Processed Products Regulations

1. These Regulations may be cited as the Processed Products Regulations.

2. (1) In these Regulations,

“acceptable method” means a method of analysis or examination designated by the Minister as acceptable for use in the administration of the Act and these Regulations; (méthode acceptable)

“acidified low-acid food product” means a food product that has been treated by pickling or fermentation so as to attain an equilibrium pH of 4.6 or lower after heat processing; (produit alimentaire peu acide à pH réduit)

“adulterated”, in respect of a food product, means adulterated within the meaning of sections B.01.046 and B.01.047 or Division 15 of Part B of the Food and Drug Regulations; (falsifié)

“Agency” means the Canadian Food Inspection Agency established by section 3 of the Canadian Food Inspection Agency Act; (Agence)

“brine pack” means a pack in which a water and salt solution is used as the packing media with or without the addition of sugar; (conservé dans la saumure)

“commercial sterility” means the condition of a food product that is free from viable forms of microorganisms, including spores, capable of growing in the food product above a temperature of 4°C; (stérilité commerciale)

“container” means the package in which a food product is offered for sale; (contenant)

“contaminated”, in respect of a food product, means containing a chemical, drug, food additive, heavy metal, industrial pollutant, ingredient, medicament, microbe, pesticide, poison, toxin or any other substance not permitted by, or in an amount in excess of limits prescribed under, the Canadian Environmental Protection Act, 1999, the Food and Drugs Act or the Pest Control Products Act; (contaminé)

“critical factors” means those physical and chemical factors that affect the ability of the thermal process to achieve commercial sterility; (facteurs critiques)

“Director” means the person designated by the President of the Agency; (directeur)

“establishment” means any place in which fruits or vegetables, or any product thereof, are prepared for food; (établissement)

“first dealer” means any person operating as a wholesaler, retailer or distributor who buys and sells under his own private label any food product packed for him in a registered establishment; (premier commerçant)

“food” has the same meaning as in section 2 of the Food and Drugs Act; (aliment)

“food additive” has the same meaning as in section B.01.001 of Part B of the Food and Drug Regulations; (additif alimentaire)

“food product” or “product” means any article of food prepared wholly or in part from fruit or vegetable; (produit alimentaire)

“grade” means a grade established for canned and frozen fruits and vegetables pursuant to sections 3.1 and 4; (catégorie)

“head space” means that space between the top edge or rim of the container and the upper level of the contents; (espace libre)

“heavy pack” means a pack in which a minimum amount of water required for proper processing is used as the packing media; (conserve épaisse)

“hermetically sealed container” means a container that is designed and intended to be secure against the entry of microorganisms including spores; (contenant hermétiquement scellé)

“ingredient” means an individual unit of food that is combined with one or more other individual units of food to form an integral unit of food; (ingrédient)

“label” means any printed, stencilled, lithographed or embossed label, sticker, seal, wrapper, stencil or receptacle; (étiquette)

“low-acid food product” means a food product any component of which has a pH value above 4.6 and a water activity (Aw) above 0.85 after thermal processing; (produit alimentaire peu acide)

“operator” means the person who is responsible for operating a registered establishment; (exploitant)

“prepackaged product” means any product that is packaged in a container in such a manner that it is ordinarily sold to or used or purchased by a consumer without being re-packaged; (produit préemballé)

“principal display panel” has the same meaning as in subsection 2(2) of the Consumer Packaging and Labelling Regulations; (espace principal)

“principal display surface” has the same meaning as in subsection 2(1) of the Consumer Packaging and Labelling Regulations; (principale surface exposée)

“processed” means, in respect of a food product, canned, cooked, frozen, concentrated, pickled or otherwise prepared to assure preservation of the food product in transport, distribution and storage, but does not include the final cooking or preparation of a food product for use as a meal or part of a meal such as may be done by restaurants, hospitals, food centres, catering establishments, central kitchens or similar establishments where food products are prepared for consumption rather than for extended preservation; (transformé)

“registered establishment” means an establishment that is registered pursuant to subsection 11(1); (établissement agréé)

