Date: 2015-07-24Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2015/1213 of 22 July 2015 authorising extension of uses of flavonoids from Glycyrrhiza glabra L. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2015) 4968)
Executive Summary:
This Commission Implementing Decision (EU) 2015/1213, dated 22 July 2015, authorizes the extension of uses for flavonoids from Glycyrrhiza glabra L. (Glavonoid) as a novel food ingredient within the European Union. It follows a request from Kaneka Pharma Europe NV and addresses objections raised by member states. The decision specifies conditions for the use, labeling, and marketing of Glavonoid in certain food categories.
Key Points / Main Content:
Authorisation and Scope:
* Glavonoid, as specified in Annex I, is authorized for placement on the market in the Union as a novel food ingredient for uses defined in Annex II.
* This authorisation is without prejudice to the provisions of Directive 96/8/EC and Directive 1999/21/EC.
* Glavonoid shall not be sold to the final consumer as such.
Labelling Requirements:
* The designation on food labelling must be "flavonoids from Glycyrrhiza glabra L.".
* Labelling must include a statement that the product should not be consumed by pregnant or breastfeeding women, children, and young adolescents.
* Individuals taking prescription drugs should only consume the product under medical supervision.
* A maximum daily intake of 120 mg of Glavonoid is specified.
* The amount of Glavonoid in the final food product must be indicated on the labelling.
* Beverages containing Glavonoid must be presented as single portions.
Specifications of Glavonoid (Annex I):
* Glavonoid is an extract derived from Glycyrrhiza glabra roots/rootstock, extracted with ethanol and medium-chain triglycerides.
* It is a dark-brown liquid containing 2.5-3.5% glabridin, with defined limits for moisture, ash, peroxide value, glycyrrhizinic acid, fat, protein and carbohydrates.
Authorised Uses (Annex II):
* Glavonoid is authorised for use in foods intended for energy-restricted diets for weight reduction (only for 120mg daily consumption products presented as a replacement for the whole of the daily diet).
* Glavonoid is authorised for use in dietary foods for special medical purposes (120mg daily consumption).
Impact Analysis:
Kaneka Pharma Europe NV:
* Impact: As the applicant, Kaneka Pharma Europe NV is authorized to market Glavonoid for extended uses.
* Action Required: Ensure compliance with the specifications and labelling requirements outlined in the decision.
Food Manufacturers:
* Impact: Food manufacturers can now use Glavonoid in specific food categories, provided they adhere to the maximum content levels and labelling requirements.
* Action Required: Reformulate products as necessary, adjust labelling to meet the new requirements, and ensure compliance with maximum content levels.
Consumers:
* Impact: Consumers have access to food products containing Glavonoid, with specific usage guidelines and warnings.
* Action Required: Be aware of the labelling information, including warnings about consumption by specific populations and recommended daily intake.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Commission Implementing Decision EU 2015/1213: Commission Implementing Decision authorizing extension of uses of flavonoids from Glycyrrhiza glabra L. as a novel food ingredient.
Regulation EC No 258/97: Regulation of the European Parliament and of the Council concerning novel foods and novel food ingredients.
Glycyrrhiza glabra L.: Botanical name of licorice, the source of flavonoids discussed in the document.
Belgium: Country in Europe where Kaneka Pharma Europe NV made a request to the competent authorities for extension of uses of flavonoids from Glycyrrhiza glabra L.
Kaneka Pharma Europe NV: A company that requested the extension of uses of flavonoids from Glycyrrhiza glabra L. as a novel food ingredient.
Commission Directive 96/8/EC: Commission Directive on foods intended for use in energy-restricted diets for weight reduction.
Commission Directive 1999/21/EC: Commission Directive on dietary foods for special medical purposes.
24.7.2015 EN Official Journal of the European Union L 196/19
COMMISSION IMPLEMENTING DECISION (EU) 2015/1213
of 22 July 2015
authorising extension of uses of flavonoids from Glycyrrhiza glabra L. as a novel food ingredient
under Regulation (EC) No 258/97 of the European Parliament and of the Council
(notified under document C(2015) 4968)
(Only the Dutch and the French texts are authentic)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997
concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,
Whereas:
(1) The specification of flavonoids from Glycyrrhiza glabra L. has been laid down and its placing on the market has
been authorised in several foods at certain maximum use levels by Commission Implementing Decision
2011/761/EU (2).
