New development
Explicit requirement for laboratory quality control for titanium dioxide
Bulgaria · environment and laboratories · adopted act
An amendment to Regulation No. 3 of 22 May 2013, promulgated on 29 September, adds an explicit requirement for a quality assurance system for laboratory analyses in the monitoring of titanium dioxide production installations. The change enters into force on the day of promulgation and affects operators and laboratories that provide the relevant results. The practical verification should cover documented procedures, validation of results and evidence of quality control. The addition itself should not be presented as a new general obligation for accreditation of all laboratories under ISO/IEC 17025.
New tariff for seed control and laboratory approval from October 1
Bulgaria · seeds, testing and certification · adopted act
The Council of Ministers adopted, by Decree No. 163, a new tariff for the services of the Executive Agency for Variety Testing, Approbation and Seed Control. Published on September 29, it enters into force on October 1, 2026 and covers tests, field inspections, sampling, analyses and certificates. Among the fees listed are 1,022 euros for checking compliance when approving a laboratory and 38 euros for an international orange certificate. Producers, traders and laboratories should compare the requested services and their budgets with the new items. The change in the tariff in itself does not mean a change in the testing methods.
Changes in international transport documents
Bulgaria · international road transport · adopted act
The amendments to Regulation No. 11 on international road transport, promulgated on 29 September, update the requirements for transport documents and technical conformity forms. For international bus and cabotage transport, the availability of a driver qualification card and the relevant technical certificate should be checked. Forms related to the ECMT regime have also been changed. The general effect starts from the promulgation, but the new Article 20 has been postponed by 18 months. Carriers must distinguish immediate documentary obligations from future procedures and maintain the traceability of permits already issued.
Temporary restrictions on the export of petroleum products have been lifted
Bulgaria · petroleum products and market access · adopted act
The National Assembly repealed the decision of 31 October 2025 on temporary restrictions on exports and intra-community supplies of petroleum products. The repeal was promulgated on 29 September and is effective from the same date. It is essential for producers, traders, warehousekeepers and logistics operators who have been complying with this specific national regime in their supplies. Before resuming or changing a flow, the contractual terms, customs regime, origin and product documents should be checked. The repeal does not remove independently applicable sanctions, excise rules or quality and traceability requirements.
Fees for new industrial geographical indications have been set
Bulgaria · craft and industrial geographical indications · adopted act
Decree No. 160, promulgated on September 29, supplements the Patent Office's tariff with fees for geographical indications of craft and industrial products. It provides for 262 euros for an application, 189 euros for an opposition, 68 euros for provisional national protection and 71 euros for control. This is important budgetary and procedural information for producers and organizations preparing protection and proofs of origin. The final provision links the effect to the date of the introduction of the euro, and not to the day of publication. In ongoing proceedings, the applicable charging should be checked individually, without assuming an automatic retroactive surcharge.
MHRA clarifies when COVID test requires new CTDA certificate
United Kingdom diagnostics and medical devices updated official guidance
The MHRA update of 28 September 2020 clarifies that certain changes to a COVID test are not covered by renewal and require an application for a new CTDA certificate. These include changes to the intended use, sample types, gene targets, RT-PCR protocol and extraction or amplification platforms. This affects manufacturers and applicants who are managing product changes for the UK market. The specific change should be compared with the limits of the current certificate and the necessary validation documentation should be prepared. The guidance does not constitute evidence that the contemplated future CTDA revocation is already in place.
New Finnish authority in the EU-US mutual recognition scheme
EU electromagnetic compatibility adopted act
The Official Journal publishes Decision No 80/2026 of the Joint Committee of the EU-US Mutual Recognition Agreement. It adds Etteplan Finland Oy in Jyväskylä to the list of European conformity assessment bodies in the sectoral annex for electromagnetic compatibility. The decision is effective from 17 August, while its official publication is on 29 September. Manufacturers and test contractors can check this additional possibility to serve the US market. Before commissioning, it is necessary to check the exact product scope and the recognised procedures; the listing is not a universal recognition for all products.
