EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/2865  Rev1 
(POOL/E2/2022/2865/2865R1 -EN.docx) 
D089305/03  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards the 
food additive stearyl tartrate (E 483)  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards the 
food additive stearyl tartrate (E 483)  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning 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 10(3) and Article 
14 thereof , 
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the 
Council of 1 6 December 2008 establishing a common authorisation procedure for food 
additives, food enzymes and food flavourings2, and in particular Article 7(5) thereof,  
Whereas:  
(1) Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives 
approved for use in foods and their conditions of use.  
(2) Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food 
additives may be updated either on the initiative of the Commission or following an 
application  
(3) Commission Regulation  (EU) No 231/20123 lays down specifications for food 
additives that are listed in Annex II to Regulation (EC) No 1333/2008.  
(4) Stearyl tartrate (E 483) is a substance authorised in certain foods in accordance with 
Annex II to Regulation (EC) No 1333/2008.  
(5) On 11 March 2020, the European Food Safety Authority (‘the Authority ’) issued  a 
scientific opinion on the re -evaluation of stearyl tartrate  (E 483) as a food additive4. 
The opinion stated that there was a lack of adequate toxicological data on stearyl 
tartrate . In addition, adequate data that could allow read -across from data on other 
substances were lacking. Consequently, the Authority was not able to confirm the 
safety of stearyl tartrate  as a food additive and concluded that the acceptable daily 
intake (ADI)  for this substance could not be confirmed . 
(6) On 19 January 2021, the Commission launched a public call for technical  and 
scientific  data on the permitted food additive stearyl tartrate  (E 483), targeting the data 
                                                 
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 Regulati on (EC) No 1333/2008 of the European Parliament and 
of the Council (OJ L 83, 22.3.2012, p. 1).  
4 EFSA Journal 2020;18(3):6033 .  
EN 2  EN needs identified by the Authority . However, no business operator committed to 
provide the requested toxicological data for stearyl tartrate  (E 483). Without those 
data, the Authority cannot complete the re -evaluation of the safety of stearyl tartrate  as 
a food additive . Therefore,  it cannot  be determined whether this substance still fulfils 
the conditions pursuant to Article 6(1) of Regulation (EC) No 1333/2008 for inclusion 
in the Union list of approved food additives.  
(7) It is therefore appropriate to remove stearyl tartrate  (E 483) from the Union list of 
approved food additives.   
(8) Due to the absence of appropriate toxicological data  to confirm the safety of stearyl 
tartrate (E 483)  as a food additive , its inclusion in the list of authorised food additives 
can no longer be justified and stearyl  tartrate ( E 483) should be deleted from the Union 
list of authorised food additives. Annex II to Regulation (EC) No 1333/2008 and the 
Annex to Regulation (EU) No 231/2012 should be amended accordingly .  
(9) In order to enable food business operators to find a lternatives to stearyl tartrate (E 
483), this Regulation should start to apply six months after the date of its entry into 
force.  
(10) It is also appropriate to provide for a transitional period during which foods containing 
stearyl tartrate (E 483) that have b een lawfully placed on the market before the date of 
application  of this Regulation  may continue to be marketed.   
(11) 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  
Annex  II to Regulation (E C) No 1333 /2008 is amended in accordance with the Annex  to this 
Regulation.  
Article 2  
In the Annex to Regulation (EU) No 231/2012, the entr y for the food additive  stearyl tartrate 
(E 483) is deleted . 
Article 3 
Foods containing stearyl tartrate (E 483) that have been lawfully placed on the market before  
… [6 month s after the date of entry into force ] may continue to be marketed until their date of 
minimum durability or ‘use-by date ’. 
Article 4 
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from  … [6 months after the date of entry into force ]. 
This Regulation shall be binding in its entirety and directly applicable in all Member States.   
EN 3  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN