On January 1, 2018, EU 2015/2283 the new novel foods regulation took effect, replacing EU regulations 1169/2011 and 258/97. This first and immediate impact of this regulation is that all authorizations (new or old) are generic instead of applicant specific, which means that once one company provides data that enables a novel food to be sold in the EU and it is approved by the European Food Safety Authority (EFSA) than any company wanting to sell the same item may do so, providing they adhere to the authorization conditions, labeling and specification requirements. This allows any company to market previously authorized novel foods whether or not they were the applicant. This should significantly reduce the price of some novel foods already approved as it does provide for more competition and will increase the availability of novel food ingredients.
Data Protection Provision
Knowing that this may discourage innovation, the new regulation establishes a data protection provision. This provision allows the applicant to apply for an individual authorization, which if approved, allows a five-year proprietary protection for this applicant’s data, etc. Thereby, companies which have invested many hours and expense in research and innovation have, potentially, a five-year exclusivity period on sales of the novel food. The fear of the insect industry, which is generally comprised of small companies, is that this provision will lead to global firms entering and taking over the insect business thereby preventing them from selling their products.
This regulation creates more categories of novel foods which hopefully will organize things a little better. The standard novel food categories of vitamins, minerals, food supplements, etc. are included, plus foods derived from specific production or technological innovation such as nanomaterials, those with molecular structure intentionally changed and insects. Indeed, insects are novel foods as they weren’t widely sold in the EU prior to May 1997. In the Netherlands and Belgium items such as insect burgers and nuggets are available at some retailers. Other insect products are sold in restaurants across Europe. Some of these insect products are being sold to the animal food and feed industry. Producers of products currently being sold without novel foods approval must submit applications for authorization by January 2, 2020. This will create the legalization of insects as ingredients, feed or food, but really will not help those that are producing insect products within the EU and selling them beyond its borders.
Applications will be managed online and there will be a simplified, authorization procedure. There will also be more transparency and efficiency in approving or denying a novel food application. Once a novel food is approved it will be placed on the Union list and at that point it can be sold in the EU.
The real impact of this regulation comes in a procedure to simplify the approval of traditional foods from third countries. These are foods that have history of safe use and consumption, and providing that no member state can produce proof of safety concerns, they will be allowed into the EU and a structured notification system for these products will be developed. This will allow some foods, such as insect and insect-derived food, to provide proof to the EFSA that there is a history of safe consumption and to be able to get around the ‘yuck’ factor that has prevented some of these insect products from being sold in the EU.
There is also the possibility of reducing some confusion, even in those countries that are not EU members but adhere to the EU regulation. For an example, insect based protein bars sold in Switzerland which, when they were marketed to Iceland, were removed for violating the EU novel food regulations. A similar item is being sold in the United Kingdom.
Insects have been traditionally consumed in Asia, Africa and Latin America and form part of the diet of at least 2 billion people. More than 1,900 species of insect are consumed. As with any protein source there are potential risks to using insects as food. Raw insect protein can be a source of Salmonella, Campylobacter, and pathogenic E.coli. There are also potential allergic reactions to insects by those that are allergic to seafood and dust mites. Of course, if the insects are feeding on traditional feeds this will not be an issue but if feeding from waste products then more research into the safety aspects will be required. Essentially, insects and products will have to be subjected to the standard food safety (microbial, chemical, etc.) and labeling (nutritional, identification, etc.) aspects of any protein material.
Some products that are fried or baked will have specific parameters, such as acrylamide, to be checked. Other aspects of safety will be questions about whether an insect can be eaten whole or whether only specific parts can be safely consumed. Is there a limit of the amount of a specific insect before it becomes a toxicity issue? There are quality and sensory aspects that will need to be considered, possible package and process safety considerations too. Will certain ingredients such as preservatives, sweeteners, and colorants be allowed in these products? These are already considerations for products that are not novel foods and for items that have been previously approved as novel foods.
So, will we soon be ordering insect burgers from our local fast food restaurant, with the standard fixings and our fried insect sticks as a side order? Probably not, but food habits change – as raw fish is now widely consumed in the EU, likewise fungal products.
People now living in the EU, but originally from other countries and who would otherwise regularly consume these insects based foods will help to create a market incentive as they choose to purchase and eat what they traditionally consume. It is anticipated that this same group may also open restaurants to serve these traditional insect foods, once they are approved for sale. There is also the reality that the world’s food supply must increase by 70% by 2050 to support a world population of 9 billion plus. Unless something dramatically changes, insects are going to part of the increase world food supply even in countries where these products haven’t traditionally been consumed.
Novel Food Traditional Safety
As with all foods supplies, this insect supply will have to be monitored for food safety through auditing, testing, quality inspection, certification and supply chain transparency, DNA analysis for proper identification, other adulteration tests and since these lists of approved foods will be changing on a regular basis the access to a regulatory database such as SGS Digicomply to provide details of these changes.
Canada, China, Australia and New Zealand have developed regulations involving novel foods because of new ingredients and genetically modified products. While safety is included in these regulations, the real issue is that these novel foods are a food that does not have a history of human consumption in that country. This does create an artificial barrier of selling foods typical consumed in one country to another country.
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Global Food Inspection Technical Manager
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