Food Additives - Submission Preparation

What is a Food Additive Submission?

A food additive submission is the term used to refer to a request, accompanied by supporting information, to amend the Canadian Food and Drug Regulations to permit a food additive to be used in retail food in Canada. Submissions take the form of a cover letter explaining the nature of the request and an information package containing specific types of information that must be assessed by Health Canada before legal steps can be taken to permit the requested use. The person, company, or agent making the request is referred to as a "petitioner".

Is There a Standard Form or Format for Food Additive Submission?

There is no set format for making food additive requests but there are certain types of information that should be included in the submission, as explained below. A "food additive submission checklist" should also be included with the submission package. The checklist is a tool intended to assist the petitioner in assembling the submission package and to assist Health Canada in verifying that the submission package contains the required information that will allow a safety evaluation to be initiated.

What are the Different Types of Food Additive Submissions?

The nature of the requests found in food additive submissions varies, but the requests can generally be described as listed below.

• Requests for the use of a "new" food additive
  A "new" food additive is one that had never before been approved for use in retail foods in Canada.
• Requests to "extend the use" of an already-permitted food additive
  Listings of permitted food additives include the common name of the food additive, a list of the foods in which the additive may be used, and the maximum level of use. Therefore, a food additive submission is required in order for Health Canada to consider any requests to extend the list of foods in which a food additive may be used.
• Requests to change the "maximum level of use" of an already-permitted food additive
  As is the case for requests to extend the use of a food additive, a food additive submission is required in order for Health Canada to consider any requests to change the maximum level of use of a food additive.
• Requests to add a new organism to the list of permitted sources of enzymes used as food additives
  Enzymes are produced by living organisms. Enzymes that are used in the food industry are often obtained from bacteria and fungi. When an enzyme is used as a food additive, not only is the enzyme evaluated by Health Canada, but the enzyme source is also evaluated. Both the enzyme and its permitted sources are listed in the Food and Drug Regulations. Therefore, a request to extend the list of permitted source organisms for a particular enzyme must be made in the form of a food additive submission.

What Types of Information Should be Included in a Food Additive Submission?

A detailed guide for the preparation of a food additive submission can be found in "A Guide for the Preparation of Submissions on Food Additives".

The following summary of the guidance may also be of assistance when preparing a submission package.

The types of information that should be included in a food additive submission are itemised below, shown as they appear in Division 16, Section B.16.002 of the Food and Drug Regulations:

1. a description of the food additive, including its chemical name and the name under which it is proposed to be sold, its method of manufacture, its chemical and physical properties, its composition and its specifications and, where that information is not available, a detailed explanation;
2. a statement of the amount of the food additive proposed for use, and the purpose for which it is proposed, together with all directions, recommendations and suggestions for use;
3. where necessary, in the opinion of the Director, an acceptable method of analysis suitable for regulatory purposes that will determine the amount of the food additive and of any substance resulting from the use of the food additive in the finished food;
4. data establishing that the food additive will have the intended physical or other technical effect;
5. detailed reports of tests made to establish the safety of the food additive under the conditions of use recommended;
6. data to indicate the residues that may remain in or upon the finished food when the food additive is used in accordance with good manufacturing practice;
7. a proposed maximum limit for residues of the food additive in or upon the finished food;
8. specimens of the labelling proposed for the food additive; and
9. a sample of the food additive in the form in which it is proposed to be used in foods, a sample of the active ingredient, and, on request a sample of food containing the food additive.

Note that in the case of submissions dealing with already-approved food additives, item (e) would not necessarily be required in the submission package because the toxicity of that food additive has already been evaluated and characterized, and Health Canada regularly monitors any new toxicological data on already-permitted food additives.

Item (h) is relevant to new food additive submissions. Food additives already listed in the Food and Drug Regulations are known to be commercially available in a form that meets food-grade specifications and in packaging that is labelled according to regulatory requirements.

Item (i) is not generally requested at the initial stage of the evaluation except in the case of a new food additive. Such samples could, however, be requested at any point during Health Canada's evaluation regardless of the nature of the submission.

What Happens to a Food Additive Submission once it is Sent to Health Canada?

A food additive submission must go through "two processes" before the food additive can be used in the requested manner. The first process is the safety evaluation. More detail on how the safety evaluation is conducted and managed can be found in the following document. At the conclusion of the safety evaluation, if all of the components of the food additive submission are found to be satisfactory, a senior management committee considers the petitioner's request and makes a decision with regards to whether the submission should proceed to the regulatory phase. The regulatory phase includes the preparation of directions for amending the Food and Drug Regulations to allow the requested food additive use and the preparation of supporting documents for the amendment. It may also include work to issue what is called an Interim Marketing Authorization (see below). After appropriate approvals have been obtained, the regulatory amendments go into force once published in Canada Gazette Part II. Petitioners are notified of the date of publication.

What is an Interim Marketing Authorization (IMA)?

An Interim Marketing Authorization or IMA is a mechanism that can be used to bridge the period between a favourable decision by the senior management committee to recommend to the Governor-in-Council an amendment of the food additive tables and the final appearance of the enabling amendment in the Canada Gazette Part II, after which the use of the additive becomes legal for use in foods offered for sale in Canada.

Although the senior management committee may recommend issuance of an IMA, the decision to actually issue it rests with the Assistant Deputy Minister of Health Canada. The IMA itself must be published in the Canada Gazette Part I and does not take effect until such publication occurs. The IMA, once issued, allows a petitioner to legally sell the food involved while awaiting the enabling amendments to be made.

It is important to note that an IMA does not shorten the time it takes to conduct a scientific evaluation of the submission but it can shorten the time it takes to legally permit the use of a food additive in a particular area of use.

Where Should a Food Additive Submission be Mailed?

Food additive submission packages that are relatively short (e.g. 20 pages or less) and that can be easily transmitted by e-mail, may be submitted electronically. If, however, there are more than 20 pages of printed material, three hardcopies of the submission must be mailed to Health Canada. Contact information can be viewed in Section 2.1.5 of "A Guide for the Preparation of Submissions on Food Additives".