How Additives Get Approved in the EU: Inside Chapter II of the Food Additives Regulation
Union lists, conditions for authorisation and the rules behind every approved E number – explained by InfoCons
From proposal to approval: how the EU decides which additives are allowed – InfoCons Consumer Protection
If Chapter I of Regulation (EC) No 1333/2008 tells us what a food additive is, Chapter II tells us how an additive earns the right to be used at all. This chapter, covering Articles 4 to 14, establishes the Union lists of authorised food additives and the strict conditions a substance must satisfy before it can appear on those lists. It is, in effect, the gatekeeping mechanism of the entire European additive system, and InfoCons – Consumer Protection considers it one of the most important chapters for citizens to understand.
The Union lists: only what is on the list may be used – InfoCons Consumer Protection
Article 4 sets the positive list principle. Only food additives included in the Union list in Annex II may be placed on the market as such and used in foods under the conditions of use specified there. Likewise, only food additives included in the Union list in Annex III may be used in food additives, food enzymes and food flavourings, under the conditions specified. Additives in Annex II are listed on the basis of the categories of food to which they may be added, while additives in Annex III are listed on the basis of the additives, enzymes, flavourings or nutrients to which they may be added. All listed additives must comply with the specifications referred to in Article 14.
This is a crucial safeguard. The default position is prohibition: a substance is not allowed simply because no one has forbidden it. On the contrary, it is forbidden unless and until it has been positively authorised and placed on a Union list under defined conditions.
Article 5 reinforces this by prohibiting non-compliant additives and non-compliant foods. No person may place on the market a food additive or any food containing such an additive if the use of that additive does not comply with the regulation. In other words, both the substance and the finished food must respect the rules.
The three golden conditions for authorisation – InfoCons Consumer Protection
Article 6 lays down the general conditions for including and using additives on the Union lists. A food additive may be included only if it meets three cumulative conditions and, where relevant, other legitimate factors including environmental ones. First, on the basis of the available scientific evidence, it must not pose a safety concern to the health of the consumer at the level of use proposed. Second, there must be a sufficient technological need that cannot be achieved by other economically and technologically practicable means. Third, its use must not mislead the consumer.
Beyond these three conditions, the additive must offer advantages and benefits to the consumer, contributing to one or more objectives: preserving the nutritional quality of the food; providing necessary ingredients or constituents for foods manufactured for groups of consumers with special dietary needs; enhancing the keeping quality or stability of a food or improving its organoleptic properties, provided this does not mislead the consumer; or aiding the manufacture, processing, preparation, treatment, packaging, transport or storage of food, provided the additive is not used to disguise faulty raw materials or undesirable practices, including unhygienic ones.
There is a narrow derogation: an additive that reduces the nutritional quality of a food may still be included in Annex II if the food is not a significant component of a normal diet, or if the additive is necessary for foods intended for groups with special dietary needs.
Special conditions for sweeteners and colours – InfoCons Consumer Protection
Articles 7 and 8 add extra requirements for two functional classes that particularly affect consumer perception. A food additive may be included in the sweeteners category only if, in addition to the general objectives, it also serves one or more of the following: replacing sugar in the production of energy-reduced foods, non-cariogenic foods or foods with no added sugar; replacing sugar where this allows an increase in the shelf life of the food; or producing foods intended for particular nutritional uses.
A food additive may be included in the colours category only if, beyond the general objectives, it also helps to: restore the original appearance of food whose colour has been affected by processing, storage, packaging and distribution; make food more visually attractive; or give colour to food that is otherwise colourless. These specific conditions recognise that sweeteners and colours shape how consumers judge a product, and therefore demand a clear justification.
What the lists must contain, and how much may be used – InfoCons Consumer Protection
Article 9 confirms that additives are assigned to a functional class in Annexes II and III based on their principal technological function, while noting that assignment to one class does not exclude use for several purposes. Article 10 sets out the content of the Union lists: for each additive, the entry states the name of the additive and its E number; the foods to which it may be added; the conditions under which it may be used; and, where appropriate, any restriction on selling the additive directly to the final consumer.
Article 11 governs the quantities used. When the conditions of use are set, the amount used is limited to the lowest level necessary to achieve the desired effect, and the specified amounts take into account the acceptable daily intake (or equivalent) established for the additive and the likely daily intake from all sources, including for special consumer groups. Where circumstances allow, no maximum numerical level is set and the additive is used according to the quantum satis principle. Maximum levels set in Annex II apply to foods as marketed, unless otherwise stated, with a specific rule for dehydrated or concentrated foods that must be reconstituted. For colours, maximum levels apply to the colouring principle contained in the colouring preparation.
New production methods, GMOs and specifications – InfoCons Consumer Protection
Article 12 addresses changes in production or raw materials. If an additive already on a Union list undergoes a significant change in production methods or starting materials, or a change in particle size – for example through nanotechnology – the additive prepared by these new methods is considered a different additive, and a new listing or a change of specifications is required before it can be placed on the market. This is a forward-looking safeguard that keeps the authorisation tied to the actual substance being produced.
