1. The Concept and Application of RMOAs (Risk Management Option Analyses)
NI China Chemical Regulatory Workshop
Kai-Sebastian Melzer
17 September 2019

2. Introduction: EU-REACH

3. Introduction REACH: R(egistration) E(valuation)
A(uthorisation + Restriction) of
CH(emicals)
In addition: REACH is a piece of legislation that overarches other chemicals management legislation of the EU  need for coordination and ensuring consistency

4. Objective of Registration of substances in EU
REACH Recital 19: “[t]he registration provisions should require manufacturers and importers to generate data on the substances they manufacture or import, to use these data to assess the risks related to these substances and to develop and recommend appropriate risk management measures. To ensure that they actually meet these obligations, as well as for transparency reasons, registration should require them to submit a dossier containing all this information to the Agency. Registered substances should be allowed to circulate on the internal market.” (emphasis added)

5. Objective of Evaluation in EU-REACH
REACH Recital 20: “[t]he evaluation provisions should provide for follow-up to registration by allowing for checks on whether registrations are in compliance with the requirements of this Regulation and if necessary by allowing for generation of more information on the properties of substances. […]” (emphasis added)

6. (Regulatory) Risk Management under REACH
Regulatory Risk Management Options under REACH:
Authorisation and
Restriction
Always to be kept in mind: Regulatory risk management is most effective, if targeted at where risk management by private stakeholders is not sufficient

7. RMOAs: The means to put REACH Risk Management Options into context

8. REACH Authorisation and Restriction in a Nutshell
Not limited to SVHCs
First, a risk needs to be identified that meets two conditions:
Unacceptable
Community-wide (= relevant for the whole EU)
Restriction can be adopted and targets the above risk  this gives flexibility:
It can be very strict (e.g. ban)
Or it can be targeted (e.g. the specific use of a substance)
Authorisation:
Limited to substances of very high concern (SVHCs)
First, the substance needs to be identified as SVHC (Candidate Listing)
Then, in a separate step, it needs to be included in the list of substances for authorization
 No use of the substance, unless an authorization has been granted for the individual use and user
Strict but targeted restrictions are normally preferred by industry over sweeping authorization requirements, which trigger considerable administrative workload and uncertainty

9. The early days of REACH Authorisation
Background: Article 57 of REACH establishes which hazards may qualify a substance for identification as Substance of Very High Concern (SVHC). The hazards are:
Category 1A or 1B (not Cat. 2) Carcinogens
Category 1A or 1B (not Cat. 2) Mutagens
Category 1A or 1B (not Cat. 2) Reprotoxicants
PBTs (persistent, bioaccumulative + toxic)
vPvBs (very persistent + very bioaccumulative)
Hazards, which give rise to “an equivalent level of concern” to the above
CMRs
Early days: Presumption that all substances with the above hazards should be identified as SVHCs and then subjected to Authorisation

10. Perspective by many stakeholders in industry
Authorisation is applied in a sweeping fashion and cannot be easily targeted at specific uses of a substance that raise concerns  can be disproportionate to the identified concern
Authorisation is time and resource consuming for industry and administritavely heavy for the regulator (applications for specific uses and ideally separately by users or small groups of companies using the substance in a very similar fashion)
The identification of the substance as such stigmatizes the substance, even when it makes important contributions to society, including to environmental objectives
The EU REACH authorities may – without realizing – negatively impact other EU policies

11. Learnings since the early days of REACH (1)
Not all substances with the hazards described in Article 57 need to be identified as SVHCs
Why is that?
REACH grants discretion:
Article 57: substances with the listed properties may be identified as SVHCs
Article 59: specific decision-making is required for identification of an SVHC (no automatic legislative process triggered by CMR 1A or 1B classification)
Note: Some EU REACH authorities share this analysis, others tend to lean to the interpretation of the early days of REACH
EU’s SVHC Roadmap: Only “relevant” SVHCs should identified as SVHCs and then potentially be subjected to authorization

12. Learnings since the early days of REACH (2)
Where there is discretion the EU’s proportionality principle needs to be observed by authorities applying EU law
Regulatory risk management needs to address identified risks
Where, taking into account existing risk management measures, no risk can be identified, no regulatory action is required
Where there is an identified risk, all regulatory risk management options offered by EU legislation (not only EU REACH) need to be considered
After identification of a risk, authorities are required to identify the most proportionate risk management option available in the EU
In doing so, they should take into account the benefits society draws from uses of the substance
A tool to ensure the above is needed. This tool is the RMOA.

13. Tool to identify the most proportionate risk management option
Risk Management Option Analysis (RMOA):
This tool is not explicitly foreseen by EU REACH
Study on behalf of the European Defence Agency (EDA): The conduct of RMOAs can be deemed to be required by the EU’s proportionality principle
Conduct of RMOAs:
Guidance on how to conduct RMOAs is limited
EU Member States and ECHA may conduct RMOAs:
In the absence of Guidance, each authority conducts the assessment in a different way
 Outcome may depend more on the authority conducting the assessment than on consistent criteria and approaches
Nevertheless, the conduct of RMOAs is a leap forward in proportionate application of EU legislation on chemicals management

14. Integration of the different REACH processes + Integration with other chemical mgmt legislation (1)
Scheme designed by ECHA. Available on

15. Integration of the different REACH processes + Integration with other chemical mgmt legislation (2)
Step 1:
Scheme designed by ECHA. Available on

