Notification Detail

Draft Regulation laying down the definition of maximum levels of tetrahydrocannabinol (THC) in food.

Notification Number: 2018/546/I (Italy )
Date received: 30/10/2018
End of Standstill: 31/01/2019 ( 30/04/2019)

Issue of comments by: Commission,Spain
Issue of detailed opinion by: Czech Republic
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Message 002

Communication from the Commission - TRIS/(2018) 02979
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2018/0546/I

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 201802979.EN)

1. Structured Information Line
MSG 002 IND 2018 0546 I EN 30-10-2018 I NOTIF

2. Member State

3. Department Responsible
Direzione generale per il mercato, la concorrenza, il consumatore, la vigilanza e la normativa tecnica
Divisione XIII - Normativa tecnica
00187 Roma - Via Sallustiana, 53
tel. +39 06 4705.5340 - e-mail:

3. Originating Department
Direzione generale per l'igiene e la sicurezza degli alimenti e la nutrizione
Ufficio 6 - DGISAN

4. Notification Number
2018/0546/I - C50A

5. Title
Draft Regulation laying down the definition of maximum levels of tetrahydrocannabinol (THC) in food.

6. Products Concerned
Foodstuffs derived from hemp.

7. Notification Under Another Act
- Council Regulation (EC) No 315/93 on contaminants in food

8. Main Content
The draft Regulation to which the notification relates, comprising eight articles and three annexes, contains provisions regarding the definition of maximum levels of THC in foodstuffs.
The limits are defined specifically for certain foodstuffs derived from hemp (seeds, flour obtained from seeds, oil obtained from seeds) and for supplements containing foodstuffs derived from hemp. Article 2 of Commission Regulation (EC) 1881/2006 shall apply to other foodstuffs.
On the basis of the precautionary principle, the limits are defined as the sum of the active substance (A9-THC, A9-tetrahydrocannabinol) and of the inactive acid precursor (A9-THCA-A, delta-9-tetrahydrocannabinolic acid A) which, in specific situations, could lead to the formation of the active substance. The Regulation also clarifies the relationship between hemp and food use.
The Regulation provides instructions for operators in the food sector and the competent authorities on the application of regulations on food hygiene and official inspections. The Regulation also provides clarification for the competent authorities and operators in the sector on foodstuffs derived from hemp that can be produced and placed on the market at a national level, without prejudice to the provisions of mutual recognition provided for in Article 7 of the draft decree.

9. Brief Statement of Grounds
The issue of this Regulation is necessary for the protection of health. This is pursuant to Article 5 of Council Regulation 315/1993/EEC, in anticipation of adoption of Community provisions.
Furthermore, said limits are defined pursuant to the national provisions provided for in Article 5 of Law No 242 of 2 December 2016.

10. Reference Documents - Basic Texts
Reference(s) to basic text(s): Law No 242 of 2 December 2016 “Provisions for the promotion of hemp cultivation and the related agro-industrial sector”, Article 5: attached

11. Invocation of the Emergency Procedure

12. Grounds for the Emergency

13. Confidentiality

14. Fiscal measures

15. Impact assessment

16. TBT and SPS aspects
TBT aspect

No - the draft has no significant impact on international trade.

SPS aspect

No - the draft is neither a sanitary nor phytosanitary measure.

European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043

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