New development
Accreditation for sustainable fuels certification is postponed to 2028.
EU · accreditation and sustainable fuels · adopted regulation
Implementing Regulation (EU) 2026/2470, published on 29 October, postpones the application of Article 11(1) of Regulation (EU) 2022/996 from 1 January 2027 to 1 January 2028. The change concerns the accreditation of certification bodies carrying out checks under voluntary and national fuel sustainability schemes. The amending Regulation itself enters into force on 18 November 2026. The reason is the time needed to assess the suitability of the schemes for accreditation and to accredit bodies. Certification bodies and scheme owners should update their transitional plans and contractual deadlines. The postponement does not waive the remaining requirements for auditing, sustainability and emission verification.
New harmonized references for testing dryers
EU · electrical appliances and testing laboratories · harmonised standards decision in force
From 29 October, Implementing Decision (EU) 2026/2370 publishes the references to EN 61121:2013 and the amendment EN 61121:2013/A12:2025 for household tumble dryers. They support the ecodesign and energy labelling requirements of Regulations 2023/2533 and 2023/2534. At the same time, the independent reference to EN 60704-2-6:2012 is deleted and the old communication from 2014 is repealed. This does not mean that noise measurement is no longer required: the tumble dryer standard contains the relevant normative reference. Manufacturers and laboratories must check the publications, reports and technical files used. The presumption of conformity applies to the requirements that the standards actually cover.
Recycled plastics: declarations of conformity are changing
EU · food packaging and traceability · adopted regulation with transitional measures
Regulation (EU) 2026/2376, published on 29 October, amends the documentation for compliance of recycled food contact plastics. The new Article 5a regulates the transmission and acceptance of declarations in the non-retail chain and provides for specific exemption conditions for packaged foods. The act enters into force on 18 November. For products compliant with the previous regime, the transition for declarations A and B is until 18 February 2027, and for declarations C and P until 18 May 2027. Recyclers, processors and food businesses should map their roles to the applicable template and update their delivery documents, instructions and acceptance checks.
US updates formaldehyde testing methods for wood-based panels
United States · wood products, laboratories and certification · final rule
EPA published a final amendment to 40 CFR Part 770 on formaldehyde from composite wood products on October 28. Effective November 27, 2026, regulatory methods and product standards are being updated, including ASTM D6007-22, and ISO 12460-2:2024 is being added as an alternative small chamber quality control method. The change affects manufacturers, laboratories, certification bodies, and importers of covered products in the United States. European suppliers should verify the methods in their contracts, test scopes, and ongoing monitoring procedures. The selection of a new acceptable method should not be considered an automatic change to the limit values or an exemption from certification and records.
EMA clarifies transition to ICH M13B for bioequivalence
EU · pharmaceuticals and clinical trials · new implementation guidance
On 28 October, EMA published document EMA/208474/2026 on the practical implementation of ICH M13B, adopted by the CHMP on 15 October. The guidance on exemption from additional bioequivalence studies at other dose strengths will apply from 17 March 2027. It will then specifically replace sections 4.1.6 and 4.2.2 of the current European guideline; the remaining issues not covered will continue to be assessed against the applicable documents. Applicants and contract research organisations should review the planned studies and dossiers. For submissions after this date, deviations, including for studies already completed, must be justified in the application and will be assessed on a case-by-case basis.
ELAN: the legal value of electronic documents is being clarified
EU and third countries · agricultural trade and certification of origin · adopted regulation
Implementing Regulation (EU) 2026/2389, published on 29 October, specifies the voluntary use of ELAN by issuing authorities of third countries during the transitional period. The changes distinguish between documents with legal value in the system and documents used outside it and provide for the publication of a list of participating countries. The general entry into force is on 5 November 2026; the mandatory stage for the relevant third country documents remains on 17 January 2028. Importers of agricultural products and their suppliers should check the specific issuing authority, the type of document and its status in ELAN. A test record or parallel paper copy should not automatically be accepted as valid evidence.
Upcoming deadlines
One week until the new recognition of RSB EU RED
EU / international scope · sustainable fuels and certification · adopted decision — T–7
Implementing Decision (EU) 2026/2316 on the recognition of the RSB EU RED scheme, published on 16 October, enters into force on 5 November. Reminder T-7 concerns the new stage of an already reflected act. The decision covers the specified sustainability and emissions criteria, including for renewable fuels of non-biological origin and recycled carbon fuels, and applies until 5 November 2031. Operators and auditors must compare the specific fuels and the criteria to be verified with Article 1, as well as the mass balance evidence and chain of custody data. Recognition of the scheme does not automatically certify the compliance of an individual operator, batch or issued certificate.
Opinions on the transfer of wine control are being accepted until November 5
Bulgaria · viticulture, winemaking and official control · official consultation — T–7
There is one week left until November 5 for opinions on the draft amendment to the Law on the Bulgarian Food Safety Agency, published by the Ministry of Agriculture and Food on October 22. It is proposed that the activities of the Executive Agency for Vine and Wine be transferred to the BFSA. The draft provides for continuity of registers and proceedings, as well as preservation of the validity of the issued acts, certificates and document templates under the specified conditions. This is a consultation, not a transfer. Wineries, laboratories and industry organizations can indicate practical risks to service, traceability and control and check how the proposed transition affects their documents.
Seed control: seven days to comment on the institutional change
Bulgaria · seed material, testing and certification · official consultation — T–7
On November 5, the consultation on the draft amendment to the Law on Seed and Propagating Material, opened on October 22, ends. It is proposed that the functions specified for the Executive Agency for Variety Testing, Approbation and Seed Control be assigned to the Executive Agency for Selection and Reproduction in Agriculture. The changes affect the competent authority in a number of provisions for control, testing and certification. Today's signal is a reminder T–7 and does not mean that the new authority is already exercising these powers. Producers, traders and testing structures should check the administrative continuity, the current documents and procedures that would be affected, and submit specific proposals before the end of the discussion.
Strategic Watch
FDA proposes an electronic template for investigational device applications
USA · medical devices and regulatory filings · official consultation
On October 28, the FDA announced a draft guidance document for an electronic template for Investigational Device Exemption (IDE) applications. The document is intended for sponsors submitting applications to CDRH and CBER and explains the resources for structured electronic preparation of information. Comments are being accepted until December 28, 2026. The draft is not final and is expressly not intended for implementation at this time. Medical device manufacturers with clinical programs for the U.S. market can compare the proposed structure with their technical and clinical evidence. The practical task is to identify gaps and difficulties in preparation without presenting the draft as a new mandatory requirement.
EPA proposes eliminating program for large methane releases
USA · oil, natural gas and emissions monitoring · official consultation
On October 29, EPA published a draft of a further revision to the oil and gas sector rules, which includes a proposal to eliminate the Super Emitter Program. This is a draft change to the regime for detecting and following up on large releases, not a program that has already been canceled. Comments on the proposal are being accepted until December 16, 2026; a virtual public hearing is scheduled for November 13. Operators, measurement service providers, and supply chain participants should assess the implications for the use of external data and contractual verification of emissions. The US consultation does not independently change applicable European or contractual requirements.
Published by MG Global in partnership with ERPI.
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