#32026R0352Commission Implementing Regulation (EU) 2026/352 authorising L-arginine produced with Escherichia coli CCTCC M 20231961 as a feed additive for all animal species
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This regulation authorises the use of L-arginine (minimum 98.5% purity on dry matter basis) produced by fermentation with the genetically modified strain Escherichia coli CCTCC M 20231961 as a nutritional feed additive in the functional group of amino acids. It is approved for all animal species both in complete feed and in drinking water. The additive is considered safe for target animals when used according to nutritional needs, safe for consumers and the environment. EFSA could not conclude on skin/eye irritation or sensitisation potential. For ruminants, the additive must be rumen-protected to be effective. Use in drinking water raises hygiene concerns and must comply with feed hygiene rules. Labelling must warn about considering all essential amino acids to avoid nutritional imbalances.
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Key Changes
- Authorises 3c366i L-arginine produced with E. coli CCTCC M 20231961 (≥98.5% purity) for all animal species
- Allows use in complete feed and drinking water with mandatory labelling on storage, stability and amino acid balance
- Requires rumen-protected form when used in ruminants
+ 3 more changes with Pro
Obligations
What this law requires
Ensure L-arginine is rumen-protected when fed to ruminants to maintain efficacy
Ensure L-arginine product contains minimum 98.5% purity on dry matter basis and use ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD or IEC-VIS) to verify arginine content in feed additive, premixtures, compound feed, and drinking water
Indicate storage conditions, stability to heat treatment, and stability in water for drinking in the directions for use of the additive and premixtures
Include label warning stating: 'The supplementation with L-arginine, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid nutritional imbalances'
Indicate moisture content on the label of the L-arginine additive product