April 14, 2016
Miles McEvoy
Deputy Administrator, National Organic Program (NOP)
1400 Independence Ave. SW, Room 2642-S
Mail Stop 0268
Washington, DC 20250-0268
RE: USDA-AMS-NOP (AMS-NOP-15-0085-0001, NOP-15-16); Department of Agriculture,
Agriculture Marketing Services; Notice of Public Meeting for the National Organic Science Board
Dear Mr. McEvoy,
On March 16, 2016, the Agriculture Marketing Service (AMS) announced a meeting of
the National Organic Science Board (NOSB) to assist the United States Department of
Agriculture (USDA) in the development of standards for substances to be used in organic
production and to advise the Secretary of Agriculture on any other aspects of the
implementation of Organic Foods Protection Act (OFPA) of 1990 (OFPA). In addition AMS
announced a notice for public comment, written and oral, to address topics noted on the
meeting agenda. The Natural Products Association (NPA) is submitting this white paper on
carrageenan as a general public written comment to docket AMS-NOP-15-0085-0001, NOP-1516 Department of Agriculture, Agriculture Marketing Services; Notice of Public Meeting for the
National Organic Science Board. The NPA was founded in 1936 to promote and protect the
unique values and shared interests of retailers and suppliers of natural nutritional foods and
natural products. The NPA is a non-profit 501(c)(6) association whose mission is to advocate for
USDA/NOSB April 14, 2016 2 the rights of consumers to have access to products that will maintain and improve their health,
and for the rights of retailers and suppliers to sell these products. We are the oldest and largest
trade association in the natural products industry representing over 1,400 members accounting
for almost 10,000 retail, manufacturing, wholesale, and distribution locations of natural products,
including foods, dietary supplements, and health/beauty aids. Thank you for the opportunity to
comment.
Executive Summary

Carrageenan should be permitted in organic foods and organic infant formula because it
is a safe direct food additive when used at levels presently found in foods

In the May 3, 2013 proposed rule from USDA AMS, carrageenan was allowed as a nonsynthetic substance permitted in organic foods

USDA AMS rejected the NOSB’s attempt to exclude carrageenan from organic infant
formula in the proposed rule

Carrageenan has a long history of safe use in foods

Carrageenan is allowed under 21 CFR 172.620 as a direct food additive

Carrageenan is considered Generally Recognized As Safe (GRAS) in accordance with
21 CFR 182.7255

The US Food and Drug Administration (FDA), the nation’s leading authority on food
safety issues, has never prohibited the use of carrageenan in infant formula. It is
permitted for use in infant formula by FDA’s Office of Nutrition and Labeling

The World Health Organization’s (WHO) Joint Expert Committee of Food Additives
(JECFA) concluded it is safe for food use and that it is not necessary to specify an
acceptable daily intake (ADI) limit

Carrageenan has received the highest rating granted by JECFA for any food ingredient

The European Economic Community recognized carrageenan for its safety and utility as
an approved emulsifier, stabilizer, thickening and gelling agent

Carrageenan is a natural product and is not carcinogenic, inflammation-provoking, nor
significantly absorbed by the gut

Oral feeding studies using non-human primate animal models (baboons) have shown no
adverse effects when raised from birth to 112 days on infant formula containing up to 5fold the level of carrageenan typically present in human infant formula
USDA/NOSB April 14, 2016 3 Background
The OFPA (7 U.S.C. 6501-6522) authorized establishment of the National List of
Allowed and Prohibited Substances (National List). The National List, a subpart within the USDA
organic regulations (7 CFR 205.600 through 205.607), identifies synthetic substances that may
be used in organic production and non-synthetic (natural) substances that are prohibited in
organic crop and livestock production. The exemption and prohibitions granted on the National
List are required to be reviewed every 5 years under the OFPA by the NOSB. The Secretary of
Agriculture has authority under OFPA to renew such exemptions and prohibitions. If substances
are not reviewed by the NOSB within 5 years of their inclusion on the National List and renewed
by the Secretary, their authorized use or prohibition expires. On June 1, 2011, the USDA AMS
published an Advanced Notice of Proposed Rulemaking (ANPR) (76 FR 31495) in the Federal
Register, announcing the NOSB’s review of exempted and prohibited substances due to sunset
in 2013. AMS subsequently posted these comments for public review and provided these
comments to the NOSB in advance of their review of these substances. At its November 2011
and May 2012 meetings, the NOSB reviewed a number of substances, including carrageenan,
under the 2013 Sunset review. On May 3, 2013 USDA published its proposed actions in the
Federal Register (78 FR 25879), pursuant to recommendations made available from the NOSB
regarding the status of carrageenan as a substance allowed in organic food.
Following their 2011 and 2012 meetings, the NOSB recommended, that carrageenan be
listed again as an allowed substance in foods labeled organic in the US; however, the NOSB
surprisingly recommended that carrageenan be excluded from use in organic infant formula.
NOSB gave safety concerns as their reasoning. NOSB also recommended to indicate specific
allowed forms of carrageenan by Chemical Abstract Service (CAS). In their proposed rule,
USDA decided to accept the NOSB recommendation to continue to allow carrageenan as a
non-synthetic substance permitted in organic food, but they decided to reject the NOSB
recommendation to exclude carrageenan from organic infant formula.
The NOSB justification to exclude carrageenan from organic infant formula was based in
part on the NOSB’s interpretation of a 2003 opinion of the European Commission’s Scientific
Committee for Food (SCF). In response to NOSB’s recommendations, the National Organic
Program (NOP) concluded that the NOSB erred in making its 2012 recommendation to restrict
USDA/NOSB April 14, 2016 4 the use of carrageenan and prohibit its use in organic infant formula, a recommendation based
solely on a statement about newborn infants expressed in 2003 by the SCF. The SCF reported
the following:
“Although there is no direct evidence of harm from carrageenan in infants and no
toxicologically significant effects were seen in infant baboons fed carrageenan in
commercial infant formulae for 16 weeks, high levels of reassurance are needed
to permit additives in infant formulae.”
SCF also concluded that “there is no evidence of any adverse effects in humans from exposure
to food-grade carrageenan, or that exposure to degraded carrageenan from use of food-grade
carrageenan is occurring.”
The National Organic Program (NOP), which is overseen by the Agricultural Marketing
Service (AMS), an agency of the US Department of Agriculture, noted these statements as well
as carrageenan’s status as a direct food additive and its safety when used in the amount
necessary as an emulsifier, stabilizer, or thickener in foods. Furthermore, the food safety
authority here, the US Food and Drug Administration (FDA) does not prohibit the use of
carrageenan in infant formula under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350(a)). Therefore, the NOP’s proposed rule allowed the continued use of carrageenan without
restriction.
Prior to a May 2012 NOSB meeting, the Handling Subcommittee conducted a review of
past NOSB recommendations, technical reports, historical documents, and public comments
and concluded that the available information indicates that the substance is:

