EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/2257 Rev.1 
(PLAN/E2/2023/2257/2257R1 -EN.docx) 
D094934/03  
[…](2024) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II and Annex III to Regulation (EC) No 1333/2008 of the European 
Parliament and of the Council as regards the food additives tartaric acid (L(+) -) (E 334), 
sodium tartrates (E 335), potassium tartrates (E 336), sodium potassium tartrate (E 3 37) 
and calcium tartrate (E 354)  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II and Annex III to Regulation (EC) No 1333/2008 of the European 
Parliament and of the Council as regards the food additives tartaric acid (L(+) -) (E 334), 
sodium tartrates (E 335), potassium tartrates (E 336), sodium potassium tartrate (E 337) 
and calcium tartrate (E 354)  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the Eu ropean 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)  thereof,  
Having regard to Regulation (EC) No 1331/2008 of the European Parlia ment 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) Annex II to Regulation (EC) No 1333/2008 lays down a Union l ist of food additives 
approved for use in foods and their conditions of use. Annex III to Regulation (EC) No 
1333/2008 lays down a Union list of food additives including carriers approved for use 
in food additives, food enzymes, food flavourings, nutrients  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) Tartaric acid (L(+) -) (E 334), sodium tartrates  (E 335), potassium tartrates (E 336), 
sodium  potassium tartrate (E 337)  and calcium tartrate (E 354) are substances 
authorised in accordance with Regulation (EC) No 1333/2008. Th ose food additives 
are currently authorised for use at quantum satis  and included in Group I , in Annex II, 
Part C of that Regulation , which covers food additives, other than colours and 
sweeteners, with an ‘acceptable daily intake not specified’ or for which the most 
recent risk assessment concluded that ‘there is no need for a numerical acceptable 
daily intake ’. In addition, tartaric acid (L(+) -) (E 334), sodium tartrates (E 335), 
potassium tartrates (E 336), sodium potassium  tartrate (E 337) and calcium tartrate (E 
354) are authorised for use in specific food categories w ith a numerical maximum 
level or at quantum satis .  
(4) On 11 March 2020, the European Food Safety Authority ( ‘the Authority ’) issued a 
scientific opinion on the re -evaluation of tartaric acid (L(+) -) (E 334), sodium tartrates 
 
1 OJ L 354, 31.12. 2008, p. 16 , ELI:  http://data.europa.eu/eli/reg/2008/1333/oj . 
2 OJ L 354, 31.12.2008, p. 1 , ELI:  http://data.europa.eu/eli/reg/2008/1331/oj .  
EN 2  EN (E 335), potassium tartrates (E 3 36), potassium sodium tartrate (E 337) and calcium 
tartrate (E 354) as food additives3. A group acceptable daily intake (ADI) was 
established for tartaric acid -tartrates (E 334 - 337 and E 354) of 240 mg/kg bw per 
day, expressed as tartaric acid. The expo sure estimates for the different population 
groups for the most relevant exposure scenario did not exceed the group ADI of 240 
mg/kg bw per day, expressed as tartaric acid.  
(5) On 19 January 2021, the Commission launched a public call for technical data on th e 
permitted food additives tartaric acid (L(+) -) (E 334), sodium tartrates (E 335), 
potassium tartrates (E 336), sodium potassium  tartrate (E 337) and calcium tartrate (E 
354), requesting food business operators to submit, among other  thing s, data on the 
uses of th ose food additives in accordance with Annex II, Part E and Annex III, Parts 
2, 3 and 4 and Section A of Part 5 of Regulation (EC) No 1333/2008. The call 
specified that in the absence of data for a food category in which the intentional use of 
those food additives is currently authorised, the Commission would consider that there 
is no interest that the food additives remain authorised in th at food category and that 
consequently the respective authorisation would be withdrawn.   
(6) Business operators pr ovided data on the uses of th ose food additives in accordance 
with Annex II, Part E of Regulation (EC) No 1333/2008 for several, but not all, food 
categories.  
(7) Business operators provided data on the uses of th ose food additives in accordance 
with Annex III, Parts 2 and 4 and Section A of Part 5 of Regulation (EC) No 
1333/2008. However, no data were provided for uses in accordance with Annex III, 
Part 3.  
(8) Taking into account the re -evaluation by the Authority, in particular, the establishment 
of a gr oup ADI for tartaric acid (L(+) -) (E 334), sodium tartrates (E 335), potassium 
tartrates (E 336), sodium potassium  tartrate (E 337) and calcium tartrate (E 354), it is 
appropriate to remove those food additives from Group I, create a new group for the m 
and review their conditions of use. Furthermore, g iven the provided data on the uses of 
those food additives in accordance with Annex II and Annex III to Regulation (EC) 
No 1333/2008, it is appropriate to amend the current conditions of use of th ose food 
additives by withdrawing the authorisations in food categories for which no data were 
provided in response to the call for data . Moreover, given those provided data on the 
uses and the dietary exposure calculated by the Authority, it is appropriate to establis h 
numerical maximum use levels for food categories for which data were provided. It is 
also appropriate to remove some inconsistencies as regards the conditions of use of 
tartaric acid (L(+) -) (E 334), sodium tartrates (E 335), potassium tartrates (E 336)  in 
different categories.  
(9) The application of new maximum levels should be deferred, and a transitional period 
should be provided for products placed on the market before the date of application of 
the respective maximum levels to allow the food business ope rators, including small 
and medium enterprises, to adapt to the new conditions of use laid down in this 
Regulation.  
(10) Regulation (EC) No 1333/2008 should therefore be amended accordingly.  
(11) The measures provided for in this Regulation are in accordance with t he opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
 
3 EFSA Journal 2020;18(3):6030.   
EN 3  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this 
Regulation.  
Article 2  
Annex III to Regulation (EC) No 1333/2008 is amended in accordance with Annex II to this 
Regulation.  
Article 3  
Foods containing tartaric acid (L(+) -) (E 334), sodium tartrates (E 335), potassium tartrates (E 
336), sodium potassium tartrate (E 337) or calcium tartrate (E 354) that do not comply with 
this Regulation and  have been lawfully placed on the market before … [ 6 months after the 
date of entry into force  of this Regulation ] may remain on the market 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  of this Regulation ]. 
This Regulation shall be bi nding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN