EUROPEAN
COMMISSION

Brussels, 14.10.2020
COM(2020) 667 final

COMMUNICATION FROM THE COMMISSION TO THE EUROPEANPARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIALCOMMITTEE AND THE COMMITTEE OF THE REGIONS
Chemicals Strategy for Sustainability
Towards a Toxic-Free Environment{SWD(2020) 225 final} - {SWD(2020) 247 final} - {SWD(2020) 248 final} {SWD(2020) 249 final} - {SWD(2020) 250 final} - {SWD(2020) 251 final}

EN

EN

1.

SUSTAINABLE CHEMICALS FOR THE GREEN AND DIGITAL TRANSITION

The European Green Deal1, European Union’s new growth strategy, has set the EU on acourse to become a sustainable climate neutral and circular economy by 2050. It has also set
a goal to protect better human health and the environment as part of an ambitious approach to
tackle pollution from all sources and move towards a toxic-free environment. Chemicals are
everywhere in our daily life and play a fundamental role in most of our activities, as they
form part of virtually every device we use to ensure our well-being, protect our health andsecurity, and meet new challenges through innovation. Chemicals are also the building blocks
of low-carbon, zero pollution and energy- and resource-efficient technologies, materials andproducts. The increased investment and innovative capacity of the chemicals industry toprovide safe and sustainable chemicals will be vital to offer new solutions and support both
the green and the digital transitions of our economy and society.
At the same time, chemicals with hazardous properties can cause harm to human healthand the environment. While not all hazardous chemicals raise the same concerns, certain
chemicals cause cancers, affect the immune, respiratory, endocrine, reproductive andcardiovascular systems, weaken human resilience and capacity to respond to vaccines2 andincrease vulnerability to diseases3.
Exposure to these harmful chemicals is therefore a threat to human health. In addition,
chemical pollution is one of the key drivers putting the Earth at risk4, impacting andamplifying planetary crises such as climate change, degradation of ecosystems and loss of
biodiversity5. New chemicals and materials must be inherently safe and sustainable, fromproduction to end of life, while new production processes and technologies must be deployed
to allow the chemical industry’s transition to climate neutrality.
The EU already has one of the most comprehensive and protective regulatory
frameworks for chemicals, supported by the most advanced knowledge base globally.
This regulatory framework is increasingly becoming a model for safety standards
worldwide6. The EU has been undeniably successful in creating an efficiently functioning
internal market for chemicals, in reducing the risks to humans and the environment posed bycertain hazardous chemicals, such as carcinogens7 and heavy metals8, and in providing a
predictable legislative framework for companies to operate in.

1

COM(2019) 640.
Substances such as PFOS and PFOA are associated with reduced antibody response to vaccination; EFSA, Scientificopinion on PFAS.
3
Linking pollution and infectious disease, C&en, 2019; Environmental toxins impair immune system over multiple
generations, Science Daily, October 2, 2019.
4
Rockström, J. et al., Planetary Boundaries: Exploring the Safe Operating Space for Humanity. Ecology and Society, 2009.
5
Examples include negative effects on pollinators, insects, aquatic ecosystems and bird populations.
6
A. Bradford, The Brussels effect, 2020.
7
1 million new cancer cases are estimated to have been prevented in the EU over the last 20 years; SWD(2019)199.
8
Including mercury, cadmium and arsenic, SWD(2019)199.
2

1

Facts and figures about chemicals, the chemicals industry9 and chemicals legislation
 Global sales of chemicals were 3347 billion euro in 2018 where Europe was the second
biggest producer (accounting for 16.9% of sales) although this share has halved over the last
20 years and forecasts predict a further decline by 2030 to move from second to third position.
 Chemical manufacturing is the fourth largest industry in the EU comprising 30 000
companies, 95% of which are SMEs, directly employing approximately 1.2 million people
and 3.6 million indirectly.
 The EU has a comprehensive framework comprising approximately 40 legislative instruments
including the Regulation on Registration, Evaluation, Authorisation and Restriction ofChemicals (REACH)10, the Regulation on the Classification, Labelling and Packaging of
hazardous substances (CLP)11 and amongst many others the legislation addressing the safetyof toys, cosmetics, biocides, plant protection products, food, carcinogens in the workplace aswell as legislation on environmental protection.
 Human biomonitoring studies in the EU point to a growing number of different hazardous
chemicals in human blood and body tissue, including certain pesticides, biocides,
pharmaceuticals, heavy metals, plasticisers and flame retardants12. Combined prenatal
exposure to several chemicals has led to reduced foetal growth and lower birth rates13.
 84% of Europeans are worried about the impact of chemicals present in everyday products on
their health, and 90% are worried about their impact on the environment14.

Nevertheless, in order to develop and deploy the sustainable chemicals that enable the green
and digital transitions and to protect environment and human health, in particular that ofvulnerable groups15, innovation for the green transition of the chemical industry and its
value chains must be stepped up and the existing EU chemicals policy must evolve andrespond more rapidly and effectively to the challenges posed by hazardous chemicals.
This includes ensuring that all chemicals are used more safely and sustainably, promotingthat chemicals having a chronic effect for human health and the environment - substances ofconcern16 – are minimised and substituted as far as possible, and phasing out the mostharmful ones for non-essential societal use, in particular in consumer products.
9

CEFIC, Facts and Figures Report, 2020.
Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals. OJ L 396,
30.12.2006.
11
Regulation (EC) No 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures. OJ L 353,
31.12.2008.
12
European Commission, Study for the Strategy for the Non-Toxic Environment, p. 123.
13
Ibid.
14
Eurostat, Eurobarometer, 2020.
15
For the scope of this Strategy, vulnerable groups are those populations more vulnerable to chemicals exposure, because fordifferent reasons have a higher sensitivity or a lower threshold for health effects, are more exposed or more likely to be
exposed, or have a reduced ability to protect themselves. Vulnerable groups typically include pregnant and nursing
women, the unborn, infants and children, the elderly people as well as workers and residents subject to high and/or longterm chemical exposure.
16
These include, in the context of this strategy and related actions, primarily those related to circular economy, substanceshaving a chronic effect for human health or the environment (Candidate list in REACH and Annex VI to the CLP
Regulation) but also those which hamper recycling for safe and high quality secondary raw materials.
102A more coherent, predictable and stronger regulatory framework, combined with nonregulatory incentives, will drive the necessary innovation, deliver increased protection, while
enhancing the competitiveness of the European chemical industry and its value chains. To
ensure a level playing field between EU and non-EU players, the EU must ensure full
enforcement of its rules on chemicals both internally and at its borders, and promote them asa gold standard worldwide, in line with our international commitments.
The COVID-19 pandemic has not only added to the urgency to protect human and planetary
health but it has also made us aware that manufacturing and supply chains have become
increasingly complex and globalised for some critical chemicals, such as those to produce
pharmaceuticals. The EU must strengthen its open strategic autonomy with resilient value
chains and diversify sustainable sourcing for those chemicals that have essential uses for ourhealth and for achieving a climate-neutral and circular economy.
This strategy highlights the areas where the Commission wants to make greater progress, inclose concertation with stakeholders to fine-tune these objectives as part of rigorous impact
assessment processes building on the ample evidence already gathered on the performance ofexisting legislation17. The Commission will establish a high-level roundtable withrepresentatives from industry including SMEs, science and the civil society to realise thestrategy’s objectives in dialogue with the stakeholders concerned. Discussions of theroundtable are envisaged to focus in particular on how to make the chemicals legislation
work more efficiently and effectively and how to boost the development and uptake ofinnovative safe and sustainable chemicals across sectors.

