ARTICLE
Auteur(s) : Carole Kohler
Conseil Alimentation Santé, 35 rue des Equarts, 79000 Niort,
France
Novel foods are foods and food ingredients that have not been
used for human consumption to a significant degree within the
Community before 15 May 1997. Regulation (EC) No 258/97 [1] of 27
January 1997 of the European Parliament and the Council lays out
detailed rules for the authorisation of novel foods and novel food
ingredients.
Foods commercialised in at least one Member State before the
entry into force of the Regulation on Novel Foods on 15 May 1997,
are on the EU market under the “principle of mutual recognition”.
In order to ensure the highest level of protection of human health,
novel foods must undergo a safety assessment before being placed on
the EU market. Only those products considered to be safe for human
consumption are authorised for marketing.
Legislation
Regulation (EC) No 258/97 is applying to foods and food ingredients
that have not been on the EU market to a significant degree before
May 1997 and that fall under the following categories:
- – foods and food ingredients with a new or intentionally
modified primary molecular structure;
- – foods and food ingredients consisting of or isolated
from micro-organisms, fungi or algae;
- – foods and food ingredients consisting of or are
isolated from plants or isolated from animals; except for food and
food ingredients obtained by traditional propagating or breeding
practices and having a history of safe food use;
- – foods and food ingredients to which has been applied a
production process not currently used, where that process gives
rise to significant changes in the composition or structure of the
foods or food ingredients which affect their nutritional value,
metabolism or level of undesirable substances.
The regulation is not applicable to:
- – food additives, falling within the scope of Council
Directive 89/107/EEC of 21 December 1988 [2] ;
- – flavourings for use in foodstuffs, falling within the
scope of Council Directive 88/388/EEC of 22 June 1988 [3];
- – extraction solvents used in the production of
foodstuffs, falling within the scope of Council Directive
88/344/EEC of 13 June 1988 [4].
GMO’s
Since 2003, most GMOs have been approved under regulation (EC) No
1829/2003 [5]. New GMO maizes, applications for the marketing of
which were submitted under Regulation (EC) No 258/97, have been
authorised. Their labelling is based on regulation (EC) No
1829/2003 and they are subject to the traceability requirements
established by Regulation (EC) No 1830/2003 [6].
Notified foods
Novel foods or novel food ingredients may follow a simplified
procedure, only requiring notifications from the company, when they
are considered by a national food assessment body as “substantially
equivalent” to existing foods or food ingredients (as regards their
composition, nutritional value, metabolism, intended use and the
level of undesirable substances contained therein).
Application report
Companies that want to place a novel food on the EU market need to
submit their application in accordance with Commission
Recommendation 97/618/EC [7] that concerns the scientific
information and the safety assessment report required.
The identification of essential information for assessment is
guided by eight structured schemes provided the information
required to support the safety and nutritional evaluation of the
novel food:
- I. Specification of the novel food.
- II. Effect of the production process applied to the
novel food.
- III. History of the organism used as the source of the
novel food.
- IX. Anticipated intake/extent of use of the novel
food.
- X. Information from previous human exposure to the novel
food or its source.
- XI. Nutritional information on the novel food.
- XII. Microbiological information on the novel food.
- XIII. Toxicological information on the novel food
Evaluation procedure
Before being placed on the market, the foods and foods ingredients
referred to in the regulation must undergo Community assessment, as
a result of which an authorisation decision may be taken.
Under the assessment procedure, the applicant (manufacturer,
retailer…) must submit his application to the Member State which
will market for the first time the Novel foods. Hence, the
competent body of the Member State which receives the application
must make an initial assessment and determine whether or not an
additional assessment is required. If neither the Commission,
assisted by the Standing Committee on the Food Chain and Animal
Health1 nor the Member States raise
an objection, and if no additional assessment is required, the
Member State informs the applicant that he may place the product on
the market.
In other cases the Commission must take an authorisation
decision with the assistance of the Standing Committee for
Foodstuffs. Any decision or provision concerning a novel food or
food ingredient which is likely to have an effect on public health
must be referred to the Scientific Committee for Food.
