Registrations and Approvals
Grünbiotics’ products are registered in numerous countries around the world. We have successfully met the approval process in numerous international jurisdictions and comply with specific regulations and guidelines in each respective overseas markets.
Our products have gained approval as Medical Foods in a range of countries and regions:
Medical Foods are generally defined as foods taken by those with a serious disorder, disease or medical condition who are unable to meet specialised nutritional needs via their normal diet.
Nutritional supplements and functional foods differ to Medical Foods in that they are designed for healthy people to help maintain their health.
Pharmaceuticals are also taken by those with a serious disorder, disease or medical condition; however, they are a manufactured drug or medicine for treating a disease.
Approval processes, registration requirements and labelling differs from country to country:
“Food for Special Medical Purpose” by the Codex Alimentarius Commission – FAO-WHO/UN in Australia and New Zealand, the European Union and China
“Medical Foods” in the United States
“Foods for Special Dietary Uses” in Canada
“Food for Specified Health Uses” in Japan
Grünbiotics’ products have successfully navigated extremely challenging and complex approval processes and landscapes across different countries to become registered.
Accreditations & Approvals
Our Medical Nutrition Food Products
Via our partners and their state-of-the-art manufacturing facilities and distribution processes, Grünbiotics products share some or all of the following accreditations and approvals:
HACCP and GMP
BRC Global Standard for Food Safety
Registration and Approval Process by Country (ANZ, Europe, China & the U.S.)
Some of the international markets that we have successfully gained registration in include:
Australia & New Zealand and the ANZ Food Standards Code
Grünbiotics’ products – Neurofolin® and Neurothrive® – are Food for Special Medical Purpose (FSMP) in Australia and New Zealand. The ANZ Food Standards Code defines FSMP as a food “for the dietary management of a disease, disorder or medical condition” whose nutritional requirements cannot be met by normal foods.
As a FSMP in Australia, our products are typically recommended by doctors, pharmacists and other healthcare professionals as part of a comprehensive treatment plan and are available in pharmacies.
FSMP products are not able to be purchased as a typical food product would (i.e. at the local shop). They are also not viewed as a therapeutic good in Australia. As such, they do not require approval by the Therapeutic Goods Administration (TGA).
FSMPs are regulated by the Australia New Zealand Food Standards Code (FSANZ). In particular, Standard 2.9.5, Schedule 29, Standard 1.4.1 and Schedule 19. These Standards regulate the sale of FSMP, its composition and labelling. Grünbiotics’ products strictly adhere to this code.
The European Union and the European Food Safety Authority (EFSA)
Grünbiotics’ products comply with guidelines set down by The European Food Safety Authority (EFSA). The EFSA provides independent scientific advice and protection (for people, animals and environment) in regards to existing and emerging food-related risks. The EFSA provides advisory to those responsible for regulating food safety in Europe.
As Food for Special Medical Purpose in the European Union, Grünbiotics’ products comply with the following legislation and guidelines:
Regulation on Food for Specific Groups (FSG Regulation) applies to FSMP:
(EU) No 609/2013 - This Regulation establishes compositional and information requirements for FSMP and other food categories
Includes Eastern Europe, Europe, European Union Countries, Northern Europe
The European Food Safety Authority (EFSA) issues scientific and technical guidance on FSMP in the context of Regulation (EU) No 609/2013
Commission Delegated Regulation 2016/128 applies to FSMP:
Supplements Regulation (EU) No. 609/2013 of the European Parliament and of the Council
Relates to the specific compositional and information requirements for FSMP
Is valid from 2019
Regulation 178/2002 – General Food Law applies to FSMP:
EU Member states are responsible for enforcement of this regulation
National authorities enforce FSMP legislation (such as verification of product as an actual FSMP and compliance)
China and the Chinese State Drug Administration (SDA)
Grünbiotics’ products in China are within the responsibility of The Chinese State Drug Administration (SDA). The SDA – formerly the China Food and Drug Administration (CFDA) – is responsible for drug and food safety, protection of intellectual property and product quality issues in China.
The laws and regulations in China pertaining to FSMP, of which Grünbiotics is compliant, include:
The Food Safety Law of the People’s Republic of China (2015) – this legislation ensures food safety and safeguards public health and safety. From 2019, all Food for Special Medical Purpose must attain a registration certificate.
Testing – to obtain registration, China requires a number of tests be conducted, including:
Items listed in the product standard
Others (when required)
FSMP Stability Research – provides information related to change rules of product quality characteristics over time under certain environmental factors
FSMP Label – labelling requirements for Food for Special Medical Purposes, including compliance with:
GB 29922-2013 General Rules of FSMP - National Food Safety Standard on the General Rules for Foods for Special Medical Purposes
FSMP Manufacturing GB 29923-2013 - Good manufacturing practice for FSMP – National Food Safety Standard
FSMP Clinical Trials Quality Control – This includes complete statistical analysis reporting and data, detailing information about clinical trials
FSMP Application Dossiers – application and registration of FSMP products requires a detailed format and content, including such items as: R&D reports; samples of product labels; test reports; evidence material of R&D capacity, production capacity and test capacity; certifying document issued by government authorities or legal service agencies in the producing country (region) of origin proving that (a) the applicant is the overseas manufacturer and (b) that the product is allowed to be sold on the market.
Other relevant legislation includes:
Food Safety National Standards for Labelling of the Pre-packaged Foods for Special Dietary uses (GB13432-2013)
The Administrative Measures of Food Production License
The Administrative Measures of Food Operation License
The Provisional Regulations on Food Advertising
Advertisement Law of People’s Republic of China (2015)
Food Safety National Standards for the Uses of Food Additives (GB 2760-2014）
The United States Food and Drug Administration (FDA)
Grünbiotics’ products in the USA are regulated by the United States Food and Drug Administration (FDA). The FDA protects public health by assuring foods are safe, effective, wholesome, sanitary and properly labelled across 50 U.S. States and other territories.
As a Medical Food, Grünbiotics’ products comply with the following legislation and guidelines:
The Orphan Drug Act (ODA) – in the United States, Medical Foods are contained under The Orphan Drug Act (ODA). Initially established to encourage drug development for “rare” diseases, The OCA’s threshold for a rare disease is considered to be less than 200,000 people. In the United States, Medical Foods differ to foods for special dietary use by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision and intended for the specific dietary management of a disease or condition.
Medical Food Manufacturing – to be registered by the FDA, the manufacturing of Medical Foods must also comply with:
Current good manufacturing practice
Registration of food facilities
Thermally processed low-acid foods packaged in hermetically sealed containers
Labelling of Medical Foods – to be approved by the FDA, Medical Foods must adhere to the following labelling regulations:
A statement of identity
An accurate statement of the net quantity of contents
The name and place of business of the manufacturer, packer, or distributor
A complete list of ingredients, listed by their common or usual name and in descending order of predominance
Medical Food Ingredients – ingredients added to Medical Foods must be safe and compliant with the United States Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations
False or Misleading Claims (includes Medical Foods) – Regulated by the United States Federal Food, Drug, and Cosmetic Act