
Is FSANZ's approach to QuornTM (mycoprotein) consistent with previous FSANZ policy? By Joe Lederman and Charles Fisher FoodLegal Lawyers and Consultants © Lawmedia Pty Ltd, March 2011 A fact sheet recently released by Food Standards Australia New Zealand (FSANZ) on the safe use of mycoprotein in the Australian food industry raises questions as to when a “non-traditional food” will not be considered a Novel food. When a food is considered by FSANZ to be a Novel food it must go through a full assessment by FSANZ for public health and safety. FSANZ’s response to reports of adverse reactions to this mycoprotein product contrasts with the action taken by FSANZ on a very traditional and natural food, cassava. The leniency displayed by FSANZ in relation to mycoprotein and the contrasting conservative approach to cassava are symptomatic of inconsistency in the FSANZ approach to scientific-based public health and safety risk assessment. What is “Quorn™”? On 2 March 2011, FSANZ circulated an email publicizing a Fact Sheet on “Quorn™ (mycoprotein)” issued by FSANZ in February 2011, stating that foods made with this substance are permitted to be used in the manufacture and sale of foods in the retail market in Australia and New Zealand. Currently there appears to be one branded product range in the Australian market using the brand “Quorn™”. Products marketed under this name have included various formed meat-style products such as mince, sausages, strips, patties, etc. (Incidentally, there are legal restrictions in Australia concerning sausages made without meat being called “sausages” but that is a subject in itself for another day). Despite a long history of consumption in the UK (since 1986), the question was asked whether it might be necessary to assess whether or not Quorn is a Novel food under Standard 1.5.1 of the Australia New Zealand Food Standards Code (the Food Standards Code) - given that foods containing mycoprotein have been available in Australia only since 2010. The mycoprotein product is also marketed as a natural alternative for meat. As such, the Quorn product competes with other various accepted non-meat substitutes such as soy, whey, caseinate, and gluten. What is a “Novel food”? Standard 1.5.1 of the Food Standards Code uses a two-step process to define a “Novel food”: The food substance must be a non-traditional food; and It must a substance which requires an assessment of its public health and safety. If a substance meets both of these two requirements, it is a Novel food. The determination is important; firstly because no Novel food can be sold in Australia without express approval in the Food Standards Code and, secondly, an applicant to use a Novel food can be granted a 15 month exclusivity period for the novel aspect. (It should be noted this is apart from any subsisting Intellectual Property rights such as patents which confer their own exclusivity by law). An example of a Novel food exclusivity period is that which has applied to Kraft’s permission (under Standard 1.5.1 of the Food Standards Code) to use phytosterols in low fat cheese. A *non-traditional food* is defined in the same Standard as: (a) a food that does not have a history of consumption in Australia or New Zealand; or (b) a substance derived from a food, where that substance does not have a history of human consumption in Australia or New Zealand other than as a component of that food; or (c) any other substance, where that substance, or the source from which it is derived, does not have a history of human consumption as a food in Australia or New Zealand. All three sub-clauses implicitly refer to “consumption” (presumably “human” consumption in all three sub-clauses) of the reference food in Australia and New Zealand as a primary condition. There is no definition of “traditional” per se in the Food Standards Code but in the case of a Novel food it may be assumed that “traditional” food has the opposite meaning to a “non-traditional food”. FSANZ View on Quorn™ as a “Novel food” FoodLegal notes that the Advisory Committee on Novel Foods (ACNF) is a body that receives submissions from food companies with novel or innovative food product so that the ACNF can make a recommendation to FSANZ as to when a food should be considered as a Novel food. In this role, the ACNF has superseded the previous Novel Foods Reference Group (NFRG). The ACNF meets regularly to consider substances that may or may not be Novel foods. See also Terms of Reference and membership for ACNF. In separate correspondence from FSANZ, on the subject of mycoprotein, FSANZ stated: “The ACNF [Advisory Committee on Novel Foods] noted that [the Quorn™ product] was a non-traditional food in Australia and New Zealand, as there was not a history of human consumption in these countries. When a food is considered non-traditional, the ACNF then discusses whether an assessment of public health and safety is required before the product can be sold as a food in Australia and New Zealand. The ACNF noted extensive information provided by the enquirer and additional information identified by FSANZ in considering whether a pre-market safety assessment by FSANZ would be required. The history of consumption of the product in the UK and other countries also influenced the ACNF’s consideration. The ACNF noted some adverse reactions had been reported overseas; however, the incidence of these reactions was not common (around 1 in 134,000 to 1 in 175,000). The ACNF was satisfied that the Quorn™ product was safe for consumption as a food and was therefore not a novel food (as a novel food must be a non-traditional food and require an assessment of public health and safety considerations – as defined in Standard 1.5.1).” (Email of 4 March 2011 from Jonathon Kite –Senior Food Scientist of FSANZ to food technologist A F Zipper). What implications do the adverse reactions have? The FSANZ Fact Sheet dated February 2011 