Risk analysis as a component of conformity work for food packaging

Ensuring the legal conformity of food packaging is an important aspect for packaging manufacturers to build trust among food producers. Conformity work is an integral part of all common GFSI standards such as the BRC Global Standard for Packaging, IFS PACSecure, FSSC 22000 and related legal requirements, e.g. the Regulation (EC) No. 2023/2006 on good manufacturing practices for materials and articles intended to come into contact with food.

The components fo conformity work include:

  • Legal requirements
  • Communication with customers
  • Raw material selection and evaluation
  • Process assessment and control
  • Assessment of the end product Documentation

Legal Requirements

The packaging manufacturer must always keep abreast of new legal requirements and changes. The interpretation of the requirements and the determination of the specific need for action by the company is particularly important.

Communication with customers

Here, it is recommended that all the requirements of food manufacturers or packers are determined and documented first. Some companies now use detailed questionnaires. The purpose of the packaging plays an essential role within the framework of order testing and development: Important parameters are temperature, type of packaging, storage time, heating processes and many more.

Raw material selection and Evaluation

The main question in this context is the suitability of the respective raw material for its intended purpose. To this end, detailed and up-to-date documentation from the supplier must be available and evaluated based on the following criteria:

  • Which substances does the raw material contain and what are the limit values?
  • Under which conditions are the limits observed?
  • What possible impurities does the raw material contain?
  • Does the raw material contain substances that are not listed in Annex I of the Regulation (EC) No. 10/2011 on plastic materials and articles intended to come into contact with food?
  • How was the safety assessment for these substances carried out?

Raw materials can only be approved if these questions have been positively clarified. Under certain circumstances, approval is also associated with certain restrictions. For example, it would be conceivable that an additive in a film may only be used up to a certain layer thickness.

Process assessment and Control

A risk analysis serves as a basis for the preparation of the process assessment and control (hazard and risk management system). The requirements for the risk analysis in the GFSI standards essentially follow the HACCP concept of the Codex Alimentarius. The risk analysis takes into account not only health hazards for end users, but also the functionality and quality (BRC Global Standard for Packaging) of the manufactured packaging.

Important questions in this context are:

  • What influence does the process have on the manufactured packaging material?
  • How is it ensured that only the correct raw materials are used?
  • How must the process parameters be chosen? (UV drying in offset printing, adherence to the recipe and curing times when using isocyanate-containing laminating adhesive, validation of the intermediate cleaning when using different ink systems on a printing press, etc.)
  • What are the dangers of intermixing and what measures are being taken?

Assessment of the end product

The main question within the framework of the assessment is: Is the finished product suitable for the specified application and legally secure? Fundamental investigations have established global migration, NIAS screening and organoleptic testing according to DIN 10955 (sensor technology standard). If necessary, compliance with specific migration limits must also be examined. This involves compliance with limit values for certain substances in packaging materials.


The crucial tasks within the framework of documentation relate to the creation of a legally compliant declaration of conformity, submission to the user and permanent updates of the documentation in case of changes.

About the author

Kerstin Bartsch is a food chemist and quality manager and has worked as an auditor and environmental management officer for many years. Anyone wishing to meet Ms. Bartsch on site will have the opportunity on 06 December 2019 in Cologne at our Event for packaging manufacturers (in German only).