Vol. 144, No. 6 — March 17, 2010

Registration

SOR/2010-41 February 23, 2010

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1604 — Food Additives)

P.C. 2010-210 February 23, 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 (1604 — Food Additives).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS
(1604 — FOOD ADDITIVES)

AMENDMENTS

1. Item A.1 of Table V to section B.16.100 of the Food and Drug Regulations (see footnote 1) is amended by adding the following after subitem (10) in columns III and IV opposite the permitted source beginning with “Aspergillus niger var.;”:

Item No.	Column III Permitted in or Upon	Column IV Maximum Level of Use
A.1	(11) Plant-based beverages	(11) Good Manufacturing Practice
	(12) Infant cereal products	(12) Good Manufacturing Practice

2. The permitted source of item A.1 of Table V to section B.16.100 of the Regulations in column II beginning with “B a cillus amyloliquefaciens EBA 20 (pUBH2);” is replaced by the following:

Item No.

Column II Permitted Source

A.1

Bacillus amyloliquefaciens EBA 20 (pUBH2); Bacillus licheniformis; Bacillus licheniformis BML 592 (pAmyAmp); Bacillus licheniformis BML 730 (pAmyAmp); Bacillus licheniformis LA 57 (pDN1981); Bacillus licheniformis LAT8(pLAT3); Bacillus licheniformis LiH 1159 (pLiH1108); Bacillus licheniformis LiH 1464 (pLiH1346); Bacillus licheniformis PL 1303 (pPL1117); Bacillus licheniformis MOL2083 (pCA164-LE399)

3. The permitted source “Bacillus stearothermophilus” of item A.1 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
A.1	Bacillus licheniformis 3253 (plCatH-3253); Bacillus licheniformis 3266 (plCatH-3266ori1); Bacillus stearothermophilus; Bacillus subtilis B1.109 (pCPC800)

4. The permitted source “Bacillus subtilis B1.109 (pCPC800)” of item A.1 of Table V to section B.16.100 of the Regulations in column II and the portions in columns III and IV opposite that permitted source are repealed.

5. The portion of item A.2 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
A.2	Bacillus subtilis BRG-1 (pBRG1); Bacillus subtilis DN1413 (pDN1413); Bacillus subtilis LFA 63 (pLFA63); Bacillus subtilis RB-147 (pRB147)

6. Item P.6 of Table V to section B.16.100 of the Regulations is amended by adding the following after subitem (12) in columns III and IV opposite the permitted source beginning with “Aspergillus oryzae var.;” :

Item No.	Column III Permitted in or Upon	Column IV Maximum Level of Use
P.6	(13) Plant-based beverages	(13) Good Manufacturing Practice

7. The portion of subitem C.8(2) of Table XIV to section B.16.100 of the English version of the Regulations in column II is amended by replacing “Unstandardized foods” with “Unstandardized bakery products”.

8. Subsection B.25.062(2) of the Regulations is amended by striking out “or” at the end of paragraph (f), by adding “or” at the end of paragraph (g) and by adding the following after paragraph (g):

(h) infant cereal products that contain amylase in accordance with Table V to section B.16.100.

9. The English version of the Regulations is amended by replacing “Unstandardized bakery foods” with “Unstandardized bakery products” in the following provisions:

(a) the portion of subitem A.1(2) of Table II to section B.16.100 in column II;

(b) the portion of subitem A.2(3) of Table II to section B.16.100 in column II;

(c) the portion of subitem A.2A(2) of Table II to section B.16.100 in column II;

(d) the portion of subitem C.1(2) of Table II to section B.16.100 in column II;

(e) the portion of subitem C.2(2) of Table II to section B.16.100 in column II;

(f) the portion of subitem C.3(2) of Table II to section B.16.100 in column II;

(g) the portion of subitem C.6(2) of Table II to section B.16.100 in column II;

(h) the portion of subitem P.2(2) of Table II to section B.16.100 in column II;

(i) the portion of subitem P.3(2) of Table II to section B.16.100 in column II;

(j) the portion of subitem S.1(2) of Table II to section B.16.100 in column II;

(k) the portion of subitem S.2(2) of Table II to section B.16.100 in column II;

(l) the portion of item P.5 of Table IV to section B.16.100 in column II;

(m) the portion of subitem I.1(2) of Table V to section B.16.100 in column III;

(n) the portion of subitem P.6(11) of Table V to section B.16.100 in column III;

(o) the portion of item M.8 of Table VIII to section B.16.100 in column II;

(p) the portion of subitem A.9(2) of Table X to section B.16.100 in column II;

(q) the portion of subitem A.10(2) of Table X to section B.16.100 in column II;