“registered label” means a label that is registered pursuant to section 44; (étiquette enregistrée)

“scheduled process” means the thermal process alone, or in combination with critical factors, chosen by the operator for a given food product formulation, container type and size and unit of thermal processing equipment that will achieve at least commercial sterility; (traitement programmé)

“shipping container” means a receptacle, package or wrapper in which containers of food products are placed for transportation; (contenant d’expédition)

“solid pack” means a pack in which the fruit or vegetable has been partially or wholly precooked before processing so as to allow the product to pack closely with the minimum amount of free liquid; (conserve compacte)

“substitute” means any food product that resembles a processed product in appearance and is prepared for the same uses as the processed product but does not meet the standards set out in these Regulations for the processed product; (succédané)

“syrup pack” means a pack in which sugar, invert sugar, honey, dextrose or glucose, in dry or liquid form, is used with water as the packing media; (conservé dans le sirop)

“vacuum pack” means a pack in which a minimum amount of packing media is used and the vacuum in the can is created mechanically; (conservé sous vide)

“water activity” means the ratio of water vapour pressure of the food product to the vapour pressure of pure water at the same temperature and pressure; (activité de l’eau)

“water pack” means a pack in which water is used as the packing media. (conservé dans l’eau)

SOR/79-541, s. 1; SOR/81-337, s. 1; SOR/86-622, s. 1; SOR/87-133, s. 1; SOR/87-350, s. 1(F); SOR/87-372, s. 1; SOR/88-383, s. 1; SOR/91-687, s. 1; SOR/93-330, s. 1; SOR/93-496, s. 1; SOR/95-548, s. 2; SOR/97-300, s. 1; SOR/98-579, s. 1; SOR/2000-184, s. 23; SOR/2003-6, s. 40.

2.1 (1) Subject to subsections (2) and (3), no person shall market a food product in import, export or interprovincial trade as food unless the food product, including every substance used as a component or ingredient thereof,

(e) where irradiated, is irradiated in accordance with Division 26 of Part B of the Food and Drug Regulations; and

(f) meets all other requirements of the Food and Drugs Act and the Food and Drug Regulations with respect to the food product.

(2) No food product that is adulterated or contaminated shall be mixed with a food product that is not adulterated and not contaminated for the purpose of bringing the adulterated or contaminated food product into compliance with the requirements of paragraphs (1)(a) to (f).

(4) For the purposes of paragraph (1)(d), “prepared in a sanitary manner” means prepared in accordance with the provisions of sections 16 and 17.

2.2 A food product that is adulterated or contaminated may be marketed in import, export or interprovincial trade as animal food if it is

2.3 An inspector may direct that a food product be disposed of or destroyed where the inspector suspects on reasonable grounds that the food product

(c) does not meet the requirements of subsection 2.1(1) or section 2.2 and cannot be prepared in such a manner that it meets those requirements; or

2.4 No person shall market in import, export or interprovincial trade any food product in a container

3. Where a grade or standard is established under these Regulations for a processed product, no person shall market in import, export or interprovincial trade any substitute for that processed product in such a manner that the substitute is likely to be mistaken for the processed product.

3.1 The grades for canned fruits and vegetables set out in Table I of Schedule I, the grade names therefor and the standards therefor are as prescribed in that Table.

4. The grades for frozen fruits and vegetables set out in Table II of Schedule I, the grade names therefor and the standards thereof, are as prescribed in that Table.

5. The grades for canned and frozen fruits and vegetables set out in Schedule I that are imported and sold in their original containers are as prescribed in that Schedule and the grade names therefor are as set out in section 3 of Schedule V.

5.1 [Repealed, SOR/93-330, s. 2]

6. The standards for fruit and vegetable products set out in Schedule II are as prescribed in that Schedule.

6.1 A fruit or vegetable product for which a standard is set out in these Regulations shall contain only the ingredients set out in the standard prescribed for the product in Schedule I or II.

