Hygiene Standards for FCM

Hygiene Standards for FCM
Philippines

The below version control table serves to document all updates made to the report. The purpose is to ensure the information is always accurate and up-to-date.

1. Overview of relevant regulatory standards on hygiene standard for food contact materials

Food Contact Articles (FCAs) are the finished or final form made up of one or multiple different food contact substances/materials and food contact chemicals such as adhesives and printing inks. Food contact substance/material is any substance that is intended for use as a component of materials used in packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect on such food. FCA are chemicals that can migrate from the materials into food. As they do so, they may alter the characteristics of the food unacceptably or have adverse effects on the taste and/or odor of foods [1]. 

Regulation of FCAs is specified in R.A. 10611 also known as the Food Safety Act of 2013 [2] which states that food is adulterated if it is in a container having in whole or in part any poisonous or deleterious substance. Moreover, any food packaging contact material which results or may reasonably be expected to result, or indirectly in it becoming a component or otherwise affecting the characteristics of any food is considered a food additive according to the Bureau Circular 2006-016 or the Updated List of Food Additives [3].

Under FDA Circular No. 2022-0011 entitled “Guidelines on the Application and Issuance of Voluntary Certification of Food Contact Articles (FCA) Used for Prepackaged Processed Food Products”, the FDA Common Services Laboratory (CSL) is assigned to determine the suitability of FCAs for use in the packing, packaging, transporting, or holding of food [1].

Primary packaging is the term used to designate the layer of packaging in immediate contact with the product, thus, it is the first packaging layer in which the product is contained. It is constructed considering the product itself and any existing secondary layers of packaging [1].

2. General Standards for Hygiene Requirements for Food Contact Materials

All FCMs shall be manufactured in compliance with good manufacturing practice (GMP) [4,5]. Hygiene management is an important element of the quality assurance system in GMP. The following measures should be complied with in hygiene management:

1. Hygiene measures, as appropriate to the process and/or position in the supply chain, should be implemented, maintained, and documented for personnel, factories, warehouses, and transportation containers/vehicles/vessels.
2. Pest control measures, as appropriate to the process and/or position in the supply chain, should be maintained and documented or the justification for lack of one should be documented [4]. 

FCMs supplied in accordance with the ASEAN Guidelines shall be accompanied by a Declaration of Compliance (DoC) stating compliance with the applicable requirements. The Declaration shall be made available by business operators to the competent authorities and customers on demand. Retailers of FCM not yet in contact with food are not required to make DoC available to their customers [6].

If the FCM used as a food packaging material resulted to or may reasonably be expected to result to, or indirectly in it becoming a component or otherwise affecting the characteristics of any food, the FCM is considered a food additive [3], thus the hygiene requirements for food production may be used.

The general guidelines for hygiene requirements under GMP [7] are as follows:

1. Personnel

a. Disease control

Any person who has an illness, open lesions, including boils, sores, infected wounds, or any other abnormal source of microbial contamination must not work in any operation (in a food processing center) which could result in the food, food-contact surface, or food packaging materials becoming contaminated.

b. Cleanliness

The following applies to people who work in direct contact with food preparation, food ingredients, or surfaces of equipment or utensils that will contact with food: they must wear clean outer garments, maintain a high degree of personal cleanliness, and conform to hygienic practices while on duty; they must wash their hands thoroughly and, if they are working at a job where it is necessary, they must also sanitize their hands before starting work, after each absence from the workstation and at any other time when the hands have become soiled or contaminated; they must also remove all unsecured jewelry. People who are actually handling food should remove any jewelry that cannot be properly sanitized from their hands; it is necessary to wear effective hair restraints, such as hairnets, caps, headbands, or beard covers; operators must not store clothing or other personal belongings in food processing areas. Also, eating food, drinking beverages, or using tobacco (in any form) must not be allowed in food processing area; all necessary steps have to be taken by supervisors to prevent operators from contaminating foods with microorganisms or foreign substances such as perspiration, hair, cosmetics, tobacco, chemicals, and medicants.

c. Education and training

Persons who are monitoring the sanitation programs must have the education and/or experience to demonstrate that they are qualified. Food handlers and supervisors should receive training that will make them aware of the danger of poor personal hygiene and unsanitary work habits.

d. Supervision

Someone must be assigned the responsibility that all personnel will comply with all the requirements of these GMPs.

