China's Announcement on the Approval of Simplified Registration Certificates for new Chemical Substances from 8th Batch in 2025

June 5, 2025

On June 05, 2025, the the Ministry of Ecology and Environment of the People's Republic of China in accordance with Measures for the Environmental Management and Registration of New Chemical Substances ministry has reviewed the five application materials for the simplified registration for five new chemical substances that meet the relevant requirements and are intended to be approved for registration.

Following are the new chemical substances approved under the environmental management simplified registration certificate in 2025:
1. 2,4,8,10-tetraoxa-3,9-dithiosna[5.5]undecane 3,3,9,9-tetroxide
2. 1,3,5-Tris(6-isocyanate hexyl)-1,3,5-triazine-2,4,6(1 H,3H,5 H)-trione with (two, three, and four) Reaction products of pentaerythritol acrylate and 1,2-propanediol monoacrylate
3. (5R,6S)-6-[(R)-1-(tert-butyldimethylsiloxy)ethyl]-7-oxo-3-(propylthio)-4-thio-1-azabicyclo[ 3.2.0] Allyl hepta-2-en-2-carboxylic acid
4. 2-(1,4-dimethyl-3-penten-1-yl)-1-methyl-cyclopropylmethanol
5. 2-[(acetoxy)imino]-1-[1-(4-benzoylphenyl)-1 H-indol-3-yl]oct-1-one

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Ministry of Ecology and Environment (MEE); Simplified registration certificates; Environmental management; 2-(1,4-dimethyl-3-penten-1-yl)-1-methyl-cyclopropylmethanol; 2-[(acetoxy)imino]-1-[1-(4-benzoylphenyl)-1 H-indol-3-yl]oct-1-one

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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