Efforts to regulate: progress and problems

 

EU regulatory mainstays and their shortcomings

Throughout its existence, the EU has developed an important body of chemical legislation including, since 2007, the wide-ranging Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals, known as REACH.69 The Regulation on Classification, Labelling and Packaging of Chemicals (CLP) aims—among its other purposes—to determine whether substances or mixtures display hazardous properties. Together, REACH and CLP frame several further laws to regulate specific products and uses of substances, such as rules on toy safety, substances in contact with food, as well as cosmetic and personal care products.

These texts contain serious shortcomings in effectively assessing and managing chemicals, especially in restricting the most harmful substances. In 2019, the Council of the European Union acknowledged:

“the importance of reviewing and revising, as appropriate, existing testing requirements to ensure that health objectives of particular relevance for children and other vulnerable groups are adequately, consistently and coherently addressed (e.g. neurotoxicity, impacts on immune system, endocrine disruption, toxicokinetics etc.) across EU chemicals legislation”.70

The Council recognized the need to develop a “relevant mechanism coordinating the protection of vulnerable groups such as children and pregnant and breastfeeding women.” This was to include consistent risk-management requirements in relevant EU legislation regarding substances of concern, including neurotoxins and EDCs.71

The European Parliament has also repeatedly called on the European Commission to address concerns over children’s harmful exposure to hazardous chemicals. In 2020, Parliament called for regulatory measures to “adequately protect vulnerable groups such as children, pregnant and breastfeeding women or elderly people.”72 It urged the Commission to adopt “a cross-cutting definition of vulnerable groups, and propose if appropriate, to adapt accordingly current scientific assessment approaches, as well as to align to the highest standards the protection of vulnerable groups throughout all chemical legislation.” 73 Parliament further asked the Commission to give "particular attention to chemicals that accumulate and persist in bodies, those that are transmitted to children through pregnancy or breast milk, and chemicals that can have effects across generations.”74

The Chemicals Strategy for Sustainability (2020)

In 2020, to update existing legislation and fill the gaps, the Commission issued a far-reaching plan for reform as part of the Green Deal: the Chemicals Strategy for Sustainability (CSS). The new strategy promised to revise key components of chemical legislation such as REACH and CLP, as well as sectoral regulations, such as those governing toys and cosmetics. The Commission also recognized explicitly that “vulnerable population groups—such as children, pregnant women, and elderly people—are particularly sensitive to chemicals with certain hazardous properties.”75

The CSS stressed that, to protect health, in particular that of vulnerable groups, the existing EU chemicals policy must evolve and respond more rapidly and effectively. It also committed to ensuring the safety of children from hazardous chemicals in childcare articles and to extend regulations governing chemicals in toys to other children’s products. The Commission further promised that children’s right to health would be also addressed in the new EU Strategy on the Rights of the Child.

The EU remains far from fulfilling these promises, but has made some progress:

  • In December 2023, EU institutions adopted a provisional agreement on the revision of the CLP rules, which clarifies standards on classification and labeling, including new hazard classes for EDCs and persistent and mobile chemicals.76
  • The Commission proposed an ambitious regulation on toy safety (TSR) in July 2023 to replace outdated standards.77 This text is to be amended, debated, and adopted in the Parliament and the Council on a date scheduled tentatively for 2025.
  • A proposal for a wide-ranging restriction on highly persistent chemicals known as per- and polyfluoroalkyl substances (PFAS) was published in 2023 and is currently being analyzed by the European Chemicals Agency.
  • Research and scientific projects have been funded at the EU level, including via Horizon Europe. For example, the EURION project is helping to improve identification of EDCs, and the European Human Biomonitoring Initiative (HBM4EU) is informing safer chemical management practices.78

Key promises remain unfulfilled, notably those of the Restrictions Roadmap (2022),79 which describes ongoing and future work under REACH, including several new restrictions on highly hazardous chemicals.80 As stated by the European Environmental Bureau (EEB) and ClientEarth, although bisphenols, PFAS, phthalates, and flame retardants are now under consideration, “most of these substances are likely to continue to be manufactured and used in the EU, to the detriment of our health and that of ecosystems, our economy and the broader state of the environment.”81

The current chemical legislation framework also suffers from inconsistency. For instance, BPA is currently prohibited from baby bottles but not other plastics, such as toys.82 Only a thorough revision of all relevant chemicals laws can harmonize such inconsistencies, bringing predictability to the assessment and management of all chemicals across products and sectors.

Unfortunately, several pivotal revision proposals are being delayed or dropped. The goal of the cornerstone revision of REACH, promised by the CSS, is to achieve a toxic-free environment. The Commission itself has stressed that achieving the goals of the Green Deal requires revision of the rules governing the registration, evaluation, authorisation, and restriction of chemicals in the EU.83 Despite the importance of this revision, the Commission decided in autumn 2023 to shelve it for an undefined period.84 This decision has forestalled the development of a comprehensive system to review all harmful substances or chemical groups and to impose adequate restrictions on them.

