COMMISSION REGULATION (EU) 2024/1756

of 25 June 2024

amending and correcting Regulation (EU) 2023/915 on maximum levels for certain contaminants 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. The experience gained since the entry into force of that Regulation has revealed a lack of clarity of some points in the table of Annex I to that Regulation. It has thus become necessary to clarify those points.

(2)

In the absence of specific rules on sampling and analysis for the control of maximum levels for ergot sclerotia in unprocessed cereal grains except unprocessed rye grains, point 1.8.1 of the table of Annex I to Regulation (EU) 2023/915 provides that such sampling and analysis are to be performed in accordance with part B of Annex I to Commission Regulation (EC) No 401/2006 (3). Since in the meantime specific rules on sampling and analysis for the control of maximum levels for ergot sclerotia have been laid down by Commission Implementing Regulation (EU) 2023/2782 (4), the reference to Regulation (EC) No 401/2006 in point 1.8.1 of the table of Annex I to Regulation (EU) 2023/915 should be deleted.

(3)

Point 1.9.5 of the table of Annex I to Regulation (EU) 2023/915 sets out a maximum level for T-2 and HT-2 toxins in bakery wares containing at least 90 % milling products of oats. This maximum level is intended to apply to bakery wares with a high content of oats. However, based on experience with the composition of food available on the market, in many cases bakery products with a high content of oats, such as oat cakes, contain less than 90 % milling products of oats, normally between 75 % and 85 %. Therefore, point 1.9.5 of the table of Annex I to Regulation (EU) 2023/915 should be amended accordingly.

(4)

In the absence of specific rules on sampling and analysis for the control of maximum levels for tropane alkaloids in baby food and processed cereal-based food for infants and young children, point 2.2.1 of the table of Annex I to Regulation (EU) 2023/915 provides that such sampling and analysis are to be performed in accordance with part J of Annex I to Regulation (EC) No 401/2006. Since in the meantime specific rules on sampling and analysis for the control of maximum levels for tropane alkaloids have been laid down by Commission Implementing Regulation (EU) 2023/2783 (5), the reference to Regulation (EC) No 401/2006 in point 2.2.1 of the table of Annex I to Regulation (EU) 2023/915 should be deleted.

(5)

To ensure consumer safety, the maximum level for hydrocyanic acid in linseed placed on the market for the final consumer laid down in point 2.3.2 of the table of Annex I to Regulation (EU) 2023/915 should be applicable independently of the processing stage of the linseed. That point should therefore be amended accordingly.

(6)

As unprocessed oats before milling are placed on the market with the husk, the maximum level for contaminants in unprocessed oats set out in points 1.2.9 and 1.5.1 of the table of Annex I to Regulation (EU) 2023/915 should apply to unprocessed oats with the husk included, even if the husk is inedible.

(7)

Regulation (EU) 2023/915 aims to lay down maximum contaminant levels for unprocessed cereals placed on the market at the stage just before first-stage processing. As the current wording is not precise enough, that wording should therefore be corrected in the relevant entries in the table of Annex I to Regulation (EU) 2023/915.

(8)

For ochratoxin A, a maximum level is established in point 1.2.10 of the table of Annex I to Regulation (EU) 2023/915 for products derived from unprocessed cereal grains except products listed in other entries and for cereals placed on the market for the final consumer. The relevant point lacks clarity. To avoid any misunderstanding, the relevant point should be corrected to clarify that the wording ‘placed on the market for the final consumer’ refers only to ‘cereals’ and not to ‘products derived from unprocessed cereal grains’.

(9)	Rice products are excluded from certain food listed in Annex I to Regulation (EU) 2023/915. In order to clarify the scope of this exclusion, the content of the rice products should be defined in the relevant points in the table of Annex I to Regulation (EU) 2023/915.

(10)

For zearalenone, a maximum level is established in point 1.5.3 of the table of Annex I to Regulation (EU) 2023/915 for cereals placed on the market for the final consumer, cereal flour, semolina, bran and germ as final product placed on the market for the final consumer except products listed in other entries. The relevant point lacks clarity. To avoid any misunderstanding, the relevant point should be corrected to clarify that the wording ‘placed on the market for the final consumer’ refers only to ‘cereals, bran and germ’ and not to ‘cereal flour and semolina’.

