Produits d'Huiles fixes - Orale

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La présente monographie vise à servir de guide à l'industrie pour la préparation de demandes de licence de mise en marché (DLMM) et d'étiquettes dans le but d'obtenir une autorisation de mise en marché d'un produit de santé naturel. Elle ne vise pas à être une étude approfondie de l'ingrédient médicinal.

Notes

Cette monographie n'appuie que les acides gras se retrouvant naturellement dans les huiles fixes, incluant les huiles concentrées mais elle exclut les huiles fixes enrichies avec des acides gras supplémentaires.
Les préparations contenant des huiles essentielles/volatiles (par ex., celles préparées par distillation) dépassent le cadre de cette monographie.
Les huiles hydrogénées et partiellement hydrogénées dépassent le cadre de cette monographie.
Cette monographie peut être utilisée pour appuyer les produits à ingrédient unique ou à ingrédients multiples contenant un ou plusieurs ingrédient(s) médicinal(aux) du tableau 1.
Les parenthèses contiennent des éléments d'information additionnels (facultatifs) qui peuvent être inclus dans la DLMM ou sur l'étiquette du produit à la discrétion du demandeur.
La barre oblique (/) indique que les termes et/ou énoncés sont synonymes. Le demandeur peut utiliser n'importe lequel des termes ou énoncés indiqués.

Date

28 mars 2024

Nom(s) propre(s), Nom(s) commun(s) et Information(s) d'origine

Tableau 1 : Nom(s) propre(s), Nom(s) commun(s) et Information(s) d'origine
Nom(s) propre(s)	Nom(s) commun(s)	Information(s) d'origine
Nom(s) propre(s)	Nom(s) commun(s)	Matière(s) d'origine	Partie(s)
Borago officinalis	Huile de bourrache	Borago officinalis	Graine
Camelina sativa	Huile de lin bâtard	Camelina sativa	Graine
Cannabis sativa	Huile de graines de chanvre	Cannabis sativa	Graine
Carthamus tinctorius	Huile de carthame	Carthamus tinctorius	Graine
Cocos nucifera	Huile de noix de coco	Cocos nucifera	Albumen (graine d'angiosperme)
Huile de foie de morue	Huile de foie de morue	Gadidae¹	Foie
Cucurbita pepo	Huile de graines de citrouille	Cucurbita pepo	Graine
Huile de canola	Huile de canola Huile de colza Huile de graines de canola	Brassica napus Brassica juncea Brassica rapa	Graine
Huile de poisson²	Huile de poisson	Ammodytidae Carangidae Clupeidae Engraulidae Gadidae³ Osmeridae Salmonidae Scombridae	En entier
Helianthus annuus	Huile de tournesol	Helianthus annuus	Graine
Hippophae rhamnoides	Huile de fruit d'argousier	Hippophae rhamnoides	Fruit
Hippophae rhamnoides	Huile de graines d'argousier	Hippophae rhamnoides	Graine
Huile de krill	Huile de krill	Euphasia pacifica Euphausia superba	En entier
Linum usitatissimum	Huile de lin Huile de graines de lin	Linum usitatissimum	Graine
Oenothera biennis	Huile d'onagre Huile de primerose	Oenothera biennis	Graine
Olea europaea	Huile d'olive	Olea europaea	Fruit
Prunus dulcis	Huile d'amande Huile d'amandes douces	Prunus dulcis	Graine
Ribes nigrum	Huile de pépins de cassis	Ribes nigrum	Graine
Salvia hispanica	Huile de graines de chia	Salvia hispanica	Graine
Schizochytrium spp.	Huile de schizochytrium	Schizochytrium spp.	En entier
Huile de phoque	Huile de phoque	Cystophora cristata Erignathus barbatus Halichoerus grypus Pagophilus groenlandicus Phoca vitulina Pusa hispida	Petit lard
Huile de calmar	Huile de calmar	Todarodes pacificus Docidicus gigas Illex argentinus Illex illecebrosus	En entier
Triticum aestivum	Huile de germe de blé	Triticum aestivum	Germe (graine)
Vitis vinifera	Huile de pépins de raisin	Vitis vinifera	Graine

Références: Noms propres: BDIPSN 2023; Noms communs: BDIPSN 2023; Informations d'origine: FCC 2023, ITIS 2023, USP-NF 2023, Ph.Eur 2023, Linnamaa et al. 2010, Yurko-Mauro et al. 2010, Dubois et al. 2007, Callaway et al. 2005, Hoffmann 2003, Yang et al. 1999.

