Operational question for QA, regulatory and importers of weight-control products: after 2025/2058, which additive food category applies to a product that replaces one or two main meals (not the whole daily diet) — 13.3 or 18.2 — and what must operators re-map? The act’s answer: 18.2. Category 13.3 covers only total diet replacement for weight control (TDR) as defined in Regulation (EU) No 609/2013. CELEX 32025R2058.
1. What the act does
Commission Regulation (EU) 2025/2058 of 14 October 2025 (OJ L series 2025/2058, 15.10.2025; ELI: eli/reg/2025/2058/oj; EUR-Lex: CELEX 32025R2058):
- Article 1 — Annex II to 1333/2008 is amended as set out in Annex I to 2025/2058 (Part D category titles + Part E lists);
- Article 2 — Annex III is amended as set out in Annex II (nutrient carriers; updated “nutrients” definition + references to 01.10 and 13.1);
- Article 3 — Annex II is corrected as set out in Annex III (E code 969 Advantame: cat. 13.2 → ML 10; cat. 13.3 → ML 8);
- Article 4 — entry into force on the twentieth day after OJ publication → 4 November 2025.
Legal basis: Article 10(3) of Regulation (EC) No 1333/2008 and Article 7(5) of Regulation (EC) No 1331/2008. Recitals: update references from repealed Directive 2009/39/EC to Regulation (EU) No 609/2013 (foods for specific groups — FSG).
2. 13.3 vs 18.2 — the key split
Before 2025/2058, category 13.3 covered dietary foods for weight control intended to replace total daily food intake or an individual meal. After the amendment:
• 13.3 = only total diet replacement for weight control (TDR) as defined in Regulation (EU) No 609/2013;
• products replacing one or two main meals of an energy-restricted diet (weight-loss / weight-maintenance claims) → new subcategory 18.2, whose title refers to the conditions in Regulation (EU) No 432/2012.
| Product | Additive category | Reference act | Do not confuse with |
|---|---|---|---|
| TDR — replaces the whole daily diet | 13.3 | 609/2013 (FSG) | Not a 1–2 meal replacement |
| Replacement of 1–2 main meals | 18.2 | 432/2012 claim conditions | Not in the scope of 609/2013 |
| Food supplement (“diet” shake as a supplement) | 17.1 / 17.2 | Directive 2002/46/EC | Do not shortcut via the 18.2 list |
| FSMP | 13.2 (and related) | 609/2013 + 2016/128 | Separate track; not 432/2012 claims |
3. Other category moves (gluten, 01.10, 18.1)
- 13 — title: from “foods intended for particular nutritional uses” (Directive 2009/39/EC) to foods for specific groups as defined in 609/2013;
- 13.1.4 (other foods for young children — milk-based) — deleted; new subcategory 01.10 under category 01 (dairy products and analogues) — for additive-list purposes only; authorised additives and conditions are intended to remain materially unaffected;
- 13.1.5 / 13.1.5.1 — remove the phrase “special formulae for infants”; FSMP for infants/young children under 609/2013;
- 13.4 (foods for persons intolerant to gluten, Reg. 41/2009) — deleted from 13 → 18.3 (foods specially produced to reduce the gluten content of gluten-containing ingredients or to substitute those ingredients);
- 18.1 — new residual category: processed foods not covered by 18.2 and 18.3, excluding foods for infants and young children.
4. What the act does not do
- does not authorise new health claims for meal replacements — claim conditions remain in 432/2012;
- does not bring 1–2 meal replacements into the scope of 609/2013 (only TDR stays in FSG);
- does not change food-supplement categories 17.1 / 17.2;
- does not abolish FSMP / IF / FOF regimes — it updates legal references to 609/2013 and Delegated Regulations 2016/127 and 2016/128;
- does not unlock novel food or replace national notification duties (e.g. GIS in Poland).
AGRINFO (secondary summary): the changes are for legal consistency; authorised additive lists for those products are preserved/moved and are not a trade ban.
5. Operator checklist
- Is the SKU a TDR (whole daily diet) → 13.3 + 609/2013 compositional rules, or a 1–2 meal replacement → 18.2 + 432/2012 claim conditions?
- Have internal additive matrices / spec sheets been updated (13.3/13.4 → 18.2/18.3; IYC milk → 01.10)?
- Are gluten specialty products mapped to 18.3, not FSG 13?
- Does the team avoid treating a category move as a new claim authorisation?
- Do “diet” / shake products that are food supplements still sit in cat. 17 — without shortcutting via the 18.2 list?
- Is the E 969 (Advantame) correction in 13.2/13.3 reflected in specs (ML 10 / 8)?
Glossary
- FSG
- Foods for specific groups — Regulation (EU) No 609/2013 (inter alia IF/FOF, baby food, FSMP, TDR).
- TDR
- Total diet replacement for weight control — whole daily diet under 609/2013; after 2025/2058 = additive cat. 13.3.
- Cat. 18.2
- Meal replacements for weight control — 1–2 meal products; title refers to 432/2012 conditions.
- Cat. 18.3
- Gluten specialty foods (ex 13.4) — outside FSG 13.
- Cat. 01.10
- Dairy drinks and similar for young children (ex 13.1.4) — additives-only category.
- 1333/2008
- Food additives regulation — Annex II Parts D/E = categories and lists.
Conclusion
From 4 November 2025, Regulation (EU) 2025/2058 splits what the old category 13.3 mixed: TDR stays in 13.3 (609/2013), while one- or two-meal replacements move to 18.2 (432/2012 conditions). Gluten specialty → 18.3; young-child milk drinks → 01.10. For operators the work is SKU and additive-matrix remapping — not a new claim and not a change of supplement status.
Primary sources
- Commission Regulation (EU) 2025/2058 — CELEX 32025R2058; ELI eli/reg/2025/2058/oj; OJ L 15.10.2025; EIF 4 Nov 2025. OJ republication (ES): DOUE-L-2025-81494.
- Regulation (EC) No 1333/2008 — food additives; Annexes II and III.
- Regulation (EU) No 609/2013 — FSG; TDR in scope.
- Regulation (EU) No 432/2012 — meal-replacement claim conditions (title of cat. 18.2).
- Regulation (EC) No 1331/2008 — common authorisation procedure; Art. 7(5) as a legal basis for 2025/2058.