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Good manufacturing practices for infant formula

A guidance document for infant formula manufacturers
2021

Table of contents

1.0 Introduction

The Good Manufacturing Practices (GMPs) for Infant Formula establish general requirements for effective control of ingredients, formulations, processes, facilities and equipment used for the production of all infant formulas to be sold, distributed or marketed in Canada, regardless of whether the infant formula is manufactured in Canada or in another country whose manufacturing regulations may differ from those of Canada. These GMPs provide guidance for manufacturing of infant formulas compliant with Sections 4, 5, 6 and 7 of the Food and Drugs Act (FDA); Part B, Divisions 1, 16, 23, 25, and 27 and Part D of the Food and Drug Regulations (FDR); all relevant sections of the Safe Food for Canadians Act (SFCA) and Safe Food for Canadians Regulations (SFCR), in particular, Parts 2, 3, 4 and 5.

Infant formulas (also referred to as human milk substitutes) are generally sold in three formats: (1) as a ready-to-feed liquid, referred to as ready to serve in the FDR; (2) a liquid concentrate that must be diluted with water; or (3) as a powder that is reconstituted using water. The specific steps in the manufacturing process may vary from one type of infant formula to another depending on its composition, and from one individual manufacturer to another.

Generally, powdered infant formula is manufactured by one of three processes, wet mixing, dry (blending) mixing or combined (wet mixing and dry mixing) (Codex Alimentarius Commission – CAC/RCP 66-2008). In the wet mix process, all ingredients (liquid or powder) are mixed or dissolved in the wet stage to produce a liquid mix. The liquid mix is then pasteurized, homogenized, standardized, concentrated by evaporation, and spray dried. Vitamins or heat sensitive ingredients are added before drying. In the dry mix process, all ingredients of the infant formula are sourced from suppliers pre-dried, and then processed dry and blended to obtain the desired final formula. In the combined process, some of the ingredients such as proteins, carbohydrates and fat are processed using the wet mix process and then dried to form a base powder. Ingredients such as vitamins, minerals or additional carbohydrates are added in dry form to the base powder to form the desired final product.

On completion of drying or blending/mixing steps, the final product from each of the three processes can be packaged into cans/flexible containers. The finished product is held until it undergoes final testing, including for nutrient content, uniformity, and microbial analysis.

For liquid ready-to-feed or concentrate formulas, the constituents of the infant formula are subjected to a wet mix process that may involve dissolution of ingredients in hot water, an initial standardization, homogenization and emulsification, and a subsequent standardization prior to commercial sterilization in container (retort) or out of container (aseptic process).

The general information for the manufacturing of powder or liquid infant formula is summarized in references such as the Codex Code of hygienic practice for powdered formulae for infant and young children (Codex Alimentarius Commission (CAC/RCP 66- 2008; last updated in 2009) and Jiang and Guo, 2014).

Biological, chemical, and physical hazards may be associated with various stages/steps in the processing of powder or liquid infant formula and several control points may be identified. The GMPs require that manufacturers of ingredients, packaging materials and infant formula apply a combination of control measures in processing to effectively control the identified hazards in the infant formula. For example, for microbiological controls, the pasteurization in the wet-mix processing is a key step in ensuring the safety of powder infant formula and is therefore considered the Critical Control Point (CCP); whereas the commercial sterility treatment in the manufacturing of liquids is considered the CCP.

The definition of "sell" in Section 2 of the FDA is "offer for sale, expose for sale, have in possession for sale or distribution, and distribute, whether or not the distribution is made for consideration". For the purpose of this document, the terms "importer" and "distributor" are encompassed by the term "manufacturer", but may be used independently when referring to establishments who do not produce the infant formula, but otherwise engage in marketing activities.

All Infant Formula manufacturers are required to be licensed in accordance with Sections 10 (2) and 13 (2) of the SFCA in order to conduct various activities (for example, manufacturing, labelling, packaging) for infant formulas. Infant formulas are foods under the scope of the SFCR, which provisions apply to foods for human consumption to be imported, exported, or inter-provincially traded and includes not only manufacturing processes but traceability, labelling and advertising as well.

The three pillars of the SFCR comprise: Part 2 pertaining to trade; Part 3 on Licences; and Part 4 on Preventive Controls, which are mandatory for infant formula manufacturing. Other parts of the SFCR pertinent to infant formula manufacturing include Part 5 for Traceability; Part 10 for Packaging; and Part 11 for Labelling. In order for the Canadian Food Inspection Agency (CFIA) to grant a licence, the manufacturer must declare on their licence application that they are meeting Part 4 (Preventive Controls), and that they prepare, keep and maintain a written preventive control plan (PCP) such as a Preventive Control Program designed to meet these GMP requirements.

There are analogous sections and common regulatory oversight among the various statutory authorities, namely the FDA and FDR (administered by Health Canada) and SFCA and SFCR (administered by CFIA). All infant formula manufacturers are ultimately responsible for complying with both sets of regulations.

For a detailed discussion of the regulations applicable to infant formula manufacturing, please refer to Section 2.1.

Part B, Division 25 of the FDR sets out the requirements for infant foods, including infant formula. The Division defines the common name of a human milk substitute as being "infant formula" and stipulates that pre-market notification is required for infant formulas. All manufacturers are required to notify Health Canada, at least 90 days prior to the marketing of any new infant formula or of a formula that has undergone a major change in formulation, manufacturing or packaging. Some examples of when the pre-market notification of an infant formula is required, under Division 25, include:

Effective implementation of GMPs is essential to assure consistent nutrient quality, safety, and nutritional adequacy of infant formula products. Infant formula may constitute the sole source of nutrition of an infant for up to six months after birth. After six months, although other foods are typically introduced into the diet of the infant, infant formulas may still constitute a major source of nutrients up to one year of age. This is a period during which rapid growth and brain development affect key aspects of a child's long term health status and well-being. Effective GMPs are critical to ensure that infant formulas are safe and effective for the infants consuming them.

Canadian manufacturers are responsible to ensure that infant formula products imported from foreign manufacturing facilities for distribution in Canada are manufactured in accordance with these GMPs. Conclusive evidence of GMP conformance at the foreign manufacturing facility should be available in Canada. These GMPs will also be used to evaluate technical and quality aspects of pre-market notification submissions for new or changed infant formulas, and infant formulas containing a new ingredient or new source of an ingredient.

The Hazard Analysis Critical Control Point (HACCP) principles for control of hazards have been widely accepted and applied both in Canada and internationally. The HACCP system is a mandatory regulatory requirement in some food industry sectors wherein its principles have been incorporated into food regulations. An example is the Preventive Control Plan (PCP) of the SFCR, which is based on the General Principles of Food Hygiene that is a recommended International Guideline issued by the Codex Alimentarius Commission.

For the purposes of HACCP, hazards associated with infant formulas refer to any agent in, or conditions of manufacturing that can cause illness, injury or death of an infant. These hazards fall into three categories, namely biological, chemical and physical:

There are internationally recognized food safety management systems and standards that can also be applied in the manufacturing of infant formulas. The ISO (International Organization for Standardization) 9000 family of standards (for example, ISO 9001:2015) define minimum requirements for a company's Quality Management System, which can be used to establish and maintain effective management processes for all activities affecting quality of products. More specific to the food industry, ISO 22000:2018 is a global food safety management system standard.

HACCP and ISO are not prescribed in the Canadian regulations for manufacturing infant formula. However, all infant formula manufacturers are required to have in place effective GMPs and related quality control procedures which provide equivalent results, and which satisfy all applicable regulatory requirements. These may not be part of a formal program but must be one that complies with basic food safety conditions and activities necessary to maintain a hygienic environment. The program should also meet good manufacturing practices at all stages of handling infant formulas. In this regard, adherence to HACCP principles or ISO standards will alleviate any concerns regarding whether the necessary level of compliance can be achieved in accordance with current regulations since these standards already include prerequisite program components. These prerequisite programs should be working effectively prior to HACCP implementation. This GMP guidance document encourages the application of HACCP principles or ISO standards in infant formula establishments as a means to identify and monitor CCPs, to prevent contamination and failure incidents, and to continuously improve products and processes.

In Canada, the PCP, which is based on HACCP principles, is mandatory under SFCR. The objective of the PCP is to specify minimum requirements for an effective food safety system that can be incorporated into the production of any food commodity, including infant formulas, for marketing in Canada. The PCP is a written document, which is in paper or electronic format and must include:

A documented PCP is required for most infant formula manufacturers. There are some exceptions, for example, when gross annual food sales of infant formula are $100,000 or less. CFIA should be consulted for guidance on whether exemptions apply to their manufacturing establishment or whether a documented PCP is required in order to obtain a licence. Regardless of whether a written PCP is required or not, the manufacturer must adhere to and practice preventive control measures.

Acquiring a licence does not guarantee that the GMP requirements listed in Division 25 of the FDR would be met.

1.1 Purpose

The purpose of this guidance document is to provide manufacturers of infant formulas appropriate guidance to effectively achieve compliance with all relevant Canadian regulations and ensure a safe, nutritionally adequate food for infants. The document also provides guidance on incorporating a food safety system designed to prevent safety hazards (for example, biological, physical, or chemical) from coming into contact with infant formulas during production.

Health Canada uses the GMPs as a basis on which to assess the manufacturing information received in pre-market submissions for new or changed infant formulas. The GMPs in turn can be used to develop written PCPs which the CFIA will use in assessing Canadian manufacturers on their ability to ensure domestic and imported infant formula meet Canadian legislation.

1.2 Scope

The GMPs described in this document apply to the production of all infant formula, in various formats, which includes, but is not limited to powders, liquid concentrate and ready to feed. The material in this Guide reflects the provisions of the FDA, FDR, SFCA and SFCR pertaining to manufacturing of infant formula.

1.3 Reference documents and codes of practice

This GMP document should be used in conjunction with the international Codex Alimentarius Codes of Practice, Standards and Guidelines and/or a national equivalent to ensure the production of safe and nutritionally adequate products in accordance with the FDA, FDR, SFCA and SFCR. For a complete list of recommended Codex International Documents (standards, codes and guidelines), please refer to Appendix 2.

