New development
Large combustion plants: notification without undue delay
Bulgaria · industrial emissions and monitoring · entry into force
From October 6, the amendments to Decree No. 173 in the ordinance on emissions from large combustion installations have been applied. In the monitoring section, a requirement has been added that the relevant notification by the operator and the taking of the measures requested by the RIEW should be done without unnecessary delay. The act was promulgated on October 2; today's signal is for the onset of the legal stage, not for a new publication. Operators and the laboratories servicing them should review the procedures for transmitting results, escalation and documenting actions. The practical test is whether the time between establishing the relevant circumstance, notification and reaction can be tracked and justified during control.
Electric vehicles get technical evidence rules
Bulgaria · micromobility and technical tests · adopted regulation
Decree No. 176, published on 6 October in the State Gazette, adopts an ordinance on the registration of individual electric vehicles in municipalities. Proof of ownership, technical parameters and identification, as well as a declaration of technical fitness, are provided for. Where technical documents cannot be provided, a protocol from a technical service under the Road Traffic Act, which carries out inspections and tests, is required. The general entry into force is on 10 October, but the chapters on registration and register keeping have been postponed by 12 months after promulgation. Suppliers, shared vehicle operators and technical services should check the availability of factory identifiers, specifications and translations. Promulgation does not mean the immediate start of registration.
CRC regulates the technical conditions for local networks in 3.8–4.2 GHz
Bulgaria · radio equipment and electronic communications · adopted regulatory decision
With Decision No. 299, promulgated on October 6, the Communications Regulation Commission introduces technical conditions for local terrestrial broadband networks in the 3800–4200 MHz band. The new Annex No. 11 defines frequency blocks, operating mode, power limits and data for base stations that accompany the application. Restrictions are also provided around airport runways to protect radio altimeters. The decision enters into force in accordance with the general procedure on October 10. Industrial users, integrators and testing laboratories must compare the design parameters and evidence of compliance with the new conditions. The presence of appropriate equipment in itself does not replace the necessary authorization to use the spectrum.
FDA Expands 510(k) Exemption for Certain Toxicology Tests
USA · medical devices and laboratory diagnostics · final decision — in effect
Effective October 6, the FDA is expanding the exemption from 510(k) prior notification for certain Class II toxicology test systems, including those intended for federal drug research programs. The final decision removes a specific exception from an existing exemption and does not deregulate all toxicology tests. The restrictions on intended use, labeling, and applicable device categories, as well as other regulatory requirements, remain in place. Manufacturers and European exporters should verify the exact 21 CFR 862 section, product code, and allowable claims. For laboratories and suppliers, the key is consistency between actual use and documented intended use; a 510(k) exemption does not override quality management.
F-gas certification fix affects three language versions
EU · refrigeration and certification · adopted regulation - linguistic correction
Implementing Regulation (EU) 2026/2214, published on 6 October, corrects the Hungarian, Lithuanian and Polish versions of the certification rules under Regulation 2024/2215. The corrections concern wording on responsibilities, knowledge and practical tests for equipment and refrigerants. The Bulgarian language version is not amended. The act enters into force on 26 October. Certification and training organisations using the affected translations should check the examination materials and competency matrices. For Bulgarian companies with partners or personnel from these markets, a targeted check of the documentation used is appropriate. The correction should not be presented as a new pan-European certification scheme or automatic invalidation of issued certificates.
Strategic Watch
EA BSA retains its status under the EA multilateral agreement
Bulgaria / Europe · accreditation and international recognition · active baseline
The European Accreditation Organization published on 2 October a decision, valid from 29 September, by which the Bulgarian Accreditation Service (EA) retains its status as a signatory to the EA MLA after a re-assessment. The decision covers calibration, testing, including medical laboratories, inspection, certification of systems, products and persons, as well as validation and verification. The next full assessment is planned for June 2029. This is an initial reflection of an already effective decision, not a new act from today. For organizations using accredited services, the practical step remains to check the specific scope of the chosen body. The status of the national body does not automatically extend the scope of an individual certificate or laboratory.
The EC places emphasis on the reliability of water monitoring in Bulgaria
Bulgaria / EU · waters, laboratories and ecological evidence · official assessment and recommendations
In the assessment of the third river basin management plans in Bulgaria, the European Commission recommends more complete monitoring data, consistent methodologies and comparable baseline values. The document SWD(2026) 501 is from 2 October and was made public on 5 October. Among the highlights are the reliability of hydromorphological methods and the consistent definition of quality indicators. This is an assessment of implementation, not a new regulation or an automatic change of permits. River basin directorates, laboratories and water users or dischargers should check the comparability and traceability of their data. For environmental management systems, the signal is to assess the quality of evidence, not just the availability of measurements.
EU sets out its position on CBAM inclusion in the EEA
EU / European Economic Area · carbon emissions and supply chains · adopted position - draft subsequent decision
Decision (EU) 2026/2240, published on 6 October, sets out the EU position on the inclusion of the CBAM mechanism in the Agreement on the European Economic Area. The attached draft provides for the participation of Norway and Iceland, with the exception of Liechtenstein, and rules on the register, customs data and proof of prior release for free circulation. The draft contains phased dates, including 1 December 2026 for certain provisions and 1 January 2027 for general application. This does not yet constitute evidence that the EEA Joint Committee has adopted the final regime. Importers and carbon accounting teams should follow the subsequent decision and map the affected flows, without treating the draft dates as unconditional obligations.
CPSC opens hearing on micromobility battery safety
USA · batteries and product safety · standard draft consultation
The U.S. Consumer Product Safety Commission announced on October 5 a virtual hearing on the draft mandatory standard for lithium-ion batteries and electrical systems in micromobility products. The hearing is on October 21, and applications for participation and written presentations are due by 5:00 p.m. EST on October 15 - 12:00 a.m. on October 16 in Sofia. The draft uses applicable voluntary standards with amendments to limit fires and thermal spread. This is an opportunity for comments, not a final adopted product requirement. Manufacturers, exporters, and laboratories can review the proposed tests and present technical arguments to demonstrate safety.
FDA shows how it verifies food radiological safety certificates
USA / Indonesia · food, laboratories and import certification · international strategic signal
The FDA published on 5 October an assessment of the Indonesian system for certifying certain shrimp and spice supplies under the Cesium-137 program. The official certification bodies and laboratory evidence, including the scope of ISO/IEC 17025 accreditation, were reviewed. Deviations identified in sampling and measurement duration were corrected and accepted by FDA; the recognition of the competent bodies was maintained. The report does not introduce a new general regime for European imports. Its implications for food chains and laboratories are specific: the certificate must be supported by a valid sample, an appropriate method and traceable results. Organizations with affected supplies should verify the actual product and geographic scope of the US program.
Published by MG Global in partnership with ERPI.
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