SPEECH/03/169
Margot Wallström
Member of the European Commission, responsible for
Environment
"Beyond REACH"
European Voice Conference
Brussels, 31 March and 1 April 2003
Dear Ladies and Gentlemen,
I would like to start by talking about ourselves, penguins and polar bears.
What do we have in common with these animals? The very uncomfortable reality is
that each one of us here today carries several hundred synthetic substances in our
bodies, chemicals that persist and bioaccumulate. They are found in breast milk and
the placenta, thus affecting the foetus and new-born babies. They are also found in
deep-sea living organisms and in animals living in the Arctic and Antarctic, where
they were never used.
A significant number of industrial chemicals can act as endocrine disrupters, posing
the risk of interference with the reproductive or immune system or causing cancer at
very low concentrations. And we do not know enough about the mechanisms they
work through. It is a fact, though, that various diseases are on the increase, such as
testicular cancer and reproductive disorders, and a link to chemicals exposure
seems likely.
It is of course also true that modern society depends on chemicals. They are used
in the vitamin pill you took this morning, the microphone in front of me and the
clothes that we are wearing. It is therefore not surprising that the production of
chemicals has increased dramatically during the last decades. In that perspective,
our insufficient knowledge about the chemicals in use and their impact on human
health and environment is a cause of deep concern.
The new chemicals policy will radically change the way in which we deal with
chemicals.
It will make a major contribution to the protection of human health and the
environment.
For the first time ever, we will put in place a system to produce sufficient information
on the chemicals we use in significant quantities. Chemicals that pose
unmanageable and unacceptable risks will be phased out. Chemicals whose risks
are manageable can be appropriately handled - and we will know that all the other
ones don’t pose problems.
The new policy introduces a radical paradigm shift, which breaks with the past: In
the future; the chemicals industry will be responsible for generating and providing
the necessary information about their own products in line with corporate
responsibility. Not -- as it is today -- the public authorities having to prove that a
chemical is hazardous.
This radical shift in dealing with chemicals is indispensable if we are serious about
protecting human health and the environment.
The timing of this conference here is very appropriate. The Commission will shortly
present its legislative proposal, which follows the White Paper that we published in
early 2001.
The name of the conference is also well chosen. “Beyond REACH” implies that
devising REACH and eventually getting it up and running is a process, not an end
result.
This process can be compared to building a house – a smart house that serves a
vital overarching purpose and must satisfy many individual needs and requirements.
Such a construction must of course be well prepared and thought through.
From the outset, everybody, all those who produce, handle and use chemicals have
agreed that we need a new house - that the existing chemicals policy has too many
shortcomings and needs to be radically reformed.
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Participation in the discussions on what the new house should look like to serve its
purpose has been impressive – we have consulted with industry, NGOs,
consumers, regulators and other stakeholders, including many of you here today.
We have taken serious note of the Parliament's Resolution and Council's
Conclusions on the White Paper. A vast majority of those consulted or who have
raised their voices indeed supports the objectives of the reform.
First and foremost, REACH will close today's unacceptable knowledge gap!
At the same time, REACH will maintain and enhance the competitiveness of the
very important chemicals industry, which is the third-largest manufacturing industry
in the EU and directly employs 1.7 million people.
REACH will also be transparent and open so everybody who uses chemicals in one
way or the other has access to important information.
REACH must also be compatible with the internal market, ongoing international
efforts in the field of chemicals management, WTO rules and regulations.
Also, at the top of our minds has been the need to restrict animal testing to an
absolute minimum. The Commission supports alternative test methods, for instance
via our research programmes. But, we should not forget that at present, we are
unwittingly testing chemicals on both living humans and animals. This is clearly
unacceptable.
In all this, it has been crucial that REACH works in practice – that the technical
aspects of the system are neither too bureaucratic, nor too cumbersome, but able to
deliver the desired results as efficiently as possible and over an acceptable period
of time.
To reconcile all these requirements has been a formidable challenge. We have had
to strike a very careful balance between all those factors.
But this is what sustainable development is about – taking account of the economic,
social and environmental consequences of the policies that we formulate.
And I am delighted to state today that the legislative proposal meets the objectives
we set out in the White Paper - and has clarified it regarding some important
issues.
