EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2017/1196  Rev1 
(POOL/E2/2017/1196/1196 -R1-EN.docx  
D092050/02  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) 2023/915 as regards maximum levels of T -2 and HT -2 toxins 
in food  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) 2023/915 as regards maximum levels of T -2 and HT -2 toxins 
in food  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Council Regulation (EEC) No  315/93 of 8  February 1993 laying down 
Community procedures for contaminants in food1, and in particular Article  2(3) thereof,  
Whereas:  
(1) Commission Regulation (E U) 2023 /9152 sets maximum levels for certain 
contaminants  in food.  
(2) T-2 and HT -2 toxin s are mycotoxins produced by various Fusarium  species.  T-2 toxin 
is rapidly metabolised to a large number of products, with HT-2 toxin being a major 
metabolite.  
(3) The European Food Safety Authority (‘the Authority’) adopted in 2011 a scientific 
opinion on the risks for animal and public health related to the presence of T -2 and 
HT-2 toxin s in food and feed3. The Authority established a gro up tolerable daily intake 
(TDI) of 0,1 µg/kg body weight ( bw) for the sum of T -2 and HT -2 toxins. Estimates of 
chronic human dietary exposure to the sum of T -2 and HT -2 toxins based on the 
available occurrence data were below the group -TDI for populations of all age groups, 
and thus not an immediate health concern.  
(4) Taking into account the conclusions of the 2011 scientific opinion, Commission 
Recommendation 2013/165/EU4 was adopted to collect more data on T -2 and HT -2 
toxin s in cereals and cereal products , to better  understand the year -to-year variation in 
occurrence  and to obtain more information on the influence of food processing (e. g. 
cooking) and agronomic factors on the presence of T -2 and HT -2 toxin s.  
(5) In 20 17, the Authority adopted a scientific opinion on the appropriateness to set a 
group health based guidance value for T -2 and HT -2 toxin s and their modified forms5. 
A group acute reference dose (ARfD) of 0 ,3 µg/kg bw for the sum of T-2 and HT -2 
toxin s and their modifi ed forms  was established . Additionally, a  group -TDI for the 
 
1 OJ L 37, 13.2.1993, p. 1.  
2 Commission Regulation (E U) 2023 /915 of 25 April 2023 on maximum levels for certain contaminants 
in food  and repealing Regulation (EC) No 1881/2006  (OJ L  119, 5.5.2023, p. 103 ).  
3 Scientific opinion on the risks for animal and public health related to the presence of T -2 and HT -2 
toxin in food and feed. EFSA Journal 2011;9(12):2481 , https://doi.org/ 10.2903/j.efsa.2011.2481 .     
4 Commission Recommendation 2013/165/EU  of 27  March 2013 on the presence of T -2 and HT -2 toxin 
in cereals and cereal products  (OJ L 91, 3.4.2013, p. 12) . 
5 Scientific opinion on the appropriateness to set a group health based guidance value for T2 and HT2 
toxin and its modified forms. EFSA Journal 2017;15(1):4655, https://doi.org/10.2903/j.efsa.2017.4655 .  
EN 2  EN sum of T -2 and HT -2 toxin s and their modified forms of 0,02 µg/kg bw was 
established replacing the previous group -TDI of 0,1 µg/kg bw.  
(6) Also in 2017, the Authority published a scientific report on the h uman and animal 
dietary exposure to T -2 and HT -2 toxin s6. Acute dietary exposure estimates in that 
report did not indicate an exceedance of the group ARfD  established by the Authority . 
However , certain chronic dietary exposure scenarios exceed ed the group -TDI in 
infants, toddlers and other children, and at high exposures also in adolescents, 
indicating a potential health concern . 
(7) In order to ensure a high level of public health protection, i t is therefore appropriate to  
establish maximum levels concerning the presence in food of T-2 and HT -2 toxin s 
taking into account the most recent occurrence data. However, since  there are very 
limited occurrence data available on the presence of the modified forms  of T-2 and 
HT-2 toxi ns and no routine method for their analysis is available , the maximum levels 
are established at this time only for the sum of T -2 and HT -2 toxin s.   
(8) In order to ensure that good agricultural practices are applied to minimize the presence 
of T-2 and HT-2 toxin s in cereals , it is important to lay down a maximum level for 
unprocessed cereals. As unprocessed oats , before milling or before being used in 
cereal products placed on the market for the final consumer , are placed on the market 
with the husk, th e maximum level for T -2 and HT -2 toxin s in unprocessed oat  grain s 
should apply to the unprocessed oat  grain s with the husk included, even if the husk is 
inedible.  
(9) As the levels of occurrence of T -2 and HT -2 toxins are the highest in oat   grains, it is 
important that additional efforts are made  to further lower the presence of T -2 and HT -
2 toxins in oat grains and that the Commission is informed of the progress made and of 
the new occurrence data with the aim to lower in the future the maximum level for T -2 
and HT-2 toxins in oat grains and oat grain products.   
(10) Regulation (E U) 2023 /915 should therefore be amended accordingly.  
(11) It is appropriate to provide for a transitional period for food lawfully  placed on the 
market before the date of application of this Regulation  taking into account that certain 
foods covered by this Regulation have a long shelf life .  
(12) To enable economic operators to prepare for the new rules introduced by this 
Regulation, it i s appropriate to provide for a reasonable time until the new maximum 
levels apply .  
(13) 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  
Regulation (E U) 2023/915  is amended as follows:  
(1) in Article 8, the following paragraph 5 is added:  
 
6 Scientific report on human and animal dietary exposure to T -2 and HT -2 toxin. EFSA Journal 
2017;15(8):4972, https://doi.org/10.2903/j.efsa.2017.4972 .   
EN 3  EN ‘5. Member States and interested parties shall communicate by 1 January 202 8 to 
the Commission the results of investigations undertaken and progress made 
with regard to the application of prevention measures to reduce contamination 
by T-2 and HT -2 toxin s in oats and oat products.  
Member States and interested parties shall report o n a regular basis to the 
Authority  the occurrence data on T -2 and HT -2 toxin s in oats and oat 
products. ’; 
(2) Annex I is amended in accordance with the Annex to this Regulation.  
 
Article 2   
Food listed in the Annex , lawfully placed on the market before 1 July 2024, may remain on 
the market  until their date of minimum durability or use -by date.   
Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journ al of the European Union . 
It shall apply from 1 July 2024.  
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