EU Food Regulation: Hot topics in 2019

Posted 12 February, 2019

These are times of high uncertainty on the business front. From the ever tedious EU and UK Brexit deal, to the fragile truce in US and China trading relations, there are hurdles at every corner. It is also a complex picture from a policy perspective, where central themes to look out for in 2019 include potential food legislation changes that may follow Brexit, the need for further harmonization of EU food policy and first experiences under the new Novel Foods regulation. Dr. Elinor McCartney, President of the Spanish-based food chain regulatory consultancy, Pen & Tec Consulting Group, spoke with The World of Food Ingredients in a wide ranging interview on the current EU regulatory environment.

The Brexit Picture

As widely predicted, UK Prime Minister Theresa May’s proposed Withdrawal Agreement, setting out an orderly exit from the EU, was massively voted down by MPs on January 15, 2019. At the time of writing, there was little clarity around whether a Plan B would be proposed, Article 50 would be delayed, whether a new vote on the UK’s exit from the EU would take place or even on whether Brexit would happen at all.

The result leaves the food industry facing even more uncertainty and fuels growing concerns that the UK is heading for a “catastrophic” no-deal scenario.

But one of the fallbacks of Brexit could be that it would present the UK with a unique opportunity to modernize its food regulation. But the UK must tread carefully in order to remain compliant with EU standards, to avoid losing trading rights with the EU, or, in the event of a more pragmatic post-BREXIT approach to GMOs (genetically modified organisms), risk alienating GMO-skeptical UK consumers, McCartney stresses.

“There is an opportunity for the UK, if Brexit does go ahead, to overhaul GMO legislation to allow cutting edge biotechnology in the door, e.g. CRISPR – a simple yet powerful tool for editing genomes. In other words the UK could take a more modern approach to safety in the food chain,” McCartney notes as an example. “The two difficulties that this presents relate to how the EU would trade with the EU, which would then have different GMO legislation and what about acceptance by UK consumers, who tend to be the same as other EU consumers in their attitudes to GM crops?” she adds.

For McCartney, food regulation will not be the first priority in the Brexit quagmire, however. “In the short term, I think there’s going to be so much going on in terms of just trying to keep a lot of other essential goods available, such as pharmaceutical supplies,” she notes. “Secondly, if the UK wants to continue trading with the EU, currently the UK’s biggest trading partner, effectively they must keep the same legislation,” she notes.

Last year, the EU already took action against large food companies selling inferior quality products in eastern European countries with the same packaging and branding as the “gold standard” products sold in western EU countries. The EU bloc accounts for some 60 percent of the UK’s trade. “The EU is going to be very strong on harmonization of legislation, advertising and food quality. If the UK wants to continue to trade with the EU they will have to respect those standards ,” she says.

Post-Brexit trading will require investment on the part of UK companies operating in the food chain. “Many FBOs (food/feed business operators) will be forced to open offices in the EU to be compliant with EU food chain safety controls. The EU Commission and Member States require an EU-based entity to assume responsibility in the event of a food safety problem. So that is an added cost for UK businesses that don’t already have an office in the EU,” McCartney explains. The alternative is to devolve that responsibility to an EU distributor, for example, who must then ensure that UK suppliers are EU-compliant. In short, there will be added costs and paperwork.

The Brexit debate has featured scare stories around food safety, with hype that chlorinated chicken and hormone-treated beef from the US will now make their way into the UK once EU regulatory barriers fall post-Brexit.

McCartney understands both the EU and US side of the argument. “One of the American complaints is that these are false trade barriers and they may have a point. Why is rinsing chicken carcasses with chlorine any worse than putting chlorine in our drinking water?” she notes. “On the other hand, the EU takes the attitude that by rinsing chicken carcasses with chlorine and water it’s a kind of invitation to reduce hygiene standards earlier on in the process because it will be rinsed post-slaughter. You are also perhaps indulging in chicken production practices that are not as beneficial to animal welfare,” she says.

One aspect that the UK may consider in the case of Brexit would be a reconsideration of the much misunderstood concept of “E numbers,” which have very negative connotations in the eyes of many UK consumers. But as McCartney quips, any rechristening of E numbers would be cosmetic, since all E numbers are linked to substances that have already been assessed for safety.

