II
(Non-legislative acts)
REGUL ATIONS
COMMI SSION REGUL ATION (EU) 2021/1408 
of 27 August 2021
amending Regulation (EC) No 1881/2006 as regards maximum levels of tropane 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 tropane 
alkaloids, in foodstuffs.
(2) Atropine is the racemic mixture of (-)-h yoscyamine and (+)-hy oscyamine of which only the (-)-h yoscyamine 
enantiomer exhibits anticholi nergic activity . It is not alwa ys possible to distinguish between the enantiomers of 
hyoscyamine, for analytical reasons. However , as the synthesis of tropane alkaloids in plants leads to 
(-)-hy oscyamine and (-)-scopolamine and not to (+)-hy oscyamine and (+)-scopolamine, analytical results on atropine 
and scopolamine in food of plant origin reflects the occur rence of (-)-hy oscyamine and (-)-scopolamine respectively .
(3) The European Food Safety Author ity (‘the Author ity’) adopt ed in 2013 an opinion on tropane alkaloids in food and 
feed(3). The Authority established a group acute reference dose (‘ARfD’) of 0.016 μg/kg per body weight (‘b.w .’) 
expressed as the sum of (-)-hy oscyamine and (-)-scopolamine, assuming equivalent poten cy. The Author ity 
concluded that, based on the limited information available, the dietar y exposure of todd lers could significantly 
exceed the group ARfD. It theref ore highlight ed the need for better charact erisation of tropane alkaloids in food and 
feed, either naturally or as contaminants, and recommended compiling analytical data on the occur rence 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) 2016/239 (4)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 Jour nal 2013;11(10):3386, 113 pp. doi:10.2903/j.efsa.2013.3386.
(4)Commission Regulation (EU) 2016/239 of 19 Febr uary 2016 amending Regulation (EC) No 1881/2006 as regar ds maximum levels of 
tropane alkaloids in certain cereal-based foods for infants and young children (OJ L 45, 20.2.2016, p. 3).EN Offi cial Jour nal of the European Union 30.8.2021                                                                                                                                           L 304/1  (5) The Author ity published a call for proposals to investigat e the concentrations of tropane alkaloids in a wide rang e of 
plant-der ived food products across different regions within the Union, followi ng the recommendation in its opinion 
from 2013. The inve stigation’s findings were published on 8 December 2016 (5).
(6) On 5 Febr uary 2018 , the Author ity published a scientific repor t on the assessment of acute dietar y exposure to 
tropane alkaloids in the Union population, taking into account new occur rence data (6). For several acute exposure 
estimate s, the ARfD was exce eded for several population groups. This make s the presence of tropane alkaloids, in 
particular atropine and scopolamine, a health concer n.
(7) Maximum levels of those tropane alkaloids should theref ore be set for foodstuffs found to contain a high 
concentration of them and contr ibuting signif icantly to the exposure of the population, namely certain cereals, 
products derived from them and herbal infusions. As regar ds, in particular , cereals and cereals products, good 
agricultural and harvesting practices minimise contamination of the crop by seeds of species containing tropane 
alkaloids, such as Datur a stramonium. In case of contamination, those seeds can be removed for certain cereals by 
sorting and cleaning. However , they cannot easily be removed from sorghum, millet, maize and buckwheat . Given 
that 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) Further more, recent monitor ing data indicate that processed cereal based foods and baby foods for infants and 
young children containing maize or maize derived products can also be contaminate d with tropane alkaloids. It is 
theref ore appropr iate 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 theref ore be amended according ly.
(10) Given that good agricultural and harvesting practices have only recently been introduced or implement ed and in 
order to allow the food business operat ors to adap t to the new requirements set out in this Regulation while 
ensur ing the protection of vulnerable populations, it is appropr iate to provide, as regard foods other than foods for 
infants and young children containing maize, a reasonable period until the maximum levels start applying and for a 
transitional period for all foodstuffs whic h have been lawfully placed on the market before the date of its application.
(11) 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,
HAS ADOPTED THIS REGUL ATION:
Article 1
The Annex to Regulation (EC) No 1881/2006 is amended in accordance with the Annex to this Regulation.
Article 2
Processed cereal-based foods and baby foods for infants and young children, containing maize or their derived products, 
lawfully placed on the mark et before the entr y into force of this Regulation, may remain on the market until their date of 
minimum durability or use-by- date .
(5)Mulder , PPJ., De Nijs, M., Castel lari, M., Hor tos, M., MacDonald, S., Crews, C., Hajslo va, J. and Stranska, M., 2016. ‘Occur rence of 
tropane alkaloids in food’. EFSA suppor ting publication 2016:EN-1140, 200 pp. doi:10.2903/sp.efsa.2016.EN-1140.
(6)Arcella, D., Altier i, A., Hor váth, Zs, 2018. ‘Scientifi c repor t on human acute exposure assessment to tropane alkaloids’. EFSA Jour nal 
2018;16(2):5160, 29 pp. doi:10.2903/j.efsa.2018.5160.EN Offi cial Jour nal of the European Union L 304/2                                                                                                                                           30.8.2021  Foodstuffs listed in points 8.2.2. to 8.2.9. of the Annex, lawfully placed on the mark et before 1 Sept ember 2022 , may 
remain on the mark et until their date of minimum durability or use-b y-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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 August 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 30.8.2021                                                                                                                                           L 304/3  ANNEX 
In the Annex to Regulation (EC) No 1881/2006, section 8, entr y 8.2 is replaced by the follo wing:
‘Foodstuffs (1)Maximum level (μg/kg)
8.2. Tropane alkaloids (*)
Atropine Scopolamine
8.2.1. Processed cereal-based foods and baby foods for infants and young 
children, containing millet, sorghum, buckwheat , maize or their 
derived products (3) (29)1,0 1,0
Sum of atropine and 
scopolamine
8.2.2. Unprocessed millet and sorghum (18) 5,0 as from 1 Sept ember 2022
8.2.3. Unprocessed maize (18) with the excep tion of
— unpro cessed maize intended to be processed by wet milling (37) and
— unpro cessed maize for popping15 as from 1 September 2022
8.2.4. Unprocessed buckwheat (18) 10 as from 1 September 2022
8.2.5. Maize for popping
Millet, sorghum and maize placed on the mark et for the final consumer
Milling products of millet, sorghum and maize5,0 as from 1 Sept ember 2022
8.2.6. Buckwhea t placed on the mark et for the final consumer
Milling products of buckwheat10 as from 1 September 2022
8.2.7. Herbal infusions (dried product) with the excep tion of the herbal 
infusions referred to in 8.2.8.25 as from 1 September 2022
8.2.8. Herbal infusions (dried product) of anise seeds 50 as from 1 September 2022
8.2.9. Herbal infusions (liquid) 0,20 as from 1 Sept ember 2022
(*)The tropane alkaloids referred to are atropine and scopolamine.’EN Offi cial Jour nal of the European Union L 304/4                                                                                                                                           30.8.2021