Comprehensive Guide to FDA 21 CFR 172.848 Testing of Calcium Disodium EDTA in Sauces Laboratory Testing Service Provided by Eurolab
The testing service provided by Eurolab for FDA 21 CFR 172.848 Testing of Calcium Disodium EDTA in Sauces is governed by a set of standards that ensure the accuracy, precision, and reliability of the results. These standards are developed and published by various organizations, including ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials), EN (European Committee for Standardization), TSE (Turkish Standards Institution), and others.
Legal and Regulatory Framework
The legal and regulatory framework surrounding this testing service is governed by the Food and Drug Administrations (FDA) 21 CFR Part 172, which sets forth the standards for food additives. Specifically, Section 172.848 deals with Calcium Disodium EDTA in sauces. The FDA requires that all food additives, including Calcium Disodium EDTA, be tested to ensure their safety and efficacy before they can be used in foods.
International and National Standards
The following international and national standards apply to this specific laboratory test:
ISO 3696: Water for analytical laboratory useASTM E691: Standard practice for conducting an interlaboratory study to determine the precision of a test methodEN 1360: Foodstuffs - Determination of moisture content (oven drying method)TSE ISO 17025: General requirements for the competence of testing and calibration laboratoriesStandard Development Organizations
The following standard development organizations are involved in developing standards related to this testing service:
International Organization for Standardization (ISO)American Society for Testing and Materials (ASTM)European Committee for Standardization (EN)Turkish Standards Institution (TSE)Evolution of Standards
Standards evolve over time as new technologies, research findings, and regulatory requirements emerge. This ensures that standards remain relevant and effective in ensuring the safety and efficacy of food additives.
Standard Numbers and Scope
The following standard numbers and scope apply to this testing service:
ISO 3696: Water for analytical laboratory use - Specifies the requirements for water used in analytical laboratoriesASTM E691: Standard practice for conducting an interlaboratory study to determine the precision of a test method - Provides guidance on conducting interlaboratory studies to evaluate the precision of test methodsEN 1360: Foodstuffs - Determination of moisture content (oven drying method) - Specifies the requirements for determining the moisture content of foodstuffs using the oven drying methodTSE ISO 17025: General requirements for the competence of testing and calibration laboratories - Specifies the general requirements for the competence of testing and calibration laboratoriesStandard Compliance Requirements
The following industries require compliance with these standards:
Food manufacturersPharmaceutical companiesCosmetic manufacturersResearch institutionsIn addition to the standards mentioned above, the following standards are relevant to this testing service:
ISO 17025: General requirements for the competence of testing and calibration laboratories - Specifies the general requirements for the competence of testing and calibration laboratoriesASTM E3004: Standard practice for validation of a laboratory test method - Provides guidance on validating laboratory test methodsEN 13426: Foodstuffs - Determination of moisture content (near-infrared spectroscopy method) - Specifies the requirements for determining the moisture content of foodstuffs using near-infrared spectroscopyThe following standard development organizations are involved in developing standards related to this testing service:
International Organization for Standardization (ISO)American Society for Testing and Materials (ASTM)European Committee for Standardization (EN)Business and Technical Reasons
This specific test is needed and required for several business and technical reasons:
To ensure the safety and efficacy of food additives, including Calcium Disodium EDTATo comply with FDA regulations and guidelinesTo maintain quality assurance and quality control standardsTo ensure product safety and reliabilityTo provide competitive advantages in the marketConsequences of Not Performing This Test
The consequences of not performing this test include:
Non-compliance with FDA regulations and guidelinesPotential health risks to consumersDamage to brand reputation and customer trustFinancial losses due to product recalls or regulatory actionsIndustries and Sectors
The following industries and sectors require this testing service:
Food manufacturersPharmaceutical companiesCosmetic manufacturersResearch institutionsRisk Factors and Safety Implications
The risk factors and safety implications associated with this testing service include:
Potential health risks to consumers due to non-compliance with FDA regulations and guidelinesDamage to brand reputation and customer trust due to product recalls or regulatory actionsFinancial losses due to product recalls or regulatory actionsThis specific test is needed and required for several business and technical reasons:
To ensure the accuracy, precision, and reliability of test resultsTo maintain quality assurance and quality control standardsTo ensure product safety and reliabilityTo provide competitive advantages in the marketThe consequences of not performing this test include:
Non-compliance with FDA regulations and guidelinesPotential health risks to consumersDamage to brand reputation and customer trustFinancial losses due to product recalls or regulatory actionsThe following industries and sectors require this testing service:
Food manufacturersPharmaceutical companiesCosmetic manufacturersResearch institutionsThe risk factors and safety implications associated with this testing service include:
Potential health risks to consumers due to non-compliance with FDA regulations and guidelinesDamage to brand reputation and customer trust due to product recalls or regulatory actionsFinancial losses due to product recalls or regulatory actionsThis specific test is needed and required for several business and technical reasons:
To ensure the accuracy, precision, and reliability of test resultsTo maintain quality assurance and quality control standardsTo ensure product safety and reliabilityTo provide competitive advantages in the marketThe consequences of not performing this test include:
Non-compliance with FDA regulations and guidelinesPotential health risks to consumersDamage to brand reputation and customer trustFinancial losses due to product recalls or regulatory actionsThe following industries and sectors require this testing service:
Food manufacturersPharmaceutical companiesCosmetic manufacturersResearch institutionsThe risk factors and safety implications associated with this testing service include:
Potential health risks to consumers due to non-compliance with FDA regulations and guidelinesDamage to brand reputation and customer trust due to product recalls or regulatory actionsFinancial losses due to product recalls or regulatory actions