<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>Chiazaad
Tweede beoordeling van de veiligheid voor de consument, volgens de
Europese verordening 258/97 betreffende nieuwe voedingsmiddelen en
nieuwe voedselingrediënten
Chia seed
Second opinion regarding consumer safety, in accordance with European
Regulation 258/97 concerning novel foods and novel 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, Natuur en Voedselkwaliteit/
the Minister of Agriculture, Nature and Food Quality
Nr 2004/05VNV, Den Haag, 9 september 2004
No. 2004/05VNV, The Hague, September 9, 2004
</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 vraagstuk-
ken op het gebied van de volksgezondheid” (art. 21 Gezondheidswet).
     De Gezondheidsraad ontvangt de meeste adviesvragen van de bewindslieden van
Volksgezondheid, Welzijn & Sport; Volkshuisvesting, Ruimtelijke Ordening & Milieu-
beheer; Sociale Zaken & Werkgelegenheid en Landbouw, Natuur en Voedselkwaliteit.
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 overheids-
beleid.
     De adviezen van de Gezondheidsraad zijn openbaar en worden in bijna alle gevallen
opgesteld door multidisciplinaire 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 to 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 and Food Quality. The Council can publish advi-
sory reports on its own initiative. It usually does this in order to ask attention for devel-
opments or trends that are thought to be relevant to government policy.
     Most Health Council reports are prepared by multidisciplinary committees of Dutch
or, sometimes, foreign experts, appointed in a personal capacity. The reports are avail-
able to the public.
Deze publicatie kan als volgt worden aangehaald:
Gezondheidsraad. Commissie Veiligheidsbeoordeling nieuwe voedingsmiddelen.
Chiazaad. Den Haag: Gezondheidsraad, 2004; publicatie nr 2004/05VNV.
Preferred citation:
Health Council of the Netherlands. Committee on the Safety Assessment of Novel
Foods. Chia seed. The Hague: Health Council of the Netherlands, 2004; publication no.
2004/05VNV.
auteursrecht voorbehouden/all rights reserved
U kunt het advies downloaden van www.gr.nl/
This report can be downloaded from www.healthcouncil.nl
</pre>

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<pre>  Inhoud/Contents
  Brief aan de Minister van Volksgezondheid, Welzijn en Sport 4
  Letter to the Dutch Minister of Health, Welfare and Sport 7
  Literatuur/Literature 10
  Bijlagen/Annexes 12
A De Adviesaanvraag/Request for advice 13
B De commissie/The committee 15
C EU-procedure/EU-procedure 17
D Samenvatting van het dossier/Executive summary of the dossier 20
E Eerste beoordeling/First assessment 28
  Inhoud/Contents                                                  3
</pre>

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<pre>Gezondheidsraad                               Vice-voorzitter
Health Council of the Netherlands
Aan de Minister van Volksgezondheid,
Welzijn en Sport
Onderwerp         : Tweede beoordeling veiligheid chiazaad (Salvia hispanica L.)
Uw kenmerk        : VGB/VL2494916
Ons kenmerk       : 2004/05VNV, U-1168/MR/CvR/cv/622-DI
Datum             : 9 september 2004
Mijnheer de minister,
Dit schrijven dient ter beantwoording van de adviesaanvraag over de veiligheid van nieuwe
voedingsmiddelen en nieuwe voedselingrediënten, die door u mede namens de Minister van
Landbouw, Natuur en Voedselkwaliteit aan de Gezondheidsraad is voorgelegd. Aan de orde is een
zogenoemde tweede beoordeling, conform de Europese verordening 258/97, van hele en tot meel
vermalen zaden van chia (Salvia hispanica L.), een plant uit de familie der lipbloemigen
(Lamiaceae of Labiatae). Deze producten komen niet direct beschikbaar voor de consument, maar
zullen in meergranenbrood worden verwerkt. De aanvrager die deze nieuwe voedselingrediënten
op de Europese markt wil brengen is de firma R. Craig and Sons [M] Ltd. De beoordeling is
verricht door de Commissie ‘Veiligheidsbeoordeling nieuwe voedingsmiddelen’ van de
Gezondheidsraad (Commissie VNV).
De eerste beoordeling van de aanvraag voor markttoelating is verricht door de Advisory Committee
on Novel Foods and Processes (ACNFP) van het Verenigd Koninkrijk. De ACNFP heeft geen
bezwaar tegen markttoelating van chiazaad en chiameel. Wel plaatst de ACNFP de kanttekening
dat er nog onduidelijkheid bestaat over potentiële allergene eigenschappen van deze producten. De
aanvrager stelt daarom een uitgebreide etikettering voor, die consumptie door personen met een
bekende allergie voor andere zaden moet voorkomen. De ACNFP is van mening dat op deze
manier de consument geen onacceptabel risico loopt. Zij merkt op dat deze benadering de
keuzevrijheid van de consument wellicht onnodig beperkt, maar dit is niet van invloed op haar
positieve conclusie van de veiligheidsbeoordeling.
De Commissie VNV maakt bezwaar tegen toelating op de markt van chiazaad en chiameel als
voedselingrediënten (hierna aangeduid als chia). Zij baseert haar oordeel op de informatie in het
Bezoekadres                                                            Postadres
Parnassusplein 5                                                       Postbus 16052
2511 VX    Den Haag                                                    2500 BB    Den Haag
Telefoon (070) 340 7520                                                Telefax (070) 340 7523
                                                                       www.gr.nl
</pre>

