07.03.2016
More and more food is being produced industrially and distributed through retail chains. As a result, the production and sale of food is becoming increasingly regulated. Almost all countries now have detailed standards designed to ensure food safety. Since around half of all food is packaged, in addition to the food itself, its ingredients, and their declaration, food contact materials—such as labels—are also subject to regulations. In a three-part series of articles, we will use the European market as an example to illustrate how label printing is affected, what the implications are, and how these can be successfully addressed in practice. This first part deals with the fundamental question of the relevance of the regulations for label printers.
The Food Safety Regulation (EC) 178/202 serves as the umbrella regulation governing the production and marketing of foodstuffs. This is supplemented by regulations governing the handling of food contact materials and their production. The European Food Safety Authority (EFSA) defines food contact materials as any object intended to come into contact with food. These items must be manufactured in such a way that they cannot release anything into the food that is harmful to health, do not cause any unacceptable changes to the food, and do not affect the food organoleptically (sensory properties such as taste, smell, color, etc. Wikipedia). The following regulations mainly apply:
According to the EFSA definition, a label may also fall into the category of food contact materials and be subject to the relevant regulations. Indirect food contact via the migration of, for example, color components is treated as direct food contact in the regulation. A distinction between primary, secondary, and tertiary packaging is no longer provided for in the applicable EU regulations. This means that the migration risk, i.e., the risk of unwanted transfer of packaging components to the food, is of central importance in determining the production methods for a label.
The main risk with labels is diffusion or transfer (set-off), with UV ink posing a particularly high migration risk. The formulations of standard UV inks are not ideal for use on food contact materials and can lead to a significant migration risk. However, the substrate and auxiliary materials such as cleaning agents, oils and fats, plasticizers from ink rollers and printing plates, etc. must also be taken into account in a migration risk assessment.
As a general rule, the distributor bears legal responsibility for ensuring that both the food (contents) and the packaging comply with the relevant regulations. However, partial responsibility for the various packaging components is usually delegated to suppliers by means of a declaration of conformity. Every manufacturer of packaging components must therefore produce their share of the delivery in accordance with the applicable regulations and also prove this with a declaration of conformity. The label printer is thus obliged to produce the label in accordance with GMP guidelines and to comply with the migration values emanating from the label in accordance with the applicable regulations.
What sounds relatively simple in theory is much more difficult in practice. First and foremost is the fact that proof of conformity cannot be provided directly during the manufacture of a label and can only be obtained at great expense from an accredited institute. In addition, the respective migration properties depend on the contents, the barrier properties of the packaging, the storage conditions, the shelf life, and the further processing of the products. In practice, however, label printers are rarely aware of all these parameters and are unlikely to be able to provide analytical proof of compliance with migration values for every order. Reliable proof of conformity can therefore only be provided if there is cooperation along the entire value chain.
In addition to the legal consequences, it is above all the damage to their image that brand manufacturers and retail chains fear. Many of the major food manufacturers and retail chains have therefore already developed in-house standards based on EU regulations, which are applied accordingly within the value chain (e.g. Nestlé, REWE, and McDonald's).
Migration types (red frame = primarily to be considered in label printing)
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Self-assessment based on a simplified migration risk scenario
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Low-migration ink systems promise a way out of this situation. However, the term "low-migration" inks should not be confused with a standard or EU regulation. Rather, this term is used by ink manufacturers to describe UV printing inks that, when used correctly on the appropriate type of packaging, comply with legal requirements. Furthermore, the use of "low-migration" inks alone does not satisfy the regulations. Instead, the entire production process must be changed. This starts with sales, which needs to know significantly more about the specific intended use of the label, and ends with the printing press, which must be converted to low-migration production.
The impact of low-migration label production on a label printing company and what needs to be considered when switching to low-migration labels will be discussed in the second part of this series of articles in the next issue of Gallus In Touch.
