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Helsinki Chemicals Forum 2019 | 1
Helsinki Chemicals
Forum 2019
Stakeholder views on hot topics in chemicals safety
23-24 May 2019
2 | Helsinki Chemicals Forum 2019
International think-tank
Welcome to this report on the debates held at the eleventh
annual Helsinki Chemicals Forum.
This year 191 delegates from 31 countries witnessed the
Forum discussion on five main themes, including how to pick
the best options to manage risks of SVHCs, approaches to
plastic circularity and the struggle between data access and
protection of intellectual property.
The Helsinki think-tank promoted the case for the safe
administration of chemicals while taking stock of the diverse
political landscape and the hurdles to preserving human health
and the environment.
The Forum commenced with an exploration of the pros and
cons of various risk management options to regulate SVHCs
where panellists discussed predictability, transparency and
effectiveness of current legislative instruments.
This was followed by an exchange of views on grouping
and avoiding regrettable substitution. The third panel
session examined ways to measure how different chemical
management systems are performing.
Panel four focused on plastics and circularity, a theme which
is ever present on the public agenda. Experts discussed how
recycled goods can bring value if chemicals within them are
properly managed.
And the final debate of the event looked at quality of and
access to data on chemicals with panellists sharing their
positions on the tricky triangle of compliance, company
confidentiality and consumer confidence.
This report, prepared by independent intelligence and insight
provider Chemical Watch, intends to be a balanced and
accessible reflection of two days of debate as a means to
further understanding. We have not taken sides or judged
comments on their accuracy, veracity or fairness.
This is not a formal report because the annual Forum is
not an official session and its conclusions do not represent
a consensus. Instead, the report offers a reference point
for policy makers, companies, academics and others –
presenting the voice of the people in the room at this
important global gathering.
The final pages of the report comprise an unedited selection
of questions and observations that were posted on the
Forum message wall during the event to capture insights
from the delegates
Luke Buxton
Europe Editor
Chemical Watch
Charlotte Niemiec
Deputy News Editor
Chemical Watch
Andrew Turley
Science Editor
Chemical Watch
Helsinki Chemicals Forum 2019 | 2
Chemical Watch is the leading global provider of independent
intelligence and insight for product safety professionals
managing chemicals.
We help businesses across value chains stay ahead of
the dynamic chemicals management agenda by providing
access to in-depth knowledge, tools and a network of experts.
Our aim: to empower our members to transform product
safety management and unlock the full value of regulatory
compliance within their business by providing…
A one-stop intelligence source: independent global news,
insight and analysis to inform product safety decisions.
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An extensive calendar of events featuring expertise from
across our global business and regulatory network.
Interactive and flexible e-Learning, training and webinars to
boost individual and team expertise and continuously develop
their skills.
Resources and support to raise the level of chemicals safety
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departments to drive product stewardship.
Find out more.
Who is Chemical Watch?
Helsinki Chemicals Forum 2019 | 3
Contents
Keynote addresses: Beyond 2020 – circularity and the role
of chemicals
Panel 1: How to choose the best possible risk management
option to regulate substances of very high concern
Panel 2: Grouping of chemical substances and how to avoid
regrettable substitution
Panel 3: How to measure the performance of different chemical
management systems
Panel 4: Plastics and circularity – from pollution to a value based
proposition for all
Panel 5: The quality of and access to data on chemicals
Writing on the wall: An unedited selection of comments posted
to the message wall by the audience
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Helsinki Chemicals Forum contacts
Chemical Watch contacts
Helsinki Chemicals Forum
www.helsinkicf.eu
Chemicals Forum Association
Messuaukio 1, 00521 Helsinki,
Finland
Geert Dancet
Secretary general
+ 32 468 300787
geert.dancet@messukeskus.com
Tarja Gordienko
Communications manager
+358 50 584 7262
tarja.gordienko@messukeskus.
com
Maiju Helpi
Project manager
+358 50 344 0451
maiju.helpi@messukeskus.com
Riikka Heiskala
Project manager
+358 40 905 1873
riikka.heiskala@messukeskus.com
Luke Buxton
Europe editor
+44 (0)20 3637 5793
luke.buxton@chemicalwatch.com
Charlotte Niemiec
Deputy news editor
+44 (0)1553 341 206
charlotte.niemiec@chemicalwatch.
com
Andrew Turley
Science editor
+44 (0)20 3637 5794
andrew.turley@chemicalwatch.com
4 | Helsinki Chemicals Forum 2019
Promising start
In its vision for a truly circular economy, the European
Commission has laid down some “very significant” proposals
including the plastic strategy and analysis of the interface
between chemicals, product and waste legislation, Daniel
Calleja, director general of the European Commission’s DG
Environment told delegates. And others are in the works,
such as Echa’s database on SVHCs in articles under the
waste framework Directive.
Chemicals and the industry are the “foundation” of the
economy, he added, because they are used every day and
many economic sectors depend on them. The importance
of the sector “will not diminish; it will grow in the future –
chemical solutions can increase the durability of materials
and products and […] can play an important role in
transforming waste into the new resource”.
But more needs to be done to guarantee the safety of
products in the EU because the presence of hazardous
chemicals within them “destroys” consumer trust
and support.
Merging models
Echa has an instrumental part to play in helping to deliver
the circular economy. It needs to approach this by
considering how chemicals legislation can feed into policy
development in Brussels in as friction-free a fashion as
possible, Echa’s executive director Bjorn Hansen said.
In order to promote circularity, chemicals and waste policies
need to merge. One of the “fundamental stepping stones”,
he said, is to understand that ‘material’ means mixture and
to always replace the use of the term ‘material’ with ‘mixture’.
When companies import mixtures from outside Europe,
the substances within them need to be registered.
Once this merging approach is implemented, differences
between chemicals and waste policies can be identified.
“Bases already exist from which to start building a circular
economy, to start contributing when the policies evolve and
include support from scientific and technical bodies.”
Interfaces between disparate legislation are being
established to widen understanding and fill gaps, but
there is a lot of work to be done to better harmonise them.
