Regulatory Compliance Consulting in Other Countries
Comprehensive regulatory compliance services for Australia, Canada, China, New Zealand, Singapore, and other global markets.
Applicable Objects
This requirement applies to food ingredients used in general foods, infant formula, infant foods, or foods for special medical purposes marketed in Australia and New Zealand that are classified as Novel Foods (i.e., ingredients without a significant history of consumption, or non-traditional foods requiring a public health and safety assessment).
Compliance Pathway Overview
A Novel Food application must be submitted to Food Standards Australia New Zealand (FSANZ). Following FSANZ’s scientific assessment and confirmation by the Australia and New Zealand Food Ministers’ Meeting, the ingredient is approved and listed in the Australia New Zealand Food Standards Code – Schedule 25: Permitted Novel Foods.
Our Services
- Feasibility Assessment
- Data Gap Analysis
- Preparation of Application Materials
- GMP/HACCP System Development
- Toxicological Testing Assistance and Design
- FSANZ Inquiry and Supplementary Response
Applicable Objects
This requirement applies to food ingredients used in general foods, infant formula, infant foods, or foods for special medical purposes marketed in Australia and New Zealand that are classified as Novel Foods (i.e., ingredients without a significant history of consumption, or non-traditional foods requiring a public health and safety assessment).
Compliance Pathway Overview
A Novel Food application must be submitted to Food Standards Australia New Zealand (FSANZ). Following FSANZ’s scientific assessment and confirmation by the Australia and New Zealand Food Ministers’ Meeting, the ingredient is approved and listed in the Australia New Zealand Food Standards Code – Schedule 25: Permitted Novel Foods.
Our Services
- Feasibility Assessment
- Data Gap Analysis
- Preparation of Application Materials
- GMP/HACCP System Development
- Toxicological Testing Assistance and Design
- TGA Inquiry and Supplementary Response
Applicable Objects
This requirement applies to food ingredients used in general foods, infant formula, infant foods, or foods for special medical purposes marketed in Singapore that are classified as Novel Foods (i.e., ingredients without a history of human consumption in Singapore within the past 20 years, or those produced using new technologies or processes).
Compliance Pathway Overview
A Novel Food application must be submitted to the Singapore Food Agency (SFA). Following scientific assessment and approval, the ingredient is authorized and the applicant receives an official SFA approval letter.
Our Services
- Feasibility Assessment
- Data Gap Analysis
- Preparation of Application Materials
- GMP/HACCP System Development
- Toxicological Testing Assistance and Design
- SFA Inquiry and Supplementary Response
Applicable Objects
This requirement applies to food ingredients used in general foods, infant formula, infant foods, or foods for special medical purposes marketed in Canada that are classified as Novel Foods (i.e., ingredients lacking a history of safe consumption, significantly altered through new processes, or derived from genetically modified sources).
Compliance Pathway Overview
A Novel Food application must be submitted to Health Canada (HC). Following scientific assessment and approval, the ingredient is authorized, the applicant receives an official HC approval letter, and the product is listed in Health Canada’s Completed Safety Assessments of Novel Foods, including GM Foods.
Our Services
- Local Agent Services
- Feasibility Assessment
- Data Gap Analysis
- Preparation of Application Materials
- GMP/HACCP System Development
- Toxicological Testing Assistance and Design
- Health Canada Inquiry and Supplementary Response
Applicable Objects
This requirement applies to ingredients used in natural health products marketed in Canada.
Compliance Pathway Overview
A Natural Product Number (NPN) application must be submitted to the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada. Upon review and approval, the Minister issues a product licence, and the ingredient is recorded in the Natural Health Products Ingredients Database (NHPID).
Our Services
- Local Agent Services
- Feasibility Assessment
- Data Gap Analysis
- Preparation of Application Materials
- GMP/HACCP System Development
- Toxicological Testing Assistance and Design
- Health Canada Inquiry and Supplementary Response
Applicable Objects
This requirement applies to food ingredients used in general foods, infant formula, infant foods, or foods for special medical purposes marketed in China that are classified as New Food Raw Materials (i.e., ingredients without traditional consumption in China).
Compliance Pathway Overview
A New Food Raw Material application must be submitted to the National Health Commission (NHC) of China. After a safety assessment by the China National Center for Food Safety Risk Assessment (CFSA) and approval by the NHC, the ingredient is authorized and listed in the New Food Raw Material Announcement Directory.
Our Services
- Feasibility Assessment
- Data Gap Analysis
- Preparation of Application Materials
- Toxicological Testing Assistance and Design
- Organize Pre-evaluation Meeting
- CFSA Inquiry and Supplementary Response
Applicable Objects
This requirement applies to food additives intended for use in China that are not listed in the National Food Safety Standard for the Use of Food Additives (GB 2760).
Compliance Pathway Overview
A new variety of food additive application must be submitted to the National Health Commission (NHC) of China. Following a safety assessment by the China National Center for Food Safety Risk Assessment (CFSA) and approval by the NHC, the additive is authorized and included within the permissible use scope of GB 2760.
Our Services
- Feasibility Assessment
- Data Gap Analysis
- Preparation of Application Materials
- GMP/HACCP System Development
- Toxicological Testing Assistance and Design
- Organize Pre-evaluation Meeting
- CFSA Inquiry and Supplementary Response