More on this topic on the Internet:
http://www.efsa.europa.eu
07.03.2016
More and more food is being produced industrially and distributed through retail chains. As a result, the production and sale of food is becoming increasingly regulated. Almost all countries now have detailed standards designed to ensure food safety. Since around half of all food is packaged, in addition to the food itself, its ingredients, and their declaration, food contact materials—such as labels—are also subject to regulations. In a three-part series of articles, we will use the European market as an example to illustrate how label printing is affected, what the implications are, and how these can be successfully addressed in practice. This first part deals with the fundamental question of the relevance of the regulations for label printers.
The Food Safety Regulation (EC) 178/202 serves as the umbrella regulation governing the production and marketing of foodstuffs. This is supplemented by regulations governing the handling of food contact materials and their production. The European Food Safety Authority (EFSA) defines food contact materials as any object intended to come into contact with food. These items must be manufactured in such a way that they cannot release anything into the food that is harmful to health, do not cause any unacceptable changes to the food, and do not affect the food organoleptically (sensory properties such as taste, smell, color, etc. Wikipedia). The following regulations mainly apply:
According to the EFSA definition, a label may also fall into the category of food contact materials and be subject to the relevant regulations. Indirect food contact via the migration of, for example, color components is treated as direct food contact in the regulation. A distinction between primary, secondary, and tertiary packaging is no longer provided for in the applicable EU regulations. This means that the migration risk, i.e., the risk of unwanted transfer of packaging components to the food, is of central importance in determining the production methods for a label.
The main risk with labels is diffusion or transfer (set-off), with UV ink posing a particularly high migration risk. The formulations of standard UV inks are not ideal for use on food contact materials and can lead to a significant migration risk. However, the substrate and auxiliary materials such as cleaning agents, oils and fats, plasticizers from ink rollers and printing plates, etc. must also be taken into account in a migration risk assessment.
As a general rule, the distributor bears legal responsibility for ensuring that both the food (contents) and the packaging comply with the relevant regulations. However, partial responsibility for the various packaging components is usually delegated to suppliers by means of a declaration of conformity. Every manufacturer of packaging components must therefore produce their share of the delivery in accordance with the applicable regulations and also prove this with a declaration of conformity. The label printer is thus obliged to produce the label in accordance with GMP guidelines and to comply with the migration values emanating from the label in accordance with the applicable regulations.
What sounds relatively simple in theory is much more difficult in practice. First and foremost is the fact that proof of conformity cannot be provided directly during the manufacture of a label and can only be obtained at great expense from an accredited institute. In addition, the respective migration properties depend on the contents, the barrier properties of the packaging, the storage conditions, the shelf life, and the further processing of the products. In practice, however, label printers are rarely aware of all these parameters and are unlikely to be able to provide analytical proof of compliance with migration values for every order. Reliable proof of conformity can therefore only be provided if there is cooperation along the entire value chain.
In addition to the legal consequences, it is above all the damage to their image that brand manufacturers and retail chains fear. Many of the major food manufacturers and retail chains have therefore already developed in-house standards based on EU regulations, which are applied accordingly within the value chain (e.g. Nestlé, REWE, and McDonald's).
Migration types (red frame = primarily to be considered in label printing)
Self-assessment based on a simplified migration risk scenario
Low-migration ink systems promise a way out of this situation. However, the term "low-migration" inks should not be confused with a standard or EU regulation. Rather, this term is used by ink manufacturers to describe UV printing inks that, when used correctly on the appropriate type of packaging, comply with legal requirements. Furthermore, the use of "low-migration" inks alone does not satisfy the regulations. Instead, the entire production process must be changed. This starts with sales, which needs to know significantly more about the specific intended use of the label, and ends with the printing press, which must be converted to low-migration production.
The impact of low-migration label production on a label printing company and what needs to be considered when switching to low-migration labels will be discussed in the second part of this series of articles in the next issue of Gallus In Touch.
More on this topic on the Internet:
http://www.efsa.europa.eu