has been released to reassure Australian consumers of the apparent safety of products containing mycoprotein/Quorn – in response to reports of adverse reactions. Republished also in the FSANZ email of 2 March 2011 sent out by FSANZ’s Communications Advisor Lydia Buchtmann, FSANZ’s Fact Sheet dated February 2011 stated [FoodLegal has added emphasis of the relevant issues in bold print below]: Mycoprotein is a source of dietary protein and fibre derived from a fungus. It is used in a limited range of meat-free foods marketed under the brand name Quorn™. Although Quorn products have been available in Australia only since 2010, they have been consumed in the United Kingdom since 1986 and in the United States since 2001. Because of this history of use, the mycoprotein in Quorn products is not a novel food. Some consumers have reported adverse reactions after eating mycoprotein-based products. Research in Europe suggests that while most consumers can eat these products safely, about 1 in 100,000 to 200,000 people may react to them. Because it's made from a fungus, it's possible that some people who react to other fungi or moulds (including when they breathe them in) may also react to mycoprotein. While FSANZ is not aware of any medically confirmed reactions to Quorn products in Australia, consumers who may have had a reaction are advised to stop eating the food and see a medical practitioner. Like many processed foods, various ingredients and additives may be used to make a variety of mycoprotein-based products. The ingredients may include known allergens such as milk and egg. Some consumers may have intolerance to the mycoprotein itself or other ingredients in these products. *Either mycoprotein or Quorn™ will be listed in the ingredients list on food labels. Consumers can check the label and avoid products that may be of concern to them.* Based on the information supplied to the ACNF, clearly the ACNF has decided that there was no need to assess the public health and safety of consuming Quorn™ and, as such, Quorn™ is not regarded by FSANZ to be a Novel food. However, this is despite the fact that Quorn™ was only introduced in Australia as recently as 2010, and the FSANZ viewpoint says the adverse health reactions to the product are not worthy of a scientific public health and safety assessment by FSANZ. FSANZ has issued its Fact Sheet clarifying the nature and the extent of the danger, and simply issues a warning that concerned consumers should check product labels, and avoid the product. By making this warning, FSANZ is assuming that each consumer is aware of their potential adverse reaction - when this would not always be the case, e.g. for first time consumers. This restrained reaction from FSANZ (although no doubt considered appropriate by FSANZ) stands in stark contrast to the way FSANZ responded in 2008 to news that cassava chips contain a natural toxicant called linamarin. At the time, FSANZ had no evidence of any adversely affected consumers and yet FSANZ took steps to introduce a highly contentious new food standard for cassava chips based on dubious science as outlined below. Moreover, the New South Wales Food Authority pursued a food company to recall cassava chip products with no evidence of adverse consumer reactions or risk to public health. FSANZ Proposal P1002 In relation to cassava chips, FSANZ developed a new food standard and on 30 April 2009, the Food Standards Code was amended to limit the permissible amount of hydrocyanic acid in ready-to-eat cassava chips to 10 mg/kg. This is in comparison to other food products such as confectionery and marzipan, which may currently be sold in Australia containing levels of hydrocyanic acid up to 25 mg/kg and 50 mg/kg respectively. There has been no explanation as why cassava chips should be treated singularly differently from these other foods. Moreover, the whole issue concerning cassava chips appears to have been instigated by factors that had nothing to do with food safety at the time. As reported in other earlier FoodLegal Bulletin articles on this subject, the First Review Report for Proposal 1002 – Hydrocyanic Acid in Ready-to-Eat Cassava Chips acknowledged that the recommendation of FSANZ in relation to cassava chips was based on limited scientific evidence. Furthermore, the new limit placed on hydrocyanic acid levels was put in place despite the fact that ready-to-eat cassava chips were and continue to be sold in Australia for over 27 years without any known reports of adverse reactions and also discounting the fact that cassava flour has been a staple of millions of people in Africa and South America for many centuries. Inconsistent FSANZ reactions So, in the case of a product that has been sold for more than 27 years with not a single known report of any food safety issue, FSANZ prepared a safety assessment and developed a new food standard. As a consequence, the Food Standards Code was amended to impose an extremely onerous maximum level for one food product based on very limited available scientific evidence. In the case of another food product that has only been recently introduced into Australia and has already caused adverse health reactions, FSANZ has decided to refrain from making an assessment as to its safety. We are not saying that either product is unsafe but we must question why FSANZ scientists have taken such a different approach for each case. See also FSANZ Fact Sheet on Quorn, dated February 2011 News article on March 8 2011 in Australian Food News reporting the sale by Premier Foods of the Quorn Foods business to Exponent Private Equity for GBP 205 million (US$331.9 million). This is general information rather than legal advice and is current as of 11 Mar 2011. We therefore recommend you seek legal advice for your particular circumstances if you want to rely on advice or information to be a basis for any commercial decision-making by you or your business.

