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In-depth analyses and articles on EU food law, food supplements, labelling and regulatory compliance.

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“Gluten-free” on a food supplement: when it is allowed, how to read the 20 mg/kg rule of Regulation 828/2014, and what about oats, wheat maltodextrin and “contains no gluten”?

A gluten-free supplement must contain at most 20 mg/kg gluten as sold (shell included), not per portion. Closed list of statements (Art. 3 Reg. 828/2014), oats under Annex Part B, allergens separately (Notice 2017/C 428/01 pt 12), Art. 7 FIC.

Vitamin B6 in food supplements: where Poland’s 6 mg limit (Resolution 2/2024) comes from with an EFSA UL of 12 mg, and how to count the dose for pyridoxine and P5P

Max 6 mg vitamin B6 per daily portion of adult supplements in Poland (Food Supplements Team Resolution 2/2024, formerly 18 mg). EFSA UL 12 mg minus diet, Art. 5 Dir. 2002/46, Noria C-672/15, P5P conversion, children, BfR 0.9 mg.

Monacolins from red yeast rice in food supplements: the 3 mg limit of Regulation 2022/860 and the draft Part A ban in Annex III — what applies now and how the transition period runs

Today: < 3 mg monacolins per daily portion and 4 warnings (Part B, Annex III, Reg. 1925/2006). The draft moves monacolins to Part A: PAFF 13.05.2026, EP objection rejected 8.10.2026, 12-month transition. Claim deleted (2024/2041).

“Probiotic” on a food supplement as a health claim: Article 2(2)(5) and Article 10 of Regulation 1924/2006 — what can be said about bacterial cultures?

“Contains probiotics” is a health claim (Commission guidance 2007, point III.1; EU Ombudsman 2273/2023/MIK). No permitted claim → prohibited under Art. 10(1). Neutral category name under § 5 of the Polish regulation, strain, CFU; “prebiotic”, chicory inulin.

Best-before date on a food supplement: the Annex X format of Regulation 1169/2011 — when month and year are enough, and when the date replaces the lot number

Food supplements: ‘Best before end’ with month and year for 3–18 months’ durability, year alone beyond 18 months (FIC Annex X). A date without a day does not replace the lot number (Dir. 2011/91/EU). −20% tolerances until the date; Polish Art. 52.

‘Sugar-free’ on a food supplement: Annex conditions of Regulation 1924/2006 and Article 7 nutrition information — what is measured per 100 g and what per daily portion?

SUGARS-FREE ≤0.5 g/100 g of the food ready for consumption, WITH NO ADDED SUGARS depending on the recipe (including premix carriers), and Article 7 information for supplements under Art. 8 of Directive 2002/46/EC per daily portion. Polyols, sweeteners, tolerances, GIS.

EFSA 10368: guidance on data requirements for bisphenols other than BPA in food contact materials

16.10.2026 EFSA Journal DOI 10.2903/j.efsa.2026.10368: data requirements for the safety assessment of bisphenols other than BPA and their derivatives in FCMs. Guidance is not an authorisation; it supplements the Note for Guidance in the context of Commission Regulation (EU) 2024/3190. Migration tiers 0.05 / 5 / 60 mg/kg.

Caffeine in a food supplement: how must it be labelled under Annex III point 4.2 of Regulation 1169/2011?

“Contains caffeine. Not recommended for children or pregnant women” in the same field of vision as the name “food supplement”, with caffeine in mg per recommended daily portion. Point 4.1 (beverages >150 mg/l) vs 4.2, guarana per SCoPAFF 2017, EFSA 2015, PL resolution 16/2019, no authorised claims.

Lead, cadmium and mercury in food supplements: what does the Regulation 2023/915 limit apply to?

Pb 3.0 / Cd 1.0 (3.0 at ≥80% seaweed or bivalves) / Hg 0.10 mg/kg in the product as placed on the market, capsule shell included (Art. 2(3)). Raw materials with own limits, Table 4b of Reg. 333/2007, the x − U rule, mg/kg vs dose. CELEX 32023R0915; 32007R0333.

Carry-over of additives from a vitamin/mineral premix: when does Article 18(3) of Reg. 1333/2008 turn a carrier into an additive of the finished supplement?

Annex III Part 5 (Section A) authorises additives in nutrient preparations — not automatic technological use in category 17. Technological-function test (Art. 18(3)) vs carry-over. CELEX 32008R1333; 32011R1130; 32018R1497.

