Compliance and safety in MRO: regulation of food contact materials (EC 1935/2004)
Technical analysis: Food contact materials regulation (EC 1935/2004): MRO implications for food plants
Enter
Standard (EC) No. 1935/2004, which regulates food contact materials, plays a critical role in ensuring safety and compliance in the food industry. This regulation specifies requirements for materials used in food installations, including equipment, tools and components that come into direct contact with food. Compliance with this standard not only reduces the risks of contamination and chemical exposure, but also ensures compliance with international and national safety requirements.
Application area and critical industries
Standard (EC) No. 1935/2004 applies to all materials that may come into contact with food, including equipment, tools, packaging and components used in food production processes. It includes requirements for plastics, metals, coatings and other materials used in equipment such as pneumatic systems, pumps, piping, filters and sensors.
In Ukraine, where the food industry plays an important role in the economy, compliance with this standard is especially important for enterprises involved in the production of prepared foods, processing of agricultural products and food storage.
Basic Requirements
| Requirement | Description | Deadlines |
|---|---|---|
| Compliance | All materials in contact with food must comply with the requirements of (EC) No. 1935/2004 and additional directives such as (EC) No. 10/2011. | Since the standard came into force in 2005. |
| Certification | Manufacturers and suppliers are required to provide certificates of conformity confirmed by laboratories accredited by ISO/IEC 17025. | Constantly. |
| Material Information | Each component must be accompanied by technical data, including chemical composition, temperature range, wear resistance level and cleaning methods. | Upon delivery. |
| Cleaning and disinfection | Materials must be compatible with cleaning and disinfection chemicals specified in standard protocols. | From the date of entry into force. |
Impact on MRO operations
Compliance with Standards (EC) No. 1935/2004 has a significant impact on MRO operations, including maintenance, repair and replacement of components. Major changes include:
- Mandatory use of certified components that meet food contact requirements.
- Increased complexity of documentation associated with certificates and testing reports.
- Cleaning and disinfection procedures need to be reviewed.
- Increasing requirements for storage and transportation of components.
These changes require MRO teams to take a more rigorous approach to component selection and use, ensuring safe and reliable manufacturing processes.
Component Requirements
In the food industry, the key components that require compliance with standards (EC) No. 1935/2004 are:
- Pneumatic valves and sensors: must be made of materials compatible with food products and have certificates of conformity to ISO 14469.
- Pipes and fittings: Materials must comply with the requirements of EN 13445 and EN 13480 and be certified to comply with (EC) No. 1935/2004.
- Pumps and compressors: it is necessary to use materials that do not react chemically with food and comply with the requirements EN 13141.
- Filters and separators: must be made of materials that ensure safe interaction with food products and have certificates of conformity according to ISO 22000.
Compliance with these requirements ensures that all components used in food installations ensure product safety and quality.
Checklist for Maintenance Managers
- Check the certificates of conformity of all components used in production installations.
- Ensure that materials in contact with food comply with (EC) No. 1935/2004.
- Update cleaning and disinfection documentation as required.
- Check the storage and transportation of components to ensure they are protected from contamination.
- Conduct regular inspections to ensure compliance with standards.
- Ensure availability of certified spare parts that meet requirements.
- Train personnel on how to handle components that comply with (EC) No. 1935/2004.
- Conduct compliance audits and correct deficiencies.
- Use only ingredients that have been tested for food compatibility.
- Update information about materials and their characteristics.
- Check equipment regularly to ensure compliance.
- Maintain testing and certification records.
- Use only certified cleaning and disinfection methods.
- Provide access to certificates and testing reports.
- Conduct regular inspections to ensure compliance with standards.
Common non-compliance problems
Auditors often identify the following problems:
- Lack of certificates of conformity for components in contact with food.
- Materials do not comply with the requirements of (EC) No. 1935/2004.
- Improper storage or transportation of components.
- Failure to follow cleaning and disinfection protocols.
- Disorganized certification documentation.
These problems can lead to serious consequences, including fines, damages and threats of qualification.
Sanctions and liability
Failure to comply with the requirements of (EC) No. 1935/2004 may result in the following consequences:
- Fines: The maximum fine for a violation can be up to EUR 100,000, depending on the severity of the violation.
- Ceasement: Businesses may be closed temporarily or permanently in the event of serious violations.
- Losses: production stoppages, pollution damage and possible loss of customers.
- Liability: Business owners may be subject to criminal liability in the event of injury to health or life.
These consequences highlight the need for strict adherence to standards and regular auditing.
Conclusion
Compliance with the requirements of (EC) No. 1935/2004 is critical to ensure safety and quality in the food industry. To effectively manage MRO and comply with standards, it is important to use certified, compliant components.
UNITEC-D GmbH offers a wide range of certified components that comply with standards (EC) No. 1935/2004, EN, ISO and DSTU. We guarantee reliability, accuracy and compliance for your production infrastructure. Visit UNITEC-D E-Catalog and select components that will keep your production safe and efficient.
Links
- Regulation (EC) No. 1935/2004 of 2004-04-25
- Directive (EC) No. 10/2011
- ISO/IEC 17025:2017
- EN 13445:2009
- EN 13480:2003
- EN 13141:1999
- ISO 22000:2018