Date: 2026-05-29Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2026/1148 of 28 May 2026 concerning the renewal of the authorisation of beta-carotene and a preparation of beta-carotene as feed additives for all animal species and repealing Implementing Regulation (EU) 2015/1103
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
Commission Implementing Regulation (EU) 2026/1148 renews the authorisation of beta-carotene and its preparations as feed additives for all animal species until 18 June 2036, repealing Regulation (EU) 2015/1103. The regulation introduces new identification numbers (3a160 and 3a160i) and establishes a maximum content limit for calves in milk replacers to ensure consumer safety. Specific transitional measures are provided, allowing the continued use of existing stocks produced under previous rules until 2027 or 2028, depending on the product type.
**Key Points / Main Content**
**Authorisation and Classification**
* **Renewal:** Beta-carotene and beta-carotene preparations are authorised as nutritional additives for all animal species.
* **Functional Group:** Classified under "vitamins, pro-vitamins and chemically well-defined substances having similar effect."
* **Duration:** The authorisation is valid for 10 years, expiring on 18 June 2036.
**Technical Specifications and Limits**
* **Identification Numbers:** Updated to 3a160 for beta-carotene and 3a160i for the preparation of beta-carotene.
* **Maximum Content:** A limit of 50 mg/kg of complete feed (12% moisture) is established specifically for calves in milk replacers.
* **Purity Criteria:** Additives must contain a minimum of 96% total colouring matters, with other carotenoids restricted to ≤ 3%.
* **Impurity Limit:** Triphenylphosphine oxide (TPPO) must be ≤ 100 mg/kg of the additive.
**Safety and Labeling**
* **User Safety:** Feed business operators must establish operational procedures and provide Personal Protective Equipment (PPE)—including eye, skin, and respiratory protection—for users handling additive 3a160i.
* **Labeling Requirements:** Directions for use must specify storage conditions and the additive's stability to heat treatment.
* **Method of Analysis:** Specific spectrophotometry and HPLC methods are defined for determining beta-carotene levels in additives, premixtures, and compound feed.
**Transitional Provisions**
* **Additives and Premixtures:** Products produced and labelled before 18 June 2026 according to old rules may be placed on the market until 18 December 2026 and used until stocks are exhausted.
* **Compound Feed (Food-producing animals):** Products produced and labelled before 18 June 2027 may be marketed and used until stocks are exhausted.
* **Compound Feed (Non-food producing animals):** Products produced and labelled before 18 June 2028 may be marketed and used until stocks are exhausted.
**Impact Analysis**
**Stakeholder: Feed Additive Manufacturers and Suppliers**
**Impact**
Manufacturers must update their production and labelling processes to reflect new identification numbers, purity standards, and maximum concentration limits for specific animal categories.
**Action Required**
Update product labels to include required storage and heat stability information; ensure the 50 mg/kg limit is reflected in formulations for calf milk replacers; and update safety data sheets to reflect the new identification numbers.
**Stakeholder: Feed Business Operators and Industrial Users**
**Impact**
Users are identified as being at risk for skin, eye, and respiratory irritation when handling certain preparations.
**Action Required**
Establish formal operational procedures and organisational measures to mitigate risks; mandate the use of appropriate PPE (eyes, skin, and breathing protection) for employees handling the additives or premixtures.
**Stakeholder: Calf Rearers and Livestock Producers**
**Impact**
The regulation restricts the unlimited use of beta-carotene in milk replacers due to concerns over consumer exposure via calf liver.
**Action Required**
Verify that milk replacers and compound feeds purchased for calves do not exceed the maximum authorized level of 50 mg/kg.
Key Entities Referenced
Commission Implementing Regulation (EU) 2026/1148: The primary legislative act renewing the authorization of beta-carotene and its preparations as feed additives for all animal species.
Regulation (EC) No 1831/2003: The foundational European Parliament and Council regulation governing the authorization, use, and labeling of additives in animal nutrition.
European Food Safety Authority (EFSA): The primary scientific regulator responsible for evaluating the safety and efficacy of beta-carotene for animals, consumers, and the environment.
