Knowledge Base
Articles and Analyses
In-depth analyses and articles on EU food law, food supplements, labelling and regulatory compliance.
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Berberine and the EFSA Draft Opinion 2026: Art. 8 of Regulation (EC) No 1925/2006 and the Annex III Mechanism
Analysis of the EFSA NDA Panel draft opinion on berberine (January 2026), the Art. 8 procedure under Regulation 1925/2006, the Annex III mechanism, and the consequences for food supplement manufacturers.
Exporting Food Supplements to the United Kingdom: FSA, BTOM and Assimilated Law after Brexit
A practical guide to exporting food supplements from Poland/the EU to the UK: assimilated law, BTOM, FSA, OPSS, Natasha's Law, health claims and novel food after Brexit.
Registration of Food Supplements and FSMP in Romania – A Practical Guide for Manufacturers and Distributors
A practical guide to Romanian notification procedures for food supplements and food for special medical purposes (FSMP) – competent authorities, documentation, mutual recognition and electronic submission.
Lex Szarlatan (Bill 2598): four amendments that are missing
The 'Lex Szarlatan' bill is meant to protect patients, but in its current form it also penalises genuine warnings and provides no mechanism to correct decisions when medical knowledge changes. Here are four amendments and the reasons they are worth introducing.
Herbs, Tradition and Lex Szarlatan: The Botanical Amendment to Parliamentary Print 2598
The definition of pseudo-medical practice in the draft 'Lex Szarlatan' bill may capture lawful information about herbal food supplements and traditionally registered herbal medicinal products. Here is an amendment that draws a clear line — without weakening patient protection.
Dextransucrase from GMO B. subtilis approved by EFSA: what this changes for food producers in the EU
EFSA has issued a positive scientific opinion on dextransucrase from GMO B. subtilis. What does this mean for producers? Legal analysis and practical consequences.
Clinical Trials of Food Supplements — What to Know Before Commissioning One
Legal basis, Bioethics Committee requirements, contract structure and budget — a complete guide before commissioning a clinical trial of a food supplement in Poland.
Fortified food vs food with added other substances — the boundary that determines labelling and notification obligations
Analysis of the boundary between fortified food (Chapter II of Regulation 1925/2006) and food with added other substances (Chapter III) — consequences for labelling, nutrition declaration tables, and GIS notification.
Non-Standard Market Access Pathways for Medicinal Products
Named patient import, parallel import, ATMP hospital exemption and compassionate use — a legal analysis of four mechanisms for accessing medicinal products outside standard marketing authorisation.
AI in Courts and Law Firms: What Really Works and What Is a Myth – Global Review 2024–2026
How is AI changing law around the world? We debunk myths (Estonia) and examine real deployments (USA, UK, China, India) – facts, scandals and conclusions for lawyers.
CBD and Hemp in Food Supplements: A Compendium of EU and US Regulations for 2026
A complete overview of CBD and hemp regulations in supplements: EU novel food, FDA position, THC thresholds, NDI procedure. A practical guide for manufacturers.
9 Things That Distinguish Supplement Oversight in the USA vs the EU in 2026 – and What This Means for Manufacturers
Who regulates food supplements in the USA and EU, what inspectors look for, and what penalties manufacturers face. A comparison of FDA, FTC, GIS and EFSA in 2026.
Garfield AI Wins First Case Prepared 100% by AI – What This Means for LegalTech and Food Law
UK firm Garfield AI won a £7,000 case prepared entirely by artificial intelligence. An analysis of the significance of this precedent for regulatory lawyers and the food supplements industry.
EFSA 2026: New Dioxin and PCB Limits in Food – What Are the Risks for Producers Who Fail to Comply in Time?
New dioxin and PCB limits from 2026 – specific changes for food producers and importers. Which product categories are affected, what penalties apply, and what to do now.
EFSA 2026: New Dioxin and PCB Limits in Food – What Are the Risks for Producers Who Fail to Comply in Time?
New dioxin and PCB limits from 2026 – specific changes for food producers and importers. Which product categories are affected, what penalties apply, and what to do now.
Food enzymes from GMO strains under EFSA scrutiny: what the wave of new opinions means for your production
EFSA is issuing new scientific opinions on enzymes from GMO strains. What does this mean for authorisation, labelling and Polish Chief Sanitary Inspectorate (GIS) inspections? A practical analysis for food manufacturers.
Helicobacter pylori: how two Australians overturned a medical dogma and won the Nobel Prize
The story of the discovery of Helicobacter pylori by Barry Marshall and Robin Warren. From a ridiculed hypothesis and self-infection in 1984 to the Nobel Prize in 2005. Facts, dates, publications.
Helicobacter pylori: How Two Australians Overturned a Medical Dogma and Won the Nobel Prize
The story of the discovery of Helicobacter pylori by Barry Marshall and Robin Warren. From a ridiculed hypothesis and self-infection in 1984 to the Nobel Prize in 2005. Facts, dates, publications.
New Alliance for Ashwagandha Standardisation – What It Means for Food Supplement Manufacturers
An international ashwagandha standards alliance has been established. Find out how the new guidelines will affect the supplement market and what you need to change.
The longevity boom and scientific reality: the gap between promises and evidence in food supplements
Which health claims in longevity food supplements will pass a Polish Chief Sanitary Inspectorate (GIS) inspection? An analysis of the gap between marketing and the requirements of Regulation 1924/2006.
The longevity supplement boom and scientific reality: the gap between promises and evidence
Which health claims in longevity supplements will pass scrutiny by the Polish Chief Sanitary Inspectorate (GIS)? An analysis of the gap between marketing and the requirements of Regulation 1924/2006.
Omega-3, Biological Age and B12 in Athletes: How New 2026 Research Changes Health Claims
Legal analysis of new research on omega-3, biological age and B12 in athletes. Which health claims will pass scrutiny from the Polish Chief Sanitary Inspectorate (GIS) and EFSA in 2026?
Campylobacter in poultry: rising positive flocks in Norway and implications for the EU supply chain
An analysis of the campylobacteriosis epidemiological situation in Norway and the risks for EU poultry importers. Control obligations and practical steps.
Climate Change and Salmonella Antibiotic Resistance: What EU Food Manufacturers Need to Know
How potential climate change affects Salmonella antibiotic resistance and what this means for food safety in the EU. Practical guidance for manufacturers.
Hidden Pharmaceutical Substances in Food Products – The Case of Chocolate with Sildenafil. Implications for Manufacturers
How chocolate manufacturers expose themselves to penalties by adding sildenafil. A practical guide to regulations and compliance procedures for the food industry.
Food Poisoning in Germany: What Producers Should Know from a 10-Year Analysis
Analysis of food poisoning cases in Germany 2014–2024. Practical conclusions for food producers – regulations, errors, and prevention systems.
Salmonella in Moringa Leaf Powder – What Supplement Manufacturers Must Know
A practical guide for supplement manufacturers: regulations, testing, and procedures to prevent Salmonella contamination in moringa powder. Real legal implications explained.
Salmonella in Moringa Leaf Powder – What Supplement Manufacturers Need to Know
A practical guide for supplement manufacturers: regulations, testing, and procedures to prevent Salmonella contamination in moringa powder. Real legal implications explained.
FSA/HSA for Supplements in the USA: Will the Change Reach Europe?
Analysis of FSA/HSA regulatory changes in the USA for dietary supplements. Implications for European and Polish manufacturers. Expert advice.
FSA/HSA for Supplements in the USA: Will the Change Reach Europe?
Analysis of FSA/HSA regulatory changes in the USA for dietary supplements. Implications for European and Polish manufacturers. Expert guidance.
\"Lex Szarlatan\" (UD207): Is a Total Ban on Unconventional Medicine the Best Way to Protect Patients?
Bill UD207 criminalises complementary health practices. Will prohibition improve safety – or push the market underground? A legal risk analysis, EU comparison and proposal for sensible regulation – status as of November 2025.
Differences in Allergen Labelling: European Union, United States and Canada - A Practical Overview for the Food Industry
Comparative analysis of allergen labelling lists and requirements (including Contains, May Contain, Gluten-Free) in the EU (14 allergens), USA (9 allergens) and Canada (11 allergens).
Berberine and the EFSA Draft Opinion 2026: Art. 8 of Regulation (EC) No 1925/2006 and the Annex III Mechanism
Analysis of the EFSA NDA Panel draft opinion on berberine safety (January 2026), the Art. 8 procedure under Regulation 1925/2006, the Annex III mechanism, and consequences for food supplement manufacturers.
8 Facts About Berberine and the EFSA Opinion That Could Reshape the EU Supplements Market
EFSA's opinion on berberine establishes no safe intake level. What does this mean for food supplement manufacturers in the EU? Legal implications, risks, and required actions.
Botulism in Infant Formula and FDA Knowledge of Facility Deficiencies: What EU FSMP Manufacturers Should Know Before Appearing on the RASFF List
The Abbott/Similac case revealed that a regulatory authority's prior knowledge of facility deficiencies does not relieve the manufacturer of liability. Practical conclusions for EU FSMP producers and importers.
CBD: A Tale of Two Regulators. How British Pragmatism Exposes EU Bureaucracy.
Comparative analysis of CBD regulation as Novel Food in the United Kingdom (FSA) and the European Union (EFSA). Conclusions for the future of the cannabinoid market.
CJEU Aldi Ruling: What Supplement Manufacturers Need to Know About Pest Control and Hygiene
Analysis of the CJEU judgment concerning Aldi. Practical guidelines for supplement manufacturers regarding pest control and hygiene requirements.
CJEU and Ashwagandha - Analysis of Judgment C-386/23 and Consequences for the Industry
Accessible and practical analysis of the CJEU judgment C-386/23 concerning ashwagandha. Legal, marketing and regulatory consequences for dietary supplements in the EU.
Ban on 'Clinically Proven' Claim in the USA - NAD/NARB Decision (Case #7487) and Implications for EU Manufacturers
Analysis of the NAD/NARB decision (Case #7487) in the Tru Niagen case - ban on the 'clinically proven' claim for an NAD+ supplement. Comparison with EU regulations and conclusions for manufacturers.
Creatine and cancer: how a study headline outpaced the science and what this means for food supplement manufacturers
A study on creatine and cancer triggered widespread alarm. What did it actually find? What legal risks do health claims pose for manufacturers?
Decentralised Clinical Trials for Food Supplements: Hybrid Trial Models and the Substantiation of Health Claims
How do DCTs and hybrid clinical trials change the substantiation requirements for food supplement health claims? A practical analysis for manufacturers.
EFSA Scientific Opinion on a GMO-Derived Enzyme (Dextransucrase): What It Means for EU Food Producers
EFSA issued a favourable scientific opinion on dextransucrase from genetically modified Bacillus subtilis. A scientific opinion is not an authorisation — we explain the applicable regulations and what producers must do.
8 Regulatory Traps for Mercury in Food and Supplements That Cost Exporters Their Markets
EFSA vs ATSDR: divergent mercury limits in food pose real risks for exporters and food supplement manufacturers. Discover 8 key discrepancies.
8 Things You Need to Know About Tightened Controls on Tahini and Halva from Syria Imported into the EU
The European Commission has increased the frequency of controls on tahini and halva from Syria. What does this mean for importers and distributors in the EU?
Exporting Food Supplements to the UK: FSA, BTOM and Assimilated Law After Brexit
A practical guide to exporting food supplements from the EU to the UK: assimilated law, BTOM, FSA, OPSS, Natasha's Law, health claims and novel food after Brexit.
Excessive Depiction of Fruits, Vegetables or Spices on Food Labels - What the Law and Case Law Say
Images of fruits and vegetables on labels can be misleading even with a correct ingredient list. CJEU Teekanne judgment (C-195/14), UOKiK decisions and Voivodeship Administrative Court in Krakow - full case law analysis and safe labelling practices.
9 Pitfalls Identified by the UK FSA That Can Block Exports of Meat and Food Products to the UK
The FSA detects meat adulteration and allergen errors. 9 concrete lessons for Polish manufacturers exporting to the United Kingdom.
How to Launch a Polish Food Supplement on the German Market in 2025/2026? Complete Legal Guide
Europe's largest supplement market - a complete guide updated for November 2025: BVL notification, German VAT, uvZTA 7%, PZN, labelling, and the most common mistakes made by Polish manufacturers.
Health Claims and Doctor Recommendations: How to Avoid the Trap of Art. 12(c) of Regulation 1924/2006
Can you refer to a doctor's authority in supplement advertising? Analysis of Art. 12(c) of Regulation 1924/2006. Learn the difference between a prohibited endorsement and a permissible expertise statement.
Japanese Food on the EU Market: What the Law Actually Requires
Importing Japanese supplements, collagen drinks and functional foods into the EU: novel food status, veterinary controls, labelling, health claims and EPA tariff preferences.
Lex Charlatan (UD207): Is a Total Ban on Unconventional Medicine the Best Patient Protection?
The UD207 bill criminalises complementary practices. Will prohibition increase safety, or push the market underground? Legal risk analysis, EU comparisons, and a proposal for sensible regulation - as of November 2025.
Are Multivitamins Effective? An Evidence-Based Analysis
State of knowledge for 2025: Analysis of multivitamin effectiveness based on Cochrane, USPSTF, NIH and ACSM studies. Review of evidence for cognitive function, cardiovascular health and sports.
NMN in the European Union: Legal or Not? Status as of 2026
Legal status of NMN (nicotinamide mononucleotide) in the EU: EFSA positive opinion, no Commission implementing act yet, applicant-specific authorisation with data protection, consequences for importers.
Navigating Non-Alcoholic Beverage Labelling in the EU: Trends and Challenges 2025
The non-alcoholic beverage market is booming, but labelling '0.0%' is a minefield. Discover the EU and Polish legal requirements, ABV limits, and testing methods (GC) demanded by inspectorates in 2025.
Postbiotics for Weight Loss: What EU Law Allows You to Claim and Where EFSA Awaits
Postbiotics as a new trend in weight management. Analysis of EU regulations, labelling requirements, and legal pitfalls for manufacturers. Practical expert advice.
Registering Food Supplements and FSMPs in Romania: A Practical Guide
A practical, status-qualified guide to Romanian notification routes for food supplements and foods for special medical purposes (FSMP), including competent authorities, dossiers, mutual recognition and electronic filing.
Supreme Administrative Court 2024 Judgments (II GSK 589/23, 627/23, 806/23): End of Automatic Supplement Blocking by Sanitary Inspectorate in Poland
Practical analysis of the 2024 Supreme Administrative Court judgments concerning Art. 32 of the Act on Food Safety and Nutrition. End of automatic supplement blocking by the Sanitary Inspectorate in Poland.
The Vanishing Lactobacillus? What the Probiotic Naming Revolution Means for Your Label
Analysis of changes in probiotic nomenclature: why Lactobacillus is disappearing, the legal consequences, and how to update dietary supplement labels.