EC Delegated Regulation (EU) 2025/1222 Amends European Regulation (EU) 1272/ 2008 to Harmonised Classification and Labelling of Certain Substances

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
Pre-market Approval Required?	Yes – Manufacturer registration and notification	Yes – Pre-market notification and composition review	No – Comply with standards, but no pre-approval	Yes – Mandatory registration with SAMR	Yes – Prior approval and product registration required
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

June 20, 2025

On June 20, 2025, the European commission published "Commission Delegated Regulation (EU) 2025/1222 of 2 April 2025 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling of certain substances". This delegated regulation emphasize on addition and replacement of certain chemical substances from Annex VI of Regulation (EC) No 1272/2008. This regulation is effective from July 10, 2025.
Part 3, Table 3, of Annex VI to Regulation (EC) No 1272/2008 is amended by adding following substances:
1. 2-ethylhexanoic acid, monoester with propane-1,2-diol
2. N-1-naphthylaniline; N-phenylnaphthalen-1-amine
3. tetrairon tris(pyrophosphate); ferric pyrophosphate
4. α,α’-propylenedinitrilodi-o-cresol
5. ozone
6. dinitrogen oxide
7. barium chromate
8. Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical CO2
9. Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents
10. barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]; C.I. Pigment Red 53:1
11. 2-bromo-2-(bromomethyl)pentanedinitrile; [DBDCB]
12. 9-octadecenoic acid (Z)-, sulfonated, potassium salts [1]; Reaction products of fatty acids, C18 (unsaturated) alkyl with sulfur trioxide, potassium salts [2]; 9(or 10)-sulphooctadecanoic acid, potassium salt [3]
13. bixlozone (ISO); 2-(2,4-dichlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one
14. 2,3-epoxypropyl isopropyl ether
15. tetrahydrofurfuryl methacrylate
16. trimethyl phosphate
17. fluoroethylene
18. 2-bromo-3,3,3-trifluoroprop-1-ene
19. 2-methyl-2H-isothiazol-3-one hydrochloride; 2-methyl-2,3-dihydro-1,2-thiazol-3-one hydrochloride
20. 2,3-epoxypropyl o-tolyl ether
21. methyl oct-2-ynoate
22. dinotefuran (ISO); (RS)-1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine
Following chemical substances respectively replaces corresponding index numbers 015-012-00-1, 601-027-00-6, 602-025-00-8, 607-231-00-1, 613-044-00-6, 613-045-00-1, 615-008-00-5, 616-145-00-3, 616-211-00-1, 616-212-00-7:
1. 2-phenylpropene; α-methylstyrene
2. pethoxamid (ISO); 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl)acetamide
3. tetraphosphorus trisulphide; phosphorus sesquisulphid
4. 1,1-dichloroethylene; vinylidene chloride
5. 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate; isophorone di-isocyanate
6. folpet (ISO); N-(trichloromethylthio)phthalimide
7. captan (ISO); 1,2,3,6-tetrahydro-N-(trichloromethylthio)phthalimide
8. clopyralid (ISO); 3,6-dichloropyridine-2-carboxylic acid
9. proquinazid (ISO); 6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one
10. 3-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl butylcarbamate

Source

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ%3AL_202501222

Consumer News Region

European Union

Consumer News Tags

European Commission (EC); Harmonised classification and labelling; α,α’-propylenedinitrilodi-o-cresol; Dinitrogen oxide; 2-phenylpropene; α-methylstyrene

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

Aspect	USA	EU	Australia	India	UAE
Regulatory Authority	FDA Center for Tobacco Products (CTP) / CDER	EC / Member States	TGA / FSANZ	Ministry of Health and Family Welfare and National Tobacco Control Cell (NTCC)	ESMA / MOHAP
Major Regulation Governing Compliance	Family Smoking Prevention and Tobacco Control Act (TCA);	Tobacco Products Directive 2014/40/EU (TPD); Novel Food Regulation	Therapeutic Goods Act 1989; Tobacco and Nicotine legislation; (Therapeutic Goods Standards for Nicotine and Therapeutic Vaping Products – TGO 110)	Food Safety and Standards Act (COTPA, 2003 and 2023 Amendment Rules; Prohibition of Electronic Cigarettes Act, 2019)	UAE Federal Law No. 15 (Tobacco Control); ESMA standards
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
Timeline for Registration	12-24 months (PMTA review can be lengthy)	6-18 months, depending on product and approval	6-12 months depending on product class	Traditional tobacco – no registration pathway; Other nicotine categories – as applicable	6-12 months registration and approval

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