Some further reflections on dealing with substance classifications

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I wanted to provide an update to the post of 20 November.

It’s important to understand and then mirror the thinking of the decision-makers. Ignoring their world view may be purifying,  but it is going to make winning your case harder.

Points 32-44 are new, as are personal observations  6 and 7.  The personal observations are mine,. The rest is mainstream thinking of the vast majority of the Commission and Government officials.

 

 

 

 

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.
  32. Just because a substance appears in nature does not mean it is safe.  Many natural substances are toxic and can cause cancer.
  33. The UN’s GHS system does not mention any substance. All it does is lay out the criteria that are used for classifying substances. Global classification can happen by way of the WHO’s IARC.
  34. The EU does not cut and paste IARC’s classification. There are no automatic consequences in Europe. In to other regions, like California, there is.
  35. Our understanding of the hazardous properties of a substance evolves over time. Just because a substance has been used for a long time does not mean that the classification can’t change.
  36. The labelling requirement helps protect the health and safety of workers throughout the supply chain.
  37. Other than transposal in the ATP, there is no need to consider other options.
  38. Dealing with substances by way of OELs for workers protection would not cover individual consumers or the self-employed.
  39. CLP gives information on hazardous properties of substances and on basic safety measures to be taken (e.g. wear gloves), while other pieces of legislation (e.g., REACH, OSH) provide more detailed risk management measures to deal with specific hazard properties identified under CLP.
  40. An impact assessment on each and every substance would be difficult to perform. The current system is not set up for it. It is unlikely if industry has the data to support this exercise
  41. Reducing rates of cancer has a positive economic impact. It can’t be ignored.
  42. There are significant downstream impacts for classification carcinogen category 1 (known or presumed carcinogen), but for carcinogens category 2 (suspected human carcinogens), there are no such significant direct consequences.
  43. For some legislation,  category 2  carcinogen (suspected human carcinogens) the legislation (e.g. plant protection products, biocidal products, food additives, contaminants, water and pharmaceuticals), there are no or minor consequences.
  44. For other another group of legislation (food contact materials, plastic food contact materials, toys, feed additives, cosmetics and EU Ecolabel),  category 2 means you need the granting of authorisation, exemption, and the demonstration of safe use.

 

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.
  6. Civil servants and politicians are reluctant to engage on chemicals.
  7. They are more reluctant to engage if ‘cancer’ is mentioned.