GRAS assessment dossier prepared for Peruvian Sacha Inchi

29 April 2014
ITC News
ITC provided technical support for the development of a GRAS assessment dossier for sacha inchi oil. This safety regulation is an essential requirement for Peruvian exporters to trade in the US market.

Sacha inchi is a plant native to Peru cultivated by smallholders in the Amazon basin. The kernel of the fruits is consumed as a snack (such as covering it with chocolate) or used for producing oils used in cooking and salads. Sacha inchi is considered a super food due to its high content of Vitamin E and omega 3 fatty acids. Sacha inchi oil is currently gaining international recognition for its health properties and is thus heavily in demand.

However, Peruvian enterprises face technical barriers to trade, particularly from the US and Canadian markets. One such barrier is the regulation “Generally Recognized as Safe” (GRAS) approval, a key Food and Drug Administration (FDA) market entry requirement in to USA. Under GRAS, in order for companies from USA to use sacha inchi in large volumes, an assessment must be conducted to prove that the product does not affect the health of the consumers. In the EU market, exporters face a similar barrier in the form of the Novel Foods regulation.

In order to achieve the approval of sacha inchi as a safe product in the US market, ITC provided technical support for the development of the GRAS dossier and facilitated marked access for Peruvian SMEs  exporting sacha inchi oil.  This involved carrying out clinical research to characterize the chemical, botanical and pharmaceutical properties to ensure it is safe.

In December 2013 the complete GRAS dossier for sacha inchi oil was sent to the FDA for approval. This dossier, if approved, will allow sacha inchi to be traded in large quantities in the US market, thus opening up a big opportunity for smallholder farmers. ITC’s beneficiaries have written:

Michel Paz Monge (Shanantina CEO) -

“Benefit of GRAS assessment would be huge. Focusing on the point of the grower- He would be leaving aside other types of illegal crops allowing the economy of San Martin region to be more dynamic. As a company we would broaden our expectations of selling our products to different markets.”

Walter Wallis, (CEO amazon health) -

“The sacha inchi has components to be successful in the market and to offer development alternatives that are so needed in the country and for that we need to be strategic”.

Want to learn more? Watch video on enterprises taking part in the project.