7. [Repealed, SOR/91-687, s. 4]

8. The grade names established by these Regulations may be applied to containers of fruit and vegetable products only on the following terms and conditions:

(a) except in the case of an imported product sold in its original container, the product was prepared in a registered establishment in accordance with these Regulations; and

(b) the product was packed in a container prescribed in Part III and was marked as prescribed in Part IV.

9. (1) Except as authorized by these Regulations or by an inspector, no person shall ship or transport from the establishment in which it was packed, any fruit or vegetable product for which grades are established in these Regulations unless there has been applied to the container of the product a grade name established by these Regulations.

(2) This section does not apply to fruit and vegetable products in Schedule I designated as “optional” and on which grade labelling is not mandatory.

9.1 (1) The operator of a registered establishment or an importer of food products may apply in writing to the Director for an authorization to test market a food product that does not meet the requirements of these Regulations.

(a) the name, address and telephone number of the applicant and the facsimile number or the registration number of the establishment;

(iii) formulation and method of manufacture, if other than as established under these Regulations;

(d) an estimate of the total quantity of the food product that will be test marketed;

(e) a description of the demographic or geographic area or areas intended to be covered by the test marketing;

(f) the expected duration of the test marketing period, up to a maximum of 24 months;

(i) the containers to be used meet the requirements of Division 23 of Part B of the Food and Drug Regulations;

(ii) the labelling of the container is not misleading as to the nature, quantity, quality, composition, character, safety, value, variety or origin of the food product, and meets the requirements of the Consumer Packaging and Labelling Act and the Consumer Packaging and Labelling Regulations, and

(i) three samples of any label, or reasonable facsimiles of them, that will be applied to the food product.

(3) Every application for a test marketing authorization shall be accompanied by at least one sample of the food product to be test marketed.

(4) Where facsimile labels are submitted with the application referred to in subsection (1), the holder of the test marketing authorization shall submit a final label to the Director within 90 days after the date of issue of the authorization.

(5) The Director may issue a written authorization to the operator of a registered establishment or to an importer of food products to test market a food product for a period of up to 24 months where the Director is satisfied, based on information available to the Director, that the test marketing of the food product will not

(6) The Director may cancel an authorization issued pursuant to subsection (5) where

10. (1) An application for the registration of an establishment, or for the renewal or amendment of an existing registration, shall be made to the Director, in a form provided by the Agency, accompanied by the applicable fee prescribed by the Canadian Food Inspection Agency Fees Notice, and shall contain the following information:

(a) the name, address, including the postal code, telephone number and, if any, facsimile number of the applicant and of the establishment, where they are different from those of the applicant;

(b) whether it is an application for a new registration or for the renewal or amendment of an existing registration;

(d) whether the establishment is owned by individual, a partnership, a co-operative or a corporation;

(e) the name under which the establishment operates, where the name is different from that of the applicant;

(f) the names and titles of all owners, partners, officers and directors of the establishment; and

(g) whether the establishment packs low-acid food products or acidified low-acid food products in hermetically sealed containers.

(2) Every application referred to in subsection (1) shall have annexed thereto a copy of an outline of a sanitation program for the establishment indicating

(b) the equipment available for use to bring about and maintain clean and sanitary conditions; and

SOR/79-918, s. 1; SOR/86-622, s. 3; SOR/87-372, s. 2; SOR/97-300, s. 2; SOR/2000-183, s. 17; SOR/2000-184, s. 30; SOR/2003-6, s. 43(F).

11. (1) Where an establishment, in respect of which an application referred to in subsection 10(1) has been made, complies with the conditions prescribed by sections 13 to 19, the Director shall

(a) register the establishment by entering its name in the register of registered establishments of the Agency and by assigning it a registration number; and

(b) issue to the operator of the establishment a Certificate of Registration for the establishment.

(2) The operator of a registered establishment shall post and keep posted the Certificate of Registration issued to him under subsection (1) in a conspicuous place in the establishment for the period during which the certificate remains in force.

(3) The operator of a registered establishment shall not assign or transfer the Certificate of Registration issued for that establishment.

12. (1) Subject to subsections (2) and (5), the Certificate of Registration shall remain in force for the 12-month period following the date of issuance.

