Ponceau 4R
Encyclopedia
Ponceau 4R , SX purple) is a synthetic
colourant that may be used as a food colouring
. It is denoted by E Number
E124. Its chemical name is 1-(4-sulpho-1-napthylazo)- 2-napthol- 6,8-disulphonic acid, trisodium salt.
Ponceau 4R is a red azo dye which can be used in a variety of food products, and is usually synthesized from aromatic hydrocarbon
s from petroleum
.
). Additionally, it is a histamine
liberator, and may intensify symptoms of asthma
.
Ponceau 4R is considered carcinogen
ic in some countries, including the USA, Norway
, and Finland
, and it is currently listed as a banned substance by the U.S. Food and Drug Administration
(FDA). Since 2000, the FDA has seized Chinese-produced haw flakes
(a fruit candy) on numerous occasions for containing Ponceau 4R.http://web.archive.org/web/20090209160957/http://www.fda.gov/bbs/topics/ENFORCE/ENF00655.html
EFSA
has decided on 2009-09-23 to lower the Acceptable Daily Intake
(ADI) for Ponceau 4R from 4 mg
/kg
to 0.7 mg/kg bodyweight per day.
The substance causes increased migration of nuclear DNA in glandular stomach, bladder (≥ 100 mg/kg) and colon tissue (≥ 10 mg/kg). Clastogenic activity was seen in bone marrow at dosages equivalent to an intake ≥ 80 mg/kg, but no carcinogenic effects were noted.
The production process may result in unsulphonated aromatic amines to be present in concentrations of up to 100 mg/kg which may be linked to cancer
.
Also the EFSA panel noted that the JECFA
limit for lead
is ≤ 2 mg/kg whereas the EC
specification is ≤ 10 mg/kg. The colour additive can also increase the intake of aluminium
beyond the tolerable weekly intake (TWI) of 1 mg/kg/week. Therefore the limit for aluminum may become adjusted to accommodate for this.
revised advice on certain artificial food additives, including E124.
Professor Jim Stevenson from Southampton University, and author of the report, said: "This has been a major study investigating an important area of research. The results suggest that consumption of certain mixtures of artificial food colours and sodium benzoate preservative are associated with increases in hyperactive behaviour in children.
"However, parents should not think that simply taking these additives out of food will prevent hyperactive disorders. We know that many other influences are at work but this at least is one a child can avoid."
The following additives were tested in the research:
On 10 April 2008, the Foods Standard Agency called for a voluntary removal of the colours (but not sodium benzoate) by 2009. In addition, it recommended that there should be action to phase them out in food and drink in the European Union (EU) over a specified period.
The EFSA (European Food Safety Agency) has found the results of the Southampton study to be ambiguous and inconclusive and recommends no changes to current EU regulations pending results of further well designed testing of colourants.
UK ministers have agreed that the six colourings will be phased out by 2009.
Chemical synthesis
In chemistry, chemical synthesis is purposeful execution of chemical reactions to get a product, or several products. This happens by physical and chemical manipulations usually involving one or more reactions...
colourant that may be used as a food colouring
Food coloring
Food coloring is a substance, liquid or powder, that is added to food or drink to change its color. Food coloring is used both in commercial food production and in domestic cooking...
. It is denoted by E Number
E number
E numbers are number codes for food additives that have been assessed for use within the European Union . They are commonly found on food labels throughout the European Union. Safety assessment and approval are the responsibility of the European Food Safety Authority...
E124. Its chemical name is 1-(4-sulpho-1-napthylazo)- 2-napthol- 6,8-disulphonic acid, trisodium salt.
Ponceau 4R is a red azo dye which can be used in a variety of food products, and is usually synthesized from aromatic hydrocarbon
Aromatic hydrocarbon
An aromatic hydrocarbon or arene is a hydrocarbon with alternating double and single bonds between carbon atoms. The term 'aromatic' was assigned before the physical mechanism determining aromaticity was discovered, and was derived from the fact that many of the compounds have a sweet scent...
s from petroleum
Petroleum
Petroleum or crude oil is a naturally occurring, flammable liquid consisting of a complex mixture of hydrocarbons of various molecular weights and other liquid organic compounds, that are found in geologic formations beneath the Earth's surface. Petroleum is recovered mostly through oil drilling...
.
Health effects
Because it is an azo dye, it may elicit intolerance in people allergic to salicylates (aspirinAspirin
Aspirin , also known as acetylsalicylic acid , is a salicylate drug, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication. It was discovered by Arthur Eichengrun, a chemist with the German company Bayer...
). Additionally, it is a histamine
Histamine
Histamine is an organic nitrogen compound involved in local immune responses as well as regulating physiological function in the gut and acting as a neurotransmitter. Histamine triggers the inflammatory response. As part of an immune response to foreign pathogens, histamine is produced by...
liberator, and may intensify symptoms of asthma
Asthma
Asthma is the common chronic inflammatory disease of the airways characterized by variable and recurring symptoms, reversible airflow obstruction, and bronchospasm. Symptoms include wheezing, coughing, chest tightness, and shortness of breath...
.
