The EFSA Journal (2008) 628-633, 1-19

Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on a request related to a 18th list of substances for food contact materials Question N° EFSA-Q-2007-167, EFSA-Q-2006-0177, EFSA-Q-2005-152, EFSA-Q-2007-0022, EFSA-Q-2007-0004, EFSA-Q-2007-024

Adopted on 31 January 2008

SCIENTIFIC PANEL MEMBERS Fernando Aguilar, Herman Autrup, Sue Barlow, Laurence Castle, Riccardo Crebelli, Wolfgang Dekant, Karl-Heinz Engel, Nathalie Gontard, David Gott, Sandro Grilli, Rainer Gürtler, John Christian Larsen, Jean-Charles Leblanc, Catherine Leclercq, François Xavier Malcata, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Ivonne Rietjens, Paul Tobback, Fidel Toldrá.

SUMMARY

Within the general task of evaluating substances intended for use in materials in contact with food according to the Regulation (EC) No.1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with foodstuffs, the AFC Panel evaluated the following substances: Ref. No.: Name of the substance: CAS number: SCF_List: Restriction: Remark for Commission:

18117 Glycolic acid 79-14-1 3 Only to be used behind a PET layer None

© European Food Safety Authority, 2008

18th list of FCM substances

Ref. No.: Name of the substance: CAS number: SCF_List: Restriction: Remark for Commission:

40155 N,N'-Bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N'diformylhexamethylenediamine 124172-53-8 3 0.05 mg/kg food Migration from polyolephines may exceed this restriction Migration into fatty foods may exceed this restriction

Ref. No.: Name of the substance: CAS number: SCF_List: Restriction: Remark for Commission:

62215 Iron 7439-89-6 3 None The substance is intended for use in PET based food contact materials

Ref. No.: Name of the substance: CAS number: SCF_List: Restriction: Remark for Commission:

72141 2,2’-(1,4-Phenylene)bis[4H-3,1-benzoxazin-4-one] 18600-59-4 3 0.05 mg/kg food, including hydrolysis products Fat consumption Reduction Factor (FRF) is applicable

Ref. No.: Name of the substance: CAS number: SCF_List: Restriction: Remark for Commission:

76807 Polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1-hexanol 073018-26-5 2 Group-TDI: 0.5 mg/kg .b.w. (with Ref. Nos. 76780, 76790, 76866) FRF is applicable

Ref. No.: Name of the substance: CAS number: SCF_List: Restriction: Remark for Commission:

92200 Terephthalic acid, bis(2-ethylhexyl)ester 6422-86-2 2 TDI = 1 mg/kg bw None

The EFSA Journal (2008) 628-633, 2-19

18th list of FCM substances

KEYWORDS Food Contact Materials, Plastics, Monomers, Additives, Ref. No. 18117, CAS number 79-14-1, Glycolic acid; Ref. No 40155, CAS No. 124172-53-8, N,N'-Bis(2,2,6,6-tetramethyl-4-piperidyl)N,N'-diformylhexamethylenediamine; Ref. No. 62215, CAS number 7439-89-6, Iron; Ref. No 72141, CAS No 18600-59-4, 2,2’-(1,4-Phenylene)bis[4H-3,1-benzoxazin-4-one]; Ref. No 76807, CAS No 073018-26-5, Polyester of adipic acid with 1,3-butanediol, 1,2-propanediol and 2-ethyl-1hexanol; Ref. No. 92200, CAS number 6422-86-2, Terephthalic acid, bis(2-ethylhexyl)ester.

BACKGROUND Before a substance is authorised to be used in food contact materials and is included in a positive list EFSA´s opinion on its safety is required. This procedure has been established in Articles 8 and 9 of the Regulation (EC) No. 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food 1 . TERMS OF REFERENCE The EFSA is required by Article 10 of Regulation (EC) No. 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food to carry out risk assessments on the risks originating from the migration of substances from food contact materials into food and deliver a scientific opinion on: 1. 2.

new substances intended to be used in food contact materials before their authorisation and inclusion in a positive list; substances which are already authorised in the framework of Regulation (EC) No. 1935/2004 but need to be re-evaluated.