16. Integration of the different REACH processes + Integration with other chemical mgmt legislation (3)
Step 2:
Scheme designed by ECHA. Available on

17. Integration of the different REACH processes + Integration with other chemical mgmt legislation (4)
Step 3:
Scheme designed by ECHA. Available on

18. Integration of the different REACH processes + Integration with other chemical mgmt legislation (5)
Step 4:
= Regulatory Risk Management under REACH
= Classification under CLP (EU implementation of GHS)
= Regulatory Risk Management under other EU legislation
= No need for regulatory Action
Scheme designed by ECHA. Available on

19. Hazard profile of the substance
Elements considered in EU RMOAs (1/2) (Based on RMOA template of October 2015)
Regulatory measures that are already applied to (envisaged for) the substance
Hazard profile of the substance
Tonnage
Different uses (e.g. intermediate uses, uses at industrial sites, uses by professional workers, consumer uses, article service life)

20. Elements considered in EU RMOAs (2/2) (Based on RMOA template of October 2015)
Additional information (optional, but crucial from industry perspective):
Emission, exposure and/or risk(s) per use
Information on alternatives, including on R&D
Preliminary socio-economic considerations, if possible
Any other information which facilitates understanding (e.g. information on hazard or risk assessments in EU, OECD or other fora)
Missing information / uncertainties, where relevant

21. Conclusions of RMOAs (Based on RMOA template of October 2015)
Need for (further) risk management:
Description of the concern(s) which trigger(s) the consideration of further risk management + objectives for further risk management
Identification and assessment of Risk Management Options (RMOs)
List of potential RMOs and/or combination thereof
Justify conclusion

22. Relevance beyond the EU
The SVHC concept is considered in many jurisdictions
Of great importance to look into the application of the SVHC concept in the EU and apply learning lessons
The RMOA tool is extremely helpful in regulating effectively
In each jurisdiction, there are a number of different legislative tools to address chemicals management
RMOAs can help promote the use of synergies between different pieces of regulatory tools for chemicals management
Guidance on how to conduct RMOAs and what to consider in RMOAs should be developed
The SVHC concept should always be considered jointly with the RMOA tool

23. The Nickel Institute’s experience with RMOAs

24. Nickel Institute experience with conduct of RMOAs – French RMOAs
France selected a group of nickel compounds for the conduct of RMOAs
It selected two Ni compounds as representative for the other Ni compounds (based on hazard and use profiles)
Gathering of input from relevant sectors (including site visits)
Yes
Hazard?
(potential SVHC)
At workplace in some Contributing Exposure Scenarios (e.g. cleaning)
Risk? If so, where?
Options in two pieces of legislation
Identifi-cation of RMO options …
Important for socio-economic analysis and selection of RMO
Use-specific Analysis of alter-natives
Important for conclusion
Use-specific Socio-economic analysis
Selection of most targeted RMO outside REACH
Assess-ment of effective-ness of RMOs …

25. Nickel compounds and their uses
Examples of uses: Batteries and catalysts (essential for achieving low carbon policy objectives)
Ni sulphate and Ni oxide are representative for the other inorganic Ni compounds in terms of …
Hazard profiles and
Use profiles

26. Nickel Institute experience with conduct of RMOAs – German-Hungarian RMOAs
Two Ni compounds had not been included in the French grouping  Germany and Hungary conducted RMOAs
Differences:
Only one use (one sector)
Based on learnings from French RMOA, industry had improved the data-set on real exposure  For this use, only residual risk, if any
Public consultation and one follow-up meeting with contributors
Based on the above no regulatory action appeared necessary. In light of other uses of Ni compounds, Germany and Hungary supported the French general conclusion for Ni compounds, i.e. to adopt an Occupational Exposure Limit Value (OEL) under Workplace legislation

28. Follow-up after the RMOAs
Workplace authorities, with the support of REACH authorities, have started to put the Occupational Exposure Limit Value (OELV) in place
An outdated recommendation for an appropriate OELV was updated
Socio-economic assessment has been prepared
Member States, Trade Unions and Employer representatives have adopted an OEL-recommendation by consensus
The legislative process is expected to be started in 2020
Current expectation by NI: Compliance with future OELs will be costly, but overall achievable and proportionate.

29. RMOA-like considerations outside the EU

30. Discussions at OECD
Membership of the Organisation for Economic Co-operation and Development:

31. OECD debate on processes like RMOAs
Questions explored at an OECD workshop in January 2019:
What are the existing regulatory options and how to choose the best risk management approach?
What are the elements necessary to take a decision?
Can effective contributions from industry enable a deeper analysis at an early stage of the regulatory process?

32. Industry Observations at the OECD Workshop
Authorities have an interest in keeping systems like RMOAs manageable
Industry has an interest in a broad scope and some depth of analysis in RMOAs
Industry can facilitate the conduct of RMOAs with relevant information
Challenges for industry:
It needs to be ensured that information will be considered
The information needed has to be predictable
When the information is available and used, the process becomes more effective. Regulatory objectives are achieved in most proportionate manner

33. Conclusion

34. Conclusion The development of RMOA-like approaches is encouraged:
It enables targeted and effective regulation
It also enables an integration between different national pieces of legislation and is a basis for cooperation between different authorities
Industry would benefit from more Guidance so as to contribute effectively to RMOAs

35. Kai-Sebastian Melzer Senior Regulatory Affairs Manager