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One test: technological function in the final food. If an additive from a vitamin/mineral premix has no technological function in the finished supplement, its presence may be justified as carry-over under Annex III Part 5 conditions. If it does perform such a function in the tablet, capsule or liquid — Article 18(3) of Regulation (EC) No 1333/2008 treats it as an additive of that supplement: it must meet the conditions of use in Annex II for category 17 (17.1 solid / 17.2 liquid).

Legal basis: Reg. (EC) No 1333/2008 Arts 2–4, Art. 18, Annex II Part E cat. 17, Annex III Part 5 (Section A vs B); Reg. (EU) No 1130/2011 (Union list in Annex III); Reg. (EU) 2018/1497 (category 17 restructuring); Directive 2002/46/EC Art. 2; Reg. (EU) No 1169/2011 Art. 18 and Annex VII.
Decision map: Part 5 vs Article 18(3) and category 17
Fig. 1. Operator decision: a Part 5 authorisation does not end the analysis — only the absence of a technological function in the finished product keeps the carry-over path open.

1. Two lists, two purposes

Article 4(1) of Regulation 1333/2008: only additives on the Union list in Annex II may be used in foods under the conditions set there. Article 4(2) and (4): Annex III covers additives used in food additives, enzymes, flavourings and in nutrients or categories thereof.

A food supplement within the meaning of Article 2 of Directive 2002/46/EC is a food. Category 17 in Part E of Annex II (“Food supplements as defined in Directive 2002/46/EC”) is therefore the right place for additives of the finished supplement. Regulation (EU) 2018/1497 replaced the earlier layout: the subcategories now in force are 17.1 (solid form) and 17.2 (liquid form), excluding supplements for infants and young children; former 17.3 was deleted.

Annex III Part 5 (“Food additives in nutrients”) — populated in particular by Regulation 1130/2011 and later amendments — splits into:

  • Section A — additives in nutrients other than those intended for foods for infants and young children under point 13.1 of Part E of Annex II;
  • Section B — additives in nutrients intended for those IYC foods.

For a typical adult supplement, Section A is the starting point. Section B does not “open” adult category 17.

2. What Article 18 says — and how to read it for premixes

Article 18 (“Carry-over principle”) permits the presence of an additive, inter alia:

  • paragraph 1(a) — in a compound food where the additive is permitted in one of the ingredients;
  • paragraph 1(b) — in a food to which a food additive, food enzyme or food flavouring has been added, where the additive is permitted in that additive/enzyme/flavouring, has been carried over by that route, and has no technological function in the final food;
  • paragraph 1(c) — “reverse carry-over” (a food used solely to prepare a compliant compound food).

Article 18(3): where an additive in a flavouring, food additive or food enzyme is added to a food and has a technological function in that food, it shall be considered a food additive of that food — not of the added flavouring, additive or enzyme — and must then comply with the conditions of use provided for that food.

In the letter of Article 18(1)(b) and (3) in the consolidated text (verified against the EU snapshot to end-2020 and the original OJ text), the words used are food additive, food enzyme or food flavouring — not “nutrient”. At the same time, Article 4(4) and Part 5 of Annex III create a parallel regime for nutrient preparations, often with limits “in the preparation” and — in selected rows — limits in the final food. For a supplement operator the practical test is the same one Article 18(3) spells out for the analogous situation: does the substance act technologically in the finished product?

Contrast between Part 5 and category 17
Fig. 2. The same E-number can be lawful as a carrier in the premix (Part 5) and still need separate compliance with category 17 if it performs a function in the finished form.

3. Decision map for QA / regulatory

QuestionIf YESIf NO
Is the E-number present only because it was in the vitamin/mineral preparation (Part 5)?Check the Section A row: ML in the preparation, “carrier?”, final-food limitTreat as intentional use in the product → go straight to cat. 17
In the finished blend / granulate / syrup, does it perform a technological role (anti-caking of the whole blend, tablet lubricant, emulsifier, thickener…)?Art. 18(3) → additive of the supplement → Annex II 17.1 or 17.2Carry-over path possible — stay within Part 5 conditions
Is the form 17.1 (solid) or 17.2 (liquid)?Pick the correct Part E row; MLs are often calculated on the ready-to-consume product—
Does the cat. 17 row point to Group I / restrictions?Check exclusions (e.g. selected gums in dehydrated supplements intended to rehydrate on ingestion)Do not assume “qs = no conditions”
Are you conflating Part 5 with GIS approval?Separate the layers: additives ≠ notificationOK

