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Stricter regulation applies to antimicrobial substances when used as biocides compared to cosmetics under current EU legislation
Stockholm University, Faculty of Science, Department of Environmental Science.ORCID iD: 0000-0001-5900-221X
Stockholm University, Faculty of Science, Department of Environmental Science.ORCID iD: 0000-0002-9193-1147
Stockholm University, Faculty of Science, Department of Environmental Science.ORCID iD: 0000-0003-2697-2310
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.

Place, publisher, year, edition, pages
2022. Vol. 8, p. 229-242
Keywords [en]
Antimicrobial substances, Biocides, Chemicals regulation, Cosmetics, Environmental risk assessment, One substance one assessment
National Category
Environmental Engineering Earth and Related Environmental Sciences
Identifiers
URN: urn:nbn:se:su:diva-206343DOI: 10.1016/j.emcon.2022.04.003ISI: 000832947100001Scopus ID: 2-s2.0-85129480582OAI: oai:DiVA.org:su-206343DiVA, id: diva2:1670617
Available from: 2022-06-16 Created: 2022-06-16 Last updated: 2025-01-31Bibliographically approved
In thesis
1. Inconsistencies and missing links in EU chemicals legislation
Open this publication in new window or tab >>Inconsistencies and missing links in EU chemicals legislation
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
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:nbn:se:su:diva-227293 (URN)978-91-8014-707-1 (ISBN)978-91-8014-708-8 (ISBN)
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

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Kättström, DianaRudén, ChristinaÅgerstrand, Marlene

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