ARCHIVED - Interim Marketing Authorization (IMA) (Schedule 923)

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) of the Food and Drugs Act, hereby makes the annexed Regulations Amending the Food and Drug Regulations (923).

Regulations Amending the Food and Drug Regulations (923)

Amendments

1. The Food and Drug Regulations(1)are amended by adding the following after section B.01.055:

B.01.056. (1) Notwithstanding sections B.01.042 and B.01.043, where a food does not comply with the requirements of these Regulations, the manufacturer or distributor of the food, or of a food additive, agricultural chemical, veterinary drug, vitamin, mineral nutrient or amino acid present in the food, may make a written request to the Director

(a) for the exemption of the food from the application, in whole or in part, of the requirements relating to it under these Regulations;

(b) for a Notice of Interim Marketing Authorization concerning the food that confirms the exemption; and

(c) that these Regulations be amended.

(2) For the purposes of this section, a food does not comply with the requirements of these Regulations if

(a) any of the following is present in the food:

(i) a food additive that is

(A) set out in column I of an item of any of the tables to section B.16.100 in an amount that exceeds the maximum level of use set out in column III or IV of that item in respect of that food, or

(B) not included in the standard for that food in these Regulations,

(ii) an agricultural chemical, or any of its derivatives, set out in column I of an item of Table II to Division 15 of Part B, in an amount that exceeds the maximum residue limit set out in column III of that item,

(iii) a veterinary drug set out in column I of an item of Table III to Division 15 of Part B in an amount that exceeds the maximum residue limit set out in column III of that item,

(iv) an ingredient in a form other than the form described in the standard for that food in these Regulations, or

(v) a vitamin, mineral nutrient or amino acid

(A) that is not set out in the Table to section D.03.002, or

(B) the level of use of which is at variance with the level permitted under these Regulations;

(b) the food

(i) is not set out in column IV of Table II to Division 15 of Part B and contains an agricultural chemical or any of its derivatives set out in column I of that Table,

(ii) is not set out in column IV of Table III to Division 15 of Part B and contains a veterinary drug set out in column I of that Table, or

(iii) is not set out in column II of any of Tables I to IV and VI to XV or in column III of Table V to section B.16.100, and contains a food additive set out in column I of that Table.

(3) The request referred to in subsection (1) shall be accompanied by the following information:

(a) the common name and description of the food;

(b) the reasons for which the exemption, the Notice of Interim Marketing Authorization and an amendment to these Regulations are required;

(c) a description of every proposed variation from the requirements of these Regulations;

(d) adequate data, including results of tests and scientific analysis, that demonstrate that the use of the food will not be detrimental to the health of the purchaser or user; and

(e) where the request relates to the addition of a vitamin, mineral nutrient or amino acid to the food, a statement, with supporting documentation, as to the consistency of the request with the General Principles for the Addition of Essential Nutrients to Foods adopted by the Joint Food and Agriculture Organization of the United Nations / World Health Organization Codex Alimentarius Commission and published in the Codex Alimentarius (Rome, 1996), as amended from time to time.

(4) Where the Director determines after examining the request and the information submitted under subsection (3) that use of the food will not be harmful to the health of the purchaser or user, the Director shall exempt the food from the application, in whole or in part, of the requirements relating to it under these Regulations and issue a conditional or unconditional Notice of Interim Marketing Authorization relating to the food. The Director shall also indicate his or her intention to recommend that these Regulations be amended in relation to the food.

(5) The Notice of Interim Marketing Authorization issued under subsection (4) shall set out

(a) the common name and description of the food;

(b) the reasons for which the exemption is established and the Notice of Interim Marketing Authorization issued; and

( c) such of the following as are applicable to the food:

(i) the maximum residue limit of any agricultural chemical or any of its derivatives, expressed in parts per million,

(ii) the maximum level of use of any food additive that the food is permitted to contain, or have on it, expressed in the applicable units or measurement,

(iii) the maximum residue limit of any veterinary drug, expressed in parts per million, and

(iv) the minimum and maximum limits for the addition of any vitamin, mineral nutrient or amino acid, expressed in the applicable units of measurement.

