Botanicals

EFSA Updates Timeline For Rosales Botanical Feed Flavourings Feed Additive Assessment

EFSA has extended the risk assessment timeline for botanically defined Rosales group feed flavourings, keeping application EFSA-Q-2011-00188 open with a new deadline of 18 June 2027 under the EU feed additives regulation. This pushes any EU authorisation decision into at least mid-2027, prolonging uncertainty for feed additive manufacturers and requiring forward planning around potential changes to formulations and market access.

3 May 2026, 09:16open.efsa.europa.euEuropean Union

EFSA Ongoing Risk Assessment of Althaea Tincture Botanically Defined Flavourings for All Animal Species

EFSA is assessing an application to extend or modify the authorised use of Althaea tincture botanically defined flavourings as feed additives for all animal species, with its scientific opinion expected by late 2026. This could influence future EU feed additive authorisations and formulations containing this botanical extract, so feed and premix manufacturers may wish to monitor the outcome and prepare for possible adjustments.

3 May 2026, 07:23open.efsa.europa.euEuropean Union

EFSA Places Xia Powder 435 Novel Food Modification Application Under EC Validation

EFSA has updated its novel foods record for Xia Powder 435 to show that the modification application remains at intake status but has completed suitability checks and is now under European Commission validation as of late April 2026. This procedural step indicates the dossier is moving forward within the EU novel foods framework, but no changes to the existing authorisation apply yet, so food companies should monitor for the eventual EFSA opinion and Commission implementing act that could alter conditions of use or labelling.

30 Apr 2026, 10:38open.efsa.europa.euEuropean Union

China Customs, NHC, SAMR and NMPA Launch Pilot Classification for Imported Food and Drug Substances

China’s customs, health, market regulation and drug authorities have launched Joint Announcement No. 237 of 2025, a pilot regime that uses a dynamic list of 30 traditional botanicals to classify imported food and drug substances based on their declared end use. This change immediately alters border procedures and compliance risk for importers using these materials in foods, health foods and medicines, easing clearance for non-medicinal uses while making misclassification or changes of use more visible and enforceable.

30 Apr 2026, 08:25nmpa.gov.cnChina

EU EFSA Registers Turmeric (Curcuma longa L.) Oleoresin Novel Food Application (Intake Stage)

EFSA has registered a new novel food application (EFSA-Q-2026-00090) for a Turmeric (Curcuma longa L.) oleoresin preparation under the EU Novel Food Regulation, with the dossier currently at intake and suitability-check stage in early 2026. If authorised, this ingredient could expand permitted uses of standardised curcuminoid extracts in EU food and supplement products, signalling potential formulation and market opportunities for botanicals suppliers and brand owners.

28 Apr 2026, 19:08open.efsa.europa.euEuropean Union

EMA Consults on Revision 2 of Guideline on Declaration of Herbal Substances and Preparations in Herbal Medicinal Products

In April 2026 the European Medicines Agency opened a public consultation on Revision 2 of its guideline on how herbal substances and preparations must be declared in SmPCs, package leaflets and labelling for herbal and traditional herbal medicinal products, with comments due by 30 June 2026. The update tightens expectations for marketing authorisation holders and extract suppliers to provide consistent DERgenuine and herbal-mass declarations, explicit extraction solvent details and clearer naming of herbal components, which is likely to drive dossier and labelling adjustments across EU herbal product portfolios.

28 Apr 2026, 12:30ema.europa.euEuropean Union

EEA Joint Committee Decision 255/2025 Adds 2025 EU Feed Additive Regulations to Annex I to the EEA Agreement

EEA Joint Committee Decision 255/2025 updates Annex I of the EEA Agreement to incorporate a package of 14 2025 EU feed additive regulations, with entry into force from 6 December 2025 and publication in April 2026. This extends EU feed additive authorisation, renewal and correction measures for enzymes, microbial products, essential oils and vitamin additives to operators in Iceland and Norway (but not Liechtenstein), aligning their feed and premix compliance conditions with the latest EU regime.

21 Apr 2026, 20:12eur-lex.europa.euEuropean UnionIcelandNorway

Korea MFDS Publishes Functional Ingredient Monograph for Banaba Leaf Extract

In March 2026, Korea’s Ministry of Food and Drug Safety published a technical monograph consolidating safety and functional evidence for Banaba leaf extract as a health functional food ingredient. This gives manufacturers and ingredient suppliers a clear MFDS reference point for using Banaba leaf extract in Korean health functional foods, supporting dossier preparation, claim justification, and alignment with future re-evaluation outcomes.

