EU Declaration of Compliance (DoC) for Food Contact Materials Guide

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Certain food contact materials must be accompanied by a Declaration of Compliance when sold or distributed in the European Union. This responsibility to issue a Declaration of Compliance generally falls on the manufacturer or other companies that introduce the product on the EU market

For context, food contact materials can refer to food packaging materials, drinking bottles, cutlery, and other products and materials in contact with food and beverages.

In this guide, we answer common questions about FCM Declaration of Compliance requirements in the EU.

Covered regulations

  • Plastic Materials Regulation (EU) 10/2011
  • Recycled Plastic FCM Regulation (EU) 2022/1616
  • Use of Bisphenol A in FCM Regulation (EU) 2024/3190
  • Restriction of Use of Certain Epoxy Derivatives in FCM Regulation (EC) 1895/2005
  • Ceramic FCM Directive 84/500/EEC
  • Active and Intelligent FCM Regulation (EC) 450/2009
  • Regenerated Cellulose Film FCM Directive 2007/42/EC
  • Polyamide and Melamine Plastic Kitchenware from China or Hong Kong SAR (China) Regulation (EU) 284/2011

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Food Contact Materials Regulations in the European Union: An Overview

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Food contact materials and articles imported or manufactured in the European Union are subject to various regulations. These regulations, wihch are often collectively referred to as Food Contact Materials (FCM) regulations, cover substance restrictions, documntation, labelling, testing and other requirements.

In this guide, we list many of the key EU FCM regulations and explain when these are relevant, and break down many of their respective requirements.
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Bisphenol A (BPA) Regulations in the European Union: An Overview

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Bisphenol A (BPA) is used to enhance the durability of plastics and can be found in food contact materials, toys, and other plastic products. The downside is that Bisphenol A also have a negative health impact, which is why the substance is subject to bans and restrictions in the European Union.

This guide explains how regulations such as the Use of Bisphenol A in FCM Regulation (EU) 2024/3190 and the Toy Safety Directive restrict the use of Bisphenol A.
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Single-Use Plastics Directive: An Overview

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Single Use Plastic Straws

The Single-Use Plastics Directive contains specific requirements and prohibitions that affect the manufacturing and importation of single-use plastic products, oxo-degradable plastics products, and fishing gear. These are products that are used only once or are used for a short period before being discarded.

This guide covers the Single-Use Plastics Directive and explains how it relates to certain plastic products. Additionally, we refer to implementing measures and commission guidelines and address common questions related to the Directive.
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Bisphenol A (BPA) Regulations in the United States: An Overview

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Bisphenol A (BPA) is an organic chemical used to improve durability and heat resistance in plastics. As such, it has long been used when manufacturing plastic products, from kitchen utensils and toys to certain medical devices.

That said, studies show that BPA may interfere with hormones, and cause other damage to the human body. It’s therefore not surprising that BPA is regulated in the United States, especially in food contact products designed for children.

In this guide, we explain what importers and manufacturers must know about BPA restrictions, including FDA 21 CFR, California Proposition 65, and other state regulations.

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Cookware Regulations and Standards in the United States

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Cookware Regulations in the United States
Cookware such as frying pans and woks are covered by food contact material regulations such as 21 CFR or even guidance documents, which for example might regulate lead or cadmium contamination in ceramic products.

Different requirements apply depending on the material, some of which are not even related to food contact materials. For example, specific requirements apply to wooden products and by extension wooden cookware.

In this guide, we cover relevant requirements for cookware such as substance restrictions, labeling, and testing.

Note that the products listed as examples in this guide might not always be specifically mentioned by the regulations. This is because the scope of most relevant regulations is based on specific substances or materials, not products.

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Food Contact Materials Regulations in the United States: An Overview

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Food contact materials comprise products and packaging that are meant to come into contact with food or drinks. This includes cookware, cutlery, and food containers. While the main focus of food contact materials regulations is the restrictions of substances that are deemed to be dangerous (e.g. heavy metals), other requirements might also apply – such as labeling.

In this guide, we summarize various food contact material regulations in the United States, including substance restrictions, labeling, documentation, and testing requirements.
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Cookware Regulations and Standards in the European Union

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Cookware Regulations in the European Union

Cookware imported and manufactured for sales in the EU are subject to various regulations, substance restrictions, labelling, documentation, and testing requirements. Some of these regulations are specific to various types of food contact materials.

But, there are also regulations and directives that cover consumer products in general, including cookware. Hence, this guide is not only covering food contact materials, but a broad set of compliance requirements for cookware as a category.

More specifically, we break down the requirements depending on the materials, as this impacts the applicable requirement.s

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Baby Feeding Bottle Standards and Regulations in the EU: An Overview

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Planning to import or manufacture baby feeding bottles in the European Union? Childcare products, including baby feeding bottles, are strictly regulated. More specifically, baby bottles must both meet strict mechanical safety standards, and food contact material regulations.

In this guide, we cover relevant safety standards, substance restrictions, labelling, documentation, and testing requirements.

In addition, this guide also covers compliance risks that baby feeding bottle importers and manufacturers must be aware of.

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Generally Recognized as Safe (GRAS) Guide for Importers and Manufacturers

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Generally Recognized As Safe
The US FDA designates substances as Generally Recognized as Safe (GRAS) if experts have determined via scientific processes that said substances do not pose any inherent health risks. Substances that are GRAS can be found on the FDA’s Food Additives Status List.

This guide covers what GRAS is, food ingredients that have been sanctioned before the implementation of the Federal Food, Drug, and Cosmetics (FD&C) Act, and which direct and indirect food substances are affirmed as GRAS.

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