Food additive re-evaluations

Introduction

Food additives are substances added intentionally to foodstuffs to perform certain technological functions, for example to colour, to sweeten or to help preserve foods.

Under EU legislation from 2008, the safety of all food additives authorised for use in the EU prior to 20 January 2009 must be re-evaluated. The deadline for completion of the re-evaluation of all food additives is 2020, however, given the large volume of work the programme is likely to continue beyond then.

Latest

In late 2019 our experts started to re-evaluate sweeteners, which is the final group of authorised food additives scheduled for re-evaluation by 2020. Before starting we developed ‘scientific protocols’ to define upfront how to assess their toxicity and consumer exposure. We consulted publicly on the protocols and held an open public meeting to discuss the work programme.

Calls for data

For effective re-evaluations, it is critical that EFSA receives scientific data (e.g. on chemical and biological properties, toxicological studies and levels in food) from additive producers, food processors and other sources. Despite launching several general and specific calls for data on food additives since 2006, there is still an on-going shortage of data on substances used as food additives. EFSA urges producers and users of food additives to provide all their available information for the safety assessment of food additives to properly protect consumers.

Role

EFSA’s expert Panel on Food Additives and Flavourings (FAF) carries out the re-evaluation of authorised food additives. The Panel reviews all the relevant scientific evidence on the additive including the original scientific evaluation plus data gathered from open literature and information provided following calls for data. EFSA may also issue additional calls for more specific data to complete an assessment.

Re-evaluation programme

EFSA’s experts set the following criteria for scheduling the re-evaluation of the various types of additives:

  • The priorities set in the Regulation EU 257/2010 re-evaluation programme
  • The existence of new scientific evidence or technical information made available since the last evaluation that may affect the assessment of the safety of a food additive
  • The time elapsed since the last evaluation of a food additive by the European Commission’s former Scientific Committee on Food (SCF) or by EFSA
  • Cases where an acceptable daily intake (ADI) could not be established or a temporary ADI was established by the SCF or the basis for the ADI established by the SCF was unclear.

Milestones

2019 Updated Re-evaluation of food additives: tentative work programme 2019

2019 EFSA issues new advice on phosphates

2017 EFSA reviews the safety of glutamates

2016 The last two re-evaluations of food colours complete this major programme. Overall, EFSA re-assesses 41 food colours.

2014 A statement on the conceptual framework for risk assessments of certain food additives included in the re-evaluation programme.

2013 Re-evaluation of the sweetener aspartame is brought forward and completed following a request from European Commission.

2012 A Strategy for the re-evaluation of food additives is adopted based on the timeline set by European Commission in Regulation EU 257/2010

EU framework

Under Regulation EC 1333/2008, EFSA must re-evaluate by 2020 all food additives authorised for use in the EU prior to 20 January 2009.

Regulation EU 257/2010 establishes a programme for the re-evaluation of approved food additives, the details of which are described in Annex II. The deadlines for the re-evaluations vary by group (see table below). The timetable may be adjusted should a safety concern arise for an individual additive and/or should new data be made available requiring further review ahead of the agreed deadline.

EU timelines for the re-evaluation of certain food additives (Regulation EU 257/2010)

Deadlines

Food additives

Status

15 Apr 2010

Food colours 1: E 123, E 151, E 154, E 155, E 180

Completed

31 Dec 2010

Food colours 2: E 100, E 127, E 131, E 132, E 133, E 142, E 150a, E 150b, E 150c, E 150d, E 161b, E 161g, E 170

Completed

31 Dec 2015

Food colours 3: E 101, E 120, E 140, E 141, E 153, E 160a, E 160b, E 160c, E 160e, E 160f, E 162, E 163, E 171, E 172, E 174, E 175

Completed

31 Dec 2015

Preservatives and antioxidants: E 200-203; E 210-215, E 218-252, E 280-285; E 300-E 321, E 586

Completed

31 Dec 2016

Emulsifiers, stabilisers, gelling agents: E 322, E 400-E 419, E 422-E 495, E 1401-E 1451 (remaining priorities: E 483, E 472a-f)

Ongoing

31 Dec 2016*

Silicon dioxide: E 551

Glutamic acid and glutamates: E 620-625

Completed

31 Dec 2018

All remaining food additives other than colours and sweeteners (remaining priorities: E 900, E 904, E 626-629, E 630-633, E 634-635)

Ongoing

31 Dec 2020

All remaining sweeteners

Aspartame (E 951) completed

*Extended deadline

 

Follow-up activities

During the re-evaluation of food additives EFSA may identify issues or data gaps that require follow up, such as:

  • EFSA was not able to re-evaluate, and therefore to reconfirm, the safety of an additive and/or derive an Acceptable Daily Intake (ADI) due to the lack of relevant scientific data.
  • EFSA lowered the ADI of an additive due to the limited availability of toxicological data.
  • The exposure assessment carried out by EFSA suggests a potential exceedance of the ADI for one or more population groups.
  • EFSA raised issues concerning the specifications of some additives as laid down in Regulation EU 231/2012.

For each additive (or groups of additives addressed together) requiring a follow-up a specific call for data will be published on DG SANTE’s website on Food Additives, or here on our website.

Published