Novel food
Encyclopedia
Novel food is defined as a type of food
that does not have a significant history of consumption or is produced by a method that has not previously been used for food.
s have no history of “significant” consumption in the European Union
prior to 15 May 1997. Any food or food ingredient that falls within this definition must be authorised according to the Novel Food legislation, Regulation (EC) No 258/97 of the European Parliament
and of the Council
.
A company that wishes to submit an application under this legislation should consult the guidance document compiled by the European Commission
, which highlights the scientific information and the safety assessment report required in each case.
The Novel Food regulation stipulates that foods and food ingredients falling within the scope of this regulation must not:
There are two possible routes for authorization under the Novel Food legislation: a full application and a simplified application. The simplified application route is only applicable where the EU member national competent authority, e.g. Food Standards Agency
(FSA) in the UK, believes that the novel food in question is substantially equivalent to an existing food or food ingredient.
The FSA has provided guidance for companies that wish to submit a simplified novel food application.
There have been a number of products launched as a result of food or food ingredients authorised under the Novel Food legislation. Benecol
, containing phytostanols and Flora ProActiv, containing phytosterol
s are commercially successful products that help to reduce cholesterol
levels.
Originally, the Novel Food legislation was conceived by the European Commission in response to the arrival of food products derived from GM crops. These types of GM derived food are now regulated by separate legislation, Regulation (EC) No 1829/2003 of the European Parliament and of the Council.
In its current format, exotic fruit and vegetables, which have a long history of safe use outside of the European Union, fall within the definition of a novel food. As a consequence, each of these food products must undergo a safety assessment prior to being marketed. This has long been an issue of contention for food manufacturers and producers outside the EU who view this as an economic trade barrier . A good example of this situation can be illustrated with Baobab
(Adansonia digitata). This fruit is wild-harvested across Southern Africa and has a long history of use as a food amongst the indigenous tribes in this continent. Nonetheless, Baobab Dried Fruit Pulp required authorisation under the Novel Food legislation before any food products containing this ingredient could be marketed in the EU.
The Baobab Dried Fruit Pulp novel food application, pioneered by John Wilkinson
of Herbal Sciences International, a botanical regulatory consultancy company, together with their client Phytotrade Africa, was also the first successful submission to demonstrate safety without the need for animal testing. Instead, this application used the history of use alongside detailed analyses of the nutritional and phytochemical
components in Baobab to demonstrate safety. This has lowered the costs for approval from an average of 10 million euros to less than 100,000 euros and thus opened the EU to access non western fruits, vegetables and nutraceutical
s while at the same time saving unnecessary animal testing.
, European Commission
and Council of the European Union
began talks to revise the regulation because it was accepted that essential elements needed to be discussed and resolved.
However, the revision came to a standstill on 28 March 2011 when the three institutions failed to reach agreement at a final conciliation meeting on the issue of cloning. Disagreement centred on the European Parliament being in favour of a total EU market ban on foods from clones and their offspring/descendants, while some members of the Council of the European Union were not in favour as they considered offspring to be bred using normal (or traditional) methods, therefore not falling under the definition of a novel food.
According to the European Parliament it had tried to compromise, backing down on demands for a full ban on food from cloned animals and their descendants, to mandatory labelling of all food products from clones and their offspring as a bare minimum. The Council of the European Union decided that the solution presented by the European Parliament could not be implemented in practice because it would not be in compliance with the international trade rules that the European Union has signed.
The cloning technique is not banned at EU level, and since March 2011 it has been unclear if and how the institutions will move forward on a revision of the regulation. Therefore the existing novel food regulation, adopted in 1997, remains in place.
, novel foods are regulated under the Novel Foods Regulations. The regulations define novel food as
The Novel Foods Regulation requires that a company wanting to sell a novel food notify Health Canada by prior to marketing or advertising the product. Pre-market notification permits Health Canada to conduct a thorough safety assessment of all biotechnology-derived foods to demonstrate that a novel food is safe and nutritious before it is allowed in the Canadian marketplace.
To date, more than 90 novel foods have been approved for sale in Canada including a number of canola
, corn, cottonseed and flax
crop lines. Some of the novel traits include herbicide tolerance and pest and disease resistance. In spite of the benefits brought about by the development of novel foods, there are also a number of concerns that have been raised concerning their potential impact on the environment and on human health and safety.
Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals...
that does not have a significant history of consumption or is produced by a method that has not previously been used for food.
