SAFE & LEGAL
Novel foods
When placing a product on the UK or EU market, companies must do their best to ensure that the product is compliant with all relevant compositional and labelling laws.
For vitamins and minerals, it is possible to access positive lists1,2 where the permitted vitamins and minerals and their sources can be found (also available in CRN UK’s Seven Easy Steps publication). However, when it comes to substances other than vitamins and minerals, how does a company ensure that it would not be considered to be a novel food?
The UK and EU novel food laws3,4 have 10 categories of what constitutes a novel food, as follows:
‘novel food’ means any food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of Member States to the Union, and that falls under at least one of the following categories:
(i) food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the Union before 15 May 1997;
(ii) food consisting of, isolated from or produced from microorganisms, fungi or algae;
(iii) food consisting of, isolated from or produced from material of mineral origin;
(iv) food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the Union and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by:
– traditional propagating practices which have been used for food production within the Union before 15 May 1997; or
– non-traditional propagating practices which have not been used for food production within the Union before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances;
(v) food consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices which have been used for food production within the Union before 15 May 1997 and the food from those animals has a history of safe food use within the Union;
(vi) food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae;
(vii) food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances;
(viii) food consisting of engineered nanomaterials as defined in point (f) of this paragraph;
(ix) vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013, where:
– a production process not used for food production within the Union before 15 May 1997 has been applied as referred to in point (a) (vii) of this paragraph; or
– they contain or consist of engineered nanomaterials as defined in point (f) of this paragraph;
(x) food used exclusively in food supplements within the Union before 15 May 1997, where it is intended to be used in foods other than food supplements as defined in point (a) of Article 2 of Directive 2002/46/EC;
It can be difficult for a company to determine whether the substance they want to use is not a novel food or whether it will fall under one of the ten listed categories.
There are some resources that are publicly available that can help a company start the process of checking whether the substance they want to use is novel or not, and these are as follows:
EU Novel food catalogue
EU Consultation process on novel food status list of decisions
In addition, the Finnish Food Authority has a list on its website of other useful resources.
These lists above are not exhaustive and queries can sometimes still remain over a substance’s novel food status. There is an official route that can be followed, referred to as the Article 4 consultation process, by which companies can gain a categorical determination by the UK or EU authorities as to a substance’s status in the UK or EU territories. However, many companies do not want to take that official route at an early stage in their investigations.
CRN UK has access to additional lists of other substances, including a list of established ingredients that was produced by CRN UK in 2001 and accepted, following a number of checks, by the UK Food Standards Agency (FSA) at the time. This list is still used by the FSA today in their investigation of the novel food status of substances.
CRN UK’s members can obtain initial information on the status of a substance they might be considering using, which can help them determine whether:
– they are confident to proceed with using the ingredient;
– they should initiate a formal UK and/or EU consultation into its status;
– they should not use the ingredient; or
– they should consider a novel food authorisation process.
See here to find out more about membership of CRN UK.
References
1 GB: Schedules 1 and 2 of The Nutrition (Amendment etc.) (EU Exit) Regulations 2019 2 EU/NI: Annexes I and II Directive 2002/46/EC on food supplements as amended
3 GB: Retained Regulation (EU) 2015/2283 on novel foods, as at 31 December 2020 4 EU/NI: Regulation (EU) 2015/2283 on novel foods as amended
Footnote:
Great Britain (GB: England, Wales and Scotland) currently follows retained European Union (EU) law as it stood at 23:00 GMT on 31st December 2020; GB legislation refers to this retained EU law, but future amendments will be made via GB law.
In most aspects relating to foods, Northern Ireland (NI) will continue to follow current and future EU laws, unless the political situation changes in relation to the NI Protocol.
Peel and read labels
The CRN UK led a working group of the Office for Product Safety and Standards (OPSS) Business Expert (Food Standards & Labelling) Group to produce a guidance document for the use of peel and read (peelable) labels on food products, including food supplements. This document, which can be found HERE, has been made available to enforcement via their Knowledge Hub and is also freely available to businesses.
Compliance Roundtable
The CRN UK is part of a coalition of trade associations, including the European Specialist Sports Nutrition Alliance, the Council for Responsible Nutrition UK and the Proprietary Association of Great Britain. All of these associations work actively with their members, regulatory authorities, policy-makers and the media to defend the reputation of the food supplements and functional food sectors across the UK and the continent.
Vitamin D in food supplements
Click HERE to download a tripartite statement on vitamin D in food supplements
CBD-containing products
Cannabidiol (CBD) is one of many chemicals called cannabinoids and it is found within hemp and cannabis. Hemp and related products, such as cold-pressed oils, are not considered to be novel in foods because there is evidence to show a significant history of consumption before May 1997. However, the novel food status of CBD extracts was confirmed in January 2019.
The Food Standards Agency (FSA) has guidance for businesses on CBD, which can be found here. [https://www.food.gov.uk/business-guidance/cannabidiol-cbd]
Food Standards Scotland’s (FSS) guidance on CBD can be found here. [https://www.foodstandards.gov.scot/business-and-industry/safety-and-regulation/novel-foods-regulation/cannabidiol-cbd]
The FSA also has food safety advice on CBD, which can be found here. [https://www.food.gov.uk/safety-hygiene/cannabidiol-cbd]
Compliance with legislation on irradiation
Good Practice Guide on Compliance with the Legislation on Irradiation of Food Ingredients particularly for Food Supplements with Foreword by Jeff Rooker, Chair, Food Standards Agency.
FREE DOWNLOAD
Food Standards Agency Download: Know your legal obligations
This document is for businesses such as gyms, fitness suites, health shops and tanning salons which sell or supply food supplements.
The information will help you understand what is required of a business selling or supplying food supplements.