essential for organic production,

compatible with organic production practices,

does not reveal unacceptable risks to the environment, human, or animal health
as a result of its use or manufacture1
Neither the Handling Subcommittee proposal submitted prior to the May NOSB meeting nor the
full NOSB issued a recommendation stating that carrageenan use in food should be prohibited.2
1
Handling Subcommittee Proposal on Carrageenan. February 21, 2012. Available at the NOP Web site
: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5097825&acct=nosb. USDA/NOSB April 14, 2016 5 NPA submits these comments to urge NOSB to continue to allow carrageenan in organic
foods and in organic infant formula. Carrageenan is a non-synthetic natural substance, which
fits within the scope of the NOP as a permitted organic food. Carrageenan is also permitted to
be used in foods as a direct food additive. AMS conducted an independent review which
included consultation with FDA to gain a detailed understanding of the relevant regulations
allowing for use of carrageenan in foods or infant formula. FDA, the food safety authority in the
US, continues to maintain that carrageenan is safe for use in foods and infant formulas as
codified in the federal regulations. If in the future FDA does issue a finding supporting a
prohibition of carrageenan in any or all foods, AMS has stated that it will take appropriate action
to come into alignment with other federal agencies with updated findings of toxicity. NPA has no
problems supporting a re-evaluation of carrageenan’s science in the future, but it has
consistently demonstrated a safe profile in human foods.
One of the missions of NPA is to urge the use of natural ingredient alternatives in lieu of
synthetic ones. Carrageenan is natural and reduces the need for synthetic food additives as
emulsifier, stabilizers, or thickeners in foods, including infant formula. NPA urges the NOSB to
evaluate carrageenan under the same lens as other venerable food safety authorities have,
including USDA and USFDA, and devoid of the emotional fears which are unsupported by
science. This negative rhetoric, while not based on science, has unjustly served to cloud
carrageenan’s clear demonstrated safety and discourage its use as a bona fide natural and
organic food additive. NPA urges the NOSB to recommend carrageenan’s current permitted use
in organic foods and organic infant formula.
What is Carrageenan?
The name “carrageenin” was originally coined in 1862 for the gelatinous material
extracted by water from certain seaweed algaes.3 Its name is derived from the Irish word,
“carraigeen,” meaning “rock moss”. Therefore, carrageenan in its raw, red seaweed form, is
sometimes called ‘Irish Moss,’ a common name for Chondrus crispus. The present spelling of
‘carrageenan’ has only come into the present lexicon over the past quarter century, as it was
2
NOSB Recommendation on Carrageenan. May 25, 2012. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5098921 3
Lewis JG, Stanley NF, Guist GG. (1988). Commercial production and application of algal hydrocolloids. In: Algae and human affairs (Lembi CA, Waaland JR (eds.)). Cambridge University Press, Cambridge, pp 205‐236. USDA/NOSB April 14, 2016 6 changed by the American Chemical Society to reflect the use of –an as an affix denoting the
presence of a polysaccharide.4
Carrageenan is a broad term typically used to describe a heterogeneous group of foodgrade sulfated polysaccharide polymers of galactose obtained from many different species of
seaweeds of the algae class Rhodophyceae. It does NOT include the non-food grade derivative
which is termed poligeenan. Food-grade carrageenan has been used in cooking for hundreds of
years as a thickening, stabilizing, emulsifying, and gelling agent. Three main types of
carrageenan are commercially available, which are known in the food industry as iota, kappa,
and lambda carrageenans. The difference between these types are not differences in the
chemical structure but rather composition and degree of sulfation at specific locations in the
polymer chain. Processed Eucheuma seaweed, which also comes from the Rhodophyceae
class, is also considered alongside “carrageenans” because it is derived from either E. cottonii
(kappa-carrageenan) or E. spinosum (lambda-carrageenan). Carrageenan, a substance with
hydrocolloid properties owing to sulfated polyglycan structure, has an average relative
molecular mass above 1000 kDa.
Uses of Carrageenan. Carrageenan has been used as a food stabilizer for hundreds of
years in or by different cultures around the world. Today thousands of seaweed family farmers
along the Atlantic coastal regions of the Northeast US and provinces of Canada and in Asia and
Africa rely on this naturally-occurring seaweed. In the US, the food additive “carrageenan” is
often used in dairy products and is an approved additive commonly used in kosher, halal and
foods certified as ‘organic’. In the Far East marine algae of the genus Eucheuma in the
Solieriaceae family have a long history of use as articles of food, for their supposed medicinal
properties in traditional medicines, and in trades such as bookbinding wherein their mucilage is
used as an adhesive.5,6 ,7 The Malayan word, “agar-agar” actually refers to the Eucheuma
species, which is known to yield carrageenans rather than agar-type polysaccharides.
Since their original identification and extraction from Irish moss (Chondrus crispus),
carrageenans have been found in seven different botanical families, including Solieriaceae,
Hypneaceae, Rhabdoniaceae, Phyllophoraceae, Gigartinaceae, Furcellariaceae, and
4
McHugh DJ (2003). A guide to the seaweed industry. Rome: FAO Fisheries Technical Paper No. 441. Eisses J. (1953). Seaweeds in the Indonesian trade. Indon J Nat Sci 1: 41‐56. 6
Zaneveld JS. (1955). Economic marine algae of tropical south and east Asia and their utilization. Spec Publ IPFC (3):55. 7
Zaneveld JS. (1959). The utilization of marine algae in tropical south and east Asia. Econ Bot 13: 89‐131. 5
USDA/NOSB April 14, 2016 7 Rhodophyllidaceae.8 While not all of these have been used commercially, present-day sources
of carrageenans extend beyond Irish moss. Seaweeds used for carrageenan production include
Chondrus crispus, C. ocellatus, Gigartina stellate, G. acicularis, G. pistillata, G. canaliculata, G.
chamissoi, G. radula (formerly Iridea spp.), G. skottsbergii, Gymnogongrus furcellatus,
Eucheuma cottonii, E. spinosum, E. gelatinae, Furcellaria fastigiata, Hypnea musciformis, and
H. spicifera. Condrus crispus is largely harvested along the coasts of Maine and Massachusetts
as the maritime Provinces of Canada.
In nature, carrageenans provide structural support for the spatial arrangement of plants.
The use of seaweed extracts for medicinal purposes can be traced back 600 years.9 Early food
uses of carrageenans began in Ireland 200 years ago when extracted seawood or “Irish moss”
was used to aid in the thickening and gelling of puddings. Although carrageenans were first
extracted in 1837, their structure was not determined until the mid-1950’s. Commercial product
of carrageenans began in the 1930’s in the United States. In Western societies, the algae
Chondrus crispus and sun-beached whole plants of Gigartina stellate have been used for
centuries in the manufacture of jellies and milk puddings (blanc mange).10
