Vol. 144, No. 14 — July 7, 2010

Registration

SOR/2010-143 June 17, 2010

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1560 — Food Additives)

P.C. 2010-768 June 17, 2010

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), hereby makes the annexed Regulations Amending the Food and Drug Regulations (1560 – Food Additives).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS
(1560 — FOOD ADDITIVES)

AMENDMENTS

1. (1) Paragraphs B.08.033(3)(a) and (b) of the Food and Drug Regulations (see footnote 1) are replaced by the following:

(a) aminopeptidase derived from Lactococcus lactis, bovine rennet derived from aqueous extracts from the fourth stomach of adult bovine animals, sheep and goats, chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105), lipase derived from Animal pancreatic tissue; Aspergillus niger var.; Aspergillus oryzae var.; Edible forestomach tissue of calves, kids or lambs; Rhizopus oryzae var. or from Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2); Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)); Rhizopus niveus, milk coagulating enzyme derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), from Mucor pusillus Lindt by pure culture fermentation process or from Aspergillus oryzae RET-1 (pBoel777), pepsin derived from glandular layer of porcine stomach, phospholipase derived from Aspergillus oryzae (pPFJo142), protease derived from Micrococcus caseolyticus var. or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of any cheese to which subsection (1) applies;

(2) Paragraphs B.08.033(3)(d) and (e) of the Regulations are replaced by the following:

(d) a milk coagulating enzyme derived from Endothia parasitica and enzymes described in paragraph (a), in the manufacture of Parmesan cheese and Romano cheese;

(e) protease derived from Aspergillus oryzae var., Aspergillus niger var. or Bacillus subtilis var., in the manufacture of Colby cheese; and

2. Paragraph B.08.034(2)(a) of the Regulations is replaced by the following:

(a) aminopeptidase derived from Lactococcus lactis, chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105), lipase derived from Animal pancreatic tissue; Aspergillus niger var.; Aspergillus oryzae var.; Edible forestomach tissue of calves, kids or lambs; Rhizopus oryzae var. or from Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2); Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)); Rhizopus niveus, milk coagulating enzyme derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), from Mucor pusillus Lindt by pure culture fermentation process or from Aspergillus oryzae RET-1 (pBoel777), pepsin derived from glandular layer of porcine stomach, phospholipase derived from Aspergillus oryzae (pPFJo142) or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs;

3. Paragraph B.08.035(2)(a) of the Regulations is replaced by the following:

(a) other than chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin derived from glandular layer of porcine stomach or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of cream cheese; and

4. Paragraph B.08.037(2)(a) of the Regulations is replaced by the following:

(a) other than chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin derived from glandular layer of porcine stomach or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of a product to which subsection (1) applies; and

5. Paragraph B.08.038(2)(a) of the Regulations is replaced by the following:

(a) other than chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin derived from glandular layer of porcine stomach or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of a product to which subsection (1) applies; and

6. Paragraph B.08.039(2)(a) of the Regulations is replaced by the following:

(a) other than chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin derived from glandular layer of porcine stomach or rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in the manufacture of a product to which subsection (1) applies; and

7. (1) Subparagraphs B.08.051(d)(iv) and (v) of the Regulations are replaced by the following:

(iv) rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs,

(v) a milk coagulating enzyme derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), from Mucor pusillus Lindt by pure culture fermentation process or from Aspergillus oryzae RET-1 (pBoel777), in an amount consistent with good manufacturing practice,

(2) Paragraph B.08.051(d) of the Regulations is amended by adding the following after subparagraph (vi.1):

(vi.2) pepsin derived from glandular layer of porcine stomach,

8. (1) Subparagraph B.08.077(b)(vi) of the Regulations is replaced by the following:

(vi) rennet derived from aqueous extracts from the fourth stomach of calves, kids or lambs, in an amount consistent with good manufacturing practice,

(2) Subparagraph B.08.077(b)(ix) of the Regulations is replaced by the following:

(ix) a milk coagulating enzyme derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), from Mucor pusillus Lindt by pure culture fermentation process or from Aspergillus oryzae RET-1 (pBoel777), in an amount consistent with good manufacturing practice,

9. Paragraph B.14.007(a) of the Regulations is replaced by the following:

(a) where sold for use in preserved meat or preserved meat by-product, may contain any of ascorbic acid, calcium ascorbate, erythorbic acid, iso-ascorbic acid, potassium nitrate, potassium nitrite, sodium ascorbate, sodium carbonate, sodium erythorbate, sodium iso-ascorbate, sodium nitrate and sodium nitrite, provided that these nitrates and nitrites, if any, are packaged separately from any spice or seasoning.

