Vol. 146, No. 7 — March 28, 2012
Registration
SOR/2012-46 March 15, 2012
FOOD AND DRUGS ACT
Regulations Amending the Food and Drug Regulations (1632 — Phospholipase)
P.C. 2012-295 March 15, 2012
His 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 (1632 — Phospholipase).
REGULATIONS AMENDING THE FOOD AND DRUG
REGULATIONS (1632 — PHOSPHOLIPASE)
AMENDMENTS
1. Subparagraph B.13.001(e)(iii) of the Food and Drug Regulations (see footnote 1) is replaced by the following:
- (iii) amylase, amylase (maltogenic), asparaginase, bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, phospholipase, protease, pullulanase or xylanase,
2. Subparagraph B.13.005(d)(iii) of the Regulations is replaced by the following:
- (iii) amylase, amylase (maltogenic), asparaginase, bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, phospholipase, protease, pullulanase or xylanase,
3. Paragraph B.13.021(h) of the Regulations is replaced by the following:
- (h) amylase, amylase (maltogenic), asparaginase, bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, phospholipase, protease, pullulanase or xylanase;
4. Item P.5A of Table V to section B.16.100 of the Regulations is amended by adding the following in columns II to IV after the permitted source “Aspergillus oryzae (pPFJo142)”:
| Item No. |
Column II |
Column III |
Column IV |
|---|---|---|---|
P.5A |
Aspergillus niger (PLA-54) |
(1) Bread; Flour; Whole (2) Unstandardized bakery products (3) Unstandardized whole (4) Modified lecithin |
(1) Good Manufacturing Practice (2) Good Manufacturing Practice (3) Good Manufacturing Practice (4) Good Manufacturing Practice |
COMING INTO FORCE
5. 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 a submission from industry requesting that the Regulations be amended to enable the use of the enzyme phospholipase derived from a genetically modified Aspergillus strain, Aspergillus niger (PLA-54), that carries the gene from a porcine pancreas coding for this enzyme. This enzyme will be used in the production of bread, flour, whole wheat flour, unstandardized bakery products, unstandardized whole egg, unstandardized egg yolk and modified lecithin at maximum levels of use consistent with good manufacturing practice.
Evaluation of available data supports the safety and effectiveness of this food additive in the above specified uses. Therefore, the Regulations are amended to permit the use of the above noted food additive as described.
These amendments benefit consumers by allowing greater availability of food products in the marketplace while continuing to help protect their health and safety. In addition, these amendments benefit industry by facilitating the manufacture of food products. Phospholipase improves dough stability and dough handling properties, resulting in improved quality of the final bread product. Phospholipase also improves oil/water mixing, increased viscosity and heat stability in egg and lecithin.
Description and rationale
These amendments to the Regulations enable the use of the enzyme phospholipase produced from a new genetically modified micro-organism, as described above.
There is no anticipated increase in cost to government from the administration of these amendments to the Regulations. The use of food additives is optional and therefore a manufacturer choosing to use a food additive in its products voluntarily assumes the costs associated with its use and compliance with the Regulations.
An Interim Marketing Authorization (“IMA”) was issued to permit the immediate use of this food additive as proposed in the submission while the regulatory process was undertaken to amend the Regulations. It was published in the government notices section of the Canada Gazette, Part Ⅰ, on October 10, 2009. The IMA expired on October 10, 2011. Health Canada confirms that the results of the pre-market safety assessment that was conducted prior to the issuance of the IMA to permit the use of phospholipase in bread, flour, whole wheat flour, unstandardized bakery products, unstandardized whole egg, unstandardized egg yolk and modified lecithin remain valid.
The Minister has the option to recommend or not to the Governor in Council that the Regulations be amended to permit the uses described above for this food additive. Based on its safety and efficacy assessment and the history of safe use of phospholipase in the above mentioned foods since the issuance of the IMA, the Minister is recommending that amendments be made to enable these uses.
Consultation
These amendments permit the use of phospholipase in bread, flour and whole wheat flour, foods for which standards are set out in Division 13 (Grain and Bakery Products) of the Regulations. No consultation regarding the use of phospholipase was deemed necessary as lipases are already permitted in these foods for similar uses.
Health Canada has announced, through posting on its Web site, the publication in the Canada Gazette, Part Ⅰ, of this IMA and the proposed regulatory amendments. Health Canada also notified World Trade Organization members of this IMA and the proposed regulatory amendments at the time of publication of the IMA in the Canada Gazette, Part Ⅰ. Since the publication of this IMA in the Canada Gazette, Part Ⅰ, the Government has received no objections or safety concerns regarding these uses.
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 and list of ingredients, and perform on-site verification of the manufacture of the product. The frequency of inspection depends on the compliance history in relation to the manufacturing of a particular type of product, the compliance history 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