The Keynote Speech by Geert Dancet, Executive Director, ECHA: Lessons learned from a decade of REACH.

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Keynote by Mr Geert Dancet, Executive Director,
European Chemicals Agency
‘Lessons learnt from a decade of REACH’
2016 Helsinki Chemicals Forum
26 May 2016, Helsinki
Ladies and gentlemen,
It gives me very great pleasure to join you once again at the Helsinki
Chemicals Forum. It is a wonderful opportunity to take time to discuss
together - colleagues from industry, from regulatory authorities in the EU
Member States and beyond, from multilateral organisations and from civil
society. Because, wherever we work, we have one common objective – to
make our respective corners of the world a little bit safer.
In the next few minutes, I am going to take the opportunity to give you a
preview of the lessons we have learned from a decade of REACH. The lessons
are contained in an important report, produced by my Agency every five years,
to look at how REACH and CLP are being implemented: what’s going well, what
less well, and which issues really need to be addressed. I trust that you find it
interesting and thought provoking. Only a few moments ago, my colleagues
sent the report to the European Commission and published it on our website,
so my presentation really is ‘hot off the press’.
But before I talk to you about our report’s findings, I want to briefly remind
you of the journey we have made in Europe, since REACH was agreed under
the Finnish Presidency in 2006, almost 10 years ago.
Let’s take a look back
The REACH Regulation took nearly ten years to agree. It represented a
complete overhaul of the European Union’s chemicals legislation and replaced
a set of laws that were then more than 40 years old. What provoked the
change? There were a number of factors. Firstly, there was a growing concern
about the lack of information on the health and environmental effects of
chemicals to which we were exposed in Europe. Secondly, there was a desire
that dangerous substances should be more quickly identified and more quickly
restricted, or phased out by authorisation. Thirdly, innovation and the
development of newer, cleaner chemicals needed to be incentivised. And
finally, whilst recognising the need for more and better information on

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substances, there was also a feeling that testing chemicals on animals should
be avoided. These were the political desires and concerns that led to REACH.
Of course REACH was not alone in shaping this new world - the globally
harmonised classification and labelling system for hazardous chemicals was
incorporated into EU law as the CLP regulation. And that law also made it much
quicker to harmonise the classifications of the most dangerous substances.
It was always going to be an ambitious project – closing the knowledge gap by
requiring companies to generate data on their chemicals and on how to use
them safely. And this was all to be done whilst maintaining the
competitiveness of EU industry and encouraging innovation. Let’s not forget
that there were many who said that this was a bridge too far and would never
be achieved.
But equally, we must never underestimate the resourcefulness and
determination of European business! By mid-2018, the vast majority of
substances on the European market will have been registered and re-classified
according to the law. A little over ten years after REACH entered into force,
European citizens and businesses will have - for the first time - a complete
picture of the safety of the chemicals that they consume on a daily basis. An
enormous achievement, especially since this will have been done in a very
challenging period of economic instability.
What does ECHA’s report say?
The main conclusion of our report is that the REACH and CLP Regulations are
working and – by and large - delivering the expected ambitious results.
Companies manufacturing, formulating, importing and using industrial
chemicals are taking their responsibilities on board. There are also encouraging
signs that industry is continuing to innovate and maintain its competitiveness.
So, is the REACH machine in place and are companies responding?
The short answer is yes. Since the entry into force of REACH in 2007 and the
establishment of the Chemicals Agency here in Helsinki, there have been two
registration deadlines for the most hazardous substances and the ones
produced in the largest volumes. We have received over 54 000 registration
dossiers containing information on 14 000 chemicals. At the same time,
companies have provided the Agency with the classification of their hazardous
substances: over 6.5 million notifications in total, covering close to 130 000
substances.
Much of the work to collect and provide information on the hazards and safe
use is done with other companies registering the same substance, very often
their direct competitors. This information is now freely available on ECHA’s

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website to every authority, organisation, citizen and company anywhere in the
world. Before REACH, even public authorities responsible for chemical safety
did not have access to this level of information.
However, whilst companies are clearly responding to the legislation, it must be
said that a significant proportion of REACH registration dossiers do not contain
data of a sufficiently high quality. The main weaknesses are: one: a lack of
clarity about the identity of substances; two: providing poor justifications for
using alternatives to testing on vertebrate animals; three: not providing
sufficiently detailed information on the uses of substances and their potential
exposure to people; and four: not having robust risk management (or
mitigation) measures for each use to arrive to zero effect.
Furthermore, companies have an obligation to continuously update their
registration dossiers whenever new information becomes available – something
that many are not doing.
Why is the quality of data so important? Actually, it’s not only important – it is
absolutely fundamental. Without quality data, the safe use of chemicals by the
actors along the supply chains cannot be achieved. Without quality data, it is
impossible to differentiate between the substances that can be used safely and
those that cannot. Without quality data, the Agency and the Member States
are unable to prioritise the most hazardous substances for regulatory attention
– and more than that, they may take action on substances that do not require
it. Consequently, without quality data, the risk management of substances that
represent an unacceptable risk to human health or the environment can be
delayed.
So, is Europe safer as a result of REACH?
This of course is the 1 billion Euro question! And, in our report, we are showing
that it is.
I want to talk to you briefly about one very positive impact - the phasing out of
the most hazardous chemicals, one of the aims of REACH. There are currently
almost 170 so-called substances of very high concern on the Candidate List,
and they are all destined to be phased out. But, to protect competitiveness,
REACH enables companies to apply for temporary authorisation to continue
using one of those substances. To get that authorisation, they need to
demonstrate that its risks can be controlled until a safer alternative can be
found.
So far, 31 substances were placed on the list of substances requiring
authorisation. This, together with around 20 new restrictions and over 200
opinions on harmonised classifications, have led to valuable and positive
human health and environmental benefits.

