Flavourings: 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester, and hesperetin dihydrochalcone

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

Commission Regulation (EU) 2026/175 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 hesperetin dihydrochalcone in the Union list of flavourings

Update

The European Union (EU) has added two substances – 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester, and hesperetin dihydrochalcone – to the list of flavourings that can be used in foods.

Impacted Products

Flavoured fermented milk products (including heat-treated products), processed fruit and vegetables, confectionery, chewing gum, breakfast cereals, bread and rolls, herbs, spices, seasonings, sauces, alcoholic and non-alcoholic beverages (including alcohol-free and low-alcohol), potato-, cereal-, flour-, or starch-based snacks, cheese and cheese products, dairy analogues (including beverage whiteners), fats and oils, meat preparations, processed fish and fishery products, processed eggs and egg products, edible ices, beer and malt beverages

What is changing?

The EU has added the following to the list of auhorised flavourings that can be used in foods:

• [3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester, for the uses given in Table 1
• hesperetin dihydrochalcone-one, for the uses given in Table 2.

For more information on the food categories used in these Tables, see guidance from the European Commission (2025).

Why?

The European Food Safety Authority (EFSA) evaluated the safety of 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester and hesperetin dihydrochalcone under specific conditions in certain foods, and concluded that there is no safety concern at the levels proposed by the applicant (EFSA 2024, 2025).

Timeline

Products in Tables 1 and 2 containing 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester and hesperetin dihydrochalcone, respectively, can be placed on the EU market from 15 February 2026.

Background

Regulation 1334/2008 prohibits adding certain undesirable natural substances to food. It also lays down maximum levels for some substances that are naturally present in flavourings, but that may raise concerns for human health. The Regulation defines different types of flavourings, and lists the substances for which evaluation and approval are required.

The Union list of flavouring substances approved for use in and on foods (Regulation 872/2012) was adopted in 2012.

When EFSA evaluates flavouring substances, it allocates a unique identification number called an FL-number. FL comes from “FLAVIS”, the EU’s flavouring information system. The FL numbers for these substances are:

• 3-[3-(2-isopropyl-5-methyl-cyclohexyl)-ureido]-butyric acid ethyl ester: 16.136
• hesperetin dihydrochalcone: 16.137.

The FL-number is not used for labelling purposes.

Resources

Sources

Tables & Figures

Source: based on Regulation 2026/172

Source: based on Regulation 2026/175