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Food Safety

Re-evaluation

About re-evaluation

To ensure the business continuity during the COVID-19 outbreak, any data related to the safety re-evaluation of food additives (e.g. replies to DG SANTE calls for data related to the follow-up on the safety re-evaluation of food additives) should be submitted to the Commission by using the online platform CIRCABC. These measures will remain in place until further notice. No parallel or later submission of the same data in a physical medium (as well as paper copies) is required.

Please check the Guidance for online data submission on Food Improvement Agents via CIRCABC Sante-Cad-In Group for further practical information on how to use the CIRCABC platform for the online submissions.

Food additives permitted before 20 January 2009 must go through a new risk assessment by the European Food Safety Authority (EFSA).

Commission Regulation (EU) No 257/2010 set up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008.

Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain amended Regulation (EC) No 178/2002 and Regulation 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings and is applicable as of 27 March 2021. Further information on the implementation of that Regulation can be found on DG SANTE’s website .

Commission Regulation (EU) No 257/2010 has been adjusted by Commission Implementing Regulation (EU) 2021/148 in order to provide for levels of transparency and confidentiality that are comparable to those applicable in the context of the procedure for updating the Union list of approved food additives, while taking into account of the specificities of the re-evaluation procedure.

Clarification on transitional provisions for E 422, E 475 and E 476 as laid down by Commission Regulation (EU) 2023/1329 and for E 471 as laid down by Commission Regulation (EU) 2023/1428

The European Commission adopted, on 29 June 2023, Regulation (EU) 2023/1329 amending the specification for glycerol (E 422), polyglycerol esters of fatty acids (E 475) and polyglycerol polyricinoleate (E 476). On 7 July 2023, the European Commission adopted Regulation (EU) 2023/1428 amending the specification for mono- and diglycerides of fatty acids (E 471).

Commission Regulation (EU) No 2023/1329 enters into force on 20 July 2023, i.e. on the twentieth day following that of its publication in the Official Journal of the European Union and Commission Regulation (EU) No 2023/1428 enters into force on 30 July 2023.

In order to mitigate the potential impact on food business operators, transitional measures were included in the Regulation. Please see the schematic representation of the transitional measures.

Questions & Answers on titanium dioxide

A selection of the most frequently asked questions through the re-evaluation process:

Deadlines for re-evaluation:

Most food colours by the end of 2011 (closed)
Aspartame by November 2013 (closed) - NB: this re-evaluation was advanced due to the publication of new scientific data
Remaining colours by the end of 2015 (closed)
Preservatives, antioxidants, glutamates, silicon dioxide by the end of 2015-2016 (closed)
Other sweeteners by the end of 2020 (ongoing)
All other additives by the end of 2018 (ongoing)

State of play of the re-evaluation of safety of permitted food additives by EFSA as of 7 December 2022:

  • 315 food additives approved before 20 January 2009 to be re-evaluated by EFSA
  • 126 scientific opinions published by EFSA on the re-evaluation of the safety of food additives, covering 230 individual food additives
  • 85 food additives still to be re-evaluated by EFSA

Summary table of permitted food additives and status of their re-evaluation by EFSA (status as of 7 December 2022).

Approach for the follow-up of EFSA’s scientific opinions on the re-evaluation of the safety of permitted food additives for which some concerns have been identified.

EFSA scientific opinion - Follow-ups