The vast, arid plains of southern Africa may be hostile to many crops, but they conceal an untapped treasure that could be worth millions. Punctuating the brilliant blue skyline is the baobab, a species of tree that can grow 30m high with a trunk 10m in diameter. It carries a tangy fruit of the same name that can be eaten fresh or pressed and that contains six times the vitamin C of oranges and twice as much calcium as milk.
You’d think given its superfood status, it’d be a no-brainer to secure a listing in a UK supermarket. Not so. It has taken two years of legal wrangling to gain permission from the EU this month to bring dried pulp of the fruit into the UK for use in cereal bars, biscuits and confectionery, fruit juices and sport beverages (The Grocer, 12 July, p58). And PhytoTrade Africa, the trade body that won the approval, may well think itself lucky given that the average time for a so-called novel food to win approval is currently more than three years.
Fortunately, the next raft of novel foods may not find the process quite so bruising or protracted. A relaxation of the novel foods law is being pored over by EU bureaucrats that could open the door to a host of weird and wonderful new foods and ingredients, such as the peach palm and the desert date (see over). If a new regulation is adopted next year, as seems likely, it will be a further one to two years before it comes into force in the UK. But will the wait be worth it?
Given the onerous nature of the current regime, anything would be an improvement as far as most novel food producers are concerned. Regardless of a food’s health benefits, as soon as it is classified as a novel food – ie a food that was not eaten in quantity in the EU before 15 May 1997 – it has to start jumping through the novel foods approval hoops before it can be sold in the EU.
Any food regarded as novel has to go through the system, even if it has a long history of safe consumption outside the EU. Baobab is case in point. “Africans have long used its fruit pulp for refreshing drinks and as a baking ingredient,” points out Cyril Lombard, PhytoTrade Africa’s market development manager. “It’s a traditional food for pregnant women and for children because of its high calcium content.”
Unfortunately, this wasn’t enough to exempt it. So convoluted is the current process, it’s no surprise most suppliers or producers do their best to avoid it altogether.
That’s easier said than done. Suppliers of goji berries nearly saw the burgeoning market brought to an abrupt halt last year when concerns were raised that they may be a novel food. They eventually argued that the berries were being imported and consumed to a significant degree prior to 1997. Import figures, statements from retailers as well as recipes published in a mainstream food magazine were given in evidence.
But others have no choice but to go through the painful and lengthy approval process. It takes an average of 1,191 days for a novel food to be approved. Although only five negative decisions have been given to date, “it’s the large amounts of uncertainty” that really grate, according to George Gordon, head of public affairs, Unilever UK & Ireland, who knows about the novel food regime only too well.
Cholesterol-lowering spread Benecol had been sold in Europe prior to 15 May 1997, so it did not need to go through the novel foods regime. But when Unilever wanted to launch a similar product in the EU a year later in 1998, it was caught by the novel foods regime. Over two years afterwards, permission was finally granted to Unilever to place ‘yellow fat spread with added phytosterol-esters’ on the EU market – resulting in the launch of Flora Pro-activ. But by then Benecol had enjoyed a significant head start.
The current time-lag creates an unwelcome element of uncertainty in the early and crucial development stage of new products, preventing companies from being able to tell their customers when a new novel food product will be available on the market, believes Unilever. For manufacturers wanting to use foods that do fall into the novel category, the time it takes for an application to go through can mean a huge difference to future profit margins.
An application by Canadian company Prairie Lane in May 2004, for an opinion on the novel food status of the saskatoon berry illustrates just how arbitrary the process can be. Prairie Lane tried to claim what is known as ‘substantial equivalence’, where an approval is sought for a product under a simplified procedure because it is almost exactly like another product already widely available in the EU. It argued that the saskatoon berry was substantially equivalent to the blueberry.
The UK ruled it was not an equivalent product, but it subsequently came to light that the saskatoon had been commercialised in Finland back in 1996, and following notification by the Finnish authorities the berry was approved at the end of 2004 on the basis that it wasn’t novel.
