In view of the fact that the European Food Safety Authority has not been able to confirm the safety of octile gallate (E 311) and dodecyl gallate (E 312) due to the lack of toxicological data, the European Commission has prohibiting the use of these substances in nineteen foodstuffs and in a category of food additives. Food containing the relevant additives placed on the market before 25 October 2018 may continue to be marketed until 25 April 2019.

IN DEPTH
The European Commission, with the EU Regulation of 4 October 2018 n. 1481, ordered the prohibition of the use of octile gallate (E 311) and dodecile gallate (E 312) in nineteen food products and in a category of food additives.

The Regulation in question, which enters into force on 25 October 2018, states that food containing the relevant additives placed on the market before that date may continue to be marketed until 25 April 2019.

Provisions envisaged by EU Regulation no. 2018/1481

In view of the fact that:

• the legislation regulating food additives requires that all additives authorized in the Union before 20 January 2009 must undergo a new risk assessment by the European Food Safety Authority;
• the food additives gallate of octyl (E 311) and dodecile gallate (E 312) have been authorized according to the relative technical specifications, as antioxidants in a variety of foods, as well as in food flavorings;
• in view of the new risk assessments carried out in May and October 2015, the European Food Safety Authority, in finding a lack of toxicological data on the additives in question, was not able to confirm the relative safety;
• the Commission, in May 2017, announced a call for tenders for the collection of scientific and technological data to support the Authority's needs, which gave a negative result in view of the fact that no commercial operator provided the requested data;
• in the absence of the data in question, the Authority can not complete the new safety assessment for octile gallate (E 311) and dodecile gallate (E 312) and consequently it is not possible to establish whether these substances:

-) do not pose safety problems for the health of consumers;
-) can reasonably be considered as a technical necessity which can not be replaced by other economically and technologically feasible means;
-) does not mislead consumers about their use;

the Commission, in the Community legislation governing:

• the production, marketing and use of food additives, ordered the cancellation of the reference of the octile gallate (E 311) and the dodecile gallate (E 312) in the list:

-) EU of food additives other than dyes and sweeteners authorized in foodstuffs;
-) definitions of additive groups - other additives that could be regulated in combination;
-) of authorized food additives and related conditions of use in the relevant food categories;

• the technical specifications of food additives, ordered the cancellation of the reference of the octile gallate (E 311) and the dodecile gallate (E 312).

Food categories in which from October 25, 2018 the use of octile gallate (E 311) and dodecile gallate (E 312) is prohibited

From 12 August 2018 it is forbidden to use octile gallate (E 311) and dodecile gallate (E 312):

• in dehydrated milk;
• in oils and fats substantially free of water (except anhydrous milk fat);
• in other emulsions of oils and fats, including spreads and liquid emulsions;
• in butter and cream spreads based on nuts;
• in cheese obtained from whey;
• in processed products based on potatoes;
• in chewing gums;
• in breakfast cereals;
• in precooked or processed cereals;
• in fine bakery products;
• in meat products not subjected to heat treatment;
• in meat products subjected to heat treatment;
• in condiments;
• in soups, soups and broths;
• in sauces;
• in snacks based on potatoes, cereals, flour or starch;
• in processed nuts;
• in food supplements in solid form, including capsules, tablets and the like, except for chewing tablets;
• in food supplements in liquid form;
• in food supplements in the form of syrup or chewing pills.

From October 25, 2018 the use of octile gallate (E 311) and dodecile gallate (E 312), as food additives in food flavorings and related supports, is prohibited.