ALERT! Green tea extract ‘nootropic’ now a prohibited novel food

As of February 2025, the Food Standards Australia New Zealand (FSANZ) has classified green tea extract (camellia sinensis) as a non-traditional and novel food due to concerns about liver toxicity. Novel foods are deemed to be unsafe for human consumption and their use in products sold as or in food is prohibited in Australia. Considering the safety risk assessment by the regulator, non-compliance with the requirements may result in significant penalties for suppliers as well as de-listing, consumer claims, and brand damage. And, unlike ashwagandha, newly non-compliant foods cannot be easily transitioned to sale as complementary medicine because green tea has been listed on the Poisons Standard and use is restricted.

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Why is green tea extract a trending ‘nootropic’ nutritive substance?

Green tea, as a beverage, has a long history of traditional consumption in Asia and a shorter history of consumption in Europe. Scientific evidence suggests green tea consumption may yield antioxidant, anti-inflammatory, anti-microbial, and anti-carcinogenic benefits primarily derived from the high presence of polyphenolic compounds.

However, green tea hasn’t been listed as a novel food, green tea extract has. Green tea extracts are sometimes called ‘nootropics’. ‘Nootropics’ are ingredients, including substances such as caffeine, L-theanine, etc that are thought to help improve cognitive processes, assist with working memory, and performance. Concentrated and refined forms of green tea have a history of use both as additive substances (flavourings and colourings) and, critically, as a way of supplementing or fortifying foods with additional nutritive substances (vitamins, minerals, amino acids) while skating around specific permission requirements that ordinarily apply because of the historic ability to position such extracts as permitted additives or, simply, ‘food’ ingredients.

Why has green tea extract been prohibited/restricted?

Novel foods are non-traditional foods that require a safety assessment by FSANZ prior to being sold in and as food. Notably, while FSANZ acknowledges the long-established traditional history of consumption of green tea as an infusion, the determination is based on lack of evidence to demonstrate history of traditional consumption of ‘catechin enriched (concentrated/elevated) green tea extracts’ as food.

Green tea extract or camellia sinensis, which has been classified as a novel food, is a refined form of the plant, concentrated for particular nutritive/technological purposes, which can contain extremely high levels of catechins as a result of processing. Catechins are a specific type of polyphenolic (antioxidant) compound; critically, green tea extract has higher levels of epigallocatechin gallate (EGCG) which may affect the body by disrupting inflammatory processes or protecting against damage as a result of inflammation and/or reducing oxidative stress damage to cells.

However, sometimes too much of a good thing can be very bad for you. While consumption of green tea at traditional levels as food is considered safe, consumption of high levels of catechins in concentrated green tea extract has been associated with liver toxicity and can cause gastrointestinal disorders. The tolerance for safety risk in products sold as food is very low and because a clearly safe level has not been established, the recent novel food determination applies to all ‘green tea extracts’ regardless of catechin content unless the extract meets the safety requirements for an approved additive. The safety risk has also been judged to be significant enough to warrant tighter regulation of the use of green tea extracts in low-risk complementary medicines which, taken together, indicates genuine cause for concern as to the safety of this ingredient.

Is your green tea ingredient a prohibited extract?

The February novel food determination prohibiting green tea extracts is purposely broad because a clearly safe level of catechin consumption (above traditional levels) has not yet been established and because levels can vary significantly due to method of processing and context of use. The systematic reviews show that catechin levels vary considerably depending on the product and preparation. For example, matcha is more concentrated and can contain up to 137x the amount of EGCG as other forms of green tea. A 2018 systematic review suggests that a 240ml serving of green tea may provide approximately 187mg of EGCG.

The safety assessment, however, specifically excludes the use of green tea extracts as food additives: guidance on the regulatory requirements of ‘food additives’ and ‘processing aids’ can be accessed here. This is because food additives are subject to existing specific permission requirements which are based on both safety and efficacy.

