EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10004/2022 
(POOL/E2/2022/10004/10004 -EN.docx)   
D080145/03  
[…](2022) XXX  draft 
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending the Annex to Commission Regulation (EU) No 231/2012 laying down 
specifications for food additives listed in Annexes II and III to Regulation (EC) No 
1333/2008 of the European Parliament and of the Council as regards the presence of 
ethylene oxide in food additives  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending the Annex to Commission Regulation (EU) No 231/2012 laying down 
specifications for food additives listed in Annexes II and III to Regulation (EC) No 
1333/2008 of the European Parliament and of the Council as regards the presence of 
ethylene oxide in food additives  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Fun ctioning of the European Union,  
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the 
Council of 16 December 2008 on food additives1, and in particular Article 14 thereof,  
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the 
Council of 16 December 2008 establishing a common authorisation procedure for food 
additives, food enzymes and food flavourings2, and in particular Article 7(5)  thereof,  
Whereas:  
(1) Commission Regulation (EU) No 231/20123 lays d own specifications for food 
additives listed in Annexes II and III to Regulation (EC) No 1333/2008.  
(2) The specifications for food additives may be updated in accordance with the common 
procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, ei ther on the 
initiative of the Commission or following an application from a Member State or an 
interested party.  
(3) Ethylene oxide is an important chemical substance having multiple uses , including the 
use as a sterilising agent and as a raw material in the m anufacture of various products. 
Ethylene oxide, however, is a substance of concern classified as carcinogenic, 
mutagenic and toxic for reproduction  in accordance with Regulation (EC) No 
1272/2008 of the European Parliament and of the Council4. It is neither approved as a 
biocidal product under Regulation (EU) No 528/2012 of the European Parliament and 
of the Council5 nor as an active substance for use in plant protection products in 
                                                 
1 OJ L  354, 31.12.2008, p.  16. 
2 OJ L  354, 31.12.2008, p.  1. 
3 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food 
additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and 
of the Council (OJ L 83, 22.3.2012, p. 1).  
4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1).  
5 Regulation (EU) No 528/2012 of the European Parli ament and of the Council of 22 May 2012 
concerning the making available on the market and use of biocidal products (OJ L 167 27.6.2012, p. 1 ).  
EN 2  EN accord ance with  Regulation (EC) No 1107/2009 of the European Parliame nt and of the 
Council6.   
(4) Regulation (EU) No 231/2012 provides  that ethylene oxide may not be used for 
sterilising purposes in food additives. However, there is no quantified limit for the 
presence of ethylene oxide regarding  all food additives. In accorda nce with that 
Regulation a limit of not more than 0 ,2 mg/kg of ethylene oxide is set out only for 
those food additives , in the production of which ethylene oxide is used . That limit was 
first established by Commission Directive 2003/95/EC7, based on the op inion of the 
Scientific Committee on Food of 6 May 20028, which concluded that whilst estimated 
intakes from the few food additives manufactured using ethylene oxide are very low, 
intakes from food sources should be as low as possible since ethylene oxide is both 
genotoxic and carcinogenic.  
(5) Recently, there have been several RASFF notifications concerning findings of 
ethylene oxide in a number of foodstuffs , and in particular in a number of food 
additives used for the manufacture of a variety of foodstuffs. On the basis of those 
notifications and information regarding official controls performed by Member States , 
Commission Implementing Regulation (EU) 2021/22469 established measures as 
regards goods of non -animal origin entering the Un ion from certain third countries  in 
order to protect human health in relation to the possible  risk of contamination with 
ethylene oxide . However, a s regards food additives, the enforcement of Union law 
may raise difficulties, because of it is difficult to establish whether the presence of 
ethylene oxide results from its use in the sterilisation of  the food additives in breach of 
Regulation No 231/2012 or f rom any other reason.  
(6) In order to avoid those difficulties and to ensure a high level of protection of human 
health, it is therefore appropriate to lay down that the presence of ethylene oxide, 
irrespective of its origin,  is not authorised for all food additives. For this purpo se, a 
maximum limit for residues of ethylene oxide specific for food additives should be set 
out at the limit of quantification in those products, that is, at the validated lowest 
residue concentration, which can be currently quantified and reported by rou tine 
monitoring with validated control methods . In order to ensure consistency with 
Regulation (EC) No 396/2005 of the European Parliament and of the Council10, in 
particular, with the limits it sets out for the raw materials used for the production of 
food additives, the residues of ethylene oxide should be defined  in the same terms as 
in that Regulation.  
                                                 
6 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the pl acing of plant protection products on the market and repealing Council Directives 
79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1 ). 
7 Commission Directive 2003/95/EC of 27 October 2003 amending Directive 96/77/EC laying down 
specific purity criteria on food additives other than colours and sweeteners (OJ L 283, 31.10.2003, p. 
71). 
8 Opinion of  the Scientific Committee on F ood on impurities of ethylene oxide in food additives, 17 April 
2002 . 
9 Commission Implementing Regulation (EU) 2021/2246 of 15 December 2021 amending Implementing 
Regulation (EU) 2019/1793 on the temporary increase of official controls and emergency measures 
governing the entry into the Union of certain goods from certain thi rd countries implementing 
Regulations (EU) 2017/625 and (EC) No 178/2002 of the European Parliament and of the Council (OJ 
L 453, 17.12.2021, p. 5).  
10 Regulation (EC) No 396/2005 of the European Parliament and of the Council  of 23 February 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).   
EN 3  EN (7) Bearing in mind that  the amendment of the specifications is not liable to have an y 
negative effect on human health , a safety evaluation by the European Fo od Safety 
Authority in accordance with Article 3(2) of Regulation (EC) No 1331/2008 is not 
necessary .  
(8) The Annex to Regulation (EU) No 231/2012 should therefore be amended 
accordingly.  
(9) The measures provided for in this Regulation are in accordance with the  opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
The Annex to Regulation (EU) No 231/2012 is ame nded in accordance with the Annex  to this 
Regulation.  
Article 2  
This Regulation shall enter into for ce on the twentieth day following 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,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN