Annexes to COM(2020)667 - Chemicals Strategy for Sustainability Towards a Toxic-Free Environment

Please note

This page contains a limited version of this dossier in the EU Monitor.

dossier COM(2020)667 - Chemicals Strategy for Sustainability Towards a Toxic-Free Environment.
document COM(2020)667 EN
date October 14, 2020
agreement on the problem definition will be key, favouring the assessment by groups of substances with structural or functional similarities. The use of available resources and expertise shall be optimised, through a clear allocation of responsibilities as well as good cooperation among all actors.

COORDINATE AND SIMPLIFY ACTIONS ACROSS EU CHEMICAL LEGISLATION

The 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 across legislation;

·establish an expert working group of Member States, Commission services and EU Agencies 68 to discuss initiatives on hazard/risk assessment on chemicals across chemical legislation, taking into account also the specificities of the sector concerned;

·establish a coordination mechanism within the Commission to agree and synchronise, 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 of technical and scientific work on chemicals performed under the relevant pieces of legislation to European agencies, including work of the SCHEER and SCCS 69 ; 

·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 implementation 70 .

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 is available, and that re-use rights are sometimes too restrictive. They also highlight a number of shortcomings in the interoperability and accessibility of chemical data 71 . 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 made more coherent and to the extent possible harmonised. It strives to free the data access of technical or administrative obstacles, according to the principles that data should be easily findable, interoperable, secure, shared and reused by default 72 . Data will be made available in appropriate formats and tools – i.e. IUCLID 73 and IPCHEM 74 - to ensure interoperability. ‘One substance, one assessment’ will also build greater trust in the scientific underpinning of the EU decision-making process for chemicals, building on the important steps taken regarding transparency in the EU food safety sector 75 .

METHODOLOGIES AND DATA

The Commission will:

·ensure that the CLP Regulation is the central piece for hazard classification and allows the Commission to initiate harmonised classifications 76 ;

·review the definition of nanomaterial 77  and ensure its coherent application across legislation using legally binding mechanisms;

·develop a common open data platform on chemicals 78 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 values 79 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 and readily 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 is considered necessary 80 ;

·remove legislative obstacles for the re-use of data and better streamline the flow of chemical data between EU and national authorities;

·extend the principle of open data and the relevant transparency principles from the EU 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 of this, 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 EU 81 and imported 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 requirements 82 . Stepping up implementation and enforcement of chemicals legislation is urgently needed to ensure compliance for the production and placing on the market of chemicals as well as for their release and disposal.

The implementation of the new market surveillance Regulation 83 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 which additional measures could be put in place to strengthen the enforcement of REACH at the EU’s borders 84 , as well as to promote cooperation with online market platforms 85 .

Furthermore, enforcement of EU chemicals legislation is not equally effective throughout the EU, 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 tools 86 , better exploit digital tools for faster 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 networks 88  and authorities 89 to avoid duplication of actions and increase effectiveness.

Ongoing activities aim at improving compliance with environmental legislation relevant to chemicals 90 . A good example is the Environmental Compliance and Governance Forum 91 , which brings together Member States’ chemicals authorities and environmental enforcement networks 92 . The upcoming zero pollution action plan will initiate further specific actions to control 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 with legislation. This will be pursued by implementing consumer protection rules 93 .

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 and revoking 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, imported articles, classification and labelling and restrictions;

·extend the scope of action of the European Anti-Fraud Office for coordination and investigation, to tackle the circulation of illicit chemical products in the EU 94 ;

·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 relevant Commission 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 to European 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 Regulation 95 – uniform conditions and frequency of checks for certain products where specific risks or serious breaches of applicable 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-date knowledge. 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 and this knowledge base has been widely used also in other parts of the world. Still, there is much knowledge to be acquired by authorities on the intrinsic properties of a vast majority of chemicals, 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 an immense knowledge challenge, and the expected future rise in chemical production and use risks further widening the ‘unknown territory of chemical risks’.


