The revisions seek to make clear the additives authorised for use in subcategories such as capsules, tablets and liquid formulations also providing conditions of use in children and young children.
As outlined in the Official Journal of the European Union, the revisions now delete food subcategory 17.3 and rewording the titles of food subcategories 17.1 and 17.2.
The wording in these subcategories are now “Food supplements supplied in a solid form, excluding food supplements for infants and young children,” and “Food supplements supplied in a liquid form, excluding food supplements for infants and young children” respectively.
“This will better reflect which products are covered by/included in each of the food subcategories,” the ruling said.
“As a result of the deletion of food subcategory 17.3 food additives' entries which were included in that food subcategory should be transferred to either food subcategory 17.1 or 17.2 to ensure that there is transparency and legal certainty regarding the use of food additives in those foods.
“For clarity and enforcement purposes also the title of food category 17 should be amended to ‘Food supplements as defined in Directive 2002/46/EC’.”
Part E changes
Additionally, Part E of the Union list, which sets out the authorised additives for each of these subcategories and their conditions of use, also underwent revision.
Part E now lists the maximum levels of use indicated for colours, polyols, sweeteners, including E 200-213, E 338-452, E 405, E 416, E 426, E 432-436, E 459, E 468, E 473-475, E 491-495, E 551-553, E 901-904, E 961, E 1201-1204, E 1505 and E 1521, prepared following the instructions of use provided by the manufacturer.
“The dilution factor for those food supplements that have to be diluted or dissolved has to be communicated together with the instructions of use,” the amendment stated.
The Commission added that since the Union list is amended to provide clarification to the current authorised uses of additives, it is not likely to have an effect on human health and would not need the opinion of the European Food Safety Authority (EFSA).
Octyl gallate and dodecyl gallate
In other regulation-related news, the EC also make available further amendments to Regulation (EC) No 1333/2008 that ban the use of the antioxidants octyl gallate (E 311) and dodecyl gallate (E 312).
The substances, authorised as antioxidants in a variety of foods, as well as in food flavourings, was the subject of a Scientific Opinion by EFSA, specifically re-evaluating dodecyl gallate (E 312) as a food additive.
Here it also concluded that the Acceptable Daily Intake (ADI) for propyl gallate (E 310), octyl gallate (E 311) and dodecyl gallate (E 312) should no longer be valid.
The opinion added that a sufficient toxicological database would be required for an adequate assessment of the safety of dodecyl gallate as a food additive.
Additive safety unconfirmed
Further action was taken later in 2015 when EFSA re-evaluated octyl gallate (E 311) as a food additive.
The opinion stated that there was a lack of adequate toxicological data on octyl gallate and the Authority was not able to confirm the safety of this additive.
Last year, the Commission launched a public call for scientific and technological data on all three food additives.
However, EFSA confirmed that no firms were able to provide the requested toxicological data for the substances adding, “Without it the Authority cannot complete the re-evaluation of the safety of octyl gallate and dodecyl gallate as food additives”.
“Consequently it cannot be determined whether those substances still fulfil the conditions pursuant to Article 6(1) of Regulation (EC) No 1333/2008 for inclusion in the Union list of approved food additives.”