COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/500 
of 6 Apr il 2020 
author ising the placing on the market of partially defatted chia seed (Salvia hispanica) powders as 
novel foods 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 submit a draf t implementing act 
author ising the placing on the Union mark et of a novel food and on the updat e of the Union list. 
(4) On 18 Apr il 2018, the compan y Access Business Group International LLC (‘the applicant’) submitted a request to the 
Commission to place partially defatted chia seed (Salvia hispanica) powder on the Union mark et as novel food in 
accordance with Article 10(1) of Regulation (EU) 2015/2283. The applicant request ed for the chia seed (Salvia 
hispanica) powder to be used in a number of food cate gories for the general population as follows: unflavoured 
fermented milk products, including natural unflavoured butt ermilk (excluding steri lised butte rmilk) non-heat- 
treated after fermentation; unflavoured fermented milk products, heat-treated after fermentation; flavour ed 
fermented milk products including heat-treat ed products; confectioner y; fruit and veget able juices; fruit and 
veget able nectars and similar products; flavoured drinks; food supplements as defined in Directive 2002/46/EC of 
the European Parliament and of the Council (3), excl uding food supplements for infants and young children; pasta. 
(5) On 16 July 2018, the applicant submitted a request to the Commission to place another partially defa tted chia (Salvia 
hispanica) seed powder on the Union market as novel food in accordance with Article 10(1) of Regulation (EU) 
2015/2283. The applicant requested for the chia seed (Salvia hispanica) powder to be used in a number of food 
catego ries for the general population as follows: confecti oner y; fruit and vegetable juices; fruit and vegetable nectars 
and similar products; flavoured drinks; food supplements as defined in Directive 2002/46/EC, excluding food 
supplements for infants and young children; pasta. 
(6) The two applications to the Commission concer n the author isation of two differ ent partially defatted chia seed 
(Salvia hispanica) powders as a novel food. Both chia seed (Salvia hispanica) powders are partially defatted, obtained 
by pressing and grinding of the whole chia seeds (Salvia hispanica). Main differ ences between the two powders are 
particle sizes and the content of some macronutr ients. The powder with high protein cont ent has a particle size 
below 130 μm and prote in content of at least 40 %, while the powder with high fibre conte nt has a particle size 
below 400 μm and dietar y fibre cont ent of at least 50 %. The proposed uses of both powders are also similar . 
(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). EN Offi cial Jour nal of the European Union L 109/2                                                                                                                                             7.4.2020   (7) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food 
Safety Author ity (‘Author ity’) on 22 June 2018 and 22 October 2018 respectively , asking it to provid e a scientific 
opinion by carrying out an assessment for chia seed (Salvia hispanica) powders as novel foods. Taking into 
consideration the similar ities between the two types of partially defatted chia seed (Salvia hispanica) powders, their 
safety assessment by the Auth ority was merged. 
(8) On 15 May 2019, the Authority adopt ed the scientific opinion ‘Safety of chia seeds (Salvia hispanica L.) powders, as 
novel foods, pursuant to Regulation (EU) 2015/2283’ (4). That opinion is in line with the requirements of Article 11 
of Regulation (EU) 2015/2283. 
(9) In that opinion, the Author ity concluded that partially defatt ed chia seed (Salvia hispanica) powders are safe under the 
assessed conditions of use. Theref ore, the opinion of the Author ity gives suffi cient grounds to establish that partially 
defatt ed chia seed (Salvia hispanica) powders, under the assessed uses and use levels, when used in unflavoured 
fermented milk products, including natural unflavoured butt ermilk (excluding steri lised butte rmilk) non-heat- 
treated after fermentation; unflavoured fermented milk products, heat-treated after fermentation; flavour ed 
fermented milk products including heat-treat ed products; confectioner y; fruit and veget able juices; fruit and 
veget able nectars and similar products; flavour ed drinks; food supplements as defined in Directive 2002/46/EC, 
excl uding food supplements for infants and young children, compl y with Article 12(1) of Regulation (EU) 
2015/2283. 
