ELI: http://data.europa.eu/eli/reg/2023/2379/oj 1/3COMMI SSION REGUL ATION (EU) 2023/2379 
of 29 September 2023
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 additiv e stear yl 
tartrate (E 483) 
(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) and Article 14 thereof,
Havi ng regard to 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 (2), 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 followi ng an application.
(3) Commission Regulation (EU) No 231/2012 (3)lays down specifi cations for food additives that are liste d in Annex II 
to Regulation (EC) No 1333/2008.
(4) Stea ryl tartrate (E 483) is a substance author ised in certain foods in accordance with Annex II to Regulation (EC) 
No 1333/2008.
(5) On 11 March 2020 , the European Food Safety Auth ority (‘the Author ity’) issued a scientifi c opinion on the 
re-evaluation of stear yl tartrate (E 483) as a food additive (4). The opinion stated that there was a lack of adequate 
toxicological data on stearyl tartrate. In addition, adequat e data that could allow read-across from data on other 
substances were lacking. Consequently , the Author ity was not able to conf irm the safety of stear yl tartrate as a food 
additive and concluded that the accepta ble daily intake (ADI) for this substance could not be conf irmed.
(6) On 19 Januar y 2021 , the Commission launched a public call for technical and scientifi c data on the permitted food 
additive stearyl tartrate (E 483), targe ting the data needs identif ied by the Authority. However , no business operator 
committed to provid e the request ed toxicological data for stearyl tartrate (E 483). Without those data, the Author ity 
cannot compl ete the re-evaluation of the safety of stearyl tartrate as a food additive. Theref ore, 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 theref ore appropr iate to remo ve stearyl tartrate (E 483) from the Union list of appro ved food additives.
(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 specificat ions 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)EFSA Journal 2020;18(3):6033.
Offi cial Jour nal  
of the European Union EN 
L series    
2023/2379  3.10.2023ELI: http://data.europa.eu/eli/reg/2023/2379/oj 2/3(8) Due to the absence of appropr iate toxicological data to conf irm the safety of stearyl tartrate (E 483) as a food 
additive, its inclusion in the list of author ised food additives can no long er be justif ied and stearyl tartrate (E 483) 
should be delet ed from the Union list of author ised food additives. Annex II to Regulation (EC) No 1333/2008 and 
the Annex to Regulation (EU) No 231/2012 should be amended according ly.
(9) In order to enable food business operat ors to find altern atives to stear yl tartrate (E 483), this Regulation should start 
to apply 6 months after the date of its entr y into force.
(10) It is also appropr iate to provide for a transitional period during which foods containing stearyl tartrate (E 483) that 
have been lawfully placed on the market before the date of application of this Regulation may continue to be 
mark eted.
(11) 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 II to Regulation (EC) 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 stear yl tartrate (E 483) that have been lawfully placed on the mark et before 23 Apr il 2024 may continue 
to be mark eted until their date of minimum durability or ‘use-b y date’.
Article 4
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
It shall apply from 23 Apr il 2024 .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 Septembe r 2023 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 3.10.2023 EN  ELI: http://data.europa.eu/eli/reg/2023/2379/oj 3/3ANNEX 
Annex II to Regulation (EC) No 1333/2008 is amended as follows :
(1) in Part B, in Table 3 ‘Additives other than colours and sweeteners’, the entr y for the food additive E 483 Stear yl tartrate 
is delet ed;
(2) Part E is amended as follows:
(a) in cate gory 01.4 (Flavour ed fermented milk products including heat-treat ed products), the entr y concer ning the 
food additive E 483 (Stearyl tartrate) is deleted;
(b) in cate gory 07.1 (Bread and rolls), the entr y concer ning the food additive E 483 (Stearyl tartrate) is deleted;
(c) in cate gory 07.2 (Fine baker y wares), the entr y concer ning the food additive E 483 (Stearyl tartrate) is delet ed;
(d) in catego ry 16 (Desser ts excl uding products covered in categor ies 1, 3 and 4), the entr y concer ning the food 
additive E 483 (Stearyl tartrate) is deleted.OJ L, 3.10.2023 EN