10. The portion of section B.14.009 of the French version of the Regulations before paragraph (a) is replaced by the following:

B.14.009.[N]. La marinade, la saumure et le mélange de salaison à sec employés dans le marinage des viandes conditionnées ou conservées et des sous-produits de viande conditionnés ou conservés peuvent renfermer

11. (1) The portion of subitem C.3(7) of Table I to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article	Colonne II Permis dans ou sur
C.3	(7) Liant à viande ou liant à (désignation du produit de viande)

(2) The portion of subitem C.3(9) of Table I to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
C.3	(9) Dried egg-white (dried albumen); Dried whole egg; Dried whole egg mix; Dried yolk; Dried yolk mix

12. The portion of subitem S.2(3) of Table I to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
S.2	(3) Dried egg-white (dried albumen); Dried whole egg; Dried whole egg mix; Dried yolk; Dried yolk mix

13. The portion of subitem 1(2) of Table III to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
1.	(2) Dried whole egg; Dried yolk; Frozen whole egg; Frozen yolk; Liquid whole egg; Liquid yolk

14. The portion of subitem A.02(1) of Table V to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Permitted in or Upon
A.02	(1) Cheddar cheese; (naming the variety) Cheese

15. (1) The portion of item B.1 of Table V to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article	Colonne II Source premise
B.1	Extrait aqueux du 4e (véritable) estomac de bovins, de moutons et de chèvres adultes

(2) The portion of item B.1 of Table V to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Permitted in or Upon
B.1	Cheddar cheese; Cottage cheese; Cream cheese; Cream cheese spread; Cream cheese spread with (naming the added ingredients); Cream cheese with (naming the added ingredients); (naming the variety) Cheese

16. The portion of subitem C.1(2) of Table V to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Permitted in or Upon
C.1	(2) Liquid egg-white (liquid albumen), liquid whole egg or liquid yolk, destined for drying

17. The portion of subparagraph C.3(ii) of Table V to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted Source
C.3	Aspergillus niger var. awamori, GCC0349 (pGAMpR); Kluyveromyces marxianus var. lactis, DS1182 (pKS105)

18. The portion of subitem G.3(2) of Table V to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Permitted in or Upon
G.3	(2) Liquid egg-white (liquid albumen), liquid whole egg or liquid yolk, destined for drying

19. (1) The portion of subitems L.2(2) and (3) of Table V to section B.16.100 of the Regulations in column III opposite the permitted source “Animal pancreatic tissue; Aspergillus niger var.; Aspergillus oryzae var.; Edible forestomach tissue of calves, kids or lambs; Rhizopus oryzae var.” is replaced by the following:

Item No.	Column III Permitted in or Upon
L.2	(2) Dried egg-white (dried albumen); Liquid egg-white ( liquid albumen)
	(3) Cheddar cheese; (naming the variety) Cheese; Processed cheddar cheese

(2) The portion of item L.2 of Table V to section B.16.100 of the French version of the Regulations in column II beginning with “Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2);” is replaced by the following:

Article	Colonne II Source permise
L.2	Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2); Rhizomucor miehei (Cooney et Emerson) (précédemment nommé Mucor miehei (Cooney et Emerson)); Rhizopus niveus

(3) The portion of subitem L.2(2) of Table V to section B.16.100 of the Regulations in column III opposite the permitted source “Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2); Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)); Rhizopus niveus” is replaced by the following:

Item No.	Column III Permitted in or Upon
L.2	(2) Cheddar cheese; (naming the variety) Cheese

(4) Item L.2 of Table V to section B.16.100 of the Regulations is amended by adding the following in columns II to IV before the permitted source “Penicillium camembertii”:

Item No.	Column II Permitted Source	Column III Permitted in or Upon	Column IV Maximum Level of Use
L.2	Aspergillus oryzae AI-11 (pBoel 960)	(1) Bread; Flour; Whole wheat flour	(1) Good Manufacturing Practice
		(2) Unstandardized bakery products	(2) Good Manufacturing Practice
		(3) Modified fats and oils	(3) Good Manufacturing Practice
	Aspergillus oryzae BECh2#3 (pCaHj559); Aspergillus oryzae (MStr115) (pMStr20)	(1) Bread; Flour; Whole wheat flour	(1) Good Manufacturing Practice
		(2) Unstandardized bakery products	(2) Good Manufacturing Practice
		(3) Modified lecithin	(3) Good Manufacturing Practice
		(4) Unstandardized egg products	(4) Good Manufacturing Practice
	Aspergillus niger (pCaHj600/MBin118#11)	Modified fats and oils	Good Manufacturing Practice

