(1)

Commission Regulation (EU) 2023/915 (2) sets maximum levels for certain contaminants in foodstuffs.

(2)

In 2015, the European Food Safety Authority (‘the Authority’) Panel on Contaminants in the Food Chain (CONTAM Panel) adopted a scientific opinion on the risks to human health related to the presence of tetrahydrocannabinol (THC) in milk and other food of animal origin (3). THC, more precisely Δ9-THC, is the most relevant constituent of the hemp plant Cannabis sativa. The CONTAM Panel 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 in hemp-derived foods and foods containing hemp or hemp-derived ingredients, Commission Recommendation (EU) 2016/2115 (4) was adopted.

(4)

On 7 January 2020, the Authority published a scientific report assessing acute human exposure to Δ9-THC (5), 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 overestimate acute exposure to Δ9-THC in the Union, the current exposure to Δ9-THC is considered a potential health concern.

(5)

Maximum levels have been set for the sum of Δ9-THC and Δ9-THCA, expressed in Δ9-THC equivalents, in hemp seeds and hemp seed derived products by Regulation (EU) 2023/915 to ensure a high level of human health protection.

(6)

Since, as stated in the Novel Food status Catalogue, water infusion of hemp leaves (when not accompanied by the flowering and fruiting tops) consumed as such or as part of herbal infusions is not novel (6) and does not require an authorisation pursuant to Regulation (EU) 2015/2283 of the European Parliament and of the Council (7), it is appropriate to also establish a maximum level for the sum of Δ9-THC and Δ9-THCA, expressed in Δ9-THC equivalents, in hemp leaves for water infusion and hemp leaves infusions (ready to drink herbal infusion) to ensure a high level of human health protection.

(7)

The maximum level does not take into account consumption of hemp leaves infusions by infants and young children. It is therefore appropriate that there is a warning on the label that the prepared water infusion should not be consumed by infants and young children. Furthermore, the maximum level takes into account the limited migration of Δ9-THC and Δ9-THCA from the leaves into the water infusion given that Δ9-THC and Δ9-THCA are lipophilic. As the migration increases significantly by adding during steeping a fatty ingredient, such as cream or milk, it is necessary to provide the warning that the fatty ingredient is to be added only after steeping.

(8)

Regulation (EU) 2023/915 should therefore be amended accordingly.

(9)

To enable economic operators to prepare for the new rules on hemp leaves for water infusion and hemp leaves infusions (ready to drink herbal infusion), it is appropriate to provide for a reasonable time until the new rules apply. It is also appropriate to provide for a transitional period for food containing delta-9-tetrahydrocannabinol (Δ9-THC), which was lawfully placed on the market before the date of application of this Regulation.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Article 10(1) is amended as follows:

(2)

Annex I is amended in accordance with the Annex to this Regulation.