COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/2129 
of 2 December 2021
author ising the placing on the market of calcium fructoborate 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) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regar d to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing 
Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) 
No 1852/2001 (1), and in particular Article 12 thereof,
Whereas:
(1) Regulation (EU) 2015/2283 provides that only novel foods author ised and included in the Union list may be placed 
on the mark et within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Imple menting Regulation (EU) 2017/2470 (2)
establishing a Union list of author ised novel foods was adopt ed.
(3) On 25 March 2019 , the compan y VDF FutureCeuticals, Inc. (‘the applicant’) submitted an application to the 
Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 to place calcium fructo borat e on the Union 
mark et as a novel food. The applicant requeste d calcium fructo borate to be used in food supplements as defined in 
Directive 2002/46/EC of the European Parliament and of the Council (3), for the adult population, excl uding 
pregnant and lactating women.
(4) The applicant also submitted a request to the Commission for the protection of propr ietar y data for a number of 
data submitted in suppor t of the application, namely , detailed descr iption of the production process (4); methods of 
analysis (5); certificates of analysis (6); stability repor t(7); dietar y boron intak e assessment (8); toxicokinetic study (9); 
bacterial reverse mutation test (10); in vitro mammalian micronucleus assa y(11); 90-da y toxicity study in rats (12); 
(1)OJ L 327, 11.12.2015, p. 1.
(2)Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance 
with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).
(3)Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of the 
Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).
(4)Section 2.b.1/VDF Calcium Fructoborat e - Production Process.pdf.
(5)Methods of analysis, excluding Ther mogra vimetr ic Analysis (TGA) - Annex C - Methods of Analysis - CONF .pdf.
(6)Annex D - Certificates of Analysis -CO NF.pdf.
(7)Annex E - Stability - CONF .pdf.
(8)Annex F - Boron Intake Repor t – CONF .pdf.
(9)Annex G - Nemzer , 2018 - CONF&PR OP.pdf (Unpublished Study repor t 2018).
(10)Annex G - Schreib et al., 2015 - CONF&PR OP.pdf (Unpublished Study repor t 2015a).
(11)Annex G - Donath et al., 2015 - CONF&PR OP.pdf (Unpublished Study repor t 2015b).
(12)Annex G - Bauter et al 2015 1 CONF&PR OP.pdf; Annex G - Bauter et al 2015 2 CON F&PR OP.pdf (Unpublished Study repor t 2015c).EN Offi cial Jour nal of the European Union 3.12.2021 L 432/13  particle size analysis (13); particle size method of analysis (14); fructo se analysis (15); amino acid analysis (16); 
microorg anisms analysis (17); physioch emical stability (18); stability of fructo se in the novel food (19); back ground 
dietar y boron intakes (20); boron dissociation under varying pH(21).
(5) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food 
Safety Author ity (‘the Author ity’) on 10 July 2019 , requesting it to provi de a scientifi c opinion by carrying out a 
safety assessment of calcium fructo borate as a novel food.
(6) On 25 May 2021 , the Author ity adopt ed its scientifi c opinion on the ‘Safety of calcium fructo borate as a novel food 
pursuant to Regulation (EU) 2015/2283’ (22). This opinion is in line with the requirements of Article 11 of 
Regulation (EU) 2015/2283.
(7) In that opinion, the Auth ority concluded that the novel food, calcium fructoborat e, is safe for the adult population, 
excl uding pregnant and lactating women, at intake levels up to 220 mg/da y (3,14 mg/kg bw per day). Theref ore, the 
opinion of the Author ity gives sufficient grounds to establish that calcium fructo borate under the specifi c conditions 
of use complies with Article 12(1) of Regulation (EU) 2015/2283.
(8) Since few data are available regarding the safety of calcium fructoborat e in the population under 18 years of age and 
by pregnant and lactating women, a labelling should be provid ed in order to properly inform the consumers that the 
food supplements containing calcium fructo borate should not be consumed by those population groups.
(9) In its opinion, the Author ity considered that all the data for which the applicant requeste d data prote ction, excep t for 
the dietar y boron intake assessment and background dietar y boron intakes, served as a basis to establish the safety of 
the novel food. On this basis, the Commission considers that the conclusions on the safety of calcium fructo borate 
could not have been reac hed without the data from the repor ts of those studies.
(10) The Commission request ed the applicant to further clarify the justification provi ded with regard to their propr ietar y 
claim over those data and to clarify their claim to an excl usive right of reference to those data, as required under 
Article 26(2)(b) of Regulation (EU) 2015/2283.
(11) The applicant declared that, at the time of the submission of the application, they held propr ietar y and excl usive 
rights of reference to those data under national law, and that theref ore third parties cannot lawfully access or use 
those data or refer to those data.
(12) The Commission assessed all the information provid ed by the applicant and considered that the applicant has 
suffi ciently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 
2015/2283. Theref ore, detailed descr iption of the production process; methods of analysis; certificates of analysis; 
stability repor t; toxicokinetic study ; bacterial reverse mutation test; in vitro mammalian micronucleus assa y; 90-da y 
toxicity study in rats; particle size analysis; particle size method of analysis; fructo se analysis; amino acid analysis; 
microorg anisms analysis; physiochemical stability ; stability of fructose in the novel food; boron dissociation under 
varying pH contained in the applicant’s file, on which the Author ity based its conclusion on the safety of the novel 
food and without which it could not have assessed the novel food, should not be used by the Auth ority for the 
benefit of any subsequent applicant for a period of 5 years from the date of entr y into force of this Regulation. 
According ly, only the applicant should be author ised to place calcium fructoborat e on the market within the Union 
during that period.
