Wallström’s vision for safe use of chemicals in Europe

Date: 20/03/03

Environment Commissioner Margot Wallström, in conjunction with enterprise chief Erkki Liikanen, plans a raft of changes to 'the way we deal with chemicals'. Here, Wallström answers key questions put to her by Karen Carstens

Why does the European Commission want to reform chemicals policy?

Because the Commission believes it is high time to provide Europe with a modern and efficient system to ensure safe use of chemicals, and close the huge knowledge gap that exists today about the impact of chemicals on people's health and the environment.

Europeans are increasingly concerned about safety of chemical substances, and they rightly expect the EU to take action. In this context, the competitiveness of Europe's important chemicals industry will, to a large extent, depend on its sustainability.

The Commission's upcoming proposals for legislation on registration, evaluation and authorisation of chemicals [REACH] is therefore in everybody's interest. The way we deal with chemicals today does not provide sufficient protection of human health or the environment, and it is easy to see why.

The current system, which came into force in 1981, covers only a small part of the more than 100,000 substances which were on the market at that time. This means that they are still produced, sold and used without any requirement to provide information on the properties of the substances.

As a result, we are confronted with the unacceptable and potentially very dangerous knowledge gap mentioned above. Also, at the moment, it is up to the public authorities to acquire information and, if a substance gives rise to concern, to prove that it is problematic. This process is much too slow.

The same goes for the stricter system for placing new substances on the market, introduced in 1981. Only 3,400 new substances have been tested since then, and less than 20 have been put through the existing substances programme.

What is new in REACH compared to the present EU legislation?

First and foremost, the new system places responsibility for safety issues where it should belong: with the producers and importers of chemicals.

REACH introduces a radical change, by shifting the burden of proof on the safety of chemicals to industry. This means it is up to the company producing the chemical or the importer of a substance, rather than public authorities, to take responsibility for providing information necessary for assessing risks and to put in place adequate risk-reduction measures.

At the same time, we do not want to repeat the mistakes of the past, ie by introducing too demanding or cumbersome procedures that will not work efficiently.

The transparency of REACH - safety information about chemicals will be publicly accessible - will strengthen the efficiency of the system: it will give downstream users, workers, professional users, consumers and others the information they need.

When will the new proposal be presented to the public?

The essentials of the new chemicals policy - the political aims and strategy to achieve them - were presented in the White Paper adopted by the Commission in February 2001. The legislative text will, after a first debate in the Commission, be subject to an internet consultation whereby stakeholders will have an opportunity to comment upon the workability of the proposal.

The Commission is expected to adopt the proposal in July.

Four different categories of 'intermediates' have been designated for different treatment. What exactly does this mean?

To effectively protect consumers' health and the environment by ensuring safe use of chemicals, it is necessary for our new system to be comprehensive with regard to the substances it will cover.

At the same time, a differentiated approach to groups of chemicals enables us to devise a system that avoids imposing unnecessary burdens on industry.

We have sought to create mechanisms and procedures that will eliminate duplication and unnecessary costs, and to fix requirements that are proportionate to the risks. An example of this approach is our way of dealing with 'intermediates' - chemicals used in the production process to make other chemicals.

For this kind of substance, we envisage different degrees of requirements - depending on how and where the substance is used, taking its degree of exposure to the environment into account.

What kinds of compromises have been struck between DG Environment and DG Enterprise?

This important proposal for legislation, which is being prepared under the joint responsibility of Erkki Liikanen and myself will, as always, be presented in its final form by the whole Commission.

In the new chemicals strategy, the Commission has committed itself to safeguarding several objectives, to secure a high level of protection for health and the environment and to safeguard the competitiveness of the EU chemicals industry. Of course, Mr Liikanen and I have worked closely to strike the right balance.

I am convinced - and this is indeed my ambition - that the legislative package will succeed in meeting the objectives set out in the White Paper. The strategy we outlined has been fully respected and has been strengthened in important aspects.

For example, Mr Liikanen and I have agreed to expand the scope to include substances that accumulate in our bodies or in the environment. At the same time, we have worked hard to ensure the system can deliver without being too costly or burdensome to industry or the authorities.

Are you confident that there will not be too much criticism from stakeholders during the internet consultation?

I think it is important to recall that the White Paper has been subject to long and wide-ranging consultations with all stakeholders, which helped shape thelegislation we are now finalising.

The internet consultation is a continuation of the transparency which has characterised the preparation of the legislation on chemicals. It is, of course, not designed to start general consultations all over again, but more of a fine-tuning process, before we kick off the legislative process in Council and Parliament. This is why we talk about "workability" - for example, making sure that we use the relevant terminology.