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<pre>Gezondheidsraad                               Vice-voorzitter
Health Council of the Netherlands
Onderwerp           : Tweede beoordeling veiligheid chiazaad (Salvia hispanica L.)
Ons kenmerk         : 2004/05VNV, U-1168/MR/CvR/cv/622-DI
Pagina              :2
Datum               : 9 september 2004
dossier (zie Bijlage D voor een samenvatting) en het rapport van de eerste beoordeling door de
ACNFP (zie Bijlage E).
      De Commissie VNV is het eens met de ACNFP dat de kwaliteit van het productieproces
gewaarborgd lijkt. De aanvrager heeft op verzoek van de ACNFP aanvullende informatie verstrekt
inzake het beheersen van microbiologische risico’s en het garanderen van de kwaliteit tijdens
opslag en transport. Volgens de Engelse beoordelaars is de firma in staat om te voldoen aan de
algemeen geldende eisen voor voedselveiligheid.
      Gezien de bestanddelen (eiwit, olie en vezel) van chia is er vanuit voedingskundig oogpunt
geen bezwaar tegen het gebruik hiervan in brood. Een karakteristiek van dit zaad is het relatief
hoge gehalte aan α-linoleenzuur, een zogeheten n-3 meervoudig onverzadigd vetzuur.
      De aanvrager stelt voor om chia tot een totaalgehalte van 5% in meergranenbrood te
verwerken. Bij de voorgestelde toepassing schat de aanvrager de gemiddelde inneming van dit
nieuwe voedselingrediënt door volwassenen in de Engelse bevolking op 2,1 gram per dag (97,5
percentiel: 11,6 g). De Commissie VNV tekent aan dat de voor deze schatting gebruikte
consumptiegegevens voor brood niet meer dan een globale indicatie geven. Ook is het onbekend in
hoeverre deze inneming representatief is voor de Europese bevolking. Zo wordt er in Nederland in
vergelijking met het Verenigd Koningrijk meer brood gegeten (Hul98).
      Eén van de belangrijkste punten van kritiek van de Commissie VNV op het dossier is dat
resultaten van toxicologisch proefdieronderzoek, die noodzakelijk zijn voor de
veiligheidsbeoordeling, geheel ontbreken. De commissie vindt dit, in tegenstelling tot de ACNFP,
onacceptabel. Er zijn wel voederproeven bij legkippen en braadkuikens uitgevoerd, maar
dergelijke proeven zijn geen substituut voor gestandaardiseerd toxicologisch onderzoek. Ook
concludeert de commissie dat het dossier onvoldoende resultaten van mensgebonden onderzoek
bevat. Gegevens over eerdere consumptie in Latijns-Amerika zijn slechts anekdotisch en daardoor
niet van waarde voor de veiligheidsbeoordeling.
      De Commissie VNV heeft ook kritiek op het onderzoek naar eventuele allergene
eigenschappen van chia. De aanvrager heeft zich hiervoor geconcentreerd op mogelijke
kruisreacties tussen chia en bepaalde andere zaden, te weten pinda’s en noten. Allergische reacties
tegen chia of tegen zaden van verwante planten zijn niet bekend uit de wetenschappelijke
literatuur. Bij het testen van patiëntensera met reactiviteit tegen pinda of noten, reageerden er
enkele met eiwitten uit chia. Twaalf personen, die waren geselecteerd op basis van
overgevoeligheid voor pinda of noten, ondergingen een huidtest met een extract van chia. Bij twee
van hen, die eveneens gevoelig waren voor sesamzaad, werden positieve reacties waargenomen.
Bezoekadres                                                                Postadres
Parnassusplein 5                                                           Postbus 16052
2511 VX     Den Haag                                                       2500 BB    Den Haag
Telefoon (070) 340 7520                                                    Telefax (070) 340 7523
                                                                           www.gr.nl
</pre>

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<pre>Gezondheidsraad                                  Vice-voorzitter
Health Council of the Netherlands
Onderwerp           : Tweede beoordeling veiligheid chiazaad (Salvia hispanica L.)
Ons kenmerk         : 2004/05VNV, U-1168/MR/CvR/cv/622-DI
Pagina              :3
Datum               : 9 september 2004
Hun sera reageerden met een 15 kD-eiwit uit chia. Hierop vroeg de ACNFP om aanvullend
onderzoek naar mogelijke kruisreacties bij patiënten met een allergie voor zaden, zoals mosterd of
sesamzaad. De aanvrager is hierop niet ingegaan, maar kwam met het voorstel om producten met
chia te etiketteren als ongeschikt voor mensen met een allergie tegen zaden1. Volgens de ACNFP
zou dit weliswaar de keuzemogelijkheden voor allergische individuen verder beperken, maar is het
wel een afdoende maatregel om de veiligheid van het product te garanderen. Zij meent dat
patiëntenorganisaties en allergieklinieken op de hoogte moeten worden gesteld van een eventuele
introductie van dit nieuwe product.
      De Commissie VNV is van mening dat de mogelijke allergene eigenschappen van dit product
nader zouden moeten worden onderzocht vóór marktintroductie. De commissie meent ook dat er
op dit moment nog onvoldoende wetenschappelijke basis bestaat voor de etikettering zoals nu door
de firma voorgesteld.
Samenvattend is de Commissie VNV het niet eens met de conclusie van de eerste beoordeling
door de ACNFP. Zij is van mening dat chia voorlopig niet op de markt zou moeten worden
toegelaten, in afwachting van nader onderzoek naar mogelijke toxische en allergene
eigenschappen van dit product.
Ik onderschrijf de conclusies en aanbevelingen van de Commissie VNV.
Hoogachtend,
Prof. dr JGAJ Hautvast
1
  Uit de beschikbare documentatie is niet duidelijk of de voorgestelde etikettering alleen gericht zou zijn op
patiënten met allergie tegen sesamzaad of mosterd, of tevens andere zaden zou betreffen.
Bezoekadres                                                                     Postadres
Parnassusplein 5                                                                Postbus 16052
2511 VX     Den Haag                                                            2500 BB     Den Haag
Telefoon (070) 340 7520                                                         Telefax (070) 340 7523
                                                                                www.gr.nl
</pre>