Carrageenans are used to gel, thicken, suspend or emulsify to enable stabilization,
syneresis control, bodying, binding, and dispersion. Most of its uses in foods have been
designed for dairy applications. The carrageenans of Chondrus crispus comprise both kappaand lambda-carrageenans, and is often the preferred application for chocolate milk stabilization.
Carageenan is unique in its ability at very low concentration (300 ppm) to suspend cocoa in
chocolate milk. No other gum has been found to equal the task. Carrageenan forms a delicate
milk gel structure, undetectable on pouring or drinking the milk, in order to hold the cocoa in
suspension. Typical dairy applications of carrageenan include frozen desserts (ice milk, ice
cream), pasteurized milk products (chocolate, eggnog, fluid skim milk, creaming mixture for
cottage cheese), sterilized milk products (chocolate, infant formulas), milk gels (custards,
8
Deslandes E et al., (1985). Evidence for lambda‐carrageenans in Solieria chrodalis (Solieriaceae) and Callibepharis jubata, C. ciliate and Cystoclonium purpureum (Rhodophyllidaceae). Bot Mar 28: 317‐318. 9
IARC. (1983). IARC Monographs on the evaluation of the carcinogenic risk of chemicals to humans. World Health Organization 31: 79‐94. 10
Smith HM. (1905). The utilization of seaweeds in the United States. Bull US Bur Fish 24: 169‐171. USDA/NOSB April 14, 2016 8 cooked flans, pudding/pie fillings), whipped products (whipped cream, aerosol whipped cream),
cold prepared milks (instant breakfast, shakes), and acidified milks (yogurt).11,12
Carrageenans specifically tailored for water-thickening applications are usually lambdatype or the sodium salt of mixed lambda and kappa. These extracts dissolve in either cold or hot
water to form viscous solutions. Typical water applications of carrageenan include dessert gels,
low-calorie jellies, pet foods (canned), fish gels, syrups, fruit drink powders and frozen
concentrates, relishes, pizza/barbecue sauces, imitation milk, imitation coffee creams, whipped
artificial toppings, non-dairy puddings, and toothpastes.9,10
Chemistry of Carrageenans. Carrageenans are hydrocolloid copolymers consisting of
potassium, sodium, magnesium, calcium and ammonium sulfate esters of D-galactose and 3.6anhydro-D-galactose. Hexoses are alternatively linked by α-1,3 and β-1,4 bonds in the polymer.
The major copolymers in carrageenans are designated as lambda, kappa or iota, depending on
the number and location of the sulfate moieties on the hexose backbone. The presence of pure
lambda, kappa or iota carrageenans rarely occurs in nature. Instead, units of each type of
copolymer are often mixed together. Because of their tendency to be found together, the
following definition of carrageenans has been developed by the industry as copolymers made
up of either more or less sulfated glactose units or of sulfated or non-sulfated
3,6anhydrogalactose units. These units are alternately linked in α-1,3 and β-1,4 positions in the
polymer. Since they contain half ester sulfate moieties they are strongly anionic polymers. In
this respect they differ from agars and alginates, the other two classes of commercially exploited
seaweed hydrocolloids.13
The molecular weight of the carrageenan polysaccharide polymer depends upon the
method of extraction from the seaweed starting material. For food applications, current industrial
water extraction produces food grade or carrageenan, known to have molecular weights ( >
100,000 daltons) in the typical range between 200,00–400,000 daltons. The Food Chemicals
11
Guiseley KB, Stanley NF, and Whitehouse PA. (1980). Carrageenan. In: Handbook of water‐soluble gums (RL Davidson, ed.). McGraw‐Hill Book Co. New York, pp.5‐1‐5‐30. 12
Moirano A. (1977). Sulfated seaweed polysaccharides. In: Food Colloids (HD Graham, ed.). AVI Publishing Co., Westport, CT. pp. 347‐381. 13
Agars, though also containing galactan polysaccharides, do not contain half‐ester sulfates and may be considered to be nonionic. Alginates, though anionic, are polymers of mannuronic and guluronic acids and as such owe their ionic character to carboxyl rather than sulfate groups. In this respect, alginates are more akin to the pectins found in land plants rather than to the copolymers of other seaweed hydrocolloids. USDA/NOSB April 14, 2016 9 Codex specifies the purity of commercial food grade carrageenan14 with an ester sulfate content
between 18% and 40%.
At times the safety of carrageenan has been questioned owing to confusion with
degraded carrageenan, which is derived by extensively depolymerizing carrageenan in the
presence of acid and high heat. Prior to 1988, “degraded carrageenan’ and poligeenan were
used interchangeably,15,16 and the terms caused confusion because negative observations
associated with poligeenan/degraded carrageenan were attributed incorrectly to ‘carrageenan’.
Therefore, food grade carrageenan has often been confused with ‘degraded carrageenan’,
which is not food-grade.17 Poligeenan’s low molecular weight precludes it from exhibiting
functionality and applicability in food because it lacks the viscosity and gelling properties of food
additives like carrageenans.
Poligeenan is a low viscosity, low molecular weight (10-20 kDa), sulfated polygalactan
polymer used exclusively in clinical diagnostic applications. Its polymeric structure is derived
from the backbone of carrageenan; however, poligeenan is NOT an approved food additive in
the US. Poligeenan and carrageenan are completely different products. Non-food grade or
degraded carrageenan has been officially termed poligeenan by the United States Adopted
Names (USAN) Council, which is sponsored by the American Medical Association, the
American Pharmaceutical Association, and the US Pharmacopoeial Convention, so as not to
confuse their chemistry with that of food grade carrageenans. USAN published a monograph on
poligeenan that characterizes the chemistry of this non-food grade product. The International
Agency for Research on Cancer assigned poligeenan to carcinogenic risk category 2B (possibly
carcinogenic to humans).18 Poligeenan was ironically researched for treating peptic ulcers, but
is recognized today for its toxicity and lack of utility for the food industry.
Toxicity of Carrageenan
14
Food Chemicals Codex. (1983). Food Chemicals Codex, 3rd edition. National Academy Press. Washington, DC. pp. 74‐75. 15
Beattie IA, Blakemore WR, Dewar ET, and Warwick MH. (1970). A study of orally‐administered degraded ccarrageenan in the baboon. Food Cosmet Toxicol 8: 257‐266. 16
Beattie IA, Blakemore WR, Dewar ET, and Warwick MH. (2014). Corrigendum to “A study of orally‐administered degraded carrageenan in the baboon” [Food Cosmet Toxicol 8 (1970) 257‐266]. Food Chem Tox 75: 189. 17
United States Adopted Names Council (USAN). (1988). List no. 297 new names, poligeenan. Clin Pharmacol Ther 44: 246‐248. 18
IARC. (2014). IARC Monographs on the Evaluation of Carcinogenic Risks to Human. World Health Organization Internal Report 14/002, Lyon, France, April 18‐19. USDA/NOSB April 14, 2016 10 All compounds exhibit toxicity. Instead, it depends on the dose/level of exposure as to
whether it is safe for human consumption. A number of animal models have been used to
evaluate the acute toxicity of food grade carrageenan, and the following toxicities have been
reported for carrageenan: 19