Implementing Regulation (EU) 2015/1103: The prior legislative act that granted the original 10-year authorization for beta-carotene, which is repealed by this regulation.
Standing Committee on Plants, Animals, Food and Feed: The regulatory committee that provided the formal opinion required for the adoption of these feed additive measures.
Official Journal EN
of the European Union L series
2026/1148 29.5.2026
COMMISSION IMPLEMENTING REGULATION(EU) 2026/1148
of 28 May 2026
concerning the renewal of the authorisation of beta-carotene and a preparation of beta-carotene as
feed additives for all animal species and repealing Implementing Regulation (EU) 2015/1103
(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 and renewing such an authorisation.
(2) Beta-carotene was authorised for 10 years as a feed additive for all animal species by Commission Implementing
Regulation (EU) 2015/1103(2). The terms of authorisation allow the use of beta-carotene as an additive consisting of
a preparation.
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of
the authorisation of beta-carotene and a preparation of beta-carotene as feed additives for all animal species,
requesting the additives to be classified in the additive category ‘nutritional additives’ and in the functional group
‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’. That application was
accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 25 June 2025(3)that, the applicant
has provided evidence that the use of beta-carotene and of the preparation of beta-carotene produced by chemical
synthesis remains safe for all animal species as well as for consumers and the environment under the conditions
currently authorised. In addition, the Authority stated that among food-producing animals, the consumption of liver
from veal calves may result in additional exposure, so unlimited use of beta-carotene as an additive in milk replacers
may be a concern for consumer safety. The Authority further concluded that beta-carotene is not a skin and eye
irritant nor a skin sensitiser. One of the evaluated preparations containing 10 % beta-carotene was shown not to be a
skin sensitiser. However, no conclusions on the safety for the user could be reached for other preparations. The
Authority stated that the application for renewal of the authorisation does not include a proposal for amending or
supplementing the conditions of the original authorisation that would have an impact on the efficacy of the
additives. Therefore, it concluded that there is no need for assessing the efficacy of the additives in the context of the
renewal of the authorisation. The Authority considered that there is no need for specific requirements of post-market
monitoring.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) Commission Implementing Regulation (EU) 2015/1103 of 8 July 2015 concerning the authorisation of beta-carotene as a feed
additive for all animal species. (OJ L 181, 9.7.2015, p. 57, ELI: http://data.europa.eu/eli/reg_impl/2015/1103/oj).
(3) EFSA Journal2025;23:e9549, https://doi.org/10.2903/j.efsa.2025.9549.
ELI: http://data.europa.eu/eli/reg_impl/2026/1148/oj 1/5EN
OJ L, 29.5.2026
(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and
recommendations reached in the assessment carried out regarding the method of analysis of beta-carotene as a feed
additive in the context of the previous authorisation are valid and applicable for the current application. In
accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005(4), an evaluation report of the
Reference Laboratory is therefore not required.
(6) In view of the above, the Commission considers that beta-carotene and the preparation of beta-carotene satisfy the
conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of those
additives should be renewed. In addition, the Commission considers that appropriate protective measures should be
taken to prevent adverse effects on the health of the users of the additives. The Commission further considers that
due to the risk for consumer safety by the consumption of liver from veal calves, a maximum level should be set for
calves. Those protective measures should be without prejudice to other workers’ safety requirements under
Union law.
(7) As a consequence of the renewal of the authorisation of beta-carotene and the preparation of beta-carotene,
Implementing Regulation (EU) 2015/1103 should be repealed.
(8) Since the identification number of the additives has been modified and a maximum content level has been authorised
for calves (milk-replacers), it is appropriate to provide for a transitional period for interested parties to prepare
themselves to meet the new requirements resulting from the renewal of the authorisation.
(9) 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
Renewal of the Authorisation
The authorisation of the substance and the preparation specified in the Annex, belonging to the additive category
‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having
similar effect’, is renewed subject to the conditions laid down in that Annex.
Article 2
Repeal
Implementing Regulation (EU) 2015/1103 is repealed.