“Knowing where chemicals are in the system, that is where
in the REACH phase or the waste phase, will become more
and more important as the EU moves towards circularity.”
Beyond 2020 – circularity and the role of chemicals
KEYNOTE ADDRESSES
Speakers
Daniel Calleja, director general of DG Environment, European Commission
Bjorn Hansen, executive director, Echa
Context
The current consumer model in the linear economy is not sustainable as the population grows. The equivalent of 1.6 Earths
would be needed if we want to continue with our current consumption of resources. A circular economy seeks to reduce
consumption, to reuse, recycle, maintain the value of products and materials for as long as possible. By making waste a
resource it can be used again and create further value. However a circular economy can only be successful if it ensures
protection of the environment and human health by eliminating substances of concern from recycled products. Such an
economy will be driven by innovation and will enhance competitiveness.
Helsinki Chemicals Forum 2019 | 5
State of play
•	 There is a lack of predictability and transparency about
how legislation is moving forward. Further standardisation
of the RMOA process is suggested to improve this
•	 RMOAs facilitate discussion and it is good to keep it
that way
•	 It is important to have the correct information to make
the right decisions
•	 The main concern of NGOs is that authorisation is given
regardless of alternatives being available. The recent lead
chromates court case ruling against the Commission
illustrates that change is needed
•	 Authorisation is sometimes seen as having few friends
because it is still very new in its operation and the legal
text is not unambiguous
•	 Having said that, authorisation is viewed by some as
a very reasonable approach and there is quite a lot of
support for it, but the devil is in the implementation
•	 The REACH authorisation process seems to be a major,
but not the only, driver for substitution
•	 There can sometimes be overambitious expectations
with certain stakeholders thinking the easy option is
not to authorise
•	 From a member state point of view, authorisation is more
appealing than restrictions because it is quick and the
information reveals uses and alternatives
•	 In the US, risk evaluation is a precursor under the new
TSCA law. If the EPA determines that a chemical presents
a risk, risk management action is taken and a proposal
must be made within one year, and a final rule published
within two years
Suggested actions
•	 Industry needs to be more proactive looking at
alternatives, but its constraints, such as cost and
uncertainty on what to assess and lack of guidance,
should be heard
•	 Communication in the supply chain should be
better organised
•	 When considering an RMOA it is important to apply more
broad thought and consider wider initiatives, such as the
circular economy and climate change rather than just
focusing on chemicals management
•	 More consistency is needed in regulating substances
of very high concern
•	 There is a case for industry and authorities to share
the burden of managing SVHCs
•	 Work should be done to boost public understanding of risk
management and socio-economic analysis of chemicals
How to choose the best possible risk management
option to regulate substances of very high concern
PANEL 1
Moderator
Panelists
Otto Linher, REACH Unit, DG Grow, EU Commission
France Capon, European Precious Metals Federation
Fleur van Broekhuizen, Bureau REACH, RIVM
Frida Hök, Chemsec
Matti Vainio, Echa
Tala Henry, US EPA
Context
The EU is using a mix of different instruments – authorisation, restriction, occupational exposure limits – to reduce risks
of chemicals of concern. What are the pros and cons for each of them and how do other regulatory authorities manage
unacceptable risks of such chemicals?
6 | Helsinki Chemicals Forum 2019
Key questions
•	 What would a grouping-based approach look like,
for example, on a wide group of bisphenols?
•	 What level of (un)certainty is acceptable?
Lay of the land
•	 Regulators cannot continue with a substance-by-
substance approach. A group-based approach would
be a ‘game changer’ for the supply chain and a sensible
one for regulatory assessments, but it must be based on
robust and justified scientific criteria. Regulatory controls
of groups are required to avoid regrettable substitution
•	 The onus should be on companies to demonstrate
and inform supply chains if data has the same or
similar properties
•	 Grouping as a concept is not new – there are already
group restrictions under REACH for phthalates or
solvents, for example
•	 Industry has the tools to assess by grouping but it does
not have the necessary data yet
•	 Grouping would provide consistency, speed up
assessment, avoid animal testing and help predict effects.
This is key in the light of the 2020 challenge to have a
sufficient understanding of all remaining substances
registered above 100 tonnes/year – and a longer term
target to do the same for all chemicals
•	 Echa’s Read-Across Assessment Framework (RAAF)
aims to organise criteria for expert opinions and guides
registrants and the agency. Some stakeholders say it
fails because for over 80% of dossiers there is a lack
of sufficient evidence to substantiate assumptions
•	 More time is needed to develop new technologies for
substitution – it can take years to come up with a suitable
alternative that goes beyond the product phase and
takes into account waste and recycling. A regrettable
substitution is a regrettable investment, a lost opportunity
and a waste of resources
•	 A one-size-fits-all approach to regulatory chemicals as
a class should not be considered as chemicals can have
widely different properties. A similar family group is not
a sufficient reason for grouping
The way forward
•	 Industry must take a holistic approach that looks at
the full lifecycle
•	 Some feel regulators should draw up further scientifically-
based guidance on read-across best practice
Grouping of chemical substances and how to avoid
regrettable substitution
Moderator
Panelists
Andrew Turley, Chemical Watch
Jack de Bruijn, Echa
Dr Kerry Nugent, IMAP, NICNAS
Ninja Reineke, CHEM Trust
Maggie Saykali, Cefic
Context
Regulators and stakeholders have expressed growing interest in grouping ‘similar chemicals’ in order to speed up risk
assessment and management and prevent inadvertently substituting one problem chemical with another. But there is
no consistency in the way grouping is carried out globally.
PANEL 2
Helsinki Chemicals Forum 2019 | 7
Data challenge
•	 In an ideal world, one would show that diseases are
avoided because of chemicals management, but relevant
data is rarely available. This means that the analyst must
work with other, less useful indicators
•	 The data that is available generally suffers from low levels
of harmonisation and compatibility. One must compare
like with like, which means accounting for variations in
population, timing in relation to regulation and geography
•	 Data for environmental effects is particularly scarce.