¹Huile de foie de morue : Les noms communs des espèces et non pas la famille peuvent être listés sur l'étiquette.

²Huile de poisson : Correspond à l'huile du corps entier d'un ou plus d'espèces des familles listées dans le Tableau 1 dans sa forme naturelle, et/ou sous forme triglycéride/triacylglycérol concentrée et/ou sous forme estérifiée concentrée (BP 2023; Ph.Eur. 2023; Froese and Pauly 2022). Les noms communs des espèces et non pas les familles peuvent être listés sur l'étiquette.

³Huile de poisson : Pour les huiles de poisson incluant des espèces de Gadidae comme matière d'origine, le contenu en vitamine A et D doit être testé afin d'assurer que les doses maximales quotidiennes rencontrent la monographie des Suppléments de multivitamines/minéraux pour chaque groupe d'âge.

Voie d'administration

Orale

Forme(s) posologique(s)

Cette monographie exclut les aliments et les formes posologiques semblables aux aliments tel qu'indiqué dans le document de référence Compendium des monographies.

Les formes posologiques acceptables pour la voie d'administration orale sont indiquées dans la liste déroulante dans le formulaire web de demande de licence de mise en marché pour les demandes officinales.

Usage(s) ou fin(s) et Dose(s)

Sous-population(s)

Adulte 18 ans et plus

Quantité(s)

Consulter les tableaux 2 et 3.

