II
(Non-legislative acts)
REGUL ATIONS
COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/2191 
of 10 December 2021
author ising the placing on the market of fresh plants of Wolffia arrhiza and/or Wolffia globosa as a 
traditional food from a third countr y 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 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 15(4) 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. Traditional food from a third countr y is a novel food defined in Article 3(2)(c) of 
Regulation (EU) 2015/2283.
(2) Commission Implementing Regulation (EU) 2017/2468 (2)lays down administrative and scientific requirements 
concer ning traditional foods from third countr ies.
(3) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Imple menting Regulation (EU) 2017/2470 (3)
establishing a Union list of author ised novel foods was adopt ed.
(4) On 7 September 2020 , the compan y GreenOn yx Ltd (‘the applicant’) submitted a notifi cation to the Commission of 
their intention to place fresh plants of Wolffia arrhiza and Wolffia globosa on the Union mark et as a traditional food 
from a third countr y in accordance with Article 14 of Regulation (EU) 2015/2283. The applicant requested that the 
fresh plants of Wolffia arrhiza and Wolffia glob osa be used as such by the general population.
(5) Pursuant to Article 7(2) of Implementing Regulation (EU) 2017/2468, the Commission request ed additional 
information from the applicant as regar ds the requirements for validity of the notification. The request ed 
information was submitte d on 16 October 2020 .
(1)OJ L 327, 11.12.2015, p. 1.
(2)Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements 
concer ning traditional foods from third countr ies 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. 55).
(3)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).EN Offi cial Jour nal of the European Union 13.12.2021 L 445/1  (6) The data present ed by the applicant demonstrate that fresh plants of Wolffia arrhiza and/or of Wolffia glob osa as such 
have a histo ry of safe food use in Southeast Asia, in particular in Laos, Myanmar and Thailand.
(7) Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 20 Januar y 2021 , the Commission forwarded the valid 
notificati on to the Member State s and to the European Food Safety Author ity (‘the Authority’).
(8) No duly reasoned safety objections to the placing on the mark et within the Union of fresh plants of Wolffia arrhiza 
and Wolffia globosa were submitted to the Commission by the Member State s or the Auth ority within the 4-month 
period laid down in Article 15(2) of Regulation (EU) 2015/2283.
(9) On 30 June 2021 , the Author ity published its ‘Techn ical Repor t on the notific ation of fresh plants of Wolffia arrhiza 
and Wolffia glob osa as a traditional food from a third countr y pursuant to Article 14 of Regulation (EU) 2015/2283 
’(4). The Author ity concluded that the available data on the compo sition and the histo ry of use of the fresh plants of 
Wolffia arrhiza and Wolffia glob osa and the data provided on the traditional food cultivated under the conditions of 
vertical farming as descr ibed in the notifi cation do not raise safet y concer ns.
(10) In that repor t, the Author ity note d that the safety of the fresh plants of Wolffia arrhiza and Wolffia globosa is strong ly 
influenced by the envi ronmental conditions of the water s where these plants are grown. Theref ore, the presence of 
heavy metals and microcystins in these fresh plants cannot be excl uded. Moreover , certain levels of some trace 
elements contained therein, such as copper , molybdenum, zinc, boron and manganese, which may be due to the use 
of fertilisers in the cultivation of fresh plants of Wolffia arrhiza and Wolffia glob osa may pose a safety concer n for 
human health. It is theref ore appropr iate to establish maximum levels of heavy metals, microcystins, copper , 
molybdenum, zinc, boron and mang anese in the specific ations of this traditional food in the Union list of 
author ised novel foods.
(11) The Commission should theref ore author ise the placing on the mark et within the Union of fresh plants of Wolffia 
arrhiza and/or of Wolffia globosa as such and update the Union list of author ised novel foods according ly.
(12) Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly,
HAS ADOPTED THIS REGUL ATION:
Article 1
1. The fresh plants of Wolffia arrhiza and/or of Wolffia glob osa, as specif ied in the Annex to this Regulation, shall be 
included as a traditional food from a third countr y in the Union list of author ised novel foods established in Implementing 
Regulation (EU) 2017/2470.
2. The entr y in the Union list refer red to in paragraph 1 shall include the conditions of use and specifications laid down 
in the Annex to this Regulation.
Article 2
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 3
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
(4)EFSA Suppor ting Publications, https://doi.org/10.2903/sp.efsa.2021.EN-6658EN Offi cial Jour nal of the European Union L 445/2 13.12.2021  This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 December 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 13.12.2021 L 445/3  ANNEX 
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1) the following entr y is inser ted in Table 1 (Author ised novel foods):
‘Authorised novel food Conditions under which the novel food may be used Additio nal specific labelling requirements Other requirements
Wolffia arrhiza and/or Wolffia 
glob osa fresh plants 
(Traditional food from a third 
countr y)Specifi ed food catego ry Maximum levels The designation of the novel food on the labelling 
of the foodstuffs containing it shall be “Wolffia 
arrhiza and Wolffia globosa” or “Wolffia arrhiza” or 
“Wolffia glob osa” depending on the plant used.’Wolffia arrhiza and/or Wolffia 
glob osa fresh plants as such
(2) the following entr y is inser ted in Table 2 (Specif ications):
‘Authorised Novel Food Specificatio ns
Wolffia arrhiza and/or Wolffia globosa fresh plants 
(Traditional food from a third countr y)Descr iption/Def inition:
The traditional food consists of fresh plants of Wolffia arrhiza (L.) Horkel ex Wimm. and/or of Wolffia globosa (Roxb.) Hartog & Plas 
(family : Araceae).
Microbiological criter ia:
Total plate count: < 103 CFU/g
Total yeast and mould count: < 100 CFU/g
Total Enterobact eriaceae: < 100 CFU/g
Escher ichia coli: < 100 CFU/g
Salmonella: Absence in 25 g
Lister ia monocytog enes: Absence in 25 g
Staphy lococcus aureu s: Absence/10 g
Hea vy met als:
Lead: < 0,3 mg/kg
Arsenic (inorg anic): < 0,10 mg/kg
Cadmium: < 0,2 mg/kg
Chromium: < 1 mg/kg
Mercur y: < 0,10 mg/kg
Trace elements:
Copper: < 0,8 mg/kg
Molybdenum: < 0,3 mg/kgEN Offi cial Jour nal of the European Union L 445/4 13.12.2021  Zinc: < 5 mg/kg
Boron: < 5 mg/kg
Mang anese: < 6 mg/kg
Cyanot oxins:
Microcystins: 0,006 μg/g
Pesticides:
Pesticide levels in accordance with Code number 0254000 (“Subgroup (d) wate rcresses” in the group of Leaf vege tables, herbs and 
edible flowers) set out in Regulation (EC) No 396/2005 (1).
(1)Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 Febr uary 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).
(*) CFU: Colony Forming Units.’EN Offi cial Jour nal of the European Union 13.12.2021 L 445/5