(i) the establishment does not comply with any provision of the Act or these Regulations,

(ii) the operator of the establishment does not comply with any provision of the Act or these Regulations, or

(iii) it is reasonable to believe that public health will be endangered if the establishment is allowed to continue operating; and

(b) where the operator has failed or is unable to take immediate corrective action.

(a) an inspector has prepared a written report setting out the reasons for the suspension and the corrective measures required and has forwarded a copy of that report to the operator; and

(b) where a cancellation procedure has been commenced under subsection (5), until the resolution of the cancellation issue; or

(a) where the establishment does not comply with any provision of the Act or these Regulations; or

(b) where the operator of the establishment fails to comply with any provision of the Act or these Regulations.

(a) an inspector has, at the time of his inspection, notified the operator of the failure to comply with any provision of the Act or these Regulations;

(i) identifying the provision of the Act or these Regulations that has not been complied with, and

(ii) specifying the period of time for compliance with that provision of the Act and these Regulations in order to prevent the cancellation of the registration;

(c) the operator has failed to comply with or failed to bring the establishment into compliance with any provision of the Act or these Regulations within the period of time specified in the inspection report or continues, after that period, to violate or fail to comply with any provision of the Act or these Regulations;

(d) the operator has been given an opportunity to be heard in respect of the cancellation; and

SOR/86-622, s. 3; SOR/87-372, s. 2; SOR/93-496, s. 6; SOR/97-300, s. 3; SOR/2000-183, s. 18; SOR/2000-317, s. 2; SOR/2003-6, s. 44.

13. Every establishment registered pursuant to section 11 shall be situated on land that

(c) is not in such proximity to any source of pollution or any place that harbours insects, rodents or other vermin that food products in the establishment are likely to be contaminated.

14. (1) Every establishment registered pursuant to section 11 shall

(b) be constructed of material that is durable and free of any noxious constituent;

(c) be protected against the entrance of insects, birds, rodents and other vermin or anything likely to contaminate food products;

(d) have floors, walls and ceilings in the preparation and packing areas that are constructed in such a way that they can be cleaned and are impervious to moisture;

(e) have rooms and areas with adequate lighting, ventilation and plumbing to meet the requirements of the operations carried out therein and constructed so as to facilitate their cleaning and disinfection;

(f) be equipped, in areas where food is exposed, with light bulbs and fixtures that are of a type that will not cause food contamination in the event of breakage;

(g) have a sufficient number of rooms to accommodate separation of incompatible operations;

(iv) in the case of lavatories, separate from and not leading directly into any room used for handling a food product;

(i) subject to subsection (2), be capable of supplying potable hot and cold water that is protected against contamination and is adequate in quantity and pressure to serve the water needs of the registered establishment;

(i) in accordance with the plumbing code of the province in which the establishment is located,

(iv) designed and constructed so that there is no cross-connection between the effluent of human wastes and any other wastes in the establishment, and

(l) have, for the inspection, processing, packaging, grading, marking or storing of a food product, equipment that is

(i) constructed of corrosion-resistant material, free of any noxious constituent and cleanable,

(ii) accessible for cleaning, servicing and inspection or easily disassembled for those purposes, and

(n) have adequate facilities and means for the thorough washing, cleaning and sanitizing of equipment;

(o) be equipped with appropriate container cleaning equipment located in the establishment; and

(p) have adequate means of establishing, maintaining and verifying the temperature and humidity of rooms where raw materials are located and food products are stored.

(2) A registered establishment may use water other than potable water referred to in paragraph (1)(i) where it is used solely for fire protection, boilers or auxiliary services and there is no connection between the system for that water and the system for potable water.

14.1 and 14.2 [Repealed, SOR/87-372, s. 2]

15. Every operator of a registered establishment shall maintain and operate the establishment in accordance with sections 16 to 19.

16. (1) The building, equipment and utensils and all other physical facilities of a registered establishment shall be maintained in a sanitary condition that prevents contamination of a food product.

