New development
New RSB EU RED recognition for sustainable fuels
EU · Energy and sustainability verification · decision adopted
The European Commission published on 16 October Implementing Decision (EU) 2026/2316 recognising the voluntary scheme RSB EU RED. The decision covers the demonstration of applicable sustainability and emission saving criteria for biofuels, bioliquids and biomass fuels, as well as requirements for renewable fuels of non-biological origin and recycled carbon fuels. It will enter into force on 5 November 2026 and will apply until 5 November 2031. For manufacturers, traders and auditors, the practical step is to verify the scope of certification, traceability, mass balance and emissions data. Recognising the scheme does not automatically certify the compliance of every fuel or operator.
Uniform environmental conditions for poultry and pig farms
EU · Livestock and industrial emissions · decision adopted
With Implementing Decision (EU) 2026/2260 published on 16 October, the Commission sets out uniform conditions for the operation of poultry and pig installations falling within the scope of Annex Ia to the Industrial Emissions Directive. The conditions concern ammonia emissions, nitrogen and phosphorus discharges, monitoring and the techniques used. Alternative techniques require scientifically sound validation and documented data. Implementation is phased in: no later than 8 October 2030 for the largest group, 2031 for the next and 2032 for the remaining installations covered. Operators should check their capacity in animal units, measurement methods and necessary investments. This is not a new immediate obligation for all farms.
Difenoconazole: new residue definition and transition to May 2027.
EU · Food, feed and laboratory testing · adopted regulation
Regulation (EU) 2026/2299, published on 16 October, amends the maximum residue limits for difenoconazole and the residue definition for products of animal origin. This concerns not only the limits but also the substance that the laboratory must determine for compliance control. The act enters into force on 5 November 2026 and the new rules apply from 5 May 2027. For products placed on the EU market before that date, the previous regime is foreseen to continue. Manufacturers, importers and laboratories must match the product codes, the analytical scope and the agreed specifications, keeping evidence of the date of placing on the market.
Pinoxaden: updated limits and confirmed data
EU · Grain, food and laboratory testing · adopted regulation
Regulation (EU) 2026/2289, published on 16 October, updates, among other amendments, the residue limits for pinoxaden in barley, wheat and rye. After assessing the additional data, EFSA considers that the identified gaps for livestock products have been closed; the relevant limits are maintained and the notes on their indicative nature are removed. The change will enter into force on 5 November 2026. Grain producers, feed businesses, traders and laboratories need to review the applicable product codes, the residue definition and the batch acceptance criteria. The confirmation of the data does not replace the control of residues or the need for traceable laboratory results.
OSHA adds Norwegian laboratory to Nemko's recognized scope
USA / Norway Electrical safety and conformity assessment final recognition
OSHA is expanding the recognition of Nemko North America under the US Nationally Recognized Testing Laboratory Program by adding a testing site in Lysaker, Norway. The final decision has been published and will take effect on October 16, 2026. The significance for European manufacturers is the ability to perform certain tests for the US market at this site within the scope of the recognized competence. The decision is not a blanket endorsement of all products or standards. Before commissioning testing, the manufacturer should check the specific standard, the recognized scope of the organization, and the capabilities of the laboratory. For the TIC sector, this is a direct change in the geographical scope of regulatory recognition.
FDA introduces new grounds for technical rejection of eCTD dossiers
USA · Pharmacy and regulatory filings · official notice
The FDA announced on October 16 new, high-stakes criteria for the technical validation of electronic regulatory dossiers (eCTDs). Starting January 16, 2027, the agency will reject submissions that do not meet the specified checks for versions 3.2.2 and 4.0, subject to applicable exemptions and exceptions. For pharmaceutical companies and dossier preparation service providers, this means updating and testing validators before submission. The exact error codes, system configuration, and quality control of packages should be verified. The notice does not mandate a general migration to version 4.0 and does not automatically end the use of version 3.2.2.
FDA opens transition to eCTD 4.0 for existing dossiers
USA · Pharmacy and digital evidence · new technical milestone
Starting October 16, 2026, FDA will begin supporting forward compatibility to eCTD 4.0 for applications originally submitted in version 3.2.2. A separate notice allows subsequent submissions in version 4.0 while preserving the lifecycle history and ongoing regulatory activities of the application. This is a new technical capability, not a blanket obligation for all companies to migrate immediately. Affected manufacturers and regulatory teams should evaluate the compatibility of tools, dossier structure, and traceability procedures. It is prudent to conduct a controlled test of the conversion and linkages to previous documents prior to the first submission using this route.
Upcoming deadlines
ISO 14001: the remaining two weeks until the preparatory stage of the BSA EA
Bulgaria · Accreditation and Management Systems · upcoming deadline — T–14
On October 30, 2026, the deadline announced by the BSA Agency for its preparatory activities for accreditation and transition to BDS ISO 14001:2026 will come. This is a reminder of the existing schedule published on September 10, and not a new change to the standard. Certification bodies must submit a declaration, analysis of changes, action plan and evidence of readiness by January 31, 2027. The general transition for certified organizations ends on April 30, 2029. The practical task now is to verify the competence of personnel, updated procedures and the schedule for client audits. The October deadline should not be presented as a date on which client certificates lose validity.
Strategic Watch
Medicine supplies: draft regime to prevent shortages published
EU · Pharmacy and sustainability of supply · international strategic signal - legislative stage
On 16 October, Council Position (EU) No 12/2026, adopted at first reading on 28 September, on the future Regulation on the authorisation and supervision of medicinal products, was published. Article 121 of the text provides for up-to-date plans to prevent shortages of prescription medicines and other specified products. The planned information includes a risk assessment and a map of production dependencies in the supply chain. This is a legislative text at a certain stage and does not prove that the new obligation is already in place. Authorisation holders and their manufacturing partners can start analysing the available data and responsibilities by following the final act, transitional periods and future EMA guidance.
ENISA NIS360: two weeks to participate in the survey
EU · Cybersecurity and risk management · consultative study — T–14
ENISA's NIS360 survey remains open until 30 October 2026; today's alert is a reminder with two weeks remaining. The initiative, announced on 1 July, collects views from national competent authorities and organisations in sectors with high NIS2 criticality on cybersecurity maturity and sector criticality. The results will inform the next NIS360 report in 2027. Participation is voluntary and does not replace regulatory notification, audit or certification. It is useful for eligible organisations to identify a competent participant, check which questionnaire is applicable and provide agreed responses on risk management. This is not a new general deadline for the implementation of NIS2.
Published by MG Global in partnership with ERPI.
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