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<pre>Letter to the Dutch Minister of Health,
Welfare and Sport
On September 9, 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 and Food Quality. The subject in question is a second opinion, in accordance
with European Regulation 258/97, concerning whole Chia seeds (Salvia hispanica L.),
and Chia seeds that have been milled to flour. Chia is a member of the Mint family
(Lamiaceae or Labiatae). These products will not be directly available to consumers, but
will be incorporated into multigrain bread. The applicant who wishes to introduce these
novel food ingredients to the European market is R. Craig and Sons [M] Ltd. This
assessment was carried out by the Health Council Committee on the Safety Assessment
of Novel Foods (VNV Committee).
     The initial assessment of the application for marketing authorisation was carried out
by the Advisory Committee on Novel Foods and Processes (ACNFP), in the United
Kingdom. The ACNFP has no objection to Chia seed and Chia flour being admitted to
the market. However, the ACNFP has commented that there is still some doubt about the
extent of the allergenic potential of these products. The applicant therefore proposes the
use of extensive labelling, in order to prevent individuals with a known allergy to other
seeds from consuming these products. The ACNFP takes the view that, in this way, con-
sumers will not run undue risk. It points out that while this approach may restrict con-
Letter to the Dutch Minister of Health, Welfare and Sport                                  7
</pre>

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<pre>sumers’ freedom of choice, this has no bearing on its favourable conclusions with regard
to the safety assessment.
     The VNV Committee is against admitting Chia seed and Chia flour to the market as
food ingredients (referred to hereinafter as Chia). It bases its views on the information
contained in the dossier (see Appendix D for the summary) and on the report of the ini-
tial assessment by the ACNFP (see Appendix E).
     The VNV Committee concurs with the ACNFP that, in terms of quality, the produc-
tion process appears to incorporate the necessary safeguards. At the ACNFP's request,
the applicant provided supplementary information on the management of microbiologi-
cal risks, and on guaranteeing quality during storage and transport. The British assessors
feel that the company is able to meet the generally accepted food safety requirements.
     In view of Chia’s ingredients (protein, oil, and fibre), from the nutritional point of
view, there is no objection to its use in bread. One characteristic of this seed is that it
contains relatively large amounts of alpha-linolenic acid, an n-3 polyunsaturated fatty
acid. The applicant proposes that Chia be incorporated into multigrain bread, at total
content of up to 5%. In the proposed application, the applicant estimates that the average
intake of this novel food ingredient by adults in the population of Britain will be 2.1
grams per day (97.5 percentile: 11.6 g). The VNV Committee notes that the consump-
tion data for bread, which were used for this estimate, provide nothing more than a
rough indication. Furthermore, it is not known to what extent this intake is representa-
tive of the population of Europe as a whole. For instance, in comparative terms, more
bread is consumed in the Netherlands than in the United Kingdom (Hul98).
     One of the VNV Committee's main criticisms of the dossier is that it contains no
data whatsoever from toxicological studies in experimental animals, which are essential
to the safety assessment. Unlike the ACNFP, the Committee feels that this is unaccepta-
ble. While feeding trials were carried out in laying hens and broiler chickens, such tests
are no substitute for a standardised toxicological study. The Committee also concludes
that the dossier contains too few results from research involving human subjects. Data
on past consumption in Latin America is purely anecdotal, so it is of no value in terms of
the safety assessment.
     The VNV Committee is also critical of the research conducted into Chia’s possible
allergenic properties. In this context, the applicant has focused on possible cross-reac-
tions between Chia and certain other seeds, namely peanuts and nuts. The scientific lit-
erature contains no information concerning allergic reactions to Chia or to the seeds of
related plants. Of various patient sera with reactivity to peanuts or nuts, some reacted to
Chia proteins. Twelve individuals, selected on the basis of hypersensitivity to peanuts or
nuts, underwent a skin prick test using a Chia extract. Positive reactions were observed
in two of these individuals, who were also sensitive to sesame seed. Their sera reacted
against a 15 kD protein from Chia. In response to this, the ACNFP requested that fol-
Letter to the Dutch Minister of Health, Welfare and Sport                                   8
</pre>

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<pre>  low-up studies of possible cross-reactions be carried out in patients with allergic reac-
  tions to seeds, such as mustard or sesame seed. The applicant did not fall in with this
  suggestion, but instead proposed that all products containing Chia should be labelled as
  being unsuitable for individuals with seed allergies*. According to the ACNFP, while
  this would further restrict the choices available to allergic individuals, it is nevertheless
  an adequate means of guaranteeing the product’s safety. It takes the view that patient
  support groups and allergy clinics should be informed about the possible introduction of
  this novel product.
       The VNV Committee feels that this product’s possible allergenic properties should
  be further investigated prior to market introduction. The Committee believes that the
  scientific basis for the labelling, proposed by the applicant, is presently inadequate.
       In summary, the VNV Committee cannot concur with the conclusion of the initial
  assessment by the ACNFP. It believes that Chia should not be admitted to the market for
  the time being, pending further research into this product's possible toxic and allergenic
  properties.
  I endorse the conclusions and the recommendations of the VNV Committee.
  (signed) professor JGAJ Hautvast
* On the basis of the available documentation, it is not clear whether the proposed labelling would focus purely on patients
  with an allergy to sesame seed or mustard, or whether it would also make mention of allergies to other seeds.
  Letter to the Dutch Minister of Health, Welfare and Sport                                                                9
</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
      (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 of the European Communities 1997; L43: 1-6).
EG97a Aanbeveling (EG) nr. 97/618/EG 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. Publikatieblad 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 of the European Communities 1997; L253:
      1-36).
EG03  Verordening (EG) nr. 1829/2003 van het Europees Parlement en de Raad van 22 september 2003 inzake
      genetisch gemodificeerde levensmiddelen en diervoeders. Publicatieblad van de Europese Unie 2003; L268:
      1-23.
      (Regulation (EC) nr. 1829/2003 of the European Parliament and of the Council of 22 September 2003
      concerning genetically modified food and feed. Official Journal of the European Union 2003; L268: 1-23.)
FAO96 Biotechnology and Food Safety. Report of a joint FAO/WHO Consultation. Rome, FAO 1996.
      Literatuur/Literature                                                                                      10
</pre>

