If unsure whether a product is a Novel Food, an applicant can ask a Member State authority for a ruling. The authority issues a binding opinion and sends it to the European Commission, which shares it with other Member States for consultation. If they agree, the decision stands.
It is a necessary stage in the Novel Food application process, Luca Bucchini, managing director at food supplement regulatory consultancy Hylobates Consulting, told NutraIngredients in a Q&A.
However, he warned it can be exploited by competitors to create costly delays and uncertainty for certain ingredients.
NI: What role does Article 4 play in a Novel Food application?
Luca Bucchini (LB): A Novel Food application is required when a food (in practice, a substance or a plant, etc.) is novel — not consumed in the EU (or UK) before 1997. If the food is not novel, i.e., consumed in the EU or UK before 1997, an application is not required.
Article 4 is about deciding whether a food was consumed before 1997, or is so similar to foods consumed before 1997, that it is not novel and an application is not required. If food businesses are not sure whether a food is novel or not, they can use article 4 to have a final opinion.
NI: What are the pros and cons for brands submitting to Article 4?
LB: The obvious pro is legal certainty that the food is not n ovel. Imagine a company spending maybe hundreds of thousands of euros to build a Novel Food dossier with toxicology and other data, only to be told the application was not necessary because the food is not novel.
So an Article 4 opinion provides clarity that either a dossier is required, or the food is confirmed as non-novel, and one can reassure both customers and authorities.
Obviously, the negative is that one can get an answer that one does not like. Many substances have been on the market for decades, but if someone suddenly asks the question, ‘What is the evidence of use before 1997?’— this proof may be difficult to find.
In a case like this, a substance that is widely used could suddenly be declared a Novel Food and prohibited for use until approval, which could take maybe three or four years, and is a long delay for a product or ingredient that had been on the market for decades.
NI: Is Article 4 potentially being misused strategically to cause problems for certain ingredients?
LB: Yes, it is a real concern; Article 4 has been used as a competitive tool to challenge manufacturers of alternative ingredients.
Obviously, there is a counterargument: if one invests into a Novel Food application, one wants to make sure it is necessary — the substance really is novel and requires an application whereas competitors with similar substances are also held to the same standard.
Unfortunately, the process is managed by Member States rather than the Commission, so consistency may sometimes be an issue. In addition, some businesses request Article 4 consultations out of ignorance, without realizing the potential consequences.
NI: So, how is it being used as a competitive tool?
LB: Imagine one is producing a substance from synthetic sources. It is clearly novel. However, there is a natural equivalent where the status is uncertain, so one applies for Novel Food for one’s synthetic form, and simultaneously requests an Article 4 opinion on the natural source.
Authorities may conclude the natural source is also novel, but the suppliers of that natural source then face the burden of proving otherwise, which is something that takes time, especially since Article 4 requests remain non-public until a decision is made. So, although this can be reversed with evidence, the delay creates a temporary advantage for the synthetic product.
For example, imagine one supplies creatine monohydrate, and one has competition from other sources of creatine, an Article 4 request can create uncertainty for one’s competitors. Even if they ultimately prove non-novel status, they may lose valuable time in the market whereas one benefits from one’s own product clarity.
NI: Given this, do you think Article 4 is fit for purpose?
LB: I think it is a necessary tool, but it should be more transparent. Requests should be made public as soon as they are received, including the applicant’s name, with the opportunity for all parties to submit data. The process should also be centralized under the Commission to ensure consistency and be limited to foods where real uncertainty exists.
NI: Would more transparency about who exactly raises the regulatory questions and who is addressed therefore help clear up whether the process is being used fairly or manipulated?
LB: The Member States resist transparency with all their might, which ultimately does not make sense. At a minimum, businesses should get a warning that a consultation request is being considered so they can provide relevant data. And yes, it is being misused — fault the Member States for this.