Three clove supplements are permitted with separate transition periods
EU · feed and analytical methods · adopted act
Regulation 2026/2158 authorises clove bud oil, leaf oil and beta-caryophyllene-rich fraction of Syzygium aromaticum as flavouring feed additives. Published on 29 September, the act enters into force on 19 October 2026 and lays down conditions of use, characteristics and analytical control, including methods using gas chromatography. Producers and laboratories must verify the identity, dosages by animal category, labelling and worker protection measures. Transitional rules distinguish between additives and premixtures, feed for productive animals and feed for non-productive animals; exhaustion of stocks is only permitted if the relevant conditions are met.
Køge has been added to the ports with an approved weighing system
EU / Denmark · fisheries and independent weighing · adopted act
With Regulation 2026/2155, the European Commission includes the Danish port of Køge in the list of applications for the special derogation from the permissible differences in the assessment of certain unsorted catches. The act enters into force on 6 October. The approval is based on facilities and procedures for weighing, dewatering, sampling and video surveillance, as well as the responsibility of approved independent third parties. Fishing businesses, traders and control authorities must verify the applicability to the specific catch and port procedure. This is not a general exemption from accurate reporting, nor a new authorisation for every European port.
Conditional exemption for access to 240 Talgo wagons
EU / Sweden · railway safety and accessibility · adopted act
Decision 2026/2139 accepts the request from Sweden for the non-application of the specific requirement for the position of access steps for 240 Talgo T-230 carriages. The exemption is conditional and applies until 31 December 2035. It requires alternative operational measures in the safety management system, such as announcements, ramps or the restriction of certain doors, together with targeted supervision by the national authority. For manufacturers, operators and assessors, the case demonstrates the need for the technical deviation to be supported by verifiable compensatory measures. The authorisation is not automatically transferable to other carriages, operators or countries.
Italy may allow Vikane for certain heritage wooden structures
EU / Italy · biocides and cultural heritage · adopted act
Decision 2026/2142 allows Italy to authorise the biocidal product Vikane with sulfuryl fluoride for certain large fixed wooden parts of cultural heritage. The European decision was published on 29 September and outlines the possibility of a national authorisation until 30 September 2031. It is not in itself a national authorisation for free sale or general use. Conservation organisations, professional contractors and control teams must check the specific authorised site, the application restrictions and the competence of the personnel. Documented necessity and safety measures remain key for the commissioning and control of the treatment.
European basis for special treatments with ethylene oxide in the Czech Republic
EU / Czech Republic · biocides and cultural heritage · adopted act
With Decision 2026/2150, the European Commission allows the Czech Republic to authorise biocidal products containing ethylene oxide for the protection of movable cultural heritage objects until 31 July 2031. The publication of 29 September constitutes a specific legal basis and not a general product approval for the European market. The institutions and contractors concerned must check the national authorisation, specialised facilities, training and residue control. The procedures described include multi-stage ventilation and residue monitoring. Evidence of the safe completion of the treatment and the admissibility of the specific method must be required when commissioning.
Separate derogation for ethylene oxide at cultural sites in Slovakia
EU / Slovakia · biocides and cultural heritage · adopted act
Decision 2026/2153 allows Slovakia to authorise biocidal products containing ethylene oxide for the protection of movable cultural heritage objects until 31 July 2031. The act was adopted on 28 and published on 29 September. The regime is independent of the similar decision for the Czech Republic and does not automatically create interchangeable national authorisations. Slovak contracting authorities and contractors must establish the applicable national decision, the permitted uses and the necessary protective procedures. The objects, responsibilities and evidence for the safe conduct of the specialised treatment should be clearly defined in the contracts and control documentation.
The protected name Aceite Valle del Tiétar has been registered.
EU / Spain · food and certification of origin · adopted act
Regulation 2026/2167 registers Aceite Valle del Tiétar as a protected designation of origin for Spanish olive oil. The act was published on 29 September and entered into force on 19 October 2026. The registration is relevant for producers, importers, traders and control bodies that use or verify this name. Before labelling and offering, the product specification, origin and proof of conformity must be verified. The protection does not constitute free permission for use of the name by any supplier; contracts, catalogues and traceability must reflect affiliation to the defined regime.
Moving between sanction applications does not mean exemption
EU · sanctions compliance and suppliers · adopted act
Regulation 2026/2191 transfers four individuals and Alliance Fleuve Congo from Annex Ia to Annex I of the EU regime for the Democratic Republic of the Congo. The act was published on 29 September and entered into force the following day. The change reflects their inclusion in the UN regime and should not be read as a lifting of restrictions. Organisations that verify counterparties, payments and supply chains should update the legal basis and the matching of identifiers, while maintaining continuity of control. Automated systems should not release records simply because they have been deleted from one application.