ACKNOWLEDGEMENTS The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food wishes to thank Herman Autrup, Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Wolfgang Dekant, Roland Franz, Nathalie Gontard, Eugenia Lampi, Jean-Claude Lhuguenot, François Xavier Malcata, Maria Rosaria Milana, Karla Pfaff, Tjoena Siere, Paul Tobback, Detlef Wölfle* and Esther Zondervan* for their contribution to the draft opinion. * D. Wölfle, expert of the working group, declared that he had participated in the evaluation of the substance Ref. No. 92200 by the national food safety authority of Germany. This was not considered as a conflict of interest. It was not considered as a conflict of interest and he was invited to participate in the discussions. Esther Zondervan, expert of the working group, declared an interest for the substance Ref. 18117, 62215 and 76807 as the TNO has submitted the dossiers on behalf of applicant. This was considered as a conflict of interest. Thus she has left the room during the discussion. He has stayed in the room only to answer questions. 1

This Regulation replaces Directive 89/109/EEC of 21 December 1988, OJ L 40, 11.2.1989, P.38 The EFSA Journal (2008) 628-633, 3-19

18th list of FCM substances

ASSESSMENT Within this general task the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) evaluated the following substances used in food contact materials. The substances examined are listed in ascending order of their Reference Number (REF No.), with their chemical name, Chemical Abstract Number (CAS No.) and classification according to the “SCF list”. (Since in the past the evaluation of substances used in food contact materials was undertaken by the Scientific Committee on Food (SCF), the same system of classification into a “SCF list” is retained for uniformity purposes). The definitions of the various SCF lists and the abbreviations used are given in the appendix. The studies submitted for evaluation followed the SCF guidelines for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation (http://ec.europa.eu/food/fs/sc/scf/out82_en.pdf).

Ref. No.: Name of the substance: CAS number: Document reference:

18117 Glycolic acid 79-14-1 SDS EFSA/AFC/FCM/1139-Rev.0A/18117 of January 2008

General information:

Glycolic acid is naturally present in a variety of fruits, vegetables, meats, and beverages at concentrations up to 50 mg/kg (Harris and Richardson, 1980). According to the petitioner glycolic acid is intended to be used as a monomer for polyglycolic acid (PGA) which is used as a middle layer of multi-layer structures with poly(ethylene terephthalate) (PET), e.g. PET/PGA/PET bottles. The final product is intended for contact at room temperature with aqueous, acidic and alcoholic foods containing up to 15% v/v ethanol.

Previous evaluations (by SCF or AFC):

None (new substance)

Available data used for this evaluation: Non-toxicity data: Toxicity data: -

Data on identity Data on physical and chemical properties Data on the intended use and authorisation of the substance Data on migration of the substance Data on oligomers Gene mutation in bacteria In vitro chromosomal aberrations in cultured mammalian cells The EFSA Journal (2008) 628-633, 4-19

18th list of FCM substances

Ref. No.: Name of the substance:

18117 Glycolic acid - In vitro mammalian cells gene mutations - In vivo mouse bone marrow micronucleus test

Evaluation:

Glycolic acid is a hydrophilic acid stable up to 100 °C. The migration of glycolic acid, its dimer (diglycolic acid) and its cyclic dimer (glycolide), from a 330 ml PET/PGA/PET bottle which contained a PGA layer with a thickness at the requested level, was determined in 10% ethanol and 3% acetic acid. The test conditions were 10 days at 40 °C for both 3% acetic acid and 10% ethanol and 30 days at 40 °C for 10% ethanol. The surface to volume ratio was 7.6 dm²/kg food. There was no detectable migration of glycolic acid, diglycolic acid or glycolide at a detection limit of 34 µg/kg in all cases. No migration of oligomers of glycolic acid was detected in the same simulants under similar testing conditions. Glycolic acid did not induce mutagenicity or chromosome aberrations in mammalian cells. In a bacterial reversion test glycolic acid was weakly mutagenic to the E. coli strain TA W2 only in presence of metabolic activation and negative for S. typhimurium strain. An in-vivo micronucleus assay in mouse gave negative results. The positive result in bacteria is overruled by the clearly negative results obtained in mammalian cells in vitro and in viv. Accordingly, based on the available data on mutagenicity and chromosomal aberration, glycolic acid is considered as nongenotoxic. The same conclusion was drawn by the US-EPA in 2001 (US-EPA, 2001). In 2004, the Scientific Committee for Cosmetics and Non-Food Products (SCCNFP, 2004) concluded that glycolic acid may be safely used in cosmetics at a concentration up to 4%.