This decision should be reversed, and a new timetable identified for a full revision of EU chemicals legislation. Only this can improve clarity, predictability, coherence, and harmonization of the legislation across EU member states. It will also support research and innovation efforts towards greener, healthier solutions, while supporting the long-term resilience of our ecosystems, agriculture, food system, and economy.

 

In focus: PFAS, the ‘forever pollutants’

Per- and polyfluoroalkyl substances (PFAS) include thousands of synthetic chemicals containing very strong, carbon-fluorine bonds, which resist degradation. Widely known as ‘forever pollutants’, PFAS are easily transported in the environment, often over long distances, and are associated with harm to human and ecological health.

Current EU chemical regulations are insufficient to prevent the continuing pollution of children and their environment by PFAS. The chemicals can have endocrine-disrupting properties85 with significant impacts on foetal growth and foetal development with consequences for birth outcomes including preterm birth, children’s development, and health into adulthood.86 Harm following exposure can be irreversible and be passed from one generation to the next.87

  • In 2023, the Forever Pollution Project88 confirmed that up to 17,000 sites in Europe were contaminated by PFAS, and identified a further 21,500 sites presumed to be contaminated due to current or past industrial activity.
  • In 2018, the EU Food Safety Authority (EFSA) found that exposure of a considerable part of the European population exceeded the provisional tolerable weekly intakes, even when based on estimates of low exposure. Additionally, in 2020, the EFSA outlined in its scientific evaluation on the risks to human health related to the presence of PFAS in food89 that “toddlers and other children had approximately twofold higher mean intake than older age groups.”
  • The research programme HBM4EU reported that higher maternal PFAS levels can be associated with an increased propensity for infections in children up to four years old.90 A growing number of “PFAS hotspots” were also identified, where exposure was around 100 times the average and presented “a risk to human health.”
  • In 2022, a study examined self‑reported diseases in mothers and their children living with contamination of perfluoroalkyl substances, finding that mothers with higher risk perception related to PFAS exposure reported more health issues and autoimmune disorders.91
  • A large study conducted on Finnish pregnant people and published in 2023 revealed that prenatal exposure to some PFAS is associated with a higher risk of childhood leukaemia. This research found that children born in the late 1980s and early 1990s, when exposure levels to PFOS (a type of PFAS) were highest, had the highest risk of acute lymphoblastic leukaemia (i.e. the most common childhood cancer worldwide).92

On the evidence, PFAS are widespread in Europe and lead to significant harms to children’s health, family finances, and national economies93 – costs that only grow as PFAS contamination continues.

In 2019, Milieu Consulting carried out a study on these costs in the European Economic Area (EEA), focusing on the costs borne by communities near chemical plants where PFAS has contaminated drinking water.94 The study estimated that 12.5 million people in the EEA living close to PFAS contamination were affected by elevated risks of all-cause mortality (meaning death due to any cause).95 As such, the most affected communities (particularly people living nearby PFAS manufacturing plants) suffered from higher mortality rates, and between 11,745 and 13,843 deaths in the EEA were directly linked to PFAS.96 The health-related costs of exposure of affected communities to PFAS represented an annual total of €41-49 billion,97 and the overall estimated cost of environmental remediation was very wide, ranging up to €170 billion.98

Just twelve companies are responsible for most PFAS production worldwide, at huge profit.99 and yet these contribute little to the costs of mitigation and remediation of their pollution.

In 2023, five EU member states collectively proposed to ban PFAS from a wide range of industrial and consumer uses.100 The EU now has the opportunity to take up this restriction proposal as a bloc, in line with its promises in the Child Rights Strategy and the CSS, which commits to phase out PFAS completely. As discussions continue, the chemical industry and conservative political groups are lobbying against change in hope of diluting the outcome.101 The fight against PFAS pollution is far from over.

In 2023, media revealed that one of the largest PFAS manufacturers, Dupont/Chemours, sought to hide their knowledge of the chemicals’ harmful health effects.102 The EU cannot rely on industry’s diligence alone to protect its citizens.

The inaction of this company, which is aware of the damages PFAS cause, also highlighted the lack of strong provisions regarding the control, enforcement, and compliance with the obligations set out under several EU chemicals legislation, such as REACH. PFAS pollution occurred and is occurring while REACH was and is in force. An ambitious and thorough revision of REACH, including its restriction process, is urgent to prevent other harmful contamination from happening again.

For further details, see CRIN’s submission on the PFAS restriction proposal.

 
 
 
 

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Footnotes

69 EU, Consolidated text: Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), December 2006.


70 Council of the EU, Conclusions: Towards a Sustainable Chemicals Policy Strategy of the Union, June 2019.


71 Ibid.


72 EU Parliament, Resolution on the Chemicals Strategy for Sustainability (2020/2531(RSP)), July 2020.


73 Ibid.


74 Ibid.


75 Vulnerable population groups are defined in the CSS as “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. (...)”


76 EU Commission, Commission welcomes provisional agreement on improving classification, labelling and packaging of hazardous chemicals, December 2023.