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<pre>GR92   Commissie Toxicologische aspecten van biotechnologisch bereide producten. Productveiligheid bij nieuwe
       biotechnologie. Den Haag, Gezondheidsraad 1992, publicatienummer 1992/03.
GR02   Commissie Veiligheidsbeoordeling nieuwe voedingsmiddelen. Veiligheidsbeoordeling van nieuwe
       voedingsmiddelen. Den Haag, Gezondheidsraad 2002, publicatienummer 2002/05VNV.
       Committee on the Safety Assessment of Novel Foods. Safety assessment of novel foods. The Hague, Health
       Council 2002, publication number 2002/05VNV.
Hul98  Hulshof KFAM, Kistemaker C, Bouman M. De consumptie van groepen voedingsmiddelen door de
       Nederlandse bevolkingsgroepen – Voedselconsumptiepeiling 1997–1998. TNO-rapport V98.804, Zeist,
       1998
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.
WHO91  Strategies for assessing the safety of foods produced by biotechnology. Report of a joint FAO/WHO
       Consultation. Geneva, WHO 1991.
       Literatuur/Literature                                                                                  11
</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
                                                                12
</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 voedingsmid-
        delen en nieuwe voedselingrediënten. Daarmee werd de veiligheidsbeoordeling onderdeel van een com-
        munautaire 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 veilig-
        heidsbeoordeling 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 voedse-
        lingrediënten. Het is namelijk een veiligheidsbeoordeling vóór het op de markt brengen van met name voe-
        dingsmiddelen 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
        De Adviesaanvraag/Request for advice                                                                           13
</pre>

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<pre>nieuwe 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 gege-
vens 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 responsi-
bility 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 food-
stuffs with a genetically modified basis and functional foods or nutraceuticals). We also feel that if assess-
ments 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 objec-
tive by, for example, allowing perusal of the application dossier (insofar as consistent with the need to pro-
tect 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                                                                           14
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<pre>Bijlage B
        De commissie/The committee
        •  Prof. dr EG Schouten, voorzitter/chairman
           hoogleraar epidemiologie; Wageningen Universiteit and Researchcentrum
           professor of epidemiology; 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
           emeritus hoogleraar statistiek; Technische Universiteit Eindhoven/
           professor of statistics; Technical University Eindhoven
        •  Dr FM Nagengast
           gastro-enteroloog; Academisch Ziekenhuis Nijmegen/
           gastro-enterologist; Academic Hospital Nijmegen
        •  Dr ir JMA van Raaij
           voedingsfysioloog; Wageningen Universiteit and Researchcentrum/
           food physiologist; Wageningen University and Research centre
        De commissie/The committee                                                                 15
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<pre>•  Prof. dr ir G Schaafsma
   hoogleraar voeding; TNO Voeding, Zeist/
   professor of nutrition; TNO Nutrition and Food Research, Zeist
•  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, toxicologisch patholoog; TNO Voeding, Zeist/
   toxicologist, toxicologic pathologist; TNO Nutrition and Food Research, Zeist
•  Dr ir F van der Wilk, adviseur/advisor
   COGEM, Bilthoven/
   Committee on Genetic Modification, Bilthoven
•  Dr CMA van Rossum, secretaris/scientific staff member
   Gezondheidsraad, Den Haag/
   Health Council of the Netherlands, The Hague
•  Dr M Rutgers, secretaris/scientific staff member
   Gezondheidsraad, Den Haag/
   Health Council of the Netherlands, The Hague
Administratieve ondersteuning/Administrative assistance: CL Vuijst, MSc;
Gezondheidsraad, Den Haag/Health Council of the Netherlands, The Hague.
Layout: J van Kan; Gezondheidsraad, Den Haag/
Health Council of the Netherlands, The Hague.
De commissie/The committee                                                          16
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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 (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 nieuw voedingsmiddel in de zin van de Europese verordening 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 (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 (GR02).
            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 veiligheids-
        beoordelingsautoriteit in actie. In Nederland is dat de Minister van Volksgezondheid,
        Welzijn en Sport. Zij heeft de Gezondheidsraad verzocht haar van advies te dienen. De
        EU-procedure/EU-procedure                                                                17
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<pre>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 Permanent Comité voor de voedselketen en de diergezondheid. Alle Euro-
pese 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 de Europese Autoriteit voor voedselveiligheid (EAV). Komt
men dan nog niet tot overeenstemming dan beslist de Europese Ministerraad. Sinds 18
april 2004 moeten veiligheidsdossiers van voedingsmiddelen van genetisch gemodifi-
ceerde oorsprong rechtstreeks ingediend worden bij de EAV (EG03).
English translation
When manufacturers bring novel foodstuffs onto the market, consumer safety has to be
ensured. In 1997, a European Regulation (EG97) came into force, laying down the pro-
cedure for approving the market introduction of novel foodstuffs. The procedure recog-
nizes 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 (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 (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 lat-
est scientific knowledge in the field (GR02).
     Having compiled a dossier in line with the guidelines, the manufacturer has to sub-
mit 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.
EU-procedure/EU-procedure                                                                    18
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<pre>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 find-
ings for the minister; this report must also comply with the European Recommendation
(EG97a, 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 the Food Chain and Animal Health. All other European member
states are invited to express a ‘second opinion’ regarding the dossier and the first opin-
ion. The Standing Committee then arrives at a final judgement. If a dossier is particu-
larly contentious, the European Commission calls upon the European Food Safety
Authority (EFSA) for advice. If consensus still cannot be reached, the issue is referred to
the European Council of Ministers. From April 18th 2004 safety dossiers of food from
genetically modified origin have to be submitted to EFSA directly (EC03).
EU-procedure/EU-procedure                                                                     19
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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 20
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<pre>R Craig & Sons [M] Ltd

APPLICATION FOR APPROVAL OF
WHOLE CHIA SEED AND GROUND
WHOLE CHIA AS NOVEL FOOD
INGREDIENTS

SUMMARY

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<pre>Chia — seed and flour Novel Food application Summary

