<b>Bijsluiter</b>. De hyperlink naar het originele document werkt niet meer. Daarom laat Woogle de tekst zien die in dat document stond. Deze tekst kan vreemde foutieve woorden of zinnen bevatten en de opmaak kan verdwenen of veranderd zijn. Dit komt door het zwartlakken van vertrouwelijke informatie of doordat de tekst niet digitaal beschikbaar was en dus ingescand en vervolgens via OCR weer ingelezen is. Voor het originele document, neem contact op met de Woo-contactpersoon van het bestuursorgaan.<br><br>====================================================================== Pagina 1 ======================================================================

<pre>-
  Docosahexaeenzuurrijke olie
  Tweede beoordeling van de veiligheid voor de consument, volgens de
  Europese verordening 258/97 betreffende nieuwe voedingsmiddelen en
  nieuwe voedselingrediënten
  Docosahexaenoic acid rich oil
  Second opinion regarding consumer safety, in accordance with European
  Regulation 258/97 concerning novel foods and novel food ingredients
  Gezondheidsraad:
  Commissie Veiligheidsbeoordeling nieuwe voedingsmiddelen (VNV)
  Health Council of the Netherlands:
  Committee on the Safety Assessment of Novel Foods
  aan/to:
  de Minister van Volksgezondheid, Welzijn en Sport/
  the Minister of Health, Welfare and Sport
  de Minister van Landbouw, Natuurbeheer en Visserij/
  the Minister of Agriculture, Nature management and Fisheries
  Nr. 2002/03VNV, Den Haag, 26 augustus 2002
  No. 2002/03VNV, The Hague, August 26 , 2002
</pre>

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<pre>De Gezondheidsraad, ingesteld in 1902, is een adviesorgaan met als taak de regering
en het parlement “voor te lichten over de stand der wetenschap ten aanzien van
vraagstukken op het gebied van de volksgezondheid”(art. 21 Gezondheidswet).
    De Gezondheidsraad ontvangt de meeste adviesaanvragen van de bewindslieden
van Volksgezondheid, Welzijn & Sport; Volkshuisvesting, Ruimtelijke Ordening &
Milieubeheer; Sociale Zaken & Werkgelegenheid en Landbouw, Natuurbeheer &
Visserij. De Raad kan ook eigener beweging adviezen uitbrengen. Het gaat dan als
regel om het signaleren van ontwikkelingen of trends die van belang kunnen zijn voor
het overheidsbeleid.
    De adviezen van de Gezondheidsraad zijn openbaar en worden in bijna alle
gevallen opgesteld door multidisciplinair samengestelde commissies van -op
persoonlijke titel benoemde- Nederlandse en soms buitenlandse deskundigen.
The Health Council of the Netherlands, established in 1902, is an independent
scientific advisory body. Its remit is “to advise the government and Parliament on the
current level of knowledge with respect tot public health issues” (Section 21, Health
Act).
    The Health Council receives most requests for advice from the Ministers of
Health, Welfare & Sport; Housing, Spatial Planning & the Environment; Social Affairs
& Employment, and Agriculture, Nature management & Fisheries.
    Most Health Council reports are prepared by multidisciplinary committees of
Dutch or, sometimes, foreign experts, appointed in a personal capacity. The reports are
available to the public.
Deze publicatie kan als volgt worden aangehaald:
Gezondheidsraad: Commissie Veiligheidsbeoordeling nieuwe voedingsmiddelen.
Docosahexaeenzuurrijke olie. Den Haag: Gezondheidsraad, 2002; publicatie nr.
2002/03VNV.
Preferred citation:
Health Council of the Netherlands: Committee on the Safety Assessment of Novel
Foods. Docosahexaenoic acid rich oil. The Hague: Health Council of the Netherlands,
2002; publication no. 2002/03VNV.
auteursrecht voorbehouden
</pre>

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<pre>all rights reserved</pre>

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<pre>  Inhoud/Contents
  Brief aan de Minister van Volksgezondheid, Welzijn en Sport 4
  Letter to the Minister of Health, Welfare and Sport 8
  Literatuur/Literature 11
  Bijlage/Annexes 13
A De Adviesaanvraag/Request for advice 14
B De commissie/The committee 16
C EU-procedure/EU-procedure 18
D Samenvatting van het dossier/Executive summary of the dossier 21
E Eerste beoordeling/First assessment 32
  Brief aan de Minister van VWS                                    4
</pre>

