Product Compliance Resources provided by ProductIP

2021-11-25

UK FCM legislation since Brexit

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

Retained EU laws for Food Contact Materials (FCMs)

Food Contact Materials (FCMs) are materials that are intended to be in contact with food. 

Prior to Brexit, certain EU laws for FCMs took effect in the UK. This EU legislation is still the basis for UK legislation. The EU has a legal EU framework for FCMs. The general principles of this Framework Regulation include traceability of FCMs and the raw materials and/or chemicals with which the FCMs are made or processed with, documentation, labelling, safety, inertness, etc. Next to the framework regulation, there is a Good Manufacturing Practices (GMP) regulation for FCMs. This GMP regulation stipulates the minimum requirements for the mandatory quality assurance and quality control (QA/QC) processes used to measure and assure the quality and the safety of FCMs. The FCM framework regulation has categorized 17 different materials in Annex 1 Only four of the seventeen materials are harmonised by EU regulations or EU directives. These four harmonised materials are plastics, ceramics, active and intelligent materials and regenerated cellulose film (RCF). Measures for specific FCMs are basically about inertness. Inertness means that during contact with the food no matter (molecules) from the FCM may migrate to the food.  The above described EU laws are implemented in England, Scotland, Wales and Northern Ireland. The UK government has made business guidance for retained EU laws.

Changes to UK FCM legislation since Brexit

In general, you may consider measures for specific FCMs as a kind of database of positive (authorised) substances which might be used in the manufacture or processing of FCMs. Even for authorised substances, restrictions might apply, such as migration limits or maximum allowable concentration in the final FCM.

In the UK specific FCM regulations only apply for four categories of FCMs, viz.;

  • plastic monomers and additives
  • active/intelligent materials (AIMs)
  • recycled plastic processes
  • regenerated cellulose film (RCF)

The measures for the above FCM categories are based on retained EU regulations.

Monomers, additives in plastic FCMs and additives in RCF

Authorised substances that were listed in the EU plastic regulation (EU) 10/2011 before January 1, 2021, are retained in UK legislation. Authorised substances that were listed in the RCF Directive 2007/42/EC before January 1, 2021, are also retained in UK legislation. New additives, monomers or other substances in the manufacture or processing of plastics or RCFs which are not listed in the applicable UK legislation are subject to authorisation. To apply for an authorisation the “UK regulated products application service must be used”. Substances which then are authorised will be listed in UK legislation. The UK government has made Food contact materials authorisation guidance.

AIMs and recycled plastic processes 

The positive lists for AIMs and recycled plastic processes have not yet been established in legislation. Until the positive lists are in place these products may be placed on the market or continue to operate in the UK if they meet the requirements of the General Food Law Regulations. For details please consult the Food contact materials authorisation guidance.

FCMs for which no specific UK FCM regulation exist

For many FCMs no specific UK regulations are applicable. In general, FCMs must comply with the General Food Law Regulations. Therefore the UK manufacturers or importers must be able to demonstrate the safety of none specific UK regulated FCMs. The UK is a member of the Council of Europe (CoE).  While the resolutions are not legally binding they are accepted as guidance documents in the absence of UK legislation. 

These resolutions cover plastic colourants, polymerisation aids, coatings, silicones, paper and board, cork, metals and alloys, ion-exchange resins, rubber and packaging inks.

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