COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/973 
of 6 July 2020 
author ising a change of the conditions of use of the novel food ‛protein extract from pig kidne ys’ and 
amending 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 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) 
which establishes a Union list of author ised novel foods was adopt ed. 
(3) On 29 Febr uary 2012, the compan y Sciot ec Diagnostic Technologies, GmbH informed the Commission, pursuant to 
Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3), of its intention to place on 
the mark et ‘protein extract from pig kidne ys’ as a novel food ingredient to be used in foods for special medical 
purposes as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (4), and in food 
supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5). Theref ore, 
prote in extract from pig kidne ys was included in the Union list of novel foods. 
(4) On 14 May 2019, the compan y Dr Health Care España, S.L. made a request to the Commission to extend the 
conditions of use of the prote in extract from pig kidne ys within the meaning of Article 10(1) of Regulation 
(EU) 2015/2283. The application request ed to include enteric coated tablets as an allowed form of prot ein extract 
from pig kidne ys to be used in foods for special medical purposes and in food supplements, in addition to the 
currently author ised enteric coated encapsulate d pellets. 
(5) The Commission did not request an opinion from the European Food Safety Author ity, as the amendment of the 
conditions of use of the novel food prote in extract from pig kidneys by including enter ic coated tablets as an 
allowe d form of protein extract from pig kidneys to be used in foods for special medical purposes and in food 
supplements, is not liable to chang e the effects of this author ised novel food on human health. 
(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 
foods ingredients (OJ L 43, 14.2.1997, p. 1). 
(4)Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young 
children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, 
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament 
and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35). 
(5)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). EN Offi cial Jour nal of the European Union 7.7.2020                                                                                                                                            L 215/7   (6) The maximum level of prot ein extract from pig kidneys as a novel food currently author ised to be used in enteric 
coated encapsulated pellets in foods for special medical purposes, and in food supplements, is 3 capsules/da y, 
corresponding to 12,6 mg pig kidne y extract a day. The proposed use of the enter ic coate d tablets form will not 
alter the currently author ised maximum level of the novel food. Theref ore, it is appropr iate to amend the section of 
the Union list on the conditions of use of protein extract from pig kidneys to author ise its use also in enteric coated 
tablets form at the same maximum author ised level as the already author ised forms of use of this novel food. 
(7) The Annex to Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly. 
(8) 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. The entr y in the Union list of author ised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 
refer ring to the ‘prote in extract from pig kidne ys’ shall be amended as specified in the Annex to this Regulation. 
2. 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 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, 6 July 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 215/8                                                                                                                                             7.7.2020   ANNEX 
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: 
(1) in Table 1 (Author ised novel foods), the entr y for ‘Prot ein extract from pig kidneys’ is replaced by the followi ng: 
‘                                                                
Author ised novel food Conditions under which the novel food may be used Additional specif ic labelling requirements Other 
requirements 
‘Protein extract from pig kid­
ney s Specified food categor y Maximum levels   
Food Supplements as defined in Directive 
2002/46/EC 3 capsules or 3 tablets/da y; equalising 
12,6 mg pig kidne y extract a day Diamine 
oxidase (DAO) content: 0,9 mg/da y (3 
capsules or 3 tablets with a cont ent of 
DAO of 0,3 mg/capsule or 0,3 mg/tablet)’ Food for special medical purposes as de­
fined in Regulation (EU) No 609/2013   
’ 
(2) in Table 2 (Specif ications), the entr y for ‘Protein extract from pig kidne ys’ is replaced by the following: 
‘                                                                
Author ised Novel Food Specif ication 
‘Protein extract from pig kidne ys Descr iption/Def inition: 
The prote in extract is obtained from homogenised pig kidne ys through a combination of salt precipitation and high speed centr ifugation. The 
obtained precipitate contains essentially proteins with 7 % of the enzyme diamine oxidase (enzyme nomenclature E.C. 1.4.3.22) and is 
resuspended in a physiologic buff er system. The obtained pig kidne y extract is formulated as encapsulated enter ic coated pellets or enteri c coated 
tablets to reac h the active sites of digestion. 
Basic Product: 
Specifi cation: pig kidney prot ein excerpt with natural cont ent of Diamine oxidase (DAO): 
Phys ical condition: liquid 
Colour: brownish 
Appearance: slightly turbid solution 
pH value: 6,4–6,8 
Enzymatic activity: > 2 677 kHDU DAO/ml (DAO REA (DAO Radioextractionassa y)) 
Microbiological criter ia: 
Brachyspir a spp.: negative (Real Time PCR) 
Lister ia monocytog enes: negative (Real Time PCR) EN Offi cial Jour nal of the European Union 7.7.2020                                                                                                                                            L 215/9   Staphylococc us aureus: < 100 CFU/g 
Influenza A: negative (Reverse Transcr iption Real Time PCR) 
Escher ichia coli: < 10 CFU/g 
Total aerobic microbiological count: < 105 CFU/g 
Yeasts/moulds count : < 105 CFU/g 
Salmonella: Absence/10g 
Bile salt resistant enterobact eriaceae: < 104 CFU/g 
Final product : 
Specifi cation pig kidne y protein excerpt with natural conte nt of DAO (E.C. 1.4.3.22) in an enteri c coated formulation: 
Phys ical condition: solid 
Colour: yellow grey 
Appearance: micropellets or tablets 
Enzymatic activity: 110-220 kHDU DAO/g pellet or g tablet (DAO REA (DAO Radioextractionassa y)) 
Acid stability 15 min 0,1M HCl follo wed by 60 min Borat pH = 9,0: > 68 kHDU DAO/g pellet or g tablet (DAO REA (DAO Radioextractionassa y)) 
Humidity: < 10 % 
Staphylococc us aureus: < 100 CFU/g 
Escher ichia coli: < 10 CFU/g 
Total aerobic microbiological count: < 104 CFU/g 
Total combined yeasts/moulds count: < 103 CFU/g 
Salmonella: Absence/10g 
Bile salt resistant enterobact eriaceae: < 102 CFU/g’   
’ EN Offi cial Jour nal of the European Union L 215/10                                                                                                                                           7.7.2020