Crack the compliance code: What you need to know about FDA and EU regulatory requirements

Imagine the scenario: Production is running smoothly, orders are coming in – and then the quality department calls. A spot check reveals irregularities in the documentation for a component material. It may start with extra paperwork, but it can quickly escalate to recalls, lost production time and weakened customer confidence.

The reality today is that companies in the food and pharmaceutical manufacturing sectors are increasingly faced with demands for full documentation and traceability – not only from the authorities, but also from customers and business partners. For many, compliance is therefore shifting from an administrative exercise to a strategic priority. In other words: a business-critical control point that can mean the difference between stable growth and acute crisis management.

When you have this area under control, you don’t just gain peace of mind. You ensure operational reliability, predictability and the ability to respond quickly to market demands. That’s precisely why we’ve gathered everything from the ‘what-you-need-to-know’ category here, so you can quickly and easily get an overview of the most important regulations.

In modern food or pharmaceutical production, compliance is about more than just passing an audit. It’s about ensuring that every component of your process stands up to scrutiny, both technically and regulatorily. With a firm grasp of this area, you’ll have a significant head start due to:

• Smoother exports: You can sell more easily beyond national borders if your components comply with both EU and FDA regulations.
• Greater operational reliability: You reduce the risk of production stoppages, costly retrofits and documentation chaos.
• Greater confidence: You demonstrate to both customers and partners that your production is not only efficient, but also reliable and of high quality.

When compliance is systematically integrated, it ceases to be a burden and instead becomes a mark of quality for your manufacturing business.

In the US, the FDA has established the framework against which much of the world measures itself. FDA Title 21 sets out the chemical requirements for materials in contact with food. For you as a manufacturer, this assures that your equipment meets US chemical safety requirements. It's the foundation for exporting to the US market.

Within EU legislation, it's worth being aware of three key regulations that together ensure your operations and product quality:

• EC 1935/2004: Regulation ensuring that components don’t release substances that could harm health or alter the product’s taste and smell.
• EU 10/2011: Regulation on plastic materials in contact with food. Contains a list of permitted raw materials and fixed migration limits. Industrial hoses are tested here under realistic conditions to document their chemical stability during operation.
• EC 2023/2006 (GMP): Regulation concerning good manufacturing practice. Ensures that components are produced under controlled conditions with strict quality control.

Behind the extensive documentation requirements lies a fundamental desire to protect the consumer. As the focus on safety has increased, compliance has therefore shifted from being a technical requirement to being at the top of the agenda.

An industrial hose isn’t ‘just’ an industrial hose. It typically consists of several layers – inner rubber, reinforcement, outer rubber, and coupling. As a whole, the hose solution must not only meet internal technical requirements regarding medium, pressure, and temperature, but also legal requirements concerning, for example, the contact material (the inner lining).

• Rubber hoses (elastomers): You must be able to document that they don’t release harmful substances. Here, FDA 21 CFR 177.2600 is the key regulation that helps ensure that the rubber does not release undesirable substances during testing.
• Plastic hoses (polymers): Subject to EU 10/2011, which requires specific migration tests at defined temperatures and contact times.
• Stainless steel fittings: The focus here is on EN 10204 3.1 certificates, which clearly describe the steel’s composition, test results, and traceability.

In practice, hoses and fittings are the first and most overlooked line of defense against contamination. A single error in material selection can challenge even the best quality control.

When putting together your next hose solution, it's advisable to follow these steps to ensure that documentation and safety are top-notch:

• Know your medium and temperature: Start by identifying whether the medium contains oil, acid, or alcohol. Temperature is crucial, as it dictates how the material reacts chemically and what specific documentation is required to prevent migration.
• Know your material: Remember that rubber, plastic, and steel require different approvals. For example, our Teflon tubes and hoses (PTFE) are FDA-approved.
• Check the couplings: A hose consists of several layers. Be aware that each layer and the associated fittings must meet their own technical and regulatory requirements to work together under pressure. Here, the 3.1 certificate can be valuable.
• Verify traceability: Ensure that full documentation of the materials’ origin is available. You must be able to identify where the material comes from and where it is used in your supply chain.

In the busy day-to-day production, complex regulations and changing legal requirements can easily slip into the background. These are areas that demand constant attention because the rules are often changing – and it's precisely here that we make a difference for you.

With our combination of component knowledge and insight into technical documentation, we can help you put together solutions that meet current industry requirements and standards right from the start.

We’re here to help. Find answers to your questions in our compliance section, or get in touch for a quick chat on +45 7020 0422 or inquiry@alfotech.eu.

Plastic hoses are primarily regulated in the EU via EU 10/2011, which sets out very specific requirements for migration testing of polymers. Rubber hoses (elastomers), on the other hand, often fall under the more general requirements of EC 1935/2004 or the German BfR recommendations, as there’s not yet a harmonized EU regulation specifically for rubber in the same way as for plastic.

This certificate is your guarantee of full traceability back to the casting batch. It documents the steel’s chemical composition and mechanical properties, which is critical to ensure that the material does not corrode or release undesirable substances into the medium under the given operating conditions.

No, although FDA standards are internationally recognized, components manufactured in the EU must comply with the EU’s own regulations, such as EC 1935/2004 and EU 10/2011. A component may well be FDA-approved without meeting the EU’s specific migration limits, and therefore documentation for both sets of regulations is required for export.

The documentation for a hose is closely linked to the test conditions under which the material was approved. If you use a hose for fatty media or at higher temperatures than it was tested for, the material may react differently chemically. This may ultimately lead to illegal migration of substances into your product.

Under EC 2023/2006 (GMP), you must be able to identify the origin of all materials that come into contact with your product. In the event of a fault, you must be able to quickly trace the component back through the supply chain to assess whether other batches are affected, thereby minimizing the scope of any recall.