Regulatory non-authorisation in the UK and EU
Alitame was never placed on the EU positive list of permitted food additives (Annex II to Regulation 1333/2008) and consequently has no E-number authorisation for use in food sold in the UK or EU. The UK FSA approved-additives list, which reflects assimilated EU law post-Brexit, does not include E956. This means its absence from shelves in the UK is a legal matter, not a consumer choice.
E956 Alitame does not appear on the UK FSA list of approved food additives and E-numbers.
2025RegulatoryUK Food Standards Agency, Approved additives and E numbers
Alitame is not included in Annex II of Regulation (EC) No 1333/2008 on food additives, the EU positive list that defines which additives may legally be used in food.
RegulatoryEuropean Commission, Food Additives Database, Regulation (EC) No 1333/2008
Approvals outside the UK and EU
Alitame received regulatory approval in Australia and New Zealand (FSANZ), Mexico, and China. In the United States, Pfizer filed a food additive petition with the FDA in 1986; the petition was later transferred to other parties and approval was granted in 2002 for certain uses. These approvals involved safety reviews at anticipated levels of intake, and regulators in those jurisdictions set acceptable daily intake figures.
FSANZ authorises alitame as a food additive in Australia and New Zealand for use in specified food categories including beverages, confectionery, and table-top sweeteners.
RegulatoryFood Standards Australia New Zealand (FSANZ), Food Standards Code
The US FDA approved alitame for certain food uses following a food additive petition; an acceptable daily intake was established during that review.
2002RegulatoryUS Food and Drug Administration (FDA), Food Additive Status List
Breakdown and aspartate content
Alitame is metabolised in the body to aspartic acid (an amino acid) and the D-alanine amide component. The aspartate released is the same amino acid found naturally in many foods. Unlike aspartame, alitame does not break down to phenylalanine, so it does not pose a risk to people with phenylketonuria (PKU) through that route. Because alitame was never authorised in the EU or UK, EFSA has never published a formal opinion or re-evaluation on it. The EU re-evaluation programme for sweeteners only covers additives already on the Annex II positive list; alitame's absence from that list means it falls entirely outside that programme.
Alitame is hydrolysed in the gut to aspartic acid and a D-alanyl amide; it does not yield phenylalanine, distinguishing it metabolically from aspartame.
Regulatory reviewRegulatory toxicology reviews (JECFA and FSANZ dossiers)
EFSA's re-evaluation programme for food additives covers only those substances already authorised under EU law before 20 January 2009. Alitame was never on the EU positive list and therefore falls outside the scope of that programme; no EFSA Journal opinion on alitame exists.
2024RegulatoryEFSA, Re-evaluation programme for authorised food additives; EFSA Sweeteners topic page