Key Terms
- Food additive
- Any substance not normally consumed as food nor used as a characteristic food ingredient, intentionally added for a technological purpose in manufacture, processing, preparation, treatment, packaging, transport, or storage, which becomes a component of the food [Art. 3(2)(a)].
- E number
- A numerical code preceded by the letter 'E' assigned to each authorised food additive for identification purposes on the Union lists in Annexes II and III. Used across the EU for standardised labelling and regulatory reference.
- Quantum satis
- A use condition where no maximum numerical level is set; the additive must be used at the lowest level necessary to achieve the intended purpose, in accordance with good manufacturing practice, without misleading the consumer [Art. 3(2)(h)].
- Functional class
- A category listed in Annex I (e.g. sweetener, colour, preservative, emulsifier, thickener) based on the principal technological function a food additive performs in the food [Art. 3(2)(c), Art. 9].
- Carry-over principle
- The rule under Article 18 permitting the presence of a food additive in a composite food when the additive is authorised in one of its ingredients, provided carry-over levels remain within the limits that would result from proper use in that ingredient.
- Processing aid
- A substance intentionally used during food processing to fulfil a technological purpose, not consumed as food itself, which may leave technically unavoidable residues that present no health risk and have no technological effect on the final product [Art. 3(2)(b)].
- EFSA
- European Food Safety Authority — the EU agency providing independent scientific advice on food safety. EFSA conducts risk assessments of food additives before authorisation and during the systematic re-evaluation programme under Article 32.
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Frequently Asked Questions
What is the positive-list principle under Regulation (EC) No 1333/2008?
Only food additives explicitly listed in Annex II (for use in foods) or Annex III (for use in food additives, enzymes, flavourings, and nutrients) may be used and placed on the EU market [Art. 4]. Any additive not on the list is prohibited. This applies regardless of whether the substance is safe — authorisation must be granted through the common procedure under Regulation (EC) No 1331/2008 before use.
Which food additives are being withdrawn from infant and special medical foods?
Several hydrocolloids are being withdrawn from food categories 13.1.5.1 and 13.1.5.2 (special medical purposes for infants/young children): locust bean gum (E 410) and pectins (E 440) by 18 August 2026 per Regulation (EU) 2026/196; sodium carboxy methyl cellulose (E 466) by 27 April 2027 per Regulation (EU) 2025/666; guar gum (E 412) from categories 13.1.1 and 13.1.5.1 by 18 August 2026, and from 13.1.5.2 by 27 April 2027. These withdrawals follow EFSA safety re-evaluations that found insufficient safety data for use in vulnerable populations.
What does 'quantum satis' mean and how should it be applied?
Quantum satis means no maximum numerical level is specified, but the additive must be used at a level not higher than necessary to achieve the intended technological purpose, in accordance with good manufacturing practice, and provided the consumer is not misled [Art. 3(2)(h)]. It is not a blank cheque — food business operators must document their rationale for the levels used.
How does the carry-over principle work?
Under Article 18, the presence of a food additive in a food is permitted if the additive is authorised in a food ingredient (compound ingredient, additive, enzyme, flavouring, or nutrient) and carries over into the final food via that ingredient, provided the level in the final food does not exceed the level that would be introduced under proper use. However, the carry-over principle does not apply to unprocessed foods and certain other foods listed in Annex II, Part A, Tables 1 and 2 [Art. 18(1)(a)].
Are there transitional provisions for products already on the market?
Yes. Each amending regulation includes its own transitional provisions. Typically, additives lawfully placed on the market before the application date may continue to be used until stocks are exhausted, and foods containing those additives may remain on the market until their date of minimum durability or use-by date. For example, Regulation (EU) 2025/666 allows foods containing E 466 in infant medical food categories placed on the market before 27 April 2027 to be sold until expiry.
What are the penalties for using non-authorised food additives?
The Regulation itself does not prescribe specific penalties — enforcement is delegated to Member States under the General Food Law, Regulation (EC) No 178/2002. National food safety authorities may impose administrative fines, order product recalls and market withdrawals, seize non-compliant goods, and in serious cases pursue criminal prosecution. Cross-border enforcement is coordinated through the RASFF system.
How often is the Regulation amended?
Very frequently. The consolidated version as of 4 November 2025 incorporates 63 amendments since the original adoption in 2008. Eight further amending regulations from the 2025-2026 period are entering into force through 2027. Food business operators must continuously monitor the Official Journal of the EU for updates to Annexes II and III.
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