The Codex Alimentarius is a collection of standards, guidelines and codes of practice adopted by the Codex Alimentarius Commission (CAC). The Commission was established by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) to protect consumer health and promote fair practices in food trade. These documents are considered international standards.

The Codex food safety standards are science-based recommendations related to food safety and quality. Codex food safety texts are often used as references in World Trade Organization (WTO) trade disputes.

Note: A code of practice is a set of written rules which explains how people working in a particular profession should behave.

Codex codes of practice – including codes of hygienic practice – define the production, processing, manufacturing, transport and storage practices for individual foods, groups of foods, or foods in general that are considered essential to ensure the safety and suitability of food for consumption.

2.0 Manufacturing requirements for all infant formulas

In order for an infant formula to be manufactured in accordance with Canadian regulations and meet the GMP requirements, the infant formula must meet safety, quality and effectiveness standards or criteria and be manufactured under hygienic or sanitary conditions. Failure to meet any one of the criteria listed below may result in the infant formula being deemed to be non-compliant with GMPs and not fulfilling the manufacturing requirements.

  1. The infant formula must meet the nutritional composition requirements set out in section B.25.054 (1) and Table II of Division 25 of the FDR. Failure to meet the nutrient levels (all essential and non-essential) at acceptable levels (for example, within the specified minimum and maximum levels) will make the infant formula non-compliant and in contravention of the FDA and FDR. The nutrient composition of infant formulas is specifically referred to in several sections of the FDR: B.25.054, B.25.055, and B.25.056. For labelling purposes, the nutrient content declaration is specified in section B.25.057 of the FDR. The nutrient levels in formulas complying with manufacturing GMPs may differ slightly from the declared nutrient levels on infant formula labels. There are allowable overages of nutrient levels, which may exceed levels specified in regulations in order to overcome nutrient losses over time. This is permitted to ensure that the product continues to meet the labelled nutrient levels throughout its shelf life period.
  2. The infant formula must not contain any ingredients or components that are not permitted to be included or added in accordance with: (1) Division 16 – the Lists of Permitted Food Additives; (2) Sections B.25.054, B.25.056, B.25.062 of the FDR; and (3) Part D.03.002 Table, Infant Formulas and Formulated Liquid Diets, of the FDR. This also means that only compliant sources of raw ingredients can be included in the manufacturing process and that all incoming ingredients must be quality control tested at the outset. Furthermore, the infant formula must not contain any physical, chemical or biological contaminants in amounts exceeding any relevant established limits or, in the absence of established limits, in amounts which may represent a hazard to infants. The infant formula must meet all purity requirements and be within the maximum levels for lead and melamine as set out in Part 2 of the List of Contaminants and Other Adulterating Substances in Foods and Health Canada's Maximum Levels for Chemical Contaminants in Foods New infant formula ingredients or components that have undergone a safety assessment in infants and have been cleared by Health Canada may be added to infant formulas. If the infant formula is to contain any ingredient that is novel, the ingredient must first be assessed for safety under Division 28 (Novel Foods) of the FDR. For example, arachidonic acid and docosahexaenoic acid sources were assessed under Division 28 prior to being permitted for addition to infant formulas. Novel Food decisions are posted on Health Canada's website.
  3. The infant formula must be nutritionally adequate, that is to say, the formula must support adequate growth and development of infants in accordance with Health Canada's guidance documents. In the FDR, paragraphs B.25.046 (2) (i) for new infant formulas and B.25.048 (2) (d) for major change, and subsection B.25.054 (1) specify the criteria against which infant formulas are assessed for nutritional adequacy. Nutritional adequacy is an indicator of nutritional quality.
  4. The infant formula must be manufactured to comply with Sections 4, 5, 6 and 7 of the FDA, Divisions 25 and 27 of the FDR and all relevant sections of the SFCA and SFCR, in particular with respect to complying with the preventive control provisions in Part 4 of SFCR. These GMPs provide detailed guidance on how the requirements can be met.
  5. The infant formula must be packaged and labelled in accordance with the FDA, Divisions 1, 23, 25, and 27 of Part B of the FDR, and the SFCA and SFCR (Parts 10 and 11). The SFCR prescribes requirements for bilingual labelling type size (height) for information, the manner of declaring the net quantity, and pictorial representations, all of which are applicable to infant formulas. The SFCR requires the PCP to include the measures taken to ensure that specific packaging and labelling requirements are met. Details are found in CFIA's guidance on Preventive Control Plans (PCP) for consumer protection.

2.1 Regulations applicable to infant formula manufacturing

Section 4 of the FDA defines the conditions required for the manufacture of foods intended for sale in Canada and the requirement that the food is safe for human consumption. This section, in part, prohibits the sale of food that has in it a poisonous or harmful substance; is unfit for human consumption, rotten, adulterated or manufactured or stored under unsatisfactory conditions. This section in the FDA is mirrored in the SFCA.

Section 7 of the FDA prohibits the manufacture of food under unsanitary conditions. Part 4 of the SFCR defines the preventive controls that enable these conditions for manufacturing foods safe for human consumption.

Section 5 of the FDA specifies the proper labelling and packaging of these foods and prohibits the label or sale of any food in a manner that is false, misleading or deceptive. Parts 10 (Packaging) and 11 (Labelling) of the SFCR set out the requirements for labelling and packaging of foods. Section 6 of the FDA prescribes the standard for food that is imported into Canada. SFCA Part 4 prohibits a person to import any food that is prohibited under Section 4 of the FDA.

Part 2 (Trade) 8(1), of the SFCR complements the FDA by specifying that any food sent or conveyed from one province to another, imported or exported must not be contaminated; must be edible; must not consist in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance; and must have been manufactured, prepared, stored, packaged and labelled under sanitary conditions. The fraud provisions of the FDA is captured in SFCA 6(1), which prohibits a person to manufacture, prepare, package, label, sell, import or advertise a food commodity in a manner that is false, misleading or deceptive or is likely to create an erroneous impression. Food that does not meet the criteria set out in FDA, FDR, SFCA and SFCR may be deemed as being fraudulent, unsafe, unfit or unacceptable for human consumption.

Part B of the FDR and the SFCR provide the regulatory requirements for all food sold for human consumption, which includes infant formulas.

Part B, Division 1 of the FDR (Labelling) specifies the mandatory labelling requirements on food labels, including infant formulas.

Part B, Division 16 of the FDR (Food Additives) prohibits the sale of any substance as a food additive or a food containing a food additive unless there are provisions for the additive's use. The Lists of Permitted Food Additives, which are incorporated by reference into Marketing Authorizations, lists all food additives that are currently permitted in Canada, the foods they are permitted in or upon, the maximum level of use in those foods and other applicable conditions of use. Under Section B.01.045 of the FDR, food additives are required to meet specifications for the additive set out in Part B of the FDR, or where no specifications exist in Part B, to meet the specifications set out in the Food Chemicals Codex which is published by the United States Pharmacopeial Convention or the Combined Compendium of Food Additive Specifications, which are prepared by the Joint Food and Agriculture Organization of the United Nations/World Health Organization Expert Committee on Food Additives.

Part B, Division 23 of the FDR (Food Packaging Materials) prohibits the sale of any food in a package that may transfer to its contents any substance deemed injurious to the health of a consumer of the food. Health Canada conducts pre-market safety assessments of food packaging materials for infant formulas. In the case of a favourable assessment, Health Canada issues a letter of no objection (LONO).

Part B, Division 25 of the FDR sets out requirements for infant formulas, and B.25.046 sets out the information required to be provided by manufacturers in the pre-market assessment of infant formulas.

Part B, Division 27 of the FDR (Low-Acid Foods Packaged in Hermetically Sealed Containers) describes low-acid foods (foods, other than an alcoholic beverage, where any component of the food has a pH greater than 4.6 and a water activity greater than 0.85) packaged in a hermetically sealed container (designed to prevent the entry of air and microorganisms). This regulation applies to liquid infant formula that is a thermally processed low-acid food in a hermetically sealed container. Section 48(1) of the SFCR also applies to the thermal processing of low-acid food in a hermetically sealed package.

Part D of the FDR (Vitamins, Minerals and Amino Acids) deals with vitamins, minerals and amino acids and the amounts of each that may be included in foods. Only those vitamins, minerals and amino acids listed in Part D are permitted for inclusion in the manufacturing of infant formulas and this information must be interpreted in conjunction with Division 25.

3.0 Detailed GMP requirements

This section summarizes the current requirements for manufacturing of liquid and powder infant formulas.

Infant formula is currently based on milk protein, soy protein isolate or amino acids, with additional ingredients.

The manufacturer shall implement a quality control procedure as per 3.6, 3.9.2 and 3.10 to test each nutrient in each nutrient premix used during manufacturing, and conduct appropriate in-process and finished product testing of nutrients (prior to product release) to ensure that all nutrients required by the regulations and any nutrient added by the manufacturer are present at the appropriate levels in each batch of infant formula. Stability testing is also required as per 3.13 of these GMPs. For each infant formula product, the manufacturer shall conduct stability analysis for selected nutrients with sufficient frequency to substantiate the maintenance of nutrient content up to the expiration date of the product when subjected to normal conditions of storage and distribution. Health Canada should be consulted for guidance on nutrient testing as per 3.13 of these GMPs. This is a fundamental requirement of the GMPs.

The Codex Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (CODEX STAN 72-1981, revised 2007, last amended in 2016), is an international standard, which is mostly consistent with the nutrient specification contained in the Canadian regulations, and provides additional guidance on the essential composition and quality factors for infant formula. The Standard for Follow-up Formula (CODEX STAN 156-1987, last amended in 2017) is also pertinent in setting forth the nutrient specifications for infant formulas. These Codex Standards indicate the specification by stating the lower and maximum, or manufacturers' guidance upper levels, as applicable, for macronutrients (total carbohydrates, protein, lipids, linoleic acid, alpha-linolenic acid, amino acids), vitamins (vitamin A, D3, E, K, thiamine, riboflavin, niacin, vitamin B6, B12, pantothenic acid, folic acid, vitamin C, biotin), minerals and trace elements (iron, calcium, phosphorus, magnesium, sodium, chloride, potassium, manganese, iodine, selenium, copper, and zinc), optional ingredients(choline, myo-inositol, L-carnitine and DHA), and food additives.

