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Enabling statute: Food and Drugs Act
    Food and Drug Regulations
Disclaimer: These documents are not the official versions (more).
Source: http://laws.justice.gc.ca/en/F-27/C.R.C.-c.870/238522.html
Regulation current to September 15, 2006

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PART II

Acepromazine and its salts

Acépromazine et ses sels

Acetanilide

Acétanilide

Adrenocortical hormones and their salts and derivatives, (except hydrocortisone or hydrocortisone acetate, when sold as a single medicinal ingredient in a concentration that provides 0.5% hydrocortisone in preparations for topical use on the skin)

Hormones corticosurrénales, leurs sels et dérivés (sauf l’hydrocortisone et l’acétate d’hydrocortisone vendus comme ingrédient médicinal unique dans les préparations pour usage topique sur la peau et présents dans celles-ci en concentration de 0,5 % d’hydrocortisone)

Aminopyrine and its derivatives

Aminopyrine et ses dérivés

Amprolium and its salts

Amprolium et ses sels

Antipyrine (except preparations for topical use)

Antipyrine (sauf dans les préparations pour usage topique)

Apramycin and its salts

Apramycine et ses sels

Azithromycin and its salts and derivatives

Azithromycine, ses sels et dérivés

Centella asiatica extract and active principles thereof

Centella asiatica (extrait de) et ses principes actifs

Chlorhexidine and its salts, when used as a topical oral preparation

Chlorhexidine et ses sels, dans les préparations pour usage oral topique

Chlorothiazide and its salts and derivatives

Chlorothiazide, ses sels et dérivés

Chlorpromazine and its salts

Chlorpromazine et ses sels

Cholestyramine resin

Colestyramine (résine de)

Clarithromycin and its salts and derivatives

Clarithromycine, ses sels et dérivés

Cyclizine

Cyclizine

Dihydrostreptomycin and its salts and derivatives

Dihydrostreptomycine, ses sels et dérivés

Dirithromycin

Dirithromycine

Ergot alkaloids and their salts

Ergot (alcaloïdes d’) et leurs sels

Erythromycin and its salts and derivatives

Érythromycine, ses sels et dérivés

Folic acid

Acide folique

Framycetin and its salts and derivatives

Framycétine, ses sels et dérivés

Furaltadone and its salts

Furaltadone et ses sels

Furazolidone and its salts

Furazolidone et ses sels

Furosemide

Furosémide

Griseofulvin and its salts and derivatives

Griséofulvine, ses sels et dérivés

Iron derivatives for parenteral use only

Fer, ses dérivés pour usage parentéral seulement

Kanamycin and its salts and derivatives

Kanamycine, ses sels et dérivés

Levamisole and its salts

Lévamisole et ses sels

Lincomycin and its salts and derivatives

Lincomycine, ses sels et dérivés

Liothyronine and its salts

Liothyronine et ses sels

Mebendazole

Mébendazole

Meclizine and its salts when sold in concentrations greater than 25 mg per dosage unit

Méclizine et ses sels s’ils sont vendus en une concentration supérieure à 25 mg par unité posologique

Neomycin and its salts and derivatives

Néomycine, ses sels et dérivés

Nicarbazin

Nicarbazin

Nitrofurantoin and its salts

Nitrofurantoine et ses sels

Novobiocin and its salts and derivatives

Novobiocine, ses sels et dérivés

Nystatin (except preparations for topical use on the skin) and its salts and derivatives

Nystatine (sauf dans les préparations pour usage topique sur la peau), ses sels et dérivés

Oleandomycin and its salts and derivatives

Oléandomycine, ses sels et dérivés

Penicillin and its salts and derivatives, (except amoxicillin, ampicillin, azlocillin, benzathine penicillin, carbenicillin, cloxacillin, dicloxacillin, hetacillin, mecillinam, methicillin, mezlocillin, nafcillin, oxacillin and ticarcillin and their salts and derivatives)

