Date: 2026-03-16Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2026/585 of 13 March 2026 concerning the denial of authorisation of ginseng extract from Panax ginseng C.A. Meyer as a feed additive for cats and dogs
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
Commission Implementing Regulation (EU) 2026/585 denies the authorization of ginseng extract from *Panax ginseng* C.A. Meyer as a feed additive for cats and dogs. This decision follows the applicant's failure to demonstrate the safety of the substance or provide necessary characterization data. The regulation mandates specific market withdrawal deadlines for existing stocks of the additive, premixtures, and compound feeds by July and October 2026.
**Key Points / Main Content**
**Denial of Authorization**
* The European Commission has officially denied the authorization of ginseng extract (*Panax ginseng* C.A. Meyer) as a feed additive in the category of "sensory additives" and the functional group "flavouring compounds."
* The denial applies specifically to the use of the additive for cats and dogs.
**Basis for the Decision**
* The European Food Safety Authority (EFSA) issued an inconclusive opinion on March 17, 2021, stating it could not confirm the safety of the additive for users, cats, or dogs.
* The applicant failed to provide a full characterization of the additive or respond substantively to Commission requests for supplementary information made between 2021 and 2025.
* The substance did not meet the conditions for authorization set out in Regulation (EC) No 1831/2003.
**Market Withdrawal Timelines**
* **Existing stocks of the additive and premixtures:** Must be withdrawn from the market by July 5, 2026.
* **Feed materials and compound feed:** Products manufactured with the additive or premixtures before July 5, 2026, must be withdrawn from the market by October 5, 2026.
**Legal Entry into Force**
* The regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
* The measures are binding in their entirety and directly applicable in all Member States.
**Impact Analysis**
**Feed Additive Manufacturers and Applicants**
* **Impact:** The specific ginseng extract can no longer be marketed or used as a legal feed additive for cats and dogs within the EU.
* **Action Required:** Manufacturers must halt production for these species and ensure all existing stocks of the additive are removed from the market by July 5, 2026.
**Feed Producers (Premixtures and Compound Feed)**
* **Impact:** Producers are prohibited from incorporating this ginseng extract into new premixtures or final feed products for cats and dogs.
* **Action Required:** Operators must withdraw premixtures containing the extract by July 5, 2026, and ensure all final feed products containing the substance are off the market by October 5, 2026.
**EU Member State Competent Authorities**
* **Impact:** Authorities are responsible for monitoring and enforcing the withdrawal of these products from the internal market.
* **Action Required:** Regulatory bodies must ensure compliance with the phased withdrawal deadlines of July 5 and October 5, 2026.
Key Entities Referenced
Regulation (EC) No 1831/2003: The primary EU legislative framework governing the authorization, use, and re-evaluation of additives in animal nutrition.
European Food Safety Authority (EFSA): The EU agency responsible for providing the scientific opinion that concluded the safety of ginseng extract could not be established.
Standing Committee on Plants, Animals, Food and Feed: The regulatory body that provided the opinion in favor of the measures to deny authorization and withdraw the additive from the market.
Council Directive 70/524/EEC: The historical legislation under which ginseng extract was previously authorized before the current re-evaluation process.
Official Journal EN
of the European Union L series
2026/585 16.3.2026
COMMISSION IMPLEMENTING REGULATION(EU) 2026/585
of 13 March 2026
concerning the denial of authorisation of ginseng extract from Panax ginsengC.A. Meyer as a feed
additive for cats and dogs
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on
additives for use in animal nutrition(1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the
grounds and procedures for granting or denying such authorisation. Article 10 of that Regulation provides for the
re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2).
(2) The substance ginseng extract from Panax ginsengC.A. Meyer was authorised without a time limit in accordance with
Directive 70/524/EEC as a feed additive for cats and dogs. This substance was subsequently entered in the Register of
Feed Additives as existing product, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an
application was submitted for the authorisation of ginseng extract from Panax ginsengC.A. Meyer as a feed additive
for cats and dogs, requesting the additive to be classified in the additive category ‘sensory additives’ and in the
functional group ‘flavouring compounds’. The application was accompanied by the particulars and documents
required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) As provided for by Article 5(1) of Regulation (EC) No 1831/2003, it is for the applicant for the authorisation of a feed
additive to adequately and sufficiently demonstrate, in accordance with the implementing rules referred to in
Article 7 of that Regulation, that the conditions for authorisation set out in Article 5(2) and (3) of that Regulation
are satisfied.
(5) The European Food Safety Authority (‘the Authority’) in its opinion of 17 March 2021(3), could not conclude on the
safety of ginseng extract from Panax ginsengC.A. Meyer for the user and for cats and dogs at the proposed use levels,
since the applicant did not provide the full characterisation of the additive.
(6) By letter of 12 October 2021, the Commission gave the applicant the opportunity to submit supplementary
information to address the inconclusive opinion of the Authority. In the absence of a reply, an email was sent to the
applicant on 4 February 2025 informing about the intention to deny the authorisation. Despite several reminders,
the applicant has not reacted on substance.
(7) It derives from the Authority’s opinion of 17 March 2021 that the applicant has not adequately and sufficiently
demonstrated that ginseng extract from Panax ginsengC.A. Meyer is safe under the proposed conditions of use, when
used as a feed additive for cats and dogs.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1, ELI: http://
data.europa.eu/eli/dir/1970/524/oj).
(3) EFSA Journal2021; 19(4):6526. https://doi.org/10.2903/j.efsa.2021.6526.
ELI: http://data.europa.eu/eli/reg_impl/2026/585/oj 1/2EN
OJ L, 16.3.2026
(8) In view of the above, it cannot be considered that ginseng extract from Panax ginseng C.A. Meyer satisfies the
conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the
authorisation of this substance as a feed additive belonging to the additive category ‘sensory additives’ and in the
functional group ‘flavouring compounds’ for use for cats and dogs should be denied.
(9) Therefore, ginseng extract from Panax ginseng C.A. Meyer and feed containing it should be withdrawn from the
market as soon as possible as far as the use for cats and dogs is concerned. However, a limited period should be
allowed for the withdrawal from the market of the existing stocks of those products, in order to enable operators to
comply properly with the withdrawal obligation.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Denial of authorisation
The authorisation of ginseng extract from Panax ginseng C.A. Meyer as additive in animal nutrition, belonging to the
category ‘sensory additives’ and in the functional group ‘flavouring compounds’, for use for cats and dogs, is denied.
Article 2
Withdrawal from the market
1. Existing stocks of the additive referred to in Article 1, which is intended for dogs and cats, and of premixtures
containing it, which are intended for dogs and cats, shall be withdrawn from the market by 5 July 2026.
2. Feed materials and compound feed which have been produced with the additive or premixtures referred to in
paragraph 1 before 5 July 2026, and which are intended for dogs and cats, shall be withdrawn from the market by
5 October 2026.
Article 3
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 March 2026.
For the Commission
The President
Ursula VON DER LEYEN
2/2 ELI: http://data.europa.eu/eli/reg_impl/2026/585/oj