Conclusion: SCF_List: Restriction: Remark for Commission: Needed data or information:

References:

Based on the above-mentioned data the substance is classified: 3 Only to be used behind a PET layer None None

-

Unpublished data submitted by the petitioner, July 2007 The EFSA Journal (2008) 628-633, 5-19

18th list of FCM substances

Ref. No.: Name of the substance:

18117 Glycolic acid - Harris KS., Richardson KE., 1980: Glycolate in the diet and its conversion to urinary oxalate in the rat. Investigative Urology, 18, p. 106-109. - SCCNFP, 2004: Position paper on the safety of alpha-hydroxy acids. SCCNFP/0370/00, 28.6.2000 and SCCNFP/0799/04 adopted by the SCCNFP during the 28th plenary meeting of 25 May 2004: Evaluation and opinion on Alpha- hydroxy acids. http://ec.europa.eu/health/ph_risk/committees/sccp/documents/ out284_en.pdf - US-EPA, 2001: Dupont/Glycolic Acid Test Plan & Robust Summary 08-17-2001, http://www.epa.gov/HPV/pubs/summaries/glyclacd/c13125.pdf

Ref. No.: Name of the substance:

40155 N,N'-Bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N'diformylhexamethylenediamine 124172-53-8 EFSA/AFC/FCM/848-Rev.IA/40155 of November 2007

CAS number: Document reference: General information:

According to the petitioner N,N’-Bis(2,2,6,6-tetramethyl-4piperidyl)-N,N’-diformylhexamethylenediamine is a UV light stabilizer intended to be used in all kinds of polymers. It is mainly for use in polystyrene (PS), high impact polystyrene (HIPS), acrylonitrile-butadiene-styrene copolymers (ABS) and polypropylene (PP). Final materials are intended to come in contact with all types of aqueous foodstuffs and without restrictions concerning contact time and temperature. Major foreseen food contact applications are kitchen equipment (ABS or PP), disposable cutlery or disposable cups (PS/HIPS) and big bags made from PPtapes, e.g. for the packaging of bulk quantities of flour and similar dry food.

Previous evaluations (by SCF or AFC):

None (new substance)

Available data used for this evaluation: Non-toxicity data: -

Data on identity, physical and chemical properties Data on intended use and authorisation of the substance The EFSA Journal (2008) 628-633, 6-19

18th list of FCM substances

Ref. No.: Name of the substance:

40155 N,N'-Bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N'diformylhexamethylenediamine Data on migration of the substance and its impurities Data on the residual content

Toxicity data: -

Evaluation:

Gene mutation in bacteria In vitro chromosomal aberrations in cultured mammalian cells In vitro gene mutation in cultured mammalian cells Bone marrow micronucleus test in mice 28-day repeated dose toxicity study in rats Prediction of toxicokinetics

Specific migration tests were carried out using a HIPS sample containing 0.5% of N,N’-Bis(2,2,6,6-tetramethyl-4-piperidyl)-N,N’diformylhexamethylenediamine. The migration in 10 % ethanol was lower than the detection limit (0.015 mg/kg food simulant). In 3 % acetic acid, the migration ranged from not detectable ( 747 mg/kg bw/day. Due to rapid elimination of the absorbed terephthalic acid, bis(2ethylhexyl) ester in the form of polar metabolites, a potential for accumulation is considered unlikely. The impurity terephthalic acid, (2-ethylhexyl) methyl ester did not induce mutations in bacteria or mammalian cells and therefore is considered as non-genotoxic. It is also expected to be rapidly metabolized by hydrolysis to polar metabolites. Therefore, a potential for bioaccumulation of the impurity is considered unlikely. Di-2-ethylhexylterephthalate was a very weak peroxisome proliferator in rat liver at a daily dose of > 2 000 mg/kg food after 21 days of feeding. Di-2-ethylhexylterephthalate did not induce an estrogenic effect in vivo in an uterotropic assay. Based on the NOAEL from a 2-year combined toxicity/carcinogenicity study of 79 mg/kg bw/day, a TDI of 1 mg/kg bw/day for DEHT is derived by rounding up. The Panel also noted that terephthalic acid, dimethyl ester has been evaluated by the SCF in 1986 (SCF, 1986) and a TDI of 1 mg/kg bw has been set. Based on the data examined and the TDI of the terephthalic acid, bis(2-ethylhexyl) ester and of terephthalic acid, dimethyl ester, the Panel concluded that no more data were needed for the impurity terephthalic acid, (2-ethylhexyl) methyl ester. Based on the above-mentioned data the substance is classified:

Conclusion: SCF_List: Restriction: Remark for Commission: Needed data or information

References:

2 TDI = 1 mg/kg bw None None

-

Unpublished data submitted by the petitioner (January 2007) EC (European Commission), 1986: Report the Scientific Committee on Food, 17th series on certain monomers and other starting substances to be used in the manufacture of plastic materials and articles intended to come into contact with foodstuffs (Opinion expressed on 14 December 1984) http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_17.pdf The EFSA Journal (2008) 628-633, 16-19

