# L_2022206EN.01001101.xml

| 8.8.2022 | EN | Official Journal of the European Union | L 206/11 |
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8.8.2022

EN

Official Journal of the European Union

L 206/11

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COMMISSION REGULATION (EU) 2022/1370

of 5 August 2022

amending Regulation (EC) No 1881/2006 as regards maximum levels of ochratoxin A in certain foodstuffs

(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 (EC) No 1881/2006 (2) sets maximum levels for certain contaminants, including ochratoxin A, in foodstuffs. |
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(1)

Commission Regulation (EC) No 1881/2006 (2) sets maximum levels for certain contaminants, including ochratoxin A, in foodstuffs.

| (2) | Ochratoxin A is a mycotoxin naturally produced by fungi of the genus Aspergillus and Penicillium and is found as a contaminant in a wide variety of foods, such as cereals and cereal products, coffee beans, dried fruits, wine and grape juice, spices and liquorice. Ochratoxin A is formed during sun drying and storage of crops. The formation can be prevented by applying good drying and storage practices. |
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(2)

Ochratoxin A is a mycotoxin naturally produced by fungi of the genus Aspergillus and Penicillium and is found as a contaminant in a wide variety of foods, such as cereals and cereal products, coffee beans, dried fruits, wine and grape juice, spices and liquorice. Ochratoxin A is formed during sun drying and storage of crops. The formation can be prevented by applying good drying and storage practices.

| (3) | In 2020, the European Food Safety Authority (‘the Authority’) adopted an update of the scientific opinion on ochratoxin A in food (3). The Authority considered that it was not appropriate to establish a health based guidance value for ochratoxin A and that the Tolerable Weekly Intake of 120 ng/kg body weight (bw) as established by the Authority in 2006 is consequently no longer valid. It further concluded that the calculated margins of exposure for carcinogenic effects of ochratoxin A indicate a possible health concern for certain consumer groups. |
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(3)

In 2020, the European Food Safety Authority (‘the Authority’) adopted an update of the scientific opinion on ochratoxin A in food (3). The Authority considered that it was not appropriate to establish a health based guidance value for ochratoxin A and that the Tolerable Weekly Intake of 120 ng/kg body weight (bw) as established by the Authority in 2006 is consequently no longer valid. It further concluded that the calculated margins of exposure for carcinogenic effects of ochratoxin A indicate a possible health concern for certain consumer groups.

| (4) | Maximum levels for ochratoxin A have already been established for certain foods by Regulation (EC) No 1881/2006. Taking into account that ochratoxin A has been found in foods for which no maximum level has been established yet and which contribute to the human exposure to ochratoxin A, it is appropriate to set a maximum level also for these foods such as dried fruit other than dried vine fruit, certain liquorice products, dried herbs, certain ingredients for herbal infusions, certain oilseeds, pistachio nuts and cocoa powder. Even if the relationship between the level of ochratoxin A in malt and in non-alcoholic malt beverages, and in dried dates and date syrup needs to be further clarified, it is also appropriate to set already a maximum level in non-alcoholic malt beverages and date syrup. Also taking into account the available occurrence data, it is appropriate to lower the existing maximum levels of ochratoxin A in certain foods, such as bakery products, dried vine fruit, roasted coffee and soluble coffee. In addition, the existing provisions for ochratoxin A in certain spices has been broadened to all spices. For cheese and ham, additional monitoring on the presence of ochratoxin A is appropriate before establishing maximum levels. |
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(4)

Maximum levels for ochratoxin A have already been established for certain foods by Regulation (EC) No 1881/2006. Taking into account that ochratoxin A has been found in foods for which no maximum level has been established yet and which contribute to the human exposure to ochratoxin A, it is appropriate to set a maximum level also for these foods such as dried fruit other than dried vine fruit, certain liquorice products, dried herbs, certain ingredients for herbal infusions, certain oilseeds, pistachio nuts and cocoa powder. Even if the relationship between the level of ochratoxin A in malt and in non-alcoholic malt beverages, and in dried dates and date syrup needs to be further clarified, it is also appropriate to set already a maximum level in non-alcoholic malt beverages and date syrup. Also taking into account the available occurrence data, it is appropriate to lower the existing maximum levels of ochratoxin A in certain foods, such as bakery products, dried vine fruit, roasted coffee and soluble coffee. In addition, the existing provisions for ochratoxin A in certain spices has been broadened to all spices. For cheese and ham, additional monitoring on the presence of ochratoxin A is appropriate before establishing maximum levels.

| (5) | Regulation (EC) No 1881/2006 should therefore be amended accordingly. |
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(5)

Regulation (EC) No 1881/2006 should therefore be amended accordingly.

| (6) | 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. It is also appropriate to provide for a transitional period for foodstuffs lawfully placed on the market before the date of application of this Regulation. |
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(6)

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. It is also appropriate to provide for a transitional period for foodstuffs lawfully placed on the market before the date of application of this Regulation.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(7)

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

The Annex to Regulation (EC) No 1881/2006 is amended in accordance with the Annex to this Regulation.

