New development
The new medical framework agreement comes into force
Bulgaria · healthcare and laboratories · adopted act
On September 25, the National Framework Contract for Medical Activities for 2026–2028 was promulgated and entered into force as a general rule. Applicant medical and healthcare institutions have a 30-day deadline for applications and documents to the RHIF. The contract provides for compliance checks, including on-site checks, and evidence of external quality control for the relevant laboratory activities. Not all provisions enter into force today: there are explicitly stated exceptions from September 1 and February 1, 2027. Managements must compare the applicable package, quality documents and reporting procedures, checking the transitional rules for the old templates and the future XML formats.
Dental Framework Contract opens new application deadline
Bulgaria · dental care · adopted act
The National Framework Contract for Dental Services for 2026–2028 was published on September 25 and, as a general rule, enters into force on the same day. Contractors applying for a contract with the NHIF must submit applications and documents within 30 days. Compliance checks and a procedure for eliminating deficiencies are foreseen. From October 1, a separate provision for reporting pediatric and surgical dental care with a limit of eight hours per day on average, calculated for the calendar month, comes into effect. Practices should check the contract documentation, workload and reporting software; the transition to new electronic formats does not occur automatically with the publication alone.
SEU: service and evidence receive new rules
Bulgaria · agriculture and electronic evidence · adopted act
The amendments to the Agricultural Support Act, published on 25 September, introduce effective rules for electronic service through the Electronic Services System. The email serves as a notification, but is not service in itself. For certain payment acts, a fiction of service is provided for after one month if the document has not been downloaded; other acts have a different order. The system records the sending and downloading, and the checks can end with an electronically signed report. Applicants must organize regular control of the profile and storage of evidence. Transitional cases and rules for additional documents are checked separately.
Register and inspections for perennial crops and greenhouses
Bulgaria · agriculture and inspection · adopted act
The amendments to the Agricultural Producers Support Act, effective from 25 September, provide for a specialized database for permanent crops and greenhouses. A one-year deadline has been given for its creation, and physical inspections of the relevant areas must be carried out by 31 May 2027. The inspections include representatives of the agricultural administration and the competent seed agency and are documented with a protocol. This is a new element of administrative traceability, not a stand-alone private certification scheme. Farmers should check the data on the crops and greenhouses, the documents on the areas and the organization for presence at the inspection, taking into account the exceptions in the legal scope.
Active farmer: check financial evidence
Bulgaria · agriculture and eligibility · adopted act
The adopted amendments to the Agricultural Producers Support Act, promulgated and effective on 25 September, affect the verification of the status of „active farmer“. The legal criteria require that income from agricultural activities is at least 10 percent of the total income of the enterprise; an alternative test requires that annual direct payments be at least 2 percent of income from non-agricultural activities. Applicability depends on the specific category of applicant and the other conditions in the law. Farmers and their accountants must compare declarations, financial data and official information exchanged before assuming that they meet the requirement. The change is not an automatic recognition of all registered producers.
Mandatory construction insurance is changing
Bulgaria · construction and conformity assessment · adopted act
Decree No. 149 of 18 September, promulgated on 25 September, amends the Regulation on Compulsory Insurance in Design and Construction and enters into force immediately. The restriction related to the lack of a compliance assessment by a consultant is removed from the specified provisions. Constructions of the first and second categories are added to the relevant group of minimum insurance amounts, and the amounts in the regulation are expressed in euros. The affected participants must check their applicable role, the category of the construction and the coverage under the policy. It is not enough to mechanically convert an old document if the amendment also changes the scope of the obligation.
New rules for balance in the management bodies of public companies
Bulgaria · corporate governance and accountability · adopted act
The rules on gender balance in the management bodies of public companies, published on 25 September, enter into force on the same day. The companies concerned must bring their operations into compliance within six months. They provide for a target of 33 percent representation of the under-represented gender, based on the calculation established in the law, transparent selection criteria and accountability. Micro, small and medium-sized enterprises are excluded under the legal conditions. The companies concerned must verify the scope, numerical composition, nomination procedures and evidence of comparative assessment. The first reporting is in 2027 for 2026; the percentage does not replace the other competence and selection requirements.
Final duties on pea protein from China
EU · food, laboratories and imports · adopted act
Implementing Regulation (EU) 2026/2101 imposes definitive anti-dumping duties on the covered pea protein originating in China and enters into force on 26 September. The product definition includes a protein content of more than 65 percent, calculated on the dry matter. The rates vary according to the manufacturer and the application of an individual rate requires the declaration provided for in a valid commercial invoice. For importers, this links the customs treatment to the evidence of composition, origin and manufacturer. Analytical results, codes and invoices for each consignment should be verified. The act also regulates the definitive collection of provisional duties secured, without creating a new food certification scheme.
