Approvals and certifications in the food industry
Which documents are relevant for sensors, connectivity and accessories – and how do you choose the right ones for your application?
In the food and beverage industry, hygiene, product safety and material resistance are crucial – including for sensors, cables and connectivity. Regulatory requirements and customer specifications can only be met cleanly in projects if the right evidence is selected early and documented unambiguously. At its core, it comes down to two questions: Is the material suitable for food contact and can it withstand the real cleaning and process profile? This article gives you a compact overview of FDA (USA), the EU framework regulation (EC) No. 1935/2004 as well as ECOLAB-related resistance evidence for cleaning and disinfection chemicals, and shows how to bring scope, variants and the documentation chain together in an audit-ready way.
The essentials at a glance
Clarify the use case first:
Food contact (direct/indirect), target market (EU/USA), cleaning profile (chemicals, temperature, cycles).
EC 1935/2004 (EU):
Framework regulation for materials in food contact – evidence via declaration of compliance plus supplier evidence.
Rule of thumb:
Evidence only helps if its scope covers your installation situation – including type of contact, product-wetted materials, cleaning, temperature and variant status.
FDA (USA):
In projects, suitability for food contact is often documented via manufacturer declarations and a clear definition of material, variant and operating conditions.
ECOLAB:
Resistance evidence in cleaning environments, important with frequent or aggressive cleaning cycles. The decisive factor is the test conditions compared to the cleaning plan.
Remember:
Documents are not an end in themselves. What matters is whether the evidence fits your installation situation and the actual cleaning profile.
Why evidence is crucial in the food sector
In hygiene-critical production environments, components must not only function reliably, but also be demonstrably suitable. Sensors, connectivity and accessories are often exposed to moisture, splash water, temperature changes and intensive cleaning – sometimes also in product-adjacent areas. Appropriate evidence helps you document requirements in an audit- and acceptance-ready manner. At the same time, it reduces project risks such as material damage due to cleaning, questions during audits, or rework caused by missing or unsuitable documentation.
Typical triggers for evidence in projects
Product and media contact (direct or indirect):
Provide proof of material suitability for the target market (EU/USA).
Audits and quality management:
Provide complete, traceable and clearly assignable documentation (including supplier evidence).
Cleaning and disinfection:
Provide evidence of resistance to the chemicals used and typical process conditions.
Customer specifications and acceptance:
Evidence must match the item variant and installation location.
An overview of the most important standards
FDA
FDA (USA) – material suitability for food contact
In the US context, FDA requirements concern materials and components intended to come into contact with food. In projects, compliance is often documented via a manufacturer's declaration of conformity. The decisive factor is the scope: Does the evidence cover the actually product-wetted materials, surfaces and variants used in your application?
- Clear assignment to item number and variant
- Material/specification details of the relevant (product-wetted) parts
- Description of the use context (type of contact and typical conditions)
- Issuer, contact person and traceability
EC 1935/2004
EC 1935/2004 (EU) – framework regulation for food contact
Regulation (EC) No. 1935/2004 is the EU framework regulation for materials and articles intended to come into contact with food. In practice, a declaration of compliance is often the key evidence. For audit-robust documentation, it is also important that relevant supplier evidence is available and that the documentation chain remains traceable – especially when multiple tiers of suppliers are involved.
Table: Documents in the EU context – how they are used in projects
| Document | Purpose in projects/audits |
|---|---|
| Declaration of compliance | Formal confirmation of compliance for product/material within the defined scope |
| Supplier evidence | Closes the documentation chain (material basis, supplier details, traceability) |
| supplementary test documents (if applicable) | Support assessment for special operating conditions (if available) |
Supplier
Manufacturer
Integrator/plant engineering
Operator/QM
Audit/acceptance
ECOLAB
ECOLAB – resistance to cleaning & disinfection chemicals
An ECOLAB statement (or corresponding resistance confirmation) relates to the resistance of materials, surfaces or seals to cleaning and disinfection chemicals. This is particularly relevant where cleaning is frequent and components are regularly exposed to high chemical and thermal loads. The key is to look at the test conditions: Which cleaning media and concentrations were tested, at which temperatures and exposure times, and how many cycles were covered. Only if these parameters match your real cleaning plan is the evidence truly robust for selection, acceptance and audits.
