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Inconsistencies and missing links in EU chemicals legislation
Stockholm University, Faculty of Science, Department of Environmental Science.ORCID iD: 0000-0001-5900-221X
2024 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

The EU chemicals legislation consists of the Regulation on Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) and the Regulation on Classification, Labelling, and Packaging of Substances and Mixtures (CLP), complemented by over fifty regulations and directives regulating specific uses and products. While regulating individual uses may offer a faster and simpler approach to protecting human health and the environment from hazardous chemicals, it can also lead to inconsistencies, such as gaps and overlaps. These inconsistencies may arise for chemicals with multiple uses, each governed by separate legislation.

The overall objective of this work was to understand the links between different pieces of EU chemicals legislation, to identify inconsistencies in the regulation of chemicals covered by multiple regulations and, in particular, to explore the implications of these inconsistencies for the protection of human health and the environment. First, we compared how antimicrobial substances are regulated when used in biocidal products compared to cosmetics (Paper I). The risk assessment of cosmetic preservatives focused solely on human health, omitting environmental data and environmental risk assessment. Once granted, the approval of cosmetic preservatives remained valid indefinitely until revoked by the European Commission, with no requirement to update the dossier based on new information. Based on these findings, we examined whether the approved cosmetic preservatives were hazardous to the aquatic environment or persistent, and if so, whether the risks were efficiently managed by REACH (Paper II). The analysis showed that environmental hazards of cosmetic preservatives and other ingredients are overlooked by the Cosmetic Products Regulation and might not be effectively managed by REACH. Next, the linkage between the CLP and other pieces of chemicals legislation was examined, mapping out regulatory obligations, arising from the new CLP hazard classes for endocrine disruption for human health (ED HH), endocrine disruption for the environment (ED ENV), PBT/vPvB, and PMT/vPvM (Papers III and IV). Meeting criteria for human health hazards under the CLP triggered more regulatory obligations across multiple regulations, compared to when fulfilling the criteria for physical or environmental hazards. Implementation of the new CLP hazard classes will require revision of regulations with existing risk management measures connected to the CLP hazard criteria.

The results and conclusions of the studies included in this thesis highlight the need for addressing the existing inconsistencies in order to strengthen the protection of human health and the environment. The provided recommendations address the need for harmonisation of the chemicals legislation and more efficient management of hazardous chemicals.

Place, publisher, year, edition, pages
Stockholm: Department of Environmental Science, Stockholm University , 2024. , p. 27
Keywords [en]
REACH, Cosmetic Products Regulation, Biocidal Products Regulation, CLP, new hazard classes, PBT/vPvB, EDC, PMT/vPvM, endocrine disruptor, Chemicals Strategy for Sustainability
National Category
Environmental Sciences
Research subject
Environmental Sciences
Identifiers
URN: urn:nbn:se:su:diva-227293ISBN: 978-91-8014-707-1 (print)ISBN: 978-91-8014-708-8 (electronic)OAI: oai:DiVA.org:su-227293DiVA, id: diva2:1843739
Public defence
2024-04-29, De Geersalen, Geovetenskapens hus, Svante Arrhenius väg 14 and online via Zoom, public link is available at the department website, Stockholm, 10:00 (English)
Opponent
Supervisors
Available from: 2024-04-04 Created: 2024-03-11 Last updated: 2024-03-26Bibliographically approved
List of papers
1. Stricter regulation applies to antimicrobial substances when used as biocides compared to cosmetics under current EU legislation
Open this publication in new window or tab >>Stricter regulation applies to antimicrobial substances when used as biocides compared to cosmetics under current EU legislation
2022 (English)In: Emerging Contaminants, ISSN 2405-6650, E-ISSN 2405-6642, Vol. 8, p. 229-242Article in journal (Refereed) Published
Abstract [en]