Acute oral toxicity (rat), LD50 > 5,000 mg/kg

Acute dermal toxicity (rabbit), LD50 > 2,000 mg/kg

Acute inhalation toxicity (rat), 4-hr LC50 > 930.8 ± 74.4 mg/m3

Non-sensitizing to skin (guinea pig)
Carrageenan has shown not to be teratogenic.20,21,22 A study conducted on rats and hamsters at
the Eppley Institute for Cancer Repesearch demonstrated that carrageenans are not
carcinogenic. An early review of the physiological effects of carrageenans has been published.23
Carrageenan toxicity was reviewed by WHO’s JECFA at its thirteenth,24 seventeenth,25
twenty-eighth,26 fifty-first,27 fifty-seventh,28 sixty-eighth,29 and now seventy-ninth meeting.30
Following reports of cecal and colonic ulceration in guinea pigs and rabbits induced by a highly
19
Weiner ML, Freeman C, McCarty JD, and Fletcher MJ. (1989). Acute toxicity of carrageenan, V. Int Cong Toxicol 52: July 16‐21, 1989. 20
Collins TFX, Black TN, and Prew JH. (1977). Long term effects of calcium carrageenan in rats. 1. Effects on reproduction. Food Cosmet Toxicol 15: 533‐538. 21
Collins TFX, Black TN, and Prew JH. (1977). Long term effects of calcium carrageenan in rats. 2. Effects on fetal development. Food Cosmet Toxicol. 15: 539‐545. 22
Collins TFX, Black TN, and Prew JH. (1979). Effects of calcium and sodium Carrageenans and iota‐carrageenan on hamster foetal development. Food Cosmet Toxicol. 17: 443‐449. 23
Stancioff DJ and Renn DW. (1975). Physiological effects of carrageenan. In: Physiological effects of food carbohydrates, A Jeans and J Hodge, eds.) American Chemical Society Washington, DC, pp. 282‐295. 24
JECFA. (1970). Specifications for the identity and purity of food additives and their toxicological evaluation: some food colours, emulsifiers, stabilizers, anticaking agents, and certain other substances. Thirteenth report of the Joint FAO/WHO Expert Committee on Food Additives. FAO Nutrition Meetings Series No. 46. WHO Technical Report Series, No. 445. 25
JECFA. (1974). Toxicological evaluation of certain food additives with a review of general principles and of specifications. Seventeenth report of the Joint FAO/WHO Expert Committee on Food Additives. FAO Nutrition Meetings Series No. 53. WHO Technical Report Series, No. 539 and corrigendum. 26
JECFA. (1984). Evaluation of certain food additives and contaminants. Twenty‐eighth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series, No. 710 and corrigendum. 27
JECFA. (2000). Evaluation of certain food additives. Fifty‐first report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series, No. 891. 28
JECFA. (2002). Evaluation of certain food additives and contaminants. Fifty‐seventh report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series, No. 909. 29
JECFA. (2007). Evaluation of certain food additives and contaminants. Sixty‐eighth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series, No. 947. 30
JECFA. (2015). Safety evaluation of certain food additives. Seventy‐ninth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Food Additive Series, No. 70. USDA/NOSB April 14, 2016 11 degraded carrageenan provided, ironically, for the symptomatic relief and cure of peptic and
duodenal ulcers in man, intensive investigations into the safety of carrageenans were carried
out by the FDA and other groups. By late 1976, food-grade carrageenan, defined as having a
water viscosity of no less than 5 mPa.s at 1.5% concentration and 75 °C,31 had been
demonstrated to be safe. In 1984, JECFA, a working group of the Codex Alimentarius
Commission of the WHO (FAO/WHO), completed their intensive toxicological review of
carrageenan. JECFA established an Acceptable Daily Intake (ADI) “not specified” at its twentyeighth meeting on the basis of the results of a number of toxicological studies on carrageenans
obtained from various sources. The committee, which included expert toxicologists from around
the world, confirmed that carrageenan could be safely used in food and that it was unnecessary
to specify an ADI.32 At the fifty-first meeting in 2000, JECFA concluded that both the toxicities of
processed Eucheuma seaweed and carrageenan were sufficiently similar. They concluded that
the ADI “not specified” status would be extended, pending clarification from rodent studies on
tumor promotion of known experimental colonic carcinogens by carrageenan. A summary of
those tumor promotion studies is found below.
The safety of carrageenan for use in foods was confirmed once again at the fifty-seventh
meeting of JECFA in Rome in June 2001. JECFA once again recommended an ADI of “not
specified”. This recommendation of the Committee was made after a review of all of the current
toxicology and carcinogenicity studies on carrageenan by Drs. Cohen and Ito, two of the world’s
experts in the field.33 It also included consideration of studies not cited by Tobacman in her 2001
review. Despite the emotional arguments surrounding carrageenan and unsubstantiated science
to support those beliefs, carrageenan is still considered to be safe by the world’s leading
authorities on food safety. It is unclear to NPA how any scientist is unwilling to evaluate the
totality of evidence which supports the safe use of carrageenan. Dr. Tobacman instead
castigates the US FDA in her own words as having “ignored the harmful potential of
carrageenan for over 20 years.”34 It would be a huge federal crime, one of conspiracy and
cover-up, for FDA to ignore supposed mountains of evidence linking carrageenan to human
31
U.S. Food and Nutrition Board. (1981). Committee on Codex Specification, Carrageenan. In: Food Chemicals Codex, 3d ed. National Academy Press, Washington, DC. pp. 74‐75 32
JECFA. (1984). Evaluation of Certain Food Additives and Contaminants (E407—Carrageenan). Twenty‐eighth report of the Joint FAO/WHO Expert Committee on Food Additives. World Health Organization Technical Report Series 710. Geneva, Switzerland. 33
JECFA. (2001). Summary and conclusions. Fifty‐seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives, Rome, June 5‐14. 34
Tobacman J. (2002). Carrageenan in foods: response. Environ Health Persp (Correspondence) 110: A176‐177. USDA/NOSB April 14, 2016 12 toxicity. NPA believes there is a lack of understanding regarding the regulatory framework for
foods as well as a lack of evidence to demonstrate clear toxicity for an overall burden of proof.
Regulatory agencies have been critical of Dr. Tobacman’s research methods. In their response
to Dr. Tobacman’s papers, the European Commission Scientific Committee for Food concluded
that it “did not support the hypothesis that breast cancer may be causally related to intakes of