The regime for Burundi has been extended until October 2027.
EU · sanctions compliance · adopted act
By Decision 2026/2197, the Council extends the restrictive measures under Decision 2015/1763 against Burundi until 31 October 2027. The new act was published on 29 September and entered into force on 30 September. This is a change in the duration of an existing regime and does not constitute evidence of a new general ban on trade with the State. Organisations with relevant counterparties must replace the old expiry date in their records and maintain checks on the applicable restricted persons and transactions. An automatic expiry of the controls in October 2026 would create a compliance gap.
Ten new faces in the EU's separate regime for the situation in Russia
EU · sanctions compliance · adopted act
Regulation 2026/2193 adds ten natural persons to Annex IV to Regulation 2024/1485 concerning the situation in Russia. It was adopted, published and entered into force on 28 September; the notice to the persons concerned was published on 29 September. This is a separate sanctioning regime and should be reflected separately in the compliance registers. Organisations should renew checks on counterparties and related persons, cross-check identifiers and document the resolution of possible matches. The new entries should not be confused with other lists or become a blanket conclusion prohibiting any transaction with Russia.
The list under Regulation 269/2014 has been expanded
EU · sanctions compliance · adopted act
Regulation 2026/2184 adds ten persons and seventeen entities to Annex I to Regulation 269/2014 for actions undermining the territorial integrity, sovereignty and independence of Ukraine. The act is in force since its publication on 28 September, with a subsequent notification on 29 September. For organisations, the practical action is to update the sanctions data and the verification of counterparties, including the identification options and the applicable legal grounds. This extension is different from the new entries under the Russia regime. The audit trail should indicate under which regime a match was found and how the specific transaction was assessed.
Time-limited authorization for ERO MN begins
EU · biocides and comparative assessment · legal stage reached
The Union authorisation period for the biocidal product family ERO MN under Regulation 2026/1974, published earlier this month, starts on 29 September. The authorisation EU-0035833-0000 is limited to 31 August 2030. Following the comparative assessment, only the use for disinfection of animal transport vehicles is eligible for renewal. This does not mean that other authorised uses are prohibited as of today. Suppliers, livestock and food businesses should check the specific use, product characteristics and restrictions in their documentation. Planning of long-term contracts should take into account the different status of future renewals.
Exemption for certain air dryers enters into force
EU · F-gases and equipment · entry into force
On 29 September, Regulation 2026/1975 on a temporary exemption for certain categories of compressed air refrigeration dryers entered into force. The actual application of the exemption is from 1 January 2027 to 31 December 2030 and is limited to the described capacities and types of equipment containing fluorinated gases. Manufacturers, importers and assessors should check the technical classification and the required labelling under Regulation 2024/573. Today's legal step is not a general postponement of the restrictions on F-gases. The market access documents should demonstrate why exactly the specific model falls under the exemption.
The updated Annex II for pharmaceutical tariff codes is applied.
USA · pharmaceutical supply and customs compliance · implementation occurred
Effective at 12:01 a.m. Eastern Time on September 29, Annex II to Federal Register Notice 2026-19498 on the Pharmaceutical Tariff Regime will be effective. It replaces the list of tariff codes in Annex IV to Proclamation 11020. European manufacturers, exporters, and U.S. importers should verify the classification of specific goods and the supporting documents for their declaration. This is an expiration notice for a previously published document, not a new publication today. Annex II should not be confused with the individual terms of Annex I or interpreted as a blanket exemption for pharmaceutical shipments from all duties.
EMA requires preparation of a change in the information for oxacillin
EU · pharmacy and pharmacovigilance · regulatory recommendation for product information
EMA published on 28 September the PRAC recommendation on EPITT 20223 for oxacillin. Marketing authorisation holders should prepare an application for a change to the product information within two months of publication, with a calendar reference date of 28 November. The update concerns the warnings and the description of a drug reaction with eosinophilia and systemic symptoms. Regulatory and pharmacovigilance teams should check existing national texts, translations and the submission route. This is a safety and information management action for authorised products and not a general suspension of sales.