(2) Every registered establishment shall be operated in accordance with the sanitation program referred to in subsection 10(2).

(3) Operations in relation to the preparation, packaging, marking, storage and other handling of a food product in a registered establishment shall be carried out under strict sanitary control.

(4) A registered establishment shall have notices posted in prominent places instructing employees engaged in the preparation, packaging, marking, storing or other handling of a food product to clean their hands immediately after using toilet facilities.

(5) In a registered establishment, no material or coating shall be used in repairing the walls, ceilings, floors, doors, windows and other parts of any area in which food products are prepared, packaged, marked, stored or otherwise handled unless it is durable and free of any noxious constituent.

(6) Product sorting and inspection working surfaces in a registered establishment shall have a minimum illumination of 540 lx.

(7) All lavatories, sinks and drains in a registered establishment shall be maintained in a manner that prevents any odours or fumes therefrom from pervading any room where food or food products are prepared, packaged, marked, stored or otherwise handled.

(8) The operator of a registered establishment shall maintain an effective and safe rodent and insect control program and shall exclude dogs, cats and other pets from the establishment.

(9) Any detergent, sanitizer or other chemical agent in a registered establishment shall be properly labelled, stored and used in a manner that prevents contamination of a food product or a food product contact surface.

(10) Container cleaning equipment in a registered establishment shall be operated in a manner that ensures that containers used for food, when cleaned, are free from foreign material.

(11) Equipment and utensils used to handle inedible or contaminated materials in a registered establishment shall be so identified and shall not be used to handle edible products.

(12) No food product and no substance used in the preparation, packaging or other handling of a food product in a registered establishment shall be exposed to a source of contamination.

(13) No fruit or vegetable and no other food intended for use as an ingredient of a processed product in a registered establishment shall be maintained at a temperature and humidity that may cause that food to deteriorate or become unsuitable for human consumption.

(14) No food product shall be allowed to come into contact with anything in a registered establishment that might adversely affect the quality, colour or appearance of the product.

(15) Where steam is used in the processing of a food product in a registered establishment, the steam shall be generated from potable water.

(16) In a registered establishment, raw materials intended for use in a food product shall be washed as needed to remove soil or other contamination.

(17) Raw materials intended for use in a food product shall be inspected, sorted and culled in a clean and sanitary manner in order to remove unfit materials prior to the introduction of those raw materials into the processing line in a registered establishment.

17. (1) No person who is suffering from or is a known carrier of a communicable disease or who has an open and infected lesion shall work in any area of a registered establishment where there is a danger of contaminating a food product or a food product contact surface with pathogenic micro-organisms.

(2) Every person engaged in the preparation, packaging, marking, storing or other handling of a food product in a registered establishment shall clean his hands thoroughly immediately after using toilet facilities and as frequently as necessary to prevent the contamination of a food product.

(3) Every person handling a food product in a registered establishment shall wear sanitary clothing and hair covering and, where gloves are used in the handling of a food product, only gloves that are made of an impermeable material and are maintained in a sound, clean and sanitary condition.

(4) No person shall use tobacco in any form, chew gum or consume food of any kind except water dispensed from a drinking fountain in any part of a registered establishment in which a food product is prepared, packaged, marked, stored or otherwise handled.

(5) No person engaged in the preparation or packaging of a food product in a registered establishment shall wear an object or use a substance that may fall into or otherwise contaminate the food product.

SOR/79-918, s. 4; SOR/82-720, s. 1; SOR/86-622, s. 3; SOR/87-372, s. 2; SOR/2003-6, s. 47(F).

18. and 19. [Repealed, SOR/2003-6, s. 48]

20. Containers used to pack the canned fruit and vegetable products set out in column I of an item of Table I to Schedule III shall meet the specifications prescribed in columns II and III of that item.

21. (1) Subject to subsection (2), containers used to pack the frozen fruit and vegetable products set out in column I of an item of Table II of Schedule III shall meet the specifications prescribed for that item in that Table.

(2) Containers of a size smaller than the smallest size prescribed for items (3) to (9) of Table II of Schedule III, respectively, may be used to pack the vegetable products set out in column I of those items if the containers bear the registered labels required by these Regulations.