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<pre>Aanbiedingsbrief (4 A4tjes)
Brief aan de Minister van VWS 5
</pre>

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<br><br>====================================================================== Pagina 6 ======================================================================

<pre>Brief aan de Minister van VWS 6</pre>

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<br><br>====================================================================== Pagina 7 ======================================================================

<pre>Brief aan de Minister van VWS 7</pre>

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<br><br>====================================================================== Pagina 8 ======================================================================

<pre>Brief aan de Minister van VWS 8</pre>

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<pre>Letter to the Dutch Minister of Health,
Welfare and Sport
On August 26, 2002, professor JGAJ Hautvast, Vice-president of the Health Council
of the Netherlands wrote as follows to the Minister of Health, Welfare and Sport:
     This letter has been prepared in reply to your request for advice regarding the
safety of novel foods and food ingredients, also made on behalf of the Minister of
Agriculture, Nature Management and Fisheries. The subject in question is a so-called
second opinion, in accordance with European Regulation 258/97, concerning a
docosahexaenoic-acid-rich oil. The applicant, the company OmegaTech, is going to
market this oil under the trade name of DHA GoldTM (DHA: docosahexaenoic acid).
The oil is being produced using the microalgae Schizochytrium sp. The new product
will not be directly available for consumers, but will be incorporated in variety of
foodstuffs. This assessment has been carried out by the ‘Committee on Safety
Assessment of Novel Foods’ (VNV Committee) of the Health Council of the
Netherlands.
     The initial assessment of the application for market introduction was carried out in
the United Kingdom by the Advisory Committee on Novel Foods and Processes
(ACNFP) of the Food Standards Agency. The ACNFP concluded that the DHA-rich oil
is safe for consumption as a food ingredient to be used as indicated in the dossier. The
Committee based its view on scientific knowledge of fatty-acid metabolism, current
human dietary exposure levels and safety studies carried out by the applicant. The
ACNFP states that the applicant, who manufactures the oil, has agreed to inform those
food producers wishing to incorporate the oil into their products of the recommended
Letter to the Dutch Minister of Health, Welfare and Sport                                 9
</pre>

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<pre>daily dietary allowance of DHA. This information must be made available to
consumers by means of appropriate labelling of the DHA-enriched final food products.
The VNV Committee based its views on the report of the initial assessment by the
ACNFP and on the information contained in the dossier. The VNV Committee largely
agrees with the British assessment. It appears that, in terms of quality, the production
process incorporates the necessary safeguards. The DHA content of the oil is 35 to
45%, and it contains neither undesirable components nor microbiological
contaminants.
     From the nutritional point of view, there is no objection to the use of this oil whose
identified ingredients are already present in our normal diet to some degree. With a
view to the potential health benefits, various national and international scientific
organisations and advisory councils recommend a daily intake of the so-called fish-oil
fatty acids, eicosapentaenoic acid (EPA) and DHA. This recommended intake varies
considerably, not just at the global level, but also within Europe itself. The values
range from 200 mg to almost 2000 mg per individual per day. The VNV Committee
notes that, in the Netherlands, a relatively low intake of fish-oil fatty acids is
recommended. Last year, the Health Council has published an advisory report entitled
‘Dietary reference intakes: energy, proteins, fats, and digestible carbohydrates’
(GR01). This report put forward the view that an average daily intake of 200 mg of
fish-oil fatty acids is sufficient to produce beneficial health effects, namely reduced
mortality from cardiovascular diseases. It was not possible to draw up separate
standards for EPA and DHA.
     On average, UK adults currently consume 107 mg of DHA per day as part of their
normal diet. As a supplement to the initial assessment, the VNV Committee concludes
that the DHA intake data for inhabitants of the other EC member states is too poorly
supported. This is because these are based on the FAO Food Balance Sheets, which
only indicate how much of a given foodstuff is available per head of population. The
Committee therefore wonders to what extent UK consumers, about whom the dossier
does provide detailed and reliable food-consumption information, are representative of
the European population as a whole.
     The applicant proposes 550 mg per day as the intended total DHA intake value.
The amount of DHA in the normal diet could thus be supplemented with about 440 mg
of DHA from the new oil. To this end, one or two portions of a product that has been
enriched with DHA Gold oil should be sufficient. However, this level of intake is close
to the upper DHA intake level that is considered to be safe by the United States FDA
(1997), namely 1500 mg per day. Based on the results of extensive toxicological
studies in experimental animals and safety studies in humans, the ACNFP concludes
that there is no evidence that such high levels of consumption would lead to adverse
Letter to the Dutch Minister of Health, Welfare and Sport                                   10
</pre>

