Food grade flocculants refers to the application of such flocculants as opposed to a designation by a regulatory or trade organization that when food grade flocculants are applied properly according to manufacturer’s instructions, they will not cause deleterious effects to humans or animals. Food grade flocculants are non-ingredient processing aids chemicals. A more common designation of food grade flocculants is GRAS. The term food grade flocculants can be considered a subcategory of chemicals which are GRAS. This abbreviation stands for Generally Regarded As Safe. This designation is nearly 100 years old. This designation refers to generic names and categories of chemicals rather than trade or proprietary names of chemical formulations. GRAS substances can be found on the labels of thousands of food products on store shelves. An example of common chemical names of GRAS chemicals are: potassium sorbate, hydrochloric acid, caustic soda, sodium hexametaphosphate, calcium EDTA, amino acids, phosphoric acid used in carbonated beverages, hydrofluoro silicic acid and potassium permanganate used to treat potable water. The presence of these substances within guidelines is considered acceptable and GRAS chemicals are permissible in numerous substances. Food industry professionals, researchers and regulators have established guidelines for manufacturing for health and safety regarding the application of food grade flocculants and chemicals.

The term food grade flocculants does not mean that one can ingest multiple pounds of GRAS chemicals without any adverse health and safety effects. The intent of GRAS was to facilitate the approval and use of various chemical formulations which could be considered significant non-ingredient processing aids to food production. GRAS further means that the chemical substance, such as food grade flocculants, is not expected to cause harmful effects on humans or animals.

Our website has several technical papers about food grade flocculants and GRAS definitions. These documents should provide adequate information on the subject of food grade flocculants and GRAS.

The Federal Food and Dug Administration, FDA, has a functional group called the Meat Inspection Division, MID. This department publishes annually a list of chemicals by trade name which are approved for use in food plants. The chemical categories include cleaning and CIP chemicals, retort cooling chemicals, boiler water treatment chemicals, cooling water treatment chemicals and other non-ingredient formulations. These chemicals are considered under the broad category of maintenance or utility treatment chemicals and do not include food grade flocculants or any ingredients. The list of chemicals was commonly referred to as the “yellow book.”

Part 21 of the Code of Federal Regulations, CFR, discusses food grade flocculants and chemicals in a number of sections including 172, 173 and 180. These sections discuss the use of food grade flocculants as processing aids rather than ingredients. An example would be food grade flocculants used to clarify sugar cane juice in the production of granular sugar. These sections quite clearly specify the difference between an ingredient and processing aid. The latter facilitates production and manufacturing without altering the structure or performance of the raw material intended for human consumption. These sections further list FDA’s approval for various types of food packaging such as paper, coated papers, and paperboard cartons which will come in contact with food or food products. An example of this would be chemicals used to treat wood pulp from which craft paper cartons which hold boxed beef would be made. Food grade flocculants qualify as processing aids.

At the present time the FDA does not sanction the use of food grade flocculants as food ingredients, even if those chemical formulations are considered GRAS. Food grade flocculants are only permitted for use as processing aids in food production, rather than food ingredients themselves.

 USP’s Relationship with Food Grade Chemical Ingredients

USP, U. S. Pharmacopeial Convention, maintains the Food Chemicals Codex, FCC, a world-wide compendium of resources about food grade flocculants and chemicals. Herewith are data from FCC which we believe will be useful to not only research and development personnel but also to engineers and managers in the food chemical industry in assessing their needs for food grade flocculants.

USP began establishing documentary standards for food ingredients in 2006 when it acquired the Food Chemicals Codex (FCC)—a compendium of quality and purity specifications and methods—from the Institute of Medicine. USP’s rich history and nearly 200 years of experience setting standards for pharmaceuticals and more recently, dietary supplements, excipients, and more made the organization well suited to undertake the task of updating and expanding FCC.

The Food Chemicals Codex, FCC, is a compendium of internationally recognized standards for the purity and identity of food ingredients. It features approximately 1,100 monographs, including food-grade chemicals, processing aids, foods (such as vegetable oils, fructose, whey, and amino acids), flavoring agents, vitamins, and functional food ingredients (such as lycopene, olestra, and short chain fructooligosaccharides). The FCC also supports ingredients such as sucrose and essential oils that are not commonly found in other food additive standards resources.

Published since 1966, the FCC plays a key role in safeguarding commerce and public health by providing essential criteria and analytical methods to authenticate and determine the quality of food ingredients. FCC standards are beneficial to all players in the food industry. They are used as agreed standards between suppliers and manufacturers in ongoing purchasing and supply decisions and transactions. They can aid manufacturers in distinguishing genuine products from inferior or adulterated ingredients and substances, thereby helping to make the food supply chain safer and assuring consumers of the quality of the food products they eat.

