Safety assessment of the substance poly(2‐hydroxypropanoic acid), n‐octyl/n‐decyl esters, for use in food contact materials
Abstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of poly(2‐hydroxypropanoic acid), n‐octyl/n‐decyl esters (OLA8), which is intended to be used as a plasticiser into polylactic acid (PLA) in contact with non‐fatty foods. OLA8 is intended to be u...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-07-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2023.8100 |
| _version_ | 1797754729924657152 |
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| author | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Andrew Chesson Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Laurence Castle Emma Di Consiglio Roland Franz Nicole Hellwig Stefan Merkel Maria Rosaria Milana Eric Barthélémy Remigio Marano Ellen Van Haver Gilles Rivière |
| author_facet | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Andrew Chesson Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Laurence Castle Emma Di Consiglio Roland Franz Nicole Hellwig Stefan Merkel Maria Rosaria Milana Eric Barthélémy Remigio Marano Ellen Van Haver Gilles Rivière |
| author_sort | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) |
| collection | DOAJ |
| description | Abstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of poly(2‐hydroxypropanoic acid), n‐octyl/n‐decyl esters (OLA8), which is intended to be used as a plasticiser into polylactic acid (PLA) in contact with non‐fatty foods. OLA8 is intended to be used at up to 5% and 15% w/w with or without starch, respectively (or with other additives with similar function). The migration for 10 days at 40°C from the film without starch was 0.16 mg/kg in 10% ethanol and 0.01 mg/kg in 3% acetic acid, while from the film with the starch it was well above 0.05 mg/kg food in all simulants. Some of the testing conditions were inconsistently reported. The substance did not induce gene mutations in bacterial cells and did not induce structural chromosomal aberrations or polyploidy in mammalian cells, thus, does not raise concern for genotoxicity. Instead of providing a 90‐day oral toxicity study, a hydrolysis study in ■■■■■ was submitted to read‐across from the authorised starting substances, ■■■■■ and the ■■■■■. However, the data provided did not allow to perform the read‐across, thus no appropriate toxicological data were provided to support migration above 0.05 mg/kg food (including for contact with 10% ethanol and use in combination with starch). The Panel concluded that OLA8 does not raise a safety concern for the consumer if it is used as an additive at up to 15% w/w in the manufacture of PLA articles that do not contain starch (and other additives with similar function), that are intended to be in contact for 10 days at 40°C with foods simulated by 3% acetic acid and from which the migration does not exceed 0.05 mg/kg food. |
| first_indexed | 2024-03-12T17:36:50Z |
| format | Article |
| id | doaj.art-84c5a431627744ee9dc3399948863e92 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-03-12T17:36:50Z |
| publishDate | 2023-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-84c5a431627744ee9dc3399948863e922023-08-04T10:16:08ZengWileyEFSA Journal1831-47322023-07-01217n/an/a10.2903/j.efsa.2023.8100Safety assessment of the substance poly(2‐hydroxypropanoic acid), n‐octyl/n‐decyl esters, for use in food contact materialsEFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Claude LambréJosé Manuel Barat BavieraClaudia BolognesiAndrew ChessonPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiMarcel MengelersAlicja MortensenInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornLaurence CastleEmma Di ConsiglioRoland FranzNicole HellwigStefan MerkelMaria Rosaria MilanaEric BarthélémyRemigio MaranoEllen Van HaverGilles RivièreAbstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of poly(2‐hydroxypropanoic acid), n‐octyl/n‐decyl esters (OLA8), which is intended to be used as a plasticiser into polylactic acid (PLA) in contact with non‐fatty foods. OLA8 is intended to be used at up to 5% and 15% w/w with or without starch, respectively (or with other additives with similar function). The migration for 10 days at 40°C from the film without starch was 0.16 mg/kg in 10% ethanol and 0.01 mg/kg in 3% acetic acid, while from the film with the starch it was well above 0.05 mg/kg food in all simulants. Some of the testing conditions were inconsistently reported. The substance did not induce gene mutations in bacterial cells and did not induce structural chromosomal aberrations or polyploidy in mammalian cells, thus, does not raise concern for genotoxicity. Instead of providing a 90‐day oral toxicity study, a hydrolysis study in ■■■■■ was submitted to read‐across from the authorised starting substances, ■■■■■ and the ■■■■■. However, the data provided did not allow to perform the read‐across, thus no appropriate toxicological data were provided to support migration above 0.05 mg/kg food (including for contact with 10% ethanol and use in combination with starch). The Panel concluded that OLA8 does not raise a safety concern for the consumer if it is used as an additive at up to 15% w/w in the manufacture of PLA articles that do not contain starch (and other additives with similar function), that are intended to be in contact for 10 days at 40°C with foods simulated by 3% acetic acid and from which the migration does not exceed 0.05 mg/kg food.https://doi.org/10.2903/j.efsa.2023.8100poly(2‐hydroxypropanoic acid)n‐octyl/n‐decyl estersplasticiserpolylactic acidPLAFCM substance No. 1088 |
| spellingShingle | EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) Claude Lambré José Manuel Barat Baviera Claudia Bolognesi Andrew Chesson Pier Sandro Cocconcelli Riccardo Crebelli David Michael Gott Konrad Grob Evgenia Lampi Marcel Mengelers Alicja Mortensen Inger‐Lise Steffensen Christina Tlustos Henk Van Loveren Laurence Vernis Holger Zorn Laurence Castle Emma Di Consiglio Roland Franz Nicole Hellwig Stefan Merkel Maria Rosaria Milana Eric Barthélémy Remigio Marano Ellen Van Haver Gilles Rivière Safety assessment of the substance poly(2‐hydroxypropanoic acid), n‐octyl/n‐decyl esters, for use in food contact materials EFSA Journal poly(2‐hydroxypropanoic acid) n‐octyl/n‐decyl esters plasticiser polylactic acid PLA FCM substance No. 1088 |
| title | Safety assessment of the substance poly(2‐hydroxypropanoic acid), n‐octyl/n‐decyl esters, for use in food contact materials |
| title_full | Safety assessment of the substance poly(2‐hydroxypropanoic acid), n‐octyl/n‐decyl esters, for use in food contact materials |
| title_fullStr | Safety assessment of the substance poly(2‐hydroxypropanoic acid), n‐octyl/n‐decyl esters, for use in food contact materials |
| title_full_unstemmed | Safety assessment of the substance poly(2‐hydroxypropanoic acid), n‐octyl/n‐decyl esters, for use in food contact materials |
| title_short | Safety assessment of the substance poly(2‐hydroxypropanoic acid), n‐octyl/n‐decyl esters, for use in food contact materials |
| title_sort | safety assessment of the substance poly 2 hydroxypropanoic acid n octyl n decyl esters for use in food contact materials |
| topic | poly(2‐hydroxypropanoic acid) n‐octyl/n‐decyl esters plasticiser polylactic acid PLA FCM substance No. 1088 |
| url | https://doi.org/10.2903/j.efsa.2023.8100 |
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