Duplication also plagues the regime. In theory, a manufacturer could receive approval for use of a novel food after just one safety assessment carried out by the member state authority that receives the application. In practice, however, the European Food Safety Authority (EFSA) often ends up carrying out another safety assessment because of objections raised by other member states. To date, only one authorisation has been granted without the EFSA carrying out its own assessment – an application on behalf of Arla Food Ingredients amba to use the sugar D-Tagatose as a food ingredient in baked goods and ready-to-eat cereals.
Another complication is that securing approval for a fruit does not necessarily mean approval has been secured for any other substance derived from that fruit and vice versa.
Such is the case with the baobab. Another example is that of the kiwiberry. Efficas has applied for approval to use kiwiberry concentrate in a number of products traditionally consumed in the EU.
Although Waitrose was selling fresh kiwiberries last year, because the concentrate is being separated from its source, it must gain separate novel foods approval before it is sold in the EU.
Needless to say, securing approval for a novel food is not cheap. “It is costly for industry to provide all the data required, which discourages innovation,” says a Food and Drink Federation spokeswoman. “That is especially true for small businesses.”
Fortunately, the European Commission has acknowledged some of these issues. Under the proposed new regime, applications will be handled by a centralised body, the EFSA, which will conduct the sole safety assessment. The thinking is that a ‘one door, one key’ approach will lead to a more unified and efficient system, significantly reducing the time it takes for a novel food to become authorised.
The commission has also recommended a simplified application process for foods that have a history of safe consumption outside the EU. If this particular proposal is enshrined in the legislation, it will mean foods such as baobab pulp ought to find a far quicker route to market.
Replacing such a “cumbersome and unsuitable” regime can only be a welcome move, says Lombard, who feels the proposed regime would be “a positive step for us and much more fair to products that have a history of safe use”.
Unilever’s Gordon is equally in favour of a more centralised system of authorisation and believes it might remove some of the inconsistency that currently exists. He also foresees benefits in the ‘one voice’ approach. While the authorisation procedure for health foods is separate from novel foods, “we’re interested in having health and safety being looked at by the same group and at the same time”, he says.
However, he has some reservations, particularly over the allocation of resources within the EFSA to the new regime. On the face of the proposals, centralisation of the approvals system would increase the workload of the EFSA. “That’s the big question for us: is the EFSA set up to do this? We certainly hope it is,” says Gordon.
Even if it is still tricky to win approval for a novel food, you can bet more applications will be submitted over the next few years as more suppliers wake up to the potential rewards of gaining access to 27 European markets. The potential scale of the influx of novel foods to the EU is difficult to gauge, but the European Commission describes it as “significant”.
Most experts predict if not a tsunami of new foods hitting stores, at least a decent-sized wave. “I would be surprised if there isn’t a greater flow of new materials coming through the system,” says Lombard.
Elizabeth Hyde, Solicitor at law firm Eversheds, agrees. “There’s certainly an incentive for companies to try and have novel foods introduced because of that quicker turnaround,” she says.
Meanwhile, manufacturers must wait. Even if the new regime is approved, it is unlikely to come into force in the UK before 2011. If and when it does, who knows what will replace the baobab as the next big thing?
You’d think given its superfood status, it’d be a no-brainer to secure a listing in a UK supermarket. Not so. It has taken two years of legal wrangling to gain permission from the EU this month to bring dried pulp of the fruit into the UK for use in cereal bars, biscuits and confectionery, fruit juices and sport beverages (The Grocer, 12 July, p58). And PhytoTrade Africa, the trade body that won the approval, may well think itself lucky given that the average time for a so-called novel food to win approval is currently more than three years.
Fortunately, the next raft of novel foods may not find the process quite so bruising or protracted. A relaxation of the novel foods law is being pored over by EU bureaucrats that could open the door to a host of weird and wonderful new foods and ingredients, such as the peach palm and the desert date (see over). If a new regulation is adopted next year, as seems likely, it will be a further one to two years before it comes into force in the UK. But will the wait be worth it?
Given the onerous nature of the current regime, anything would be an improvement as far as most novel food producers are concerned. Regardless of a food’s health benefits, as soon as it is classified as a novel food – ie a food that was not eaten in quantity in the EU before 15 May 1997 – it has to start jumping through the novel foods approval hoops before it can be sold in the EU.