2. Plants and grounds

Grounds around a food processing center which are under the control of this center must be free from conditions such as improperly stored equipment; litter, waste, or refuse; uncut weeds or grass close to buildings; excessively dusty roads, yards, or parking lots; inadequately drained areas - potential foot-borne filth or breeding places for insects or microorganisms; inadequately operated systems for waste treatment and disposal.

Plant construction and design shall: provide enough space for sanitary arrangement of equipment and storage of materials; floors, walls, and ceilings must be constructed so that they are cleanable and must be kept clean and in good repair; separate by partition, location, time and other means, any operations that may cause cross-contamination of food products with undesirable microorganisms, chemicals, filth or other extraneous material; provide effective screening or other protection to keep out birds, animals and vermin such as insects and rodents. provide adequate ventilation to prevent contamination of foods with odors, noxious fumes, or vapors (including steam); light bulbs, skylights or any other glass must be of the safety type or protected so that glass contamination cannot occur in case of breakage.

3. Sanitary operations

a. General maintenance

The plant and all fixtures must be kept in good repair and maintained in a sanitary condition. Cleaning operations must be conducted in a manner that will minimize the possibility of contaminating foods or equipment surfaces that contact with food.

b. Pest control

• No animals or birds are allowed anywhere in the plant.
• Programs must be in effect to prevent contamination by animals, birds, and pests, such as rodents and insects.
• Insecticides and rodenticides may be used as long as they are used properly (according to label instructions).
• These pesticides must not contaminate food or packaging materials with illegal residues.

c. Sanitation of equipment and utensils

• Utensils and equipment surfaces that are in contact with food must be cleaned as often as necessary to prevent food contamination.
• Equipment surfaces that are not in contact with food should be cleaned as frequently as necessary to minimize the accumulation of dust, dirt, food particles, etc.
• Single-service articles such as disposable utensils, paper cups, paper towels, etc., should be:
  • Stored in appropriate containers
  • Handled, dispensed, used, and disposed of in a manner that prevents contamination of food or equipment
• Where there is the possibility of introducing undesirable microorganisms into food, all utensils and equipment surfaces that contact with food must be cleaned and sanitized before use and following any interruption during which they may have become contaminated.
• When utensils or equipment are used in a continuous production operation, they must be cleaned and sanitized on a predetermined schedule.
• Any facility, procedure, machine, or device may be used for cleaning and sanitizing, as long as it has been established that the procedure will do the job effectively.

d. Storage and handling of clean portable equipment and utensils

• This refers to portable equipment or utensils that have surfaces that will contact foods.
• When such equipment or utensils have been cleaned and sanitized, they should be stored in a manner that will protect the food contact surfaces from splash, dust, and other contamination.

4. Sanitary facilities and controls

a. Water supply.

Any water that comes into contact with food or processing equipment must be safe and of adequate sanitary quality.

b. Sewage disposal

Must flow into an adequate sewage system or be disposed of through other adequate means.

c. Plumbing

Must be of adequate size and design to:

• Supply enough water to areas in the plant where it is needed.
• Properly convey sewage or disposable liquid waste from the plant.
• Not create a source of contamination or unsanitary conditions.
• Provide adequate floor drainage where hosing-type cleaning is done or where operations discharge water or liquid waste onto the floor.
• Ensure that there is no backflow from cross-connection between piping systems that discharge waste water or sewage and those that carry water for food or food manufacturing.

d. Toilet facilities

• Toilets and hand-washing facilities must be provided inside the fruit and vegetable processing centers.
• Toilet tissue must be provided.
• Toilets must be kept sanitary and in good repair.
• Toilet rooms must have self-closing doors.
• Toilet rooms must not open directly into areas where food is exposed unless steps have been taken to prevent airborne contamination (for example: double doors, positive airflow, etc.).
• Signs must be posted that direct employees to wash their hands with soap or detergent after using the toilet.

e. Hand-washing facilities

• Adequate and convenient hand-washing and, if necessary, hand-sanitizing facilities must be provided anywhere in the plant where the nature of employees' jobs requires that they wash, sanitize, and dry their hands.
• These hand-washing facilities must provide:
  1. Running water at a suitable temperature.
  2. Effective hand-cleaning and hand-sanitizing preparations.
  3. Clean towel service or suitable drying devices.
  4. Easily cleanable waste receptacle.
  5. Water control valves designed and constructed to protect against recontamination of clean, sanitized hands.
  6. Signs directing employees handling unprotected food to wash and, if appropriate, sanitize their hands before starting work, after each absence from the workstation, and any other time when the hands have become soiled or contaminated.

f. Rubbish and offal disposal must be handled in such a manner that they do not serve to attract or harbor pests or create contaminating conditions.

