Review of Legal Acts
Council Regulation (EU) 2025/2257 on Fishing Opportunities with São Tomé and Príncipe
This regulation sets out the fishing quotas for EU member states in the waters of São Tomé and Príncipe, under the new Fisheries Partnership Agreement Protocol. It dictates the number of vessels from Spain, France, and Portugal that can fish for tuna and other species. Spain has been allocated 15 tuna seiners and 7 surface longliners, while France is assigned 11 tuna seiners and Portugal is permitted 2 surface longliners. This ensures that fishing activities are in line with the agreement.
Commission Regulation (EU) 2025/2222 on Health Claims Regarding Joselito® Ham
This regulation prohibits the use of specific health claims related to Joselito® ham. The manufacturer, Cárnicas Joselito S.A., sought authorization to claim that their ham could increase antioxidant substances, reduce blood pressure and plasma triglycerides, decrease oxidative stress, and prevent cardiovascular and intestinal diseases. However, the European Food Safety Authority (EFSA) found insufficient evidence to support these claims. The regulation, therefore, blocks Cárnicas Joselito S.A. from advertising or marketing their ham with the claim that it lowers blood LDL-cholesterol or blood pressure within the EU.
Commission Regulation (EU) 2025/2223 on Health Claims Regarding Citicoline and Memory
This regulation blocks the use of a specific health claim concerning citicoline and its effect on memory. An application was submitted to claim that citicoline supports memory function in healthy middle-aged and elderly persons experiencing age-related memory impairment. However, EFSA deemed the scientific evidence insufficient to support this claim. As a result, food businesses cannot legally claim that citicoline improves memory in such individuals when marketing food products within the EU.
Review of each of legal acts published today:
Directive (EU) 2025/2205 of the European Parliament and of the Council of 22 October 2025 on driving licences, amending Regulation (EU) 2018/1724 of the European Parliament and of the Council and Directive (EU) 2022/2561 of the European Parliament and of the Council, and repealing Directive 2006/126/EC of the European Parliament and of the Council and Commission Regulation (EU) No 383/2012 (Text with EEA relevance)
Directive (EU) 2025/2206 of the European Parliament and of the Council of 22 October 2025 amending Directive (EU) 2025/2205 as regards certain driving disqualifications
Commission Implementing Regulation (EU) 2025/2265 of 5 November 2025 amending Annexes V and XIV to Implementing Regulation (EU) 2021/404 as regards the entries for Canada, the United Kingdom and the United States in the lists of third countries, territories, or zones thereof authorised for the entry into the Union of consignments of poultry and germinal products of poultry, and of fresh meat of poultry and game birds
Commission Implementing Regulation (EU) 2025/2241 of 5 November 2025 amending Implementing Regulation (EU) 2019/627 as regards post-mortem inspections of bovine animals, sheep and goats
Commission Implementing Regulation (EU) 2025/2237 of 29 October 2025 on the registration of the geographical indication Antep Lahmacunu / Gaziantep Lahmacunu (PGI) in the Union register of geographical indications pursuant to Regulation (EU) 2024/1143 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2025/2236 of 29 October 2025 on the registration of the geographical indication Hatay Kaytaz Böreği (PGI) in the Union register of geographical indications pursuant to Regulation (EU) 2024/1143 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2025/2228 of 29 October 2025 on the registration of the geographical indication Etyeki Pezsgő (PDO) in the Union register of geographical indications pursuant to Regulation (EU) 2024/1143 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2025/2239 of 29 October 2025 on the registration of the geographical indication Fragola della Basilicata (PGI) in the Union register of geographical indications pursuant to Regulation (EU) 2024/1143 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2025/2250 of 4 November 2025 amending and correcting Annex I to Implementing Regulation (EU) 2023/594 laying down special disease control measures for African swine fever
Commission Implementing Regulation (EU) 2025/2216 of 4 November 2025 amending Implementing Regulation (EU) 2023/2757 imposing a definitive anti-dumping duty on imports of imports of trichloroisocyanuric acid originating in the People’s Republic of China following a partial interim review pursuant to Article 11(3) of Regulation (EU) 2016/1036 of the European Parliament and of the Council
Commission Regulation (EU) 2025/2240 of 5 November 2025 amending Regulation (EU) 2023/1442 as regards the transitional measures for plastic materials and articles manufactured with salicylic acid or untreated wood flour or fibres
Commission Regulation (EU) 2025/2225 of 5 November 2025 amending Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards magnesium L-threonate as a source of magnesium used in the manufacture of food supplements
Commission Regulation (EU) 2025/2224 of 5 November 2025 amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of the Council and Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards monosodium salt of L-5-methyltetrahydrofolic acid as a source of folic acid added to foods and as a source of folate used in the manufacture of food supplements
Council Regulation (EU) 2025/2257 of 29 September 2025 on the allocation of fishing opportunities under the Protocol on the implementation of the Fisheries Partnership Agreement between the Democratic Republic of São Tomé and Príncipe and the European Community (2025–2029)
This Council Regulation (EU) 2025/2257 concerns the allocation of fishing opportunities for EU member states under the new Protocol (2025-2029) implementing the Fisheries Partnership Agreement between the EU and the Democratic Republic of São Tomé and Príncipe. The regulation specifies how many fishing vessels from each member state are allowed to fish in the waters of São Tomé and Príncipe. This ensures that the fishing activities are distributed according to the terms of the Protocol.
