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Taking a Formulation Global? Do Your Homework…

By Patrick Morris, Fortitech | September 15, 2011

When you’re a global company servicing the food, beverage and pharmaceutical industries, it pays to do your homework and be prepared when it comes to developing product formulations, which will eventually be adopted in many countries worldwide. For instance, an ingredient or nutrient that is GRAS (Generally Recognized As Safe), within a nutrient premix, in a country like the U.S., may not necessarily be approved for food or beverage fortification in another country.

The regulations set forth by FDA are not necessarily in line with the European Food Safety Authority (EFSA) within the European Union, CODEX Alimentarius (CODEX) or the Agência Nacional de Vigilância Sanitária (ANVISA) in South America. In light of this and other challenges, we feel we can offer some guidance for manufacturers hoping to capitalize on some of the trends that are resonating with consumers today.

A newcomer to the functional drink category is the antithesis to an energy drink—relaxation drinks. These are becoming more prominent in the U.S., and GABA (Gamma Amino Butyric Acid) seems to be the ingredient of choice. There is mounting data suggesting it has functional properties to calm the brain.

But GABA’s application, while long popular with beverage manufacturers, has expanded outside that arena. So when preparing chocolate bar samples that addressed relaxation in Brazil, we needed to consider that under ANVISA, GABA could be consumed as a supplement, but not as a food additive. According to the technical team in our Campinas facility, the alternatives were either L-theanine or L-tryptophan.

Another area of concern relates to a manufacturer making the same product in two different locations, using two different technologies. Nutrient market forms and overages may need to be different to ensure the finished product at both locations is in spec—i.e., has the right color etc.—and adheres to the guidelines set forth by the regulatory authority in that country.

In addition to the regulations set forth by the various governing bodies in the many regions of the world, religious considerations may also apply. Having your facility certified as Kosher and/or Halal is an additional step that must be taken in order to operate in the global marketplace.

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