(r) the portion of subitem A.2(3) of Table XIV to section B.16.100 in column II;

(s) the portion of subitem A.3(3) of Table XIV to section B.16.100 in column II;

(t) the portion of subitem A.4(3) of Table XIV to section B.16.100 in column II;

(u) the portion of subitem C.1(2) of Table XIV to section B.16.100 in column II;

(v) the portion of item C.2 of Table XIV to section B.16.100 in column II;

(w) the portion of item C.3 of Table XIV to section B.16.100 in column II;

(x) the portion of subitem C.4(2) of Table XIV to section B.16.100 in column II;

(y) the portion of subitem C.5(2) of Table XIV to section B.16.100 in column II;

(z) the portion of subitem C.6(3) of Table XIV to section B.16.100 in column II;

(z.1) the portion of item C.7 of Table XIV to section B.16.100 in column II;

(z.2) the portion of subitem P.2(2) of Table XIV to section B.16.100 in column II;

(z.3) the portion of subitem P.4(2) of Table XIV to section B.16.100 in column II; and

(z.4) the portion of item S.1 of Table XIV to section B.16.100 in column II.

COMING INTO FORCE

10. 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 permit the use of enzymes produced from the following genetically modified and conventional sources of micro-organisms:

• Amylase produced from Bacillus subtilis, Aspergillus oryzae and barley in the production of plant-based beverages;
• Protease produced from Bacillus subtilis in the production of plant-based beverages;
• Amylase (maltogenic) produced from genetically modified Bacillus subtilis BRG-1 (pBRG1) in starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), bread, flour, whole wheat flour and unstandardized bakery products;
• Amylase produced from genetically modified Bacillus licheniformis MOL2083 (pCA164-LE399) in starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), and in distillers’ and brewers’ mash;
• Amylase (maltogenic) produced from genetically modified Bacillus subtilis RB-147 (pRB147) in bread, flour, whole wheat flour and unstandardized bakery products;
• Amylase produced from Aspergillus oryzae var. in the production of infant cereal products;
• Amylase produced from genetically modified Bacillus licheniformis 3266 (plCatH-3266ori1) in starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), bread, flour, whole wheat flour and unstandardized bakery products, and in distillers’ and brewers’ mash;
• Amylase produced from genetically modified Bacillus licheniformis 3253 (plCatH-3253) in starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), bread, flour, whole wheat flour and unstandardized bakery products, and in distillers’ and brewers’ mash.

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 as described.

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

The amendments also correct inconsistencies in the Tables to section B.16.100 of the English version of the Regulations by replacing the expression “unstandardized bakery foods” with “unstandardized bakery products”, and the expression “unstandardized foods” with “unstandardized bakery products.”

Description and rationale

The amendments enable the use of the enzymes amylase, amylase (maltogenic) and protease produced from genetically modified and conventional sources of micro-organisms as described 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, Health Canada 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

• July 17, 2004, amylase and protease enzymes in the production of beverages made from rice, multi-grain and soya, and oat and soya;
• July 31, 2004, amylase (maltogenic) in starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), bread, flour, whole wheat flour and unstandardized bakery products;
• August 5, 2006, amylase in starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), and in distillers’ and brewers’ mash;
• December 1, 2007, amylase (maltogenic) in bread, flour, whole wheat flour and unstandardized bakery products;
• March 1, 2008, amylase in the production of infant cereals;
• May 31, 2008, amylase produced from Bacillus licheniformis 3266 (plCatH-3266ori1) in starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), bread, flour, whole wheat flour and unstandardized bakery products, and in distillers’ and brewers’ mash;
• May 31, 2008, amylase produced from Bacillus licheniformis 3253 (plCatH-3253) in starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), bread, flour, whole wheat flour and unstandardized bakery products, and in distillers’ and brewers’ mash.

Consultation

The amendments permit the use of these food additives in foods for which there are compositional and health and safety standards set out in Division 13, Grain and Bakery Products, of the Regulations. Since amylase, amylase (maltogenic) and protease enzymes from various sources have a long history of safe use as permitted food additives in Canada in standardized bread, flour and whole wheat flour, no additional amendment is required to the standards for these foods.

Health Canada has announced, through postings on its Web site, the publication in the Canada Gazette, Part I, of these IMAs and the proposed regulatory amendments. Since the publication of these IMAs in the Canada Gazette, Part I, between 2004 and 2008, the Government has received no objections or safety concerns regarding the use of these enzymes from the sources named above.

Implementation, enforcement and service standards

The Canadian Food Inspection Agency (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, 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

John Salminen
Acting 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:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with extensible hypertext markup language (XHTML 1.0 Strict).