Lizzie Vann Foundation
Regulation. Additives
Regulation. Additives
Before the UK left the European Union (EU) all food laws were the same across the EU and across the four countries of the UK. Since ‘Brexit’, in theory, additives are authorised and regulated by the Food Standards Agency and Food Standards Scotland but in practice almost all authorisation remains harmonised with the EU. As part of the Brexit deal however, food standards in Northern Ireland must comply with those of the EU. This means that realistically UK food manufacturers are unlikely to produce food that cannot be sold across the UK (or Europe). There has been one additive that has been allowed for use in England, Scotland and Wales which is not allowed in the EU and you can find out more about this by following links on the additives pages to the artificial colour Titanium Dioxide (E171). Scroll down this page for an example of a substance that has been authorised for use in the EU but which has not yet been authorised in the UK (E267 – buffered vinegar).
On 19 May 2025, the UK government and the European Union (EU) agreed to pursue a new Sanitary and Phytosanitary (SPS) agreement which will come into force by mid-2027. This means that there will be alignment with EU regulations in a number of areas including those covering:
- Food Additives:Â Specifically Regulation 1333/2008.
- Food Enzymes and Flavourings: Regulations 1332/2008 and 1334/2008.
It is therefore unlikely that there will be further deviation from the EU in terms of additive regulation at the current time, but Government change could alter this again in the future.
On 20 January 2026, the European Food Safety Authority (EFSA) published new guidance establishing the scientific data requirements for applications concerning food additives.
EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings), Castle, L., Andreassen, M., Aquilina, G., Bastos, M. L., Boon, M. et al (2026).
Guidance on the scientific data requirements for an application for authorisation of a food additive submitted under Regulation (EC) No 1331/2008. EFSA Journal, 24(1), e9778. https://doi.org/10.2903/j.efsa.2026.9778.
The original guidance was published in June 2012 and this updated framework represents an evolution in the regulatory approach to food additive safety assessment within the European Union. The current revision builds on experience accumulated through numerous assessments conducted over more than a decade and incorporates methodological developments in risk assessment that have emerged since 2012.Â
The 2026 update integrates multiple ‘horizontal’ and cross-cutting EFSA guidance published post-2012, such as the guidance on mixtures, benchmark dose modelling, threshold of toxicological concern, allergenicity assessment, genotoxicity/aneugenicity (the capacity of a substance to cause chromosomal aberrations i.e. the loss or gain of whole chromosomes during cell division) evaluation, and engineered nanomaterials, as well as the latest flavourings guidance (November 2022). Horizontal guidance refers to regulatory frameworks and legal guidelines governing agreements between competitors operating at the same level of the supply chain, such as joint research, production, or sustainability initiatives.
The new guidance introduces several significant changes in assessment:
- The guidance now addresses small particles, including nanoparticles, explicitly. Where a particulate fraction is present, applicants must substantiate whether conventional assessment suffices or whether nano-specific requirements apply. Analytical methods must now demonstrate fitness-for-purpose for detecting and characterising small particles and nanoparticles.
- The FAIM (Food Additive Intake Model) is now the mandatory tool for assessing exposure to an additive in the general population (infants ≥16 weeks through elderly). The guidance pays particular attention to vulnerable populations, with specific provisions for infants below 16 weeks of age. For this age group, FAIM does not apply; instead, applicants must use alternative approaches per EFSA’s 2017 guidance, applying conservative infant formula consumption data (200 and 260 ml/kg bw/day). The standard acceptable daily intake (ADI) concept does not apply to infants below 16 weeks.
You can find out about the FAIM model here https://www.efsa.europa.eu/sites/default/files/applications/FAIM-instructions.pdf
You can find out more about the guidance on the risk assessment of substances present in food intended for infants below 16Â weeks of age here.
https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4849
- The new guidance also integrates several cross-cutting EFSA documents published since 2012 relating to toxicological assessment: guidance on mixtures, benchmark dose modelling, threshold of toxicological concern (TTC), allergenicity considerations and genotoxicity/aneugenicity assessment.
The guidance establishes a clear “stop” rule: if a proposed food additive is concluded to be genotoxic in vivo via a relevant route of administration, safety cannot be established and applicants should not perform further toxicological testing. This represents a critical decision point in the assessment pathway.
- Full environmental assessment is also now required on a case-by-case basis, triggered by specific factors or literature indicating environmental concern.
Regulation. Additives
Do we also use global evidence?
