Draft Commission Regulation 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)

Draft Annex

Update

The EU has notified (G/SPS/N/EU/645) to the World Trade Organization (WTO) a proposal to remove stearyl tartrate (E 483) from the list of approved food additives because EFSA cannot complete the re-evaluation of the safety of its use as a food additive due to inadequate 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) will be deleted from the EU list of authorised food additives, Annex II to Regulation (EC) No 1333/2008, Part B, Table 3 ‘Additives other than colours and sweeteners’. The Annex to Regulation (EU) No 231/2012 will be amended accordingly.

Why?

The EU can no longer justify the inclusion of stearyl tartrate (E 483) in the list of authorised food additives due to inadequate toxicological data. The European Food Safety Authority could not confirm its safety as a food additive (EFSA, 2020).

Timeline

The Commission estimates that the Regulation will be published and entered into force in Q3, 2023. The ban on the use of stearyl tartrate (E 483) in foods will apply from Q1, 2024.

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 of processed foods containing stearyl tartrate (E 483) will need to find alternatives to this additive by Q1, 2024.

Comments or concerns about potential impacts can be submitted via the National SPS notification authority of the country concerned to the EU SPS Enquiry Point until 21 August 2023.

Background

On 11 March 2020, the European Food Safety Authority (EFSA) issued a scientific opinion stating 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 for its re-evaluation. The acceptable daily intake (ADI) for this substance could not be confirmed.

On 19 January 2021, the Commission launched a public call for business operators to provide toxicological data for this substance to continue its inclusion in the EU list of approved food additives. However, no business operator provided the requested data. Therefore, it cannot be determined whether this substance still fulfils the conditions for inclusion in the EU list pursuant to Article 6(1) of Regulation (EC) No 1333/2008.

Resources

Sources

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