Joint Expert Groups

FCMJEG

1.170          The COT considered risk assessments prepared by the Joint Expert Group on Food Contact Materials (FCMJEG) regarding the following regulated product applications:

• On the safety of the use of phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate (HEMAP) as a component in the manufacture of kitchen countertops and sinks. This assessment was for HEMAP only, and not the final reaction mixture used in the manufacture. The final assessment was published in July 2024.
• On the safety of the use of calcium tert-butylphosphonate as an additive used in the manufacture of plastic materials and articles intended to come into contact with food. The final assessment is expected to be published early 2025.

On the safety of the recycling processes:

• Document on the evaluation of the recycled poly(ethylene terephthalate) decontamination process operated by LINPAC for use in the manufacture of articles in contact with food.
• On the recycled poly(ethylene terephthalate) decontamination process operated by Wellman Neufchâteau Recyclage (subsidiary of Indorama Ventures) for use in the manufacture of materials and articles in contact with food.
• On the evaluation of the safety of the process for the recycling of post-consumer poly(ethylene terephthalate) into food contact materials.

1.171          These items above are currently reserved as the Committee Advice Papers are not currently published.

Committee Advice Document on the safety of 2-hydroxyethyl methacrylate phosphate as a monomer for use in the manufacture of plastic food contact materials and articles

1.172          The COT considered a Committee Advice Document (CAD) prepared by the Joint Expert Group on Food Contact Materials (FCMJEG) regarding an application for 2-hydroxyethyl methacrylate phosphate (HEMAP) as a monomer in a commercial product for use in the manufacture of kitchen countertops and sinks that are intended for contact with all types of food (RP1190).

1.173          All components of the commercial product are listed in assimilated Regulation EU No. 10/2011 on plastic materials and articles intended to come into contact with food. The application and the following assessment are for HEMA only, not the commercial product.

1.174          Satisfactory information regarding the identity of substance, physical and chemical properties, intended application of substance, data on migration of substance and toxicological data were submitted.

1.175          The toxicological information that formed the basis of the risk assessment was a bacterial reverse mutation test (Ames test), and an in vitro mammalian micronucleus test, on the commercial product. Results of the Ames test and in vitro micronucleus (MN) test showed no mutagenic, clastogenic or aneugenic potential for the commercial product under the experimental conditions described.

1.176          The specific migration of the sum of HEMAP plus its phosphate and diphosphate esters under the worst-case conditions of use was 24.8 µg/6 dm2 (assumed that this is equivalent to contact with 1 kg food). Taking into account that the specific migration of the sum of HEMA plus its phosphate and diphosphate esters is not expected to exceed 50 µg/kg food and the negative results in the Ames and in vitro micronucleus tests, the FCMJEG proposed a specific migration limit (SML) of 0.05 mg/kg food for HEMA.

1.177          Overall, the COT considered the information and data provided in the FCMJEG CAD sufficient to conclude that there was no concern for a risk to human health from the use of HEMA in the specific final commercial mixture in the manufacture of kitchen countertops and sinks up to a maximum percentage in formulation of 0.35%.

1.178       The full FCM JEG CAD can be found at: FCMJEG Applications | Committee on Toxicity.

Committee Advice Document on calcium tert-butylphosphonate as an additive for use in the manufacture of plastic food contact materials and articles

1.179       The COT considered a Committee Advice Document (CAD) prepared by the FCMJEG regarding an application for calcium tert- butylphosphonate as an additive used in the manufacture of plastic materials and articles intended to come into contact with food (RP1702). 

1.180       The information on the identity of calcium tert- butylphosphonate, the physical and chemical properties and intended application were considered satisfactory.

1.181       Results from the overall and specific migration tests from the plastic to the test food demonstrated the migration of calcium tert-butylphosphonate to be close to or below the limit of detection (up to 10 μg/kg).

1.182    Owing to the low migration of calcium tert-butylphosphonate as an additive under the conditions of use specified in the application, limited toxicology testing was required. Results of the Ames test and in vitro micronucleus (MN) as tests for possible carcinogenicity and genotoxicity, test showed no mutagenic, clastogenic or aneugenic potential for the commercial product under the experimental conditions described. 

1.183       The FCM JEG concluded that calcium tert-butylphosphonate is unlikely to be of concern for potential genotoxicity, especially based on the likely low exposure to humans.  

1.184       Overall, there is unlikely to be a risk to health from the use of calcium tert-butylphosphonate as an additive in the manufacture of plastic materials and articles intended to be in contact with food. However, the potential health risk to infants <younger than 16 weeks via feeding bottles could not be assessed because infants <younger than 16 weeks are expected to be exclusively fed on breast milk and/or infant formula. There is a lack of data including exposure data for this age group.  

1.185       Calcium tert-butylphosphonate was therefore recommended for approval. Risks associated with calcium tert-butylphosphonate in infants was not assessed for use as an additive to plastics as outlined in the application and specified above other than for uses with contact with infant formula and human milk.   

1.186       The full FCM JEG CAD is due to be published shortly and can be found at: FCMJEG Applications | Committee on Toxicity. 

AEJEG assessments

1.187       The COT also considered Risk Assessments prepared by the Joint Expert Group on Additives, Enzymes and other Regulated Products (AEJEG) regarding the following regulated product applications:

• Committee Advice on the safety of the Application to modify the conditions of use of E 401 (sodium alginate) for use as a surface treatment in entire fruits and vegetables.
• Extension of use of nisin (E 234) to a new food category “egg analogues”.
• Application for a change in the steviol glycoside specification in the United Kingdom to include a new manufacturing method for Steviol Glycosides including Rebaudioside D.
• Authorisation of new food additive substance Glycolipids.

1.188       All items are currently reserved as they cover draft AEJEG Committee Advice Papers not currently published.

1.189       AEJEG Committee Advice Papers will be published in 2025.