How to Obtain and Maintain a Declaration of Conformity (DoC) for Food Contact Materials

As a Caffepress distributor or OEM brand partner, ensuring the safety and compliance of our food contact materials (FCMs) is paramount. A crucial aspect of this compliance is the Declaration of Conformity (DoC), a document that declares a product meets the applicable regulations for food contact safety. This article provides a comprehensive guide on how to obtain and maintain a valid DoC for FCMs, helping you navigate the regulatory landscape and uphold our commitment to delivering safe and high-quality products.

Understanding the Declaration of Conformity (DoC)

A Declaration of Conformity is a self-declaration by the manufacturer (or, in some cases, the importer or distributor taking on the manufacturer’s responsibilities) stating that a product complies with all applicable European Union (EU) regulations concerning food contact materials. While the EU provides the framework, specific requirements might vary slightly based on individual member states’ national legislation. For products destined for markets outside the EU, such as the US, equivalent documentation demonstrating compliance with regulations like those set by the FDA is required. This document is not a test report itself, but rather a statement supported by adequate testing and documentation. Its existence is crucial for demonstrating due diligence and enabling the traceability of FCMs throughout the supply chain.

The DoC is a dynamic document. It must be kept up-to-date, reflecting any changes in the product formulation, manufacturing process, or applicable regulations. Failure to maintain a valid DoC can result in serious consequences, including product recalls, legal penalties, and damage to your brand’s reputation.

Obtaining a Declaration of Conformity

The process of obtaining a DoC involves several key steps. As Caffepress distributors and OEM brands, you are not directly responsible for creating the DoC for the materials and products we supply. However, understanding the process allows you to ensure we provide you with all the necessary documentation and support.

1. Identify Applicable Regulations

The first step is to identify the relevant regulations for the specific food contact material in question. In the EU, the primary regulation is Regulation (EC) No 1935/2004, which establishes a general framework for all FCMs. In the US, the FDA regulations under Title 21 of the Code of Federal Regulations (CFR) are the primary reference. This framework is further supplemented by specific regulations for certain types of materials, such as:

• Plastics: Regulation (EU) No 10/2011 (and its amendments) for plastic FCMs in the EU.
• Regenerated Cellulose Film: Directive 2007/42/EC for regenerated cellulose film in the EU.
• Active and Intelligent Materials: Regulation (EC) No 450/2009 for active and intelligent FCMs in the EU.
• Specific Materials: Regulations may also exist for materials like ceramics, glass, silicone, and coatings, depending on the market.

We, at Caffepress, are responsible for staying updated on the latest regulatory changes. However, understanding the basics helps you to ensure that our products meet your specific market requirements.

2. Conduct Material Testing

Compliance with FCM regulations requires rigorous testing to ensure that the material does not release harmful substances into food at levels that could endanger human health or bring about an unacceptable change in the composition or characteristics of the food. This testing is typically conducted by accredited laboratories and involves:

• Overall Migration Testing: Measures the total amount of substances that migrate from the material into a food simulant.
• Specific Migration Testing: Measures the migration of specific substances, such as heavy metals, phthalates, and primary aromatic amines (PAAs).
• Substance Identification: Identifying all substances used in the material’s composition, including monomers, additives, and colorants.
• Compliance with Specific Restrictions: Ensuring compliance with specific limits and restrictions for certain substances as defined in the relevant regulations (e.g., Specific Migration Limits – SMLs).

Caffepress provides comprehensive test reports and material specifications to support the DoC. We work with reputable laboratories to ensure the accuracy and reliability of our testing data.

3. Prepare the Declaration of Conformity

Based on the testing results and material specifications, the manufacturer (Caffepress) prepares the Declaration of Conformity. The DoC must contain the following information:

• Identity and address of the business operator issuing the declaration: Clearly identifies Caffepress as the responsible party.
• Identity of the FCM: Provides a detailed description of the material, including its trade name, grade, and composition.
• Date of the declaration: Indicates when the DoC was issued.
• Confirmation of compliance: Explicitly states that the FCM complies with the relevant regulations (e.g., Regulation (EC) No 1935/2004, Regulation (EU) No 10/2011).
• Adequate information to allow traceability of the material or article: Provides batch numbers or other identifying information to trace the FCM back to its origin and manufacturing process.
• Information on substances subject to restriction: Lists any substances used in the material that are subject to specific migration limits (SMLs) or other restrictions, along with their respective limits.
• Specifications on the use of the material or article: Includes information on the intended use of the material, such as the types of food it is intended to contact, temperature range, and duration of contact.
• Where applicable, information on the functional barrier behind which the substance is used: Relevant for multi-layer materials.
• Supporting documentation: References the test reports, material specifications, and other documents that support the declaration.

We provide a standardized DoC template for all our products, ensuring consistency and clarity.

Maintaining a Valid Declaration of Conformity

Obtaining a DoC is not a one-time event. It is an ongoing process that requires regular monitoring and updates. Here’s how to maintain a valid DoC:

• Regularly review regulations: Stay informed about changes in FCM regulations, both at the EU and national levels, as well as in other target markets like the US.
• Monitor material changes: Any changes in the material formulation, manufacturing process, or supplier of raw materials must trigger a re-evaluation of the DoC.
• Conduct periodic testing: Conduct regular testing to verify that the material continues to meet the required standards. The frequency of testing depends on the risk assessment of the specific material and its application.
• Update the DoC: Update the DoC whenever there are changes in regulations, material composition, or testing results. The updated DoC should clearly indicate the date of revision and the nature of the changes.
• Maintain records: Keep all supporting documentation, including test reports, material specifications, and supplier declarations, readily available for inspection.

Caffepress is committed to providing you with updated DoCs and supporting documentation whenever necessary. We proactively monitor regulatory changes and conduct regular testing to ensure the ongoing compliance of our products.

Your Responsibilities as a Distributor/OEM Brand

While Caffepress is responsible for creating and maintaining the DoC, you also have important responsibilities:

• Request and review the DoC: Ensure that you receive a valid DoC for each FCM product you purchase from us. Review the DoC carefully to ensure it covers the specific product and its intended use.
• Communicate intended use: Inform us of the intended use of the FCM product, including the types of food it will contact, temperature range, and duration of contact. This information is crucial for ensuring the DoC is appropriate.
• Store and handle materials properly: Store and handle FCM products according to the manufacturer’s instructions to prevent contamination or degradation that could affect their safety.
• Maintain traceability: Maintain records of all FCM products purchased, including the DoC and batch numbers, to ensure traceability in case of a recall or other issue.
• Inform Caffepress of any issues: Immediately inform us of any issues or concerns regarding the safety or compliance of FCM products.

Summary

Obtaining and maintaining a Declaration of Conformity is essential for ensuring the safety and compliance of food contact materials. By understanding the regulations, conducting thorough testing, and diligently maintaining the DoC, we, together, can ensure that our products meet the highest standards of food safety. Caffepress is committed to providing you with the necessary documentation and support to navigate the regulatory landscape and maintain consumer trust. By working together, we can ensure that our products are safe, compliant, and of the highest quality.