Major Modernization of EFSA Approved Food Color Additives

16 Sep 2016 --- The European Food Safety Authority (EFSA) has re-assessed 41 food color additives as part of a long-term re-evaluation program to bring assessments up to date. As many food additives were initially evaluated and approved a long time ago, the European Commission asked a EFSA team to re-evaluate all additives that had been authorized before January 2009, taking into account any new evidence.

Based on EFSA’s scientific advice, the Commission and member states then decide whether to change the conditions of use for an additive or even remove it from the EU list of authorized food additives to protect consumers. 

The task was due for completion by 2020, however Ruud Woutersen, vice-chair of EFSA’s panel on food additives and nutrient sources added to food (ANS) and chair of the working group and his team have completed it ahead of schedule. As food colors were among the first additives to be authorized, their re-evaluation has been prioritized.

“Overall, the ANS panel re-assessed 41 food colors. We reviewed all available, relevant scientific studies as well as data on toxicity and human exposure, from which we drew conclusions regarding the safety of the substance. As part of the evaluations, the Panel established, when possible – i.e., when sufficient information was available – an Acceptable Daily Intake (ADI) for each substance,” Woutersen says.

“A first batch of six re-evaluations was delivered in 2009, and the re-evaluation of most food colors was completed by 2012. In between then and now, the panel also continued and finalized the re-evaluation of many other food additives. For example, we completed the re-evaluation of the sweetener aspartame in 2013 – a landmark piece of work – and completed most preservatives and antioxidants.” 

Talking about the challenges involved in the re-assessment process, Woutersen explains what happens when scientific is not readily available. 

“With new additives, an applicant is required to submit detailed chemical and toxicological information. This is not the case for re-evaluations. In the absence of sufficient data, assessments may remain inconclusive; or the panel can set a temporary ADI, as we did in 2009 for Sunset Yellow, which was reconsidered in 2014.”

“Since 2007 EFSA has launched 15 calls for data on food additives, six of which were related to food colors. Thanks to new concentration data becoming available, we were able to refine exposure assessments, for example of caramel colors (2012) and Allura Red (2015).”

The re-evaluations have had an impact so far and in light of new information, EFSA lowered the ADI for several food colors. 

“As a result, in 2012, the European Commission lowered the maximum levels of three of these colors (E 104, E 110, E 124) for food uses. Another significant impact was the market withdrawal of the color Red 2G (E 128) in 2007. New scientific evidence made available at that time indicated that use of this food additive could be a safety concern. EU decision-makers agreed with EFSA that this color could not be regarded as safe for humans and it was subsequently suspended from use in the EU.”

Completing the food color re-evaluations is an important milestone for EFSA, adds Woutersen and although food color additives has been done there are still a considerable number of food additives to be re-evaluated by the 2020 deadline. 

“Of course we are prepared to respond to any ad hoc requests from the Commission, or as part of a self-tasking activity, to review colors and other additives in the light of newly available scientific information or changing conditions of use.”

“You’re never too old to learn, and in tackling these complex evaluations together with peers from other scientific disciplines I discover something new at every meeting. My main scientific role in this work, as a board certified toxicologic pathologist, is quite specialized. So it’s essential for me to hear, for example, from the chemists and biochemists about the specifications of the compounds under review in order to be able to determine whether the animal studies have been performed with the compound as marketed. Equally important is the information we receive from the medical doctors and epidemiologists about potential effects on humans.”

“Our exposure assessment experts also help shape the final conclusions a lot; you can only estimate the potential risks for consumers if you know to what extent people may be exposed. So, as well as being extremely proud to contribute to consumer safety in Europe, the interdisciplinary nature of the work has been, and continues to be, a major motivation to participate in the panel and its working groups.”

by Gaynor Selby