European Union
Novel foods or novel food ingredientIngredient
An ingredient is a substance that forms part of a mixture . For example, in cooking, recipes specify which ingredients are used to prepare a specific dish. Many commercial products contain a secret ingredient that is purported to make them better than competing products...
s have no history of “significant” consumption in the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
prior to 15 May 1997. Any food or food ingredient that falls within this definition must be authorised according to the Novel Food legislation, Regulation (EC) No 258/97 of the European Parliament
European Parliament
The European Parliament is the directly elected parliamentary institution of the European Union . Together with the Council of the European Union and the Commission, it exercises the legislative function of the EU and it has been described as one of the most powerful legislatures in the world...
and of the Council
European Council
The European Council is an institution of the European Union. It comprises the heads of state or government of the EU member states, along with the President of the European Commission and the President of the European Council, currently Herman Van Rompuy...
.
A company that wishes to submit an application under this legislation should consult the guidance document compiled by the European Commission
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
, which highlights the scientific information and the safety assessment report required in each case.
The Novel Food regulation stipulates that foods and food ingredients falling within the scope of this regulation must not:
- present a danger for the consumer,
- mislead the consumer,
- differ from foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer.
There are two possible routes for authorization under the Novel Food legislation: a full application and a simplified application. The simplified application route is only applicable where the EU member national competent authority, e.g. Food Standards Agency
Food Standards Agency
The Food Standards Agency is a non-ministerial government department of the Government of the United Kingdom. It is responsible for protecting public health in relation to food throughout the United Kingdom and is led by a board appointed to act in the public interest...
(FSA) in the UK, believes that the novel food in question is substantially equivalent to an existing food or food ingredient.
The FSA has provided guidance for companies that wish to submit a simplified novel food application.
There have been a number of products launched as a result of food or food ingredients authorised under the Novel Food legislation. Benecol
Benecol
is a brand of cholesterol lowering food products owned by and is a trademark of Finnish company Raisio Group.Raisio Group licenses the Benecol brand and sells the effective and safe cholesterol lowering ingredient, Plant stanol ester, to food companies around the world...
, containing phytostanols and Flora ProActiv, containing phytosterol
Phytosterol
Phytosterols, which encompass plant sterols and stanols, are steroid compounds similar to cholesterol which occur in plants and vary only in carbon side chains and/or presence or absence of a double bond. Stanols are saturated sterols, having no double bonds in the sterol ring structure. More than...
s are commercially successful products that help to reduce cholesterol
Cholesterol
Cholesterol is a complex isoprenoid. Specifically, it is a waxy steroid of fat that is produced in the liver or intestines. It is used to produce hormones and cell membranes and is transported in the blood plasma of all mammals. It is an essential structural component of mammalian cell membranes...
levels.
Originally, the Novel Food legislation was conceived by the European Commission in response to the arrival of food products derived from GM crops. These types of GM derived food are now regulated by separate legislation, Regulation (EC) No 1829/2003 of the European Parliament and of the Council.
In its current format, exotic fruit and vegetables, which have a long history of safe use outside of the European Union, fall within the definition of a novel food. As a consequence, each of these food products must undergo a safety assessment prior to being marketed. This has long been an issue of contention for food manufacturers and producers outside the EU who view this as an economic trade barrier . A good example of this situation can be illustrated with Baobab
Baobab
Adansonia is a genus of eight species of tree, six native to Madagascar, one native to mainland Africa and the Arabian Peninsula and one to Australia. The mainland African species also occurs on Madagascar, but it is not a native of that island....
(Adansonia digitata). This fruit is wild-harvested across Southern Africa and has a long history of use as a food amongst the indigenous tribes in this continent. Nonetheless, Baobab Dried Fruit Pulp required authorisation under the Novel Food legislation before any food products containing this ingredient could be marketed in the EU.
The Baobab Dried Fruit Pulp novel food application, pioneered by John Wilkinson
John Wilkinson (scientist)
Dr John Wilkinson is an English scientist who program led the first European degree course for herbal medicine at Middlesex University in the UK in 1994.-Early life:...
of Herbal Sciences International, a botanical regulatory consultancy company, together with their client Phytotrade Africa, was also the first successful submission to demonstrate safety without the need for animal testing. Instead, this application used the history of use alongside detailed analyses of the nutritional and phytochemical
Phytochemical
Phytochemicals are biologically active chemical compounds that occur naturally in plants . Phytochemicals are the molecules responsible for the color and organoleptic properties . For example, the deep purple color of blueberries and the smell of garlic...
components in Baobab to demonstrate safety. This has lowered the costs for approval from an average of 10 million euros to less than 100,000 euros and thus opened the EU to access non western fruits, vegetables and nutraceutical
Nutraceutical
Nutraceutical, a portmanteau of the words “nutrition” and “pharmaceutical”, is a food or food product that reportedly provides health and medical benefits, including the prevention and treatment of disease. Health Canada defines the term as "a product isolated or purified from foods that is...
s while at the same time saving unnecessary animal testing.