Any food regarded as novel has to go through the system, even if it has a long history of safe consumption outside the EU. Baobab is case in point. “Africans have long used its fruit pulp for refreshing drinks and as a baking ingredient,” points out Cyril Lombard, PhytoTrade Africa’s market development manager. “It’s a traditional food for pregnant women and for children because of its high calcium content.”
Unfortunately, this wasn’t enough to exempt it. So convoluted is the current process, it’s no surprise most suppliers or producers do their best to avoid it altogether.
That’s easier said than done. Suppliers of goji berries nearly saw the burgeoning market brought to an abrupt halt last year when concerns were raised that they may be a novel food. They eventually argued that the berries were being imported and consumed to a significant degree prior to 1997. Import figures, statements from retailers as well as recipes published in a mainstream food magazine were given in evidence.
But others have no choice but to go through the painful and lengthy approval process. It takes an average of 1,191 days for a novel food to be approved. Although only five negative decisions have been given to date, “it’s the large amounts of uncertainty” that really grate, according to George Gordon, head of public affairs, Unilever UK & Ireland, who knows about the novel food regime only too well.
Cholesterol-lowering spread Benecol had been sold in Europe prior to 15 May 1997, so it did not need to go through the novel foods regime. But when Unilever wanted to launch a similar product in the EU a year later in 1998, it was caught by the novel foods regime. Over two years afterwards, permission was finally granted to Unilever to place ‘yellow fat spread with added phytosterol-esters’ on the EU market – resulting in the launch of Flora Pro-activ. But by then Benecol had enjoyed a significant head start.
The current time-lag creates an unwelcome element of uncertainty in the early and crucial development stage of new products, preventing companies from being able to tell their customers when a new novel food product will be available on the market, believes Unilever. For manufacturers wanting to use foods that do fall into the novel category, the time it takes for an application to go through can mean a huge difference to future profit margins.
An application by Canadian company Prairie Lane in May 2004, for an opinion on the novel food status of the saskatoon berry illustrates just how arbitrary the process can be. Prairie Lane tried to claim what is known as ‘substantial equivalence’, where an approval is sought for a product under a simplified procedure because it is almost exactly like another product already widely available in the EU. It argued that the saskatoon berry was substantially equivalent to the blueberry.
The UK ruled it was not an equivalent product, but it subsequently came to light that the saskatoon had been commercialised in Finland back in 1996, and following notification by the Finnish authorities the berry was approved at the end of 2004 on the basis that it wasn’t novel.
Duplication also plagues the regime. In theory, a manufacturer could receive approval for use of a novel food after just one safety assessment carried out by the member state authority that receives the application. In practice, however, the European Food Safety Authority (EFSA) often ends up carrying out another safety assessment because of objections raised by other member states. To date, only one authorisation has been granted without the EFSA carrying out its own assessment – an application on behalf of Arla Food Ingredients amba to use the sugar D-Tagatose as a food ingredient in baked goods and ready-to-eat cereals.
Another complication is that securing approval for a fruit does not necessarily mean approval has been secured for any other substance derived from that fruit and vice versa.
Such is the case with the baobab. Another example is that of the kiwiberry. Efficas has applied for approval to use kiwiberry concentrate in a number of products traditionally consumed in the EU.
Although Waitrose was selling fresh kiwiberries last year, because the concentrate is being separated from its source, it must gain separate novel foods approval before it is sold in the EU.
Needless to say, securing approval for a novel food is not cheap. “It is costly for industry to provide all the data required, which discourages innovation,” says a Food and Drink Federation spokeswoman. “That is especially true for small businesses.”
Fortunately, the European Commission has acknowledged some of these issues. Under the proposed new regime, applications will be handled by a centralised body, the EFSA, which will conduct the sole safety assessment. The thinking is that a ‘one door, one key’ approach will lead to a more unified and efficient system, significantly reducing the time it takes for a novel food to become authorised.
The commission has also recommended a simplified application process for foods that have a history of safe consumption outside the EU. If this particular proposal is enshrined in the legislation, it will mean foods such as baobab pulp ought to find a far quicker route to market.