In order to comply with these GMPs, the essential ingredients must be present at the specified levels in the final product throughout its shelf-life period. Overages for individual nutrients, as appropriate, to ensure that the required minimum levels are met throughout the shelf-life of the formula, will be included in the maximum value. Essential ingredients present in amounts significantly above or below these levels may constitute non-compliance with the GMPs. Infant formula must be packaged in order to prevent spoilage and contamination under all normal conditions of handling, storage and distribution in the country where the product is manufactured, sold, or exported to for sale.

Food additives with a variety of technical functions, such as emulsifying and thickening agents, acidity regulators, and antioxidants have specific permitted food additive uses in certain infant formulas. Only food additives that have demonstrated safety in use in infant formula for consumption by infants are included in the Lists of Permitted Food Additives. When used, these permitted additives must meet their required specifications and must respect their maximum levels of use and other conditions.

A complete list of ingredients and a declaration of the nutritive values must appear on the label (refer to Section 3.12 for further details).

3.1 GMP update, revision process and notes

Infant formula products, manufacturing processes, packaging systems, and related practices change and evolve on an on-going basis in response to scientific, technical, regulatory and marketing developments. In order to ensure that this GMP standard continues to reflect current practices and requirements, it will be reviewed and updated, when necessary, to reflect on-going developments in both manufacturing practices and regulations affecting infant formulas. The CFIA, infant formula manufacturers, and other interested parties were consulted for input during the current revision process (2017 to 2019).

3.2 Premises and equipment

Prerequisite programs are generally required in order to meet the GMPs for premises (outside property, building, sanitary facilities, water/steam/ice sources) and for equipment (general equipment design, equipment installation, equipment maintenance and calibration). The CFIA's guidance on Preventive Controls Plans of the SFCR provides detailed information on prerequisite programs.

Infant formula manufacturing, storage and distribution facilities shall be designed, constructed and maintained in a manner which permits operations to be conducted under safe, clean, sanitary and orderly conditions to prevent contamination with harmful substances, which may be of a biological, chemical (include allergenic) or physical nature.

Infant formula processing facilities shall satisfy the applicable design, layout and operational requirements of regulatory agencies responsible for establishment licensing and/or inspection. Site plans and floor plans for each level of the facility should be available at the facility.

Facilities shall be located in an area, and operated in a manner which minimizes the risk of environmental contaminants of all types from internal and external sources. For instance, the building facility shall not be located in close proximity to environmentally polluted areas, areas subject to flooding, areas prone to pest infestation and areas where waste, debris or refuse is located.

The physical location of the manufacturing site must be such that roadways to and from the site are properly graded, compacted, dust-proofed and constructed to ensure adequate drainage of the site as well as the surroundings.

Production areas where products and materials are exposed shall be effectively segregated from storage areas, lunchrooms, washrooms and other service areas.

Surfaces of walls, floors, ceilings and equipment used where materials or products are exposed shall be designed and maintained in a sanitary condition to prevent contamination of materials and products.

Equipment shall be designed, operated and maintained in a manner to prevent contamination and to enhance the safety and quality of the product. All processing systems, retort/aseptic processing systems should be validated by a process engineer or a process authority, where appropriate.

Manufacturers shall ensure that adequate resources (for example, personnel, supervision, time, materials, equipment, tools, computers, support services) are provided to ensure effective operation and maintenance of facilities, equipment and processes.

3.3 Qualification, training and health of personnel

Prerequisite programs are required in order to meet the GMP requirements for personnel training, health and hygiene. Please refer to the Preventive Control provisions specified in Part 4 of the SFCR. All personnel involved in the design, production, testing, storage and distribution of infant formula shall be adequately qualified by education, training and experience to competently conduct the responsibilities with which they are charged.

Personnel required to perform internal quality audits shall be adequately trained and have education on auditing techniques and procedures.

Management responsibilities, authority and reporting relationships shall be clearly defined and documented, and communicated to all affected personnel.

Manufacturers should identify the on-going training needs of all personnel including new employees and ensure that these are met and documented. As technology and regulatory requirements with respect to nutrition change, personnel need to receive on-going training on current methodologies, specifications and regulations that impact the manufacturing of infant formulas for changing markets.

Manufacturers should prepare and periodically update a written annual training plan indicating what training will be provided and by whom (internal or external service providers). The training plan should include identification of training requirements including new or updated skills and knowledge necessary for effective operation of new technologies and/or equipment introduced to the establishment, such as automated production, retort operator training and test equipment, HACCP system and the importance of allergen concerns and their associated critical control factors.

Training records shall be maintained for all personnel involved in the development, production and testing of infant formula products.

An operational practice guidance document or standard operating procedure for working in manufacturing areas should be prepared and should detail the requirements for health screening for new employees, and on-going monitoring of current employees. Employees who have open wounds or communicable diseases are not permitted to work in areas where materials or products are exposed.

3.4 Document, data approval and change control

Establishing and maintaining written documentation for all steps of the manufacturing process are considered essential features of meeting GMPs.

Written procedures shall be implemented for effective control of approval, distribution and revision of all critical controlled documents and data including:

Controlled documents shall be approved by authorized personnel, and identified by a unique document number, revision number/code, and/or issue date.

Procedures shall be specified for documentation and approval of temporary revisions of controlled documents when necessary, including authorization by qualified personnel. Temporary changes in procedures shall not be implemented without proper authorization, including consideration of related documents, processes and validation requirements.

All affected users should be notified promptly of changes in controlled documents.

Additional training should be provided to users if necessary to ensure effective implementation of approved changes.

All obsolete documents shall be promptly removed from distribution. Any copies maintained for reference for legal, business or technical purposes should be stored separately from current documents and clearly marked as obsolete or suspended.

3.5 Hygiene, sanitation and contamination control

There are Codex standards that can be applied in order to meet the GMP requirements, for example, General Principles of Food Hygiene.

A hazard analysis conducted on each step of the manufacturing process is a necessary step in developing a HACCP program and is the most effective way to identify CCPs that are listed in the master manufacturing documents.

The manufacturer shall implement a written sanitation program which includes cleaning procedures for premises and equipment as well as instructions on the sanitary handling of all materials and equipment used in production.

Employee health and hygiene requirements must be effectively implemented in the handling of all materials used in the production of infant formula. The hygiene requirements shall clearly define clothing requirements, including personal protective equipment (PPE) and hygiene procedures (for example, hand washing) for company personnel and visitors. PPE refers to protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer's body from injury, infection and contaminating infant formula during production. The hazards addressed by PPE widely include physical, electrical, heat, chemical, biohazard and airborne particulate matter, which may result in contaminating infant formula. The SFCR provides detailed guidance, for example, Section 76 of the SFCR requires protective clothing to be in good condition, clean and sanitary.

All materials, ingredients, and products shall be clearly identified and stored under sanitary conditions which prevent contamination and/or quality deterioration. Materials of different types (for example, liquid chemicals, bagged raw materials, premixes, packaging materials) should be stored in separate areas of the warehouse in order to prevent contamination or mix-ups. Appropriate storage should be based on risk assessment of the materials.

Adequate facilities, suitably designated and separate from other areas, should be provided for cleaning utensils and equipment. Such facilities must have an adequate supply of hot and cold potable water where appropriate in accordance with Sections 70 and 71 of the SFCR. Potable water means water that meets the water specification and standards indicated in applicable regulations in the country of production. Health Canada's Guidelines for Canadian Drinking Water Quality Summary Table, published in February 2019 outlines the measured parameters for setting a standard to achieve quality drinking water. These parameters are microbiological, chemical, radiological and aesthetic in nature. As well, the SFCR requires water that might come in contact with foods, such as infant formula, and for sanitation purposes be potable. CFIA provides guidance on Water for use in the preparation of food. For the production of infant formulas outside of Canada, the standards in the foreign country must meet or be comparable with those of Canada.

Written procedures shall be implemented for cleaning and storage of processing equipment in order to prevent microbiological contamination, chemical contamination and accidental cross-contamination of a food allergen, gluten source, or food additive from previous production runs. Validation of cleaning for such substances may include a test to verify the absence of allergens. More guidance can be found in CFIA's Cleaning and Sanitation Program. Automated cleaning systems such as Clean-In-Place (CIP) systems shall be validated to ensure their effectiveness in achieving cleaning and sanitation objectives and in preventing contamination.

In general, non-food chemicals used must be safe and suitable for food use, and must not result in the contamination of food as required by the Preventive Control provisions in Part 4 of the SFCR.

Written procedures shall be implemented for approval, storage and use of approved cleaning chemicals and pesticides. Chemical products shall not be used unless approved for the specified applications by a technically qualified person.

Cleaning chemicals, pesticides and other non-ingredient chemicals shall be stored in a designated area segregated from the areas used for storage of raw materials and products. Storage should be based on risk assessment of chemicals.

The CFIA provides Guidance for Food Establishments Concerning Construction Materials and Packaging Materials and Non-Food Chemicals that includes how to demonstrate the safety of these products.

Written procedures should be implemented for periodic monitoring of environmental quality in processing and storage areas, and for prevention of environmental contamination.

A pest control program shall be established, implemented and documented, which includes approval and control of designated pesticide products and pest control contractors. The SFCR also requires establishments to be protected against the entry of pests. Animals are not permitted in the facility (including pets) and pest control activities must not contaminate food as specified in Section 51 of the regulation.

Records of cleaning and sanitation, environmental monitoring and pest control shall be maintained at the manufacturing establishment as required by the SFCR, which requires records related to the PCP to be kept for two years after the day on which the record is made (three years for Low-Acid Food processing records).

