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Notice in the language of complainants
- 28 JULY 2026
Notice in English (can be automatically translated)
Information about the state of play of the multiple complaint registered under reference CPLT(2024)02420 concerning the Italian Decree of 27 June 2024 classifying cannabis derived CBD for oral consumption as a pharmaceutical active ingredient
This communication provides information about the state of play of the series of complaints registered under the above reference number.
The complaints claim that the Ministerial Decree of 27 June 2024 results in a ban on commercialisation of CBD for oral consumption derived from Cannabis sativa extract and allege that it would breach Articles 34, 36 and 101 of the Treaty on the Functioning of the EU (TFEU), Regulation (EU) No 1308/2013, (1) Regulation (EU) No 1307/2013 (2) and Directive (EU) 2015/1535. (3)
The Commission has not been in a position to finalise its assessment of the complaints, for the following reasons.
On 16 July 2025, the Commission adopted a proposal for a Regulation amending Regulation (EU) No 1308/2013 (4) which refers to scientific evidence providing that hemp varieties with levels of THC up to 0,3% present low risk for human health. This proposal, which appears relevant to the assessment of the complaint, is currently being considered by the co-legislators.
It is also noted that, with ordinance of 11 November 2025 (5), the Italian Council of State referred some questions to the Court of Justice of the European Union for a preliminary ruling. In particular, the Court of Justice is called upon to interpret the relationship between Articles 34-36 of the TFEU and the Italian legislation, including the Presidential Decree No 309/90 also mentioned in the complaint, that limits the production and marketing of cannabidiol extracted from leaves and inflorescences of cannabis sativa plants with a THC content below the threshold provided in Regulation (EU) No 1307/2013 (as repealed by Regulation (EU) 2021/2115 (6)).
Moreover, the Court is asked to consider the relationship between the Italian legislation and the Regulations (EU) No 1308/2013 and 1307/2013 (as repealed by Regulation (EU) 2021/2115), possibly also in the light of the abovementioned Commission’s proposal.
The Commission is also informed that the contested Ministerial Decree was challenged before the Italian Council of State, which temporarily suspended the application of the Decree (7).
The Commission will inform the complainants through this website of any next steps it decides to take in accordance with the Commission Communication ‘EU law: Better results through better application’. (8).
[1] Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007, OJ of 20.12.2013, L 347/671, as amended.
[2] Regulation (EU) No 1307/2013 of the European Parliament and of the Council of 17 December 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) No 637/2008 and Council Regulation (EC) No 73/2009, OJ of 20.12.2013, L 347/608, repealed.
[3] Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services, OJ of 17.9.2015, L 241/1([4] Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) No 1308/2013 as regards the school fruit, vegetables and milk scheme (‘EU school scheme’), sectoral interventions, the creation of a protein sector, requirements for hemp, the possibility for marketing standards for cheese, protein crops and meat, application of additional import duties, rules on the availability of supplies in time of emergencies and severe crisis and securities, COM/2025/553 final.
[5] Ordinanza N. 08813/2025, REG.PROV.COLL. N. 07267/2023 REG.RIC.
[6] Regulation (EU) 2021/2115 of the European Parliament and of the Council of 2 December 2021 establishing rules on support for strategic plans to be drawn up by Member States under the common agricultural policy (CAP Strategic Plans) and financed by the European Agricultural Guarantee Fund (EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and repealing Regulations (EU) No 1305/2013 and (EU) No 1307/2013, OJ L 435, 6.12.2021, p. 1.
[7] Ordinanza cautelare, N. 09053/2025 REG.RIC.
[8] C(2016)8600.