(11)

The wording of the exception in point 2.3.1 of the table of Annex I to Regulation (EU) 2023/915 to the maximum levels for hydrocyanic acid in oilseeds for crushing and oil refining should be aligned with the wording of the exception to the maximum levels for aflatoxins in groundnuts (peanuts) and other oilseeds for crushing for refined vegetable oil production set out in point 1.1.4 of that table. Point 2.3.1 of the table in Annex I to Regulation (EU) 2023/915 should therefore be corrected accordingly.

(12)

To resolve possible ambiguity and improve the enforcement of maximum levels for dioxins and polychlorinated biphenyls (PCBs) in certain products of animal origin, the wording of the remarks concerning these products in section 4 of the table of Annex I to Regulation (EU) 2023/915 should be corrected.

(13)	In order to ensure the consistent enforcement of maximum levels for dioxins and PCBs in venison, a clarification of the animal species from which the meat originates should be added in point 4.1.1.8 of the table of Annex I to Regulation (EU) 2023/915.

(14)

There have been inconsistencies in the enforcement of the maximum levels for polycyclic aromatic hydrocarbons in certain products for infants and young children established by Regulation (EU) 2023/915. To avoid such inconsistencies, a distinction should be drawn between products placed on the market as powder and products placed on the market as liquid.

(15)	Dehulling is the process of removing the hull of a seed and it is considered to be part of the cleaning process. To avoid that dehulling may be considered to be part of first-stage processing, note 6 to the table of Annex I to Regulation (EU) 2023/915 should be corrected accordingly.

(16)	Regulation (EU) 2023/915 should therefore be amended and corrected accordingly.

(17)	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 I to Regulation (EU) 2023/915 is amended in accordance with Part A of the Annex to this Regulation.

Article 2

Annex I to Regulation (EU) 2023/915 is corrected in accordance with Part B of the Annex to this Regulation.

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.

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

Done at Brussels, 25 June 2024.

For the Commission

The President

Ursula VON DER LEYEN

(1) OJ L 37, 13.2.1993, p. 1, ELI: http://data.europa.eu/eli/reg/1993/315/oj.

(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, ELI: http://data.europa.eu/eli/reg/2023/915/oj).

(3) Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs (OJ L 70, 9.3.2006, p. 12, ELI: http://data.europa.eu/eli/reg/2006/401/oj).

(4) Commission Implementing Regulation (EU) 2023/2782 of 14 December 2023 laying down the methods of sampling and analysis for the control of the levels of mycotoxins in food and repealing Regulation (EC) No 401/2006 (OJ L, 2023/2782, 15.12.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2782/oj).

(5) Commission Implementing Regulation (EU) 2023/2783 of 14 December 2023 laying down the methods of sampling and analysis for the control of the levels of plant toxins in food and repealing Regulation (EU) 2015/705 (OJ L, 2023/2783, 15.12.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2783/oj).

ANNEX

PART A

Annex I to Regulation (EU) 2023/915 is amended as follows:

in the table, in section 1 (mycotoxins), in the entry for ergot sclerotia and ergot alkaloids, point 1.8.1 is replaced by the following:

‘1.8.1

Ergot sclerotia

Maximum level (g/kg)

Remarks

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

In case scouring (6) is applied in the presence of ergot sclerotia, the cereals shall first undergo a cleaning step before scouring.’

in the table, in section 1 (mycotoxins), in the entry for T-2 and HT-2 toxins, point 1.9.5 is replaced by the following:

‘1.9.5

Bakery wares containing at least 75 % milling products of oats

100

Including small bakery wares.’

in the table, in section 2 (plant toxins), in the entry for tropane alkaloids, point 2.2.1 is replaced by the following:

‘2.2.1

Baby food and processed cereal-based food for infants and young children (3), containing millet, sorghum, buckwheat, maize or their derived products

1,0

Derived products relate to products containing at least 80 % these cereal products.

