Food colours are food additives which are added to foods mainly for the following reasons:
- to make up for colour losses following exposure to light, air, moisture and variations in temperature
- to enhance naturally occurring colours
- to add colour to foods that would otherwise be colourless or coloured differently.
Food colours are contained in many foods, including snack foods, margarine, cheese, jams and jellies, and desserts, drinks, etc. Each food colour authorised for use in the European Union is subject to a rigorous scientific safety assessment.
EFSA’s Panel on Food Additives and Nutrient Sources added to food (ANS) carries out the safety assessment of food colours. The Panel’s safety evaluations of food colours and other food additives involve a review of all available, relevant scientific studies as well as data on toxicity and human exposure, from which the Panel draws conclusions regarding the safety of the substance.
From 2009 to 2016, the ANS Panel re-evaluated the safety of all previously authorised food colours as part of the re-evaluation of all food additives in use before January 2009.
Consideration whether certain food colours are likely to trigger adverse allergic reactions is carried out by EFSA’s Panel on Dietetic Products, Nutrition and Allergies.
Colours used in food and feed
Colours used as food additives may also be authorised for use as feed additives. The evaluation of the safety of food additives and feed additives is carried out by different Scientific Panels at EFSA, with different data requirements due to the separate regulatory frameworks in the two areas. However, EFSA’s Panels co-ordinate their scientific work to ensure consistency in their risk assessment approaches and consideration of the available scientific information within these fields.
2016 Re-evaluation of all previously authorised food colours completed. Overall, the ANS Panel re-assessed 41 food colours, taking into account new studies where available.
2013 EFSA scientists further strengthen co-ordination of food and feed additive evaluations, highlighting joint work on colours
2012 Re-evaluation of most food colours completed
2008 EFSA evaluated Southampton study on food colours and child behaviour
EFSA has three main tasks in relation to food colours:
- Evaluating the safety of new food colours or proposed new uses of existing food colours before they can be authorised for use in the EU
- Re-evaluating all food colours already permitted for use in the EU before 20 January 2009 (completed in 2016)
- Responding to ad-hoc requests from the European Commission to review certain food colours in the light of new scientific information and/or changing conditions of use.
Setting the “safe level”
As part of its safety evaluations of food colours and other additives EFSA seeks to establish, when possible (e.g. when sufficient information is available), an Acceptable Daily Intake (ADI) for each substance.
The ADI is the amount of a substance that people can consume on a daily basis during their whole life without any appreciable health risk. ADIs are usually expressed in mg per kg of body weight per day (mg/kg bw/day). The ADI can apply to a specific additive or a group of additives with similar properties. When re-evaluating previously authorised additives, EFSA may either confirm or amend an existing ADI following review of all available evidence.
When there are insufficient data for establishing an ADI, a margin of safety may be calculated to determine whether estimated exposure might be of potential concern.
In other cases, for example, for substances that are already present in the body or regular components of the diet or that did not indicate adverse effects in animal studies, there is no need to set an ADI.
Under EU legislation, all additives including colours must be authorised before they can be used in foods.
The authorisation procedure starts with submission of a formal request to the European Commission consisting of an application dossier on the substance, containing scientific data on its proposed uses and use levels. The Commission then sends the dossier to EFSA and requests it to evaluate the safety of the substance for its intended uses. The European Commission decides whether to authorise the substance based on EFSA’s safety assessment. Authorisation of proposed new uses of existing food additives follows the same procedure.
Once authorised, these substances are included in the EU list of permitted food additives laid down in Regulation EC 1333/2008, which also specifies their conditions of use. Authorised food additives must also comply with approved purity criteria laid down in Regulation EU 231/2012.
In December 2008, existing legislation was consolidated into four simplified regulations covering all so-called food improvement agents (i.e. food additives, food enzymes and flavourings). Regulation EC 1331/2008 introduced a common authorisation procedure for these agents. Regulation EC 1333/2008 on food additives established a Union list of authorised food additives, which was published in full in Regulation EU 1129/2011.
- EU legislation on food additives – European Commission
The European Commission may occasionally request EFSA’s advice on food allergies when deciding upon the possible inclusion of food colours in the list of food allergens in Annex IIIa of Directive 2000/13/EC on the labelling, presentation and advertising of foodstuffs.
1. Why has EFSA been assessing colours in recent years?
EFSA’s expert Scientific Panel which deals with food additives, the ANS Panel, has started re-assessing all of the permitted food colours (45 in total), giving priority to those synthetically produced and later to those obtained from natural sources. The re-evaluation of previously authorised food colours is scheduled to be completed by 2015.
2. Can the same colours used in food also be used in feed?
3. Why did EFSA release a Statement about a group of colours in June 2013?
EFSA’s experts released the Statement after reviewing new data on the colour Allura Red AC (E 129) and five other chemically related colours, known collectively as ‘sulphonated mono azo dyes’. The ANS Panel has established Acceptable Daily Intakes (ADI) for these colours following previous evaluations. (The ADI is the amount of a substance that people can consume every day over the course of a lifetime without any appreciable risk to health.) In its 2013 Statement, the Panel reconfirmed that there is currently no reason to revise the ADI for Allura Red AC (E 129).
EFSA recommended, however, that new tests be carried out to address uncertainties related to the possible genotoxicity of Allura Red AC. Genotoxicity is the ability of a substance to damage DNA, the genetic materials of cells. This recommendation also applies to the other ‘sulphonated mono azo dyes’ in this group: Amaranth (E 123), Ponceau 4R (E 124), Sunset Yellow FCF (E 110), Tartrazine (E 102) and Azorubine/Carmoisine (E 122).