USP acquired the FCC in 2006 and has instituted a new timely, transparent revision process through the FCC Forum. The FCC is published every two years in print and online formats and is offered as a subscription that includes a main edition and intervening supplements.

FCC Contents: Monographs, Methods, and More

The FCC has two main sections: monographs and appendices. Monographs are listed alphabetically and generally cover a single ingredient. Monographs, where applicable, provide information about each ingredient such as: Chemical Structure, Chemical Formula, Chemical Weight, INS Number, CAS Numbers, Function, Definition, Packaging, Storage, Labeling, Requirements, IR Spectra, food grade flocculants and the like.

There are also several “family” monographs, which cover a group of substances. These include “Enzyme Preparations,” “Food Starch,” and “Spice Oleoresins.” In addition, the specification is included and consists of a series of tests, procedures for the tests, and acceptance criteria. Monographs may also specifyUSP Reference standards or other materials needed to perform the tests. The FCC’s appendices contain step-by-step guidance for general physical tests, chemical tests, specific tests, and apparatus use, as well as useful information for stakeholders such as food ingredient Good Manufacturing Practices.

Regulatory Recognition and International Impact

The FCC is published in the United States, but regulatory agencies, manufacturers, vendors, and other users of food ingredients recognize it worldwide.

Food production-from “farm to fork”-has become a globalized, complicated process. The food ingredient supply chain for a finished product can incorporate multiple manufacturers and suppliers from around the world. With each exchange, vulnerabilities to the food safety system increase, and as a result governments, retailers, and consumers have intensified their scrutiny of food ingredient quality. Although food grade flocculants perform necessary processing benefits in food production, food grade flocculants are not considered as ingredient chemicals.

To help manufacturers, suppliers, and regulators safeguard the food supply, USP provides documentary (i.e., written) and physical Reference Standards for determining food ingredient authenticity and purity. These standards help limit the introduction of potential adulterants and other problems at the ingredient level, and serve as a widely acknowledged quality benchmark in the buying and selling of food ingredients and food grade flocculants in the global marketplace.

Food grade flocculants and Chitosan

Our food grade flocculants are manufactured from copolymerized acrylate and acrylic acid derivatives. Petrochemicals are significant feed stocks for our food grade flocculants. In this respect it is accurate to say that our food grade flocculants are man-made from naturally occurring substances whereas chitosan is made from an animal source. Thus, some would call chitosan an organic or “natural” food grade flocculant even though it is processed with other chemicals such as caustic soda, as mentioned below.

Chitosan is a linear polysaccharide composed of randomly distributed β-(1-4)-linked D-glucosamine (deacetylated unit) andN-acetyl-D-Glucosamine (acetylated unit). It is made by treating shrimp and other crustacean shells with the alkali sodium hydroxide. Commercial chitosan is derived from the shells of shrimp and other sea crustaceans. Chitosan is produced commercially by deacetylation of chitin, which is the structural element in the exoskeleton of crustaceans (such as crabs and shrimp) and cell walls of fungi.

Chitosan as a food grade flocculant can have appeal to certain flocculant users, however, we are told that availability, price and dosage product rates make wide-spread application of chitosan as a food grade flocculant limited. Please see the next paragraph.

Chitosan as a food grade flocculant

Chitosan can also be used in water processing engineering as a part of a filtration process. Chitosan causes the fine sediment particles to bind together, and is subsequently removed with the sediment during sand filtration. It also removes phosphorus, heavy minerals, and oils from the water. Chitosan can be an important additive in the filtration process. Sand filtration apparently can remove up to 50% of the turbidity alone, while the chitosan with sand filtration removes up to 99% of the turbidity. Chitosan has been used to precipitate caseins from bovine milk and in cheese making.

Chitosan is also useful in other filtration situations, where one may need to remove suspended particles from a liquid. In combination with bentonite clays, gelatin, silica gel, isinglass, and other fining agents, it is used to clarify wine, mead, and beer. Added late in the brewing process, chitosan improves flocculation, and removes yeast cells, fruit particles, and other detritus that cause hazy wine. Chitosan combined with colloidal silica is becoming a popular fining agent for white wines, because chitosan does not require acidic tannins (found primarily in red wines) with which to flocculate.

Food Grade Flocculants Economics/Cost Effectiveness

Our food grade flocculants are available in a wide variety of physical forms, packaging options, delivery methods to meet the smallest to the largest user’s volume requirements. Please contact our sales department at water@tramfloc.com for further information about food grade flocculant samples, product selection, budgetary estimates, quotations and technical recommendations.

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List of Approved Food Grade Flocculants

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