Botanicals

EDQM Publishes Pharmeuropa 38.2 Draft Ph. Eur. Texts For Consultation

The EDQM has opened consultations on 46 new or revised European Pharmacopoeia (Ph. Eur.) standards, covering key active substances and general testing chapters. Businesses should assess these drafts before the June 30, 2026 deadline, as adopted monographs become mandatory quality and safety requirements for pharmaceutical market access in Europe.

Great Britain: HSE Proposes Not To Classify Rapeseed Oil (CAS 8002-13-9)

The UK HSE has proposed maintaining the "Unclassified" status for rapeseed oil under GB CLP, following a comprehensive hazard assessment. This confirmation provides regulatory certainty for manufacturers, ensuring no new labeling requirements or supply chain disruptions between the UK and EU markets.

3 Apr 2026, 18:03hse.gov.ukUnited Kingdom

Great Britain: HSE Agency Opinion Proposes Skin Sens. 1B Classification for Thermally Treated Garlic Juice

The UK Health and Safety Executive (HSE) has proposed a new mandatory classification for thermally treated garlic juice as a Skin Sensitiser (Category 1B) under GB CLP. This alignment with EU standards will trigger mandatory label and safety data sheet updates and may restrict the authorization of amateur-use biocidal products.

3 Apr 2026, 18:00hse.gov.ukUnited Kingdom

EFSA Peer Review Intake and Upcoming Consultation for Black Pepper Oleoresin (BPO) Under Regulation (EC) No 1107/2009

EFSA has scheduled a public consultation on the assessment of Black Pepper Oleoresin (BPO) as a new pesticide active substance, closing June 6, 2026. Stakeholders should review the assessment report to anticipate potential use restrictions and ensure the regulatory dossier supports the eventual EU approval of this botanical extract.

2 Apr 2026, 09:35open.efsa.europa.euEuropean Union

Great Britain Issues Non-Approval Decisions For Biocidal Active Substances Under GB BPR

GB ministers have confirmed the non-approval of several biocidal active substances, including DBNPA and silver nitrate, effective April 1, 2026. Businesses must phase out treated articles by September 2026 and remove biocidal products from the market by April 2027 to avoid enforcement action.

1 Apr 2026, 18:47hse.gov.ukUnited Kingdom

EU EFSA NDA Panel Cannot Establish Safety of CO2 Hemp Extract Novel Food Under Regulation (EU) 2015/2283

EFSA has issued a negative scientific opinion on CO2 hemp extracts, concluding that safety cannot be established due to insufficient characterization and toxicological data. This decision reinforces the high evidentiary bar for cannabinoid-based novel foods, signaling continued market access delays and the need for more robust, substance-specific safety data.

1 Apr 2026, 18:44efsa.europa.euEuropean Union

Poland Adopts Regulation Banning Chelidonium Majus as a Food Enrichment Substance

Poland has banned Chelidonium majus in foods and supplements effective April 2, 2026, following national health assessments. Operators must urgently reformulate products and clear inventory by May 2, 2026, to mitigate enforcement risks and ensure continued market access.

1 Apr 2026, 14:24dziennikustaw.gov.plPoland

Peru Adopts Law No. 32570 Amending Law No. 30198 on Street Vending of Medicinal Plant Beverages

Peru has enacted Law No. 32570 to formalize the street vending of medicinal plant and traditional grain beverages as regulated microenterprises. This development mandates stricter adherence to food hygiene standards and municipal registration, signaling a shift toward professionalized oversight and sanitary compliance in the informal food sector.

29 Mar 2026, 17:05busquedas.elperuano.pePeru

EU Commission Terminates Novel Food Authorisation Procedure for Epimedium sagittatum (NF 2021/2383) Without Union List Update

The European Commission has terminated the novel food authorization procedure for Epimedium sagittatum, refusing its addition to the Union list of authorized ingredients. Businesses must exclude this botanical from EU product formulations and market entry strategies to avoid non-compliance with novel food regulations.

29 Mar 2026, 05:36ec.europa.euEuropean Union

European Commission Terminates Novel Food Procedure for Spilanthol Extract Powder (NF 2019/1394)

The European Commission has terminated the authorization procedure for Spilanthol extract powder as a novel food, effective March 2026. This confirms the ingredient remains unauthorized for the EU market, necessitating immediate formulation reviews and the suspension of market entry plans for affected food products.