CJEU C-524/18 (Schwabe): Article 10(3) — when is a general health claim “accompanied” by a specific claim?

CJEU judgment of 30 Jan 2020, C-524/18: “accompanying” in Art. 10(3) Reg. 1924/2006 has a substantive and a visual dimension. Front-of-pack general claim without a linked specific claim fails. CELEX 62018CJ0524; Decision 2013/63/EU.

EFSA e10301: benfotiamine as a novel food — safety not established at 300 mg/day

9 October 2026 EFSA Journal 10.2903/j.efsa.2026.10301 (adopted 6 August 2026, Gall Pharma GmbH): benfotiamine (CAS 22457-89-2) in food supplements for adults up to 300 mg/day. NDA Panel: identity insufficient (possible nanoparticles), production process not confirmed, microbiological stability without a conclusion, no data on metabolic fate. Safety not established; higher thiamine bioavailability not quantified into a conversion factor.

FSMP and “modification of the normal diet”: do food supplements and fortified foods count? (Commission Notice 2017/C 401/01 §§60–68)

Yes: Commission Notice 2017/C 401/01 §§60–66 treats food supplements (2002/46/EC) and fortified foods (1925/2006) as part of “modification of the normal diet” in Art. 2(2)(g) of Reg. 609/2013. Decision map and §§67–68 factors.

Organic food supplements and pesticide residues: what EU organic certification guarantees, and what it does not

Same MRLs under Reg. 396/2005 for organic and conventional; a non-authorised substance triggers an Art. 29 Reg. 2018/848 investigation, not automatic loss of status; supplements with added vitamins and minerals cannot be organic (pt 2.2.2(f), CJEU C-137/13, C-240/23). EFSA data, RCTs and the 2026 Commission report.

Vitamin and mineral tolerances in food supplements: how far may an official control result deviate from the declared value?

2012 Commission guidance: vitamins −20%/+50%, minerals −20%/+45% around a food-supplement declaration, measurement uncertainty included. How to calculate the range after rounding, why a declaration at a claim threshold leaves only measurement uncertainty downwards, the Polish 15% NRV minimum, shelf life, second opinion.

Polyols in food supplements: when must the label warn of laxative effects (FIC Annex III point 2.4)?

More than 10% added polyols (E 420, E 421, E 953, E 965–E 968) in a supplement’s mass makes “excessive consumption may produce laxative effects” mandatory. How to calculate the threshold, glycerol, the “with sweetener(s)” statement, erythritol after EFSA 2023, e-commerce.

EFSA e10340: arabinofuranosidase NZYM-GV in sugar is an opinion, not an authorisation

8 Oct 2026 EFSA Journal 10.2903/j.efsa.2026.10340: α-L-arabinofuranosidase from GM Trichoderma reesei NZYM-GV, beet and cane milling, 1.1 mg TOS/kg raw material, exposure 0.009 mg TOS/kg bw/day, NOAEL 1116, MoE ≥124000. Not a 1332/2008 listing.

Titanium dioxide (E 171) in food supplements: why a capsule shell may not contain it although E 171 is still in Annex II

Regulation 2022/63 deleted E 171 from Group II quantum satis colours, to which supplement categories 17.1–17.3 refer. The Annex II Part B entry serves medicines only (Directive 2009/35/EC). Carry-over, E 555 pearlescent pigments, transition, SWD(2025) 244 and Case T-690/25.

EFSA e10341: phospholipase A1 from Fusarium commune LFC is an opinion, not an authorisation

7 Oct 2026 EFSA Journal 10.2903/j.efsa.2026.10341: non-GM phospholipase A1 strain LFC, 2 processes, exposure up to 0.432 mg TOS/kg bw/day, NOAEL 1124, MoE ≥2601. A FEZ opinion is not a 1332/2008 listing.

“Source of vitamin” on a food supplement: which portion does 15% NRV refer to, and what it means for health claims

A “source of” vitamin or mineral claim needs 15% NRV, “high” 30%. FIC Annex XIII has no daily-portion basis, but Article 5(1)(d) of Regulation 1924/2006 and Article 8 of Directive 2002/46/EC point to the daily portion. The same threshold opens 432/2012 health claims; in Poland it is also a composition minimum.

Novel food catalogue of 6 October 2026: chaga only in supplements

On 6 October 2026 the Commission portal dated eight novel-food catalogue entries. Inonotus obliquus is “not novel in food supplements”. That is not an authorisation and not a 2017/2470 listing.