Pénicilline, ses sels et dérivés, (sauf amoxicilline, ampicilline, azlocilline, benzathine pénicilline, carbénicilline, cloxacilline, dicloxacilline, hétacilline, mécillinam, méthicilline, mezlocilline, nafcilline, oxacilline et ticarcilline, leurs sels et dérivés)

Physostigmine salicylate (except preparations for oral or topical use only)

Physostigmine (salicylate de), (sauf dans les préparations pour usage oral et topique seulement)

Polymyxin B and its salts and derivatives, (except for topical use or for local action in the oral cavity or nasal passages)

Polymyxine B, ses sels et dérivés, (sauf pour usage topique ou local dans la cavité buccale ou dans les voies nasales)

Primidone

Primidone

Promazine and its salts

Promazine et ses sels

Reserpine and its salts

Réserpine et ses sels

Ronidazole and its salts and derivatives

Ronidazole, ses sels et dérivés

Sex hormones, except the following:

Hormones sexuelles, sauf :

Androisoxazole

Androisoxazole

Androstanolone

Androstanolone

Androstenediol and its derivatives

Androstènediol et ses dérivés

Bolandiol and its derivatives

Bolandiol et ses dérivés

Bolasterone

Bolastérone

Bolazine

Bolazine

Boldenone and its derivatives

Boldénone et ses dérivés

Bolenol

Bolénol

Calusterone

Calustérone

Clostebol and its derivatives

Clostébol et ses dérivés

Cyproterone and its derivatives

Cyprotérone et ses dérivés

Diethylstilbestrol and its derivatives

Diéthylstilbestrol et ses dérivés

Drostanolone and its derivatives

Drostanolone et ses dérivés

Enestebol

Énestébol

Epitiostanol

Épitiostanol

Ethylestrenol

Éthylestrénol

Fluoxymesterone

Fluoxymestérone

Formebolone

Formébolone

Furazabol

Furazabol

4-Hydroxy-19-nortestosterone and its derivatives

Hydroxy-4-nor-19 testostérone et ses dérivés

Levonorgestrel, when sold in concentrations of 0.75 mg per oral dosage unit

Lévonorgestrel, s’il est vendu en une concentration de 0,75 mg par unité posologique orale

Mebolazine

Mébolazine

Megestrol and its derivatives

Mégestrol et ses dérivés

Mesabolone

Mésabolone

Mesterolone

Mestérolone

Metandienone

Métandiénone

Metenolone and its derivatives

Méténolone et ses dérivés

Methandriol

Méthandriol

Methyltestosterone and its derivatives

Méthyltestostérone et ses dérivés

Metribolone

Métribolone

Mibolerone

Mibolérone

Nandrolone and its derivatives

Nandrolone et ses dérivés

Norboletone

Norbolétone

Norclostebol and its derivatives

Norclostébol et ses dérivés

Norethandrolone

Noréthandrolone

Oxabolone and its derivatives

Oxabolone et ses dérivés

Oxandrolone

Oxandrolone

Oxymesterone

Oxymestérone

Oxymetholone

Oxymétholone

Prasterone

Prastérone

Quinbolone

Quinbolone

Stanozolol

Stanozolol

Stenbolone and its derivatives

Stenbolone et ses dérivés

Testosterone and its derivatives

Testostérone et ses dérivés

Tibolone

Tibolone

Tiomesterone

Tiomestérone

Trenbolone and its derivatives

Trenbolone et ses dérivés

Zeranol

Zéranol

Vitamin K, except Vitamin K1 and Vitamin K2 sold

(a) for external use in humans; or

(b) in an oral dosage form for use in humans if the maximum recommended daily dose is 0.120 mg or less

Sodium fluoride (in solid oral dosage forms containing more than one milligram of fluoride ion)

Sodium (fluorure de) (sous forme posologique solide orale contenant plus d’un milligramme d’ion fluor)

Spectinomycin and its salts and derivatives

Spectinomycine, ses sels et dérivés

Spiramycin and its salts and derivatives

Spiramycine, ses sels et dérivés

Streptomycin and its salts and derivatives

Streptomycine, ses sels et dérivés

Sulphonamides and their salts and derivatives

Sulfamides, leurs sels et dérivés

Tetracycline and its salts and derivatives (except doxycycline when sold for intramuscular administration in caged birds)