Tableau 2 : Usages ou fins, doses quotidiennes associées et composantes d'activité (AL - Acide linoléique; AAL - Acide alpha-linolénique; AEP - Acide eicosapentaénoïque; ADH - Acide docosahexaénoïque; ADP - Acide docosapentaénoïque; AGL-Acide gamma-linolénique; AO - Acide oléique)
Ingrédients médicinaux	Méthodes de préparation	Usages ou fins	Doses quotidiennes¹	Composantes d'activité
Huile de bourrache	Huile fixe non-normalisée	Source d'acides gras essentiels pour le maintien d'une bonne santé Source d'acides gras oméga-6 pour le maintien d'une bonne santé Source d'acide linoléique (LA) pour le maintien d'une bonne santé	Huile : 3,7-5 g	S/O
Huile de bourrache	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 5 g et AL, AAL, AGL et/ou AO selon le tableau 3*	AL, AAL, AGL, AO
Huile de canola	Huile fixe non-normalisée	S/O	Huile : jusqu'à 15 g	S/O
Huile de canola	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 15 g et AL, AAL et/ou AO selon le tableau 3*	AL, AAL, AO
Huile de caméline	Huile fixe non-normalisée	S/O	Huile : jusqu'à 15 g	S/O
Huile de caméline	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 15 g et AL, AAL et/ou AO selon le tableau 3*	AL, AAL, AO
Huile de chanvre	Huile fixe non-normalisée	S/O	Huile : jusqu'à 15 g	S/O
Huile de chanvre	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 15 g et AL, AAL, AGL et/ou AO selon le tableau 3*	AL, AAL, AGL, AO
Huile de carthame	Huile fixe non-normalisée	S/O	Huile : jusqu'à 15 g	S/O
Huile de carthame	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 15 g et AL, AAL et/ou AO selon le tableau 3*	AL, AAL, AO
Huile de noix de coco	Huile fixe non-normalisée	Source d'antioxydants/Fournis des antioxydants Source d'antioxydants/Fournis des antioxydants qui aident à combattre/à protéger (les cellules) contre/à réduire (les effets oxydatifs des/les dommages oxydatifs causés par/les dommages cellulaires causés par) les radicaux libres	Huile : jusqu'à 15 g	S/O
Huile de noix de coco	Huile fixe normalisée	Source d'antioxydants/Fournis des antioxydants Source d'antioxydants/Fournis des antioxydants qui aident à combattre/à protéger (les cellules) contre/à réduire (les effets oxydatifs des/les dommages oxydatifs causés par/les dommages cellulaires causés par) les radicaux libres et/ou Selon le tableau 3	Huile : jusqu'à 15 g et AL, AAL et/ou AO selon le tableau 3*	AL, AAL, AO
Huile de foie de morue	Huile fixe normalisée	Selon la monographie de l'huile de foie de morue	Huile : jusqu'à 4 g et Quantités de AEP, ADH, Vitamine A et Vitamine D selon la monographie de l'huile de foie de morue	AEP, ADH, Vitamine A, Vitamine D
Huile de foie de morue	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 4 g et Quantités minimales de AEP et/ou ADH selon le tableau 3* et Quantités maximales de AEP, ADH, Vitamine A et Vitamine D selon la monographie de l'huile de foie de morue	AEP, ADH, Vitamine A, Vitamine D
Huile de graines de citrouille	Huile fixe non-normalisée	S/O	Huile : jusqu'à 15 g	S/O
Huile de graines de citrouille	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 15 g et AL et/ou AO selon le tableau 3*	AL, AO
Huile de poisson	Huile fixe normalisée	Selon la monographie de l'huile de poisson	Selon la monographie de l'huile de poisson	AEP, ADH
Huile de poisson	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 10 g et AEP et/ou ADH selon le tableau 3*	AEP, ADH
Huile de tournesol	Huile fixe non-normalisée	Source d'antioxydants/Fournis des antioxydants Source d'antioxydants/Fournis des antioxydants qui aident à combattre/à protéger (les cellules) contre/à réduire (les effets oxydatifs des/les dommages oxydatifs causés par/les dommages cellulaires causés	Huile : jusqu'à 15 g	S/O
Huile de tournesol	Huile fixe normalisée	Source d'antioxydants/Fournis des antioxydants Source d'antioxydants/Fournis des antioxydants qui aident à combattre/à protéger (les cellules) contre/à réduire (les effets oxydatifs des/les dommages oxydatifs causés par/les dommages cellulaires causés par) les radicaux libres et/ou Selon le tableau 3	Huile : jusqu'à 15 g et AL et/ou AO selon le tableau* 3*	AL, AO
Huile de graine d'argousier	Huile fixe non-normalisée	S/O	Huile : jusqu'à 5 g	S/O
Huile de graine d'argousier	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 5 g et AL, AAL et/ou AO selon le tableau 3*	AL, AAL, AO
Huile de fruit d'argousier	Huile fixe non-normalisée	S/O	Huile : jusqu'à 5 g	S/O
Huile de fruit d'argousier	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 5 g et AL, AAL et/ou AO selon le tableau 3*	AL, AAL, AO
