New development
Chlorpyrifos has been added to the persistent organic pollutants regime
Delegated Regulation (EU) 2026/1423, published on 10 September, adds chlorpyrifos to Annex I of the persistent organic pollutants regime. The act enters into force on 30 September 2026 and does not provide for exemptions for specific uses. The permitted unintentional trace contamination is limited to 0.01 mg/kg in substances, mixtures and articles. This is not a new maximum residue limit for residues in food and should not be confused with the previous non-approval of the pesticide. Manufacturers, importers and laboratories should check the material specifications, information from suppliers and the suitability of analytical methods to detect such low concentrations.
New restricted areas for sheep and goat pox in Bulgaria
Implementing Decision (EU) 2026/2052, published on 10 September, updates the areas for sheep and goat pox following thirteen additional outbreaks between 20 and 31 August. The newly affected districts include Kardzhali and Yambol. For certain parts of them, the protection measures are indicated until 6 October and the surveillance measures until 24 October 2026; other districts have different deadlines. Breeders, transporters and traders must check the exact geographical applications, permitted movements and veterinary documents before each delivery. This is not a uniform ban for the whole country and the indicated end date does not exclude a subsequent extension.
Updated bird flu zones and missed deadline for the common framework
By Implementing Decision (EU) 2026/2056, published on 10 September, the Commission updated the zones following outbreaks of highly pathogenic avian influenza in the Plovdiv region and the French department of Maine-et-Loire. For the Bulgarian zones covered, 27 September for protection and 6 October 2026 for surveillance were specified. At the same time, Article 5 of Decision 2023/2447, which limited the application of the general framework to 30 September, was deleted. This does not make the individual local restrictions indefinite. Poultry farms, traders and veterinary compliance officers should check the location, applicable deadlines and documents for movements of birds and products.
Corrected Bulgarian text for the import of dogs and cats
Corrigendum 2026/90764, published on 10 September, removes Australia from the Bulgarian text of Article 2(1) of Decision 2006/146/EC. The general prohibition in this provision thus applies to dogs and cats from Peninsular Malaysia, as in the English text. This is a linguistic correction and not a new general import authorisation from Australia. The separate Article 3 for Australian cats and its conditions remain applicable. Veterinary professionals, operators and intermediaries should update their Bulgarian reference materials and check the full regime and accompanying documents rather than relying on the isolated corrected text.
New guideline for pharmacovigilance inspections applies from today
The second edition of Module III of the EMA Good Pharmacovigilance Practices has been applicable since 10 September 2026. The document was dated 4 September and published on 9 September. It reflects the legal provisions on subcontracting, clarifies remote inspections and updates risk-based planning. Subcontractors can also be inspected when the relevant contractual clause is not already included. Marketing authorisation holders and their partners should check contracts, access to records, the system master file and the readiness to provide documents. The guidance is not a stand-alone new regulation.
EMA updates guidance on medicinal product data under Article 57
On 9 September, EMA published version 3.21 of the detailed guidance on electronic submission of medicinal products under Article 57 and version 1.15 of the accompanying questions and answers. The changes concern, among other elements, the applications for multilingual markets, MedDRA coding and the description of the packaging. The updated clarifications also reflect the new XEVMPD web interface. Marketing authorisation holders should check the submission rules, data quality controls and working instructions. The publication does not establish a new general registration deadline of 9 September; the earlier date mentioned in the version history should not be interpreted as a new retroactive obligation.
FDA announces interim policy for preparation of neonatal nutritional solutions
In the September 9 Federal Register, FDA announced an interim policy for the preparation of certain initial parenteral nutrition solutions for newborns. The guidance provides limited regulatory flexibility through March 8, 2027, for specific formulations and conditions. The regimes for licensed pharmacies and registered external compounding facilities differ; this is not a blanket exemption from good manufacturing practices. Organizations involved in the U.S. supply chain should verify acceptable formulations, shelf life, stability, and integrity of the container-closure system. The policy does not constitute a marketing authorization in the EU and should not be extrapolated to other products.
Upcoming deadlines
One week left until the new construction product rating systems
Delegated Regulation (EU) 2026/1310 on the systems of assessment and verification under the new regime for construction products enters into force on 17 September 2026. This alert is a reminder T-7 and not a new publication of the act of 28 August. The regulation sets out horizontal rules and a breakdown by product family, including a 3+ system for environmental sustainability characteristics. Manufacturers, notified bodies and laboratories should identify which system and technical specification apply to the specific product. Entry into force alone does not mean an automatic replacement of all certificates or a universal re-testing; the applicable transitional conditions need to be checked.
