EN Official Journal of the European Union L 327/103

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

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,

Whereas:

(1) The European Food Safety Authority (EFSA) Panel on Contaminants in the Food Chain (CONTAM) adopted a scientific opinion on tetrahydrocannabinol (THC) in milk and other food of animal origin (1).

(2) Tetrahydrocannabinol, more precisely delta-9-tetrahydrocannabinol (Δ9-THC) is the most relevant constituent of the hemp plant Cannabis sativa. EFSA established an acute reference dose (ARfD) of 1 μg Δ9-THC/kg b.w.

(3) Only limited data on the presence of Δ9-THC in food of animal origin are available and limited data are available from the transfer rate from feed to food of animal origin. Therefore there is a need to have more data on the presence in food of animal origin, of which evidence is available that the food of animal origin is produced by animals being fed with feed containing hemp or hemp derived feed materials.

(4) Furthermore, more occurrence data are needed on the presence of Δ9-THC in hemp-derived foods and foods containing hemp or hemp-derived ingredients. It is also appropriate if possible to analyse the non-psychoactive precursors delta-9-tetrahydrocannabinolic acids (2-COOH-Δ9-THC termed Δ9-THCA-A and 4-COOH-Δ9-THC termed Δ9-THCA-B) and other cannabinoids (such as delta-8-tetrahydrocannabinol (Δ8-THC), cannabinol (CBN), cannabidiol (CBD) and delta-9-tetrahydrocannabivarin (Δ9-THCV).

(5) It is therefore appropriate to recommend the monitoring of the presence of Δ9-THC, its precursors and other cannabinoids in food.

HAS ADOPTED THIS RECOMMENDATION:

(1) Member States should, with the active involvement of food business operators and other interested parties, perform monitoring for the presence of Δ9-Tetrahydrocannabinol (Δ9-THC) in food of animal origin and Δ9-Tetrahydrocannabinol (Δ9-THC), its non-psychoactive precursors delta-9-tetrahydrocannabinolic acids (2-COOH-Δ9-THC termed Δ9-THCA-A and 4-COOH-Δ9-THC termed Δ9-THCA-B) and other cannabinoids (such as delta-8-tetrahydrocannabinol (Δ8-THC), cannabinol (CBN), cannabidiol (CBD) and delta-9-tetrahydrocannabivarin (Δ9-THCV) in hemp-derived foods and foods containing hemp or hemp-derived ingredients. For the monitoring of food of animal origin, evidence should be available that the food of animal origin is produced by animals being fed with feed containing hemp or hemp derived feed materials.

(2) In order to ensure that the samples are representative for the sampled lot, Member States should follow the sampling procedures laid down in Commission Regulation (EC) No 401/2006 (2).

(3) The method of analysis to be used for monitoring is preferably chromatographic separation coupled with mass spectrometry (LC-MS or GC-MS) following an appropriate clean-up step (liquid-liquid (LLE) or solid phase extraction (SPE)). Preference should be given to chromatographic techniques that allow the determination of Δ9-THC separately, its precursors and other cannabinoids in hemp-containing food products.

(4) Member States, food business operators and other interested parties should ensure that the analytical results are provided on a regular basis and by the latest by October 2018 to EFSA in the EFSA data submission format in line with the requirements of EFSA's Guidance on Standard Sample Description (SSD) for Food and Feed (3) and the additional EFSA's specific reporting requirements.

Done at Brussels, 1 December 2016. For the Commission Vytenis ANDRIUKAITIS Member of the Commission

(1) EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2015. Scientific Opinion on the risks for human health related to the presence of tetrahydrocannabinol (THC) in milk and other food of animal origin. EFSA Journal 2015;13(6):4141, 125 pp. doi:10.2903/j.efsa.2015.4141

(2) Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs (OJ L 70, 9.3.2006, p. 12).

(3) http://www.efsa.europa.eu/en/data/toolbox