New development
CBAM: EA BSA is listed as ready to accept applications
EU / Bulgaria · accreditation and carbon verification · updated official information
The European Commission published on 25 September an updated table on the readiness of national authorities to provide CBAM accreditation. It lists the Bulgarian Environmental Agency as a body that will provide the service and is ready to accept applications. This does not mean that a specific Bulgarian verifier has already been accredited. The table distinguishes readiness for applications from the acceptance of applicants from third countries. Organisations planning verification of input emissions should confirm with the competent authority the applicable scope, documents and assessment schedule. Applicants should separately check the actual accreditation of the selected verifier and its sectoral scope.
Final duties on Chinese pea protein take effect today
EU / China · food ingredients and market access · adopted act - entry into force
On 26 September, Implementing Regulation (EU) 2026/2101 imposing definitive anti-dumping duties on covered pea protein from China entered into force. The act was published on 25 September; today's alert is for the new legal stage and not a re-announcement of the document. The rates are 40.5 or 67.1 percent depending on the manufacturer and the applicable category. For an individual rate, a valid commercial invoice with the intended declaration is required; in the absence of one, the rate for all other companies applies. Importers and food producers should check the product scope, manufacturer, TARIC code and invoice evidence before the next customs clearance.
Customs registration of covered duck meat begins
EU / China · food and customs traceability · adopted act - start of registration
As of 26 September, Implementing Regulation (EU) 2026/2118 requires customs registration of certain imports of Peking duck meat originating in China. The document was published the day before and covers specifically listed product forms and customs codes. Registration is foreseen for nine months and does not constitute an anti-dumping duty imposed in itself. It allows for possible subsequent retroactive collection only if the legal conditions are met. Importers, distributors and processors should keep accurate records of origin, product classification and deliveries and assess the possible contractual risk, without presenting the amount of alleged dumping as an already accepted rate.
FDA authorizes certain uses of D2-enriched inactive yeast
USA · food, specifications and testing · final order
The FDA issued a final order on September 25, effective as of that date, for the use of inactive baker's yeast with vitamin D2 in certain food categories. The authorization in the new section 21 CFR 172.383 is limited to specific product categories, maximum quantities, and specifications, including purity and microbiological parameters. It is not a general authorization for all foods and does not replace EU requirements. U.S. exporters and laboratories should compare formulations, shipping specifications, and test protocols. Objections and requests for hearings are accepted until October 26 under the U.S. due process.
US updates training for passenger ship personnel
United States · maritime transport and jurisdiction · final rule
A final rule issued by the U.S. Coast Guard on September 25, effective October 26, updates the application of STCW to personnel on passenger ships engaged on international voyages. It applies to U.S.-flagged ships within the scope of the rule and includes emergency briefing, crowd management training for the relevant positions, and documentary evidence of training completed. It does not establish a universal requirement for all ships and all voyages. Shipowners, marine personnel agents, and training centers should compare position matrices, certifications, and evidence of maintained competence with the new texts in 46 CFR 11 and 12.
EPA Clarifies Scope of Title V Permit Inspections
United States · industry and environmental permitting · final rule
EPA published final amendments to the Title V operating permit rules on September 25, effective October 26. They clarify how pre-construction permits determine applicable requirements and what issues may be addressed in subsequent Title V inspections. The general obligation to prevent accidental releases under section 112(r)(1) is not included in this specific permitting mechanism, but the obligation itself is not waived. International groups with U.S. operations should update their compliance records and audit programs, distinguishing between permit conditions, separate legal obligations, and challenge procedures.
OFAC removes no longer-needed special license for Syria
United States · sanctions compliance · final rule
On September 25, OFAC published and implemented an amendment that removes the special general license for Syria in 31 CFR 596.505. The reason for this is the separate removal of the designation of Syria as a state sponsor of terrorism, effective August 24. This is a specific regulatory provision, not a blanket authorization for all transactions with Syrian counterparties. U.S.-affiliated entities should update their sanctions references and continue to conduct person, property, commodity, and destination screening. Other U.S. restrictions and the EU’s stand-alone regimes should be evaluated separately prior to contracting or shipping.