Figure: The unknown territory of chemical risks, EEA 96


2.4.1.Improved availability of chemical data

The EU is still lacking a comprehensive information base on all substances placed on the market and on their overall environmental footprint, including their impact on climate, and this hinders the proper management of chemicals and products and does not allow for a full sustainability assessment. In particular polymers, which are the fundamental building blocks of 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 requirements on 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 improved 98 .

INFORMATION REQUIREMENTS

The Commission will:

·make a proposal to extend the duty of registration under REACH to certain polymers of 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 of substances with critical hazard properties, including effects on the nervous and the immune systems;

·amend REACH information requirements to enable identification of all carcinogenic substances manufactured or imported in the EU, irrespective of the volume.


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 environment 99 . Monitoring the presence of chemicals in humans and ecosystems is key to improve the understanding of their impact, and should be further promoted, including to understand the links between chemicals and gender 100 . 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 in chemical 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 chemicals 101 . 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 of chemical hazard and risk assessments.

SCIENCE-POLICY INTERFACE

The Commission will:

·establish and update a research and innovation agenda for chemicals, driven by a EU-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 capacities 102  to also move away from animal testing;

·provide financial support for EU-wide human and environmental (bio)monitoring capacities, complementing ecosystem monitoring initiatives 103 ;

·develop an EU early warning and action system for chemicals 104 to ensure that EU policies address emerging chemical risks as soon as identified by monitoring and research;

·develop a framework of indicators to monitor the drivers and impacts of chemical pollution and to measure the effectiveness of chemicals legislation 105 .


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. World chemicals turnover was valued at €3,347 billion in 2018 106 and production is expected to double by 2030. Chemical-intensive sectors like construction, automotive and electronics are also growing, increasing the demand for chemicals and creating opportunities, but also risks 107 . Although its contribution to the global burden of disease is still underestimated 108 , chemical pollution is recognised to be a threat to the right to a life with dignity, notably for children 109 and in particular in low and middle-income countries 110 .

In 2015, the international community recommitted to achieve the target of a global sound management of chemicals by 2020 111 , which is also an essential cross-cutting element to achieve 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 met 112 . A real sense of urgency is needed. The European Union can and must play a leading role 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 associated with 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 Chemicals 113 . This fragmentation has hampered the overall impact and effectiveness of existing organisations, programmes and initiatives.

Global strategic objectives and targets are needed for an ambitious international framework that addresses the current fragmentation and fosters coherent policies and action by all relevant international organisations 114 , governments and stakeholders, including industry. A renewed Strategic Approach to International Chemicals Management is the essential multilateral agreement that will allow to fully address the sound management of chemicals 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 of chemicals 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, in line with EU’s international commitments.

INTERNATIONAL LEADERSHIP

The EU will:

·step up its international advocacy to meet the 2030 Agenda’s goals and targets for the sound management of chemicals, in particular by having a leading role and promoting the implementation of existing international instruments 116 as well as EU standards globally;

·strive for the adoption of global strategic objectives and targets for the sound management of chemicals and waste beyond 2020 to reflect life cycle approaches for chemicals, 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 and consumers;

·propose to introduce, adapt or clarify criteria/hazard classes in UN GHS 117 ;

·promote the development of common standards and innovative risk assessment tools internationally, notably with the OECD, and promote their use under international 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 in transition. EU chemicals legislation has positioned the EU as a frontrunner in health and environmental 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 the playing field and to increase the market share for companies that produce and use safe and sustainable chemicals.

Closer international cooperation and coordination is also imperative. The Commission is committed 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 promote and mainstream the sound management of chemicals through their life cycle and the transition to a toxic-free and circular economy, as essential cross-cutting elements for sustainable development and taking into account policy coherence for development.

Finally, sharing the EU’s knowledge base is important to support developing countries, but also for the benefit of mutual acceptance of data among OECD and other relevant countries. 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 and resources, shall also be put to the benefit of EU international policies and leadership.