(6) The Notice of Interim Marketing Authorization issued under subsection (4) must be published in the Canada Gazette Part I and has effect beginning on the date of publication.

(7) The Director may, by a notice published in the Canada Gazette Part I, revoke an exemption and Notice of Interim Marketing Authorization relating to a food where the Director believes on reasonable grounds, after reviewing any information that comes to the attention of the Director, that use of the food is or may be harmful to the health of the purchaser or user.

(8) A Notice of Interim Marketing Authorization issued under subsection (4) in relation to a food loses its effect on the coming into force of any amendment to these Regulations resulting from the Director's recommendation referred to in that subsection.

2. Section B.15.002 of the Regulations is amended by adding the following after subsection (3):

(4) A food set out in a Notice of Interim Marketing Authorization published under subsection B.01.056(6) is exempt from paragraph 4(d) of the Act in respect of any agricultural chemical or derivative of such a chemical, and any veterinary drug, set out in that notice that is present in the food in an amount not exceeding the maximum residue limit, expressed in parts per million, set out for the food in that notice.

COMING INTO FORCE

3. These Regulations come into force on < >.

1. C.R.C., c. 870

Regulatory Impact Analysis Statement

(This statement is not part of the Regulations.)

Description

The current Food and Drug Regulations specify a number of stringent controls on the sale of foods in Canada including:

- ingredients which may be used in foods for which standards are prescribed

- food additives which may be used in various foods

- maximum limits for residues of agricultural chemicals and veterinary drugs

- vitamin, mineral nutrient or amino acids which may be added to certain foods.

Proposals to change any of the foregoing requirements can originate from a variety of sources such as industry, health professionals, consumer groups and within government. As a first step, each proposal is subjected to a thorough evaluation by the Health Protection Branch (HPB) relative to any health, safety and nutritional implications for consumers, protection of the public from fraud and the need to ensure availability of an abundant food supply. When a proposal is considered acceptable by HPB, a formal procedure to amend the Regulations is initiated. This process includes publication of the proposed amendment in the Canada Gazette, Part I, for comment by interested parties; revision of the proposed amendment as appropriate based on input received; and publication of the final regulation in the Canada Gazette, Part II. The time-frame for completion of the regulatory amendment process varies with the complexity of the subject, but is usually at least six months and may be considerably longer.

The current procedure for amending the Regulations was instituted to ensure transparency of the process and provide an opportunity for all interested parties to comment before a change is effected. This is particularly important for amendments which impose new restrictions relative to the sale of food or would, for example, introduce a new food additive which could have a major impact on the composition or nutritive value of the food supply. However, many regulatory amendments are relatively minor in nature such as those that expand the permitted uses for a food additive which is already approved for use in Canada. Other amendments allow for the use of ingredients which have broad international acceptance but for which approval has not been previously requested for use in Canada. For these situations, both consumers and industry are denied the benefits resulting from the use, for example, of a food additive, while the regulations are being amended, even though a thorough evaluation has not identified any health, safety or nutritional concerns for the public.

As a general rule, all foods sold in Canada must be in compliance with the Food and Drugs Act and Regulations and there is no broad authority to exempt a food from these requirements. Nevertheless, Sections B.01.054 and B.01.055 of the Regulations specify conditions under which a Letter of Temporary Marketing Authorization (TMA) may be issued which allows a manufacturer or distributor to sell a food not in compliance with the Regulations for a limited time "in order to generate information in support of an amendment to the Regulations".

On June 10, 1995, Schedule No. 923 was published in the Canada Gazette, Part I, for comment. This schedule proposed to expand the TMA concept to allow a food not in compliance with the Regulations to be marketed while an amendment to permit its on-going legal sale is being processed. To differentiate from TMAs, it was proposed that this provision in the Regulations would be called "Interim Marketing Authorization" (IMA).

To ensure that the procedure was fair, equitable and transparent, and that the public interest was maintained, it was proposed that the following conditions apply to the issuance of an IMA.

