<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>Bacterieel dextraan
Bacterial dextran
Tweede beoordeling van de veiligheid voor de consument, volgens de
Europese verordening 258/97 betreffende nieuwe voedingsmiddelen
en nieuwe voedselingrediënten
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 Staatssecretaris van Landbouw, Natuurbeheer en Visserij
the State Secretary for Agriculture, Nature management and Fisheries
Nr 1999/4VNV, Den Haag, 21 december 1999
No. 1999/4VNV, The Hague, December 21, 1999
</pre>

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<pre>Deze publicatie kan als volgt worden aangehaald:
Gezondheidsraad: Commissie Veiligheidsbeoordeling van nieuwe voedingsmiddelen.
Bacterieel dextraan. Den Haag: Gezondheidsraad, 1999; publicatie nr 1999/4VNV.
Preferred citation:
Health Council of the Netherlands: Committee on the Safety assessment of novel foods.
Bacterial dextran. The Hague: Health council of the Netherlands, 1999; publication no.
1999/4VNV.
auteursrecht voorbehouden
all rights reserved
</pre>

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<pre>  Inhoud/Contents
  Brief aan de Minister van Volksgezondheid, Welzijn en Sport 5
  Letter to the Minister of Health, Welfare and Sport 7
  Literatuur/Literature 9
  Bijlagen/Annexes 11
A De adviesaanvraag/Request for advice 13
B De commissie/The committee 15
C EU-procedure/EU procedure 17
D Samenvatting dossier/Executive summary of the dossier 21
E Eerste beoordeling/ First opinion 29
3 Inhoud/Contents
</pre>

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<pre>4 Bacterieel dextraan/bacterial dextran</pre>

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<pre>  Brief aan de Minister van
  Volksgezondheid, Welzijn en Sport
  Op 21 december 1999 schreef prof. dr JGAJ Hautvast, Vice-voorzitter van de
  Gezondheidsraad, aan de Minister van Volksgezondheid, Welzijn en Sport
  Dit schrijven dient ter beantwoording van de door u mede namens de Staatssecretaris
  van Landbouw, Natuurbeheer en Visserij aan de Gezondheidsraad voorgelegde
  adviesaanvraag over de veiligheid van bacterieel dextraan. Aan de orde is beoordeling
  van bedoelde veiligheid in het kader van de Europese verordening (EG 258/97) inzake
  nieuwe voedingsmiddelen en nieuwe voedselingrediënten. De eerste beoordeling in
  genoemd kader is verricht door de Hoge Gezondheidsraad van België. De Hoge
  Gezondheidsraad heeft het product ‘bacterieel dextraan’ beoordeeld als veilig voor
  consumptie in bakwaren, zoals gespecificeerd in het dossier. De Commissie
  ‘Veiligheidsbeoordeling nieuwe voedingsmiddelen’ van de Gezondheidsraad heeft geen
  aanvullende vragen of opmerkingen bij het dossier en bij de door de Hoge
  Gezondheidsraad uitgebrachte eerste beoordeling.
      Dit aldus geformuleerde advies heb ik heden ook aangeboden aan de Staatssecretaris
  van Landbouw, Natuurbeheer en Visserij.
5 Brief aan de Minister van Volksgezondheid, Welzijn en Sport
</pre>

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<pre>  Letter to the Netherlands Minister of
  Health, Welfare and Sport
  On December 21, 1999, prof. dr JGAJ Hautvast, vice president of the Health Council of
  the Netherlands wrote as follows to the Minister of Health, Welfare and Sport:
  This document has been prepared in response your request, also on behalf of the State
  Secretary for Agriculture, Nature Management and Fisheries for advice regarding the
  safety of bacterial dextran. This assessment is needed in the context of European
  Regulation EC 258/97, concerning novel foods and novel food ingredients. A first
  opinion on the subject had previously been expressed in accordance with the regulation
  by the Belgian Supreme Health Council. The Supreme Health Council concluded that
  bacterial dextran is safe for consumption in bakers’ wares, as specified in the dossier.
  The Netherlands Committee on the safety assessment of novel foods has no additional
  questions or remarks concerning the dossier and the intial assessment of the Supreme
  Health Council.
      This advice is also presented to the State secretary for Agriculture, Nature
  management and Fisheries.
7 Letter to the Dutch Minister of Health, Welfare and Sport
</pre>