(10) In its scientific opinion, ‘Safety of chia seeds (Salvia hispanica L.) as a novel food for extended uses pursuant to 
Regulation (EU) 2015/2283’ (5) the Auth ority considered one study which pointe d to the possible formation of 
acrylamide when chia seeds (Salvia hispanica) are used in foods, requir ing heat treatment at or abov e 120 °C in their 
manufact ure, processing or preparation. The Authority considered that this study is also applicable to the 
assessment of the chia seed (Salvia hispanica) powders, since they only differ from chia seeds (Salvia hispanica) already 
included in the Union list as regards defatting, a treatment whic h is neutral with regard to the formation of 
acrylamide. 
(11) The Author ity noted that the food ‘pasta’ may be subject to heat treatment to temperatures abov e 120 °C and 
poten tially could represent a relevant source of acrylamide, while other proposed food catego ries do not present 
safety concer ns in relation to possible formation of acrylamide. 
(12) In the opinion on safety of chia seed (Salvia hispanica L.) powders, the Author ity considered that additional 
information is needed from the applicant and/or from the public domain, to address the potential for acrylamide 
formation when foods containing chia seed (Salvia hispanica) powders undergo heat treatment at or above 120 °C. In 
accordance with Article 11(4) of Regulation (EU) 2015/2283 the Author ity has requeste d additional information 
from the applicant relating to poten tial formation of process contaminants whic h may be formed during processing 
and production of a food (at the level of the manuf acturer) and/or when a food with added chia seed (Salvia hispanica) 
powders is subjected to cooking (heat treatment at consumer level). The period set for the provis ion of the additional 
information was set for the 13 May 2019. Although the applicant provid ed additional information by the set 
deadline, the Author ity concluded that the information provid ed is not sufficient to address poten tial formation of 
acrylamide in pasta at temperatures above 120 °C whic h could pote ntially represent a relevant source of acrylamide 
at consumer level. 
(13) In the absence of information on the poten tial formation of acrylamide in ‘pasta’, if subject to such heat treatment, 
the Auth ority deferred the evaluation of chia seeds powder in pasta to when the additional information becomes 
available. It follows, that the Commission, at this stage, does not dispose of the opinion of the Auth ority necessar y 
pursuant to Article 12(1)(a) and (c) of Regulation (EU) 2015/2283 for the appro val of the use of chia seed (Salvia 
hispanica) powders in pasta that may be subject to heat-treatment at or abov e 120 °C. Theref ore, a further decision 
about such use will be take n after the publication of the relevant opinion of the Author ity. 
(4)EFSA Journal 2019;17(6):5716. 
(5)EFSA Journal 2019;17(4):5657. EN Offi cial Jour nal of the European Union 7.4.2020                                                                                                                                            L 109/3   (14) The opinion of the Author ity also identif ied two case repor ts from the available scientific literature, which linked the 
consum ption of chia seeds (Salvia hispanica) to allergic reactions and concluded on this basis that allergic reactions 
upon consump tion of chia seeds may occur . Further more, the Author ity considers that the allergen ic pote ntial of 
chia seed (Salvia hispanica) powders is similar to that of chia seeds (Salvia hispanica) because the manufactur ing steps 
emplo yed in the production of the powders are not expect ed to modify the allergenic pote ntial of the chia seeds 
(Salvia hispanica). Consider ing that, to date , only those two allergy cases have been repor ted and, in light of the 
widespread consum ption of chia seeds (Salvia hispanica) and their presence on the Union and global mark et for 
man y years, no specifi c labelling requirements concer ning poten tial allergic reactions upon consump tion of chia 
seed (Salvia hispanica) powders should be included in the Union list of author ised novel foods, until further scientifi c 
evidence on the allergen ic pote ntial of chia seeds (Salvia hispanica) is obtained and assessed by the Author ity. 