20. (1) The portion of item L.4 of Table V to section B.16.100 of the English version of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted Source
L.4	Egg-white

(2) The portion of item L.4 of Table V to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Permitted in or Upon
L.4	Cheddar cheese; (naming the variety) Cheese

21. The portion of subitem M.1(1) of Table V to section B.16.100 of the Regulations in column III opposite the permitted source “Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)) or Mucor pusillus Lindt by pure culture fermentation process or Aspergillus oryzae RET-1 (pBoel777)” is replaced by the following:

Item No.	Column III Permitted in or Upon
M.1	(1)  Cheddar cheese; Cottage cheese; (naming the variety) Cheese; Sour cream

22. The portion of subitem P.1(1) of Table V to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Permitted in or Upon
P.1	(1) Dried egg-white (dried albumen); Liquid egg-white (liquid albumen)

23. The portion of subitem P.5(2) of Table V to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Permitted in or Upon
P.5	(2) Cheddar cheese; Cottage cheese; Cream cheese; Cream cheese spread; Cream cheese spread with (naming the added ingredients); Cream cheese with (naming the added ingredients); (naming the variety) Cheese

24. Table V to section B.16.100 of the Regulations is amended by adding the following after item P.5:

Item No.	Column I Additive	Column II Permitted Source	Column III Permitted in or Upon	Column IV Maximum Level of Use
P.5A	Phospholipase	Streptomyces violaceoruber	(1) Modified lecithin	(1) Good Manufacturing Practice
			(2) Unstandardized egg products	(2) Good Manufacturing Practice
		Aspergillus oryzae (pPFJo142)	Cheddar cheese; (naming the variety) Cheese	Good Manufacturing Practice

25. (1) The portion of item P.6 of Table V to section B.16.100 of the English version of the Regulations in column II beginning with “Aspergillus oryzae var.;” is replaced by the following:

Item No.	Column II Permitted Source
P.6	Aspergillus oryzae var.; Aspergillus niger var.; Bacillus subtilis var.

(2) The portion of subitem P.6(1) of Table V to section B.16.100 of the Regulations in column III opposite the permitted source “Micrococcus caseolyticus var.” is replaced by the following:

Item No.	Column III Permitted in or Upon
P.6	(1) (naming the variety) Cheese

26. (1) The portion of item R.1 of Table V to section B.16.100 of the English version of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted Source
R.1	Aqueous extracts from the fourth stomach of calves, kids or lambs

(2) The portion of subitem R.1(1) of Table V to section B.16.100 of the Regulations in column III is replaced by the following:

Item No.	Column III Permitted in or Upon
R.1	(1) Cheddar cheese; Cottage cheese; Cream cheese; Cream cheese spread; Cream cheese spread with (naming the added ingredients); Cream cheese with (naming the added ingredients); (naming the variety) Cheese; Sour cream

27. The portion of item A.1.1 of Table VIII to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
A.1.1	Dried egg-white (dried albumen); Dried whole egg; Dried yolk; Frozen egg-white (frozen albumen); Frozen whole egg; Frozen yolk; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk

28. The portion of subitems C.9(1) and (2) of Table VIII to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
C.9	(1) Frozen egg-white (frozen albumen); Liquid egg-white (liquid albumen)
	(2) Dried egg-white (dried albumen)

29. The portion of subitems S.6.1(1) and (2) of Table VIII to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
S.6.1	(1) Dried egg-white (dried albumen)
	(2) Frozen egg-white (frozen albumen); Liquid egg-white (liquid albumen)

30. The portion of subitems S.9A(1) and (2) of Table VIII to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
S.9A	(1) Frozen egg-white (frozen albumen); Liquid egg-white (liquid albumen)
	(2)  Dried egg-white (dried albumen)

31. The portion of item T.4 of Table VIII to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
T.4	Dried egg-white (dried albumen); Frozen egg-white (frozen albumen); Liquid egg-white (liquid albumen)

32. The portion of subitem L.1(1) of Table X to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

L.1

(1) Ale; Baking powder; Beer; Bread; Cider; Cottage cheese; Creamed cottage cheese; Dried egg-white (dried albumen); Dried whole egg; Dried yolk; French dressing; Frozen egg-white (frozen albumen); Frozen whole egg; Frozen yolk; Ice cream mix; Ice milk mix; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk; Malt liquor; Mayonnaise; Olives; Pickles; Porter; Relishes; Salad dressing; Sherbet; Stout

33. The portion of subitem P.9(3) of Table X to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
P.9	(3) Ice cream mix; Ice milk mix; Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product