(13)Calcium Fructoborate - Particle Size COAs.pdf.
(14)Calcium Fructoborate - Particle Size MOA.pdf.
(15)Attac hment - Response 3 – Fructoborate Analysis.pdf.
(16)Attac hment - Response 5 - Amino Acid Analysis.pdf.
(17)Attac hment - Response 6 - Micro Analysis.pdf.
(18)Attac hment - Response 7 - Physiochem Stability .pdf.
(19)Attac hment_Clar ification_Resp_Q8_Fr uctose_Stability_C ONF .pdf.
(20)Ca Fructoborate_Response EFSA Q9-11_17 Jul 2020.pdf.
(21)Ca Fructoborate_Response EFSA Q_ADME_06 Apr 2021.pdf.
(22)EFSA Jour nal 2021;19(6):6661.EN Offi cial Jour nal of the European Union L 432/14 3.12.2021  (13) However , restr icting the author isation of calcium fructo borate and of the reference to the data contained in the 
applicant’s file for the sole use of the applicant, does not prevent other applicants from applying for an 
author isation to place on the market the same novel food, provid ed that their application is based on legally 
obtained information suppor ting such author isation under Regulation (EU) 2015/2283.
(14) Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly.
(15) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
1. Calcium fructo borate as specif ied in the Annex to this Regulation shall be included in the Union list of author ised 
novel foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of 5 years from 23 December 2021 only the initial applicant,
Com pany: VDF FutureCeuticals, Inc.,
Address: 300 West 6th Street Momence, Illinois 60954, the Unit ed States,
is author ised to place on the mark et within the Union the novel food refer red to in paragraph 1, unless a subsequent 
applicant obtains author isation for that novel food without reference to the data protect ed pursuant to Article 2 or with 
the agreement of VDF FutureCeuticals, Inc.
3. The entr y in the Union list refer red to in paragraph 1 shall include the conditions of use and labelling requirements 
laid down in the Annex.
Article 2
The data contained in the application file on the basis of whic h the novel food refer red to in Article 1 has been assessed by 
the Author ity, claimed by the applicant as propr ietar y and without whic h the novel food could not have been author ised, 
shall not be used for the benefi t of a subsequent applicant for a period of 5 years from 23 December 2021 without the 
agreement of VDF FutureCeuticals, Inc.
Article 3
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 4
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.EN Offi cial Jour nal of the European Union 3.12.2021 L 432/15  This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 December 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 432/16 3.12.2021  ANNEX 
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1) in Table 1 (Author ised novel foods), the follo wing entr y is inser ted:
‘Authorised novel foodConditions under which the novel food may be 
usedAdditional specific labelling requirementsOther 
requirementsData prot ection
Calcium fructoborat eSpecifi ed food 
catego ryMaximum levels1.The designation of the novel food 
on the labelling of the foodstuffs 
containing it shall be ‘calcium fruc­
tobor ate’.
2.The labelling of food supplements 
containing calcium fructo borate 
shall bear a statement that those 
food supplements should not be 
consumed by population under 
18 years of age and by pregnant 
and lactating women.Auth orised on 23 December 2021 . This inclusion is 
based on propr ietar y scientific evidence and scientific 
data protect ed in accordance with Article 26 of 
Regulation (EU) 2015/2283.
Applicant: VDF FutureCeuticals, Inc., 300 West 6th Street 
Momence, Illinois 60954, the United State s.
Dur ing the period of data protection, the novel food 
calcium fructo borate is author ised for placing on the 
market within the Union only by VDF FutureCeuticals, 
Inc., unless a subsequent applicant obtains author isation 
for the novel food without referen ce to the propr ietar y 
scientifi c evidence or scientifi c data protect ed in 
accordance with Article 26 of Regulation (EU)  
2015/2283 or with the agreement of VDF 
FutureCeuticals, Inc.
End date of the date protection: 23 December 2026 ’Food supplements as 
defined in Directive  
2002/46/EC for the 
adult population, 
excl uding food 
supplements for 
pregnant and 
lactating women220 mg/da yEN Offi cial Jour nal of the European Union 3.12.2021 L 432/17  (2) in Table 2 (Specif ications), the followi ng entr y is inser ted:
‘Authorised Novel Food Specificatio ns
Calcium fructoborat eDescr iption/Definition
The novel food is calcium fructoborat e, a calcium salt tetrah ydrat e of a bis(fr ucto se) ester of boric acid in the form of a powder , represent ed 
by Ca[(C6H10O6)2B]2•4H2O, with a molecular mass of 846 Da.
The novel food is produced by chemical synthesis whereby fructo se is combined with boric acid in wate r to produce a bis(fr ucto se) ester of 
boric acid through various heating and mixing processes. Calcium carbonate is then added to produce a solution containing the calcium salt 
of fructo borate (tetrah ydrat e). The solution is freeze-dr ied, ground to produce the final powdered product, and then packag ed and stored 
under representative storage conditions (22 ± 1°C RH 55-60 %).
Char acter istics/composition
Free moisture: < 5,0 %
Calcium: 4,5-5 %
Boron: 2,5-2,9 %
Fructo se: 80-85 %
Ash: 15-16 %
Heavy metals
Arsenic: ≤ 1 mg/kg
Micr obiological criteria
Total plate count: ≤ 1 000 CFU/g (a)
Yeast and mould: < 100 CFU/g
Colif orms: ≤ 10 CFU/g
Escher ichia coli: < 10 CFU/g
Salmonella spp.: Absence in 25 g
Coagulase-positive staph ylococci: Absence in 1 g
(a) CFU: colony forming units’EN Offi cial Jour nal of the European Union L 432/18 3.12.2021