EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10242/2021 
(POOL/E2/2021/10242/10242 -EN.docx)  
D071863/02  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of ergot sclerotia 
and ergot alkaloids in certain foodstuffs  
(Text with EEA relevance)  
 EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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 food1, and in particular Article  2(3) thereof,  
Whereas:  
(1) Commission Regulation (EC) No  1881/20062 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 Clavicep s 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 feed3. 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 µ g/kg b.w. per day. It concluded that , although the 
available data d id 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 alkaloids4. 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.  
 
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 Roldá n, R., 2017. Scientific report on human and 
animal dietary exposure to ergot alkaloids. EFSA  Journal 2017;15(7):4902, 53 pp. 
https://doi.org/10.2903/j.efsa.2017.4902 . EN 2  EN (5) The Authority also examined the relationship between the presence of ergot scler otia 
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 t he absence of sclerotia does not exclude the presence of ergot alkaloids. 
A reason is that t he handling of cereals break s the sclerotia, resulting in ergot dust, 
which  is then adsorbed  to the cereal grains . 
(6) It is therefore appropriate to lower the maximum level s 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 fo r 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 reg ards milling products, it is appropriate to establish different maximum levels of 
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 absorbed to bran.  
(9) Furthermore, since it is expected that achievable levels of contamination will continue 
to dec rease for some milling products, it is appropriate to provide that stricter 
maximum levels should apply in the mid- term to those products. In order to allow the 
Commission to monitor the progression towards those stricter maximum levels  and to 
assess the p ossible changes in the levels due to the changes in agricultural practices, as 
well as in climatic and environmental factors , Member States and interested parties 
should be required to provide the necessary 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 concentrate as a consequence of its production process. Therefore, a higher 
maximum level for ergot alkaloids in wheat gluten should be established. 
(11) Due to changes in Annex I to Regulation (EC) No 396/20055, a corresponding 
footnote in the Annex of Commission Regulation (EC) No 1881/2006 should be 
modified. 
(12) In order to enable economic operators to prepare  for the application of the new rules 
introduced by this Regulation, it is appropriate to provide for a reasonable time until 
the maximum levels apply and to provide for a transitional period for foodstuffs 
lawfully placed on the market before the date of application of this Regulation . 
 
5 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 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 3  EN However, as regards rye, lower levels of contamination of ergot sclerotia may not be 
reasonably achieved yet and it is therefore appropriate to allow a longer period to 
allow for a stricter application of good agricultural prac tices and for the application of 
improved sorting and cleaning techniques.  
(13) Regulation (EC) No 1881/2006 should therefore be amended accordingly. 
(14) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on P lants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation (EC) No 1881/2006 is amended as follows:  
(1) In Article 9, paragraph 4 is replaced by the following:   
“4. Member States and interested parties shall communicate by 1 January 2023 to 
the Commission the results of investigations undertaken and the progress with 
regard to the application of prevention measures to avoid contamination by 
ergot sclerotia and ergot a lkaloids in rye and rye milling products and ergot 
alkaloids in milling products of barley, wheat, spelt and oats grains. 
Member States and interested parties shall report on a regular basis to the 
EFSA database the occurrence 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 January 2022, 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 J anuary 2022.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission 
 The President  
 Ursula VON DER LEYEN