3.6 Quality assurance, quality control and laboratory operations

General guidelines on validation of physical, chemical, and microbiological test methods are found in Appendix 1, which also provides some guidance on validation of manufacturing processes. If there are any concerns regarding ensuring GMP compliance, consultation with both Health Canada and CFIA is recommended.

The manufacturer shall have a Quality Assurance/Quality Control (QA/QC) department under the direction of a technically qualified person who reports directly to a unit other than production.

The scope, responsibilities and operations of QA and QC activities including laboratory operations shall be documented in approved, controlled procedures and test and inspection methods. These procedures and methods shall include handling and secure storage of production and test records and related data including electronic data acquisition, storage and back-ups where used.

The manufacturer shall maintain, or have access to, suitably equipped laboratories to control the production and acceptance of raw ingredients, packaging materials, in-process and finished products. Method and process validation and stability capabilities may also be required.

Chemical, microbiological and physical test facilities shall be designed, equipped, staffed and operated to facilitate generation of reliable quality control test results. In-house laboratories, particularly those conducting microbiological analysis, require design and procedures to minimize the risk of contaminating the processing facilities. The infrastructure of the laboratory may require specific design features such as outdoor venting to meet licensing requirements of the SFCA and SFCR.

Analytical and test methods shall be valid for their intended purpose. Methods used to evaluate materials and products should be sufficiently specific, accurate and precise to provide reliable data on which to base an assessment of product quality and safety.

Test methods should be standard compendium or internationally recognized methods (such as, Association of Official Analytical Chemists, International United States Pharmacopeia, Federal Communications Commission, microbiological methods published in the Compendium of Analytical Methods). Chemical, microbiological and physical analysis/test methods shall be documented in sufficient detail that a trained analyst or technician can perform the method correctly and consistently, and can produce reliable test results within the known capability of the method. Method validation studies should be planned, conducted and documented to demonstrate equivalence of new or revised methods to standard compendium or internationally recognized methods. Retrospective validation and/or trend analysis may be useful in some situations.

Third party contract laboratories and test facilities shall be selected, approved and used under control of the QA/QC department based on their test capability including effective operating controls and procedures. These shall also be accredited laboratories and test facilities.

Manufacturing processes shall be monitored at appropriate in-process stages to ensure that activities (for example, process steps) are conducted according to established procedures and specifications. Special attention should be focused on both control points and CCPs.

Sampling and testing at all stages (for example, incoming, in-process, or finished product) shall be conducted according to a pre-determined sampling plan designed to provide a valid basis for acceptance or rejection of materials and products.

Procedures for identification, handling and storage of samples shall be clearly documented, including instructions for preparations of composite samples where relevant.

Laboratory instruments and apparatuses shall be calibrated prior to first use and at defined intervals in accordance with a written calibration program, approved calibration methods, and valid calibration standards (refer to ISO standards for guidance).

Calibration records for critical equipment typically include an identification of the equipment, the date of calibration, the person responsible and the calibration results.

3.7 Receiving and storage

The establishment should have one or more designated receiving areas with adequate space for temporary handling of incoming materials. Receiving areas shall be designed and operated in a manner which prevents transfer of contaminants into the facilities. Sections 72, 73 and 74 of the SFCR provides the requirements for conveyances, unloading and loading, and storage.

Approved procedures should clearly describe suitable handling methods for non-food chemicals (such as insecticides, lubricants). Non-food chemicals should never be co-mingled with food ingredients in the receiving area.

Procedures for material identification and status control should be documented and effectively implemented to prevent mix-ups, including an effective means of lot control for identification of all incoming materials. Suitable facilities, equipment and documented procedures shall be used for sampling of incoming materials to prevent contamination of materials and test samples, and to ensure correct identification and storage of samples.

Sampling should be conducted in a controlled environment where practical.

Storage areas and material handling equipment shall be operated and maintained in a safe, orderly manner which prevents damage or mix-ups, and accidental addition of or coming into contact with food allergens.

Spills in all areas shall be cleaned up in a timely manner, reported to responsible personnel in accordance with approved protocols and procedures and documented in an emergency response plan. An emergency response plan may be part of an administrative oversight plan established by the manufacturer in accordance with a prerequisite program such as ISO or HACCP.

Any material or product which is held for rework, reprocessing or re-inspection shall be identified, segregated, and effectively restricted from inadvertent use or shipment until planned activities have been completed.

Rejected material and product shall be quarantined, identified as "rejected" and securely stored until its disposal by approved means. All disposals of rejected material and product shall be clearly documented. Section 62 of the SFCR, also requires any contaminated or non-compliant food to be identified and segregated upon arrival at the establishment (for example, recalled food, exported food that has been returned).

Waste materials should be physically segregated from incoming materials and disposed of by approved, safe and effective procedures in accordance with approved protocols and requirements specified in a preventive control plan.

3.8 Ingredient and packaging material control

Each raw ingredient, packaging-material and nutrient premix shall be covered by acceptable written specifications which specify applicable physical, chemical, microbiological and identification test requirements that meet all regulations and other pertinent details. All material specifications shall be maintained under effective document control.

Specifications for ingredients and packaging materials shall include applicable packaging requirements and storage conditions. (See also 3.12 of this document, below). All food-contact materials shall be composed of substances that are safe, suitable, and acceptable for use by Health Canada. Specifications should clearly identify food contact/barrier layer composition, if any.

Food establishments are responsible for demonstrating that the construction materials, packaging materials and non-food chemicals used in their facilities are safe and suitable for their intended use. This is an essential part of GMPs to prevent the contamination of food products from these materials.

Manufacturing specifications should include expiry dates and retest criteria (where permitted) to ensure quality and potency of labile properties. The manufacturer shall maintain records of retest and/or disposition of any material which exceeds its approved usage period.

Water used in production shall meet potable water standards as a minimum, and shall be tested on a sufficient frequency to ensure consistent, acceptable quality. As previously discussed in Section 3.5 of the GMPs, please refer to requirements for potable water in Canada, described in the Canadian Drinking Water Guidelines, issued by Health Canada and Sections 70 and 71 of the SFCR. From a safety perspective, any water coming into contact with food (for example, use on food contact surfaces, use in direct heating of food, use as an ingredient) must meet the same water potability standard. The only water that does not need to meet the potability requirements is boiler water that will not directly come into contact with food.

Steam, ice, process water and other manufacturing aids which come into direct contact with materials or products shall have approved specifications and shall be tested on a sufficient frequency to ensure their quality. Furthermore, there shall be adequate plumbing safeguards in place to protect from cross contamination.

The manufacturer shall ensure that nitrogen, compressed air or other gases that are utilized in the production of infant formulas for any purpose, including in the cleaning of equipment or surfaces do not contaminate the infant formula or otherwise introduce contaminants or foreign material into the finished product. Steps shall be taken to prevent contamination by ensuring the delivery systems of such gases are regularly monitored, maintained and controlled to prevent such contamination.

Written procedures shall be implemented for selection, approval and control of suppliers of ingredients and packaging materials. There should be an ongoing program to ensure the continuing reliability of each vendor, such as vendor audits and/or third party audits.

Each shipment of raw ingredient, packaging material or premix shall be assigned a lot number, and held in quarantine pending its testing and release by QA/QC. Controls include but are not limited to product composition, nutrition profile and safety including microbiological, chemical (including allergen) concerns.

Each lot of incoming material shall be sampled and tested by approved methods to confirm compliance with specifications unless the manufacturer has records to show that the material is consistently within specifications. As a minimum, each lot of raw material shall be tested for identity after receipt by the manufacturer. If the supplier has testing results, they should provide these to the manufacturer or refer to Section 3.9.2 for more guidance.

Criteria for reduced testing of purchased materials shall be documented and approved if used. Reduced or skip-lot testing may be authorized by QA/QC after accumulation of sufficient historical data, typically 3 – 5 distinct lots or separate lots of a material, to establish the vendor's reliability and consistency.

Raw ingredients that are accepted without a supplier's certification, but are relied upon to provide required nutrients in the infant formula, must be sampled and analyzed for each relied-upon nutrient unless the manufacturer has records to show that each nutrient is consistently within specifications.

3.9 Process validation, qualification and control

In general, prerequisite programs are required and internationally published Codex standards should be adhered to. In particular, reference is made to the technical and equipment standards specified in the Code of Hygienic Practice for Low and Acidified Low Acid Canned Foods (CAC/RCP 23-1979) and the Code of Hygienic Practice for Aseptically Processed and Packaged Low-Acid Foods (CAC/RCP 40-1993), which applies to liquid infant formulas. For powders, the Code of Hygienic Practice for Powdered Formulae for Infants and Young Children (CAC/RCP 66-2008) is applicable.

Scheduled processes for low-acid canned foods must be established only by competent persons having expert knowledge of thermal processing and having adequate facilities for making such determinations. The required heat process shall be established with accepted scientific methods and the manufacturer must have evidence to demonstrate that the processes used to manufacture, process and package the food rendered and maintained the food commercially sterile. For aseptically processed and packaged infant formula, the scheduled process must be established taking into consideration the following elements: product, product contact surfaces, container materials, gases and equipment.

The provisions for application of the scheduled process to low-acid foods and documentation are provided in Part 4, Division 3, subsections 48(1), (3) and (4) of the SFCR. Information to support the development and implementation of a preventive control plan for packing food in containers is provided on the CFIA website.

General guidelines on process validation are included in Appendix 1. CFIA's Preventive Control Plan (PCP) guidance also provides more in-depth information on how to develop a PCP that will meet all requirements of process validation and or evidence of effectiveness, and quality control requirements. The Codex Guidelines for the Validation of Food Safety Control Measures, CAC/GL 69 – 2008, Section VI, also provides pertinent information on validation processes.

The manufacturer must designate technically qualified personnel responsible for developing and implementing a QA/QC program. They should be familiar with and implement effective controls based on applicable Codex Codes of Practice or their national equivalents for manufacturing processes for infant formulas and guidelines provided by a process authority.

