ONC Worldwide Regulatory Achievements

GLOBAL

  • Full compliance with the voluntary Fish Oil Monograph of the Global Organization for EPA and DHA Omega-3 (GOED)

UNITED STATES

  • GRAS (Generally Recognized as Safe) status for several fish oils and microencapsulated fish oils
  • Nutrient content claim for EPA and DHA from fish oil

CANADA

  • Natural Health Product licenses for fish oil capsules (first in Canada for an Ethyl Ester fish oil)
  • Novel Food approvals for 18/12, Bonito and Tuna microencapsulated fish oils

EUROPEAN UNION

  • Full compliance with new hygiene requirements for the production and import of fish oil into the European Union (Regulation 853/2004/EC as amended)

ASIA PACIFIC

  • Expanding regulatory involvement in Asian countries and providing support to customers fortifying food and dietary supplement products for market launch in Asian markets
  • Approval from the Australian TGA for the use of concentrated triglyceride fish oils in complementary medicines

 

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