Contents

Section No Page

Administrative Data
Application

Identification of Relevant Submission Requirements

A WN m
Rn Ur BR W

Summary
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<pre>1. Administrative Data

Applicant:

Person Responsible for dossier:

R Craig & Sons [M] Ltd
76 Old Portglenone Road
Ahoghill

Co. Antrim

Northern Ireland

BT42 1LQ

Mr David L Armstrong
R Craig & Sons [M] Ltd
76 Old Portglenone Road
Ahoghill

Co. Antrim

Northern Ireland

BT42 1LQ

Tel: 0044 2825 871344
Fax: 0044 2825 871156

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<pre>2. Application

This application seeks approval under Regulation (EC) No 258/97 of the European
Parliament and of the Council of 27" January 1997 concerning novel foods and novel
food ingredients for Chia (Salvia hispanica L) seed and flour. Chia has historically
been consumed in South America but has not hitherto been used for human
consumption to a significant degree within the European Community and so general

approval, as a Novel Food Ingredient is required.
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<pre>3. Identification of Relevant Submission Requirements

The structured scheme (Table II, Part I under EC Regulation No. 258/97) has been
followed to determine which of schemes I-X are essential to provide data permitting a

safety and nutritional evaluation of the Novel Food Ingredient.

Chia may be classified as a complex novel food from a non-GM source (2.2).

Relevant requirements for submission to this class are as follows:

I Specification of the Novel Food

II Effect ofthe production process applied to the Novel Food
II History of the organism used as the source of the Novel Food
IX Anticipated intake/extent of use of the Novel Food

XI Nutritional information on the Novel Food

XII Microbiological information on the Novel Food

XIII Toxicological information on the Novel Food

This information has been provided in full in our application dossier, ‘ Application for

Approval of Chia (Salvia hispanica L) seed and flour as a Novel Food Ingredient’.
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<pre>4. Summary

Nutritionists now recommend that not only should the number of calories that are
obtained from fat in our diet be decreased, but that we increase our intake of n-3 fatty
acids. As a result, consumers are becoming increasingly aware of the nutritional
content of the foods they purchase and the importance of increasing dietary levels of
n-3 fatty acids in the ongoing battle against coronary heart disease. Introduction of
whole Chia seeds and ground whole Chia as food ingredients in bread within Europe

would broaden the number of dietary sources of n-3 fatty acids with terrestrial origins.

Chia (Salvia hispanica L) is a summer annual herbaceous plant belonging to the mint
family. Chia seeds are high in oil, and in particular the n-3 fatty acid a-linolenic acid
(C18:3, n-3). Chia was a major food crop of the Aztecs, which was ‘rediscovered’ and
is now grown contractually for R Craig & Sons [M] Ltd in sub-tropical conditions in

Argentina and Peru.

Chia seeds contain 33% oil, 57% of which is the n-3 fatty acid a-linolenic acid. In
addition, Chia seeds are an abundant source of protein (21%), fibre (28%) and contain

a wide range of vitamins and minerals.

Chia seeds are not processed in any way prior to their use a as a food ingredient.
Seeds are not chemically treated prior to sowing, however they do receive chemical
treatments by way of herbicides and fertilizers. As Chia is grown contractually for R
Craig & Sons [M] Ltd, chemical treatments shall comply with current EU legislation.
The seed is generally allowed to ripen naturally and is mechanically harvested. Post-
harvest, the seeds are cleaned mechanically. In production of ground whole Chia, the

seeds are simply passed through a hammer mill.

Anticipated intake was calculated using the National Diet Survey figures (2002) for
soft grain bread consumption. Pilot studies indicate that Chia shall be included in

these types of bread at a level no greater than 5%. As a result mean anticipated intake

is calculated to be 2.1g/person/day.

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<pre>Safety of the Novel Food has been assessed by microbiological and toxicological

means. In addition large scale human allergenicity studies have determined that there
are no adverse effects from consumption of whole Chia seeds at relatively high levels
and although there was moderate IgE binding to protein in the allergenicity trial, this
protein was shown to be susceptible to peptic digestion and therefore probably does

not represent a food allergy hazard.

