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)

• CELEX: Implementing Decision (EU) 2017/2373
• Articles: 5

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.

Schedules & Appendices

ANNEX I

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

C 8 H 10 O 3

Molecular mass

154,16 Da

CAS No.

10597-60-1

Description: Hydroxytyrosol is a pale-yellow viscous liquid.

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

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

( 1 )   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 Regulation (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) 1234/2007 ( OJ L 347, 20.12.2013, p. 671 ).