The manufacturer must have a letter from Health Canada verifying the pre-market notification for each infant formula marketed in Canada. Any major change including changes in ingredients, processing, or packaging requires a new pre-market notification.

The production of each batch of infant formula shall be conducted according to the approved master manufacturing documents.

Relevant processing procedures and instructions shall be readily available for easy reference by process operators.

Records shall be completed during the production of each batch, documenting the actual lot number and quantity of each ingredient added, the completion of each step of the manufacturing procedure, and the actual results of all in-process measurements. Batch records should be filled out as the process is completed to the greatest extent possible without compromising critical processing operations. Critical stages of the manufacturing process shall be monitored in such a way as to ensure that no unexpected nutrient losses occur during processing. Process deviations from scheduled processes for sterile products, or from specified action limits for CCPs, and any resulting corrective actions, shall be documented, evaluated and approved by technically qualified persons. Suitable methods shall be used to evaluate and verify product homogeneity or uniformity after mixing and blending operations, the consistency in composition and the absence of unintended ingredients.

The performance of automated/computer controlled equipment shall be controlled and monitored by appropriate methods to ensure on-going reliable operation. Access to automated and computerized setting shall be restricted to personnel who are qualified and authorized to adjust settings when necessary. Equipment and computer controlled systems should be validated upon first use. (See Section 3.2, Paragraph 8)

Approval of temporary changes or deviations from established processing conditions shall be authorized in writing by a technically qualified person based on appropriate consideration of their potential effects on product quality and safety. In the case of retort and aseptic processing, the qualified person is referred to as the "Process Authority".

Process operators shall be given adequate training under close supervision before they are allowed to work independently with new technologies and/or new work processes introduced to processing areas.

Any in-process product transferred to another establishment for further processing or packaging shall be effectively identified, controlled and documented to prevent inadvertent mix-ups.

3.9.1 Process validation

Refer to Appendix 1 and consult the CFIA's SFCR guidance finder for more information.

Prior to the first commercial release of any new infant formula, process qualification studies shall be planned, conducted by technically qualified persons and properly documented. These studies may include concurrent validation studies when appropriate, and should demonstrate that defined processing procedures and instructions, using the specified ingredients, materials and equipment, consistently yield a product which meets the required specifications (may require several batches). Validation batches may be released for sale subject to meeting all quality, stability and regulatory requirements.

Significant changes in blending and mixing operations, including premix blending, shall be validated and approved based on appropriate validation protocols. Special attention should be given to validation of uniform distribution of minor and trace components.

Significant changes in the function of automated and computer controlled equipment shall be validated by appropriate methods to ensure capability, reliability, consistency, and freedom from drift over time.

Records of process validation studies, including notes of significant changes to the process, shall be approved by technically qualified persons and stored on the manufacturing premises for a minimum of three years. Process validation records should always be available for the process in use.

3.9.2 Premix control

Each nutrient premix shall be manufactured according to approved master manufacturing documents and shall be analyzed for each nutrient. Premix specifications shall refer to test methods and limits for each nutrient.

Each premix batch should be sampled and analyzed for one or more indicator nutrients to confirm homogeneous distribution of minor components.

Process controls and testing/release responsibilities shall be clearly defined for each premix purchased from a third party premix manufacturer.

The premix supplier shall provide a complete certificate of analysis unless the receiving infant formula manufacturer completes full retesting prior to production.

At a minimum, each premix lot shall be sampled after receipt by the infant formula manufacturer and tested to confirm its correct identity and uniformity.

Premixes shall be stored in approved packaging under controlled conditions which ensure preservation of quality and potency until the designated expiry or retest date.

A premix shall not be used after its expiry date unless it has been re-approved by QA/QC with an extended expiry date.

The manufacturer is responsible for conducting appropriate stability studies to verify the assigned expiry date of premixes containing labile nutrients (for example, those subject to oxidation, adversely impacted by light or moisture).

3.9.3 Reprocessing or rework of infant formula

Any proposed rework, reprocessing, sorting, and/or re-inspection instructions shall be documented and approved by authorized and qualified QA/QC personnel prior to undertaking the activity. In general, the QA/QC plan should restrict the amount of infant formula that can be reprocessed or reworked, which may differ from one type of product to another and from one manufacturer's process to another.

Rework, reprocessing or re-inspection of an infant formula product shall be conducted under carefully controlled conditions to prevent contamination or deterioration of the product. Carryover of nutrients in rework should be considered and nutrient addition adjusted accordingly. Completion of such activities shall be supervised, documented and approved by qualified personnel.

Rework should be controlled to avoid the presence of unintended ingredients, by only reworking the same product back into a batch. Consideration should be given to including reworked lots in the stability program to monitor for possible long-term adverse impact on product quality.

Results of such activities, including related test and inspection results, shall be documented and approved by the designated QA/QC authority prior to product release or rejection.

3.9.4 Calibration and maintenance of manufacturing and test equipment

There should be a master schedule of required calibration activities including calibration frequency, methods, and required accuracy or performance criteria. These comprise part of the Master Manufacturing documents.

Written procedures shall be available for calibration of critical inspection, test and measuring devices including computerized and/or automated equipment and dispensing devices.

Procedures for all forms of maintenance, such as reactive maintenance (i.e. repair when broken), preventative maintenance (i.e. regular maintenance at regular intervals) and predictive maintenance (i.e. use of indicators, such as vibration sensors to trigger maintenance before the equipment fails) of all equipment shall be established in order to ensure control of critical manufacturing processes.

A planned preventive maintenance program and procedures shall be documented and implemented for critical processing equipment, and for support facilities and equipment essential for maintenance of effective control of critical manufacturing processes.

Planned calibration and maintenance activities shall be completed on schedule. Related critical calibration and maintenance records shall be retained in accordance with the SFCR, which requires records related to the preventive control plan to be kept for two years after the day on which the record is made (three years for low-acid canned food processing records).

Processing equipment and inspection, test and measurement devices which no longer function correctly shall be promptly removed from service and repaired or replaced. When defective processing equipment or inspection, test and measuring devices have been detected, appropriate action shall be taken to prevent use or distribution of non-conforming products. Potentially affected products, including released lots in distribution, shall be quarantined or held if necessary pending completion of a retrospective investigation to determine if product quality and/or safety has been adversely affected.

3.10 Finished product control

Each lot of finished infant formula product shall be sampled according to an approved sampling plan by the manufacturer. The sample shall be representative of the lot and held in quarantine until it has been evaluated. Once tested, the lot is released for sale by the QA/QC department. Each batch or lot shall be tested for compliance with its nutrient composition, chemical, microbiological, physical and packaging specifications.

Finished product specifications and test results shall confirm correct addition of each nutrient required or quantified on the label. Suitable indicator nutrients may be tested to confirm correct addition and distribution of nutrient premixes (generally one or more nutrients should be tested per premix).

Each nutrient required or quantified on the label and added individually to the batch shall be tested at some point to confirm its correct addition.

Specifications should include appropriate tests to confirm uniform distribution of representative nutrients throughout the batch, especially for labile or trace components. Uniformity testing may be reduced when confirmed by suitable process validation studies, in-process controls and process history.

Section 48(3) (b) of the SFCR provides the requirements for each application of the scheduled process to low-acid canned foods. In particular, for each application of the scheduled process to low-acid canned food, the SFCR requires a record of incubations results for verification of the process to meet microbiological criteria. General guidelines on incubation testing can be found in Codex CAC/RCP 23-1979 Code of Hygienic Practice for Low and Acidified Low Acid Canned Foods, Section 4.2.2.

Each lot of powdered infant formula products should meet, as a minimum, the microbiological criteria presented in Table 1. Due to sampling plan limitations, microbiological safety of foods cannot be achieved through end product testing alone. The compliance of finished products should be ensured by controlling hazards through application of good hygienic practices (GHP) and the HACCP system. The following microbiological criteria have been adopted by Health Canada's Bureau of Microbial Hazards. These recommendations are in accordance with the Code of Hygienic Practice for Powdered Formulae for Infants and Young Children (Codex Alimentarius Commission CAC/RCP 66-2008). These criteria are updated periodically. To obtain an electronic copy of the micro criteria, please send an email to the Bureau of Microbial Hazards with the subject heading "Health Canada's Interim Microbiological Criteria for Powdered Infant Formula".

Table 1. Microbiological criteria for powdered infant formula

Guideline

Sampling plan parameters

n

c

m

M

Aerobic Colony Count*

5

2

500/g

5000/g

Enterobacteriaceae (EB)

10

2*

0/10 g

0

Salmonella spp.

60

0

0/25 g

0

Cronobacter spp.

30

0

0/10 g

0

c = the maximum allowable number of defective sample units in a 2-class plan or marginally acceptable sample units in a 3-class plan;
n = number of sample units that must conform to the criteria;
m = a microbiological limit which, in a 2-class plan, separates good quality from defective quality or, in a 3-class plan, separates good quality from marginally acceptable quality;
M = a microbiological limit which, in a 3-class plan, separates marginally acceptable quality from defective quality.

*Contaminations in up to 2 sample units are tolerated (c =2). It is assumed that the product is sufficiently homogenous that high level contamination will fail the microbiological criterion (in case of a high level contamination, it is expected that more than 2 sample units will test positive for EB and the lot will be unacceptable).

If EB are detected in three sample units, the lot has to be tested for Cronobacter spp. and Salmonella spp. before its release, and improvements in production hygiene to minimize contamination should be implemented. If no pathogens are detected, the lot can be released (acceptable); the lot is unacceptable if pathogens are detected (zero tolerance for Salmonella spp. in 25 g. and zero tolerance for Cronobacter spp. in 10 g).

Lots should be examined using a method in Health Canada's Compendium of Analytical Methods in which the "application" section is appropriate for the intended purpose. When Compendium methods are unavailable, other acceptable methods may be used. For details about other acceptable methods, contact the Microbiological Methods Committee.

