Commission Implementing Regulation (EU) 2021/1974 of 12 November 2021 authorising the placing on the market of dried fruits of Synsepalum dulcificum 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)
Commission Implementing Regulation (EU) 2021/1974 of 12 November 2021 authorising the placing on the market of dried fruits of Synsepalum dulcificum 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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
1. Dried fruits of Synsepalum dulcificum , 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 5 years from 5 December 2021, only the initial applicant,
Company: Medicinal Gardens S.L.;
Address: Marqués de Urquijo 47, 1° D, Office 1, Madrid, 28008, Spain,
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 novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Medicinal Gardens S.L.
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.
The studies contained in the application file on the basis of which the novel food referred to in Article 1 have been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of 5 years from 5 December 2021 without the agreement of Medicinal Gardens S.L.
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1)
in Table 1 (Authorised novel foods), the following entry is inserted:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data protection
‘ Synsepalum dulcificum dried fruits
Specified food category
Maximum levels
1.
The designation of the novel food on the labelling of food supplements containing it shall be ‘dried Synsepalum dulcificum fruits’
2.
The labelling of food supplements containing Synsepalum dulcificum dried fruits shall bear a statement that this food supplement should be consumed by adults only excluding pregnant and lactating women.
Authorised on 5 December 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: Medicinal Gardens S.L. Marqués de Urquijo 47, 1° D, Office 1, Madrid, 28008, Spain.
During the period of data protection, the novel food is authorised for placing on the market within the Union only by Medicinal Gardens S.L. unless a subsequent applicant obtains authorisation for that 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 Medicinal Gardens S.L.
End date of the data protection: 5 December 2026.’
Food Supplements as defined in Directive 2002/46/EC for adult population excluding pregnant and lactating women
0,7 g/day
(2)
in Table 2 (Specifications), the following entry is inserted:
Authorised Novel Food
Specification
‘
Synsepalum dulcificum dried fruits
Description/Definition:
The novel food is lyophilised pulp and skin of pitted fruits of Synsepalum dulcificum (Schumach. & Thonn.) Daniell that belongs to the Sapotaceae family. The resulting dried cake is milled into a powder.
Characteristics/Composition:
Moisture (g/100 g): < 6
Ash (g/100 g): 3,5-8,5
Total carbohydrates (g/100 g): 70-87
Sugars (g/100 g): 50-75
Fibre (g/100 g): 1-6,5
Total protein (g/100 g): 3,5-6,0
Miraculin ( *1 ) (g/100 g): 1,5-2,5
Total fat (g/100 g): 0,50-3,50
Microbiological criteria:
Total aerobic colony count: < 10 4 CFU ( *2 ) /g
Bacillus cereus (presumptive): < 100 CFU/g
Sulfite-reducing Clostridia : ≤ 30 CFU/g
Total Enterobacteriaceae: < 100 CFU/g
Yeasts and moulds: < 500 CFU/g
Pesticides:
Pesticide levels in accordance with Code number 0820990 (‘others’ in the group of fruit spices) set out in Regulation (EC) No 396/2005 ( 1 )
( *1 ) Miraculin is part of the total protein content.
( *2 ) CFU: colony forming units.
( 1 ) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ( OJ L 70, 16.3.2005, p. 1 ).’
