Commission Implementing Regulation (EU) 2018/1133 of 13 August 2018 authorising the placing on the market of dried aerial parts of Hoodia parviflora 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.)
1. Dried aerial parts of Hoodia parviflora as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of five years from the date of entry into force of this Regulation only the Applicant:
Company: Desert Labs, Ltd
Address: Kibbutz Yotvata, 88820, Israel
is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the same novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Desert Labs, Ltd.
3. 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.
4. The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.
The study contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the applicant as fulfilling the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Desert Labs, Ltd.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1)
The following last column is added in Table 1 (Authorised novel foods):
‘Data protection’
(2)
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
Data protection
‘ Dried aerial parts of Hoodia parviflora
Specified food category
Maximum levels
The designation of the novel food on the labelling of the foodstuffs containing it shall be “dried aerial parts of Hoodia parviflora ”
Authorised on 3 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: Desert Labs, Ltd Kibbutz Yotvata, 88820 Israel.
During the period of data protection the novel food dried aerial parts of Hoodia parviflora is authorised for placing on the market within the Union only by Desert Labs, Ltd unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Desert Labs, Ltd.
End date of the data protection: 3 September 2023.’
Food Supplements as defined in Directive 2002/46/EC for adult population
9,4 mg/day
(3)
The following entry is inserted in Table 2 (Specifications) in alphabetical order:
Authorised Novel Food
Specification
‘ Dried aerial parts of Hoodia parviflora
Description/Definition:
It is the whole dried aerial parts of Hoodia parviflora N.E.Br., (family Apocynaceae )
Characteristics/Composition
Plant material: Aerial parts of at least 3-year-old plants
Appearance: Light green to tan fine powder
Solubility (water): > 25 mg/mL
Moisture: < 5,5 %
A w : < 0,3
pH: < 5,0
Protein: < 4,5 g/100 g
Fat: < 3 g/100 g
Carbohydrate (including dietary fibre): < 80 g/100 g
Dietary fibre: < 55 g/100 g
Total sugars: < 10,5 g/100 g
Ash: < 20 %
Hoodigosides
P57: 5–50 mg/kg
L: 1 000 –6 000 mg/kg
O: 500–5 000 mg/kg
Total: 1 500 –11 000 mg/kg
Heavy metals:
Arsenic: < 1,00 mg/kg
Mercury: < 0,1 mg/kg
Cadmium: < 0,1 mg/kg
Lead: < 0,5 mg/kg
Microbiological criteria:
Aerobic plate count: < 10 5 CFU/g
Escherichia coli : < 10 CFU/g
Staphylococcus aureus : < 50 CFU/g
Total coliforms: < 10 CFU/g
Yeast: ≤ 100 CFU/g
Mould: ≤ 100 CFU/g
Salmonella species: Negative/25 g
Listeria monocytogenes : Negative/25 g
CFU: Colony Forming Units’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
