Reference Materials
Certified and non-certified reference materials (CRMs/RMs) used in analytical chemistry to ensure the accuracy, traceability, and reliability of measurements for chemical, environmental, food, and clinical testing.
Foresight tracks Reference Materials developments and surfaces the alerts most likely to matter before they turn into missed deadlines, recalls, or escalation work.
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1 May 2026, 13:40
Latest Reference Materials alerts
The most recent regulatory and guidance signals tracked by Foresight
EU Delegated Regulation 2026/314 Adds Nine Drug Precursors To Category 1 Lists
The EU has now published Delegated Regulation (EU) 2026/314 in the Official Journal, formally adding nine synthetic cathinone and amphetamine precursors to the Category 1 EU drug precursor lists with effect from September 2026. Chemical and pharmaceutical supply chains handling these intermediates must prepare for full Category 1 licensing, authorisation, and monitoring obligations for intra-EU movements and import/export trade, significantly tightening diversion-risk controls.
European UnionChina NMPA Issues 103rd Batch of Reference Preparations for Generic Drugs (Notice 8/2026)
China's NMPA released the 103rd batch of generic-drug reference preparations in March 2026, introducing new substances and updating marketing authorization holder data. Generic drug developers must align bioequivalence studies and regulatory dossiers with these updated comparators to ensure consistency and maintain market access.
ChinaEU PAFF Committee Supports Revoking GM Maize MON 87403/87419 And Sends Soybean MON 94637 Authorisation To Appeal Committee
The EU PAFF Committee has endorsed the market withdrawal of two GM maize traits and referred the approval of a new GM soybean to the Appeal Committee following a regulatory deadlock. Companies should prepare for the formal revocation of maize authorisations and anticipate continued political uncertainty for new biotech approvals in the European market.
European UnionBrazil (ANVISA) Opens Public Consultation 1,384/2026 on Brazilian Pharmacopeia Committees Regulation
Brazil’s ANVISA has launched a public consultation to revise the governance and operational framework of the Brazilian Pharmacopeia committees. This restructuring will influence how pharmaceutical quality standards and reference substances are established, impacting long-term compliance and market access strategies.
BrazilUS DEA Updates Exempt Chemical Preparations Under the Controlled Substances Act
The US DEA has finalized status updates for hundreds of chemical preparations, granting or denying exemptions from Controlled Substances Act requirements. Businesses should audit product portfolios against the updated lists to confirm which preparations benefit from reduced regulatory burdens and which require full DEA compliance.
United StatesUS DEA Issues Importer Registration Application Notice for Controlled Substances — United States Pharmacopeial Convention
The US Drug Enforcement Administration has published an application from the United States Pharmacopeial Convention to import 40 classes of controlled substances as analytical reference standards. Approval will stabilize the supply of certified materials essential for pharmaceutical quality control and raw material testing compliance across the industry.
United StatesCzech Republic Designates SZPI Brno Laboratory as National Reference Laboratory for Honey
Czechia has formally designated a National Reference Laboratory for honey to strengthen the enforcement of EU food quality and authenticity standards. Producers and importers should expect increased scrutiny as authorities deploy advanced analytical methods to detect adulteration and ensure market transparency.
CzechiaEuropean UnionEDQM Publishes February 2026 Newsletter on European Pharmacopoeia Reference Standards
The EDQM has updated the European Pharmacopoeia reference standards for February 2026, introducing new materials and replacement batches. Manufacturers must update quality control protocols and procurement schedules to ensure testing remains compliant with current compendial requirements.
European UnionUS FDA Final Rule Revokes 21 CFR 2.19 Methods of Analysis Regulation
The US FDA has finalized the revocation of 21 CFR 2.19, removing outdated 1980s analytical method requirements for enforcement actions effective March 23, 2026. This shift enables the agency to adopt modern, validated testing methods via guidance documents, requiring industry to monitor evolving compliance programs rather than static regulations.