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<pre>8 Bacterieel dextraan/bacterial dextran</pre>

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<pre>       Literatuur/Literature
EG97   Verordening (EG) 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.
EG97a  Aanbeveling (EG) nr 97/618/EC 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 (EG) nr. 258/97 van het Europees
       Parlement en de Raad 1997; L253: 1-36.
FAO96  Biotechnology and Food Safety. Report of a joint FAO/WHO Consultation. Rome, FAO 1996
GR92   Commissie Toxicologische aspecten van biotechnologisch bereide producten. Productveiligheid bij
       nieuwe biotechnologie. Den Haag, Gezondheidsraad 1992, publicatienummer 1992/03
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 (draft).
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
       doo 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.
9      Literatuur
</pre>

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<br><br>====================================================================== Pagina 10 ======================================================================

<pre>WHO91 Strategies for assessing the safety of foods produced by biotechnology. Report of a joint FA/WHO
      Consultation. Geneva, WHO 1991.
10    Bacterieel dextraan/bacterial dextran
</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
11
</pre>

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<pre>12 Bacterieel dextraan/bacterial dextran</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
13      De adviesaanvraag/Request for advice
</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 (under reference GZB/VVB 003428):
   Since May 1977, 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
   reponsibility 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 the 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 applicants (insofar as consistent with the need to protect
   the conficentiality of commercially sensitive information) and publishing the criteria upon which safety
   assessments are made.
   The Minister of Health, Welfare and Sport,
   Dr E. Borst-Eilers
14 Bacterieel dextraan/bacterial dextran
</pre>

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<pre>Bijlage B
        De commissie/The committee
            Dr LM Schoonhoven, voorzitter/chairman
            emeritus hoogleraar entomologie; Wageningen Universiteit en Researchcentrum/
            emeritus professor of entomology; Wageningen University and Researchcentre
            Dr JEN Bergmans, adviseur/advisor
            COGEM, Den Haag/COGEM, The Hague
            Dr A Brouwer
            hoogleraar milieutoxicologie; Vrije Universiteit, Amsterdam/ professor
            ofenvironmental toxicology; Free University, Amsterdam
            Dr CAFM Bruijnzeel-Koomen
            hoogleraar dermatologie/allergologie; Academisch Ziekenhuis Utrecht/ professor of
            dermatology/allergology; Academic Hospital Utrecht
            Dr EJ Kok
            toxicoloog; RIKILT-DLO Wageningen/ toxicologist; RIKILT-DLO, Wageningen
            Dr CF van Kreijl
            moleculair-bioloog; RIVM Bilthoven/ molecular biologist; RIVM, Bilthoven
            Dr R Top, adviseur/advisor
            Ministerie van VWS; Den Haag/ Ministry of Health, Welfare and Sport; The Hague
            Dr F Nagengast
            gastro-enteroloog; Academisch Ziekenhuis Nijmegen/ gastro enterologist; Academic
            Hospital Nijmegen
            Dr G van Poppel
            voedingsfysioloog; TNO Voeding, Zeist/ food physiologist; TNO Food, Zeist
15      De commissie/The committee
</pre>