Antimicrobial substances are substances that have the ability to kill or slow down the growth of microorganisms such as bacteria, algae and fungi. Exposure of microorganisms to low concentrations of antimicrobial substances may lead to the development of antimicrobial resistance. To protect human health and the environment and to limit resistance, the risks for the release of these substances into the environment should be minimized from all sources. Under the current EU legal framework, some specific uses of antimicrobial substances are strictly regulated whereas others are not. When antimicrobial substances are used as active substances in biocidal products, such as disinfectants, they are regulated by Biocidal Products Regulation. When the same substances are used as preservatives in cosmetic products they fall under Cosmetic Products Regulation. In this paper, we investigated how the regulation of antimicrobial substances differ when used in biocidal products compared to cosmetic products. This was achieved by performing a systematic comparison using document analysis with focus on aims, scope, information requirements, and risk assessment procedures for biocidal active substances and cosmetic preservatives. One of the main differences identified is that no environmental data or environmental risk assessment are required for approval of cosmetic preservatives. In contrast, environmental data and risk assessment for both the active substances and one representative product would be required for the approval of the same substance if used as a biocidal active substance. This means first that a substance not approved for use in biocidal products due to its hazardous environmental properties can still be approved as a cosmetic preservative. And second, the environmental release of antimicrobial substances from cosmetic products remains unassessed and uncontrolled, despite the obvious risks of cosmetic ingredients being emitted into the environment via wastewater. From this, we recommend that an environmental risk assessment is added to the requirements for market approval of cosmetic preservatives to achieve the aim of a high level of protection for the environment as set by several EU regulations. This would be in line with the “one substance – one assessment” approach proposed by the European Commission. While the details of “one substance – one assessment” approach are not decided, it is believed to contribute to more coordinated and transparent chemical safety assessments and enhance interlinking between the regulations.

Keywords
Antimicrobial substances, Biocides, Chemicals regulation, Cosmetics, Environmental risk assessment, One substance one assessment
National Category
Environmental Engineering Earth and Related Environmental Sciences
Identifiers
urn:nbn:se:su:diva-206343 (URN)10.1016/j.emcon.2022.04.003 (DOI)000832947100001 ()2-s2.0-85129480582 (Scopus ID)
Available from: 2022-06-16 Created: 2022-06-16 Last updated: 2024-03-11Bibliographically approved
2. Out of REACH: environmental hazards of cosmetic preservatives
Open this publication in new window or tab >>Out of REACH: environmental hazards of cosmetic preservatives
Show others...
2024 (English)In: Human and Ecological Risk Assessment, ISSN 1080-7039, E-ISSN 1549-7860Article in journal (Refereed) Epub ahead of print
Abstract [en]

The EU Cosmetic Products Regulation requires neither environmental data nor environmental risk assessment for individual ingredients or finished cosmetic products. Instead, it relies on REACH to address environmental risks linked to cosmetic ingredients, including preservatives. We investigated how the environmental risks of cosmetic preservatives are managed by REACH. We identified preservatives of environmental concern and examined if any of these had been selected for Substance Evaluation, proposed for or identified as an SVHC, required authorization or were proposed for, or subject to, restriction under REACH. More than half of the preservatives approved under the Cosmetic Product Regulation, 70 of 137, were identified as being of environmental concern according to the criteria set in this study. Some of the approved preservatives were no longer produced or used in the EU due to their hazardous properties. However, they remained approved and may still enter the EU via the imported products. Our results also indicate that the environmental aspects of cosmetic ingredients, including preservatives, are not efficiently managed by REACH. Besides the known issues in REACH, we identified additional areas in the interface between REACH, CLP and the Cosmetic Products Regulation that call for improvement. Here, we provide practical suggestions in line with the Chemicals Strategy for Sustainability. If implemented, these measures would strengthen the protection of the environment from hazardous cosmetic ingredients.

Keywords
CLP, REACH, cosmetic preservatives, environmental hazards, one substance - one assessment
National Category
Environmental Sciences
Identifiers
urn:nbn:se:su:diva-225982 (URN)10.1080/10807039.2023.2301073 (DOI)001137432000001 ()2-s2.0-85181745587 (Scopus ID)
Available from: 2024-01-31 Created: 2024-01-31 Last updated: 2024-03-11
3. Fulfilling the criteria for CLP classification: the implications for substances under the EU chemicals legislation
Open this publication in new window or tab >>Fulfilling the criteria for CLP classification: the implications for substances under the EU chemicals legislation
Show others...
(English)Manuscript (preprint) (Other academic)
Abstract [en]

The implementation of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) through Regulation (EC) 1272/2008 (CLP) is central to chemical regulation in the European Union (EU). The CLP mandates manufacturers and importers to classify substances and mixtures according to hazard criteria, with notifications submitted to the European Chemicals Agency (ECHA). Substances meeting hazard criteria must be appropriately labelled and packaged to communicate hazards effectively. The CLP establishes hazard classification criteria but does not independently restrict the use of hazardous chemicals. Instead, it serves as a basis for regulatory obligations in other specific regulations. 