COOPERATION WITH THIRD COUNTRIES

The EU will:

·promote the sound management of chemicals through international cooperation and partnerships, in bilateral, regional and multilateral fora, including through cooperation with Africa 119 , 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.Conclusions

This strategy is an opportunity to reconcile the societal value of chemicals with human health and planetary boundaries as well as to support industry in producing safe and sustainable 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 the foundations for the upcoming zero pollution action plan and contributing to the success of the Europe’s beating cancer plan. The strategy is also complementary to the European industrial strategy 120 , the recovery plan for Europe 121 , the circular economy action plan, and other European Green Deal strategies and initiatives such as the pharmaceuticals strategy, the hydrogen strategy and the batteries initiative.

New legislative initiatives announced in this strategy will be underpinned by the Commission’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 this Strategy, 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 and stakeholders in a coordinated way to encourage them to actively participate.

(1) COM(2019) 640 .
(2) Substances such as PFOS and PFOA are associated with reduced antibody response to vaccination; EFSA, Scientific opinion 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 .
(9) CEFIC, Facts and Figures Report , 2020.
(10) 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 for different 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 long term chemical exposure.
(16) These include, in the context of this strategy and related actions, primarily those related to circular economy, substances having 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.
(17) This includes recent fitness checks and evaluations of EU chemical legislation.
(18) COM(2001) 88 .
(19) At this stage, safe and sustainable-by-design can be defined as a pre-market approach to chemicals that focuses on providing a function (or service), while avoiding volumes and chemical properties that may be harmful to human health or 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.
(22) 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 .
(27) COM(2018) 32 .
(28) Ibid .
(29) Notably, building on ECHA’s SCIP database, ongoing work on REACH review (action 3), COM(2018)0116 , and the development of product passports.
(30) Taking into account the relevant State aid rules.
(31) EEA, Industrial pollution in Europe ; State of the environment and outlook report , 2020.
(32) 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 of specific 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 a framework 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 as environmentally 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.
(36) Within the EU’s cohesion policy, smart specialisation is a place-based approach.
(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 health directives 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 pre-determined 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 specific considerations (e.g. characteristics of the hazard, vulnerability of certain population groups, non-controllable or widespread 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 for humans and the environment, and risk management measures are triggered based on their outcomes. SWD(2019) 199 .
(43) The right to health for children will also be addressed in the upcoming EU Strategy on the right of the child.
(44) 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 the scope of chemicals covered by the EU chemicals regulatory framework is much broader than the specific scope of chemicals covered by the Montreal Protocol.
(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.
(49) SWD(2020) 248.
(50) 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 agents at work (OJ L 131, 5.5.1998) foresees that the risk presented by a combination of chemical agents shall be assessed and managed.
(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 a second 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 States concerning the manufacture, presentation and sale of tobacco and related products. OJ L 127, 29.4.2014. 
(56) COM(2019) 264 .  
(57) 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 and health 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.
(62) More details in SWD(2020) 247.
(63) Stockholm, Rotterdam and Basel Conventions and OECD.
(64) COM (2019)264.
(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.
(69) Scientific Committee on Health, Environmental and Emerging Risks and Scientific Committee on Consumer Safety.
(70) 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 and information, 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’, and amend them if necessary.
(77) As set in Recommendation 2011/696/EU on the definition of nanomaterial OJ L 275, 20.10.2011. 
(78) 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 and the 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.
(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 the enforcement 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.
(94) Drawing inspiration from the rules on mutual administrative assistance in customs matters.
(95) Regulation (EU) 2019/1020 on market surveillance and compliance of products. 
(96) EEA, The European Environment – State and outlook report , 2020.
(97) Review of REACH, COM (2018) 0116
(98) Ibid.
(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 under chemicals legislation; SWD (2020)10
(102)  E.g. predictive toxicology or virtual human platforms
(103)  E.g. monitoring initiatives under EU environment legislation and monitoring schemes such as LUCAS , EMBAL, the upcoming 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 .
(106) CEFIC, Facts and Figures Report , 2020
(107) 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 to minimize 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 of Chemicals (IOMC).
(116) Notably the Stockholm, Rotterdam and Minamata Conventions.
(117) 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, and clarify criteria for germ cell mutagenicity.
(118) CEFIC, Facts and Figures Report , 2020.
(119) Towards a comprehensive Strategy with Africa, JOIN(2020)4 ‘.
(120)   COM/2020/102
(121)   COM/2020/456