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

A food supplement for adults notified in Poland should contain no more than 6 mg of vitamin B6 in the recommended daily portion. That figure was adopted by the Polish Food Supplements Team (Zespół do spraw Suplementów Diety) in Resolution No 2/2024 of 10 September 2024. It replaced the former 18 mg threshold of Resolution No 18/2019, and the Chief Sanitary Inspectorate (GIS) applies it when assessing notifications. The 6 mg figure is derived from the tolerable upper intake level (UL) of 12 mg/day set by EFSA in 2023, after deducting vitamin B6 taken in with the diet. The UL covers all forms of vitamin B6, so the limit refers to the amount of vitamin B6 per portion, not to the mass of pyridoxine hydrochloride or pyridoxal 5′-phosphate (P5P). There are still no EU-wide maximum levels. Germany’s BfR proposes 0.9 mg per product.

1. What Resolution No 2/2024 actually says

The resolution has three short paragraphs and a statement of reasons. The Team adopted it under Art. 9(2b)(1)–(3) of the Polish Act on the State Sanitary Inspection. It amends Resolution No 18/2019 of 13 March 2019, which allowed 18 mg of vitamin B6 in the recommended daily portion of a supplement for adults.

GIS publishes this value in its overview “Useful information for formulating food supplements” (Table 2, item 9: “Vitamin B6, 6 mg, resolution 2/2024”). Unlike vitamin K or folic acid, no recommended warning is attached to vitamin B6.

2. Where 12 mg comes from: the 2023 EFSA opinion

The EFSA NDA Panel published its opinion on the UL for vitamin B6 on 17 May 2023 (EFSA Journal 2023;21(5):8006). The critical effect is peripheral neuropathy. The Panel could not identify a lowest-observed-adverse-effect level (LOAEL) from human data, so it derived the UL in two ways:

• Human data: a reference point of 50 mg/day from the case–control study by Dalton and Dalton (1987). There, neuropathy was reported in 48% of women taking less than 50 mg a day for at least 6 months. An uncertainty factor of 4 gives 12.5 mg/day.
• Animal data: a LOAEL of 50 mg/kg body weight in Beagle dogs, an uncertainty factor of 300 and a body weight of 70 kg give 11.7 mg/day.

The midpoint of the range, rounded down, is 12 mg/day for adults, including pregnant and lactating women. The earlier UL of the Scientific Committee on Food (SCF) from 2000 was 25 mg. EFSA also cites nutrivigilance data. In the Netherlands, 33 cases with a documented dose involved supplements providing up to 50 mg of vitamin B6 a day. The French system reports cases of neuropathy at supplemental intakes below 25 mg a day.

Two conclusions of the opinion matter directly for the label. First, the UL “relate[s] to vitamin B6 intake from all dietary sources and all vitamin B6 vitamers”. There is therefore no separate, higher threshold for P5P. The Panel only flagged the need for more research on differences in toxicity between vitamers. Second, EFSA considered it unlikely that the UL is exceeded in EU populations, “except for regular users of food supplements containing high doses of vitamin B6”. The risk lies with supplements, not with the ordinary diet.

3. From 12 to 6 mg: the arithmetic of Article 5 of Directive 2002/46/EC

Article 5(1) of Directive 2002/46/EC requires maximum amounts of vitamins per daily portion of a supplement to take into account (a) upper safe levels established by scientific risk assessment, having regard to the varying sensitivity of consumer groups, and (b) intake from other dietary sources. Paragraph 2 adds reference intakes. Resolution 2/2024 applies exactly this scheme. It deducts high dietary intake (P95 about 5.2 mg) from the 12 mg UL and obtains a remainder of about 6.8 mg. The Team adopted 6 mg.

The Court of Justice has twice explained how Member States may set such limits until the Commission adopts EU limits. In C-446/08 Solgar Vitamin’s France (29.04.2010) it held that a limit must rest on a UL established by scientific risk assessment, not on hypothetical considerations. In C-672/15 Noria Distribution (27.04.2017, paras 31–36) it added that limits may be set “at a level significantly lower” than the UL. The condition is justification by the criteria of Article 5(1) and (2) and respect for proportionality. The Court rejected, by contrast, setting limits as a fixed multiple of recommended daily intakes. The “UL minus diet” method fits that pattern. The 6 mg limit is therefore not an RDA multiplier but the result of Article 5.

The same pattern can produce very different results. The BfR, in Opinion No 008/2024 of 22 February 2024, starts from the most sensitive group covered by its recommendation, adolescents aged 15–17: 10.7 mg minus a dietary P95 of 7.1 mg gives 3.6 mg. It splits this remainder equally between supplements and fortified foods (1.8 mg each). It then applies a factor of 2 in case several supplements are taken at once. The result is 0.9 mg per daily portion of a product for persons aged 15 and over. In 2021, with the old 25 mg UL, the same method gave 3.5 mg.