Much of the evidence review process still looks to EFSA and the global JECFA committee. JECFA is an international scientific expert committee administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and WHO. It has been meeting since 1956 to evaluate the safety of food additives, contaminants, naturally occurring toxicants and residues of veterinary drugs in food.
Regulation. Additives
Can there be controversy about additives that are authorised?
All committees take portfolios of evidence from industry as well as from expert committees or the scientific literature, and in some cases the majority of evidence may come from the company that wishes to have an additive authorised.
There has been criticism of the membership of committees and how some committees have reviewed evidence and you can find out more about this in the regulatory conflict of interest section here (x-link).
Regulation. Additives
The case of buffered vinegar
In September 2023, ‘buffered vinegar’ was authorised for use as a food additive within the EU. The authorisation followed a discussion by the EU ScoPAFF (Standing Committee on Plants, Animals, Food and Feed) that such products (buffered vinegar, dried vinegar or vinegar powder), which have an adjusted pH through the use of additives such as sodium carbonate (E 500) and/or sodium hydroxide (E 524) or by following a specific fermentation process, were being used within the food industry for a technological function (e.g. as a preservative). The Committee concluded that the use of ‘buffered vinegar’ to deliver a technological effect represents an intentional use as a food additive and would therefore require an additive authorisation before use. At the time of writing, although the EU has now authorised buffered vinegar (E 267) to be used as a food additive, providing it is compliant with the specification laid down in Regulation (EU) No 231/2012, the authorisation is not automatically applicable in Great Britain (GB) (but will apply in Northern Ireland). Until such an application has been assessed, ‘buffered vinegar’ would still be categorised as an unauthorised additive in GB where it is being used for a technological function, unless the Food Standards Agency and/or Food Standards Scotland provide an opinion to the contrary.
(De Siena et al, 2022)
Regulation. Additives
The Regulation on the registration, evaluation, authorisation and restriction of chemicals (REACH)
Authorities such as the European Food Safety Authority (EFSA) and the FDA require safety assessments of additives before approval for food use. In this context, an acceptable daily intake (ADI) level and maximum food additive use and exposure levels could be established [15]. A maximum use level of an additive could be defined as the highest additive concentration determined to be functionally effective in a food category. It is generally expressed as mg additive/kg of food. The maximum level of food additive Foods 2022, 11, 2205 3 of 20 emulsifier exposure combines food consumption data with food concentration data.
There are three main factors involved in estimating the estimated daily intake (EDI) for a food additive: (i) frequency—how often a person daily eats a particular food containing the substance; (ii) portion size—how much of the food a person eats; and (iii) concentration— how much of the substance is in a given amount of the food. The EDI is calculated by multiplying these factors (EDI = frequency × portion size × concentration) [16]. However, to date, data on the concentrations of the emulsifiers within (ultra)processed food are lacking. Consequently, estimations of emulsifier intake can be overestimated or underestimated.
An extensive database of all manufactured foods with accurate concentrations of food additives is needed to assess the population’s emulsifier exposure. Recently, a French survey estimated exposure to 13 food additives using the methods proposed in the 2001 Report from the European Commission on Dietary Food Additive Intake in the European Union [17,18]. However, comparing these results with published data, it remains challenging to draw standardized estimations due to the differences in diets between countries, methodologies, data availability, and targeted populations. Another possible approach to estimate real food additive dietary exposure is to simulate meals for adults and children, as proposed by Leclercq et al. [19], for different food additives and combine different food products in each meal. This work could be undertaken by several European countries or at an international level for other and specific diets.
The Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA) represents the international scientific expert committee administered jointly by the Food and Agriculture Organization of the United Nations (FAO) and the WHO. It proposes an international numbering system to name food additives, including emulsifiers [20]. The E-number (i.e., E-171) must be indicated after having specified the technological function of the food-additive emulsifiers. The FDA imposes that all ingredients used in foods are listed by their common name. However, many manufacturers can replace the name of food additives with a number only, leading to some confusion among consumers. Moreover, none of these national authorities require the quantities of emulsifiers on food labels.
This review gathers current knowledge on the safety, legislation, and manufacturing use of emulsifiers commonly found in processed foods, opening the debate on the lack of assessment of the impact of cumulative intake of food additives and the potential ‘cocktail’ effects/interactions of mixtures. Furthermore, currently, only the presence of emulsifiers, and not their quantity, is reported on food labels, making it impossible to estimate emulsifier intakes. Moreover, food emulsifiers without a specified ADI can be used without limitations other than current good manufacturing practice. Probably, daily emulsifier intakes are currently underestimated, especially in Western countries
