The framework regulation— 1935/2004—outlines that food contact materials and articles shall be manufactured with good manufacturing practices. This podcast will elaborate on the requirements of food contact GMP under EU-level regulation 2023/2006. Stream our podcast now to learn more about the regulation of good manufacturing practice, or GMP, a crucial part of the regulatory scheme.
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Hello everyone. Welcome to our special podcast series about food contact materials and articles regulations. My name is Gülcan Erkaya, food contact regulatory affairs expert, and today I am with Emmi Heino, food contact supply chain specialist.
Previously in this podcast series, we talked about food contact materials regulations, including the framework regulation and material-specific regulations. Today, we will be covering the regulation on good manufacturing practice, or GMP, which is a crucial part of the regulatory scheme and cannot be overlooked.
Emmi, would you like to start by explaining what the GMP regulation is about?
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Thank you, Gülcan. Absolutely.
As you may remember, we mentioned in the first podcast of this series, that the framework regulation— 1935/2004—outlines that food contact materials and articles shall be manufactured with good manufacturing practices in place. To elaborate on the actual requirements of food contact GMP, we have a specific EU level regulation 2023/2006. Compliance with this regulation, as with most of the other food contact material regulations in the EU, is self-declarable by business operators, so there is no requirement for third-party certification.
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And you might find yourself wondering what types of food contact materials the GMP regulation covers. The answer to that is simple: it applies to all types of material categories listed in Annex 1 of the framework regulation.
Since there are different actors throughout the various stages of a food contact material’s supply chain, you might wonder who is responsible for having the GMP in place…
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That is a great question, Gülcan.
The GMP regulation applies to the manufacturing, processing, and distributing stages of food contact materials and articles; however, the manufacturer of the starting material is excluded. So, anyone designing and manufacturing materials with the intention to use them in food contact materials and articles must follow good manufacturing practices. The regulation does mention that the implementation level of the requirements should be proportional to the size of the business, so the extent to which the requirements and implementation measures apply must be evaluated on a case-by-case basis.
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Thank you, Emmi.
Can you give us a high-level overview of what is required by the GMP regulations?
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Firstly, it states that there must be a quality assurance system in place. This means, you need to make sure you have competent personnel who understand that the materials are manufactured for food contact and, consequently, might have to adhere to special rules. It also means there must be adequate equipment, facilities, and specifications and standard operation procedures in place relevant to the manufacturing of food contact materials and articles.
Secondly, the GMP regulation states that quality control measures shall be in place to monitor the implementation of the good manufacturing practices. Non-conformities shall be recorded alongside a determination of corrective and preventive actions.
A functioning documentation system must also be in place with appropriate revision and archive management systems. All specifications and other documentation related to the manufacturing process and operations relevant to food contact compliance must also be recorded.
Thirdly, the annex of the GMP regulation outlines the requirements for the application of printing inks onto the non-food contact side of food contact materials and articles. The manufacturer is to ensure that the constituents of the inks do not migrate to food in concentrations that may be harmful to human health or alter the composition or organoleptic properties of food. Migration can occur either through the direct food contact layer or via set-off. Situations where materials are piled up or reeled, where the printed surface is in direct contact with the non-printed surface, are referred to as a “set off”.
The annex of the regulation also describes requirements for a quality assurance system for the recycling processes of plastic food contact materials. These processes are covered by the recycled plastics regulation, EU 282/2008. However, given that the regulation for recycled plastics changed in October of 2022, the new regulation being called EU 1616/2022, the annex of the GMP regulation will be amended in the near future.
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You mentioned many elements that are also required by well-known quality management system, or QMS, standards, such as ISO 9001. How do those relate to the food contact GMP? Is ISO certification required, or is there a benefit to being ISO-certified?
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Thank you, Gülcan, for bringing this up. Indeed, this is a question that arises often in discussions around food contact GMP.
You are right that the elements of quality assurance and control, as well as documentation systems, are elements of a quality management system, but there is no requirement within the GMP regulation for a certified quality management system, whether ISO or other. If a business operator is certified to ISO 9001, it does not directly imply GMP compliance either; however, it is a good starting point. In addition to QMS, business operators must take into consideration the possible contamination risks in the manufacturing and handling of food contact materials and articles, and this is something that would not necessarily be automatically covered in business operators’ QMS.
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I believe, in addition to the QMS, contamination prevention and control is really the key factor in the food contact GMP program.
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Yes, indeed. And adding to that, the GMP regulation is really a tool that ensures materials are consistently manufactured and are not only of good quality but also compliant with the applicable regulations and limits batch-to-batch and year-to-year.
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Thank you, Emmi. This sums up the topic perfectly.
We would like to thank everyone for listening to this episode, and if you did not already listen to the two previous episodes of our podcast series, we welcome you to do so at your convenience.
Thank you and bye for now.
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Thank you for listening, and take care.