Adhesives and Food Contact Materials (FCM)
What are food contact adhesives or glues?
Food contact adhesives or glues, are used to assemble two or more parts, surfaces of Food Contact Materials (FCM) together such as e.g. solid wood, solid bamboo, paper and board, cork etc.
Resins such as melamine resins or epoxy resins filled with e.g. wood or bamboo flower to make polymeric (plastic ) composites are not considered to be food contact adhesives or glues, they are plastics, and have to comply with Plastics Implementing Measure (PIM) Regulation (EU) 10/2011.
How are Food Contact adhesives regulated?
Adhesives for food contact articles have to fulfil the requirements of the Framework Regulation (EC) 1935/2004. Adhesives are mentioned in Annex I of this Regulation, along with sixteen other groups of food contact materials.
Only four from the seventeen groups of materials are harmonised by EU Directives or Regulations: plastics, ceramics, active and intelligent materials and generated cellulose.
For all other categorised materials in the framework regulation, including adhesives, special directives or regulations are planned in the future. At this moment national legislation applies to these materials in many EU Member States.
All available legislation for FCMs, regulated on member state level and or based on European directives and or regulations, have a certain way of applying restrictions in common. There are positive lists, negative lists, migration limits, residual or quantity limits in finished materials.
- Positive lists are lists of chemical substances, raw materials and or additives. Only those “positive” substances are allowed in the manufacture and or processing of FCMs. Authorised (positive) substances can be subject of migration limits or other restrictions;
- Negative lists are lists of chemical substances that are forbidden to use in the manufacturing or processing of FCMs;
- Residual or quantity limits are allowed concentration thresholds of chemical substances in the finished FCM;
- Migration limits are maximum allowable transfers (migration) of a certain chemical substance or a substance group from FCMs into food.
An analogy can be drawn from the information in the positive lists of other material groups. This is easy when adhesives are based on synthetic polymers. Most of the monomers and other raw materials needed for the production of adhesive polymers are listed and evaluated in the plastic Regulation (EU) 10/2011. To some of these substances, specific migration values and/or quantity limits have been allocated.
National measures for adhesives
On European level, there is are no regulated adhesive components by means of a directive or regulation.
The Plastics Implementing Measure (PIM) Regulation (EU) 10/2011 is used as a basis for several pieces of national legislation on adhesive used for/on paper, board, wood, cork and other materials.
The following EU member states have national measures for adhesives:
- Croatia for polymeric adhesives used in any food contact material;
- France for adhesives used in wood;
- Germany for adhesives used in paper and cardboard;
- Italy for adhesives used in paper and cardboard and regenerated cellulose films (RCF);
- The Netherlands for adhesives used in wood, cork, paper and cardboard;
- Spain for polymeric adhesives used in any food contact material.
What is the best approach to demonstrate safety of Food Contact Adhesives or glue?
Preferably the glue or adhesive ingredients should be listed in the positive Union List, that is included as Annex I of the plastics food contact materials regulation (EU) 10/2011. The applicable migration or thresholds in the final FCM are subject of potential laboratory analysis.
A food-grade declaration for the glue referring to the Union List is required and part of the technical file.
On this food-grade declaration, you shall find a statement that only substances are used that are listed in the Union List. The glue/adhesive ingredients for which restrictions apply should be mentioned on the food-grade declaration.
Otherwise, a laboratory cannot make a correct test protocol/plan, then it would be trying to find a needle in a haystack. The test plan must be based on the food-grade declaration of the adhesive used.
Remember that Good Manufacturing Practice (GMP ) is a mandatory part of the Food Contact Materials legislation. Knowing the used materials and substances is an important element of GMP.