Registration of imports of covered duck meat from China
EU · food and international supplies · adopted act
As of 26 September, Implementing Regulation (EU) 2026/2118 makes imports of certain Peking duck meat originating in China subject to registration. Registration is foreseen for nine months and is a stage of a trade procedure and not a definitive duty in itself. For the deliveries covered, importers must provide accurate data on the product, origin, quantity and customs declaration. This is important for traceability and possible subsequent customs treatment, including if the legal conditions for retroactive measures are met. Before the goods are released, the exact product scope and the codes in the act should be compared, without assuming that all poultry products are affected.
Union authorisation for Christeyns biocidal product group
EU · biocides, hygiene and food safety · adopted act
Implementing Regulation (EU) 2026/2116 grants a Union authorisation for the „Christeyns Peracetic Acid Biocidal Product Family“. The authorisation is valid from 15 October 2026 to 30 September 2036 and covers the products and uses specified in the Annex, including product types 2, 3 and 4. It does not unconditionally authorise all peracetic acid-based products. Food chain operators, hygiene operators and suppliers must compare the specific product with the approved characteristic, dosage, contact time and protective measures. In the event of an audit, the evidence shall be compliance with the authorised use and not only the presence of a known active substance.
Lavender supplements: permission and separate withdrawal mode
EU · feed and analytical control · adopted act
Implementing Regulation (EU) 2026/2120 authorises tincture of Lavandula angustifolia Mill. as a feed additive for all animal species and at the same time provides for the withdrawal of the different additive from Lavandula angustifolia × Lavandula latifolia. The act enters into force on 15 October. The two botanical origins are not interchangeable and the transitions for additives, premixtures and compound feed are different. Manufacturers must check the specifications, labels, dates of production and stocks, as well as the prescribed analytical and protective measures. For the audit, it is essential that the batch is linked to the exact authorised additive, rather than the general description „lavender“ being accepted as sufficient evidence.
Renewed authorization for L-cysteine in cats and dogs
EU · pet food and testing · adopted act
Implementing Regulation (EU) 2026/2129 renews the authorisation of L-cysteine hydrochloride monohydrate as a sensory feed additive for cats and dogs and repeals the previous act. The new regime enters into force on 15 October and includes specifications on origin, purity, analytical control and safe handling. Transitional conditions are provided for the additive, premixtures and feed produced and labelled under the old rules. Pet food manufacturers should check suppliers, certificates of analysis and labelling. The level of 25 mg/kg specified in the Annex is a recommended content under relevant conditions and should not be presented as a universal legal maximum.
Soybean GMB151 × DAS-44406-6 authorization
EU · GMOs, food, feed and laboratories · adopted act
Implementing Decision (EU) 2026/2112, published on 25 September, authorises the placing on the market of certain products containing, consisting of or produced from soybean GMB151 × DAS-44406-6. The scope includes food, feed and other specified uses, but excludes cultivation. The validity is ten years from the notification, the exact date of which should not be replaced by the date of publication. Importers, producers and laboratories must verify the unique identifier, the validated detection method, the reference material and the applicable labelling requirements. The authorisation is for the specific genetic event and is not automatically transferable to other varieties or combinations. Batch documents must allow for this identification.
Authorization for soybean MON 94313
EU · GMOs, food, feed and laboratories · adopted act
Implementing Decision (EU) 2026/2117, published on 25 September, authorises the placing on the market of certain products containing, consisting of or produced from MON 94313 soybean. The scope includes food, feed and other specified uses, but excludes cultivation. The validity is ten years from the notification, the exact date of which should not be replaced by the date of publication. Importers, producers and laboratories must verify the unique identifier, the validated detection method, the reference material and the applicable labelling requirements. The authorisation is for the specific genetic event and is not automatically transferable to other varieties or combinations. Batch documentation must allow for this identification.
Renewed authorization for maize MON 87460
EU · GMOs, food, feed and laboratories · adopted act
Implementing Decision (EU) 2026/2121, published on 25 September, renews the authorisation for the placing on the market of certain products containing, consisting of or produced from MON 87460 maize. The scope includes food, feed and other specified uses, but excludes cultivation. The validity is ten years from the notification, the exact date of which should not be replaced by the date of publication. Importers, producers and laboratories must check the unique identifier, the validated detection method, the reference material and the applicable labelling requirements. The authorisation is for the specific genetic event and is not automatically transferable to other varieties or combinations. Batch documents must allow for this identification.