Typical cleaning stressors (examples):
- alkaline cleaners
- acidic cleaners and disinfectants
- hot water and temperature changes
- high-pressure and foam applications
- frequent cleaning cycles (daily/multiple times per day)
Food compliance and certificates – a quick summary
FDA (USA)
Material suitability for food contact
What for?
Material suitability of product-wetted materials in the US context.
When relevant?
When there is product or media contact and the target market is the USA (or US customer requirements apply).
Form of evidence
Manufacturer declaration and/or manufacturer documentation with a clearly defined scope (material, variant, operating conditions).
EC 1935/2004
EU framework regulation for food contact
What for?
Framework requirements for materials and articles with food contact in the EU.
When relevant?
For EU projects with direct or indirect food contact, especially in audit-critical lines.
Form of evidence
Declaration of compliance plus supplier evidence to close the documentation chain (supplementary test documents if applicable).
ECOLAB
Resistance to cleaning and disinfection chemicals
What for?
Resistance of materials, surfaces and seals to cleaning and disinfection media.
When relevant?
With frequent cleaning cycles, aggressive chemicals, temperature changes, high pressure or foam cleaning.
Form of evidence
Resistance confirmation or test report with clear test parameters (chemicals, concentration, temperature, exposure time, cycles) and comparison to the cleaning plan.
Approval vs certification vs declaration of compliance – what's what?
In projects, terms are often used inconsistently. For clear alignment between engineering, purchasing and QM, a pragmatic distinction helps:
| Term | Meaning in practice | Typical evidence |
|---|---|---|
| Declaration of compliance | Manufacturer confirms compliance with relevant requirements | Declaration of compliance (scope/variant) |
| Certification | Test criteria/test series confirm defined properties | Certificate/test evidence (e.g. resistance) |
| Approval | Project- or market-specific requirement/approval (e.g. due to customer requirements) | Approvals/requirements catalogues/customer specifications |
Remember:
For acceptance and audits, what counts is that the evidence fits the use case. Scope, variant status and alignment with contact and cleaning profiles matter – not merely the existence of a document.
Evidence matrix (guidance)
| Use case | Typical need | Quick check |
|---|---|---|
| EU project + food contact | EC 1935/2004 declaration of compliance + supplier evidence | Are the declaration and supplier chain complete and assigned to the variant? |
| US project + food contact | FDA declaration of conformity | Does the evidence cover product-wetted surfaces/materials and variants? |
| Frequent aggressive cleaning/disinfection | Resistance evidence (e.g. ECOLAB) | Do test conditions match the real cleaning profile (chemicals/temp/cycles)? |
| Audit-critical line / customer acceptance | Combination per market + complete documentation package | Are documents versioned, clearly named and quickly retrievable? |
Further solutions and starting points
If you want to move on directly from the selection guide, these entry points are recommended:
Sensors for food applications
Robust sensors for hygiene-critical environments.
More insights for the food industry
Further practical articles and selection guides in the industry hub.
Sensor cables & connectivity
Components for moisture, cleaning and mechanical stress.
Sensors for the food industry
Food & beverage industry – hygienic, reliable, suitable for CIP/SIP and ideal for IO-Link.
Connectivity in the food industry
Connectivity for the food and beverage industry that easily withstands daily cleaning cycles with foam, high pressure and chemicals.
Frequently asked questions (FAQ) about approvals in the food industry
That depends on the target market. For applications in the USA, FDA-related evidence is relevant; for EU projects, classification under EC 1935/2004. In international projects, both sets of evidence may be required – depending on market, use case and food contact.
An ECOLAB statement relates to the resistance of materials/surfaces/seals to cleaning and disinfection chemicals. This is particularly relevant when cleaning is frequent and chemical, thermal or mechanical loads occur.
A declaration of compliance is often the key evidence. In practice, it is also important that scope and variant are unambiguous and that the documentation chain remains traceable – especially in audit-critical applications.
At a minimum: suitable declarations of compliance for the target market and use case, relevant supplier evidence to close the documentation chain and – in the case of intensive cleaning – resistance evidence that matches the cleaning profile.
Any questions left?
Here you can find our FAQ
