Commission Regulation (EU) 2024/1038 of 9 April 2024 amending Regulation (EU) 2023/915 as regards maximum levels of T-2 and HT-2 toxins in food

Official Journal EN of the European Union L series 2024/1038 10.4.2024 COMMISSION REGULATION (EU) 2024/1038 of 9 April 2024 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 food(1), and in particular Article 2(3) thereof,

Whereas:

(1) Commission Regulation (EU) 2023/915(2)sets maximum levels for certain contaminants in food.

(2) T-2 and HT-2 toxins 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 toxins in food and feed(3). The Authority established a group 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/EU(4) was adopted to collect more data on T-2 and HT-2 toxins 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 toxins.

(5) In 2017, the Authority adopted a scientific opinion on the appropriateness to set a group health based guidance value for T-2 and HT-2 toxins and their modified forms(5). A group acute reference dose (ARfD) of 0,3 μg/kg bw for the sum of T-2 and HT-2 toxins and their modified forms was established. Additionally, a group-TDI for the sum of T-2 and HT-2 toxins 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 human and animal dietary exposure to T-2 and HT-2 toxins(6). 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 exceeded the group-TDI in infants, toddlers and other children, and at high exposures also in adolescents, indicating a potential health concern.

(1) OJ L 37, 13.2.1993, p. 1.

(2) Commission Regulation (EU) 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).

(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).

ELI: http://data.europa.eu/eli/reg/2024/1038/oj 1/5EN OJ L, 10.4.2024

(7) In order to ensure a high level of public health protection, it is therefore appropriate to establish maximum levels concerning the presence in food of T-2 and HT-2 toxins 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 toxins 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 toxins.

(8) In order to ensure that good agricultural practices are applied to minimise the presence of T-2 and HT-2 toxins 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, the maximum level for T-2 and HT-2 toxins in unprocessed oat grains should apply to the unprocessed oat grains 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 (EU) 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 is 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 (EU) 2023/915 is amended as follows:

(1) in Article 8, the following paragraph 5 is added: ‘5. Member States and interested parties shall communicate by 1 January 2028to 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 toxins in oats and oat products.

Member States and interested parties shall report on a regular basis to the Authority the occurrence data on T-2 and HT-2 toxins 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.

2/5 ELI: http://data.europa.eu/eli/reg/2024/1038/ojEN OJ L, 10.4.2024 Article 3 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 1 July 2024.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 9 April 2024.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg/2024/1038/oj 3/5ANNEX In Section 1 (Mycotoxins) of Annex I to Regulation (EU) 2023/915, the following entry 1.9 (T-2 and HT-2 toxins) is added: ‘1.9 T-2 and HT-2 toxins Maximum level (μg/kg) Remarks Sum of T-2 and HT-2 toxins For the sum of T-2 and HT-2 toxins, maximum levels refer to lower bound concentrations, which are calculated on the assumption that all the values below the limit of quantification are zero.

1.9.1 Unprocessed cereal grains except products listed in 1.9.1.1, 50 Except unprocessed maize grains intended to be processed by wet

1.9.1.2, 1.9.1.3 and 1.9.1.4 milling and except rice.

The maximum level applies to unprocessed cereal grains placed on the market for first-stage processing (6).

1.9.1.1 Unprocessed malting barley grains 200 The maximum level applies to unprocessed malting barley grains placed on the market for first-stage processing (6).

1.9.1.2 Unprocessed barley grains other than malting barley grains 150 The maximum level applies to unprocessed barley grains placed on the market for first-stage processing (6).

1.9.1.3 Unprocessed maize grains and unprocessed durum wheat grains 100 Except unprocessed maize grains for which it is evident, e.g. through labelling or destination, that they are intended for use in a wet milling process only (starch production).

The maximum level applies to unprocessed maize grains and unpro­ cessed durum wheat grains placed on the market for first-stage pro­ cessing (6).

1.9.1.4 Unprocessed oat grains with inedible husk 1 250 The maximum level applies to unprocessed oat grains with husk placed on the market for first-stage processing (6).

The maximum level applies to the oat grains with the inedible husk included.

1.9.2 Cereals placed on the market for the final consumer except pro­ 20 Except rice. ducts listed in 1.9.2.1 and 1.9.2.2

1.9.2.1 Oats placed on the market for the final consumer 100

1.9.2.2 Barley, maize and durum wheat placed on the market for the final 50 consumer 4/5

ELI:

http://data.europa.eu/eli/reg/2024/1038/oj EN OJ L,

10.4.20241.9.3 Milling products of cereals except products listed in 1.9.3.1 20 Except milling products of rice. and 1.9.3.2

1.9.3.1 Milling products of oats (including oat bran) 100

1.9.3.2 Bran from cereals other than oats and milling products of maize 50

1.9.4 Bakery wares except products listed in 1.9.5, pasta, cereal snacks 20 Except rice products. and breakfast cereals except products listed in 1.9.6, 1.9.7 Including small bakery wares. and 1.9.8 Pasta means pasta (dry) with a water content of approximately 12 %.

1.9.5 Bakery wares containing at least 90 % milling products of oats 100 Except rice products.

Including small bakery wares.

1.9.6 Oat flakes 100

1.9.7 Breakfast cereals consisting of at least 50 % of cereal bran, milling 50 products of oat grains, milling products of maize grains, whole oat grains, barley grains, maize grains or durum wheat grains, and consisting of less than 40 % of milling products of oat grains and whole oat grains

1.9.8 Breakfast cereals consisting of at least 50 % of cereal bran, milling 75 products of oat grains, milling products of maize grains, whole oat grains, barley grains, maize grains or durum wheat grains, and of at least 40 % of milling products of oat grains and whole oat grains

1.9.9 Baby food and processed cereal-based food for infants and young 10 Except rice products. children (3) The maximum level applies to the dry matter (5) of the product as placed on the market.

1.9.10 Food for special medical purposes intended for infants and young 10 Except rice products. children (3) The maximum level applies to the dry matter (5) of the product as placed on the market.’

ELI:

http://data.europa.eu/eli/reg/2024/1038/oj 5/5 OJ L,

10.4.2024 EN