carrageenan and other water-soluble polymers used as food additives. The committee noted
that such correlations might be found for any dietary component or chemical to which there has
been increasing exposure during the twentieth century.”35 Europe’s SCF also found nothing new
in Dr. Tobacman’s manuscripts that had not already been considered in determining the safety,
purity criteria, and ADI status for carrageenan.
Carrageenan and Gut Toxicity. The question of whether dietary carrageenan passes
through the body without effect or provokes an inflammatory response in humans is an import
aspect to the NOP decision. Despite arguments to the contrary in social media and blogs, oral
feeding studies confirm that carrageenan in food passes through the human body essentially
unaltered. It is not significantly absorbed, is non-carcinogenic, does not induce tumor formation
in the colon, and does not induce gastrointestinal (GI) tract inflammation.36 Studies indicate
carrageenan passes through the body quantitatively.37,38 Male and female infant baboons show
no adverse effects when raised from birth to 112 days on infant formula containing up to 5x the
level of carrageenan typically present in human infant formula.39 Multi-generational studies with
rats fed up to 5% carrageenan show no adverse effects.40,41 Lifetime studies of rats and
hamsters fed up to 5% carrageenan show no adverse effects.42 A 40-week study of rats fed up
35
Scientific Committee on Food (2003a). Opinion of the Scientific Committee on Food on carrageenan. Brussels: European Commission; 5 March. (SCF/CS/ADD/EMU/199 Final). 36
Weiner ML, Nuber D, Blackemore WR, Harriman JF, and Cohen SM. (2007). A 90‐day dietary study on kappa carrageenan with emphasis on the gastrointestinal tract. Food Chem Tox 45: 98‐106. 37
Uno Y, Omoto T, Goto Y, Asai I, Nakamura M, and Maitani T. (2001). Molecular weight distribution of carrageenan studies by a combined gel permeation/inductively coupled plasma (GPC/ICP) method. Food Add Contam 18: 763‐772. 38
Tomarelli RM, Tucker WD Jr, Bauman LM, Savini S, and Weaber JR. (1974). Nutritional qualities of processed milk containing carrageenan. J Agric Food Chem 22: 819‐824. 39
McGill HC Jr., McMahan CA, Wigodsky HS, and Sprinz H. (1977). Carrageenan in formula and infant baboon development. Gastroent 73: 512‐517. 40
Collins TFX, Black TN, and Prew JH. (1977). Long term effects of calcium carrageenan in rats. 1. Effects on reproduction. Food Cosmet Toxicol 15: 533‐538. 41
Collins TFX, Black TN, and Prew JH. (1977). Long term effects of calcium carrageenan in rats. 2. Effects on fetal development. Food Cosmet Toxicol 15: 539‐545. 42
Rustia M, Shubik P, and Patil K. (1980). Lifespan carcinogenicity tests with native carrageenan in rats and hamsters. Cancer Lett 11: 1‐10. USDA/NOSB April 14, 2016 13 to 5% carrageenan in the diet shows no adverse effects.43 A 90-day study of rats fed up to 5%
carrageenan (and containing 7% mean low molecular weight tail) showed no adverse effects.44
Studies indicate that carrageenan passes through the GI tract tightly bound to proteins in
ingested foods. The unique structure of carrageenan resembles that of cellulose, which is not
recognized by the enzymes of the human digestive tract. Acid hydrolysis does not occur either
because studies indicate that the conditions necessary to break down carrageenan do not exist
in the GI tract.
A 2001 review of carrageenan by Tobacman45 raised questions about the toxicity of
carrageenan on the GI tract. The concern was really over the potential for degraded
carrageenan (low molecular weight), or poligeenan, to be formed by acid hydrolysis in the
stomach and the possibility that this material could promote cancer of the colon. The lines of
evidence in rodents were that 1) rats fed degraded carrageenan have been shown to develop
colorectal tumors;46 and 2) studies involving tumor initiation with the genotoxic carcinogen
azoxymethane suggested that degraded carrageenan has the potential to promote colon cancer
in rats.47 These findings led to degraded carrageenan being classified by the International
Agency for Research on Cancer (IARC) as 2B, a possible human carcinogen, based on animal
studies. Native carrageenan (not degraded) has been classified by IARC as 3, which is
unclassifiable with respect to carcinogenicity in humans. To determine whether the rodent data
could be extrapolated to humans, Taché et al used a highly sensitive aberrant crypt assay to
examine the potential for carrageenan to promote azoxymethane-induced colonic cancer in
human flora-associated rats.48 In other words, rats with human gut flora were compared with
rats of normal rodent microbiologic flora to determine if gut flora in rodents is the cause of tumor
promotion. They found no tumor promoting effect of carrageenan in rats containing human gut
microbes, but use of normal rodent flora confirmed their earlier finding of tumor promotion.
43
Abraham R, Benitz KF, Mankes R, and Rosenblum I. (1985). Chronic and subchronic effects of various forms of carrageenan in rats. Ecotoxicol Environ Saf 10: 173‐183. 44
Weiner ML, Nuber D, Blakemore WR, Harriman JF, and Cohen SM. (2007). A 90‐day dietary study on kappa carrageenan with emphasis on the gastrointestinal tract. Food Chem Toxicol 45: 98‐106. 45
Tobacman JK. (2001). Review of harmful gastrointestinal effects of carrageenan in animal experiments. Environ Health Perspect 109: 983‐994. 46
Ishioka T, Kuwabara N, Oohashi Y, Wakabayashi K. (1987). Induction of colorectal tumors in rats by sulfated polysaccharides. CRC Crit Rev Toxicol 17: 215‐244. 47
Corpet DE, Taché S, Preclare M. (1997). Carrageenan given as a jelly, does not initiate, but promotes the growth of aberrant crypt foci in the rat colon. Cancer Lett 114: 53‐55. 48
Taché S, Peiffer G, Millet AS, and Corpet DE. Carrageenan gel and aberrant crypt foci in the colon of
conventional and human flora-associated rats. Nutr Cancer 37: 193-198. USDA/NOSB April 14, 2016 14 These studies but the entire issue of the risk of tumor promotion to rest because the
carrageenan was administered in drinking water and therefore was available for degradation in
the acidic environment of the stomach. Therefore, the cancer-promoting effect demonstrated
from the earlier study was a rodent-specific phenomenon, requiring a full complement of rat
microbial flora. It was evident that carrageenan does not promote colonic tumors in humans.
Dr. Tobacman continues to cite two FDA studies in the early 1970s using rhesus
monkeys49,50 as her basis to castigate carrageenan as a dangerous harbinger of gut