Furthermore, most environmental effects data that
is available relates to aquatic effects
Analysis
•	 One must account for a lot of confounding factors.
For example, climate change might shift one’s baseline
•	 Generally, it is very difficult to casually link the impact to
the regulation
•	 Biomonitoring data is very useful, particularly for providing
baselines for specific chemicals
Infrastructure issues
•	 The retail sector has examples of performance
measurement approaches for chemicals management
systems that might be applied to other sectors. Perhaps also
those approaches might be applied to regulatory chemicals
management systems applied by national governments
•	 Generating the data needed for performance
measurement is expensive. Therefore, one needs to make
difficult choices about resourcing. For example, when
should one stop monitoring one chemical in order to free
up resources for another?
•	 In Canada, there is an ongoing, gradual shift towards
increased resources allocated to measurement of
performance. In previous years, there were a lot of
competing priorities
•	 One must wait for change to reveal itself. The effects
of chemicals management do not become apparent
overnight. This is a fundamental challenge
•	 Ideally, the performance measurement is included at
the very start of the process. It should be part of the
design of the chemicals management system
•	 One’s approach to performance measurement has
to change as policy goals change. This is difficult
•	 Good chemicals management systems operating in
industry may not be visible
•	 The pubic values chemicals management but perhaps
not in a consistent way. For example, producers face a
lot of pressure from consumers while actors further up
the supply chain face much less
Recommendations
•	 Greater investment in biomonitoring might be beneficial
•	 Chemicals management efforts should be more
visible. This would aid data collection and performance
measurement in general
How to measure the performance of different
chemical management systems
Moderator
Panelists
Eeva Leinala, OECD
Elena Montani, DG Environment, European Commission
Mike Schade, Mind the Store Campaign for Safer Chemicals
Daren Kelland, Health Canada
Marco Camboni, RPA Europe
Context
What are meaningful indicators to measure success? Do different stakeholders measure success differently? What needs to
be measured over time? What is the cost of action or inaction? How can value for money of the different regulatory systems
be assessed?
PANEL 3
8 | Helsinki Chemicals Forum 2019
Thought starters
•	 How can we translate ambitious government policy
on reducing plastic in the environment to action on
the ground?
•	 How can industry work with key stakeholders, such as
the recycling industry and producers of single-use
plastics, to achieve a circular economy?
•	 How can industry ensure it is not reintroducing hazardous
chemicals back into products when recycling?
Main points
•	 Transitioning from a linear to a circular economy will
require the expertise of the whole value chain and eco-
design, but there is a lack of knowledge on what materials
to use
•	 The presence of hazardous chemicals in articles or
products is a disruptor to circularity
•	 Government and industry should be looking for solutions
upstream, but the current perspective is on waste
management at the “end of the line”
•	 Both in the supply chain and in products, microplastics
is a priority problem to be solved
•	 The EU’s ban on single-use plastics is a positive step.
Single-use plastic products represent the equivalent of 50
billion plastic bottles entering the environment annually
•	 Removing legal gaps where hazardous chemicals are
allowed in food contact materials is essential to ensuring
clean recycling streams.
•	 Industry often uses the terms ‘biodegradable’ and ‘bio-
based’ interchangeably, but there are stark differences
Possible solutions
•	 Global cooperation is necessary to solve the problem and
will assist countries in their policy making to address the
issue of marine litter
•	 Industry needs to think about the entire lifecycle of plastic
products, from design and production to use and recycling
•	 Sustainably-designed products will help boost
recycling rates and pave the way for more competitive,
environmentally-friendly production. This must be done
on a global level
•	 Companies should take full responsibility for their
products throughout the value/supply chain
•	 Some participants suggested that industry, not
government, should be responsible for developing
improved instructions for labelling on products containing
microplastics. New rules should require mandatory
reporting to Echa to ensure they are functioning
effectively. This will provide Echa with a good knowledge
base to draw up further regulation
Plastics and circularity – from pollution to a value
based proposition for all
Moderator
Panelists
Jacob Duer, Chemicals and Health Branch, UN Environment Programme
Ingeborg Mork Knutsen, Ministry of Climate Change and Environment, Norway
Lorraine Francourt, Dow Chemical
Justine Maillot, Zero Waste Europe
Mark Blainey, Echa
Eva Karlsson, Houdini Sportswear
Context
Plastic litter in the marine environment stems from a failure to adopt a circular approach. Plastics undergo a chemical
production process, a usage pattern and then become a waste management issue. More focus is needed on uses and
consideration of possible alternatives at the national level coupled with better education of consumers and waste producers
on sorting and segregation plastics. Future opportunities exist for the collection, processing and use of plastic waste as a
secondary resource but better technology and its proper utilisation are key.
PANEL 4
Helsinki Chemicals Forum 2019 | 9
Setting the scene
•	 Data is deemed to be of good quality if it is reliable,
reproducible, relevant and based on Good Laboratory
Practice
•	 Quality is not the same as compliance. Lack of compliance
in the EU is an issue but it is not the only one
•	 The vast quantity and the dynamic nature of data is a
challenge and requirements are complex and can add to
the difficulties of dealing with data
•	 Standardisation will not keep up with the pace of scientific
developments, which creates gaps. At the same time,
authorities insist on a robust validation system to which
scientists should also contribute
•	 Mutual acceptance of data will need to evolve; it should not
stop at OECD test guidelines, but will have to be expanded
to other types of methods like read-across and (Q)SARs
•	 There are calls for a simpler way to share data between
companies and with authorities and the public - here the
concept of an ‘i-data’ model comes into play, which would
carry a subscription charge. One factor affecting this is
the question of who owns the data and how to assure
fairness amongst companies contributing different levels
of information
Wider issues
•	 Outside of industry, there is demand for more data from
governments in developing nations, academics, NGOs
and the general public. International discussion would only
work if more and more voices are invited to take part.