PRAC sets new product-specific data deadlines
EU · pharmacy and regulatory evidence · data requests and periodic reports
The PRAC package, published on 28 September, also contains specific requests for additional information or assessment in periodic safety update reports. The next 60 days include 3 November for anakinra and gefitinib, 11 November for certain TNF inhibitors and 17 November for deucravacitinib. The requests are addressed to specific marketing authorisation holders and do not create the same obligation for all companies. The affected teams should link each deadline to the exact EPITT alert, the required dataset and the responsible holder. The presence of an alert and a request for analysis should not be presented as a definitive causal relationship.
Sierra Salamanca changes tasting evaluation criteria
EU / Spain · wine and organoleptic control · approved standard specification amendment
The standard amendment to the Sierra Salamanca specification, published on 29 September, updates the organoleptic descriptions in line with the criteria for the work of tasting panels under UNE-EN-ISO 17025. Separate rules for ageing and presentation of wines are also being changed. The Vino de Pueblo designation with the name of a municipality requires that at least 85% of the grapes come from that municipality. Producers, tasting laboratories and control bodies must verify the evaluation forms, labels and proofs of origin. The removal of details of the control body from the specification does not mean that control over the protected designation is no longer exercised.
Upcoming deadlines
Three thresholds for sheep and goat pox zones
EU / Bulgaria · animal husbandry and veterinary control · T–7 / T–14 / T–30
Today's radar reaches three thresholds under Decision 2026/2052: seven days until 6 October for the designated protection zones in Kardzhali and Yambol, fourteen days until 13 October for the protection zones in Blagoevgrad and thirty days until 29 October for the surveillance zones in Stara Zagora. These are deadlines for specifically described territories, not for entire districts without distinction. Breeders, transporters and processors should check the location of the site, the current national orders and the conditions for movement. The expiry of a protection phase does not automatically mean the abandonment of the surveillance zone or the restoration of any trade flow.
The deadline for one zone for bird flu does not exempt all sites
EU / Bulgaria · poultry farming and veterinary certificates · T–7
There are seven days left until 6 October for the specified surveillance period for outbreak BG-HPAI(P)-2026-00011. The deadline is maintained in the current Annex to Decision 2026/2187, published on 28 September. At the same time, later restrictions are foreseen for the separate outbreak 00012, including a surveillance zone with Rakovski until 27 October. Poultry farms, traders and veterinary document issuing authorities should check whether the specific site also falls within another active zone. Therefore, 6 October cannot be used as a general date for the release of the Plovdiv region or for the automatic resumption of exports.
The new SOPUROXID specification applies from October 6th.
EU · biocides and product change management · T–7
On 6 October, Regulation 2026/2046 will enter into force, replacing the summary of characteristics of the SOPUROXID biocidal product family under authorisation EU-0026179-0000. Today's reminder is at the T-7 threshold for an already published act. Among the amendments is the removal of the classification as flammable liquid, category 3, only for meta-SPC 4, together with administrative updates. The holder, suppliers and professional users should check the labels, technical files and controlled copies of the information. The change does not mean that all the hazards of the entire family are eliminated, nor that the conditions can be transferred between different meta-SPCs.
Seven days for comments on RETC expansion
USA · electrical testing and laboratory accreditation · consulting · T–7
OSHA is accepting comments on the proposed extension of the Renewable Energy Test Center’s recognition as a nationally recognized testing laboratory through October 6. The preliminary conclusion, published on September 21, covers UL Standard 1741 and an additional site in Fremont. It is relevant to manufacturers of inverters, converters, and related equipment, as well as laboratories and certification bodies. Today’s notice is a T–7 reminder, not a new final recognition. Interested organizations can review the proposed scope boundaries and submit technical arguments under docket number OSHA-2010-0013 before planning to use the future extension.
TÜV SÜD America Scope Opinions Due October 6
USA · batteries and laboratory recognition · consultation · T–7
OSHA’s separate consultation on TÜV SÜD America also closes on October 6. The proposed expansion includes UL 2580 for electric vehicle batteries and UL 2743 for portable power supplies. The September 21 publication is a preliminary conclusion on the nationally recognized testing laboratory regime, not a final authorization for the new scope. Manufacturers, suppliers, and evaluators should verify the compliance of planned tests with the specific standards and submit relevant comments under file OSHA-2007-0043. The selection of a laboratory for a final recognized procedure should be based on the current decision, not just the proposal.