Article 2

Foodstuffs listed in the Annex, lawfully placed on the market before 1 January 2023, 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 Journal of the European Union.

It shall apply from 1 January 2023.

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

Done at Brussels, 5 August 2022.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (OJ L 364, 20.12.2006, p. 5).

2

(3)  Scientific Opinion on the risk assessment of ochratoxin A in food. EFSA Journal 2020; 18(5):6113, 150 pp. https://doi.org/10.2903/j.efsa.2020.6113.

3

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ANNEX

In section 2 of the Annex to Regulation (EC) No 1881/2006, entry 2.2 is replaced by the following:

| Foodstuffs (1) | Maximum level (μg/kg) |
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| ‘2.2 | Ochratoxin A | |
| 2.2.1 | Unprocessed cereals (18) | 5,0 |
| 2.2.2 | All products, derived/processed from unprocessed cereals, with the exception of foodstuffs listed in 2.2.3, 2.2.4, 2.2.5, 2.2.12 and 2.2.13
  Cereals placed on the market for the final consumer | 3,0 |
| 2.2.3 | Bakery wares, cereal snacks and breakfast cereals






  — | products not containing oilseeds, nuts or dried fruit |

Foodstuffs (1)

Maximum level (μg/kg)

‘2.2

Ochratoxin A

2.2.1

Unprocessed cereals (18)

5,0

2.2.2

All products, derived/processed from unprocessed cereals, with the exception of foodstuffs listed in 2.2.3, 2.2.4, 2.2.5, 2.2.12 and 2.2.13

Cereals placed on the market for the final consumer

3,0

2.2.3

Bakery wares, cereal snacks and breakfast cereals

—

products not containing oilseeds, nuts or dried fruit

| — | products containing at least 20 % dried vine fruit and/or dried figs |
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—

products containing at least 20 % dried vine fruit and/or dried figs

| — | other products containing oilseeds, nuts and/or dried fruit |
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—

other products containing oilseeds, nuts and/or dried fruit

2,0

4,0

3,0

2.2.4

Non-alcoholic malt beverages

3,0

2.2.5

Wheat gluten not placed on the market for the final consumer

8,0

2.2.6

Dried fruit

| — | dried vine fruit (currants, raisins and sultanas) and dried figs |
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—

dried vine fruit (currants, raisins and sultanas) and dried figs

| — | other dried fruit |
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—

other dried fruit

8,0

2,0

2.2.7

Date syrup

15

2.2.8

Roasted coffee

| — | roasted coffee beans and ground roasted coffee, excluding soluble coffee |
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—

roasted coffee beans and ground roasted coffee, excluding soluble coffee

| — | soluble coffee (instant coffee) |
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—

soluble coffee (instant coffee)

3,0

5,0

2.2.9

Wine (including sparkling wine, excluding liqueur wine and wine with an alcoholic strength of not less than 15 % vol.) and fruit wine (11)

2,0 (12 )

2.2.10

Aromatised wine, aromatised wine-based drinks and aromatised wine-product cocktails (13)

2,0 (12 )

2.2.11

Grape juice, concentrated grape juice as reconstituted, grape nectar, grape must and concentrated grape must as reconstituted, placed on the market for the final consumer (14)

2,0 (12 )

2.2.12

Processed cereal-based foods for infants and young children and baby foods (3) (7)

0,50

2.2.13

Dietary foods for special medical purposes intended for infants and young children (3) (10)

0,50

2.2.14

Spices, including dried spices, except Capsicum spp.

Capsicum spp. (dried fruits thereof, whole or ground, including chillies, chilli powder, cayenne or paprika)

Mixtures of spices

15

20

15

2.2.15

Liquorice (Glycyrrhiza glabra, Glycyrrhiza inflate and other species)

| — | liquorice root, including as an ingredient in herbal infusions |
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—

liquorice root, including as an ingredient in herbal infusions

| — | liquorice extract (42) for use in food in particular beverages and confectionary |
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—

liquorice extract (42) for use in food in particular beverages and confectionary

| — | liquorice confectionary containing ≥ 97 % liquorice extract on dry basis |
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—

liquorice confectionary containing ≥ 97 % liquorice extract on dry basis

| — | other liquorice confectionary |
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—

other liquorice confectionary

20

80

50

10,0

2.2.16

Dried herbs

10,0

2.2.17

Ginger roots for use in herbal infusions

Marshmallow roots, dandelion roots and orange blossoms for use in herbal infusions or in coffee substitutes

15

20

2.2.18

Sunflower seeds, pumpkin seeds, (water) melon seeds hempseeds, soybeans

5,0

2.2.19

Pistachios to be subjected to sorting, or other physical treatment, before placing on the market for final consumer or use as ingredient in food

Pistachios placed on the market for final consumer or use as ingredient in foodstuffs

10,0

5,0

2.2.20

Cocoa powder

3,0 ’

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