COMMI SSION REGUL ATION (EU) 2020/268 
of 26 Febr uary 2020 
amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council 
as regards the use of sorbic acid (E 200) in liquid colour preparations for the decorativ e colour ing of 
egg shells 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on 
food additives (1), and in particular Article 10(3) thereof, 
Whereas: 
(1) Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives appro ved for use in food 
additives, food enzymes, food flavourings, nutr ients and their conditions of use. 
(2) That list may be updated in accordance with the common procedure refer red to in Article 3(1) of Regulation (EC) 
No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission or 
follo wing an application. 
(3) Pursuant to Part 2 of Annex III to Regulation (EC) No 1333/2008, sorbic acid (E 200) is an already author ised food 
additive in colour preparations at a maximum level of 1 500 mg/kg in the preparation, sing ly or in combination 
with potassium sorbate (E 202), benzoic acid (E 210), sodium benzoate (E 211) and potassium benzoate (E 212), 
and at a maximum level of 15 mg/kg in the final product, expressed as the free acid. 
(4) On 27 Apr il 2017, an application was submitte d for the author isation of the use of a higher maximum level of 
sorbic acid (E 200), 2 500 mg/kg, in liquid colour preparations for sale to the final consumer for the decorative 
colour ing of egg shells. The application was subsequently made available to the Member States by the Commission 
pursuant to Article 4 of Regulation (EC) No 1331/2008. 
(5) Sorbic acid (E 200) is used as a preser vative in colour preparations. The applicant has demonstrate d that the 
currently author ised maximum level of sorbic acid (E 200) in colour preparations of 1 500 mg/kg is not sufficient 
to consist ently ensure appropr iate preser vation, and consequently microbiological safety , of liquid colour 
preparations for the decorative colour ing of egg shells. This is due to the use of food colours from natural origin in 
the preparations, which are not sterile, and the needed shelf life for such a seasonal product. The application shows 
that the level of sorbic acid (E 200) needed to achieve the intended technological function was 2 500 mg/kg in the 
colour preparations. It results from the tests carried out by the applicant that, under normal use (colour ing of 
undamag ed to slightly damaged eggs), the migration of sorbic acid (E 200) from the egg shell to the edible part of 
the egg is below the level of detection of 5 mg/kg. Consequently , according to the application, the request ed higher 
level of sorbic acid (E 200) in liquid colour preparations for the decorative colour ing of egg shells would not lead to 
an increase of the exposure of consumers to sorbic acid (E 200). 
(6) On 30 June 2015, the European Food Safet y Author ity (‘the Author ity’) issued a Scientific Opinion on the re- 
evaluation of, among others, sorbic acid (E 200) and potassium sorbat e (E 202) (3), as a result of whic h it established 
a new temporar y group acceptable daily intak e (‘ADI’) for sorbic acid (E 200) and potassium sorbat e (E 202), 
expressed as 3 mg sorbic acid/kg bw/da y. The Auth ority concluded that this temporar y group ADI for sorbic acid 
(E 200) and potassium sorbate (E 202) was exce eded at the high intake level in the toddler and children population 
groups in one countr y. The Authority recommended that a further reproductive toxicity study is perf ormed in 
order to reconsider the temporar y group ADI for sorbic acid (E 200) and potassium sorbate (E 202). 
(1)OJ L 354, 31.12.2008, p. 16. 
(2)Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common 
author isation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1). 
(3)EFSA Journal 2015;13(6):4144. EN Offi cial Jour nal of the European Union L 56/4                                                                                                                                            27.2.2020   (7) On 10 June 2016, the Commission launched a public call for scientifi c and technological data on, among others, 
sorbic acid (E 200) and potassium sorbat e (E 202) (4), targe ting the data needs identif ied by the Author ity. Business 
operat ors have carried out the reproductive toxicity study in rats recommended by the Auth ority for sorbic acid 
(E 200) and potassium sorbat e (E 202), the data from whic h were sent to the Author ity for evaluation. As a result, 
on 1 March 2019, the Author ity published a scientific opinion on the follo w-up of the re-evaluation of sorbic acid 
(E 200) and potassium sorbate (E 202) as food additives (5). On the basis of the new reproductive toxicity data, the 
Authority established a group ADI, expressed as 11 mg sorbic acid/kg bw per day for sorbic acid (E 200) and 
potassium sorbate (E 202). The Author ity compared this new group ADI to the most realistic exposure assessment 
scenar io estimated in its Scientific Opinion of 30 June 2015, and noted that such exposure did not excee d the 
group ADI in any population group, neither at the mean nor at the high intake levels. 
(8) Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the Author ity 
in order to update the Union list of food additives set out in Annex III to Regulation (EC) No 1333/2008, excep t 
where the update in question is not liable to have an effect on human health. 
(9) The exte nded use of sorbic acid (E 200) in liquid colour preparations for the decorative colour ing of egg shells, 
requeste d by the applicant, requires an updat e of the Union list. The exte nded use of sorbic acid (E 200) does not 
lead to an increase of the exposure to sorbic acid (E 200) and is not liable to have an effect on human health. 
Moreover , according to the Author ity, the exposure to sorbic acid (E 200) and to potassium sorbat e (E 202) under 
the already author ised uses and use levels is not of safety concer n, as it does not lead to the exceedance of the ADI. 
Consequently , is not necessar y to seek the opinion of the Auth ority. 
(10) Theref ore, it is appropr iate to author ise the use of sorbic acid (E 200) as a preser vative in liquid colour preparations 
for the sale to the final consumer for the decorative colour ing of egg shells at the maximum level of 2 500 mg/kg in 
the preparation. 
(11) Annex III to Regulation (EC) No 1333/2008 should theref ore be amended according ly. 
(12) 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 
Annex III to Regulation (EC) No 1333/2008 is amended in accordance with 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, 26 Febr uary 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     
(4)http://ec.europa.eu/f ood/safety/f ood_impro vement_agents/additives/re-evalua tion_en 
(5)EFSA Journal 2019;17(3):5625. EN Offi cial Jour nal of the European Union 27.2.2020                                                                                                                                            L 56/5   ANNEX 
In Part 2 of Annex III to Regulation (EC) No 1333/2008, the followi ng entr y is inser ted after the entr ies for food additives ‘E 200-202 Sorbic acid – potassium sorbate’, ‘E 210 Benzoic acid’ , 
‘E 211 Sodium benzoate’ and ‘E 212 Potassium benzoate’:                                                                
‘E 200 Sorbic acid 2 500 mg/kg in the preparation Liquid colour preparations for sale to the final consumer for the 
decorative colour ing of egg shells’   EN Offi cial Jour nal of the European Union L 56/6                                                                                                                                            27.2.2020