34. The portion of subitem S.6(1) of Table X to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

S.6

(1) Apple (or rhubarb) and (naming the fruit) jam; Baking powder; Dried egg-white (dried albumen); Dried whole egg; Dried yolk; Fig marmalade; Fig marmalade with pectin; Frozen egg-white (frozen albumen); Frozen whole egg; Frozen yolk; Ice cream mix; Ice milk mix; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk; Malted milk powder; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Oil-soluble annatto; Pineapple marmalade; Pineapple marmalade with pectin; Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product

35. The portion of subitem S.8(1) of Table X to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.

Column II Permitted in or Upon

S.8

(1) Apple (or rhubarb) and (naming the fruit) jam; Dried egg-white (dried albumen); Dried whole egg; Dried yolk; Fig marmalade; Fig marmalade with pectin; Frozen egg-white (frozen albumen); Frozen whole egg; Frozen yolk; Gelatin; Ice cream mix; Ice milk mix; Liquid egg-white (liquid albumen); Liquid whole egg; Liquid yolk; Meat binder or (naming the meat product) binder where sold for use in preserved meat or preserved meat by-product; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Pineapple marmalade; Pineapple marmalade with pectin

36. The portion of subitem S.15(2) of Table X to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
S.15	(2) Gelatin; Ice cream mix; Ice milk mix; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk; Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product

37. The portion of subitem C.7(1) of Table XII to section B.16.100 of the French version of the Regulations in column II is replaced by the following:

Article	Colonne II Permis dans ou sur
C.7	(1) Marinade, saumure et mélange de salaison à sec employés dans le marinage des viandes conditionnées ou conservées et des sous-produits de viande conditionnés ou conserves

38. The portion of subitem S.2(1) of Table XII to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted in or Upon
S.2	(1) Ice cream mix; Ice milk mix; Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product; Sherbet

39. (1) The English version of the Regulations is amended by replacing “egg white” with “egg-white” in the following provisions:

(a) subsection B.01.009(5);

(b) clause B.02.100( b )(xii)(A);

(c) paragraph B.08.033(3)( f );

(d) paragraph B.08.034(2)( c ); and

(e) item 27 of the table to section D.03.002 in column I.

(2) The English version of the Regulations is amended by replacing “Chymosin” with “chymosin” in the following provisions:

(a) subparagraphs B.08.051( d )(vi) and (vi.1); and

(b) subparagraphs B.08.077( b )(x) and (xi).

COMING INTO FORCE

40. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issue and objectives

The Food and Drug Regulations (the Regulations) regulate the sale and use of food additives in Canada, listing the permitted food additives and how they may be used. Health Canada has received submissions from industry requesting that the Regulations be amended to enable the use of enzymes produced from the following genetically modified and conventional sources of micro-organisms:

• lipase produced by Aspergillus oryzae AI-11 (pBoel 960) genetically modified to contain the lipase gene from Thermomyces lanuginosus in the production of modified triglycerides (modified fats and oils) and in flour for the production of bread;
• lipase produced by Aspergillus oryzae BECh2#3 (pCaHj559) genetically modified to contain a hybrid gene from Thermomyces lanuginosus and Fusarium oxysporum, in the production of bread, flour and unstandardized bakery products and in the modification of whole egg or egg yolk and lecithin;
• lipase obtained from a genetically modified Aspergillus oryzae micro-organism, Aspergillus oryzae (MStr115) (pMStr20), that carries the gene from Fusarium oxysporum, in the production of bread, flour and unstandardized bakery products and in the modification of whole egg or egg yolk and lecithin;
• lipase derived from a genetically modified Aspergillus niger micro-organism, Aspergillus niger (pCaHj600/ MBin118#11), that carries the gene from Candida antarctica coding for this enzyme, in the production of modified fats and oils; and
• phospholipase derived from a genetically modified Aspergillus oryzae micro-organism, Aspergillus oryzae (pPFJo142), that carries the gene from Fusarium venenatum, in the production of cheddar, mozzarella and pizza cheese.

In addition, Health Canada has received a submission to permit the use of the phospholipase enzyme produced by the following conventional source of micro-organism:

• phospholipase obtained from Streptomyces violaceoruber in the production of modified lecithin, and the hydrolysis of phospholipids in egg yolk, whole egg, blends of yolk and albumen and in soy lecithin.

