EFSA issues opinion on ENZY CARBOPLUS for all porcine species
Executive summary
EFSA issued a scientific opinion on 9 November 2026 on ENZY CARBOPLUS®, covering a request to extend the feed additive's use to all porcine species for fattening and production. The preparation is already authorised for all poultry, weaned piglets and minor weaned porcine species, so the file concerns a wider scope rather than a new additive. The opinion is a step in the EU authorisation procedure: a Commission draft regulation, Member State endorsement, publication in the Official Journal and entry into force remain outstanding, and no effective date has been established.
Key data
- EFSA opinion date: 9 November 2026[1]
- Current EU authorised scope: All poultry, weaned piglets and minor weaned porcine species[1]
- Typical EU validity period for feed additive authorisations: 10 years[2]
- Earlier EFSA opinion on ENZY CARBOPLUS®: December 2017[4]
Cropenta Market Analysis
EFSA's 9 November 2026 opinion evaluates a request to extend the use of ENZY CARBOPLUS®, an authorised zootechnical digestibility enhancer, to all porcine species for fattening and production. The file is a scientific step within the EU authorisation procedure: an authorised use still requires a Commission draft regulation, Member State endorsement, publication in the Official Journal and entry into force, and no effective date has been established. The direct regulatory effect on EU feed manufacturers, formulators, importers and distributors is therefore one of pending compliance requirements, while the evidence does not establish any effect on prices, supply volumes or demand for the preparation.[1, 2, 3, 4, 5, 6]
Why it matters
- EU feed manufacturers, formulators and importers must distinguish the current authorised use from the wider porcine scope covered by the EFSA application until a Commission regulation is published and enters into force.
- Documentation and labelling systems for zootechnical digestibility enhancers will need to reflect the authorised species and production categories only, and the final regulation once in force.
- The evidence establishes no effect on prices, supply volumes or demand, so no commercial outcome should be inferred from the opinion alone.
EFSA issued a scientific opinion on 9 November 2026 on the safety and efficacy of ENZY CARBOPLUS®, a feed additive combining xylanase produced with Komagataella phaffii DSM 25376 and beta-glucanase produced with K. phaffii DSM 26469.[1] The application, made at the request of the European Commission, covers an extension of use to all porcine species for fattening and production.[1]
The opinion concerns an existing authorised preparation. ENZY CARBOPLUS® is classified as a zootechnical feed additive in the functional group of digestibility enhancers, and its current EU authorisation covers all poultry, weaned piglets and minor weaned porcine species.[1] The file therefore addresses a wider species and production-category scope, not the introduction of a new additive, and the scientific opinion alone does not place the widened use on the market.
Where the opinion sits in the authorisation process
Feed additives cannot be marketed in the EU without prior authorisation based on a scientific evaluation by EFSA, and that evaluation covers safety for human and animal health and the environment as well as efficacy.[2, 6] The governing legal framework is Regulation (EC) No 1831/2003.[2, 3] If the opinion is favourable, the European Commission prepares a draft regulation for authorisation, and the final authorisation is issued as a Commission Regulation after discussion and endorsement by Member States.[2, 6] Authorisations for feed additives are typically valid for 10 years in the EU.[2, 6]
No effective date is established at this stage. The steps still outstanding are a European Commission draft regulation, Member State endorsement, publication in the Official Journal and entry into force; the available record does not show any of them as completed.[2]
Earlier scientific record on the same preparation
An earlier EFSA opinion from December 2017 concluded that ENZY CARBOPLUS® was safe for target species, consumers and the environment, and extrapolated the efficacy conclusions to all avian species and all porcine species.[3, 4] That earlier assessment also recorded the preparation as a potential respiratory sensitizer, while finding it not to be a skin or eye irritant or a dermal sensitizer.[3, 4] The 2017 opinion predates the current application and does not by itself establish the outcome of the 2026 assessment.
A separate authorisation for the same production organisms
Commission Implementing Regulation (EU) 2025/2556 of 17 December 2025 concerns a preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 as a feed additive for chickens for laying or breeding, turkeys for breeding, minor poultry species for fattening and minor poultry species for laying or breeding, and amends Implementing Regulation (EU) 2018/1090.[3] That authorisation addresses poultry categories and is separate from the porcine extension now under assessment.
Background positions on the EU framework
FEFAC, the European Feed Manufacturers' Federation, states that the EU feed additive legal framework requires modernisation to improve sustainability in the feed and livestock sector.[5] The association also notes that feed additives contribute to optimised resource use, appetite stimulation and balancing of essential nutrients, and that new applications for feed additives support animal welfare and physiological status, potentially reducing antibiotic use.[5] These are the federation's own positions rather than established outcomes of the current file. FEFAC also points out that the EU remains highly dependent on third countries for the supply of certain essential feed additives, such as vitamins.[5]
What to monitor
- Publication of a European Commission draft regulation on the porcine extension of ENZY CARBOPLUS®.
- Member State endorsement of the draft regulation.
- Publication of the final Commission Regulation in the Official Journal of the European Union.
- Entry into force of the final authorisation and any stated transition period.
Disclaimer
This article, including the market analysis, has been compiled automatically from publicly available sources and is intended for information purposes only. The content does not constitute advice and does not necessarily represent the views of Cropenta. No rights can be derived from the information. Cropenta gives no guarantees as to its accuracy or completeness and, to the extent permitted by law, accepts no liability for its use.
Technical Questions
What enzymes does ENZY CARBOPLUS® contain, and how are they produced?
The product consists of xylanase produced with Komagataella phaffii DSM 25376 and beta-glucanase produced with Komagataella phaffii DSM 26469. The beta-glucanase is identified in the source as beta-glucanase, and the 2017 opinion refers to endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase.
What is the regulatory category of ENZY CARBOPLUS®?
It is classified as a zootechnical feed additive in the functional group of digestibility enhancers, meaning the functional group recorded for the additive within the EU authorisation framework.
How does the separate 2025 poultry authorisation relate to the current porcine application?
The Commission's Implementing Regulation (EU) 2025/2556 of 17 December 2025 addresses a preparation of endo-1,4-beta-xylanase produced with Komagataella phaffii DSM 25376 and endo-1,3(4)-beta-glucanase produced with Komagataella phaffii DSM 26469 for poultry categories, with the authorisation held by Kaesler Nutrition GmbH. It is a separate instrument from the porcine extension now under EFSA assessment.
When does the extended porcine use become applicable?
The available record identifies the remaining procedural steps and does not state a date on which the extended use becomes applicable. The authorisation period of 10 years applies to authorisations generally and does not supply a start date for this extension.
- 1.EFSA: Safety and efficacy of a feed additive consisting of xylanase (produced with Komagataella phaffii DSM 25376) and beta-glucanase (produced with Komagataella phaffii DSM 26469) (ENZY CARBOPLUS®) for all porcine species for fattening and reared for…
- 2.EFSA: Feed additives | EFSA
- 3.EUR-Lex: L_202502556EN.000101.fmx.xml
- 4.FAO: Safety and efficacy of ENZY CARBOPLUS® (endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase) as a feed additive for avian species, weaned piglets and minor weaned porcine species
- 5.FEFAC: Feed additives | FEFAC
- 6.amfep.org: Feed enzymes (Regulatory - About enzymes) - AMFEP
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