Chemicals Strategy For Sustainability PARLIAMENT, THE .

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EUROPEANCOMMISSIONBrussels, 14.10.2020COM(2020) 667 finalCOMMUNICATION FROM THE COMMISSION TO THE EUROPEANPARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIALCOMMITTEE AND THE COMMITTEE OF THE REGIONSChemicals Strategy for SustainabilityTowards 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}ENEN

1.SUSTAINABLE CHEMICALS FOR THE GREEN AND DIGITAL TRANSITIONThe 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 seta goal to protect better human health and the environment as part of an ambitious approach totackle pollution from all sources and move towards a toxic-free environment. Chemicals areeverywhere in our daily life and play a fundamental role in most of our activities, as theyform 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 blocksof 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 boththe 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, certainchemicals 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 ofbiodiversity5. New chemicals and materials must be inherently safe and sustainable, fromproduction to end of life, while new production processes and technologies must be deployedto allow the chemical industry’s transition to climate neutrality.The EU already has one of the most comprehensive and protective regulatoryframeworks for chemicals, supported by the most advanced knowledge base globally.This regulatory framework is increasingly becoming a model for safety standardsworldwide6. The EU has been undeniably successful in creating an efficiently functioninginternal 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 apredictable legislative framework for companies to operate in.1COM(2019) 640.Substances such as PFOS and PFOA are associated with reduced antibody response to vaccination; EFSA, Scientificopinion on PFAS.3Linking pollution and infectious disease, C&en, 2019; Environmental toxins impair immune system over multiplegenerations, Science Daily, October 2, 2019.4Rockström, J. et al., Planetary Boundaries: Exploring the Safe Operating Space for Humanity. Ecology and Society, 2009.5Examples include negative effects on pollinators, insects, aquatic ecosystems and bird populations.6A. Bradford, The Brussels effect, 2020.71 million new cancer cases are estimated to have been prevented in the EU over the last 20 years; SWD(2019)199.8Including mercury, cadmium and arsenic, SWD(2019)199.21

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 secondbiggest producer (accounting for 16.9% of sales) although this share has halved over the last20 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 000companies, 95% of which are SMEs, directly employing approximately 1.2 million peopleand 3.6 million indirectly. The EU has a comprehensive framework comprising approximately 40 legislative instrumentsincluding the Regulation on Registration, Evaluation, Authorisation and Restriction ofChemicals (REACH)10, the Regulation on the Classification, Labelling and Packaging ofhazardous 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 hazardouschemicals in human blood and body tissue, including certain pesticides, biocides,pharmaceuticals, heavy metals, plasticisers and flame retardants12. Combined prenatalexposure 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 ontheir health, and 90% are worried about their impact on the environment14.Nevertheless, in order to develop and deploy the sustainable chemicals that enable the greenand digital transitions and to protect environment and human health, in particular that ofvulnerable groups15, innovation for the green transition of the chemical industry and itsvalue 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.9CEFIC, Facts and Figures Report, 2020.Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals. OJ L 396,30.12.2006.11Regulation (EC) No 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures. OJ L 353,31.12.2008.12European Commission, Study for the Strategy for the Non-Toxic Environment, p. 123.13Ibid.14Eurostat, Eurobarometer, 2020.15For 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 beexposed, or have a reduced ability to protect themselves. Vulnerable groups typically include pregnant and nursingwomen, the unborn, infants and children, the elderly people as well as workers and residents subject to high and/or longterm chemical exposure.16These 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 CLPRegulation) 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, whileenhancing the competitiveness of the European chemical industry and its value chains. Toensure a level playing field between EU and non-EU players, the EU must ensure fullenforcement 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 planetaryhealth but it has also made us aware that manufacturing and supply chains have becomeincreasingly complex and globalised for some critical chemicals, such as those to producepharmaceuticals. The EU must strengthen its open strategic autonomy with resilient valuechains 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 impactassessment 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 legislationwork 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 FOREU CHEMICALS POLICYAlmost 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 withthe European Green Deal, the strategy strives for a toxic-free environment, where chemicalsare produced and used in a way that maximises their contribution to society includingachieving the green and digital transition, while avoiding harm to the planet and to currentand future generations. It envisages the EU industry as a globally competitive player in theproduction and use of safe and sustainable chemicals. The strategy proposes a clearroadmap and timeline for the transformation of industry with the aim of attracting investmentinto 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 managementThis strategy sets a pathway towards implementation of this vision through actions tosupport innovation for safe and sustainable chemicals, strengthen the protection of humanhealth and the environment, simplify and strengthen the legal framework on chemicals, builda 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 chemicalsThe transition to chemicals that are safe and sustainable by design is not only a societalurgency but also a great economic opportunity, as well as a key component of EU’s recoveryfrom the COVID-19 crisis. Considering the trends in global chemical production, this is anopportunity for the EU chemical industry to regain competitiveness by further developingsafe 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 andResilience 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 alsobe mindful of socio-economic consequences including employment impacts on specificregions, sectors, and workers.2.1.1. Promoting safe and sustainable-by-design chemicalsEurope 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 harmfulsubstances has not occurred at the expected pace20 and frontrunners still encounter majoreconomic and technical barriers21. This transition needs stronger policy and financial19At 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 onclimate change, resource use, ecosystems and biodiversity from a lifecycle perspective.20Eurostat, Chemicals production and consumption statistics, 2020.21Wood and Lowell Center for Sustainable Production, Report for the European Commission ‘Chemicals innovation actionagenda’, 2019.4

