II
(Non-legislative acts)
REGUL ATIONS
COMMI SSION REGUL ATION (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 foodstuff s 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regard to Council Regulation (EEC) No 315/93 of 8 Febr uary 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 fung al structures from Claviceps species replacing kernels on grain ears or 
seeds on grass heads, visible as large discoloured sclerotia. These sclerotia contain differ ent classes of alkaloids.
(3) On 28 June 2012 , the European Food Safe ty Auth ority (‘the Auth ority’) adopt ed an opinion on ergot alkaloids in 
food and feed (3). The Author ity based its risk assessment on the main Claviceps purpurea ergot alkaloids, namely 
ergometr ine, ergotamine, ergosine, ergocr istine, ergocr yptine, ergocor nine, as well as the corresponding –inine 
epimers. It established a group acute referen ce dose of 1 μg/kg body weight (b.w .) and a group tolerable daily intak e 
of 0,6 μg/kg b.w. per day. It concluded that, although the available data did not indicate that there was cause for 
concer n for any population subgroup, the dietar y exposure estimates relat ed to a limited number of food groups, 
and a possible unknown contr ibution from other foods could not be discounte d.
(4) On 6 July 2017 , the Auth ority published a scientifi c repor t on human and animal dietar y exposure to ergot 
alkaloids (4). For certain population groups, exposure estimates to ergot alkaloids indicate an exposure close to the 
tolerable daily intak e. For the highest exposure estimat es, the main contr ibut ors to chronic dietar y exposure were 
differ ent types of bread and rolls, in particular those containing or made excl usively of rye. The highest acute 
exposure estimat es indicate an acute exposure close to the acute reference dose.
(1)OJ L 37, 13.2.1993, p. 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).
(3)Scientific Opinion on Ergot alkaloids in food and feed. EFSA Journal 2012;10(7):2798. [158 pp.] doi:10.2903/j.efsa.2012.2798.
(4)Arcella, D., Gomez Ruiz, J-A., Innocenti, ML and Roldán, R., 2017. Scientific repor t on human and animal dietar y exposure to ergot 
alkaloids. EFSA Journal 2017;15(7):4902, 53 pp. https://doi.org/10.2903/j.efsa.2017.4902EN Offi cial Jour nal of the European Union 25.8.2021                                                                                                                                           L 301/1  (5) The Author ity also examined the relationship between the presence of ergot sclerotia and of ergot alkaloids. At 
higher levels, a statistically significant linear relationship between the cont ent of sclerotia and the levels of ergot 
alkaloids could be obser ved. However , this relationship could not alwa ys be demonstrate d at lowe r 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, whic h is then adsorbed to the cereal grains.
(6) It is theref ore appropr iate to lowe r the maximum level for ergot sclerotia and establish maximum levels for ergot 
alkaloids in those foodstuffs with signif icant levels of such alkaloids, contr ibuting 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 
theref ore be reduced in consequence. In this regar d, it is also appropr iate to clarify the stage at whic h maximum 
levels for ergot sclerotia in unpro cessed cereals apply in order to eliminate problems as regar ds their application.
(8) As regar ds milling products, it is appropr iate 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, lowe r levels of 
ergot alkaloids are more difficult to achieve and, theref ore, 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 regar ds milling 
products of other cereals, different maximum levels should be set depending on the ash conte nt of the products in 
order to take account of the fact that products containing more bran (higher ash conte nt) have naturally higher 
levels of ergot alkaloids as dust of ergot sclerotia is adsorbed to bran.
(9) Further more, since it is expecte d that achievable levels of contamination will continue to decrease for some milling 
products, it is appropr iate to provide that stricter maximum levels should apply in the mid-te rm to those products. 
In order to allow the Commission to monitor the progression towards those stricter maximum levels and to assess 
the possible change s in the levels due to the change s in agricultural practices, as well as in climatic and 
environmental factors, Member States and interest ed parties should be required to provid e the necessar y data and 
information.
(10) Wheat gluten, as a by-product of the wet milling process, has been shown to contain higher levels of ergot alkaloids 
despite the application of good practices as ergot alkaloids concentrat e as a consequence of its production process. 
Theref ore, a higher maximum level for ergot alkaloids in wheat gluten should be established.
(11) Due to chang es in Annex I to Regulation (EC) No 396/2005 of the European Parliament and of the Council (5), a 
corresponding footnote in the Annex of Regulation (EC) No 1881/2006 should be modified.
(12) In order to enable economic operat ors to prepare for the application of the new rules introduced by this Regulation, 
it is appropr iate to provide for a reasonable time until the maximum levels apply and to provi de for a transitional 
period for foodstuffs lawfully placed on the market before the date of application of this Regulation. However , as 
regards rye, lower levels of contamination by ergot sclerotia may not be reasonably achieve d yet and it is theref ore 
appropr iate to allow a long er period to allow for a stricter application of good agricultural practices and for the 
application of improved sorting and cleaning techniques.
