COMMISSION IMPLEMENTING DECISION (EU) 2017/2373
of 14 December 2017
authorising the placing on the market of hydroxytyrosol as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document number C(2017) 8423)
(Only the Spanish text is authentic)
Article 1
Article 2
Article 3
ANNEX I
SPECIFICATIONS OF HYDROXYTYROSOL
Definition:
Chemical name |
IUPAC name: 4-(2-hydroxyethyl)-benzene-1,2-diol Synonyms: 3-Hydroxytyrosol 3,4-dihydroxyphenylethanol Dihydroxyphenylethanol 2-(3,4-Di-hydroxyphenyl)-ethanol |
Chemical formula |
C8H10O3 |
Molecular mass |
154,16 Da |
CAS No. |
10597-60-1 |
Specifications:
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
Authorised uses of hydroxytyrosol
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(1)), 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 |