Huile de krill	Huile fixe normalisée	Source d'AEP (acide éicosapentaénoïque) et d'ADH (acide docosahexaénoïque) pour le maintien d'une bonne santé Source d'acides gras oméga-3 pour le maintien d'une bonne santé Source d'acide gras omega-3 tel qu'AEP et ADH	Huile : jusqu'à 4,1 g et AEP+ADH : 100 mg ou plus	AEP, ADH
Huile de krill	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 4,1 g et AEP et/ou ADH selon le tableau 3*	AEP, ADH
Huile de lin	Huile fixe non-normalisée	Source d'acide gras essentiel (acide alpha-linolénique (AAL)) pour le maintien d'une bonne santé Source d'acides gras oméga-3 pour le maintien d'une bonne santé Source d'acide alpha-linolénique (AAL) pour le maintien d'une bonne santé	Huile : 0,23-32 g	S/O
	Huile fixe non-normalisée	Source d'acide gras essentiel (acide linoléique (AL)) pour le maintien d'une bonne santé Source d'acides gras essentiels (acide alpha-linolénique (AAL) et acide linoléique (AL)) pour le maintien d'une bonne santé Source d'acides gras oméga-6 pour le maintien d'une bonne santé Source d'acide linoléique (AL) pour le maintien d'une bonne santé	Huile : 7,7-32 g	S/O
	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 32 g et/ou AL, AAL et/ou AO selon le tableau 3*	AL, AAL, AO
Huile d'onagre	Huile fixe non-normalisée	Source d'acides gras essentiels pour le maintien d'une bonne santé Source d'acides gras oméga-6 pour le maintien d'une bonne santé Source d'acide linoléique (AL) pour le maintien d'une bonne santé	Huile : 1,3-6 g	S/O
Huile d'onagre	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 6 g et AL, AAL, AGL et/ou OA selon le tableau 3*	AL, AAL, AGL, AO
Huile d'olive	Huile fixe non-normalisée	Source d'antioxydants/Fournis des antioxydants Source d'antioxydants/Fournis des antioxydants qui aident à combattre/à protéger (les cellules) contre/à réduire (les effets oxydatifs des/les dommages oxydatifs causés par/les dommages cellulaires causés par) les radicaux libres	Huile : jusqu'à 15 g	S/O
Huile d'olive	Huile fixe normalisée	Source d'antioxydants/Fournis des antioxydants Source d'antioxydants/Fournis des antioxydants qui aident à combattre/à protéger (les cellules) contre/à réduire (les effets oxydatifs des/les dommages oxydatifs causés par/les dommages cellulaires causés par) les radicaux libres et/ou Selon le tableau 3	Huile : jusqu'à 15 g et AL et/ou AO selon le tableau 3*	AL, AO
Huile d'amande	Huile fixe non-normalisée	S/O	Huile : jusqu'à 15 g	S/O
Huile d'amande	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 15 g et AL, AAL et/ou AO selon le tableau 3*	AL, AAL, AO
Huile de pépins de cassis	Huile fixe non-normalisée	S/O	Huile : jusqu'à 10,5 g	S/O
Huile de pépins de cassis	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 10,5 g et AL, AAL, AGL et/ou AO selon le tableau 3*	AL, AAL, AGL, AO
Huile de chia	Huile fixe non-normalisée	S/O	Huile : jusqu'à 4,5 g	S/O
Huile de chia	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 4,5 g et AL, AAL et/ou AO selon le tableau 3*	AL, AAL, AO
Huile de Schizochytrium	Huile fixe normalisée	Aide à soutenir la santé cognitive et/ou les fonctions cérébrales	ADH : 200-2000 mg	AEP, ADH
Huile de Schizochytrium	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 5 g et AEP et/ou ADH selon le tableau 3*	AEP, ADH
Huile de phoque	Huile fixe normalisée	Selon la monographie de l'huile de phoque	Selon la monographie de l'huile de phoque	AEP, ADH, ADP
Huile de phoque	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 10 g et AEP, ADH et/ou ADP selon le tableau 3*	AEP, ADH, ADP
Huile de calmar	Huile fixe non-normalisée	S/O	Huile : jusqu'à 5 g	S/O
Huile de calmar	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 5 g et AEP et/ou ADH selon le tableau 3*	AEP, ADH
Huile de germe de blé	Huile fixe non-normalisée	Source d'antioxydants/Fournis des antioxydants Source d'antioxydants/Fournis des antioxydants qui aident à combattre/à protéger (les cellules) contre/à réduire (les effets oxydatifs des/les dommages oxydatifs causés par/les dommages cellulaires causés	Huile : jusqu'à 15 g	S/O
Huile de germe de blé	Huile fixe normalisée	Source d'antioxydants/Fournis des antioxydants Source d'antioxydants/Fournis des antioxydants qui aident à combattre/à protéger (les cellules) contre/à réduire (les effets oxydatifs des/les dommages oxydatifs causés par/les dommages cellulaires causés par) les radicaux libres et/ou Selon le tableau 3	Huile : jusqu'à 15 g et AL, AAL et/ou AO selon le tableau 3*	AL, AAL, AO
Huile de pépins de raisin	Huile fixe non-normalisée	S/O	Huile : jusqu'à 15 g	S/O
Huile de pépins de raisin	Huile fixe normalisée	Selon le tableau 3	Huile : jusqu'à 15 g et AL, AAL et/ou AO selon le tableau 3*	AL, AAL, AO