Tétracycline, ses sels et dérivés (sauf doxycycline si elle est vendue pour administration intramusculaire aux oiseaux en cage)

Thiabendazole

Thiabendazole

Thyroid

Thyroïde

Tioconazole and its salts

Tioconazole et ses sels

Trimeprazine and its salts

Triméprazine et ses sels

Tylosin and its salts and derivatives (except when sold for the treatment of chronic colitis in dogs)

Tylosine, ses sels et dérivés (sauf lorsque vendu pour le traitement de la colite chronique chez le chien)

Veratrum album and its alkaloids and their salts

Veratrum album, ses alcaloïdes et leurs sels

Veratrum viride and its alkaloids and their salts

Veratrum viride, ses alcaloïdes et leurs sels

Virginiamycin and its salts and derivatives

Virginiamycine, ses sels et dérivés

Vitamin A

Vitamine A

Vitamin D

Vitamine D

Vitamine K, sauf la vitamine K1 et la vitamine K2 vendues :

(a) soit pour usage externe destiné aux humains;

(b) soit sous une forme posologique orale destinée aux humains si la dose quotidienne maximale recommandée est de 0,120 mg ou moins

 SOR/78-423, s. 5; SOR/78-427, s. 11; SOR/79-754, s. 1; SOR/80-279, s. 1; SOR/81-334, s. 6; SOR/81-358, s. 2; SOR/82-1072, s. 1; SOR/85-551, s. 2; SOR/86-91, s. 5; SOR/86-955, s. 1; SOR/87-332, s. 1; SOR/87-447, s. 1; SOR/87-496, ss. 1 to 18; SOR/87-669, ss. 1, 2; SOR/88-351, ss. 1 to 11; SOR/88-511, ss. 1 to 11; SOR/89-195, s. 1; SOR/89-454, ss. 1 to 4; SOR/89-504, ss. 1 to 4; SOR/89-572, ss. 1 to 45; SOR/90-119, ss. 1 to 10; SOR/90-173, s. 2(F); SOR/90-443, ss. 1(F) to 4 (F), 5, 6(F) to 15(F); SOR/90-585, ss. 1 to 5; SOR/91-197, ss. 1, 2(F); SOR/91-521, ss. 1 to 15; SOR/92-95, ss. 1 to 9; SOR/92-386, ss. 4 to 8; SOR/92-591, s. 2; SOR/92-647, ss. 1 to 15; SOR/92-724, s. 1; SOR/93-110, ss. 1 to 3, 4(E), 5(E), 6 to 11; SOR/93-243, s. 2; SOR/93-435, ss. 1 to 38; SOR/94-166, ss. 1 to 17, 18(E), 19 to 30; SOR/94-286, ss. 1, 2; SOR/94-458, ss. 1 to 13; SOR/94-462, s. 1; SOR/94-557, ss. 1 to 9; SOR/94-461, s. 1; SOR/95-59, s. 1; SOR/95-172, s. 2; SOR/95-201, s. 1; SOR/95-546, s. 1; SOR/96-253, ss. 1, 2; SOR/96-306, s. 1; SOR/97-140, s. 1; SOR/97-407, s. 1; SOR/97-410, ss. 1, 2; SOR/97-414, s. 1; SOR/97-543, ss. 8, 9; SOR/97-544, s. 1; SOR/97-567, s. 1; SOR/98-291, ss. 1 to 7; SOR/98-292, s. 1; SOR/98-293, s. 1; SOR/98-294, s. 1; SOR/99-370, ss. 1, 2(F), 3, 4(F); SOR/99-373, s. 1; SOR/99-374, ss. 1(F), 2; SOR/99-412, s. 1; SOR/2000-119, s. 1; SOR/2000-124, s. 1; SOR/2000-197, ss. 1, 2; SOR/2000-219, s. 2; SOR/2000-403, ss. 1, 2; SOR/2001-95, s. 1; SOR/2001-531, s. 1; SOR/2002-53, s. 1; SOR/2002-418, s. 1; SOR/2003-34, ss. 6 to 8; SOR/2003-36, s. 1; SOR/2003-80, ss. 1, 2; SOR/2003-248, s. 1; SOR/2003-327, s. 1; SOR/2004-108, ss. 1 to 6; SOR/2005-105, s. 1; SOR/2005-167, s. 1; SOR/2005-270, s. 1; SOR/2005-307, s. 1; SOR/2006-143, s. 1; SOR/2006-144, ss. 1, 2.