New final deposit rates for certain Turkish pipes
USA / Turkey · metals and customs evidence · final administrative review
The US Department of Commerce published on September 25 the final results of the review of the anti-dumping measure on large diameter welded pipes from Turkey. A margin of 1.89 percent was set for the listed HDM and Cimtas; the corresponding cash deposit requirements apply to covered imports as of the date of publication. This is not a uniform rate for all Turkish steel products or all producers. European traders and international suppliers should match the producer, the written product scope and the import operation. Historical accrual for the period May 2024 - April 2025 and deposits for new shipments should be verified as separate procedures.
Zero deposit for LG Chem's covered superabsorbent polymer
US/Republic of Korea · polymers and market access · final administrative review
The final results of the US anti-dumping review of superabsorbent polymers from the Republic of Korea were published on September 25. LG Chem was set a zero margin for the review period December 2023-November 2024, and the deposit rate for the relevant new imports was zero as of the date of publication. This does not invalidate the entire anti-dumping order and does not automatically exempt other manufacturers or intermediary chains. Suppliers of hygiene and other product materials should verify the identity of the manufacturer, origin and applicable product description. Historical import documents and duty drawback declarations remain a separate verification.
CAFTA–DR: four lining fabrics added to shortage list
USA / CAFTA–DR · textiles and proof of origin · final determinations under general regime
As of September 25, the US CITA committee added four precisely defined lining fabrics to Annex 3.25 of CAFTA–DR in unlimited quantities. The definitions cover two variants of polyester and cupro, printed viscose lining and dyed polyester and viscose lining. The overall practical consequence is a change in the list of materials not available in sufficient commercial quantities in the region, rather than a blanket exemption for all textile imports. European suppliers to regional production chains should compare the composition, construction, weight, width and processing with each individual specification. The right to preference for the finished product requires a separate verification of the rules of origin.
US introduces annual notification of explosives warehouses
United States · industrial safety and records · final rule
A final ATF rule, published on September 25, updates the notification requirements for local fire departments for the storage of industrial explosives. Effective October 26, the rule requires written notifications every twelve months, notification upon termination of storage, and retention of copies for five years. The initial notification requirement is not new. The change is relevant to lawfully operating U.S. mining, construction, and other operators, including multinational group entities. They should review their responsibilities, timelines, and recordkeeping and compare the first applicable renewal with the specific transitional provisions of the final text.
ATF Finalizes Amendments to Safe Explosives Act
United States · industrial licensing and control · final rule
ATF published a final rule under the Safe Explosives Act on September 25, effective October 26. It finalizes two earlier interim regimes and clarifies administrative requirements for responsible persons and authorized personnel, among other amendments to 27 CFR 555. Therefore, not all of the provisions constitute entirely new obligations. Lawful industrial operators in the United States and international groups with such facilities should compare their current procedures with the final rule, including notification of personnel changes and regulatory references used. The review should maintain the distinction between the permit regime, facility safety, and separate transportation regulations.
Upcoming deadlines
Kyustendil: 14 days until the specified date for the surveillance zones
Bulgaria / EU · livestock and veterinary control · current measure — T–14
The end of the minimum period for the surveillance zones around the contained outbreak of sheep and goat pox in Kyustendil district is indicated on 10 October, in accordance with Implementing Decision (EU) 2026/2052. Today's alert is a reminder T-14, not a new outbreak or a new document. The date does not automatically mean that animals can be moved or that all national measures are lifted. Farmers, transporters and operators in the chain should check the location of the site, the current orders of the competent authority and the necessary veterinary documents. Before actual movement, it should be confirmed whether there has been a new extension or change of zones in the meantime.
