
Current developments in food law and policy in Australia and internationally (November 2024) Current developments in food law and policy in Australia and internationally By Joe Lederman and John Thisgaard (FoodLegal Co-Principals) © Lawmedia Pty Ltd, November 2024 Australian and New Zealand regulatory developments 1. AICIS seeks comments on timeline for amendments to Industrial Chemicals Categorisation Guidelines In October 2024 the Australian Department of Health opened consultation on its proposed timeline for implementing changes to the Industrial Chemicals Categorisation Guidelines (Guidelines). The Guidelines include guidance for manufacturers or importers of industrial chemicals in determining which pre-market approval steps apply to their product. The Guidelines were introduced in 2020. The Department of Health intends to update the Guidelines in September 2025, and annually thereafter unless more urgent change is required. Submissions are due by 5 December 2024. 2. NHMRC seeks public comment on new draft guidance in Australian Drinking Water Guidelines In October 2024, the National Health and Medical Research Council (NHMRC) requested submissions on the treatment of Per- and Polyfluoroalkyl Substances (PFAS) under the Australian Drinking Water Guidelines. PFAS can damage the immune system, the liver and can cause cancer. Under the proposed changes, the limits of various PFAS have been reduced and new limits have been introduced, including: · The limit for Perfluorooctanoic acid has been reduced from 560 ng/L to 200 ng/L · The limit for perfluorooctane sulfonate ratio relative to other PFAS limit has been reduced · A new limit of 1000 ng/L has been introduced for Perfluorobutane sulfonate. Submissions close on 22 November 2024. 3. ABAC panel finds ‘Knickers Agave Spirit’ appealed to minors On 30 September 2024, the Alcohol Beverages Advertising Code (ABAC) adjudication panel found that Bunster’s social media advertising of its product ‘Knickers Agave Spirit’, was in breach of the ABAC Code. A complaint was raised that the alcoholic beverage was advertised as a chocolate bar and likely to be confused as such. The complaint was upheld by the ABAC Panel. The ABAC Panel found that the beverage was advertised to be strongly related to a confectionary product that is familiar and popular with minors. On that basis, it had a strong appeal to minors. The company deleted the Instagram post in response. Food and beverage businesses should be mindful when marketing alcoholic beverages in association with confectionary items and FoodLegal can advise on such matters. 4. Consultation on draft amendments to the Gene Technology Act In September 2024, the Department of Health and Aged care, following a review by the Gene Technology Standing Committee, prepared the Gene Technology Amendment Bill 2024. The draft bill seeks to amend the Gene Technology Act 2000 (Cth). The draft bill would introduce the following changes to Australia’s regulation of genetic technology: · GMOs should be classified into risk-based categories · GMO permits should be assessed more quickly · Civil and criminal penalties for breach of certification and accreditation conditions Submissions closed on 8 November 2024. New Zealand 5. New Zealand implements new advertising rules On 1 November 2024, substantial changes to the advertising codes overseen by the New Zealand Advertising Standards Authority took effect. The changes are as follows: a. The Food and Beverage Advertising code, which replaces the existing provisions in the Advertising Standards Code; b. The Children’s Advertising Code, which replaces the previous Children and Young People’s Advertising Code; and c. Modification of two rules in the existing Advertising Standards Code, which are covered in the new Food and Beverage Code. 6. The Ministry for Primary Industries (MPI) extends consultation on proposed changes for importing food and fibre plants for planting On 23 October 2024, the NZ Ministry for Primary Industries (MPI) extended the length of a consultation for proposed changes to options for importing food and fibre plants for planting. The proposed amendments include changes to quarantine duration as well as location for inspections. The original consultation end-date was 20 December 2024, which has now been extended to 31 March 2025. 