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<pre>health effects. The VNV Committee concurs with this view. On safety grounds, it has
therefore no objections to the new product being placed on the market for the intended
purpose of achieving an additional daily intake of about 440 mg of DHA. However, the
VNV Committee does foresee practical problems given the margin of a factor of three
between the intented intake and the safe upper level of intake. A major point of
criticism is that the applicant has failed to provide specific details of the range of
foodstuffs into which the DHA-rich oil would be incorporated. Also, the Committee is
not convinced that consumers would limit themselves to just one of the DHA-enriched
products per day, as suggested by the applicant. In addition, the VNV Committee
would like to point out that Dutch supermarkets already stock products with elevated
DHA levels.
     The applicant company OmegaTech, which produces the new oil, has agreed to
advise end-producers of the DHA-enriched foodstuffs concerning appropriate use of
DHA Gold. However, the VNV Committee feels that this promise is too vaguely
worded. The VNV Committee very much doubts that this would prevent the safe upper
intake level from being exceeded. It is by no means clear how the applicant can be
expected to monitor all possible uses of the new ingredient. The VNV Committee
proposes that the new oil should only be approved for use in a limited and well defined
range of products. It agrees with the ACNFP, which has imposed additional labelling
requirements to ensure that consumers are informed both about the recommended
dietary allowance of DHA and the safe upper intake level. The Commission would also
like to highlight the option of post marketing surveillance, to determine the extent to
which the intake guarantees can be met.
     The VNV Committee has established that there is a need for improved scientific
support for the maximum safe level of intake of fish-oil fatty acid, providing a better
understanding of possible long-term effects. It has been found that exceeding the upper
intake level has an effect on blood coagulation. Given the current level of scientific
knowledge, it is not known to what extent this might result in adverse health effects.
Finally, the VNV Committee points out that additional toxicological information is
required in case the DHA-rich oil will be used in infant formulae. The toxicological
data provided in the dossier is insufficient for an evaluation of the safety of this
specific application.
     In summary, the VNV Committee does not object to authorisation of the new
ingredient DHA GoldTM on the European market, provided that it is incorporated into
a limited and well-defined range of foodstuffs. Each product must be clearly labelled,
indicating the recommended daily dietary allowance for fish-oil fatty acids, the group
of substances to which DHA belongs. As a precautionary measure, the Committee
recommends that also a maximum daily number of servings should be indicated on the
Letter to the Dutch Minister of Health, Welfare and Sport                               11
</pre>

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<pre>label, because it is not known for certain whether adverse health effects can be
excluded by exceeding an intake of 1500 mg.
    I endorse the conclusions and recommendations of the VNV Committee,
(signed) professor JGAJ Hautvast
Letter to the Dutch Minister of Health, Welfare and Sport                        12
</pre>