The experience is all too be aware of the lenght of this
procedure, in average 2 to 6 years. It should be mentionnned as
well that the choice of the member state is important. In fact, the
evaluation systems of the different authorities are not
equivalent : some countries such as Belgium and UK offer a
cooperative but charged approach with the applicant, around 3000 to
4000 € for a complete dossier.
Authorisations
The authorisation decision defines the scope of the authorisation
and specifies, as appropriate, the conditions of use, the
designation of the food or food ingredient, its specification and
the specific labelling requirements.
A total of 80 applications2 have
been made between May 1997 and March 2008 including the GM foods
applications. Three categories of Novel foods are in practice
requested:
- – innovative food (e.g. phystosterols foodstuffs,
threhalose, phospholipids isolated from egg yellow);
- – traditional food from third countries (e.g. noni
juice);
- – food produced by new production techniques with
possible impact on food (e.g. high-pressure pasteurised fruit
juice).
For 20 products the application of the placing on the market was
withdrawn or was refused (e.g. nangai nuts, Stevia
rabaudiana); and for 140 products the notification3 of the placing on the market was recognised
(e.g. argan oil).
By March 2008, thereby 37% of novel foods requested have been
approved to be commercialised in the Europe. Novel food lipids are
representating respectively 7.5% of the total of applications and
about 20% of the novel foods authorised (table
1).
Table 1 Novel food lipids: authorised and under
evaluation (june 2008).
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Novel food lipids authorised
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Novel food lipids under evaluation (june 2008)
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- – Yellow fat spreads with added phytosterol-esters,
- – DHA-rich oil,
- – Rapeseed oil high in unsaponifiable matter,
- – Maize germ oil high in unsaponifiable matter,
- – ENOVA™-oil, Diacylglycerol Oil (DAG oil),
- – MultOils (oil containing a diacylglycerol-rich fat
component and a free phytosterol esters component).
- – Diminicol, phytosterol enriched fat ingredient
- – Refined Echium oil (Echium plantagineum),
- – Allanblackia seed oil for use in yellow fat spread and
cream based spreads,
- – Oil enriched with phytosterols/phytostenols.
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- – Vegetable oil from Inca Inchi (Plukenetia volubilis
linneo),
- – Conjugated Linoleic Acid (CLA),
- – Triterpene rich Shea Butter Unsaponifiables,
- – Lipid extract from Euphausia superba,
- – Cis-9-cetyl myristoleate
- – Tomato oleoresin containing lycopene for use in foods
for special medical purposes and food uses
- – Synthetic lycopene in sunflower oil dispersion
- – Additional uses of DHA (docahexaenoic acid)-rich oil
from microalgae Ulkenia sp.
- – Fungal Oil SUN-TGA40S
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Review of Regulation (EC) No 258/97
A revision of the Novel Food Regulation is deemed necessary in
order to reflect the fact that genetically modified (GM) food no
longer falls under its scope, to create a more favourable
legislative environment for innovation in the food industry, and to
better facilitate both internal and external trade in foodstuffs.
An online consultation4 on the
revision of Novel Food Regulation (EC) No 258/97 was launched by
the European Commission, to gather input from the general public,
stakeholders and Member States in order to carry out an impact
assessment for a future legislative proposal to revise the current
Novel Food Regulation.
From the 14th of January 2008, the European Commission has
adopted a proposal (COM(2007)872)5 to
revise the Novel Foods Regulation (EC) No 258/97 with a view to
improving the access of new and innovative foods to the EU market,
while maintaining a high level of consumer protection and ensuring
food safety. Under the draft regulation, novel foods would be
subject to centralised authorisation procedure. The Commission will
receive the application for authorisation and the European Food
Safety Authority (EFSA)6 will carry
out the scientific assessment on the product.
The “one door – one key” approach will be taken for the approval
of novel foods, just as it will be for food additives, food enzymes
and food flavourings. This means that the applicant may make one
application for approval covering all these possible uses of the
substance in question.
The proposal also sets out data protection rules, which aim to
protect newly developed foodstuffs once authorised, and encourage
companies to invest in developing new types of foods and food
production techniques. Moreover, a notification procedure is
introduced for foods which have not been traditionally sold in the
EU but which have a safe history of use in third countries.