Is FSANZ's approach to QuornTM (mycoprotein) consistent with previous FSANZ policy?

By Joe Lederman and Charles Fisher

FoodLegal Lawyers and Consultants
© Lawmedia Pty Ltd, March 2011

A fact sheet recently released by Food Standards Australia New Zealand (FSANZ) on the safe use of mycoprotein in the Australian food industry raises questions as to when a “non-traditional food” will not be considered a Novel food. When a food is considered by FSANZ to be a Novel food it must go through a full assessment by FSANZ for public health and safety. FSANZ’s response to reports of adverse reactions to this mycoprotein product contrasts with the action taken by FSANZ on a very traditional and natural food, cassava. The leniency displayed by FSANZ in relation to mycoprotein and the contrasting conservative approach to cassava are symptomatic of inconsistency in the FSANZ approach to scientific-based public health and safety risk assessment.

What is “Quorn™”?

On 2 March 2011, FSANZ circulated an email publicizing a Fact Sheet on “Quorn™ (mycoprotein)” issued by FSANZ in February 2011, stating that foods made with this substance are permitted to be used in the manufacture and sale of foods in the retail market in Australia and New Zealand. Currently there appears to be one branded product range in the Australian market using the brand “Quorn™”.

Products marketed under this name have included various formed meat-style products such as mince, sausages, strips, patties, etc. (Incidentally, there are legal restrictions in Australia concerning sausages made without meat being called “sausages” but that is a subject in itself for another day).

Despite a long history of consumption in the UK (since 1986), the question was asked whether it might be necessary to assess whether or not Quorn is a Novel food under Standard 1.5.1 of the Australia New Zealand Food Standards Code (the Food Standards Code) - given that foods containing mycoprotein have been available in Australia only since 2010.

The mycoprotein product is also marketed as a natural alternative for meat. As such, the Quorn product competes with other various accepted non-meat substitutes such as soy, whey, caseinate, and gluten.

What is a “Novel food”?