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<pre>      Literatuur/Literature
EC97  Verordening (EC) Nr. 258/97 van het Europees Parlement en de Raad van 27 januari 1997 betreffende
      nieuwe voedingsmiddelen en nieuwe voedselingrediënten. Publikatieblad van de Europese
      Gemeenschappen 1997; L43: 1-6 (Regulation (EC) No 258/97 of the European Parliament and of the
      Council of 27 January 1997 concerning novel foods and novel food ingredients. Official Journal 1997; L
      043: 1-6)
EC97a 97/618/EC: Aanbeveling van de Commissie van 29 juli 1997 betreffende de wetenschappelijke aspecten en
      de presentatie van de informatie die nodig is om aanvragen voor het in de handel brengen van nieuwe
      voedingsmiddelen en nieuwe voedselingrediënten te ondersteunen alsmede het opstellen van de verslagen
      van de eerste beoordeling uit hoofde van Verordening (EC) nr. 258/97 van het Europees Parlement en de
      Raad. Publicatieblad van de Europese Gemeenschappen 1997; L253: 1-36 (97/618/EC: Commission
      Recommendation 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 of the Council. Official Journal 1997; L 253: 1-36)
FAO96 Biotechnology and Food Safety. Report of a joint FAO/WHO Consultation. Rome, FAO 1996.
FAO01 Evaluation of allergenicity of genetically modified foods. Report of a joint FAO/WHO expert consultation
      on allergenicity of foods derived from biotechnology. Rome, FAO 2001.
GR92  Commissie Toxicologische aspecten van biotechnologisch bereide producten. Productveiligheid bij
      nieuwe biotechnologie. Den Haag, Gezondheidsraad 1992, publicatienummer 1992/03.
      Literatuur/Literature                                                                                     13
</pre>

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<pre>GR01   Gezondheidsraad. Voedingsnormen: energie, eiwitten, vetten en verteerbare koolhydraten. Den Haag:
       Gezondheidsraad, 2001; publicatie nr. 2001/19. (Health Council of the Netherlands. Dietary Reference
       Intakes: energy, proteins, fats and digestable carbohydrates. The Hague: Health Council of the
       Netherlands, 2001; publication no. 2001/19)
OECD93 Safety evaluation of foods derived by modern biotechnology. Concepts and principles. Paris, OECD 1993.
OECD96 OECD Workshop on Food Safety Evaluation. Paris, OECD 1996.
OECD98 Report of the OECD workshop on the toxicological and nutritional testing of novel foods. Paris, OECD
       1998.
OECD00 Report of the task force for the safety of novel foods and feeds. Paris, OECD 2000.
SCF99  Opinion concerning the scientific basis for determining whether food products, derived from genetically
       modified maize, could be included in a list of food products which do not require labelling because they
       do not contain (detectable) traces of DNA or protein. Brussels, Scientific Committee on Food of the EU
       1999.
SSC99  Opinion of the Scientific Steering Committee on microbial resistance, Brussels, Scientific Steering
       Committee of the EU 1999.
WHO91  Strategies for assessing the safety of foods produced by biotechnology. Report of a joint FAO/WHO
       Consultation. Geneva, WHO 1991.
WHO00  Safety aspects of genetically modified foods of plant origin. Report of a joint FAO/WHO expert
       consultation on foods derived from biotechnology. Geneva, WHO 2000.
       Literatuur/Literature                                                                                    14
</pre>

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<pre>A De adviesaanvraag/Request for advice
B De commissie/The committee
C EU-procedure/EU-procedure
D Samenvatting van het dossier/Executive summary of the dossier
E Eerste beoordeling/First assessment
  Bijlagen/Annexes
</pre>

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<pre>Bijlage A
        De Adviesaanvraag/Request for advice
        Op 18 augustus 1999 schreef de Minister van Volksgezondheid, Welzijn en Sport aan
        de Voorzitter van de Gezondheidsraad (brief kenmerk GZB/VVB 993428):
        Sinds mei 1997 is in de Europese Unie de Verordening (EG) 258/97 van kracht inzake nieuwe
        voedingsmiddelen en nieuwe voedselingrediënten. Daarmee werd de veiligheidsbeoordeling onderdeel van
        een communautaire procedure.
             Met u is reeds de mogelijkheid besproken de beoordeling door de Gezondheidsraad te laten uitvoeren.
        Ik verzoek u dan ook mede namens de Staatssecretaris van Landbouw, Natuurbeheer en Visserij, in deze
        eerste fase van uitvoering van de Europese Verordening (EG) 258/97 gedurende een aantal jaren, de
        veiligheidsbeoordeling gestalte te geven. Voor het onderbrengen bij de Gezondheidsraad pleit het
        experimentele karakter dat de beoordeling de eerste jaren zal hebben. Dit experimentele karakter komt
        voort uit het feit dat het een nieuw soort beoordeling betreft van deels nieuwe categorieën van
        voedingsmiddelen of voedselingrediënten. Het is namelijk een veiligheidsbeoordeling vóór het op de
        markt brengen van met name voedingsmiddelen van een genetisch gemodificeerde oorsprong en
        zogenaamd functional foods (nutriceutica). Daarnaast ga ik ervan uit dat de onafhankelijke
        wetenschappelijke advisering door de Gezondheidsraad het vertrouwen van de Europese Commissie en de
        andere lidstaten in het Nederlandse oordeel nog versterkt.
             Mijn beleid is erop gericht een zo groot mogelijke openheid en transparantie te realiseren van de
        gevolgde procedure en de beoordeling om de consument vertrouwen te geven in de veiligheid van de
        nieuwe
        De Adviesaanvraag/Request for advice                                                                     16
</pre>

