Dz.U. 2026 item 1115
Folate and magnesium forms on the Polish MZ list ≠ a free novel-food pass

Operational question: does adding a vitamin or mineral chemical form to the Polish MZ composition-and-labelling regulation automatically unlock unrestricted use of that form in a PL/EU food supplement? Answer: no. The national list (Dz.U. 2026 item 1115) is an implementation layer for Directive 2002/46/EC. For both new entries, Union novel-food conditions, applicant data protection, act-specific labelling and — in Poland — GIS notification still apply. Listing does not “unlock” health claims.

1. What does Dz.U. 2026 item 1115 change?

The act of 19 August 2026, published on 21 August 2026 (Journal of Laws 2026 item 1115; ELI PDF: D20261115.pdf), amends the Minister of Health Regulation of 9 October 2007 on the composition and labelling of food supplements (consolidated text Dz.U. 2023 item 79, as amended e.g. by Dz.U. 2025 item 1182). Legal basis: Article 27(6)–(7) of the Act of 25 August 2006 on food and nutrition safety.

In Annex 2:

• section 1 point 10 (folate forms) adds letter (d): monosodium salt of L-5-methyltetrahydrofolic acid;
• section 2 (magnesium forms) adds point 41b: magnesium L-threonate (L-treonian magnezu).

§ 2: the regulation enters into force 14 days after publication → 5 September 2026. It does not force reformulation of products already lawfully on the market; it opens additional form options in the national catalogue.

2. The Union layer that already existed before 5 Sep 2026

Before a form appears in Polish Annex 2, at least two EU tracks must close:

1. Novel food — Regulation (EU) 2015/2283 plus a Union-list entry (Implementing Regulation (EU) 2017/2470) with use conditions, labelling and any data protection (Article 26).
2. Vitamin/mineral source in supplements — Annex II to Directive 2002/46/EC (amended by Commission regulation).

For these forms the Commission had already adopted both sets:

Dz.U. 2026 item 1115 is therefore a national closing of the forms list, not the first Union authorisation. Operator error: treating 5 Sep 2026 as the day everything becomes free without reading the 2017/2470 annex.

3. Folate: 2024/1037 + 2025/2224

Implementing Regulation (EU) 2024/1037 authorises monosodium salt of L-5-methyltetrahydrofolic acid as a novel food and inserts it into list 2017/2470. Key Table 1 conditions:

• Food supplements under Directive 2002/46 — excluding supplements for infants and young children; levels “in accordance with Directive 2002/46” (plus the other food categories listed in the entry under 609/2013 and 1925/2006).
• Designation: “Monosodium salt of L-5-methyltetrahydrofolic acid (folic acid)”.
• Labelling statement: food supplements containing the form should not be consumed by infants and young children (children under 3 years of age).
• Data protection: only Merck & Cie KmG for 5 years from 30 April 2024, unless a later applicant obtains authorisation without protected data or with Merck’s agreement; end of data protection: 30 April 2029 (Articles 2–3).

EFSA opinion (safety + folate bioavailability): DOI 10.2903/j.efsa.2023.8417 (Journal 2023;21:e8417). EFSA opinion ≠ market authorisation — the Commission opens the market via the list entry and conditions.

Regulation (EU) 2025/2224 adds the form to Annex II of Directive 2002/46 (folate source in supplements) and Annex II of Regulation (EC) No 1925/2006 (fortification), with a cross-reference to novel-food list conditions.

4. Magnesium: 2024/2694 + 2025/2225

Implementing Regulation (EU) 2024/2694 authorises magnesium L-threonate. Table 1 conditions:

• category: food supplements for adults, excluding pregnant and lactating women;
• maximum level: 250 mg/day (as stated in the Maximum levels column — the act text does not restate this as “elemental magnesium”);
• designation: “Magnesium L-threonate”;
• labelling: statement that the supplements should be consumed by adults only, excluding pregnant and lactating women;
• data protection: only AIDP Inc. for 5 years from 7 November 2024; end of protection: 7 November 2029.

EFSA opinion: DOI 10.2903/j.efsa.2024.8656 (Journal 2024;22:e8656) — safety under the proposed conditions and magnesium bioavailability. Again: opinion ≠ authorisation.