For example, REACH now requires that specific uses of high-concern substances,
such as PBTs – persistent, bio-accumulative and toxic pollutants - and vPvBs - very
persistent and very bio-accumulative substances – will have to be authorised. Also,
the use of endocrine disrupters and substances of an equivalent level of concern
will be included under authorisation on a case-by-case basis.
All in all, by generating and making available information on chemicals, REACH will
produce a win-win situation for everybody:
for citizens who are in contact with chemicals every day and demand to know more
about them so they can deal with them responsibly and safely;
for workers who handle chemicals and want risks to be as low as possible
for the chemicals industry because its image as a high sustainability sector will
improve, increasing its competitiveness; innovation will be enhanced
for policy makers who have a duty to protect human health and the ecosystem;
and for society as a whole because human health and the environment will suffer
less harm. This will reduce the costs of treating chemicals-related diseases and
dealing with the long-term damage done to the environment.
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Now, the first question that comes to mind is: Why has the existing regulatory
system not been able to deliver what we need?
Firstly, for those 140 substances put on the priority list for high production volume
chemicals, only 11 assessments have been concluded over a ten-year time span.
This is clearly unacceptable.
Secondly, the authorities have been responsible for risk assessment and
development of risk management measures. In doing that, they have been obliged
to follow cumbersome procedures. It is high time to place this responsibility where it
belongs, with the industry, and the procedures must be smooth and efficient.
Thirdly, the current system does not encourage innovation and substitution. Today,
it is much less hassle to continue to market an existing chemical (that we really do
not know anything about) than to put a new, less hazardous and more efficient
chemical on the market because this requires testing.
Fourthly, the current regulatory system is based on altogether some 60 individual
pieces of legislation. We need one Regulation and one door through which all the
information on chemicals will go in and come out again. REACH will be this one
Regulation and create a one-stop shop.
So, how will REACH actually work?
As you know, REACH stands for R - Registration, E – Evaluation, A – Authorisation,
of CH - Chemicals.
Registration means that chemicals produced or imported in volumes higher than
one tonne per year and per manufacturer or importer will have to be registered in a
central database.
Five types of information will be required: the properties, intended uses, likely
exposure scenarios, the potential risks to human health and the environment, and
how these risks are to be managed.
Chemicals produced or imported in high volumes (above 100 tonnes per year and
per producer or importer) and those that give rise to concern will need to be
evaluated. Before I elaborate evaluation, allow me to mention a few more aspects of
registration.
There has been a lot of speculation whether intermediates, chemicals that are used
to manufacture other chemicals, will have to be registered. The answer is: yes, they
will. It would be irresponsible from the point of view of human health and the
environment not to include them, and we need a comprehensive system to avoid
that some potentially problematic substances could slip through any loopholes.
But at the same time we have been keen not to overburden the system and to keep
it proportionate. Those intermediates that are never separated out from other
substances (so-called non-isolated intermediates) will be exempted altogether.
Requirements for other categories will depend on their degree of exposure.
Intermediates that are handled just as any other substance on the market, must of
course be subject to exactly the same requirements as these. Reduced registration
requirements will also apply to polymers.
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Also, it is important to mention that substances that are manufactured for processoriented Research and Development will be exempted for five years with the
possibility of renewal for a further maximum of five years from the registration
requirement, irrespective of volume. This is to ensure that development of new
products will not be too costly for EU producers compared to non-EU competitors.
We have also included this provision to encourage innovation and substitution. We
need the industry to strive continuously to produce safer, less hazardous
substances, which can replace those that cause concern.
Evaluation: Evaluation will be compulsory for the high-tonnage group, and can be
initiated by the public authorities in cases of concern, regardless of tonnage. On the
basis of proposals from companies in the registration, the authorities will decide on
testing strategies to focus information requirements and minimise the use of
laboratory animals wherever possible.
Authorisation relates to substances of very high concern. Specific uses of such
chemicals will have to be authorised by the Commission or, in cases of strictly local
use, by Member States, based on comprehensive data and risk assessments that
industry will deliver.
While it has been clear from the beginning that CMRs, that is carcinogenic,
mutagenic or reprotoxic substances, would fall under this category, we have now,
as I have already explained, also included PBTs and vPvBs. Endocrine disrupters
and substances of an equivalent level of concern will also be included on a case-bycase basis.
This, I am deeply convinced, has been necessary to be able to control the risks of
these substances.