18th list of FCM substances

APPENDIX DEFINITION OF THE SCF LISTS The classification into a SCF_List is a tool used for tackling authorisation dossiers and do not prejudice the management decisions that will be taken on the basis of the scientific opinions of the AFC Panel and in the framework of the applicable legislation Substances, e.g. foods, which may be used in the production of plastic materials and articles, e.g. food ingredients and certain substances known from the intermediate metabolism in man and for which an ADI need not be established for this purpose. Substances, e.g. food additives, for which an ADI (=Acceptable Daily Intake), a tADI (=temporary ADI), a MTDI (=Maximum Tolerable Daily Intake), a PMTDI (=Provisional Maximum Tolerable Daily Intake), a PTWI (=Provisional Tolerable Weekly Intake) or the classification "acceptable" has been established by this Committee or by JECFA. Substances for which this Committee has established a TDI or a t-TDI.

List 0

List 1

List 2 List 3

Substances for which an ADI or a TDI could not be established, but where the present use could be accepted. Some of these substances are self-limiting because of their organoleptic properties or are volatile and therefore unlikely to be present in the finished product. For other substances with very low migration, a TDI has not been set but the maximum level to be used in any packaging material or a specific limit of migration is stated. This is because the available toxicological data would give a TDI, which allows that a specific limit of migration or a composition limit could be fixed at levels very much higher than the maximum likely intakes arising from present uses of the additive. Depending on the available toxicological studies a restriction of migration into food of 0.05 mg/kg of food (3 mutagenicity studies only) or 5 mg/kg of food (3 mutagenicity studies plus 90-day oral toxicity study and data to demonstrate the absence of potential for bio-accumulation in man) may be allocated. (for monomers)

List 4 4A 4B List 4

Substances for which an ADI or TDI could not be established, but which could be used if the substance migrating into foods or in food simulants is not detectable by an agreed sensitive method. Substances for which an ADI or TDI could not be established, but which could be used if the levels of monomer residues in materials and articles intended to come into contact with foodstuffs are reduced as much as possible. (for additives)

The EFSA Journal (2008) 628-633, 17-19

18th list of FCM substances

Substances for which an ADI or TDI could not be established, but which could be used if the substance migrating into foods or in food simulants is not detectable by an agreed sensitive method. Substances that should not be used.

List 5 List 6

Substances for which there exist suspicions about their toxicity and for which data are lacking or are insufficient. The allocation of substances to this list is mainly based upon similarity of structure with that of chemical substances already evaluated or known to have functional groups that indicate carcinogenic or other severe toxic properties.

6A 6B List 7 List 8 List 9

List W

Substances suspected to have carcinogenic properties. These substances should not be detectable in foods or in food simulants by an appropriate sensitive method for each substance. Substances suspected to have toxic properties (other than carcinogenic). Restrictions may be indicated. Substances for which some toxicological data exist, but for which an ADI or a TDI could not be established. The required additional information should be furnished. Substances for which no or only scanty and inadequate data were available. Substances and groups of substances which could not be evaluated due to lack of specifications (substances) or to lack of adequate description ( groups of substances ). Groups of substances should be replaced, where possible, by individual substances actually in use. Polymers for which the data on identity specified in "SCF Guidelines" are not available. "Waiting list". Substances not yet included in the Community lists, as they should be considered "new" substances, i.e. substances never approved at national level. These substances cannot be included in the Community lists, lacking the data requested by the Committee.

Term used relevant to migration: Overall migration (OM): The sum of the amounts of volatile and non volatile substances, except water, released from a food contact material or article into food or food simulant Specific migration:

The amount of a specific substance released from a food contact material or article into food or food stimulant

The EFSA Journal (2008) 628-633, 18-19

18th list of FCM substances

List of abbreviations: ABS AFC CAS Da DEHT EC EFSA HIPS Mw NDA NOAEL PET PP PGA PMTDI PVC PS REF N° SCCNFP SCF TDI US-EPA UV

Acrylonitrile-butadiene-styrene Scientific Panel on food additives, flavourings, processing aids and materials in contact with food Chemical Abstract Dalton Terephtalic acid, bis(2-ethylhexyl) ester European Commission European Food Safery Authority High impact polystyrene Weight average molecular weight Dietetic products, nutrition and allergies No observed adverse effect level Poly(ethylene terephtalate) Polypropylene Polyglycolic acid Provisionnal maximum tolerable daily intake Polyvinyl chloride Polystyrene Reference Number Scientific Committee for Cosmetics and Non-Food Products Scientific Committee on food Tolerable daily intake United States Environmental Protection Agency Ultra-violet

The EFSA Journal (2008) 628-633, 19-19