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 Control
Controls 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
Thank you
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