What is a Novel Food?

Product formulation is an important part of the Food / Sports Supplement industry. In an industry where competition is extremely fierce, redesigning products through research and development becomes highly important. Developing new ingredients may make the difference between a typical product and a blockbuster. However, for products to be marketed and sold in the EU market, regulations and directives need to be followed. It is here where ingredient development may be influenced by the Novel Food Regulation (EC 258/97).

So what is a Novel Food? According to Regulation (EC) 258/97 (revision of the Regulation is pending), Novel Foods are:

– foods and food ingredients with a new or intentionally modified primary molecular structure;
– foods and food ingredients consisting of or isolated from microorganisms, fungi or algae;
– foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;
– foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.

which have not been on the European market before the day in which the Regulation entered into force on 15 May 1997,

It is here that we see that Novel Foods have been typically modified chemically, through manufacturing processes, consist of or isolated from microorganisms or plants and animals other than typical means having a history of safe food use (i.e., not consumed in the EU before 1997).

One may also search the Novel Food Catalogue. It is important to note that this database is for informational purposes only and one should always check with their national authorities to be sure.

How can a substance be determined to be a Novel Food or not when uncertainty exists? A technical data sheet is an excellent first piece of information to use to understand the contents of a substance. One may also contact the producing company requesting further information, explanations etc. Also, it may be possible to read the patent (if the ingredient has been patented) to understand how the ingredient was created (generally a patent awarded of 1997 is evidence that a subtance is a novel food).

Sport Nutrition Team

Republic of San Marino and Italy: protocol of cooperation on food supplements is being implemented

The General Direction of Food and Nutritional Safety (DGSAN) of Italy and the Department of Prevention of the Institute of Social Security for the Republic of San Marino (DPRSM) are now working together to facilitate cooperation in product and manufacturing conformity to EU community legislation. The protocol, which recently entered into force, specifically looks at the entrance of new products to the market and the verification of manufacturing facilities and processes situated in San Marino.

Before this accord took place, a food supplement importer residing in San Marino, which is not a EU Member State, had to notify the Italian Ministry of Health of the product that was to be imported and sold in Italy. What has changed is that now, the same Italian importer that resides in San Marino must add “RepSM” in the subject line of the notification form (found on the website: www.salute.gov.it). Also, if a note of reply is requested from the Italian Ministry of Health, the same “RepSM” must be present in the subject line. All communications to and from the Italian Ministry of Health will also be forwarded on to the DPRSM. If food supplements have a positive review from the DGSAN, the product will be included in the specific registry on the website located above.

It is important to note that both offices will be collaborating in the area of misleading advertising that does not conform to EU / Italian standards. DGSAN will make note of any advertising that is misleading / illegal on websites located in San Marino and will communicate this to the DPRSM and the DPRSM will do the same for Italian websites.

The second major impact of this collaboration is the control of production facilities by Italian authorities (DGSAN) with assistance from the DPRSM within San Marino. If an inspection takes place and the production facility is given recommendations on how to conform to legislation, the DPRSM will verify that the recommendations have been implemented. If and when they have been put into place, the DPRSM will communicate to the DGSAN to close the procedure on said production facility.

In practice the protocol, which enforces a previous agreement, means that the Republic of San Marino is relying on the Italian authorities, regulations and administrative practices for the assessment and management of food supplements and dietetic products, and that there should be no differences in the products marketed in the two countries.

While the general procedure is relatively straightforward, specific situations should be analyzed on a case-by-case basis, especially for sports nutrition products.

The Sports Nutrition Team

%d bloggers like this: