FEICA, the Association of the European Adhesive and Sealant Industry, publishes a summary report of a FEICA risk assessment on cyclic esters present in polyester adhesives intended to be used in food contact materials.
Encourages Downstream Users to Carry Out Risk Assessment
The report aims to provide information for downstream users to carry out their own risk assessments. Also, the report outlines the main findings and explains that human exposure to cyclic esters from polyester pre-polymers in food packaging adhesives is not relevant from a toxicological point of view.
Cyclic esters are of interest in food contact applications because small quantities of non-reactive cyclic esters are created as by-products alongside the high molecular weight chain polyesters used in the manufacture of laminating adhesives intended for use in food contact applications.
Use of Authorized Monomers for Plastic Materials in EU
In the European Union (EU), all polyesters used for laminating adhesives intended for use in food contact applications shall be based on monomers authorized to be used in plastic materials and articles intended to come into contact with foodstuffs according to the Plastics Regulation (EU) No. 10/2011.
The long-chain polymers of the polyester do not have migration potential, but the smaller cyclic esters could potentially migrate into the food. The cyclic esters are non-intentionally added substances (NIAS) and therefore require a risk assessment. European Food Safety Authority’s (EFSA) note for guidance for petitioners’ states that migratable substances from food packaging with a molecular weight of less than 1000 Da are important from the toxicological point of view as they could be absorbed in the gastrointestinal tract.
Cyclic Esters Task Force Developed Assessment Document
FEICA created a Cyclic Esters Task Force comprising several member companies who shared study results and expertise with the aim of developing a risk assessment document to assist downstream users in their risk assessments.
ChemSafe facilitated data sharing and developed common risk assessment. The data suggests the human exposure to cyclic esters representing Non-intentionally Added Substances (NIAS) from polyester pre-polymers in adhesives in food packaging applications does not present a risk to consumers. Attention should be paid to food packaging systems that generate cyclic esters containing ortho-phthalic acids because they does not hydrolyze and exposure to these NIAS could be different than to other cyclic esters since they exhibited different behavior in the above mentioned studies.
Impact of Ortho-phthalic Esters in Food Packaging
On 4 June 2020, FEICA organized a webinar on a FEICA risk assessment for cyclic esters, which was attended by more than 100 registrants. Dr. Matthias Frischmann, food chemist and head of corporate analytics at Henkel in Düsseldorf, introduced the topic of cyclic esters, explained the risk assessment that was carried out and the responsibilities of each actor in the supply chain of polyurethane (PU) and heat seal adhesives.
“
More investigation is needed to better understand the impact of ortho-phthalic esters from food packaging. The Summary Report is based on the current state of knowledge. Further evaluation will be possible in the case that new data becomes available. In the meantime, FEICA hopes that the document will assist downstream users in their risk assessment activities,” said Jana Cohrs – Rahmoun, executive director regulatory affairs of FEICA.
Source: FEICA