This study investigates the regulatory implications of meeting hazard criteria under the CLP across EU regulations and directives listed in EUCLEF. Results reveal that fulfilling criteria for human health hazard classes triggers regulatory obligations in the highest number of regulations/directives, with carcinogenicity, mutagenicity, and reproductive toxicity (CMR) leading to obligations in 19 of 20 pieces of legislation linked to the CLP. Conversely, physical, environmental, and ozone layer hazards are associated with fewer regulations and directives, resulting in fewer prohibitions.

The study underscores the pivotal role of the CLP in EU chemical legislation and the need for coherence and consistency across regulations. While regulatory obligations are primarily aimed at substances meeting hazard criteria, issues with self-classification variability and limitations in harmonized classification processes were observed. Moreover, the complexity of the regulatory structure poses challenges for stakeholders and policymakers, including inconsistencies, compliance difficulties, and the need for frequent revisions. Addressing these challenges is critical for enhancing regulatory effectiveness and ensuring a more coherent and harmonized approach to chemical management in the EU.

Keywords
CLP, hazard classification, EU legislation, chemical strategy for sustainability
National Category
Environmental Sciences
Research subject
Environmental Sciences; Toxicology
Identifiers
urn:nbn:se:su:diva-227279 (URN)
Available from: 2024-03-11 Created: 2024-03-11 Last updated: 2024-03-11
4. An analysis of the impact of the new CLP hazard classes on EU chemicals legislation
Open this publication in new window or tab >>An analysis of the impact of the new CLP hazard classes on EU chemicals legislation
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(English)Manuscript (preprint) (Other academic)
Abstract [en]

The European Union (EU) recently introduced four [MÅ1] new hazard classes to the Classification, Labelling and Packaging (CLP) Regulation (EC) 1272/2008. The classes are endocrine disruption for human health (ED HH) and the environment (ED ENV), persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), and persistent, mobile and toxic (PMT) or very persistent and very mobile (vPvM). This action was a direct consequence of the EU's Chemicals Strategy for Sustainability, which aims at strengthening the protection of human health and the environment, as well as reinforcing the CLP Regulation as the central piece of the chemicals legislation. This study examined the regulatory obligations triggered by these new hazard classes, as well as the existing obligations for endocrine disrupters and PBT/vPvB substances identified in other EU regulations. In addition, we compared the CLP criteria for endocrine disruption and PBT/vPvB to criteria existing in other EU regulations and investigated how these criteria are used in the EU chemicals legislation. 

 

The European Union (EU) recently introduced four new hazard classes to the Classification, Labelling and Packaging (CLP) Regulation (EC) 1272/2008. The classes are endocrine disruption for human health (ED HH) and the environment (ED ENV), persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), and persistent, mobile and toxic (PMT) or very persistent and very mobile (vPvM). This action was a direct consequence of the EU's Chemicals Strategy for Sustainability, which aims at strengthening the protection of human health and the environment, as well as reinforcing the CLP Regulation as the central piece of the chemicals legislation. This study examined the regulatory obligations triggered by these new hazard classes, as well as the existing obligations for endocrine disrupters and PBT/vPvB substances identified in other EU regulations. In addition, we compared the CLP criteria for endocrine disruption and PBT/vPvB to criteria existing in other EU regulations and investigated how these criteria are used in the EU chemicals legislation. 

 We found that the implementation of the new hazard classes under the CLP Regulation into existing EU chemicals legislation will require the revision of all regulations that rely on the CLP hazard criteria for risk management. Without revision, the immediate impact of the new hazard classes will only extend to the six regulations and the regulatory obligations they contain, all of which apply to all hazardous substances under the CLP Regulation. Meanwhile, substances with endocrine disrupting and PBT/vPvB properties are already being identified and regulated using criteria from regulations other than the CLP. When comparing the criteria for identification of endocrine disrupters and PBT/vPvB substances across the chemicals legislation, we found that the criteria differed between regulations. The findings aim to support the efficient implementation of the new CLP hazard classes and harmonization of criteria across regulations, in line with the Chemicals Strategy for Sustainability.

Keywords
CLP, new hazard classes, PBT/vPvB, EDC, PMT/vPvM, endocrine disruptor
National Category
Environmental Sciences
Research subject
Environmental Sciences; Toxicology
Identifiers
urn:nbn:se:su:diva-227281 (URN)
Available from: 2024-03-11 Created: 2024-03-11 Last updated: 2024-03-16

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