Regulatory

ADI

ADI stands for Acceptable Daily Intake and describes an amount for a food additive relative to body weight which a person can consume without risks on a daily basis over a lifetime. 

Dietary Supplements

According to the US Food and Drug Administration definition, these are: "Products that intended to supplement the diet. These products are typically botanicals, vitamins, minerals".

Applicable countries:

  • United States – labeled with “Supplement Facts” and are regulated differently from conventional food
  • Example: Stevia leaves and extracts have been permitted for use dietary supplements in the US since 199

A reference can be found here

EFSA

EFSA is an acronym for the European Food Safety Authority. EFSA is tasked with science-based evaluation of safety and preparation of scientific opinions and advice to support legislation in the EU. This activity is sometimes called risk assessment. The advice of EFSA underpins food safety in the EU. EFSA has published a comprehensive brochure that provides valuable information:

A reference can be found here.

Steviol glycosides received a favorable opinion in April 2010. The European Commission requested EFSA to conduct a risk assessment following submission of new data that was submitted by 3 applicants requesting the approval of Steviol glycosides for use in the EU as a food sweetener. The favorable scientific opinion opened the door for approval by the European Union which took place on 11 November 2011.

The EU regulation on Steviol glycosides can be found here

FCC Monograph

FCC Monograph on Rebaudioside A

In 2009, the FCC monograph for Rebaudioside A was established and published in the 2009 FCC Supplement and in the Seventh Edition of the FCC in September, 2010.

It contains specifications related to the ingredient's identity, purity, and potential impurities, as well as supporting analytical test procedures and use of USP chemical Reference Standards.

The chemical Reference Standards were established through USP's open, independent, and collaborative testing process to ensure their suitability for the intended uses in the monograph test procedures. The FCC Rebaudioside A monograph and associated Reference Standards provide an objectively established standard against which both producers and purchasers can compare their ingredients to ensure their quality.

A reference can be found here.

At the moment, the FCC is working on a monograph based on the Steviol Glycosides monograph from the 73rd JECFA Session in 2010.

Food Chemicals Codex (FCC)

The FCC is a compendium of internationally recognized standards for the purity and identity of food ingredients. It features about 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 is published in the United States by the U.S. Pharmacopeia, but regulatory agencies, manufacturers, vendors, and other users of food ingredients recognize it worldwide. In some countries, FCC standards may serve as a legal requirement for manufacturing or importing a food ingredient.

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 members of the food industry:

(a). They are used as agreed standards between suppliers and manufacturers in ongoing purchasing and supply decisions and transactions and

(b). 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. 

GRAS

GRAS is an acronym for Generally Recognized as Safe. This is a regulatory designation used in the United States where substances added to food must either be approved by Food and Drug Administration (FDA) as food additives or through a self-affirmation process, be generally recognized as safe (GRAS). While there is no premarket notification required for GRAS substances, the standard for safety that applies to general recognition is the same as the standard that is applicable to food additives.

The United States FDA offers a voluntary GRAS notification program. An inventory of GRAS notifications, along with corresponding agency responses, is available online. For more information about GRAS or the GRAS process, visit the link below.

A reference can be found here.

Steviol glycosides are GRAS for general purpose sweetener use. This regulatory status is the result of multiple GRAS notifications for Steviol glycosides that have been submitted to the FDA since 2008. To date, the FDA has responded to each of these notifications stating that the Agency has no questions or objection to safety findings at this time regarding the GRAS status of purified Steviol glycosides meeting purity criteria of not less than 95% total glycosides and Rebaudioside A and/or stevioside as principal components.

GSFA

GSFA stands for the Codex General Standard for Food Additives.
The GSFA database can be found here.

INS No.

INS (International Numbering System) is a number linked to Codex and refers to the number a food additive is assigned in the Codex classification system (CAC/GL 36-1989).

Natural Health Products (NHP)

Natural Health Products is a term used by the Canadian Department of Health for products which can contain medical ingredients and/or restore, correct or modify organic functions in humans.

Applicable countries: Canada

Example: Health Canada has published a safety monograph for Stevia. To date, Health Canada has approved the use of stevia and its extracts as a non-medicinal ingredient (sweetener) in a large number of natural health products, and as a medicinal ingredient in multiple natural health products (NHPs).

References can be found here

Novel food

Definition: Novel foods are foods and food ingredients that have not been used for human consumption to a significant degree within the Community before 15 May 1997. A separate regulation is applied to GM-derived food and food ingredients.

Applicable countries:

European Union: Stevia rebaudiana (plant and dried leaves)

Applicant-Katholieke Universiteit Leuven Laboratory of Plant Physiology - 7 November 1997

Commission Decision- refusing the placing on the market of Stevia rebaudiana - 2000/196/EC

Regulation EC 258/97 of 27 January 1997 of the European Parliament and the Council lays out detailed rules for the authorization of novel foods and novel food ingredients.

Commission Decision 2000/196/EC 22 February 2000 refusing the placing on the market of Stevia rebaudiana Bertoni.

Click here for more information from Health Canada 

Click here for more information from Food Standards Australia/New Zealand - FSANZ

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