(2) On 19 March 2014, the company Kaneka Pharma Europe NV made a request to the competent authorities of
Belgium for extension of uses of flavonoids from Glycyrrhiza glabra L. as a novel food ingredient.
(3) On 6 August 2014, the competent food assessment body of Belgium issued its initial assessment report. In that
report it came to the conclusion that the extension of uses of flavonoids from Glycyrrhiza glabra L. meets the
criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.
(4) On 22 September 2014, the Commission forwarded the initial assessment report to the other Member States.
(5) Reasoned objections were raised within the 60 day period laid down in the first subparagraph of Article 6(4) of
Regulation (EC) No 258/97. Additional explanations by the applicant alleviated the concerns to the satisfaction of
Member States and the Commission.
(6) Commission Directive 1999/21/EC (3) lays down requirements for dietary foods for special medical purposes.
Commission Directive 96/8/EC (4) lays down requirements on foods intended for use in energy-restricted diets for
weight reduction. The use of flavonoids from Glycyrrhiza glabra L should be authorised without prejudice to the
requirements of those legislations.
(7) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS DECISION:
Article 1
Flavonoids from Glycyrrhiza glabra L. (hereinafter referred to as ‘Glavonoid’), as specified in Annex I may be placed on the
market in the Union as a novel food ingredient for the uses specified in Annex II without prejudice to the provisions of
Directive 96/8/EC and Directive 1999/21/EC.
Glavonoid shall not be sold to the final consumer as such.
(1) OJ L 43, 14.2.1997, p. 1.
(2) Commission Implementing Decision 2011/761/EU of 24 November 2011 authorising the placing on the market of flavonoids from
Glycyrrhiza glabra L. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
(OJ L 313, 26.11.2011, p. 37).
(3) Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, p. 29).
(4) Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction (OJ L 55,
6.3.1996, p. 22).L 196/20 EN Official Journal of the European Union 24.7.2015
Article 2
1. The designation of Glavonoid authorised by this Decision on the labelling of the foodstuffs containing it shall be
‘flavonoids from Glycyrrhiza glabra L.’.
2. There shall be a statement on the labelling of the foods where the product was added as a novel food ingredient
indicating that:
(a) the product should not be consumed by pregnant and breast feeding women, children and young adolescents; and
(b) people taking prescription drugs should only consume the product under medical supervision;
(c) a maximum of 120 mg of Glavonoid per day should be consumed.
3. The amount of Glavonoid in the final food shall be indicated on the labelling of the food containing it.
4. Beverages containing Glavonoid shall be presented to the final consumer as single portions.
Article 3
This Decision is addressed to Kaneka Pharma Europe NV Triomflaan 173, 1160 Brussels, Belgium.
Done at Brussels, 22 July 2015.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission24.7.2015 EN Official Journal of the European Union L 196/21
ANNEX I
SPECIFICATIONS OF GLAVONOID
Description
Glavonoid is an extract derived from the roots or rootstock of Glycyrrhiza glabra by extraction with ethanol followed by
further extraction of this ethanolic extract with medium-chain triglycerides. It is a dark-brown coloured liquid,
containing 2,5 % to 3,5 % of glabridin.
Specifications
Parameter
Moisture less than 0,5 %
Ash less than 0,1 %
Peroxide value less than 0,5 meq/kg
Glabridin 2,5 to 3,5 % of fat
Glycyrrhizinic acid less than 0,005 %
Fat including polyphenol-type substances not less than 99 %
Protein less than 0,1 %
Carbohydrates not detectableL 196/22 EN Official Journal of the European Union 24.7.2015
ANNEX II
AUTHORISED USES OF GLAVONOID
Food category Maximum content of Glavonoid
Foods intended for use in energy-restricted diets for weight reduction (only for 120 mg of daily consumption
products presented as a replacement for the whole of the daily diet)
Dietary foods for special medical purposes 120 mg of daily consumption