Pyrrolizidine alkaloids in botanical food supplements: how does the 400 µg/kg level in Regulation 2023/915 apply?

Annex I point 2.4.10 of Regulation 2023/915: 400 µg/kg for the lower-bound sum of 21 + 14 PAs in supplements with botanical preparations, measured in the product as placed on the market; pollen 500 µg/kg. Footnote 13 scope, extract inclusion maths, Part L sampling (2023/2782) and the x − U rule.

Annex II FIC exemptions in food supplements: which allergen derivatives need no emphasis?

The closed list of allergen exemptions in Annex II to Regulation 1169/2011 as it applies to supplement formulations: soy tocopherols and oil, wheat maltodextrin, fish gelatine as vitamin carrier, lactitol. What is not exempt (soy lecithin, wheat dextrin, lactose, fish oil, krill), Article 20 carriers and Notice 2017/C 428/01.

EFSA e10317: frozen locust paste is an opinion, not a Union-list entry

5 Oct 2026 EFSA Journal 10.2903/j.efsa.2026.10317: frozen paste from blanched Locusta migratoria, protein 13.8–14.8 g/100 g (N×6.25). Safe at the proposed uses. Not an amendment of 2017/2470 or 2021/1975.

EFSA e10331: cellulase from Trichoderma reesei NZYM-FS is an opinion, not an authorisation

1 Oct 2026 EFSA Journal 10.2903/j.efsa.2026.10331: GM cellulase NZYM-FS, 4 processes, exposure up to 0.140 mg TOS/kg bw/day, NOAEL 1292, MoE ≥9229. A FEZ opinion is not a 1332/2008 listing.

EFSA e10338: aspergillopepsin I from Aspergillus sp. LPL 3U-3-10 is an opinion, not an authorisation

30 Sept 2026 EFSA Journal 10.2903/j.efsa.2026.10338: 16 processes, exposure up to 4.673 mg TOS/kg bw/day, NOAEL 1800, MoE ≥385. A FEZ opinion is not a 1332/2008 listing.

EU food supplement regulations: which act applies before you sell

Directive 2002/46/EC covers vitamins and minerals and part of the label. Other ingredients, claims and notification sit in other acts. A map for companies, not a consumer guide.

NSA II GSK 1813/24: “dosing” and “composition” on food-supplement labels in Poland

Polish NSA judgment of 6 May 2025 (II GSK 1813/24): “dawkowanie” alone does not breach Art. 7(1)(b) Reg. 1169/2011; a “skład” heading without “składniki” breaches Art. 18(1) FIC. CBOSA doc/42A0A1D7D7.

Regulation (EU) 2026/1206: Indian botanical food supplements under Annex II — ETO checks at 10%

After EU 2026/1206 (EIF 30 June 2026), Indian food supplements containing botanicals (CN ex 1302, ex 2106) sit in Annex II of Reg. 2019/1793: special entry conditions + ethylene oxide (sum EO+2-CE) identity/physical checks at 10%. Annex I ≠ Annex II. CELEX 32026R1206.

Dz.U. 2026 item 1115: new folate and magnesium forms on the Polish MZ list — not a free novel-food pass

From 5 Sep 2026, Polish MZ Regulation (Dz.U. 2026 item 1115) adds monosodium L-5-MTHF and magnesium L-threonate to Annex 2. A national listing does not waive Union novel-food conditions (2024/1037, 2024/2694), data protection or GIS notification.

CJEU C-721/24 (Vista-Life Pharma): Article 2(2)(5) — intake frequency and administration route as health claims; Article 14(2) — disease-risk statement without verbatim wording and without repetition in written advertising

CJEU 17 September 2026, C-721/24 Vista-Life Pharma: statements on frequency of intake and/or method of administration are health claims when linked to a beneficial health effect or to the absence/reduction of an adverse effect; Article 14(2) need not be reproduced verbatim but must cover both points; written advertising need not repeat Article 14(2) if it appears on the actual packaging. CELEX 62024CJ0721; ECLI:EU:C:2026:775.

Food supplement notification in the EU: where it is required (8-country map)

Directive 2002/46 does not impose one EU notification. Map: GIS, BVL, DVFA, MZe, Romania, Sweden, Austria, Norway — plus plants and “other substances”.

EFSA E 962 (2026): aspartame-acesulfame salt — ADIs confirmed, supplement MPLs unchanged

EFSA opinion e10259 (Jul/Sep 2026): no safety concern for E 962/E 950/E 951; aspartame ADI 40 mg/kg bw/day reconfirmed, acesulfame K ADI 15 mg/kg bw/day. This does not amend Annex II to Reg. 1333/2008 or Reg. 231/2012 — food-supplement MPLs in 17.1/17.2 stay in force.

CJEU C-657/24 (Kyberg Pharma): Article 10(2) — written advertising of a food supplement is not “labelling”; no duty to repeat points (a)–(d)

CJEU 17 September 2026, C-657/24 Kyberg Pharma v Schutzverband: Article 10(2) of Regulation 1924/2006 — written advertising to promote a food supplement does not come under “labelling”; mandatory information need not be repeated in press advertising if already on the labelling. CELEX 62024CJ0657; ECLI:EU:C:2026:657.

Shellac (E904) food additive in FSMP: Regulation (EU) 2026/189 — tablets, 46,000 mg/kg

From 18 February 2026, Commission Regulation (EU) 2026/189 authorises shellac (E 904) as a glazing agent in food category 13.2 FSMP only in tablet and coated tablet forms — ML 46,000 mg/kg. Specs in Reg. 231/2012 updated: wax-free, wax ≤0.2%. No authorisation in 13.1.5. CELEX 32026R0189.

CJEU C-626/24 (Pragon): Article 9(7) OCR precludes general advance arrival notification for intra-EU food supplements

CJEU 21 May 2026, C-626/24 Pragon v SZPI: Article 9(7) of Regulation 2017/625 precludes national law requiring every recipient of food supplements from another Member State to report arrival in advance and supply risk-analysis / control-planning data. Exhaustive harmonisation; strict-necessity test. CELEX 62024CJ0626.

5 questions before choosing a food-law advisor for supplements

B2B decision checklist: GIS notification vs ‘self under the regulation’, who files private label, novel food as GIS blocker, claims on label vs WWW, when FBO checklist vs individual risk assessment.

Regulation (EU) 2026/1825: 3-MCPD and glycidyl ester MLs in baby food and oils

Commission Regulation (EU) 2026/1825 of 29 July 2026 amends Annex I to Reg. 2023/915 (points 5.3 and 5.4) and adds Art. 10(1)(r): lower MLs for oils destined for baby food and new MLs for baby food / cereal-based food from 1 January 2027; transitional stock to MDD. CELEX 32026R1825.

Quercetin: scientific evidence versus EU health claims

Quercetin has zero authorised health claims in the EU — EFSA rejected all four proposals back in 2011 (DOI 10.2903/j.efsa.2011.2067). What newer preclinical research and the small Q-CABG RCT (Aging Cell 2025) actually show, and what a label still cannot say.

CJEU C-301/25 (Lidl Italia): Article 3(4) of Directive 2005/29 does not preclude UCPD penalties alongside Article 7 FIC

CJEU 30 April 2026, C-301/25 Lidl Italia v AGCM: Article 3(4) of Directive 2005/29 does not preclude penalties under national UCPD transposition where the same conduct also falls under Article 7 of Regulation 1169/2011. Complementary regimes — no conflict. CELEX 62025CJ0301.

Regulation (EU) 2026/1118: refusal of a health claim — creatine and cognitive function

From 16 June 2026, Commission Regulation (EU) 2026/1118 refuses to authorise an Art. 13(5) health claim on creatine and improvement of cognitive function (applicant Alzchem; EFSA-Q-2024-00106). EFSA did not establish cause-and-effect; the claim is not added to the Union list. Contrast with the authorised muscle-strength claim (2017/672). CELEX 32026R1118.

Regulation (EU) 2026/196: gums, pectins and E 1450 in infant foods and FSMP

Since 18 August 2026, Commission Regulation (EU) 2026/196 applies: it amends Reg. 1333/2008 (uses of E 407, E 410, E 412, E 414, E 415, E 440, E 1450) and Reg. 231/2012 (specifications). E 412 deleted from IF and infant FSMP 13.1.5.1; combined limits in category 01.10; E 412 transition to 27 April 2027 and E 1450 to 18 February 2028. CELEX 32026R0196.

EU Health Claims vs Supplement Notification — Poland GIS Explained

Health claims are EU-harmonised; product notification is national. How the two layers work, with Poland’s GIS as the worked example for FBO teams.

Health claims on food supplements — EU law and practice after C-386/23

How to use health claims on a supplement label and website: 1924/2006, the Register, botanicals after the CJEU judgment and the GIS notice — FBO checklist.

Introducing food supplements in Poland — 7-step importer playbook (PSSE, GIS, label)

Operational importer playbook: seven numbered steps from PSSE to warehouse, private label, mutual-recognition myth, e-commerce and red flags.

Novel food and food supplements — Art. 4 checklist and EU authorisation clock (2026)

How to check novel-food status for a supplement ingredient: catalogue vs Union list, Article 4 consultation, EFSA/Commission clocks, and why a GIS filing does not cure a missing list entry.

EFSA 10 Sept 2026: aspartame-acesulfame salt (E 962) no safety concern at ADI 40 and 15 mg/kg

EFSA completed the re-evaluation of E 962 on 10 September 2026. No safety concern at current exposure. Aspartame ADI 40 mg/kg bw/day; acesulfame K ADI 15 mg/kg bw/day. Additive safety is not a health claim.

GIS food-supplement notification in Poland — Art. 30 procedure and common objections (2026)

GIS notification step by step: PSSE → ESP, sell after filing, Article 30, common objection categories, and when a new notification is required — FBO checklist.

Placing food supplements on the market in Poland — importer overview (UPO, Art. 30)

Importer overview: GIS notification is not a pharma registration, EU seat options, UPO after filing and FBO duties. Not the seven-step playbook.

Rhizomucor pusillus mycelium: what studies say about health-related effects

Research review of Rhizomucor pusillus CBS 143028 (Fermotein®) biomass: composition, DIAAS 61%, micronutrients, MyDi postprandial amino acids, TOMMY GI tolerance and Hb — with clear evidence limits. No invented clinical benefits.

Vitamin D: EU health claims versus scientific evidence

Vitamin D: EU claims vs science — HRS/BMJ Open 2025: routine supplementation linked to faster cognitive decline in older adults with normal 25(OH)D; no dementia claim; VitaMIND RCT shows no cognitive benefit.

Labelling starch in the ingredients list: E 1442 as a bulking agent

Two routes in Annex VII to Regulation (EU) No 1169/2011: starch as an ingredient (Part B, no E number) and chemically modified starch as an additive (Part C). If the principal function of E 1442 is bulking agent: category plus name or E 1442. Authorisation under Regulation 1333/2008 is a separate question.

Repeating nutrition information on labels: FSMP, supplements, fortified foods

Article 30(3) of Regulation 1169/2011 does not include protein. FSMP: absolute ban on repetition — Article 6(2) of Regulation 2016/128 is a derogation from Article 30(3), not a producer choice. Judgment C-315/24 of 9 October 2025.

Maize: gut and eye data, zero EU health claims for lutein and zeaxanthin

Yellow maize supplies lutein, zeaxanthin, fibre and ferulic acid. That does not open an EU label. EFSA rejected the vision claim for lutein and zeaxanthin; resistant starch has a 14% condition — a typical sweet-corn cob is not a product designed to meet it.

Anaerobutyricum soehngenii: gut microbiota, butyrate and the limits of scientific evidence

Taxonomy of A. soehngenii (historically labelled Eubacterium hallii / L2-7), discovery history, human-gut ecology, known butyrate mechanisms, and what remains uncertain. An EFSA CH106 safety opinion is not a Regulation 1924/2006 health-claim authorisation.

Carotenoids, lutein and zeaxanthin: a mortality tweet versus zero EU health claims

Siim Land’s thread (PMID 36752230) on circulating carotenoids and mortality, plus the MPOD meta at 5–20 mg/day. Regulation 432/2012 contains no authorised claim for lutein or zeaxanthin. EFSA 2011/2012/2014 and Regulation 2021/77.

Bay leaf (Laurus nobilis): extracts, glycaemia and cholesterol versus SANCO claims

What human and preclinical data actually show for Laurus nobilis, and which C.L.A.I.M.S./SANCO records exist. A metabolic signal is not an authorised EU health claim.

Chocolate, the gut microbiome and mood: what does the cocoa evidence actually show?

Can dark chocolate affect the gut and the brain? We examine randomized trials, cocoa polyphenol mechanisms and the limits of the evidence — without therapeutic promises.

Plant-based meat and dairy alternatives under EFSA review: microbiological findings and producer duties

What EFSA report EN-10271 says about microbiological safety of plant-based meat and dairy alternatives and the duties of RTE food producers.

Protein in the diet: how much do we really need?

A comprehensive review of dietary protein: EFSA reference values, muscle, ageing, plant and animal sources, kidney health and what protein-restriction research can—and cannot—tell us.

