Novel Food & Food Additive Services

Although “novel foods” are not defined in the United States (U.S.), any new food ingredient is considered either as a food additive (requiring a pre-market approval by the U.S. Food and Drug Administration (FDA)) or are Generally Recognized as Safe (GRAS) for specific uses, which can be determined by consensus of a panel of qualified experts. While GRAS notifications to the FDA are voluntary, a “no questions” response from FDA provides additional assurances of the regulatory status to end users of the ingredient and is useful in importing ingredients manufactured outside of the U.S.  Typically, new (novel) food ingredients undergo a GRAS determination.

The European Union’s (EU’s) Novel Foods Regulation (EC) No 258/97 applies to foods and food ingredients that have not been used for human consumption to a significant degree within the European Community before 15 May 1997. 

In January 2018 the EU Novel Food Regulation (EU) 2015/2283  came into full force, where new submissions now go direct to the Commission and EFSA. There is a new Union List of Novel Foods  which has a generic list of all approved ingredients. There will also be a new part of the list for approvals subject to exclusive use of proprietary scientific data for a period of 5 years. Submissions must be made to the new Commission Electronic Portal  based on the new specific submission regulations and European Food Safety Authority (EFSA) guidance. Additionally, a new regulation  for the determining whether an ingredient is or is not novel via consultation with a member state and subsequent notification of the Commission and other Member States.

There is also a separate notification with scrutiny procedure for “traditional foods from third countries” which are foods or food ingredients derived from primary production and have been confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a significant number of people in at least one country from outside the EU.

Intertek can help with all aspects of novel foods from determination and regulatory strategy to identifying dossier requirements and assisting to design, plan and manage the data acquisition process as well as preparing, submitting and stewardship to successful conclusion. We have unrivalled experience and success for our clients for 20 years.

 

In Canada, under the Food and Drugs Act and Regulations, novel foods are defined as foods/ingredients without a history of safe use as a food in Canada, are produced via novel processes, or have been modified by genetic manipulation. These novel foods require a pre-market assessment by Health Canada prior to being put on the market.

The regulation of novel food and ingredients in China are regulated according to the Administrative Measures for Safety Review of New Food Materials (2013).  Novel foods encompass animal, plant, or micro-organisms or substances derived from these sources, food substances with structural changes, or newly developed food materials.  Pre-market approval of novel food materials is conducted by the National Health and Family Planning Commission (NHFPC).

In Japan, different regulatory requirements are applied depending on the classification of a new food ingredient of interest. If the new food ingredient is a food, no pre-market assessment and authorization by the Ministry of Health, Labour and Welfare (MHLW) is required, but it must be ensured that the ingredient is compliant with the Food Sanitation Act (Act No. 233, 1947). On the other hand, if the new food ingredient is a food additive, a pre-market assessment and authorization is required prior to filing an Import Notification.

Novel foods in Australia/New Zealand are regulated under the Food Standards Code, specifically Standard 1.5.1, by Food Standards Australia/New Zealand (FSANZ). Additional considerations include whether a food is considered “traditional” or not.

Intertek has experience with novel food applications for countries not listed above as well, including South Korea, Brazil, Thailand, and others.