MOODY NEWS — October 13, 2026.

New development

Attraction services: register ties registration to safety evidence

Bulgaria · Attraction services and conformity assessment · Promulgated decree

In the State Gazette, issue 94 of October 13, 2026, Decree No. 187 on the register of providers of high-risk attraction services was promulgated. The documentary package includes a safety plan, insurance documents and evidence of compliance and initial inspection. Where documents from the manufacturer are missing, the electronic file must contain a conformity assessment certificate issued by an accredited body. Until the introduction of the register, applications are submitted via secure electronic delivery or another admissible electronic channel. The Ministry of Tourism must announce the start date of operation. Providers, municipalities and assessment bodies should check the completeness of the evidence; promulgation does not mean that the register is already operational.

Indexation of construction contracts: quarterly report with acts and protocols

Bulgaria · Construction and Public Procurement · Decree — effective from October 13

From October 13, 2026, Decree No. 184 changes the methodology for indexation of public procurement contracts as a result of inflation. In construction, the quarter of actual performance is the leading quarter, not the moment of acceptance. Within 30 days after the relevant quarter, the parties draw up an interim report on the type, quantity and value of the works. The acts and protocols under Regulation No. 3 of 2003 and the remaining contractual evidence are attached to it. Advance payments and other inflationary changes are taken into account. Contracting authorities, builders and consultants must synchronize construction records, financial calculations and the audit trail. Unfinished written requests for indexation are completed according to the new procedure.

Bird flu: new zones and longer restrictions in Plovdiv region

EU / Bulgaria · Poultry farming and chain safety · Implementing Decision - updated measures

Implementing Decision (EU) 2026/2295 published on 13 October 2026 updates the zones for highly pathogenic avian influenza. A new outbreak in the Plovdiv district is included for Bulgaria, and delayed cleaning and disinfection extends the measures around the outbreak BG-HPAI(P)-2026-00011. For it, the protection zone is indicated until 2 November, and the surveillance zone until 11 November. For BG-HPAI(P)-2026-00013, the relevant dates are 6 and 15 November. Poultry farms, transporters and suppliers must match their addresses with the exact territorial scope and the current national orders. The dates are minimum periods of the measures, not automatic movement authorisation. The old reminder of 27 October does not cover all affected areas.

EU and Turkey publish AEO mutual recognition regime

EU / Turkey Customs and security of supply Decision published - provisional entry into force

Decision No 1/2026 of the EU-Turkey Customs Cooperation Committee on the mutual recognition of Authorised Economic Operator programmes was published on 13 October 2026. It was adopted on 16 July and covers security and safety, including the European AEOS authorisation. It provides for fewer checks on this risk profile, priority checks and trade continuity mechanisms. Entry into force is subject to mutual notification of completed procedures; today's publication does not prove that the facilitations are already applied. Exporters and logistic operators should check the scope of the authorisation, the identification data and the practical instructions of customs. The decision does not automatically recognise product certificates or CE conformity.

FDA allows salt substitutes in foods with standardized identity

United States · Food and Exports · Final Rule - Effective December 14

FDA published a final rule on October 13, 2026, permitting salt substitutes in covered foods with regulatory identity when salt is a required or permitted ingredient. The rule takes effect on December 14. The substitute must be safe and suitable, reduce sodium, and perform the functions of the salt it replaces without changing the basic nature and essential characteristics of the food. Manufacturers and exporters to the United States should review the specific product standard, formulation, labeling, and safety evidence. The change is not a blanket authorization for any ingredient. The dairy product amendments in parts 131 and 133 are open for objections until November 12.

EPA postpones start date for certain emergency plans until 2030

United States · Industry and Environmental Compliance · Final Rule - Future Deadline Change

In a final rule published on October 13, 2026, EPA is postponing the initial deadline for certain Clean Water Act hazardous substance emergency response plans from June 1, 2027, to June 1, 2030. The amendment is effective December 14, 2026, and affects covered non-transportation land-based facilities that may cause significant harm to water. Separate deadline rules remain for new facilities and subsequent changes. European groups with U.S. sites must verify applicability under 40 CFR 118.3 and update their records of obligations and preparedness plans. The postponement does not waive other environmental and emergency obligations.

Strategic Watch

FDA Finalizes Guidance for Manufacturing Changes for Biosimilars

USA · Biopharmacy and laboratory evidence · International strategic signal - final direction

On October 13, 2026, the FDA issued final guidance for manufacturing changes after authorization of biosimilars and interchangeable biosimilars. It supersedes the July 2024 draft and clarifies information on the different notification categories, analytical comparability, and quality evidence, consistent with ICH Q5E. Products authorized under the 351(k) procedure are covered, including changes to processes, equipment, and sites. Authorization holders, contract manufacturers, and laboratories should review the management of changes, validation, and scientific justification of comparative data. The guidance is advisory and not a new stand-alone regulatory regime; existing notification and approval obligations are not waived. No general transition deadline has been announced.

Planting potatoes from botanical seeds: new tests and labels from 2028.

EU · Seed production and phytosanitary testing · Directive adopted - future implementation

Implementing Directive (EU) 2026/2250, published on 13 October 2026, adapts the requirements for seed potatoes produced from true botanical seed. It makes the production of pre-basic material subject to official testing or testing under official supervision and provides for the testing of a representative sample of seeds for Potato spindle tuber viroid. A specific indication on the label for the varieties concerned is also added. Member States must adopt national measures by 31 December 2027 and apply them from 1 January 2028. Seed producers, laboratories and control authorities should plan for methods, traceability and labelling. This is an adopted future regime and not an immediate obligation from today.

Published by MG Global in partnership with ERPI.