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

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
This overview isn’t intended to scare anyone, and it is available from the europa.eu website
You probably won’t be able to read this, but the visual is intended to show how the legislation is structured.

4. Overview of EU Food Contact Materials Legislation
These are the two areas that I’m speaking about today and this table is intended to show the structure of the legislation surrounding Food Contact Materials.
Framework Directive is at the top, and it’s clear that GMP legislation is intended to sit with it and be relevant to all of the specific material measures.

5. Overview of EU Food Contact Materials Legislation
It’s important to note that the vast majority of legislation is associated with Plastics, with some focus on cellulose film and ceramics.
The legislation for plastics is also relevant for coatings and is associated with migration limits, recycled material and recycled material content, as well as additives to the materials.
For all other materials, paper and board, glass, metals etc., it is expected that specific measures may be put in place and the Framework Directive sets out those groups of materials.

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
So, to start with the Framework legislation
- the Commission Regulation on Materials and Articles Intended to come into Contact with Food
As such it relates to all materials that could possibly come into contact with food, materials like refrigerator linings, kitchen work surfaces, as well as items such as food packaging and consumer disposable products such as paper plates and plastic knives and forks.
The crossover with the BRC Global Standard for Packaging is clear here, the Standard is applicable to all packaging and packaging materials.

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
The requirement of the Framework directive are based in Article 3.
Requiring that… (read through slide)
Active or intelligent packaging is permitted in the legislation as long as its function is not to mask spoilage.
It is very broad legislation, but it does supply three very pertinent questions for a packaging development technologist to ask his or her self when evaluating the suitability of packaging for a specific use.

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
The requirements in these clauses require and facilitate traceability through all stages of production.

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
Declaration of Compliance
Senior Management Commitment
Specification and Document Control
These requirements facilitate the evidence of compliance through a Declaration of Compliance for all finished products – packaging items.
Senior Management Commitment is required by the Standard, and this is partially demonstrated through awareness of legal requirements and technical changes in industry.
Specification and accurate documentation control can support the requirement of the Standard and the legislation.

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
The most noticeable feature of this piece of legislation is that it is very brief. There is no specific requirement.
The legislation requires that a manufacturer is able to demonstrate GMP through a quality control system and the appropriate documentation
The quality assurance system should take account of the site’s personnel, their knowledge and skills and the nature of the site. It should also be relative to the size of business, so nothing becomes too onerous on the company.
The quality control system should monitor performance against GMP and identify any areas of failure to be able to correct them.
The documentation requirements state that the business should maintain the appropriate documentation regarding specifications, manufacturing and processes that relate to the compliance and safety of the products.

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 Process Control
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 you Hvala vam što ste