Metals and Inorganics Sectoral Approach (MISA)

MISA was planned in 2018 as a 3-year cooperative programme between ECHA and the metals industry with a double objective: address outstanding technical and scientific issues related to the chemicals assessment of metals and inorganics and in parallel, further improve the REACH registration dossiers . It was decided end 2020 to extend this programme by a year as key discussions were still ongoing, e.g., on the assessment of inorganic UVCBs.

MISA fits with ECHA's Integrated Regulatory Strategy (IRS) and the 2020 SAICM objectives. ECHA’sl – IRS aims at accelerating data generation, identification of groups of substances of concern, and progressing on regulatory risk management . It applies to all tonnage bands.

MISA was designed as a voluntary programme that participating metals and inorganics consortia & associations endorsed by signing a "Framework for Cooperation" which contained a MISA general rolling action plan, covering the period 2018-2021. The programme aimed at covering as many metal compounds and inorganics as possible.

MISA’s action plan focused on two equally important parallel tracks:

Track 1: a gradual and planned improvement of the compliance, quality and understanding of the metals/inorganics registration dossiers
Track 2: addressing outstanding technical and methodological issues that allow to improve the relevance of hazard, risk assessment and risk management of metals and inorganics.

MISA started by defining the baseline situation using surveys run in 2017 within the sector to obtain an overview of the situation for a number of registration dossiers for metals, metal compounds and inorganics. Findings were compiled in Baseline Reports. This was followed by the definition of common priorities for chemicals management’s progress on Track 1 and Track 2. These priorities were reported and communicated in a general rolling action plan with proposed actions and deliverables (e.g., thematic workshops, guidance update). The general rolling action plan has been reviewed and updated on a regular basis and communicated.

Where individual consortia & associations identified the need to improve the quality of their REACH registration dossiers (e.g., after a thematic workshop), they integrated the planning and progress made with these actions in consortia (MISA) & associations workplans submitted to ECHA with the appropriate priority.

A monitoring and review of progress made with MISA was carried out at sectoral level and included recommendations for further review of priorities/actions.

Both ECHA and Eurometaux displayed information on the MISA program on their respective websites, including a possibility for metals/inorganics not covered by MISA to get information/be involved in the programme. ECHA’s website also includes a list of participating metals/consortia.

What did MISA bring to the participants?

Participants benefited from sharing knowledge and practical guidance on issues specific to metals and inorganics, like for instance hazard identification and classification, reporting and assessment of UVCBs and exposure assessment.

Joining increased the possibilities for data sharing and supported cost effective improvement of registration dossiers. MISA also allowed to further build on the resources that industry has invested on during the 10 years ofREACH registration, making the best use of the REACH data, by improving, valorising and using these.

What does MISA expect from participants?

Participating consortia & associations, ECHA & Eurometaux co-signed a ‘Framework for Cooperation’, which implied some commitments for the period 2018-2021.

By signing up to MISA, consortia & associations committed to implement an improvement strategy based on collective priorities. The priorities as well as the supportive tools were defined in the MISA general rolling action plan. Participants were expected to participate actively in the different thematic workshops, and to prepare the discussions by running self-assessment tools (i.e., questionnaires) ahead of the workshops ECHA supported the MISA activities by participating in thematic workshops on priorities, providing examples and commenting on deliverables. The reports of the workshops, which included specific recommendations were used by the participants to identify the improvements needed in their REACH files and design a workplan.

Industry participants also agreed to an open communication on the goals, priorities and progress made with the MISA general programme. The bilateral communication with ECHA (e.g., on workplans, difficulties to meet update deadlines) was set up via a specific MISA mailbox. ECHA did set up a regular follow-up of the work plans/updates by doing some checks and reporting the outcomes to the different consortia.

It was also clearly communicated that while MISA encouraged a priority-based continuous improvement of chemicals management, it was not a substitute for the compliance with legal REACH obligations and for related regulatory action.However, it was expected that MISA would reduce the need for such regulatory action by the means of an increased availability of improved information concerning chemicals and risk management handling, as well as by resolving outstanding technical issues.

After the end of the programme, ECHA published a report summarising the key outcomes of the program (include link)

The first MISA thematic workshop took place on 02 October 2018 (in Brussels) and focused on information requirements for human health, adaptations, waiving, read-across and weight-of-evidence.

The second MISA workshop took place on 07 February 2019 (in Helsinki) and focused on environmental information requirements.

The third MISA workshop took place on 05 November 2019 (in Brussels) and focused on UVCBs registration.

The fourth MISA workshop's aim was to improve the quality/reliability of the exposure data in the registration dossiers, measured and modelled for human health, environment at local and regional levels.

Due to the Covid-19 crisis and the workshop's postponement (initially planned for April 2020), this fourth MISA workshop on Exposure was held in 4 separate webinars in 2020-2021.

Webinar 1 - Life cycle Tree took place on 23 October 2020

Webinar 2 - Workplace exposure took place on 23 November 2020

Webinar 3 - Environmental exposure took place on 26-27 January 2021

Webinar 4 - Consumer exposure and humans exposed via the environment exposure took place on 07 May 2021

All these workshops/webinars were based on the data collected from the Self-Assessment Tools on Exposure that were circulated to members ahead of the workshop/webinars.

Available documents and useful links:

Metals and Inorganics Sectoral Approach (MISA) rolling action plan

MISA updated rolling action plan

Framework for Cooperation

List of substances (updated November 2019)

https://echa.europa.eu/-/echa-and-eurometaux-agree-on-framework-for-cooperation

Executive Summaries of MISA Workshops:

MISA Priority Setting Workshop (January 2018)

MISA Workshop on Priority 1: "How to improve REACH registration dossiers on Human Health information requirements" (October 2018)

MISA Workshop on Priority 2: "How to improve REACH registration dossiers on Environmental info requirements" (February 2019)

MISA Workshop on Priority 3: "UVCBs"

MISA Workshop on Priority 4: "Exposure":