support, as well as advice and assistance in particular for SMEs, and requires a concertedeffort from all: authorities, businesses, investors and researchers.Regulatory tools22 need to be exploited to drive and reward the production and use of safeand sustainable chemicals. It is particularly important to incentivise industry to prioritiseinnovation 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 promotecooperation and sharing of information across sectors and the value chain and providetechnical 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 LIFEprogramme, other relevant EU funding and investment instruments and public-privatepartnerships;map and address safe and sustainable-by-design skills mismatches and competencegaps, and ensure adequate skills at all levels - including in vocational and tertiaryeducation, 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 saferchemicals by industry in the EU by requiring on-site risk assessments and byrestricting the use of substances of very high concern.2.1.2. Achieving safe products and non-toxic material cyclesIn a clean circular economy it is essential to boost the production and uptake of secondaryraw materials and ensure that both primary and secondary materials and products are alwayssafe. The recently adopted circular economy action plan26 has shown that this requires acombination 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 to22Under REACH, in line with the review of REACH, COM(2018)0116, action 5, and other legislation, such as the EcolabelRegulation, the Ecodesign and Industrial Emissions Directives.23Please see footnote 16.24In line with the Bioeconomy Strategy, COM(2018) 673; the environmental sustainability of bio-based chemicals should beproven from a full life-cycle perspective.25Subject to compliance with applicable State aid rules.26COM(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, valuechain 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 inthe 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 limitvalue for hazardous substances should apply for virgin and recycled material. However, theremay 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 clearlydefined applications where there is no negative impact on consumer health and theenvironment, and where the use of recycled material compared to virgin material is justifiedon 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 anoverall 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 introducingrequirements, also as part of the Sustainable Product Policy Initiative, giving priorityto 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 introducinginformation requirements in the context of the Sustainable Product Policy Initiativeand tracking the presence of substances of concern through the life cycle of materialsand products29;ensure that authorisations and derogations from restrictions for recycled materialsunder REACH are exceptional and justified;support investments in sustainable innovations30 that can decontaminate wastestreams, increase safe recycling and reduce the export of waste, in particular plasticsand textiles;develop methodologies for chemical risk assessment that take into account thewhole life cycle of substances, materials and products.27COM(2018) 32.Ibid.29Notably, building on ECHA’s SCIP database, ongoing work on REACH review (action 3), COM(2018)0116, and thedevelopment of product passports.30Taking into account the relevant State aid rules.286

2.1.3. Greening and digitalising the production of chemicalsChemical production is one of the most polluting, energy and resource-intensive sectors andis closely integrated with other energy-intensive sectors and processes. While the Europeanchemical industry has already invested in improved manufacturing plants, the green anddigital transition still requires significant investments for the sector31. Novel and cleanerindustrial processes and technologies would help not only to lower the environmentalfootprint 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 EuropeanGreen Deal, and fuels such as renewable hydrogen and sustainably produced biomethanecould 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, chemicalinnovations can bring sustainable solutions across sectors to reduce the overallenvironmental footprint of production processes.Beyond the role played by technology, innovations in business models can be an importantdriver for the green transition

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 of Chemicals (REACH)10, the .

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