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Ensuring Regulatory Compliance for Flavor Companies

Patty Benson, SAFC

Regulatory compliance in the flavors industry has become increasingly complex as flavor manufacturers deal with often-conflicting worldwide requirements. Here I will share what I—and of course my company—have learned from a recent evaluation of the regulatory compliance position of the flavor and fragrance product line in the service of the industry’s evolving needs.

A Case for Change

In today’s market, the increased emphasis and customer demand for food regulatory compliance provides an opportunity for companies to make a solid commitment to operate in accordance with all applicable global regulations. This begins with the identification of compounds most widely used in the food and flavoring industries and ensuring that these materials meet the strict regulatory compliance requirements of the world’s fast-growing food industry.

As with all large projects, success can be only be ensured by involving major stakeholders to define program requirements and design solutions. In our case, a company-wide cross-functional team was chartered, including representatives from the marketing, operations, quality control, quality assurance, distribution, purchasing and executive management groups.

Identifying Improvement Opportunities

First, we identified the compliance requirements required by the food industry. Worldwide regulations were compiled and reviewed to distinguish those applicable to the manufacture and distribution of flavors. The American Institute of Baking’s (AIB) Consolidated Standards for Food Safety and AIB’s Consolidated Standards for Food Distribution Centers were identified as reliable resource documents.1 These documents are derived from several worldwide standards and provided a solid foundation by which to evaluate food safety risk and thus, build a food safety program. To ensure that industry best practices and programs were implemented and maintained, our organization engaged AIB’s third-party GMP audit services, which offer comprehensive evaluation of the adequacy of food safety programs, management systems, pest control programs, operational methods and personnel practices, in addition to maintenance for food safety, and cleaning practices.2

AIB’s training audits assess current programs and identify opportunities for improvement. Preparation for such an audit includes a review of applicable regulations, a review of the AIB training audit report, benchmarking oneself against other food companies, and facility walkthroughs with engineering personnel. In our case, the compilation and evaluation process identified opportunities under four main categories: facility improvements, policy upgrades, vendor qualification improvement and personnel practices.

Facility Upgrades

Our process made it clear that facility upgrades were required in order for our Milwaukee, Wisconsin, and Steinheim, Germany, sites to meet food standards and customer expectations. Representatives from operations departments at both locations were tapped to lead the redesign and upgrade projects. Working with the engineering group and qualified outside contractors specializing in these types of projects, the operations team identified areas for improvement and developed an implementation plan and timeline for project completion.

Following an evaluation process that led to the reshuffling of activities both domestically and overseas, it was determined that an investment was need to upgrade packaging stations, install a controlled HVAC system, flooring, receiving docks and lighting, replacement windows and cooler, and other general facility maintenance.

Policy Upgrades

Using an existing ISO 9001:2000-certified quality management system as the backbone for our enhancements to meet food safety standards, representatives from the company’s quality assurance departments at each respective site led the policy upgrade project. Following evaluation, the standards identified that required improvement or further definition included our pest control policy, food sanitation policy and glass policy. Several lower-level procedures were also identified for revision, including the need to establish a food safety committee and an HACCP program.

Project “owners” were then assigned to develop or revise the identified policies and procedures, and timelines for approval were established. A cross-functional food safety committee was set up at each site, including personnel from quality assurance, quality control, operations, engineering and maintenance. The food safety committee developed the HACCP program at both sites that was responsible for identifying program concerns, driving improvement initiatives, and generally maintaining the ongoing food safety program.

Vendor Qualification

When the majority of one’s flavor and fragrance products are purchased from vendors, a robust vendor management system is key to certifying products as “food grade” and enabling timely delivery to customers at a competitive price. This requires that purchasing departments lead the vendor qualification improvement project. This team should develop a system that includes a comprehensive vendor questionnaire, a risk-based on-site vendor audit program, and a vendor performance measurement metric. Key to this process is ensuring that the vendors supplying products comply with applicable regulations and industry standards. Our company had strong vendor relationships in place and this, along with the purchasing team’s persistence in qualifying each vendor, was indispensable to this effort being successful. In the end, one’s program should certify that vendors have the capability to provide customers with the necessary documentation, including information and certification on genetically modified organisms (GMO), allergens, natural status, etc. In addition, a strong QC testing program must be in place to ensure that all product lots meet purity, identity and heavy metals requirements.

Personnel Practices To improve personnel responsibilities and training, job roles must be developed, training plans designed and training programs delivered. A key fundamental requirement to the success of any improvement plan is cultural change within the organization. Those new to the food industry environment must acclimatize themselves to the unique standards of cleanliness, documentation, and material control, which differ from the research chemical business. Acting under operations and quality assurance teams, an education program should be deployed. Of course, adding personnel with previous food manufacturing experience to the operations and quality assurance groups can bring best practices to facilities, emphasize the importance of compliance and enhance the cultural atmosphere.

Maintenance of the Improvement Program

AIB standards rely upon an ongoing internal audit program to maintain compliance and identify areas for further improvement. Individual site management should look for areas for improvement and address corrective actions through planning and implementation. In the case of SAFC, each site’s quality assurance team is responsible for maintenance of the internal audit program, though auditors from several areas participate using a cross-functional approach that allows numerous parties to evaluate areas and share new ideas and best practices. The food safety audit program is supplemented by an internal audit program carried out to maintain the ISO 9001:2000 certification held by each site. Auditors outside of the food safety committee perform these audits and are able to provide input based on general quality management systems.

To ensure our quality systems and regulatory compliance, internal audit systems should be supplemented by external audits from three different sources: AIB, which can perform yearly audits utilizing the appropriate consolidated standard for the site; each site’s ISO registrar, which can perform annual surveillance audits; and customer audits, which provide additional input. Adhering to the well-organized effort detailed here can improve companies’ compliance position and enhance the growth of flavor and fragrance product lines.



  1. The American Institute of Baking’s (AIB) Consolidated Standards for Food Safety,; AIB Consolidated Standards for Food Distribution Centers,
  2. AIB GMP audits:

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