inflammation. Dr. Tobacman continues to confuse the suspected toxicity of poligeenan with the
lack of any toxicity of carrageenan.51,52,53 It was not until 1983 that commercial food-grade
standards for carrageenan were finalized by the Food Chemicals Codex.54 Today, food-grade
carrageenan sold by industry is in range between 200,00–400,000 daltons with an ester sulfate
content between 18% and 40%. The material used in the 1970s was hardly food-grade
carrageenan, defined for use as a direct food additive today. Failure to use material sold in
commerce in any toxicology study can lead to erroneous findings and emotional hysteria, which
do not have any place in regulatory science. This was certainly the case in 2013 with a recent
choice by the National Toxicology Program (NTP), a branch of the National Institute of
Environmental Health Science (NIEHS), which opted to test non-decolorized whole leaf extract
of aloe vera, which has never been sold in commerce, for evidence of toxicity and
carcinogenesis.55 Decolorized or charcoal-filtered aloe, which is sold commercially, does not
exhibit the same toxicity.
Ulcerative colitis became highlighted as a potential issue for carrageenan. Carrageenan
has been used to induce inflammation in known susceptible animal models to test the antiinflammatory properties of new candidate drugs. In these drug studies, liquid, non-gelling type of
49
Informatics, Inc. (1972). Monograph on Carrageenan. Vol 1. TR‐72‐1552‐03. Rockville, MD. Benitz K‐F, Goldberg L, and Coulston F. (1973). Intestinal effects of carrageenans in the rhesus monkey (Macaca mulatta). Food Cosmet Toxicol 11: 565‐575. 51
Cohen S and Ito N. (2002). A critical review of the toxicological effects of carrageenan and processed Eucheuma seaweed on the gastrointestinal tract. Crit Rev Toxicol 32: 413‐444. 52
Weiner ML, Nuber D, Blakemore WR, Harriman JF, and Cohen SM. (2007). A 90‐day dietary study on kappa carrageenan with emphasis on the gastrointestinal tract. Food Chem Toxicol 45: 98‐106. 53
Carthew P. (2002). Safety of carrageenan in foods. Environ Health Perspect 110: A176. 54
Food Chemicals Codex. (1983). Food Chemicals Codex, 3rd edition. National Academy Press. Washington, DC. pp. 74‐75. 55
NTP. (2013). Toxicology and carcinogenesis studies of a nondecolorized whole leaf extract of Aloe barbadensis Miller (aloe vera) in F344/N rats and B6C3F1 mice (drinking water studies). NTP Technical Report TR 577, NIH Publication No. 13‐5910. 50
USDA/NOSB April 14, 2016 15 carrageenan is frequently used to induce inflammation by subcutaneous injection in animal
models for investigation of the inflammation process and the effects of anti-inflammatory drugs.
Approved use of carrageenan as a food involves oral ingestion, not subcutaneous injection.
Effects of injection of carrageenan into tissues or into the blood of animals are irrelevant in
discussions of carrageenan food safety. These methods bypass the normal limits on ingestion
present in the GI tract. While guinea pigs are sensitive to the induction of colitis by carrageenan,
nonhuman primates (NHPs) are resistant to the same induction of colitis by carrageenan. Most
scientists consider NHPs to be a more appropriate animal model for comparison and
approximation to humans. Therefore, any extrapolation of carrageenan-induced ulcerative colitis
data from rodent models to humans is inappropriate when NHP data is available. The only
conclusion one can draw from the ulcerative colitis studies is that rodents are not the most
appropriate animal model to study the effect of carrageenan on gut inflammation as they do not
produce or predict the null result found in primates.
Based upon the lack of gastrointestinal toxicity or carcinogenic effect, USDA AMS was in
position to accept NOSB’s recommendation to renew the listing of carrageenan, which meets
the requirements under the OFPA (7 U.S.C. 6501-6522), at its twenty-eighth, fifty-first, fiftyseventh, sixty-eighth, and seventy-ninth meetings. USDA and FDA have concluded that there is
no information clearly demonstrating that there is evidence for a carcinogenic effect for food
grade carrageenan use in foods or infant formula. The available research supports the
conclusion that food grade carrageenan is safe. Furthermore, thorough reviews by independent
scientific organizations like JECFA is an unbiased way of evaluating the relevant state of the
science of this organic food additive. WHO JECFA concluded that carrageenan is safe at levels
already permitted for use in foods. Numerous regulatory agencies have also consistently
determined carrageenan to be safe, non-carcinogenic, and lacking any hazards to human
health. This scientific consensus is not only USFDA but also includes the United Nations’ Food
and Agriculture Organization, WHO, European Commission’s SCF, European Food Safety
Authority (EFSA), as well as regulatory agencies from China, Japan, and Brazil.
Carrageenan and Infant Formula. As breastfeeding rates of new mothers declined in the
1960s and 1970s, the reliance on infant formulas skyrocketed. This prompted a greater
scientific understanding of nutrition in newborns among clinicians and a much closer scrutiny
USDA/NOSB April 14, 2016 16 over all ingredients in infant formula products by regulatory agencies. 56,57 Carrageenan had
been used in the US since the late 1950s in liquid infant formulas to prevent fat separation and
thereby assure more uniform nutrition. In 1972, FDA reviewed carrageenan because of the
studies of two researchers several years prior who set out to look into the cause of peptic ulcers
in guinea pigs with carrageenan.58 They found that only at very high doses both hydrolysed
(degraded) and unhydrolyzed (non-degraded) carrageenan, the type used in food, could
produce ulcerations in the guinea pig cecum. Ulceration was found to be much more
pronounced with hydrolyzed (degraded) carrageenan. They speculated that this ulceration was
a precursor and therefore surrogate market for ulcerative colitis. FDA’s 1972 review of
carrageenan in liquid infant formula highlighted the benefits over any risks to infants from
degraded carrageenan. Europe has a different threshold for allowing natural substances in
commercial infant formula. Carrageenan has not been permitted as a food additive for baby
formula since 1992 in Europe because the United Kingdom’s Food Advisory Committee requires
high levels of assurance to permit additives in infant formula, and any perception of risk for
infants is enough to warrant a zero tolerance policy. The Committee did concluded the following:

