Generally recognized as safe (GRAS)

The U.S. Federal Food, Drug and Cosmetic Act1 (FFDCA) provides for two regulatory mechanisms for the addition of substances to foods.
They are the food additive petition process and the Generally Recognized as Safe (GRAS) process. GRAS is unique to the U.S. and is sometimes not well understood.
Though not official, the IFAC GRAS Best Practices Guide is intended to serve as a compilation of available U.S.
Food and Drug Administration (FDA) regulations, guidance documents and industry best practices to help determine the GRAS status of a substance
Generally Recognized as Safe or GRAS is an FDA designation for a substance that it considers as safe.
FDA stands for the Food and Drug Administration. The FDA is a federal agency of the United States that is responsible for protecting and promoting public health.
GRAS is an acronym.
Therefore, we pronounced the letters as a word. In other words, we do not say ‘G-R-A-S’ (we do not utter each letter’s name separately).

1. Generally recognized as safe (GRAS) By Assist.Prof . Dr. Berciyal Golda. P VICAS

2. Introduction The U.S. Federal Food, Drug and Cosmetic Act1 (FFDCA) provides for two regulatory mechanisms for the addition of substances to foods. They are the food additive petition process and the Generally Recognized as Safe (GRAS) process. GRAS is unique to the U.S . and is sometimes not well understood. Though not official, the IFAC GRAS Best Practices Guide is intended to serve as a compilation of available U.S. Food and Drug Administration (FDA) regulations, guidance documents and industry best practices to help determine the GRAS status of a substance.

3. What is GRAS (Generally Recognized as Safe)? Generally Recognized as Safe  or  GRAS  is an FDA designation for a substance that it considers as safe. FDA stands for the  F ood and  D rug  A dministration. The FDA is a federal agency of the United States that is responsible for protecting and promoting public health. GRAS is an acronym. Therefore , we pronounced the letters as a word. In other words, we do not say ‘G-R-A-S’ (we do not utter each letter’s name separately ).

4. Substances that the FDA considers as generally recognized as safe include those present in pesticides and food, for example. Specifically, however, the term applies to foods. In other words, if a substance, such as a pesticide, has a safe status, its presence in food is not harmful to human health. A substance that the FDA generally recognized as safe is exempt from the FFDCA food additive tolerance requirements. FFDCA stands for  F ederal  F ood,  D rug, and  C osmetic  A ct.

5. Generally recognized as safe  ( GRAS ) is a  United States   Food and Drug Administration  (FDA) designation that a chemical or substance added to food is considered safe by experts .  An ingredient with a GRAS designation is exempted from the usual  Federal Food, Drug, and Cosmetic Act  (FFDCA)  food additive  tolerance requirements. The concept of food additives being "generally recognized as safe" was first described in the  Food Additives Amendment of 1958 , and all additives introduced after this time had to be evaluated by new standards. The FDA list of GRAS notices is updated approximately each month, as of 2021.

6. History On 1 January 1958, the FDA established the  Food Additives Amendment of 1958 , with a list of 700 food substances that were exempt from the then-new requirement that manufacturers test food additives before putting them on the market .  On August 31, 1960, William W. Goodrich, assistant general counsel of the FDA, addressed the annual meeting (16 Bus. Law. 107 1960–1961) of the FFDCA. The purpose of the meeting was the forthcoming March 6, 1961, effective date of the enforcement provisions of the "Food Additives Amendment of 1958", referred to as GRAS .

7. Purpose/Scope The intended purpose of this Guide is to serve as a resource to food ingredient producers who wish to establish a GRAS position on a substance to be used in a food. The Guide is also intended for use by food and dietary supplement producers in developing GRAS positions on the ingredients in their products. This Guide provides an overview of U.S. FDA regulations and guidance documents for substances that are considered GRAS, explains and adds clarity to the U.S. GRAS process , describes the options available to producers and users to obtain a food ingredient GRAS determination and recommends best practices .

8. GRAS designation and listing Substances can be generally recognized as safe either by self-affirmation or by qualified non-governmental experts. Self-Affirmation The pharmaceutical, food, or agricultural chemicals company had performed  all the necessary due diligence  on the substance. Additionally , an expert panel had reviewed all safety concerns. The manufacturer is willing to use its findings to defend its chemical’s or substance’s generally recognized as safe status.

