RMMOA

ELiSANA is conducting Risk Management Measures Options Analysis (RMMOA) on four phenolic benzotriazoles

The aim of this project

Collect robust scientific data to support regulatory actions that accurately reflect true environmental risks

Identify current and potential risk mitigation measures (RMM) used during the manufacture of products containing UV-light stabilisers

Background

2022: RMOA (Risk Management Option Analysis) from the German Competent Authority
2022: ECHA’s PBT EG (Persistent, Bioaccumulative and Toxic Expert Group) assessment
2023: SVHC (Substances of Very High Concern) nomination of UV-326 and UV-329 and their inclusion in the Candidate List)
2024: CLH intention on UV-P, now classified as Toxic (Aquatic Acute toxicity category 1, M=10)
2024: Assessment of Regulatory Needs (ARN) for Hydroxyphenyl Benzotriazoles. This has indicated a range of further actions for UV-light stabilisers, including compliance checks, and the potential for a REACH restriction. Justifications for the need for a REACH restriction include:
- Releases to the environment from consumer and widespread professional uses cannot be avoided.
- Widespread professional uses are typically non-contained and non-automated leading to releases to the environment. The aim of the RMMOA launched by ELiSANA is to provide important data to competent authorities in case a restriction on these substances is initiated.

ELiSANA has already provided ECHA with comprehensive scientific data on the known environmental effects of UV-326, UV-329 and UV-P through three public consultations over the last three years.

At this stage of the process, no Restriction process has been initiated. However, based on the findings of the ARN, ELiSANA cannot exclude the possibility that measures may be introduced to contain emissions resulting from the use of these four substances: UV-326, UV-329, UV-234 and UV-P. Further efforts are needed to demonstrate that these phenolic benzotriazoles are already successfully managed under the Regulations in place and to confirm on the best alternative Regulatory Management Measure Option.

What is an RMMOA?

A Regulatory Management Measures Options Analysis (RMMOA) is an assessment (case-by-case analysis) of regulatory needs concerning one or more substances. The purpose of an RMMOA is to help authorities decide whether further regulatory risk management activities are required for a substance and to identify the most appropriate instrument to address a concern. An RMMOA can conclude that regulatory risk management at EU level is required for a substance (e.g. in the context of harmonised classification and labelling, REACH restriction, other EU legislation) or that no regulatory action is required at EU level.

ELiSANA’s RMMOA

ELiSANA has decided to work with Ricardo to conduct an RMMOA on a selection of four phenolic benzotriazoles (see below). The RMMOA aims to ensure that ELiSANA and its stakeholders have an in-depth understanding of the RMMs that are employed to control emissions of the selected UV-light stabilisers from selected applications in the EU-27.

Scope & Goal

The focus of the RMMOA will be on a selection of four phenolic benzotriazoles, whose specific uses/ applications shall be looked at:

Chemicals in scope

UV-329 (CAS 3147-75-9; EC 221-573-5)
UV-326 (CAS 3896-11-5; EC 223-445-4)
UV-234 (CAS 70321-86-7; EC 274-570-6)
UV-P (CAS 2440-22-4; EC 219-470-5)

Phenolics benzotriazoles general structure (1)

Sectors in scope

1. Renewable energy
2. Building and construction
3. Electronics
4. Coatings, paints and inks
5. Adhesives and sealants
6. Mobility and automotive
7. Textiles and fibres
8. Wire and cable
9. Production of alkyl derivatives
10. Packaging
11. Sports equipment

In scope: RMMs during the use of UV-light stabilisers in the manufacture of other goods.

Out of scope: Emissions from the manufacture of UV-light stabilisers; emissions from use of consumer goods.

Geographical scope

The assessment will focus on industrial and, where possible, professional uses of selected UV-light stabilisers in the EU-27.

WEBINAR: Stakeholder consultation for the ELiSANA Ricardo study on risk management measures and emission reductions for UV-326, UV-329, UV-234 and UV-P

A webinar explaining the project and how to fill in the questionnaire was held on 18th March 2025. You can find the recording below.