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There is considerable evidence that companies are being innovative in finding
safer alternatives. And, since REACH has been in force, almost 1 500 new
substances have been put on the market. Encouragingly, that trend is also
increasing.
More could undoubtedly be done to promote substitution, but the upward
pressure for safer chemicals from regulators, downstream users, retailers and
consumers should also not be underestimated.
However, I also want to highlight one of the less successful aspects, and a
particular concern for ECHA - the exposure of consumers to substances of very
high concern in articles. I am talking here largely about articles imported into
the EU. Companies are required to inform ECHA of substances of very high
concern in articles, but the number of notifications is worryingly low. We need
to see additional efforts made by importers and stronger enforcement in this
area if consumers are to be effectively protected.
Is unnecessary testing on vertebrate animals being avoided?
Yes, but more can still be done. The basic responsibility for avoiding
unnecessary testing on animals lies with individual companies. REACH requires
them to share animal test data as part of the process of registering their
substances and this works well. Companies also make extensive use of
alternatives to testing on animals, such as reading-across from similar
chemicals and gathering a weight of evidence to justify their arguments.
Unfortunately, this is often poorly justified and documented and can ultimately
result in the need to do animal tests after all. ECHA has worked to provide
companies with guidance in this area, especially for the 2018 registration
deadline that requires data on endpoints for which alternative test methods are
available.
All this sounds very promising, so what needs to change?
It is true to say that, on balance, the Agency does not see any imminent need
to revise the REACH Regulation. The system as described by the law is
fundamentally working and, where improvements need to be made, they can
mostly be done by refining the practical implementation of the legislation or by
changing the Annexes of REACH. Nevertheless, should the European
Commission decide to amend the law, we can suggest a number of changes to
smooth or improve its clarity and effectiveness.
Even without changing REACH, we suggest several legislative initiatives that
can usefully be considered and that can have a strong impact. First of all, as
I’ve mentioned, the quality of the data on chemicals needs to be improved and

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updated. This is not yet being done consistently enough. So the change
needed is attitudinal or behavioural on the part of companies, but of course the
European Commission could consider implementing legislation to make that
requirement clearer.
Secondly, the data on nano forms of substances needs to improve. Many
companies are holding back on providing nano data because there are no
explicit information requirements in REACH. The European Commission is
working on that, but in the meantime, industry needs to lead by example and
provide data on nano forms of their substances. Working internationally on
emerging issues like nanomaterials and endocrine disruptors would in my view
also bring benefits to the safe management of chemicals across the globe.
Thirdly, there are very many contradictory self-classifications in the
classification and labelling inventory. Far too many to be justifiable or correct.
This variation is resulting in confusion for users of chemicals – which
classification can they believe? ECHA recommends a change in the CLP law to
oblige companies to resolve any unjustified differences. I would welcome your
consideration of how the work carried out by authorities in your countries could
contribute to this.
Fourthly, EU citizens need to have more reliable information on substances of
very high concern in the products they buy. The current legal requirement for
information on substances in articles is not working well enough. A
fundamental review of the obligations as part of the European Commission’s
work on the circular economy would be very helpful and could boost the drive
towards a non-toxic environment.
Finally, we also see opportunities to clarify further the interface between
REACH and other pieces of legislation regulating chemicals and chemical
products. The data base ECHA is building represents a significant investment
by the companies themselves and the regulatory authorities in Europe. This
data could be used more widely to comply with other pieces of EU and - in my
view also non-EU - legislation, thus reducing unnecessary burdens on
businesses and facilitating world trade. Moreover, when reviewing chemical
legislation or introducing new laws, the synergies with REACH and CLP should
be explored. I am particularly looking forward to the ideas generated by Panel
3 that could help us to make maximum use of the information generated by
REACH for other purposes.
All the commitments which we make in the report and most of
recommendations especially towards industry and the Member States are
made to make the integrated regulatory strategy that ECHA adopted last year
a success by 2020.

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Is the REACH journey almost over?
Absolutely not. There are a variety of milestones ahead as we work towards
the safer use of chemicals and a non-toxic environment. The 2018 registration
deadline and the UN goals for the safe use of chemical are just the first.
In 2018, we will have a complete picture of all the substances produced at
over one tonne in the EU. That information will surely reveal more substances
requiring risk management, as well as safer alternatives for industry to
consider. The 2020 and 2030 world sustainability goals on chemicals set the
direction for further action.
But this is a journey whose finishing line stretches much further into the
future.
The chemicals sector has always been dynamic, with new substances being
developed and old ones phased out on a regular basis. Added to that, scientific
advances continue to increase our understanding on the impact of chemicals
and their safe use. These two factors will surely bring change.
And at a societal level, change is guaranteed. There are many reasons why
regulators worldwide are looking for ever safer and more efficient ways of
improving our lives and economies. The European Commission’s thinking on
the circular economy, which will be discussed by Panel 1, is just one example
of that. As is the drive to a non-toxic environment, which is also relevant for us
today.
The good news is that increasingly, we are all on this journey together. REACH
and CLP are instrumental in bringing about the necessary change for a much
safer world and - as demonstrated in our report - we in Europe are making
very good progress. I am also particularly pleased that our work is contributing
to chemical safety far beyond Europe, through the substance information and
other material that we make available on our website.
Ladies and gentlemen, I wish you a productive time at this year’s Helsinki
Chemicals Forum and I look forward to the lively discussions over the coming
two days and to the conclusions.
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