7. NZ MPI updates import requirements for animal products The New Zealand MPI has made the following amendments to the requirements for animal products which are imported into New Zealand: · On 31 October 2024, the MPI updated its Animal Products Notice: Sampling Regimes for Monitoring. The notice replaces the previous version issued on 23 May 2024 under section 167(2) of the Animal Products Act 1999. The notice is relevant for food businesses exporting farmed or hunted red meat animals, poultry, fish or bee products to NZ. The notice involves a number of procedural changes, largely relating to sampling numbers. · On 29 October 2024, the MPI updated its Animal Products Notice: Maximum Permissible Levels. This notice replaces the previous one issued on 30 January 2023. The notice is relevant for anyone exporting animal material or animal products intended for human consumption to NZ, other than dairy products. The new notice revises schedule 1: Specified maximum permissible levels and schedule 2: Veterinary medicines where no maximum permissible levels apply. Food Standards Australia New Zealand (FSANZ) News 8. FSANZ seeks submissions on Application A1269 – Cultured quail as a novel food On 12 November 2024 FSANZ invited submissions from industry with respect to Application A1269 by Vow Group Pty Ltd to permit cell-cultured quail as a novel food. Submissions are due by 24 December 2024. 9. FSANZ commences assessment of Application A1318 - Steviol glycosides produced by enzymatic conversion On 11 November 2024 FSANZ commenced its assessment of Application A1318 by Sichuan Ingia Biosynthetic Co., Ltd. to permit rebaudioside M (a steviol glycoside) produced by the enzymatic conversion method, using enzymes derived from genetically modified Escherichia coli BL21. FSANZ will announce an opportunity to comment at a later date. 10. FSANZ approves amendments to Food Standards Code On 8 November 2024 FSANZ approved amendments to the Australia New Zealand Food Standards Code (Food Standards Code) arising out of the following Applications: · Application A1260 - 2-methyloxolane as a processing aid · Application A1289 - Food derived from disease-resistant, low-reducing sugars and reduced browning potato line BG25 · Application A1291 - Glucoamylase from GM Aspergillus niger (gene donor: Gloeophyllum sepiarium) as a processing aid FSANZ has notified the Food Ministers’ Meeting of its approval. The Food Ministers’ meeting has 60 days to either request FSANZ to review its decision, or inform FSANZ it does not intend to request a review. 11. FSANZ commences assessment of Application A1314 – Permitting small dogs and cats in aircraft cabins On 7 November 2024 FSANZ commenced its assessment of Application A1314 by Virgin Australia to permit companion animals (small dogs and cats) to accompany their owners aboard airline cabins under controlled conditions. The reason for FSANZ involvement is to assess the risks associated with existing food safety systems or the modifications for safety plans. FSANZ will announce an opportunity to comment at a later date. 12. FSANZ calls for comment on Application A1299 - Fructosyltranserase from Aspergillus oryzae as a processing aid On 7 November 2024, FSANZ called for comment on Application A1299 to permit immobilized fructosyltransferase (EC 2.4.1.9) from Aspergillus oryzae as a processing aid. The application, made by Tate and Lyle Solutions USA LLC, would permit the substance as a processing aid in the manufacture of short-chain fructooligosaccharides from sucrose. Submissions are due by 5 December 2024. 13. FSANZ commences assessment of Application A1315 for food additives derived from mushrooms On 29 October 2024 FSANZ commenced its assessment of Application A1315 by Chinova Bioworks Inc to permit the use of chitosan and beta-1,3-glucans from Agaricus bisporus (white button mushrooms) as a food additive in food and beverage products. FSANZ will announce an opportunity to comment at a later date. 14. Amendments to Food Standards Code gazetted On 29 October 2024 amendment no. 233 was gazetted. The amendment incorporates amendments to the Food Standards Code arising from the following Applications and Proposal: · Application A1247 - D-allulose as a novel food · Application A1284 - Triacylglycerol lipase from GM Trichoderma reesei as a processing aid · Proposal P1063 - Code revision (2024) – Added sugar(s) claims On 17 October 2024 amendment no. 232 was gazetted, which includes amendments to the Food Standards Code arising from Application A1287 - Food derived from short-stature corn line MON94804. 