Food additives: EU bans stearyl tartrate

Commission Regulation (EU) 2023/2379 of 29 September 2023 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards the food additive stearyl tartrate (E 483)

Update

The EU has banned the use of stearyl tartrate (E 483) in food from 23 April 2024. E 483 has been removed from the list of approved food additives because EFSA could not confirm its safety for use as a food additive due to insufficient toxicological data.

Impacted Products

Flavoured fermented milk products including heat-treated products, bread and rolls, fine bakery wares and desserts containing E 483 (stearyl tartrate)

What is changing?

Stearyl tartrate (E 483) is an emulsifier previously authorised for use in fermented milk products, bread and rolls, fine bakery products, and desserts.

The new Regulation deletes E 483 from the EU list of food additives authorised to be used in foods. E 483 was listed in Annex II to Regulation (EC) No 1333/2008, Part B, Table 3 “Additives other than colours and sweeteners”.

E 483 will also be deleted from the Annex to Regulation (EU) No 231/2012 which sets out specifications for food additives.

Why?

The European Food Safety Authority re-evaluated stearyl tartrate (E 483) and could not confirm its safety as a food additive due to inadequate toxicological data (EFSA 2020).

Timeline

Foods containing stearyl tartrate (E 483) may not be put on the EU market after 23 April 2024. Foods containing E 483 that are put on the market before 23 April 2024 may continue to be marketed until their date of minimum durability or use-by date.

What are the major implications for exporting countries?

The removal of stearyl tartrate (E 483) from the EU list of authorised food additives may have an impact on exporting countries that provide food products containing this additive to the EU market.

If exporting countries fail to comply with the new EU regulations, their products may be rejected at the EU border and prevented from entering the market. This could result in financial losses for exporters and a disruption of trade relations between the exporting country and the EU.

Recommended Actions

Suppliers to the EU market of flavoured fermented milk products, bread and rolls, fine bakery wares, and desserts need to check for possible use of stearyl tartrate (E 483) in these products and replace E 483 with alternative emulsifiers.

Background

In March 2020, EFSA concluded that it was not able to confirm the safety of stearyl tartrate (E 483) as a food additive due to a lack of adequate toxicological data (EFSA 2020). The lack of data meant that it was unable to confirm an acceptable daily intake (ADI).

In January 2021, the European Commission called for business operators to provide toxicological data for this substance. However, no data was submitted. EFSA was therefore unable to complete the evaluation.

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