EU \u00b7 pressure equipment \u00b7 adopted act - harmonised standards<\/p>\n
On 2 October, the European Commission published Implementing Decision (EU) 2026\/2211, which updates the harmonised standards under Directive 2014\/68\/EU for pressure equipment. The changes cover boilers, refrigeration systems, qualification of welding operators and brazing procedures. Specific restrictions have been introduced for EN 12953-6:2024: certain provisions of it do not give presumption of conformity with certain essential requirements. The decision enters into force on the day of publication, and the deletion of certain old references applies from 2 April 2028. Manufacturers and notified bodies should update the conformity matrices, technical files and test plans, including additional evidence for requirements beyond the presumption. This does not make the application of the standards mandatory.<\/p>\n
Bulgaria \u00b7 industrial emissions and laboratory control \u00b7 promulgated regulatory act<\/p>\n
In the State Gazette, issue 91 of 2 October 2026, Decree No. 173 was promulgated, amending the rules for large combustion installations. According to the general rule for entry into force, the changes are effective from 6 October. In the monitoring provisions, a requirement is added to notify the operator and certain actions required by the RIEW to be without undue delay. The conditions for a temporary exemption from the sulfur dioxide standards in the event of an extreme shortage of low-sulfur fuels are also specified, as well as the information to the European Commission. Operators and service laboratories should check the escalation procedures, responsibilities and measurement records. The amendment does not constitute a general exemption from the emission standards: the exemption is individual, conditional and limited to six months.<\/p>\n
England and Wales \u00b7 forensic laboratories \u00b7 implementation start; transition completed<\/p>\n
The transition for the updated FSA-MTP101 fingerprint comparison sub-activities in England and Wales ended on 2 October 2026. Version 2 of the Forensic Science Regulator\u2019s mandatory Code of Practice requires that the sub-activities carried out are reflected in the scope of accreditation. The regulator\u2019s guidance makes the declaration of compliance conditional on the full requirements being met; failure to do so results in a declaration of non-compliance. This affects the relevant fingerprint bureaus and forensic laboratories, not all ISO\/IEC 17025 laboratories. Organisations should check their accreditation scope, method validation and report wording. The general operation of version 2 began in October 2025; the stage from 2 October 2026 is a specific accreditation transition.<\/p>\n
USA \u00b7 pharmacy and drug safety \u00b7 final non-binding guidance<\/p>\n
On October 1, the FDA released Revision 2 of the final ICH E2B(R3) guidance for electronic submission of individual safety reports. The revision incorporates the 2025 ICH technical updates and is accompanied by material on compatibility between versions. This is non-binding guidance and not a new stand-alone legal deadline. For pharmaceutical companies and pharmacovigilance system providers, the practical task is to compare controlled specifications and data conversion with the current revision. It is recommended that they review message validation, acknowledgement processing, and contractual responsibilities for exchanges with external partners, without assuming that publication alone changes all applicable reporting deadlines.<\/p>\n
International \u00b7 standardization and management systems \u00b7 upcoming stage \u2014 standardization rules<\/p>\n
The announced date for implementation of the unified edition 2026 of the ISO\/IEC Directives, Part 1 is 5 October. The final text, edition 21, replaces the 2024 procedures and individual supplements of ISO, IEC and JTC 1 with a common framework for technical work. This concerns national standards bodies, technical committees and experts developing international standards. For management system specialists, the harmonized approach in Annex Q is also important. Organizations participating in committees should check their working procedures and transitional materials. These are rules for the development of standards, not an EU directive or an automatic change to existing certificates.<\/p>\n
USA \/ international methodology \u00b7 AI, testing, verification and validation \u00b7 consultation \u2014 deadline October 6<\/p>\n
