Like all components of food contact materials, adhesives have to be compliant to Article 3 of EU Regulation 1935/2004 which means: No transfer of substances on/into the food in amounts which could endanger human health.
But no specific regulation in EU or member states how to implement this requirement.
Adhesive industry shall provide a proposal for future regulation which is a practicable solution for industry and considers the interests of consumer safety.
Most of the adhesive industry enterprises are SMEs
Specificity of adhesives
For formulation of adhesives approx. 4000 substances are used.
Each adhesive formulation is composed of up to 15 components.
Especially adhesives SMEs have a high degree on innovation and produce small scale tailor made formulations for specific applications.
In reactive adhesive types during application polymerization occurs at the curing step
Only a part of the substances is already evaluated on EU level (e.g. Plastics Directive 2002/72/EC) or on national level (e.g. German BfR Recommendation XIV plastics dispersions)
Toxicity testing of all used adhesive raw materials and subsequent evaluation by EFSA, as it would be necessary for a positive list, would take decades and produce an enormous cost burden.
Hundreds of materials would be out of scope, as they lack the information required by the risk assessment agencies.
A highly restricted pool of raw materials would limit innovation in the adhesive sector.
Approach of MIGRESIVES project for an alternative tool for showing and assuring consumer safety of adhesives in food contact applications
1. Classification of the adhesives components by theoretical evaluation, mathematical modelling and analytical experiments in:
Substances which do not migrate.
Substances which do not migrate at a given functional barrier (application, contact conditions).
Substances which have an SML in an EU list which cannot exceeded at the intended application.
Substances which have an SML which need to be measured.
Not yet evaluated substances, which can migrate in such amounts that a toxicological evaluation would be necessary.
2. Testing concept and tools for using and applying this classification to defined adhesives and adhesive applications by analysis methods and mathematical modelling.
Dr. Roland Franz
Dr. Angela Stoermer
Verfahrenstechnik und Verpackung
(Process Engineering and Packaging)