21 Apr 2026, 16:15mfds.go.krSouth Korea

EMA Opens Call for Scientific Data on Quercus Cortex Herbal Monograph

In March 2026, the European Medicines Agency launched an open call for scientific data to support the periodic review of its EU herbal monograph on Quercus cortex (oak bark). Herbal medicinal product manufacturers and other stakeholders should assess whether they have post-2018 safety or efficacy evidence to submit by mid-June 2026 so that any future revisions of the monograph reflect the current state of the science.

21 Apr 2026, 14:57ema.europa.euEuropean Union

EMA Call for Scientific Data on Arctii Radix (Burdock Root) Herbal Monograph

EMA’s herbal committee has launched a March–June 2026 call for scientific data to support the periodic review of the EU herbal monograph on Arctii radix (Arctium lappa L., burdock root). This early assessment step could lead to updated evidence expectations or revised indications for EU herbal medicinal products containing burdock root, so manufacturers and sponsors should consider submitting relevant recent data.

21 Apr 2026, 14:57ema.europa.euEuropean Union

EMA HMPC Calls for Scientific Data on Chamomillae Romanae Flos Herbal Monograph

EMA’s herbal medicines committee has opened a three‑month call for scientific data to support the periodic review of the EU herbal monograph on Chamomillae romanae flos (Roman chamomile flower) from 15 March to 15 June 2026. Companies and other stakeholders using this herbal substance in medicinal products should consider submitting up‑to‑date efficacy and safety evidence that could influence future monograph revisions and regulatory expectations.

21 Apr 2026, 14:57ema.europa.euEuropean Union

EMA Issues Call For Scientific Data On Peppermint Oil Herbal Monograph

EMA’s herbal medicines committee has opened a 15 March–15 June 2026 call for scientific data to support the periodic review of the EU monograph on peppermint oil (Menthae piperitae aetheroleum). Companies and experts involved in peppermint-oil herbal medicines should consider submitting evidence and monitor the review, as any future monograph changes could alter EU expectations on indications, safety warnings, and supporting data.

21 Apr 2026, 14:56ema.europa.euEuropean Union

EMA HMPC Opens Call for Scientific Data on Feverfew Herb Monograph (Periodic Review)

In March 2026, EMA’s herbal committee opened a three-month call for scientific data to support the periodic review of the EU feverfew herb (Tanaceti parthenii herba) monograph. Manufacturers and other data holders for feverfew-based migraine medicines should assess available evidence and consider contributing, as the review could reshape monograph conclusions and national licensing conditions for these products.

21 Apr 2026, 14:53ema.europa.euEuropean Union

Nebraska LB901 Enacts 10% Kratom Excise Tax and Strengthens Kratom Consumer Protection Act

Nebraska has enacted omnibus tax bill LB901, effective immediately upon gubernatorial approval, which creates a 10% state excise tax on retail kratom products from 2027 and strengthens enforcement of the existing Kratom Consumer Protection Act. Kratom manufacturers, distributors, and retailers serving the Nebraska market should prepare for new excise tax liabilities and tighter product‑control rules, including restrictions on selling kratom products during testing and the risk of delisting adulterated products from the state’s registered product list.

16 Apr 2026, 13:37nebraskalegislature.govUnited States

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

The European Directorate for the Quality of Medicines has opened consultations on 46 new and revised pharmaceutical standards covering active substances and general testing methods. Companies should evaluate these drafts immediately to anticipate mandatory changes to quality specifications and testing protocols required for European market access.

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

The UK HSE has formally proposed maintaining the unclassified status for rapeseed oil under GB CLP following a comprehensive hazard assessment. This confirmation provides long-term regulatory certainty and ensures continued alignment with EU standards, avoiding any new labeling burdens or supply chain friction.

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 has proposed a new mandatory classification for thermally treated garlic juice as a Skin Sensitiser Category 1B. This development triggers 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 as a new pesticide active substance through June 2026. This review will determine the market access conditions and permissible use cases for this botanical extract in the European plant protection sector.

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

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

Great Britain has finalized the non-approval of several biocidal active substances including DBNPA and silver nitrate effective April 2026. Manufacturers must audit supply chains and initiate phase-out plans for treated articles and biocidal products to meet staggered market exit deadlines through 2027.

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

The European Food Safety Authority has issued a negative opinion on CO2 hemp extracts, concluding that safety cannot be established due to significant data gaps. This decision reinforces the high evidentiary bar for cannabinoid-based novel foods and signals continued market access barriers for manufacturers without robust safety dossiers.

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