MOODY NEWS — October 23, 2026.

New development

EA BSA updates the schedule for ISO 14001:2026

Bulgaria · Accreditation and Environmental Management Systems · New Accreditation Guideline

On October 23, the Bulgarian Accreditation Service published an updated approach for transition to BDS EN ISO 14001:2026. The new table provides for the acceptance of applications for initial accreditation and re-accreditation only under the new version after October 31, 2026. Certification bodies must submit a declaration and evidence of transition by January 31, 2027; the transition of certified clients is completed by April 30, 2029. This is a national accreditation guidance, not a new publication of the standard. Bodies should update plans, competence and communication with clients, using the new timetable instead of the earlier preparatory communication.

National milestones for ISO 9001:2026 have been set

Bulgaria · Accreditation and Quality Management · Transition Accreditation Rule

The Bulgarian Agency for Quality Assurance (BAA) published its approach to transition to BDS EN ISO 9001:2026 on October 23. After March 31, 2027, the agency will accept applications for initial accreditation and re-accreditation only under the new version. Certification bodies must submit a declaration with an analysis of changes, a plan, updated procedures and records of competence by April 30, 2027. The transition of certified clients must be completed by September 30, 2029. Accredited certificates under the new version can be issued after a successful transition and a re-issued accreditation certificate. The practical task is to coordinate the audit programs and personnel training with the individual national stages.

New schedule for certifying authorities

Bulgaria · Certification of Persons · Transition Accreditation Rule

On October 23, the BSA Executive Agency announced the national approach for the transition to BDS EN ISO/IEC 17024:2026. Bodies for certification of persons must submit a declaration and evidence of readiness by March 31, 2028, and the transition must be completed by March 31, 2029. After October 1, 2027, initial accreditations and reaccreditations will be assessed against the new version. The guidance highlights changes in impartiality, translations, recertification and the use of artificial intelligence. Bodies should map the affected processes, plan training and provide records of internal audit and management review. This is a specific national transition, not just a strategic expectation.

New evidence and procedures for unlicensed drugs

Bulgaria · Healthcare and pharmaceutical supplies · Amendment to regulation published

The amendments to Regulation No. 10 of 2011, promulgated on 23 October, specify the control of receipt, storage and dispensing of unauthorized medicinal products. Medical institutions must approve standard operating procedures by 23 December 2026. Upon delivery, the wholesaler provides a batch certificate of quality or batch release, a declaration of compliance with Good Distribution Practice and documents on the quantity and remaining shelf life. This is an adopted change with a separate organizational deadline, not a project. Hospital pharmacies and suppliers should verify incoming control, responsibilities and traceability records with the new requirements.

Firefighting equipment on vehicles has been specified

Bulgaria · Fleets and fire safety · Published technical requirement

The amendment to Regulation No. I-45, published on October 23, introduces differentiated requirements for fire extinguishers according to the category, mass and locations of the vehicle. For category M1 up to 3.5 tons and for N1, at least one powder fire extinguisher with a minimum of 1 kg of powder is provided for classes A, B and C. For heavier categories, the requirements are different; maintenance under the Road Traffic Act is also required. The regulation enters into force on October 27, 2026. Fleet managers should check the category of each vehicle, the available equipment and the evidence of its maintenance, without applying a common minimum to all vehicles.

Transition to electronic certificates for registration of new vehicles

Bulgaria · Automobiles and proof of conformity · Adopted change with a transitional period

The amendment to Regulation No. I-45, published on 23 October, sets out the transition for the presentation of EU certificates of conformity for the initial registration of new vehicles. Until 29 November 2026, the owner shall present the valid original issued by the manufacturer. After this date, for categories M, N, O and L, the original documents will not be required when an electronic certificate is available under the regulation. The condition of electronic availability is essential: the abolition of the paper document does not mean the abolition of the proof of conformity. Manufacturers, importers and dealers must verify the electronic exchange and the coincidence of identification data before applying for registration.