Extended approval for K-HDO — product type 8
EU · biocides for wood protection · adopted act
Implementing Decision (EU) 2026/2119 postpones the expiry of the approval of K-HDO for product-type 8. The new expiry date is 30.06.2029 and the decision enters into force on 15 October 2026. This is an extension linked to an ongoing renewal evaluation and not a new general authorisation for all products containing this substance. The change is not a final renewal following a completed evaluation. Manufacturers and professional users should check their regulatory records, specific product authorisations and conditions of use. When checking compliance, a distinction should be made between the approval of the active substance and the authorisation of the specific biocidal product.
Extended approval for IPBC — product type 13
EU · biocides and working fluids · adopted act
Implementing Decision (EU) 2026/2124 postpones the expiry of the approval of IPBC for product-type 13. The new expiry date is 31.05.2029 and the decision enters into force on 15 October 2026. This is an extension linked to an unfinished renewal evaluation and not a new general authorisation for all products containing this substance. The extension only concerns the specified product-type and not all uses of the substance. Manufacturers and professional users should check their regulatory records, specific product authorisations and conditions of use. When checking compliance, a distinction should be made between the approval of the active substance and the authorisation of the specific biocidal product.
Extended approval for hydrogen peroxide — product types 1–5
EU · biocides and disinfection · adopted act
Implementing Decision (EU) 2026/2131 extends the expiry date of the approval of hydrogen peroxide for product types 1-5. The new expiry date is 31.07.2029 and the decision will enter into force on 15 October 2026. This is an extension linked to an ongoing renewal evaluation and not a new general authorisation for all products containing this substance. Product type 6 is not included in this extension and should not be presented as covered. Manufacturers and professional users should check their regulatory records, specific product authorisations and conditions of use. When checking compliance, a distinction should be made between the approval of the active substance and the authorisation of the specific biocidal product.
Fix in the Polish version of ESRS
EU · sustainability reporting and assurance · linguistic correction of an adopted act
On 25 September, a correction was published in the Polish version of Delegated Regulation (EU) 2026/1563 on European sustainability reporting standards. The wording on climate transition, labour indicators and certain concepts, including calculation records, are affected. This is not a new set of standards for all languages and does not in itself introduce a new common reporting deadline. Groups using the Polish text for guidance to companies or for data verification should compare the corrected passages with their working templates. It is important for auditors and verifiers that the language version does not lead to different interpretations of evidence or incorrectly calculated indicators.
Corrected add-on identifiers in French text
EU · feed and traceability · linguistic correction of an adopted act
The corrigendum published on 25 September to Implementing Regulation (EU) 2026/1822 corrects the identification numbers of the feed additives mint, thyme and sage in the French text. The codes 2b282-t, 2b455-t and 2b414-t are indicated. This is a correction of the identification and not a new authorisation or amendment of all the technical conditions of use. Operators using French specifications, declarations or label templates should check whether the old entries have been carried over into their product files. Traceability requires a correct matching of the botanical origin, name and code of the additive, especially when dealing with several similar plant extracts.
Updated general catalog of vegetable varieties
EU · seeds and varietal identity · official amendment to catalogue
On 25 September, the European Commission published supplement H 2026/8 to the Common Catalogue of Varieties of Vegetable Species. It reflects the notifications from the Member States for the period 1–31 July and contains additions, amendments and deletions; among the added entries is the Bulgarian onion variety Orma. For seed producers and traders, the catalogue is important for varietal identity and market access. The exact entry, the maintainer and the possible deadline for offering deleted varieties should be checked. Not all entries have the same transitional regime and the date of publication should not be presented as the date of national registration of each variety.
The safeguard measure for electrical steel begins today
EU · electrical steel and transformers · implementation of an adopted act has occurred
On 25 September, the provisional safeguard measure under Implementing Regulation (EU) 2026/2133 for certain products of oriented electrical steel entered into force. The act was published on 18 September; today's notification is a legal stage and not a new publication. The regime is foreseen for 155 days and distinguishes between products, quotas and applicable duties. In the case of cores included in transformers, it is essential to declare the mass of the core and not the entire transformer. Importers should check the origin, exemptions, classification and documents for the quantity. The flat rate or quota regime for one category should not be automatically transferred to another.
