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Managing chemical risks in the EU: Data use and new approaches for decision-making
Stockholm University, Faculty of Science, Department of Environmental Science.ORCID iD: 0000-0002-1301-9726
2024 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Man-made chemicals benefit our living standards, but exposure to the (most) harmful ones can lead to negative, irreversible effects on human health and the environment. The risk management of harmful chemicals aims to protect human health and the environment from unacceptable risks. Decisions made on management measures are often based on data generated by the chemicals’ producers and/or importers. However, risk management measures have been criticised for not fulfilling their expected purpose, and risk assessors and decision-makers can have different ways of assessing hazards and risks, and hence, can have diverging opinions on the most suitable risk management measures for harmful chemicals. 

The overall objective of this thesis was to contribute to a better understanding of how information about harmful chemicals put on the EU market are, or could be, used to improve the overall protection of the environment and human health. Two main questions were asked: First, what data are used for the decision-making on chemical risk management under EU regulations? And second, how could available data be used differently through the use of new approaches to improve risk management? The questions were addressed by exploring three risk management procedures in the EU. These were the restriction and authorisation procedures under the REACH Regulation (EC No 1907/2006), as well as the environmental management under the Plant Protection Products Regulation (EC No 1107/2009). 

First, an analysis of key studies used to restrict substances under the REACH Regulation showed that non-standard studies contribute to risk management decisions, and that the REACH database may not provide sufficient information for adequate hazard identification and risk management (Paper I). Second, data generated in the course of the REACH authorisation procedure should, in theory, provide sufficient and relevant data to implement the essential use concept, a new approach to risk management presented in the EU Chemical Strategy for Sustainability (Paper II). An analysis of applications for authorisation, however, revealed that for approximately one-third of the analysed uses no clear decision could be made on their essentiality when applying the currently suggested essential use criteria (Paper III). Last, a first exploration of the relative risks of insecticides suggests that the more complex higher-tier studies, in particular mesocosm studies, are highly heterogeneous in their design and may not be useful for a systems-based environmental risk assessment that aims to enhance the level of protection of biodiversity on a larger scale. However, as expected, the risk quotients of the investigated substances decreased by adding higher-tier data. The added benefit of performing higher-tier studies could be further explored by investigating the magnitude of decrease of risk quotients (Paper IV). 

Place, publisher, year, edition, pages
Stockholm: Department of Environmental Science, Stockholm University , 2024. , p. 36
Keywords [en]
risk management, decision-making, REACH, data use, essential use concept, Chemical Strategy for Sustainability, plant protection products, environmental risk assessment
National Category
Environmental Sciences
Research subject
Environmental Sciences
Identifiers
URN: urn:nbn:se:su:diva-225058ISBN: 978-91-8014-633-3 (print)ISBN: 978-91-8014-634-0 (electronic)OAI: oai:DiVA.org:su-225058DiVA, id: diva2:1824650
Public defence
2024-02-16, 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: 2024-01-24 Created: 2024-01-07 Last updated: 2024-01-12Bibliographically approved
List of papers
1. Characterisation and analysis of key studies used to restrict substances under REACH
Open this publication in new window or tab >>Characterisation and analysis of key studies used to restrict substances under REACH
2022 (English)In: Environmental Sciences Europe, ISSN 2190-4707, E-ISSN 2190-4715, Vol. 34, no 1, article id 83Article in journal (Refereed) Published
Abstract [en]

Background: Understanding how scientifc studies are used in regulatory risk assessments is important since it infuences the outcome of an assessment, and thus the level of protection of human health and the environment. Withinthe REACH legislation (Registration, Evaluation, Authorisation and Restriction of Chemicals, EC Nr. 1907/2006) hazardinformation on clearly defned (eco-)toxicological endpoints are submitted for the registration of substances, and thisinformation is intended for concluding on potential hazards and risk as well as subsequent risk management measures such as restrictions. The present study aimed to (1) characterise key studies used by the European ChemicalsAgency’s Committee for Risk Assessment to restrict hazardous substances; (2) analyse if the REACH registration database provided the key studies used in these restrictions, and (3) investigate potential expert disagreements related tothe use of non-standard studies in the restrictions.