15. FSANZ calls for submissions on Application A1302 for food made from a GM corn line On 22 October 2024, FSANZ called for submissions with respect to Application A1302 by Syngenta Australia Pty Ltd to permit the sale and use of food made from a new genetically modified (GM) corn line MZIR260. The corn line has been modified to be resistant to lepidopteran insect pests, including fall armyworm.   Submissions are due by 4 December 2024. Australian Competition and Consumer Commission (ACCC) News 16. ACCC publishes “free range” labelling guidance for poultry businesses impacted by bird flu On 13 November 2024 the ACCC published guidance for the making of ‘free range’ claims on poultry products where suppliers have been impacted by an outbreak of the deadly avian influenza H5N1 in Australia. According the guidance, poultry producers affected by a H5N1 government housing order will have a 90-day grace period where they can continue selling products with ‘free range’ labelling without a risk of enforcement action by the ACCC. 17. ACCC brings proceedings against Magnamail for alleged promotional misrepresentations On 8 November 2024, the ACCC commenced proceedings against Magnamail in the Australian Federal Court for allegedly making false or misleading representations in contravention of the Australian Consumer Law. The ACCC alleges that Magnamail falsely represented that if consumers ordered certain products from its catalogues, they would be eligible to enter into a draw to win cash prizes of up to $25,000 or other prizes such as iPads or jewellery. However, in fact the prizes had already been drawn and new customers were not eligible for a major prize. Although this case does not concern a food business, food businesses should be careful when offering special incentives or rewards to new customers. Trade promotions including prize draws are also subject to additional State and Territory requirements. 18. ACCC approves mergers in food and pharma industries The ACCC has approved the following corporate acquisitions: · On 1 November 2024 the ACCC stated it would not oppose Sanitarium’s proposed acquisition of the brand and intellectual property assets necessary for the supply of Vita Brits from Nestle. The ACCC concluded that the acquisition would not substantially lessen competition as Vita Brits is unlikely to be a strong competitive constraint on existing Sanitarium brand Weet Bix in the absence of the acquisition. · On 7 November 2024 the ACCC stated it would not oppose a proposed merger between Sigma Healthcare and Chemist Warehouse, subject to a court-enforceable undertaking that Sigma (which is a pharmaceutical wholesaler and franchisor) would allow existing franchisee pharmacies to exit existing franchise arrangements. The ACCC concluded that the merger would not substantially lessen competition as sufficient retail pharmacies and distribution channels will remain to ensure competition and multiple levels in the supply chain. United States 19. FDA, NIH and CDC releases consensus statement on infant formula and Necrotizing Enterocolitis On 3 October 2024, the US Food and Drug Administration (FDA), the Centre for Disease Control (CDC) and the National Institute of Health (NIH) issued a consensus statement regarding allegations of a link between infant formula and necrotizing enterocolitis (NEC). NEC is a condition in infants where the intestine tissue lining becomes inflamed and dies, making an infant vulnerable to life-threatening illness. NEC is one of the leading causes of pre-term infant mortality. Some studies had suggested a higher correlation between infant formula consumption and NEC risk, and some lawsuits in the US had been filed on this basis. The FDA has now clarified that infant formula consumption does not actually cause NEC but rather that mother’s milk and donor milk provides the greatest degree of protection against NEC. 20. USDA update on guidance for animal raising and environmental claims On 10 September 2024, the United States Department of Agriculture Food Safety and Inspection Service (USDA FSIS) updated its guideline on ‘Substantiating Animal-Raising or Environment-Related Labelling Claims’. Under the updated guidance, food businesses are strongly encouraged to use third-party certifiers to substantiate animal-raising claims. Labels that truthfully display a third-party certifier’s name, logo and website do not need to further explain their certification on the product label. The guidance also encourages the use of additional documentation to substantiate animal-raising claims such as “pasture-raised”, “pasture-fed” or “pasture grown”. 