# L_2022211EN.01008301.xml

| 12.8.2022 | EN | Official Journal of the European Union | L 211/83 |
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12.8.2022

EN

Official Journal of the European Union

L 211/83

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COMMISSION REGULATION (EU) 2022/1393

of 11 August 2022

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 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 in foodstuffs. |
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(1)

Commission Regulation (EC) No 1881/2006 (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 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 Authority established an acute reference dose (ARfD) of 1 μg Δ9-THC/kg body weight (bw). |
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(2)

In 2015, 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 origin (3). 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) 2016/2115 (4) was adopted. |
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(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) 2016/2115 (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 a potential health concern. |
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(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 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 delta-9-tetrahydrocannabinolic acid (Δ9-THCA) can be converted into Δ9-THC through processing, the maximum levels should be set for the sum of Δ9-THC and Δ9-THCA, expressed in Δ9-THC equivalents. |
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(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 delta-9-tetrahydrocannabinolic acid (Δ9-THCA) can be converted into Δ9-THC through 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. |
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(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. |
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(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, |
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(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, 11 August 2022.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 37, 13.2.1993, p. 1.

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).

2

(3)  European Food Safety Authority (EFSA) Journal 2015;13(6):4141

3

(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).

4

9

(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

5

9

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ANNEX

In Section 8 of the Annex to Regulation (EC) No 1881/2006, the following entry 8.6 is added:

| Foodstuffs | Maximum level (mg/kg) |
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| ‘8.6. | Delta-9-tetrahydrocannabinol (Δ9-THC) equivalents
   (*1) | |
| 8.6.1. | Hemp seeds | 3,0 |
| 8.6.2. | Ground hemp seeds, (partially) defatted hemp seed and other hemp seed derived/processed products (*2) with the exception of the products referred to in 8.6.3. | 3,0 |
| 8.6.3. | Hemp seed oil | 7,5 |

Foodstuffs

Maximum level (mg/kg)

‘8.6.

Delta-9-tetrahydrocannabinol (Δ9-THC) equivalents
   (*1)

8.6.1.

Hemp seeds

3,0

8.6.2.

Ground hemp seeds, (partially) defatted hemp seed and other hemp seed derived/processed products (*2) with the exception of the products referred to in 8.6.3.

3,0

8.6.3.

Hemp seed oil

7,5

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(*1)  the maximum level refers to the sum of delta-9-tetrahydrocannabinol (Δ9-THC) and delta-9-tetrahydrocannabinolic acid (Δ9-THCA), expressed as Δ9-THC. A factor of 0,877 is applied to the level of Δ9-THCA and the maximum level refers to the sum of Δ9-THC + 0,877 x Δ9-THCA (in case of a separate determination and quantification of Δ9-THC and Δ9-THCA).

*1

9

9

9

9

9

9

9

9

(*2)  hemp seed derived/processed products are products derived/processed exclusively from hemp seeds.’

*2

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