2.

TOWARDS A TOXIC-FREE ENVIRONMENT: A NEW LONG-TERM VISION FOR
EU CHEMICALS POLICY

Almost 20 years after the first strategic approach to chemicals management in Europe18, thetime has come to chart a new long-term vision for the EU’s chemical policy. In line with
the European Green Deal, the strategy strives for a toxic-free environment, where chemicals
are produced and used in a way that maximises their contribution to society including
achieving the green and digital transition, while avoiding harm to the planet and to current
and future generations. It envisages the EU industry as a globally competitive player in the
production and use of safe and sustainable chemicals. The strategy proposes a clear
roadmap and timeline for the transformation of industry with the aim of attracting investment
into safe and sustainable products and production methods.

1718This includes recent fitness checks and evaluations of EU chemical legislation.
COM(2001) 88.

3

Figure: The toxic-free hierarchy – a new hierarchy in chemicals management

This strategy sets a pathway towards implementation of this vision through actions to
support innovation for safe and sustainable chemicals, strengthen the protection of humanhealth and the environment, simplify and strengthen the legal framework on chemicals, build
a comprehensive knowledge base to support evidence-based policy making, and set theexample of sound management of chemicals globally.
2.1.

Innovating for safe and sustainable EU chemicals

The transition to chemicals that are safe and sustainable by design is not only a societal
urgency but also a great economic opportunity, as well as a key component of EU’s recovery
from the COVID-19 crisis. Considering the trends in global chemical production, this is an
opportunity for the EU chemical industry to regain competitiveness by further developing
safe and sustainable chemicals and to bring sustainable solutions across sectors, notably forconstruction materials, textiles, low-carbon mobility, batteries, wind turbines and renewableenergy sources. The Commission proposal on Next Generation EU, and its Recovery and
Resilience Facility, provides for EU Member States to invest in projects that facilitate thegreen and digital transition of EU industries, including in the chemical sector, and boost thecompetitiveness of sustainable EU industry. The transition to sustainable chemicals will also
be mindful of socio-economic consequences including employment impacts on specificregions, sectors, and workers.
2.1.1. Promoting safe and sustainable-by-design chemicals
Europe has frontrunner companies and the scientific and technical capacity to lead thetransition to a safe and sustainable-by-design approach19 to chemicals. Regulatory andmarket initiatives have to a large extent been established, but substitution of most harmful
substances has not occurred at the expected pace20 and frontrunners still encounter major
economic and technical barriers21. This transition needs stronger policy and financial
19

At this stage, safe and sustainable-by-design can be defined as a pre-market approach to chemicals that focuses onproviding a function (or service), while avoiding volumes and chemical properties that may be harmful to human healthor the environment, in particular groups of chemicals likely to be (eco) toxic, persistent, bio-accumulative or mobile.
Overall sustainability should be ensured by minimising the environmental footprint of chemicals in particular on
climate change, resource use, ecosystems and biodiversity from a lifecycle perspective.
20
Eurostat, Chemicals production and consumption statistics, 2020.
21
Wood and Lowell Center for Sustainable Production, Report for the European Commission ‘Chemicals innovation action
agenda’, 2019.

4

support, as well as advice and assistance in particular for SMEs, and requires a concerted
effort from all: authorities, businesses, investors and researchers.
Regulatory tools22 need to be exploited to drive and reward the production and use of safe
and sustainable chemicals. It is particularly important to incentivise industry to prioritise
innovation for substituting, as far as possible, substances of concern23. Moving to safe andsustainable-by-design chemicals, including to sustainable bio-based chemicals24, andinvesting in finding alternatives to substances of concern is crucial for human health and theenvironment, as well as an important precondition for reaching a clean circular economy.
SAFE AND SUSTAINABLE-BY-DESIGNThe Commission will:









develop EU safe and sustainable-by-design criteria for chemicals;
establish an EU-wide safe and sustainable-by-design support network to promote
cooperation and sharing of information across sectors and the value chain and provide
technical expertise on alternatives;
ensure the development, commercialisation, deployment and uptake of safe andsustainable-by-design substances, materials and products through financial support25– in particular to SMEs – under Horizon Europe, cohesion policy, the LIFE
programme, other relevant EU funding and investment instruments and public-private
partnerships;
map and address safe and sustainable-by-design skills mismatches and competence
gaps, and ensure adequate skills at all levels - including in vocational and tertiary
education, research, industry and among regulators;
establish, in close cooperation with stakeholders, Key Performance Indicators tomeasure the industrial transition towards the production of safe and sustainablechemicals;
ensure that the legislation on industrial emissions promotes the use of safer
chemicals by industry in the EU by requiring on-site risk assessments and by
restricting the use of substances of very high concern.
2.1.2. Achieving safe products and non-toxic material cycles

In a clean circular economy it is essential to boost the production and uptake of secondary
raw materials and ensure that both primary and secondary materials and products are always
safe. The recently adopted circular economy action plan26 has shown that this requires a
combination of actions upstream, to ensure that products are safe and sustainable-by-design,and downstream, to increase safety of and trust in recycled materials and products. However,the creation of a well-functioning market for secondary raw materials and the transition to22

Under REACH, in line with the review of REACH, COM(2018)0116, action 5, and other legislation, such as the Ecolabel
Regulation, the Ecodesign and Industrial Emissions Directives.
23
Please see footnote 16.
24
In line with the Bioeconomy Strategy, COM(2018) 673; the environmental sustainability of bio-based chemicals should be
proven from a full life-cycle perspective.
25
Subject to compliance with applicable State aid rules.
26
COM(2020) 98.

5

safer materials and products is being slowed down by a number of issues, in particular thelack of adequate information on the chemical content of products27. Consumers, value
chain actors as well as waste operators therefore cannot make informed choices.
To move towards toxic-free material cycles and clean recycling and ensure that “Recycled in
the EU” becomes a benchmark worldwide, it is necessary to ensure that substances ofconcern in products and recycled materials are minimised. As a principle, the same limit
value for hazardous substances should apply for virgin and recycled material. However, there
may be exceptional circumstances where a derogation to this principle may be necessary.
This would be under the condition that the use of the recycled material is limited to clearly
defined applications where there is no negative impact on consumer health and theenvironment, and where the use of recycled material compared to virgin material is justified
on the basis of a case by case analysis.
Regulatory actions need to go hand-in-hand with increased investments in innovativetechnologies to address the presence of legacy substances in waste streams, which could inturn allow to recycle more waste28. This is particularly important for certain plastics andtextiles. Sustainable innovations and technologies will have to be developed for this purpose.
Technologies such as chemical recycling could also have a role but only if they ensure an
overall positive environmental and climate performance, from a full life cycle perspective.
NON-TOXIC MATERIAL CYCLESThe Commission will:








minimise the presence of substances of concern in products by introducing
requirements, also as part of the Sustainable Product Policy Initiative, giving priority
to those product categories that affect vulnerable populations as well as those with thehighest potential for circularity, such as textiles, packaging including food packaging,furniture, electronics and ICT, construction and buildings;
ensure availability of information on chemical content and safe use, by introducing
information requirements in the context of the Sustainable Product Policy Initiative
and tracking the presence of substances of concern through the life cycle of materials
and products29;
ensure that authorisations and derogations from restrictions for recycled materials
under REACH are exceptional and justified;
support investments in sustainable innovations30 that can decontaminate waste
streams, increase safe recycling and reduce the export of waste, in particular plastics
and textiles;
develop methodologies for chemical risk assessment that take into account thewhole life cycle of substances, materials and products.