5. Equipment and utensils

• Equipment and utensils must be designed and constructed so that they are adequately cleanable and will not adulterate food with lubricants, fuel, metal fragments, contaminated water, etc.
• Equipment should be installed so that it, and the area around it, can be cleaned.
• Food contact surfaces shall be made of nontoxic materials and must be corrosion-resistant.
• Seams on food contact surfaces shall be smoothly bonded, or maintained in order to minimize the accumulation of food particles, dirt, and organic matter.
• Equipment in processing areas that does not come into contact with food shall be constructed so that it can be kept clean.
• Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be maintained in a sanitary condition.
• Each freezer and cold storage compartment shall have an indicating thermometer, temperature measuring or recording device, and should have an automatic control for regulating temperature, or an automatic alarm system to indicate a significant temperature change.
• Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, etc. shall be adequate in number, accurate, and maintained.

6. Processes and controls

There must be an individual who is responsible for supervising the overall sanitation of the plant.

a. Raw materials and ingredients

• Must be inspected and sorted to ensure that they are clean, wholesome, and fit for processing into human food.
• Must be stored under conditions that will protect against contamination and minimize deterioration.
• Must be washed or cleaned to remove soil and other contamination:
  • Water used for washing, rinsing, or conveying food products must be of sanitary quality.
  • Water must not be reused for washing, rinsing, or conveying if contamination of food may result.
  • Containers and carriers (such as trucks or railcars) should be inspected to ensure that their condition has not contaminated raw ingredients.
• Raw materials shall not contain levels of microorganisms that may produce food poisoning or other disease, or they shall be pasteurized or otherwise treated during manufacturing operations so that the product will not be adulterated.
• Materials susceptible to contamination with natural toxins, e.g., aflatoxin, shall comply with national and international official levels before they are incorporated into the finished food.
• Materials susceptible to contamination with pests, undesirable microorganisms, or extraneous material, shall comply with national and international regulations, guidelines, and defect action levels.
• Materials shall be stored in containers, and under conditions that protect against contamination.
• Frozen materials shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents contamination.

b. Manufacturing operations

• Food processing equipment must be kept in a sanitary condition through frequent cleaning and, when necessary, sanitizing. If necessary, such equipment must be taken apart for thorough cleaning.
• It is necessary to process, package, and store food under conditions that will minimize the potential for undesirable microbiological growth, toxin formation, deterioration, or contamination. To accomplish this may require careful monitoring of such factors as time, temperature, humidity, pressure, flow rate, etc. The object is to ensure that mechanical breakdowns, time delays, temperature fluctuations, or other factors do not allow the foods to decompose or become contaminated.
• Food shall be held under conditions that prevent the growth of undesirable microorganisms as follows:
  1. Refrigerated foods shall be maintained at 45° F or below;
  2. Frozen foods shall be maintained in a frozen state;
  3. Acid or acidified foods are to be held in hermetically sealed containers at ambient temperatures and shall be heat-treated to destroy mesophyllic microorganisms.
• Measures such as sterilizing, irradiating, pasteurizing, etc., shall be adequate to destroy or prevent the growth of undesirable microorganisms.
• Work-in-process shall be protected against contamination.
• Finished food shall be protected from contamination.
• Equipment, containers, and utensils shall be constructed, handled, and maintained to protect against contamination.
• Measures, e.g., sieves, traps, and metal detectors, shall be used to protect against the inclusion of metal or other extraneous material in food.
• Food or materials that are adulterated shall be disposed of in a manner that prevents other food from being contaminated.
• Mechanical manufacturing steps such as washing, peeling, etc., shall be performed to protect against contamination by providing adequate protection from contaminants that may drip, drain, or be drawn into the food, by adequately cleaning and sanitizing all food-contact surfaces, and by using time and temperature controls at and between each manufacturing step.
• Heat-blanching should be done by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to the next manufacturing step without delay.
• Filling, assembling, packaging, and other operations shall be performed in such a way that the food is protected against contamination by:
  1. Use of a quality control operation in which the Critical Control Points are identified and controlled during manufacturing;
  2. Adequate cleaning and sanitizing of all food-contact surfaces and food containers;
  3. Using materials for food containers and food-packaging materials that are safe and suitable;
  4. Providing physical protection from contamination, particularly airborne contamination;
  5. Using sanitary handling procedures.
• Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of aw for preventing the growth of undesirable microorganisms shall be processed and maintained at a safe moisture level by:
  1. Monitoring the aw of food;
  2. Controlling the soluble solids/water ratio in finished food;
  3. Protecting finished food from moisture pickup, by use of a moisture barrier, or by other means, so that the Aw of the food does not increase to an unsafe level.
• Food such as, but not limited to, acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below by: - Monitoring the pH of raw materials, food in the process, and finished food; - Controlling the amount of acid or acidified food added to low-acid food.
• If ice is used and comes in contact with food products, it must be made from potable water and be in a sanitary condition.
• Areas and equipment that are used to process human food should not be used to process non-human food-grade animal feed or inedible products unless there is no possibility of contaminating human food.
• A coding system should be utilized that will allow positive lot identification in the event it is necessary to identify and segregate lots of food that may be contaminated.
  1. Records should be kept for a period of time that exceeds the shelf-life of the product, except that
  2. Records need not be kept beyond two years.

