GRAS List - Generally Recognized As Safe

The GRAS list consists of a number of substances known to be safe under certain conditions of use. It is a list published by the American FDA and is updated approximately every month.

GRAS List FDA

GRAS is the acronym for Generally Recognized As Safe. It is a qualification issued by the American FDA for a food additive giving its approval to be used, but always considering a certain use. It is important to emphasize this point, i.e., that the GRAS condition or status is for the use of the substance rather than the substance itself. All these substances are included in what is called the GRAS list.

They are substances generally recognized, by qualified experts trained in safety assessment, as having been shown through scientific procedures to be safe under a given condition of use.

The origin of GRAS dates back to 1958, in the United States, when there began to be widespread concern about the increasing use of chemical derivatives in the food industry. It is then that this amendment is enacted with the intention of evaluating and demonstrating - prior to its use in food - the safety of a particular substance. The concept of "food additive" is then defined but at the same time it is considered that certain substances intentionally added to food would not require a pre-marketing study by the FDA to ensure their safety, either because their safety was already established on the basis of a long history of use of this substance in food or according to the very nature of the substance, its habitual use and the information available on it. As a result of this amendment, the status of many substances being used in food was clarified and what was commonly known as the GRAS List was developed.

GRAS is the acronym for Generally Recognized As Safe. The origin of GRAS dates back to 1958, in the United States

This list has been updated over the years and we can find the latest version at this link: GRAS Notices. It contains all notifications issued by companies with the intention of achieving GRAS status for a particular substance. The company provides all the information it considers necessary while waiting for the response from the FDA. Among these substances, there are known microorganisms that act as probiotics.

EFSA Qualified Presumption of Safety (QPS)

In Europe, the EFSA (European Food Safety Authority) is the body that assesses the safety of micro-organisms used in food for their study and authorization before their use and release on the market. If the assessment concludes that a person is not a security risk, he or she is granted "QPS status".

This system was introduced by EFSA in 2007 based on the concept and purpose of the American FDA's GRAS program, but taking into account European regulatory practices. This is how the Qualified Presumption of Safety (QPS) came about, with the aim of providing the mechanisms to recognize and give weight to the knowledge obtained through research or by experience of use.

The aim was not simply to replicate the American GRAS model but to adapt it to the situation in Europe. Take, for example, antibiotic resistance, which is an undesirable and high-profile problem in Europe, while it is less important in the United States.

This list of microorganisms with QPS status is updated every 3 years. The latest version is from 2019 and can be found here.

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