Results: Our analysis showed that 58% of the 53 scrutinised key studies were non-standard studies, all available bypaying a fee or through open access. Sixteen (30%) of the key studies were consulted from external sources outsidethe REACH registration database by the Committee for Risk Assessment. Only one study of the 16 external key studieswas a standard study. Further, 9% (5/53) of the key studies used by the Committee for Risk Assessment were inaccessible to third parties, all were standard studies. The uses of non-standard studies were (unsuccessfully) challenged forfve substances during the public consultation.

Conclusions: These results suggest that non-standard studies contributed to the identifcation and management ofsubstances of concern, that the REACH registration database may not be sufcient for the identifcation and management of uncontrolled hazards and risks, and that the transparency of the decisions made by the Committee for RiskAssessment was partially hampered due to the use of standard studies inaccessible to third parties.

Keywords
REACH, Risk assessment, Risk management, Restriction, Key study, Non-standard, Guideline, Transparency, Registration, Database
National Category
Earth and Related Environmental Sciences
Identifiers
urn:nbn:se:su:diva-209504 (URN)10.1186/s12302-022-00662-8 (DOI)000849650900001 ()2-s2.0-85137556983 (Scopus ID)
Available from: 2022-09-20 Created: 2022-09-20 Last updated: 2024-01-07Bibliographically approved
2. The essential-use concept: a valuable tool to guide decision-making on applications for authorisation under REACH?
Open this publication in new window or tab >>The essential-use concept: a valuable tool to guide decision-making on applications for authorisation under REACH?
2023 (English)In: Environmental Sciences Europe, ISSN 2190-4707, E-ISSN 2190-4715, Vol. 35, article id 5Article in journal (Refereed) Published
Abstract [en]

Background In 2020, the European Commission published the Chemical Strategy for Sustainability (CSS) in which it aims to increase the level of protection for human health and the environment from hazardous chemicals. Part of the implementation of the CSS will involve a reform of the REACH authorisation and restriction processes. One option for the reform of the authorisation process is to implement the essential-use concept as a tool to guide decision-making on applications for authorisation to make the process more efficient and to align it with societal needs. The purpose of this study is to investigate whether changes in the legal text that defines the authorisation process, and of the amount and type of information that applicants should provide in an application for authorisation, are needed to enable an implementation of the essential-use concept.

Results The results suggest that no fundamental changes in the regulatory requirements are needed and that applicants should already provide sufficient and relevant information to the authorities to determine if the use(s) applied for is (are) essential.

Conclusions Although the REACH authorisation already provides a legal and practical basis for an implementation of the essential-use concept, the feasibility of the essentiality assessment and its potential to make the decision-making on applications more efficient are highly dependent on the quality of the information provided and the clearness of decision criteria. However, if an applicant successfully demonstrates that the risk related to the use(s) applied for is adequately controlled, it could not be legally justified for the European Commission to refuse an authorisation by arguing that the use(s) applied for is (are) non-essential.

Keywords
Essential-use concept, Chemical Strategy for Sustainability, Authorisation process, Assessment for decision-making, REACH, Substance of Very High Concern
National Category
Earth and Related Environmental Sciences Law
Identifiers
urn:nbn:se:su:diva-215163 (URN)10.1186/s12302-022-00708-x (DOI)000913553800001 ()2-s2.0-85146633982 (Scopus ID)
Available from: 2023-03-02 Created: 2023-03-02 Last updated: 2024-01-07Bibliographically approved
3. Identifying non-essential uses to phase out Substances of Very High Concern under REACH
Open this publication in new window or tab >>Identifying non-essential uses to phase out Substances of Very High Concern under REACH
Show others...
(English)Manuscript (preprint) (Other academic)
National Category
Environmental Sciences
Identifiers
urn:nbn:se:su:diva-225055 (URN)
Available from: 2024-01-07 Created: 2024-01-07 Last updated: 2024-01-07
4. Exploring the relative risks among insecticides
Open this publication in new window or tab >>Exploring the relative risks among insecticides
(English)Manuscript (preprint) (Other academic)
National Category
Environmental Sciences
Identifiers
urn:nbn:se:su:diva-225057 (URN)
Available from: 2024-01-07 Created: 2024-01-07 Last updated: 2024-01-07

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