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Efsa Food Additives Evaluation Essay

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Re-evaluation of titanium dioxide (E - 171) as a food additive - 2016 - EFSA Journal - Wiley Online Library

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Re-evaluation of titanium dioxide (E 171) as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)
  • Requestor: European Commission
  • Question number: EFSA-Q-2011-00348
  • Panel members: Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes
  • Acknowledgements: The Panel wishes to thank the members of the Standing Working Group on the re-evaluation of food colours: Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Maria Jose Frutos, Pierre Galtier, David Gott, Claude Lambré, Jean-Charles Leblanc, Agneta Oskarsson, Jeanne Stadler, Paul Tobback, Ine Waalkens-Berendsen and Rudolf Antonius Woutersen for the preparatory work on this scientific opinion and EFSA staff members: Federica Lodi, Ana Rincon and Alexandra Tard for the support provided to this scientific opinion. The ANS Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific opinion.
  • Adopted: 28 June 2016

The present Opinion deals with the re-evaluation of the safety of titanium dioxide (TiO2. E 171) when used as a food additive. From the available data on absorption, distribution and excretion, the EFSA Panel on Food Additives and Nutrient Sources added to Food concluded that the absorption of orally administered TiO2 is extremely low and the low bioavailability of TiO2 appears to be independent of particle size. The Panel concluded that the use of TiO2 as a food additive does not raise a genotoxic concern. From a carcinogenicity study with TiO2 in mice and in rats, the Panel chose the lowest no observed adverse effects levels (NOAEL) which was 2,250 mg TiO2 /kg body weight (bw) per day for males from the rat study, the highest dose tested in this species and sex. The Panel noted that possible adverse effects in the reproductive system were identified in some studies conducted with material which was either non-food-grade or inadequately characterised nanomaterial (i.e. not E 171). There were no such indications in the available, albeit limited, database on reproductive endpoints for the food additive (E 171). The Panel was unable to reach a definitive conclusion on this endpoint due to the lack of an extended 90-day study or a multigeneration or extended-one generation reproduction toxicity study with the food additive (E 171). Therefore, the Panel did not establish an acceptable daily intake (ADI). The Panel considered that, on the database currently available and the considerations on the absorption of TiO2. the margins of safety (MoS) calculated from the NOAEL of 2,250 mg TiO2 /kg bw per day identified in the toxicological data available and exposure data obtained from the reported use/analytical levels of TiO2 (E 171) would not be of concern. The Panel concluded that once definitive and reliable data on the reproductive toxicity of E 171 were available, the full dataset would enable the Panel to establish a health-based guidance value (ADI).

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Food additive re-evaluations

Food additive re-evaluations

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. Their use is allowed until their review is complete. The deadline for completion of the re-evaluation of all food additives is 2020.

In July 2016, EFSA completed the last two re-evaluations of food colours, reaching an important milestone in the re-evaluation programme. Overall, the ANS Panel re-assessed 41 food colours. As a result of this work, the maximum levels of three colours (E 104, E 110, E 124) were lowered and the colour Red 2G (E 128) was removed from the market.

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.

EFSA’s expert Panel on Food Additives and Nutrient Sources Added to Food (ANS) 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.

The ANS Panel 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 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.

2016 Completed the last two re-evaluations of food colours completing this major programme. Overall, the ANS Panel re-assessed 41 food colours.

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

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

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

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. All substances authorised under previous legislation are allowed until their re-evaluation is complete.

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)

Food Additives Associations, Trade Associations for Food Additives, Associations for Food Ingredients

Food Additives Associations

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The European Food Information Council, EUFIC
The European Food Information Council, EUFIC, is a non-profit organization that provides information on food and food-related topics to the media, health and nutrition professionals. EUFIC publishes a regular newsletter, FOOD TODAY, on subjects of current interest. It maintains relations with a network of independent scientific experts, food specialists, educators, government agencies and consumer organizations.
For more information visit:

International Food Information Council.
IFIC is primarily a U.S. communications organization. It is recognized globally for food and health issues and participates in an informal network of independent food information organizations in Europe, Asia, Australia, New Zealand, Canada, Japan and Latin America.

IFIC's main purpose is to bridge the gap between science and communications by collecting and disseminating scientific information on food safety, nutrition and health and translate research into understandable and useful information.
For more information visit:

European Food Safety Authority (EFSA)
The European Food Safety Authority (EFSA) is a European Union (EU) risk assessment agency regarding food and feed safety. EFSA provides independent scientific advice and clear communication on existing and emerging risks. It is a separate legal entity, independent from the other EU institutions.
It was set up in Brussels in 2002. EFSA's risk assessments provide risk managers (consisting of EU institutions with political accountability, i.e. European Commission, European Parliament and Council) with a sound scientific basis for defining policy driven legislative or regulatory measures required to ensure a high level of consumer protection with regards to food safety.
For more information visit: http://www.efsa.eu.int/

The Joint FAO/WHO Expert Committee on Food Additives (JECFA)
The evaluation of food additives at the international level was initiated as a result of a Joint FAO/WHO Conference on Food Additives held in Geneva in 1955. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) is an international scientific committee administered jointly by the Food and Agriculture (FAO) and the World Health Organization (WHO). Its initial purpose was to evaluate the safety of food additives. The scope now includes the evaluation of contaminants, naturally occurring toxicants and residues of veterinary drugs in food.

