E129 – Alura AC

What is E 129 additive?

Food additive E 129 belongs to the category of synthetic azo dyes. It imparts red colour and is permitted for use in a wide range of food products.

Which foods contain the food additive E 129?

E 129 additive can be used in a diverse range of products, such as:

alcoholic and non-alcoholic beverages,
canned fruit and vegetable products,
fat-based desserts,
dried fruit and vegetables,
fruit and vegetables in vinegar, oil or brine,
fruit and vegetable preparations with the exception of compotes,
processed and unprocessed meat,
cakes, biscuits, wafers, snacks, confectionery,
fish and canned fish,
melted cheese,
sauces,
seasoning,
mustard,
food supplements and
dietary preparations, etc.[1]

Are there any side effects from consuming the food additive E 129?

Because it is an azo dye, with recognised toxic potential, it can cause intolerance in people sensitive to salicylates. As a histamine releaser, it can intensify the characteristic symptoms of asthma.

Read too:E551 – Silicon dioxide

E 129 additive may cause allergies or intolerance reactions manifested by: digestive irritation with dyspeptic disorders, rash, dizziness, headache, nausea, etc.

In asthmatics, it can cause attacks of bronchospasm. People with an increased sensitivity to azo compounds may consume products containing this additive with caution.[2]

Red Allura AC (E 129) was first evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1980 and by the EU Scientific Committee for Food (SCF) in 1984 and 1989. Both committees established an acceptable daily intake (ADI) of 0-7 mg/kg body weight (bw)/day. The SCF, JECFA and TemaNord evaluations concluded, based on the in vivo and in vitro mutagenicity studies available at that time, that Allura Red AC showed no genotoxic activity. Recent results indicated that in an in vivo Comet assay, Allura Red AC induced significant increases in nuclear DNA migration in both glandular stomach and colon tissue, in the absence of overall cytotoxicity in these tissues. The group considered, in light of the negative carcinogenicity studies, that the biological significance of the Comet test results is uncertain.

A study conducted in mice at doses of 1200 to 2400 mg/kg body/day for two generations (Tanaka, 1994) showed no significant systematic adverse effects on reproductive and behavioural parameters.

What are the characteristics of E 129 additive?

Synonyms: CI red food colouring 17

Definition Allura Red AC consists essentially of disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.

Read too:E950 Acesulfame K

Red allura AC is synthesized by coupling 5-amino-4-methoxy-2-toluenesulfonic acid diazotate with 6-hydroxy-2-naphthalene sulfonic acid

Red allura AC is described as sodium salt.

Calcium and potassium salts are also allowed.

Chemical name 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo)-naphthalene-6-disodium sulfonate

Chemical formula C₁₈ H₁₄ N₂ Na₂ O₈ S ₂

Molecular weight: 496.42

Composition

Contains not less than 85 % total colouring matters calculated as sodium salt

Description:Dark red powder or granules

Appearance of Red aqueous solution

Read too:E202 – Potassium sorbate

Identification Spectrometry

Maximum in water at ca. 504 nm

Purity Water insoluble matter Not more than 0,2 % Purity

Auxiliary colouring matters Not more than 3,0 %.

Organic compounds other than dyestuffs:

– 6-hydroxy-2-naphthalene sulfonic acid, sodium salt: Not more than 0,3

– 4-amino-5-methoxy-2-methyl-benzene sulfonic acid: Not more than 0,2 %; and

– 6,6-oxybis (2-naphthalene sulfonic acid),

– disodium salt: Not more than 1,0 %

Unsulfonated primary aromatic amines: Not more than 0,01 % (calculated as aniline)

Ether extractables – For a pH 7 solution, not more than 0,2 %.

Arsenic Not more than 3 mg/kg

Read too:E122 – Azorubine

Lead Not more than 2 mg/kg

Mercury Not more than 1 mg/kg

Cadmium Not more than 1 mg/kg

Maximum daily intake/body: 7 mg/kg body

Description max. daily intake: The daily intake for human consumption is up to 7 mg/kg body weight.

Intake dose in food: 100-500 mg/kg

Why is it necessary to use E 129?

The use of the additive is necessary for the colouring of food categories referred to in Regulation No 1129/2011 where the natural colour has been degraded during processing, storage or transport.

