EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10670/2021 CIS 
(POOL/E2/2022/10670/10670 -EN 
CIS.docx)  
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of delta -9-
tetrahydrocannabinol (Δ9-THC) in hemp seeds and products derived therefrom  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of delta -9-
tetrahydrocannabinol (Δ9-THC) in hemp  seeds and products derived therefrom  
(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 proc edures 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 delta -9-tetrahydrocannabinol  (Δ9-THC ), in foodstuffs.  
(2) In 20 15, the European Food Safety Authority (‘the Authority’)  Panel on Contaminants 
in the Food Chain adopted a scientific opinion on the risks to human health related to 
the presence of tetrahydrocannabinol (THC) in milk and other food of animal origin3. 
THC , more precisely Δ9-THC , is the most relevant constituent of the hemp 
plant  Cannabis sativa.  The Authority  established an acute reference dose (ARfD) of 1 
μg Δ9-THC/kg body weight  (bw) .   
(3) In order to obtain more data on the presence of Δ9-THC and other relevant non -
psycho -active precursors in hemp -derived foods and foods containing hemp or hemp -
derived ingredients , Commission Recommendation (EU) 2016/21154 was adopted.  
(4) On 7 January 2020 , the Authority published a scientific report assessing  acute human 
exposure to Δ9-THC5, taking into account the occurrence data generated through 
Recommendation (EU) 2016/2115 . The ARfD of 1 μg/kg bw was exceeded in certain 
acute exposure estimates. Although the exposure estimates are expected to 
overestimat e acute exposure to Δ9‐THC in the Union , the current exposure to Δ9-THC  
is a potential health concern.  
(5) Maximum levels should therefore be set in hemp seeds and hemp seed derived 
products to ensure a high level of human health protection. Since d elta-9-
tetrahydrocannabinolic acid (Δ9-THCA) can be converted into Δ9-THC through 
                                                 
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 European Food Safety Authority ( EFSA )  Journal 2015;13(6):4141  
4 Commission Recommendation (EU) 2016/2115  of 1 December 2016  on the monitoring of the presence 
of Δ9-tetrahydrocannabinol, its precursors and other cannabinoids in food  (OJ L 327, 2.12.2016, p. 103) . 
5 EFSA (European Food Safety Authority), Arcella D, Cascio C and Mackay K, 2020.  Acute human 
exposure assessment to tetrahydrocannabinol ( Δ9-THC) . EFSA Journal 2020;18(1):5953,  41 pp. 
https://doi.org/10.2903/j.efsa.2020.5953   
. EN 2  EN processing, the maximum levels should be set for the sum of Δ9‐THC and Δ9-THCA, 
expressed in Δ9‐THC  equivalents . 
(6) Regulation (EC) No 1881/2006 should therefore be amended accordingly.  
(7) To enable economic operators  to prepare for the new rules introduced by this 
Regulation, it is appropriate to provide for a reasonable time until the maximum levels 
apply . It is also appropriate  to provide for a transitional period for foodstuffs lawfully 
placed on the market before the date of application of this Regulation .  
(8) 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.  
Article 2   
Foodstuffs listed in the Annex , lawfully placed on the market before 1 January  2023, 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 January 2023.  
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