4. Typical traps (no brand enforcement stories)

  • Silicon dioxide (E 551) — in Part 5: inter alia up to 50 000 mg/kg in the dry powdered nutrient preparation; in cat. 17 often qs as E 551–553 when it is an additive of the product. If E 551 from the premix is also used to free-flow the whole tablet blend, it does not “hide” under Part 5.
  • Magnesium salts of fatty acids (E 470b) — in Part 5: qs, may be used as a carrier; in tableting practice it is often also a lubricant of the finished form — then assess the function in the final product.
  • Glycerol (E 422), polysorbates (E 432–436), propylene glycol (E 1520) — Part 5 has its own limits (e.g. polysorbates only in specified vitamin preparations; E 1520 with a combined foodstuff limit). A limit “in the preparation” is not free dosing into a supplement syrup without checking cat. 17.2.
  • Quantum satis vs numeric MLs — qs does not waive “no more than needed to achieve the purpose” or Group I / Part E footnotes.
  • 17.3 — no longer exists after 2018/1497; do not plan compliance under the old subcategory.

5. Labelling (FIC)

Regulation 1169/2011 Article 18: ingredients are listed. Annex VII Part C provides that additives (and enzymes) belonging to certain categories need not be named where their presence is due only to carry-over within the meaning of Article 18(1)(a) or (b) of Regulation 1333/2008 and they serve no technological function in the finished product. Conversely: on the Article 18(3) path (function in the finished supplement), the additive is an ingredient of that product and belongs in the list — with the functional class and name / E-number under FIC.

6. What the acts do not decide

  • They do not make a GIS notification a second additive authorisation.
  • They do not “unlock” health claims — additive status ≠ Reg. 1924/2006.
  • They do not replace the assessment whether a substance is an additive at all under Article 3(2)(a) (technological purpose) or e.g. a nutrient / carrier outside that definition — that is a separate factual qualification.

7. Operator checklist

  1. Map E-number sources in the BOM: premix vs dosing into the blend / coating / syrup.
  2. Part 5 Section A — row, ML, carrier, final-food limit.
  3. Technological-function test in the form you place on the market (17.1 vs 17.2).
  4. If there is a function — compliance with Part E cat. 17, Group I, footnotes, conversion to the ready-to-consume product.
  5. FIC label — carry-over without function vs full ingredients-list entry.
  6. Documentation — premix specs, mass balance, justification of “no function” or proof of cat. 17 compliance; GIS separately.

Glossary

Carry-over
Presence of an additive in the final food resulting from authorised use in an ingredient / preparation, without a technological function in the finished product (Art. 18(1)).
Article 18(3)
Reclassification: an additive from a flavouring/additive/enzyme (and, in practice for premixes, where it functions in the product) becomes an additive of the final food and must meet that food’s Annex II conditions.
Annex III Part 5
List of additives in nutrients; Section A (other than IYC) vs Section B (IYC).
Category 17
Food supplements in Annex II Part E; after 2018/1497: 17.1 solid, 17.2 liquid.

Conclusion

A vitamin premix with a lawful Part 5 carrier does not green-light “dropping in” the same E-number as a technological tool of the finished form. First Part 5 and the carry-over balance; then the function test in the final product; if there is a function — Article 18(3) and category 17. A GIS notification does not replace that analysis.

Educational B2B material, not legal advice. Analysis based on Regulation 1333/2008 (Arts 4, 18, Annexes II/III), Regulation 1130/2011, Regulation 2018/1497, Directive 2002/46/EC and Regulation 1169/2011. Qualification of a specific formula depends on materials, process and form. Manufacturers, importers, distributors: B2B contact.

Primary sources

  1. Regulation (EC) No 1333/2008 — Arts 3, 4, 18; Annex II Part E cat. 17; Annex III Part 5; CELEX 32008R1333 / consolidated 02008R1333.
  2. Regulation (EU) No 1130/2011 — establishing the Annex III list (including nutrients); CELEX 32011R1130.
  3. Regulation (EU) 2018/1497 — amending category 17 (17.1/17.2; deletion of 17.3); CELEX 32018R1497.
  4. Directive 2002/46/EC — Art. 2 (food supplement definition); CELEX 32002L0046.
  5. Regulation (EU) No 1169/2011 — Art. 18; Annex VII (ingredients list, Part C — carry-over); CELEX 32011R1169.