Conclusion
In practice, novel foods are newly developed innovative foods and
foods produced by new technologies with possible impact on food, as
well as exotic traditional foods from outside the EU. Since 2004,
GM foods are separately regulated by Regulation (EC) No 1829/2003.
The EU has since 1997 received 80 applications for approval from
more than 45 companies (GM foods included). Over recent years, 7-10
applications per year have been submitted.
The consultation from 2002 to 2007 of the main stakeholders has
underlined the importance of and the need to develop and update the
regulation; in order to streamline the authorisation procedure,
develop a more adjusted safety assessment system for traditional
food from third countries, and to improve the efficiency,
transparency and application of the authorisation system.
The proposal of the revision of regulation has been adopted in
January 2008. Normally, the revision of this regulation shall not
enter into force before 2010. Thus, the companies would benefit of
a more favourable legislative environment for innovation in the
food industry, and of a better foodstuffs trade between Europe and
the rest of the world. The consumer would also benefit from a wider
choice of safe novel foods.
References
1 European Parliament and of the Council. Regulation (EC) No 258/97
of the European Parliament and of the Council of 27 January 1997
concerning novel foods and novel food ingredients. OJL 043,
14/02/1997, p. 0001-6)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31997R0258:EN:HTML.
2 European Council. Council Directive 89/107/EEC of 21 December
1988 on the approximation of the laws of the Member States
concerning food additives authorized for use in foodstuffs intended
for human consumption. OJL 40, 11/2/1989, p. 27–33)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31989L0107:EN:HTML.
3 European Council. Council Directive 88/388/EEC of 22 June 1988
on the approximation of the laws of the Member States relating to
flavourings for use in foodstuffs and to source materials for their
production. OJL 184, 15/7/1988, p. 61-6
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31988L0388:EN:HTML.
4 European Council. Council Directive 88/344/EEC of 13 June 1988
on the approximation of the laws of the Member States on extraction
solvents used in the production of foodstuffs and food ingredients.
OJL 157, 24/6/1988, p. 28–33)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31988L0344:EN:HTML.
5 European Parliament and of the Council. Regulation (EC) No
1829/2003 of the European Parliament and of the Council of 22
September 2003 on genetically modified food and feed, (OJ L 268,
18/10/2003, p. 1–23)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32003R1829:EN:HTML.
6 European Parliament and of the Council. Regulation (EC) No
1830/2003 of the European Parliament and of the Council of 22
September 2003 concerning the traceability and labelling of
genetically modified organisms and the traceability of food and
feed products produced from genetically modified organisms and
amending Directive 2001/18/EC, (OJ L 268, 18/10/2003, p. 24–28)
http://ec.europa.eu/environment/biotechnology/pdf/regu1830_2003.pdf.
7 European Commission. Commission Recommendation 97/618/EC of 29
July 1997 concerning the scientific aspects and the presentation of
information necessary to support applications for the placing on
the market of novel foods and novel food ingredients and the
preparation of initial assessment reports under Regulation (EC) No
258/97 of the European Parliament and of the Council, (OJ L 253,
16/09/1997, p. 0001 – 0036).
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31997H0618:EN:HTML.
1 Health & Consumer Protection
Directorate General (DG SANCO).
http://ec.europa.eu/dgs/health_consumer/index_fr.htm.
2 The liste of Applications for
Authorisation of novel foods.
http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm.
3 The liste of Notifications of novel
foods.
http://ec.europa.eu/food/food/biotechnology/novelfood/notified_en.htm.
4 Responses to the online consultation on
the revision of novel food regulation EC 258/97, Summary report on
the impact assessment for a Regulation replacing Regulation (EC) no
258/97 on novel foods and novel food ingredients, Report on impact
assessment for a Regulation replacing Regulation (EC) no 258/97 on
novel foods and novel food ingredients.
http://ec.europa.eu/food/food/biotechnology/novelfood/initiatives_en.htm.
5 COM(2007)872: Proposal for a Regulation
of the European Parliament and of the Council on novel foods and
amending Regulation (EC) No xxx/xxxx [common procedure].
http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm.
6 Official website of the European Food
Safety Authority (EFSA).
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_home.htm.
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