Understanding European Requirements on GMP for Food Contact Materials
The goal of all retailers is to provide profitable, safe products to their clients. For suppliers of food and drink, this means not only safe consumables but also safe packaging. To ensure this, the European Union (EU) requires manufacturers of food contact materials (FCM) to comply with good manufacturing practices (GMP).
Ensuring safe, edible food reaches the consumer is a complex undertaking. The retailer must be assured the complete supply chain, for both foodstuff and packaging, is compliant with necessary regulations, and delivers a safe, quality product to the end consumer.
The Supply Chain for Food and FCM
As the graphic shows, the supply chain from raw materials to consumption and post-consumption – landfill, recycling and thermal recover – involves several economic operators. Each operator has their own requirements relating to regulations and the business. For the retailer, it is essential to be assured the standards along the supply chain comply with relevant legislation and best practice in manufacturing.
GMP is a quality assurance tool that give retailers the necessary control along the supply chain to ensure consistency and the delivery of quality, safe products.
European Regulations on Food Contact Materials
Stakeholders will be aware of the international glass/fork symbol. Somewhat similar to the European CE mark, the glass/fork symbol demonstrates that foodstuffs contained within an FCM are safe for human consumption.
Under framework Regulation (EC) No. 1935/2004, the glass/fork symbol is mandatory for FCM sold in EU markets unless the articles are, because of their characteristics, clearly intended to come into contact with food. This regulation also requires FCM to be manufactured to GMP, so, while the glass/fork symbol is not a demonstration of GMP compliance, it does show GMP has been observed.
GMP is the basic control measure and procedure manufacturers should follow to ensure safe, compliant FCM. Other EU regulations that cover GMP for FCM include:
- No. 1935/2004 – lineout of GMP requirements
- No. 882/2004 – for officials looking at FCM compliance
- No. 2023/2006 – for manufacturers. Defines scope, definitions, quality assurance (QA)/quality control (QC) systems, documentation
- No. 282/2008 – amends No. 2023/2006
Manufacturers should be aware that Regulation (EC) No. 1935/2004 states the requirement for FCM to be manufactured to GMP, but it is Regulation (EC) No. 2023/2006 that defines GMP for FCM. Article 3 (a) defines it as:
“‘Good Manufacturing Practice (GMP)’ means those aspects of quality assurance which ensure that materials and articles are consistently produced and controlled to ensure conformity with the rules applicable to them and with the quality standards appropriate to their intended use by not endangering human health or causing an unacceptable change in the composition of the food or causing a deterioration in the organoleptic characteristics thereof.”
Stakeholders should not mistakenly think that because Regulation (EC) No. 2023/2006 specifically references printing inks and recycled plastics it does not apply to other FCM. Regulation (EC) No. 1935/2004 lists 17 materials in Annex I, covering all forms of FCM, and these must all conform to the requirements for GMP.
To present a quality product to the market, manufacturers cannot rely on only testing the end product. Instead, they must implement a robust system of QA and QC processes – the building blocks of GMP – along the whole production chain. QA is a mechanism to help manufacturers control their processes, QC helps them control quality. Together, they create a robust quality assurance system that can be documented.
The business operator is responsible for implementation of a documented QA system. It ensures:
- Employees are sufficiently trained
- Responsibilities are defined
- Correct organization and processes are in place
- Traceability is assured
- Suitability to manufacturing safe, compliant FCM
- Technical know-how is in place to control:
- Chemical processes
- Processing machine
- Workplace conditions
- Treatment of products
Business operators need to be aware that the correct choice of material and selection of supplier hold a vital contribution to achieving GMP, as they can have a deep impact upon production process management.
As with QA, the QC system must be effective and suitable for controlling quality. It should cover all aspects of the business, from raw materials and parts selection, through manufacturing, transportation, storage, and include supervision and corrective actions. A robust QC system will allow:
- Intervention in the production process
- Corrective measures to ensure compliant production
- Illustrate effectiveness to authorities
Proving Compliance with GMP
Part of implementing effective QA and QC systems is the creation of clear and accurate documentation. This can either be paper or electronic, but it must be available to the authorities to prove compliance.
Documentation must include both supportive documents, such as details of specifications, details of material composition, Declarations of Conformity and test report, and operative documents. These might include documents detailing:
- Selection of materials
- Registration of production data
- Production controls – e.g. temperature records, cleaning charts
- Procedure of corrective action
- Control of finished product – e.g. testing
- Personal training
- Storage management
- Distribution/Shipping protocols
The key to showing compliance with GMP to authorities is documentation, as it cannot be tested.
Ten Golden Rules for GMP Compliance
To ensure GMP compliance, manufacturers should:
- Get the facility design right from the start
- Validate processes
- Write good procedures and ensure they are followed
- Identify responsibilities and roles
- Keep good records
- Train and develop staff
- Practice good hygiene
- Maintain facility and equipment
- Build quality into the lifecycle
- Perform regular audits
SGS Solution: Food Contact Materials
SGS offers a range of services to help companies develop and market FCM. Our global network of accredited laboratories can assist with testing and certifying food contact materials against local and regional regulations in Europe, North American, South American (Mercorsur) and the Asian Pacific. Our experts will help you gain access to your target market in an expedient and cost-effective way. In addition, SGS offers GMP certification for food packaging materials, based on BSI PAS 223, and GMP audits for management systems, based on FSSC 22000 part one and two.
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To learn more about SGS services, contact:
Dr. Udo Krischke
Consumer and Retail
Global Technical Manager RSTS & Operational Integrity Manager
SGS Germany GmbH
t: +49 (0)6128 - 744 235