27

COM(2018) 32.
Ibid.
29
Notably, building on ECHA’s SCIP database, ongoing work on REACH review (action 3), COM(2018)0116, and thedevelopment of product passports.
30
Taking into account the relevant State aid rules.
28

6

2.1.3. Greening and digitalising the production of chemicals
Chemical production is one of the most polluting, energy and resource-intensive sectors andis closely integrated with other energy-intensive sectors and processes. While the European
chemical industry has already invested in improved manufacturing plants, the green anddigital transition still requires significant investments for the sector31. Novel and cleaner
industrial processes and technologies would help not only to lower the environmental
footprint of chemicals production but also to reduce costs, improve market readiness andcreate new markets for the European sustainable chemicals industry.
Energy efficiency must be prioritised in accordance with the ambition of the European
Green Deal, and fuels such as renewable hydrogen and sustainably produced biomethane
could play a decisive role for the sustainability of energy sources 32. Digital technologies –such as the internet of things, big data, artificial intelligence, smart sensors and robotics – canalso play an important role in greening manufacturing processes. In addition, chemical
innovations can bring sustainable solutions across sectors to reduce the overall
environmental footprint of production processes.
Beyond the role played by technology, innovations in business models can be an importantdriver for the green transition of the industry producing and using chemicals. Opportunities toshift from traditional production and use of chemicals to chemicals as a service33 should be
explored and promoted. Such innovations could optimise the use of expertise and ensure
resource efficiency during the entire life cycle, as well as encourage place-based innovationand the involvement of SMEs. These developments will be supported by the EU sustainablefinance taxonomy34, to help guide funds towards the manufacturing and use ofenvironmentally sustainable chemicals.
INNOVATING INDUSTRIAL PRODUCTION
The Commission will support, through its financial instruments and research and innovation
programmes35:

research and development in advanced materials for applications in the energy,
construction, mobility, health, agriculture and electronics sectors to deliver the green
and digital transition;
research, development and deployment of low-carbon and low environmental
impact chemical and material production processes;
research and development of innovative business models such as performance-based
business model to ensure a more efficient use of chemicals and other resources and

31

EEA, Industrial pollution in Europe; State of the environment and outlook report, 2020.
The hydrogen strategy for a climate-neutral Europe underlines the need for demand-side support measures, and for an
uptake of renewable hydrogen in specific end-use sectors such as the chemical sector. Such quotas or minimum shares
could also be considered for other renewable fuels such as bio methane. COM(2020) 301.
33
‘Chemicals as a service’ includes chemicals leasing but also the leasing of services such as logistics, development ofspecific chemical processes and applications, and waste management.
34
Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of aframework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088. The Commission will adopt
delegated acts to specify technical screening criteria for how and when economic activities can qualify asenvironmentally sustainable.
35
The European structural and investment funds, the Just Transition Mechanism, InvestEU, the Strategic Investment
Facility, React-EU, Horizon Europe and the Digital Europe programme.
32

7


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


the minimization of wastes and emissions;re-skilling and up-skilling the workforce involved in the production and use ofchemicals towards the green and digital transition;access to risk finance, in particular for SMEs and start-ups;
development and deployment of infrastructure allowing to switch to the use,transport and storage of electricity from renewable / carbon-neutral energy sources
for the production of chemicals;
increase the current deployment rate of available technologies for manufacturing
purposes such as internet of things, big data, artificial intelligence, automation, smart
sensors and robotics.

2.1.4. Strengthening the EU’s open strategic autonomy
Over the past decades, manufacturing and supply chains have become increasingly complex
and globalised for some critical chemicals, e.g. raw materials, intermediates, active
pharmaceutical ingredients. The COVID-19 pandemic has highlighted that the limited
number of suppliers for some chemicals used in essential societal applications may poserisks, for example to the availability of medicines and to EU’s capacity to respond to healthcrises. EU’s resilience to supply disruptions is not only key to guarantee availability ofchemicals used in health applications but also for achieving the overall sustainability goals
as set in the European Green Deal, including technologies for climate neutrality, such asbatteries, wind turbines and photovoltaics, for clean material circularity and for the zeropollution ambition.
A more resilient economy and healthcare systems requires the existing chemical production
capacity in the EU to thrive, sufficiently diversified sources of supply and a better
management of the risk of disruption at all levels, strategic reserves and stockpiling, as wellas mechanisms to ensure that supply chains can continue to operate unaffected in case of acrisis.
STRENGTHENING EU’S OPEN STRATEGIC AUTONOMY
The Commission will:

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
36

in line with the European Council Conclusions of October 2020 and the announced
update of the Industrial Policy Communication, identify strategic dependencies andpropose measures to reduce these dependencies;
identify strategic value chains in particular for technologies and applications relevant
for the green and digital transition where critical chemicals are important building
blocks;engage with stakeholders to increase the Union’s strategic foresight on chemicals;
promote interregional collaboration along sustainable chemicals value chains,through smart specialisation36, in order to accelerate the development of joint
investment projects;
promote the EU’s resilience of supply and sustainability of chemicals used in

Within the EU’s cohesion policy, smart specialisation is a place-based approach.

8essential applications for society through EU funding and investment mechanisms37.
2.2.

Stronger EU legal framework to address pressing environmental and healthconcerns

Although the EU’s approach to chemicals management has been effective in reducing humanand environmental exposures to certain problematic substances, ongoing and emerging healthand environmental concerns call for a strengthening of the legal framework to rapidly
respond to scientific findings, making it more coherent, simple and predictable for all actors.
In particular, the REACH and CLP Regulations should be reinforced as EU’s cornerstones
for regulating chemicals, and be complemented by coherent approaches to assess andmanage chemicals in existing sectorial legislation, especially that regulating consumer
products.
2.2.1. Protect consumers, vulnerable groups and workers from the mostharmful chemicals
Consumers are widely exposed to chemicals present in products, from toys and childcare
articles to food contact materials, cosmetics, furniture and textiles, to name a few, andmillions of workers across the EU daily come into contact with chemical agents that can beharmful to them38. Vulnerable population groups - such as children, pregnant women andelderly people – are particularly sensitive to chemicals with certain hazardous properties39.
One of the biggest health benefits of the EU chemicals legislation in the past decades has
been the reduction in the exposure of citizens to carcinogenic substances. This has beenpossible in particular thanks to a preventive approach across legislation – the ‘genericapproach to risk management’40 - which means that carcinogenic substances have been
generally banned from most consumer products and for uses that expose vulnerable groups,
while allowing limited exemptions under conditions clearly defined in law. Such preventive
approach is simpler, generally faster and provides clear signals to all actors - enforcement
authorities, industry and downstream users - on the types of chemical substances where
innovation should be prioritised by the industry41.
However, the vast majority of chemicals in the EU is currently regulated on a case-by-casebasis and for each specific use42. Ample evidence and citizens’ worries justify that for themost harmful chemicals the generic approach to risk management becomes the default
37