Replacing such a “cumbersome and unsuitable” regime can only be a welcome move, says Lombard, who feels the proposed regime would be “a positive step for us and much more fair to products that have a history of safe use”.
Unilever’s Gordon is equally in favour of a more centralised system of authorisation and believes it might remove some of the inconsistency that currently exists. He also foresees benefits in the ‘one voice’ approach. While the authorisation procedure for health foods is separate from novel foods, “we’re interested in having health and safety being looked at by the same group and at the same time”, he says.
However, he has some reservations, particularly over the allocation of resources within the EFSA to the new regime. On the face of the proposals, centralisation of the approvals system would increase the workload of the EFSA. “That’s the big question for us: is the EFSA set up to do this? We certainly hope it is,” says Gordon.
Even if it is still tricky to win approval for a novel food, you can bet more applications will be submitted over the next few years as more suppliers wake up to the potential rewards of gaining access to 27 European markets. The potential scale of the influx of novel foods to the EU is difficult to gauge, but the European Commission describes it as “significant”.
Most experts predict if not a tsunami of new foods hitting stores, at least a decent-sized wave. “I would be surprised if there isn’t a greater flow of new materials coming through the system,” says Lombard.
Elizabeth Hyde, Solicitor at law firm Eversheds, agrees. “There’s certainly an incentive for companies to try and have novel foods introduced because of that quicker turnaround,” she says.
Meanwhile, manufacturers must wait. Even if the new regime is approved, it is unlikely to come into force in the UK before 2011. If and when it does, who knows what will replace the baobab as the next big thing?
Five novel foods being evaluated by the FSA:
DHA-rich microalgal oil: an application was made in 2007 by Martek Biosciences for use in bakery products, nutrition bars, non-alcoholic drinks and milk-based drinksKiwiberry concentrate: in 2007 Efficas applied to use kiwiberry concentrate in drinks, cereal products, milk products, sugars, preserves, confectionery and savoury snacksPhosphated distarch phosphate: derived from maize and used in the EU as a thickener, the company National Starch Food Innovation applied in 2005 to use the substance as a dietary fibreD-ribose: having recently submitted an application to the FSA in April 2008, Bioenergy hopes to use this naturally occurring sugar in a range of sports and energy drinksLentinan-rich extract: GlycaNova wants to use this substance, made from fermented shiitake mushrooms, as a food supplement and ingredient. It applied for approval in July 2008Five exotic foods that may make it to the UK one day... The desert date: grown in Africa, particularly Sudan, it is similar to the dates we know, with a dark, sticky flesh Dika nuts: can be roasted and either eaten as they are or ground and used to thicken hot dishes Marama: a plant that produces beans that could become an alternative to the peanut or soyabean Egusi seeds: fat and protein-rich seeds used in West African egusi soupPeach palm: both the ‘heart of palm’ and the fruit of the plant can be eaten
DHA-rich microalgal oil: an application was made in 2007 by Martek Biosciences for use in bakery products, nutrition bars, non-alcoholic drinks and milk-based drinksKiwiberry concentrate: in 2007 Efficas applied to use kiwiberry concentrate in drinks, cereal products, milk products, sugars, preserves, confectionery and savoury snacksPhosphated distarch phosphate: derived from maize and used in the EU as a thickener, the company National Starch Food Innovation applied in 2005 to use the substance as a dietary fibreD-ribose: having recently submitted an application to the FSA in April 2008, Bioenergy hopes to use this naturally occurring sugar in a range of sports and energy drinksLentinan-rich extract: GlycaNova wants to use this substance, made from fermented shiitake mushrooms, as a food supplement and ingredient. It applied for approval in July 2008Five exotic foods that may make it to the UK one day... The desert date: grown in Africa, particularly Sudan, it is similar to the dates we know, with a dark, sticky flesh Dika nuts: can be roasted and either eaten as they are or ground and used to thicken hot dishes Marama: a plant that produces beans that could become an alternative to the peanut or soyabean Egusi seeds: fat and protein-rich seeds used in West African egusi soupPeach palm: both the ‘heart of palm’ and the fruit of the plant can be eaten
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