Production, packaging and QA/QC test records shall be reviewed and approved by a technically qualified person of the QA/QC department prior to release of the lot.

Finished product shall not be shipped from the manufacturing site prior to release unless the manufacturer maintains effective control of the warehouse facility to which it is shipped.

Subsequent to reviews as part of pre-market notification, there are procedures in place to ensure that labels continue to be in compliance with the FDA and FDR, as well as all applicable regulations and that all labelling information is accurate.

3.11 Contract manufacturing and control of imported infant formula

All manufacturers who contract third parties for the production and/or packaging of infant formulas must ensure the contracted party has the capability to comply with these GMPs and applicable regulations. Section 11(1) of the SFCR requires importers to ensure that imported infant formula has been manufactured, prepared, stored, packaged and labelled in a manner and under conditions that provide at least the same level of protection as that provided by the preventive control provisions in the SFCR.

The manufacturer shall designate a technically qualified person in Canada to oversee and approve relevant quality, GMP, technical and regulatory matters. This designated person shall oversee effective control systems for product release, handling and investigation of complaints, review and approval of stability studies and expiry dates, and maintenance of product master documents and internal audit reports. All copies of the Master Manufacturing documents and other documentation pertinent to the imported product (in paper or electronic format) must be retained on-site in Canada or be accessible in Canada in accordance with the SFCR.

The manufacturer remains ultimately responsible for product release, and for compliance with all aspects of production, including lot testing.

3.12 Packaging and labelling

Please refer to Division 23, of the FDR - Food Packaging Materials for guidance on the requirements on safe packaging of foods, which includes infant formulas. In particular, there are some constituent packaging materials (for example, vinyl chloride, polyvinyl chloride formulations containing octyltin chemicals, and acrylonitrile based materials) that are deemed inappropriate for packaging infant formulas. In general, the packaging must not absorb nutrients from the infant formula into the packaging or leach unacceptable amounts of chemicals from the packaging into the infant formula. A Letter of No Objection (LONO) from Health Canada is required for all infant formula packaging materials. For more guidance, please contact smiu-ugdi@hc-sc.gc.ca.

The Division 25 of the FDR, in B25.057 and B25.059, requires all infant formulas to be labelled in a specific format. This includes presenting the nutrient content information in a manner that is legible, easy to understand and does not contain any false and misleading statements. The content of protein, fat, available carbohydrate, ash and where present, fibre in the food shall be expressed in grams; the energy values expressed in calories; all vitamins and mineral nutrients listed in Table II of Division 25, in milligrams or international units; quantity of choline and any added nutritive substance normally contained in human milk and not referred to in B25.054 (1) (a) in milligrams or grams and all expressed per 100 mL or 100 gram offered for sale and per serving ready-to-serve. For general information on nutrition labelling, B.01.401 of the FDR may also be consulted.

On the label or in any advertisement of infant formulas, the following statements or claims relating to the content in the food are prohibited:

The label shall also contain adequate directions for the preparation, use and storage of the infant formula after the container has been opened, as well as the expiration date.

Parts 10 (Packaging) and 11 (Labelling) of the SFCR are corresponding regulations that set out the packaging and labelling requirements that apply to infant formulas to comply with these GMPs.

3.13 Stability program and expiry date control

The manufacturer shall establish and maintain a stability program, which should specify the stability sample requirements, test schedule and required physical, chemical and microbiological test requirements for each product or product family. The stability program shall monitor product quality of a sufficient number of batches of each product over the labelled shelf-life to support overall conclusions regarding the stability and physical properties of all ingredients, in particular the labile ingredients, as well as at the expiry date.

The stability program should specify the number of batches to be tested per year for each product depending on production volumes (for example, one batch per quarter, or one batch per six month period). The number of batches and frequency of stability testing may be reduced once a sufficient database has been developed, but should not be less than once per shelf-life and each time a change has been implemented into the manufacturing process, which change may have an impact on the stability.

For each infant formula product, the manufacturer shall conduct stability analysis for selected nutrients with sufficient frequency to substantiate the maintenance of nutrient content up to the expiration date of the product when subjected to normal conditions of storage and distribution.

The stability program should include provisions for special stability studies to be initiated on products which have been reprocessed or reworked, and on processing/formulation trial batches. In special cases, it may be appropriate to evaluate the stability of returned or expired goods.

The manufacturer shall maintain documents of the stability program, all procedures for all infant formula products and packaging container variations in order to monitor product quality over shelf-life and to support the authorized expiry dates. Responsibility and authority for interpretation of stability test results and for setting and revising product expiry dates shall be defined. This is normally a QA/QC responsibility.

Product samples for stability studies shall be stored under controlled conditions which reflect normal shelf-life storage and, in special cases, well defined, accelerated stress conditions which may occur in distribution (for example, freeze/thaw cycles or elevated temperature).

A product-specific stability protocol shall be documented by qualified and authorized personnel for each new or significantly changed infant formula product and/or packaging format. Responsible QA/QC personnel shall be notified promptly when stability tests indicate a possible concern with nutrient content or physical stability. The situation shall be investigated, communicated and appropriate action initiated if concerns are verified.

Stability data and records should be stored in a manner which facilitates their retrieval for review, analysis and summary reporting. These documents must be retained as per the set out requirements in the SFCR (two years after the day on which the record is made, three years for low acid canned food processing records).

3.14 Nonconformance reporting and corrective/preventive action

A procedure for the identification of problems and nonconformance should be documented in a standard operating procedure manual as a resource for all personnel involved in the manufacturing process.

The manufacturer shall implement and maintain a system for documenting problems encountered at all stages of the manufacturing process, from incoming ingredients to the final product release, any incidents of nonconformance, and the results of related investigations conducted with each problem and decisions and corrective or preventive actions taken to address each problem. Section 82(1) of the SFCR requires operators and importers to immediately investigate if they suspect, on reasonable grounds, that a food presents a risk of injury or does not meet other requirements.

The disposition of all nonconforming materials and products shall be subject to review and approval by the manufacturer's QA/QC department or other authorized manager.

The manufacturer should conduct a periodic review of historical nonconformance and manufacturing process problems in order to identify and initiate appropriate corrective or preventive actions on adverse performance trends and/or recurring problems.

3.15 Customer complaints and resolution

A customer complaint procedure shall be in place and capable of quickly identifying new, recurring or related complaints on specific products and/or lots of products.

The responsibility for recording, investigating and reporting on customer complaints shall be documented in approved procedures. The complaint handling process shall be capable of quickly escalating critical complaints and problems to senior management and regulatory officials in situations which could involve significant health or safety risks and/or potential recall.

Responsibilities for medical input, initiating follow-up or corrective action, communicating with regulatory and corporate officials, and responding to the complainant shall be clearly defined.

SFCR Part 4, Division 5, Section 83(2) requires records of the details of the complaint, results of the investigation and action taken to be kept for two years after the day on which the actions are completed.

3.16 Internal quality audits (or self-inspections)

The purpose of internal audits or self-inspections is:

Periodic internal quality audits of all activities outlined in this GMP document shall be carried out by qualified personnel according to an established audit plan and schedule.

The scope of the internal audit program and activities should include contract manufacturers, foreign manufacturers of imported products and suppliers of raw and packaging materials. There should be a written procedure for how the internal quality audits are conducted. SFCR 89 (1) (vi) requires written procedures for verifying that the PCP is implemented as written and resulting product is safe and suitable food.

All activities covered by the Infant Formula GMPs shall be audited at a frequency which reflects their importance, but for all requirements, at a minimum frequency of once per year or as specified in a prerequisite program. The general guidance is an annual audit. The frequency of internal audits should be increased for critical activities when on-going experience such as performance trends, non-conformance or complaints indicates potential weaknesses or the need for on-going improvement.

Personnel conducting internal audits shall be trained as quality auditors, and shall be independent of the activities they audit (that is, they shall not audit their own areas of responsibility).

Corrective actions to address audit findings shall be initiated, documented and completed in a timely manner. Records of internal audits shall be maintained for a minimum of two years in accordance with the PCP provisions of the SFCR.

3.17 Product distribution, returned goods and recall

Written procedures shall be implemented and maintained for control of the manufacturer's warehousing, distribution and shipping activities, including proper stock rotation throughout the distribution channels.

Detailed distribution records shall be maintained, for a minimum period of one year after the product's expiry date or as per the requirements in the SFCR (two years after the day on which the record is made, three years for low acid canned food processing records).

Written procedures shall be available for control, evaluation and disposition of returned goods. Effective controls should be in place to ensure that returned goods are not restocked for resale without assurance of their continued safety and quality.

There shall be a written procedure for handling recall of infant formula. The recall procedure shall clearly define the manufacturer's company, responsibilities for evaluating health risks, making recall decisions, communicating with government officials and other external parties, and for implementing and reporting results of the recall.

Distribution records shall be readily accessible and should facilitate product recall by permitting traceability of individual lots of infant formula from the manufacturer to the retailer, in the event of a product recall. Part of the QA/QC program shall be to test the capability of the distribution system to identify, control, trace and reconcile individual infant formula lots and these should be tested periodically in a mock recall activity. Subsection 84(2) of the SFCR requires mock recalls every 12 months, with records kept for two years. Any deficiencies shall be corrected.

During the recall of infant formula, the manufacturer shall track progress of the recall and maintain effective control of all returned and remaining quantities of affected lots.

At the completion of a recall, a final report shall be prepared including final results of traceability, recovery and disposal of recalled product, related investigations and corrective actions, and communications with regulatory authorities.

Corrective action shall be taken to effectively prevent similar recalls in the future. This may require process control changes, changes in ingredients, changes in the manufacturing process steps and/or changes in the tolerance levels implemented in the manufacturing process. It may also require changes to packaging materials and the stability testing program.

3.18 Quality records and retained samples

The manufacturer shall maintain or have accessible, in Canada, all required manufacturing and quality control records, results of all analyses carried out, distribution records and customer complaints for each lot of infant formula for a minimum of one year after the product's expiry date or longer if specified in the SFCR. The record retention time period specified by the PCP of the SFCR indicates these documents must be kept for a minimum of two years after the day on which the record is made (three years for low-acid canned food processing records).

