EFSA Journal 2012;10(3):2641 ABSTRACT SCIENTIFIC OPINION Scientific Opinion on the safety evaluation of the substance, titanium nitride, nanoparticles, for use in food contact materials 1 EFSA Panel on food contact materials, enzymes, flavourings and processing aids (CEF) 2, 3 European Food Safety Authority (EFSA), Parma, Italy This scientific opinion of EFSA deals with the safety evaluation of titanium nitride, nanoparticles with the European Commission REF. No 93485 and FCM substance No 807, for use as additive in PET plastics. A request has been submitted for an extension of use in thermoformed PET sheets/films in addition to the use in PET bottles, evaluated by the EFSA in 2008. Under the intended conditions of use, no migration of the substance into food is expected and therefore no exposure of the consumer via food is expected. Based on this, the CEF Panel concluded that there is no safety concern for the consumer if the substance is used up to 20 mg/kg in only PET plastics intended for contact with all types of foodstuffs under conditions of any duration of time and at temperatures up to and including hot-fill. European Food Safety Authority, 2012 KEY WORDS Titanium nitride; Nanoparticles; REF. No 93485; FCM Substance No 807; Food contact materials; Safety assessment; Evaluation. 1 On request from the Food Standards Agency, UK, Question No EFSA-Q-2011-01079, adopted on 22 March 2012. 2 Ulla Beckman Sundh, Mona-Lise Binderup, Leon Brimer, Laurence Castle, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean-Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Fidel Toldrá and Detlef Wölfle. One member of the Panel declared an interest as his Institute submitted the application on behalf of the applicant for the previous evaluation in 2008. This was considered as a conflict of interest and he was asked to leave the room during discussion and vote. Correspondence: cef@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Food Contact Materials for the preparation of this opinion: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Eugenia Lampi, Jean-Claude Lhuguenot, Maria Rosaria Milana, Karla Pfaff, Fatima Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the support provided to this EFSA scientific output. Suggested citation: EFSA Panel on Food Contact Materials, Flavourings, Enzymes and Processing Aids; Scientific Opinion on the safety evaluation of the substance, titanium nitride, nanoparticles, for use in food contact materials. EFSA Journal 2012;10(3):2641. [8 pp.] doi:10.2903/j.efsa.2012.2641. Available online: www.efsa.europa.eu/efsajournal European Food Safety Authority, 2012
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 CEF Panel received a request from the Food Standards Agency (UK) for safety evaluation of a substance following a corresponding application from the ColorMatrix Group Inc., UK. The request received and the outcome of the safety evaluation is summarised below: The EFSA was requested to re-evaluate the additive titanium nitride, nanoparticles, with the European Commission reference number REF. No 93485 and the FCM substance No 807, for its extension of use in thermoformed PET sheets/films for contact with all types of foodstuffs under conditions including long-term storage and at temperatures up to hot-fill. The substance has been evaluated by the CEF Panel in 2008 for use in PET bottles. The CEF Panel had concluded that the intended use of this nanoparticulate substance would not give rise to exposure of the consumer via migration into food and therefore the substance would not be of toxicological concern if used only as requested in PET bottles up to 20 mg/kg. Based on the information provided on the new intended conditions of use described for thermoformed PET articles in contact with food which are covered by the previous migration tests and theoretical migration modelling, the CEF Panel concluded that the conditions are such that no migration is to be expected. Therefore, there is no safety concern for the consumer if the substance is used at up to 20 mg/kg in only PET plastics intended for contact with all types of foodstuffs under conditions of any duration of time and at temperatures up to and including hot-fill. EFSA Journal 2012;10(3):2641 2
TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background as provided by the legislation... 4 Background as provided by the legislation... 4 Terms of reference as provided by the legislation... 4 Assessment... 5 1. Introduction... 5 2. General information... 5 3. Data available in the dossier used for this evaluation... 5 4. Evaluation... 5 1.1. 6 Conclusions... 6 Documentation provided to EFSA... 6 References... 6 Appendices... 7 Abbreviations... 8 EFSA Journal 2012;10(3):2641 3
BACKGROUND AS PROVIDED BY THE LEGISLATION 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 4. According to this procedure the industry submits applications to the Member States competent Authorities which in their turn transmit the applications to the EFSA for their evaluation. The application is supported by a technical dossier submitted by the industry following 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 (EC, 2001). In this case, EFSA received an application from the Food Standards Agency (UK) requesting the reevaluation of the additive titanium nitride, nanoparticles (CAS No. 25583-20-4 for TiN not in nanoform) with the European Commission REF. No 93485 and the FCM substance No 807. TERMS OF REFERENCE AS PROVIDED BY THE LEGISLATION 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 substances which are already authorised in the framework of Regulation (EC) No. 1935/2004 but need to be re-evaluated. 4 This Regulation replaces Directive 89/109/EEC of 21 December 1988, OJ L 40, 11.2.1989, P.38. EFSA Journal 2012;10(3):2641 4
