New development
New and extended avian influenza zones in Bulgaria
EU / Bulgaria · poultry farming and veterinary control · adopted act · new development
Implementing Decision (EU) 2026/2395 published on 26 October adds protection and surveillance zones around a new outbreak of highly pathogenic avian influenza in the Stara Zagora district. Restrictions have also been extended for three outbreaks in the Plovdiv district due to the later completion of cleaning and disinfection. For Rakovski, the protection measures are foreseen until at least 3 November, and for the new outbreak around Elenino and Hristiyanovo — until 21 November, with subsequent surveillance until 30 November. Farms, transporters and traders must check the specific site and route against the current annex and national measures. The expiry of a specified date does not automatically mean a permit to move.
EU recognises equivalence of active substance controls in Singapore
EU / Singapore · pharmacy and GMP · adopted act · regulatory equivalence
By Implementing Decision (EU) 2026/2347, the European Commission adds Singapore to the list of third countries with an equivalent regulatory framework for active substances for medicinal products for human use. The act was published on 26 October and will enter into force on 15 November 2026. The decision follows a documentary assessment and an on-site visit, including observation of inspections in March. For European importers and manufacturers, this is a reason to review the documentary requirements for suppliers and the evidence of regulatory supervision. The recognition concerns the specified control system; it does not constitute an authorisation for an individual medicinal product and does not waive the need for qualification of suppliers and compliance with applicable GMP requirements.
Approvals of active plant protection substances have been extended
EU · plant protection and market access · adopted regulation · transitional periods
Implementing Regulation (EU) 2026/2348, published on 26 October, extends the approval periods of a number of active substances for plant protection products until the renewal procedures are completed. The act enters into force on 29 October 2026, and the new expiry dates vary for each substance. For example, buprofezin is set at 15 March 2027, and for amidosulfuron at 31 August 2027. Authorisation holders, suppliers and farms should update their substance- and product-specific registers. The extension is not a definitive renewal, does not replace national product authorisations and does not in itself change the permitted residue levels in food.
New training requirements for US-flagged passenger ships come into effect
USA · maritime transport and personnel competence · current rule · new stage
The U.S. Coast Guard’s final rule for personnel on U.S.-flagged passenger ships carrying more than 12 passengers on international voyages will take effect on October 26, 2026. It requires familiarization with passenger ship emergency procedures and expands the scope of passenger management training for certain categories of seafarers. Operators and crews must have evidence of the training conducted available upon inspection. For Bulgarian manning agencies and training centers, the practical step is a comparison of positions, programs, and records with U.S. requirements. This is a new stage under the September 25 act, not a new universal obligation for all ships.
NRC introduces rule for using evidence from already authorized reactor designs
United States · nuclear energy and technical demonstration · final rule · future implementation
On October 26, the U.S. Nuclear Regulatory Commission published final amendments that allow the licensing of commercial reactors to use relevant information from previously authorized federal reactor designs. The rule goes into effect on November 25, 2026, and applies to facilities that have been tested and demonstrated to be capable of safe operation. The applicant must explain how the characteristics of the previous authorization satisfy the NRC’s requirements. For developers and international engineering providers, this means carefully structuring test results, design rationale, and traceability of evidence. A previous federal authorization does not automatically translate into a license for commercial operation.
Upcoming deadlines
Last week for opinions on seed import rules
Bulgaria · agriculture, certification and laboratories · consulting · T–7
The public consultation on the draft amendments to the Act on Seed and Propagating Material ends on 2 November 2026. This is a reminder with seven days remaining, not a new law: the draft was published on 1 October. The proposed Articles 57–59 specify certificates and labels for imports, including OECD and ISTA documents for the relevant categories, as well as laboratory checks based on risk analysis. Importers, suppliers and laboratories should check the traceability between batches and accompanying documents, the envisaged exceptions and the practical feasibility of the deadlines. The remaining week allows for specific difficulties and proposals to be presented to the Ministry of Agriculture and Food.
FDA accepts comments on VIP information exchange until November 2
USA · medical devices and manufacturer assessment · consultation · T–7
FDA is accepting comments on the continuation of the Voluntary Improvement Program for eligible medical device manufacturers through November 2, 2026. This reminder comes with seven days remaining before the November 2 deadline set out in the October 1 notice. The program uses independent assessments of organizational capabilities and performance facilitated by the Medical Device Innovation Consortium, but the consultation is about information sharing and administrative burden. It does not create a new mandatory certification scheme and does not replace applicable regulatory requirements. Manufacturers and evaluators should review what data is being provided, who is accountable, and whether the efforts described reflect real-world practice before submitting a comment.
Canada discusses uniform requirements for workplace first aid kits
Canada · OHS and standardized first aid kits · consultation · T–7
The Canadian draft to harmonize workplace first aid kits through the CSA Z1220 standard is open for comments until November 2, 2026. The proposal was published on October 3 and proposes changes to five Canada Labour Code regimes applicable to federally regulated employers. It affects the composition and selection of kits, but is not yet a new requirement. Suppliers to the Canadian market and international organizations with local operations will find it useful to compare their product specifications, risk assessment and internal OH&S procedures with the draft. The remaining seven days provide an opportunity to point out practical difficulties without automatically assuming mandatory certification of every kit.
Strategic Watch
NRC confirms ASME OM-2 component testing guideline
USA / international sector · nuclear facilities and testing · international strategic signal · confirmed direction
On October 26, the NRC confirmed the final status of Regulatory Guide 1.220, Revision 0, for the Acceptability of the ASME OM-2 Code for Testing Components in Nuclear Facilities. The guidance adopts the 2024 edition with the regulatory positions as the approach for developing and implementing in-service testing programs. It is effective August 18, 2026; today’s notice confirms that no significant adverse comments have been received requiring change. It is important for engineering providers and testing organizations to verify the specific acceptance conditions and compliance of their procedures. This does not automatically make the code mandatory for every facility or legally enforceable in the EU.
NHTSA proposes changes to testing and management of automotive lights
USA · automobiles, components and testing laboratories · consultation · draft technical rule
The US NHTSA published on 26 October a draft amendment to FMVSS No. 108 on automotive lighting, with comments due by 25 November 2026. The proposal concerns test conditions for certain headlamps and design limitations, as well as controls and indicators for vehicles with automated driving systems without manual controls. Voluntary light markings for such systems are also being discussed. This is a draft, not a new, effective technical obligation. Vehicle and component manufacturers, as well as test laboratories, should align the affected procedures and product configurations with the proposal. The US process does not automatically change the EU type-approval requirements.
Published by MG Global in partnership with ERPI.
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