E.g. European structural and investment funds, the Just Transition Mechanism, European Strategic Investment Funds,
ReactEU, Horizon Europe, subject to compliance with State aid rules when they apply.
38
For chemicals where the workplace exposure is determined to be the dominating risk, the occupational safety and healthdirectives are particularly relevant.
39
SWD(2019) 199.
40
In the EU legislative framework for chemicals, a ‘generic approach to risk management’ is an automatic trigger of predetermined risk management measures (e.g. packaging requirements, restrictions, bans, etc.) based on the hazardous
properties of the chemical and generic considerations of their exposure (e.g. widespread uses, uses in products destined
to children, difficult to control exposure). It is applied in a number of pieces of legislation on the basis of specificconsiderations (e.g. characteristics of the hazard, vulnerability of certain population groups, non-controllable orwidespread exposure). SWD(2019) 199.
41
SWD(2019) 199.
42
‘Specific risk assessments’ consider the hazard, the use of the substances and related specific exposure scenarios forhumans and the environment, and risk management measures are triggered based on their outcomes. SWD(2019) 199.

9

option, in particular as regards their use in consumer products. This will be done
gradually. Firstly, the Commission will extend the generic approach to risk management toensure that consumer products do not contain chemicals that cause cancers, gene mutations,affect the reproductive or the endocrine system, or are persistent and bioaccumulative.
Secondly, the Commission will immediately launch a comprehensive impact assessment todefine the modalities and timing for extending the same generic approach, with regard to
consumer products, to further chemicals, including those affecting the immune, neurologicalor respiratory systems and chemicals toxic to a specific organ.
Extending the generic approach will ensure that consumers, vulnerable groups and the naturalenvironment are more consistently protected, while still allowing for the use of these mostharmful chemicals where proven essential for society. The criteria for essential uses of thesechemicals will have to be properly defined to ensure coherent application across EU
legislation, and will in particular take into consideration the needs for achieving the green anddigital transition.
PROTECTION AGAINST MOST HARMFUL CHEMICALSThe Commission will:








43
44

extend the generic approach to risk management to ensure that consumer products –including, among other things, food contact materials, toys, childcare articles,
cosmetics, detergents, furniture and textiles - do not contain chemicals that cause
cancers, gene mutations, affect the reproductive or the endocrine system, or are
persistent and bioaccumulative. In addition, immediately launch a comprehensive
impact assessment to define the modalities and timing for extending the same genericapproach, with regard to consumer products, to further harmful chemicals, including
those affecting the immune, neurological or respiratory systems and chemicals
toxic to a specific organ;in the meantime, while the generic approach to risk management is not in place,prioritise all the above-listed substances for restrictions for all uses and throughgrouping, instead of regulating them one by one;ensure the safety of children43 from hazardous chemicals in childcare articles andother products for children (other than toys) to provide the same level of protection as
in toys, through the mandatory legal requirements of the General Product Safety
Directive and restrictions in REACH;
define criteria for essential uses44 to ensure that the most harmful chemicals are only
allowed if their use is necessary for health, safety or is critical for the functioning ofsociety and if there are no alternatives that are acceptable from the standpoint ofenvironment and health. These criteria will guide the application of essential uses inall relevant EU legislation for both generic and specific risk assessments;
extend to professional users under REACH the level of protection granted toconsumers;

The right to health for children will also be addressed in the upcoming EU Strategy on the right of the child.
Taking into account the definition of essential uses in the Montreal Protocol on Substances that Deplete the Ozone Layer,
which was introduced to assess whether the use of certain chemicals is actually necessary, while acknowledging that thescope of chemicals covered by the EU chemicals regulatory framework is much broader than the specific scope ofchemicals covered by the Montreal Protocol.

10

strengthen protection of workers by defining, in the process of the upcoming
Strategic Framework for Health and Safety at work, further priorities for addressing
workers’ exposure to hazardous substances, including by identifying most harmful
substances for which the Commission will propose to set occupational limits
following the established consultation process in the area of health and safety at work.
Also, strengthen protection of workers, notably by proposing lowering existing
occupational limit values for lead and asbestos and establishing a binding limit value
for di-isocyanates.

The exposure of humans and the environment to endocrine-disrupting chemicals requires
specific attention. These substances are increasingly linked to diseases acting via thehormonal system45. Their use is on the rise, representing a serious risk to human health andwildlife as well as creating an economic cost for society. As hormones control brain
development and growth, exposure to endocrine-disruptors during foetal development andpuberty can lead to irreversible effects, some being detected only many years later 46.
Although some pieces of legislation47 are able to identify endocrine disruptors, the EU
regulatory system is overall fragmented, limited and needs to be consolidated and simplified
to ensure that endocrine disruptors are recognised in a timely manner and that exposure ofhumans and the environment is minimised. This requires the adoption of the preventive
generic approach to risk management across legislation48, especially to avoid the use of
endocrine disruptors in consumer products.
ENDOCRINE DISRUPTORSThe Commission will:

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



propose to establish legally binding hazard identification of endocrine disruptors,
based on the definition of the WHO, building on criteria already developed forpesticides and biocides, and apply it across all legislation;
ensure that endocrine disruptors are banned in consumer products as soon as they
are identified, allowing their use only where it is proven to be essential for society;strengthen workers’ protection by introducing endocrine disruptors as a category of
substances of very high concern under REACH;
ensure that sufficient and appropriate information is made available to authorities
to allow the identification of endocrine disruptors by reviewing and strengthening
information requirements across legislation;
accelerate the development and uptake of methods to generate information on
endocrine disruptors through screening and testing of substances.
2.2.2. Protecting people and the environment from the combination effects ofchemicals

45

Endocrine-related disorders impact in particular the functioning of the thyroid, the immune system, the reproduction
system and the overall human metabolism. SWD(2020) 249.
46
C. Ganzleben, A. Kazmierczak, Leaving no one behind – understanding environmental inequality in Europe, 2020.
47
REACH Regulation; Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market;
and Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products.
48
SWD(2020) 249.

11

People and other living organisms are daily exposed to a wide mix of chemicals originatingfrom various sources. Significant progress has been made in recent years to close someknowledge gaps on the impact of the combination effect of those chemicals. However, thesafety of chemicals in the EU is usually assessed through the evaluation of single substances,or in some cases of mixtures intentionally added for particular uses, without considering the
combined exposure to multiple chemicals from different sources and over time49. For people,
the combination effects of chemicals may intensify in closed environments. Some pieces oflegislation50 require to assess the cumulative exposure to the same chemical from different
sources. Explicit requirements to take into account the impact of unintentional mixtures isgenerally lacking, currently existing for the protection of workers 51. The pesticides andbiocides legislation require to consider cumulative and synergistic effects 52. For pesticides,
progress has been made in developing a targeted methodology, and work will be accelerated
so that existing provisions can be fully implemented53.
To adequately address the combination effect of chemical mixtures, legal requirements need
to be consistently in place to ensure that risks from simultaneous exposure to multiple
chemicals are effectively and systematically taken into account across chemicals-related
policy areas. As it is currently not realistic nor economically feasible to specifically assess
and regulate an almost infinite number of possible combinations of chemicals, scientificconsensus is emerging that the effect of chemical mixtures needs to be taken into accountand integrated more generally into chemical risk assessments.54 In parallel, targeted
methodologies could be further developed and explored for specific policy areas.
CHEMICAL MIXTURESThe Commission will:

assess how to best introduce in REACH (a) mixture assessment factor(s) for thechemical safety assessment of substances;introduce or reinforce provisions to take account of the combination effects in otherrelevant legislation, such as legislation on water, food additives, toys, food contact
material, detergents and cosmetics;
improve the assessments of the mixtures used in the manufacture of tobacco andrelated products by using where possible existing EU agencies55.