Updated vehicle approval tables come into effect
EU · cars and type approval · entry into force
Delegated Regulation (EU) 2026/1753, published on 24 September, enters into force on 25 September and amends the technical tables in Annex II to the vehicle type-approval framework. The update includes references to Euro 7 and related battery, emission and testing requirements, as well as applicable UN regulations. Manufacturers, technical services and suppliers should align their product files with the correct order for the vehicle category. The entry into force of this update does not mean that all Euro 7 requirements start at the same time today. The individual application and transition dates should remain clearly distinguished.
US restricts stockpiling of polysilicon products on imports
United States · photovoltaics and customs evidence · interim final rule
The US Bureau of Industry and Security published an interim final rule on 24 September to limit the stockpiling of polysilicon and covered derivatives. The specified period of effect is from 22 September to 3 December 2026. The regime includes monitoring of historical volumes, quantitative limits for new importers and an individual exemption procedure with documentary evidence and certification by a senior representative. European suppliers must verify the status of the US importer, the product code, ownership and destination of the shipment. This rule should not be confused with the separate measures scheduled to start on 4 December, nor should it be presented as a general ban on all imports.
Clarified exemption of aluminum material for cans from US tariffs
USA / affected exporting countries · aluminum and packaging · final partial lifting of trade measures
On September 24, the U.S. Department of Commerce published final findings that partially revoke anti-dumping and countervailing measures on certain aluminum beverage can material. The countries listed in the measure, including several EU members, are affected. The exemption is determined by the written product description, regardless of the customs code; the conditions include thickness, material condition, and lubricant layer. The measure also affects covered, pending import operations. Exporters should check technical certificates and files with their customs representative. This is not a waiver of all duties on aluminum sheet or an automatic refund for any historical shipment.
Upcoming deadlines
Renugarant: 14 days until the end of the TRIS period
Netherlands / EU · fertilizers and certification · notified project — T–14
On 9 October, the TRIS waiting period for the Dutch notification 2026/0347/NL for the Renugarant scheme expires. The reminder is at the T-14 threshold; the document is not new and the draft is not presented as an accepted right. The proposal links the use of certain processed fertilisers to registration or certification of the manufacturer and to sampling and analysis requirements. It is also relevant for foreign suppliers. Interested companies and conformity assessment bodies should check the applicable conditions and the possibility to react to the notification. The end of the waiting period does not in itself prove national acceptance or start of implementation.
TGA: final week for opinions on transparency for medical devices
Australia · medical devices and supervision · consultation — T–7
The Australian TGA consultation on sharing more information about medical devices closes on 2 October. Today’s reminder is for T–7 and not a new publication of the draft. It is discussing wider public disclosure of post-market quality, safety and performance results, including where compliance is found without action. The topic also affects diagnostic devices and foreign manufacturers in the Australian market. They should assess the impact on technical dossiers, product communication and working with the local sponsor and provide comments if necessary. The proposal is not a new regime and is different from individual device shortage initiatives.
Strategic Watch
Published summary of Google Search DMA decision
EU · digital services and regulatory compliance · international strategic signal - published summary of decision
On 25 September, an official summary of the European Commission's decision of 23 July in case DMA.100193 on Google Search was published. It addresses self-preference in ranking and provides for the cessation of the identified non-compliance within a notification period. This is a publication of an earlier decision, not a new general ban for all digital businesses. For platform-dependent organisations and digital compliance teams, the document is a strategic signal for demonstrating equal treatment and measuring ranking results. Specific follow-up measures should be followed up, without calculating the deadline from today's publication or assuming that implementation has already been achieved.
US proposes shorter period for poultry import refunds
USA · poultry and veterinary certifications · consultation on proposed rule
The US APHIS is proposing changes to import rules for highly pathogenic avian influenza. The draft, published on 24 September, reduces certain HPAI-related periods before export to the US from 90 to 28 days and amends wording in veterinary certificates accordingly. Comments are being accepted until 23 November 2026. This is not a general reduction in all quarantine periods: other diseases and import conditions have their own regime. European exporters and competent veterinary authorities should check which products and certificates are affected and assess the proposal. Until final adoption, the current requirements will be respected.
CPSC proposes broader measures against dangerous blind cords
USA · consumer products and testing · consultation on proposed rule
The US CPSC published a draft on September 24 to expand the characteristics under which blinds and other window coverings are considered a significant product hazard. The proposal addresses accessible cords, continuous loops, certain mechanisms and warning labels and references ANSI/WCMA A100.1-2022. Comments are being accepted until November 23. For European manufacturers, importers and testing laboratories, this is an early warning of changes in design checks and market access. The draft is not a new, existing certification scheme. Product types should be compared to the specific proposed criteria and technical opinions should be prepared, without assuming final adoption.
Published by MG Global in partnership with ERPI.
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