21. FDA releases policy guideline on adulteration in fish and fishery products On 1 November 2024, the US FDA released a final compliance policy guide on FDA attitudes on adulteration of fish and fishery products with Scombrotoxin (histamine). The guideline is aimed at protecting consumers from the effects of scrombrotoxin fish poisoning by taking action against products that have a lower level of histamine than the earlier thresholds. Scrombrotoxin poisoning is caused by spoilage that forms from bacteria, and it is more likely in certain fish species such as tuna and mahi-mahi. Good hygiene practices such as rapidly chilling fish and maintaining appropriate time and temperature controls can prevent scrombrotoxin poisoning. 22. FDA extends comment period for sodium reduction guidelines On 1 November 2024, the US FDA extended the comment period for its voluntary Phase 2 sodium reduction goals. The voluntary goals, released on 15 August 2024, are designed to support a maxim daily sodium intake of 2,750 mg- which is 20% lower than the target outlined in Phase 1. However, this target is still higher than the recommended maximum intake of 2300 mg/day. The initial comment period was open until 14 November 2024. However, the time has now been extended to 13 January 2025. 23. FDA releases supplement to the Food Code On 4 November 2024, the US FDA has released the ‘Supplement to the 2022 Food Code’. The supplement is an update to the 2022 Food Code. It is aimed that reducing the risk of foodborne illness in retail and foodservice business. Some of the new updates include: · New provisions on disinfecting food contact surfaces as well as non-food contact and equipment surfaces · Updating testing requirements for food employees diagnosed with various foodborne illnesses such as Salmonella · Clarifications on container refill and re-use. China 24. China to lift ban on Australian lobster imports by end of 2024 During October 2024, the Australian Government announced the China has promised to lift a ban on Australian rock lobsters by the end of 2024. The industry has struggled since the imposition of trade restrictions against Australia in 2020 and 2021. China has removed tariffs on other Australian products such as wine, coal and barley since then. Indonesia 25. Indonesia implements new quarantine requirements for dairy exports On 1 October 2024, the Indonesian Quarantine Authority (IQA) issued new quarantine rules on milk and milk product exports to Indonesia. Australian businesses must comply with the new rules, which include new requirements to submit prior notice of exports to IQA. A prior notice must include documentation such as a health/sanitary/ phytosanitary certificate, GMO status and information on testing laboratory accreditation. United Kingdom 26. UK abandons plans for mandatory “not for EU” labelling On 30 September 2024 the UK Government announced that it will not proceed with plans to introduce mandatory ‘not for EU’ labelling for meat and dairy products. The UK Government cited concerns the law would increase manufacturing costs, damage exports and degrade marketing. The law was planned to apply to a broader range of products from July 2025. The labels are already being enforced on products in Northern Ireland, to prevent British products from entering. 27. UK updates guidance on Extended Producer Responsibility On 15 October 2024, the UK Department for Environment, Food & Rural Affairs updated its guidance: ‘Extended producer responsibility for packaging: report packaging data’. In this context, ‘extended producer responsibility’ means the organisations responsible for producing packaging waste will be responsible for dealing with the costs. The guidance explains which organisations the new regulations apply to, as well as the information that must be collected and submitted and the fees that apply. 28. UK FSA launches sandbox program for cell-cultivated products On 8 October 2024 the UK Food Standards Agency (FSA) launched a sandbox program for cell-cultivated products such as cell-based meat, in collaboration with Food Standards Scotland (FSS). No cell-cultivated foods are currently permitted for use in the UK at the date of this article (November 2024). The sandbox program is intended to collect data on cell-cultivated products as well as conduct safety tests and develop safety programs. It is intended that framework can then be used to more quickly process applications by businesses for cell-cultivated products. This is general information rather than legal advice and is current as of 13 Nov 2024. 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.