49

SWD(2020) 248.
E.g. food contact materials and environmental legislation; SWD(2020) 248
51
Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agentsat work (OJ L 131, 5.5.1998) foresees that the risk presented by a combination of chemical agents shall be assessed andmanaged.
52
SWD(2020) 248.
53
This will be done initially under the Regulation (EC) No 396/2005 on maximum residue levels of pesticides and in asecond phase under the Regulation on Plant Protection Products.
54
SWD(2020) 248.
55
Directive 2014/40/EU on the approximation of the laws, regulations and administrative provisions of the Member Statesconcerning the manufacture, presentation and sale of tobacco and related products. OJ L 127, 29.4.2014.
50

12

2.2.3. Towards zero chemical pollution in the environment
Hazardous chemicals and their complex interaction with other environmental stressors canhave long-term and large-scale environmental impacts on the terrestrial and marine
environment. They can contribute to the reduction of ecosystem resilience, leading to rapid
declines in animal populations and, ultimately, to extinctions56, as well as impacting humanhealth and wellbeing, not least through the possible presence of contaminants in the foodchain. It is estimated that 2.8 million potentially contaminated sites exist in the EU, mainly
from waste disposal and treatment, posing a significant environmental hazard for terrestrial
and aquatic ecosystems and affecting the productivity of soils57. The current regulatory andpolicy framework struggles to take this into account and needs to be strengthened.
CHEMICAL POLLUTION IN NATURAL ENVIRONMENTThe Commission will:








propose new hazard classes and criteria in the CLP Regulation to fully addressenvironmental toxicity, persistency, mobility and bioaccumulation;
introduce endocrine disruptors, persistent, mobile and toxic and very persistentand very mobile substances as categories of substances of very high concern;
ensure that the information made available to authorities on substances allows
comprehensive environmental risk assessments by strengthening requirements
across legislation;
address the impact on the environment of the production and use of pharmaceuticals
in the upcoming pharmaceuticals strategy for Europe58;
support research and development for decontamination solutions in terrestrial andaquatic environments;
reinforce the regulation of chemical contaminants in food to ensure a high level ofhuman health protection.

Per- and polyfluoroalkyl substances (PFAS) require special attention, considering the large
number of cases of contamination of soil and water - including drinking water59 - in the EU
and globally60, the number of people affected with a full spectrum of illnesses and the relatedsocietal and economic costs61. That is why the Commission proposes a comprehensive set ofactions to address the use of and contamination with PFAS. Those aim to ensure, inparticular, that the use of PFAS is phased out in the EU, unless it is proven essential forsociety.

56

COM(2019) 264.
European Commission, Status of local soil contamination in Europe, 2018.
58
And following up the Strategic Approach to Pharmaceuticals in the Environment, COM(2019) 128.
59
WHO, Keeping our water clean: the case of water contamination in the Veneto Region, Italy, 2017.
60
Study funded by the Nordic Council of Ministers, The Costs of Inaction. A socioeconomic analysis of environmental andhealth impacts linked to exposure to PFAS, 2019.
61
Costs from exposure to PFAS in Europe have been estimated between EUR 52 and EUR 84 billion per year; Ibid.
57

13

PFAS62
The Commission will:






ban all PFAS as a group in fire-fighting foams as well as in other uses, allowing
their use only where they are essential for society;address PFAS with a group approach, under relevant legislation on water,
sustainable products, food, industrial emissions, and waste;address PFAS concerns on a global scale through the relevant international fora63
and in bilateral policy dialogues with third countries;
establish an EU-wide approach and provide financial support under research andinnovation programmes to identify and develop innovative methodologies for
remediating PFAS contamination in the environment and in products;
provide research and innovation funding for safe innovations to substitute PFAS
under Horizon Europe.
2.3.

Simplifying and consolidating the legal framework

The EU regulatory framework for hazard and risk assessment and management of chemicals
is comprehensive and complex. Overall, EU chemicals legislation delivers results asintended and is fit-for-purpose. However, a number of significant weaknesses prevent the EU
chemicals legislation from living up to its full potential64. If not rapidly addressed, theframework will struggle to timely and efficiently cope with the current and future production
and use of chemicals. A key ambition of this strategy is to ensure simplification of thisframework, as well as the consolidation and full implementation of the EU rules on
chemicals.
2.3.1. One substance, one assessment
The complexity of assessment procedures represents a specific challenge for authorities andstakeholders. It can lead to inconsistencies, slow procedures, inefficient use of resources andunnecessary burdens.
The Commission will strive to make those assessment processes simpler and moretransparent, in order to reduce the burden on all stakeholders and to make decision-making
faster as well as more consistent and predictable. This process will also support the gradualmove away from assessing and regulating chemicals substance-by-substance to regulatingthem by groups.

62

More details in SWD(2020) 247.
Stockholm, Rotterdam and Basel Conventions and OECD.
64
COM (2019)264.
63

14

Chemical safety assessments are being initiated under various pieces of legislation, byvarious actors and at different points in time, and they are carried out by various EU
agencies65, scientific committees66, expert groups or Commission departments. Stakeholders
and the general public struggle to keep track of regulatory processes and resulting decisions.
‘One substance, one assessment’ will ensure that the initiation and priority setting of thesafety assessments are done in a coordinated, transparent and to the extent possible
synchronised manner taking into account the specificities of each sector. When an assessment
is proposed under one piece of legislation, full account shall be taken of the planning underother pieces of legislation, so that coordinated action is ensured. This could be mostefficiently done by building on the success of the ‘Public Activities Coordination Tool’, theexisting mechanism in place under REACH and CLP67. To avoid duplication of work, earlyagreement on the problem definition will be key, favouring the assessment by groups ofsubstances with structural or functional similarities. The use of available resources andexpertise shall be optimised, through a clear allocation of responsibilities as well as good
cooperation among all actors.
COORDINATE AND SIMPLIFY ACTIONS ACROSS EU CHEMICALLEGISLATIONThe Commission will:

use a single ‘Public Activities Coordination Tool’ to provide an up-to-date overview
of all planned and ongoing initiatives on chemicals by authorities acrosslegislation;
establish an expert working group of Member States, Commission services and
EU Agencies68 to discuss initiatives on hazard/risk assessment on chemicals acrosschemical legislation, taking into account also the specificities of the sector

65

The European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA), the European Medicines Agency(EMA) and the European Environment Agency (EEA).
66
Scientific Committee on Health, Environmental and Emerging Risks (SCHEER), Scientific Committee on Consumer
Safety (SCCS).
67
ECHA, Public Activities Coordination Tool.
68
EFSA, ECHA, EMA and EEA.

