Source: European Food Safety Authority
12/11/2009
12 November 2009 - After reviewing all the available evidence, the European Food Safety Authority's scientific panel on additives, the ANS Panel, has lowered the Acceptable Daily Intakes (ADIs) for the artificial food colours Quinoline Yellow (E104), Sunset Yellow FCF (E110) and Ponceau 4R (E124).[1] As a result, the Panel concluded that exposure to these colours could exceed the new ADIs for both adults and children.
The Panel found that the currently available data did not require a change to the existing ADIs for the three other colours evaluated – Tartrazine (E102), Azorubine/Carmoisine (E122) and Allura Red AC (E129). According to the Panel, only some children who consume large amounts of food and drink containing Azorubine/Carmoisine or Allura Red AC could exceed the ADIs for these colours.
John Larsen, the Chair of the ANS Panel, said: “Many food colours have been in use for decades since their initial approval and so after such a long period of use we are now looking at the overall data available, including any new evidence on their safety, to help protect European consumers. We are doing this work systematically for all food additives, and have started with these colours for which some concerns have been raised.”
The six colours re-evaluated by the Panel can be used in a range of foodstuffs including soft drinks, bakery products and desserts. The Panel concluded that one of the colours, Tartrazine, may bring about intolerance reactions – such as irritations to the skin – in a small part of the population. For the remaining five colours (Quinoline Yellow, Sunset Yellow FCF, Ponceau 4R, Azorubine/Carmoisine and Allura Red AC), no firm conclusion could be drawn on a possible link with intolerance reactions from the limited scientific evidence available.
EFSA is currently assessing the safety of all individual food additives which are approved for use in the EU, starting with food colours. The European Commission asked EFSA to consider these six colours as a priority after a study was published by Southampton University (McCann et al) in 2007 – the so-called “Southampton study” – linking certain mixtures of these colours and the preservative sodium benzoate with hyperactivity in children.
John Larsen added: “We have now reduced the ADIs for three of the six colours we assessed, but for different reasons in each case as different data were available on each individual compound. The data which are currently available – including the Southampton study itself – did not substantiate a causal link between the individual colours and possible behavioural effects.”
Why has EFSA assessed these colours now?
EFSA is currently reviewing the safety of all food additives which have been approved for use in the EU, as many additives were initially authorised for use a long time ago and in a number of cases new scientific data have since become available.
EFSA’s expert panel which deals with food additives, the ANS Panel, has started re-assessing all of the permitted food colours (45 in total). EFSA was asked by the European Commission to look at these six colours as a matter of priority as certain safety concerns had been raised about them.
What were EFSA’s main conclusions?
After reviewing all of the available evidence, the ANS Panel has reduced the Acceptable Daily Intake (ADI) for three of the colours in question, namely Quinoline Yellow (E104), Sunset Yellow FCF (E110) and Ponceau 4R (E124). As a result, the Panel concluded that exposure to – or consumption of – these colours could exceed the new ADIs for both adults and children.
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.
For five of the six of the colours (Quinoline Yellow, Sunset Yellow FCF, Ponceau 4R, Azorubine/Carmoisine and Allura Red AC), the Panel concluded that the evidence which is currently available did not establish a causal link between the individual colours and intolerance reactions such as irritations to the skin or nose. The Panel concluded that Tartrazine may bring about intolerance reactions in a small part of the population.
For all six colours, the Panel concluded that the evidence currently available did not substantiate a causal link between the individual colours and possible behavioural effects.
If people consume more than the ADI, does this mean that they are at risk? If so, what of?
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. 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 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.
The ANS Panel reduced the ADIs for three of the six colours which were assessed, as new data suggested that the levels at which they may cause negative health effects in animal experiments could be lower than previously thought. However, this was done for different reasons in each case as different data were available on each individual compound.
What foods are these colours used in?
The colours can be used in a range of foodstuffs, including soft drinks, bakery products, desserts, sauces, seasonings and confectionery.
Which population groups have the highest exposure levels? In which countries?
