Food Contact Substance

    

Food Contact Substance (FCS) is any substance that can reasonably be expected to become a component of, or directly or indirectly affect, the characteristics of food. This includes substances intended for use in the production, manufacturing, packaging, processing, storage, transportation, or holding of food, as well as any sources of radiation involved in the production process.

We provide FCS review and Food Contact Notification services, ensuring compliance with regulatory submissions to the U.S. FDA, EU EFSA, UK FSA, Switzerland, and other countries. Our specialists include technical and regulatory consultants experienced in Food Contact Notification. We leverage expertise in regulatory affairs, chemistry, toxicology, and, where applicable, ecotoxicology, environmental sciences, and risk modeling to meet our clients' needs effectively.

Food Contact Substance (FCS) means specifically to any material that comes into contact with food during packaging, holding, or processing but is not intended to be directly added to the food, become a component, or have a technical effect on it. These materials are often classified as indirect food additives and must be authorized for use according to relevant regulations in various countries (e.g., EU, United Kingdom, USA, Canada, MERCOSUR, China, Japan, Switzerland, etc.).

Such regulations ensure that manufacturers and producers of materials like plastics, paper, paperboard, printing inks, ceramics, wood, metals, cork, textiles, and adhesives use substances that are safe for their intended food contact applications. If a food contact material is not already regulated, an application for authorization may be necessary in a given country to include this new FCS on an existing positive list, thereby allowing its use.

 

Food Contact Notification (FCN) Chemistry Information

ㆍ      Identity

ㆍ      Physical/Chemical Specification

ㆍ      Manufacturing Information

ㆍ      Impurities

ㆍ      Conditions of Use

ㆍ      Technical Effect

ㆍ      Stability

ㆍ      Migration Levels in Food

ㆍ      Exposure Estimates

Our Service for Food & Dietary Supplement (Health Functional Food) Product      

	GAP Analysis		Ingredients and Label		Registration
	U.S. Agent		Facility Inspection		Food Safety
	Batch Master File		GRAS, NDI and Novel Food		Food Contact Substance

K-GMP supports international clients in safeguarding the quality, safety, and performance of their supply chain, ensuring full regulatory compliance from raw materials and ingredients through to packaging and final products.

K-GMP network offers a comprehensive range of 1:1 customized consultancy support for all types of food products. We are committed to staying up-to-date with the regulatory environment, trends and industry requirements.

For detailed information about each of the services above, contact directly our expert.

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