15







concerned;
establish a coordination mechanism within the Commission to agree andsynchronise, to the extent possible, actions across chemical legislation as regards
hazard identification/classification and risk assessment and oversee the process
towards ‘one substance, one assessment’;
rationalise the use of expertise and resources by proposing the reattribution oftechnical and scientific work on chemicals performed under the relevant pieces oflegislation to European agencies, including work of the SCHEER and SCCS69;
make a proposal to strengthen the governance of the European Chemicals Agency
and increase the sustainability of its financing model;
reform the REACH authorisation and restriction processes based on key findings
from its practical implementation70.

In order to achieve consistency of regulatory outcomes, EU chemicals legislation need to use
coherent terminology, in particular to define chemicals (e.g. nanomaterials). Policy
evaluations also show that interested parties are not always aware of what information isavailable, and that re-use rights are sometimes too restrictive. They also highlight a numberof shortcomings in the interoperability and accessibility of chemical data71. In addition,
regulatory safety assessments use various methodologies, which may lead to incoherent
outcomes, while academic studies are not sufficiently exploited. Different transparency
rules are also applied to the initiation and performance of assessments and data use.
The ‘one substance, one assessment’ approach aims to ensure that methodologies are mademore coherent and to the extent possible harmonised. It strives to free the data access oftechnical or administrative obstacles, according to the principles that data should be easily
findable, interoperable, secure, shared and reused by default72. Data will be madeavailable in appropriate formats and tools – i.e. IUCLID73 and IPCHEM74 - to ensureinteroperability. ‘One substance, one assessment’ will also build greater trust in the scientificunderpinning of the EU decision-making process for chemicals, building on the important
steps taken regarding transparency in the EU food safety sector75.
METHODOLOGIES AND DATAThe Commission will:

ensure that the CLP Regulation is the central piece for hazard classification andallows the Commission to initiate harmonised classifications76;

69

Scientific Committee on Health, Environmental and Emerging Risks and Scientific Committee on Consumer Safety.
REACH Review, COM(2018) 0116.
71
COM(2019) 264.
72
In line with the EU data strategy.
73
ECHA, IUCLID.
74
European Commission, IPCHEM.
75
In particular in terms of mandatory notification of commissioned studies and accessibility of all scientific data andinformation, as defined for the transparency of the EU risk assessment in the food chain. See Regulation (EU)2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain OJ L 231, 6.9.2019.
76
In particular by adding endocrine disruptors, and PBTs/vPvBs, assessing the need for specific criteria for immunotoxicity
and neurotoxicity, currently under the hazard endpoints ‘Specific target organ toxicity’ and ‘reproductive toxicity’, andamend them if necessary.
70

16









review the definition of nanomaterial77 and ensure its coherent application acrosslegislation using legally binding mechanisms;
develop a common open data platform on chemicals78 to facilitate the sharing,access and re-use of information on chemicals coming from all sources;
promote reuse and harmonisation of human and environmental health-based limit
values79 among EU risk assessors and managers through a centralised and curated
EU repository;
establish tools and practices to ensure that relevant academic data is easily andreadily accessible for safety assessments and is suitable for regulatory purposes;
enable EU and national authorities to commission testing and monitoring of
substances as part of the regulatory framework when further information isconsidered necessary80;
remove legislative obstacles for the re-use of data and better streamline the flowof chemical data between EU and national authorities;
extend the principle of open data and the relevant transparency principles from theEU food safety sector to other pieces of chemical legislation.
2.3.2. A zero tolerance approach to non-compliance

All chemicals, materials and products produced in the EU or placed on the European market
must fully comply with EU information, safety and environmental requirements. In spite ofthis, currently almost 30% of the alerts on dangerous products on the market involve risks
due to chemicals, with almost 90% of those products coming from outside the EU81 andimported articles and online sales representing a particular challenge. Equally, only one
third of the registration dossiers of the chemical substances registered by industry under
REACH are fully compliant with the information requirements82. Stepping up
implementation and enforcement of chemicals legislation is urgently needed to ensurecompliance for the production and placing on the market of chemicals as well as for theirrelease and disposal.
The implementation of the new market surveillance Regulation83 as well as the forthcoming
measures to reinforce the EU Customs Union will strengthen enforcement both within the
single market and at the EU’s external borders. The Commission is considering which77

As set in Recommendation 2011/696/EU on the definition of nanomaterial OJ L 275, 20.10.2011.
As part of the European Green Deal data space announced under the EU data strategy.
79
E.g. PNECs, DNELs, health based occupational exposure limit values, water quality standards, maximum total daily
intake, etc.
80
Building on existing practices, such as the REACH substances evaluation, the watch lists under the water framework andthe ground water directives, Land Use and Coverage Area frame Survey, HBM4EU, and the proposed European
Partnership for Risk Assessment.
81
Data extracted from the EU’s Safety Gate/Rapex.
82
The European Commission concluded in the REACH Review that the non-compliance of registration dossiers was a key
issue hampering progress. ECHA and the Commission have in the meantime developed a Joint Action Plan to step up
compliance checks on all registration dossiers.
83
Regulation (EU) 2019/1020 on market surveillance and compliance of products, which will enter into application in July
2021 OJ L 169, 25.6.2019.
7817

additional measures could be put in place to strengthen the enforcement of REACH at the
EU’s borders84, as well as to promote cooperation with online market platforms85.
Furthermore, enforcement of EU chemicals legislation is not equally effective throughout theEU, due to the different capacities and resources at national level. Member States must
increase their enforcement capacity to levels where they can be effective, allowing to reap
the benefits from the EU’s rapid information and alert tools86, better exploit digital tools forfaster action and optimise resources, including of market surveillance authorities. The
European Chemicals Agency’s Forum for exchange of information and enforcement 87 has
proven effective in advancing the harmonisation of enforcement and will extend its
cooperation with existing enforcement networks88 and authorities89 to avoid duplication ofactions and increase effectiveness.
Ongoing activities aim at improving compliance with environmental legislation relevant tochemicals90. A good example is the Environmental Compliance and Governance Forum91,
which brings together Member States’ chemicals authorities and environmental enforcement
networks92. The upcoming zero pollution action plan will initiate further specific actions tocontrol chemical pollution.
Actions to empower consumers and consumer organisations will also be key, as their
behaviour is a powerful driver to industrial change and to ensuring compliance withlegislation. This will be pursued by implementing consumer protection rules93.
ZERO TOLERANCE FOR NON-COMPLIANCE
The Commission will:

strengthen the principles of 'no data, no market' and the ‘polluter-pays’ under
REACH, in particular by requiring compliance of all registration dossiers andrevoking the registration numbers in case of non-compliance;
propose to entrust the Commission with the duty to carry out audits in Member
States, where relevant, to ensure compliance and enforcement of chemicals
legislation, in particular REACH, and use infringement procedures as necessary;target known areas of high risk of non-compliance, in particular online sales,

84

A study is currently ongoing on how to integrate REACH requirements into customs processes. This will be followed by
an impact assessment to identify options forward.
85
A number of online platforms have signed a Safety Pledge to remove from their online listings any product reported in
Safety Gate/RAPEX.
86
RAPEX and RASFF are tools which inform consumers and Member States authorities in case of products posing a risk;
Safety gate for consumers.
87
The Forum for Exchange of Information on Enforcement (Forum) is a network of authorities responsible for theenforcement of the REACH, CLP, PIC, POP and the biocidal products Regulations.
88
E.g. SLIC (occupational safety and health), PARCS (customs), IMPEL (waste and industrial emissions).
89
I.e market surveillance authorities dealing with chemical legislation covering REACH, cosmetics, biocides, customs
authorities, consumer protection authorities and agencies such as ECHA.
90
For example, legislation on waste and industrial emissions.
91
European Commission, Environmental Compliance and Governance Forum.
92
IMPEL (inspectors), EnviCrimeNet (police), ENPE (prosecutors) and EUFJE (judges).
93
The representative actions mechanism could be used to collectively enforce breaches of EU law instruments
COM(2018) 0184 final.

