Evaluation of Novel Plastic Additive for Food Contact Materials

The applicant has submitted a dossier in support of their application for the authorisation of ‘triphenyl phosphite, polymer with CHDM and polypropylene glycol, C10‐16 alkyl esters’ renamed by the Panel ‘phosphorous acid, triphenyl ester, polymer with 1,4‐cyclohexanedimethanol (CHDM) and polypropylene glycol, C10‐16 alkyl esters’ to be used in plastic FCM.
Additional information was provided by the applicant during the assessment process in response to requests sent by EFSA on 04 April 2023 (see Section 5).
In accordance with Art. 38 of the Commission Regulation (EC) No 178/2002² and taking into account the protection of confidential information and of personal data in accordance with Articles 39 to 39e of the same Regulation and of the Decision of the EFSA's Executive Director laying down practical arrangements concerning transparency and confidentiality,³ the non‐confidential version of the dossier is published on Open.EFSA.⁴According to Art. 32c(2) of Regulation (EC) No 178/2002 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre‐submission phase and public consultations,⁵ EFSA carried out a public consultation on the non‐confidential version of the application from 7 to 28 February 2024, for which no comments were received.
Data submitted and used for the evaluation are:
Non‐toxicological data and information–

Chemical identity

–

Description of manufacturing process of substance/FCM

–

Physical and chemical properties

–

Intended use

–

Existing authorisation(s)

–

Migration of the substance

–

Content and migration of oligomers

–

Identification, quantification and migration of reaction products and impurities

Toxicological data–

Bacterial gene mutation tests

–

In vitro mammalian cell gene mutation tests

–

In vitro mammalian cell micronucleus tests

–

28‐day oral toxicity studies in Wistar rats

–

A 90‐day oral toxicity study in Wistar rats

–

Reasoning on potential accumulation in human

–

Delayed neurotoxicity studies following acute exposure in white Leghorn hens