The maximum level applies to the product as placed on the market.’

in the table, in section 2 (plant toxins), in the entry for hydrocyanic acid, including hydrocyanic acid bound in cyanogenic glycosides, point 2.3.2 is replaced by the following:

‘2.3.2

Whole, ground, milled, cracked, chopped linseed placed on the market for the final consumer

150

The maximum level does not apply to whole, ground, milled, cracked, chopped linseed placed on the market for the final consumer in small quantities where the warning “Only to be used for cooking and baking. Do not consume raw!” appears in the principal field of vision of the label (using the specific font size (11)). The whole, ground, milled, cracked, chopped linseed with the warning message shall comply with the maximum level provided for in 2.3.1.’

PART B

Annex I to Regulation (EU) 2023/915 is corrected as follows:

in the table, in section 1 (mycotoxins), in the entry for ochratoxin A, points 1.2.9 and 1.2.10 are replaced by the following:

‘1.2.9

Unprocessed cereal grains

5,0

The maximum level applies to unprocessed cereal grains (in case of oats, grains with husk) placed on the market for first-stage processing (6).

1.2.10

Cereals placed on the market for the final consumer

Products derived from unprocessed cereal grains except products listed in 1.2.11, 1.2.12, 1.2.13, 1.2.23 and 1.2.24

3,0

Including processed cereal products.

Products derived from unprocessed cereal grains relate to products containing at least 80 % cereal products.’

in the table, in section 1 (mycotoxins), the entry for deoxynivalenol is corrected as follows:

(a)

point 1.4.7 is replaced by the following:

‘1.4.7

Bakery wares, cereal snacks and breakfast cereals

400

Except rice products (products of which rice or processed products from rice are the only cereal ingredients).

Including small bakery wares.’

(b)

points 1.4.9 and 1.4.10 are replaced by the following:

‘1.4.9

Baby food and processed cereal-based food for infants and young children (3)

150

Except rice products (products of which rice or processed products from rice are the only cereal ingredients).

The maximum level applies to the dry matter (5) of the product as placed on the market.

1.4.10

Food for special medical purposes intended for infants and young children (3)

150

Except rice products (products of which rice or processed products from rice are the only cereal ingredients).

The maximum level applies to the dry matter (5) of the product as placed on the market.’

in the table, in section 1 (mycotoxins), the entry for zearalenone is corrected as follows:

(a)

points 1.5.1 to 1.5.4 are replaced by the following:

‘1.5.1	Unprocessed cereal grains except products listed in 1.5.2	100	Except unprocessed maize grains intended to be processed by wet milling and except rice. The maximum level applies to unprocessed cereal grains (in case of oats, grains with husk) placed on the market for first-stage processing (6).
1.5.2	Unprocessed maize grains	350	Except unprocessed maize grains for which it is evident, e.g. through their 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 placed on the market for first-stage processing (6).
1.5.3	Cereals, bran and germ placed on the market for the final consumer Cereal flour and semolina Except products listed in 1.5.5, 1.5.6 and 1.5.8	75	Except rice and rice products (products of which rice or processed products from rice are the only cereal ingredients).
1.5.4	Bread, pastries, biscuits, cereal snacks and breakfast cereals except products listed in 1.5.5	50	Except rice products (products of which rice or processed products from rice are the only cereal ingredients). Includes small bakery wares.’

(b)

point 1.5.8 is replaced by the following:

‘1.5.8

Baby food and processed cereal-based food for infants and young children (3)

Except rice products (products of which rice or processed products from rice are the only cereal ingredients).

The maximum level applies to the dry matter (5) of the product as placed on the market.’

in the table, in section 1 (mycotoxins), in the entry for fumonisins, point 1.6.1 is replaced by the following:

‘1.6.1

Unprocessed maize grains

4 000

Except unprocessed maize grains for which it is evident, e.g. through their 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 placed on the market for first-stage processing (6).’

in the table, in section 1 (mycotoxins), the entry for T-2 and HT-2 toxins is corrected as follows:

(a)

point 1.9.4 is replaced by the following:

‘1.9.4

Bakery wares except products listed in 1.9.5, pasta, cereal snacks and breakfast cereals except products listed in 1.9.6, 1.9.7 and 1.9.8

Except rice products (products of which rice or processed products from rice are the only cereal ingredients).

Including small bakery wares.

Pasta means pasta (dry) with a water content of approximately 12 %.’