Références : DPSNSO 2023; Zielinska et al. 2017; Quinn et al. 2010; Yang et al. 1999; Leventhal et al. 1994.

¹La quantité des huiles fixes peut aussi être représentée en quantité volumétrique (c.-à-d. ml) en se basant sur les informations de densités listées en Annexe 1.

*La quantité totale d'un acide gras spécifique (par ex., AL) dans un produit doit rencontrer la dose minimale listée dans le Tableau 3 pour appuyer une allégation de ce tableau. Il n'est pas obligatoire que chaque huile rencontre la dose minimale d'un acide gras spécifique si la quantité totale d'un acide gras dans le produit fini la rencontre.

Tableau 3 : Usages ou fins selon les composantes d'activité - acides gras
Composantes d'activité : acides gras¹	Usage(s) ou fin(s)	Dose quotidienne minimale²
AL	Source d'acide linoléique (AL) pour le maintien d'une bonne santé Source d'acide gras oméga-6 pour le maintien d'une bonne santé Source d'acide gras essentiel pour le maintien d'une bonne santé	850 mg
AAL	Source d'acide alpha-linolénique (AAL) pour le maintien d'une bonne santé Source d'acide gras oméga-3 pour le maintien d'une bonne santé Source d'acide gras essentiel pour le maintien d'une bonne santé	80 mg
AL + AAL	Source d'acides gras essentiels pour le maintien d'une bonne santé	850 mg d'AL et 80 mg d'AAL
AEP + ADH ou AEP + ADP ou ADH + ADP ou AEP + ADH + ADP	Source d'acides gras oméga-3 pour le maintien d'une bonne santé	100 mg
AEP	Source d'acide eicosapentaénoïque (AEP) pour le maintien d'une bonne santé	100 mg
ADH	Source d'acide docosahexaénoïque (ADH) pour le maintien d'une bonne santé	100 mg
	Aide à soutenir/maintenir la santé cognitive Aide à soutenir/maintenir les fonctions cérébrales	150 mg
	Aide à soutenir/maintenir lu fonctionnement des yeux Aide à soutenir/maintenir la santé oculaire	200 mg
ADP	Source d'acide docosapentaénoïque (ADP) pour le maintien d'une bonne santé	100 mg
AEP + ADH	Aide à soutenir/maintenir la/une santé cardiovasculaire/du cœur (normale) Aide à soutenir/maintenir une/les fonction(s) cardiovasculaire(s)/du cœur (normale(s))	200 mg
AEP + ADH	Aide à soutenir/maintenir les taux normaux de triglycérides/triacyglycérols (sanguins) Aide à réduire (les taux de)/(les) triglycérides/triacyglycérols (sanguins)	1000 mg
AGL	Source d'acide gamma-linoléique (AGL)	100 mg
AO	Source d'acide oléique (AO)	100 mg

¹Pour les produits proposant des allégations sur ce tableau, les activités doivent être indiquées pour les constituants d'acides gras correspondants.
²Références: DPSNSO 2023; EFSA 2010a; EFSA 2010b; EFSA 2009; Simopolous 2007; IOM 2006; IOM 2002; Simopolous 1999

Note : Les usages ci-dessus peuvent être combinés sur l'étiquette du produit (par ex., Aide à réduire les triglycérides et à maintenir la santé cardiovasculaire).