22. Containers used to pack the fruit and vegetable products set out in column I of an item of Table III to Schedule III shall meet the specifications prescribed in columns II and III of that item.

23. [Repealed, SOR/2001-80, s. 1]

24. The volume capacity of glass or other types of containers not made of metal shall be equal to the volume capacity of metal containers for the various products set out in Table I and Table III of Schedule III.

24. and 24.1 [Repealed, SOR/89-266, s. 3]

25. (1) Notwithstanding sections 20 to 23 and subject to subsection (4), any fruit or vegetable products set out in Tables I to IV of Schedule III may be marketed in containers of a volume or weight exceeding the greatest volume or weight set out in those Tables where

(i) for a product packed by weight, a net quantity of product that is not more than 20 kg, or

(ii) for a product packed by volume, a net quantity of product that is not more than 20 L;

(b) the net quantity of product declared on the labels of containers is a whole number multiple of 500 g for a product packed by weight or of 500 mL for a product packed by volume;

(d) in the case of Canadian products, they are prepared in a registered establishment and the containers bear the registered labels required by these Regulations; and

(i) the importer has submitted to the Director a copy of the labels to be used on the containers, and

(ii) the importer has received written notice from the Director that the labels referred to in subparagraph (i) meet the requirements of these Regulations.

(2) Containers of a size smaller than the smallest size specified in Table I to Schedule III may be used to pack the fruit and vegetable juices and concentrated apple juice set out in that Table if the containers bear the registered labels required by the Regulations.

(3) Containers of a size smaller than the smallest size specified in Table III to Schedule III may be used to pack the fruit juices, jams, jellies, marmalades, grape juice, concentrated grape juice, grape juice from concentrate, pickles, relishes, chutneys, olives, horseradish sauce and creamed horseradish set out in that Table if the containers bear the registered labels required by these Regulations.

(4) Paragraphs (1)(b) and (c) do not apply in respect of containers of fruit or vegetable products referred to in subsection (1) that bear labels that have been registered as required by these Regulations prior to the coming into force of those paragraphs.

(5) Subsection (4) shall cease to be in force 2 years after the day on which paragraphs (1)(b) and (c) come into force.

SOR/80-762, s. 2; SOR/82-672, s. 1; SOR/87-133, s. 3; SOR/93-496, s. 3; SOR/2001-80, s. 2; SOR/2003-6, s. 49.

26. (1) The minimum net and drained weights, and the average drained weights of containers for canned fruits and vegetables set out in Table I of Schedule IV, are as prescribed in that Table.

(2) The maximum head space for metal containers set out in Table II of Schedule IV are as prescribed in that Table.

(3) The minimum fill of containers for frozen fruits and vegetables is a fill of not less than 90 per cent of the inner capacity of the container.

(4) The percentage of drained solids of Beans with Pork or Beans with Pork and Tomato Sauce or Vegetarian Beans, as specified in sections 28 and 29 of Schedule II, shall be determined by an acceptable method.

(5) The percentage of drained solids of Canned Tomatoes, as specified in section 52 of Table I of Schedule I, shall be determined by an acceptable method.

(6) The net and drained weights of canned fruits and vegetables, as specified in Table I of Schedule IV, except those products mentioned in subsections (4) and (5), shall be determined by an acceptable method.

27. Notwithstanding section 26, all containers of fruit and vegetable products shall be filled as full as processing will permit and no more syrup, brine or water shall be added than is necessary for proper processing.

28. (1) Canned fruits shall be packed in a packing media of

(b) fruit juice, fruit juices, fruit juice from concentrate or fruit juices from concentrate; or

(c) a syrup consisting of water, fruit juice, fruit juices, fruit juice from concentrate or fruit juices from concentrate, in combination with sugar, invert sugar, honey, dextrose or glucose, in dry or liquid form, or any combination thereof.

