New development
New rules for identification when exchanging health data
EU · digital health and conformity assessment · regulation adopted with phased implementation
Implementing Regulation (EU) 2026/2099 introduces rules for identification and authentication for cross-border exchanges via MyHealth@EU. Published on 22 September, the act enters into force on 12 October 2026, but the main application starts on 26 March 2027, with individual requirements having later dates. Identification data and assurance levels are defined for healthcare professionals, providers and national systems. A pathway is also foreseen for the level to be confirmed by a conformity assessment body. Organisations should map the means of identification, the evidence of reliability and the implementation stages, without taking the October date as the start of all obligations.
EU restricts poultry shipments from six new areas in the US
EU / US · animal products and veterinary control · adopted regulation
Implementing Regulation (EU) 2026/2149, published on 22 September, amends the import lists following new outbreaks of highly pathogenic avian influenza in the United States. The act enters into force on 23 September 2026. Six restricted areas have been added in South Dakota, North Dakota and Minnesota, affecting the specified categories of poultry, germinal products and fresh meat. This is not a general ban on US exports. Importers and veterinary control teams should verify the area code, product category, dates of production and dispatch and accompanying certificate before accepting consignments.
Greece updates sheep and goat pox zones
EU / Greece · livestock farming and cross-border supplies · emergency measures decision adopted
Implementing Decision (EU) 2026/2123, published on 22 September, replaces the Annex with the restriction zones for ovine and caprine pox in Greece. The update follows new outbreaks, including first cases in Argolis and Arta, and contains different regional deadlines. For a number of additional zones, the measures are set until 31 December 2026. Breeders, transporters and traders in the Balkan chains must check the exact origin and applicable restrictions before movement. The publication is not a general date for lifting the measures and does not replace national veterinary authorisations for a specific operation.
The text of the Consumer Credit Directive has been corrected.
EU · financial services and documentary compliance · official correction
Corrigendum 2026/90798 to Directive (EU) 2023/2225 on consumer credit was published on 22 September. The revised Bulgarian text corrects references and wording, including in the scope, related contracts, information on the annual percentage rate of charge and advisory services. This is a correction to an already adopted act and not a new directive or a new transitional period. Lenders, intermediaries and compliance teams should compare the legal references and client templates used with the corrected text. It is particularly important that old citations in procedures and checklists do not continue to point to an incorrect provision.
The production specification of Pago de Arínzano has been changed.
EU / Spain · wine and certification of origin · approved standard amendment to PDO
Publication C/2026/4824 of 22 September announces the approval of a standard amendment to the specification for the protected designation Pago de Arínzano. The changes concern technological conditions, including fermentation in barrels, the vessels used and the control of density. This is an amendment to a specific product specification and not a general rule for all wines. Producers, control bodies and traders of this product must check the technological instructions and batch records with the current version. The date of the European publication should not be automatically used as a date of national approval or as a new transitional period.
Updated list of illegal fishing vessels enters into force
EU · fishing, imports and traceability · new stage of adopted regulation
On 22 September, Implementing Regulation (EU) 2026/2045, published on 15 September, enters into force. It replaces Part B of the European list of vessels involved in illegal, unreported and unregulated fishing. Today's signal is for a legal milestone, not a new publication of the document. Importers, processors and operators in the seafood chain should update their supplier checks and catch certificates. The matching should use reliable vessel identifiers and not just a similar name to avoid incorrect blocking or missed deliveries.
The definitive anti-dumping regime for PBTC begins today
EU / China · chemicals and water treatment · entry into force of definitive duties
Implementing Regulation (EU) 2026/2088 enters into force on 22 September, the day after its publication. The definitive anti-dumping duties on the covered PBTC and its tetrasodium salt originating in China range from 156.7% to 192.2% depending on the manufacturer. Today's inclusion reflects the start of the action and does not reintroduce yesterday's act as a new one. For importers and industrial users, it is important to verify the exact chemical identity, origin, manufacturer and invoice required for an individual rate. The tariff description and customs documents must be matched before calculating the costs of the specific shipment.
New African Swine Fever zones now in effect
EU · pig farming and veterinary compliance · entry into force of new restricted zones
On 22 September, Implementing Regulation (EU) 2026/2135 enters into force, replacing Annexes I and II to the African swine fever regime under Regulation 2023/594. At the same time, Provisional Act 2026/1973 for Lazio is repealed. The repeal does not automatically mean free movement: the updated zones and the corresponding conditions apply. Pig farms, slaughterhouses, transporters and traders must check the location of the establishment and the documentation before dispatch. This signal marks the legal stage following yesterday's publication, without presenting the document itself as published today.