1. Categories of amendments eligible for IMA would be limited to a food which:

(a) contained an agricultural chemical or any of its derivatives for which a maximum residue limit for any food has been established in Division 15;

(b) contained a veterinary drug for which a maximum residue limit in any food has been established in Division 15;

(c) contained a food additive which is listed for use in any food in Division 16;

(d) contained an ingredient in a form not listed in the standard for that food in the Regulations;

(e) contained an added vitamin or mineral nutrient for which no provision for such addition is given in the Table to Division 3, Part D, of the Regulations and which is necessary to restore that vitamin or mineral nutrient to a level contained in the food prior to processing.

2. An IMA would only be issued for proposed amendments which were believed to have broad support from stakeholders such that publication for comment, in the Canada Gazette, Part I, was not expected to result in any change.

3. As part of the submission to amend the Food and Drug Regulations, industry would make a written request for the issuance of an IMA, and the IMA would be given, for the listed categories of amendments, under the authority of the Director (i.e. Assistant Deputy Minister), Health Protection Branch.

4. Complete details of the issuance of an IMA would be published in the Canada Gazette.

5. All manufacturers, importers and distributors would be free to market foods under the provisions of the IMA. These foods would have to meet all other requirements of the Regulations including any labelling related to the IMA (e.g., change in the list of ingredients).

6. An IMA would not have a fixed duration but would remain in effect until the proposed regulatory amendment was promulgated.

7. If at any time after issuance of an IMA, a decision was made not to promulgate the proposed amendment, it was proposed that a notice in this regard be published in the Canada Gazette. Manufacturers, importers and distributors that marketed foods under the provisions of the IMA would be given an appropriate time period to modify products, consistent with any perceived adverse impact on the public from continued sale of the foods.

A total of nine (9) submissions were received as a result of the publication of this proposal in the Canada Gazette. All were generally supportive of the initiative but a number of suggestions for modifications of the criteria for the issuance of an IMA were received as well as requests for clarification of certain aspects of the proposal. The following is a summary of these comments and the Department's response :

1. The current Food and Drug Regulations have established a general limit of 0.1 ppm for residues of agricultural chemicals in foods which are not specifically listed in Table II, Division 15. There are a number of agricultural chemicals which have been fully evaluated as to safety by the Pest Management Regulatory Agency (PMRA) of the Department, but a specific limit has not been established in the Regulations because residues are expected to be less than 0.1 ppm. It was proposed that the criteria for the issuance of an IMA include agricultural chemicals in this category. This request will be considered in a future proposal to amend the regulatory provisions related at the issuance of an IMA.

2. The original proposal would have limited the issuance of an IMA to amendments which would permit the addition of vitamin and/or mineral nutrient which is necessary to restore the nutrient(s) to a level contained in the food prior to processing. Submissions received requested that all amendments related to the addition of nutrients be eligible for an IMA. As the addition of nutrients to a food is intended to enhance the nutritional well-being of Canadians, the earliest possible implementation of an amendment in this regard was considered to be in the public interest. This request was, therefore, accepted provided the addition of the nutrients was consistent with the General Principles for the Addition of Essential Nutrients to Foods adopted by the Joint Food and Agriculture Organization of the United Nations/World Health Organization Codex Alimentarius Commission.

3. A request was made that amendments which adopted standards elaborated by the Joint Food and Agriculture Organization/World Health Organization Codex Alimentarius Commission (Codex) be eligible for an IMA. Canada has been a member of Codex since it was created in 1962 and actively participates in Committees dealing with various aspects of the health, safety, nutritional quality and labelling of foods. The Agreement on Sanitary and Phytosanitary Measures of the World Health Organization (SPS/WTO) recognizes the standards developed by Codex as the basis on which countries should establish their national regulatory requirements. The Department believes that the issuance of an IMA as requested would be consistent with Canada's obligations under SPS/WTO and its commitment to the international standard setting objectives of Codex. However, as this use of an IMA was not part of the initial proposal, it was not considered appropriate for adoption at this time. A separate regulatory amendment will be proposed in this regard in the near future.

4. A request was also received that amendments pertaining to labelling (such as for permitted claims or class names for ingredients) be eligible for an IMA. As labelling amendments were not part of the initial proposal with respect to the IMA concept, it was concluded that this matter should also be deferred and be the subject of specific consultation with interested parties prior to any action being taken.