29 Mar 2026, 05:35ec.europa.euEuropean Union

Germany Issues Consumer Warning for 'Epimedyumlu Bitkisel Karisimli Macun' Containing Sildenafil

German authorities have issued a nationwide consumer warning for a herbal food paste found to contain the undeclared prescription drug sildenafil. This enforcement action underscores the heightened scrutiny on botanical supplements and the significant legal and reputational risks of adulteration with pharmaceutical ingredients.

28 Mar 2026, 20:34lebensmittelwarnung.deGermany

Germany BVL Publishes 2nd Edition of List of Algae and English Preface to Lists of Substances

Germany’s BVL has released the 2nd edition of the "List of Algae," updating the official classification framework for algae used in food and dietary supplements. Businesses must verify that algae-based ingredients align with these updated safety and regulatory profiles to mitigate risks related to unauthorized novel foods or medicinal product classifications.

28 Mar 2026, 20:34bvl.bund.deGermany

China NMPA Files Nine New Cosmetic Ingredients in March 2026

China’s NMPA accepted filings for nine new cosmetic ingredients in March 2026, including botanical extracts and a novel peptide complex. This expansion of the approved raw material list offers new formulation opportunities, though firms must monitor the upcoming three-year safety reporting requirements.

28 Mar 2026, 20:32cirs-group.comChina

Colombia: Draft Resolution On GMP Manuals For Herbal Products

Colombia has proposed new Good Manufacturing Practice (GMP) manuals and inspection protocols for herbal products, including sterile preparations, to standardize quality controls for domestic and imported goods. Manufacturers and importers must prepare for stricter compliance oversight and potential operational adjustments to meet these formalized quality management and inspection standards.

27 Mar 2026, 20:40members.wto.orgColombia

US FDA Issues Online Advisory Letter to Divine Rx Nutrition for Disease-Claim Supplements

The FDA has issued an advisory letter to Divine Rx Nutrition for marketing supplements with unapproved disease-treatment claims, classifying them as illegal new drugs. This action signals continued aggressive enforcement against online health-claim violations, requiring firms to strictly audit digital marketing and labeling to mitigate regulatory risk.

27 Mar 2026, 18:39fda.govUnited States

Netherlands Council Of State Refers Food Supplement–Medicine And Online Review Questions To CJEU (ECLI:NL:RVS:2026:1651)

The Dutch Council of State has referred questions to the CJEU to clarify the legal boundary between food supplements and medicinal products, specifically focusing on whether online consumer reviews can trigger a reclassification. This case will determine if retailers can be held liable under pharmaceutical laws for user-generated content and whether products clearly defined as supplements can be legally treated as medicines based solely on digital presentation.

27 Mar 2026, 08:25uitspraken.rechtspraak.nlNetherlandsEuropean Union

Minnesota Senate Judiciary Committee Revises 25 March 2026 Hearing Agenda on Kratom Age and Smoke Alarm Batteries

Minnesota is progressing legislation to restrict kratom sales to adults 21+ and mandate sealed 10-year batteries for replacement smoke alarms. Businesses must prepare for stricter age-verification for botanicals by August 2026 and ensure fire safety equipment meets updated testing standards by 2027.

27 Mar 2026, 07:48senate.mnUnited States

UK COT Publishes Papers for 31 March 2026 Meeting on Echinacea, Fluoride and Plant Extracts

The UK Committee on Toxicity (COT) is reviewing health risks associated with Echinacea, fluoride, berberine, and hydroxycitric acid during its March 2026 meeting. These assessments signal potential future restrictions or labeling requirements for botanical supplements and consumer products containing these substances in the UK and EU markets.

26 Mar 2026, 19:33cot.food.gov.ukUnited Kingdom

EU CA Meeting Reviews Progress of BPR Active Substance Review and Renewal Programme (March 2026)

The EU has signaled a critical need to accelerate the BPR active substance review programme to clear a significant backlog before the 2030 deadline. Manufacturers face increased risk of sudden market exits for substances failing renewal, alongside stricter scrutiny of endocrine-disrupting impurities that could trigger mandatory substitution.

26 Mar 2026, 19:31circabc.europa.euEuropean Union

EDQM European Pharmacopoeia Commission Adopts 50 Texts for Ph. Eur. Issue 13.2

The European Pharmacopoeia Commission has adopted 50 new and revised texts for Issue 13.2, set to become legally binding on April 1, 2027. Pharmaceutical manufacturers must assess impacts on quality control specifications, particularly for elemental analysis and glass packaging, to ensure compliance before the implementation deadline.

26 Mar 2026, 19:23edqm.euEuropean Union