
Article 1 
Without prejudice to Regulation (EC) No 1925/2006, hydroxytyrosol as specified in Annex I to this Decision may be placed on the Union market as a novel food ingredient intended for the general population, excluding children under the age of three years, pregnant women, and lactating women, for the uses defined and at the maximum levels established in Annex II to this Decision.
Article 2 

1. The designation of hydroxytyrosol authorised by this Decision for the labelling of the food products shall be ‘hydroxytyrosol’.
2. 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’.
Article 3 
This Decision is addressed to Seprox Biotech, Centro Empresarial Ingenia N-8, Parque Tecnológico Fuente Álamo, 30320 Fuente Álamo, Murcia, Spain.
Done at Brussels, 14 December 2017.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX I

Chemical name IUPAC name: 4-(2-hydroxyethyl)-benzene-1,2-diolSynonyms:3-Hydroxytyrosol3,4-dihydroxyphenylethanolDihydroxyphenylethanol2-(3,4-Di-hydroxyphenyl)-ethanol
Chemical formula C8H10O3
Molecular mass 154,16 Da
CAS No. 10597-60-1

Description: Hydroxytyrosol is a pale-yellow viscous liquid.


Parameter Specifications
Description Slightly yellow viscous liquid
Moisture ≤ 4,0 %
Odour Characteristic
Taste Slightly bitter
Solubility (water) Miscible with water
pH 3,5-4,5
Refractive Index (25 °C) 1,571-1,575
Hydroxytyrosol and organic by-products of the chemical synthesis 
Hydroxytyrosol ≥ 99,0 %
Acetic acid ≤ 0,4 %
Hydroxytyrosol acetate ≤ 0,3 %
Sum of homovanillic alcohol, iso-homovanillic alcohol, and 3-methoxy-4-hydroxyphenylglycol ≤ 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

ANNEX II

Food category Maximum level
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), 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