CMVP Active List Moves to FIPS 140-3
USA / international shipping · cryptography and testing · validation scheme transition occurred
As of September 22, the CMVP active list includes only FIPS 140-3 validations, as per NIST’s published clarifications. FIPS 140-2 validations are being moved to the historical list; this does not constitute a withdrawal of any certificate or a ban on any existing use. Cryptographic module vendors and organizations with contractual requirements for active validation should check the specific certificate and the sponsor’s policy. The version, configuration, and exact scope of the module are important, not a general marketing claim that the entire product is certified.
US places diphenidine under Schedule I control
United States · laboratories and controlled substances · final rule
DEA published a final rule on September 21st to list diphenidine in Schedule I, effective October 21st, 2026. The control covers activities such as manufacturing, import, export, distribution, research, and chemical analysis in the applicable U.S. jurisdiction. This is an adopted regime, not a draft for discussion. Laboratories, analytical materials suppliers, and international partners with operations in the U.S. should verify their availability and applicable registrations, storage, and reporting. Prior coordination with compliance officers is required, and there is no assumption that a previous registration automatically covers the new classification.
US imposes temporary measures on Chinese packaging sheet metal
USA / China · metals, packaging and market access · preliminary anti-dumping determination with measures
On September 21, the U.S. Department of Commerce issued a preliminary affirmative anti-dumping determination on certain Chinese tin- or chromium-coated flat steel products. The specified monetary security is 130,17%, with a dumping margin of 136,52%. This is not a final order, but it provides for the suspension of definitive customs clearance and security, including retrospective coverage under established critical circumstances. Importers and international metal packaging chains should verify the written product description, origin, and dates of import. Resale through a third country does not, in itself, change the origin of the goods.
Upcoming deadlines
ERO MN: seven days until the start of the permit
EU · biocides and disinfection · reminder T–7
The Union authorisation of ERO MN under Implementing Regulation (EU) 2026/1974 starts on 29 September 2026. Today is the T-7 threshold and the act itself was published on 9 September. The authorisation is for the specified uses in veterinary hygiene and in the food and feed sector, valid until 31 August 2030. The comparative assessment distinguishes between uses and renewal options; it does not immediately prohibit all authorised uses. Suppliers and professional users should check the summary of characteristics, the label and the permitted uses before including them in disinfection programmes.
The F-gas exemption comes into effect on September 29th
EU refrigeration equipment and compressed air reminder T–7
Implementing Regulation (EU) 2026/1975 enters into force in seven days, on 29 September 2026. The essential distinction is that the exemption provided for applies from 1 January 2027 to 31 December 2030. It covers specific categories of equipment with certain capacities used for drying compressed air, and not all products containing F-gases. Manufacturers, importers and conformity assessors should check the product category, capacity, intended use and labelling. The act was published on 9 September; today's reminder does not mean a general postponement of the bans under the basic regulation.
SOPUROXID: two weeks until updated features
EU · biocides and product documentation · reminder T–14
On 6 October 2026, Implementing Regulation (EU) 2026/2046 entered into force, replacing the Annex with the characteristics of the SOPUROXID biocidal product family. The act was published on 16 September; today the T-14 threshold is reached. The changes include administrative data and the removal of the classification as flammable liquid, category 3, for the products in the specific meta-SPC 4. This does not remove all hazards for the entire family. The holder, distributors and professional users must match the labels, information sheets and internal instructions with the exact product and the applicable part of the authorisation.
Sheep and goat measles: deadlines for Kardzhali and Yambol
Bulgaria / EU · animal husbandry and veterinary control · reminder T–14
Implementing Decision (EU) 2026/2052 sets 6 October 2026 as the end of the protection period for the designated areas around outbreaks in the districts of Kardzhali and Yambol. Today is T–14 until that date. A subsequent surveillance period from 7 to 24 October is foreseen for the same territories, and the additional restrictions have separate deadlines. Farmers, transporters and traders must check the exact zones and the national orders in force before moving animals or products. The specified date does not automatically constitute permission to resume trade and does not mean the lifting of all measures in the two districts.
Two weeks until the end of the specified supervision period near Rakovski
Bulgaria / EU · poultry farming and security of supply · reminder T–14
The current Annex to Implementing Decision (EU) 2026/2109 sets 6 October 2026 as the end of the specified surveillance period for the affected settlements around the Rakovski outbreak. Today, T–14 is reached by this date. For Rakovski itself, the protection period is until 27 September, followed by surveillance from 28 September to 6 October. Poultry farms, transporters and traders must distinguish between these stages and check the exact scope of the national measures. The calendar reminder does not prove that the restrictions will be lifted without further official verification of the epizootic situation.