77 EU Commission, Protecting children from unsafe toys and strengthening the Single Market – revision of the Toy Safety Directive.


78 HBM4EU, What we do.


79 EU Commission, Staff working document restrictions roadmap under the CSS, April 2022.


80 EEB and ClientEarth, A roadmap to nowhere? The EU’s bold plan to quit the most harmful chemicals is a year old. We assess its effectiveness, April 2023.


81 Ibid.


82 ANSES, Sécurité des couches pour bébé: Avis révisé de l’Anses, Rapport d’expertise collective, January 2019, ANSES found formaldehyde, together with 37 hazardous substances, in diapers (p. 99-103); Opinion from MEPs Maria Arena, Anja Hazekamp, Tilly Metz, Frédérique Ries, Are there dangerous chemicals in disposable nappies in EU?, July 2022; EEB, Babies exposed to highly toxic nappies face severe disease threat later in life, July 2022.


83 EU Commission, Chemicals legislation – revision of REACH Regulation to help achieve a toxic-free environment.


84 EU Commission Work Programme 2024 https://commission.europa.eu/strategy-documents/commission-work-programme/commission-work-programme-2024_en; Euractiv, EU quietly shelves REACH regulation on toxic chemicals, October 2023; EEB, Déjà vu: Commission’s Work Programme bows to chemical and farm industry pressure yet again, October 2023.


85 Endocrine Society, PFAS Chemicals: EDCs contaminating our water and food supply and Colleen S. et al., Early life exposures to perfluoroalkyl substances in relation to adipokine hormone levels at birth and during childhood, Journal of Clinical Endocrinology & Metabolism, Volume 104, Issue 11, Pages 5,338–5,348, June 2019.


86 Govarts, E. et al., Combined effects of prenatal exposures to environmental chemicals on birth weight, 2016; Wang, Mansem, L.S. et al., Concentrations of perfluoroalkyl substances (PFASs) in human embryonic and foetal organs from first, second, and third trimester pregnancies, March 2019; Danish Environmental Protection Agency, Exposure of children and unborn children to selected chemical substances, 2017; Balbus, J.M., et al., Early-life prevention of non-communicable diseases, 2013; Hyötyläinen, T. et al., In utero exposures to perfluoroalkyl substances and the human fetal liver metabolome in Scotland: a cross-sectional study, January 2024.


87 Report of the SR on the Implications for Human Rights of the Environmentally Sound Management and Disposal of Hazardous Substances and Wastes, A/HRC/33/41, August 2016.


88 The Forever Pollution Project: Journalists tracking PFAS across Europe, see also Le Monde, 'Forever pollution': Explore the map of Europe's PFAS contamination, February 2023.


89 EFSA, PFAS in food: EFSA assesses risks and sets tolerable intake,, September 2020.


90 HBM4EU Newspaper, European Human Biomonitoring Initiative, April 2022.


91 Girardi, P. et al., Mothers living with contamination of perfluoroalkyl substances: an assessment of the perceived health risk and self‑reported diseases, Environmental Science and Pollution Research, March 2022.


92 Jones, R. et al., Maternal serum concentrations of per- and polyfluoroalkyl substances and childhood acute lymphoblastic leukemia, December 2023.


93 Cordner, A. et al., The True Cost of PFAS and the Benefits of Acting Now, July 2021.


94 Goldenman G. et al., Cost of inaction: a socio-economic analysis of environmental and health impacts linked to exposure to PFAS; Nordic Council of Ministers, Copenhagen, March 2019.


95 Ibid. Calculation method detailed in Table A2.3: Calculation of annual monetised impact of elevated mortality due to elevated PFAS exposure – Nordic and EEA countries.


96 Ibid. See Table 22: Monetised annual costs due to elevated risk of all-cause mortality for adults living close to PFAS contamination.


97 Ibid. See Table 40: Estimated health-related costs of exposure to PFAS at different levels of exposure.


98 Ibid. See Table 4: Aggregated costs covering environmental screening, monitoring where contamination is found, water treatment, soil remediation, and health assessment.


99 Chemsec, The top 12 PFAS producers in the world and the staggering societal costs of PFAS pollution, May 2023.


100 ECHA, ECHA publishes PFAS restriction proposal, February 2023.


101 Horel, S., 'Forever chemicals': Industrialists lobby to avoid ban on toxic substances, Le Monde, Les Décodeurs, February 2023; Corporate Europe Observatory, Toxics industry fights back against proposed 'forever chemicals' ban, July 2023.


102 Dutch Parliament, recording of the hearing (in Dutch); NOS, press article on the hearing; BNNVARA, press article on Chemours scandal in Dordrecht, July 2023.