Mode(s) d'emploi

Énoncé non requis

Règles et restrictions pour les associations

Un usage ou fin n'est acceptable que si au moins un ingrédient médicinal/composante d'activité associé(e) avec cette allégation est présent(e) dans le produit à la dose ou au-dessus de la dose minimum quotidienne indiquée dans les tableaux 2 et 3.
Les ingrédients médicinaux qui ne respectent pas la dose minimale quotidienne pour un usage ou fin seront considérés comme des ingrédients médicinaux complémentaires acceptables dans la formulation du produit.
Tous les ingrédients médicinaux inclus dans cette monographie peuvent être associés selon les restrictions suivantes :

La dose quotidienne maximale d'un produit contenant des associations d'huiles ne doit pas dépasser 15,0 g par jour (DPSNSO 2023). Les doses quotidiennes maximales des ingrédients médicinaux individuels, indiquées dans le tableau 2, s'appliquent.
La dose quotidienne maximale d'une association AEP+ADH ou AEP+ADH+ADP dans un produit unique ne doit pas dépasser 5000 mg par jour pour les individus de 18 ans et plus (US FDA 2019; EFSA 2012).

Durée(s) d'utilisation

Énoncé non requis.

Mention(s) de risque

Précaution(s) et mise(s) en garde

Produits contenant de l'huile de chanvre, de l'huile d'argousier, de l'huile de krill, de l'huile de pépins de cassis et/ou de l'huile de calmar

Consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin avant l'utilisation si vous êtes enceinte ou si vous allaitez.

Produits contenant de l'huile de poisson

Douleur causée par l'arthrite rhumatoïde

Consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/médecin/docteur si les symptômes s'aggravent.

Équilibre de l'humeur

Consultez un praticien de soins de santé/fournisseur de soins de santé/professionnel de la santé/docteur/médecin avant l'utilisation si vous avez des troubles psychologiques tels que l'anxiété ou la dépression.

Contre-indications(s)

Énoncé non requis.

Réaction(s) indésirable(s) connue(s)

Produits contenant de l'huile de krill et/ou de l'huile de calmar

Cessez l'utilisation si une hypersensibilité/allergie se manifeste (SC 2017).

Ingrédients non médicinaux

Doivent être choisis parmi ceux de la version actuelle de la Base de données des ingrédients des produits de santé naturels (BDIPSN) et respecter les restrictions mentionnées dans cette base de données.

Conditions d'entreposage

Doivent être établies conformément aux exigences décrites dans Règlement sur les produits de santé naturels.

Produits contenant de l'huile de Schizochytrium, de l'huile de caméline, de l'huile de chanvre, de l'huile de foie de morue, de l'huile de poisson, de l'huile d'argousier, de l'huile de krill, de l'huile de lin, de l'huile de pépins de cassis, de l'huile de chia, de l'huile de phoque et/ou de l'huile de calmar sauf les produits encapsulés

Réfrigérer après l'ouverture (Wille et Gonus 1989).

Tous les produits (information pour l'industrie; pas pour l'étiquetage)

À être emballé dans un contenant hermétique, dans un endroit frais et à l'abri de la lumière (Ph.Eur. 2023; USP-NF 2023).

Spécifications

Les spécifications du produit fini doivent être établies conformément aux exigences décrites dans le Guide de référence sur la qualité des produits de santé naturels de la Direction des produits de santé naturels et sans ordonnance (DPSNSO).
L'ingrédient médicinal doit être conforme aux exigences mentionnées dans la BDIPSN.
L'huile de foie de morue, l'huile de poisson, l'huile de krill, l'huile de phoque et l'huile de calmar sont des huiles marines et doivent respecter les exigences sur les contaminants dans les huiles marines du Guide de référence sur la qualité des produits de santé naturels de la DPSNSO pour les produits renfermant ces ingrédients.
Pour tous les produits contenant un ou plusieurs ingrédients de cette monographie, les exigences sur la résistance des huiles à l'oxydation du Guide de référence sur la qualité des produits de santé naturels de la DPSNSO doit être respectée.
Pour tous les produits ayant une ou plusieurs des activités indiquées dans la section des doses, une analyse doit être faite afin de confirmer l'activité/les activités en question.