•	 The public’s demand for transparency should not
jeopardise intellectual property rights. That said, robust
summaries must not be confidential
•	 The data, which often requires technical expertise to
comprehend, could be misunderstood and misinterpreted
by the general public. This could lead to unjustified
concerns over safety. But there are arguments that the
public should have the right to access the data anyway
Key take-home messages
•	 The extensive world-leading REACH database should be
used as a valuable societal tool and discussions should
take place on how to develop this
•	 Iuclid could be seen as a model for global data exchange
and a first step is a pilot between Echa, the US EPA and
Canada. However, while the tool offers transparency it does
not always guarantee quality
The quality of and access to data on chemicals
Moderator
Panelists
Hugo Waeterschoot, Eurometaux
Mike Rasenberg, Echa
Bob Diderich, OECD
Karel De Schamphelaere, SETAC and Ghent University
Nicholas Ball, Dow Chemical
Elisa Coghlin, Argentina chemicals directorate
Eva Karlsson, Houdini Sportswear
Context
While the quantity of data on chemicals continues to rise, quality can often vary and gaps exists. Managing such volumes
presents a challenge in terms of formatting or IT processing, reliability, analysis and actions taken on the condition of the data
itself. The difficulty lies in ensuring relevant actors have access to high quality relevant data, which is used to help limit the
health and environment impacts of substances of concern, while handling competing interests.
PANEL 5
10 | Helsinki Chemicals Forum 2019
The Writing on the Wall
An unedited selection of comments and questions raised on the message wall
Panel 1: How to choose the best possible risk
management option to regulate substances of very
high concern
•	 Should we not systematically promote retrospective
efficiency assessments and potentially change the RMO?
•	 How can RMOAs be carried out in a consistent manner
across member states? Are there any practical tools
/ requirements that can be used - e.g. stakeholder
consultation?
•	 REACH risk management should all be about the
efficiency and efficacy of relevant substances contributing
and not conflicting with other EU-EHS policies
•	 In the US EPA’s selection of existing chemicals for
risk evaluation, there does not seem to be always
harmonisation with the REACH SVHC list (data available)
- how much are they looking into other lists globally
such as the SVHC in their decision making? And is there
motivation to share data? Chemicals regulated under
TSCA are considered substitutes for REACH
•	 Do risk assessment processes of US EPA, such as the IRIS
programme, feed into the risk management processes
where very hazardous substances are identified?
Panel 2: Grouping of chemical substances and how
to avoid regrettable substitution
•	 Grouping for risk management should focus on the
manufacturing and their use. Is that not a clear reason
to split it from grouping for data generation and effect as
now is mostly done?
•	 If using read-across is good enough for registration
purposes, should it not be good enough for risk
management decisions?
•	 What tools are out there that can help brands and
retailers, when phasing out a chemical of concern,
ensure that the substitution is leading to a safer and
healthier product? What tools can help businesses avoid
regrettable substitution?
•	 How successful has Australia's IMAP assessment scheme
been in terms of timing and efficacy? Would Dr Nugent
recommend a grouping approach based on Australia's
experience? Will the IMAP scheme continue to operate
under the AICIS?
•	 Should regulators evaluate and restrict PFAS chemicals as
a class/group? For instance we're beginning to learn about
the hazards of certain short chained PFAS such as GenX,
which are also showing up in the environment around the
world
•	 This panel discussion on grouping touches a point from
this morning’s panel on authorisation: when is it right
to say the ‘function’ or performance characteristic is
unacceptable to society because there are no chemicals
available with manageable risks?
•	 Maggie Saykali calls for dialogue and cooperation but is
there a fundamental difference of values between industry,
regulators and civil society? Would a company ever by
itself conclude that risk assessment and read-across
results mean it needs to stop using a group of chemicals?
Would it put this above its economic priorities? Does she
have examples?
Helsinki Chemicals Forum 2019 | 11
Panel 3: How to measure the performance
of different chemical management systems
•	 Listening to Mike Schade: have to agree he’s focusing
on the right people - retailers. Markets always move faster
than regulators. From chemicals industry perspective
it is also more problematic as it is all about reputation,
not science
•	 The U.S. CPSC accepted a petition calling for the agency
to restrict halogenated flame retardants as a class
in products like electronics, furniture, and children's
products. Should other agencies worldwide also consider
regulating halogenated FRs as a class?
•	 To have a bigger influence on the international stage,
should the EU not aim for more restrictions based on risk
assessments, given that the SVHC concept only exists in
the EU?
Panel 4: Plastics and circularity – from pollution to
a value based proposition for all
•	 Could Echa explain how/why extensive mandatory
reporting of non-restricted microplastics can contribute
to environmental improvement? We see only massive
difficulties due to complex supply chains
•	 There are serious doubts that the Echa proposal is in line
with the REACH requirements (e.g. substance identity, risk
assessment). Will Echa take this concern seriously and
check the legal basis?
•	 The microplastic draft legislation is the worst piece of
work ever completed by Echa; poorly thought out and
written. It’s clearly Echa overstepping powers. Hopefully
the EU will see sense and throw it out in its current guise.
•	 Some plastics are fundamentally hazardous. PVC vinyl
plastic is a perfect example, manufactured with very
hazardous chemicals including mercury, PFAS, asbestos,
chlorine gas, and vinyl chloride monomer. And its disposal
releases the PBT dioxin.
•	 Are the End Plastic Waste Alliance going to take actions
in developing systems that would allow downstream
industrial users, consumers and recyclers to track the
chemical content in different plastics?
•	 How does the EU plastics strategy address hazardous
chemicals used in plastics, like PVC or vinyl? From
production to disposal, PVC uses or releases very
hazardous chemicals: chlorine gas, asbestos, PFAS,
mercury, phthalates, vinyl chloride, and dioxin.
Panel 5: The quality of and access to data
on chemicals
•	 Raw data is informative but also the information of
the tested material composition. This is unfortunately
something that will be problematic in the regulatory
data arena
•	 Manufacturers and importers are responsible in the EU
for the chemical safety of their products. They are the
experts on their chemicals, hold all the data. To Jack de
Bruijn’s points on keeping the burden of proof on REACH
registrants and the possible need for agreed standards
for robust read-across - isn’t it in industry’s interest to
welcome both of these?
