Date: 2026-01-27Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Regulation (EU) 2026/172 of 26 January 2026 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester in the Union list of flavourings and correcting certain CAS numbers
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
Commission Regulation (EU) 2026/172, dated January 26, 2026, amends Annex I to Regulation (EC) No 1334/2008, adding 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester to the Union list of flavourings. The regulation also corrects the Chemical Abstracts Service (CAS) numbers for specific flavouring substances. This regulation will enter into force 20 days after its publication in the Official Journal of the European Union.
**Key Points / Main Content**
* **Flavouring Substance Inclusion:**
* 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester (FL No 16.136) is added to the Union list of flavourings.
* Specific usage conditions and maximum limits are set for various food categories.
* **CAS Number Corrections:**
* The CAS numbers for the following flavouring substances in Annex I to Regulation (EC) No 1334/2008 are corrected:
* FL No 08.017: corrected to '97-67-6'
* FL No 08.127: corrected to '13794-15-5'
* FL No 16.041: corrected to '150436-68-3'
* FL No 16.132: corrected to '67604-48-2'
**Impact Analysis**
**Stakeholder: Food Manufacturers**
* **Impact:** Can now use 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester as a flavouring substance in their products, within the specified limits. The regulation also ensures that they use correct CAS numbers when referring to particular flavouring substances.
* **Action Required:** Update flavouring substance records and processes to include 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester, adhering to the specified usage conditions. Update CAS numbers for flavouring substances accordingly.
**Stakeholder: Regulatory Bodies (e.g., Member States)**
* **Impact:** Responsible for monitoring and enforcing the correct use of flavouring substances, including the newly authorized substance and corrected CAS numbers.
* **Action Required:** Update monitoring and enforcement procedures to reflect the new inclusion and CAS number corrections.
**Stakeholder: European Food Safety Authority (EFSA)**
* **Impact:** EFSA's opinion was considered during the decision to authorise the inclusion of the new flavoring substance. EFSA's previous assesment is the basis for this regulation.
* **Action Required:** No action is required.
Key Entities Referenced
Regulation (EC) No 1334/2008: Regulation of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods. This regulation is being amended by the current document.
European Food Safety Authority ('the Authority'): The authority that evaluated the safety of 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester as a flavouring substance.
COMMISSION REGULATION (EU) 2026/172: Commission Regulation amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester in the Union list of flavourings and correcting certain CAS numbers.
Official Journal EN
of the European Union L series
2026/172 27.1.2026
COMMISSION REGULATION(EU) 2026/172
of 26 January 2026
amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council
as regards the inclusion of 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester in
the Union list of flavourings and correcting certain CAS numbers
(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 1334/2008 of the European Parliament and of the Council of 16 December 2008 on
flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council
Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC(1), and in
particular Article 11(3) thereof,
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008
establishing a common authorisation procedure for food additives, food enzymes and food flavourings(2), and in
particular Article 7(5) thereof,
Whereas:
(1) Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for
use in and on foods and their conditions of use.
(2) Commission Implementing Regulation (EU) No 872/2012(3) adopted the Union list of flavouring substances and
introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008.
(3) That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC)
No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State
or by an interested party.
(4) On 16 March 2020, an application was submitted to the Commission for the authorisation of 3-[3-(2-isopropyl-
5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester (FL No 16.136), as a flavouring substance to be used in various
foods falling under a number of food categories referred to in the Union list of flavourings and source materials. The
application was notified to the European Food Safety Authority (‘the Authority’) for its opinion. The Commission also
made the application available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.
(5) In its opinion adopted on 16 December 2024(4), the Authority evaluated the safety of 3-[3-(2-isopropyl-5-methyl-
cyclohexyl)-ureido]-butyric acid ethyl ester (FL No 16.136) when used as a flavouring substance and concluded that
such use under the proposed conditions of use does not raise a safety concern.
(6) In the light of the opinion of the Authority, since the use of 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric
acid ethyl ester (FL No 16.136) as a flavouring substance does not give rise to safety concerns under the specified
conditions of use and it is not expected to mislead the consumer, it is appropriate to authorise such use.
(1) OJ L 354, 31.12.2008, p. 34, ELI: http://data.europa.eu/eli/reg/2008/1334/oj.
(2) OJ L 354, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1331/oj.
(3) Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for
by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC)
No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and
Commission Decision 1999/217/EC (OJ L 267, 2.10.2012, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2012/872/oj).
(4) EFSA Journal2025; 23:e9201 (https://doi.org/10.2903/j.efsa.2025.9201) .
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OJ L, 27.1.2026
(7) In addition, the Chemical Abstracts Service registry numbers (CAS Nos) listed in Annex I to Regulation (EC)
No 1334/2008 for the flavouring substances FL Nos 08.017, 08.127, 16.041 and 16.132 are incorrect and should
be corrected.
(8) Annex I to Regulation (EC) No 1334/2008 should therefore be amended and corrected accordingly to include
3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester (FL No 16.136) in the Union list of
flavourings and to correct the CAS Nos for the flavouring substances FL Nos 08.017, 08.127, 16.041 and 16.132.
(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
Annex I to Regulation (EC) No 1334/2008 is amended in accordance with Annex I to this Regulation.
Article 2
Annex I to Regulation (EC) No 1334/2008 is corrected in accordance with Annex II to this Regulation.
Article 3
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, 26 January 2026.
For the Commission
The President
Ursula VON DER LEYEN
2/4 ELI: http://data.europa.eu/eli/reg/2026/172/ojANNEX I
In Part A, Section 2, Table 1, of Annex I to Regulation (EC) No 1334/2008, the following entry is inserted after the entry concerning FL No 16.135:
‘16.136 3-[3-(2-isopropyl-5-methyl-cyclohexyl)- 1160112-20-8 2203 In category 1.7 – not more than EFSA’
ureido]-butyric acid ethyl ester 6 mg/kg
In category 1.8 (only cheese
analogues) – not more than
6 mg/kg
In category 2.1 – not more than
8 mg/kg
In category 4.2 (only vegetables)
– not more than 8 mg/kg
In category 8.2 – not more than
8 mg/kg
In category 8.3 – not more than
8 mg/kg
In category 9.2 – not more than
8 mg/kg
In category 10.2 – not more
than 10 mg/kg
In category 12.2 – not more
than 20 mg/kg
In category 12.5 – not more
than 10 mg/kg
In category 12.6 – not more
than 10 mg/kg
In category 14.1 – not more
than 1,7 mg/kg
In category 15.1 – not more
than 20 mg/kg
ELI:
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ENANNEX II
In Part A, Section 2, of Annex I to Regulation (EC) No 1334/2008, Table 1 is corrected as follows:
(1) in the entry for FL No 08.017, the number in the third column is replaced by ‘97-67-6’;
(2) in the entry for FL No 08.127, the number in the third column is replaced by ‘13794-15-5’;
(3) in the entry for FL No 16.041, the number in the third column is replaced by ‘150436-68-3’;
(4) in the entry for FL No 16.132, the number in the third column is replaced by ‘67604-48-2’.
4/4
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EN
OJ
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