Guidance on using the Register of Substances in Plastic Food Contact Materials

Introduction

This electronic register is for information purposes. It sets out a list of substances (monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids) permitted for use in plastic food contact materials (FCMs) in Great Britain and provides reference to the plastic FCM legislation. The register does not replace assimilated Regulation 10/2011 on plastic materials and articles intended to come into contact with food, which is the legal basis for the placing on the market and use of substances in plastic FCM.

Understanding the register fields

Substances permitted for use in plastic FCMs are not grouped into any particular category, though it is important to note that some may have specific restrictions.

Each substance in plastic FCM entry on the register includes its name, and where applicable:

• FCM number
• CAS number
• EEC packaging material reference No.
• Substance name
• Intended use
• Fat Consumption Reduction Factor (FRF)
• Specific migration limit (SML), including group restrictions (where applicable)
• Restrictions and specifications
• Specific notes on compliance

FCM number

The FCM number bears no specific relevance other than it was originally allocated to a substance based on the time of first entry to the register under the legislation.

CAS number

This is a unique identifier for chemical substances. Some may be modified substances, of which a CAS number may not be available.

Substance name

This will set out the chemical name of the substance. Some chemicals may not be identifiable by their common name and so it will be important to check all relevant fields.

Intended use

This will specifically set out what circumstances the substance can be used for. There are two categories:

• Use as additive or polymer production aid; and/or
• Use as monomer or other starting substance or macromolecule obtained from microbial fermentation

It will simply state yes/no as to whether any of the above categories are applicable.

An ‘additive’ means a substance which is intentionally added to plastics to achieve a physical or chemical effect during processing of the plastic or in the final material or article; it is intended to be present in the final material or article.

A ‘polymer production aid’ means any substance used to provide a suitable medium for polymer or plastic manufacturing; it may be present but is neither intended to be present in the final materials or articles nor has a physical or chemical effect in the final material or article.

‘Monomer’ or other starting substance’ means:

• a substance undergoing any type of polymerisation process to manufacture polymers; or
• natural or synthetic macromolecular substance used in the manufacture of modified macromolecules; or
• a substance used to modify existing natural or synthetic macromolecules

Fat consumption reduction factor (FRF)

The FRF is defined as: (Mass fraction fat in food (g fat/kg of food))/ 200. The potential for migration of a substance from a material into a fatty foodstuff is estimated based on the above formula.

Specific Migration Limit (SML)

This is the maximum permitted amount of a substance released from a material that can migrate into a food or food simulant. The limits are typically expressed in mg of substance per kg of food (mg/kg). It may indicate whether the substance belongs to a group of similar substances and include a separate specific migration limit (SML(T)). This means the maximum permitted sum of particular substances released in food or food simulants expressed as total of moiety of the substances indicated. Where non-detectable (ND) is indicated, the substance should not migrate in detectable quantities. A detection limit of 0.01 mg substance per kg food is applicable unless specified. Where no SML is provided, a generic specific migration limit of 60 mg/kg applies.

Restrictions and Specifications

This sets out restrictions other than the SML specifically mentioned (if applicable) and it contains specifications related to the substance.

Specific notes on compliance

If applicable this sets out the detailed rules applicable for verification of compliance for a substance. It may direct the reader to other sections.

Summary page

Individual substances in plastic FCM entries may be expanded into a summary page with additional information. This summary page includes links to the legislation of plastic materials and articles intended to come into contact with food.

Search

The register enables a free-text search of entries.

Authorised substances in plastic FCMs

This will set out the substances that have been authorised for use in plastic materials and articles intended to come into contact with food. There may be additional restrictions where indicated. If no additional information concerning specifications or restrictions is specified, a specific migration limit (SML) of 0.01 mg substance per kg food is applicable.