Formpak Active

Estragol and Methyl Eugenol

Important changes in classification of Methyl Eugenol, Estragol and other ingredients were included in the IFRA /IOFI Labelling Manual 2009, as follows:

• Estragol changes from R22 to R22-40-43-68
• Methyl Eugenol changes from R22 to R22-40-68

This impacts the classification of several essential common oils including Aniseed, Bay, Basil, Fennel and Pine Oil Yarmor.  There are some tricky issues surrounding the R phrase R68.

R68 Complications

The EC regulations about R68 have some complications. R68 can actually mean two entirely different hazards, and in addition these hazards have different general concentration limits. Formpak distinguishes these different hazards by giving these different risk phrases. So:-

• R68 in various combinations with risk phrases R20, R21 and R22 e.g. R68/20/22 is for substances with a possible risk of irreversible effects. These have general concentration limit 10%. In Formpak these are entered with their regular risk phrase e.g. Camphor would have risk phrase “R68/22”.
• R68 on its own is for mutagenic category 3 substances, which have a general concentration limit of 1%. In Formpak these are entered with risk phrase “R68M” to distinguish that they are mutagenic category 3 e.g. Estragol would have risk phrase “R68M”.

When you update the classifications of Estragol and Methyl Eugenol on your Formpak system, it is essential you use the R phrase R68M and not just R68 so that the correct concentration limits are used in the hazard calculations.

If you have any questions or comments please let us know.