GMP 2023/2006 and Compliance Joanna Griffiths Technical Packaging Manager

1. GMP 2023/2006 and Compliance Joanna Griffiths Technical Packaging Manager BRC Global Standards

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

3. Overview of EC Packaging Legislation

4. Overview of EU Food Contact Materials Legislation

5. Overview of EU Food Contact Materials Legislation

6. 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

7. 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

8. 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

9. Demonstrating Compliance Traceability at all stages of manufacture • Traceability • Process Control • Packaging Print Control

10. Other Provisions: Compliance Declarations • Compliance declarations for relevant materials • Written declaration to demonstrate compliance with specific legal requirements • Available on demand

11. Demonstrating Compliance Compliance • Declaration of Compliance • Senior Management Commitment • Specification and Document Control

12. GMP…

13. 2023/2006 • Focus is quality assurance • Not jeopardising food safety or adversely affecting food • Specific rules on inks and coatings • Currently relevant in EU

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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. Thank youHvala vam što ste