Vol. 145, No. 23 — November 9, 2011
Registration
SOR/2011-235 October 27, 2011
FOOD AND DRUGS ACT
Regulations Amending the Food and Drug Regulations (1613 — Food Additives)
P.C. 2011-1266 October 27, 2011
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 (1613 — Food Additives).
REGULATIONS AMENDING THE
FOOD AND DRUG REGULATIONS
(1613 — FOOD ADDITIVES)
AMENDMENTS
1. (1) Subparagraphs B.09.016(c)(ix) to (xi) of the French version of the Food and Drug Regulations (see footnote 1) are replaced by the following:
- (ix) les colorants pour aliments suivants : ß-apo-8′-caroténal, canthaxanthine, carotène, curcuma, ester éthylique de l’acide ß-apo-8′-caroténoïque et rocou, visés au tableau Ⅲ de l’article B.16.100,
- (x) les émulsifs suivants : lécithine, mono- et diglycérides, monoglycérides et tristéarate de sorbitan, visés au tableau Ⅳ de l’article B.16.100,
- (xi) les rajusteurs du pH suivants : acide citrique, acide lactique, acide tartrique, bicarbonate de potassium, bicarbonate de sodium, carbonate de potassium, carbonate de sodium, citrate de potassium, citrate de sodium, hydroxyde de potassium, hydroxyde de sodium, lactate de potassium, lactate de sodium et tartrate double de sodium et de potassium, visés au tableau Ⅹ de l’article B.16.100,
(2) Subparagraph B.09.016(c)(xii) of the Regulations is replaced by the following :
- (xii) the following Class Ⅱ and Class Ⅳ preservatives: ascorbyl palmitate, ascorbyl stearate, benzoic acid, butylated hydroxyanisole, butylated hydroxytoluene, calcium sorbate, citric acid esters of mono- and di-glycerides, monoglyceride citrate, monoisopropyl citrate, potassium benzoate, potassium sorbate, propyl gallate, sodium benzoate, sodium sorbate and sorbic acid, as set out in Table XI to section B.16.100, and
(3) Subparagraph B.09.016(c)(xiii) of the French version of the Regulations is replaced by the following:
- (xiii) les agents séquestrants suivants : citrate de stéaryle et éthylènediaminetétraacétate de calcium disodique, visés au tableau XII de l’article B.16.100.
2. The portion of item 1A of Table Ⅲ to section B.16.100 of the French version of the Regulations in Column Ⅰ is amended by replacing “Ester éthylique de l’acide ß-apo-8′-caroténoique” with “Ester éthylique de l’acide ß-apo-8′-caroténoïque”.
3. The portion of subitem A.3(3) of Table Ⅳ to section B.16.100 of the Regulations in Column Ⅲ is replaced by the following:
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Column Ⅲ |
|---|---|
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A.3 |
(3) 0.024% as consumed |
4. Table Ⅳ to section B.16.100 of the Regulations is amended by adding the following after item C.17:
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Column Ⅰ |
Column Ⅱ |
Column Ⅲ |
|---|---|---|---|
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C.18 |
Citric Acid Esters of Mono- and Di-glycerides |
(1) Infant formula based on crystalline amino acids or protein hydrolysates, or both (2) Unstandardized foods |
(1) 0.155% as consumed (2) Good Manufacturing Practice |
5. (1) The portion of subitem P.3(12) of Table Ⅳ to section B.16.100 of the Regulations in Column Ⅲ is replaced by the following:
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Column Ⅲ |
|---|---|
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P.3 |
(12) 250 p.p.m. in soup as consumed |
(2) The portion of subitem P.3(14) of Table IV to section B.16.100 of the English version of the Regulations in Column Ⅲ is replaced by the following:
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Column Ⅲ |
|---|---|
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P.3 |
(14) 120 p.p.m. in beverage as consumed |
6. The portion of subitem S.18(6) of Table Ⅳ to section B.16.100 of the Regulations in Column Ⅲ is replaced by the following:
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Column Ⅲ |
|---|---|
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S.18 |
(6) 250 p.p.m. in soup as consumed |
7. (1) The portion of subitems B.1(1) to (5) of Part Ⅳ of Table XI to section B.16.100 of the Regulations in Column Ⅲ is replaced by the following:
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Column Ⅲ |
|---|---|
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B.1 |