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<pre>Bijlage E
        Eerste beoordeling/First assessment
        Eerste beoordeling/First assessment 28
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<pre>ADVISORY COMMITTEE FOR NOVEL FOODS AND PROCESSES
OPINION ON AN APPLICATION UNDER THE NOVEL FOODS REGULATION FOR
CHIA (Salvia hispanica L)
Applicant                            Robert Craig and Sons
Responsible Person                   David Armstrong
EC Classification                    2.2
Introduction
1. An application was submitted by R Craig & Sons [M] Ltd. to the UK Competent
     Authority for authorisation of whole Chia (Salvia hispanica L) seed and ground
     whole Chia as a novel food ingredient in soft grain bread.
2. Chia (Salvia hispanica L) is a summer annual herbaceous plant belonging to the
     mint family (Labiatae). The seed of the Chia plant has a long history of
     consumption in South America and was a major part of the diet in pre-Columbian
     civilisations, mainly in the Aztec population. If approved in Europe, Chia seeds
     would provide consumers with an alternative source of the n-3 polyunsaturated
     fatty acid, alpha-linolenic acid. A number of studies carried out by one South
     American company suggest that incorporating Chia seeds into hens’ diets results
     in eggs with an increased content of n-3 fatty acids, thereby providing another
     potential source of these fatty acids in the diet.
3. The applicant will import whole Chia seeds that are mechanically harvested from
     conventionally-grown crops in two locations: Peru and Argentina. The whole
     ground Chia to be marketed in the EU will be produced in the UK by milling the
     imported whole seeds.
I. Specification of the novel food
pp 5 – 9 of the application dossier
4. Chia (Salvia hispanica L) is a summer annual herbaceous plant belonging to the
     Labiatae family.
5. Detailed compositional analyses of Chia seed are given in the application dossier
     for these analyses the applicant has tested four samples from four consignments
     of Chia from Peru, for proximate analysis, fatty acid composition and heavy metal
     content. Whilst details of the methods employed in the proximate analysis and
     heavy metal analysis are not given, fatty acid profiling was carried out to
     accredited procedures. Mineral, vitamin and carbohydrate analyses were also
     carried out on seed in Argentina. Although details of the methods of analysis are
                                                                                     1
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<pre>     not given, the applicant states that the analytical laboratory in Buenos Aires which
     carried out the analyses is a member of the Union of International Independent
     Laboratories and is approved by the UK Grain and Feed Trade Association to
     issue certificates of analysis for feed ingredients.
     Discussion The Committee was satisfied with the specification of the Novel
     Food.
II. Effect of the production process applied to the novel food
pp 10 – 11 of the application dossier
6. Whole Chia seeds are not processed in any way prior to their use as             a food
     ingredient. The seeds are grown in Argentina and Peru under contract          for the
     applicant who states that agronomic practices will be carried out to fully   comply
     with EC legislation. Details of the cultivation conditions are given          in the
     application.
7. Post-harvest, the seed is cleaned mechanically and not subjected to any chemical
     treatments. The seed is stored in sacks within a fully enclosed warehouse facility
     in preparation for shipment. Although the information on the storage and transport
     conditions is limited, following a request from the Committee concerning proposed
     conditions of handling, storage and shipment, the applicant submitted a proposed
     HACCP procedure the use of which would minimise batch to batch variation. The
     seeds are monitored during transport and storage whilst the proposed HACCP
     plan describes measures to be put in place to control temperature and humidity
     during storage and transport. The applicant has also provided data in respect of
     potential microbial contamination of Chia seed.
     Discussion The Committee was satisfied that the proposed method of production
     is controlled, and that the in-transport and in-process monitoring steps are
     appropriate to ensure a safe and consistent product. The Committee accepted the
     proposed HACCP procedures offered sufficient reassurance that the applicant
     would be able to ensure the quality of the product.
III. History of the organism used as a source of the novel food
pp 12 – 13 of the application dossier
8. Chia (Salvia hispanica L) seeds have a history of use as a food and a medicine,
     mainly by the Aztecs up until colonisation by the Europeans. Historically, Chia
     seeds were roasted and ground to form a meal called ‘pinole’, then mixed with
     water to form a porridge or made into cakes. Although grown only on a very small
     scale, and with rudimentary technological methods, Mexican Indian descendants
     are still producing this grain. Chia seeds are also used in a Mexican beverage
     ‘chia fresca’ in which the seeds are soaked in water and then flavoured with fruit
     juice and consumed as a drink.
9. An extensive research and development programme on Chia has been
     undertaken in South America to determine the feasibility of growing this crop on a
     commercial scale. This has resulted in the development of new production areas
                                                                                         2
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<pre>     and methods. Chia crops have been bred conventionally in South America and
     have not undergone genetic modification.
     Discussion The Committee noted that there was limited evidence of recent food
     use for this product.
IX. Anticipated intake/extent of use of the novel food
      pp 14 – 16 of the application dossier
10. If approved, the applicant’s proposed use of Chia is for inclusion of the whole and
     ground seed as ingredients in soft grain bread. Based on data from the UK
     National Diet and Nutrition Survey of Adults Aged 19-64 years (2002), the
     applicant has estimated the amount of the novel ingredient that will be consumed
     as follows.
11. Pilot studies conducted by the applicant have determined that the level of Chia
     seeds or whole ground Chia included in the soft grain bread mix shall be 5%. On
     this basis, daily Chia consumption figures, calculated for British adults would give
     a mean intake of 2.1g/person/day. High level consumers could consume up to
     12.9g/day (97.5 th percentile; adult males).
12. In the UK, soft grain bread includes brands that are directly marketed for
     consumption by children. The applicant did not included estimates of Chia intake
     for different age groups, but the Food Standards Agency additionally provided
     estimates based on food consumption data from Diet and Nutrition Surveys of
     different age groups in Britain.
                            Soft grain bread consumption            Chia consumption
                                       (g/person/day)                (g/person/day)
                              Mean              High level      Mean           High level
                                            (97.5th percentile)            (97.5th percentile)
Age 1½-4½                        22                 65           1.1               3.2
Age 4-18                         29                 86*          1.4               4.3*
Adult 19-64                      43                231*          2.1              11.6*
* Note: with the exception of the youngest age group, the low number of consumers of soft grain bread
in each survey means that the estimates of high level consumption may not be statistically valid. The
figures can therefore only be used as a rough guide to the amount of Chia that would be consumed.
     Discussion As the proposed range of foods was narrow the Committee was
     content that the intended use of the product did not give any cause for concern,
     based on the scientific information currently available.
X. Nutritional information on the novel food
      pp 17 – 19 of the application dossier