•	 I like the idea to make data available due a ‘subscription’.
I think to make this happen the first step need to be that
the industry aligns to the extent that ‘data will be shared’
and of course on access prices. How do you imagine to
align industry on this?
•	 There has been quite some discussion around the
properties of chemicals. However, many substances that
have their chemical identities in the REACH dossiers are
claimed as confidential business information. In such
cases, even if the property data are of good quality, they
cannot be reused. How can we solve this issue?
•	 Based on the need from developing countries and in
the interest of making progress on international goals
relating to chemical management, why doesn't industry
declare open access? It is naive to believe that a fee is a
workable solution

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HCF Final Report 2019

  • 1. Helsinki Chemicals Forum 2019 | 1 Helsinki Chemicals Forum 2019 Stakeholder views on hot topics in chemicals safety 23-24 May 2019
  • 2. 2 | Helsinki Chemicals Forum 2019 International think-tank Welcome to this report on the debates held at the eleventh annual Helsinki Chemicals Forum. This year 191 delegates from 31 countries witnessed the Forum discussion on five main themes, including how to pick the best options to manage risks of SVHCs, approaches to plastic circularity and the struggle between data access and protection of intellectual property. The Helsinki think-tank promoted the case for the safe administration of chemicals while taking stock of the diverse political landscape and the hurdles to preserving human health and the environment. The Forum commenced with an exploration of the pros and cons of various risk management options to regulate SVHCs where panellists discussed predictability, transparency and effectiveness of current legislative instruments. This was followed by an exchange of views on grouping and avoiding regrettable substitution. The third panel session examined ways to measure how different chemical management systems are performing. Panel four focused on plastics and circularity, a theme which is ever present on the public agenda. Experts discussed how recycled goods can bring value if chemicals within them are properly managed. And the final debate of the event looked at quality of and access to data on chemicals with panellists sharing their positions on the tricky triangle of compliance, company confidentiality and consumer confidence. This report, prepared by independent intelligence and insight provider Chemical Watch, intends to be a balanced and accessible reflection of two days of debate as a means to further understanding. We have not taken sides or judged comments on their accuracy, veracity or fairness. This is not a formal report because the annual Forum is not an official session and its conclusions do not represent a consensus. Instead, the report offers a reference point for policy makers, companies, academics and others – presenting the voice of the people in the room at this important global gathering. The final pages of the report comprise an unedited selection of questions and observations that were posted on the Forum message wall during the event to capture insights from the delegates Luke Buxton Europe Editor Chemical Watch Charlotte Niemiec Deputy News Editor Chemical Watch Andrew Turley Science Editor Chemical Watch Helsinki Chemicals Forum 2019 | 2 Chemical Watch is the leading global provider of independent intelligence and insight for product safety professionals managing chemicals. We help businesses across value chains stay ahead of the dynamic chemicals management agenda by providing access to in-depth knowledge, tools and a network of experts. Our aim: to empower our members to transform product safety management and unlock the full value of regulatory compliance within their business by providing… A one-stop intelligence source: independent global news, insight and analysis to inform product safety decisions. Access to the world’s largest and most influential community of product safety professionals managing chemicals. An extensive calendar of events featuring expertise from across our global business and regulatory network. Interactive and flexible e-Learning, training and webinars to boost individual and team expertise and continuously develop their skills. Resources and support to raise the level of chemicals safety awareness in companies and improve compliance across departments to drive product stewardship. Find out more. Who is Chemical Watch?
  • 3. Helsinki Chemicals Forum 2019 | 3 Contents Keynote addresses: Beyond 2020 – circularity and the role of chemicals Panel 1: How to choose the best possible risk management option to regulate substances of very high concern Panel 2: Grouping of chemical substances and how to avoid regrettable substitution Panel 3: How to measure the performance of different chemical management systems Panel 4: Plastics and circularity – from pollution to a value based proposition for all Panel 5: The quality of and access to data on chemicals Writing on the wall: An unedited selection of comments posted to the message wall by the audience p.4 p.5 p.6 p.7 p.8 p.9 p.10 Helsinki Chemicals Forum contacts Chemical Watch contacts Helsinki Chemicals Forum www.helsinkicf.eu Chemicals Forum Association Messuaukio 1, 00521 Helsinki, Finland Geert Dancet Secretary general + 32 468 300787 geert.dancet@messukeskus.com Tarja Gordienko Communications manager +358 50 584 7262 tarja.gordienko@messukeskus. com Maiju Helpi Project manager +358 50 344 0451 maiju.helpi@messukeskus.com Riikka Heiskala Project manager +358 40 905 1873 riikka.heiskala@messukeskus.com Luke Buxton Europe editor +44 (0)20 3637 5793 luke.buxton@chemicalwatch.com Charlotte Niemiec Deputy news editor +44 (0)1553 341 206 charlotte.niemiec@chemicalwatch. com Andrew Turley Science editor +44 (0)20 3637 5794 andrew.turley@chemicalwatch.com
  • 4. 4 | Helsinki Chemicals Forum 2019 Promising start In its vision for a truly circular economy, the European Commission has laid down some “very significant” proposals including the plastic strategy and analysis of the interface between chemicals, product and waste legislation, Daniel Calleja, director general of the European Commission’s DG Environment told delegates. And others are in the works, such as Echa’s database on SVHCs in articles under the waste framework Directive. Chemicals and the industry are the “foundation” of the economy, he added, because they are used every day and many economic sectors depend on them. The importance of the sector “will not diminish; it will grow in the future – chemical solutions can increase the durability of materials and products and […] can play an important role in transforming waste into the new resource”. But more needs to be done to guarantee the safety of products in the EU because the presence of hazardous chemicals within them “destroys” consumer trust and support. Merging models Echa has an instrumental part to play in helping to deliver the circular economy. It needs to approach this by considering how chemicals legislation can feed into policy development in Brussels in as friction-free a fashion as possible, Echa’s executive director Bjorn Hansen said. In order to promote circularity, chemicals and waste policies need to merge. One of the “fundamental stepping stones”, he said, is to understand that ‘material’ means mixture and to always replace the use of the term ‘material’ with ‘mixture’. When companies import mixtures from outside Europe, the substances within them need to be registered. Once this merging approach is implemented, differences between chemicals and waste policies can be identified. “Bases already exist from which to start building a circular economy, to start contributing when the policies evolve and include support from scientific and technical bodies.” Interfaces between disparate legislation are being established to widen understanding and fill gaps, but there is a lot of work to be done to better harmonise them. “Knowing where chemicals are in the system, that is where in the REACH phase or the waste phase, will become more and more important as the EU moves towards circularity.” Beyond 2020 – circularity and the role of chemicals KEYNOTE ADDRESSES Speakers Daniel Calleja, director general of DG Environment, European Commission Bjorn Hansen, executive director, Echa Context The current consumer model in the linear economy is not sustainable as the population grows. The equivalent of 1.6 Earths would be needed if we want to continue with our current consumption of resources. A circular economy seeks to reduce consumption, to reuse, recycle, maintain the value of products and materials for as long as possible. By making waste a resource it can be used again and create further value. However a circular economy can only be successful if it ensures protection of the environment and human health by eliminating substances of concern from recycled products. Such an economy will be driven by innovation and will enhance competitiveness.