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<pre>       Dr JMA van Raaij
       voedingsfysioloog; Wageningen Universiteit and Researchcentrum/ food
       physiologist; Wageningen University and Researchcentre
       Dr WHM Saris
       hoogleraar voedingsfysiologie; Universiteit Maastricht/ professor of food
       physiology; Maastricht University
       Dr EG Schouten
       hoogleraar epidemiologie; Landbouwuniversiteit Wageningen/ professor of
       epidemiology; Wageningen University
       Dr GJA Speijers
       toxicoloog; RIVM Bilthoven/ toxicologist; RIVM Bilthoven
       Dr WJ Stiekema
       hoogleraar bioinformatica; Wageningen Universiteit en Researchcentrum/ professor
       of bioinformatics; Wageningen University and Researchcentre
       Dr WM de Vos
       hoogleraar microbiologie; Wageningen Universiteit en Researchcentrum/ professor
       of microbiology; Wageningen University and Researchcentre
       Dr JAG van de Wiel, secretaris/ executive secretary
       Gezondheidsraad, Den Haag/ Health Council of the Netherlands, The Hague
   Administratieve ondersteuning: C Brussee; Gezondheidsraad, Den Haag/ Administrative
   assistance: C Brussee; Health Council of the Netherlands, The Hague.
16 Bacterieel dextraan/bacterial dextran
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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 richtlijn van kracht waarin
        de procedure is geregeld voor de goedkeuring voor marktintroductie van een nieuw
        voedingsmiddel (EG97). 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
        in deze zin nieuw voedingsmiddel moet de aanvrager een veiligheidsdossier overleggen
        volgens aanbevelingen van de Europese Commissie (EG97a). 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 (WHO91, FAO96). Ook de Gezondheidsraad heeft zich over dit onderwerp
        gebogen (GR92). Sinds het verschijnen van de aanbevelingen van de EU wordt in
        internationaal verband (SSC99, SCF99, OEC98) gewerkt aan explicitering en
        aanpassing aan de stand van de wetenschap.
             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
        veiligheidsbeoordelingsautoriteit in actie. In Nederland is dat de Minister van
        Volksgezondheid, Welzijn en Sport. Zij heeft de Gezondheidsraad verzocht haar van
17      Europese procedure/EU procedure
</pre>

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<pre>   advies te die-nen. 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 (EG97a, 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 permanente Comité voor de menselijke voeding. 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 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
   assured. In 1997, a European Directive (EC97) came into force, laying down the
   procedure for approving the market introduction of novel foodstuffs. The procedure
   recognises 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 substiantially equivalent
   to any existing product. (If a foodstuff is substiantially equivalent to any existing
   product, it is sufficient to inform the authorities of its market introduction). Foodstuff
   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
   Recommentations of the European Commission (EG97a). 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 (WHO91, FAO96). The
   Health Council of the Netherlands has also considered the question (GR92). Since
   publication of the EU recommendations, international efforts have been made to clarify
   and adapt the latest scientific knowledge in the field (SSC99, SCF99, OEC98).
        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
   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) to advise the minister on behalf of the Council.
18 Bacterieel dextraan/bacterial dextran
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<pre>        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 for Food. All other European member states
   are invited to express a ‘second opinion’ regarding the dossier and the first opinion. The
   Permanent Committee then arrives at a final judgement. If a dossier is particularly
   contentious, the European Commission calls upon the Scientific Committee for Food for
   advice. If consensus still cannot be reached, the issue is referred to the European Council
   of Ministers.
19 Europese procedure/EU procedure
</pre>

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<pre>Bijlage D
        Samenvatting dossier/
        Executive summary of the dossier
21      Samenvatting dossier/Executive summary of the dossier
</pre>

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<pre>22 Bacterieel dextraan/bacterial dextran</pre>

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<pre>23 Samenvatting dossier/Executive summary of the dossier</pre>

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<pre>24 Bacterieel dextraan/bacterial dextran</pre>

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<pre>25 Samenvatting dossier/Executive summary of the dossier</pre>

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<pre>26 Bacterieel dextraan/bacterial dextran</pre>

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<pre>27 Samenvatting dossier/Executive summary of the dossier</pre>

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<pre>28 Bacterieel dextraan/bacterial dextran</pre>

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<pre>Bijlage E
        Eerste beoordeling/First assessment
29      Eerste beoordeling/First assessment
</pre>

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<pre>30 Bacterieel dextraan/bacterial dextran</pre>

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<pre>31 Eerste beoordeling/First assessment</pre>

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<pre>32 Bacterieel dextraan/bacterial dextran</pre>

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<pre>33 Eerste beoordeling/First assessment</pre>

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<pre>34 Bacterieel dextraan/bacterial dextran</pre>

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<pre>35 Eerste beoordeling/First assessment</pre>

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<pre>36 Bacterieel dextraan/bacterial dextran</pre>

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<pre>37 Eerste beoordeling/First assessment</pre>

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<pre>38 Bacterieel dextraan/bacterial dextran</pre>

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<pre>39 Eerste beoordeling/First assessment</pre>

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<pre>40 Bacterieel dextraan/bacterial dextran</pre>

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<pre>41 Eerste beoordeling/First assessment</pre>

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<pre>42 Bacterieel dextraan/bacterial dextran</pre>

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<br><br>