EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10246/2021 
(POOL/E2/2021/10246/10246 -EN.docx)  
D071865/012  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of tropane 
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 tropane 
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 tropane alkaloids,  in foodstuffs.  
(2) Atropine is the racemic mixture of ( -)-hyoscyamine and (+) -hyoscyamine of which 
only the ( -)-hyoscyamine e nantiomer exhibits anticholinergic activity. It is not always 
possible to distinguish between the enantiomers of hyoscyamine, for analytical 
reasons. However, as the synthesis of tropane alkaloids in plants leads to ( -)-
hyoscyamine and (-)-scopolamine and not to (+) -hyoscyamine  and (+) -scopolamine , 
analytical results on atropine and scopolamine in food of plant origin reflects the 
occurrence of ( -)-hyoscyamine  and ( -)-scopolamine respectively.  
(3) The European Food Safety Authority (‘the Au thority’) adopted in 2013 an opinion on 
tropane alkaloids in food and feed3. The Authority established a group acute reference 
dose (‘ARfD’) of 0.016 μg/kg per body weight (‘b.w.’) expressed as the sum of ( -)-
hyoscyamine and ( -)-scopolamine, assuming equi valent potency. The Authority 
concluded that, based on the limited information available, the dietary exposure of 
toddlers could significantly exceed the group ARfD. It therefore highlighted the need 
for better characterisation of tropane alkaloids in food  and feed, either naturally or as 
contaminants, and recommended compiling analytical data on the occurrence of 
tropane alkaloids in cereals and oilseeds.  
(4) Taking into account the conclusions of the opinion, maximum levels for atropine and 
scopolamine were  established by Commission Regulation (EU) 2016/2394 in 
processed cereal based foods and baby foods for infants and young children, 
containing millet, sorghum, buckwheat or their derived products.  
 
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 tropane alkaloids in food and feed. EFSA Journal 2013;11(10):3386, 113 pp. 
doi:10.2903/j.efsa.2013.3386.  
4 Commission Regulation (EU) 2016/239 of 19 February 2016 amending Regulation (EC) No 1881/2006 
as regards maximum levels of tropane alkaloids in certain cereal -based foods f or inf ants a nd young 
children (OJ L 45, 20.2.2016, p. 3)  EN 2  EN (5) The Authority published a call for proposals to investigate  the concentrations of 
tropane alkaloids in a wide range of plant -derived food products across different 
regions within the Union , following the recommendation in its opinion from 2013.  The 
investigation’s  findings were  published on 8 December 20165. 
(6) On 5 February 2018, the Authority published a scientific report on the assessment of 
acute dietary exposure to tropane alkaloids in the Union population, taking into 
account new occurrence data6. For several acute exposure  estimates , the ARfD was 
exceeded for several population groups . This makes  the presence of tropane alkaloids , 
in particular atropine and scopolamine , a health concern.   
(7) Maximum levels of those tropane alkaloids should therefore be set for foodstuffs 
found to contain a high concentration of them and contributing significantly to the 
exposure  of the population , namely certain cereals, products derived f rom them and 
herbal infusions. As regards , in particular,  cereals and cereals products, g ood 
agricultu ral and harvesting practices minimise contamination of the crop by seeds  of 
species containing tropane alkaloids, such as Datura stramonium . In case of 
contamination, those seeds can be removed for certain cereals by sorting and cleaning. 
However, they can not easily be removed from sorghum, millet, maize and buckwheat. 
Given th at the maximum levels for those foodstuffs are higher than the levels set out 
for foodstuffs for infants and young children , a maximum level for the sum of atropine 
and scopolamine may be set for each of those foods  
(8) Furthermore, recent monitoring data indicate that processed cereal based foods and 
baby foods for infants and young children containing maize or maize derived products 
can also be contaminated wit h tropane alkaloids. It is therefore appropriate to extend 
to these foods the existing maximum levels for processed cereal based foods and baby 
foods for infants and young children.  
(9) Regulation (EC) No 1881/2006 should therefore be amended accordingly.  
(10) Give n that good agricultural and harvest ing practices have only recently been 
introduced or implemented  and in order to allow the food business operators to adapt 
to the new requirements set out in this Regulation  while ensuring the protection of 
vulnerable po pulation s, it is appropriate to provide , as regard  foods other than f oods 
for infants and young children containing maize, a reasonable period until the 
maximum levels start apply ing and for a transitional period for all f oodstuffs which 
have been lawfully  placed on the market before the date of its application.  
(11) 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.  
 
5 Mulder , PPJ., De Nijs , M., Castellari , M., Hortos , M., MacDonald , S., Crews , C., Hajslova , J. and 
Stranska , M., 2016.  ‘Occurrence of tropane alkaloids in food’ . EFSA  supporting publication  2016:EN -
1140, 200 pp. doi:10.2903/sp.efsa.2016.EN -1140 . 
6 Arcella , D., Altieri , A., Horváth , Zs, 2018. ‘Scientific report on human acute exposure assessment to 
tropane  alkaloids ’. EFSA Journal  2018;16(2):5160, 29 pp. doi:10.2903/j.efsa.2018.5160 . EN 3  EN Article 2   
Processed cereal -based foods and baby foods for infants and y oung children, containing  maize 
or their derived products , lawfully placed on the market before the entry into force  of this 
Regulation , may remain on the market  until their date of minimum durability or use -by-date.  
Foodstuffs listed in points 8.2.2. to 8.2.9. of the Annex , lawfully placed on the market before 
1 September 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.  
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