(13) Regulation (EC) No 1881/2006 should theref ore be amended according ly.
(14) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
(5)Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 Febr uary 2005 on maximum residue levels of 
pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).EN Offi cial Jour nal of the European Union L 301/2                                                                                                                                           25.8.2021  HAS ADOPTED THIS REGUL ATION:
Article 1
Regulation (EC) No 1881/2006 is amended as follows :
(1) in Article 9, paragraph 4 is replaced by the follo wing:
‘4. Member States and interested parties shall communicate by 1 Januar y 2023 to the Commission the results of 
investigat ions under taken and the progress with regard to the application of prevention measures to avoid 
contamination by ergot sclerotia and ergot alkaloids in rye and rye milling products and ergot alkaloids in milling 
products of barley , wheat, spelt and oats grains.
Member States and interest ed parties shall repor t on a regular basis to the EFSA database the occur rence data on ergot 
sclerotia and ergot alkaloids in rye and rye milling products and on ergot alkaloids in milling products of barley , wheat, 
spelt and oats grains.’;
(2) the Annex is amended in accordance with the Annex to this Regulation.
Article 2
Foodstuffs listed in the Annex lawfully placed on the market before 1 Januar y 2022 , may remain on the mark et until their 
date of minimum durability or use-by- date .
Article 3
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
It shall apply from 1 Januar y 2022 .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 August 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 25.8.2021                                                                                                                                           L 301/3  ANNEX 
The Annex to Regulation (EC) No 1881/2006 is amended as follo ws:
(1) In section 2, the entr ies ‘2.9 Ergot sclerotia and ergot alkaloids ’ are replaced by the follo wing:
Foodstuffs (1)Maximum level
‘2.9 Ergot sclerotia and ergot alkaloids
2.9.1. Ergot sclerotia
2.9.1.1. Unpro cessed cereals(18) with the excep tion of
— maize, rye and rice0,2 g/kg
2.9.1.2. Unpro cessed rye(18) 0,5 g/kg until 30.6.2024
0,2 g/kg as from 1.7.2024
2.9.2. Ergot alkaloids (*)
2.9.2.1. Milling products of barley , wheat, spelt and oats
(with an ash cont ent lowe r than 900mg/100g)100 μg/kg
50 μg/kg as from 1.7.2024
2.9.2.2. Milling products of barley , wheat, spelt and oats
(with an ash cont ent equal or higher than 900mg/100g)
Barle y, wheat, spelt and oats grains placed on the mark et 
for the final consumer150 μg/kg
2.9.2.3. Rye milling products
Rye placed on the market for the final consumer500 μg/kg until 30.6.2024
250 μg/kg as from 1.7.2024
2.9.2.4. Wheat gluten 400 μg/kg
2.9.2.5. Processed cereal based food for infants and young 
children (3) (29)20 μg/kg
(*)The maximum level for ergot alkaloids refers to the lowerbound sum of the following 12 ergot alkaloids: ergocor nine/ 
ergocor ninine; ergocr istine/ergocr istinine; ergocr yptine/ergocr yptinine (α- and β-form); ergometr ine/ergometr inine; ergosine/ 
ergosinine; ergotamine/ergotaminine. In the lowerbound sum, the contr ibution of each non-quantified epimer is set at zero.’
(2) Footnot e 1 is replaced by the follo wing:
‘(1) As regar ds fruits, vege tables and cereals, referen ce is made to the foodstuffs listed in the relevant categor y as 
defined in Annex I to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 
23 Febr uary 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and 
amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1). This means, inter alia, that buckwh eat 
(Fagop yrum sp) is included in ‘cereals’ and buckwheat products are included in ‘cereal products’. Tree nuts are not 
covered by the maximum level for fruit.’
(3) Footnot e 18 is replaced by the followi ng:
‘(18) The maximum level applies to unp rocessed cereals placed on the market before first-stag e processing. In 
integrat ed production and processing systems the maximum level applies in the production chain at the stage 
before first-stage processing. Integrat ed production and processing systems means system s where all incoming 
lots are cleaned, sorted and processed in the same establishment.EN Offi cial Jour nal of the European Union L 301/4                                                                                                                                           25.8.2021  Drying and cleaning, including sorting (colour sorting where applicable) and scour ing, are not considered to be 
“first-stag e processing” insof ar as the whole grain remains intact.
Scour ing is cleaning cereals by brushing or scrubbing it vigorously , combined with dust remo val (e.g. aspiration).
In case scour ing is applied in the presence of ergot sclerotia the cereals need to firstly undergo a cleaning step 
before scour ing.’EN Offi cial Jour nal of the European Union 25.8.2021                                                                                                                                           L 301/5