The determination of the suitability of FCMs for use in the packaging of food shall be based on the requirements established by the CSL to ensure the suitability of the FCMs for their intended use and their safety [1], which include the following:

A. Requirements for Online Application:

1. Request Letter stating the intended use of the food contact article(s) (FCA)
2. FCA Information must include the following information:
   • Technical Specification
   • Intended use of the product (i.e., primary or secondary packaging/direct or indirect contact with food)
   • Overview of the production process
     • *For products wherein part of its component is recycled material, the following should be submitted:
       • Recycling process
       • Source of starting material or major material that will be recycled
3. Certificate of Analysis/Quality Control Inspection Report, wherein the batch or lot number and production date of the concerned product should be indicated.
4. Health and Safety Information/Safety Data Sheet (SDS) of the concerned product (Finished product and raw materials).
5. Formulation/ Composition of the concerned FCA
   • Specific chemical name and corresponding percentage composition
   • Chemical Abstract Service Registry Number (CAS No.)
   • Percentage of all raw materials used (include the colorants and additives, if any)
     • *For food contact articles FCA made from metals and its alloy, the specific alloy should be indicated along with its elemental composition.
     • *For food contact articles FCA in which part of its components are recycled materials, all the chemicals used in the recycling process must be reflected.
6. Report of Analysis from an FDA Accredited / Recognized Laboratory as listed on the FDA website (Batch/Lot No. must be indicated in the Test Report).
7. Clear Photo of the FCA (All parts – i.e., inner and outer parts)
   • *For consideration: Submission of FCA samples via courier.
8. Proof of payment (e.g., Official Receipt, Landbank Oncoll Machine-Validated Payment, verified and posted payment by the FDA Cashier).

B. Requirements for Manual Application

1. Request Letter (State the intended use of the product).
2. Food Contact Article (FCA) Information must include the following information:
   • Technical Specification
   • Intended use of the product (i.e., primary or secondary packaging/direct or indirect contact with food)
   • Overview of the production process
     • *For products wherein part of its component is recycled material, the  following should be submitted:
       • Recycling process
       • Source of starting material or major material that will be recycled
3. Certificate of Analysis/Quality Control Inspection Report, wherein the batch or lot number of the concerned product should be indicated.
4. Health and Safety Information/Safety Data Sheet (SDS) of the concerned product (Finished product and raw materials).
5. Formulation/ Composition of the concerned Food Contact Article FCA:
   • Specific chemical name
   • Chemical Abstract Service Registry Number (CAS No.)
   • Numbers of all raw materials used (include the colorants and additives, if any).
     • * For food contact materials (FCM) made from metals and its alloy, the specific alloy should be indicated along with its elemental composition.
     • For products wherein part of its component is recycled materials, all the chemicals used in the recycling process must be reflected.
6. Report of Analysis from an FDA Accredited / Recognized Laboratory as listed on the FDA website (Batch/Lot No. must be indicated in the Test Report).
7. Representative sample.
8. Proof of payment (e.g., Official Receipt, Landbank Oncoll Machine-Validated Payment, verified and posted payment by the FDA Cashier).

