Quality at Cobetter
Manufacturing Process Focus –
Monitoring of Regulations for the Entire Manufacturing Process.
Introduction:
Higher quality standards and focus on improved customer protection lead to a series of compliance requirements in the Food and Beverage industry, consolidating and extending existing regulations on food safety. This includes requirements for products intended to come in contact with food leading to specific standards relevant for food manufacturers and their suppliers.
For food contact materials in the Food and Beverage industry, the EU Framework Regulation on Food Contact Materials - European Regulation Number (EC) 1935/2004 applies
The primary premise of all food contact regulation is that materials or articles which are intended to come into contact with foods, beverages, or other ingredients should not release materials considered harmful to health or detrimental to product quality under normal foreseeable conditions. While the US Food and Drug Administration (FDA) affirms a positive listing of materials, the EU regulations additionally establish methods by which the materials or articles that come into contact with food and beverages are evaluated.
Initially the Food and Beverage industry focused on packaging materials. It also considers products used in the production process - e.g. filters. Filters are critical components and widely used in the Food and Beverage Industry such that finished article or materials extractable testing are mandatory in Europe. FDA listing alone is not sufficient to comply with EU requirements. To ensure food contact compliance manufacturers should consider regulations where the food or beverage is produced and where it is sold. Good manufacturing practices and quality systems (International Standards Organization, ISO), Hazard Analysis and Critical Control Point (HACCP) and International Food Standard (IFS) audits have increased the need for documentation. Declarations of Compliance for food contact materials used in packaging and production help to satisfy audit requirements.
The Cobetter solution
Cobetter Food and Beverage has undertaken an exhaustive review and qualification of products sold in the Food and Beverage Industry to the current regulations. After intensive test programs including substitution of critical substances we have qualified a specific range of compliant products for the Food and Beverage market.
Food contact compliant products are easily identified by the letter ‘F’ in the Cobetter product part number. These‘F-Coded’ products include the required documentation to demonstrate how a filter conforms to the EU standards.
Vendor declarations confirmed materials of construction are appropriately listed for use with food or are specifically excluded from local regulatory requirements.
Extractables testing has included independent test laboratories utilizing relevant model fluids or simulants deemed appropriate for intended applications. Filters or components were evaluated in selected model simulants from A, B, C and or D (water, 3% acetic acid, 10% ethanol, oil) under worst case exposure conditions (e.g. extended contact time and elevated temperature), as identified on the Declaration of Compliance.
These “Declaration of Compliance” statements will be reviewed at least annually to ensure compliance to new or changes in the regulations.
By investing in a Food and Beverage specific product portfolio Cobetter supplies products that comply with the most current regulations allowing the industry to maintain the highest good manufacturing practice standards.