The ANS Panel based its conclusions on data relating to children’s exposure to these colours from 9 EU Member States and adult exposure from the UK population, which is considered to be one of the highest consumers of soft drinks in Europe. The data indicated that both average and high-level consumption levels are generally considerably higher for children than for adults.
How does EFSA’s work on these colours relate to that of the UK Food Standards Authority?
The Food Standards Authority commissioned a study, carried out by researchers from Southampton University in 2007, which indicated that certain mixtures of these colours (and the preservative sodium benzoate) may have a small effect on activity and attention in certain groups of children.
EFSA’s former AFC Panel evaluated this study in 2008 and concluded that it did not provide sufficient evidence to warrant changing the Acceptable Daily Intakes (ADIs) for the individual colours. 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 colours.
As part of its systematic review of food additives which are authorised for use in the EU, EFSA has now looked at all of the available evidence relating to each of these individual colours. These colours were assessed as a matter of priority due to the concerns which had been raised.
Do these colours cause behavioural effects in children?
The ANS Panel concluded that the scientific evidence which is currently available, including the so-called “Southampton study” (McCann et al, 2007), did not substantiate a causal link between these individual colours and possible behavioural effects. The Panel also agreed with EFSA’s earlier opinion that the McCann et al study did not provide sufficient evidence to support a change to the ADIs for these individual colours.
Why did EFSA only look at individual colours, not mixtures?
In the EU food safety system, all additives are currently assessed and authorised individually. This is because in order to protect consumers, the safety of each additive must be demonstrated on an individual basis before its authorisation for use in foods can be considered by risk managers (i.e. the European Commission, the European Parliament and the EU Member States).
It is not practically possible to assess the safety of mixtures due to the infinite number of possible combinations of additives and other substances which are naturally present in the diet, taking into account differences in food composition, consumer food choices and dietary patterns.
What happens next?
EFSA’s role is to provide independent scientific advice. Any subsequent follow-up action is the responsibility of decision-makers, i.e. the European Commission, the European Parliament and the EU Member States.
12/11/2009
12 November 2009 - After reviewing all the available evidence, the European Food Safety Authority's scientific panel on additives, the ANS Panel, has lowered the Acceptable Daily Intakes (ADIs) for the artificial food colours Quinoline Yellow (E104), Sunset Yellow FCF (E110) and Ponceau 4R (E124).[1] As a result, the Panel concluded that exposure to these colours could exceed the new ADIs for both adults and children.
The Panel found that the currently available data did not require a change to the existing ADIs for the three other colours evaluated – Tartrazine (E102), Azorubine/Carmoisine (E122) and Allura Red AC (E129). According to the Panel, only some children who consume large amounts of food and drink containing Azorubine/Carmoisine or Allura Red AC could exceed the ADIs for these colours.
John Larsen, the Chair of the ANS Panel, said: “Many food colours have been in use for decades since their initial approval and so after such a long period of use we are now looking at the overall data available, including any new evidence on their safety, to help protect European consumers. We are doing this work systematically for all food additives, and have started with these colours for which some concerns have been raised.”
The six colours re-evaluated by the Panel can be used in a range of foodstuffs including soft drinks, bakery products and desserts. The Panel concluded that one of the colours, Tartrazine, may bring about intolerance reactions – such as irritations to the skin – in a small part of the population. For the remaining five colours (Quinoline Yellow, Sunset Yellow FCF, Ponceau 4R, Azorubine/Carmoisine and Allura Red AC), no firm conclusion could be drawn on a possible link with intolerance reactions from the limited scientific evidence available.
EFSA is currently assessing the safety of all individual food additives which are approved for use in the EU, starting with food colours. The European Commission asked EFSA to consider these six colours as a priority after a study was published by Southampton University (McCann et al) in 2007 – the so-called “Southampton study” – linking certain mixtures of these colours and the preservative sodium benzoate with hyperactivity in children.