SCHEDULE K

REASONABLE DAILY INTAKE FOR VARIOUS FOODS

 

Column I

 

Column II

Item

No.

Name and Description

 

R.D.I.

 

  1.

Alimentary Pastes, dry


3.0 oz.

85 g

  2.

Bacon (side) simulated meat product that resembles side bacon, (cooked)


1.0 oz.

28 g

  3.

Beverage Bases and Mixes, Flavoured, for Addition to Milk (ready to serve)


16.0 fl.oz.

454 ml

  4.

Bread, 5 slices


5.3 oz.

150 g

  5.

Butter


2.0 oz.

57 g

  6.

Buttermilk


30.0 fl.oz.

852 ml

  7.

Cereals, Breakfast or Infant


1.0 oz.

28 g

  8.

Cereals, puffed


0.5 oz.

14 g

  9.

Cheese (other than Cottage Cheese)


2.0 oz.

57 g

10.

Cheese, Cottage


3.5 oz.

100 g

11.

Condensed Milk


15.0 fl.oz.

426 ml

12.

Cream, whipping


2.0 oz.

57 g

13.

Egg, yolk­replaced egg


3.5 oz.

100 g

14.

Evaporated Milk, Evaporated Skim Milk, Evaporated Partly Skimmed Milk


15.0 fl.oz.

852 ml

30.0 fl.oz.

 

(reconstituted to original volume)

15.

Fish, Shell Fish


3.5 oz.

100 g

16.

Fruits, dried


2.0 oz.

57 g

17.

Fruits, (other than banana, lemon, lime, watermelon)


3.5 oz.

100 g

18.

Fruits, Banana


5.3 oz.

150 g

19.

Fruits, Lemon


1.8 oz.

50 g

20.

Fruits, Lime


1.8 oz.

50 g

21.

Fruits, Watermelon


7.0 oz.

200 g

22.

Fruit Drinks, Fruit Nectars (ready to serve)


4.0 fl.oz.

114 ml

23.

Fruit Drink Bases, Mixes and Concentrates (ready to serve)


4.0 fl.oz.

114 ml

24.

Fruit Juices (other than lemon juice and lime juice)


4.0 fl.oz.

114 ml

25.

Fruit Juices, Lemon


1.0 fl.oz.

28 ml

26.

Fruit Juices, Lime


1.0 fl.oz.

28 ml

27.

Ice Cream, Ice Milk


3.5 oz.

100 g

28.

Infant Formulas, Prepared (ready to serve)


As directed by Label

29.

Instant Breakfast, Ready Breakfast (ready to serve)


As directed by Label

30.

Margarine


 2.0 oz.

57 g

31.

Meat Products


 3.5 oz.

100 g

32.

Meat Product Extenders


 3.5 oz.

100 g

33.

Extended Meat Products


 3.5 oz.

100 g

34.

Milk, whole


30.0 fl.oz.

852 ml

35.

Milk Powder (reconstituted and ready to serve)


30.0 fl.oz.

852 ml

36.

(naming the flavour) Milk


30.0 fl.oz.

852 ml

37.

Molasses


 1.5 oz.

 43 g

38.

Nuts


 1.0 oz.

 28 g

39.

Peanut Butter


 1.0 oz.

 28 g

40.

Poultry Products


 3.5 oz.

100 g

41.

Extended Poultry Products


 3.5 oz.

