[Updated] MARA Approves a Guide for the Declaration of Plant Extracts as Feed Additives

Updated on February 2, 2023:

The Guide for the Declaration of Plant Extracts as Feed Additives is approved by China's Ministry of Agriculture and Rural Affair (MARA) on February 2, 2023. As per the approved guide, this guide is also applicable to the application for adding plant extract feed additive in the Feed Additive Catalogue.

China’s Ministry of Agriculture and Rural Affairs (MARA) issued a drafted guide for the declaration of plant extracts as feed additives on August 1, 2022. Feedback can be submitted to xmjslch@agri.gov.cn by August 31, 2022.

This draft specifies the basic principle, terms and their definition, as well as the material requirements for different types of plant extracts, aiming to manage the applications for the following situations:

The application for the approval of a new feed additive;
The application for expanding the use scope of a feed additive;
The application for producing a feed additive variety whose content specification is lower than that regulated in “Specification for safe use of feed additives”;
The application for a plant extract whose production technique is with significant changes.

As per the draft, enterprises shall prepare the following materials for different types of plant extract. [Notes: “+” means required; “-” means not required; “*” means materials may be required if necessary; “±” means test research report can be replaced by literature.]

Items	Purified extracts		Component extracts		Simple extracts
Items	Plants for feed usage	Other plants	Plants for feed usage	Other plants	Plants for feed usage	Other plants
Application form for using plant extracts as food additives	+	+	+	+	+	+
Table of contents of the declaration material	+	+	+	+	+	+
[Declaration material]
1. Abstract of the declaration material	+	+	+	+	+	+
2. Product name, legal basis for the name, and product type
2.1 Generic name of the product and the legal basis for the name	+	+	+	+	+	+
2.2 Commodity name	*	*	*	*	*	*
2.3 Product type	+	+	+	+	+	+
3. Purpose of developing the product	+	+	+	+	+	+
4. Product’s component & identification report thereof, as well as information related to physicochemical properties and safety protection
4.1 Product component
4.1.1 Active component and corresponding content	+	+	+	+	+	+
4.1.2 Other components and corresponding content	+	+	+	+	+	+
4.2 Identification report	+	+	+	+	+	+
4.3 Appearance and physical properties	+	+	+	+	+	+
4.4 Physicochemical property of active components	+	+	+	+	+	+
4.5 Product safety protection information	+	+	+	+	+	+
5. Product function, application scope, and use method
5.1 Product function	+	+	+	+	+	+
5.2 Application scope and use method	+	+	+	+	+	+
6. Production technique, manufacturing method, and stability test report for the product
6.1 Production technique and manufacturing method	+	+	+	+	+	+
6.2 Product stability test report	+	+	+	+	+	+
7. The draft standard for product quality, explanation for compiling the standard and test report
7.1 The draft standard for product quality	+	+	+	+	+	+
7.2 Explanation for compiling the standard	+	+	+	+	+	+
7.3 Method validation report	*	*	+	+	+	+
7.4 Test report	+	+	+	+	+	+
7.5 Test methods for active components in feed product	*	*	*	*	-	*
8. Material requirements for safety evaluation
8.1 Target animal tolerance evaluation report	+	+	±	+	-	+
8.2 Toxicological safety evaluation report
8.2.1 Acute toxicity test	+	+	±	+	-	+
8.2.2 Genotoxicity test was changed into "Genotoxicity test (Mutagenicity test)" in the approved guide	+	+	±	+	-	+
8.2.3 28-day oral toxicity test	+	+	±	+	-	+
8.2.4 Subchronic toxicity test	+	+	±	+	-	+
8.2.5 Teratogenicity test	*	*	*	*	-	*
8.2.6 Reproductive toxicity test	*	*	*	*	-	*
8.2.7 Chronic toxicity tests (including carcinogenicity tests)	*	*	*	*	-	*
8.3 Metabolism and residue evaluation reports	-	±	-	*	-	*
8.4 Relevant literatures	*	*	*	*	*	*
9. Material requirements for effectiveness evaluation
"9.1 Test report on target animal effectiveness evaluation / Test report on property and efficacy" was changed into "9.1 Test report on effectiveness evaluation / Test report on property and efficacy" in the approved guide	+	+	+	+	±	+
9.2 Relevant literatures	*	*	*	*	*	*
10. Analysis reports on possible effects on human health	+	+	-	*	-	*
11. Labelling format, packaging requirements, storage conditions, shelf life, and precautions	+	+	+	+	+	+
12. Summary of pilot production and "three waste" treatment report
12.1 Summary of pilot production	+	+	+	+	+	+
12.2 “Three waste” treatment report	+	+	+	+	+	+
13. Joint declaration agreement	*	*	*	*	*	*
14. Other materials	*	*	*	*	*	*
15. Reference materials	+	+	+	+	+	+
16. CD (two copies)	+	+	+	+	+	+

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