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<pre>voedingsmiddelen. Ik verzoek de Gezondheidsraad hieraan bij te dragen door bijvoorbeeld inzage te geven
in de dossiers waarvoor een aanvraag wordt ingediend, waarbij uiteraard bedrijfsvertrouwelijke gegevens
worden beschermd en door de criteria, waarop de veiligheid zal worden beoordeeld, te publiceren.
De Minister van Volksgezondheid, Welzijn en Sport,
w.g. dr E Borst-Eilers
English translation
On 18 August 1999, the Minister of Health, Welfare and Sport wrote as follows to the
President of the Health Council of the Netherlands (under reference GZB/VVB
993428):
Since May 1997, Regulation (EC) 258/97 concerning novel foods and novel food ingredients has been in
force in the European Union. Under the Regulation, the safety of novel foods has to be assessed as part of
a community procedure.
      Following discussions regarding the possibility of the Health Council making such assessments, the
State Secretary for Agriculture, Nature Management and Fisheries and I wish the Council to take
responsibility for safety assessment for a period of several years during the fist phase of implementation of
European Regulation (EC) 258/97. It is considered appropriate that the Health Council should initially
take on this role because the assessment activities will be of an experimental nature, involving both a new
form of assessment (i.e. pre-marketing assessment) and, in many cases, new categories of foodstuff
(primarily foodstuffs with a genetically modified basis and functional foods or nutraceuticals). We also
feel that if assessments are made by a body with the Council’s independent scientific status, this will
support the validity of the Netherlands’ opinion in the eyes of the European Committee and other member
states.
      My wish is to make the procedure and the assessment as open and transparent as possible, so as to
enhance consumer trust in the safety of novel foods. I would like the Health Council to support this
objective by, for example, allowing perusal of the application dossier (insofar as consistent with the need
to protect the confidentiality of commercially sensitive information) and publishing the criteria upon which
safety assessments are made.
The Minister of Health, Welfare and Sport,
(signed) dr E Borst-Eilers
De Adviesaanvraag/Request for advice                                                                          17
</pre>