Strategic Watch
EU extends food crisis coordination framework
EU · food and supply sustainability · international strategic signal - decision adopted
Commission Decision C/2026/4900, published on 22 September, updates the expert group on the European Food Crisis Preparedness and Response Mechanism. It foresees one or more competent contact points from the participating countries and the continuation of the group until 11 November 2031 or until the establishment of the new group under the proposed legislative framework, whichever is earlier. This does not in itself introduce a new obligation for company stocks. Food business operators and sector organisations should monitor national contacts and future solutions for information exchange and coordination in crises.
EA discusses maritime verification on September 29
Europe / EU · accreditation and maritime emissions · strategic radar — T–7
In seven days, on 29 September, EA is planning an online workshop for national accreditation bodies on maritime verification under MRV/ETS and FuelEU Maritime. The official programme foresees the participation of the European Commission and a discussion of regulatory developments, including the proposed simplification of MRV. This is an institutional preparation and not an adopted change in accreditation requirements or publicly open training. Verification bodies and maritime operators should follow the subsequent official clarifications through their accreditation channels. They should not pre-emptively amend contracts or methodologies based solely on the announced meeting.
OSHA Considers Expansion of RETC Recognition
USA · testing and electrical certification · consultation - preliminary decision
OSHA issued a preliminary positive opinion on RETC’s application for an extension of recognition as a nationally recognized testing laboratory on September 21. UL 1741 and an additional test site are under consideration, with comments due by October 6, 2026. This is not yet a final extension of scope. Manufacturers of inverters, converters, and distributed energy connection equipment, including exporters to the United States, should review the prospective decision before choosing a certification route. Laboratories and interested organizations may submit arguments for competency and proposed scope.
TÜV SÜD America applies for additional battery testing
USA · batteries and product safety · consultation — preliminary decision
On September 21, OSHA opened an opportunity for comments on the expansion of TÜV SÜD America’s recognized scope with UL 2580 for electric vehicle batteries and UL 2743 for portable power supplies. The deadline is October 6, 2026. The published opinion is a preliminary, not a final, authorization for the new scope. Manufacturers, importers, and suppliers of battery circuits should distinguish competence under a specific standard from the general name of the certification organization. When planning tests, they should verify the final decision and the exact recognized scope of the laboratory.
FDA opens new intake for pharmaceutical manufacturing readiness
USA · pharmaceuticals and manufacturing quality · international strategic signal — voluntary program
FDA announces fifth year of CDRP pilot program for Chemistry, Manufacturing, and Control Readiness in Accelerated Development of Drugs and Biologics. Enrollment begins October 1, 2026, and is open to up to nine proposals. The program is voluntary and supports discussion of analytical methods, process control, stability, and manufacturing validation; it does not override quality or approval requirements. Developers with applicable U.S. records and their manufacturing partners should review the eligibility criteria and maturity of evidence before planning for an accelerated regulatory pathway.
NRC consults on materials evaluation for advanced reactors
USA · nuclear energy and materials · consultation - draft guideline
The US NRC has published a draft revision to DANU–ISG–2023–01 on the compatibility of materials in non-light water reactors. Comments are being accepted until 5 November 2026. The draft adds guidance for reviewing structural materials and passive structures, systems and components. This is not a final new licensing rule. Material suppliers, testing laboratories and designers in the international nuclear supply chain can review how the proposed approaches relate to their qualification evidence. Detailed technical criteria should be consulted with the design, not just the consultation notice.
HHS collects evidence on electromagnetic and radio frequency exposures
USA · measurements and safety of electronic products · consultation - request for information
The US Department of Health and Human Services (HHS) is opening a request for information on electromagnetic fields, radiofrequency radiation, and wireless exposures, with a deadline of October 21, 2026. It is seeking scientific data, exposure data, and comparisons to national and international standards. This is evidence gathering, not changing limits or confirming a specific cause-and-effect relationship. Manufacturers, measurement laboratories, and standards organizations can assess the relevance of their methods and data. An appropriate response requires a clear distinction between measured exposure, scientific uncertainty, and regulatory requirement.
CDC discusses intermediaries in health data sharing
USA · laboratories and interoperability · consultation - request for information
CDC issued a request for information on intermediaries and approaches to public health data exchange on September 21. The deadline for responses is November 20, 2026. It discusses secure, scalable, standards-based exchange, data governance, and interoperability, including links to laboratory reporting. This does not introduce any new mandatory certification for laboratories or software. Information system providers, laboratory networks, and international partners can provide practical evidence of the quality and reliability of the exchange. Technical proposals need to be separated from existing contractual and legal obligations.
