Search results for: carrageenan

  • The United States Department of Agriculture’s Agricultural Marketing Service (USDA AMS) administers the National Organic Program (NOP) under the authority of the Organic Foods Production Act of 1990 (NOP), as amended (7 U.S.C. 6501-6524).  The regulations implementing the NOP (7 CFR Part 205) includes the National List of synthetic substances that may be used and nonsynthetic substances that may not be used in organic production as well as synthetic, nonsynthetic nonagricultural, and nonorganic agricultural substances that may be used in organic handling.  The OFPA requires review of all substances included on the list within five years of inclusion to, or renewal of continued inclusion on, the National List and, if not renewed, its allowance or prohibition on the National List is no longer in effect.
  • The National Organic Standards Board (NOSB) is authorized to assist in the evaluation of substance to be included on the National List in an advisory role.  The NOSB bases its recommendation on new information pertaining to a substance’s impact on human health and the environment, its necessity due to the unavailability of wholly natural substances, and its consistency with organic production and handling.
  • The NOSB held multiple public meetings in 2016 to consider the 17 substances with 2018 sunset dates and ultimately recommended that carrageenan be removed from the National List because they determined that alternative materials, such as gellan gum, guar gum, or xanthan gum, are available for use in organic products.  USDA AMS decided to renew all 17 substances, determining for carrageenan that sufficient evidence in public comments to the NOSB that carrageenan continues to be necessary for handling agricultural products because of the unavailability of wholly natural substitutes.  Carrageenan has specific uses in an array of agricultural products, and public comments indicated that potential substitutes do not adequately replicate the replicate the functions of carrageenan in a variety of food products.
  • Carrageenan will remain on the National List as a nonsynthetic substance allowed in or on products labeled as “organic” or “made with organic [specified ingredients or food group(s)]”.

The use of carrageenan as a food ingredient has been the source of some concern in recent years based on inferences drawn from studies conducted on human cell cultures.

  • Carrageenan is an ingredient obtained from seaweed that is used widely in foods and beverages to perform gelling, thickening, and stabilizing functions.  Although many long-term studies support the safety of carrageenan consumption, concerns have been raised in recent years regarding its potential to cause gastrointestinal inflammation.  In 2012, the FDA rejected a petition seeking to ban the use of carrageenan in food, effectively validating the safety of the ingredient.  Further, in 2015, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) concluded that the use of carrageenan in infant formula is “not of concern” at levels of up to 1,000 mg per liter (see our previous blog coverage on the JECFA findings here).
  • A recent study led by internationally recognized toxicologist and carrageenan expert Dr. James M. McKim, Jr. lends further support to the safety of carrageenan, finding that carrageenan did not induce inflammation in human cells as claimed by carrageenan critics.
  • This recent study should enlighten any continued debate about the safety of carrageenan.

JECFA concludes use of carrageenan in infant formula “not of concern.”

