Food and Dietary Supplements Regulatory Services in New Zealand

Food and Food Supplements
Regulatory Services 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.

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 regulations describe several requirements, including, but not limited to labeling and 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, 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 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, and dietary supplement compliance. 

Expertise

Freyr Expertise

  • Food Product Classification
  • Formula Review/Ingredients Assessment
  • Food Label and Claims Review
  • Claims Consultation and Substantiation
  • Regulatory Strategy
  • Food Regulatory Intelligence (RI) Report
  • Periodic Updates on the Product-specific Regulatory Guidelines/Standards 
  • Novel Food Enquiry Submission
  • Novel Food Registration
  • Import Guidance
  • Regulatory Advice for Dietary Supplements
  • Review or Preparation of Nutrition Information Requirements
Freyr Advantages

ADVANTAGES

Freyr Advantages

 

End-to-end Regulatory consultation on requirements of food product classification, compliance, registration, and market launch

 

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