GMP 2023/2006 and Compliance

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GMP 2023/2006 and Compliance Joanna
Griffiths Technical Packaging Manager BRC Global
Standards
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EU Legislation

• Framework legislation on food contact materials
  1935/2006
• Good Manufacturing Practice 2023/2006
• Material specific legislation
• Regional legislation

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Overview of EC Packaging Legislation
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Overview of EU Food Contact Materials Legislation
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Overview of EU Food Contact Materials Legislation
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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

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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

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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

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Demonstrating Compliance
Traceability at all stages of manufacture

• Traceability
• Process Control
• Packaging Print Control

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Other Provisions Compliance Declarations

• Compliance declarations for relevant materials
• Written declaration to demonstrate compliance
  with specific legal requirements
• Available on demand

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Demonstrating Compliance
Compliance

• Declaration of Compliance
• Senior Management Commitment
• Specification and Document Control

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GMP
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2023/2006

• Focus is quality assurance
• Not jeopardising food safety or adversely
  affecting food
• Specific rules on inks and coatings
• Currently relevant in EU

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Requirements

• Not specific, so a system should be in place to
  demonstrate good manufacturing practice
• Quality assurance system
• Quality control system
• Documentation

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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
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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

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Demonstrating Compliance
Product Safety and Quality Manual
Documentation appropriate documentation with
respect to specifications and processing which
are relevant to compliance and safety of the
finished material.
Declaration of Compliance
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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

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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
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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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