2018-01 Deletion of an additive from the European Union list as part of the safety re-evaluation process

The Commission Regulation (EU) 2018/98 deleting calcium sorbate (E 203) from the Union list of food additives was published in the Official Journal of the EU on 23rd January 2018. This publication follows the re-evaluation of sorbic acid (E 200), potassium sorbate (E 202) and calcium sorbate (E 203) by the European Food Safety Authority and confirms that, in absence of interested business operators ready to provide the data requested by the European institutions, an additive may no longer be used in the EU.

According to the EU legislation, all food additives that were authorised in the EU before 20th January 2009 must be re-evaluated by EFSA by 2020. Sorbates were re-evaluated by EFSA in 2015 in this framework. The Authority noted that a number of data were lacking to conclude on the safety of these food additives, such as genotoxicity data on calcium sorbate. EFSA was thus not able to confirm that they were safe.

As part of its approach for the follow-up of EFSA’s scientific opinions on the re-evaluation of permitted food additives, the  European Commission launched in 2016 a public call for scientific and technological data on sorbates, targeting the needs identified in EFSA’s Scientific Opinion. No business operator has committed to provide the requested genotoxicity information.

Consequently, as a risk assessor, EFSA was not able to conclude on the safety of calcium sorbate and, as risk managers, the Commission as well as the member states could not determine whether this substance still fulfils the conditions laid out in the EU law for the inclusion into the Union list of approved additives. The Commission Regulation deleting calcium sorbate from the Union list shall come into force on 12th February 2018 and shall apply as from 12th August 2018, allowing business operators still using this substance to adapt to the new legal provisions.

 EU Specialty Food Ingredients trusts that these process and decision will contribute to strengthen consumers’ confidence in the safety of food additives permitted in the EU. 

Click here to watch the European Commission video about the EU's “safety scan for food additives”.