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What are the regulatory considerations around ‘natural’ alternatives to additives in the EU and UK?

11 June 2024 | Lewis Wallis, Helen Arrowsmith, Helen French

How are food additives regulated?

In the European Union and United Kingdom, food additives need to undergo an authorisation procedure before being used in food products. There is separate legislation for additives in feed for animals, but a similar authorisation procedure applies. A list of all authorised food additives can be found in Regulation (EC) No 1333/2008, as amended, on food additives (also assimilated in UK law), alongside the product categories to which they can be added, any restrictions and exemptions, and the maximum levels of use.

Authorisation requests must be submitted to the relevant body (European Food Safety Authority (EFSA) in the EU and Northern Ireland; Food Standards Agency (FSA) and Food Standards Scotland (FSS) in Great Britain). After review, it will be determined whether the additive is safe for use and should be authorised, along with any associated restrictions, exemptions and maximum levels, before being incorporated into the list.

What is considered a ‘food additive’ is defined in the legislation, and consists of three key points:

  1. It includes any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food (whether or not it has nutritional value).
  2. Its intentional addition has a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of a product.
  3. Its use may result in the substance, or its by-products, becoming directly or indirectly a component of foods to which it is added.

Any substance that falls under the definition must therefore be authorised for use as a food additive in the product category of the food to which you intend to add it.

When it comes to the technological purpose, the food additives legislation also lays down the additive functional classes under which a food additive can fall (i.e. the additive category that describes the function such as ‘preservative’ or ‘acidity regulator’). Where substances are used in food products as additives, they must be included in the ingredient declaration of that product with the relevant functional class, along with their name or ‘E’ number.

NOTE: Commission Regulation (EU) No 231/2012, as amended, provides specifications for all authorised additives (also assimilated in UK law). These requirements must be complied with, whether you are manufacturing food additives for sale or using them within your products.

What about ‘natural’ alternatives to food additives?

We understand that food business operators are now seeking alternative options to additives with

‘E’ numbers or unfamiliar ‘chemical-sounding’ names, which are perceived by some as unwanted additions to food. However, any ingredient/substance promoted as a ‘natural’ alternative to a food additive would still be in scope of the legislation if it falls under the above definition of a food additive and does not meet any of the exemptions listed in the legislation. It is therefore important to keep in mind this definition when discussing any alternative options with your suppliers.

If a substance is not on the authorised food additives list for your product category, and you intend to use it for a technological purpose, its addition is not permitted

This particular issue was picked up by the EU Standing Committee on Plants Animals Food and Feed (SCoPAFF) who concluded that when plant extracts have technological functions as food additives, the additives legislation would apply. In the past, for example, vegetable extracts containing high concentrations of nitrates have been added to tuna products to enhance the colour, an activity that was confirmed to be unacceptable in the EU. Within the legislation, nitrates are authorised as an additive in some product categories, but not for tuna, and addition via a vegetable extract is considered an additive use, and not a food use. The view is also aligned with FSA guidance which states that the indirect addition of nitrates to foods via nitrate-rich vegetable extracts for preservation is not permitted as this would be considered an additive function and these extracts have not been approved as food additives.

Another example that we frequently come across is ‘bamboo fibre’, which is not listed within the legislation as an authorised additive. The substance is used in some food supplements as a source of silica and may therefore be added as an active ingredient to this type of product and labelled as such. If your intention, however, is to use this substance (or any similar substance not normally consumed or used as a food ingredient) in a food as an additive for a technological purpose (e.g. anticaking agent), then this would not be permitted without the substance undergoing the additive authorisation procedure.

A further example picked up by the EU SCoPAFF is the use of rice hull powder intended to be used as an anticaking agent or as a carrier. It was concluded that where these substances/compounds are used to perform a technological function, as they are not normally consumed as a food in itself nor a characteristic ingredient of food, they would meet the definition of an additive. The substance again would therefore need to undergo authorisation before being placed on the market to be used in foods as a food additive – a point made evident by a recent application to the European Food Safety Authority for authorisation of ground rice hull as a new food additive.

We are also aware of a recent issue concerning Zein protein being used as a glazing agent for confectionery, nuts and fruits, as an alternative to authorised food additive shellac (E 904). The FSA has advised that food business operators (FBOs) in Great Britain would only be allowed to use Zein as a glazing agent/coating after it has been authorised for such use, in line with the requirements of assimilated Regulation No 1331/2008, which details the authorisation procedure for food additives. To date, no application(s) has been received by the FSA.

It isn’t necessarily what the substance is that determines whether the food additives legislation is relevant, but rather what the function of the substance is.

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 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 GB. 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.

