欧盟修订塑料食品接触材料法规

(1)

Commission Regulation (EU) No 10/2011 (2) (‘the Regulation’) lays down specific rules as regards plastic materials and articles intended to come into contact with foods.

(2)

Since the last amendment to the Regulation, the European Food Safety Authority (‘the Authority’) has published further reports on particular substances that may be used in food contact materials as well as on the permitted use of already authorised substances. In addition, certain textual errors and ambiguities were identified. In order to ensure that the Regulation reflects the most recent findings of the Authority and in order to remove any doubt as regards its correct application, the Regulation should be amended and corrected.

(3)

The authorisation of several substances in Table 1 of Annex I to the Regulation refers to note (1) in Table 3 of that Annex. Compliance is therefore verified by residual content per food contact surface area (QMA) pending the availability of an analytical method for determining the specific migration. As adequate migration testing methods are available, and the specific migration limits have been specified, the possibility to verify compliance by residual content should be removed from the entries for substances with FCM substance Nos 142, 168, 202, 387, 462, 467, 481, 502, 662, and 779.

(4)

The Authority adopted a favourable scientific opinion (3) on the use of the substance diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate, with the CAS number 976-56-7 and the FCM substance No 1007. The Authority concluded that the substance is not of a safety concern for the consumer if used up to 0,2 % w/w based on the final polymer weight in the polymerisation process to manufacture poly(ethylene terephthalate) (PET) intended for contact with all types of foods under any contact conditions of time and temperature. Therefore, that substance should be added to the Union list of authorised substances with the restriction that it is only to be used in the polymerisation process to manufacture PET and at up to 0,2 % (w/w). As the Authority indicated that the substance is used in the polymerisation process and becomes part of the polymeric backbone of the final polymer, it should be listed as a starting substance.

(5)

The Authority adopted a favourable scientific opinion (4) on the use of the substance (methacrylic acid, ethyl acrylate, n-butyl acrylate, methyl methacrylate and butadiene) copolymer in nanoform, with the FCM substance No 1016. The Authority concluded that the substance is not of a safety concern for the consumer if used as an additive at up to 10 % w/w in non-plasticised PVC or up to 15 % w/w in non-plasticised PLA, used in contact with all food types, at room temperature or below, for long-term storage. Therefore, this additive should be included in the Union list of authorised substances with the restriction that those specifications should be met.

(6)

The Authority adopted a favourable scientific opinion (5) on the use of the additive montmorillonite clay modified by dimethyldialkyl(C16-C18)ammonium chloride with FCM No 1030. The Authority concluded that the use of the mixture does not give rise to a safety concern if the substance is used at up to 12 % w/w in polyolefins intended for dry foods to which simulant E is assigned in Annex III to Regulation (EU) No 10/2011, and when used at room temperature or below, and if the migration of the substances 1-chlorohexadecane and 1-chlorooctadecane which can be present as impurities or degradation products does not exceed 0,05 mg/kg food. The Authority noted that the particles can form platelets that can be in one dimension in the nano range but that the migration of such platelets is not expected if these are oriented parallel to the film surface and when fully embedded in the polymer. Therefore, that additive should be included in the Union list of authorised substances with the restriction that those specifications should be met.

(7)

The Authority adopted a favourable scientific opinion (6) on the use of the additive α-tocopherol acetate with FCM No 1055, CAS Nos 7695-91-2 and 58-95-7. The Authority concluded that the use of the substance as antioxidant in polyolefins does not give rise to a safety concern. The Authority noted that the substance hydrolyses to α-tocopherol and acetic acid which are both authorised food additives under Regulation (EC) No 1333/2008 of the European Parliament and of the Council (7). Consequently, there is a risk that the restrictions set out by Regulation (EC) No 1333/2008 applicable to those two hydrolysis products could be exceeded. Therefore, that additive should be included in the Union list of authorised substances with the restriction that it can only be used as an antioxidant in polyolefins, and a note should be added that the restrictions set out in Regulation (EC) No 1333/2008 have to be met.

(8)

The Authority adopted a favourable scientific opinion (8) on the use of the additive ground sunflower seed hulls with FCM No 1060. The Authority concluded that the use of the substance is not a safety concern if used as an additive in plastics intended for contact with dry foods, if these are used at room temperature or below. The seed hulls should be obtained from sunflower seeds that are fit for human consumption and the plastic containing the additive should be subjected to processing temperatures not higher than 240 °C. Therefore, that additive should be included in the Union list of authorised substances wi