Hydroxytyrosol: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Fish and vegetable oils, (except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regulation (EU) No 1308/2013 (6)), placed as such on the market: 0,215 g/kg
• Spreadable fats as defined in Part VII of Annex VII of Regulation (EU) No 1308/2013, placed as such on the market: 0,175 g/kg

Additional specific labelling requirements

The designation of the novel food on the labelling of the food products containing it shall be ‘hydroxytyrosol’. The labelling of the food products containing hydroxytyrosol shall bear the following statements: (a) This food product should not be consumed by children under the age of three years, pregnant women, and lactating women; (b) This food product should not be used for cooking, baking or frying’

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description/Definition:

Hydroxytyrosol is a pale yellow viscous liquid obtained by chemical synthesis

Molecular formula: C8H10O3

Molecular weight: 154,6 g/mol

CAS No: 10597-60-1

Moisture ≤ 0,4 %

Odour: CharacteristicTaste: Slightly bitter

Solubility (water): Miscible with water

pH: 3,5-4,5

Refractive Index: 1,571-1,575

Purity:

Hydroxytyrosol: ≥ 99 %

Acetic acid: ≤ 0,4 %

Hydroxytyrosol acetate: ≤ 0,3 %

Sum of homovanillic acid, iso-homovanilic acid, and 3-methoxy-4hydroxyphenylglycol: ≤ 0,3 %

Heavy Metals

Lead: ≤ 0,03 mg/kg

Cadmium: ≤ 0,01 mg/kg

Mercury: ≤ 0,01 mg/kg

Residual Solvents

Ethyl acetate: ≤ 25,0 mg/kg

Isopropanol: ≤ 2,50 mg/kg

Methanol: ≤ 2,00 mg/kg

Tetrahydrofuran: ≤ 0,01 mg/kg

Notes

(6) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671, ELI: http://data.europa.eu/eli/reg/2013/1308/oj).

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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