5. Concern was expressed with regard to the requirement that there be evidence of broad support for an amendment as a condition for the issuance of an IMA (point #2 of the original proposal). This was based on the reluctance of some companies which petition for a regulatory amendment to release proprietary information which may affect their competitive position. It is the policy of the Department to protect the proprietary rights of petitioners and this will continue relative to the issuance of an IMA. However, the Department believes that an IMA should only be issued if stakeholders directly affected are consulted. This condition has, therefore, been retained and an IMA will not be granted if it has not been possible to conduct an appropriate degree of consultation.

6. Several responses suggested that because the IMA would be used in relation to enabling regulatory amendments of a relatively minor nature (eg. extensions of use of an approved food additive), the actual amendment should proceed directly to promulgation as a final regulation and publication in the Canada Gazette, Part II. It is currently the practice of the Department to follow this approach for this type of amendment, and no change is contemplated.

7. Clarification was requested as to the meaning of point #4 of the original proposal relative to the eligibility of an IMA for amendments for foods which contain an ingredient in a form not listed in a standard for that food. The current Regulations are very specific as to the ingredients permitted in various standards. For example, a standard may list skim milk powder but not (liquid) skim milk. It is the intention to issue an IMA to cover this type of change in the "form" of an ingredient in a standard when such has been requested.

8. Some concern was expressed that an IMA could be used to permit the marketing of food which did not meet Canadian standards and that this could be to the detriment of the public. The introduction of the IMA concept, however, does not change the scientific safety and nutritional evaluation of proposed amendments to the Regulations conducted by the Department. Only those amendments that are determined to be acceptable and meet the clearly established criteria will be eligible for an IMA. The IMA approach provides for a more responsive regulatory system while ensuring the continued protection of consumers.

The Schedule will, therefore, amend the Regulations to introduce the IMA concept as originally proposed but with the modifications outlined above.

Alternatives

The following alternatives were considered to provide a means to reduce the time required to amend the provisions of the Food and Drug Regulations relative to the sale of foods: implementation of an internal administrative process through issuance of a notice of compliance such as is used to approve the sale of drugs; and adoption by reference of standards developed by an independent third party organization. However, retention of the current procedures along with the IMA concept described in this Schedule was considered to be the most appropriate approach to ensure continued transparency and consultation with interested parties, while facilitating the introduction of amendments of a relatively minor nature.

Benefits and Costs

The adoption of the IMA concept will benefit both consumers and industry by permitting the earlier marketing of foods using improved ingredients, production and processing techniques. A review of the routine enabling amendments that were promulgated in 1996 determined that 17 of the 20 would have been eligible for IMA.

There will be no increased costs to either consumers or industry from implementation of the IMA concept. The costs to government for the administration of the IMA concept are not expected to be significant.

Consultation

In 1993, a comprehensive review of the Food and Drug Regulations was completed as part of a general initiative by the federal government to re-justify regulatory programs. This Regulatory Review exercise involved written consultation with a broad spectrum of interested parties and a series of meetings across Canada. Adoption of the IMA concept was recommended in the report of the Regulatory Review as a means to improve the responsiveness of the regulatory amendment process to the needs of consumers and industry.

The draft plan to implement the recommendations of the Regulatory Review was distributed for comment to approximately 250 stakeholders in March 1994. There was broad support from respondents to proceed with adoption of the IMA concept.

As noted above, publication of the proposal in the Canada Gazette, Part I, resulted in general support for the initiative from all nine respondents. The department's response to suggestions and comments received are outlined above under the heading Description.

The reason for the delay in seeking final approval was the necessity of consultation with the respondents and other interested parties concerning the comments. Clarification and a number of requests to extend the IMA concept were received. However, as these uses of an IMA were not part of the initial proposal, they were not considered appropriate for adoption at this time. These requests will be the subject of specific consultations and will be considered in future proposals to amend the regulatory provisions related to the issuance of an IMA.

Compliance and Enforcement

The IMA concept is enabling or permissive in nature and consequently there are no compliance or enforcement issues.

Contact
Director
Bureau of Food Regulatory, International and
Interagency Affairs
A.L. 0702C
Health Canada
Ottawa, Ontario
K1A 0L2
Tel: (613) 957-1828
Fax: (613) 941-3537
June 23, 1997

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