Special limit for sterols in two varieties of olive oil

EU · Food and laboratory testing · Delegated regulation adopted

Delegated Regulation (EU) 2026/2358, published on 23 October, amends the marketing standards for olive oil and enters into force on 24 October. For single-varietal extra virgin olive oil from Koroneiki or Nocellara del Belice, a total sterol content of at least 800 mg/kg is permitted. This is a limited exception and not a general lowering of the limit for all oils. The relevant variety must be indicated on the label and accompanying documents. Producers, importers and laboratories should update the specifications and rules for evaluating the results, combining chemical analysis with reliable proof of varietal identity.

New documentary checks along the olive oil chain

EU · Food, inspection and traceability · Regulation on conformity checks adopted

Implementing Regulation (EU) 2026/2342 updates the conformity checks for olive oil from 24 October, the day after its publication. Operators from the milling stage to bottling must identify extra virgin olive oils produced exclusively from Koroneiki or Nocellara del Belice. Upon request by the Member State, the operator responsible for labelling must provide documents demonstrating compliance with the relevant requirements, including the new variety designation. This concerns the chain of custody and not only the laboratory limit for sterols. Businesses should link batch records, supplier data and analysis results to the specific label and verify the possibility of rapid presentation during controls.

Strategic Watch

Consultation on transferring wine control to the Bulgarian Food Safety Agency

Bulgaria · Wine, official control and laboratories · Official consultation on a draft law

By November 5, the Ministry of Agriculture and Food is accepting opinions on a project to merge the Executive Agency for Vine and Wine into the Bulgarian Agency for the Protection of Vine and Wine. The bill published on October 22 provides for the transfer of laboratories in Plovdiv and Sofia, registers and control functions, including the organization of isotope analyses. The project preserves the validity of issued acts and certificates until their expiration. The proposed start date is January 1, 2027, but the change has not yet been adopted. Wineries and laboratory partners should assess the continuity of samples, documents and ongoing proceedings and submit specific opinions.

A change to the seed control authority is proposed.

Bulgaria · Seed material and conformity assessment · Official consultation on draft law

The Ministry of Agriculture and Rural Development has put forward a draft amendment to the Law on Seed and Propagating Material for public consultation with a deadline for comments of November 5, 2026. The text of October 22 provides that the functions currently assigned to the Executive Agency for Variety Testing, Approbation and Seed Control will be transferred to the Executive Agency for Selection and Reproduction in Agriculture. The proposed effective date is January 1, 2027; this does not mean that the competent authority has already changed. Seed producers and traders should check the consequences for applications, control procedures and document flows. Comments may raise questions about the continuity of services and clearly defined transitional rules.

EU recommends expanded monitoring of nitrosamines in food

EU · Food safety and laboratories · New non-binding recommendation

Recommendation (EU) 2026/2329, published on 23 October, guides Member States and food businesses on the monitoring of N-nitrosamines in different food groups. The document covers at least ten compounds and provides for appropriate analytical methods and a structured submission of data to EFSA. For most of these compounds, a limit of quantification below 1 μg/kg is recommended, with a specific approach for N-nitrososarcosine. These are requirements for the sensitivity of the analysis and not new maximum levels in foods. Laboratories and operators should review the scope of the methods, sampling and data quality before planning monitoring programmes.

FDA consults on accountability in ASCA program

US/International Laboratories Medical Device Accreditation and Testing Formal Consultation

FDA opens new round of consultation on Accreditation Scheme for Conformity Assessment (ASCA) program. The October 23 notice is to renew approval for reporting under the U.S. Administrative Burden Regime; comments are being accepted until November 23, 2026. It covers applications, continued participation, and reporting for accreditation bodies and testing laboratories. ASCA remains a voluntary program, and the document does not introduce a new general accreditation scheme. Participants and medical device manufacturers should consider the documentary burden and review the distinction between laboratory accreditation, FDA recognition, and use of results in regulatory submissions.

Published by MG Global in partnership with ERPI.