John Larsen added: “We have now reduced the ADIs for three of the six colours we assessed, but for different reasons in each case as different data were available on each individual compound. The data which are currently available – including the Southampton study itself – did not substantiate a causal link between the individual colours and possible behavioural effects.”
Why has EFSA assessed these colours now?
EFSA is currently reviewing the safety of all food additives which have been approved for use in the EU, as many additives were initially authorised for use a long time ago and in a number of cases new scientific data have since become available.
EFSA’s expert panel which deals with food additives, the ANS Panel, has started re-assessing all of the permitted food colours (45 in total). EFSA was asked by the European Commission to look at these six colours as a matter of priority as certain safety concerns had been raised about them.
What were EFSA’s main conclusions?
After reviewing all of the available evidence, the ANS Panel has reduced the Acceptable Daily Intake (ADI) for three of the colours in question, namely Quinoline Yellow (E104), Sunset Yellow FCF (E110) and Ponceau 4R (E124). As a result, the Panel concluded that exposure to – or consumption of – these colours could exceed the new ADIs for both adults and children.
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.
For five of the six of the colours (Quinoline Yellow, Sunset Yellow FCF, Ponceau 4R, Azorubine/Carmoisine and Allura Red AC), the Panel concluded that the evidence which is currently available did not establish a causal link between the individual colours and intolerance reactions such as irritations to the skin or nose. The Panel concluded that Tartrazine may bring about intolerance reactions in a small part of the population.
For all six colours, the Panel concluded that the evidence currently available did not substantiate a causal link between the individual colours and possible behavioural effects.
If people consume more than the ADI, does this mean that they are at risk? If so, what of?
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. 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 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.
The ANS Panel reduced the ADIs for three of the six colours which were assessed, as new data suggested that the levels at which they may cause negative health effects in animal experiments could be lower than previously thought. However, this was done for different reasons in each case as different data were available on each individual compound.
What foods are these colours used in?
The colours can be used in a range of foodstuffs, including soft drinks, bakery products, desserts, sauces, seasonings and confectionery.
Which population groups have the highest exposure levels? In which countries?
The ANS Panel based its conclusions on data relating to children’s exposure to these colours from 9 EU Member States and adult exposure from the UK population, which is considered to be one of the highest consumers of soft drinks in Europe. The data indicated that both average and high-level consumption levels are generally considerably higher for children than for adults.
How does EFSA’s work on these colours relate to that of the UK Food Standards Authority?
The Food Standards Authority commissioned a study, carried out by researchers from Southampton University in 2007, which indicated that certain mixtures of these colours (and the preservative sodium benzoate) may have a small effect on activity and attention in certain groups of children.
EFSA’s former AFC Panel evaluated this study in 2008 and concluded that it did not provide sufficient evidence to warrant changing the Acceptable Daily Intakes (ADIs) for the individual colours. 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 colours.
As part of its systematic review of food additives which are authorised for use in the EU, EFSA has now looked at all of the available evidence relating to each of these individual colours. These colours were assessed as a matter of priority due to the concerns which had been raised.
Do these colours cause behavioural effects in children?
The ANS Panel concluded that the scientific evidence which is currently available, including the so-called “Southampton study” (McCann et al, 2007), did not substantiate a causal link between these individual colours and possible behavioural effects. The Panel also agreed with EFSA’s earlier opinion that the McCann et al study did not provide sufficient evidence to support a change to the ADIs for these individual colours.
Why did EFSA only look at individual colours, not mixtures?
In the EU food safety system, all additives are currently assessed and authorised individually. This is because in order to protect consumers, the safety of each additive must be demonstrated on an individual basis before its authorisation for use in foods can be considered by risk managers (i.e. the European Commission, the European Parliament and the EU Member States).
It is not practically possible to assess the safety of mixtures due to the infinite number of possible combinations of additives and other substances which are naturally present in the diet, taking into account differences in food composition, consumer food choices and dietary patterns.
What happens next?
EFSA’s role is to provide independent scientific advice. Any subsequent follow-up action is the responsibility of decision-makers, i.e. the European Commission, the European Parliament and the EU Member States.
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