(1) 0.02%. If butylated hydroxytoluene, propyl gallate or tertiary butyl hydroquinone, singly or in combination, is also used, the total must not exceed 0.02% (2) 0.005%. If butylated hydroxytoluene or propyl gallate or both are also used, the total must not exceed 0.005% (3) 0.02%. If butylated hydroxytoluene or propyl gallate or both are also used, the total must not exceed 0.02% (4) 0.125%. If butylated hydroxytoluene or propyl gallate or both are also used, the total must not exceed 0.125% (5) 0.5%. If butylated hydroxytoluene or propyl gallate or both are also used, the total must not exceed 0.5% |
(2) The portion of subitem B.1(10) of Part Ⅳ of Table XI to section B.16.100 of the Regulations in Column Ⅲ is replaced by the following:
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Column Ⅲ |
|---|---|
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B.1 |
(10) 0.02% of the fat or the oil content of the food. If butylated hydroxytoluene or propyl gallate or both are also used, the total must not exceed 0.02% of the fat or the oil content of the food |
8. (1) The portion of item B.2 of Part Ⅳ of Table XI to section B.16.100 of the English version of the Regulations in Column Ⅰ is replaced by the following:
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Column Ⅰ |
|---|---|
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B.2 |
Butylated Hydroxytoluene (3,5-ditertiarybutyl-4-hydroxytoluene) |
(2) The portion of subitems B.2(1) to (5) of Part Ⅳ of Table XI to section B.16.100 of the Regulations in Column Ⅲ is replaced by the following:
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Column Ⅲ |
|---|---|
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B.2 |
(1) 0.02%. If butylated hydroxyanisole, propyl gallate or tertiary butyl hydroquinone, singly or in combination, is also used, the total must not exceed 0.02% (2) 0.005%. If butylated hydroxyanisole or propyl gallate or both are also used, the total must not exceed 0.005% (3) 0.02%. If butylated hydroxyanisole or propyl gallate or both are also used, the total must not exceed 0.02% (4) 0.125%. If butylated hydroxyanisole or propyl gallate or both are also used, the total must not exceed 0.125% (5) 0.5%. If butylated hydroxyanisole or propyl gallate or both are also used, the total must not exceed 0.5% |
(3) The portion of subitem B.2(9) of Part Ⅳ of Table XI to section B.16.100 of the Regulations in Column Ⅲ is replaced by the following:
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Column Ⅲ |
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B.2 |
(9) 0.02% of the fat or the oil content of the food. If butylated hydroxyanisole or propyl gallate or both are also used, the total must not exceed 0.02% of the fat or the oil content of the food |
9. Part Ⅳ of Table XI to section B.16.100 of the Regulations is amended by adding the following after item C.1:
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Column Ⅰ |
Column Ⅱ |
Column Ⅲ |
|---|---|---|---|
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C.1.01 |
Citric Acid Esters of Mono- and Di-glycerides |
(1) Fats and oils; Lard; Monoglycerides and diglycerides; Shortening |
(1) Good Manufacturing Practice |
(2) Unstandardized foods [except unstandardized preparations of
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(2) Good Manufacturing Practice |
||
(3) Margarine |
(3) 0.01% of the fat content. If monoglyceride citrate, monoisopropyl citrate or stearyl citrate, singly or in combination, is also used, the total must not exceed 0.01% of the fat content |
10. The portion of subitem M.1(3) of Part Ⅳ of Table XI to section B.16.100 of the Regulations in Column Ⅲ is replaced by the following:
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Column Ⅲ |
|---|---|
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M.1 |
(3) 0.01% of the fat content. If citric acid esters of mono- and di-glycerides, monoisopropyl citrate or stearyl citrate, singly or in combination, is also used, the total must not exceed 0.01% of the fat content |
11. The portion of subitem M.2(3) of Part Ⅳ of Table XI to section B.16.100 of the Regulations in Column Ⅲ is replaced by the following:
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Column Ⅲ |
|---|---|
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M.2 |
(3) 0.01% of the fat content. If citric acid esters of mono- and di-glycerides, monoglyceride citrate or stearyl citrate, singly or in combination, is also used, the total must not exceed 0.01% of the fat content |
12. The portion of subitems P.1(1) to (6) of Part Ⅳ of Table XI to section B.16.100 of the Regulations in Column Ⅲ is replaced by the following:
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Column Ⅲ |
|---|---|
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P.1 |
(1) 0.02%. If butylated hydroxyanisole, butylated hydroxytoluene or tertiary butyl hydroquinone, singly or in combination, is also used, the total must not exceed 0.02% (2) 0.005%. If butylated hydroxyanisole or butylated hydroxytoluene or both are also used, the total must not exceed 0.005% (3) 0.02%. If butylated hydroxyanisole or butylated hydroxytoluene or both are also used, the total must not exceed 0.02% (4) 0.125%. If butylated hydroxyanisole or butylated hydroxytoluene or both are also used, the total must not exceed 0.125% (5) 0.5%. If butylated hydroxyanisole or butylated hydroxytoluene or both are also used, the total must not exceed 0.5% (6) 0.02% of the fat or the oil content of the food. If butylated hydroxyanisole or butylated hydroxytoluene or both are also used, the total must not exceed 0.02% of the fat or the oil content of the food |
13. The portion of item T.1A of Part Ⅳ of Table XI to section B.16.100 of the Regulations in Column Ⅲ is replaced by the following:
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Column Ⅲ |
|---|---|
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T.1A |
0.02%. If butylated hydroxyanisole, butylated hydroxytoluene or propyl gallate, singly or in combination, is also used, the total must not exceed 0.02% |
14. The portion of item S.8 of Table XII to section B.16.100 of the Regulations in Column Ⅲ is replaced by the following:
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Column Ⅲ |
|---|---|
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S.8 |
0.01% of the fat content. If citric acid esters of mono- and di-glycerides, monoglyceride citrate or monoisopropyl citrate, singly or in combination, is also used, the total must not exceed 0.01% of the fat content |
15. Table XV to section B.16.100 of the Regulations is amended by adding the following after item 4:
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Column Ⅰ |
Column Ⅱ |
Column Ⅲ |
Column Ⅳ |
|---|---|---|---|---|
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4.1 |
Citric Acid Esters of Mono- and Di-glycerides |
(1) Natural extractives; Spice extracts (2) Unstandardized flavouring preparations |
(1) Good Manufacturing Practice (2) Good Manufacturing Practice |
16. The French version of the Regulations is amended by replacing “shortening” with “shortening” in the following provisions:
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(a) the portion of subitem L.1(1) of Table Ⅳ to section B.16.100 in Columns Ⅱ and Ⅲ;
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(b) the portion of subitem M.4(9) of Table Ⅳ to section B.16.100 in Columns Ⅱ and Ⅲ;
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(c) the portion of subitem M.5(9) of Table Ⅳ to section B.16.100 in Columns Ⅱ and Ⅲ;
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(d) the portion of item S.19 of Table Ⅳ to section B.16.100 in Column Ⅱ;
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(e) the portion of subitem D.1(1) of Table Ⅷ to section B.16.100 in Column Ⅱ;
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(f) the portion of subitem A.1(1) of Part ⅠV of Table XI to section B.16.100 in Column Ⅱ;
-
(g) the portion of subitem A.2(1) of Part Ⅳ of Table XI to section B.16.100 in Column Ⅱ;
-
(h) the portion of subitem A.3(1) of Part Ⅳ of Table XI to section B.16.100 in Column Ⅱ;
-
(
i
) the portion of subitem C.1(1) of Part Ⅳ of Table XI to section B.16.100 in Column Ⅱ;
-
(j) the portion of subitem G.1(1) of Part Ⅳ of Table XI to section B.16.100 in Column Ⅱ;
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(k) the portion of subitem L.1(1) of Part Ⅳ of Table XI to section B.16.100 in Column Ⅱ;
-
(l) the portion of subitem L.2(1) of Part Ⅳ of Table XI to section B.16.100 in Column Ⅱ;
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(m) the portion of subitem M.1(1) of Part Ⅳ of Table XI to section B.16.100 in Column Ⅱ;
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(n) the portion of subitem M.2(1) of Part Ⅳ of Table XI to section B.16.100 in Column Ⅱ;
-
(o) the portion of subitem T.1(1) of Part Ⅳ of Table XI to section B.16.100 in Column Ⅱ; and
-
(p) the portion of subitem T.2(1) of Part Ⅳ of Table XI to section B.16.100 in Column Ⅱ.
