New development
MyHealth@EU: identification rules come into force
EU · eHealth · Regulation adopted - entry into force
Implementing Regulation (EU) 2026/2099 on identification and authentication for cross-border exchanges of electronic health data enters into force on 12 October 2026. The main application starts on 26 March 2027; two provisions on the European digital identity wallet apply from 26 March 2029. For certain means of electronic identification, the level of assurance must be notified or confirmed by a conformity assessment body or equivalent. National contact points, healthcare providers and developers must verify the chosen route, responsibilities and evidence of identification. Today's legal stage does not mean immediate universal certification of healthcare institutions.
Upcoming deadlines
Global ACI: registration for annual meetings ends on October 12
International · Accreditation and Conformity Assessment · Registration Deadline - Strategic Radar
The official organizer of the Global ACI annual meetings lists October 12, 2026 as the closing date for registration. The meetings are in Panama from October 19 to 26 and are by appointment only. The program includes the technical committees for laboratories, inspection, certification, verification and validation. Participation is limited according to the status of the organization, and some sessions are closed. For accreditation bodies and participants in international schemes, this is an opportunity to follow up on upcoming discussions and prepare questions for the recognition of results. Interested parties should check eligibility and registration immediately. This is an organizational deadline, not a new obligation or a transitional period for certificates.
DHS: One week until codified rules of origin for protective equipment
United States Personal Protective Equipment and Supplies Final Rule — T–7
On October 19, 2026, the U.S. Department of Homeland Security’s final rule under the Make PPE in America Act went into effect. It codifies in the HSAR the restrictions on the purchase of certain PPE, including the U.S. origin requirements for materials and components and the exemptions provided. The major statutory restrictions do not arise for the first time with this publication. Manufacturers and suppliers servicing DHS orders must verify the chain of origin, contract clauses, and the applicability of exemptions. Product testing or CE marking are not substitutes for proof of origin. The rule is not a blanket ban on the sale of foreign PPE in the U.S. market.
US-flagged passenger ships: two weeks to review training
United States Maritime Transportation and Competence Final Rule — T–14
Effective October 26, 2026, the US Coast Guard’s amendments to the regulations for personnel on U.S.-flagged passenger ships carrying more than 12 passengers on international voyages will take effect. The regulation introduces emergency procedures and expands the scope of crowd management training to certain ratings under STCW. Documentary evidence of successful completion of training appropriate to the position and duties is required. Operators, marine personnel brokers, and training organizations serving this fleet should align emergency schedules, programs, and individual records. This is a U.S. implementation of international requirements, not an automatic change for every ship flying a Bulgarian or other flag.
EPA: two weeks until Title V permitting scope change
United States · Industry and Environment · Final Rule — T–14
On October 26, 2026, EPA’s final rule on the scope of „applicable requirements“ in the Clean Air Act Title V permitting regime will take effect. It clarifies the limited cases in which requirements under the New Source Review pre-permit regime are addressed through Title V oversight. The general obligation to prevent accidental releases of hazardous substances is not applied through this permitting mechanism; this does not mean that the obligation itself is eliminated. US facility operators and environmental compliance teams should review the requirements register, permit conditions, and audit evidence. The change is also important for European groups with production sites in the US, but does not change the EU permitting regimes.
Strategic Watch
CCFICS28: sanitary requirements enter plenary discussion stage
International · Food and Official Certification · International Strategic Signal - Draft Guidelines
The CCFICS28 session of the Codex Alimentarius is scheduled for 12–17 October 2026 in Perth. One of the issues prepared for discussion is the standardized presentation of sanitary requirements for food imports and exports. The official website links this work to the plenary discussions; adoption of the report is planned for 17 October. This is a stage in the development of guidance, not a new obligation for exporters already adopted. Competent authorities, food businesses and official certification professionals should monitor how the requirements and evidence of their compliance are described. The potential value is more comparable information between jurisdictions. Practical changes should be assessed after the publication of the agreed text and report.
Biotech Act II: Commission discusses initial regulatory options
EU Industrial biotechnology and bio-manufacturing Consultation - preparatory phase
On 12 October 2026, the European Commission organised a workshop to prepare the Biotech Act II. The programme foresees the presentation of the results of the call for evidence and the discussion of initial policy options. The initiative covers industrial biotechnology and bio-based manufacturing, and its precise scope will be determined through the impact assessment. This is not an adopted regulation or a new mandatory certification. Bio-based material producers, chemical companies and technology providers should prepare concrete data on market access barriers and on the demonstration of product characteristics. For the TIC sector, the signal is a possible future amendment of the evidence requirements, which should be monitored when the proposal is published.
Published by MG Global in partnership with ERPI.
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