Food contact materials play a crucial role within the production of food safe packages. Therefore, they must comply with all respective legal requirements. In-depth information on current food contact legislation is provided below to keep you up to date on the regulatory framework. Relative chemicals of interest and our portfolio of adhesive solutions are segmented by their respective packaging markets to help guide you through this resource of information on food safety.
A rising number of regulations and the strong demand to apply Good Manufacturing Practices (GMP) are building the framework for the design and production of food safe packaging and food contact materials.
With regard to food safety, the focus is on minimizing risks for human health caused by substances intentionally (IAS) or non-intentionally (NIAS) added during the various production stages. Producers of food products and their suppliers have to assure that for approved substances regulatory thresholds are not exceeded and that non-approved substances such as NIAS do not constitute a health risk.
Henkel Adhesive Technologies is providing product solutions and services that help you follow the respective legal requirements on safety of food contact materials.
The regulation (EC) No 1935/2004 contains general requirements but no precise instructions on how to demonstrate compliance. Article 3 of the European Regulation (EC) No 1935/2004 states that such food contact materials and articles shall not transfer their constituents into food in a quantity that could:
- Endanger human health
- Bring about an unacceptable change in the composition of the food
- Bring about deterioration in the organoleptic characteristics of the food
Adhesives have to be understood as a constituent of the food contact material. In addition, several EU member states have additional national regulations that apply to packaging materials and articles intended for food contact. Consequently, a risk assessment concerning migration and impact on the packed foodstuff has to be performed for each application.
Article 3 of EU Regulation (EC) No 1935/2004 and articles 5-7 of EU Regulation (EC) No 2023/2006 stipulate the implementation of Good Manufacturing Practices (GMP) in all operations producing packaging for food applications. GMP aims to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use.
Materials that are produced in accordance with GMP support producers of food packaging and food contact materials in their commitment to only market products that comply entirely with the European requirements for food contact materials. The European Adhesive Association FEICA has developed a GMP guideline that covers the manufacturing process of all adhesives and coatings used in the production of food contact materials with regard to the handling of hazards and food safety.
Besides the Framework Regulation, there are some material-specific regulations in place. The Plastics Regulation (EU) No 10/2011 is a specific measure for plastics in food contact. It does not apply to adhesives and coatings as it only governs plastic layers in multi-material-layers. Nevertheless, the Plastics Regulation lists specific migration limits (SML) for individual substances that have to be taken into account, with many of these also used in adhesives. Since these restrictions are based on toxicological data, no health risk is to be expected as long as they are not exceeded.
The screening of all migratable substances is essential for a proper risk assessment. At Henkel, we possess extensive knowledge about the relevant chemicals under discussion and offer comprehensive analytical services as well as in-house toxicological risk assessment capabilities. On this page, you will find knowledge on IAS/NIAS, SVHC, mineral oils and plasticizers.
In general terms, a food contact adhesive is composed mainly of intentionally added substances (IAS) and to some extent also of non-intentionally added substances (NIAS).
- Intentionally added substances (IAS) have a crucial function, e.g. for the technical performance or thermal stability
- Non-intentionally added substances (NIAS) could represent e.g.:
- Reaction by-products during the production process
Impurities that should not be present, e.g. deriving from improper use or insufficient cleaning of machines or contamination at the workplace
- Decomposition products from e.g. stabilizers or biocides
- Reaction by-products during the production process
NIAS may be formed along the entire value chain. Both IAS and NIAS listed in any regulation may safely be used as long as the regulatory restrictions are met. In this case, no separate risk assessment is necessary.
Any migratable substance not evaluated on EU or national level needs an individual in-house toxicological risk assessment to demonstrate compliance with Article 3 of Framework Regulation (EC) No 1935/2004.
The screening of (potential) chemicals under discussion is mandatory for several production processes. It requires a critical assessment of the health and environmental relevance of constituents in mixtures and articles.
Chemicals that are known to be very critical, so-called substances of very high concern (SVHC), require special attention in the risk assessment process. Article 55 of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation demands to assure that the risks from substances of very high concern are properly monitored and that these substances are progressively replaced by suitable alternative substances or technologies, if economically and technically viable. For such chemicals regulatory evaluations are considered.
Plasticizers are substances which are added to brittle materials to make them soft, ductile, or extendible, so that they can be worked more easily or acquire particular characteristics of use. The additives therefore can be found in plastics, varnishes, coating agents, sealing compounds, industrial and natural rubber articles, and adhesives.
Mineral oils have recently taken a centre stage within the food safety debate. These are not clearly defined chemical substances but highly complex mixtures of hydrocarbons with varying carbon numbers and structures. Due to this complexity, it is nearly impossible to carry out a proper toxicological risk assessment.
Mineral oil components are distinguished between MOSH (mineral oil saturated hydrocarbons) and MOAH (mineral oil aromatic hydrocarbons) components.
- The presence of carcinogenic and mutagenic substances therefore cannot be excluded.
- Such compounds may interact with the DNA, the genetic material of human cells, and can consequentially cause cancer.
- Animal studies show that MOSH may accumulate in granulomas in various tissues, mainly in liver and lymph nodes.
Non-evaluated mineral oils therefore need to be safely shielded off from the food by functional barriers. Some adhesives and inks used in packaging contain intentionally added mineral oil components.
Some mineral oil components are evaluated on European level and allowed for food contact applications or even as food additive (E905).
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