Strategic Watch
FDA consults on evidence for robotic surgical devices
USA · medical devices and testing · consulting
On September 25, the FDA announced a draft guidance on premarketing dossiers for robotic surgical devices. The document addresses the content of applications and the nonclinical and clinical evidence for the systems. The draft is not intended to be enforceable and does not create self-mandatory rules. Comments submitted by November 24 may be considered before work begins on the final version. Manufacturers, U.S. exporters, and testing teams should compare the planned evidence and technical documentation with the draft and formulate specific questions. It should not be assumed that every robotic medical device falls within its surgical scope.
US consults on changes to biocertification documents
USA · biocertification and traceability · consultation
The USDA opened a consultation on September 25 until November 24 on the information requirements of the National Organic Program. The proposal includes changes to the accreditation documents of certification bodies and clarification of the field for the US certified importer in the organic import certificate. For evidence of competence, a change in the time of provision is proposed, not the elimination of the requirement. This is not yet a new set of mandatory forms. Certification bodies, inspectors and European operators in export chains to the US should assess the administrative burden, traceability and allocation of responsibilities and, if necessary, submit a statement.
Extended deadline for proposals on the US veterinary regime
USA · veterinary biological products · consultation
USDA has extended the deadline for submissions of information and proposals on the modernization of veterinary biologics regulations to November 2. The notice was published on September 25 and moves the previous date of October 13 forward by twenty days. This is an extension of a formal request for information, not the adoption of new licensing or testing rules. For European manufacturers and laboratories working on products for the US market, the additional time allows for reasoned submissions on regulatory procedures and evidence. The specific product scope and issues in the original request should be reviewed before conclusions are drawn about future changes to the requirements.
OFAC consolidates sanctions provisions into new Part 505
USA · sanctions compliance · international strategic signal — current systematization
OFAC introduced a new part 505 of 31 CFR on September 25, which consolidates the penalties and related enforcement procedures for economic sanctions. The official text explicitly states that the systematization does not substantially change the existing penalty provisions. Therefore, it should not be presented as a new general increase in sanctions. For international organizations with a US legal relationship, the change is an occasion to review the references in policies, audit questionnaires, and procedures for responding to violations. The specific sanction regime and applicable authorities should also be checked, rather than using the new general part as the sole legal source.
US collects capacity data for essential medicines
USA · pharmaceuticals and supply chains · consulting
The US OMB launched a request for information on manufacturing capacity for essential drugs, active ingredients and key starting materials on 25 September. Responses are being accepted until 26 October. Data is being sought on existing, vacant or new capacity within the defined geographical scope, including registration status and origin of components in the chain. This is a capacity survey and not an order, a guarantee of funding or a universal localization requirement already in place. European pharmaceutical groups with relevant capacity and supply should assess the applicability, reliability of the data and sensitivity of the information before deciding whether and how to respond.
NIH suggests summary results be shared with participants
USA · clinical research and reporting · consulting
NIH published a draft policy on September 25 for sharing summary results of clinical trials with participants in plain language. The consultation is open until October 26. The proposed scope includes research supported in whole or in part by NIH, not all clinical trials worldwide. The document envisages future implementation linked to a final policy; today’s publication does not begin a new obligation. European research centers and sponsors with such funding should evaluate protocols, communication with participants, and evidence of implementation. Summary results should be distinguished from individual medical outcomes and from publication in a scientific journal.
BsUFA IV: future reviews and evaluation of production sites discussed
USA · biosimilars and regulatory assessment · consulting
On September 25, the FDA published proposed recommendations for BsUFA IV for fiscal years 2028–2032. These include future mechanisms for reviewing applications and a phased, risk-based approach to evaluating manufacturing sites. This is not a new tariff or licensing regime already in place. A public meeting is scheduled for October 26, and written comments are being accepted until November 25, U.S. time. Biosimilar drug manufacturers and their international partners should evaluate the proposed changes to their inspection readiness and interactions with FDA. Requests for oral comments and required special conditions have an earlier deadline of October 16.
