Registration
SOR/2005-98 April 5, 2005

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1205 — Corrective Amendments, Miscellaneous Program)

P.C. 2005-508 April 5, 2005

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, hereby makes the annexed Regulations Amending the Food and Drug Regulations (1205 — Corrective Amendments, Miscellaneous Program).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1205 — CORRECTIVE AMENDMENTS, MISCELLANEOUS PROGRAM)

AMENDMENTS

1. The definition "per cent" in section B.01.001 of the Food and Drug Regulations (see footnote 1) is replaced by the following:

"per cent" or "%" means per cent by weight, unless otherwise stated; (pour cent ou %)

2. The portion of paragraph 14(d) of the table to section B.01.402 of the French version of the Regulations in column 2 is replaced by the following:

Article	Colonne 2 Nomenclature
14.	d) « Thiamine », « Thiamine (vitamine B1) » ou « Thiamine (vit B1) »

3. The portion of subitem A.1(1) of Table II 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) Bread; Flour; Whole wheat flour

4. The portion of subitem G.3(3) 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	(3) Bread; Flour; Whole wheat flour

5. (1) The portion of item L.1 of Table V to section B.16.100 of the Regulations in column II is amended by replacing the expression "Aspergillus niger var. Aspergillus oryzae var.; Saccharomyces sp. Kluyveromyces fragilis (Kluyveromyces marxianus var. marxianus) and Kluyveromyces lactis (Kluyveromyces marxianus var. lactis)" with the following:

Item No.	Column II Permitted Source
L.1	Aspergillus niger var.; Aspergillus oryzae var.; Kluyveromyces fragilis (Kluyveromyces marxianus var. marxianus); Kluyveromyces lactis (Kluyveromyces marxianus var. lactis); Saccharomyces sp.

(2) The portion of subitem L.1(3) of Table V to section B.16.100 of the Regulations in column III opposite the permitted source "Aspergillus niger var.; Aspergillus oryzae var.; Kluyveromyces fragilis (Kluyveromyces marxianus var. marxianus); Kluyveromyces lactis (Kluyveromyces marxianus var. lactis); Saccharomyces sp." is replaced by the following:

Item No.	Column III Permitted in or Upon
L.1	(3) Bread; Flour; Whole wheat flour

6. (1) The portion of item L.2 of Table V to section B.16.100 of the Regulations in column II is amended by replacing the expression "Aspergillus niger var.; Aspergillus oryzae var.; Edible forestomach tissue of calves, kids or lambs; Animal pancreatic tissue; Rhizopus oryzae var." with the following:

Item No.	Column II Permitted Source
L.2	Animal pancreatic tissue; Aspergillus niger var.; Aspergillus oryzae var.; Edible forestomach tissue of calves, kids or lambs; Rhizopus oryzae var.

(2) The portion of subitem L.2(4) 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	(4) Bread; Flour; Whole wheat flour

(3) The portion of item L.2 of Table V to section B.16.100 of the Regulations in column II is amended by replacing the expression "Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2); Mucor miehei (Cooney and Emerson); Rhizopus niveus" with the following:

Item No.	Column II Permitted Source
L.2	Aspergillus oryzae (MLT-2) (pRML 787) (p3SR2); Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)); Rhizopus niveus

(4) The portion of subitem L.2(1) 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	(1) Modified fats and oils

7. The Regulations are amended by replacing the expression "Mucor miehei (Cooney and Emerson)" with the expression "Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson))" wherever it occurs in the following provisions:

(a) the portion of item 12 of the table to paragraph B.01.010(3)(b) in column I;

(b) paragraph B.08.033(3)(a);

(c) paragraph B.08.034(2)(a);

(d) subparagraph B.08.051(d)(v);

(e) subparagraph B.08.077(b)(ix); and

(f) the portion of item M.1 of Table V to section B.16.100 in column II.

8. The French version of the Regulations is amended by replacing the expression "Pain; farine; farine de blé entier" with the expression "Farine; farine de blé entier; pain" wherever it occurs in the following provisions:

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

(b) the portion of item A.4 of Table II to section B.16.100 in column II;

(c) the portion of subitem C.6(1) of Table II to section B.16.100 in column II;

(d) the portion of subitem A.1(2) of Table V to section B.16.100 in column III opposite the permitted source "Aspergillus niger var.; Aspergillus oryzae var.; Bacillus subtilis var.; Rhizopus oryzae var.; Malt d'orge";

(e) the portion of subitem A.2(2) of Table V to section B.16.100 in column III;

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

(g) the portion of subitem G.1(2) of Table V to section B.16.100 in column III opposite the permitted source "Aspergillus niger var.; Aspergillus oryzae var.; Rhizopus oryzae var.";

(h) the portion of subitem L.3(1) of Table V to section B.16.100 in column III;

(i) the portion of subitem P.6(2) of Table V to section B.16.100 in column III; and

(j) the portion of subitem P.7(2) of Table V to section B.16.100 in column III.

COMING INTO FORCE

9. 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.)

Description

These regulatory amendments correct certain sections of the Food and Drug Regulations and do not bring about any substantive amendments to the Regulations. For example, these corrections are necessary to add the "%" symbol in the definition of per cent in order to recognize the current use of the per cent symbol "%" in various tables of the Regulations. These amendments correct also inconsistencies between various provisions of the Regulations, inadvertent differences between the English and French versions of the Regulations, inaccuracies in terminology introduced into these Regulations and changes to scientific names contained in the Regulations.

Alternatives

No alternatives were considered because the corrections are non-substantive and are required to maintain accuracy and consistency in the Food and Drug Regulations.

Benefits and Costs

There is no anticipated impact on industry or the operations of the government. These amendments correct the present Regulations, but do not modify them.

Consultation

Consultation respecting these amendments is not necessary. These amendments are anticipated as integral to the regulatory process and are a result of inadvertent inaccuracies introduced in the Regulations and changes in scientific nomenclature.

Compliance and Enforcement

These amendments do not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and regulations.

Contact

Ronald Burke
Director
Bureau of Food Regulatory,
International and Interagency Affairs
Health Canada
A.L. 0702C1
Ottawa, Ontario
K1A 0L2
Telephone: (613) 957-1748
FAX: (613) 941-3537
E-mail: sche-ann@hc-sc.gc.ca

Footnote a

S.C. 1999, c. 33, s. 347

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).