Current developments in food law and policy in Australia and internationally (November 2024)

Current developments in food law and policy in Australia and internationally

By Joe Lederman and John Thisgaard (FoodLegal Co-Principals)

Australian and New Zealand regulatory developments

1. AICIS seeks comments on timeline for amendments to Industrial Chemicals Categorisation Guidelines

In October 2024 the Australian Department of Health opened consultation on its proposed timeline for implementing changes to the Industrial Chemicals Categorisation Guidelines (Guidelines).

The Guidelines include guidance for manufacturers or importers of industrial chemicals in determining which pre-market approval steps apply to their product.

The Guidelines were introduced in 2020. The Department of Health intends to update the Guidelines in September 2025, and annually thereafter unless more urgent change is required.

Submissions are due by 5 December 2024.

2. NHMRC seeks public comment on new draft guidance in Australian Drinking Water Guidelines

In October 2024, the National Health and Medical Research Council (NHMRC) requested submissions on the treatment of Per- and Polyfluoroalkyl Substances (PFAS) under the Australian Drinking Water Guidelines.

PFAS can damage the immune system, the liver and can cause cancer. Under the proposed changes, the limits of various PFAS have been reduced and new limits have been introduced, including:

· The limit for Perfluorooctanoic acid has been reduced from 560 ng/L to 200 ng/L

· The limit for perfluorooctane sulfonate ratio relative to other PFAS limit has been reduced

· A new limit of 1000 ng/L has been introduced for Perfluorobutane sulfonate.

Submissions close on 22 November 2024.

3. ABAC panel finds ‘Knickers Agave Spirit’ appealed to minors

On 30 September 2024, the Alcohol Beverages Advertising Code (ABAC) adjudication panel found that Bunster’s social media advertising of its product ‘Knickers Agave Spirit’, was in breach of the ABAC Code.

A complaint was raised that the alcoholic beverage was advertised as a chocolate bar and likely to be confused as such. The complaint was upheld by the ABAC Panel. The ABAC Panel found that the beverage was advertised to be strongly related to a confectionary product that is familiar and popular with minors. On that basis, it had a strong appeal to minors. The company deleted the Instagram post in response.

Food and beverage businesses should be mindful when marketing alcoholic beverages in association with confectionary items and FoodLegal can advise on such matters.

4. Consultation on draft amendments to the Gene Technology Act

In September 2024, the Department of Health and Aged care, following a review by the Gene Technology Standing Committee, prepared the Gene Technology Amendment Bill 2024. The draft bill seeks to amend the Gene Technology Act 2000 (Cth).

The draft bill would introduce the following changes to Australia’s regulation of genetic technology:

· GMOs should be classified into risk-based categories

· GMO permits should be assessed more quickly

· Civil and criminal penalties for breach of certification and accreditation conditions

Submissions closed on 8 November 2024.

New Zealand

5. New Zealand implements new advertising rules

On 1 November 2024, substantial changes to the advertising codes overseen by the New Zealand Advertising Standards Authority took effect. The changes are as follows:

a. The Food and Beverage Advertising code, which replaces the existing provisions in the Advertising Standards Code;

b. The Children’s Advertising Code, which replaces the previous Children and Young People’s Advertising Code; and

c. Modification of two rules in the existing Advertising Standards Code, which are covered in the new Food and Beverage Code.

6. The Ministry for Primary Industries (MPI) extends consultation on proposed changes for importing food and fibre plants for planting

On 23 October 2024, the NZ Ministry for Primary Industries (MPI) extended the length of a consultation for proposed changes to options for importing food and fibre plants for planting.

The proposed amendments include changes to quarantine duration as well as location for inspections. The original consultation end-date was 20 December 2024, which has now been extended to 31 March 2025.

7. NZ MPI updates import requirements for animal products

The New Zealand MPI has made the following amendments to the requirements for animal products which are imported into New Zealand:

· On 31 October 2024, the MPI updated its Animal Products Notice: Sampling Regimes for Monitoring. The notice replaces the previous version issued on 23 May 2024 under section 167(2) of the Animal Products Act 1999. The notice is relevant for food businesses exporting farmed or hunted red meat animals, poultry, fish or bee products to NZ. The notice involves a number of procedural changes, largely relating to sampling numbers.