Pour l'huile de poisson provenant des espèces de Gadidae

Pour les huiles de poisson incluant des espèces de Gadidae comme matière d'origine, le contenu en vitamine A et D doit être testé afin d'assurer que les doses maximales quotidiennes rencontrent la monographie des Suppléments de multivitamines/minéraux pour chaque groupe d'âge.

Huile de chanvre

Les produits renfermant de l'huile de chanvre ne doivent pas contenir plus de 10 parties par million de delta-9-Tétrahydrocannabinol (THC), ou des phytocannabinoïdes qui ont été isolés ou concentrés. La détermination de la concentration de THC doit tenir compte du potentiel de conversion de l'acide delta-9-tétrahydrocannabinolique (THCA) en THC. Les dérivés du chanvre (par ex., huile de chanvre) doivent aussi être conformes au Règlement sur le chanvre industriel (RCI). Toutes les sources de chanvre relevant du RCI devraient appartenir à un cultivar approuvé, défini dans le RCI comme une variété de chanvre industriel figurant sur la Liste des cultivars approuvés, publiée par le gouvernement du Canada sur son site Web, avec ses modifications successives.

EXEMPLE D'INFO-PRODUIT :

Veuillez consulter la ligne directrice, Étiquetage des produits de santé naturels pour plus de détails.

Info-Produit

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Annexe I

Densité des huiles fixes
Huiles fixes	Parties	Densité
Huile de bourrache	Graine	0,908 - 0,925 g/mL
Huile de lin bâtard	Graine	0,918 - 0,927 g/mL
Hemp Seed Oil	Graine	0,920 - 0,930 g/mL
Huile de canola	Graine	0,917 - 0,923 g/mL*
Huile de carthame	Graine	0,918 - 0,937 g/mL
Huile de noix de coco	Albumen (graine d'angiosperme)	0,913 - 0,919 g/mL
Huile de foie de morue	Foie	0,921 - 0,927 g/mL
Huile de graines de citrouille	Graine	0,901 - 0,924 g/mL
Huile de poisson	En entier	0,929 - 0,931 g/mL
Huile de tournesol	Graine	0,919 - 0,920 g/mL
Huile de fruit d'argousier	Fruit	0,913 - 0,919 g/mL
Huile de graines d'argousier	Graine	0,913 - 0,919 g/mL
Huile de krill	En entier	0,919 - 0,925 g/mL*
Huile de lin	Graine	0,928 - 0,935 g/mL
Huile d'onagre	Graine	0,918 - 0,930 g/mL
Huile d'olive	Fruit	0,908 - 0,914 g/mL
Huile d'amandes douces	Graine	0,913 - 0,919 g/mL*
Huile de pépins de cassis	Graine	0,919 - 0,926 g/mL
Huile de graines de chia	Graine	0,922 - 0,927 g/mL
HHuile de Schizochytrium (huile d'algue)	En entier	0,944 - 0,950 g/mL
Huile de phoque	Petit lard	0,921 - 0,927 g/mL*
Huile de calmar	En entier	0,953 - 0,959 g/mL*
Huile de germe de blé	Germe (graine)	0.922 - 0,937 g/mL
Huile de pépins de raisin	Graine	0,921 - 0,924 g/mL

*Lorsqu'une valeur unique a été trouvée dans les références, une variation de +/- 0,003 g/mL a été appliquée pour permettre une variabilité potentielle. Au moins l'une des références suivantes a été utilisée pour appuyer les intervalles de densité : Moovendhan 2021; Turck et al. 2021; Purnamayati et al. 2019; Uzunova et al. 2019; Delgado-et al. 2018; Petcu et al. 2016; Lee et al. 2014; Edwin et al. 2013; Firestone 2013; Manisha et Sharma 2011; Zhang et al. 2011; Alamu et al. 2010; Budavari 1996; Subrahmanyam et al. 1994; Kyte R.M. 1956.