![A Leading, Global, Regulatory Solutions & Services Company]()
The Largest, Global, Regulatory Solutions & Services Provider
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 |