FDA accepts petition for calcium sulfate as a colorant
USA · food colorings and market access · international strategic signal - petition filed
FDA announced on September 25 the filing of a petition by Doehler GmbH for calcium sulfate as a colorant in certain foods. The petition was filed on September 10 and addresses specific uses, including coatings for confectionery products, certain milk powders, glazes, and fillings. This is the initiation of a regulatory review, not an authorization for use. The proposal is for inclusion in a category exempt from FDA batch certification of colors; it does not address ISO certification. Manufacturers and exporters should monitor the decision and verify applicability to their formulations, and not change authorized uses solely based on the petition.
ATF Advises on Changes to Industrial Storage Exemptions
USA · industrial safety and testing · consulting
On September 25, ATF published a draft amendment to certain exemptions and categories in the Industrial Explosives Storage Regime. Comments are being accepted until November 24. The proposal refers to testing and industry practices, but does not yet change the current obligations of operators. For legally operating mining, construction, and specialized service companies in the United States, as well as related inspection teams, this is an early warning of a future change in the assessment of site compliance. The scope and evidence base of the draft should be analyzed and reasoned opinions should be prepared without applying previously proposed reliefs.
A separate ATF project systematizes warehouse safety rules
USA · industrial safety and inspection · consulting
ATF opened a separate consultation on September 25 to systematize safety requirements for industrial explosives storage facilities. The draft consolidates provisions and proposes to incorporate certain provisions of administrative guidance into the regulatory text. Comments are being accepted until November 24. This is a separate proceeding from the storage exemptions draft and does not yet constitute an effective change. U.S. operators and inspection teams should compare their checklists and regulatory references with the proposed structure. For international groups with such facilities, it is important to maintain traceability between local procedures and the final adopted requirements.
US moves to full five-year reviews of tire measures
USA / Asian production chains affected · tires and market access · international strategic signal - new stage of review
On September 25, the USITC published a decision to conduct full five-year reviews of certain trade measures on passenger car and light-duty vehicle tires. The general procedural stage covers the anti-dumping orders for the Republic of Korea, Taiwan, and Thailand and the countervailing order for Vietnam. The decision itself is dated September 4; the publication does not impose new rates or repeal measures. The schedule for further action will be announced separately. International producers, traders, and European groups with such supply chains should distinguish between the four origins and types of measures and prepare traceable product, market, and import data.
Poland proposes shifting responsibility for beverage tax
Poland / EU · beverages and regulatory accountability · international strategic signal - notified project
Poland notified on 25 September a draft amendment to the tax regime on certain beverages. It is envisaged that the responsibility will be shifted to producers, importers and intra-Community acquirers, while maintaining the covered contracting authorities. The data on the total sugar content is specified and a refund is proposed upon subsequent export or intra-Community supply. This is a draft, not an effective change in product formulations or labelling. Bulgarian and other European suppliers should check their contractual role and the evidence of the composition and movement of the goods. TRIS notes a fiscal measure without an applicable waiting period, which does not prove national acceptance.
Turkey notifies draft beer and flavored beer
Turkey · beverages and product compliance · international strategic signal - notified project
On 25 September, Turkey notified a draft Turkish Food Codex Communiqué on Beer. The scope of the notification includes beer and flavoured beer, but excludes malt beverages. The official notification links the draft to product characteristics and the prevention of misleading information to consumers. This is not evidence that the new rules have already been adopted or implemented. European exporters and their local partners should compare the product classification and the designations used with the draft. The page shows 28 December as the end of the period, but the notification is under the procedure with a candidate country; the date should not automatically become a deadline for mandatory compliance.
The EU sanctions list has a new entry from September 24
EU · sanctions control and counterparties · active baseline — first coverage
The initial effective baseline reflects Implementing Regulation (EU) 2026/2165, published and entered into force on 24 September. It adds one individual to the list under the Russia destabilising activities regime. A separate official notice to the affected individual was published on 25 September; this does not make the Regulation itself a new act as of today. Organisations should check the updates to the sanctions lists used and document checks on counterparties and related parties. The overview does not reproduce political motives as its own assessment and does not accept a name match as sufficient proof of identity.
Published by MG Global in partnership with ERPI.
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