Colouring foods vs food colours

Some substances considered as foods may be used in a product to achieve a technological function but are outside the scope of what is considered to be an additive; for example, substances used for the purpose of imparting a flavour and/or taste (e.g. glucose syrup) or for nutritional purposes (e.g. salt replacers), vitamins and minerals. However, preparations from foods and other natural source materials obtained by selective extraction (i.e. by physical/chemical extraction) of constituents (e.g. pigments) are considered additives and in scope of the legislation, therefore requiring authorisation before use. For food colours, selective extraction depends on the ratio between the extracted pigment(s) compared to the nutritive/aromatic components.

Saffron is specifically referenced in the non-legislative text (Recital 5) of Regulation (EC) No 1333/2008, as amended, as a food used for colouring (i.e. a colouring food) and is considered outside the scope of the legislation. However, if pigments from saffron have been selectively extracted with the intention that the extract is used to alter the colour of a product (i.e. a food colour), this would be considered as a food additive and must be authorised as such before use. The producer and user of such an ingredient is responsible for holding the appropriate substantiation for categorisation as a colouring food (an ingredient, e.g. paprika) or as a food colour (an additive, e.g. paprika extract, E 160c).

In summary

All substances that fall under the definition of a food additive require authorisation before they can be used. They can only be used when they are contained within the list for the product category of interest, provided in Regulation (EC) No 1333/2008, as amended, in accordance with any associated restrictions, exemptions and maximum levels.

Like in all areas of the food and drink industry, innovation in the additives space is important. It can offer opportunities for potential new ways to both achieve desired functionalities within product formulations, whilst also meeting consumer demands (e.g. for ‘clean label’ products). Whilst ‘natural’ additives/alternatives offer an exciting area of innovation, it should be kept in mind that they must still undergo authorisation as outlined in this blog.

Even if you come to the conclusion that the definition does not apply to your use of the substance, it is important to also consider any novel food implications for these ingredients/products; for more information on novel foods, see published guidance from the FSA

How we can help

Our experienced team of regulatory experts can help you ensure that your products are compliant with the legislative requirements of your target market.

Across market entry support, label review, product review and training, we offer a valuable, extensive and authoritative information and advisory service to help clients stay compliant with food legislation in more than 80 countries.

We offer formulation reviews to help you ensure the ingredients in your product are permitted and within the legal limits. Our services also include artwork and label review, regulatory translations, nutrition information table generation, ingredients and packaging, health and nutrition claims, High Fat Sugar Salt (HFSS) restrictions, regulatory horizon scanning, ingredient permissibility, assistance with dossiers, and pesticide/microbial limits.

About Lewis Wallis

Lewis is a Regulatory Affairs Advisor in the UK/EU team at Campden BRI and has previous industry experience from working for a large multi-national company. He has contributed to and written material for a variety of outputs including research publications, technical reports, food law updates, blog articles, white papers, book chapters, eBooks and guidance documents. Lewis presents on Campden BRI courses and has provided guest lectures for new product development and food policy students covering a variety of Regulatory Affairs topics.

He is a member of the IFST Food Regulatory Special Interest Group that work to host thought-provoking discussion workshops which feature experts presenting on the latest regulatory hot topics.

Alongside his current role, Lewis is a Postgraduate Researcher at University of Leeds and draws upon his regulatory expertise to conduct research at the intersection of food legislation and consumer behaviour, particularly focusing on measures designed to promote healthier and more sustainable food choices within digital food environments (e.g. online retail, meal delivery apps, social media). He has conducted research on the implementation of High Fat Sugar Salt (HFSS) restrictions within online retail and his work involves the application of nutrient profiling models to products promoted and sold in digital settings.

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About Helen Arrowsmith

Helen is a Regulatory Affairs Manager and Allergen Specialist who uses her knowledge and expertise to provide advice, training and consultancy on all aspects of UK and harmonised EU legislation, as well as food allergen analysis, cleaning validation and management. Helen presents on scheduled and tailored training courses on food law and food allergens, and oversees the production of our Food Law Alert.

After her PhD, Helen joined Campden BRI in 2004 when she spent a year as Technical Support Officer in the Food Composition Section. The next nine years were spent in the Biochemistry Section, where Helen managed the provision of technical contract services in the area of food allergen detection, provided interpretation of testing results, consultancy, research and advice on food allergen testing.

In 2014, Helen moved to our Regulatory team where she has gained comprehensive understanding and experience of food law, not just relating to food allergens.

Helen has managed various research projects; in 2023 she supervised and contributed to a Review of the literature and guidance on food allergen cleaning for the Food Standards Agency . Helen has also co-authored two guidance documents for the food industry on ‘Validation of cleaning to remove food allergens’ (Campden BRI Guideline 59) and ‘Food allergens: practical risk analysis, testing and action levels’ (Campden BRI Guideline 71).

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About Helen French

Helen has been working in the food and drink industry since 1990 and has a wealth of knowledge and experience from working in food manufacturing, at a flavour house, as a consultant, and here at Campden BRI (where Helen has been since 2013).

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How can we help?

For more information on food and feed additives or to review your formulation, contact our Regulatory Affairs team.

regulatoryadvice@campdenbri.co.uk

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