Food Contact Materials & Articles Compliance Solution

Understanding FCM Regulations

Food contact materials (FCM) refers to materials that are either intended to be brought into contact with food, are already in contact with food, or can reasonably be brought into contact with food or transfer their constituents to the food. The term also refers to materials used in food processing equipment. FCM is not chemically inert and may release harmful substances into food.

Legislation, such as in the EU, is commonly arranged as follows:

1. Framework Regulation: A framework measure sets up general requirements for all FCMs.
2. Good Manufacturing Practice (GMP): The manufacture of materials and articles must comply with good manufacturing practice (GMP) so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities that could: (a) endanger human health, (b) bring about an unacceptable change in the composition of the food, or (c) bring about a deterioration in the organoleptic properties of the food.
3. Material/Specific Regulations: Measures regulated groups of materials and articles e.g. ceramics, plastics, recycled plastic materials, regenerated cellulose film, active and intelligent materials; and measures regulated individual substances or groups of substances used in the production of FCM. These regulations normally provide a positive list and sets out limits or restrictions on the use of certain substances in FCM, as well as testing methods.

Certain regulations also specify labeling and traceability requirements for FCMs.

Why Do You Need to Comply

• Meet Safety Requirements
• Access To Local and International Markets
• The Risks of FCM Non-Compliance

Global Food Contact Standards & Regulations

• Food and Drug Administration (FDA) Regulations
• EU Food Contact Requirements

Our Regulatory Coverage of FCM Regulations

Our regulatory content in C2P is historically comprehensive with a robust QA process to ensure quality, consistency and accuracy. Below is a high level summary of our coverage for this topic:

Framework Regulation

• EU: Materials and Articles Intended to Come into Contact with Food, Regulation (EC) No 1935/2004  (and Member States implementations)
• China: General Safety Requirements for Food Contact Materials and Articles, Standard GB 4806.1-2016 
• China: General Safety Requirements for Food Contact Materials and Articles, Draft Standard GB 4806.1-20XX, April 2023
• USA: Food and Drugs, Indirect Food Additives, General, 21 CFR 174, Regulation, 1977
• Turkey: Materials and Articles in Contact with Food, Food Codex Regulation, April 2018
• Indonesia: Food Contact Materials and Packaging, Regulation No. 20/2019
• Indonesia: Food Contact Materials and Packaging, Draft Regulation, October 2023
• Saudi Arabia: Tools, Surfaces and Devices used for Food-Contact in Cooking – Amendment – (on updating list of products, etc) Technical Regulation, January 2021
• Denmark: Food Contact Materials and Penalties for Breaches Related to EU Legislation, Order No. 681, 2020
• EU: Recycled Plastic Materials and Articles Intended to Come into Contact with Foods, Regulation (EU) No 2022/1616
• Ukraine: Approving the Requirements for a Written Declaration of Food Contact Material Conformity, Order No. 1743, 2023

Good Manufacturing Practice (GMP) Regulation

• EU: Good Manufacturing Practice for Food Contact Materials, Regulation (EC) No 2023/2006
• China: General Hygiene Principles for the Production of Food Contact Materials and Products, Standard GB 31603-2015

Food Contact Material/Specific Regulations

• EU: Restriction of Certain Epoxy Derivatives in Food Contact Materials, Regulation (EC) No 1895/2005
• EU: Regenerated Cellulose Film Food Contact Materials, Directive 2007/42/EC
• EU: Ceramic Articles Intended to Come into Contact with Foodstuffs, Directive 84/500/EEC
• EU: Active and Intelligent Food Contact Materials, Regulation (EC) No 450/2009
• EU: Plastic Materials Intended to Come into Contact with Food, Regulation (EU) No 10/2011 & Other – Proposed Amendment – (on increasing quality control as regards recycled plastics, purity requirements for substances obtained from waste, natural materials, etc.) Draft Regulation, March 2024
• Egypt: Packages, Containers and Wrapping used for Food Products, Decision No. 73/2001
• China: National Food Safety Standard on Ceramic Food Contact Articles, Standard GB 4806.4-2016
• China: National Food Safety Standard on Inks for Food Contact Materials and Articles, Standard GB 4806.14-2023
• China: National Food Safety Standard on Silicone Rubber Materials and Articles Intended to Come Into Contact With Food, Draft Standard, October 2023
• Vietnam: Safety and Hygiene for Plastic Food Contact Materials, Technical Regulation, QCVN 12-1:2011/BYT, 2011
• USA: Indirect Food Additives: Adhesives and Components of Coatings, Rules, 21 CFR 175, 1977 
• Brazil: Approving the Technical Regulation on Regenerated Cellulose Films in Contact with Food, Resolution No. 217/2002
• Brazil: Silicones for the Production of Materials, Packaging, Coatings, and Equipment in Contact with Food – Draft Resolution, Public Consultation No. 1235, February 2024
• Brazil: Requirements on Metal Packaging, Coatings, and Other Equipment intended to Come into Contact with Food, Resolution RDC No. 854, 2024
• Mercosur: Technical Regulation on Positive List of Monomers, other Starting Substances & Polymers Authorized for the Manufacture of Food Contact Plastic Packaging & Equipment, Resolution MERCOSUR/GMC/RES No.02/12 – Proposed Amendment – (on positive list) MERCOSUR/LXXXV SGT N° 3/P.RES.Nº 10/23
• USA: Food and Drugs, Food Additives, 21 CFR 170, 1977 – Amendment – (on expiry of food contact substance notification requirement) Final Rule, 2024

We cover standards for our core products that are available from our partner Accuris. These are available through our Product Compliance Solution.

Why Compliance & Risks?

• Effectively Manage Risks in Your Supply Chain
• Easily Connect With Your Industry Requirements
• Global Product Compliance