9. FDA Response to GRAS Notification The company had performed all the aforementioned research, etc. It submitted a notification, informing the FDA of a determination that the use of a chemical or substance is safe. In other words, it believes it is generally recognized as safe. The FDA, following the evaluation,  subsequently responds in three possible ways : The FDA accepts the manufacturer’s determination that its substance is GRAS. There is insufficient data to give the substance a generally recognized as safe status. In other words, the manufacturer’s notification does not contain a sufficient basis for a GRAS determination. The notifier has requested that the FDA stops evaluating the GRAS notice. So , the FDA subsequently ceases evaluating it .

10. According to the FDA : “Irrespective of whether a substance is deemed to be GRAS or if its safety is established through a premarket approval process, the safety determination is always limited to the substance’s intended conditions of use.” The FDA urges manufacturers to review their GRAS notification submission procedures thoroughly . They must do this before they send their notification to the agency. Additionally, the manufacturer may, if they wish, request a pre-submission meeting with the agency.

11. THE GRAS LIST In 1958 , all food additives were put on a Generally Recognized as Safe (GRAS) List established by FDA . A list of food additives that were considered safe for consumption at that time. The substances present in the GRAS list are known as “ GRAS substances ”. Examples: acetic acid, baking soda, caffeine, calcium citrate, citric acid, corn starch, carbon dioxide, sugar, salt and many more.

12. TESTING FOOD ADDITIVES Food additives are tested under FDA scrutiny for safety. No-observable-effect-level (NOEL): The rationale for reducing NOEL by a 100-fold margin is that we assume humans are at least 10 times more sensitive to food additives than are laboratory animals . Delany Clause: “ This Clause prohibits intentionally adding to food a compound that was introduced after 1958 and causes cancer.” For Incidental food additives, FDA sets an acceptable level .

13. OBTAINING APPROVAL FOR A NEW FOOD ADDITIVE: Manufacturers must give FDA information that: Identifies the new additive Gives its chemical composition States how it is manufactured Specifies laboratory methods used to measure its presence in the food supply at the amount of intended use.

14. COMMON FOOD ADDITIVES Antimicrobials Anti-oxidants Color i ng Agents Emulsifiers Flavor i ng Agents Dietary Supplements Neutra l i z ing Agents and m any oth e rs

15. CHEMICAL FOOD ADDITIVES: Methylcyclopropene Artificial colors Artificial flavoring Aspartame Benzoic acid/Sodium Benzoate BHA/BHT Canthaxanthin Emulsifiers Astaxanthin Olestra MSG Potassium Bromate etc.

16. MAJOR FUNCTIONS Impart or maintain consistency Improve or maintain nutritional value Maintain palatability and wholesomeness Produce light texture; control alkalinity and acidity Improve sensory properties Impart desired color Control physical, chemical, and microbiological changes Facilitate handling and distribution of food stuff

17. ROLE IN IMPROVING NUTRITION Fortified foods are processed foods that have been ‘fortified’ or had vitamins and minerals added to them. For example Breakfast Cereals Can be fortified by manufacturers with B group vitamins, iron & zinc. Margarine Margarine and edible oil based spreads are required to be fortified with vitamin D. Orange Juice Some brands are fortified with calcium.

18. NEGATIVE EFFECTS Aggravates asthma and suspected to be a neurotoxin and carcinogen. Some additive may induce gastric irritation, nausea, diarrhea. May temporarily inhibit digestive enzyme function . BHA/BHT is may be carcinogenic to humans. Destroys nerve cells in brain. (H F C S ) c a uses Obesi t y , Acc e l e rated ag i ng, Insulin resistance, Diabetes mellitus. MSG causes Bronchospasm, Chest pain, rapid heartbeat Headache, nausea, Headache, nausea, drowsiness .

19. RECOMMENDATIONS The FDA and the United States Department of Agriculture (USDA) supervise and regulate the use of additives in products sold in the United States. However, people who have special diets or intolerances should be careful in selecting products in the grocery store. The U.S. government requires everyone that manufactures food to list all the ingredients on the label.