$

Download the presentation

Questions and Answers

How will the stakeholder consultation feedback be integrated into the final recommendations of the study?

The integration of feedback into the final recommendations of the study will involve a thorough review of all received input. Depending on the exact nature of the feedback, Ricardo will systematically evaluate and incorporate relevant suggestions. Although the final report may not explicitly present recommendations, any clear and actionable insights, such as implementing specific measures or adjusting certain approaches, will be carefully considered and reflected in the report. The primary focus will be to provide an estimation of emissions and outline strategies for their reduction moving forward.

How are you going to use the study?

The study, sponsored by ELiSANA, will primarily be utilised by ELiSANA and may also be made publicly available, ensuring broader access to the findings. Our intention is to leverage the study for advocacy purposes. Once management options are initiated, we will submit the RMMOA report to the relevant authorities and ECHA, as a record of the study’s depth and rigour. Furthermore, the study will serve as a future reference to illustrate the usage of these substances and provide a comprehensive overview of their applications.

How will stakeholder input be weighed against the findings of the literature review?

The stakeholder inputs and findings from the literature review will be assessed both independently and in combination. The literature review primarily examines the uses of the substances, and these insights will be integrated with stakeholder input. However, available data on emissions is limited, meaning that data related to emissions, baseline measures, and risk mitigation measures will rely primarily on stakeholder contributions. Given the scarcity of relevant literature, stakeholder feedback is crucial for providing a comprehensive analysis.

The findings on substance uses from the literature review will be combined with stakeholder input in a mapping exercise. Meanwhile, quantitative data and in-depth analysis of emissions will be predominantly drawn from stakeholder contributions. This underscores the importance of gathering as many responses as possible to ensure a robust and representative assessment of the sectors involved.

Are there plans to conduct follow-up consultations to keep stakeholders informed and to share the study results with stakeholders?

At this stage, there are no plans to conduct follow-up consultations. ELiSANA’s approach is to maintain continuous engagement with stakeholders, as we have been doing, by providing regular updates on developments related to the substances in question. Once a Restriction is initiated, there will be an open public consultation period during which stakeholders can submit their data, including any confidential information that falls outside the scope of the RMMOA study. We will ensure that stakeholders remain informed throughout this process.

Regarding the dissemination of study results, the final report may also be made publicly available, ensuring broader access to the findings.

Will this work have an impact on the REACH dossiers?

No significant impact on the REACH dossiers is anticipated. The existing information within the dossiers will remain unchanged. While we will assess the potential effects of any restrictions, the primary objective is for authorities to maintain an up-to-date overview of the uses, particularly those defined under REACH. If any registered substances contain outdated usage information, it is recommended to update the REACH records to ensure accuracy. This applies not only to the substances in scope for the study but also to other stabilisers and antioxidants. Keeping information up to date is crucial for authorities to rely on accurate data and avoid inefficiencies of working with outdated information.

When do you expect the European Commission to mandate ECHA to prepare a restriction dossier?

Currently, we have not received confirmation that this process will commence. However, we anticipate that the competent authority may initiate the process in the future. Our approach is to remain proactive and prepared for this possibility, even though no specific timeline has been established.

Is there any indication on what the Restriction may be? Would it be specific to certain uses, concentrations, etc.?

The potential Restrictions may be based on ECHA’s Assessments of Regulatory Needs. For this study, 41 light stabilisers have been grouped together. The available data primarily sourced from the REACH registration dossier. According to the information, releases to the environment from consumer and widespread professional uses cannot be fully prevented. Additionally, restricting professional uses is considered more efficient and effective than authorisation, as it allows for controls to be implemented at the market level rather than at the usage level. Industrial uses may also be included within the scope of the Restriction.

Furthermore, specific restrictions on the use of articles may be proposed due to potential exposure risks. The aim of this study is to provide supplementary data, as some information within the REACH Registration dossiers may be outdated. If you have registered any of these substances, it is advisable to ensure that all information is up to date, as this will contribute to an accurate assessment. Conducting this study is crucial to address any gaps in the existing data and help shape the direction of the restriction process.