Approvals & standards

EC 1935/2004 is the EU's general legislation for materials that come into contact with food. The requirement is that materials must not release substances in quantities that could harm health or change the taste, smell, or composition of the product. The regulation also requires documentation and traceability throughout the supply chain so that the origin and use of materials can always be identified.

When industrial hoses are used in production, liquids often pass through several process stages. Hoses without documented compliance can contaminate the contents and cause operational stoppages or product discards. EC 1935/2004 ensures that materials are assessed and documented so that food manufacturers can maintain product safety and avoid unforeseen quality problems.

EC 2023/2006 (GMP) deals with good manufacturing practice in the production of materials intended to come into contact with food. Manufacturers must have controlled processes, fixed procedures, quality management, and deviation management. The purpose is to ensure consistent quality in the materials so that they always comply with EC 1935/2004.

For industrial hoses, GMP means that the materials are manufactured under controlled conditions so that there are no variations in quality or impurities in the raw materials. This minimizes the risk of errors in production and reduces the need for replacement due to errors or contamination.

EU 10/2011 is the specific EU legislation for plastic materials in contact with food. It contains a list of permitted raw materials (Union List) and sets migration limits for how much material may be transferred to food. Testing is carried out under realistic conditions with temperature and time profiles that correspond to actual application.

Plastic-based industrial hoses are often used to transport liquids at different temperatures. EU 10/2011 documents that the hose maintains its chemical stability under operating conditions. This reduces the risk of taste deviations, quality problems, and unwanted chemical transfer.

RoHS (Restriction of Hazardous Substances) regulates the content of hazardous substances in electrical and electronic equipment, e.g. lead, cadmium, and certain flame retardants. The purpose is to protect people and the environment from harmful substances and ensure responsible waste management.

Although industrial hoses are not electronic equipment, many manufacturers choose to manufacture hoses without RoHS-regulated substances. This results in a material free of heavy metals and problematic chemicals, which reduces the risk associated with handling and disposal during the product's lifetime.

DM 21/3/73 is Italy's national regulation on materials intended to come into contact with food and contains positive lists of permitted raw materials and migration limits. It covers several types of materials, including plastics and rubber.

If industrial hoses are to be used on the Italian market, documented compliance with this regulation is required. This simplifies control processes during inspection and ensures that the materials are accepted by the authorities.

REACH regulates chemical substances in the EU and requires registration, risk assessment, and management of hazardous substances. Certain chemicals are placed on the candidate list as substances of very high concern (SVHC) and may only be used under strict conditions.

When selecting industrial hoses, REACH ensures that the material does not contain undesirable chemicals such as specific phthalates and heavy metals. This protects both employees and the end product from potential risks.

FDA Title 21 sets requirements for materials used in food contact on the US market. There are specific sections for different materials, e.g. rubber (21 CFR 177.2600) and PTFE (21 CFR 177.1550). The materials are tested for purity and migration.

FDA documentation makes it possible to use industrial hoses in production where exports to the US are involved or where customers require this type of documentation. This ensures that the materials comply with US chemical safety requirements.

The BfR (Bundesinstitut für Risikobewertung) publishes scientific recommendations on materials intended to come into contact with food. The recommendations serve as technical guidelines, particularly for materials for which there are no fully harmonized EU regulations, such as certain types of rubber.

When industrial hoses are manufactured according to BfR recommendations, this provides additional documentation of the material's properties. This is particularly useful in markets where customers demand clear material documentation.

USP Class VI is a test regime from the United States Pharmacopeia that examines biological reactivity. Materials are tested for toxicity and irritation upon contact with living tissue, among other things. It’s typically used for polymers in medical and pharmaceutical equipment.

Industrial hoses with USP Class VI are used where products with high purity requirements are handled, e.g., in pharmaceutical production. The test ensures that the material does not release substances that could affect the quality of the product.

3A Sanitary Standards define requirements for the hygienic design of process equipment. The standards focus on surface roughness, material selection, and easy-to-clean constructions. The organization behind the standards is private, and the standards are voluntary.

When hoses and connections comply with 3A requirements, cleaning becomes easier and the risk of microbial build-up is reduced. This results in more stable operation and fewer hygiene-related interruptions.

E.P. 3.1.9 in the European Pharmacopoeia sets requirements for silicone for pharmaceutical use. The requirements include testing of volatile components and migration limits.

Silicone hose in accordance with E.P. 3.1.9 is used in processes involving highly sensitive products. The documentation ensures that the material does not transfer unwanted substances and can therefore be used in sterile and critical environments.

International standard series for biological evaluation of medical devices and materials. It’s used to test whether a material is biocompatible – i.e. non-toxic and non-irritating to living tissue.

For industrial hoses in the medical or food sector, ISO 10993 means that the hose material has been tested to ensure that it doesn’t release harmful chemicals or cause unwanted reactions when in contact with products or the body. Compliance with ISO 10993 requirements is important when hoses come into contact with, for example, blood, medicine, or food.

The ATEX (ATmosphères EXplosibles) directive regulates equipment used in potentially explosive atmospheres. Hoses are passive components in themselves, but they can be classified as suitable for ATEX zones if, for example, they can dissipate static electricity.

In production involving flammable liquids or dust, the build-up of static electricity can pose a risk. A hose with antistatic properties reduces the risk of sparking and increases safety.

KTW (Kunststoff im Trinkwasser) was previously the German assessment scheme for materials in contact with drinking water. It specified test requirements for migration and sensory impact on drinking water.

Although KTW has been replaced, it’s still seen on documentation for older products. It ensures that the material does not affect the taste or quality of the water when in contact with it.

KTW-BWGL (Kunststoff im Trinkwasser-Bewertungsgrundlage) is the current German legal framework for materials in drinking water installations. It replaces KTW and sets requirements for migration, taste, odor, and microbiological impact.

An industrial hose that complies with KTW-BWGL can be used in systems where drinking or process water is involved in production. This reduces the risk of affecting product quality.

GB9685 is a Chinese standard that regulates additives in food contact materials. It contains positive lists and migration limits.

Hoses with documentation according to GB9685 can be used in connection with exports to China. This ensures that the materials meet Chinese requirements for chemical safety.

The GB 4806 series set requirements for food contact materials in China. The series includes both general and material-specific standards – e.g. GB 4806.11-2023 for rubber, which came into force in 2024.

When using industrial hoses on the Chinese market, GB 4806 provides documentation of the material's suitability. This simplifies approval processes for export and ensures stable product quality.