832:
175:). 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.
210:
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
164:
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
265:
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
214:
Following the 2011 standstill, the
Commission decided to table a new proposal in December 2013, limiting its scope to the safety of novel foods, where a general agreement had already been reached in the previous dealing, while deferring the cloning issue to separate legislation. This time,
206:
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
211:
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. Unable to move things forward, the Commission gave up the revision process for the time being.
182:, a botanical regulatory consultant (together with his 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
215:
negotiations eventually proved successful, and the Novel Food
Regulation (EC) No. 2015/2283 was finally approved in November 2015, and entered into force on 1 January 2018, following the adoption by the Commission of required implementation acts.
241:
The Novel Foods
Regulation requires that a company wanting to sell a novel food notify Health Canada prior to marketing or advertising the product. Pre-market notification permits Health Canada to conduct a thorough safety assessment of all
134:
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.
207:
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.
678:
186:
components in Baobab to demonstrate safety. This has lowered the costs for approval from an average of €10 million to less than €100,000 and thus opened the EU to access non-Western fruits, vegetables and
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682:
522:
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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.
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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
747:
161:. 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.
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Text of
Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients
618:
588:
398:
Regulation (EC) No 258/97 of the
European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients
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523:"The impact of the European Novel Food Regulation on trade and food innovation based on traditional plant foods from developing countries"
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Originally, the Novel Food legislation was conceived by the European Commission in response to the arrival of food products derived from
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696:
35:
is a type of novel food that has not existed on any regional or global consumer market before. Instead it has been "designed" using
732:
142:
There have been a number of products launched as a result of food or food ingredients authorised under the Novel Food legislation.
24:
that does not have a significant history of consumption or is produced by a method that has not previously been used for food.
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139:(FSA) in the UK, believes that the novel food in question is substantially equivalent to an existing food or food ingredient.
374:
120:
The Novel Food regulation stipulates that foods and food ingredients falling within the scope of this regulation must not:
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began talks to revise the regulation because it was accepted that essential elements needed to be discussed and resolved.
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858:
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397:
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Summaries of EU legislation > Consumers > Consumer safety > Novel foods and novel food ingredients
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to demonstrate that a novel food is safe and nutritious before it is allowed in the Canadian marketplace.
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47:) or "enhanced" using engineered additives. Examples like designer egg, designer milk, designer grains,
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117:, which highlights the scientific information and the safety assessment report required in each case.
243:
227:, novel foods are regulated under the Novel Foods Regulations. The regulations define novel food as:
44:
625:
619:"Baobab Dried Fruit Pulp – An application for Novel Foods Approval in the EU as a food ingredient"
280:
816:
780:"Factsheets and Frequently Asked Questions - Genetically Modified Foods and Other Novel Foods"
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To date, more than 90 novel foods have been approved for sale in Canada including a number of
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136:
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contention for food manufacturers and producers outside the EU who view this as an economic
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Foods that result from a process that has not been previously used for food; or
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679:"Statement from the Parliament on the collapse of the novel foods talks"
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697:"Statement from the Council on failure of conciliation on novel foods"
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661:"Food Ingredients & Food Science - Additives, Flavours, Starch"
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Foods that have undergone genetic modification and have new traits.
169:. A good example of this situation can be illustrated with baobab (
86:, the aesthetic arrangement of food items for marketing purposes.
715:"Council statement on the failure of conciliation on novel foods"
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The Baobab Dried Fruit Pulp novel food application, pioneered by
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143:
831:
748:"Parliament vote on novel foods heats up cloned animals debate"
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224:
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Applicants can consult the guidance document compiled by the
643:"List of authorisations under the old novel food regulation"
361:. Vol. 401. Boston, MA: Springer US. pp. 213–220.
262:
199:
In 2008, the European Parliament, European Commission, and
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21:
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while at the same time saving unnecessary animal testing.
71:. Designer novel food often comes with sometimes unproven
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The EU Novel Food Regulation: an unintended trade barrier
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are commercially successful products that help to reduce
146:, containing phytostanols and Flora ProActiv, containing
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Overview of the breakdown of the novel food discussions
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have no history of "significant" consumption in the
63:have been cited. The enhancement process is called
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300:Rajasekaran, A.; Kalaivani, M. (22 May 2012).
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359:Advances in Experimental Medicine and Biology
302:"Designer foods and their benefits: A review"
746:Michalopoulos, Sarantis (4 November 2015).
231:Products that have never been used as food;
733:"Novel foods review stumbles over cloning"
357:Finley, John W. (1996). "Designer Foods".
333:
195:Revision of the EU novel food regulation
520:
851:
356:
306:Journal of Food Science and Technology
762:"EUR-Lex - 32015R2283 - EN - EUR-Lex"
504:"EUR-Lex - 32003R1829 - EN - EUR-Lex"
486:"EUR-Lex - 32004D0335 - EN - EUR-Lex"
468:"EUR-Lex - 32000D0500 - EN - EUR-Lex"
450:"EUR-Lex - 32004D0333 - EN - EUR-Lex"
414:"EUR-Lex - 31997H0618 - EN - EUR-Lex"
82:Designer food is distinguished from
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593:webarchive.nationalarchives.gov.uk
124:present a danger for the consumer;
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647:Food Safety - European Commission
436:Food Safety - European Commission
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589:"ACNFP: Baobab dried fruit pulp"
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786:. Health Canada. 27 July 2003.
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1:
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542:10.1016/j.foodpol.2009.08.005
201:Council of the European Union
367:10.1007/978-1-4613-0399-2_19
312:(1). Springer Nature: 1–16.
276:Generally recognized as safe
7:
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244:biotechnology-derived foods
10:
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400:– consolidated version of
94:Novel foods or novel food
521:Hermann, Michael (2009).
318:10.1007/s13197-012-0726-8
218:
45:genetically modified food
844:EU 2013 revision of regs
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127:mislead the consumer; or
859:European Union food law
719:www.consilium.europa.eu
701:www.consilium.europa.eu
281:Substantial equivalence
51:, and enrichment with
839:at Wikimedia Commons
137:Food Standards Agency
266:health and safety.
115:European Commission
104:European Parliament
649:. 17 October 2016.
438:. 17 October 2016.
172:Adansonia digitata
65:food fortification
835:Media related to
766:eur-lex.europa.eu
665:foodnavigator.com
508:eur-lex.europa.eu
490:eur-lex.europa.eu
472:eur-lex.europa.eu
454:eur-lex.europa.eu
418:eur-lex.europa.eu
376:978-1-4613-8034-4
61:designer proteins
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735:. 29 March 2011.
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685:on 2 April 2011.
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826:External links
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571:"biotrade.org"
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189:nutraceuticals
180:John Wilkinson
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100:European Union
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57:macronutrients
43:methods (e.g.
41:bioengineering
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601:. Retrieved
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553:. Retrieved
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17:
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603:2 September
555:27 November
530:Food Policy
152:cholesterol
106:and of the
96:ingredients
84:food design
853:Categories
837:Novel food
795:References
259:cottonseed
77:superfoods
49:probiotics
18:novel food
385:0065-2598
326:0022-1155
402:7.8.2009
344:24425882
270:See also
159:GM crops
154:levels.
335:3550947
144:Benecol
108:Council
383:
373:
342:
332:
324:
251:canola
225:Canada
219:Canada
55:- and
629:(PDF)
622:(PDF)
549:(PDF)
526:(PDF)
287:Notes
53:micro
605:2009
557:2011
381:ISSN
371:ISBN
340:PMID
322:ISSN
263:flax
261:and
255:corn
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59:and
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