GMP 2023/2006 and Compliance

Joanna Griffiths

Technical Packaging Manager

BRC Global Standards

EU Legislation• Framework legislation on food contact

materials 1935/2006

• Good Manufacturing Practice 2023/2006

• Material specific legislation

• Regional legislation

Overview of EC Packaging Legislation

Overview of EU Food Contact Materials Legislation

Overview of EU Food Contact Materials Legislation

Scope of 1935/2004• The Framework Regulation

– Commission Regulation (EC) No. 1935/2004 on Materials and Articles Intended to come into Contact with Food (as amended)

• Applies to materials and articles which are: – Intended to be brought into contact with food– Already in contact with food and were

intended for that purpose– Reasonably expected to be in contact with

food under foreseeable conditions of use

Requirements• Food contact materials should be

manufactured in such a way that they do not transfer constituents to food in quantities which would: – Endanger human health– Bring about an unacceptable change in the

composition of food– Bring about a deterioration in the organoleptic

characteristics of food

Other Provisions: Traceability• Mirrors traceability requirements for food

producers, materials and articles– Treated as an ingredient

• Traceability at all stages

• ‘One forward, one back’ principle

Demonstrating Compliance

Traceability at all stages of manufacture

• Traceability• Process Control • Packaging Print Control

Other Provisions: Compliance Declarations

• Compliance declarations for relevant materials– Written declaration to demonstrate

compliance with specific legal requirements– Available on demand

Demonstrating Compliance

Compliance

• Declaration of Compliance• Senior Management

Commitment• Specification and

Document Control

GMP…

2023/2006• Focus is quality assurance

– Not jeopardising food safety or adversely affecting food

• Specific rules on inks and coatings– Currently relevant in EU

Requirements• Not specific, so a system should be in

place to demonstrate good manufacturing practice

– Quality assurance system– Quality control system– Documentation

Demonstrating Compliance

Quality Assurance System

“total sum of… arrangements made with the purpose of

ensuring materials and articles are of the quality required to ensure conformity with the rules applicable to them.”

Quality Management Policy

Demonstrating Compliance

Quality Control System“…ensure compliance of

starting materials and intermediate and finished

materials and articles with the specification determined…”

• Process Control, • Hazard and Risk Analysis

Demonstrating Compliance

Documentation“…appropriate

documentation… with respect to specifications… and

processing which are relevant to compliance and safety of the

finished material.”

Product Safety and Quality Manual

Declaration of Compliance

Inks & Coatings• Relevant due to Mineral Hydrocarbon

migration issues recent in EU

• Guideline on GMP for inks/coatings– Formulated/applied to prevent set-off

– Handled to prevent set-off

– Printed surfaces not in direct contact with food

Inks & Coatings

Detailed Rules•Eliminate set-off in formulation and handling•No direct contact with food

Process ControlControls can be set in place to ensure minimisation of risk of

contamination

Summary• Compliance with GMP requirements

depends on knowledge of industry

• Compliance with the BRC/IOP Global Standard for Packaging and Packaging Materials can aid and demonstrate compliance

• Legislation designed to minimise risk of current and future food safety issues arising from packaging

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