It’s easy enough for a company to slap a photo of someone in a white lab coat onto their website and throw around the term “compliant.”
Don’t fall for such deceptions. There are a lot of different variations in phrasing regarding regulation for materials that come in contact with food and medicine, plastics among them.
What are all the differences? And how can one know, outside of taking the manufacturer’s word for it, that the packaging for your product has the right level of compliance for your needs?
Unless a company can show certifications from verifiable third party auditors, such as the NSF, expect that the materials and/or processes used have not been audited for compliance by an independent source.
Food and medical compliance safety is not only concerned with the safety of the actual product but with all parts of the manufacturing process, from the production of the item, to the production process of the materials used in packaging, to the packaging materials themselves. All these redundancies are to ensure that your product is safe for the consumer.
And yet, even the various terminology itself can be a tangle to figure out. What exactly does compliance mean?
Food Grade / Safe / Compliant
A plastic container deemed to be ‘food safe’ may safely come in contact with food, while a ‘food grade’ product may safely contain a food product without the risk of chemical leeching. While the differences in terminology here are subtle, the materials used to produce food safe and food grade products typically overlap.
There are a handful of resins commonly used in the manufacture of food grade plastic containers and closures.
How does a company know which safety certification and process is needed?
Unfortunately, there is no easy answer. There are a variety of standards and certifications which are acceptable, and some may be more suited, others less suited, for the particular needs of your company. Foodmanufacturing.com says of food safety compliance:
“Under the Global Food Safety Initiative (GFSI) standards, major schemes (e.g., IFS PACsecure, the BRC Global Standard for Packaging, SQF Packaging, and FSSC 22000) provide guidance for the producers of packaging materials to ensure the safety and quality of food and non-food products. The GFSI standards are described as different but equal. It is important that companies determine the best fit of the GFSI options for their own company requirements. All of the standards help manufacturers, packers/fillers, and retailers demonstrate that every reasonable measure has been taken to avoid a food safety incident. Qualified legal reviews have shown that these GFSI benchmarked standards also meet nearly all of the food safety requirements of FDA/FSMA.”
Medical Grade Compliance
Products and processes denoted as “medical grade” mean that they conform to medical safety standards established by the FDA, and that the company has been audited for conformance to those standards by third party auditing agencies, such as the NSF. Such conformance can be verified by asking the manufacturer for the appropriate medical grade certifications and may speed up the review time on your product’s FDA approval:
“CDRH [Center for Devices and Radiological Health] believes that conformance with recognized consensus standards can support a reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices…. Conformance and declarations of conformance to any recognized consensus standard that clearly spells out acceptance criteria is a very effective use of standards in the premarket process. Used this way, conformity to FDA recognized consensus standards will reduce the amount of documentation that you need to submit and may allow FDA to reduce review time.”
Food and Medical Grade Compliant Processes
In order for a manufacturing process to be deemed compliant, a well-established third party auditing organization should perform regular audits on the manufacturer, and manufacturers should have employees take training in order to ensure all aspects of the production process are up to industry standards.
Strict guidelines for advertising food and medical compliance certifications ensure that companies looking to produce food and/or medical products need only look for the certifications in order to determine whether or not a company is food/medical compliant. This may seem obvious, but remember, certain manufacturing companies like to imply compliance without actually saying how they are certified.
HQC’s materials and processes are certified by the Illinois arm of the FDA and by the NSF for both food and medical safety. Our certifications include:
Food Safety SQF Level Three: There are three levels of certification for the SQF standard. Level 1 is mainly for low risk products and it incorporates fundamental food safety controls. Level 2 is a certified HACCP food safety plan that is benchmarked by GFSI. Level 3 is a comprehensive implementation of safety and quality management systems that incorporates Level 2. In many cases, a supplier’s customer has already designated a minimum level of certification.
NSF-ISR ISO 13485:2003 Certificate of Registration: ISO 13485 sets regulatory requirements or, when specified, customer requirements for a management system for medical devices or services. The primary objective of ISO 13485 is to harmonize medical device regulatory requirements for quality management systems. The standard is specific to organizations providing medical devices or services, regardless of the type or size of the organization. Based on the ISO 9001 process approach to quality management, ISO 13485 focuses on what manufacturers must do to provide safe and effective medical devices.
NSF ISO 9001:2008: ISO 9001 provides a set of uniform requirements for a quality management system. The standard is based on a number of quality management principles including a strong customer focus, support of top management, the process approach and continual improvement…. A focus on quality management is essential in sustaining business success. With over a million ISO 9001 certificates issued around the world, certification is no longer “a nice to have,” but an essential business tool.
RESOURCES ON SAFETY STANDARDS FOR PACKAGING OF FOOD AND MEDICAL GRADE ITEMS:
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