(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. Partially defa tted chia seed (Salvia hispanica) powders as specified 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. 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 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. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 6 Apr il 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 109/4                                                                                                                                             7.4.2020   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 in alphabetical order: 
Autho rised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
‘Partially defat ted chia seed 
(Salvia hispanica) powders Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it shall 
be “Partially defatt ed chia seed (Salvia hispa­
nica) powder”  Powder with high protein conten t 
Unflavoured fermented milk products, in­
cluding natural unflavoured butter milk (ex­
cluding sterilised butter milk) non-heat-trea­
ted after fermentation 0,7 % 
Unflavoured fermented milk products, heat- 
treated after fermentation 0,7 % 
Flavour ed fermente d milk products includ­
ing heat-treat ed products 0,7 % 
Conf ectioner y 10 % 
Fruit juices as defined by Directive 
2001/112/EC (*) and vegetable juices 2,5 % 
Fruit nectars as defined by Directive 
2001/112/EC and vegetable nectars and si­
milar products 2,5 % 
Flavour ed drinks 3 % 
Food supplements as defined in Directive 
2002/46/EC excl uding food supplements for 
infants and young children 7,5 g/da y 
Powder with high fibre content 
Conf ectioner y 4 %  EN Offi cial Jour nal of the European Union 7.4.2020                                                                                                                                            L 109/5   Autho rised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Fruit juices as defined by Directive 
2001/112/EC and vegetable juices 2,5 % 
Fruit nectars as defined by Directive 
2001/112/EC and vegetable nectars and si­
milar products 4 % 
Flavour ed drinks 4 % 
Food supplements as defined in Directive 
2002/46/EC excl uding food supplements for 
infants and young children 12 g/da y 
(*) Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products inten ded for human consump tion (OJ L 10, 12.1.2002, p. 58).’   
(2) in Table 2 (Specif ications), the followi ng entr y is inser ted in alphabetical order : 
Autho rised Novel Food Specification 
‘Partially defat ted chia seed 
(Salvia hispanica) powders Descr iption/Def inition: 
The novel foods are partially defatt ed chia seed (Salvia hispanica) powders obtained by pressing and grinding of the whole seeds of Salvia hispanica L. 
Physical–sensor ial: 
Foreign matte r: 0,1 %  
Powder with high prot ein content Powder with high fibre content 
Particle size ≤ 130 μm ≤ 400 μm 
Chemical composition:  
Salvia hispanica pow der with high prot ein content Salvia hispanica powder with high fibre content 
Moisture ≤ 9,0 % ≤ 9,0 % 
Prote in ≥ 40,0 % ≥ 24,0 % 
Fat ≤ 17 % ≤ 12 % 
Fibre ≤ 30 % ≥ 50 %  EN Offi cial Jour nal of the European Union L 109/6                                                                                                                                             7.4.2020   Autho rised Novel Food Specification  
Microbiological criter ia: 
Total plate count: ≤ 10 000 CFU/g 
Yeasts: ≤ 500 CFU/g 
Moulds: ≤ 500 CFU/g 
Staphy lococcus aureu s: ≤ 10 CFU/g 
Colif orms: < 100 MPN/g 
Enterobacteri aceae: ≤ 100 CFU/g 
Bacillus cereus : ≤ 50 CFU/g 
Escher ichia coli: < 10 MPN/g 
Lister ia monocytoge nes: Absence/g 
Salmonella spp.: Absence in 25 g 
Contaminants: 
Arsenic: ≤ 0,1 ppm 
Cadmium: ≤ 0,1 ppm 
Lead: ≤ 0,1 ppm 
Mercur y: ≤ 0,1 ppm 
Total aflatoxins: ≤ 4 ppb 
Ochrat oxin A: ≤ 1 ppb’   EN Offi cial Jour nal of the European Union 7.4.2020                                                                                                                                            L 109/7