13. Chia seeds have an oil content of approximately 32%, which is rich in alpha-
     linolenic acid (approximately 60%). Seeds are also high in protein (21%), are a
     rich source of vitamins B, calcium, phosphorus, potassium, zinc and copper.
14. The UK Committee on Medical Aspects of Food and Nutrition Policy (COMA)
     recommended in 1994 that individuals should increase their intake of n-3 fatty
                                                                                                      3
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<pre>     acids since raised intakes are associated with reduced risks of coronary heart
     disease. The main sources of n-3 fatty acids in the Western diet are oily fish,
     green vegetables and certain vegetable oils.
15. Alpha-linolenic acid is a significant contributor to the intake of n-3 polyunsaturated
     fatty acids (PUFA) and can be elongated and desaturated in vivo to its long-chain
     derivatives, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
     However, in man the extent and regulation of this conversion is unclear 1.
16. Chia seed contains natural antioxidants (chlorogenic acid, caffeic acid and
     flavanol glycosides) which confer a distinct technological advantage over
     alternative alpha-linolenic acid sources such as flaxseed, in terms of product
     stability and flavour quality.
17. Since Chia is intended to be used as a nutritional ingredient, any claims made on
     the food due to the inclusion of the seed or milled whole seed must comply with
     the general criteria for making nutrient content claims. Final products will need to
     be labelled with the ingredient name and the prescribed nutritional labelling
     according to Directive (79/112/EEC as amended).
      Discussion The Committee did not raise any concerns regarding the nutritional
      properties of the novel food.
XII. Microbiological information on the novel food
      p 20 of the application dossier
18. Samples were taken from four consignments of Chia seeds for microbiological
     analysis. No pathogenic organisms were detected. No substances inhibitory to
     BHK21 (C-13) cells were detected in a cytotoxicity assay.
19. No mycotoxins were detected in the screen carried out on a composite sample
     from the four Chia consignments (the applicant describes this analysis under
     scheme XIII).
     Discussion The Committee were content with the microbiological information
     supplied, but requested further information on the control of storage and transport,
     which would minimise the potential for foodborne spoilage microorganisms to
     develop. The applicant was able to supply this information and the Committee
     agreed that the proposed HACCP schema described sufficient measures that
     would control and monitor levels of moisture within the seeds during bulk storage
     and transport.
1
  In 2002, the Food Standards Agency convened a group of expert scientists to review current
research investigating whether n-3 PUFA from plant oils (alpha-linolenic acid) were as beneficial to
cardiovascular health as the n-3 PUFA from marine oils (EPA and DHA). The group concluded that
dietary intake of ALNA has been associated with a beneficial effect on coronary heart disease;
however, the results from studies investigating the effects of ALNA supplementation on CHD risk
factors have proved equivocal.
                                                                                                     4
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<pre>XIII. Toxicological information on the novel food
      pp 21-27 of the application dossier
20. A number of human clinical studies were carried out to assess the safety of this
     product, including an allergenicity study, a 4-week dietary intervention study and a
     12-week randomised, single blind crossover feeding trial.
21. The applicant has also provided details of two 8-week trials in laying hens and
     one 28-day study in broiler chickens which investigated the effects of Chia on
     hens’ egg yolk composition and chicken breast and thigh muscle.
Discussion The Committee was satisfied with the toxicological data supplied by the
applicant.
Allergenicity
p 21 - 22 of the application dossier
22. An investigation into potential allergenicity of Chia was carried out at BIBRA
     International Ltd., Surrey, Southampton University and King’s College London.
     The study described in the report was carried out to internationally accepted
     standards of Good Laboratory Practice but was not subject to any Quality
     Assurance inspection programme. The study is summarised below and more
     detailed information can be found in the application dossier.
23. No allergy-associated properties of Chia seed have been reported in the literature
     to date and no verifiable cases of patients with allergies to common UK food
     plants with any botanical relationship to Chia have been found. Chia belongs to
     the Labiatae, or Laminiaceae, family. The plants of this family include mint, sage,
     thyme, basil, pennyroyal, lavender, lemon balm, bergamot, oregano and savory.
     An allergic response to oregano and thyme is cited in the report, however this is
     related to the leaf of the plant rather than the seed. Consequently the
     investigation was targeted at the peanut and tree nut allergens as the most likely
     source of cross-reactivity.
24. An initial IgE binding screen was carried out against a panel of 30 individuals by
     Multiple Allergy Screening Test (MAST), selected on the basis of their reactivity to
     peanut. Sera from peanut allergic subjects showed low levels of serological
     binding to Chia protein in immunoblots, although this binding varied considerably
     between different serum samples. Inhibition studies indicated that IgE binding to
     Chia was specific. However, it was considered that the binding of IgE to Chia
     protein did not necessarily imply that there would be coincidental clinical reaction
     to Chia.
25. IgE binding of Chia was further analysed using sera from five double-blind
     placebo-controlled food challenge (DBPCFC) peanut sensitive individuals. None
     of these individuals were reported to have allergy to sesame seeds although one
     had sensitivity to mustard. Immunoblotting demonstrated some IgE binding in
     these sera, however this was concluded to be non-specific in nature. Furthermore
                                                                                        5
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<pre>     the applicant has suggested that Chia proteins may be highly glycosylated which
     could affect cross-reactivity.
26. Resistance to proteolytic digestion was investigated in Chia protein extracts using
     methodology based upon the recommendations of the 2001 Joint FAO/WHO
     expert consultation on foods derived from biotechnology. Immunoblot analysis
     demonstrated that all the Chia proteins were sensitive to peptic digestion with the
     exception of a 14kD band and protein bands below 6kD. The investigator
     suggests the 14kD band is non-specific cross-reactivity since this band was
     detected in the negative control serum.
27. Skin prick tests (SPT) were carried out on 12 individuals, selected because of
     sensitivity to peanut and tree nuts, to determine the clinical relevance of IgE
     binding activity observed in immunoblotting experiments. Two subjects gave
     positive SPT responses to Chia which were below the level of the histamine
     positive control challenge and therefore were considered of doubtful clinical
     significance. Both subjects were at the most broadly allergic end of the spectrum
     of sensitivities and both demonstrated sensitisation to sesame. Subsequent
     immunoblotting revealed a band that could represent an authentic IgE binding
     protein. This protein was shown to be susceptible to proteolytic digestion. The
     investigator speculates that this protein is related to sesame and its molecular
     weight could indicate it to be a profilin, a group of proteins associated with clinical
     food allergy.
     Discussion The Committee requested further information regarding the allergenic
     potential of the novel food. The applicant recognised the potential for such cross-
     reactivity but was unable to provide the requested data, citing logistic difficulties in
     assembling the necessary panel of individuals with such allergies. The applicant
