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

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 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.

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.

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.

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.

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.

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

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

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.

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 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.

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 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

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 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

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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