  • 5. Helsinki Chemicals Forum 2019 | 5 State of play • There is a lack of predictability and transparency about how legislation is moving forward. Further standardisation of the RMOA process is suggested to improve this • RMOAs facilitate discussion and it is good to keep it that way • It is important to have the correct information to make the right decisions • The main concern of NGOs is that authorisation is given regardless of alternatives being available. The recent lead chromates court case ruling against the Commission illustrates that change is needed • Authorisation is sometimes seen as having few friends because it is still very new in its operation and the legal text is not unambiguous • Having said that, authorisation is viewed by some as a very reasonable approach and there is quite a lot of support for it, but the devil is in the implementation • The REACH authorisation process seems to be a major, but not the only, driver for substitution • There can sometimes be overambitious expectations with certain stakeholders thinking the easy option is not to authorise • From a member state point of view, authorisation is more appealing than restrictions because it is quick and the information reveals uses and alternatives • In the US, risk evaluation is a precursor under the new TSCA law. If the EPA determines that a chemical presents a risk, risk management action is taken and a proposal must be made within one year, and a final rule published within two years Suggested actions • Industry needs to be more proactive looking at alternatives, but its constraints, such as cost and uncertainty on what to assess and lack of guidance, should be heard • Communication in the supply chain should be better organised • When considering an RMOA it is important to apply more broad thought and consider wider initiatives, such as the circular economy and climate change rather than just focusing on chemicals management • More consistency is needed in regulating substances of very high concern • There is a case for industry and authorities to share the burden of managing SVHCs • Work should be done to boost public understanding of risk management and socio-economic analysis of chemicals How to choose the best possible risk management option to regulate substances of very high concern PANEL 1 Moderator Panelists Otto Linher, REACH Unit, DG Grow, EU Commission France Capon, European Precious Metals Federation Fleur van Broekhuizen, Bureau REACH, RIVM Frida Hök, Chemsec Matti Vainio, Echa Tala Henry, US EPA Context The EU is using a mix of different instruments – authorisation, restriction, occupational exposure limits – to reduce risks of chemicals of concern. What are the pros and cons for each of them and how do other regulatory authorities manage unacceptable risks of such chemicals?
  • 6. 6 | Helsinki Chemicals Forum 2019 Key questions • What would a grouping-based approach look like, for example, on a wide group of bisphenols? • What level of (un)certainty is acceptable? Lay of the land • Regulators cannot continue with a substance-by- substance approach. A group-based approach would be a ‘game changer’ for the supply chain and a sensible one for regulatory assessments, but it must be based on robust and justified scientific criteria. Regulatory controls of groups are required to avoid regrettable substitution • The onus should be on companies to demonstrate and inform supply chains if data has the same or similar properties • Grouping as a concept is not new – there are already group restrictions under REACH for phthalates or solvents, for example • Industry has the tools to assess by grouping but it does not have the necessary data yet • Grouping would provide consistency, speed up assessment, avoid animal testing and help predict effects. This is key in the light of the 2020 challenge to have a sufficient understanding of all remaining substances registered above 100 tonnes/year – and a longer term target to do the same for all chemicals • Echa’s Read-Across Assessment Framework (RAAF) aims to organise criteria for expert opinions and guides registrants and the agency. Some stakeholders say it fails because for over 80% of dossiers there is a lack of sufficient evidence to substantiate assumptions • More time is needed to develop new technologies for substitution – it can take years to come up with a suitable alternative that goes beyond the product phase and takes into account waste and recycling. A regrettable substitution is a regrettable investment, a lost opportunity and a waste of resources • A one-size-fits-all approach to regulatory chemicals as a class should not be considered as chemicals can have widely different properties. A similar family group is not a sufficient reason for grouping The way forward • Industry must take a holistic approach that looks at the full lifecycle • Some feel regulators should draw up further scientifically- based guidance on read-across best practice Grouping of chemical substances and how to avoid regrettable substitution Moderator Panelists Andrew Turley, Chemical Watch Jack de Bruijn, Echa Dr Kerry Nugent, IMAP, NICNAS Ninja Reineke, CHEM Trust Maggie Saykali, Cefic Context Regulators and stakeholders have expressed growing interest in grouping ‘similar chemicals’ in order to speed up risk assessment and management and prevent inadvertently substituting one problem chemical with another. But there is no consistency in the way grouping is carried out globally. PANEL 2
  • 7. Helsinki Chemicals Forum 2019 | 7 Data challenge • In an ideal world, one would show that diseases are avoided because of chemicals management, but relevant data is rarely available. This means that the analyst must work with other, less useful indicators • The data that is available generally suffers from low levels of harmonisation and compatibility. One must compare like with like, which means accounting for variations in population, timing in relation to regulation and geography • Data for environmental effects is particularly scarce. Furthermore, most environmental effects data that is available relates to aquatic effects Analysis • One must account for a lot of confounding factors. For example, climate change might shift one’s baseline • Generally, it is very difficult to casually link the impact to the regulation • Biomonitoring data is very useful, particularly for providing baselines for specific chemicals Infrastructure issues • The retail sector has examples of performance measurement approaches for chemicals management systems that might be applied to other sectors. Perhaps also those approaches might be applied to regulatory chemicals management systems applied by national governments • Generating the data needed for performance measurement is expensive. Therefore, one needs to make difficult choices about resourcing. For example, when should one stop monitoring one chemical in order to free up resources for another? • In Canada, there is an ongoing, gradual shift towards increased resources allocated to measurement of performance. In previous years, there