1. What are food contact substances?

A Food contact substance (FCS) is any substance that can be reasonably be expected to become a component of or directly or indirectly affect the characteristics of any food. This is includes any substance intended for use in producing, manufacturing, packaging, processing, storing, transporting, or holding of food, including any source of radiation within the production process. The following substances are not considered food contact substances:

• Substances that are generally recognized as safe (GRAS);

• A substance sanctioned prior to 1958.

2. Regulatory compliance workflow

3. US FCS regulatory compliance

Declaration of Compliance

Declaration of Compliance (DoC) is a document that should be provided to downstream enterprises to ensure product safety and
regulatory compliance. Eective transmission of supply-chain information between supplier and customer helps assure a compliant status of the nished product for food contact.

Food Contatct Notifications (FCN)

In order to ensure food safet, the 1958 Regulation stipulates that all food additives, both direct and indirect, need to be approved by the US
FDA before use. For indirect food additives, such as FCSs, the US FDA has established an FCN procedure that states substances that are neither approved nor forbidden for use by the US FDA for use are required to submit an FCN.

Specicity of FCN: FCN is only valid for substances producers and suppliers who submit the application. Other manufacturers / suppliers need to apply to the US FDA even though it is for the same substance.

4. FCN application workflow

Our advantages

• Strong educational background: Experienced team procient in food chemistry, food nutrition and health, food functional component, biology, toxicology, environmental elds, etc.

• Language ability: Proficient in English, Japanese, German and Chinese, serving overseas clients with higher rate of efficiency.

• Rich experience in regulatory compliance: Accumulating years of experience in food contact material regulatory compliance for China, US, EU, etc. Can provide compliance services for multiple countries at the same time.

• Abundant resources: Cooperate with numerous accredited laboratories in China and abroad allowing us to tailor a compliance testing strategy for each individual client.

• Close relationship with authorities: Longstanding relationships with competent authorities such as US FDA and other industry professionals. These established communication channels with authorities signicantly improves service range and quality.

Our service

• Food contact material regulation consulting/customized consulting report

• Regulatory compliance analysis/new substance assessment

• Declaration of Compliance (DoC) editing/auditing

• Food contact notifcation

• Lab selection and testing supervision

• Regulatory compliance training

• Regulation translation

• Consult with competent authority

• Supplier management