Ponceau 4R is considered carcinogen
Carcinogen
A carcinogen is any substance, radionuclide, or radiation that is an agent directly involved in causing cancer. This may be due to the ability to damage the genome or to the disruption of cellular metabolic processes...
ic in some countries, including the USA, Norway
Norway
Norway , officially the Kingdom of Norway, is a Nordic unitary constitutional monarchy whose territory comprises the western portion of the Scandinavian Peninsula, Jan Mayen, and the Arctic archipelago of Svalbard and Bouvet Island. Norway has a total area of and a population of about 4.9 million...
, and Finland
Finland
Finland , officially the Republic of Finland, is a Nordic country situated in the Fennoscandian region of Northern Europe. It is bordered by Sweden in the west, Norway in the north and Russia in the east, while Estonia lies to its south across the Gulf of Finland.Around 5.4 million people reside...
, and it is currently listed as a banned substance by the U.S. Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA). Since 2000, the FDA has seized Chinese-produced haw flakes
Haw flakes
Haw flakes are Chinese sweets made from the fruit of the Chinese hawthorn. The dark pink candy is usually formed into discs one millimeter thick. Some Chinese people take the flakes with bitter Chinese herbal medicine.-History:...
(a fruit candy) on numerous occasions for containing Ponceau 4R.http://web.archive.org/web/20090209160957/http://www.fda.gov/bbs/topics/ENFORCE/ENF00655.html
EFSA
European Food Safety Authority
The European Food Safety Authority is an agency of the European Union that provides independent scientific advice and communication on existing and emerging risks associated with the food chain, created by European Regulation 178/2002....
has decided on 2009-09-23 to lower the Acceptable Daily Intake
Acceptable daily intake
Acceptable daily intake or ADI is a measure of the amount of a specific substance in food or drinking water that can be ingested on a daily basis over a lifetime without an appreciable health risk...
(ADI) for Ponceau 4R from 4 mg
Gram
The gram is a metric system unit of mass....
/kg
Kilogram
The kilogram or kilogramme , also known as the kilo, is the base unit of mass in the International System of Units and is defined as being equal to the mass of the International Prototype Kilogram , which is almost exactly equal to the mass of one liter of water...
to 0.7 mg/kg bodyweight per day.
The substance causes increased migration of nuclear DNA in glandular stomach, bladder (≥ 100 mg/kg) and colon tissue (≥ 10 mg/kg). Clastogenic activity was seen in bone marrow at dosages equivalent to an intake ≥ 80 mg/kg, but no carcinogenic effects were noted.
The production process may result in unsulphonated aromatic amines to be present in concentrations of up to 100 mg/kg which may be linked to cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
.
Also the EFSA panel noted that the JECFA
Joint FAO/WHO Expert Committee on Food Additives
The Joint FAO/WHO Expert Committee on Food Additives is a scientific expert committee that is jointly run by the United Nations Food and Agriculture Organization and the World Health Organization....
limit for lead
Lead
Lead is a main-group element in the carbon group with the symbol Pb and atomic number 82. Lead is a soft, malleable poor metal. It is also counted as one of the heavy metals. Metallic lead has a bluish-white color after being freshly cut, but it soon tarnishes to a dull grayish color when exposed...
is ≤ 2 mg/kg whereas the EC
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
specification is ≤ 10 mg/kg. The colour additive can also increase the intake of aluminium
Aluminium
Aluminium or aluminum is a silvery white member of the boron group of chemical elements. It has the symbol Al, and its atomic number is 13. It is not soluble in water under normal circumstances....
beyond the tolerable weekly intake (TWI) of 1 mg/kg/week. Therefore the limit for aluminum may become adjusted to accommodate for this.
Possible cause of hyperactivity
On 6 September 2007, the British Food Standards AgencyFood Standards Agency
The Food Standards Agency is a non-ministerial government department of the Government of the United Kingdom. It is responsible for protecting public health in relation to food throughout the United Kingdom and is led by a board appointed to act in the public interest...
revised advice on certain artificial food additives, including E124.
Professor Jim Stevenson from Southampton University, and author of the report, said: "This has been a major study investigating an important area of research. The results suggest that consumption of certain mixtures of artificial food colours and sodium benzoate preservative are associated with increases in hyperactive behaviour in children.
"However, parents should not think that simply taking these additives out of food will prevent hyperactive disorders. We know that many other influences are at work but this at least is one a child can avoid."
The following additives were tested in the research:
- Sunset yellow (E110Sunset Yellow FCFSunset Yellow FCF is a synthetic yellow azo dye, manufactured from aromatic hydrocarbons from petroleum. When added to foods, it is denoted by E Number E110...
) (FD&C Yellow #6) - Colouring found in squashes - Carmoisine (E122) - Red colouring in jellies
- Tartrazine (E102) (FD&C Yellow #5) - Yellow colouring
- Ponceau 4R (E124) - Red colouring
- Sodium benzoate (E211) - Preservative
- Quinoline yellow (E104) - Food colouring
- Allura red AC (E129) (FD&C Red #40) - Orange / red food dye
On 10 April 2008, the Foods Standard Agency called for a voluntary removal of the colours (but not sodium benzoate) by 2009. In addition, it recommended that there should be action to phase them out in food and drink in the European Union (EU) over a specified period.
The EFSA (European Food Safety Agency) has found the results of the Southampton study to be ambiguous and inconclusive and recommends no changes to current EU regulations pending results of further well designed testing of colourants.
UK ministers have agreed that the six colourings will be phased out by 2009.