Regulation (EU) 2026/1388 of the European Parliament and of the Council of 17 Jun... (32026R1388)
Regulation (EU) 2026/1388 of the European Parliament and of the Council of 17 June 2026 on plants obtained by certain new genomic techniques and their products, and amending Regulation (EU) 2017/625 (Text with EEA relevance)
- REGULATION (EU) 2026/1388 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
- of 17 June 2026
- on plants obtained by certain new genomic techniques and their products, and amending Regulation (EU) 2017/625
- (Text with EEA relevance)
- CHAPTER I
- General provisions
- Article 1
- Subject matter and objectives
- Article 2
- Scope
- Article 3
- Definitions
- Article 4
- Deliberate release of NGT plants for any purpose other than placing on the market, and placing on the market of NGT products
- CHAPTER II
- Category 1 NGT plants and category 1 NGT products
- Article 5
- Status of category 1 NGT plants and category 1 NGT products
- Article 6
- Procedure for the verification of category 1 NGT plant status for requests submitted prior to the deliberate release for any purpose other than placing on the market
- Article 7
- Procedure for the verification of category 1 NGT plant status for requests submitted prior to the placing on the market of NGT products
- Article 8
- System of exchange of information between the Commission, the Authority and Member States
- Article 9
- Database of decisions declaring category 1 NGT plant status
- Article 10
- Labelling of category 1 NGT plant reproductive material, including breeding material, and transparency of information
- Article 11
- Confidentiality
- CHAPTER III
- Category 2 NGT plants and category 2 NGT products
- Article 12
- Status of category 2 NGT plants and category 2 NGT products
- Section 1
- Deliberate release of category 2 NGT plants for any purpose other than placing on the market
- Article 13
- Notification referred to in Article 6 of Directive 2001/18/EC
- Section 2
- Placing on the market of category 2 NGT products for uses other than food or feed
- Article 14
- Notification referred to in Article 13 of Directive 2001/18/EC
- Article 15
- Specific provisions on monitoring
- Article 16
- Specific provision on analytical method performance requirements
- Article 17
- Labelling in accordance with Article 24
- Article 18
- Duration of the validity of the consent upon renewal
- Section 3
- Placing on the market of category 2 NGT plants for food or feed use and of category 2 NGT food and feed
- Article 19
- Scope
- Article 20
- Specific provisions on the application for authorisation referred to in Articles 5 and 17 of Regulation (EC) No 1829/2003
- Article 21
- Specific provisions on the opinion of the Authority
- Article 22
- Duration of the validity of the authorisation upon renewal
- Section 4
- Common provisions for category 2 NGT plants and category 2 NGT products
- Article 23
- Incentives for category 2 NGT plants and category 2 NGT products containing traits relevant for sustainability
- Article 24
- Labelling of authorised category 2 NGT products
- CHAPTER IV
- Final provisions
- Article 25
- Information requirements
- Article 26
- Exercise of the delegation
- Article 27
- Implementing acts
- Article 28
- Committee procedure
- Article 29
- Guidance
- Article 30
- Code of conduct
- Article 31
- NGT plant patent expert group and the assessment on the impact of NGT plant patenting
- Article 32
- Monitoring, reporting and evaluation
- Article 33
- Sustainability
- Article 34
- Member State controls
- Article 35
- References in other Union legislation
- Article 36
- Administrative review
- Article 37
- Amendments to Regulation (EU) 2017/625
- Article 38
- Entry into force and application
- ANNEX I
- CRITERIA OF EQUIVALENCE OF NGT PLANTS TO CONVENTIONAL PLANTS
- ANNEX II
- TRAITS REFERRED TO IN ARTICLE 3, POINT (13)(a), THAT EXCLUDE NGT PLANTS FROM CATEGORY 1 STATUS
- ANNEX III
- RISK ASSESSMENT OF CATEGORY 2 NGT PLANTS AND CATEGORY 2 NGT FOOD AND FEED
- PART 1
- General principles and information
- PART 2
- Specific information for the environmental risk assessment of category 2 NGT plants concerning hazard identification and hazard characterisation
- PART 3
- Specific information for the safety assessment of category 2 NGT food and feed concerning hazard identification and hazard characterisation
- ANNEX IV
- TRAITS REFERRED TO IN ARTICLE 23
- PART 1
- PART 2
Feedback