· On 29 October 2024, the MPI updated its Animal Products Notice: Maximum Permissible Levels. This notice replaces the previous one issued on 30 January 2023. The notice is relevant for anyone exporting animal material or animal products intended for human consumption to NZ, other than dairy products. The new notice revises schedule 1: Specified maximum permissible levels and schedule 2: Veterinary medicines where no maximum permissible levels apply.

Food Standards Australia New Zealand (FSANZ) News

8. FSANZ seeks submissions on Application A1269 – Cultured quail as a novel food

On 12 November 2024 FSANZ invited submissions from industry with respect to Application A1269 by Vow Group Pty Ltd to permit cell-cultured quail as a novel food.

Submissions are due by 24 December 2024.

9. FSANZ commences assessment of Application A1318 - Steviol glycosides produced by enzymatic conversion

On 11 November 2024 FSANZ commenced its assessment of Application A1318 by Sichuan Ingia Biosynthetic Co., Ltd. to permit rebaudioside M (a steviol glycoside) produced by the enzymatic conversion method, using enzymes derived from genetically modified Escherichia coli BL21.

FSANZ will announce an opportunity to comment at a later date.

10. FSANZ approves amendments to Food Standards Code

On 8 November 2024 FSANZ approved amendments to the Australia New Zealand Food Standards Code (Food Standards Code) arising out of the following Applications:

· Application A1260 - 2-methyloxolane as a processing aid

· Application A1289 - Food derived from disease-resistant, low-reducing sugars and reduced browning potato line BG25

· Application A1291 - Glucoamylase from GM Aspergillus niger (gene donor: Gloeophyllum sepiarium) as a processing aid

FSANZ has notified the Food Ministers’ Meeting of its approval. The Food Ministers’ meeting has 60 days to either request FSANZ to review its decision, or inform FSANZ it does not intend to request a review.

11. FSANZ commences assessment of Application A1314 – Permitting small dogs and cats in aircraft cabins

On 7 November 2024 FSANZ commenced its assessment of Application A1314 by Virgin Australia to permit companion animals (small dogs and cats) to accompany their owners aboard airline cabins under controlled conditions.

The reason for FSANZ involvement is to assess the risks associated with existing food safety systems or the modifications for safety plans.

FSANZ will announce an opportunity to comment at a later date.

12. FSANZ calls for comment on Application A1299 - Fructosyltranserase from Aspergillus oryzae as a processing aid

On 7 November 2024, FSANZ called for comment on Application A1299 to permit immobilized fructosyltransferase (EC 2.4.1.9) from Aspergillus oryzae as a processing aid. The application, made by Tate and Lyle Solutions USA LLC, would permit the substance as a processing aid in the manufacture of short-chain fructooligosaccharides from sucrose.

Submissions are due by 5 December 2024.

13. FSANZ commences assessment of Application A1315 for food additives derived from mushrooms

On 29 October 2024 FSANZ commenced its assessment of Application A1315 by Chinova Bioworks Inc to permit the use of chitosan and beta-1,3-glucans from Agaricus bisporus (white button mushrooms) as a food additive in food and beverage products.

FSANZ will announce an opportunity to comment at a later date.

14. Amendments to Food Standards Code gazetted

On 29 October 2024 amendment no. 233 was gazetted. The amendment incorporates amendments to the Food Standards Code arising from the following Applications and Proposal:

· Application A1247 - D-allulose as a novel food

· Application A1284 - Triacylglycerol lipase from GM Trichoderma reesei as a processing aid

· Proposal P1063 - Code revision (2024) – Added sugar(s) claims

On 17 October 2024 amendment no. 232 was gazetted, which includes amendments to the Food Standards Code arising from Application A1287 - Food derived from short-stature corn line MON94804.