Article 13 deals with additives falling under Regulation (EC) No 1829/2003 on genetically modified food and feed: such an additive may be included on the Union lists only if it is authorised under that regulation as well. Article 14 requires that specifications – concerning in particular origin, purity criteria and any other necessary information – be adopted when an additive is first included on the Union lists, following the common authorisation procedure of Regulation (EC) No 1331/2008.
The positive-list philosophy and what it means for safety – InfoCons Consumer Protection
The single most important idea in Chapter II is the positive-list philosophy. In many areas of life, the legal default is that anything not expressly forbidden is allowed. European additive law reverses this for food additives: nothing is permitted unless it has been expressly authorised and entered on a Union list. This inversion places the burden of proof on those who wish to use a substance, not on the consumer or the regulator to prove harm after the fact.
The practical consequence is far-reaching. A manufacturer cannot introduce a novel substance into food simply because no study has yet shown it to be dangerous. Instead, the substance must first be assessed, shown to be safe at the proposed levels, justified by a genuine technological need, and demonstrated not to mislead the consumer. Only then can it be added to the list, and even then only for specified foods, at specified levels, under specified conditions. InfoCons – Consumer Protection regards this precautionary architecture as one of the strongest features of the whole regulation.
It is also worth stressing the role of the acceptable daily intake, or ADI. For many additives, scientific bodies establish an ADI – an estimate of the amount that can be consumed daily over a lifetime without appreciable risk. Article 11 requires that the permitted quantities take the ADI and the likely intake from all sources into account. This is why the conditions of use are not arbitrary numbers: they are calibrated so that realistic consumption across the diet remains within safe boundaries.
Specifications, purity and the identity of each additive – InfoCons Consumer Protection
Authorising an additive by name is not enough; the law must also pin down exactly what that substance is. This is the role of the specifications required by Article 14, which cover in particular the origin of the additive, purity criteria and any other necessary information. Specifications ensure that an additive bearing a given E number is consistent and of controlled quality, limiting impurities and defining the substance precisely.
The importance of identity is reinforced by Article 12, which treats a significant change in production method, in starting materials, or in particle size – including through nanotechnology – as creating, in effect, a different additive that needs a fresh listing or updated specifications. Together, Articles 12 and 14 guarantee that the safety assessment behind an E number actually corresponds to the substance that ends up in food, rather than to a differently produced version of it.
What this means for the label in your hand – InfoCons Consumer Protection
Chapter II is the reason an E number can be trusted as more than a code. Every additive on the list has passed a safety assessment, has demonstrated a genuine technological need, and must not mislead you. It is tied to specifications on purity and origin, it is limited to defined foods and defined amounts, and it must be reassessed if its production changes. When you see a permitted additive on a label, you are seeing the end result of this rigorous gatekeeping process.
For consumers, the reassurance is real but it comes with a responsibility. The law guarantees that each individual additive has been vetted and limited; it does not, by itself, tell you how many additives you are accumulating across an entire basket or a whole day of eating. That cumulative dimension is where consumer awareness – and practical tools that add up the additives in your purchases – complete what the regulation begins.
The InfoCons Additives Calculator: how many additives are really in your basket? – InfoCons Consumer Protection
Understanding the law is one thing; seeing what it means for your own shopping basket is another. A single processed product can contain several additives at once, and an ordinary weekly shop can add up to dozens or even hundreds of additive occurrences once you sum every product together. What is more, the same additive can appear in many different products in the same basket, which means it enters the consumer’s diet repeatedly.
To answer this, InfoCons – Consumer Protection offers consumers the Only Additives Calculator for the food products bought or consumed. It is the only calculator for food shopping that shows the number of additives present and how many times a given additive is found in the shopping basket. Instead of looking at each product in isolation, the consumer gets a complete picture of the whole basket, seeing the real, cumulative number of additives being purchased.
The same logic applies to a single meal. A breakfast, a lunch or a dinner can bring together several processed products, each with its own set of additives. When these products are eaten together, the additives add up. A seemingly simple meal can, in reality, mean the simultaneous consumption of a surprisingly large number of food additives – colours, preservatives, emulsifiers, flavour enhancers, stabilizers and more. That is why the question “how many additives do I consume at one meal?” is just as important as “how many additives am I buying?”
As a practical solution, the InfoCons application helps consumers identify additives quickly. By scanning the barcode of an agri-food product, the app identifies the product and shows the food additives it contains, turning the “E” codes on the label into clear, easy-to-understand information. In this way, consumers can see how many additives are cumulated in their shopping basket or even in a single meal, and can make informed choices for themselves and their families – right there, in front of the shelf.
Signed:
InfoCons Consumer Protection Department of Studies and Comparative Testing