4. Legal status: a resolution is not a regulation

Polish law contains no generally binding provision setting a maximum amount of vitamin B6 in a food supplement. The Minister of Health regulation on the composition and labelling of food supplements lists permitted vitamins and their forms, but not maximum doses. The Team’s resolution is the opinion of an expert advisory body. In practice, however, it operates as a criterion in three places:

• Notification under Art. 29 of the Act. A product may be placed on the market once the notification has been validly filed. GIS may, however, open explanatory proceedings under Art. 30 and request the Team’s opinion in them. A dose above 6 mg may trigger a request to justify the composition.
• Measures of the district authority under Art. 32. Since the Supreme Administrative Court (NSA) judgments of April 2024 (II GSK 589/23, 627/23, 806/23), information that GIS has opened proceedings is not enough to suspend marketing. The authority must establish non-compliance itself, in line with Art. 138 of Regulation (EU) 2017/625. Exceeding the figure in the resolution is not automatically “non-compliance with the law”. It can, however, serve as evidence in a safety assessment under Art. 14 of Regulation (EC) No 178/2002.
• Free movement of goods. A product lawfully sold in another Member State benefits from Art. 34 TFEU and from the mutual recognition procedure of Regulation (EU) 2019/515. A restriction must be justified and proportionate within the meaning of Art. 36 TFEU and Noria. In the operative part of Noria the Court also held that a Member State applying national maximum doses must provide a procedure for placing on its market supplements that exceed them and are lawfully manufactured or marketed in another Member State. The risk assessment may not rest solely on national opinions where more recent international opinions are available. For vitamin B6 this argument works against high doses: the resolution relies precisely on the 2023 EFSA opinion, not on a national one.

The resolution therefore does not bind a court or an operator like a legal norm. It is, however, scientifically reasoned in a way consistent with Article 5 of the Directive, and with a UL of 12 mg it is currently hard to demonstrate the safety of 10–20 mg in a product for adults.

5. How to count 6 mg: vitamin B6, not the mass of the chemical form

Annex I of Directive 2002/46/EC lists “Vitamin B6 (mg)” as the nutrient and the unit of declaration. Article 8(1) and (2) requires the amount of the nutrient per daily portion to be stated in that unit. Annex II permits three forms: pyridoxine hydrochloride, pyridoxine 5′-phosphate and pyridoxal 5′-phosphate. The last form was added by Regulation (EC) No 1170/2009. The form is thus the source of the vitamin, while the declaration in the table and the comparison with the limit concern vitamin B6.

Neither the Directive nor Resolution 2/2024 states expressly in which equivalent vitamin B6 is to be counted. In its 2023 opinion EFSA converts doses of the hydrochloride into pyridoxine equivalents (e.g. 2.6 mg of hydrochloride is 2.1 mg of pyridoxine). The same molar calculation applies to the phosphate forms. The differences are material:

The values were calculated from molecular formulas. The quantity of raw material in the recipe also depends on purity and the assay in the supplier’s specification. Two common label errors are: writing “P5P 10 mg” in the table instead of the amount of vitamin B6 (10 mg of anhydrous P5P is about 6.85 mg of vitamin B6, i.e. above the limit), and declaring the mass of the hydrochloride as vitamin B6, which overstates the percentage of the nutrient reference value (NRV). It is safer to state the conversion basis in the notification file and keep a margin below 6 mg.

Overage is a separate issue. The declaration is an average value (Art. 9 of the Directive), and the 2012 Commission guidance allows vitamins in supplements to deviate by −20% to +50% over the whole shelf life. The tolerance, however, addresses uncertainty and degradation over time. It is not a tool for designing a product that deliberately contains more than the limit throughout its shelf life. With a 6 mg declaration and 30% overage, actual content at the start of shelf life is about 7.8 mg. Such a recipe is hard to defend with the argument that “we declare 6 mg”.

6. Children, pregnancy and several products at once

Resolution 2/2024 covers only products for adults. For children, figures must be derived from the EFSA UL for the relevant age. According to the EFSA opinion (Table 3), the P95 of intake from food, excluding supplements, reaches up to 2.7 mg in children aged 3–9. A product with 6 mg of vitamin B6 on its own already exceeds the UL for children aged 1–3 (3.2 mg) and 4–6 (4.5 mg). For children aged 7–10 (6.1 mg) it leaves headroom that the ordinary diet consumes. A “family” supplement with 6 mg and the instruction “for children from 4 years” therefore has no support in the EFSA data.