100 g

42.

Poultry Product Extenders


 3.5 oz.

100 g

43.

Simulated Meat Products excluding a simulated meat product that resembles side bacon


 3.5 oz.

100 g

44.

Simulated Poultry Products


 3.5 oz.

100 g

45.

Skim Milk, Partly Skimmed Milk


30.0 fl.oz.

852 ml

46.

(naming the flavour) Skim Milk, (naming the flavour) Partly Skimmed Milk


30.0 fl.oz.

852 ml

47.

Skim Milk Powder, Partly Skimmed Milk Powder (reconstituted and ready to serve)


30.0 fl.oz.

852 ml

48.

Skim Milk with Added Milk Solids, Partly Skimmed Milk with Added Milk Solids


30.0 fl.oz.

852 ml

49.

(naming the flavour) Skim Milk with Added Milk Solids, (naming the flavour) Partly Skimmed Milk with Added Milk Solids


30.0 fl.oz.

852 ml

50.

Soup (ready to serve)


 7.0 fl.oz.

200 ml

51.

Sterilized Milk


30.0 fl.oz.

852 ml

52.

Vegetable Juices


 4.0 fl.oz.

114 ml

53.

Vegetable Drinks


 4.0 fl.oz.

114 ml

54.

Vegetable Drink Concentrates, Mixes and Bases (ready to serve)


 4.0 fl.oz.

114 ml

55.

Vegetable (other than baked beans and cooked potatoes)


 3.5 oz.

100 g

56.

Vegetables, baked beans


 8.5 oz.

250 g

57.

Vegetables, cooked potatoes


 7.0 oz.

200 g

58.

Yeast


 0.5 oz.

 14 g

59.

Yogurt, plain


 5.0 oz.

150 g

 SOR/78-64, s. 10; SOR/84-300, s. 63(E).

APPENDICES I AND II

[Repealed, SOR/81-935, s. 2]

APPENDIX III

FORMS

Export Certificate

(Under theFood and Drugs Act *—R.S.C. 1970, c. F­27)

The undersigned exporter hereby certifies that the (description of article)


 

packaged and labelled as follows:


and marked in distinct overprinting with the word “Export”

1. is not manufactured for consumption in Canada,

2. is not sold for consumption in Canada, and

3. packages and the contents of such packages do not contravene any known requirement of the law of

___________________________to which it is or is about to be consigned.

(name of country or countries)

 

Dated at______________the______________day of___________19   .

Canada :    In the matter of an Export Certificate under theFood and Drugs Act,

Province of______________

 

To Wit :

I,


 

of the____________________of


 

in the____________________of


 

 

 

do solemnly declare:

 

 

1. that I am the “Exporter” issuing the certificate above set out and have a knowledge of the matters and facts herein declared to by me,

 

 

or

 

 

I am the________________________of


 

 


 

 

 

the “Exporter” issuing the certificate above set out and have a knowledge of the matters and facts herein declared to by me (describe position of declarant as the agent of the “Exporter” in case of a Corporation issuing the certificate) ,

 

 

2. that the information set out in the said certificate is true,

 

 

3. that all information relevant to the purpose of the said certificate is set out herein and no information relevant thereto has knowingly been withheld.

 

And I make this solemn declaration conscientiously believing it to be true, and knowing that it is of the same force and effect as if made under oath, and by virtue ofThe Canada Evidence Act.

 

Declared before me at____________________this


day of______________19   .

_______________        _______________

  A Commissioner for Taking Oaths

 

* See section 32 of theFood and Drugs Actand Appendix III of theFood and Drug Regulations

 

 SOR/80-318, s. 2.

SCHEDULE L

(Sections B.01.402, B.01.403, B.01.450 and B.01.454 to B.01.465)

NUTRITION FACTS TABLE FORMATS

GRAPHICS ARE NOT DISPLAYED, SEE SOR/2003-11, S. 37; ERR., VOL. 37, NO. 5

 SOR/2003-11, s. 37; err., Vol. 37, No. 5.


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