If your substance is put forward for classification or re-classification under the CLH, you need to expect that the proposal is going to be adopted.
From 2020 to 2018 the RAC has considered the classification proposals for 131 substances.
Most of the time, they agreed with the dossier submitter and backed a classification.
In 3 cases, the RAC backed no classification, contrary to the proposal from the dossier submitter.
In 3 cases, the RAC supported removing an existing classification.
And, in one case, the RAC rejected a modification of an existing classification.
So, you have around a 2% chance of beating a classification proposal.
If you want to dig deeper, you should look at the 15th ATP (link).
The dossier submitter’s proposal is going to be accepted or tightened in 93% of cases. Most of the time (70%), the RAC agrees with the dossier submitter, and in 23% of the time, the RAC take a tougher position.
In 7% of cases, the RAC took a more lenient approach than that put forward by the dossier submitter.
When the RAC deviates from the dossier submitter it is on specific endpoints.
In 1 case, the Commission took a slightly different view than the RAC. Otherwise, 99% of the time, the Commission cut and paste the RAC’s opinion.
So, if you face a proposed new classification, you need to expect that it is going to happen. If you dislike the proposal, the chances of stopping it are low.
Reading the RAC’s Minutes
The RAC’s minutes are clear and comprehensive. And, just as you would study the minutes of a Council or Committee debate, it is useful to study the minutes of the RAC.
You’ll see that that they reject many of the endpoints put forward by the dossier submitter.
New issues are raised during the public consultation that are taken up. The feedback provided in the public consultation can lead the Rapporteur to revise their opinion.
Relevant science can be presented late in the day that leads the RAC to re-classify.
Important changes happen from when the proposed dossier submits and the endpoints the RAC agree to.
The cases when the classification proposal was rejected or removed, a considerable body of science was brought to the table.