The UK has more pressing matters right now and food legislation will be lower down the pecking order for some time. “I don’t think the UK will change food legilsation very much post-Brexit. They will still want to trade with the EU and there will be a lot of other stuff that will be a higher priority than fiddling with a whole set of food legislation that is essentially the safest and the best in the world, in my opinion,” she notes.

Re-evaluating EU food chain legislation (REFIT)

One of the issues that could be up for debate in an eventual UK food policy overhaul would be the attitude of the UK towards modern biotechnology such as CRISPR. This topic is on the European agenda too, as modern biotechnologies offer significant opportunities to combat drought, heat stress, and pest attacks on essential crops in (arguably) safe and economic ways. The EU is currently “RE-evaluating for FITness” all EU food chain legislation under the REFIT process, which is now open to public consultation and comments.

One area of discussion will be around emerging technologies in the gene editing space. At the end of last year, researchers came forward in support of a proposal to amend the EU Directive on the deliberate release into the environment of GMOs. Researchers argue that new plant breeding techniques (NPBTs) developed over the past two decades have provided ample possibilities for efficient and elaborate plant research and trait development. However, diverging stakeholder opinions and politically motivated arguments have left policy-makers in the EU bereft of licence to decide on their status in relation to existing regulations.

“The European Court of Justice (ECJ) has made a ruling that the CRISPR technology for gene editing is a genetic modification under GMO legislation. The ECJ just interprets the law, which says that it is a GMO technique, even though it occurs in nature. The question in my mind is that a lot of the legislation in the food and feed chain needs a complete overhaul and many of it is in pillars: one for pesticides, one for feed, feed additives, food enzymes, food additives and food ingredients,” says McCartney.

She notes that the REFIT process is well overdue. “There are common concerns about existing approaches in food and feed – in the European Food Safety Authority (EFSA) and industry, and some surprising incongruities that need addressing by all key stakeholders, including the EU Commission, EFSA and the food & feed industries,” she says.

Current EU legislation means widely different safety approaches to the same agent used at several points in the food chain. For example a live micro-organism, let’s say a Lactobacillus acidophilus strain, could be used as a pesticide, a biostimulant, a feed additive or as a food ingredient. “Depending on the pillar, you would have to provide EFSA with the whole genome sequencing (WGS) data and a bioinformatics analysis, but no animal, consumer or environmental safety studies. As a pesticide, the applicant is required to submit a significant environmental safety data package. But, astonishingly, you could take the same L. acidophilus strain, put it into a yogurt with no requirement for a premarket safety dossier,” she explains. “Thus there is a clear need to harmonise safety requirements throughout the food chain. A Lactobacillus acidophilus strain or any other live micro-organism added to the food chain, is either safe or it is not safe, and nowadays strain safety for most bacteria can be determined without animal testing, by using WGS, bioinformatics analyses, and in vitro (phenotypic) testing for antimicrobial resistance, toxins and virulence factors.”

This has led to some seemingly unnecessary red tape in the past, within certain segments of EU legislation. “Previously, even live Saccharomyces cerevisiae, which has been used for millennia as baker’s yeast for bakery and other food products, required extensive testing for its use as a feed additive. The EU required the conduction of safety tests in rats and a battery of in vitroand in vivo genotoxicity studies for live yeast as a feed additive just 30 years ago. This wasn’t the case for it as a food additive,” she notes. But eventually this did change. “This is the good thing about progress and now we need another overhaul throughout the EU,” she notes.

An EFSA Challenge

To be fair to EC policy enforcers, they do face a complex task, as McCartney explains. At a recent stakeholder meeting, many of EFSA’s senior scientists shared that one of the biggest challenges they faced was that pesticide, feed, food and food ingredients legislation all varies. These divergences mean that there are some 40 different workflows to apply when evaluating different “REPRO” (regulated) products. EFSA have to adapt their evaluation to the studies required by each different area of food chain legislation.

“So, for example, in the case of a L. acidophilus, they would have to ask questions about environmental safety if it were to be used in a pesticide, but you don’t need to do that as a feed additive. This is since EFSA FEEDAP consider that L. acidophilus is widely prevalent in the environment and safe,” she notes. “Therefore, there is no need for environmental safety, consumer or animal studies. The whole strain can be assessed for safety on genome sequencing and in vitro testing, based on typical testing for microbial resistance,” she adds.