The regulation is structured into two articles. Article 1 defines the specific allocation of fishing opportunities among the member states, dividing them by type of vessel (tuna seiners and surface longliners) and specifying the number of vessels each member state (Spain, France, and Portugal) is permitted to operate. Article 2 stipulates the regulation’s entry into force and the date from which it applies, aligning with the provisional application of the Protocol itself. There are no previous versions mentioned in the act.
The most important provision is Article 1, which clearly states the number of vessels each member state can have actively fishing. For tuna seiners, Spain is allocated 15 vessels, and France is allocated 11 vessels. For surface longliners, Spain is allocated 7 vessels, and Portugal is allocated 2 vessels. This allocation is crucial for member states’ fishing industries and for ensuring compliance with the Fisheries Partnership Agreement.
Commission Regulation (EU) 2025/2222 of 4 November 2025 refusing to authorise a health claim made on foods and referring to the reduction of disease risk
This Commission Regulation (EU) 2025/2222 addresses the authorisation of a specific health claim made on foods, specifically concerning Joselito® ham. The core of the regulation is the refusal to authorize a health claim submitted by Cárnicas Joselito S.A. regarding the effects of their Joselito® ham on increasing antioxidant substances, reducing blood pressure and plasma triglycerides, decreasing oxidative stress, and preventing cardiovascular and intestinal diseases.
The regulation consists of a preamble outlining the legal basis and reasoning behind the decision, followed by two articles and an annex. The preamble references Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, which requires health claims to be authorized by the Commission based on scientific evidence assessed by the European Food Safety Authority (EFSA). It details the application process, EFSA’s evaluation, and the factors the Commission considers in making its decision. The key element is EFSA’s opinion that a cause-and-effect relationship between Joselito® ham consumption and the claimed health benefits (reduction of blood LDL-cholesterol concentration or blood pressure) could not be established based on the data provided. Article 1 explicitly states that the health claim described in the annex will not be included in the Union list of permitted health claims. Article 2 specifies the date of entry into force of the regulation. The annex provides a summary of the rejected health claim, referencing the relevant provisions of Regulation (EC) No 1924/2006, the food in question (Joselito® ham), the specific claim made, and the EFSA opinion reference.
The most important provision is Article 1 in conjunction with the Annex, which clearly prohibits the use of the specific health claim related to Joselito® ham. This means that Cárnicas Joselito S.A. cannot legally advertise or market their ham with the claim that it reduces blood LDL-cholesterol concentration or blood pressure in the European Union.
Commission Regulation (EU) 2025/2223 of 4 November 2025 refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children’s development and health
This Commission Regulation (EU) 2025/2223 addresses the authorization of health claims made on foods, specifically those not related to disease risk reduction or children’s health and development. It outlines the process for submitting health claims, the European Food Safety Authority’s (EFSA) role in assessing these claims, and the Commission’s decision-making process. The core of the regulation is the refusal to authorize a specific health claim regarding citicoline and its effect on memory. This decision is based on EFSA’s scientific opinion, which found insufficient evidence to support the claimed effect.
The structure of the act is straightforward. It starts with recitals that provide context and legal basis, followed by two articles that constitute the operative part of the regulation, and an annex that specifies the rejected health claim. The recitals explain the regulatory framework established by Regulation (EC) No 1924/2006, the procedure for health claim applications, EFSA’s assessment, and the Commission’s decision-making process. Article 1 explicitly states that the health claim detailed in the Annex will not be included in the Union list of permitted health claims. Article 2 specifies the date of entry into force. The Annex provides details of the rejected claim, including the applicant, the substance (citicoline), the specific claim made, and the reference to EFSA’s opinion. This regulation does not introduce changes compared to previous versions, but rather applies existing rules to a specific case.
The most important provision is Article 1 in conjunction with the Annex, which directly prohibits the use of the specific health claim regarding citicoline’s effect on memory in food labeling and advertising within the EU. This means that food business operators cannot legally claim that citicoline supports memory function in healthy middle-aged and elderly persons encountering age-related memory impairment. This regulation serves as a precedent for future health claim assessments and highlights the importance of robust scientific evidence in supporting such claims.