COMING INTO FORCE
17. 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 permit the use of citric acid esters of mono- and di-glycerides as an emulsifying agent in infant formula based on crystalline amino acids or protein hydrolysates, or both, at a maximum level of use of 0.155% as consumed.
Evaluation of available data supports the safety and effectiveness of this food additive in the above specified use. Since there are no safety concerns regarding the use of this food additive, these amendments also permit the use of citric acid esters of mono- and di-glycerides as an emulsifying agent in unstandardized foods, and as a Class IV preservative and as an extraction solvent in foods in which the use of monoglyceride citrate is currently permitted by the Regulations, such as margarine, spice extracts and shortening. These amendments reduce the regulatory burden to both government and industry.
These amendments benefit consumers, including infants, by allowing greater availability of food products while continuing to help protect their health and safety. In particular, the use of the food additive citric acid esters of mono- and di-glycerides in infant formula based on crystalline amino acids or protein hydrolysates, or both, benefits infants who cannot tolerate whole milk protein and require these types of infant formula. The food additive citric acid esters of mono- and di-glycerides is intended to keep the ingredients in these infant formula in a homogeneous and stable solution thus providing consistent and full delivery of nutrients to the infant. When these infant formula are delivered by feeding tube, the food additive citric acid esters of mono- and di-glycerides keeps the infant formula emulsified and prevents the infant formula from clogging the feeding tube.
These amendments also benefit industry by permitting the use of a new food additive in a variety of food products.
Description and rationale
These amendments enable the use of citric acid esters of mono- and di-glycerides that are not currently listed in the Tables to section B.16.100 of the Regulations as an emulsifying agent in infant formula based on crystalline amino acids or protein hydrolysates, or both, and in unstandardized foods. These amendments also permit the use of citric acid esters of mono- and di-glycerides as a Class IV preservative and as an extraction solvent in foods in which the use of monoglyceride citrate is currently permitted by the Regulations, such as margarine, spice extracts and shortening.
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 this food additive is optional.
The only regulatory options available to address this submission 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 this food additive. Based on its safety and efficacy assessment, the Minister recommends that the uses for this food additive be enabled.
These amendments are required to enable the use of citric acid esters of mono- and di-glycerides under the Regulations. These amendments also amend the French version of the Regulations by replacing the term “shortening” with “shortening” (i.e. removal of italics) in the Tables to section B.16.100. In addition, the standard for margarine in Division 9 (Fats and oils), is amended to permit the use of citric acid esters of mono- and di-glycerides in this food. Part ⅠV of Table XI and Table XV to section B.16.100 are also amended to permit the use of citric acid esters of mono- and di-glycerides in the above specified uses. Item S.8 of Table XII to section B.16.100 is amended by adding citric acid esters of mono- and di-glycerides in column III of the Table. These amendments also correct inconsistencies noted in the provisions of the Regulations that are amended.
Consultation
These amendments permit the use of this food additive in infant formula for which there are health and safety requirements set out in Division 25 of the Regulations. These amendments also permit the use of this food additive in foods for which there are standards set out in Division 9 (Fats and oils) of the Regulations.
A public consultation on the proposal to amend the Regulations to permit the use of citric acid esters of mono- and di-glycerides as an emulsifying agent in infant formula based on crystalline amino acids or protein hydrolysates, or both, and in unstandardized foods, as well as in foods in which the use of monoglyceride citrate is currently permitted by the Regulations as a Class IV preservative and as an extraction solvent, such as margarine, spice extracts and shortening, was conducted through postings on Health Canada’s Web site. The 75-day comment period started on November 18, 2010, and closed on January 31, 2011. One request was received from industry to obtain clarification about the regulatory process. Health Canada responded to this request by providing information on this process.
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