No direct evidence of harm from carrageenan in infants

No toxicologically significant effects seen in infant baboons fed carrageenan in
commercial infant formula for 16 weeks
At their seventy-ninth meeting in 2015, JECFA reviewed data published since the sixty-
eighth meeting in 2007, focusing on data of relevance to the safety assessment of the use of
carrageenan in infant formula. The use levels requested for carrageenan ranged from 90 to
1000 mg/L, with 300 mg/L as a typical use level for a standard infant formula and higher levels
up to 1000 mg/L for liquid formulas for special medical purposes containing hydrolysed protein
or amino acids. The Committee also considered a toxicological dossier on carrageenans from
the Philippines59 as well as a commentary on studies by the Tobacman lab.60 The Committee
56
Wolf JH. (2003). Low breastfeeding rates and public health in the United States. Am J Public Health 93: 2000‐
2010. 57
Murphy E. (2004). Risk, maternal ideologies and infant feeding. In: The social appetite: an introduction to the sociology of food and nutrition (L Williams and J Germov, eds.) Oxford University Press, Melbourne, pp 200‐219. 58
Marcus AJ and Watt J. (1969). Ulcerative colitis in the guinea‐pig caused by seaweed extract. J Pharmaceut Pharmacol 21: 187. 59
Republic of the Philippines. (2013). Response to the Joint FAO/WHO Expert Committee on Food Additives request for data for the seventy‐ninth meeting. Carrageenan (INS 407). Dossier prepared by FMC Corporation, Philadelphia, PA, USA, and the International Formula Council. Submitted to WHO by the Republic of the Philippines. USDA/NOSB April 14, 2016 17 evaluated new evidence from neonatal pig and minipig animal models, both of which were
deemed appropriate models for the young human infant up to at least 12 weeks of age. The
NOAEL derived from the neonatal pig study (430 mg/kg bw per day) was found to be almost
identical to that from the earlier infant baboon study of 432 mg/kg bw per day. The Committee
concluded the following:
“From these new investigations, there was no evidence of any inflammation in
the gut or any effects on immune parameters. … The Committee noted that
although the MOEs [margin of exposure] are small in magnitude, they are
derived from a neonatal pig study in which the highest dose tested was without
adverse effects on the gut or on immune parameters, supported by a neonatal
minipig study. … These new studies allay the earlier concerns that carrageenan,
which is unlikely to be absorbed, may have a direct effect on the immature gut.
The Committee also took account of the previous toxicological database on
carrageenan, which did not indicate other toxicological concerns. The Committee
concluded that the use of carrageenan in infant formula or formula for special
medical purposes at concentrations up to 1000 mg/L is not of concern.”61
NPA supports the review of the available toxicology research on carrageenan in infant formula
by JECFA, including their calls for data requests. NPA supports their evaluation of the totality of
the evidence regarding the safety of carrageenan in infant formula on the immature gut. It is
clear from the evidence that carrageenan at levels found in foods and infant formula is safe for
human consumption. There are no observed adverse effects on the intestines or other organ,
which would prompt a ban in either organic foods or infant formula. Time will tell whether EFSA
and Europe will follow suit and permit carrageenan for use in infant formula based upon these
latest investigations and most recent JECFA Committee report. For these reasons and based
our own review of the literature, carrageenan should be allowed in organic foods and organic
infant formula at the doses recommended and specifications set by JECFA.52,62
60
Tobacman J.K. (2013). Response to the call for data on carrageenan. Department of Medicine, University of Illinois at Chicago, Chicago, IL, USA, 19 November 2013. 61
JECFA. (2015). Safety evaluation of certain food additives. Seventy‐ninth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Food Additive Series, No. 70. pp 39. 62
JECFA. (2007). Evaluation of certain food additives and contaminants. Sixty‐eighth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series, No. 947. USDA/NOSB April 14, 2016 18 In Vitro Studies. A number of in vitro studies on carrageenan have been conducted by
Tobacman et al. and other groups to evaluate inflammatory pathways. It is not our intention to
evaluate each single in vitro study performed on carrageenan because these studies lack
applicability in humans. Studies bathing isolated cell lines or tissues with solutions of
carrageenan for prolonged periods of time in an incubator does not reflect the native state.
These studies are designed to determine a mechanism of action to explain what is observed in
vivo. However, inflammation does not occur in vivo in NHPs or humans. It is also noteworthy
that most of these studies have come from a single laboratory with the belief that carrageenan
can bind to and activate cellular activities to trigger inflammation, diabetes, breast cancer and
immune responses. While it is not uncommon for investigators to document interesting in vitro
findings, it should be communicated to the lay public that these in vitro cell models have little or
no relationship to events in intact animals or humans.
Semicarbazide and Carrageenan. The discovery of semicarbazide (SEM), a known
weak mutagen, in carrageenan63 started another controversy that quickly died out within 2
years. During this time, a zero tolerance level was in place for SEM in foods by FDA. Therefore,
its discovery in baby food fed a frenzy of scientific activity.64 Scientists have subsequently
demonstrated that SEM has only weak mutagenic activity and poses no risk to humans in the
amounts likely to be consumed.63,64,65,66 In fact, the EFSA, European Commission, and the
WHO/UN FAO have all declared that, based on levels reported in food, the health risk, if any, to
consumers, including infants, of SEM consumption from foods appears to be very small.67 In
their 2003 press release, EFSA conclude that there is “[n]o reason to change current dietary
habits including for babies” regarding semicarbazide found in food.68 An ad hoc expert group
was asked by EFSA to advise further on possible risks to infants given that this is the consumer
group for which potential exposure to semicarbazide on a body weight basis was likely to be the
63
Hoenicke K, Gatermann R, Hartig L, Mandix M, and Otte S. (2004). Formation of semicarbazide (SEM) in food by hypochlorite treatment: is SEM a specific marker for nitrofurazone abuse? Food Add Contam 21: 526‐537. 64
Hoenicke K and Gatermann R. (2006). How can zero tolerances be controlled? The case study of Nitrofurans. Accreditation and quality assurance. J Qual Comparabili Reliabil Chem Meas 11: 29‐32. 65
Abramsson‐Zetterberg L and Svensson K. (2005). Semicarbazide is not genotoxic in the flow cytometry‐based micronucleus assay in vivo. Toxicol Letter 155: 211‐217. 66
AFC Panel. (2005). Opinion of the scientific panel on food additives, flavourings, processing aids and materials in contact with food on a request from the commission related to semicarbazide in food. EFSA J 219: 1‐36. 67
World Health Organization. (2007). Semicarbazide. Available at http://www.who.int/foodsafety/chem/sem/en/index.html. 68
European Food Safety Authority. (2003). Press Release. EFSA gives update on semicarbazide: no reason to change current dietary habits including for babies. Precautionary action by industry recommended for baby foods. Available via: http://www.efsa.europa.eu/en/press/news/afc031015. USDA/NOSB April 14, 2016 19 highest. The expert group reiterated that while they urge a reduction by industry in the amount
of SEM, formed during the heat treatment of an approved blowing agent (azodicarbonamide) to
make sealing gaskets in lids of glass jars, in baby food jars and other foods, they urged no
immediate action on the part of consumers or retailers regarding SEM in baby foods and other
foods packed in glass jars and bottles. Despite all of these concerns, suspicions of risk, and
public inquiries, carrageenan is still regulated as safe.
Regulatory Status of Carrageenan
Carrageenan is widely used as a food additive69,70 and is approved for use as a food
additive in the US71,72 Before it was a food additive, extracts of Chondrus crispus (carrageenin)
were GRAS substances. Chondrus extract was grandfathered by the 1958 Miller amendment to
the US Food and Drug Act of 1938 through its previous history of safe use in foods. As GRAS
substances, Chondrus extract was permitted for use in food under section 21 CFR 182.7255.
Since the GRAS status only reflected one source of carrageenan, limited supply of C. crispus
led industry to explore other seaweed species. Marine Colloids Inc. petitioned the FDA to alter
the GRAS listing and permit all carrageenan to be defined by its chemistry, rather than the
seaweed source. FDA agreed to expand the seaweeds designated as sources for extraction of
carrageenan. Therefore, FDA moved to list carrageenan as a direct food additive under section
21 CFR 172.620. There is still confusion over FDA’s use of the terms “carrageenin” and
“carrageenan” in GRAS and food additive regulations as no attempt was ever made to
harmonize the two terms.
While it has been officially sanctioned for use in foods, carrageenan has been the
subject of intense scrutiny for potential health risks associated with human consumption. The
scrutiny has led to wild accusations that are not backed by science but rather emotion and
public fears that are unfounded. Many regulatory authorities and independent scientific advisory
69
Bixler HJ. (1996). Recent developments in manufacturing and marketing carrageenan. Hydrobiologia 326/327: 35‐57. 70
Shah ZC and Huffman FG. (2003). Current availability and consumption of carrageenan‐containing foods. Ecol Food Nutr 42: 357‐371. 71
http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm091048.htm (accessed April 6, 2016.) 72
*Carrageenan and its ammonium, calcium, potassium, or sodium salts ‐ STAB, REG, GMP, In foods, except for those standardized food that do not provide for such use ‐172.620, 172.626; STAB, REG/FS, <0.8% by wt of finished cheese ‐ Part 133, various sections, Cheese Prdts **Carrageenan or carrageenan salts with Polysorbate 80 ‐MISC, REG, 500 ppm polysorbate 80 in final food contain‐
ing the additives ‐ For producing foods in gel form ‐ 172.623 (See 172.620, 172.626, & 172.840 for specifications) USDA/NOSB April 14, 2016 20 committees have maintained the long-standing position that carrageenan is safe for human
consumption. The following organization have approved carrageenan’s use in foods.

