FPR 2019/1009 Annex II CMC 2 contains the below legal requirement:
CMC 2: PLANTS, PLANT PARTS OR PLANT EXTRACTS
An EU fertilising product may contain plants, plant parts or plant extracts having undergone no processing other than cutting, grinding, milling, sieving, sifting, centrifugation, pressing, drying, frost treatment, freeze-drying, extraction with water, supercritical CO2 extraction, or fiberisation at a temperature not higher than 100 °C and without any additives except water.
For the purpose of this point, plants include mushrooms and algae and exclude blue-green algae (cyanobacteria).
This is a so called limiting article. Only the explicit processes under this article are allowed. Extraction with other additives such as KOH do not fall under CMC 2.
Fermentation is not covered by CMC 2, thus it is not allowed. Of course simple treatment with water for a longer duration of time may be allowed under CMC 2, and you can soak/treat in water several times.
The addition of additives such as yeast will not be covered by CMC 2. And because the nature of the chemical substance will change the new substance will be chemically modified and fall under the requirements of CMC 1.
For CMC 2 you must supply the Notified Body with a production flowchart of the CMC 2 substance showing that it was subject to just the steps of the above description.
Drying is allowed under CMC 2, and there is no temperature limitation.
Heat treatment is not allowed under CMC 2.
However plants, plant parts or plant extracts that undergo some types of heat/steaam treatment may be allowed to fall under CMC 1 and be exempted from REACH, creating a possible workaround. Contact us to learn more.
EFCI Register has raised this topic within the EU Coordination Group for Notified Bodies to clarify the discussion between drying and heating. This page will soon be updated to accurately reflect the difference. Interested? Email us and we will inform you right away.
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