Questions and Answers: Repealing requirements for pre-market registration of construction materials, packaging materials and non-food chemicals used in federally registered meat establishments

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What regulations are amended as part of Repeal of Regulations Requiring Pre-Registration of Construction Materials, Packaging Materials and Non-Food Chemicals?

The Section 35 and paragraph 92(2)(b) of the Meat Inspection Regulations, 1990 (Regulations) pertaining to the evaluation and registration of construction materials, packaging materials and non-food chemicals by the Director have been repealed and amended, respectively.

When did this change come into force?

The regulatory changes were published in Canada Gazette, Part II on July 02, 2014 and the changes came into force the same day.

What is changed as a result of amendments to the above regulations?

Prior to the repeal of the above regulations, all construction materials (e.g. ceiling panels, flooring materials), packaging materials (e.g. wrapping, trays, pouches and bags) and non-food chemicals (e.g. detergents, sanitizers) that were used in construction and operation of federally registered meat establishments were evaluated by the Canadian Food Inspection Agency (CFIA) and upon issuing the CFIA Letter of Acceptance (LOA), added to the Reference Listing of Accepted Construction Materials, Packaged Materials and Non-Food Chemicals (the "Reference Listing"). As part of the evaluation of some of these products (packaging materials and non-food chemicals), the CFIA required a safety assessment be conducted by Health Canada. Health Canada issued a Letter of No Objection (LONO) after the safety assessment.

Effective July 2nd 2014, the repeal of Section 35 and the amendments to paragraph 92(2)(b) of the regulations resulted in elimination of pre-market mandatory evaluation and registration of construction materials, packaging materials and non-food chemicals on the Reference Listing. However, the CFIA will still require Health Canada's Letter of No Objection (LONO) for processing aids intended to be used as antimicrobial agents (e.g. Carcass washes) prior to their use in federally registered meat establishments. The Food and Drug Regulations also require mandatory Health Canada's safety assessment (Letter of No Objection) of packaging materials used in infant formula or novel process (e.g. High Pressure Processing).

What are processing aids? Why they should still need pre-approval from Health Canada?

A food processing aid is a substance that is used in or on food for a technical effect during processing or manufacture. Its use does not affect the intrinsic characteristics of the food and results in no or negligible residues of the substance or its by-products in or on the finished food (e.g. Organic acids used for Carcass washes such as lactic acid).

Please refer to Health Canada's website for the policy on differentiating food additives and processing aids.

Processing aids are directly applied on food and may play a critical function such as control or reduction of microbial pathogens. Many foreign jurisdictions such as the USA, European Union and Japan require that certain processing aids be pre-approved for use in meat products and restricts use of certain processing aids on carcasses/meat intended for export purposes. It is important that Canada maintains equivalence with other jurisdictions and therefore, the pre-market assessment of processing aids is necessary.

What products are included under the definition of construction materials, non-food chemicals and packaging materials that required evaluation and registration before the changes to the regulations?

Construction materials are materials used for the construction of interior floors, walls and ceilings surfaces as well as coatings and joint sealants that are used in federally registered food establishments' areas where foods are prepared or stored. Examples: Coatings for wall, ceiling, floor, wall and ceiling panels, pipe covers, door etc.

Non-Food Chemicals are substances or products, such as cleaners, lubricants, disinfectants that are used in processing plants and their intended use is not to become part of the food product. By virtue of their presence in the plant, they may find their way into foods during production. These substances or products are termed as "incidental additives" by Health Canada and fall outside the current interpretation of the regulatory definition of a food additive. Examples: Sanitizers, Deodorizers, Lubricants etc.

Packaging materials are products that are used to wrap, cover, hold, or protect food products and are intended to come in direct or indirect contact with food. Examples include, paper wraps, wrapping materials, films, synthetic casings, nettings, trays, pouches, cartons, cardboard boxes with coated surface and bags. Any equipment or storage materials that comes in direct contact with foods also falls within the definition of packaging materials.

Why did the CFIA make these regulatory changes to the Meat Inspection Regulations, 1990?

The changes to the regulatory requirements are aimed at reducing red tape and administrative burden on the industry. By eliminating pre-market evaluation and registration activities, the CFIA can refocus its efforts and activities on areas of greater risk.

Does this regulatory change affect food safety?

No. This regulatory change does not affect food safety. As part of preventative Hazard Analysis and Critical Control Point (HACCP) program, Operators of federally registered meat establishments still remain responsible to ensure that all construction materials, packaging materials and non-food chemical used in their establishments are safe and suitable for their intended use and that they meet all regulatory requirements.

How will CFIA verify that construction materials, packaging materials and non-food chemicals used in meat establishments meet the regulatory requirements?

The CFIA inspectors will continue to verify using the appropriate Compliance Verification System (CVS) tasks that construction materials, packaging materials and non-food chemicals used by the meat industry meet all applicable regulatory requirements. Where there are reasonable doubts on the safety of the products used, the CFIA inspectors may request submission of additional supporting documents within 60 days from the date of request (e.g. in case where supplier guarantees, LOG, are used) to conduct a more in-depth review to verify that the products meet all applicable regulatory requirements, including Division 23 of Food and Drug Regulations for packaging materials and Section 4(1) of the Food and Drugs Act for non-food chemicals. The safety and/or efficacy component of this review will be conducted by Health Canada. Federally registered meat establishments can continue to use products or materials during the period when Health Canada's safety assessment is conducted. If the safety assessment indicates potential food safety issues, the CFIA will take appropriate compliance actions.

What enforcement actions will CFIA take when meat industry does not comply with applicable regulatory requirements for use of construction materials, packaging materials and non-food chemicals?

When it comes to enforcement, the CFIA takes a risk-based approach to compliance management. When the CFIA identifies non-compliance to a particular section of the legislation it administers and enforces; actions are taken as per the Compliance and Enforcement Operational Policy.