In pregnancy and lactation the UL is 12 mg, as for adults. The resolution sets no higher or lower limit here, so a product for pregnant women falls within the adult scheme. Unlike the German method, the Polish method applies no separate factor for taking several supplements at once. The mandatory warning under Art. 6(3)(c) of the Directive (“do not exceed the recommended daily dose”) concerns one product and does not solve the problem of adding up vitamin B6 from a B complex, a magnesium-plus-B6 product and a multivitamin.

7. Health claims do not require a high dose

Regulation (EU) No 432/2012 contains several claims for vitamin B6. They include contribution to the normal functioning of the nervous system, reduction of tiredness and fatigue, regulation of hormonal activity, normal red blood cell formation and normal function of the immune system. The condition of use for each is that the product is at least a “source” of vitamin B6, i.e. contains 15% of the NRV per portion. The NRV for vitamin B6 is 1.4 mg (Annex XIII Part A of Regulation 1169/2011), so the threshold is 0.21 mg. A dose of 6 mg is about 429% of the NRV. Lowering the dose from 18 to 6 mg does not deprive the product of any permitted claim. More on the threshold: “source of vitamin” — 15% NRV per daily portion.

Messaging such as “high dose”, “mega B6” or “100 mg for the nervous system” suggests that the effect grows with the dose. The claims in Regulation 432/2012 say nothing of the kind, and with the current UL such a narrative directly contradicts the safety assessment.

8. What happens next at EU level

Since 2002, Article 5(4) of Directive 2002/46/EC has provided for maximum and minimum amounts to be adopted by the Commission. No value has been adopted to date. At the AGRIFISH Council of 11–12 December 2025, Germany, supported by 16 Member States including Poland, called on the Commission to set limits for supplements and fortified foods in 2026 (Council document 15839/25). In an answer to a parliamentary question of 25 September 2026, the Commission announced a call for evidence by the end of 2026. Targeted consultations and a staff working document setting out the methodology are to follow. The basis is to be EFSA’s updated ULs and Member States’ experience.

Until then, Article 11(2) of the Directive applies: national rules apply within the limits of the Treaty. For vitamin B6 this means a market in which the same product may be assessed differently: 6 mg in Poland, 0.9 mg in the BfR proposal, and other values in other Member States.

9. What the rules leave open

• Conversion basis. Neither the Directive nor the resolution says expressly that vitamin B6 is counted as pyridoxine equivalent. That calculation follows from EFSA’s convention and stoichiometry.
• Products notified before 10.09.2024. The resolution provides no transition period and no automatic review of the register. Its statement of reasons does, however, exclude further use of the 18 mg threshold in assessing products.
• Limit for children. The absence of a figure in the resolution does not mean freedom. It means the operator must itself demonstrate the safety of the dose against the UL for the relevant age group.
• Differences in toxicity between vitamers. EFSA flagged them as a research need. For now, the UL and the limit treat all forms alike.

10. Checklist: vitamin B6 in a supplement for the Polish market

1. Target group: state on the label who the product is for. The 6 mg limit of Resolution 2/2024 applies only to products for adults.
2. Dose: calculate vitamin B6 for the whole recommended daily portion (number of capsules times content) and keep it at no more than 6 mg.
3. Form: choose a form from Annex II of Directive 2002/46/EC and convert its mass into vitamin B6 (e.g. 8.76 mg of anhydrous P5P is 6 mg of vitamin B6).
4. Declaration: in the table, state “Vitamin B6 … mg” and % NRV (1.4 mg = 100%), not the mass of the salt or phosphate.
5. Overage: design the recipe so that actual content does not deliberately exceed the limit over the whole shelf life. The +50% tolerance is not a way to raise the dose.
6. Children: for a children’s product, derive the dose from the EFSA UL for the age group and dietary intake. Do not carry over 6 mg from the adult product.
7. Claims: use the claims of Regulation 432/2012 as worded. 0.21 mg is enough for them. Remove “high dose” messaging.
8. Documentation: keep in the GIS notification file the form specification, the conversion calculation and references to the 2023 EFSA UL and Resolution 2/2024, in case of proceedings under Art. 30 of the Act.

Frequently asked questions

How much vitamin B6 may a food supplement contain in Poland?

Under Resolution No 2/2024 of the Polish Food Supplements Team of 10 September 2024, a supplement for adults should contain no more than 6 mg of vitamin B6 in the recommended daily portion. GIS applies this value when assessing notifications. It is not a provision of a regulation but a criterion based on the EFSA UL of 12 mg/day and dietary intake.

Why is the limit 6 mg when the EFSA UL is 12 mg?

The UL covers vitamin B6 from all sources. Article 5 of Directive 2002/46/EC requires dietary intake to be deducted. The Team took into account the 95th percentile of dietary intake (about 4.4–5.2 mg), which leaves about 6.8 mg, and adopted 6 mg.