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<pre>Bijlage B
        De commissie/The committee
           Prof. dr LM Schoonhoven, voorzitter/chairman
           emeritus hoogleraar entomologie; Wageningen Universiteit en Researchcentrum/
           emeritus professor of entomology; Wageningen University and Research centre
           Prof. dr CAFM Bruijnzeel-Koomen
           hoogleraar dermatologie/allergologie; Academisch Ziekenhuis Utrecht/
           professor of dermatology/allergology; Academic Hospital Utrecht
           Ir EJ Kok
           toxicoloog; RIKILT-DLO Wageningen/toxicologist; State Institute for Quality
           Control of Agricultural Products, Wageningen
           Dr CF van Kreijl
           moleculair-bioloog; RIVM Bilthoven/molecular biologist; National Institute of
           Public Health and the Environment, Bilthoven
           Prof. dr P van der Laan
           hoogleraar statistiek; Technische Universiteit Eindhoven/
           professor of statistics; Technical University Eindhoven
           Dr B Loos, adviseur/advisor
           COGEM, Den Haag/Committee on Genetic Modification, The Hague
           Dr F Nagengast
           gastro-enteroloog; Academisch Ziekenhuis Nijmegen/
           gastro-enterologist; Academic Hospital Nijmegen
        De commissie/The committe                                                        18
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<pre>   Dr JMA van Raaij
   voedingsfysioloog; Wageningen Universiteit and Researchcentrum/
   food physiologist; Wageningen University and Research centre
   Prof. dr G Schaafsma
   hoogleraar voeding; TNO Voeding, Zeist/
   professor of nutrition; TNO Nutrition and Food Research, Zeist
   Prof. dr EG Schouten
   hoogleraar epidemiologie; Wageningen Universiteit and Researchcentrum/
   professor of epidemiology; Wageningen University and Research centre
   Dr GJA Speijers
   toxicoloog; RIVM Bilthoven/toxicologist; National Institute of Public Health and
   the Environment, Bilthoven
   Prof. dr WJ Stiekema
   hoogleraar bioinformatica; Wageningen Universiteit en Researchcentrum/
   professor of bioinformatics; Wageningen University and Research centre
   Ir R Top, adviseur/advisor
   Ministerie van VWS; Den Haag/
   Ministry of Health, Welfare and Sport; The Hague
   Prof. dr WM de Vos
   hoogleraar microbiologie; Wageningen Universiteit en Researchcentrum/ professor
   of microbiology; Wageningen University and Research centre
   Dr RA Woutersen
   toxicoloog; TNO Voeding, Zeist/
   toxicologist; TNO Nutrition and Food Research, Zeist
   Dr ir M Rutgers, secretaris/scientific staff member
   Gezondheidsraad, Den Haag/Health Council of the Netherlands, The Hague
Administratieve ondersteuning/Administrative assistance: AD Lugtenburg
Gezondheidsraad, Den Haag/Health Council of the Netherlands, The Hague
Lay-out: J van Kan
Gezondheidsraad, Den Haag/Health Council of the Netherlands, The Hague
De commissie/The committe                                                           19
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<pre>Bijlage C
        EU-procedure/EU-procedure
        Als een fabrikant een nieuw voedingsmiddel op de markt brengt, dient de veiligheid
        voor de consument gewaarborgd te zijn. In 1997 werd de Europese verordening van
        kracht waarin de procedure is geregeld voor de goedkeuring voor marktintroductie van
        een nieuw voedingsmiddel (EC97). Bij deze procedure zijn verschillende actoren
        betrokken. De aanvrager moet beoordelen of het product werkelijk ‘nieuw’ is, dat wil
        zeggen dat het nog niet eerder in de Europese Unie in substantiële mate voor
        menselijke voeding is gebruikt en ook niet wezenlijk gelijkwaardig is aan een bestaand
        product. (Voor een wezenlijk gelijkwaardig product kan worden volstaan met een
        kennisgeving van de marktintroductie.) Ook moet het niet gaan om een
        levensmiddelenadditief, aroma of extractiemiddel, omdat deze producten op een
        andere wijze worden beoordeeld. Voor een nieuw voedingsmiddel in de zin van de
        Europese verordening moet de aanvrager een veiligheidsdossier overleggen volgens
        aanbevelingen van de Europese Commissie (EC97a). Deze aanbevelingen zijn
        gebaseerd op rapporten van verschillende instanties die zich met het onderwerp nieuwe
        voedingsmiddelen bezighouden, te weten de OECD (OECD93, OECD96) en de
        WHO/FAO (FAO96, WHO91). Ook de Gezondheidsraad heeft zich al eerder over dit
        onderwerp gebogen (GR92). Sinds het verschijnen van de aanbevelingen van de EU
        wordt in internationaal verband gewerkt aan explicitering en aanpassing aan de stand
        van de wetenschap (FAO01, OECD98, OECD00, SCF99, SSC99, WHO00).
            De fabrikant levert het volgens de richtlijnen samengestelde dossier in bij het land
        waar het product het eerst op de markt zal komen. Daarop komt de nationale
        EU-procedure/EU-procedure                                                                20
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<pre>veiligheidsbeoordelingsautoriteit in actie. In Nederland is dat de Minister van
Volksgezondheid, Welzijn en Sport. Zij heeft de Gezondheidsraad verzocht haar van
advies te dienen. De Voorzitter van de Gezondheidsraad heeft hiertoe de commissie