Liikanen indicated recently that you both agree on the need to preserve innovation in the EU chemicals industry, but was a little vague on the subject of SMEs. This led some observers to speculate that you do not see eye to eye on the effects REACH could have.

Commissioner Liikanen and I are both well aware of the fact that the chemicals industry - which includes a large number of SMEs - is very important for Europe.

We both agree that it is fundamentally important to reach a high level of protection of the environment and health without compromising the competitiveness of industry.

Chemical safety is as important for SMEs as for their bigger competitors. This is why REACH information requirements relate to production volumes, uses and properties of the chemicals, and not to the number of employees of the companies.

Many SMEs that will be affected are what we call 'downstream users', that is companies that buy chemicals and use them as ingredients in their own products. At this stage in the production process, most chemicals will already be registered. The registration information will help downstream users to ensure a high level of chemical safety.

SMEs that are manufacturers will be able to take advantage of the incentives for innovation that the REACH system will create, such as exemptions from testing requirements for R&D substances.

They will be able to share administrative burdens and costs with others. Member states are well aware of the need to prepare SMEs for their new responsibilities. Some member states have already started information activities.

Will SMEs not feel overwhelmed and financially overburdened, which in turn will hamper innovation?

I am convinced that the REACH system will enhance the credibility and competitiveness of the EU chemicals industry, which will also benefit SMEs.

The credibility gap that the industry currently suffers from will be overcome, thanks to clear information about all chemicals on the market. For the reasons already explained, SMEs are unlikely to become overburdened by costs related to complying with the new legislation.

I also have quite a lot of confidence in the innovative capacity of SMEs, if they are given the necessary encouragement and incentives to develop new and safer products as substitutes for more hazardous chemicals, which is what our proposal is all about.

How are national authorities to ensure the workability of REACH? Will they not feel overwhelmed, at least initially, with adjustments that must be made?

Public authorities are already working with chemicals. The Commission's proposals will ensure a fairer and much more efficient sharing of responsibilities.

REACH will take away resource- demanding tasks from public authorities, transfer responsibility for risk assessment to industry and, thereby, will give public authorities better possibilities to focus on their core tasks of enforcement and control.

Furthermore we will establish an agency at European level to coordinate member states' efforts.

An interim strategy that will link the existing system with the new one is under development. It will include the establishment of computerised assessment tools for authorities, and training.

Animal rights groups claim REACH will lead to more animal testing. Does this not contradict your goal of protecting the environment?

Promotion of non-animal testing is one of the key principles in our proposal. Wherever animal testing can be avoided, it should be. Every effort should be made to avoid duplication of testing through, among other things, systematic collection of data and the sharing of test results among companies, which will then also be able to split the costs.

However, in order to protect human health, there will be a need for better knowledge about the effects of chemicals. In certain cases, the only way to get that knowledge is through animal testing. In order to reduce this need the Commission actively supports development and validation of alternative test methods, for example via our research programmes. We should not forget that, at present, we are unwittingly testing chemicals on both humans and animals. This is clearly unacceptable.

Estimates for the cost of REACH vary from €2.5 billion to €7 billion over ten years. What is your assessment?

The Commission's strategy aims to be cost-effective, but we should also remember that the costs to society could be immense if we continued with business-as-usual instead of introducing this new system.

Also, it is important to remember that most of the costs to industry will depend on how much information it can make readily available. Most costs are linked to testing and registration, as studies undertaken for the Commission have shown.

For direct costs, a business impact study was carried out and published in May 2002. It calculated a most-likely cost estimate at €3.7 billion.

The current proposal on registration and testing points at numbers below the original best estimate, due to differentiation of testing requirements for different groups' products.

Will EU citizens be better protected from dangerous chemicals once REACH is in place?

Yes, and this is one of the main aims of our strategy.

REACH will provide better protection of the health of the European citizen and the environment.

The information which will be available about chemicals in the future, thanks to REACH, will enable us to ensure that harmful substances are gradually eliminated from the market, or allowed onto it only when they can be used without causing risks to humans or the environment.

When the system is operational, it will become an important building block to secure more sustainable production and consumption patterns in the future.

Major feature. Environment Commissioner Margot Wallström, in conjunction with enterprise chief Erkki Liikanen, plans a raft of changes to 'the way we deal with chemicals'.

http://ec.europa.eu/environment/chemicals/index.htm http://ec.europa.eu/environment/chemicals/index.htm

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