     proposed instead to control this risk by including a precautionary statement on the
     label of chia-containing foods, informing consumers that the product was not
     suitable for people suffering from sesame and mustard seed allergies. The
     applicant also pointed out that chia will be used in softgrain bread products which
     often contain other ingredients which make them unsuitable for this group of
     allergic consumers.
     The Committee was disappointed that the applicant was unwilling to conduct
     additional allergy studies, but accepted that this approach would control the risk
     associated with cross-reactivity, although was concerned that the use of
     precautionary labelling might unnecessarily restrict the range of products
     available to allergic consumers.
Human clinical trials
pp 22-24 of the application dossier
28. The effects of dietary intervention with Chia on selected markers of coagulation
     and immune function were investigated in humans. The 4-week placebo-
     controlled dietary intervention study with Chia was carried out in 100 healthy male
     and female subjects (21-65yr) at the University of Ulster, Northern Ireland. The
     full study report can be found in the application dossier. Subjects were then
     randomly allocated to one of four intervention groups and Chia supplements were
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<pre>     included at breakfast. Chia intake was 2.5g (n=25), 5g (n=25) or 10g (n=20) per
     day for 4 weeks. The control group (n=25) received 4g of sunflower seeds per
     day. Fasting blood samples were taken before and after the intervention period
     and were assessed for haematological parameters, plasma lipid profiles and
     lymphocyte subset typing. Additionally, full anthropometric data, a lifestyle and
     food questionnaire and a questionnaire monitoring any possible adverse effects of
     the novel food were administered to each subject.
29. Dose response effects of Chia were statistically analysed. Differences between
     groups were compared using one-way ANOVA, and differences within groups
     were compared using the paired t-test. According to the investigator, no
     significant health-related effects associated with consumption of high levels (10g)
     of Chia seed were detected.           However, analysis of the adverse effects
     questionnaire revealed a significant effect of consumption of 5g per day on
     tiredness and fatigue. The study investigators concluded this to be an anomalous
     result since it was a single effect that was not dose-related. Consequently, no
     significant adverse effects on human health or well-being were seen after
     consumption of Chia, even at levels exceeding the anticipated mean daily intake.
30. The applicant also describes a human feeding trial carried out at the University of
     Toronto, Canada, on subjects with type-2 diabetes, investigating the effects of
     Chia on measures of glycaemic control and traditional and non-traditional risk
     factors of cardiovascular disease. A randomised single blind crossover trial using
     20 subjects with type-2 diabetes was carried out for 12 weeks with individuals
     consuming 25g Chia/1000kcals. Fasting blood samples and blood pressure
     measurements were taken at 0 and 12 weeks.
31. The results suggested that when used as a food supplement, the consumption of
     Chia significantly lowered systolic blood pressure compared to controls and
     favourably altered coagulation factors. No adverse effects were reported including
     no change in bleeding times, liver function or kidney parameters and no adverse
     effects on glycaemic control.
Laying hen and broiler chicken trials
pp 24 – 27 of the application dossier
32. The applicant presents three studies carried out at Queens University, Belfast, in
     laying hens and broilers, to assess the nutritional and compositional effects on
     foods produced from animals fed a diet enriched with Chia. These tests do not
     examine toxicological endpoints.
33. Two laying hen trials investigated the effects of Chia on hens’ egg yolk
     composition by manipulating the feed. The main aim of the first study was to alter
     the fatty acid composition of the egg yolk by manipulating the hen’s diet. The diets
     were carefully formulated to be isoenergetic and were supplemented with either
     1.5% soya oil, 1.5% fish oil or 14% whole Chia seed. No adverse effects were
     observed, but again no specific toxicity tests were carried out.
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<pre>Evaluation of n-3 enriched eggs in humans
p25 of the application dossier
34. This trial, carried out at the Northern Ireland Centre for Diet and Health at the
    University of Ulster, was intended to evaluate the bioavailability in humans of n-3
    fatty acids in eggs produced by hens fed a modified diet supplemented with Chia.
    This study is not relevant to the assessment of Chia as an ingredient in food.
Additional information relevant to the application
p28 of the application dossier
35. The applicant has included information on the regulatory status of Chia seed as a
    food in the USA and Canada. Chia seed is considered to be exempt from pre-
    market regulatory evaluation in the USA and pre-market notification as a novel
    food in Canada. This regulatory information does not affect the evaluation of the
    current application since novel foods undergo a different regulatory process in the
    European Union.
Overall Discussion
36. The applicant has provided sufficient information of the proposed specification,
    intended use and microbiological safety measures, and indicated that on the
    basis of four samples analysed from four separate batches of seed, these criteria
    do not give rise to concern. The Committee noted that given the large transport
    distances involved and the nature of the product, a key element in preventing any
    undesirable substances from contaminating this product is adherence to the
    proposed HACCP procedure as described by the applicant.
37. With regard to the concerns about potential allergenicity, the applicant has
    indicated that they are unable to proceed with the additional studies that would
    offer further information regarding the allergenic potential of the seed. The
    Committee agreed with the applicant that mandatory product labelling, and the
    limited proposed use of the novel food would not present undue risk to the
    consumer. However, the Committee was in agreement that labelling on the basis
    that all individuals who have previously demonstrated symptoms of allergy when
    consuming other seed based products should not consume this product,
    restricted the choice of such individuals and could not be endorsed.
38. In addition, although the proposed labelling regime could be viewed as adequate
    to protect the consumer from potential harm when consuming this novel food, the
    Committee was cautious about agreeing to this approach particularly when the
    studies requested would better inform the public of the extent of the allergenic
    potential of the novel food.
Conclusion
The Committee is satisfied that in accordance with the criteria defined in Article 3(1)
of Regulation (EC) 258/97, the evidence provided by the applicant demonstrates that
the consumption of this product is not dangerous, misleading, or nutritionally
disadvantageous to the consumer. With regard to the applicant’s intention to use
mandatory labelling to advise individuals of the potentially allergic nature of the novel
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<pre>food, the Committee wish to note that that as the extent of allergenicity to this product
remains unclear, this approach may be unduly restrictive of consumer choice. This
issue is one of consumer choice and falls outside the scope of the safety criteria
described in the regulation.
The Committee also advises that should this product be authorised then Member
States should write and inform allergy clinics and allergy support groups of the
introduction of this food these groups may then provide a useful source of on
information on the prevalence of chia, and the potential cross-reactivity with existing
food allergens.
                                                                              April 2004
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