Stress free guide to product compliance

2021-03-08
ProductIP
Expert

Polymeric food contact materials

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

Polymeric materials

Plastic, rubber and silicone materials contain polymeric materials and other chemicals.
Polymeric materials are useful chemicals made of many repeating units (monomers). These polymers can be made by one or a few types of monomers. In the manufacture of polymers are beside certain monomers all kind of other chemicals used such as such solvents, catalysts, polymerisation accelerators and inhibitors.

A single polymer does almost never comprehend the required properties for certain applications. Plastic additives are used to manufacture polymeric materials that have all desired properties, such as strength, colour, heat resistance, etc. Beside plastic additive chemicals, polymers can also be blended in order to obtain certain material properties.

Legislation for polymeric food contact materials

Plastics (including recycled plastic) are covered by specific harmonised legislation in the European Union. Rubbers (elastomers) and silicones are also covered by legislation but that is not yet harmonised in the EU.

The most comprehensive EU legislation on food contact materials is Regulation (EU) 10/2011 on plastic materials and articles. It sets the rules on the composition of plastic FCMs, and establishes a Union List of substances that are permitted for use in the manufacture of plastic FCMs. The Regulation also specifies restrictions on the use of these substances and sets rules to determine the compliance of plastic food contact materials and articles.

Adequate data on the composition of (intermediate) materials has to be communicated via the manufacturing chain, up to but not including the retail stage.

It is required to create an inventory of all polymers present in the plastic blend. For each individual polymer an inventory must be made of the chemicals used in the manufacture.
Which monomers, starting substances and processing aids have been used in the manufacture of the polymer?
These chemicals must be present in the Union List. For many authorised chemicals in the Union List restrictions might apply, such as migration limits or maximum allowed residual concentrations in the final material.
If restrictions for used chemicals are applicable, then compliance evidence must be obtained.
By blending and processing of polymers and plastic additives the final food contact material is made.

The mixing of one or more different polymers with additives is called compounding.
Again, only plastic additives which are listed in the union list might be used for plastic FCMs. For many listed additives certain restrictions apply such as migration limits or maximum allowed residual concentrations in the final material.

For polymeric materials other than plastics (such as rubber) legislative requirements are based on the same principles as stipulated in Regulation (EU) 10/2011. However instead of a single Union List, there are several authorised substance lists with accompanying restrictions applicable for certain EU member states only.

The Council of Europe (CoE) published Resolution ResAP(2004)4 on rubber materials intended to come into contact with foodstuffs. In absence of harmonised EU legislation related to rubber this resolution can be applied as guidance related to the general food contact materials requirements framework Regulation (EC) 1935/2004.

Inventory of compounding formulations

For the mandatory declaration of compliance you must investigate which polymers are in the final plastic, rubber or silicone FCM. The same applies for all used additives. And for the additives for which restrictions apply you must declare compliance for the final food contact materials on the mandatory EU Declaration of Compliance.

For the polymers applied in the final plastic, rubber or silicone FCM you must investigate if authorised chemicals have been used for which restrictions apply. For these chemicals you must also declare compliance with restrictions applicable for the final food contact materials on the mandatory EU Declaration of Compliance.

Inventory of a polymer recipes

Manufacturers of polymeric materials will normally not submit you all details regarding the chemicals used in the manufacture of polymeric granulate for further processing into a plastic, rubber or silicone blend.
However the responsible entity that is placing polymeric food contact materials on the EU market shall demand food grade declarations from the manufacturers of used raw materials.
This food grade declaration must be not confused with a "declaration of compliance" .
A food grade declaration states that only substances are used which are mentioned in authorised lists such as the Union List in Regulation (EU) 10/2011 for plastics or other national lists applicable for rubbers and silicones.

Only authorised listed substances for which restrictions apply must be explicitly mentioned on the food grade declaration. The restriction itself must also be mentioned on the food grade declaration.

Links:
Regulation (EU) 10/2011 on plastic food contact materials and articles; consolidated version 29/08/2019.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02011R0010-20190829

Council of Europe's Resolution ResAP(2004)4 on rubber products intended to come into contact with foodstuffs.
https://rm.coe.int/09000016804e9fce

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