Evaluation of available data supports the safety and effectiveness of these food additives in the above specified uses. Therefore, the Regulations are amended to permit the use of the above noted food additives in the above specified uses. Since there are no concerns regarding the safety and efficacy of these enzymes, the amendments permit the use of the phospholipase enzyme derived from Aspergillus oryzae (pPFJo142) in (naming the variety) cheese and the use of the lipase enzyme derived from Aspergillus oryzae AI-11 (pBoel 960) in unstandardized bakery products, two uses that were not currently the subject of submissions to Health Canada. These amendments reduce the regulatory burden to both government and industry.

The amendments benefit the consumers by allowing greater availability of food products while continuing to help protect their health and safety. In addition, these amendments benefit industry by facilitating the manufacture of food products.

Description and rationale

The amendments enable the use of the lipase and phospholipase enzymes produced from the genetically modified and conventional sources of micro-organisms mentioned above.

There is no anticipated increase in cost to government from the administration of these amendments to the Regulations. Furthermore, compliance costs incurred by the manufacturers are not considered to be a factor because the use of food additives is optional.

The only regulatory options available to address these submissions are for the Minister to recommend or not to the Governor in Council that the Regulations be amended to permit the uses as described above for these food additives. Based on its safety and efficacy assessment, the Minister recommends that the uses for these food additives be enabled.

Interim Marketing Authorizations (IMAs) have been issued to permit the immediate use of these food additives as proposed in the submissions while the regulatory process was undertaken to amend the Regulations. They were published in the Government Notices section of the Canada Gazette, Part I, on:

• September 15, 2001, lipase from Aspergillus oryzae AI-11 (pBoel 960) in the production of modified triglycerides (modified fats and oils) and in flour used in the production of bread.
• October 8, 2005, lipase from Aspergillus oryzae BECh2#3 (pCaHj559) in the production of bread, flour and unstandardized bakery products, and in whole egg or egg yolk modification and lecithin hydrolysis.
• January 14, 2006, lipase from Aspergillus oryzae (MStr115) in the production of bread, flour and unstandardized bakery products and in whole egg or egg yolk modification and lecithin hydrolysis.
• February 18, 2006, phospholipase from Streptomyces violaceoruber in the production of modified lecithins, and the hydrolysis of phospholipids in egg yolk, whole egg, blends of yolk and albumen and in soy lecithin.
• August 5, 2006, phospholipase from Aspergillus oryzae (pPFJo142) in the production of cheddar, mozzarella and pizza cheese.
• September 9, 2006, lipase from Aspergillus niger (pCaHj600/MBin118#11) in the production of modified fats and oils.

The amendments are required to enable these uses of the lipase and phospholipase enzymes from the sources specified above under the Regulations. The amendments also correct inconsistencies noted in certain sections of the Regulations in respect to the terminology used for eggs, cheese and meat products.

Consultation

The amendments permit the use of these food additives in foods subject to compositional and health and safety standards set out in Division 8 (Dairy Products) and in Division 13 (Grain and Bakery Products) of the Regulations, and in certain unstandardized foods, namely unstandardized bakery products, unstandardized egg products and modified fats and oils. The Canadian Food Inspection Agency (CFIA) and the Canadian Poultry and Egg Processors Council were consulted regarding the use of lipase and phospholipase for the modification of egg yolk and whole egg. Neither organization offered any objection. The CFIA also indicated that it does not object to the use of phospholipase for standardized cheeses.

In addition, Health Canada has announced, through posting on its Web site, the publication in the Canada Gazette, Part I, of the IMAs that were issued for these food additives and the proposed regulatory amendments. Since the IMAs were published in the Canada Gazette, Part I, between 2001 and 2006, the Government has received no objections or safety concerns regarding these uses.

Implementation, enforcement and service standards

The CFIA is responsible for the enforcement of the Food and Drugs Act and the Regulations with respect to foods. The CFIA uses a science-based risk management approach to set its food safety priorities. Using this approach as its foundation, the CFIA plans its inspection and testing programs for foods, taking into account the degree of risk associated with a particular sector, and concentrates its resources where risk is the greatest. Each CFIA commodity inspection program performs ingredient verifications, at which time inspectors compare formulation and list of ingredients and perform on-site verification of the manufacture of the product. The frequency of inspection depends on the history of compliance of a particular product, the history of compliance of the manufacturer and the food safety risk.

Contact

Barbara Lee
Director
Bureau of Chemical Safety
Health Canada
251 Sir Frederick Banting Driveway
Tunney’s Pasture
Address Locator: 2203B
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-0973
Fax: 613-954-4674
Email: sche-ann@hc-sc.gc.ca

Footnote a
S.C. 2005, c. 42, s. 2

Footnote b
R.S., c. F-27

Footnote 1
C.R.C., c. 870

NOTICE:
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