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Re-evaluation of food colours: EFSA completes major programme
With the recent adoption of two opinions on annatto extracts and titanium dioxide, the Authority has reached an important milestone, completing the re-evaluation of all food colours authorised before 2009.
Ruud Woutersen, Vice-Chair of EFSA’s Panel on Food Additives and Nutrient Sources Added to Food (ANS) and Chair of the Working Group tasked with the re-evaluation of food colours, explains the background, challenges and impact of this major work programme.
Why was this work carried out?
Many food additives were initially evaluated and approved a long time ago. To bring assessments up to date, the European Commission asked EFSA to re-evaluate, by 2020, all additives authorised before 20 January 2009, taking into account any new evidence. Based on EFSA’s scientific advice, the European Commission and Member States then decide whether to change the conditions of use for an additive or, if needed, remove it from the EU list of authorised food additives to protect consumers. As food colours were among the first additives to be authorised, their re-evaluation has been prioritised.
What did the work involve?
Overall, the ANS Panel re-assessed 41 food colours. 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. A first batch of six re-evaluations was delivered in 2009, and the re-evaluation of most food colours was completed by 2012. In between then and now, the Panel also continued and finalised 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.
What were the challenges?
Our ability to re-evaluate the safety of a food additive depends greatly on the availability of scientific data. 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 colours. Thanks to new concentration data becoming available, we were able to refine exposure assessments, for example of caramel colours (2012) and Allura Red (2015).
What has been the impact of the re-evaluations so far?
In light of new information, EFSA lowered the ADI for several food colours. As a result, in 2012, the European Commission lowered the maximum levels of three of these colours (E 104, E 110, E 124) for food uses. Another significant impact was the market withdrawal of the colour 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 colour could not be regarded as safe for humans and it was subsequently suspended from use in the EU.
With this work done, what’s next?
The completion of the food colour re-evaluations is an important milestone for EFSA. But our work does not stop here. There is still a considerable number of food additives to be re-evaluated by 2020. And, 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 colours and other additives in the light of newly available scientific information or changing conditions of use.
How about feed colours?
Colours used as food additives may also be authorised for use as feed additives. Their safety evaluation is carried out by EFSA’s Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), with different data requirements due to separate regulatory frameworks. To ensure consistency in their risk assessment approaches and consideration of the available scientific information, the Panels co-ordinate their scientific work. For example, in its safety assessment of the colour Patent Blue V (2013), the ANS Panel included data from studies that have also been used by the FEEDAP Panel.
Looking back, what do you personally take away from this achievement?
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 specialised. 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.
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