FCM Continuous Compliance Checks

If you’re a manufacturer of food contact materials or a supplier of raw materials for such products, it’s your responsibility to ensure that all raw materials, intermediates and correlating substances comply with current regulations. But legislation governing substances is constantly changing. Keeping abreast of any amendments that might affect your compliance can be labour-intensive and time-consuming. In addition, you could easily lose track of the current regulatory status of your substance portfolio and be non-compliant without even knowing it.

Proactively checking your regulatory status

FCM Continuous Compliance Checks relieves you of the burden of regulatory monitoring of your product portfolio. With this service, we regularly check the regulatory status of your substance portfolio and notify you of any changes that affect the compliance status of your products. By efficiently monitoring your portfolio, FCM Continuous Compliance Checks enables you to stay ahead of regulatory changes and ensure your substance portfolio and food contact materials are fully compliant at all times.

How it works

Based on the composition of your food contact material, we monitor your substance portfolio’s regulatory status every quarter. If any regulatory changes potentially impact your compliance, we report our findings to you. This includes the level of alert related to the change: low risk, no action required; medium risk, attention required in due time; or high risk, immediate action required. We also advise you on steps to take to keep your product compliant.

If desired, we can support you with the follow-up actions required to remain in compliance. This is an extra service outside the scope of an FCM Continuous Compliance Checks subscription.

Initial compliance

At the beginning of the FCM Continuous Compliance Checks subscription period, we need to have all relevant information about the product portfolio you want to monitor. That means an accurate statement of compliance (SoC) no older than three months or:

• Full composition of the products and their intended uses.
• Statements of compliance and/or compositional information from your raw material suppliers.
• If needed, a report including analytical work to verify any legal restrictions (e.g. overall and specific migration limits, residual contents, mathematical modelling).

If you don’t have this information or an SoC, we can conduct a compliance evaluation and issue an SoC. This is a service outside the scope of an FCM Continuous Compliance Checks subscription.

The compliance evaluation involves two phases:

• In Phase 1, we collect compliance information from the suppliers of the raw materials in your product, check this information against the relevant regulations, and determine which tests, if any, are required to demonstrate compliance. We also conduct risk assessments of any substances not listed in relevant legislation to determine whether the products are a danger to human health.
• In Phase 2, we perform the tests to demonstrate compliance and report the results. If the regulatory requirements are met, we will provide an SoC.

Once an SoC is available, we start the FCM Continuous Compliance Checks monitoring.

Detailed reports

Each quarter, we report any changes to you, including findings and links to the relevant documentation. Each report includes the date, level of alert, and the relevant legislation that was amended plus the transition period of the specific products and substances concerned. If your product remains compliant, you receive an SoC in the first quarter of each year.