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)
Article 1
Article 2
Article 3
ANNEX
Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
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‘ 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:
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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. |
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’ |