Are the EU Novel Food regulations stifling food innovation?

The EU Novel Food Regulation has come under fire recently for its harsh and meticulous application process, holding back—or, in some cases, outright stopping—food manufacturers from bringing their new products to market.

But is this application process necessary for consumer safety, or is it just over the top? 

In this blog post, we will delve into the nitty-gritty of what the legislation actually entails and whether it is truly stifling food innovation.

What Actually Is the EU Novel Food Regulation?

First and foremost, let’s look at what the regulation involves. The EU Novel Food Regulation is a system established by the EU to regulate the approval, marketing, and use of novel foods within the European Union. 

It is predominantly governed by Regulation (EU) 2015/2283, which came into effect on January 1, 2018, replacing earlier legislation (Regulation (EC) No 258/97).

But what is a novel food, I hear you ask? A novel food is defined by the European Commission as any food that was not significantly consumed within the EU before May 15, 1997, and falls into one of the following categories:

• Foods with a new or intentionally modified molecular structure.
• Foods consisting of or isolated from microorganisms, fungi, or algae.
• Foods derived from plants, animals, or their parts (excluding traditional breeding and cultivation).
• Foods resulting from innovative production processes or technologies, resulting in significant changes in composition or structure.
• Foods containing engineered nanomaterials.
• Vitamins, minerals, or other substances produced by new manufacturing processes.

How Does the Regulation Affect the UK If We’re Not in the EU Anymore?

The EU Novel Food Regulation still influences the UK’s rules on novel foods post-Brexit, as the UK has adopted a similar framework. Most food brands still have to apply to both UK and EU regulations if they wish to sell their products in both markets.

What Are the Main Attributes a Novel Food Must Have to Be Approved?

For a novel food to be approved, it must meet several key criteria:

1. Safety for Consumers: This includes undergoing an approval process organized by the European Commission and complying with the European Food Safety Authority (EFSA) scientific risk assessment to evaluate the food's safety.
2. Adequate Labelling: The product must be clearly labeled and not mislead customers in any way.
3. Nutritional Value: If the novel food’s purpose is to replace another type of food, it must not be a less nutritious substitute.
4. Consumer Safety: The product must be proven safe for consumption.

Other Key Elements of the Legislation

• Traditional Foods from Non-EU Countries: If a novel food is a traditional food from a non-EU country and it can be proven to have been safely consumed for over 25 years, it undergoes a faster approval process.
• Union List of Authorized Novel Foods: Approved foods are added to the Union List of Authorized Novel Foods. This list provides guidance on labeling requirements and conditions of use for other manufacturers.
• Engineered Nanomaterials: Foods with engineered nanomaterials (tiny materials, 1–100 nanometers in size, designed for special properties) undergo more rigorous testing due to potential health risks.

Benefits and Challenges of the EU Novel Food Regulation

The EU Novel Food Regulation is designed to ensure that food innovation occurs in a safe, fair, and transparent manner. Its primary objective is to protect consumers by requiring in-depth safety assessments of new or significantly altered food products before they reach the market.

This process ensures that consumers are not exposed to unsafe products, are provided with accurate information, and are not misled by false claims.

The regulation also considers environmental impacts, ensuring that innovation aligns with sustainability goals. One of its main benefits is fostering consumer trust and confidence in novel food technologies by ensuring new products are safe.

However, the regulation poses significant challenges, especially for smaller or innovative companies. While the framework applies the same rigorous standards to all manufacturers, the approval process is costly and lengthy. Substantial investments in safety research, documentation, and compliance are often deterrent for startups or small businesses, placing them at a disadvantage.

The complexity of the process, coupled with no guarantee of approval, discourages many companies from pursuing innovation. Additionally, UK-based food manufacturers face further challenges post-Brexit, as they must undergo both the UK and EU regulatory processes if they wish to market in both regions, putting UK-based small businesses at an even greater disadvantage.

The Effect of the Legislation on the Algae and Insect Market

Several companies have faced significant challenges due to the EU Novel Food Regulation, particularly in the algae and insect markets.

Insect-Based Foods

Insects have gained global attention as a sustainable protein source, but food manufacturers in the EU have faced considerable obstacles in bringing insect-based products to market. For example, companies producing cricket flour or mealworm-based snacks had to wait years for approvals under the Novel Food Regulation.

Many small startups were unable to withstand the financial burden of the lengthy and expensive safety testing process. Some companies exited the market entirely, unable to compete with brands in countries with less restrictive regulatory frameworks.

Algae-Based Foods

Algae, a sustainable superfood ingredient rich in protein and omega-3 fatty acids, has also faced challenges in gaining approval. Companies attempting to use algae strains in food products often encounter obstacles related to proving their safety, which costs both time and money. This has significantly reduced the use of algae in the EU and UK food markets, allowing competitors from other regions, like the United States and Asia, to fill the gap where regulations are less restrictive.

Market Exclusivity and Competition Issues

If products do make it through the approval process, food brands are only granted a five-year exclusivity period. This means that after five years, other companies can replicate the innovations without having to go through the same time-consuming and expensive approval process.

For example, a company investing heavily in the development and approval of an insect-based protein powder may find its product copied by larger competitors once the exclusivity period expires. This limits the company’s ability to recoup its initial costs, discouraging further innovation.

Finding a Balance

While the EU Novel Food Regulation is essential for protecting consumers, it risks stifling food innovation by imposing costly and time-consuming assessments. This reduces the likelihood of smaller businesses pursuing new ideas. To address this, policymakers could consider reducing and simplifying the approval process, offering financial support for small businesses, or extending exclusivity periods to promote innovation.

Final Thoughts

While the regulation plays a crucial role in safeguarding public health and ensuring environmental considerations, it must evolve to better balance safety with the need for innovation.

Without adjustments, the current system risks leaving European food brands at a disadvantage in the global market, hindering progress in sustainable and innovative food solutions.