15. FSANZ calls for submissions on Application A1302 for food made from a GM corn line

On 22 October 2024, FSANZ called for submissions with respect to Application A1302 by Syngenta Australia Pty Ltd to permit the sale and use of food made from a new genetically modified (GM) corn line MZIR260. The corn line has been modified to be resistant to lepidopteran insect pests, including fall armyworm.  

Submissions are due by 4 December 2024.

Australian Competition and Consumer Commission (ACCC) News

16. ACCC publishes “free range” labelling guidance for poultry businesses impacted by bird flu

On 13 November 2024 the ACCC published guidance for the making of ‘free range’ claims on poultry products where suppliers have been impacted by an outbreak of the deadly avian influenza H5N1 in Australia.

According the guidance, poultry producers affected by a H5N1 government housing order will have a 90-day grace period where they can continue selling products with ‘free range’ labelling without a risk of enforcement action by the ACCC.

17. ACCC brings proceedings against Magnamail for alleged promotional misrepresentations

On 8 November 2024, the ACCC commenced proceedings against Magnamail in the Australian Federal Court for allegedly making false or misleading representations in contravention of the Australian Consumer Law.

The ACCC alleges that Magnamail falsely represented that if consumers ordered certain products from its catalogues, they would be eligible to enter into a draw to win cash prizes of up to $25,000 or other prizes such as iPads or jewellery. However, in fact the prizes had already been drawn and new customers were not eligible for a major prize.

Although this case does not concern a food business, food businesses should be careful when offering special incentives or rewards to new customers. Trade promotions including prize draws are also subject to additional State and Territory requirements.

18. ACCC approves mergers in food and pharma industries

The ACCC has approved the following corporate acquisitions:

· On 1 November 2024 the ACCC stated it would not oppose Sanitarium’s proposed acquisition of the brand and intellectual property assets necessary for the supply of Vita Brits from Nestle. The ACCC concluded that the acquisition would not substantially lessen competition as Vita Brits is unlikely to be a strong competitive constraint on existing Sanitarium brand Weet Bix in the absence of the acquisition.

· On 7 November 2024 the ACCC stated it would not oppose a proposed merger between Sigma Healthcare and Chemist Warehouse, subject to a court-enforceable undertaking that Sigma (which is a pharmaceutical wholesaler and franchisor) would allow existing franchisee pharmacies to exit existing franchise arrangements. The ACCC concluded that the merger would not substantially lessen competition as sufficient retail pharmacies and distribution channels will remain to ensure competition and multiple levels in the supply chain.

United States

19. FDA, NIH and CDC releases consensus statement on infant formula and Necrotizing Enterocolitis

On 3 October 2024, the US Food and Drug Administration (FDA), the Centre for Disease Control (CDC) and the National Institute of Health (NIH) issued a consensus statement regarding allegations of a link between infant formula and necrotizing enterocolitis (NEC).

NEC is a condition in infants where the intestine tissue lining becomes inflamed and dies, making an infant vulnerable to life-threatening illness. NEC is one of the leading causes of pre-term infant mortality. Some studies had suggested a higher correlation between infant formula consumption and NEC risk, and some lawsuits in the US had been filed on this basis.

The FDA has now clarified that infant formula consumption does not actually cause NEC but rather that mother’s milk and donor milk provides the greatest degree of protection against NEC.

20. USDA update on guidance for animal raising and environmental claims

On 10 September 2024, the United States Department of Agriculture Food Safety and Inspection Service (USDA FSIS) updated its guideline on ‘Substantiating Animal-Raising or Environment-Related Labelling Claims’.

Under the updated guidance, food businesses are strongly encouraged to use third-party certifiers to substantiate animal-raising claims. Labels that truthfully display a third-party certifier’s name, logo and website do not need to further explain their certification on the product label. The guidance also encourages the use of additional documentation to substantiate animal-raising claims such as “pasture-raised”, “pasture-fed” or “pasture grown”.