18








imported articles, classification and labelling and restrictions;extend the scope of action of the European Anti-Fraud Office for coordination andinvestigation, to tackle the circulation of illicit chemical products in the EU94;
support Member States to prioritise integrated enforcement through multi-legislation
checks;ensure a harmonised EU-wide response and coordinated exchange of information
on enforcement of chemical legislation, by strengthening the use of relevantCommission IT platforms;
explore the use of digital tools to support market surveillance and customs authorities
as well as to improve the compliance of products containing chemicals sold online toEuropean consumers;
encourage the Member States to use the Recovery and Resilience Facility to invest in
the reinforcement of market surveillance infrastructures and digitalisation;
establish – under the Market Surveillance Regulation95– uniform conditions andfrequency of checks for certain products where specific risks or serious breaches ofapplicable Union harmonisation legislation have been continuously identified.

2.4.

A comprehensive knowledge base on chemicals

The sound management of chemicals in Europe depends on the ability of the EU and its
Member States to make their decisions based on robust and relevant, up-to-dateknowledge. The EU has, over several decades, developed world-class knowledge on
chemicals' properties and risks also thanks to the work carried out by its scientific bodies andthis knowledge base has been widely used also in other parts of the world. Still, there is muchknowledge to be acquired by authorities on the intrinsic properties of a vast majority ofchemicals, including polymers and chemicals that are not manufactured in high volumes.
Equally, knowledge on uses and exposure is fragmented, in particular as it relies on industry
to provide accurate information. The sheer number of chemicals on the market represents animmense knowledge challenge, and the expected future rise in chemical production and use
risks further widening the ‘unknown territory of chemical risks’.

94
95

Drawing inspiration from the rules on mutual administrative assistance in customs matters.
Regulation (EU) 2019/1020 on market surveillance and compliance of products.

19

Figure: The unknown territory of chemical risks, EEA96

2.4.1. Improved availability of chemical data
The EU is still lacking a comprehensive information base on all substances placed on themarket and on their overall environmental footprint, including their impact on climate, andthis hinders the proper management of chemicals and products and does not allow for a fullsustainability assessment. In particular polymers, which are the fundamental building blocksof plastics, are not subject to registration under REACH. Furthermore, information required
for substances in the low and medium tonnages under REACH does not fully allow to
identify substances with critical hazard properties. Strengthening information requirementson the carcinogenicity of substances and on other critical hazards at all production levels
plays a fundamental role in the successful fight against illnesses such as cancer 97. In addition,
the efficiency and effectiveness of the REACH evaluation procedures need to be improved98.
INFORMATION REQUIREMENTS
The Commission will:make a proposal to extend the duty of registration under REACH to certain polymersof concern;
asses how to best introduce information requirements under REACH on the overall
environmental footprint of chemicals, including on emissions of greenhouse gases;
amend REACH information requirements to enable an effective identification ofsubstances with critical hazard properties, including effects on the nervous and theimmune systems;
amend REACH information requirements to enable identification of all carcinogenic
substances manufactured or imported in the EU, irrespective of the volume.

96

EEA, The European Environment – State and outlook report, 2020.
Review of REACH, COM (2018) 0116
98
Ibid.
97

20

2.4.2. A strengthened chemical science-policy interface
Substantial efforts have been put in place to improve the scientific understanding of the
impacts of chemicals on health and the environment99. Monitoring the presence of chemicals
in humans and ecosystems is key to improve the understanding of their impact, and should befurther promoted, including to understand the links between chemicals and gender100. In
partnership with Member States, the Commission will continue to foster research and (bio)monitoring to understand and prevent chemicals-related risks and drive innovation inchemical risk assessment and regulatory science through its future framework programme
for research and innovation.
Despite a strong EU policy for the protection of animals used for scientific purposes,
adopted 10 years ago, which makes full replacement of animal testing its ultimate goal,
animals are still required to be used systematically for testing in the field of chemicals101.
Safety testing and chemical risk assessment need to innovate in order to reduce
dependency on animal testing but also to improve the quality, efficiency and speed ofchemical hazard and risk assessments.
SCIENCE-POLICY INTERFACEThe Commission will:






establish and update a research and innovation agenda for chemicals, driven by aEU-level Coordination Group, that would also promote the regulatory uptake of
research findings;
foster multidisciplinary research and digital innovations for advanced tools, methods
and models, and data analysis capacities102 to also move away from animal testing;provide financial support for EU-wide human and environmental (bio)monitoring
capacities, complementing ecosystem monitoring initiatives103;
develop an EU early warning and action system for chemicals104 to ensure that EU
policies address emerging chemical risks as soon as identified by monitoring andresearch;develop a framework of indicators to monitor the drivers and impacts of chemical
pollution and to measure the effectiveness of chemicals legislation105.

99

The European Commission has since the year 2000 provided funding of over 800 million EUR to research projects dealing
with chemical hazards and risks.
100
While policymakers begin to understand the role played by the sound management of chemicals in economic and social
development, significant linkages also exist between gender and chemicals, but gender specific data is still largely
missing. UNDP, Chemicals and Gender, 2015.
101
Directive 2010/63/EU. In 2017, over 230 000 animal tests were carried out in the EU to satisfy requirements underchemicals legislation; SWD (2020)10102
E.g. predictive toxicology or virtual human platforms
103
E.g. monitoring initiatives under EU environment legislation and monitoring schemes such as LUCAS, EMBAL, theupcoming EU Soil Observatory and the EU pollinator monitoring.
104
In connection with ongoing initiatives such as the RAPEX safety gate.
105
Building on existing initiatives and indicators, this will be part of a wider zero pollution monitoring and outlook
framework, in the context of the upcoming 8th Environment Action Programme and will also serve the Environment
Implementation Review.

21

2.5.