Strategic Watch
ISO/UNDP 53001 is now a published standard
International · management systems and sustainable development · published standard
The official ISO catalogue now shows ISO/UNDP 53001 at stage 60.60 — published, dated 28 September 2026. The standard specifies requirements for a management system related to the Sustainable Development Goals, including assessment of positive and negative impacts, targets, data and improvement. This is a new stage compared to the previous monitoring of an expected standard. Organizations and assessors can start to compare their existing systems and evidence of performance. Publication does not in itself create a legal obligation for certification or a universal accreditation transition; specific schemes and recognitions must be verified separately.
A new framework for setting and assessing the minimum wage
Bulgaria · labor compliance and organizational planning · adopted law · strategic signal
The amendment to the Labor Code, promulgated on September 29, introduces a new framework for setting the minimum wage and periodically assessing its adequacy. Criteria for purchasing power, the level and growth of wages and productivity are provided, as well as an assessment every three years with reference values for the median wage and the cost of living. The law does not set a new specific amount and does not automatically turn 60% of the median wage into a universal formula. Employers should monitor the subsequent regulation and NSI data and prepare verifiable input data for budgeting and labor compliance.
Support for laboratory validation and interlaboratory comparisons
EU/UN · laboratory competence and verification · international strategic signal
With Decision 2026/2176, the EU supports the development of the laboratory network for the UN Secretary-General's Mechanism for Investigating Alleged Use of Chemical and Biological Weapons. The act, adopted on 28 and published on 29 September, includes validation, inter-laboratory comparisons, external quality assessment and harmonisation of sample handling. Participation and capacity building are foreseen in a wider geographical scope. For specialised laboratories and competent authorities, this is a strategic signal for future evidence-based practices and cooperation. The decision is programme funding and not a new general obligation for all accredited laboratories.
EU adopts framework for responding to threats to space systems
EU · space services and continuity · adopted framework · strategic signal
Decision 2026/2195 establishes the STRA architecture for the EU response to threats to space systems and related services. The act was published and entered into force on 29 September, replacing the previous framework but preserving the existing procedures until they are updated. Information exchange, technical response and notification of affected users are foreseen. For operators and organisations dependent on satellite services, the importance lies in the future links between incident management, continuity and proof of resilience. A new private certification scheme is not automatically introduced; the specific procedures and contractual interfaces should be followed.
Application for Castagna del Partenio is open for objections
EU / Italy · food and geographical indications · consultation / objection procedure
The application for the Protected Geographical Indication Castagna del Partenio for Italian chestnuts was published on 29 September. It starts the three-month European objection period, with a calendar reference date of 29 December 2026. The document describes the product forms, origin, characteristics and labelling and traceability requirements. Producers, traders and control bodies with a legitimate interest can assess the impact on existing names and supply chains. This is an application, not a definitive registered protection. Before taking action, the admissible objection channel should be checked, including the national procedure for operators established in the EU.
The Tjockmjölk application sets conditions for origin and production.
EU / Sweden · dairy products and geographical indications · consultation / objection procedure
The publication of 29 September opens an objection procedure against the application for Tjockmjölk for a protected geographical indication. The proposed specification covers a fermented milk product from Sweden and sets out requirements for the raw material, process, characteristics and geographical origin. The three-month period has a calendar reference date of 29 December 2026. Milk processors, traders and control authorities should check how future protection would affect the names and proof of conformity. No definitive registration should be claimed at this stage. Interested operators should establish their legal interest and the applicable national or European objection procedure.
New Slovak wine application with conditions for variety, origin and aging
EU / Slovakia · wine and certification of origin · consultation / objection procedure
The application for the protected name Račanská frankovka / Račianska frankovka / Frankovka z Rače was published on 29 September. It sets out conditions for Slovak red wine, including a minimum of 90% of the Frankovka Modrá variety, geographically bound grapes and production, and at least twelve months of aging. The objection period is three months, with a calendar reference of 29 December 2026. Producers, importers and evaluators must review the analytical and organoleptic criteria and existing trade names. Publication is not a final protection; the admissibility and procedure for submitting objections are subject to separate verification.
Published by MG Global in partnership with ERPI.
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