SFCA Section 24 requires regulated parties to provide inspectors with any document, or access to any data, that they may reasonably require. Section 27 of the SFCA gives inspectors the authority to order a person to provide, on the date, at the time and place and in the manner specified by the inspector, any document, information or sample specified by the inspector (for a purpose related to verifying compliance or preventing non-compliance with the SFCA).

Under Section 90(3) of the SFCR, traceability records must be kept for two years after the day on which the food was provided to another person or sold at retail. Records can be provided electronically as long as they are in a format that can be imported and easily read by standard commercial software. Traceability documents do not need to be stored in Canada, but they must be accessible in Canada. SFCR Section 91 requires that traceability documents be accessible in Canada and provided within 24 hours, unless a shorter period is necessary to protect consumers.

Written procedures shall be implemented for secure storage of electronic records for which there is no hard paper copy. These procedures should include maintenance of back up files, and security provisions to prevent tampering with or inadvertent deletion or loss of electronic files and data.

Other documentation and items that shall be retained, in Canada, or at least accessible in Canada, for a minimum of one year after the product's expiry date or as per the requirements in the SFCR (two years after the day on which the record is made, three years for low-acid canned food processing records) are:

4.0 Glossary

Aseptic processing

A process for sterilizing liquid infant formulas wherein the sterilization of the packaging and product occurs separately, then is combined inside an aseptic environment to form a commercially sterile product. The bulk liquid is first sterilized and stored in an aseptic environment. The packaging (bottle and foil cap) is also sterilized in an aseptic environment. The sterilized infant formula is filled into the sterilized bottle and sealed all inside an aseptic environment.

Batch

A specific quantity of infant formula intended to have uniform character and quality within specified limits, which is produced according to a single manufacturing order and which may constitute the whole or a part of a lot.

Codex (Short term for Codex Alimentarius)

The Codex Alimentarius is a collection of internationally adopted food standards and related texts presented in a uniform manner. These food standards and related texts aim at protecting consumers' health and ensuring fair practices in the food trade.

Commercially sterile

Means the condition obtained in a food that has been processed by the application of heat, alone or in combination with other treatments, to render the food free from viable forms of microorganisms, including spores, capable of growing in the food at temperatures at which the food is designed normally to be held during distribution and storage. (FDR B.27.001)

Commercial sterility of equipment and containers used in aseptic processing and packaging of food

Means the condition achieved and maintained by application of heat, or other appropriate treatment, which renders such equipment and containers free from microorganisms capable of growing in the food at temperatures at which the food is likely to be held during distribution and storage (CAC/RCP 23-1979).

Contamination

An introduction or occurrence of a contaminant in food or in a food environment.

Corrective action

Any action to be taken when a nonconformance is encountered at any point in the process including designated critical control points.

Critical control factor

Means any characteristic, property, condition, aspect or other parameter, variation of which may affect the attainment of commercial sterility.

Critical Control Point (CCP)

A point, step, or procedure at or in which control can be applied and a food safety hazard can be prevented, eliminated or reduced to an acceptable level.

Critical limit

A criterion which separates acceptability from unacceptability.

Deviation

Failure to meet the critical limits or other specified requirements for a critical factor.

Establishment

Any building or area in which infant formula or its components are handled and the surroundings under the control of the same management.

Expiration date

As defined under Section B.25.001 of the FDR means, in respect of a human milk fortifier or human milk substitute, the date:

  1. after which the manufacturer does not recommend that it be consumed; and
  2. up to which it maintains its microbiological and physical stability and the nutrient content declared on the label.

Failure incidents

Deviations on critical limits and other incidents of nonconformance.

Food additive

As defined in subsection B.01.001(1) of the FDR, any substance the use of which results, or may reasonably be expected to result in it or its by-products becoming a part of or affecting the characteristics of a food, but does not include:

  1. any nutritive material that is used, recognized or commonly sold as an article or ingredient of food;
  2. vitamins, mineral nutrients and amino acids, other than those listed in the tables to Division 16 (note: these tables will be rescinded as the Lists of Permitted Food Additives are now being used instead of the tables);
  3. spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives;
  4. agricultural chemicals, other than those listed in the tables to Division 16 (note: these tables will be rescinded as the Lists of Permitted Food Additives are now used instead of the tables);
  5. food packaging materials and components thereof; and
  6. drugs recommended for administration to animals that may be consumed as food.

Food safety

A concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.

HACCP (Hazard Analysis Critical Control Point)

A systematic approach to identifying and assessing hazards and risks associated with a food operation and defining the means of their control, which are significant for food safety.

HACCP Plan

A written document designed in order to control hazards associated with specific processes and/or products within an establishment.

HACCP System

A system that includes prerequisite programs, one or more HACCP plan(s), validation documentation of control measures that have an immediate impact on food safety as well as maintenance and reassessment procedures as defined by a food safety enhancement program.

Hazard

An entity, a condition or a circumstance that has the potential to cause harm. Hazards can be biological, chemical (including allergenic) or physical.

Health claim

A statement or representation that states, suggests or implies that a relation exists between a food or component of that food and health (Codex Alimentarius Commission, 1997). The FDA governs the use of health claims on food products in Canada.

Hermetically sealed container

Means a container designed and intended to be secure against the entry of microorganisms, including spores (B.27.001 of the FDR).

Human milk substitute or infant formula

'Infant formula' or 'human milk substitute' is defined under Section B.25.001 of the FDR as any food that is labelled or advertised:

  1. for use as a partial or total replacement for human milk and intended for consumption by infants; or
  2. for use as an ingredient in a food referred to in paragraph (a).

Incubation

The term incubation refers to the holding of sample(s) of hermetically sealed, processed foods at a specified temperature for a specified period of time.

Indicator nutrient

A nutrient whose concentration is measured during the manufacture of an infant formula to confirm complete addition of a premix or other raw ingredients of which the indicator nutrient is a part.

Infant

An individual who is under the age of one year as per Section B.25.001 of the FDR.

ISO (International Organization for Standardization)

An international standard-setting body composed of representatives from various national standards organizations. As of January 2018, there are 162 members. It was founded in 1947 by the International Federation of the National Standardizing Associations, United Nations Standards and has its headquarters in Geneva, Switzerland.

Lot

Quantity of infant formula produced under identical conditions, all packages of which bear a lot number that identifies the production during a particular time interval from a particular "line" or other critical processing unit. It may be defined by a time period (for example, from sanitation to sanitation) or some other processing measure. It is often associated with a number and enables tracing of the constituent parts or ingredients as well as labour and equipment records involved in the manufacturing of an infant formula. This enables manufacturers and other entities to perform quality control checks, calculate expiration dates, and issue corrections or recall information to subsets of the production output.

Lot number

Means any combination of letters, figures, or both, by which any food or drug can be traced in manufacture and identified in distribution (FDR A.01.010). When a lot number is required by these Regulations to appear on any article, container, package or label it shall be preceded by one of the following designations: Lot number, Lot No., Lot or (L) (A.01.014).

Low-acid food

Means a food, other than an alcoholic beverage, where any component of that food has a pH greater than 4.6 and a water activity (aw) above 0.85. Water activity means the ratio of the water vapour pressure of a food to the vapour pressure of pure water at the same temperature and pressure.

Major change

As defined under Section B.25.001 of the FDR means, in respect of a human milk substitute, any change of an ingredient, the amount of an ingredient or the processing or packaging of the human milk substitute where the manufacturer's experience or generally accepted theory would predict an adverse effect on the levels or availability of nutrients in, or the microbiological or chemical safety of, the human milk substitute..

Manufacturer

Is defined under Section A.01.010 of the FDR as a person, including an association or partnership, who under their own name, or under a trade, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug.

Manufacturing order

Instructions outlining in detail the materials and procedures required to manufacture a single batch or lot of infant formula.

Master manufacturing documents

A set of reference documents detailing the identity and exact quantity of all ingredients, the approved procedures for processing and packaging, and the in-process and finished product testing requirements and specifications for a batch of infant formula at a specified facility.

Monitoring

The act, by company personnel of conducting a planned sequence of observations, tests or measurements to assess whether a critical control point, a process control and/or a prerequisite program is under control. This includes recording the results of those observations.

New human milk substitute

As per B.25.001 of the FDR, a human milk substitute that is:

  1. manufactured for the first time,
  2. sold in Canada for the first time, or
  3. manufactured by a person who manufactures it for the first time.

Non-conformance

A failure to meet an established requirement.

Normal growth

Encompasses all aspects of physical growth and normal development, including maturation of organ systems and achievement of normal functional development of motor, neurocognitive, and immune system. All of these growth and maturational development processes are major determinants of an infant's ability to achieve his/her biological potential, and can be affected by the nutritional status of an infant (IOM, 2004).

Nutritional adequacy

An infant formula is nutritionally adequate if it promotes acceptable growth and development in infant when consumed in accordance with the directions for use. Clinical trial evidence is often used to determine whether a given infant formula is nutritionally adequate.

Overage

Means the amount of a vitamin or mineral nutrient that is, within the limits of good manufacturing practice, added to a food in excess of the amount declared on the label, in order to ensure that the amount of the vitamin or mineral nutrient declared on the label is maintained throughout the durable life of the food.

Potable water

Means water fit for human consumption.

Pre-market notification

The FDR require that manufacturers notify Health Canada prior to the marketing of any new infant formula or of a formula that has undergone a major change in formulation, manufacturing or packaging. Sections B.25.046 and B.25.048 of the regulations specify the information that must be presented in the pre-market notification.

Pre-mix

A combination of ingredients containing two or more nutrients as specified on the label, which is compounded in a manufacturing operation distinct from the processing of the final product.

Prerequisite program

Food safety basic conditions and activities that are necessary to maintain a hygienic environment and good manufacturing practices throughout the establishmentthat set the foundation for implementation of a HACCP system.