In the UK most products described as food supplements (such as vitamins, minerals or amino acids) are regulated as foods and subject to the provisions of general food law such as the Food Safety Act.
If you sell food supplements you must register as a Food Business Operator (FBO) with your local authority.
FREE DOWNLOAD
Where is the best place to buy food supplements?
All retailers selling food supplements are meant to follow strict laws on how they can advertise the food supplement, what they can say about it, and also what information must be provided before you decide to buy.
Reputable retailers, regardless of the means by which they sell food supplements (eg. high street, online, catalogues etc), generally try to do their best to ensure that they are only selling legal food supplements.
Sometimes, though, a non-compliant product might slip through the net, and that is where the ‘ Three easy points you can check by looking at the label’ can come in useful (see below).
All the information that should be available about the product should be obtainable from the product label.
If you are buying online or from a catalogue, the retailers have to provide certain information about each product on their website, so you can check it before you decide to order.
Online stores can be highly variable in quality and legality, and the same variability can apply to the products they sell. Some online stores may be striving to ensure they sell only safe and legal products, others may be less careful when selecting what to sell and how they sell it.
There are certain points that should be considered before choosing to buy a food supplement from an online store.
How do you know which supplements are safe & legal?
Food supplements sold in the UK have to comply with almost 20 categories of food law (with some categories containing a number of laws) in addition to many laws relating to specific ingredients.
If you are a consumer or a retailer, you do not need to know all of these laws to be able to check whether the food supplement you want to buy or sell is safe and legal. There are seven easy steps that you can take to check compliance of a food supplement and for the first three, you do not even need access to a computer! If the food supplement does not comply with the first three points, then it is probable that there may be other concerns relating to that product. If you have a bit more time and access to the internet, you can make a further four checks.
If a food supplement does not appear to meet the requirements highlighted in the seven easy steps, then you should consider purchasing an alternative food supplement product. If you are a retailer, you should make further enquiries before agreeing to place that food supplement product on your shelf or internet site.
Three easy points to check by looking at the label:
[1] If a product is labelled as ‘Dietary Supplement’, it is non-compliant.
– All food supplements must be labelled with ‘Food Supplement’.
[2] If the product lists the vitamins, minerals and/or other active substances under ‘Supplement Facts’ or a similar heading, but then follows this by ‘Other ingredients’, listing only the carriers and other food additives etc., it is non-compliant.
– All ingredients (including the active ingredients, e.g. vitamins, minerals, fish oil, glucosamine, botanicals – plant ingredients – etc.) must be listed under the heading ‘Ingredients’ in descending order by weight of input.
– Active ingredients must be quantified separately under an appropriate heading, e.g. Nutrition Information or Supplement Facts, or within the ingredients list itself (though this is uncommon and only accepted in rare circumstances).
[3] If the quantity of vitamins A, D or E is given solely or principally as ‘IU’, it is non-compliant.
– The quantity of these vitamins must be stated on food supplement labels using the applicable units:vitamin A ‘µg RE’; vitamin D ‘µg’; vitamin E ‘mg α-TE’
– Although the voluntarily declaration of quantity in IU may sometimes be provided, this must not take priority.
Four easy checks using online lists:-
[1] The only permitted vitamins and minerals for use in Annex I of Directive 2002/46/EC on food supplements, as amended. If the product contains vitamins or minerals other than those listed (e.g. vanadium), it is non-compliant.
– List of vitamins and minerals
[2] The only permitted vitamin and mineral sources for use in food supplements are listed in Annex II of Directive 2002/46/EC on food supplements, as amended. If the product contains vitamin or mineral sources other than those listed (e.g. potassium glycinate complex), it is non-compliant.
– List of vitamins and mineral sources
[3] Certain ingredients have been determined by the UK Food Standards Agency (FSA) to be novel foods requiring authorisation before they can be permitted for use (eg. Acacia rigidula). These ingredients are listed on the FSA website. Certain other ingredients are included in the EU novel foods catalogue. Neither of these lists are exhaustive, but if any of the ingredients stated as novel are present in a product, it is non-compliant, unless proof can be provided by the company to the authorities that the ingredient falls under one of the few exceptions (as provided by the FSA).
– EU novel food catalogue
[4] If the product makes health claims, these should relate only to those authorised via Regulation 1924/2006 on nutrition and health claims (including disease risk reduction claims) and present on the EU Register on nutrition and health claims (for the EU and NI) or on the Great Britain nutrition and health claims register (for GB). Certain on-hold claims are also currently permitted. Claims which refer to preventing, treating or curing a disease/illness are not permitted.
This can be a complicated issue. UK guidance on claims can be found from the Department of Health, the Committee of Advertising Practice and the Medicines and Healthcare products Regulatory Agency:
– European Union Register of Nutrition and Health Claims.
– Department of Health Guidance on compliance with the nutrition and health claims Regulation.
– Department of Health Information relating to ‘on-hold’ claims.
– The Committee of Advertising Practice Help Notes.
– Medicines and Healthcare products Regulatory Agency Borderline products: how to tell if your product is a medicine.
What about slimming pills, weight loss and sports supplements?
Are they safe and legal?
Some food supplements have been carefully designed to provide additional support to your diet when you are trying to lose weight, complementing a reduced-calorie, balanced diet, especially when you are also trying to increase your exercise and aiming for a healthy lifestyle.
However, there are some products that promise ‘quick fat loss’ and similar claims. Such products are not always food supplements and some are not legal under any UK laws.
– Read the Medicines Agency (MHRA) information on slimming pills and ‘fast weight loss’ products at Dying to lose weight.
– Watch the Food Standards Agency information on DNP at Let’s prevent another DNP death.
– Read the MHRA warning to athletes on DMAA