Regulation (EU) 2025/2225 inserts “magnesium L-threonate” into point B of Annex II to Directive 2002/46, with a footnote that the form is as listed in the Union novel-food list (2017/2470).

5. Data protection ≠ category monopoly

Article 26 of Regulation (EU) 2015/2283 protects the applicant’s proprietary scientific data. During the protection period another FBO may not rely on those protected data without the owner’s agreement. That is not an absolute forever ban on the whole chemical class — another operator may seek its own authorisation on independent data or obtain contractual access. After protection ends (2029 for both forms) the procedural rule changes; use and labelling conditions on the list remain until the Commission amends them.

Procurement practice: the supplier questionnaire must separate (a) chemical match to the entry, (b) legal title to place that material during protection, (c) compliance with limits and labelling warnings.

6. GIS, labelling, claims — separate duties

• GIS notification (Article 29 of the Polish Food and Nutrition Safety Act) remains the duty of first placing a food supplement in Poland. Listing a form in the MZ regulation does not replace notification and is not a second novel-food authorisation. EU notification map: EU supplement notification — country map; PL procedure: GIS notification (PL).
• Act-specific labelling from the novel-food list (designation + population warnings) applies even once the form is in MZ Annex 2.
• Health claims — only under Regulation (EC) No 1924/2006 (Register / authorisation). Novel food and 2002/46 form listing do not unlock claims. Hub: health claims — supplements.

7. Operator checklist (R&D / QA / import)

1. Confirm the form is in MZ Annex 2 and in Annex II to Directive 2002/46 (after 2025/2224 or 2025/2225).
2. Read the Union novel-food list entry (2017/2470 as amended by 2024/1037 or 2024/2694): category, level, designation, warnings.
3. Verify the supplier against data protection (Merck to 30 Apr 2029 / AIDP to 7 Nov 2029) — a chemical CoA is not a legal title to place a protected form.
4. Set the label: act designation + population warnings; do not copy marketing “magnesium/folate” claims without 1924/2006.
5. Plan GIS notification for first placing in PL; do not treat 5 Sep 2026 as “product approval”.
6. Do not assume a duty to reformulate existing SKUs — the act opens options; it does not force form swaps.

Glossary

MZ Annex 2

Polish national list of vitamin and mineral forms allowed in food supplements — implementing Directive 2002/46/EC.

Annex II to Directive 2002/46/EC

Union list of vitamin and mineral forms for manufacturing food supplements.

Union novel-food list

Implementing Regulation (EU) 2017/2470 — use conditions, labelling, data protection.

Data protection (Art. 26 2015/2283)

Time-limited protection of the applicant’s proprietary data; not a forever monopoly of the chemical class.

GIS notification

Polish first-placing duty for food supplements — separate from novel food and from the forms list.

Conclusion

From 5 September 2026 the Polish MZ forms list includes monosodium L-5-MTHF and magnesium L-threonate. That is the national closing step after Union acts 2024/1037, 2024/2694, 2025/2224 and 2025/2225. Dz.U. 2026 item 1115 does not waive novel-food conditions, data protection, act labelling or GIS notification, and it does not open health claims. An operator who sees only “a new line in the MZ regulation” misses the other four decision layers.

Primary sources

1. Dz.U. 2026 item 1115 — MZ Regulation of 19 Aug 2026 amending the composition and labelling regulation for food supplements (PDF: ELI).
2. Commission Implementing Regulation (EU) 2024/1037 — monosodium L-5-MTHF (CELEX 32024R1037).
3. Commission Implementing Regulation (EU) 2024/2694 — magnesium L-threonate (CELEX 32024R2694).
4. Commission Regulation (EU) 2025/2224 — folate form in Annex II to 2002/46 and 1925/2006.
5. Commission Regulation (EU) 2025/2225 — magnesium L-threonate in Annex II to 2002/46.
6. EFSA 2023 — monosodium L-5-MTHF.
7. EFSA 2024 — magnesium L-threonate.
8. Novel food and food supplements in the EU.
9. EU supplement notification — country map.
10. Regulation (EC) No 1924/2006 — claims.