Cinnamon, ginger, the gut microbiota and glycaemia: what the evidence and SANCO actually show

A critical review of the small yoghurt-and-spices study, short-chain fatty acids, PYY, glycaemia and the regulatory status of botanical health claims in SANCO.

Legality of Indian and Chinese botanicals in the EU: national lists, Novel Food, Regulation 1925/2006 and health claims

A detailed EU regulatory guide to plant materials from India and China: Novel Food and the 15 May 1997 cut-off, national lists, Regulation 1925/2006, food supplements, EFSA, PAFF and separate health-claim rules.

Constipation and intestinal transit under EU health claims

Which claims about normal bowel function and intestinal transit appear on the EU list of permitted health claims, and which records remain subject to transitional treatment? An analysis of the C.L.A.I.M.S. report.

What to eat for constipation? Foods and supplements judged by the evidence

Kiwi, prunes, rye bread, psyllium, magnesium and probiotics for constipation: what human studies suggest, what they cannot promise and when to seek advice.

Coffee, gut microbiome and the brain: what does caffeine actually change — and what does coffee itself change?

Nature Communications study (PMC13100100) on coffee, the gut microbiome and the gut–brain axis. C.L.A.I.M.S. status of coffee and caffeine health claims: zero authorised entries in Regulation 432/2012; SANCO on-hold records only.

Cocoa flavanols: the EFSA 200 mg blood-flow claim

The EU claim needs 200 mg of cocoa flavanols a day to maintain normal blood flow. Which products qualify, and what a chocolate or supplement label still cannot say.

\"Fit\", \"Light\" and \"Invigorating\" Beer: The Limits of EU Law on Alcohol Claims (Art. 4(3) Reg. 1924/2006)

Analysis of the absolute prohibition on health claims for beverages >1.2% alcohol (Art. 4(3) Reg. 1924/2006), the CJEU judgment in Deutsches Weintor (C-544/10) and the ASA ruling in the DrinkWell case (2026). Case studies: Perła Fit, Żywiec Jasne Lekkie, Kozel Bílý Lehký, Zwierzyniec.

Import and Transit of Food of Animal Origin from Third Countries to the EU

Products containing ingredients of animal origin from third countries are subject to a special border control regime. A practical guide to import and transit routes through EU territory.

Pancreatic Cancer — Symptoms, Herbs and Alternative Medicine: What Science Says

Pancreatic cancer: early symptoms, risk factors, stages of advancement. Curcumin, mistletoe, medicinal mushrooms, cannabinoids, acupuncture and other research-backed supportive methods.

Xanthan gum (E415) and gut inflammation: new rat study and implications for food manufacturers

A Brazilian study (PLOS ONE, 2026) found that chronic consumption of xanthan gum induces colitis, increases claudin-2 expression and alters gut microbiota in rats. Analysis of regulatory implications for food and supplement manufacturers in the EU.

Caffeine: the 75 mg alertness claim was not authorised

EFSA gave a positive opinion on caffeine alertness claims, but they were never authorised; 75 mg comes from a rejected proposal. EFSA’s safety figure for healthy adults is 400 mg a day. The 2026 AHA statement does not authorise a heart claim on the label.

Japanese Food on the EU Market — What the Law Actually Requires

Importing Japanese food supplements, collagen drinks and functional foods to the EU: novel food, veterinary controls, labelling, health claims and EPA tariff preferences.

NMN in the European Union — Legal or Not? Status as of 2026

Legal status of NMN (nicotinamide mononucleotide) in the EU: EFSA opinion, absence of a Commission implementing act, applicant-specific authorisation, and implications for importers.

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.

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.

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.

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 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.

\"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.

8 Consequences of ACP Demands for the Supplements Market: What Will Change in the EU and Poland?

The American College of Physicians is demanding stricter regulation of food supplements. What are the implications for the EU market and Polish manufacturers? A legal analysis.

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).

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.

Child's death after raw milk cheese: what EU law says to raw milk producers — and whether it is enough

A tragedy following the consumption of raw milk cheese and gaps in EU regulation. What liability does the producer face, and do the rules need tightening?

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.

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?

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.

8 Things Functional Food Manufacturers Must Know Following the Positive EFSA Opinion on Lacto-N-triose II as a Novel Food

The positive EFSA opinion (July 2026) on Lacto-N-triose II as a novel food – what it means, and does not yet mean, for functional food and food supplement manufacturers, pending the Commission's implementing regulation.

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.

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.

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.