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Re-evaluation of food colours: EFSA completes major programme

From jellies to jams, from desserts to drinks, food colours are added to many foods to make up for colour loss, enhance naturally occurring colours or add colour to foods that would otherwise look colourless. As with all food additives, only colours whose safety has been assessed by EFSA can be authorised for use by EU risk managers. With the recent adoption of two opinions on annatto extracts and titanium dioxide, the Authority reached an important milestone, completing the re-evaluation of all food colours authorised before 2009.

Ruud Woutersen, Vice-Chair of EFSA’s Panel on Food Additives and Nutrient Sources Added to Food (ANS) and Chair of the Working Group tasked with the re-evaluation of food colours, explains the background, challenges and impact of this major work programme.

Why was this work carried out?

Many food additives were initially evaluated and approved a long time ago. To bring assessments up to date, the European Commission asked EFSA to re-evaluate, by 2020, all additives authorised before 20 January 2009, taking into account any new evidence. Based on EFSA’s scientific advice, the European Commission and Member States then decide whether to change the conditions of use for an additive or, if needed, remove it from the EU list of authorised food additives to protect consumers. As food colours were among the first additives to be authorised, their re-evaluation has been prioritised.

Overall, the ANS Panel re-assessed 41 food colours. We reviewed all available, relevant scientific studies as well as data on toxicity and human exposure, from which we drew conclusions regarding the safety of the substance. As part of the evaluations, the Panel established, when possible – i.e. when sufficient information was available – an Acceptable Daily Intake (ADI) for each substance. A first batch of six re-evaluations was delivered in 2009, and the re-evaluation of most food colours was completed by 2012. In between then and now, the Panel also continued and finalised the re-evaluation of many other food additives. For example, we completed the re-evaluation of the sweetener aspartame in 2013 – a landmark piece of work – and completed most preservatives and antioxidants.

Our ability to re-evaluate the safety of a food additive depends greatly on the availability of scientific data. With new additives, an applicant is required to submit detailed chemical and toxicological information. This is not the case for re-evaluations. In the absence of sufficient data, assessments may remain inconclusive; or the Panel can set a temporary ADI, as we did in 2009 for Sunset Yellow, which was reconsidered in 2014. Since 2007 EFSA has launched 15 calls for data on food additives, six of which were related to food colours. Thanks to new concentration data becoming available, we were able to refine exposure assessments, for example of caramel colours (2012) and Allura Red (2015).

What has been the impact of the re-evaluations so far?

In light of new information, EFSA lowered the ADI for several food colours. As a result, in 2012, the European Commission lowered the maximum levels of three of these colours (E 104, E 110, E 124) for food uses. Another significant impact was the market withdrawal of the colour Red 2G (E 128) in 2007. New scientific evidence made available at that time indicated that use of this food additive could be a safety concern. EU decision-makers agreed with EFSA that this colour could not be regarded as safe for humans and it was subsequently suspended from use in the EU.

The completion of the food colour re-evaluations is an important milestone for EFSA. But our work does not stop here. There is still a considerable number of food additives to be re-evaluated by 2020. And, of course, we are prepared to respond to any ad hoc requests from the Commission, or as part of a self-tasking activity, to review colours and other additives in the light of newly available scientific information or changing conditions of use.

Colours used as food additives may also be authorised for use as feed additives. Their safety evaluation is carried out by EFSA’s Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), with different data requirements due to separate regulatory frameworks. To ensure consistency in their risk assessment approaches and consideration of the available scientific information, the Panels co-ordinate their scientific work. For example, in its safety assessment of the colour Patent Blue V (2013). the ANS Panel included data from studies that have also been used by the FEEDAP Panel.

Looking back, what do you personally take away from this achievement?

You’re never too old to learn, and in tackling these complex evaluations together with peers from other scientific disciplines I discover something new at every meeting. My main scientific role in this work – as a board certified toxicologic pathologist – is quite specialised. So it’s essential for me to hear, for example, from the chemists and biochemists about the specifications of the compounds under review in order to be able to determine whether the animal studies have been performed with the compound as marketed. Equally important is the information we receive from the medical doctors and epidemiologists about potential effects on humans.

Our exposure assessment experts also help shape the final conclusions a lot; you can only estimate the potential risks for consumers if you know to what extent people may be exposed. So, as well as being extremely proud to contribute to consumer safety in Europe, the interdisciplinary nature of the work has been, and continues to be, a major motivation to participate in the Panel and its Working Groups.

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EFSA re-evaluate safety of the food additive octyl gallate

EFSA re-evaluate safety of the food additive octyl gallate

Submitted by Alison Myers on Thu, 08/10/2015 - 11:15am

Following a request from the European Commission (EC), the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to re-evaluate of the safety of octyl gallate (E 311) when used as a food additive. Octyl gallate (E 311) is authorised as a food additive in the European Union (EU). The food additive can be found in chewing gum, processed potato products, cake mixes, fats and margarines, peanut butter and breakfast cereals.

Due to the lack of detailed reports on carcinogenicity and chronic toxicity studies with octyl gallate and the absence of a basis for read-across for systemic toxicity from propyl gallate data, the Panel could not reach a definitive conclusion on the presence or absence of a carcinogenic potential of octyl gallate. The Panel identified a no observed adverse effect level of 50 mg/kg body weight per day in a reproductive toxicity study.

They concluded that, although a safety concern was unlikely from the single use (chewing gum) for which usage and analytical data were provided, an adequate assessment of the safety of octyl gallate as a food additive in all its currently permitted uses would require a sufficient toxicological database in line with its current guidance for submission for food additive evaluations.

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