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January 29, 2018

EU Regulation No. 2018/98 - Food additives: from 12 August 2018 the use of calcium sorbate (E 203) is prohibited in fifty-nine food products and in two categories of food additives

The European Commission, in view of the fact that the European Food Safety Authority has not been able to confirm the safety of calcium sorbate (E 203) due to the lack of genotoxicity data, has prohibited the use of this substance in fifty-nine food products and in two categories of food additives.

The European Commission, with the EU Regulation of 22 January 2018 n. 98), ordered the ban on the use of calcium sorbate (E 203) in fifty-nine food products and two categories of food additives.

The Regulation in question enters into force on 12 February 2018 and will apply from 12 August 2018.

Provisions envisaged by EU Regulation no. 2018/98

In view of the fact that:

  • the legislation regulating food additives provides that all food additives authorized in the Union before 20 January 2009 must undergo a new risk assessment by the European Food Safety Authority;
  • the calcium sorbate food additive (E 203) has been authorized according to the relevant technical specifications, as a preservative in a variety of foods and in the preparation of some food colors and food flavorings;
  • against the new risk assessment of June 2015, the European Food Safety Authority, in finding a lack of data on the genotoxicity of calcium sorbate, was not able to confirm its safety;
  • the Commission, in June 2016, announced a call for tenders for the collection of scientific and technological data to support the Authority's needs, which gave a negative result in view of the fact that no commercial operator provided the requested data;
  • the lack of data in question, the Authority can not complete the new safety assessment of calcium sorbate as a food additive and therefore it is not possible to establish whether this substance:
    -) does not pose problems of safety for the health of consumers;
    -) can reasonably be regarded as a technical necessity which can not be replaced by other economically and technologically feasible means;
  • does not mislead consumers about their use;

the Commission, in the Community legislation governing:

  • the production, marketing and use of food additives, ordered the deletion of the calcium sorbate reference (E 203):
    -) in the EU list of food additives other than dyes and sweeteners authorized in foods and related conditions of use;
    -) in the list of definitions of additive groups - other additives that could be regulated in combination;
    -) in the list of authorized food additives and related conditions of use in the relevant food categories;
  •  the technical specifications of food additives, ordered the deletion of the calcium sorbate reference (E 203).