Proposal to modify the List of Permitted Preservatives to authorize the use of rosemary extract

Summary

Rosemary extract is not currently authorized for use as a food additive in foods sold in Canada. As a result of the review of a food additive submission, Health Canada is proposing to:

You can submit comments on this proposal until February 21, 2026 (see the section "Consultation" for instructions).

Background

The food additives authorized for use in Canada are set out in the Lists of Permitted Food Additives. These lists are incorporated by reference into Division 16 of the Food and Drug Regulations.

A person, company or organization (referred to as petitioners) may ask Health Canada to authorize a new food additive use by filing a food additive submission.

Issue

Health Canada received a food additive submission requesting that rosemary extract be authorized for use as an antioxidant (preservative) in:

The requested maximum levels of use range from 10 ppm to 50 ppm, calculated as the sum of carnosol and carnosic acid.

Rationale

Health Canada completed a premarket safety and efficacy assessment of rosemary extract for its requested use. The assessment considered potential dietary exposure to rosemary extract and other food safety aspects (allergenicity, chemistry, microbiology, nutrition, and toxicology).

Rosemary extract acts as an antioxidant to prevent or delay oxidation in foods, such as oxidation of lipids in fats and oils which causes rancidity. The antioxidant activity of rosemary extract is primarily attributed to two major constituents of the extract, carnosol and carnosic acid. The levels of use of rosemary extract used as an antioxidant preservative are expressed as the sum of those two constituents.

Rosemary extracts can impart both flavouring and antioxidant properties, but those intended for use as an antioxidant are manufactured to selectively reduce the content of flavouring constituents and increase the content of antioxidant constituents.

The rosemary extract that was the subject of the food additive submission is manufactured by extraction of dried rosemary (Rosmarinus officinalis L.) leaves with ethanol or acetone, followed by a multistep refinement process that removes the solvent, reduces volatile flavouring constituents and enhances levels of carnosol and carnosic acid. The final rosemary extract is formulated into low flavour and low aroma commercial preparations that meet the Joint FAO/WHO Expert Committee on Food Additives (JECFA)'s Combined Compendium of Food Additive Specifications monograph for rosemary extract.Footnote 1

The outcome of Health Canada's evaluation supports authorizing rosemary extract that meets JECFA's specifications as set out in Table 2 for use as an antioxidant preservative as set out in Table 1.

Proposed modification

Health Canada proposes to authorize the requested use of rosemary extract by adding the new item R.1 and its corresponding paragraphs to the List of Permitted Preservatives, as shown in Table 1.

Table 1. Proposed modification to the List of Permitted Preservatives

Column 1

Column 2

Column 3

Column 4

Column 5

Item

Food additive

Source

Food

Purpose of use

Maximum level of use, maximum level of residue and other conditions

Notes

R.1

Rosemary extract

n/a

(a)

Brownies; Cookies; Crackers

(a)

Preservative

(a)

50 ppm, calculated as the sum of carnosic acid and carnosol

n/a

(b)

Dehydrated potato products

(b)

Preservative

(b)

50 ppm, calculated as the sum of carnosic acid and carnosol

n/a

(c)

Fried fruit chips; Grain, legume, or vegetable-based snack foods, except those snack foods set out in paragraphs (d) and (f) of this item

(c)

Preservative

(c)

20 ppm, calculated as the sum of carnosic acid and carnosol

n/a

(d)

Fruit, grain, legume, nut, or starch-based snack bars

(d)

Preservative

(d)

50 ppm, calculated as the sum of carnosic acid and carnosol

n/a

(e)

Noodles precooked with fat; Pasta precooked with fat

(e)

Preservative

(e)

10 ppm, calculated as the sum of carnosic acid and carnosol

n/a

(f)

Nuts; Peanuts; Seeds

(f)

Preservative

(f)

25 ppm, calculated as the sum of carnosic acid and carnosol

n/a

(g)

Nut spreads; Peanut spreads; Seed spreads

(g)

Preservative

(g)

25 ppm, calculated as the sum of carnosic acid and carnosol

n/a

Other relevant information

Food additive specifications

Food additives authorized for use in Canada must meet the specifications set out in the Table of Food Additive Specifications, if they exist.

Health Canada proposes to modify the Table of Food Additive Specifications by adding the new item R.1 to require that rosemary extract used as a food additive meet JECFA's specifications, as shown in Table 2.

Table 2. Proposed modification to the Table of Food Additive Specifications

Item

Column 1

Food Additive

Column 2

Specifications

R.1

Rosemary extract

Specifications set out in the Combined Compendium of Food Additive Specifications, prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and published by the Food and Agriculture Organization of the United Nations on its website, as amended from time to time.

International status

Rosemary extract is permitted for use as a food additive in Australia, New Zealand and the European Union in various foods, including most of the foods listed in Table 1.

In the United States, essential oils, oleoresins (solvent-free) and natural extractives (including distillates) of rosemary are Generally Recognized as Safe (GRAS) for their intended use.Footnote 2

Other considerations

Rosemary extract used as an antioxidant must be declared in the list of ingredients on prepackaged food labels according to the requirements for declaring food additives.

Spices, seasonings and flavouring preparations are excluded from the definition of food additive set out in the FDR. Consequently, rosemary extract that meets the standard set out in section 9.1.1 of Volume 9 of the Canadian Food Compositional Standards and is used as a flavouring is not a food additive. The use of a flavouring in food is subject to labelling requirements that apply to flavourings and any other legal provisions that apply to such use, including food compositional standards if the flavouring is to be used in standardized foods.

Implementation and enforcement

Modifications to the Lists of Permitted Food Additives, such as the List of Permitted Preservatives, and modifications to the Table of Food Additive Specifications come into effect on the day they are published on Health Canada's website, respectively.

You can consult the Notices of Proposal and Notices of Modification web page to stay informed of these modifications or register for Health Canada's Consultation and Stakeholder Information Management System to be automatically notified when they are issued.

The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.

Consultation

The consultation on the proposed modification to the List of Permitted Preservatives (shown in Table 1) and the proposed modification to the Table of Food Additive Specifications (shown in Table 2) is open for 75 days from the date of publication of this notice.

You can submit your comments on this proposal by email until February 21, 2026 at food.ibr-ipr.aliments@hc-sc.gc.ca. Please use the words "rosemary extract (P-FAA-25-02)" in the subject line of your email.

The results of the consultation, including a summary of the comments received and Health Canada's responses, will be communicated in a notice of modification published at the same time the List of Permitted Preservatives and the Table of Food Additive Specifications are modified if the proposition moves forward.

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2025-12-08