Standard 1.5.1 of the Food Standards Code uses a two-step process to define a “Novel food”:

The food substance must be a non-traditional food; and
It must a substance which requires an assessment of its public health and safety.

If a substance meets both of these two requirements, it is a Novel food. The determination is important; firstly because no Novel food can be sold in Australia without express approval in the Food Standards Code and, secondly, an applicant to use a Novel food can be granted a 15 month exclusivity period for the novel aspect. (It should be noted this is apart from any subsisting Intellectual Property rights such as patents which confer their own exclusivity by law). An example of a Novel food exclusivity period is that which has applied to Kraft’s permission (under Standard 1.5.1 of the Food Standards Code) to use phytosterols in low fat cheese.

A non-traditional food is defined in the same Standard as:

(a) a food that does not have a history of consumption in Australia or New Zealand; or

(b) a substance derived from a food, where that substance does not have a history of human consumption in Australia or New Zealand other than as a component of that food; or

(c) any other substance, where that substance, or the source from which it is derived, does not have a history of human consumption as a food in Australia or New Zealand.

All three sub-clauses implicitly refer to “consumption” (presumably “human” consumption in all three sub-clauses) of the reference food in Australia and New Zealand as a primary condition. There is no definition of “traditional” per se in the Food Standards Code but in the case of a Novel food it may be assumed that “traditional” food has the opposite meaning to a “non-traditional food”.

FSANZ View on Quorn™ as a “Novel food”

FoodLegal notes that the Advisory Committee on Novel Foods (ACNF) is a body that receives submissions from food companies with novel or innovative food product so that the ACNF can make a recommendation to FSANZ as to when a food should be considered as a Novel food.

In this role, the ACNF has superseded the previous Novel Foods Reference Group (NFRG). The ACNF meets regularly to consider substances that may or may not be Novel foods. See also Terms of Reference and membership for ACNF.

In separate correspondence from FSANZ, on the subject of mycoprotein, FSANZ stated:

“The ACNF [Advisory Committee on Novel Foods] noted that [the Quorn™ product] was a non-traditional food in Australia and New Zealand, as there was not a history of human consumption in these countries. When a food is considered non-traditional, the ACNF then discusses whether an assessment of public health and safety is required before the product can be sold as a food in Australia and New Zealand. The ACNF noted extensive information provided by the enquirer and additional information identified by FSANZ in considering whether a pre-market safety assessment by FSANZ would be required. The history of consumption of the product in the UK and other countries also influenced the ACNF’s consideration. The ACNF noted some adverse reactions had been reported overseas; however, the incidence of these reactions was not common (around 1 in 134,000 to 1 in 175,000). The ACNF was satisfied that the Quorn™ product was safe for consumption as a food and was therefore not a novel food (as a novel food must be a non-traditional food and require an assessment of public health and safety considerations – as defined in Standard 1.5.1).”

(Email of 4 March 2011 from Jonathon Kite –Senior Food Scientist of FSANZ to food technologist A F Zipper).

What implications do the adverse reactions have?

The FSANZ Fact Sheet dated February 2011 has been released to reassure Australian consumers of the apparent safety of products containing mycoprotein/Quorn – in response to reports of adverse reactions. Republished also in the FSANZ email of 2 March 2011 sent out by FSANZ’s Communications Advisor Lydia Buchtmann, FSANZ’s Fact Sheet dated February 2011 stated [FoodLegal has added emphasis of the relevant issues in bold print below]:

Mycoprotein is a source of dietary protein and fibre derived from a fungus. It is used in a limited range of meat-free foods marketed under the brand name Quorn™.

Although Quorn products have been available in Australia only since 2010, they have been consumed in the United Kingdom since 1986 and in the United States since 2001. Because of this history of use, the mycoprotein in Quorn products is not a novel food.

Some consumers have reported adverse reactions after eating mycoprotein-based products. Research in Europe suggests that while most consumers can eat these products safely, about 1 in 100,000 to 200,000 people may react to them. Because it's made from a fungus, it's possible that some people who react to other fungi or moulds (including when they breathe them in) may also react to mycoprotein.

