Today, ingredients and additives they are strictly studied, regulated and controlled. However, there are some that are exempt from the regulatory process for their consumption. These are the so-called GRAS, which experts have generally recognized as safe, based on their extensive history of use or published scientific evidence. A number of ingredients have begun to appear on the market of healthy products that are incorporated into the food matrix, so that – so-called functional designed for about 30 years. The ingredients industry had significant growth in those years.
The first ingredients were added to Baby formulato resemble mother’s milk, and from there developed carnitine, nucleic acids, taurine, docosahexaenoic, eicosapentaenoic, linoleic, linolenic and arachidonic acids, adding to all the vitamins and minerals that enriched food. for full-term babies, premature babies and small children.
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The Congress of the United States of America recognized in 1958 that many substances used in the international community do not need official review for the question securitybecause of the long history they have had in terms of food use or because of the virtue of their nature and enough information for scientists about their benefits.
The FDA first published a list of these substances that are generally recognized as safe (GRASS) in the Federal Register of December 9, 1958. This list was called GRAS. It currently appears as parts 182, 184, and 186 of the Code of Federal Regulations (CFR). In total, it contains hundreds of substances, including those added to cotton fabrics or paper and cardboard used as food packaging materials.
Congress also recognized that FDA or the United States Department of Agriculture had given express approval for specific uses substances in food before September 6, 1958, through regulations governing its use, through formal directives or opinions, or through letters not opposing such use. Some of these so-called “pre-approved” food substances are listed in CFR Part 181, but some of the pre-approved substances remain unlisted.
In 1969, President Richard M. Nixon, in his presidential message and because of the requested recommendation, asked to be more critical and to evaluate the safety of GRAS food substances. The review became a major project at the FDA’s former food office, now called the Center for Food Safety and Applied Nutrition.
GRAS is an acronym for Generally recognized as safe where the FDA approves certain substances to be added as safe. Not all GRAS are scientifically complete evidence.
FDA contracts with the Life Sciences Research Office (LSRO), established in 1962 by the Federation of American Societies for Experimental Biology (FASEB), to conduct scientific evaluations of the health aspects of GRAS or previously approved food substances. to summarize the available scientific literature, as well as to make recommendations on what, if any, restrictions on the use of the substances would be necessary to ensure their safe use in food.
LSRO has selected qualified scientists as consultants to review and evaluate the available information on each of the GRAS substances. These scientists were chosen for their expertise and formed the Select Committee on GRAS Substances (SCOGS).
The board’s evaluations are conducted independently of the FDA or any other governmental or nongovernmental group. It is worth mentioning that during 10 years of operation, the safety assessment reached 400 substances.
FDA made SCOGS interim reports available for public review in the Office of the Hearing Officer, through notices in the Federal Register, and provided an opportunity for any interested person to appear before the select committee at a hearing. presentation of data, information and opinions on the substances included in the report.
The commission considered all this information in order to reach its final conclusions. (see table 1 of the linked document). The reports were approved by said committee and the director of LSRO, and then reviewed and approved by the LSRO Advisory Board (consisting of representatives from each FASEB component company) under the authority delegated by the Executive Committee of the Federation Board of Directors. . FASEB’s Executive Director approved and forwarded the reports to the FDA.
FROM NOTICE TO CONCLUSION
After receiving the report from the select committee, the FDA reviews it scientific evidence for or against adverse health effects. It examines related information affecting the possible use of the substance and then formulates an interim regulatory decision.
If FDA tentatively concludes that the available data and information support the conclusion that the substance is GRAS for certain uses in food, then the agency issues a notice of proposed rulemaking in the Federal Register to confirm GRAS status. After reviewing the received public comments on his proposal to confirm this GRAS status, he makes a final conclusion where the available data and information confirm it.
In 1997, the FDA issued a proposed rule that, if finalized, would eliminate the petition process for GRAS certification and replace it with a notification process. The agency published this proposed rule to enable the agency to use its resources more efficiently and effectively.
FDA stated that the agency will determine whether its experience in administering GRAS notifications suggests changes to the proposed notification process. During that interim period, FDA’s Office of Food Additive Safety received approximately 25 GRAS notifications per year.
FDA has included these GRAS notices on its website along with a response to each notice. Generally, the FDA’s response falls into one of the following three categories:
1. FDA has no questions regarding the applicant’s conclusion of GRAS status.
2. The notification does not provide a basis for inferring GRAS status.
3. At the request of the notifier, the FDA discontinued its evaluation of the claim.
The FDA has not yet issued a final rule establishing the GRAS application process.
DETERMINATION OF NEW INGREDIENTS AND SUBSTANCES
Use a food substance It can be GRAS through scientific procedures or through use in food before 1958 through experience based on its common use. General recognition of security, through scientific proceduresit requires the same amount and quality of scientific evidence that is required to obtain the approval of a substance as a food additive.
The federal Food, Drug, and Cosmetic Act states that any substance intentionally added to food is a food supplement, which is subject to review and approval by the FDA, unless the substance is generally recognized among qualified professionals.
There are a number of new ingredients that are awaiting approval or have recently been approved for use and are expected to begin to be introduced into new foods or products. Some examples are: DHA from algae (Schizochytrium sp) to obtain omega 3 for infant formulas, obtaining bovine osteopontin (associated with inflammation), dolomite (combined with calcium and magnesium carbonate: CaMg (CO3)2 allowed to drink), Euglena gracilis (its hypermetabolism and the presence of glycans are studied, great interest in biotechnology) and colicin (it would be used as an antimicrobial agent in processed vegetables, fruits and meat), among others.
Table 2 is an example where you can see in detail the evidence of substances that will be functional ingredients for the development of a new product, its possible use and its qualification as GRAS (see table 2 of the linked document).
As part of a well-balanced diet low in saturated fat and cholesterol, folic acid and vitamins B-6 and B-12 may reduce the risk of vascular disease. The FDA evaluated the above claim and found that although a diet low in saturated fat and cholesterol is known to reduce the risk of heart disease and other vascular diseases, the evidence for the above claim is not conclusive. Scientific evidence contributes to GRAS status and the writing of qualified health messages (see table 3 of the linked document).
General recognition of safety, through experience based on common use in food, requires a substantial history of consumption for food use by a significant number of consumers.
* Esther Santana, graduate nutritionist. Master of Strategic Marketing. Virtual university teacher. Editor of Nutrimarketing and author of the book Food Marketing.
** Mercedes Zocchi, graduate nutritionist. university professor. Consultant for food marketing. Cooperate with Nutrimarketing.
1. (December 2018).
2. (December 2018).
3. (January 2019).
5. (January 24, 2019).