Setting the example for a global sound management of chemicals

The production, use and trade of chemicals are growing in all regions of the world. Worldchemicals turnover was valued at €3,347 billion in 2018106 and production is expected to
double by 2030. Chemical-intensive sectors like construction, automotive and electronics arealso growing, increasing the demand for chemicals and creating opportunities, but alsorisks107. Although its contribution to the global burden of disease is still underestimated108,
chemical pollution is recognised to be a threat to the right to a life with dignity, notably forchildren109 and in particular in low and middle-income countries110.
In 2015, the international community recommitted to achieve the target of a global soundmanagement of chemicals by 2020111, which is also an essential cross-cutting element toachieve most of the other Sustainable Development Goals. Although much has been done at
all levels, progress remains slow and insufficient and this global commitment has not been
met112. A real sense of urgency is needed. The European Union can and must play a leadingrole to champion and promote high standards in the world.
2.5.1. Strengthening international standards
A wide diversity of international, regional and national instruments and responses associatedwith the sound management of chemicals and waste are already in place. However, the global
governance remains extremely fragmented, and standards and compliance vary widely
across countries. For example, as of 2018, over 120 countries had not implemented the
Globally Harmonized System of Classification and Labelling of Chemicals113. Thisfragmentation has hampered the overall impact and effectiveness of existing organisations,programmes and initiatives.
Global strategic objectives and targets are needed for an ambitious internationalframework that addresses the current fragmentation and fosters coherent policies and action
by all relevant international organisations114, governments and stakeholders, including
industry. A renewed Strategic Approach to International Chemicals Management is theessential multilateral agreement that will allow to fully address the sound management ofchemicals throughout their life cycle. While it is important to use relevant international
standards, guides and methodologies when developing EU rules, unless they are ineffective
or inappropriate, it is at the same time fundamental to mainstream the sound management ofchemicals and waste in the work programmes of all relevant international organisations 115. It
will allow the EU to promote consistent policies and actions under the UN’s 2030 Agenda, inline with EU’s international commitments.
106

CEFIC, Facts and Figures Report, 2020
UNEP, Global Chemicals Outlook II, 2019.
108
The Lancet Commission on health and pollution, 2017.
109
Human Rights Committee, general comment No. 36 on the right to life, 2018.
110
UNEP, Global Chemicals Outlook II, 2019.
111
Based on the 2006 SAICM objective, target 12.4 of the UN 2030 Agenda for Sustainable Development establishes that:‘By 2020, achieve the environmentally sound management of chemicals and all wastes throughout their life cycle, in
accordance with agreed international frameworks, and significantly reduce their release to air, water and soil in order tominimize their adverse impacts on human health and the environment’.
112
UNEP, Global Chemicals Outlook II, 2019.
113
Ibid.
114
E.g. UNEP, WHO, ILO, UNIDO, World Bank, OECD, SAICM, MEAs.
115
In particular the participating organisations of the Inter-Organisation Programme for the Sound Management ofChemicals (IOMC).
107

22

INTERNATIONAL LEADERSHIPThe EU will:








step up its international advocacy to meet the 2030 Agenda’s goals and targets forthe sound management of chemicals, in particular by having a leading role andpromoting the implementation of existing international instruments116 as well as
EU standards globally;
strive for the adoption of global strategic objectives and targets for the soundmanagement of chemicals and waste beyond 2020 to reflect life cycle approaches forchemicals, in line with the post-2020 global biodiversity targets;
promote, together with industry, the implementation of the Globally Harmonized
System of Classification and Labelling of Chemicals (UN GHS) as the means for
identifying chemical hazards and communicating them to operators, workers andconsumers;
propose to introduce, adapt or clarify criteria/hazard classes in UN GHS117;
promote the development of common standards and innovative risk assessment
tools internationally, notably with the OECD, and promote their use underinternational frameworks, inter alia to shift further away from animal testing.
2.5.2. Promoting safety and sustainability standards outside the EU

While global chemicals production is estimated to double by 2030, the estimated global
share of the EU chemical industry is expected to shrink to about 10.7%118. Much of the
expected rise in chemical production will shift to developing countries and economies intransition. EU chemicals legislation has positioned the EU as a frontrunner in health andenvironmental standards on chemicals management and this strategy aims to drive EU’s
leadership in producing and using sustainable chemicals. The EU must leverage its weight in
the world to advocate safe and sustainable-by-design approaches globally, to level theplaying field and to increase the market share for companies that produce and use safe andsustainable chemicals.
Closer international cooperation and coordination is also imperative. The Commission iscommitted to supporting the capacity of EU partner countries to meet their international
obligations under the chemicals related international instruments and to adopt and enforce
high environmental, health and social standards. The EU’s external action will promoteand mainstream the sound management of chemicals through their life cycle and thetransition to a toxic-free and circular economy, as essential cross-cutting elements forsustainable development and taking into account policy coherence for development.
Finally, sharing the EU’s knowledge base is important to support developing countries, butalso for the benefit of mutual acceptance of data among OECD and other relevant countries.
116

Notably the Stockholm, Rotterdam and Minamata Conventions.
Introduce new criteria/hazard classes for PBTs/vPvBs, terrestrial toxicity, endocrine disruptors, persistency and mobility;
adapt existing criteria based on scientific knowledge and progress, i.a. to take account of alternative methods, andclarify criteria for germ cell mutagenicity.
118
CEFIC, Facts and Figures Report, 2020.
117

23

This is key to avoid duplication of work, save resources and support international standards.
The existing knowledge base and experience of EU agencies, within their mandate andresources, shall also be put to the benefit of EU international policies and leadership.
COOPERATION WITH THIRD COUNTRIESThe EU will:

promote the sound management of chemicals through international cooperation andpartnerships, in bilateral, regional and multilateral fora, including throughcooperation with Africa119, as well as cooperation with neighbours and other partners
to support their capacity to assess and manage chemicals in a sound manner;
lead by example, and, in line with international commitments, ensure that hazardous
chemicals banned in the European Union are not produced for export, including
by amending relevant legislation if and as needed;
promote due diligence for the production and use of chemicals within the upcoming
initiative on sustainable corporate governance.

3. CONCLUSIONSThis strategy is an opportunity to reconcile the societal value of chemicals with humanhealth and planetary boundaries as well as to support industry in producing safe andsustainable chemicals. It is also an opportunity to respond to the legitimate aspirations of EU
citizens for a high level of protection from hazardous chemicals and to promote the EU
industry as a global frontrunner in the production and use of safe and sustainable chemicals.
This strategy represents the necessary first step towards Europe’s zero pollution ambition
and the related targets defined in the biodiversity and farm to fork strategies, laying thefoundations for the upcoming zero pollution action plan and contributing to the success of theEurope’s beating cancer plan. The strategy is also complementary to the European industrial
strategy120, the recovery plan for Europe121, the circular economy action plan, and other
European Green Deal strategies and initiatives such as the pharmaceuticals strategy, thehydrogen strategy and the batteries initiative.
New legislative initiatives announced in this strategy will be underpinned by theCommission’s better regulation tools. Legal proposals, including a revision of the REACH
Regulation in the most targeted way possible, limited to achieving the objectives of thisStrategy, will be made on the basis of public consultations and subject to comprehensive
impact assessments, including analyses of how small and medium size enterprises (SMEs)
are affected and innovation is fostered or hindered.
The Commission invites the European Parliament and the Council to endorse this strategy
and to contribute to its implementation. The Commission will reach out to citizens andstakeholders in a coordinated way to encourage them to actively participate.

119

Towards a comprehensive Strategy with Africa, JOIN(2020)4 ‘.
COM/2020/102
121
COM/2020/456
12024