Revision of the EU novel food regulation
In 2008 the three EU institutions, European ParliamentEuropean Parliament
The European Parliament is the directly elected parliamentary institution of the European Union . Together with the Council of the European Union and the Commission, it exercises the legislative function of the EU and it has been described as one of the most powerful legislatures in the world...
, European Commission
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
and Council of the European Union
Council of the European Union
The Council of the European Union is the institution in the legislature of the European Union representing the executives of member states, the other legislative body being the European Parliament. The Council is composed of twenty-seven national ministers...
began talks to revise the regulation because it was accepted that essential elements needed to be discussed and resolved.
However, the revision came to a standstill on 28 March 2011 when the three institutions failed to reach agreement at a final conciliation meeting on the issue of cloning. Disagreement centred on the European Parliament being in favour of a total EU market ban on foods from clones and their offspring/descendants, while some members of the Council of the European Union were not in favour as they considered offspring to be bred using normal (or traditional) methods, therefore not falling under the definition of a novel food.
According to the European Parliament it had tried to compromise, backing down on demands for a full ban on food from cloned animals and their descendants, to mandatory labelling of all food products from clones and their offspring as a bare minimum. The Council of the European Union decided that the solution presented by the European Parliament could not be implemented in practice because it would not be in compliance with the international trade rules that the European Union has signed.
The cloning technique is not banned at EU level, and since March 2011 it has been unclear if and how the institutions will move forward on a revision of the regulation. Therefore the existing novel food regulation, adopted in 1997, remains in place.
Canada
In CanadaCanada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...
, novel foods are regulated under the Novel Foods Regulations. The regulations define novel food as
- Products that have never been used as food,
- Foods that result from a process that has not been previously used for food, or,
- Foods that have undergone genetic modification and have new traits.
The Novel Foods Regulation requires that a company wanting to sell a novel food notify Health Canada by prior to marketing or advertising the product. Pre-market notification permits Health Canada to conduct a thorough safety assessment of all biotechnology-derived foods to demonstrate that a novel food is safe and nutritious before it is allowed in the Canadian marketplace.
To date, more than 90 novel foods have been approved for sale in Canada including a number of canola
Canola
Canola refers to a cultivar of either Rapeseed or Field Mustard . Its seeds are used to produce edible oil suitable for consumption by humans and livestock. The oil is also suitable for use as biodiesel.Originally, Canola was bred naturally from rapeseed in Canada by Keith Downey and Baldur R...
, corn, cottonseed and flax
Flax
Flax is a member of the genus Linum in the family Linaceae. It is native to the region extending from the eastern Mediterranean to India and was probably first domesticated in the Fertile Crescent...
crop lines. Some of the novel traits include herbicide tolerance and pest and disease resistance. In spite of the benefits brought about by the development of novel foods, there are also a number of concerns that have been raised concerning their potential impact on the environment and on human health and safety.
See also
- AstaxanthinAstaxanthinAstaxanthin is a carotenoid. It belongs to a larger class of phytochemicals known as terpenes. It is classified as a xanthophyll, which means "yellow leaves". Like many carotenoids, it is a colorful, lipid-soluble pigment. Astaxanthin is found in microalgae, yeast, salmon, trout, krill, shrimp,...
- Generally recognized as safeGenerally recognized as safeGenerally recognized as safe is an American Food and Drug Administration designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act food additive tolerance requirements.-History:On January 1, 1958,...
- ChiaSalvia hispanicaSalvia hispanica, commonly known as chia, is a species of flowering plant in the mint family, Lamiaceae, native to central and southern Mexico and Guatemala. The 16th century Codex Mendoza provides evidence that it was cultivated by the Aztec in pre-Columbian times; it has been said that it was an...
- Substantial equivalenceSubstantial equivalenceSubstantial equivalence is a concept, developed by OECD in 1991, that maintains that a novel food should be considered the same as and as safe as a conventional food if it demonstrates the same characteristics and composition as the conventional food. Substantial equivalence is important from a...
- SteviaSteviaStevia is a genus of about 240 species of herbs and shrubs in the sunflower family , native to subtropical and tropical regions from western North America to South America. The species Stevia rebaudiana, commonly known as sweetleaf, sweet leaf, sugarleaf, or simply stevia, is widely grown for its...