Still key to safety in processing

Increasingly, food safety regulators worldwide are increasing the enforcement of safety and hygiene requirements at the processor level. In recent years, food contaminations occurring at processing facilities have heightened public concerns about widespread foodborne illness outbreaks resulting from a single contamination incident.

One example of regulatory response to this elevated concern is the United States Food and Drug Administration’s (FDA) new food safety initiative, the FDA Food Protection Plan. This plan focuses on three core elements to help safeguard the US food supply: prevention, intervention and response. The plan aims to promote a broad risk-based approach to food protection through increased corporate responsibility and increased collaboration and communication with stakeholders. In addition to this new plan, the FDA has requested large budget increases for food safety initiatives in the 2009 fiscal year. Given the scope and need for increased food safety enforcement in the US alone, there is still, however, concern that budget increases and new regulatory initiatives simply won’t fill the gap.

Today, many processors are actively engaged in implementing new safety and process improvements by their own initiative. Often such improvements include innovative facility and equipment design or utilisation of new processing, packaging and testing technology. However, as rising energy costs and the resulting increased cost of consumer food products becomes a major public concern, processors must seek innovative means to streamline systems and improve overall production efficiency without compromising safety and hygiene. For food and beverage processing machinery, the use of properly evaluated food grade lubricants continues to be the best option to achieve both optimal performance and maintain necessary health and hygiene standards.

International regulation of food grade lubricants

Few governments regulate the use of food grade lubricants, but two that do are the Australian Quarantine Inspection Service (AQIS) and the Canadian Food Inspection Agency (CFIA). European regulations do not currently exist for formulation of incidental contact lubricants used in food processing facilities.

In the United States, the US Department of Agriculture (USDA) formerly reviewed and authorised lubricants acceptable for use in food processing and handling facilities. These lubricants were evaluated against the requirements of 21 CFR, which establishes the requirements for food grade or incidental food contact lubricants. In 1999, NSF International, a not-for-profit public health organisation took over the responsibility of evaluating food grade lubricants and other food processing substances. Working with the USDA, NSF captured all previous review requirements and launched a third-party registration and listing program for food grade lubricants. Under the current scheme, lubricants acceptable for incidental food contact are identified or categorised as “H1” lubricants.

NSF registration of H1 lubricants

In order to register a lubricant with NSF, the lubricant formulation, including ingredients and percentage composition, and the finished product label must be submitted to NSF for independent review against the requirements of 21 CFR. In order to meet the NSF Registration requirements, the lubricant must be formulated using ingredients listed under 21 CFR Section 178.3570, which also references Generally Recognised As Safe (GRAS) substances listed under parts 182 and 184.

In addition to being 21 CFR compliant, an ingredient can be acceptable for use in an H1 lubricant if there is a:

• Food contact notification (FCN)
• Threshold of regulation (TOR) exemption
• GRAS notification, where the indicated use is as an ingredient, in a lubricant with incidental food contact
• A letter of opinion from the FDA or from a qualified legal firm is submitted to NSF for review.

In addition to the formulary requirements, the lubricant labelling must be accurate with no misleading claims and include appropriate end-use instructions. Product labels must also be traceable to the Registered Company and bear the NSF Registration Mark, including the H1 category code and unique product Registration number.

Since its inception, the NSF Registration Program for H1 lubricants has been strongly supported by lubricant manufacturers, regulatory inspection bodies and end-users alike. Global interest in the Registration Program continues to increase. Currently, over 500 H1 lubricants manufacturers are listed worldwide and 5,000 products are registered in the NSF online listing (www.nsfwhitebook.org).

NSF also offers an ingredient category designated as “HX-1” for components and additives that have been pre-screened by NSF and determined to meet the formulary requirements for finished H1 lubricants. Using pre-approved HX-1 ingredients provides a unique solution for formulators by reducing the uncertainty of ingredient suitability. The list of NSF Registered HX-1 ingredient trade names and suppliers is available on the NSF website (www.nsfwhitebook.org). The official NSF Registration letter for each ingredient may also be accessed on the NSF website. This letter specifies the use limitations for a particular lubricant ingredient. Currently, over 250 Registered HX-1 ingredients supplied by more than 50 companies are listed.

