GRAS assessment dossier prepared for Peruvian Sacha Inchi (en)

29 abril 2014
ITC Noticias
ITC provided technical support for the development of a GRAS assessment dossier for Sacha Inchi Oil. This safety standard is an essential requirement for Peruvian exporters to trade in the US market. This dossier has been submitted to the Food and Drug Administration.

Sacha Inchi is a plant native to Peru cultivated by smallholders in the Amazon basin. The kernel of the fruits is consumed as snacks (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.

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

In order to achieve the approval of Sacha Inchi as an safe product in the American market-ITC provided technical support for the development of the dossier and facilitated marked access for Peruvian SMEs  exporting Sacha Inchi oil to the US market.  This involved carrying out clinical research to characterise the chemical, botanical and pharmaceutical properties to ensure it is safe.

In December 2013 the complete Generally Recognized as Safe (GRAS) dossier for Sacha Inchi oil was sent to the Food and Drug Administration (FDA), the Consumer Protection Agency of the U.S. Government. This dossier, if approved by FDA 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. Focussing 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”.

Learn more: watch video on enterprises taking part in the project.