Commission Regulation (EU) 2021/1399 of 24 August 2021 amending Regulation (EC) No 1881/2006 as regards maximum levels of ergot sclerotia and ergot alkaloids in certain foodstuffs (Text with EEA relevance)

• Published date: 25 August 2021
• Date of Signature: 24 August 2021
• Official Gazette Publication: Official Journal of the European Union, L 301, 25 August 2021

25.8.2021 EN Official Journal of the European Union L 301/1

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COMMISSION REGULATION (EU) 2021/1399

of 24 August 2021

amending Regulation (EC) No 1881/2006 as regards maximum levels of ergot sclerotia and ergot alkaloids 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 ergot sclerotia and ergot alkaloids, in foodstuffs.

(2) The term ergot or ergot sclerotia refers to fungal structures from Claviceps species replacing kernels on grain ears or seeds on grass heads, visible as large discoloured sclerotia. These sclerotia contain different classes of alkaloids.

(3) On 28 June 2012, the European Food Safety Authority (‘the Authority’) adopted an opinion on ergot alkaloids in food and feed (3). The Authority based its risk assessment on the main Claviceps purpurea ergot alkaloids, namely ergometrine, ergotamine, ergosine, ergocristine, ergocryptine, ergocornine, as well as the corresponding –inine epimers. It established a group acute reference dose of 1 μg/kg body weight (b.w.) and a group tolerable daily intake of 0,6 μg/kg b.w. per day. It concluded that, although the available data did not indicate that there was cause for concern for any population subgroup, the dietary exposure estimates related to a limited number of food groups, and a possible unknown contribution from other foods could not be discounted.

(4) On 6 July 2017, the Authority published a scientific report on human and animal dietary exposure to ergot alkaloids (4). For certain population groups, exposure estimates to ergot alkaloids indicate an exposure close to the tolerable daily intake. For the highest exposure estimates, the main contributors to chronic dietary exposure were different types of bread and rolls, in particular those containing or made exclusively of rye. The highest acute exposure estimates indicate an acute exposure close to the acute reference dose.

(5) The Authority also examined the relationship between the presence of ergot sclerotia and of ergot alkaloids. At higher levels, a statistically significant linear relationship between the content of sclerotia and the levels of ergot alkaloids could be observed. However, this relationship could not always be demonstrated at lower levels which indicates that the absence of sclerotia does not exclude the presence of ergot alkaloids. A reason is that the handling of cereals breaks the sclerotia, resulting in ergot dust, which is then adsorbed to the cereal grains.

(6) It is therefore appropriate to lower the maximum level for ergot sclerotia and establish maximum levels for ergot alkaloids in those foodstuffs with significant levels of such alkaloids, contributing significantly to human exposure, and in foodstuffs that are relevant for the exposure of vulnerable population groups.

(7) Lower levels of ergot sclerotia can already be achieved in most cereals by the application of good agricultural practices and by the application of sorting and cleaning techniques. The existing maximum level for cereals should therefore be reduced in consequence. In this regard, it is also appropriate to clarify the stage at which maximum levels for ergot sclerotia in unprocessed cereals apply in order to eliminate problems as regards their application.

(8) As regards milling products, it is appropriate to establish different maximum levels for ergot alkaloids depending on the cereal species. Since rye is the cereal species with higher risk of contamination by ergot sclerotia, lower levels of ergot alkaloids are more difficult to achieve and, therefore, a specific maximum level should be set for rye milling products while a lower level should be set for milling products of other cereals. However, as regards milling products of other cereals, different maximum levels should be set depending on the ash content of the products in order to take account of the fact that products containing more bran (higher ash content) have naturally higher levels of ergot alkaloids as dust of ergot sclerotia is adsorbed to bran.

(9) Furthermore, since it is expected that achievable levels of contamination will continue to decrease for some milling

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