were a lot of competing priorities • One must wait for change to reveal itself. The effects of chemicals management do not become apparent overnight. This is a fundamental challenge • Ideally, the performance measurement is included at the very start of the process. It should be part of the design of the chemicals management system • One’s approach to performance measurement has to change as policy goals change. This is difficult • Good chemicals management systems operating in industry may not be visible • The pubic values chemicals management but perhaps not in a consistent way. For example, producers face a lot of pressure from consumers while actors further up the supply chain face much less Recommendations • Greater investment in biomonitoring might be beneficial • Chemicals management efforts should be more visible. This would aid data collection and performance measurement in general How to measure the performance of different chemical management systems Moderator Panelists Eeva Leinala, OECD Elena Montani, DG Environment, European Commission Mike Schade, Mind the Store Campaign for Safer Chemicals Daren Kelland, Health Canada Marco Camboni, RPA Europe Context What are meaningful indicators to measure success? Do different stakeholders measure success differently? What needs to be measured over time? What is the cost of action or inaction? How can value for money of the different regulatory systems be assessed? PANEL 3
  • 8. 8 | Helsinki Chemicals Forum 2019 Thought starters • How can we translate ambitious government policy on reducing plastic in the environment to action on the ground? • How can industry work with key stakeholders, such as the recycling industry and producers of single-use plastics, to achieve a circular economy? • How can industry ensure it is not reintroducing hazardous chemicals back into products when recycling? Main points • Transitioning from a linear to a circular economy will require the expertise of the whole value chain and eco- design, but there is a lack of knowledge on what materials to use • The presence of hazardous chemicals in articles or products is a disruptor to circularity • Government and industry should be looking for solutions upstream, but the current perspective is on waste management at the “end of the line” • Both in the supply chain and in products, microplastics is a priority problem to be solved • The EU’s ban on single-use plastics is a positive step. Single-use plastic products represent the equivalent of 50 billion plastic bottles entering the environment annually • Removing legal gaps where hazardous chemicals are allowed in food contact materials is essential to ensuring clean recycling streams. • Industry often uses the terms ‘biodegradable’ and ‘bio- based’ interchangeably, but there are stark differences Possible solutions • Global cooperation is necessary to solve the problem and will assist countries in their policy making to address the issue of marine litter • Industry needs to think about the entire lifecycle of plastic products, from design and production to use and recycling • Sustainably-designed products will help boost recycling rates and pave the way for more competitive, environmentally-friendly production. This must be done on a global level • Companies should take full responsibility for their products throughout the value/supply chain • Some participants suggested that industry, not government, should be responsible for developing improved instructions for labelling on products containing microplastics. New rules should require mandatory reporting to Echa to ensure they are functioning effectively. This will provide Echa with a good knowledge base to draw up further regulation Plastics and circularity – from pollution to a value based proposition for all Moderator Panelists Jacob Duer, Chemicals and Health Branch, UN Environment Programme Ingeborg Mork Knutsen, Ministry of Climate Change and Environment, Norway Lorraine Francourt, Dow Chemical Justine Maillot, Zero Waste Europe Mark Blainey, Echa Eva Karlsson, Houdini Sportswear Context Plastic litter in the marine environment stems from a failure to adopt a circular approach. Plastics undergo a chemical production process, a usage pattern and then become a waste management issue. More focus is needed on uses and consideration of possible alternatives at the national level coupled with better education of consumers and waste producers on sorting and segregation plastics. Future opportunities exist for the collection, processing and use of plastic waste as a secondary resource but better technology and its proper utilisation are key. PANEL 4
  • 9. Helsinki Chemicals Forum 2019 | 9 Setting the scene • Data is deemed to be of good quality if it is reliable, reproducible, relevant and based on Good Laboratory Practice • Quality is not the same as compliance. Lack of compliance in the EU is an issue but it is not the only one • The vast quantity and the dynamic nature of data is a challenge and requirements are complex and can add to the difficulties of dealing with data • Standardisation will not keep up with the pace of scientific developments, which creates gaps. At the same time, authorities insist on a robust validation system to which scientists should also contribute • Mutual acceptance of data will need to evolve; it should not stop at OECD test guidelines, but will have to be expanded to other types of methods like read-across and (Q)SARs • There are calls for a simpler way to share data between companies and with authorities and the public - here the concept of an ‘i-data’ model comes into play, which would carry a subscription charge. One factor affecting this is the question of who owns the data and how to assure fairness amongst companies contributing different levels of information Wider issues • Outside of industry, there is demand for more data from governments in developing nations, academics, NGOs and the general public. International discussion would only work if more and more voices are invited to take part. • The public’s demand for transparency should not jeopardise intellectual property rights. That said, robust summaries must not be confidential • The data, which often requires technical expertise to comprehend, could be misunderstood and misinterpreted by the general public. This could lead to unjustified concerns over safety. But there are arguments that the public should have the right to access the data anyway Key take-home messages • The extensive world-leading REACH database should be used as a valuable societal tool and discussions should take place on how to develop this • Iuclid could be seen as a model for global data exchange and a first step is a pilot between Echa, the US EPA and Canada. However, while the tool offers transparency it does not always guarantee quality The quality of and access to data on chemicals Moderator Panelists Hugo Waeterschoot, Eurometaux Mike Rasenberg, Echa Bob Diderich, OECD Karel De Schamphelaere, SETAC and Ghent University Nicholas Ball, Dow Chemical Elisa Coghlin, Argentina chemicals directorate Eva Karlsson, Houdini Sportswear Context While the quantity of data on chemicals continues to rise, quality can often vary and gaps exists. Managing such volumes presents a challenge in terms of formatting or IT processing, reliability, analysis and actions taken on the condition of the data itself. The difficulty lies in ensuring relevant actors have access to high quality relevant data, which is used to help limit the health and environment impacts of substances of concern, while handling competing interests. PANEL 5