Following are some of the tools available to manage compliance in the meat sector:

  • Request for corrective action within a specified timeframe;
  • Issuance of warning letters or penalties;
  • request for corrective actions within a specified timeframe;
  • suspension or cancellation of licences, registrations or permits for federally registered establishments;
  • recommendation to the Public Prosecution Service of Canada that violators be prosecuted, depending on the severity of the violation or the escalation of enforcement actions;
  • seize and detain shipments and products or if there is a need to control the movement of certain products, for reasons such as health, safety and quality; and
  • recall of products if it is determined that the products pose a risk to consumers.

What products would still require mandatory pre-market safety assessment by Health Canada?

The CFIA still requires Health Canada's pre-market assessment for processing aids intended to be used as antimicrobial agents (e.g. carcass washes). Food and Drug Regulations require mandatory pre-approval of packaging materials used in infant formula or novel process (e.g. High Pressure Processing).

If the meat industry does not have to pre-register construction materials, packaging materials and non-food chemicals with the CFIA, can any products be used by the food industry?

No. Operators of federally registered meat establishments still remain responsible to ensure that all construction materials, packaging materials and non-food chemical used in their establishments are safe and suitable for their intended use and meet all regulatory requirements. However, selection choice for such products will no longer be limited to products included in the 'Reference Listing'. All applicable acts and regulations related to safety of these types of products have to be met by the regulated party. The CFIA will continue to conduct inspection activities to verify that construction materials, packaging materials and non-food chemical agents meet Canadian regulatory requirements.

What will happen to the current Reference Listing of Accepted Construction Materials, Packaging and Non-Food Chemical Products maintained by the CFIA?

With these amendments, the CFIA no longer has regulatory authority to evaluate or register Construction Materials, Packaging and Non-Food Chemical Products. Therefore, the CFIA will no longer update the Reference Listing of Accepted Construction Materials, Packaging and Non-Food Chemical Products although the Reference Listing will continue to be retained on the CFIA website for a period of approximately 2 years.

How can meat industry demonstrate compliance with the regulatory requirements for use of safe and suitable construction materials, packaging materials and non-food chemicals in their establishments?

Operators of federally registered meat establishments will have following three options to demonstrate to the CFIA inspectors that the construction materials, packaging materials and non-food chemicals used in their establishments are safe and suitable for their intended use and that they meet all regulatory requirements:

  1. Continue to use products that are already pre-approved by the CFIA or Health Canada and are included in the Reference Listing, provided they continue to use the product for its intended and previously approved use (formulation, label directions, etc.).
  2. Have on file a Letter of No Objection (LONO) or Letter of Acceptance (LOA) provided by the CFIA or Health Canada for the product used. Health Canada will continue to assess packaging materials and non-food chemicals (not construction materials) on a voluntary basis if requested by the industry.
  3. Have on file a Letter of Guarantee (LOG) from the supplier of the product or material as described in the Food Safety Enhancement Program (FSEP) Manual.

How can manufacturers of packaging materials and non-food chemicals voluntarily seek assessment by Health Canada?

As a result of the repeal of Sections 35 and the amendments to paragraph 92 (2)(b) of the Meat Inspection Regulations, there are no mandatory requirements for evaluation and registration of packaging materials and non-food chemicals on the Reference Listing. However if the manufacturers of these products would like to seek voluntary assessment by Health Canada, a request can be made to Health Canada in order to obtain a Letter of No Objection (LONO). Requests for LONOs must be accompanied by data and information for assessment by Health Canada. Guidance for making submissions to HC is available on Health Canada's website.

Note: Health Canada does not evaluate or issue LONOs for construction materials.

How can manufacturers of processing aids seek mandatory pre-assessment by Health Canada?

Requests for LONOs or Interim LONOs for processing aids intended to be used as antimicrobial agents must be accompanied by data and information for assessment by Health Canada. Guidance for making submissions to Health Canada is available on Health Canada's website.

Guide for Preparing Food Processing Aid Submissions

In addition, Health Canada has recently published a policy for issuing an interim Letter of No Objection (iLONO) for processing aids to expedite the availability to the food industry of processing aids that have been assigned priority handling according to Health Canada's Policy of Priority Scheduling and Expedited Handling of Submissions that have the Capacity to Enhance Food Safety. To learn more about this policy, please refer to Technical Consultation - Policy Intent for Issuing an Interim Letter of No Objection (iLONO) for Processing Aids

What happens to submissions that are currently being reviewed by the CFIA for pre-registration of construction materials, packaging materials and non food chemicals?

As of July 2nd 2014, the CFIA will no longer evaluate products or materials for inclusion in the Reference Listing. All submissions for packaging materials and non-food chemicals that are currently being processed will be forwarded to Health Canada's Bureau of Chemical Safety for assessment. If petitioners want to retract the submission that is currently being processed, they should contact Health Canada's Bureau of Chemical Safety with their submission details.

Food Packaging Materials & Incidental Additives Section
Chemical Health Hazard Assessment Division
Health Canada
251 Sir Frederick Banting Driveway
Postal Locator 2201C
Ottawa, Ontario, K1A 0K9
Canada
Email: FPMIA-MEAAI@hc-sc.gc.ca

All construction material submissions and submissions related to gloves, aprons etc. that are currently in process will be completed by the CFIA. Any new submissions made on or after July 2nd 2014 will be returned to the Originator as the CFIA will no longer have the regulatory authority to evaluate or register construction materials, packaging materials and non-food chemicals on the Reference Listing. However the manufacturer/supplier can seek voluntary evaluation by Health Canada for packaging materials and non-food chemicals. The CFIA will not provide voluntary evaluation service for construction materials, gloves and aprons.

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