Some reflections on dealing with substance classifications

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Having done a few substance classifications (CLP), I get a few questions about the Commission and the Member States view the process. I have pulled together my notes and put down how the Commission and most Member States see the process.

I think it is key to understand how the people informing and making decisions see things. After all, if people saw things from your perspective, it is unlikely your substance would be looked at.

I have tidied up my scribbles below as a checklist.

  1. You need to provide your science when the RAC is considering the file.
  2. If you provide science after the RAC has given an opinion, the best way to re-open the file is to get a Member State to submit a new classification. There are a limited number of cases where the ECHA Executive Director re-open the file (see link).
  3. Officials (Commission and Member State) are reluctant to second guess the RAC.
  4. Officials don’t like engaging on chemical substance; they are considered too sensitive.
  5. The final outcome of the RAC will most of the most be co-opted in the ATP update.
  6. Harmonised classification under CLP is about hazard classification. Risk management is not an issue.
  7. The RAC’s view is seen as more thorough than industry’s self-classification.
  8. The main first-order consequence of classification is common labelling and packaging.
  9. This help provide information to the users when using the substance
  10. There  may be second-order impacts when classification triggers risk management in other legislation
  11. You can see the list of substances classified in Annex VI (link).
  12. The Commission considers they have a legal requirement to automatically transcribe the new opinions into the Annex; they contend they have no discretion. They follow this in most cases.
  13. The Commission and the Member States will consider constructive suggestions to effectively translate the RAC opinion to Annex VI
  14. The RAC does not rubber-stamp Member State classification dossiers.
  15. ECHA transmits a consolidated list of RAC opinions at the start of the year. It’s in the same format as the ATP.
  16. The Commission discusses the draft adaptation to technical and scientific progress (ATP) with the expert group – CARACAL.
  17. The Commission then develop the draft legal text.
  18. The Commission consults with the WTO.
  19. After the feedback, the Commission adopts the delegated act.
  20. If you review the notes, you will see some moves to make the classification more operational.
  21. Member States sometimes use the classification process as a means to get more information about a substance.
  22. Even if other legislation may address any identified risks, the Commission and most Member States believe that the CLP is the appropriate regulatory instrument.
  23. Socio-economic factors are seen as non-issues.
  24. The Commission does not consider there is the need for an automatic impact assessment for a classification.
  25. Some in the Commission question the need for a Better Regulation public consultation for a  CLP update (rerun of ECHA consultation) (link)
  26. Second-order impacts can only be considered under other pieces of legislation.
  27. The Commission may, from time to time, undertake an assessment of the impacts of a classification.
  28. A category 2 classification has limited if any direct impacts.
  29. Some legislation permits the use of category 2 granting of authorisation, exemption, demonstration of safe use.
  30. Ongoing procedures like substance evaluation do not detract from going ahead with the ATP listing.
  31. Some Member States use the CLP as a gateway to regulatory follow-up action.

A few personal observations:

  1. The key window of opportunity is the deliberations of the RAC and their final opinion.
  2. The best way to engage is with a significant and long-established body of world-class science on all substance endpoints.  As a rule of thumb, I take ten years as the minimum level.
  3. Coming in late or not at all is unlikely going to work out well.
  4. Saying you are right and the RAC is wrong are pleases that to fall on deaf ears.
  5. The burden of bringing new science to the table to re-open a RAC opinion is very high.