A flight plan for a REACH Restriction

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A flight plan for a REACH  Restriction

Poland tabled a proposal to restrict methanol in windscreen washing fluid. There was a spate of people drinking the windscreen washing fluid thinking it contained alcohol. They were poisoned.

Observations

Putting forward a REACH Restriction is a time-consuming and resource-intensive process. It’s obviously not embarked on lightly

There are time limits for the ECHA stage, but slippage seems a constant during the  Commission’s adoption.

After the submission,  the review by  RAC and SEAC raised important questions that led to revisions. A group of SEAC members appeared at best circumspect about the merits of the submission. China raised reservations during the WTO consultation.

The REACH Committee was divided. 19 voted in favour, 8 against, and there was  1 abstention. Despite this, there was no challenge by the Council or the European Parliament.

 

 

A Case Study: Methanol REACH Restriction

Procedure: RPS

  1. 2012: Poland starts work on Substance Evaluation
  2. 17 September 2015: Poland Substance Evaluation Report on Methanol concluded, recommends restriction
  3. 19 December 2013: Notification by Poland to ECHA of intention to submit a Restriction  proposal
  4. 1 August 2014: Poland submits a dossier to ECHA
  5. Conformity check by ECHA
  6. ECHA notify Poland that the dossier is not in compliance with an Annex XV dossier
  7. Poland notification of intention to re-submit
  8. 16 January 2015: Poland re-submit dossier to ECHA (link)
  9. Start Scrutiny by ECHA Committees
  10. 18 March 2015: ECHA launches public consultation on the proposal (6 months – ends 18 September 2015)
  11. 17  September 2015: ECHA public consultation deadline ends
  12. 12-13 November 2015: CARACAL updated on progress
  13. 4 December 2015: SEAC draft opinion adopted
  14. 4 December 2015: RAC Opinion adopted
  15. 9 December 2015: Press release of the adoption of the RAC Opinion
  16. 9 December 2015: SEAC draft opinion launch for public consultation
  17. 9 February 2016: Deadline for public consultation on SEAC draft opinion
  18. ECHA transmit opinions to Commission
  19. Commission prepare an amendment to restrict methanol
  20. 8-9 March 2016: CARACAL members receive an update on restriction
  21. 29 June – 1 July 2016: CARACAL members receive an update on restriction
  22. 7 October 2016: Commission notifies WTO of draft restriction
  23. 5 December 2016: Deadline for WTO consultation closes. China makes submissions.
  24. 16 February 2017: REACH Committee exchange of views on the revised proposal
  25. 24-26 October 2017: REACH Committee (Member State Committee) adopts draft measure (19 in favour, 8 against, 1 abstention) (link to voting results)
  26. File transmitted to European Parliament and Council
  27. 14 December 2017: Council working group raises no objections
  28. 10 January 2018: COREPER raise no objections
  29. 23 January 2018: Council (Economic and Financial Affairs Council) raise no objection
  30. 10 February 2018: Deadline for objections – No objections raised
  31. 18 April 2018: Restriction published in Official Journal (link)
  32. 9 May 2018: Restriction enters into force

 

Process Charts

ECHA’s process chart is good. You can find it here and below.

 

Or there is a less colorful version.

 

Blue is the political scrutiny phase.

 

Lessons Learned
There are many opportunities to make your case in the REACH Restriction process. Here are some personal observations dealing with the REACH Restriction process.
  1.  You usually have a lot of pre-warning that something is in the works. This gives you the time to prepare a robust technical and scientific case for when the proposal comes.
  2. You should go and speak with the Member State who is looking into your substance. The smart play is to assist that Member State find the answer to the questions they are after.  After all, they have the real power in this process.
  3.  If you stall and take other steps to infuriate them, you can’t be surprised when they scratch back. Pissing a government off is never a smart play in the short, medium or long term. Pissing them off when they have a lot of flexibility is plain silly.  So, don’t do it.
  4. Work with the country to solve the perceived problem. If they think you need tighter product or workplace emission standards, do everything you can to get those measures in place.
  5.  Make sure that your dossier and safety sheet is in order. Fix any gaps. If the consortium does not want to spend another 15 euro to make things better you have only yourselves to blame.
  6. Make sure that you have a world-class submission ready to go. I’ve found peer review from hell from an objective and independent third party well experienced in the particular regulatory process helpful. It will only strengthen your case, and allow any weak points to be improved or removed outside the public glare.
  7. Ideally you’ll  do this  before the actual drafting of the proposal starts and the latest before the scrutiny by ECHA starts’. The later you bring in new evidence the bigger the chance it will be omitted. If you generate new evidence during the process, it has to be world class and ground breaking if you want to be it considered. Calling to stop the process because new studies are ongoing and one must wait for new data to be available, has never worked.
  8. In practice, your best defense is to have a long term science programme independently looking at each and any problem that may be there. This allows you to have the best and most up to date evidence ready when governments come knocking to look into your substance.
  9. Turn up to the many chances you have to make your case. And, when you do so, try some humility. People tend to like likeable people.
  10. Have your case written down in different versions for the technical, scientific, and political audiences you are going to deal with. Using the same script for all audiences does not work.
  11. Some windows of opportunity are more useful than others. The Public Consultation, attending RAC/SEAC, speaking with Member States for CARACAL, and the Commission are the best. The real key is making an early and  strong written submission in the pubic consultations.
  12. The public consultation has 2 deadlines: the first one typically ends 1-2 months after the launch of the consultation. It’s not a hard deadline, but any info you want to be considered by RAC from the beginning, this is when your evidence must be submitted. If you only submit info by the end of the 6-month deadline you risk that RAC has already taking a decision on some parts like the hazard assessment and it’s very hard to reopen discussions.
  13. Most decisions are taken by written procedure, so people need to rely on strong written submissions that make the point clearly and with real and robust evidence. Statements of faith without strong data and evidence are pointless for CLP and REACH processes.
  14.  I am circumspect that the WTO notification process offers any real chance of changing direction. A lot of people will disagree with me. I’ve just never seen it work and that’s a view those closer to the files confirm.  Personally, I’ve seen objections from the USA, China and India hardens support for a proposal both for regulatory and ordinary legislative proposals.
  15. After the technical adoption, there is limited leeway inside the Commission. On Restrictions, the Commission is more prone to exercise their discretion, than say for classifications.
  16. Their margin of maneuver is greater around procedural errors.
  17. Officials in the Commission and Member States are loathed to second guess designated scientific experts (RAC) on chemical issues. It makes them very nervous.
  18. The REACH Committee seems to always back the Commission. Sometimes there are small groups of Member States who vote against the proposals for various reasons (too weak a proposal or too strong) but not enough to risk the Commission’s proposal not being carried.
  19. When the draft proposal is sent to the Council and EP for scrutiny (because Restrictions are RPS measures), there is a limited window to have things changed. The challenge is likely to come from the EP. This has happened and because it is a RPS measure, the measure falls.
  20.  If you want to reach out to the Member States or the EP, it helps to have existing relationships, be trusted, and have a compelling technical, scientific and public policy case to support you. Highlighting the bigger picture helps. The chances of success are nearly theoretical for industry backed challenges. None have succeeded.
  21. If you opt for a style of sending passive aggressive letters to officials and politicians, don’t be surprised when they lead to support for the proposal increasing.
  22. The best way forward is to make sure the conditions that lead to governments/Commission wanting to start work on a Restriction don’t happen. Once they start, it is hard to get out.