Sunset yellow (E 110) is a food colour currently authorised under Directive 954/36/EC.
In 2009, EFSA re-evaluated its safety and, based on the available scientific data, its ANS Panel reduced the ADI to 1 mg/kg bw/day but this was deemed temporary.
In addition, EFSA considered that the exposure to this substance could be too high, particularly in children.
The Commission therefore reduced the conditions of use and use levels in several food and dietary supplement categories to ensure that the use of the food colour is safe, in particular for children.
The regulator's proposal is now being finalised and is due to be presented for vote at a Standing Committee so that the new conditions of use can be adopted by the end of this year.
In this context, in July this year, the Commission asked Parma-based EFSA to review exposure by children to the food additive using currently available consumption data and the revised food and drink MPLs for Sunset Yellow. In addition, the regulator asked the agency to consider four different maximum permitted levels (10, 15, 18 and 20 mg/l) for flavoured drinks
Several food consumption databases were used to conduct the revised exposure assessment: data from the EXPOCHI project and UK NDNS survey, said EFSA.
For all scenarios, the EU risk assessor reports that the high level exposure estimates for children calculated with the proposed revised MPLs are below the temporary ADI of 1 mg/kg bw/day for all European countries considered (maximum of 0.8 mg/kg bw/day) except for UK pre-school children.
The UK group, said the agency, might slightly exceed the ADI in relation to exposure from flavoured drinks at the levels of 18 and 20 mg/l (1.1 and 1.2 mg/kg bw/day respectively).
A spokesperson for EFSA told this publication that it is now up to the Commission to make a decision on flavoured drinks usage levels in relation to Sunset Yellow and to also provide clarity on whether a actual rather than temporary ADI for Sunset Yellow will be established.
Meanwhile, Barbara Gallani, director of food safety & science at the UK trade body, the Food and Drink Federation, told FoodNavigator.com that: “Since EFSA published its revised safety assessment, which reconfirmed the safety of Sunset Yellow but with a reduced ADI, industry has been working closely with FSA and the European Commission on measures to reduce levels of use in those products which, for technical or other reasons cannot move to an alternative colour.
She reports that most UK food manufacturers have already reformulated to remove Sunset Yellow and other artificial colours as a result of FSA’s call for voluntary removal following publication of the so-called Southampton study in 2007.
We are satisfied that the resulting outcome is pragmatic and proportionate and allows the continued use of Sunset Yellow where it is needed to meet consumer expectations of product appearance and shelf life whilst ensuring usage is well within the revised ADI,” commented Gallani.
The EFSA exposure assessment revision and propose use levels for food and dietary supplements can be found here.