Except for Amaranth (E 123) which is not used in animal feed, these colours have also been or are in the process of being evaluated for use as feed additives. In 2015, EFSA concluded that Allura Red AC is not genotoxic for dogs and cats. New test data demonstrate that Allura Red AC neither damages the DNA of individual cells (comet assay) nor shows other evidence of genotoxicity (in-vivo micronucleus test). EFSA experts extrapolated safe dietary levels for dogs and cats from available toxicity studies. They calculated the highest safe dietary concentration of Allura Red AC to be 370 mg/kg complete feed for dogs and 308 mg/kg complete feed for cats.
4. What are the uncertainties referred to in EFSA’s 2013 Statement on azo dyes?
Following a review of the data, EFSA’s experts considered that these azo dyes could share a pattern of effects that deserve further investigation. However, currently the overall weight of evidence suggests that they are not genotoxic.
5. What is meant by overall ‘weight of evidence’?
People make personal weight of evidence decisions all the time in their daily lives. In risk assessment, the type of evidence considered is highly technical and often difficult to understand for a non-scientist. However, there are well-established steps in the analysis and evaluation of scientific information that help scientists to weigh up all the evidence and make decisions relying on their scientific knowledge and expertise.
6. If people consume more than the ADI, does this mean that they are at risk?
The ADI is generally derived by looking at the highest intake level at which substances do not cause harmful effects in animal experiments and applying a safety factor (typically of 100) to account for differences between humans and animals. This means that even if people exceed the ADI for a certain substance, this will not necessarily cause negative health effects.
7. When colours are used in feed additives is consumer safety an issue as well as animal safety?
The safety evaluation of feed additives also takes into consideration potential adverse effects of these substances on the target animal (i.e. the animal that consumes the feed additive directly). As well as food-producing animals, target animals could be pets and other domesticated animals (for example, horses). Specific tolerance studies are performed on the target animals to establish a safety indicator called a ‘margin of safety’ in case the additive is consumed at higher levels than recommended: the higher the margin of safety, the lower the risk for the animal.
8. What food and feed products are azo dyes and other colours used in?
Feed use also varies by colour. For example, Carmoisine (E 122), Allura Red AC (E 129) and another colour called Brilliant Blue (E 133) are used or proposed for use with cats and dogs only. On the other hand, the colours Patent Blue V (E 131) and Erythrosine (E127) are authorised as feed additive for a variety of non-food producing animals, including cats, dogs, ornamental fish and reptiles.
9. Which human population groups have the highest exposure levels to these food colours? In which countries?
Since then, new data have emerged on the actual levels of most of these colours found in food. Based on these data, EFSA is currently revising its assessments of human exposure to these original ten colours. These re-assessments are scheduled for completion by November 2014. Anyone interested in following the development of these assessments can check their progress on EFSA’s online Register of Questions.
10. Why is exposure in humans and in animals different? How does this affect risks to human and animal health?
Take for instance, the much greater variety of foods making up the human diet. Animals typically consume the same feed on a daily basis whereas people usually vary their diet throughout the day and the week. The food people have for breakfast, lunch and dinner in a single day can already contain a greater variety of ingredients and nutrients than animals eat in a lifetime. Also the average lifetime of most farm animals and domestic pets is shorter than for humans. Therefore, scientists can predict that because exposure of animals to a potential hazard occurs more often and, in comparison with people, for a greater part of their lives, the risk for animal health from a given substance may be higher than for humans.
11. Are additives evaluated differently even when they are used in both food and feed?
In spite of these differences, when assessing the safety of substances such as colours and other additives used both in food and feed, EFSA’s Panels aim to ensure consistency in their risk assessment approaches including consideration of the available scientific information within both of these fields.
12. Have any concerns been raised in the past about these colours?
EFSA’s experts evaluated the so-called “Southampton study” in 2008 and concluded that the findings could not be used as a basis for changing the ADIs for the individual additives. One of the reasons for this was that the study looked at mixtures and not individual additives – it was therefore not possible to attribute the effects to any of the individual substances.
As part of its systematic review of food additives which are authorised for use in the EU, EFSA looked at all of the available evidence relating to each of these individual colours and assessed them as a matter of priority due to the concerns which had been raised. These scientific opinions were adopted in November 2009.
13. What were EFSA’s main conclusions about the colours in the “Southampton study”?
The Panel did not change the existing ADIs for the three other colours it assessed, Tartrazine (E102), Azorubine/Carmoisine (E122) and Allura Red AC (E129). The Panel also concluded that only children who consume relatively large amounts of food and drinks containing Azorubine/Carmoisine or Allura Red AC could exceed the ADIs for these colours.
14. What is a temporary ADI?
15. Do azo dye food colours cause behavioural effects in children?
16. Why did EFSA only look at individual colours, not mixtures?
It is not always possible to assess the safety of mixtures of chemicals when using standard risk assessment approaches. The number of possible combinations of additives and other substances naturally present in the diet is practically infinite, taking into account differences in food composition, consumer food choices and dietary patterns.
The scientific community, including EFSA, is attempting to develop methods for evaluating possible risks from exposure to multiple chemicals in food. For example, the Authority has made important headway in the risk assessment of multiple pesticides and contaminants for humans, and multiple pesticides for bees. In July 2013, EFSA published its first major report on combined exposure to multiple chemicals and will continue to contribute to scientific advances in this area.
17. What happens next?
Any subsequent follow-up action is the responsibility of EU risk managers who authorise the use of additives in food and feed.