While FSANZ is not aware of any medically confirmed reactions to Quorn products in Australia, consumers who may have had a reaction are advised to stop eating the food and see a medical practitioner.

Like many processed foods, various ingredients and additives may be used to make a variety of mycoprotein-based products. The ingredients may include known allergens such as milk and egg. Some consumers may have intolerance to the mycoprotein itself or other ingredients in these products. Either mycoprotein or Quorn™ will be listed in the ingredients list on food labels. Consumers can check the label and avoid products that may be of concern to them.

Based on the information supplied to the ACNF, clearly the ACNF has decided that there was no need to assess the public health and safety of consuming Quorn™ and, as such, Quorn™ is not regarded by FSANZ to be a Novel food.

However, this is despite the fact that Quorn™ was only introduced in Australia as recently as 2010, and the FSANZ viewpoint says the adverse health reactions to the product are not worthy of a scientific public health and safety assessment by FSANZ.

FSANZ has issued its Fact Sheet clarifying the nature and the extent of the danger, and simply issues a warning that concerned consumers should check product labels, and avoid the product.

By making this warning, FSANZ is assuming that each consumer is aware of their potential adverse reaction - when this would not always be the case, e.g. for first time consumers.

This restrained reaction from FSANZ (although no doubt considered appropriate by FSANZ) stands in stark contrast to the way FSANZ responded in 2008 to news that cassava chips contain a natural toxicant called linamarin. At the time, FSANZ had no evidence of any adversely affected consumers and yet FSANZ took steps to introduce a highly contentious new food standard for cassava chips based on dubious science as outlined below. Moreover, the New South Wales Food Authority pursued a food company to recall cassava chip products with no evidence of adverse consumer reactions or risk to public health.

FSANZ Proposal P1002

In relation to cassava chips, FSANZ developed a new food standard and on 30 April 2009, the Food Standards Code was amended to limit the permissible amount of hydrocyanic acid in ready-to-eat cassava chips to 10 mg/kg. This is in comparison to other food products such as confectionery and marzipan, which may currently be sold in Australia containing levels of hydrocyanic acid up to 25 mg/kg and 50 mg/kg respectively. There has been no explanation as why cassava chips should be treated singularly differently from these other foods. Moreover, the whole issue concerning cassava chips appears to have been instigated by factors that had nothing to do with food safety at the time.

As reported in other earlier FoodLegal Bulletin articles on this subject, the First Review Report for Proposal 1002 – Hydrocyanic Acid in Ready-to-Eat Cassava Chips acknowledged that the recommendation of FSANZ in relation to cassava chips was based on limited scientific evidence. Furthermore, the new limit placed on hydrocyanic acid levels was put in place despite the fact that ready-to-eat cassava chips were and continue to be sold in Australia for over 27 years without any known reports of adverse reactions and also discounting the fact that cassava flour has been a staple of millions of people in Africa and South America for many centuries.

Inconsistent FSANZ reactions

So, in the case of a product that has been sold for more than 27 years with not a single known report of any food safety issue, FSANZ prepared a safety assessment and developed a new food standard. As a consequence, the Food Standards Code was amended to impose an extremely onerous maximum level for one food product based on very limited available scientific evidence. In the case of another food product that has only been recently introduced into Australia and has already caused adverse health reactions, FSANZ has decided to refrain from making an assessment as to its safety.

We are not saying that either product is unsafe but we must question why FSANZ scientists have taken such a different approach for each case.

See also

FSANZ Fact Sheet on Quorn, dated February 2011
News article on March 8 2011 in Australian Food News reporting the sale by Premier Foods of the Quorn Foods business to Exponent Private Equity for GBP 205 million (US$331.9 million).

This is general information rather than legal advice and is current as of 11 Mar 2011. We therefore recommend you seek legal advice for your particular circumstances if you want to rely on advice or information to be a basis for any commercial decision-making by you or your business.