ASSESSMENT 1. Introduction The European Food Safety Authority was asked by the Food Standards Agency, United Kingdom (UK), to re-evaluate the safety of titanium nitride (TiN), nanoparticles (CAS No 25583-20-4 for TiN not in nanoform) with the European Commission reference number REF. No 93485 and the FCM substance No 807. The request has been registered in the EFSA s register of received questions under the number EFSA-Q-2011-01079. The dossier was submitted by the applicant, ColorMatrix Group Inc., UK. 2. General information According to the applicant, the substance titanium nitride (TiN), nanoparticles, is intended to be used as an additive in polyethylene terephthalate (PET) up to 20 mg/kg. The final plastic is intended to come into contact with all types of foodstuffs for typical hotfill/pasteurization and/or long term storage at room temperature. The substance has been evaluated by the EFSA in 2008 for use in PET bottles (EFSA, 2008). The Panel concluded that the intended use of this nanoparticulate substance would not give rise to exposure of the consumer via food and therefore the substance would not be of toxicological concern if used only as requested in PET bottles up to 20 mg/kg. The applicant has now requested an extension in scope to include thermoformed PET sheets/films as well as the use in PET bottles that had been evaluated earlier. The same grade of PET is used for bottles and thermoformed articles. 3. Data available in the dossier used for this evaluation No new data were provided for this re-evaluation. The applicant provided only information on the new intended conditions regarding the extension in scope of the use. 4. Evaluation In the previous evaluation (EFSA, 2008) for use of the substance in PET bottles, the CEF Panel noted that titanium nitride as such is chemically inert and completely insoluble in all food simulants tested. When incorporated into PET, agglomerates were observed with a diameter of 100 500 nm, consisting of primary titanium nitride nanoparticles of diameter approximately 20 nm. In migration experiments with PET containing titanium nitride nanoparticles at a level of 20 mg/kg, there was no detectable migration of titanium, less than 5 microg Ti/L simulant, into 3% acetic acid, 10% ethanol and 95% ethanol after a contact of 2 hours at 70 C followed by 30 days at 40 C. The Panel also investigated the potential migration of TiN nanoparticles using theoretical considerations based on diffusion models and concluded that no migration is to be expected. For the thermoformed PET articles described for this evaluation, the applicant stated that the conditions of use shall include a fill temperature not exceeding 95 C for all food types including solid EFSA Journal 2012;10(3):2641 5
foods (such as vegetables, salads, eggs) and liquids (such as dressings, water). Typical PET articles would be for example the single-use cups as used on aeroplanes and trays. Taking into account that the intended uses in contact with food for this extension of scope are covered by the previous migration tests and theoretical migration modelling, the Panel concluded that the conditions are such that no migration is to be expected. Consequently, the Panel considered that the intended use of this nanoparticulate substance does not give rise to exposure of the consumer via food and therefore would not be of toxicological concern if used only in PET up to 20 mg/kg and for the food contact applications described. 1.1. CONCLUSIONS The CEF Panel concluded that there is no safety concern for the consumer if the nanoparticulate substance is used up to 20 mg/kg in only PET plastics intended for contact with all types of foodstuffs under conditions of any duration of time and at temperatures up to and including hot-fill. DOCUMENTATION PROVIDED TO EFSA Dossier referenced: N/A. Dated: September 2011. Submitted by ColorMatrix Group Inc., United Kingdom. REFERENCES EC (European Commission), 2001. Guidelines of the Scientific Committee on Food for the presentation of an application for safety assessment of a substance to be used in food contact materials prior its authorisation; http://ec.europa.eu/food/fs/sc/scf/out82_en.pdf. EFSA (European Food Safety Authority), 2008. Scientific Opinion Scientific Opinion of the Panel on food contact materials, enzymes, flavourings and processing aids (CEF) on 21st list of substances for food contact materials. The EFSA Journal (2008) 888-890, 1-14. http://www.efsa.europa.eu/en/scdocs/doc/cef_op_ej888-890_21stlist_en,3.pdf. EFSA Journal 2012;10(3):2641 6
APPENDICES APPENDIX A TERMS USED RELEVANT TO MIGRATION: Overall migration: 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 EFSA Journal 2012;10(3):2641 7
ABBREVIATIONS CAS CEF EC EFSA FCM PET REF. No SCF TiN UK Chemical Abstracts Service Scientific Panel on food contact materials, enzymes, flavourings and processing aids European Commission European Food Safety Authority Food contact material(s) Poly(ethylene terephthalate) Reference number Scientific Committee on Food Titanium nitride United Kingdom EFSA Journal 2012;10(3):2641 8