Process control

Where more than one step in an overall process may contribute to the reduction of a particular hazard, process controls are developed for the early steps of the process where the hazard cannot be fully controlled, but a subsequent step will result in the elimination or reduction of this particular hazard to an acceptable level. This final step would be determined to be a CCP.

Quarantine

The removal of an ingredient, material, or product lot from availability for use or sale. Quarantine may be achieved by physical segregation of the affected lot, or by a procedural material control system which effectively prevents use or sale of the item.

Raw ingredient or material

Any substance used in the manufacture of infant formula.

Regulatory requirements

All pertinent Acts, Regulations and Directives with respect to the FDA, FDR and Guidelines and the SFCA and SFCR.

Retort

Means a pressure vessel designed for thermal processing of food, packed in hermetically sealed containers, or a vessel or other equipment used for thermal processing (CAC/RCP 23-1979).

Risk

An estimate of the likely occurrence of a hazard and the severity of possible adverse health effect.

Safety

A reasonable certainty of no harm (US Food and Drug Administration Food Drugs and Cosmetics Act Section 409).

Scheduled process

As defined in the SFCR means a process in which a treatment is applied to a food to render the food commercially sterile, taking into account the critical physical and chemical factors that affect the treatment's effectiveness.

Sell

As defined in the FDA includes offer for sale, expose for sale, have in possession for sale, and distribute, whether or not the distribution is made for consideration.

Sterilization

Refers to any process that eliminates, removes, kills, or deactivates all forms of life and other biological agents present in a specified product. The removal of all microorganisms and other pathogens from an object or surface is achieved by treating it with chemicals or subjecting it to high heat or radiation.

Technically qualified person

A person who has had technical training relevant to their responsibilities or who is qualified by relevant practical experience.

Thermal process

Means the thermal treatment/heat treatment to achieve commercial sterility, or reduce microbial pathogens but does not lead to commercial sterility and is quantified in terms of time and temperature.

Validation

Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome (CAC/GL 69-2008).

Verification

The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended (CAC/GL 69-2008). For example, CFIA's suggested verification procedures apply to CCPs and their control measures; control measures for hazards not part of a CCP; measures taken to ensure that other regulatory requirements (for example, labelling, net quantity, grade) are met; monitoring procedures and corrective actions procedures. Section 3.16 presents internal quality audits (or self-inspections) activities as described in the GMPs, which are verification activities.

Appendix 1: Validation of manufacturing processes and test methods

This appendix provides general guidelines intended to assist responsible personnel for validating manufacturing processes and test methods.

Good management decisions are based on technical data with reliable knowledge of the inherent variation of manufacturing processes and test methods. Validation studies are used to evaluate and confirm the reliability of technical processes, equipment and methods in the hands of trained operators in order to provide confidence in the resulting data and required decisions based on good science.

When manufacturing processes or test methods are implemented for the first time or are changed, it is useful to conduct controlled validation studies to verify the reliability and consistency of the process or method under normal operating conditions with trained operators. The design of validation studies depends on many factors including the nature of the product, process, equipment, reference methods, specification limits, and other aspects.

Appendix 1A. Validation of manufacturing processes

The following guidelines should be considered when planning or reviewing validation studies to evaluate and confirm process reliability:

Appendix 1B. Validation of test methods

Chemical, microbiological, and physical test methods must be reliable when used by trained operators in order to generate high quality analytical data to support decisions on product quality. Method reliability is generally demonstrated by completion of controlled method validation studies.

Typically, an analytical method should be validated for precision, accuracy, recovery, linearity and sensitivity by repetitive analyses of samples of known composition. Another acceptable approach is to analyze several samples by the new or proposed method and by a published reference method (for example, United States Pharmacopeia (USP), Association of Official Analytical Chemists (AOAC), or Federal Communications Commission (FCC) which has been proven reliable through inter-laboratory collaborative studies prior to its adoption for publication.

Method validation involves many of the same considerations and concerns as process validation. The following factors should be considered when designing a validation protocol or when evaluating the results:

Appendix 1C. Verification procedures (for CCPs and other process indicators)

Verification (refer to Glossary) is the application of methods, procedures, tests, sampling and other evaluations, in addition to monitoring, to determine whether:

Verification activities should be included in all documented evidence to confirm the efficacy of all elements of the food safety system. Suggested verification procedures apply not only to CCPs and their control measures, but also to control measures for hazards not part of a CCP. For example, measures taken to ensure that other regulatory requirements are met, such as, nutrient levels, labelling, net quantity, and grade, are also pertinent verification activities. Furthermore, monitoring procedures for each regulatory requirement and corrective actions procedures also comprise verifications. Section 3.16 internal quality audits or self-inspections, described in the GMPs, are verification activities.

For more guidance on verification procedures, please consult the CFIA website.

Appendix 2: Reference documents and codes of practice

Appendix 2A. Recommended Codex Alimentarius documents

Appendix 2A.1 Standards

  1. Codex Alimentarius International Food Standards, "Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants", CODEX STAN 72 – 1981, last amended in 2020
  2. Codex Alimentarius International Food Standards, "Standard for Follow-Up Formula", CODEX STAN 156-1987
  3. Codex Alimentarius International Food Standards, "General Standard for the Labelling of Prepackaged Foods", CODEX STAN 1-1985, last modified 2010, last revised in 2018
  4. Codex Alimentarius International Food Standards, "General Standard for Food Additives", CODEX STAN 192-1995, last revised in 2019
  5. Codex Alimentarius International Food Standards, "General Standard for Contaminants and Toxins in Food and Feed", CODEX STAN 193-1995, last amended in 2019

Appendix 2A.2 Codes of Practice

  1. Codex Alimentarius International Food Standards, Code of Hygienic Practice for Powdered Formulae for Infants and Young Children, CAC/RCP 66 – 2008; last updated in 2009
  2. Codex Alimentarius International Food Standards, "General Principles of Food Hygiene" (CAC/RCP 1-969); last updated in 2003, last revised in 2020
  3. Codex Alimentarius International Food Standards, "Code of Hygienic Practice for Low and Acidified Low Acid Canned Foods (CAC/RCP 23-1979), last revised in 1993
  4. Codex Alimentarius Commission, Code of Hygienic Practice for Aseptically Processed and Packaged Low-Acid Foods (CAC/RCP 40-1993), last updated in 1993
  5. Codex Alimentarius International Food Standards, Code of Hygienic Practice for Low-Moisture foods (CAC/RCP 75-2015) last revised in 2016, last amended in 2018
  6. Codex Alimentarius International Food Standards, Code of Practice for the Prevention and Reduction of Lead Contamination in Foods (CAC/RCP 56-2004).
  7. Codex Alimentarius International Food Standards, Code of Practice for the Prevention and Reduction of Dioxin and Dioxin-like PCB Contamination in Food and Feed (CAC/RCP 62-2006), last revised in 2018.
  8. Codex Alimentarius Commission, Proposed Draft Code of Practice for the reduction of 3-monochloropropane-1, 2-diol esters (3-MPDE) and glycidyl esters (GE) in refined oils and products made with refined oils, especially infant formula (CX/CF 18/12/9-Add.1).

Appendix 2A.3 Guidelines

  1. Code Alimentarius International Food Standards, Guidelines on Nutrition Labelling (CAC/GL 2-1985), last revised in 2017
  2. Code Alimentarius International Food Standards, Advisory Lists of Nutrient Compounds for Use in Foods for Special Dietary Uses intended for Infants and Young Children (CAC/GL 10-1979), last updated in 2015
  3. Codex Alimentarius Commission, Guidelines for Use of Nutrition and Health Claims, CAC/GL 23-1997, last updated in 2013
  4. Codex Alimentarius Commission, Guidelines for the Assessment of the Competence of Testing Laboratories Involved in the Import and Export Control of Food, CAC/GL 27-1997, last updated in 2006
  5. Codex Alimentarius Commission, Guidelines on the Application of General Principles of Food Hygiene to the Control of Listeria Monocytogenes in Foods, CAC/GL 61-2007, last updated in 2009
  6. Codex Alimentarius Commission, Guidelines on the Application of General Principles of Food Hygiene to the control of Viruses in Food, CAC/GL 79-2012
  7. Code Alimentarius International Food Standards, Guidelines on the Application of General Principles of Food Hygiene to the Control of Foodborne Parasites, CAC/GL 88-2016, last updated in 2016
  8. Code Alimentarius International Food Standards, Guidelines on Performance Criteria for Methods of Analysis for the Determination of Pesticide Residues in Food and Feed, CAC/GL 90-2017
  9. Code Alimentarius International Food Standards, Principles and Guidelines for Monitoring the Performance of National Food Control Systems, CAC/GL 91-2017
  10. Codex Alimentarius Commission, Guidelines for the Validation of Food Safety Control Measures, CAC/GL 69 – 2008, last updated in 2013
  11. Food And Agriculture Organization of the United Nations, Food Quality and Safety Systems – A Training Manual on Food Hygiene and the Hazard Analysis and Critical Control Point (HACCP) System, FAO, 1998

Appendix 2B. Recommended CFIA publications

  1. Canadian Food Inspection Agency, Food Labelling for Industry
  2. Canadian Food Inspection Agency, Labelling Requirements for Infant Foods, Infant Formula and Human Milk
  3. Canadian Food Inspection Agency, General Principles for Labelling and Advertising
  4. Canadian Food Inspection Agency, Preventive control plan (PCP)
  5. Canadian Food Inspection Agency, Preventive controls for food businesses
  6. Canadian Food Inspection Agency, Food Imports
  7. Canadian Food Inspection Agency, The Food Safety Enhancement Program approach to a preventive control plan

Appendix 2C. Recommended reading

  1. Yiang YJ and Guo M. (2014). Processing technology for infant formula. In Guo M (Ed): Human Milk Biochemistry and Infant Formula Manufacturing Technology, Woodhead Publishing Series in Food Science, Technology and Nutrition, pp 211-229.

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