Finally, we will also provide for restriction of certain substances in order to have a
safety net in the system. This will give the possibility to introduce restrictions at EU
level on any substance, or on the manufacture, marketing or particular uses of
substances that pose unacceptable risks.
The system itself will efficiently promote substitution. Equal treatment on information
for all chemicals and that this information is made public will lead to a higher
demand for safer alternatives.
Now, who will do what under REACH in order to make it work?
The industry - manufacturers, importers as well as downstream users of chemicals will provide the necessary information, including risk assessments related to the
chemicals they manufacture or use. This information will be fed into the central
database and be available to the public. Industry will also be required to pass
important information down the supply chain, so downstream users know what they
are dealing with.
The competent authorities in the EU Member States will be in charge of following-up
on the registration dossiers and of performing evaluations. The authorities will also
be able to propose restriction measures at EU level.
The new European Agency will receive registration dossiers, manage the central
database and provide the public with information. It will also co-ordinate the work of
the Member States authorities under the evaluation procedures and support the
decision-making process related to authorisations and restrictions.
The European Commission will take decisions both on authorisations and
restrictions at the EU level. With regards to authorisations, it will prioritise which
substances have to undergo authorisations first.
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Finally, the citizens will at last have information about chemicals through the central
database. This will enable them to make informed choices, demand alternatives and
know how to handle chemicals.
As you can see, REACH is quite an elaborate system. However, an important
question is: How much will all this cost?
There will of course be costs involved in obtaining information and doing testing.
The independent Business Impact Assessment study we presented last year
estimates the direct registration and testing costs for industry at between 1.4 - 7
billion Euro over as long as eleven years, with 3.6 billion Euro as the most likely
estimate. This is less than 0.1% per year of the annual turnover of the chemicals
industry.
Costs must of course be compared with benefits. Even though they are difficult to
estimate precisely in monetary terms, the impacts will be substantial with regards to
lower risks to human health and improved environmental quality. As an example,
the likely occupational health benefits from the new regulatory system should be
estimated at between 18 and 54 billion Euro over a 30-year period, which
corresponds to an ultimate yearly reduction of some 2200 to 4300 cancer cases
over the same period
The increased trust among consumers, employees and not least investors will lead
to a more positive business climate. Just as an example, I have met chemical
industry top executives who are concerned that their sector suffers from a negative
image. They complain that ever fewer students today consider a career in
chemicals and that the industry has difficulties in recruiting talented engineers. I am
convinced that the industry’s image will be enhanced by a much larger degree of
responsibility it will assume.
Another advantage for the industry is that a more predictable regulatory system will
aid future long-term planning.
We should not forget the fact that the EU is the world's leading producer of
chemicals. With the new strategy for chemicals, we have a unique opportunity to
influence not only the business and marketing conditions in the European Union but
also in the rest of the world.
I would like to state that REACH in many ways is a textbook example of innovationfriendly regulation, since it does not tell business which chemicals to produce or
use. Instead, it sets strict harmonised requirements for all substances, with an
eleven-year phase-in period and places the responsibility for the solutions on
industry.
So where do we go from here?
We are currently finalising the legislative proposal, which will be the subject of an
Internet consultation on the workability of the proposed system, starting in May.
The purpose of this consultation is to ensure that REACH will successfully function
under real operational conditions. Stakeholders will be invited to comment on the
workability of the proposed system, including technical requirements, correct use of
definitions etc. However, it must be clear that the approach that REACH represents
will not be up for debate again – we are already committed to this -- only its
workability.
We look forward to receiving these comments, so we can take them into account as
we finalise the legislative proposal.
The Commission will then adopt the proposed Regulation before the summer break.
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The journey from the White Paper to a formal Commission proposal is almost over,
which is an important step in constructing and eventually start using the house that
will protect us from the hazards of chemicals.
Finding the right balance between the need to ensure a high level of protection of
human health and the environment and the competitiveness of an important part of
EU industry has been a remarkable challenge.
But I believe that we have lived up to it. REACH will allow us to achieve what we set
out to achieve: to gain more knowledge about chemicals so that we can take
advantage of their benefits without exposing ourselves and our environment
(including the penguins and polar bears) to unnecessary risks.
A sustainable chemicals policy, which puts the protection of people’s health and our
environment first, will enable a sustainable EU chemicals industry to prosper.
Thank you for your attention.
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