Commission Implementing Regulation (EU) 2018/460 of 20 March 2018 authorising the placing on the market of Ecklonia cava phlorotannins as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance. )

• CELEX: Implementing Regulation (EU) 2018/460
• Articles: 4

Article 1

1.    Ecklonia cava phlorotannins as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283.

2.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

3.   The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.

Article 2

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows

(1)

The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

‘

Ecklonia cava phlorotannins

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘ Ecklonia cava Phlorotannins’.

Food supplements containing Ecklonia cava phlorotannins shall bear the following statement:

(a)

This food supplement should not be consumed by children/adolescents under the age of twelve/fourteen/eighteen (*) years.

(b)

This food supplement should not be consumed by persons with thyroid disease or by persons who are aware of or have been identified as being at risk of developing thyroid disease.

(c)

This food supplement should not be consumed if other food supplements containing iodine are also consumed.

(*)

Depending on the age group the food supplement is intended for.’

Food Supplements as defined in Directive 2002/46/EC intended for the general population, excluding children under the age of 12 years

163 mg/day for adolescents from 12 to 14 years of age;

230 mg/day for adolescents above 14 years of age;

263 mg/day for adults.

(2)

The following entry is inserted in Table 2 (Specifications) in alphabetical order:

Authorised Novel Food

Specification

‘

Ecklonia cava phlorotannins

Description/Definition:

Ecklonia cava phlorotannins are obtained via alcohol extraction from the edible marine alga Ecklonia cava . The extract is a dark brown powder, rich in phlorotannins, polyphenolic compounds found as secondary metabolites in certain brown algae species.

Characteristics/Composition

Phlorotannin content: 90 ± 5 %

Antioxidant activity: > 85 %

Moisture: < 5 %

Ash: < 5 %

Microbiological criteria:

Total viable cell count: < 3 000  CFU/g

Mould/yeast: < 300 CFU/g

Coliforms: Negative to test

Salmonella spp.: Negative to test

Staphylococcus aureus : Negative to test

Heavy metals and Halogens:

Lead: < 3,0 mg/kg

Mercury: < 0,1 mg/kg

Cadmium: < 3,0 mg/kg

Arsenic: < 25,0 mg/kg

Inorganic Arsenic: < 0,5 mg/kg

Iodine: 150,0-650,0 mg/kg

CFU: Colony Forming Units’