Does 6 mg refer to the mass of P5P or to vitamin B6?

To vitamin B6. The EFSA UL covers all vitamers, and the Directive requires vitamin B6 to be declared in mg. Converted to pyridoxine, 6 mg of vitamin B6 corresponds to about 8.76 mg of anhydrous pyridoxal 5′-phosphate or 7.29 mg of pyridoxine hydrochloride.

Is the Team’s resolution binding?

It is not a generally binding legal provision. It is an opinion that GIS uses in explanatory proceedings under Art. 30 of the Polish Act on Food and Nutrition Safety. Restricting the marketing of a product requires non-compliance or a risk to be established in the specific case.

Is there a common EU limit for vitamin B6 in supplements?

No. Article 5(4) of Directive 2002/46/EC provides for EU limits, but the Commission has not adopted them. It has announced a call for evidence by the end of 2026. Until then national approaches apply, e.g. 6 mg in Poland and, in Germany, the BfR proposal of 0.9 mg.

Glossary

UL (tolerable upper intake level)

The highest chronic daily intake of a nutrient from all sources that is unlikely to pose a risk of adverse health effects. It is not a recommended dose.

Vitamin B6 vitamers

Pyridoxine, pyridoxal, pyridoxamine and their 5′-phosphates. All have vitamin B6 activity.

P5P (PLP)

Pyridoxal 5′-phosphate, the active coenzyme form of vitamin B6. Permitted in supplements since Regulation (EC) No 1170/2009.

P95

The 95th percentile of intake, i.e. the value not exceeded by 95% of the population studied. Used as a proxy for high dietary intake.

NRV

Nutrient reference value in Annex XIII of Regulation 1169/2011. For vitamin B6 it is 1.4 mg.

Conclusion

The 6 mg figure is not the product of official caution. It is the result of the Article 5 calculation of Directive 2002/46/EC: the EFSA UL of 12 mg minus vitamin B6 from a typical high diet. Once the UL was halved in 2023, the former 18 mg lost its basis, and products with 25–100 mg per daily portion exceed the adult UL by itself two to eight times. For the manufacturer three decisions are key: the dose across the whole daily portion, conversion of the form into vitamin B6, and a separate track for children. When the Commission adopts EU limits the value may change, but the method rests on the same data. The vitamin D counterpart (in Polish): maximum dose of vitamin D in a food supplement. Procedure: GIS notification and tolerances for vitamins and minerals.

Primary sources

1. Directive 2002/46/EC on food supplements (consolidated): Arts 5, 6, 8, 9, 11, 12, Annexes I and II.
2. Commission Regulation (EC) No 1170/2009 amending the lists of vitamins and minerals and their forms (pyridoxal 5′-phosphate).
3. Polish Food Supplements Team (Zespół do spraw Suplementów Diety), Resolution No 2/2024 of 10 September 2024 amending Resolution No 18/2019 on the maximum dose of vitamin B6 in the recommended daily portion of food supplements, with statement of reasons (in Polish).
4. Chief Sanitary Inspectorate (GIS), Useful information for formulating food supplements, Table 2, item 9 (in Polish).
5. EFSA NDA Panel, Scientific opinion on the tolerable upper intake level for vitamin B6, EFSA Journal 2023;21(5):8006 (sections 3.5.1.4, 3.6, 3.7, Table 3).
6. CJEU, judgment of 29.04.2010, C-446/08 Solgar Vitamin’s France and Others, ECLI:EU:C:2010:233.
7. CJEU, judgment of 27.04.2017, C-672/15 Noria Distribution, ECLI:EU:C:2017:310, paras 31–36 and operative part.
8. Polish Act of 25 August 2006 on Food and Nutrition Safety, Arts 29–32; NSA judgments of April 2024, II GSK 589/23, II GSK 627/23, II GSK 806/23.
9. Regulation (EU) No 1169/2011, Annex XIII Part A (NRV for vitamin B6 1.4 mg) and Regulation (EU) No 432/2012 (health claims for vitamin B6).
10. European Commission, Guidance document on tolerances for nutrition labelling (December 2012).
11. Regulation (EU) 2019/515 on the mutual recognition of goods.
12. BfR, Aktualisierung (2024): Höchstmengenvorschläge für Vitamin B6, Opinion No 008/2024 of 22.02.2024, doi:10.17590/20240222-141910-0.
13. Council of the EU, document 15839/25 of 10.12.2025, AOB item for the AGRIFISH Council of 11–12.12.2025: maximum levels for vitamins and minerals.
14. European Commission, answer by Commissioner Várhelyi of 25.09.2026 to the priority question by MEP C. Mullooly on maximum permitted levels for vitamins and minerals in food supplements.