(b)

points 1.9.9 and 1.9.10 are replaced by the following:

‘1.9.9

Baby food and processed cereal-based food for infants and young children (3)

Except rice products (products of which rice or processed products from rice are the only cereal ingredients).

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 children (3)

Except rice products (products of which rice or processed products from rice are the only cereal ingredients).

The maximum level applies to the dry matter (5) of the product as placed on the market.’

in the table, in section 2 (plant toxins), in the entry for tropane alkaloids, points 2.2.2 to 2.2.4 are replaced by the following:

‘2.2.2

Unprocessed millet grains and sorghum grains

5,0

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

2.2.3

Unprocessed maize grains

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

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

2.2.4

Unprocessed buckwheat grains

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

in the table, in section 2 (plant toxins), in the entry for hydrocyanic acid, including hydrocyanic acid bound in cyanogenic glycosides, point 2.3.1 is replaced by the following:

‘2.3.1

Unprocessed whole, ground, milled, cracked, chopped linseed not placed on the market for the final consumer

250

The maximum level does not apply to oilseeds for crushing for refined vegetable oil production, provided that the remaining pressed oilseeds are not placed on the market as food. In case the remaining pressed oilseeds are placed on the market as food, the maximum level applies taking into account Article 3(1) and (2).’

in the table, in section 4 (halogenated persistent organic pollutants), the entry for dioxins and PCBs is corrected as follows:

(a)

point 4.1.1 is replaced by the following:

‘4.1.1

Meat and meat products except edible offal and products listed in 4.1.3 and 4.1.4 (2)

The maximum level expressed on fat does not apply to food containing less than 2 % fat. For food containing less than 2 % fat, the maximum level applies on a product basis.

This maximum level is calculated using this formula:

Maximum level expressed on a product basis (for food containing less than 2 % fat) = maximum level expressed on fat (for that food) × 0,02.’

(b)

point 4.1.1.8 is replaced by the following:

‘4.1.1.8

of Cervidae

3,0 pg/g fat

7,5 pg/g fat

-’

(c)

points 4.1.11 and 4.1.12 are replaced by the following:

‘4.1.11

Raw milk (2) and dairy products (2)

2,0 pg/g fat

4,0 pg/g fat

40 ng/g fat

Including butter fat.

The maximum level expressed on fat does not apply to food containing less than 2 % fat. For food containing less than 2 % fat, the maximum level applies on a product basis.

This maximum level is calculated using this formula:

Maximum level expressed on a product basis (for food containing less than 2 % fat) = maximum level expressed on fat (for that food) × 0,02.

4.1.12

Eggs and egg products except goose eggs (2)

2,5 pg/g fat

5,0 pg/g fat

40 ng/g fat

The maximum level expressed on fat does not apply to food containing less than 2 % fat. For food containing less than 2 % fat, the maximum level applies on a product basis.

This maximum level is calculated using this formula:

Maximum level expressed on a product basis (for food containing less than 2 % fat) = maximum level expressed on fat (for that food) × 0,02.’

in the table, in section 5 (processing contaminants), the entry for polycyclic aromatic hydrocarbons (PAHs) is corrected as follows:

(a)

point 5.1.13 is replaced by the following:

‘5.1.13	Infant formulae, follow-on formulae (3) and young-child formulae (4)			The maximum level applies to the product as placed on the market.
5.1.13.1	placed on the market as powder	1,0	1,0
5.1.13.2	placed on the market as liquid	1,0	1,0’

(b)

point 5.1.15 is replaced by the following:

‘5.1.15	Food for special medical purposes intended for infants and young children (3)			The maximum level applies to the product as placed on the market.
5.1.15.1	placed on the market as powder	1,0	1,0
5.1.15.2	placed on the market as liquid	1,0	1,0’

10.

note 6 to the table is replaced by the following:

‘(6)

First stage processing means any physical or thermal treatment, other than drying, of or on the grain. Cleaning, including scouring, dehulling, sorting (colour sorting where applicable) and drying procedures are not considered to be “first-stage processing” insofar as the whole grain remains intact after cleaning and sorting. Scouring means cleaning cereal by brushing and/or scrubbing it vigorously, combined with dust removal (e.g. aspiration). The scouring may be followed by a colour sorting before milling.’.