21. FDA releases policy guideline on adulteration in fish and fishery products

On 1 November 2024, the US FDA released a final compliance policy guide on FDA attitudes on adulteration of fish and fishery products with Scombrotoxin (histamine). The guideline is aimed at protecting consumers from the effects of scrombrotoxin fish poisoning by taking action against products that have a lower level of histamine than the earlier thresholds.

Scrombrotoxin poisoning is caused by spoilage that forms from bacteria, and it is more likely in certain fish species such as tuna and mahi-mahi. Good hygiene practices such as rapidly chilling fish and maintaining appropriate time and temperature controls can prevent scrombrotoxin poisoning.

22. FDA extends comment period for sodium reduction guidelines

On 1 November 2024, the US FDA extended the comment period for its voluntary Phase 2 sodium reduction goals. The voluntary goals, released on 15 August 2024, are designed to support a maxim daily sodium intake of 2,750 mg- which is 20% lower than the target outlined in Phase 1. However, this target is still higher than the recommended maximum intake of 2300 mg/day.

The initial comment period was open until 14 November 2024. However, the time has now been extended to 13 January 2025.

23. FDA releases supplement to the Food Code

On 4 November 2024, the US FDA has released the ‘Supplement to the 2022 Food Code’. The supplement is an update to the 2022 Food Code. It is aimed that reducing the risk of foodborne illness in retail and foodservice business.

Some of the new updates include:

· New provisions on disinfecting food contact surfaces as well as non-food contact and equipment surfaces

· Updating testing requirements for food employees diagnosed with various foodborne illnesses such as Salmonella

· Clarifications on container refill and re-use.

China

24. China to lift ban on Australian lobster imports by end of 2024

During October 2024, the Australian Government announced the China has promised to lift a ban on Australian rock lobsters by the end of 2024. The industry has struggled since the imposition of trade restrictions against Australia in 2020 and 2021. China has removed tariffs on other Australian products such as wine, coal and barley since then.

Indonesia

25. Indonesia implements new quarantine requirements for dairy exports

On 1 October 2024, the Indonesian Quarantine Authority (IQA) issued new quarantine rules on milk and milk product exports to Indonesia.

Australian businesses must comply with the new rules, which include new requirements to submit prior notice of exports to IQA. A prior notice must include documentation such as a health/sanitary/ phytosanitary certificate, GMO status and information on testing laboratory accreditation.

United Kingdom

26. UK abandons plans for mandatory “not for EU” labelling

On 30 September 2024 the UK Government announced that it will not proceed with plans to introduce mandatory ‘not for EU’ labelling for meat and dairy products.

The UK Government cited concerns the law would increase manufacturing costs, damage exports and degrade marketing. The law was planned to apply to a broader range of products from July 2025.

The labels are already being enforced on products in Northern Ireland, to prevent British products from entering.

27. UK updates guidance on Extended Producer Responsibility

On 15 October 2024, the UK Department for Environment, Food & Rural Affairs updated its guidance: ‘Extended producer responsibility for packaging: report packaging data’.

In this context, ‘extended producer responsibility’ means the organisations responsible for producing packaging waste will be responsible for dealing with the costs.

The guidance explains which organisations the new regulations apply to, as well as the information that must be collected and submitted and the fees that apply.

28. UK FSA launches sandbox program for cell-cultivated products

On 8 October 2024 the UK Food Standards Agency (FSA) launched a sandbox program for cell-cultivated products such as cell-based meat, in collaboration with Food Standards Scotland (FSS).

No cell-cultivated foods are currently permitted for use in the UK at the date of this article (November 2024). The sandbox program is intended to collect data on cell-cultivated products as well as conduct safety tests and develop safety programs. It is intended that framework can then be used to more quickly process applications by businesses for cell-cultivated products.

This is general information rather than legal advice and is current as of 13 Nov 2024. 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.