Food Supplement Registration in New Zealand - Overview
The New Zealand food and dietary supplements market is an established yet dynamic market, focusing on product differentiation as its key growth strategy.. Food Standards Australia New Zealand (FSANZ) is the statutory body in the New Zealand government health portfolio, which develops food standards for Australia and New Zealand. However, dietary supplements are regulated under the Dietary Supplements Regulations, 1985, which falls under the Ministry for Primary Industries (MPI) Food Act, 2014. Medsafe is responsible for governing the dietary supplement regulations and the Food Act.
The New Zealand food and dietary supplement market is an established yet dynamic market that focuses on product differentiation as its key growth strategy. Food Standards Australia New Zealand (FSANZ) is the statutory body in the New Zealand government’s health portfolio that develops food standards for Australia and New Zealand. However, dietary supplements are regulated under the Dietary Supplements Regulations, 1985, which falls under the Ministry for Primary Industries (MPI) Food Act, 2014. Medsafe is responsible for governing the dietary supplement regulations and the Food Act.
In New Zealand, dietary supplements are substance(s) for oral use that are packed in a controlled dosage form and are intended to supplement the intake of the substance(s) normally derived from food. Dietary supplements must comply with the Dietary Supplements Regulations, 1985. The New Zealand food regulations describe several requirements, including, but not limited to labeling and the maximum permitted daily doses for several vitamins and minerals. There is no pre-approval process for dietary supplements. It remains the responsibility of the sponsor (the person legally responsible for placing the product on the market) to ensure that the quality of the product manufactured is of acceptable standards, that it is safe to use, and it complies with the law.
Sponsor declarations are subject to audits in New Zealand. Medsafe reserves the right to request further details regarding the manufacturing arrangements and Good Manufacturing Practice (GMP) compliance of the product while it remains on the market. A verified sponsor declaration remains valid if all details of the declaration remain unchanged. If changes are planned, the sponsor must submit an updated declaration and receive verification, in advance, of supplying the product to the New Zealand market.
Freyr provides professional assistance with the classification of food products, novel food registration, label and claims review, ingredient analysis, dietary supplement compliance and food supplement registration in New Zealand.
Food Supplement Registration in New Zealand
Expertise
- Food Product Classification.
- Food Regulatory Services New Zealand.
- Formula Review/Ingredients Assessment.
- Food Label and Claims Review.
- Claims Consultation and Substantiation.
- Food Regulatory Strategy.
- Food Regulatory Intelligence (RI) Report.
- Periodic Updates on the Product-specific Regulatory FSANZ Guidelines/Standards.
- Novel Food Enquiry Submission.
- Novel Food Registration.
- Food Import Guidance.
- Regulatory Advice for Dietary Supplements.
- Review or Preparation of Nutrition Information Requirements.
Advantages
- End-to-end Regulatory consultation on requirements of food product classification, compliance, registration, market launch, and food safety in New Zealand.
- A qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, Health Functional Foods (HFFs), health functional beverages, Foods for Special Dietary Use (FSDU), etc.
- Support in region-specific Regulatory activities.
- A strong relationship with different Health Authorities (HAs), viz. Medsafe, and an extensive partnership network across the globe.