NIST is accepting comments on the initial draft NIST AI 200-2 for the TEVV-Athlon framework through October 6, 2026. The consultation opened on August 7 and is reflected here as a strategic radar, not as a newly published document. The draft proposes a four-step approach to testing, evaluating, verifying, and validating AI systems against specific organizational goals. It does not create a mandatory certification scheme. It is useful for evaluators, developers, and procurers to verify that the proposed definitions and evidence cover their real-world applications. Practical comments can point out missing scenarios, measurement difficulties, and limitations of the assessments used without revealing confidential information.<\/p>\n
Bulgaria \u00b7 machinery and conformity assessment \u00b7 consultation - first coverage<\/p>\n
The draft of a new Regulation on the essential requirements and conformity assessment of machinery is being discussed until 31 October. The consultation was opened on 1 October and prepares the national implementation of Regulation (EU) 2023\/1230 of 20 January 2027. The draft provides for a simplified procedure for existing notified bodies while maintaining their product scope and a full procedure for new applicants. The provisions on the authorisation of bodies are planned to be effective from the future publication, not from January. Manufacturers, importers, distributors and assessment bodies should check their responsibilities, competence and documents and submit practical opinions. This is a proposal in public consultation, not an already applicable national regulation.<\/p>\n
Bulgaria \u00b7 seeds, planting material and testing \u00b7 consultation<\/p>\n
The Ministry of Agriculture and Food opened a public consultation on a draft amendment to the Act on Seed and Propagating Material on 1 October. Opinions are accepted until 2 November 2026. The draft specifies the documents for import according to the category of seeds, including OECD certificates and labels and ISTA orange international batch certificates, as well as the traceability of documents for fruit planting material from third countries. IACS may take samples of imported seeds for laboratory analysis based on risk. Importers, laboratories and certification bodies should compare the proposals with their procedures and indicate practical difficulties. This is a draft law in consultation, not an already applicable new obligation.<\/p>\n
USA \u00b7 medical devices and conformity assessment \u00b7 consultation<\/p>\n
FDA published CDRH\u2019s priorities for guidance development in fiscal year 2027 on October 1. The primary list includes guidance on the Accreditation Scheme for Conformity Assessment (ASCA) and information on quality systems for certain premarket reviews. This is a consultation on the work program, not an adoption of new requirements. Comments on the relative priority and proposed content are being accepted through November 30, 2026. Medical device manufacturers, testing laboratories, and accreditation bodies may point out practical issues with evidence and evaluation. They should distinguish the intent to publish from the final texts, which will set the regulator\u2019s future expectations.<\/p>\n
International \u00b7 human medicines and laboratories \u00b7 international strategic signal - joint opinion<\/p>\n
In a joint statement of 1 October, ICMRA calls for the wider use of scientifically sound non-animal methods for human medicines. Batch release control is of particular importance: regulators encourage the validation of alternatives, and the use of animal testing should be scientifically justified where there is no equivalent or better method. The statement is not a new legal prohibition and does not imply automatic acceptance of every alternative. Scientific validity and regulatory acceptability must be demonstrated as applicable. Manufacturers and laboratories should review their methods, validation plans and market requirements, taking into account the different national pace of transition.<\/p>\n
Canada \u00b7 chemicals, toxicological evidence and market access \u00b7 consultation - first coverage<\/p>\n
Canada is discussing future criteria for carcinogenic, mutagenic and toxic to reproduction substances under the Canadian Environmental Protection Act, 1999. The notice is in the Canada Gazette on 3 October and the online document is dated 2 October; this is the first time the topic has been covered. The proposed approach is based on GHS Categories 1A and 1B and is open for comments until 2 December 2026. The criteria will assist in identifying substances for which ban measures are prioritized, but the consultation does not in itself ban products. For European manufacturers, exporters and toxicology laboratories, this is an early warning to review classifications and the reliability of the evidence. Useful comments could address consistency with international criteria and the applicability of scientifically sound data.<\/p>\n
Published by MG Global in partnership with ERPI.<\/p>","protected":false},"excerpt":{"rendered":"
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