  • 10. 10 | Helsinki Chemicals Forum 2019 The Writing on the Wall An unedited selection of comments and questions raised on the message wall Panel 1: How to choose the best possible risk management option to regulate substances of very high concern • Should we not systematically promote retrospective efficiency assessments and potentially change the RMO? • How can RMOAs be carried out in a consistent manner across member states? Are there any practical tools / requirements that can be used - e.g. stakeholder consultation? • REACH risk management should all be about the efficiency and efficacy of relevant substances contributing and not conflicting with other EU-EHS policies • In the US EPA’s selection of existing chemicals for risk evaluation, there does not seem to be always harmonisation with the REACH SVHC list (data available) - how much are they looking into other lists globally such as the SVHC in their decision making? And is there motivation to share data? Chemicals regulated under TSCA are considered substitutes for REACH • Do risk assessment processes of US EPA, such as the IRIS programme, feed into the risk management processes where very hazardous substances are identified? Panel 2: Grouping of chemical substances and how to avoid regrettable substitution • Grouping for risk management should focus on the manufacturing and their use. Is that not a clear reason to split it from grouping for data generation and effect as now is mostly done? • If using read-across is good enough for registration purposes, should it not be good enough for risk management decisions? • What tools are out there that can help brands and retailers, when phasing out a chemical of concern, ensure that the substitution is leading to a safer and healthier product? What tools can help businesses avoid regrettable substitution? • How successful has Australia's IMAP assessment scheme been in terms of timing and efficacy? Would Dr Nugent recommend a grouping approach based on Australia's experience? Will the IMAP scheme continue to operate under the AICIS? • Should regulators evaluate and restrict PFAS chemicals as a class/group? For instance we're beginning to learn about the hazards of certain short chained PFAS such as GenX, which are also showing up in the environment around the world • This panel discussion on grouping touches a point from this morning’s panel on authorisation: when is it right to say the ‘function’ or performance characteristic is unacceptable to society because there are no chemicals available with manageable risks? • Maggie Saykali calls for dialogue and cooperation but is there a fundamental difference of values between industry, regulators and civil society? Would a company ever by itself conclude that risk assessment and read-across results mean it needs to stop using a group of chemicals? Would it put this above its economic priorities? Does she have examples?
  • 11. Helsinki Chemicals Forum 2019 | 11 Panel 3: How to measure the performance of different chemical management systems • Listening to Mike Schade: have to agree he’s focusing on the right people - retailers. Markets always move faster than regulators. From chemicals industry perspective it is also more problematic as it is all about reputation, not science • The U.S. CPSC accepted a petition calling for the agency to restrict halogenated flame retardants as a class in products like electronics, furniture, and children's products. Should other agencies worldwide also consider regulating halogenated FRs as a class? • To have a bigger influence on the international stage, should the EU not aim for more restrictions based on risk assessments, given that the SVHC concept only exists in the EU? Panel 4: Plastics and circularity – from pollution to a value based proposition for all • Could Echa explain how/why extensive mandatory reporting of non-restricted microplastics can contribute to environmental improvement? We see only massive difficulties due to complex supply chains • There are serious doubts that the Echa proposal is in line with the REACH requirements (e.g. substance identity, risk assessment). Will Echa take this concern seriously and check the legal basis? • The microplastic draft legislation is the worst piece of work ever completed by Echa; poorly thought out and written. It’s clearly Echa overstepping powers. Hopefully the EU will see sense and throw it out in its current guise. • Some plastics are fundamentally hazardous. PVC vinyl plastic is a perfect example, manufactured with very hazardous chemicals including mercury, PFAS, asbestos, chlorine gas, and vinyl chloride monomer. And its disposal releases the PBT dioxin. • Are the End Plastic Waste Alliance going to take actions in developing systems that would allow downstream industrial users, consumers and recyclers to track the chemical content in different plastics? • How does the EU plastics strategy address hazardous chemicals used in plastics, like PVC or vinyl? From production to disposal, PVC uses or releases very hazardous chemicals: chlorine gas, asbestos, PFAS, mercury, phthalates, vinyl chloride, and dioxin. Panel 5: The quality of and access to data on chemicals • Raw data is informative but also the information of the tested material composition. This is unfortunately something that will be problematic in the regulatory data arena • Manufacturers and importers are responsible in the EU for the chemical safety of their products. They are the experts on their chemicals, hold all the data. To Jack de Bruijn’s points on keeping the burden of proof on REACH registrants and the possible need for agreed standards for robust read-across - isn’t it in industry’s interest to welcome both of these? • I like the idea to make data available due a ‘subscription’. I think to make this happen the first step need to be that the industry aligns to the extent that ‘data will be shared’ and of course on access prices. How do you imagine to align industry on this? • There has been quite some discussion around the properties of chemicals. However, many substances that have their chemical identities in the REACH dossiers are claimed as confidential business information. In such cases, even if the property data are of good quality, they cannot be reused. How can we solve this issue? • Based on the need from developing countries and in the interest of making progress on international goals relating to chemical management, why doesn't industry declare open access? It is naive to believe that a fee is a workable solution