Article 3
Transitional measures
1. The feed additive beta-carotene, as authorised by Implementing Regulation (EU) 2015/1103, and premixtures
containing that additive, which are intended for all animal species and which are produced and labelled before
18 December 2026 in accordance with the rules applicable before 18 June 2026 may continue to be placed on the market
and used until the stocks concerned are exhausted.
(4) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC)
No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference
Laboratory concerning applications for authorisations of feed additive (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/
2005/378/oj).
2/5 ELI: http://data.europa.eu/eli/reg_impl/2026/1148/ojEN
OJ L, 29.5.2026
2. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and
labelled before 18 June 2027 in accordance with the rules applicable before 18 June 2026 may continue to be placed on
the market and used until the stocks concerned are exhausted if they are intended for food-producing animals.
3. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and
labelled before 18 June 2028 in accordance with the rules applicable before 18 June 2026 may continue to be placed on
the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals.
Article 4
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, 28 May 2026.
For the Commission
The President
Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg_impl/2026/1148/oj 3/5ANNEX
Minimum Maximum
content content
Identification Species or
Name of the Composition, chemical formula, description, End of period of
number of category of Maximum age Other provisions
additive analytical method mg of active substance/kg of authorisation
the additive animal
complete feed with a moisture
content of 12 %
Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect
3a160 Beta-carotene Additive composition Calves — — 50 1. In the directions for use 18 June 2036
Beta-carotene (milk of the additive and
Solid form replacers) premixtures, the storage
Triphenylphosphine oxide (TPPO) conditions and the
Other — — —
≤ 100 mg/kg of the additive. stability to heat
animal
treatment shall be
Characterisation of the active substance species indicated.
and
Beta-carotene
categories
C H
40 56
CAS number: 7235-40-7
Beta-carotene, solid form, produced by
chemical synthesis.
Purity criteria:
— (assay) min. 96 % total colouring
matters (dried substance) expressed as
beta-carotene,
— carotenoids other than beta-carotene:
≤ 3 % of total colouring matters.
Analytical method(1)
For the determination of beta-carotene in
the feed additive:
— Spectrophotometry – Food Chemical
Codex ‘β-Carotene monograph’.
For the determination of beta-carotene in
premixtures and compound feed:
— Reversed-phase high performance
liquid chromatography (HPLC) coupled
to UV detection – EN 17550.
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-
evaluation-reports_en.
4/5
ELI:
http://data.europa.eu/eli/reg_impl/2026/1148/oj
EN
OJ
L,
29.5.2026Minimum Maximum
content content Identification Species or
Name of the Composition, chemical formula, description, End of period of
number of category of Maximum age Other provisions
additive analytical method mg of active substance/kg of authorisation
the additive animal
complete feedingstuff with a
moisture content of 12 %
Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect
3a160i Beta-carotene Additive composition Calves — — 50 1. In the directions for use 18 June 2036
Preparation of beta-carotene with a (milk of the additive and
minimum of 10 % of beta-carotene. replacers) premixtures, the storage
Solid form conditions and the
Other — — —
Triphenylphosphine oxide (TPPO) stability to heat
animal
≤ 100 mg/kg of the additive. treatment shall be
species
indicated.
Characterisation of the active substance and
categories
Beta-carotene 2. For users of the additive
C H and premixtures, feed
40 56
CAS number: 7235-40-7 business operators shall
Beta-carotene, solid form, produced by establish operational
chemical synthesis. procedures and
organisational measures
Purity criteria:
to address potential risks
— (assay) min. 96 % total colouring
resulting from their use.
matters (dried substance) expressed as
Where those risks
beta-carotene,
cannot be eliminated by
— carotenoids other than beta-carotene:
such procedures and
≤ 3 % of total colouring matters.
measures, the additive
and premixtures shall be
Analytical method(1)
used with appropriate
For the determination of beta-carotene in
personal protective
the feed additive:
equipment, including
— Spectrophotometry.
eyes, skin and breathing
For the determination of beta-carotene in protection.
premixtures and compound feed:
— Reversed-phase high performance
liquid chromatography (HPLC) coupled
to UV detection – EN 17550.
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-
evaluation-reports_en.
ELI:
http://data.europa.eu/eli/reg_impl/2026/1148/oj
5/5
OJ
L,
29.5.2026
EN