Safety assessment of the process 'Morssinkhof Plastics', used to recycle high-density polyethylene and polypropylene crates for use as food contact materials.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process 'Morssinkhof Plastics', EU register No RECYC0142. The input consists of crates, boxes, trays, pallets and containers, hereafter termed 'crates', used in food contact, made of high-density polyethylene (HDPE) or polypropylene (PP). It comprises unused damaged crates, prewashed used crates and parts of crates originating from closed and controlled product loops. The process separates crates by material type and food type (fruit, vegetables and prepacked meat vs unpacked meat). Flakes from recycled HDPE or PP are produced that will be used by customers to manufacture new crates for food contact. The Panel considered that the management system put in place to ensure compliance of the origin of the input with Commission Regulation (EC) No 282/2008 and to provide full traceability from input to final product is the critical process step. It concluded that the input of the process 'Morssinkhof Plastics' originates from product loops which are in closed and controlled chains designed to ensure that only materials and articles which have been intended for food contact are used and that any contamination can be ruled out when run under the conditions described by the applicant. The recycling process 'Morssinkhof Plastics' is, therefore, able to produce recycled HDPE and PP suitable for manufacturing HDPE and PP crates intended to be used in contact with dry food, fruits and vegetables, prepacked and unpacked meat. The use of regrind from 'external' recyclers only based on private agreements, does not give reassurance to fall under the scope of Art. 4 c (i) of Commission Regulation (EC) No 282/2008 and is excluded from the present evaluation.

Safety of ethyl acrylate to be used as flavouring.

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was requested by the European Commission according to Art. 29 1(a) of the Regulation (EC) No 178/2002 to carry out a review of existing literature on the safety of ethyl acrylate [FL-no: 09.037] when used as a flavouring substance. Ethyl acrylate [FL-no: 09.037] was evaluated in 2010 by EFSA in FGE.71 as a flavouring substance, based on the 2006 JECFA evaluation. The Panel concluded that ethyl acrylate was of no safety concern at estimated level of intake as flavouring substance based on the Maximised Survey-Derived Daily Intake (MSDI) approach. The Panel has evaluated the new literature available and any previous assessments performed by JECFA (2006) and EFSA (2010). Moreover, new data on the use levels of ethyl acrylate as flavouring substance have been provided. For use as flavouring substance, the chronic dietary exposure estimated using the added portions exposure technique (APET), is calculated to be 3,545 µg/person per day for a 60-kg adult and 2,233 µg/person per day for a 15-kg 3-year-old child. Exposure from food contact materials may be up to 6,000 µg/person per day. The Panel considered that based on the available data, which covers all relevant genetic endpoints (i.e. gene mutations, structural and numerical chromosomal aberrations) there is no concern with respect to genotoxicity of ethyl acrylate. The Panel evaluated the available carcinogenicity studies conducted in rats and mice and agreed with the NTP evaluation (1998) concluding that the forestomach squamous cell papilloma and carcinoma observed in rodents were not relevant to humans. Additionally, there was no evidence of systemic toxicity in short-term and subchronic toxicity studies. Therefore, the Panel concluded that there is no safety concern for the use of ethyl acrylate as a flavouring substance, under the intended conditions of use.

Safety of benzophenone to be used as flavouring.

Benzophenone [FL-no: 07.032] has been evaluated as a flavouring substance, in FGE.69, by the EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food in 2008. Benzophenone was evaluated also by JECFA (2011) and by IARC (2013) based on studies that were not considered in the EFSA opinion on FGE.69. Therefore, the Commission requested the CEF Panel to carry out a review of existing literature on the safety of this flavouring substance. In the framework of the evaluation of benzophenone as a food contact material, the CEF Panel established a tolerable daily intake (TDI) of 0.03 mg/kg body weight (bw) per day (2009). In the present Opinion, the Panel considered the already existing evaluations by EFSA, JECFA, IARC and available literature data on benzophenone toxicity. Moreover, new data on the use levels of benzophenone as a flavouring substance have been provided. The Panel considers that there is no concern with respect to genotoxicity. The Panel considers the endocrine activities of benzophenone and its metabolite 4-hydroxybenzophenone as weak and not directly related to the observed toxic effects including the neoplastic effects in rodents. The Panel confirms that the conservative approach taken by EFSA (2009) to derive a TDI of 0.03 mg/kg bw for benzophenone is appropriate to cover the non-neoplastic effects in the chronic toxicity studies and the neoplastic effects induced in the rodent carcinogenicity studies. The TDI is in the same order of magnitude as the chronic dietary exposure of adults and children to benzophenone (10-20 µg/kg bw per day) for the amount of added flavouring substance. The Panel considers that the calculated TDI and exposure estimate are based on conservative assumptions. The Panel concludes that there is no safety concern for benzophenone under the current condition of use as a flavouring substance.