Veiligheidsbeoordeling nieuwe voedingsmiddelen (commissie VNV) ingesteld.
     De commissie beoordeelt op basis van de huidige stand van de wetenschap of de
door de fabrikant geleverde gegevens juist en volledig zijn en of zij het eens is met
diens conclusies. Zij maakt een verslag van haar bevindingen — ook volgens de
Europese aanbevelingen (EC97a, deel III) — en biedt dat de minister aan. De minister
formuleert het Nederlandse oordeel over een voedingsmiddel en brengt dat in bij het
Europese overleg in het Permanent Comité voor levensmiddelen. Alle Europese
lidstaten worden uitgenodigd hun oordeel (de zogeheten tweede beoordeling) te geven
over het dossier en over de eerste beoordeling alvorens genoemd Comité een
eindoordeel velt. Als een dossier veel vragen oproept, gaat er een adviesvraag van de
Europese Commissie naar het Wetenschappelijk Comité voor de menselijke voeding.
Komt men dan nog niet tot overeenstemming dan beslist de Europese Ministerraad.
English translation
When manufacturers bring novel foodstuffs onto the market, consumer safety has to be
ensured. In 1997, a European Regulation (EC97) came into force, laying down the
procedure for approving the market introduction of novel foodstuffs. The procedure
recognizes various actors. The applicant must decide whether a product is a novel
foodstuff, i.e. a substance that has not previously been available for human
consumption to any substantial extent within the European Union and is not
substantially equivalent to any existing product. (If a foodstuff is substantially
equivalent to any existing product, it is sufficient to inform the authorities of its market
introduction). Food additives, aromas and extracts are excluded from the provisions of
the directive, since they fall within the scope of an established assessment regime.
Before marketing a novel foodstuff, the applicant must compile a safety dossier that
complies with the Recommendations of the European Commission (EC97a). These
Recommendations are based on reports by a number of bodies that have studied the
issue of novel foodstuffs, in particular the OECD (OECD93, OECD96) and the
WHO/FAO (FAO96, WHO91). The Health Council of the Netherlands has also
considered the question earlier (GR92). Since publication of the EU recommendations,
international efforts have been made to clarify and adapt the latest scientific
knowledge in the field (FAO01, OECD98, OECD00, SCF99, SSC99, WHO00).
     Having compiled a dossier in line with the guidelines, the manufacturer has to
submit it to the competent authority in the country where the product is to be marketed
first. This dossier is assessed by the national safety assessment authority. In the
EU-procedure/EU-procedure                                                                    21
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<pre>Netherlands, this is the Minister of Health, Welfare and Sport, who is advised by the
Health Council. The President of the Health Council has created a Committee on the
Safety Assessment of Novel Foods (VNV Committee) to advise the minister on behalf
of the Council.
     On the basis of the scientific state of the art, the committee has to decide whether
the information provided by the manufacturer is accurate and complete and whether
the manufacturer’s conclusions are sound. The committee then draws up a report on its
findings for the minister; this report must also comply with the European
Recommendation (EC97a, part III). After considering the report, the minister
formulates the Netherlands’ opinion regarding the foodstuff in question, which is
discussed at European level in the Standing Committee on Foodstuffs. All other
European member states are invited to express a ‘second opinion’ regarding the dossier
and the first opinion. The Standing Committee then arrives at a final judgement. If a
dossier is particularly contentious, the European Commission calls upon the Scientific
Committee on Food for advice. If consensus still cannot be reached, the issue is
referred to the European Council of Ministers.
EU-procedure/EU-procedure                                                                 22
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<pre>Bijlage D
        Samenvatting van het dossier/
        Executive summary of the dossier
        Samenvatting van het dossier/Executive summary of the dossier 23
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<pre>Samenvatting van het dossier/Executive summary of the dossier 24</pre>

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<pre>Samenvatting van het dossier/Executive summary of the dossier 28</pre>

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<pre>Samenvatting van het dossier/Executive summary of the dossier 29</pre>

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<pre>Samenvatting van het dossier/Executive summary of the dossier 30</pre>

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<pre>Samenvatting van het dossier/Executive summary of the dossier 31</pre>

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<pre>Samenvatting van het dossier/Executive summary of the dossier 33</pre>

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<pre>Bijlage E
        Eerste beoordeling/First assessment
        Eerste beoordeling/First assessment 34
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<br><br>