PHMSA Proposes Update to Dangerous Goods Incident Reporting
USA · transport of dangerous goods · consultation - draft reporting form
PHMSA is proposing changes to DOT Form F 5800.1 for reporting dangerous goods incidents and is accepting comments until December 21, 2026. The notice, published on September 21, provides new fields, clarifications, and a reorganization of information. The draft does not immediately replace the current form. Carriers, shippers, and industrial operators with U.S. operations should compare the proposal with their procedures for collecting and verifying data after an incident. The topic is strategically relevant for international chains because the changed reporting fields may require new evidence from participants in the shipment.
FAA proposes inspection of Boeing 737 control node
USA / international aviation · aviation maintenance and inspection · consultation - draft airworthiness directive
The FAA is proposing a new directive for certain Boeing 737-8, 737-9 and 737-8200 airplanes, with a comment deadline of November 5, 2026. The draft relates to improperly installed bearings and a possible lack of a seal in an elevator control system assembly. Inspections and conditional follow-up actions are anticipated. The September 21 publication is not yet a final, mandatory directive. Aircraft operators and maintenance organizations should verify the applicability to a specific airplane, available records, and required inspection capacity, without presenting the design requirements as already in effect.
US directs federal purchases to limit Canadian goods
USA / Canada · public procurement and origin of goods · international strategic signal - presidential memorandum
A presidential memorandum of September 16, published on September 21, directs U.S. authorities to take legally permissible actions to restrict certain Canadian goods in federal civil procurement. This is not an immediate blanket ban on all Canadian products or on private trade. The practical scope depends on subsequent actions by the responsible authorities. International suppliers, including European companies with Canadian manufacturing facilities, should verify the origin of the goods offered and the specific terms of the tenders. The radar should monitor the implementing rules without presenting them in advance as already adopted.
FDA consults on information requirements for advance food notification
USA · food exports and border compliance · consultation - information burden
FDA is launching a consultation on the collection of information for the advance notification of food imports into the United States. The notice was published on September 21, and the deadline is November 20, 2026. The procedure addresses the information need and administrative burden; it does not create a new regime or repeal existing notification obligations. European and Bulgarian exporters, US importers, and logistics intermediaries can submit data on the real difficulties in preparing the information. Before participating, simplification proposals should be separated from the necessary actions for current supplies.
FSA consults on new authorisations and uses of novel foods
United Kingdom · food, specifications and market access · consultation - project permits
The UK FSA is opening a consultation on a package of novel foods applications on 21 September, with responses due by 16 November 2026. New authorisations and amendments to conditions of use, including labelling, are being discussed. This is not a final authorisation of the products. Manufacturers and exporters should check the specific specification and target market: the rules for Great Britain and Northern Ireland are not interchangeable. The FSA separately points out the possible future impact of the negotiated EU-UK agreement. This should not be seen as an automatic alignment of authorisations already in place.
UK updates roadworks safety guidelines
United Kingdom · construction and occupational health and safety · consultation - draft code
A consultation on the UK Road and Street Works Safety Code is due to open on 21 September, with a deadline of 14 December 2026. The draft covers signs, lighting, fencing and safe routes for pedestrians and cyclists. It covers the four parts of the UK, with the exceptions for motorways and expressways. This is a draft, not a revised version. Contractors, infrastructure operators and health and safety teams working in this market should compare their risk assessments, temporary traffic management and evidence of control with the proposed changes.
APHIS reviews regulatory status of MON 96012 cotton
USA · agriculture, biotechnology and traceability · consultation - application and project evaluation
APHIS has published for comment the application for non-regulated status of genetically modified cotton MON 96012 and draft phytosanitary risk assessment. The deadline is November 20, 2026. The line has been developed for resistance to specified herbicide groups. This is not a final APHIS decision, nor is it an automatic authorization for food, feed, or import into the EU. International cotton chain operators and identification laboratories should monitor the exact line and subsequent decision. When evaluating suppliers, the U.S. phytosanitary status and the individual requirements of the destination market should be distinguished.
Separate consultation on pest-resistant cotton MON 89151
USA · agriculture, biotechnology and testing · consultation - application and project evaluation
In a separate proceeding, APHIS is accepting comments through November 20, 2026, on the application for unregulated status for MON 89151 cotton and the draft pest risk assessment. The line was developed to protect against certain Lepidoptera pests. The materials published on September 21 do not constitute a final regulatory exemption and do not prejudge authorizations in other jurisdictions. Producers, traders, and testing laboratories must maintain a separate file for this identifier. Mixing it with other new lines would complicate traceability and verification of applicable market authorizations.
Published by MG Global in partnership with ERPI.
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