JECFA Technical Report Concludes Carrageenan Safety in Infant Formula

30 Jun 2015 --- Ingredient supplier FMC has noted that the FAO/WHO Joint Expert Committee on Food Additives (JECFA) released its full technical report, including a monograph regarding the safety of carrageenan in infant formula, and concluded that the use of carrageenan in infant formula was 'not of concern'.

JECFA is a committee formed by Food and Agriculture Organization (FAO) and the World Health Organization (WHO) of the United Nations and is one of the most respected independent review panels in the world. Its conclusion is one of the most important testimonials that can be given to a food additive and its reviews carry significant weight in global regulatory decisions on food additives.

In its monograph on carrageenan JECFA said that it had considered a toxicological dossier on carrageenan (Republic of the Philippines 2013) and a commentary on studies published by an academic research laboratory (Tobacman 2013).

In addition, JECFA conducted its own literature search regarding signaling pathways to inflammation and 77 references found through a search of the PubMed database of the United States National Library of Medicine.

The full technical report (WHO Food Additives Series, No. 70, 2015) is available at: http://www.who.int/foodsafety/publications/monographs/en/

In compiling its report JECFA placed significant weight on new research related to the safety of carrageenan, particularly a feeding study of neonatal piglets.

JECFA said, in part, "The Committee noted that although the MOEs (margins 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. 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 piglet study was conducted and funded by FMC Corporation and the International Formula Council. In attesting to the safety of carrageenan in infant formula, the JECFA review 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."

Dr. Roger A. Clemens, Food Science Matters advisory council member said, "JECFA and other review panels and international regulatory agencies have long recognized the safety of carrageenan in adults. This conclusion that carrageenan is safe in infant formula should further dispel consumer concerns over an additive that has a long history of safe use."

In its monograph the committee cited limitations in much of the historical research on carrageenan. Those limitations included:
• The use of poligeenan, rather than food-grade carrageenan, as a test material
• The failure to fully identify the source of carrageenan tested
• The testing of carrageenan without an accompanying protein
• Carrageenan administered as something other than food (injection into an animal paw, for instance)
• In vitro studies that were not validated by assessment of responses to a positive control, such as a known inflammatory substance
• Flaws in methodology on insulin testing
• The extrapolation of in vitro data into conclusions on the human feeding experience

In addition to the piglet studies, JECFA considered an extensive review of existing carrageenan research that appeared in Critical Reviews In Toxicology which thoroughly reviewed the extent of carrageenan research and potential pitfalls that occur when extrapolating that research into legitimate human health concerns.

Also considered was another recent peer-reviewed in vitro study conducted under Good Laboratory Practices (GLP) (The common food additive carrageenan is not a ligand for Toll-Like-Receptor 4 (TLR4) in an HEK293-TLR4 reporter cell-line model) that appeared in Food and Chemical Toxicology (78(2015) 153-158). These studies and reviews not only address historic suggestions that carrageenan may cause inflammation when digested by humans but also the flawed nature of some previous in vitro and in vivo carrageenan research.

In the introduction to the (TLR4) study it was noted that 'High molecular weight (Food-Grade) carrageenan ingested at low dosages; is not absorbed across the intestinal epithelium, is wholly excreted in feces, does not enter the systemic circulation, and does not cause intestinal ulceration or inflammation.'

JECFA acknowledged that much of the early research was conducted using 'degraded carrageenan,' an inflammatory substance now identified as 'poligeenan'. JECFA also noted animal studies in which it was demonstrated that carrageenan injected into confined spaces in an animal's body, such as the rat hind paw, pleural space, or peritoneal cavity can cause an inflammatory response. However, JECFA found that this type of testing and the local inflammation it induces, is not relevant to carrageenan use in foods.

Validating the quality of the test material and testing methodology is a primary element of research conducted under GLP, including the piglet and in vitro study reviewed by JECFA.

Dr. Clemens said, "It is unfortunate that research conducted under Good Laboratory Practices that appears in peer-reviewed journals is often discarded by consumer information sources in favor of substandard work that makes unwarranted claims about human health hazards. Thorough reviews by independent organizations like JECFA should aid us in evaluating relevant food additive science."

Carrageenan in its raw, red seaweed form, sometimes called 'Irish Moss,' has been used as a food stabilizer for hundreds of years in or by different cultures around the world. In the U.S., 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'.

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