The Food Contact Materials Regulation: An Overview for Retailers

Anyone selling drinking bottles, shakers or other containers that come into contact with food has to know the food contact materials regulation. Breaches can carry serious penalties. In this article we give you a practical overview.

What are food contact materials?

Food contact materials (FCM) are all materials and articles intended to come into contact with food. The table below shows typical examples:

Product category	Examples
Drinking vessels	Drinking bottles, shakers, beakers, cups
Packaging	Food packaging, storage containers
Accessories	Kitchen utensils, chopping boards

The legal framework

Regulation happens on two levels that complement each other:

Level	Body of rules	Scope
EU level	Framework Regulation (EC) 1935/2004 + Regulation (EU) 10/2011	All EU member states, specific to plastics
National level	LFGB + the German consumer goods regulation	Germany — supplementary national requirements

The three basic rules

1. Safety

Materials must not release constituents in quantities that could endanger human health. This is verified through migration testing — described in detail in our article on EU quality standards.

2. Inertness

Materials must not change the composition, taste or odour of food unacceptably. In practice: water from your shaker must not taste or smell different.

3. Labelling

Products have to be labelled correctly. These details matter:

Labelling	Description
The glass-and-fork symbol	Alternatively the words "for food contact" or an indication of the intended use – none of this is needed where an article is clearly intended for food, such as a shaker
Material marking	The type of plastic used (PP or Tritan, for instance) – not required by the framework regulation, but common
Responsible company	Name and address of the responsible company in the EU
Batch number	For the traceability of every production batch

Migration testing: the heart of the regulation

What is tested?

• Overall migration: the total quantity of all substances passing from the material into a food simulant (max. 10 mg/dm²)
• Specific migration: the migration of individual substances that have their own limits

Test conditions

The tests simulate real conditions of use. Duration and temperature depend on the intended use, for example:

Simulant	Stands for	Conditions
10% ethanol	Aqueous foods and drinks	24h at 40°C
3% acetic acid	Acidic drinks	24h at 40°C
20% or 50% ethanol	Alcoholic drinks, dairy products	24h at 40°C
Vegetable oil	Fatty foods	24h at 40°C

BPA — regulated particularly strictly

Bisphenol A is one of the most heavily regulated substances. As we explain in our article on BPA, BPA is restricted in food contact materials in the EU. The EU has since gone further: BPA is now banned in principle in such materials, with transitional periods still applying to certain products.

A retailer's obligations

1. The declaration of conformity

Obtain the declaration of conformity from your supplier for every product and keep it on file. Overall, three points matter for a retailer:

Point	Details
Declaration of conformity	Confirms that EU rules are met and names the material and the intended use (such as temperature and contact time)
Traceability	Documentation: who you bought from, which businesses you supplied (one step forward, one step back)
Own checks	Recommended: samples to an independent laboratory, documents kept up to date, new suppliers checked especially thoroughly

Good to know: You do not have to present the declaration of conformity to the authorities unprompted, but you must make it available on request. If you pass the goods on to other businesses, pass the declaration on with them. Set up a digital archive, then you will find the document straight away.

The consequences of a breach

Breaches of the regulation can have considerable consequences:

Consequence	Details
Fine	Substantial fines; each member state sets its own penalties
Product recall	Withdrawal from the market and, where there is a risk, a public warning; the costs are borne by the responsible company
Criminal liability	Where health is endangered deliberately
RASFF notification	An EU-wide warning in the rapid alert system for food and food contact materials

Browse our shakers, drinking bottles and pill boxes in the product overview — all of them are BPA-free and compliant with Regulation (EC) No. 1935/2004.

In summary: compliance is a duty, not an option

The food contact materials regulation is complex, but unavoidable. As a retailer of drinking bottles and shakers you have to make sure your products meet every requirement. A supplier who can document the conformity of its products makes that process considerably simpler.

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Have questions about our products? Get in touch. Send us an enquiry — we are happy to advise you.