(b) with a sweetening agent consisting of sugar, invert sugar, dextrose or glucose in dry or liquid form or any combination thereof, used either with water as a syrup or added directly to the frozen product in dry form;

(d) with a syrup consisting of water, fruit juice, fruit juices, fruit juice from concentrate or fruit juices from concentrate, in combination with sugar, invert sugar, dextrose or glucose in dry or liquid form, or any combination thereof.

29. (1) The range of the cut-out strengths of juice or syrup for canned or frozen fruits set out in Table III of Schedule IV are as prescribed in that Table.

(2) Where sugar, invert sugar, dextrose or glucose in dry form is added to the frozen fruits set out in Table IV of Schedule IV, the minimum percentage thereof that shall be added to such fruits is as prescribed in that Table.

30. Canned vegetables shall be packed in a packing media of

(a) water with or without the addition of sugar, invert sugar, dextrose or glucose in dry or liquid form; or

(b) salt and water solution with or without the addition of sugar, invert sugar, dextrose, glucose or such seasonings or other ingredients as may be prescribed in the standards set out in Table I of Schedule I.

30.1 (1) Subject to subsection (2), in a registered establishment, every low-acid food product packed in a hermetically sealed container shall be thermally processed until at least commercial sterility is achieved.

(2) Subsection (1) does not apply to a low-acid food product packed in a hermetically sealed container if it is

(a) stored continuously under refrigeration and the container in which it is packed, as well as the shipping container, is marked “Keep Refrigerated”; or

(b) kept continuously frozen and the container in which it is packed, as well as the shipping container, is marked “Keep Frozen”.

30.2 The operator of a registered establishment in which a low-acid food product packed in a hermetically sealed container is thermally processed shall

(a) keep in that establishment, for every low-acid food product that is processed,

(i) a written description of the scheduled process, together with the name of the person responsible for the development of the scheduled process, and

(b) keep the information referred to in subparagraphs (a)(i) and (ii) for at least three years after the use of the scheduled process;

(c) keep in that establishment, for each low-acid food product that is processed, a written statement of the procedures for the operation and maintenance of each unit of thermal processing equipment;

(d) keep in that establishment a written statement of a low-acid food product recall procedure;

(e) if requested by an inspector, produce a written statement of all relevant data used in the development of the scheduled process;

(f) maintain, for not less than three years after the date of processing, records that adequately set out the low-acid food product history, and that include as minimum information

(ii) the unit of thermal processing equipment used and the time, temperature and, where appropriate, the pressure of the process used,

(iv) information concerning maintenance of and modifications to each unit of thermal processing equipment and monitoring devices,

30.3 No low-acid food product packed in a hermetically sealed container shall be thermally processed in a registered establishment unless

(a) the container to be used has been found to meet the manufacturer’s specifications and is otherwise suitable for use prior to filling;

(b) the filling of the container has been controlled to ensure compliance with the scheduled process;

(c) the operation of each closing head is evaluated at frequent intervals and adjusted as required to maintain closures within the designated operating limits of the closing head;

(d) the container in which the low-acid food product is packed is marked in a legible and permanent manner to identify the establishment, the food product and the date on which the food product is thermally processed and, where any part of this information is coded, the meaning of the code used is made available to an inspector on request;

(e) the thermal processing is carried out under the continuous supervision of a person who has attended a course in thermal processing and has received a certificate of competence on completion of the course;

(f) the thermal process used meets or exceeds the requirements of the scheduled process;

(g) a written statement of the thermal process to be used for each low-acid food product and container size is located in a conspicuous place near the unit of thermal processing equipment while the unit is in use;

(h) each unit of thermal processing equipment is maintained in good working order;

(i) each unit of thermal processing equipment is equipped with adequate monitoring devices maintained in good working order;

(j) when batch thermal processing is employed, a heat sensitive indicator that visually indicates whether or not the container has been thermally processed is marked on or attached directly or indirectly to the container;

(k) the container-cooling water is of an acceptable microbiological quality and, in the case of water used in a cooling canal system, contains a residual amount of a bactericide at the discharge end of the canal; and

(l) containers are handled in such a manner as to avoid damage to the containers.