Food ingredients, additives and flavourings

• Regulation (EC) No 1333/2008 — food additives
• Regulation (EC) No 1334/2008 — flavourings
• Regulation (EC) No 1332/2008 — enzymes
• Regulation (EU) 2015/2283 — novel foods
• Regulation (EC) No 178/2002

Who has to appoint one

Suppliers of ingredients to EU food manufacturers. Additives, flavourings and enzymes may only be used if authorised and listed in the Union lists, with specified purity criteria and conditions of use.

Thresholds and exemptions

None. Authorisation is per substance and per use category, and an additive authorised for one food category may not be used in another.

What must appear on the label

For business-to-business sale: the name and E number or identification, the purity, the conditions of use and the storage requirements, plus the operator's details. For sale to consumers the full food labelling applies.

Marketplace fields

Food manufacturers demand specifications, certificates of analysis and allergen and GMO status declarations for every batch, because their own labels depend on them.

Documentation you must hold

Food business registration, specifications meeting the purity criteria in Regulation 231/2012, certificates of analysis per batch, allergen and origin declarations, novel food authorisation where the ingredient has no history of consumption before May 1997, and traceability records.

Standards and testing

Purity and identity testing against the specification, heavy metals and contaminant testing, microbiological testing where relevant, and allergen verification.

Language requirements

Business documentation in a language agreed between the parties, and consumer labelling in the national language.

When it applies

Authorisation before use. Novel food authorisation takes years and cannot be shortcut.

How long records are kept

Traceability and analysis records per food law, generally at least five years.

What happens if you do not comply

Withdrawal and destruction, and prosecution where unauthorised substances reach the food chain. The consequences cascade to every manufacturer that used the ingredient.

Who enforces it

National food safety authorities, EFSA for scientific assessment and the Commission for authorisation.

Where the boundary lies

An ingredient legal elsewhere is not legal in the Union unless it appears in the Union lists with the relevant use conditions. Botanical extracts are the most frequent novel food problem, because a long history of consumption in another region does not count.

Questions we are asked

Is an additive approved in the US usable in the EU?

Only if it is authorised in the Union lists for that food category and meets the EU purity criteria. Approval elsewhere has no effect.

What makes an ingredient novel?

No significant history of consumption in the Union before 15 May 1997, which requires authorisation before use regardless of use elsewhere.