There are no specific permissions for use of green tea extract as an additive or nutritive substance currently, however, the broad definition of ‘substance permitted for use as a flavouring substance’ captures green tea extracts that meet certain criteria. For example, the Generally Recognised As Safe standards list green tea extract as a permitted, safe, flavouring agent within the following limits:

·       74-86% Catechin mono-, di- and tri-palmitate esters derived from green tea;

·       14-15% Palmitic acid;

·       Not more than 3% for total free catechins.

To be used in food, your extract must comply with one of the definitions of permitted flavouring substances AND must be less than the new maximum threshold introduced under the Poisons Standard being 300mg of catechins in a one-day amount.

However, the use of green tea extract as an additive in food remains a grey area until further clarification is provided by FSANZ.

Green tea extract a Scheduled Poison: TGA also moves to restrict use

In Australia, a product for oral consumption can be captured within the regulatory scope of FSANZ or TGA, but not both, based on risk and purpose. The Therapeutic Goods Administration (TGA) can also make specific determinations of whether the product is or is not a ‘therapeutic good’. A guidance tool to help you assess whether your product is a ‘food’ or ‘therapeutic good’ can be found here.

Camellia Sinensis is currently listed under the Permissible Ingredients Determination by the TGA for use in ‘low risk’ complementary and listed medicine but requires specific warnings when used as an active ingredient or as a constituent in a homeopathic preparation. Importantly, the listing requires that when used in oral medicines, the following warning statements are required on the medicine label:

1.           'In rare cases, Camellia sinensis may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes, or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.'; and

2.          (FOOD) ‘To be taken with food.’

unless when:

(a)        the preparation of Camellia sinensis is derived from an aqueous extract and contains 300 mg or less epigallocatechin-3-gallate per maximum recommended daily dose; or

(b)        Camellia sinensis is used in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing Camellia sinensis must not be more than 5% of the total medicine.

The TGA has also made amendments to the Poisons Standard, and Camellia Sinensis is now classified as a Schedule 5 substance which applies to all preparations for oral consumption containing more than 300mg of EGCG per maximum recommended daily dose, therefore, products containing more than 300mg of EGCG in a volume intended to be consumed in one day cannot be sold as food and are tightly regulated even as medicines.  

What does your business need to know?

Green tea extract is a widely used ingredient in sports supplements, formulated beverages, and other food products. Businesses selling food products containing green tea extract may need to consider alternative forms of green tea or alternative extracts depending on the purpose of its use in the product, particularly if it is used as a flavouring substance or added to the product to permit the supplier to make nutrition or health claims about the product.

If green tea extract is present in any of your current food products, or if you are thinking about introducing it as an ingredient in a new food product, speak to our UC F&B experts today; we’re always on call, always in your corner. Our experts can assist you to be confident that your business and products are compliant with all applicable regulations.

Next Steps

At Universal Counsel, our F&B experts can provide a comprehensive evaluation for clients covering not only whether ingredients are currently permitted under the Food Standards Code, and whether there are potential concerns about safety, but also your options for bringing a product with those ingredients to market on a low-risk/compliant basis (whether as a food or medicine).

If you are considering including a nutritive substance or substance used in traditional/herbal medicine in one of your products, please download our Permissions Pathways Flowchart, which outlines how we get from idea to execution in being able to add a substance and also being able to talk about what that substance does.

This alert is part of our series on trending nutritive substances, nootropics, and adaptogens that are prohibited novel foods. See also:

1.           Ashwagandha

2.          L-theanine

3.          Lion’s mane

Universal Counsel commonly assists F&B business with:

• Product labelling and collateral compliance reviews
• Ingredient safety and compliance analysis including procuring scientific toxicology studies
• Strategic path to market advice for businesses operating in the food-medicine interface, specialising in functional foods and complementary medicines.
• Claims strategy and compliance tools and solutions

Download our explainer on the food-medicine interface and path to market for functional foods here.

Contact the UC F&B team today: food@universalcounsel.com.au

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