C. Requirements for Online Pre-Application Query

1. Email Inquiry which contains at least the following information about the FCA to be applied for evaluation:
   1. formulation/composition
   2. intended use and the specific food that will be contained

D. Requirements for Onsite-Pre-Application Query

1. Letter of Inquiry which contains at least the following information about the FCA to be applied for evaluation:
   1. formulation/composition;
   2. intended use and the specific food that will be contained.

It is important to note that the Philippines authority recognizes and adopts any or a combination of the following references:

• The latest edition of the “Specifications and Standards for Foods, Food Additives, etc. Under the Food Sanitation Act (Abstracts)” of the Japan External Trade Organization (JETRO).
• The latest edition of “Specifications, Standards and Testing Methods for Foodstuffs, Implements, Containers and Packaging, Toys, Detergents” of JETRO.
• Code of Federal Regulation Title 21 Part 170 to 199 of the US Food and Drug Administration.  
• Regulatory requirements of the importing country for products intended for export, if necessary.

3. Specific Hygiene Requirements per Type of Food Contact Materials 

3.1 Liquor Bottles (B2C): Glass

There is no specific requirement on hygiene for liquor bottles, thus the general requirements stated in the ASEAN Guidelines on GMP for FCM and the Commission Regulation (EC) No 2023/2006 (on which the Guidelines are based) shall be applied. [5] The European requirements are summarized below:

The business operator shall establish, implement, and ensure adherence to an effective and documented quality assurance system. That system shall: 

1. take account of the adequacy of personnel, their knowledge and skills, and the organization of the premises and equipment such as is necessary to ensure that finished materials and articles comply with the rules applicable to them;
2. be applied taking into account the size of the business run by the operator, so as not to be an excessive burden on the business.

Starting materials shall be selected and comply with pre-established specifications that shall ensure compliance of the material or article with the rules applicable to it. The different operations shall be carried out in accordance with pre-established instructions and procedures.

The business operator shall also establish and maintain an effective quality control system, which includes monitoring the implementation and achievement of GMP and identifying measures to correct any failure to achieve GMP. Such corrective measures shall be implemented without delay and made available to the competent authorities for inspections.

Lastly, the business operator shall establish and maintain appropriate documentation in paper or electronic format with respect to specifications, manufacturing formulae, and processing which are relevant to compliance and safety of the finished material or article, records covering the various manufacturing operations performed which are relevant to compliance and safety of the finished material or article and with respect to the results of the quality control system. The documentation shall be made available by the business operator to the competent authorities at their request. [5]

3.2 Casks and Barrels (B2B): Wood

There is no specific requirement on hygiene for wooden casks and barrels, thus the general requirements stated in the ASEAN Guidelines and the Commission Regulation (EC) No 2023/2006 [5] shall be applied.

3.3 Casks and Barrels (B2B): Metal

There is no specific requirement on hygiene for metal casks and barrels, thus the general requirements stated in the ASEAN Guidelines and the Commission Regulation (EC) No 2023/2006 [5] shall be applied.

4. Summary Table

5. References

1. FDA Circular No.2022-0011: Guidelines on the Application and Issuance of Voluntary Certification of Food Contact Articles (FCA) Used for Prepackaged Processed Food Products

https://www.fda.gov.ph/wp-content/uploads/2022/12/FDA-Circular-No.-2022-011.pdf 

2. R.A. 10611: The Food Safety Act of 2013

https://faolex.fao.org/docs/pdf/phi128390.pdf  

3. FDA Bureau Circular 2006-016: Updated List of Food Additives

https://www.fda.gov.ph/wp-content/uploads/2021/05/Bureau-Circular-No.-2006-016.pdf

4. ASEAN Guidelines for Good Manufacturing Practice for Food Contact Materials

https://asean.org/wp-content/uploads/ASEAN-GMP-Guideline-for-Food-Contact-Materials-endorsed-29PFPWG.pdf

5. Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006R2023&from=EN 

6. ASEAN General Guideline on Food Contact Materials

https://asean.org/wp-content/uploads/ASEAN-General-Guideline-on-Food-Contact-Materials-Endorsed-26th-PFPWG.pdf 

7. Chapter 10 Quality control/quality assurance and international trade; good manufacturing practices (gmp); hygiene requirements; hazard analysis and critical control points (haccp)

https://www.fao.org/4/v5030e/v5030e0t.htm