For McCartney, a reconsidered and harmonized process would have animal welfare and innovation benefits too. “This is also a fantastic approach for reducing or eliminating the use of experimental animals,” she points out. “It also stimulates innovation, as it means that smaller companies can be looking, for example, in the guts of human beings or nature and are isolating new species that have never been identified before. As long as they characterize the organism and construct the whole genome sequencing and run a bioinformatics analysis, according to EFSA guidance, they can develop the safety part of any dossier much faster and more economically,” she adds.

Novel Food Improvement

One field of policy that can function as a template for progress at an EU level is the cutting edge field of novel foods. These are foods that are deemed to have not been consumed to a significant degree in the EU before May 15, 1997. They consist of newly developed, innovative food, food produced using new production processes and food traditionally eaten outside of the EU. A new Novel Food Regulation (EU) 2015/2283 entered into force on January 1, 2018, which centralized the authorization procedure and set clearer data requirements.

“The new Novel Foods Regulation has been a big improvement over the old one,” McCartney states. “The old regulation was, effectively, a double or triple safety evaluation. You had to choose a Rapporteur Member State  (RMS) and submit a novel food dossier. The RMS would then conduct a scientific evaluation, after which a summary report went to the European Commission (EC) and was shared with other Member States for scrutiny. Other Member States would typically ask the same questions as the RMS and we would give the same answers,” she notes. If the other 27 Member States could not agree on safety, the dossier went on to EFSA. This ultimately meant that some 70-80 percent of submissions would go to EFSA for further assessment. The UK was a popular destination for novel foods submissions in the past, Brexit would remove the UK as an RMS for novel food dossiers.

For McCartney, the new novel food system is a significant improvement, because it is much simpler. “It is a ‘one door, one key’ process – you ask for approval from the Commission and your dossier goes straight to EFSA to evaluate it,” she says.

One year on, Pen & Tec report that the impact has been immediate, with the number of novel food dossier submissions, almost trebling from 10 in 2014 to 29 in 2018. Examples of ongoing submissions include new uses of chia seeds (Salvia hispanica), which is the edible grain of chia flowering plant of the mint family; Xia powder 125, which is partially defatted chia seed powder and allulose, a naturally occurring monosaccharide with 70 percent of the sweetness of sucrose, but with almost no caloric value.

Novel foods simplification could be a template for other changes. “The EU Commission wants to harmonize legislation across the EU, with any safety assessments and all GMOs carried out by EFSA with coherent standards. In my opinion, this is the way they need to go. There are many areas of the food regulation that need a complete overhaul and modernization,” she adds.

Our Own Worst Enemy?

But GMOs themselves are a good example of how the food industry is often its own worst enemy, for example, in how they market their products. “They emphasize all-natural, and free of GMOs, which reinforces perceptions that GMOs are “Frankenstein” food,” says McCartney.

An approach whereby many operators have prioritized marketing over substance has paved the way for many of the most hated regulations in the first place. “For example, there were many examples of the food industry making wild and exaggerated health claims on foods, which is one of the reasons we have the much hated European Nutrition & Health Claims Regulation. The EU was concerned about advertising on food products, such as, for example, saying something is ‘fat-free’ but failing to mention that the foodnwas instead full of sugar,” she notes.

Technological advances and consumer trends could help the food industry innovate with more socially responsible marketing strategies. “The cost of cell cultured meat has fallen dramatically in recent years and commercial products may not be that far away,” she notes, for example. “The other side is that you have the millennial population who are really concerned about the way we raise animals. The EU has pretty high animal welfare standards and we can do more as otherwise we will not have a meat industry, because we will not be eating meat due to concerns around animal welfare,” she adds.

McCartney believes that the EC does not have the willpower to change their regulation across the board from feed additives to pesticides, but that smaller steps are possible. “For me, it is the logical thing to do, especially in the area of botanicals and probiotics,” she notes. “I think the GMO legislation could do with an overhaul to take a more pragmatic approach. Obviously, one that is science and evidence based,” she says.

Overall, McCartney is optimistic on the outlook for optimization in European regulation. “I have been in this business for 30-40 years and I do see progress, you just have to be patient,” she concludes.

By Robin Wyers

For World of Food Ingredients: