Regulatory Compliance

Medical Food and Regulation Specificities

Our products align with Medical Food definitions across the world and comply with specific regulations as a result of this. As such, Grünbiotics has had to undertake strict approval processes, including:

Country-Specific Regulations
Medical Foods are labelled under a variety of names around the world and each adheres to specific regulatory compliance. For example, Grünbiotics’ products are viewed as “Food for Special Medical Purpose” (by the Codex Alimentarius Commission – FAO-WHO/UN, Australia and New Zealand, European Union and China), “Food for Specified Health Uses” (in Japan), “Medical Foods” (in the USA) and “Foods for Special Dietary Uses” (throughout Canada).

Medical Food Distinction & Regulations
Medical Foods are generally defined as foods taken by those with a serious disorder, disease or medical condition who cannot meet specialised nutritional requirements through normal diet. They differ to pharmaceuticals in that they are not technically manufactured drugs / medicines. In contrast to this, nutritional supplements and functional foods are developed for healthy people to help maintain their wellbeing.

Core Regulatory Areas

Food for Special Medical Purpose / Medical Food

Grünbiotics complies with core legislation that regulates the food itself and also promotes the accuracy of nutrition and health claims during product promotion, including:

• Food labelling, Presentation, Advertising & Marketing (mandatory labelling including “for the dietary management of…”)

• Nutrition and health claims (voluntary claims)

• Composition (levels of vitamins and minerals)

• Contaminants and natural toxicants (and levels)

Australian and New Zealand Regulations

Grünbiotics & FSMP

We comply with the following key FSMP regulations in Australia and New Zealand’s Food Standards Australia New Zealand Act 1991 (the FSANZ Act):

• Australia New Zealand Food Standards Code – Standard 2.9.5 – Food for special medical purposes

• Australia New Zealand Food Standards Code – Schedule 29 – Special purpose foods

• Australia New Zealand Food Standards Code – Standard 1.4.1 – Contaminants and natural toxicants

• Australia New Zealand Food Standards Code – Schedule 19 – Maximum levels of contaminants and natural toxicants

These include Definition and Labelling (ANZ Food Standards Code 2.9.5); Nutrients (ANZ Food Standards Code 2.9.5 and Schedule 29); and, Contaminants (ANZ Food Standards 1.4.1).

ANZ Food Standards Code – Standard 2.9.5 – Food for special medical purposes
The ANZ Food Standards Code – Standard 2.9.5 – Food for special medical purposes, amongst other things, provides the definition that Grünbiotics’ products align with. This Standard “regulates the sale, composition and labelling of foods specially formulated for the dietary management of individuals with certain diseases, disorders or medical conditions.”

As much as it can, the ANZ Food Standard also aligns with similar regulations in Europe and the U.S.A. Grünbiotics also adheres to the labelling of FSMPs in terms of its reference to factors such as medical supervision, medical purpose, ingredient list and dates.

ANZ Food Standards Code – Schedule 29 – Special purpose foods
Grünbiotics’ products also comply with Schedule 29 of the Food Standards Code which refers to “substances that may be added to food for special medical purposes”, “amounts of nutrients for food for special medical purposes represented as a sole source of nutrition” and “permitted forms of vitamins, minerals and electrolytes in infant formula products, food for infants and food for special medical purposes.”

ANZ Food Standards Code – Standard 1.4.1 – Contaminants and natural toxicants
As a producer of FSMPs, Grünbiotics also adheres to Standard 1.4.1. This Standard relates to contaminants and natural toxicants and the “composition of, or the presence of specified substances in, food of that kind.”

ANZ Food Standards Code – Schedule 19 – Maximum levels of contaminants and natural toxicants
Grünbiotics complies with Schedule 19 of the ANZ Food Standards Code, which refers to maximum levels / limits relating to contaminants or natural toxicants contained in Standard 1.4.1 that can pose a risk to the general public’s health and safety. Schedule 19 sets out maximum levels for natural toxicants, metal and non-metal contaminants and mercury in fish.

International Regulations

Grünbiotics & FSMP

Grünbiotics’ products also comply with regulations and guidelines in the respective overseas markets in which they are sold, including:

The European Food Safety Authority (EFSA)
The EFSA is the European Union Agency that provides independent scientific advice and protection (for people, animals and environment) in regard to existing and emerging food-related risks. The EFSA provides advisory to those responsible for regulating food safety in Europe.

The Chinese State Drug Administration (SDA) to operate under the State Market Regulatory Administration (SMRA)
Formerly the China Food and Drug Administration (CFDA), the SMRA is responsible for drug and food safety, protection of intellectual property and product quality issues. The SMRA oversees such activities as quality inspection, business registrations, certifications and accreditations, and management of intellectual property. The State Drug Administration (SDA), supervised by the SMRA, regulates life sciences and healthcare.

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.

To discover more about Grünbiotics Regulatory Compliance Program or to enquire about relevant legislation, please contact us:

Telephone: +613 8692-0006
E-mail: info@grunbiotics.com