Understanding the Regulations Around Novel Food

Novel food is becoming increasingly popular, but food manufacturers need to comply with regulations and laws to remain compliant. The EU Novel Food Regulations are a set of rules that govern how and when products that have not been previously consumed or used in the European Union (EU) can be marketed to consumers. You may be wondering why this is important, but if you have recently developed a novel food product it is important that you know what the rules surrounding its marketing are before you begin selling your new product. For more information on the European compliance services we offer click here:

What is Novel Food?

Novel food is food or ingredients that are not traditionally consumed by humans. It could be a product of new technologies and practices, such as plant-based meat alternatives, non-dairy milks, nutraceuticals, and enzyme products. Manufacturers of these products need to meet strict safety standards issued in the European Union (EU) Novel Food Regulation.

Foods with long-established history of safe use in the EU are not considered novel foods: for example bread, milk, cheese and butter; meat products such as beefburgers; fish fingers; soft drinks etc.. In addition to these many other categories of processed foods which have been produced over many years will also not be considered new or innovative enough to require authorisation under Regulation EC/1829/2003 as amended by Regulation EC/1072/2008.

Where do I find out more about the regulations around Novel Food?

You can find out more about the regulations around Novel Foods in the European Union on the following websites:

  • The EU Novel Food Regulations, which were updated in 2015 and will be applied to products placed on the market after May 2016.
  • The UK Food Standards Agency website has a useful section on what foods are considered novel, as well as information on how to apply for permission to sell them.
  • Food Standards Scotland also has some useful guidance available online about what types of food may fall under their control and how you can contact them if you have any questions about this area of law.

Similarly, Ireland’s Food Safety Authority has published an extensive list of guidance documents relating to novel foods that are worth checking out if you’re interested in learning more about this topic.

How do I know if my product is a novel food or not?

  • Look at the ingredients.
  • Look at the food’s history.
  • Look at the food’s origin.
  • Look at the processing of your product and determine if it has been altered in any way, such as by adding or removing an ingredient or changing its physical appearance (for example, by making it into a powder).

Application of Novel Foods in the Food Industry

Novel foods and ingredients can be used to create new and innovative products within the food industry. They have great potential in terms of both texture, flavor and nutrition, and provide an excellent platform for product developers to explore different options, offering meals that are healthier yet still enjoyable. Examples may include nutrient-dense snacks, probiotic fermented drinks, plant-based dairy alternatives or vegetable-based entrees.

Where can I find out more about the EU Novel Foods Regulations?

The EU Novel Food Regulations are set out in the EU Novel Food Guidance Document. This document is intended to assist you with your compliance with the regulations and it should be read in conjunction with the EU Novel Food Regulation (EC) No. 258/97 and Commission Delegated Regulation (EU) 2016/1052.
The Commission has also published a Guidance Note on how national authorities should apply the principles of mutual recognition when considering applications under Articles 10(1)(a) and 10(2) of Regulation 258/97. The Guidance Notes were updated in 2016 following input from stakeholders at an industry forum held in Brussels on 26 September 2015 as well as comments received during a public consultation exercise conducted between 17 January 2016 – 2 April 2016.”

How Do Regulations Affect Novel Food?

Novel food regulations are designed to protect consumers from potential risks associated with the consumption of novel food. Manufacturers must comply with the EU’s Novel Food Regulation to ensure safety and quality standards for their products. Regulations affect novel food in a variety of ways, including ensuring that the food is free from contaminants, properly labeled, and meets nutritional requirements. It also requires manufacturers to conduct testing on the ingredients used in their products and provide evidence of safety for both consumers and the environment.

What Are the Labelling Requirements for Novel Foods?

Labelling is a key component of the novel food regulations in Europe and other countries. Manufacturers must ensure that the labels for their products are clear, accurate, and informative about the ingredients, nutritional content, and potential allergens present in their products. In addition, any health claims made by manufacturers must be supported by scientific evidence. In some cases, manufacturers may also need to provide information about the production processes used for their products.

Regulatory Aspects of Novel Foods in the EU and Beyond

Before any new food ingredient is determined to be safe for human consumption, it must undergo thorough evaluation and approval from the appropriate authorizing bodies such as the European Food Safety Authority (EFSA). As a regulatory environment, the EU requires that all novel foods and ingredients within its jurisdiction meet safety criteria in terms of potential toxicity or allergenicity. In addition to this, other areas such as nutrition, processing methods and labelling requirements are also strictly examined. After the process has been successfully completed, the novel food will then receive authorization allowing commercial use.

What Regulatory Bodies Govern Novel Foods?

In the European Union, guidelines for novel food are governed by the European Commission (EC), and detailed regulations are enforced by the European Food Safety Authority (EFSA). Other countries have their own independent regulatory bodies, so it’s important to research the guidelines in each region you plan to sell your products. Additionally, many governments have specific requirements for obtaining approval before offering a novel food product on the market. Make sure you understand all relevant regulations and obtain the necessary approvals before launching your product.

How Can Companies Market and Sell Novel Foods?

Companies marketing and selling novel food products need to be aware of government regulations as well as consumer expectations. Packaging should clearly explain what the product is and how it differs from conventional foods, as consumers may not be familiar with these ingredients or products. Additionally, companies must provide clear nutrition labeling that meets all legal requirements, as this information helps consumers make an informed choice about their food purchases.

Who can advise me on my Novel Food product?

The Foodlaw-Reading database is a free online resource for companies and individuals who want to find out more about food law. It contains information on all aspects of food law, including the regulations around novel foods.  For specific and dedicated support in ensure your complying with novel food regulations we’d recommend you book a consultation with one of our food experts.  You can learn more about the EFSA traditional and novel food ingredient regulations by clicking here:

Services Offered by Quality Smart Solutions

With a team of federal experts, we inform and guide businesses about Food Product Classification, Food Supplement Classification, Formula Review, Label and Claims Review, Claims Consultation and Substantiation, EU Country-specific Regulatory Support, Dossier Compilation and Submission, Food products / Food Supplements Import Guidance. Our end-to-end EFSA regulatory solutions:  

Product Strategy & Classification

When you partner with us, our experts will help you in crafting product strategy and classification. You’ll know which set of EFSA Regulations your products fall to meet the compliance requirements.

Compliance Consulting

Our European compliance experts will assess all your compliance facets in order for meeting the food compliance requirements of EFSA, thereby letting you enter the European Union food marketplace and grow your business.

Regulatory Compliance

Gain the benefits of our expertise in EFSA Regulatory Compliance in the European Union for a range of health and food products and be ready to cater to any changes in regulatory compliance and get your product registered.

Expert Guidance

Worried about meeting Regulatory Compliance of EFSA? Don’t worry. We will help by delivering every piece of information and guidance required to enter the European Union marketplace without facing any issue.

Auditing & Inspection

Our Compliance team consists of former EFSA compliance experts who carry out audits and inspection of your product materials, packaging, labelling, quality to determine that you meet EFSA Compliance.

Application Assistance

Get full service related to application process, documentation process and licensing process. We support both domestic and international businesses with EFSA Regulatory solutions for product registrations.

Need Assistance for EFSA Compliance?

Please complete the form below. We will respond to you soon.

Select all applicable Services
Select countries of interest
0/5 (0 Reviews)

Subscribe to global regulatory updates

Don't miss updates from Health Canada and FDA.

If you are looking for the latest regulatory updates or want the newest regulatory requirements guides, please leave your email and we'll keep you posted.

What service are you interested in? *
We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. Privacy Policy.