  • Carrageenan is a seaweed-derived ingredient used widely in the food industry to perform gelling, thickening, and stabilizing functions.  Although many long-term studies support the safety of carrageenan consumption, concerns have been raised in recent years regarding its potential to cause gastrointestinal inflammation.
  • At its June 2015 meeting in Geneva, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) concluded that the use of carrageenan in infant formula is “not of concern” at levels of up to 1,000 mg per liter.  JECFA’s report references new studies that “allay the earlier concerns that carrageenan, which is unlikely to be absorbed, may have a direct effect on the immature gut.”
  • Although carrageenan lawfully may be used in infant formula in the United States, such use is not permitted in the EU.  In light of the new data and JECFA’s conclusive opinion on this subject, it remains to be seen whether the European Food Safety Authority (EFSA) will revisit its prior evaluation.
  • As previously discussed on this blog, there is a National List of Allowed and Prohibited Substances (the “National List”) for synthetic and nonsynthetic nonagricultural (nonorganic) substances that may be used in organic handling, and nonsynthetic substances prohibited from use in organic farming under the National Organic Program (NOP) administered by the United Stated Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS).  The National List is codified at 7 CFR 205.601 through 205.606 and items on the list must be reviewed at least every five years.  The National Organic Standards Board (NOSB) is responsible for reviewing the substances and providing a recommendation to the Secretary of USDA to either renew or remove (only available if 2/3 or more of the members of the NOSB vote to remove at a meeting with a quorum of members) substances on the National List.  AMS, which has been delegated the authority to manage the National List by the Secretary, considers the NOSB recommendation and public comment before making its decision. For more background, see our blog posts here, here, here, here and USDA resources
  • The NOSB held public meetings to discuss the substances that were sunsetting in 2019 on April 19-21 and October 31 – November 2, 2017.  There were five substances reviewed that have already been addressed by AMS (see our blog posts here and here) and on October 8 AMS announced that 24 additional substances on the National List would be renewed without change.  The substances include:
    • Chlorine materials: Calcium hypochlorite, Chlorine dioxide, Sodium hypochlorite (synthetic substance permitted in organic crop production and organic livestock production)
    • Herbicides, soap-based (synthetic substance permitted in organic crop production)
    • Mulches: Biodegradable biobased mulch film (synthetic substance permitted in organic crop production)
    • Boric acid (synthetic substance permitted in organic crop production)
    • Sticky traps/barriers (synthetic substance permitted in organic crop production)
    • Coppers, fixed (synthetic substance permitted in organic crop production)
    • Copper sulfate (synthetic substance permitted in organic crop production and organic livestock production)
    • Humic acids (synthetic substance permitted in organic crop production)
    • Vitamins, C, and E (synthetic substance permitted in organic crop production)
    • Lead salts (nonsynthetic substances prohibited from use in organic crop production)
    • Tobacco dust (nicotine sulfate) (nonsynthetic substances prohibited from use in organic crop production)
    • Glucose (synthetic substance permitted in organic livestock production)
    • Tolazoline (CAS # 59-98-3) (synthetic substance permitted in organic livestock production)
    • Attapulgite (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Bentonite (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Diatomaceous earth (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Nitrogen (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Sodium carbonate (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Acidified sodium chlorite (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Carbon dioxide (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Magnesium chloride (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Sodium phosphates (Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic”)
    • Casings (Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic”)
    • Pectin (Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic”)
  • AMS is also reviewing the NOSB recommendations to remove vitamin B1, oxytocin, procaine, and konjac flour from the National List.  Such changes will be announced in a separate rule.
  • The United States Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) is responsible for maintaining the National List of Allowed and Prohibited Substances (the “National List”) for organic handling and production as part of the National Organic Program (NOP) under the Organic Foods Production Act of 1990 (OFPA; Public Law 101-624, Nov. 28, 1990).  The National List, codified at 7 CFR 205.601 through 205.606, identifies synthetic substances that may be used and natural substances that may not be used in organic crop and livestock production as well as a limited number of non-organic substances that may be used in or on organic processed products.  The National Organic Standards Board (NOSB), a Federal Advisory Board, considers and makes recommendations to the NOP regarding the National List.  For more on the NOP, OFPA, the National List, and NOSB, see our blog posts here, here, here and USDA resources.
  • On April 30, 2018, USDA published a proposed rule to implement recommendations submitted to the Secretary of Agriculture by the NOSB. 83 FR 18744.   Those recommendations were adopted by USDA in a final rule, published on April 30, 2019, which adds elemental sulfur to the National List for use in organic livestock production and reclassifies potassium acid tartrate from a non-agricultural substance to an agricultural substances and requires the organic form of the ingredient when commercially available. 84 FR 18133.
  • The United States Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) is responsible for maintaining the National List of Allowed and Prohibited Substances (the “National List”) for organic handling and production as part of the National Organic Program (NOP) under the Organic Foods Production Act of 1990 (OFPA; Public Law 101-624, Nov. 28, 1990).  The National List, codified at 7 CFR 205.601 through 205.606, identifies synthetic substances that may be used and natural substances that may not be used in organic crop and livestock production as well as a limited number of non-organic substances that may be used in or on organic processed products.  The National Organic Standards Board (NOSB), a Federal Advisory Board, considers and makes recommendations to the NOP regarding the National List.  For more on the NOP, OFPA, the National List, and NOSB, see our blog posts here, here, and here and USDA resources.
  • On January 17, 2018, USDA published a proposed rule, 83 Fed. Reg. 2498, that would have amended the National List by adding 16 new substances to be allowed in organic production and handling, changing the use restrictions of 17 other substances already on the National List, removing a parasiticide (ivermectin) from the National List, and listing a botanical pesticide (rotenone) as a prohibited substance.  The comment period closed on March 19 and was later reopened on April 13, 83 Fed. Reg. 16010, for an additional 30 days.  The final rule was published on December 27, 83 Fed. Reg. 66559, with several changes relative to the proposed rule.  We discussed the proposed rule, in the context of the reopened comment period, in the Daily Intake Blog here.
  • In summary, USDA made the following changes in the final rule:
    • The revised limitation for micronutrient use was simplified,
    • The withdrawal period for parasiticides in fiber bearing animals was reduced from 90 to 36 days,
    • The agency clarified that the permitted methionine supplementation levels is a maximum rate,
    • The agency corrected a typo in the proposed rule that would have erroneously included zinc sulfate in both Sections 205.603(a) and 205.603(b) rather than 205.603(b) only,
    • Alternate agricultural sources for some colors derived from agricultural products is permitted, and
    • Sugar beets are no longer as an acceptable source of color derived from beets.
  • USDA clarified that microcrystalline cellulose is not the same as cellulose and is not on the National List.
  • Finally, USDA set an implementation date for all of the additions and most of the other amendments to the list of 30 days post publication (January 28, 2019).  For the removal of ivermectin and the amendments to flavors, cellulose, and glycerin, the implementation date will be December 27, 2019.