Updates on the EU novel food consultation process

Highlights:

• To date, 40 novel food consultations have been submitted
• Six (15%) were classified as non-novel as foods or for use in foods
• Four (10%) were classified as non-novel for use in food supplements

Novel foods are foods that were 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. Food business operators (FBOs), the companies or persons responsible for placing products in the market are responsible of verifying if the food they intend to place on the EU market falls within the scope of the novel food regulation (Regulation (EU) 2015/2283). When it is unclear whether a food is novel, FBOs can consult Member States on the novel food status of a food, following the procedure described in Commission Implementing Regulation (EU) 2018/456. The consultation procedure focuses on the characterisation and history of consumption of the food product within the EU.

Novel food consultations should be submitted to the competent authority of the Member State in which the product is intended to be marketed first. Once received, the authority shall validate the application and request any additional information from the applicant. After the validation, the Member State should conclude on the novel food status of the food within 4 months after the validation of the application. The decision will be made publicly available after informing the FBO. Here is a link to all the current opinions: https://ec.europa.eu/food/safety/novel_food/consultation-process_en.

To date, out of 40 novel food consultations submitted, only five (15%) foods have been classified as not novel when used as or in foods these include:

• Pine cone (Pinus sylvestris) syrup,
• Passiflora edulis f. edulis Sims.,
• Cold pressed Nigella sativa seed oil,
• Mineral enriched fungal biomass (Aspergillus oryzae),
• Olio di lentisco (oil obtained from Pistacia lentiscus berries)
• Pea (Pisum sativum) Protein Hydrolysate and Soy (Glycine max) Protein Hydrolysate

In addition, four (10%) were classified as not novel only when used in food supplements:

• Preserved pine cones (Pinus sylvestris),
• Coix lacryma-jobi seeds,
• maqui berries,
• Aqueous extract from fig leaves (Ficus carica L.)

The main reason why most foods have been considered novel was the lack of data demonstrating the history of safe use of the food in the EU. It is not sufficient to demonstrate that the source of the food is not novel. If the manufacturing process applied significantly changes the composition or structure of the food source, the food will be considered novel. This was the case with selenium-enriched mushrooms, where the mushroom (Agaricus bisporus) itself is not novel but the selenium-enriched mushrooms are novel due to the significant changes in the composition compared to the source. In contrast, it is interesting that a mineral-enriched version of Aspergillus oryzae is not considered novel. Whereas there is significant history of consumption of Agaricus bisporus and Aspergillus oryzae prior to 15 May 1997, selenium enriched mushrooms (Agaricus bisporus) grown in media containing selenium salts were considered novel but mineral enriched fungus Aspergillus oryzae grown in a medium with different salts was not considered novel since the source and the minerals (including selenium) were not novel. The reason for these different conclusions on similar cases could be i.e. that the change in nutritional value of the latter is not considered significant, or the source of selenium was different in the two cases. It is also worth noting that different authorities – in this case, the Irish (FSAI) and the UK (FSA) authorities – may have had a differing approach & therefore not reached the same opinion.

Another interesting case was pea & soy protein hydrolysates, which were classified as non-novel for use as or in foods by the FSAI recently. The reason for this conclusion was that the raw materials used in the production of the hydrolysates are not novel. Furthermore, soy protein isolate has been widely available in the EU as a food ingredient & is authorised for use in infant & follow-on formula. Interestingly, the history of pea protein consumption was verified by the food industry & corroborated by an EU Member State. Finally, the FSAI concluded that while the acid hydrolysis of proteins will likely be affected, the final composition & amino acid content & structure is unlikely to be significantly altered.

In contrast, mung bean protein isolate was classified by the UK FSA as novel for use as or in food. Even though mung beans have a history of safe use and have been consumed in powdered form prior to 1997, as there was no evidence of consumption of the isolate directly, this was considered to be novel. The applicant did provide information on the composition of the final product & it was demonstrated that fat, moisture & carbohydrate fractions were reduced during processing. The UK FSA concluded that because the final product was different from the starting material and there may be differences in exposure because of the concentration of the protein component, the mung bean isolate is novel. Moreover, because the extraction during the manufacturing process was selective, in that the protein as a whole had been concentrated relative to the starting material although only by three times the starting level, this was novel.

The novel food consultation procedure is not obligatory, but FBOs do need to determine the novel status of their products before placing on the EU market. If you are not sure about the novelty of your food, you can follow the novel food consultation procedure. More details can be found in the EC website.

Advantages of the consultation procedure include:

• If it is concluded that a product is not novel, the decision from the authorities can be used as legal proof indicating that the product can be legally marketed in the EU and a novel food application would not be required
• Companies start a dialogue with the authorities, creating awareness of the characteristics and intended use of the product before marketing it or before submitting a novel food application (if needed). The outcome of the consultation can include hints on next steps (g. FSA suggested that Pili nuts (Canarium ovatum) could be classified as traditional food and that if sufficient history of consumption of selenium-enriched mushroom was presented, it would be possible to reconsider its novel food status)
• The name of the company submitting the consultation is kept confidential so competitors will not be able to see

Disadvantages include:

• It can take up to 4-months to get a decision. This period can be extended in duly justified cases or in case the recipient Member State need additional data to continue with the assessment
• The overview of the product is published on the EC website, so even though competitors may not know which company has submitted the consultation, the details of the product will be obvious

If a product is deemed novel, an application for the authorisation of a novel food should be submitted as per Regulation (EU) 2015/2283 and Commission Implementing Regulation (EU) 2017/2469, following EFSA Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283.

However, there are still some advantages if your product is considered novel. Competitors marketing the same product illegally in the EU would also have to undergo a novel food authorisation process or may lobby and present their own evidence supporting that the product is not novel. If the novelty is then re-assessed and the product deemed not novel, this would be beneficial for all parties and a novel food authorisation would not be required.

If you are unsure about the novel status of your product, Pen & Tec can help you. We can either perform the assessment ourselves or we can assist with the consultation procedure. We have successfully helped our clients achieve a non-novel status.

Please feel free to contact us at info@pentec-consuling.eu.

References:

• Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods.
• Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods
• EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), Turck D, Bresson J-L, Burlingame B, Dean T, Fairweather-Tait S, Heinonen M, Hirsch-Ernst KI, Mangelsdorf I, McArdle H, Naska A, Neuhäuser-Berthold M, Nowicka G, Pentieva K, Sanz Y, Siani A, Sjödin A, Stern M, Tomé D, Vinceti M, Willatts P, Engel K-H, Marchelli R, Pöting A, Poulsen M,Salminen S, Schlatter J, Arcella D, Gelbmann W, de Sesm aisons-Lecarré A, Verhagen H and van Loveren H, 2016. Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283. EFSA Journal 2016;14(11):4594, 24 pp. doi:10.2903/j.efsa.2016.4594.
• Regulation (EU) 2015/2283 of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/200.

By Rosalía Flores, Regulatory Affairs Manager 

Pen & Tec Consulting