- Legal basis
- Commission Regulation (EU) 2018/1481 of 4 October 2018 deleted E311 from Annex II to Regulation (EC) No 1333/2008. This regulation is assimilated into UK law and applies in Great Britain. E311 is not listed on the UK FSA approved additives and E numbers list.
- Maximum levels
- No longer permitted. Previously authorised in fats, oils and certain fat-containing food categories.
- Safe-intake limit (ADI)
- No current ADI. The SCF originally established a group ADI of 0-0.2 mg/kg body weight per day for propyl, octyl and dodecyl gallates combined, on the basis of assumed similar biotransformation. JECFA subsequently set a separate temporary ADI of 0-0.1 mg/kg bw for octyl gallate individually. In its 2014 re-evaluation of propyl gallate (E310), the EFSA ANS Panel formally concluded there was no longer a scientific basis for the group ADI and recommended its withdrawal, citing insufficient data to support read-across between the three gallate compounds. With E311 removed from the authorised list in 2018 due to missing toxicological data, no ADI for octyl gallate is maintained by EFSA.
- History
- Octyl gallate was authorised in the EU under Regulation (EC) No 1333/2008 along with propyl gallate (E310) and dodecyl gallate (E312) as a group. A re-evaluation programme for all food additives approved before 2009 required manufacturers to submit updated toxicological dossiers. For E311 and E312, no adequate data were submitted. Commission Regulation (EU) 2018/1481 (4 October 2018) deleted both from the authorised list. Products containing E311 that had been lawfully placed on the market before that date could be sold through until 25 April 2019. E310 (propyl gallate) remained authorised. The UK assimilated this regulation on EU exit and the restriction remains in force.