Read too:E407 – Caragenan

For other categories of food products, or alcoholic and non-alcoholic beverages without colour, the use of E 129 additive aims at improving their appearance and identifying their flavour more strongly.²

What are food additives?

According to WHO[3] , substances that are added to food to maintain or improve the safety, freshness, taste, texture or appearance of food are known as food additives. For centuries, food additives have been used to preserve food, for example salt (in meat, bacon or dried fish), sugar (in marmalade) or sulphur dioxide (in wine).

Over the years, many food additives have been developed to meet the needs of food production, because large-scale food manufacturing is much more complex than small-scale home production.

Introducing additives into food is done to ensure that processed foods remain safe and in good condition throughout their journey from factories or industrial kitchens to warehouses and shops and ultimately to consumers.

Read too:E 211 – Sodium Benzoate

The use of food additives is only justified when their use has a technological need, does not mislead consumers and serves a well-defined technological function such as preserving the nutritional quality of food or enhancing the stability of food.

Food additives can be derived from plants, animals or minerals, or they can be synthetic. They are intentionally added to food to fulfil certain technological purposes. There are several thousand food additives in use, all of which are designed to perform a specific task, usually to make food more durable or appealing.

How many categories do food additives fall into?

The World Health Organization (WHO)³ has grouped food additives, based on their function, into 3 broad categories as follows:

Flavouring agents. These are added to foods to improve flavour or taste. Flavour enhancers are most commonly used in foods. There are hundreds of types of flavourings used in a wide variety of foods, from confectionery and soft drinks to cereals, cakes and yoghurt.
Enzymes or enzyme preparations. They can be obtained by extraction from plants or animal products or from micro-organisms such as bacteria and are used as alternatives to chemical-based technology.

Read too:E415 – Xanthan Gum

Enzyme preparations are mainly used in baking (to improve dough), fruit juices, wine and beer making (to improve fermentation) and cheese making (to improve curd formation).

Other additives. These are used for several reasons, such as: preservation, colouring and sweetening. They are added when food is being prepared, packaged, transported or stored and eventually become a component of the food.

How are food additives assessed for risk?

The World Health Organization (WHO), in cooperation with the Food and Agriculture Organization of the United Nations, are responsible for carrying out risk assessments of food additives. The risk assessment of food additives is carried out by the FAO/WHO Expert Committee on Food Additives (JECFA).

Only food additives that have undergone a JECFA safety assessment and do not pose a health risk to consumers may be used. This applies regardless of whether the food additives come from a natural source or are synthetic. JECFA evaluations are based on scientific analysis of all relevant biochemical, toxicological and other data on a particular additive.

National authorities, either on the basis of the JECFA assessment or on the basis of a national assessment, may then authorise the use of food additives.

The starting point for determining whether a food additive can be used without harm is to establish the acceptable daily intake. The recommended daily intake is an estimate of the amount of additive in food or drinking water that can be safely consumed daily over a lifetime without adverse health effects.

How do we know that foods contain food additives?

According to the World Health Organization³ , practices, standards and guidelines on food labelling are established globally. These standards are implemented in most countries and food manufacturers are obliged to indicate which additives are in their products. In the European Union, for example, there is legislation governing the labelling of food additives according to a set of predefined “E-numbers”. People with allergies or sensitivities to certain food additives should read labels carefully.

The World Health Organization encourages national authorities to monitor and ensure that food additives in foods and beverages produced in their countries comply with the uses, conditions and legislation.

Conclusions and Legislative Regulations E 129

In 2009 the EFSA working panel re-evaluated the use of Allura Red AC as a food additive. The Panel concluded that the present data set does not provide grounds to revise the ADI of 7 mg/kg bw/day.

The expert panel found that the specifications for Allura AC red need to be updated with regard to the percentage of sodium chloride and/or sodium sulphate as the main uncoloured components. The Panel found that the JECFA specification for lead is <2 mg/kg, while the EC specification is <10 mg/kg.[4]

Author:dr.ing. Ancuta Fulvia Manolache

Bibliographical references

[1] Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives

[2] Elena Oranescu, Food Additives-necessity and risk, SemnE Publishing House, 2005, Bucharest

[3] https://www.who.int/news-room/fact-sheets/detail/food-additives

[4] EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive on request from the European Commission. EFSA Journal 2009; 7(11):1327. [39 pp.]. doi:10.2903/j.efsa.2009.1327. Available online: www.efsa.europa.eu

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