Opinions on the amendment to M/613 on AI are being accepted until September 17
The period for feedback on the draft amendment to Decision C(2025)3871 relating to standardisation request M/613 on high-risk artificial intelligence systems is open until 17 September 2026. The period has been confirmed in the official register of the European Commission. This is a T-7 reminder on a consultation already covered, not a published harmonised standard. Developers, implementers, assessment bodies and AI governance professionals can check whether the draft reflects realistic needs for testing, documentation and demonstration of conformity. The consultation itself does not change the deadlines of the AI Act and does not provide a presumption of conformity.
Strategic Watch
British commission proposes phased authorization and ongoing oversight of medical AI
On 10 September, the National Commission for the Regulation of AI in Healthcare published recommendations for the future UK framework. These include phased authorisations based on clinical need, maturity of evidence and risk control, and monitoring of real-world outcomes throughout the life cycle. These are recommendations, not pre-established rules or new authorisation for a specific product. Medical AI manufacturers, including European exporters, should assess their readiness for traceable clinical evidence, change management and post-market surveillance. The next important stage is a formal response from government and regulators, rather than a supposed automatic mutual recognition.
EA BSA invites assessment bodies to a survey on the use of AI
In an invitation dated 8 September, the Bulgarian Accreditation Service (BAS) is inviting conformity assessment bodies to a survey by the European Accreditation Organisation on the use of artificial intelligence. Responses are being accepted until 25 September 2026. The survey covers both current use and planned implementation and will support the development of resources and more consistent assessment by accreditation bodies. This is the first reflection of an official early warning, not a new mandatory accreditation rule. Laboratories, inspection and certification bodies should identify applicable AI processes and assess participation without disclosing sensitive client data.
FDA opens up participation in discussion of flu vaccines for the Southern Hemisphere
An FDA notice dated September 9 announces a meeting of the Vaccine Advisory Committee on October 1, 2026, for the 2027 Southern Hemisphere influenza season. Written submissions that reach the committee in advance of the meeting are being accepted until September 24; requests for oral submissions have an earlier deadline of September 22. This is an advisory stage, not a final vaccine formulation or authorization. Manufacturers and laboratory partners can track the implications for antigen specifications, testing, and production planning. Participants should check the FDA’s official calendar for times, procedural requirements, and any changes.
EMA publishes timeline for clinical advice on high-risk devices in 2027.
On 9 September, EMA published a timetable for 2027 for advice to manufacturers of certain high-risk medical devices. For the first procedure, the final information package is due by 4 January, the start date is 18 January and the advice letter is due on 19 March 2027. The mechanism under Article 61(2) of the MDR supports clinical strategy and study planning; it is not a marketing authorisation or CE mark. Manufacturers of eligible class III devices and certain active class IIb devices should check the criteria and plan the pre-contact and evidence.
Separate EMA timetable for orphan devices in 2027.
EMA published on 9 September the separate regular timetable for support of orphan medical devices in 2027. The first final information package is due by 18 January, the procedure starts on 1 February and the advice letter is scheduled for 2 April 2027. The mechanism covers requests for designation and clinical advice for already designated devices. Manufacturers and notified bodies should distinguish this procedure from the general consultation for high-risk devices. Justification of limited clinical data and follow-up are particularly important; the status does not provide an automatic exemption from the MDR or CE marking.
Commission announces winter fishing restrictions in the Bay of Biscay
Communication C/2026/4829 of 10 September informs about a delegated act adopted by the Commission on 4 September to reduce incidental catches of cetaceans. For certain vessels over eight metres and fishing gears in French waters of the Bay of Biscay, an optional thirty-day suspension is described between 15 January and 27 February 2027, with notification by 8 January. In the absence of an option, the period 22 January–20 February is indicated. The alert reflects the official announcement, not the confirmed entry into force of the regulation itself. Operators and buyers should check the final legal status, applicable gears and the impact on delivery schedules.
EFTA Court clarifies the limits of ex post correction of an environmental assessment
On 10 September, the Official Journal published the operative part of the judgment of the EFTA Court of 28 April 2026 in case E-17/25 concerning the strategic environmental assessment. The Court held that the omission could not be justified solely on the grounds that the assessment would not have changed the outcome. Subsequent removal is permissible exceptionally, without circumventing the rules and covering impacts after the start of implementation. Investors, consultants and auditors of project files should check the evidence and the time scope of the assessments. This is a judicial interpretation in the EEA, not a new Bulgarian law or an automatic invalidation of every project.
Lithuania proposes excise stamps for e-cigarette liquids
A Lithuanian draft, received in the TRIS system on 9 September under the number 2026/0489/LT, provides that e-cigarette liquids sold in the country will carry special excise stamps from 1 July 2027. The proposal aims at the identification and control of excise goods regardless of their origin. It is not an adopted law and does not establish new requirements for the chemical composition of liquids. Manufacturers, importers and European suppliers should assess possible changes in packaging, marking and traceability and monitor the final text. The practical risk lies in the preparation of a market-specific process, not in a supposed immediate obligation.
Published by MG Global in partnership with ERPI.
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