COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/443 
of 25 March 2020 
author ising the change of the specif ications of the novel food sper midine-r ich wheat germ extract 
(Triticum aestivum) 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) Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the author isation and on the 
placing on the Union mark et of a novel food and on the updating of the Union list. 
(4) On 6 December 2017, the compan y TLL The Longevity Labs GmbH (‘the applicant ’), informed the Commission in 
accordance with Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3) of its 
intenti on to place on the mark et sper midine-r ich wheat germ extract (Triticum aestivum) as a novel food ingredient. 
Theref ore, sper midine-r ich wheat germ extract was included in the Union list of novel foods. 
(5) On 6 August 2019, the applicant made a request to the Commission to change the specifications of sper midine-r ich 
wheat germ extract in accordance with Article 10(1) of Regulation (EU) 2015/2283. The applicant request ed to 
increase the level of cadaveri ne from the current < 0,1 μg/g to ≤ 16,0 μg/g. 
(6) The applicant justifies the request by indicating that the change is necessar y in order to reflect the natural levels of up 
to ≤ 16,0 μg/g of cadaverine that are analytically detectable in the wheat germ of the Triticum aestivum plant. The 
currently author ised level of < 0,1 μg/g cada verine in sper midine-r ich wheat germ extract represents the limit of 
detection with the analytical method that the applicant had erroneously included in the initial notification as the 
specifi cation limit for cadaverine, and whic h was subsequently included in the Union list specifications of this novel 
food. 
(7) Cadav erine is a diamine whic h together with histamine, tyramine, and putrescine belong to the class of the biogen ic 
amines that are naturally formed as the result of bacte rial metabolism of prote ins. 
(8) The health risks of biogenic amines were evaluated by the European Food Safety Author ity (‘the Authority’) 
in 2011 (4). In the scientific opinion, the Authority noted that analytical information and food consum ption data 
from the Member State s has shown that cada verine is present in a number of foods (alcoholic beverage s, 
condiments, fish and fish products, meats, dair y products, vege tables and vegetable products) at mean levels up to 
184 mg/kg of food with the resulting intakes reachin g up to 116,1 mg of cadaveri ne per day. 
(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)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 Januar y 1997 concer ning novel foods and novel food 
ingredients. OJ L 43, 14.2.1997, p. 1. 
(4)EFSA Jour nal 2011;9(10):2393. EN Offi cial Jour nal of the European Union 26.3.2020                                                                                                                                            L 92/7   (9) Consider ing that the proposed maximum levels of cadaveri ne in the novel food and the resulting intakes on the basis 
of the author ised conditions of use of the novel food will be at least three orders of magnitude lower than the levels 
of cadaveri ne that are ingest ed from a normal diet, the Commission considers that the proposed changes in the 
cadaverine levels in the specifi cations of the sper midine-r ich wheat germ extract do not alter the safet y 
considerations that suppor ted the author isation of this novel food, and that a safety evaluation of the current 
application by the Auth ority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessar y. 
Theref ore, it is appropr iate to amend the specifi cations of the novel food sper midine-r ich wheat germ extract at the 
level for cadaverine requeste d by the applicant. 
(10) The Annex to Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly. 
(11) 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 
The entr y in the Union list of author ised novel foods, as provided for in Article 6 of Regulation (EU) 2015/2283 and included 
in Implementing Regulation (EU) 2017/2470, referr ing to the novel food sper midine-r ich wheat germ extract (Triticum 
aestivum), is amended as specified in the Annex to this Regulation. 
Article 2 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 25 Marc h 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 92/8                                                                                                                                            26.3.2020   ANNEX 
In the Annex to Implementing Regulation (EU) 2017/2470, the entr y for ‘Sper midine-r ich wheat germ extract (Triticum 
aestivum)’ in Table 2 (Specifi cations) is replaced by the following:                                                              
Autho rised Novel Food Specificat ions 
‘Sper midine-r ich wheat germ extract 
(Triticum aestivum) Descr iption/Def inition: 
Sper midine-r ich wheat germ extract is obtained from non-fe rmented, non- 
sprouting wheat germs (Triticum aestivum) by the process of solid-liquid 
extraction target ing specifi cally , but not excl usively polyamines. 
Sper midine:(N-(3-aminoprop yl)butane-1,4-diamine):0,8-2,4 mg/g 
Sper mine: 0,4-1,2 mg/g 
Sper midine trichloride < 0,1 μg/g 
Putrescine: < 0,3 mg/g 
Cadav erine: ≤ 16,0 μg/g 
Mycotoxins: 
Aflatoxins (total): < 0,4 μg/kg 
Microbiological criter ia: 
Total aerobic bacteria: < 10 000 CFU/g 
Yeast and moulds: < 100 CFU/g 
Escher ichia coli: < 10 CFU/g 
Salmonella: Absence/25g 
Lister ia monocytogenes: Absence/25g’   EN Offi cial Jour nal of the European Union 26.3.2020                                                                                                                                            L 92/9   