Carrageenan is listed by the US Food and Drug Administration (FDA) as Generally
Recognized as Safe (GRAS)73, in accordance with 21 CFR 182.7255

approved for use as a food additive by the US FDA74 in accordance with 21 CFR
172.620

Permitted for use in infant formula in the US by FDA75

It is listed in the ‘Everything Added to Food in the United States’ (EAFUS) database76

European Parliament and Council77,78

World Health Organization’s Joint Expert Committee of Food Additives (JECFA)
concluded it is safe for food use and that it is not necessary to specify an ADI limit,79 the
best rating granted by JECFA for any food ingredient

The European Economic Community recognized carrageenan for its safety and utility as
an approved emulsifier, stabilizer, thickening and gelling agent, as referenced by the
designation of E-40780,81

Food and Agriculture Organization Expert Committee on Food Additives82
Conclusion
73
U.S. Food and Drug Administration. (1979). Carrageenan, salts of carrageenan, and Chondrus extract (carrageenan); withdrawal of proposal and termination of rulemaking procedure. Fed Reg 44: 40343‐40345. 74
U.S. Food and Drug Administration. (2006). Part 172 – food additives permitted for direct addition to food for human consumption. Code of Federal Regulations, USA. 75
U.S. Food and Drug Administration. (2004). Code of Federal Regulations: CFR Title 21 Database. 76
http://www.accessdata.fda.gov/scripts/fcn/fcnnavigation.cfm?rpt=eafuslisting (accessed April 6, 2016). 77
Commission Directive. (1995). Directive No. 95/2/EC and 96/85EC. Office for Official Publications of the European Communities. 78
Carrageenan use is restricted in foods in Europe and has not been permitted for use in infant formula
because Europe’s regulatory standard is to require a “high level of reassurance” from safety studies. 79
World Health Organization. (1984). Food Additives Series No. 19, Toxicological evaluation of certain food‐
additives and food contaminants. Rome. 80
European Economic Community. (1978). Specifications for standards of purity. Off J Eur Comm. No. 1 232/12. (August 14, 1778). 81
82
Cohen S and Ito N. (2002). A critical review of the toxicological effects of carrageenan and processed Eucheuma seaweed on the gastrointestinal tract. Crit Rev Toxicol 32: 413‐444. USDA/NOSB April 14, 2016 21 Carrageenan continues to be a vital, naturally-sourced food additive in organic foods and
in organic infant formula. NPA supports its continued use as a direct food additive in organic
foods and in organic infant formula. Carrageenan has a long history of safe use in foods. FDA,
the authoritative food safety body in the US created two regulations for carrageenan. It is a
permitted food additive and it is GRAS. The FDA continues to maintain that carrageenan is safe
for use in foods and infant formulas as codified in the federal regulations. If in the future FDA
does issue a finding supporting a prohibition of carrageenan in any or all foods, AMS has stated
that it will take appropriate action to come into alignment with other federal agencies with
updated findings of toxicity. NPA has no issues supporting a re-evaluation of carrageenan’s
science in the future should such toxicology data become available.
Carrageenan is fully recognized by international regulatory authorities. The latest WHO
JECFA Committee re-evaluated yet again the most recent safety studies on carrageenan. The
Committee concluded “the use of carrageenan in infant formula or formula for special medical
purposes at concentrations up to 1000 mg/L is not of concern.” Commercial carrageenan in
foods is used well below this concentration. There are many deficiencies in the literature
regarding the gastrointestinal toxicity of carrageenan. There is absolutely no information to
clearly demonstrate a carcinogenic effect for food grade carrageenan use in foods or infant
formula.
NPA urges USDA AMS to allow carrageenan to be used in both organic foods and
organic infant formula. The NOSB should consider only the science and not the emotional
rhetoric castigating an industry which has a proven history of safe use in foods. There are no
demonstrable risks which would preclude its use at this time. Subsequent research has
continued to support the conclusion that food carrageenan is safe and has been clearly
established time and again by experts here in the US, food safety authorities around the world,
and research laboratories in the scientific community. While the safety narrative could change in
the future based upon sound scientific studies, the current state of the science suggests
carrageenan is a safe, natural alternative to synthetic emulsifiers, stabilizers, and thickeners.
We would hope that the NOSB would hold no bias against carrageenan based upon the
personal beliefs of a single scientist. Based upon the consistent recommendation of US FDA
and the world’s leading scientific authorities on food safety, NPA urges the NOSB and USDA to
conclude that carrageenan is safe at the levels found in food and therefore permitted for use in
both organic foods and organic infant formula.
USDA/NOSB April 14, 2016 22 We thank you for the opportunity to comment on this important regulatory process and
look forward to working with USDA AMS and NOSB on any future evaluations of carrageenan.
Sincerely,
Daniel Fabricant, Ph.D.
CEO, Executive Director
Natural Products Association