United StatesUS CDC Seeks Comment on PRA Revision for NCEH DLS Laboratory Quality Assurance Programs
The US CDC has proposed revisions to its laboratory quality assurance and standardization programs for public health analytes, including lead and arsenic, with comments due by March 20, 2026. These updates ensure the continued accuracy of clinical and biomonitoring data, impacting laboratories that support regulatory compliance and public health safety assessments.
United StatesUS CDC Seeks Comment on Extension of Information Collection for Traceable Opioid Material Kits
The US CDC is extending the Traceable Opioid Material Kits program through 2029 to maintain the distribution of reference standards for synthetic opioids. This ensures that forensic and clinical laboratories have the standardized tools required to monitor emerging chemical threats and maintain analytical accuracy.
United StatesEuropean Commission Publishes Delegated Regulation To Add Certain Synthetic Cathinone And Amphetamine Precursors To EU Drug Precursor Lists
The European Commission has moved nine synthetic cathinone and amphetamine precursors to the highest level of regulatory control under EU drug precursor laws. Affected pharmaceutical and chemical operators must obtain mandatory licenses and trade authorizations within a four-month transition period to maintain legal compliance and supply chain continuity.
European UnionFrance (Aquaref/INERIS) Publishes Note On Interlaboratory Comparison For Targeted Analysis Of 30 PFAS In Waters
France has validated technical standards for the targeted analysis of 30 PFAS in industrial wastewater and natural waters. This benchmarking increases regulatory pressure on industrial operators to ensure high-precision monitoring and data quality to comply with evolving discharge limits.
FranceEuropean UnionIllinois Senate Proposes Repeal of Environmental Laboratory Certification Committee Under Environmental Protection Act
Illinois legislation introduced in February 2026 proposes to dissolve the state's Environmental Laboratory Certification Committee. This governance shift streamlines administrative oversight but requires businesses to monitor the redistribution of certification authority to ensure uninterrupted environmental testing and compliance workflows.
United StatesEDQM Publishes January 2026 Updates To European Pharmacopoeia Reference Standards
The EDQM has updated the European Pharmacopoeia reference standards for January 2026, introducing new materials and establishing phased withdrawal timelines for existing standards through 2027. Pharmaceutical manufacturers must align procurement and analytical protocols with these changes to ensure uninterrupted compliance with mandatory quality control and safety testing requirements.
European UnionFranceEDQM Publishes November 2025 Newsletter On European Pharmacopoeia Reference Standards
The EDQM is implementing price increases and transitioning European Pharmacopoeia reference standards to CLP-compliant hazard labeling through 2026. Laboratory and procurement teams must adjust budgets and safety management systems to accommodate higher costs and updated hazard communication requirements.
European UnionEU Commission Amends Regulation 378/2005 on Feed Additives Reference Laboratories
The European Union has updated the administrative and technical framework for feed additive authorizations, revising rules for reference samples, fees, and laboratory evaluation reports. Applicants should anticipate adjusted costs and procedural requirements for product testing and validation to maintain compliance with the updated authorization process.
European UnionEDQM Updates European Pharmacopoeia Reference Standards and Prices (December 2025)
EDQM has updated the European Pharmacopoeia reference standards and implemented price increases effective January 2026. Manufacturers must transition to new reference materials to maintain quality control compliance and adjust procurement budgets for rising testing costs.
European UnionFranceEU Commission Extends Transitional Tolerance for Traces of GM Oilseed Rape Events Ms1xRf1, Ms1xRf2 and Topas 19/2
The EU has extended the 0.1% tolerance threshold for adventitious traces of specific legacy GM oilseed rape events in food and feed until 31 December 2028. This extension provides regulatory continuity for supply chains while mandating rigorous monitoring to ensure compliance during the final phase-out period.
European UnionJRC Publishes Editorial on Advances in Reference Materials
The European Commission’s Joint Research Centre has published a strategic review of reference materials, establishing the framework for analytical standards in industrial, food, and environmental testing over the next decade. Organizations must prepare for increasingly sophisticated conformity testing protocols and align their laboratory practices with these evolving benchmarks to ensure continued regulatory compliance and product integrity.
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