Aspect	USA	EU	Australia	China	India
Regulatory Authority	FDA (U.S. Food and Drug Administration)	EFSA (European Food Safety Authority) & European Commission	FSANZ (Food Standards Australia New Zealand)	SAMR (State Administration for Market Regulation)	FSSAI (Food Safety and Standards Authority of India)
Major Regulation Governing Compliance	21 CFR Part 106 & 107 – Infant Formula Regulations	Regulation (EU) No 609/2013 on Foods for Specific Groups (FSG)	Australia New Zealand Food Standards Code	GB Standards (e.g., GB 10765-2021) for infant formula	Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2019
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Labeling Requirements	Must meet strict CFS 21 Part 107 labeling and nutritional information requirements for infant formula.	Must comply with harmonized EU labeling rules, including allergens, nutrition info	Must comply with FSANZ labeling codes	Must follow GB labeling standards, including mandatory warnings	Must follow specific infant food labeling rules under FSSAI
Nutritional Composition Requirements	Specific nutrient content, quality control & Good Manufacturing Practices (GMP) required	Detailed compositional criteria for energy, protein, vitamins, and minerals	Must meet nutrition content standards specified by FSANZ	Stringent GB compositional standards; new updates in 2021	As per Schedules under FSSAI regulations, modeled on Codex guidelines
Claims Allowed	Limited; FDA approval required for structure-function or health claims	Only EU-authorized claims permitted; No health or nutritional claims on infant formula	Functional and nutrient claims allowed within Regulatory limits	Strict control; health/nutritional claims require SAMR review	Only pre-approved nutrition claims allowed; therapeutic claims not permitted
Clinical Evidence Required?	Yes – Especially for new formulations or ingredients	Yes – EFSA scientific dossier for novel ingredients or composition	Required for novel ingredients or changes in nutrient bioavailability	Yes – For new products or ingredient combinations	Yes – If deviating from standard composition or for novel formulations
Timeline for Registration	~6–12 months, depending on product review	~12–18 months, including EFSA evaluation	~3–6 months for market entry if compliant	~18–24 months, including safety and technical review	~12–18 months for full Regulatory clearance
Need for Local Representative	Yes	Yes	No	Yes	Yes

WTO Circulates the Notification of Italy's Proposal for Technical Regulation on Reusability Requirements of Plastic Products in Contact with Food

April 2, 2025

On April 2, 2025, the World Trade Organization (WTO) circulated a notification regarding Italy's proposal for a technical regulation under Legislative Decree 8 November 2021, n. 196. This regulation addresses the reusability requirements of plastic products intended to come into contact with food, in accordance with Annex, Part B of the decree. The proposed regulation aligns with Directive (EU) 2019/904 on the reduction of certain plastic products' environmental impact (Single-Use Plastics - SUP Directive). The goal of the regulation is to define technical characteristics to ensure the reusability of specific plastic products listed in Annex, Part B, which will be subject to a market ban if they do not meet the reusability standards. The regulation aims to prevent the marketing of products labeled as reusable but used as single-use by consumers. Final Date for Comment is 60 days from the notification (i.e. 1 June 2025)
Article 1: Provisions on Reusable Plastic Products in Contact with Food: Plates, cutlery, straws, and beverage stirrers are considered reusable and marketable as such if they meet the following criteria:a) Plates:-Diameter less than 19 cm and weight > 45 grams-Diameter between 19 and 24 cm and weight > 80 grams-Diameter > 24 cm and weight > 110 grams
b) Plastic cutlery: (forks, knives, spoons, chopsticks): Weight/length ratio > 0.5 grams per cm
c) Plastic straws: Weight/length ratio > 0.5 grams per cm (except when subject to Directive 90/385/EEC or Directive 93/42/EEC)
d) Beverage stirrers: Weight/length ratio > 0.5 grams per cm
The regulation will apply from the 180th day following its entry into force.

Source

https://docs.wto.org/imrd/directdoc.asp?DDFDocuments%2Ft%2FG%2FTBTN25%2FITA38_D…

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World Trade Organisation (WTO), Italy, Plastic, Food Contact Plastic Usage, Single-use plastics

Aspect	USA	EU	Australia	China	UAE
Regulatory Authority	FDA	EFSA & Member State Authorities	FSANZ	SAMR & NHC	ESMA & MOHAP
Major Regulation Governing Compliance	Federal Food, Drug, and Cosmetic Act (FFDCA); 21 CFR Part 110 (Current Good Manufacturing Practices)	Regulation (EC) No 178/2002 (General Food Law); Regulation (EU) No 1169/2011 on Food Information to Consumers	Food Standards Code (Australia New Zealand Food Standards Code)	Food Safety Law of the People's Republic of China (Revised 2015); GB Standards for Food Safety	UAE.S GSO 9:2017 (GCC General Requirements for Prepackaged Food)
Pre-market Approval Required?	No pre-market approval except for novel ingredients, color additives, or specific claims	No pre-market approval for general foods, but novel foods or health claims require EFSA approval.	No pre-market approval unless it's a novel food or makes health claims	Pre-market registration is required for novel foods, health foods, or products with new ingredients	Pre-market approval is required for certain foods, health products, and products with new ingredients
Processed Food Labeling Compliance /Labeling Requirements	Mandatory labeling as per FDA guidelines (Nutrition Facts, Ingredient Declaration, Allergens)	Must comply with EU Food Information Regulation (1169/2011); includes allergens, nutrition, and origin labeling.	Must follow FSANZ Food Standards Code for labeling; nutrition panels, allergens, and ingredient lists required	Must follow GB 7718-2011 (National Food Safety Standards) for labeling; mandatory nutrition facts, allergens, and shelf-life	Must follow GSO 9:2017 for pre-packaged food labeling; Arabic labeling, allergens, and nutrition facts required
Timeline for Registration	No fixed timeline: products can enter the market once compliant	No formal registration unless novel food; EFSA approval for health claims takes 12-18 months	No formal registration unless it's a novel food or makes health claims	Typically, 12-24 months for novel foods, shorter for regular processed foods	Approval may take 6-12 months for certain products. Regular processed foods can enter the market once label approval is obtained

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Pre-market Approval Required?	Yes [Pre-market Tobacco Product Application (PMTA) for vaping products; drug approvals for nicotine gum)	Yes (Novel Food approval for some products; TPD notification for tobacco products)	Yes (Therapeutic Goods Administration approval)	Conventional tobacco products – not subject to registration; Nicotine products – approval required from Drug Authorities; Vapes/e-cigarettes – not applicable	Yes (Registration and conformity assessment required)
Labeling Requirements	FDA labeling rules for tobacco and nicotine products, including warnings	EU TPD labeling requirements, health warnings	TGA labeling for therapeutic/tobacco products	Labeling requirements as per MoHFW, including warnings and prescribed content	Mandatory health warnings and labeling per ESMA/MOHAP
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WTO Circulates the Notification of Italy's Proposal for Technical Regulation on Reusability Requirements of Plastic Products in Contact with Food

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