Imagine having to prove that a new food ingredient is safe to eat. For decades, much of the answer has come from animal studies.
Today, a growing family of alternatives, known as New Approach Methodologies (NAMs), promises to change that: tests on cells, computer models and laboratory methods that tell us how a substance behaves without involving animals.
But what can these methods actually do today, when a company asks the European Food Safety Authority (EFSA) to approve a new ingredient? The answer is less spectacular than the headlines, but more interesting: NAMs are not yet replacing animal studies. They are helping decide which ones are really needed.
What are NAMs, exactly?
Surprisingly, there is no single, shared definition. Depending on the document you read, even within the same institution, the term can cover only tests on cells and computer models, or any approach that avoids animal testing altogether.
This is more than a technicality. The same evidence may count as a NAM in one reading and not in another, which makes it hard to say how widely these methods are really used. For companies, being clear about what is being claimed is the first step towards a convincing application.
Why is everyone talking about them now?
The idea itself is not new. Alternative laboratory methods were already mentioned in European food safety guidance more than twenty years ago. For a long time, though, the message from regulators stayed the same: alternative methods would be “considered case by case”.
What has changed recently is the weight these methods carry. NAMs appear by name for the first time in EFSA’s 2024 guidance on Novel Foods. In 2026, the new guidance on food additives goes a step further and turns non-animal methods into the first step of every safety assessment. After years of good intentions, it is the first time the rules really change shape.
What has really changed for food additives?
The 2026 EFSA guidance on food additives, which we introduced here, organizes the safety assessment like a staircase. You only climb to the next step if the previous one leaves open questions.
The first step is now entirely non-animal: existing knowledge about the substance, laboratory tests on cells and computer predictions. And for the first time, what happens on this first step can close the door on further testing. If the laboratory tests show that a substance does not damage genetic material and is not absorbed by the body, extensive animal studies are no longer needed. Only a short, targeted check remains.
The classic animal study has not disappeared: it has simply moved further up the staircase. The difference is that it now has to be justified, not assumed.
And what about Novel Foods?
Regarding Novel Foods, the picture is more cautious. EFSA encourages the use of NAMs, but only once they are officially recognised, and the assessment is still largely built around traditional studies.
The opinions EFSA has published since 2024 tell an interesting story. In about one in three positive opinions, EFSA did not require the full set of toxicological studies. Yet in each of these cases, the result came from well-established arguments: what the product is made of, a history of safe consumption, or its similarity to substances already approved. None of them was driven by new data generated with NAMs.
Whether these cases count as “NAM successes” depends, once again, on which definition you choose. It is a good reminder to take headline statistics on NAMs with a grain of salt.
What does this mean for companies?
Today, the real value of NAMs lies in strategy. Used at the right moment, they help a company:
- plan the safety assessment before starting any animal study;
- build a stronger case for why some studies are not needed;
- avoid unnecessary tests, saving time, costs and animals.
Their limits are just as clear. For the most complex questions, such as the long-term effects of a substance or its effects on reproduction, animal studies remain the reference for now. EFSA itself describes NAMs as tools to be progressively integrated, not yet as a full replacement.
The next challenge is not only scientific. New methods also need a faster path to official recognition, so that good science does not wait decades before it can be used in an application. It is a path EFSA has already started to work on.
Where should you start?
Whether you are preparing a food additive application under the new EFSA guidance or a Novel Food dossier, the toxicological strategy is decided before the first study is run.
Chemsafe supports companies throughout the entire regulatory process, from the design of tiered testing strategies and waiver arguments to dossier preparation and interactions with EFSA.
Contact us to discuss how NAMs can fit into your next application.
