that for parts of the chemicals industry the different provisions of Reach come down to one major thing: cost. Cost was also a central concern for the Commission when we drafted the legislation. How can we extend a high level of safety to as many chemicals as possible, without overburdening the system and harming the competitiveness of the industry?

I want to draw your attention to three features of Reach that have been designed to cut costs. First, we have attached considerable importance to volume. As a general rule, information requirements are directly linked to production volumes. Substances below 1 tonne do not have to be registered. (And remember, today we have testing requirements for new chemicals at volumes as low as 10kg.) Low volumes have low information requirements.

Second, information requirements are flexible. I have on many occasions met representatives of the industry who have informed me that they have all the data they need to ensure the safe use of chemicals. That is great news. It means that many of the information requirements will be comparatively easy to comply with.

Reach will accept many kinds of information about chemicals, as long as it is scientifically valid. Existing data should be used as far as possible. Tests from outside the EU are welcome, as well as information generated through computer modelling and other alternative methods. It should only be necessary to conduct tests on animals as a last resort.

Any animal testing that may be required for higher volumes does not go ahead until the competent authorities have looked at the testing proposal. This is to make sure that existing tests are not duplicated by unnecessary further testing, and that the results are valid.

Third, we encourage data sharing. Companies that register the same substances are invited to cooperate in collecting data and sharing costs. Companies that use test data generated by others also have to share the costs. To facilitate this cooperation, there will be a system for pre-registration.

All in all, the direct costs that will be imposed on the EU chemicals industry have been estimated at less than E4bn over an 11-year period, which corresponds to 0.1% of the industry's annual turnover. This figure is based on the model outlined in the White Paper, which we have since streamlined by removing some requirements, so the figures for the system we have actually presented are lower.

We are also looking into the indirect costs as well as the potential benefits. A final impact assessment will be presented with the final proposal for the new regulation.

It is clear that the new chemicals policy will provide opportunities for industry. This is why the initial costs should be seen as an investment, for which there will be a pay-off.

These will include:

- More demand and market opportunities for safer and more environmental friendly products

- Safer products that reduce the risks of future liability lawsuits

- Increased trust among consumers, employees and investors, which will create a more positive business environment: thus talented young people will be more interested in embarking on a career in chemicals

- Easier requirements for introducing new chemicals on to the market, encouraging development and innovation

- A more predictable and coherent regulatory system, which will aid long-term planning by industry

- Increased transparency through the supply chain will increase the power of, and confidence among, downstream users.

It is clear, however, that the benefits of the proposal will far outweigh the costs. Global risk/benefit analysis is a complex undertaking. Some studies have examined the costs of chemicals-related health problems, such as allergies and respiratory diseases. For some of them we have calculations, particularly for occupational diseases, and the figures are staggering.

The occupational health benefits of Reach are estimated at as much as E54bn over a 30-year period. And there is other damage that is difficult to express in monetary terms. For example, how much is the survival of a wild species worth?

To summarise, I believe that we have faced up to the challenge to create a sustainable chemicals policy, which puts the protection of people's health and our environment first and will enable the European chemicals industry to prosper. It is high time to act - together.

* http://europa.eu.int/yourvoice/consultations/ index_en.htm

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