Additional registration categories exist for lubricants with special applications that may come into contact with food during use. The HT-1 category was created for heat transfer fluids used in primary and secondary heating and cooling systems in food processing facilities. Ingredients used to formulate NSF Registered heat transfer fluids must be formulated with ingredients that comply with 21 CFR Section 178.3570 or 21 CFR Part 172, requirements for food additives permitted for direct addition to food.

The H3 category is designated for soluble oils used to treat hooks, trolleys and other similar equipment that may contact food or edible products. Ingredients used to formulate NSF Registered soluble oils may consist of edible oils complying with 21 CFR Section 172.860, mineral oil complying with Section 172.878, or GRAS substances complying with 21 CFR Parts 182 or 184.

This year, NSF will expand the current lubricant registration program to include mould release agents. This new registration category applies to substances added to the surfaces of moulds for manufacturing food packaging such as glass bottles or plastic containers in order to prevent the finished product from sticking to the mould. Ingredients used to formulate NSF Registered mould release agents will be required to comply with 21 CFR Section 178.3860 or Section 181.28 for release agents.

New international certification standard for food grade lubricants

In 2008, NSF launched a new product certification program for food grade lubricants that meet the requirements of

the international standard ISO 21469: 2006(E) – Safety of Machinery – Lubricants with Incidental Product Contact. This voluntary standard was drafted by the Technical Committee ISO/TC 199 and released by ISO (the International Organisation for Standardisation) in late 2006. ISO is a worldwide federation of national standards bodies.

ISO 21469 specifies the hygiene requirements for the formulation, manufacture and use of lubricants, which may be exposed to products during manufacturing or processing. This international standard applies beyond the food industry and includes in its scope lubricants used to process specialty products where hygiene is of particular concern, including cosmetics, pharmaceuticals and animal feed.

The NSF ISO 21469 Certification program requirements differ from the current H1 Registration program requirements, mainly by adding the elements of risk assessment, production facility audits and annual product testing, to the formulation and label review. For certification, the risk assessment is conducted to ensure that the manufacturer has identified and evaluated the relevant hazards associated with the manufacture and use of the certified lubricant. Production facilities are audited by NSF to confirm that certification requirements are met and the manufacturer follows good manufacturing practices (GMPs). Annual testing of the finished lubricant product is conducted to verify the integrity of the product composition. The certification process is streamlined for products that are currently H1 Registered, as the formulary requirements for H1 also satisfy the ISO 21469 standard.

With its unique history and experience in lubricant evaluation, NSF decided to offer the ISO 21469 Certification program as an extension of its current evaluation services for the specialty lubricant market. Offering a more comprehensive assessment option to lubricant manufacturers also complements NSF’s core mission of protecting and improving public health on a global scale. International regulatory agencies are already responding to the new ISO standard. The Emirates Standardisation & Meteorology Authority (ESMA), the official federal body in the United Arab Emirates, announced adoption of ISO 21469 as the mandatory requirement for incidental contact lubricants earlier this year.

NSF officially certified the first line of ISO 21469 lubricant products manufactured by Shell International Petroleum Company in March. Several other lubricant companies have also applied with NSF for ISO 21469 Certification. These companies are expected to complete the certification process later this year. Once certified, they will appear on NSF’s website.

The NSF ISO 21469 Certification program is accredited by the American National Standards Institute (ANSI). ANSI is an independent agency responsible for actively providing oversight and accrediting programs that assess conformance to globally recognised standards.

For more information about ISO 21469 Certification or H1 Registration of food grade lubricants, please visit the NSF website at www.nsf.org or contact Sarah Krol at [email protected]