13 July 2018
European Commission Amends List of Substances Permitted in Plastics Coming into Contact with Food
On 5 June 2018, Commission Regulation 2018/831 was published in the EU’s Official Journal. The new Regulation outlines amendments to Commission Regulation 10/2011 on plastic materials and articles intended to come into contact with food (the “Plastics Regulation”). Food comes into contact with many materials during its production, processing, storage, preparation and serving. Such materials are referred to as Food Contact Materials (“FCMs”) and encompass materials which are either intended to be brought into contact with food, are already in contact with food, or can reasonably be brought into contact with food or transfer their constituents to the food under normal or foreseeable use.
As Hong Kong exporters of food packaging may be aware, Annex I of the Plastics Regulation establishes a list of substances which are permitted for use in the manufacturing of plastic FCMs in line with certain restrictions and specifications. As a result of scientific research published by the European Food Safety Authority (the “EFSA”), the present amendment firstly alters the specifications for two substances already found in Annex I, and, secondly, adds two new substances to the list.
In relation to the two substances already found in Annex I, the amendment revises their Specific Migration Limits (“SML”). The Plastics Regulation uses SMLs in order to ensure the safety of plastic materials. SMLs are established by the EFSA on the basis of toxicity data, and specify the maximum amount of the substance allowed to migrate to food. As regards the substance perchloric acid, salts (perchlorate) (FCM substance No. 822), the amendment lowers the SML to 0.002 mg/kg from 0.05 mg/kg to ensure that migration of perchlorate from plastic FCM does not endanger human health.
Moreover, the EFSA re-evaluated the use of the substance phosphorous acid, mixed 2,4-bis(1, 1-dimethylpropyl)phenyl and 4-(1, 1-dimenthylropyl)phenyl triesters (FCM substance No. 974) and found that on the basis of new scientific evidence this substance is not a safety concern for the consumer if its SML is increased from 5 to 10 mg/kg, where the other existing restrictions are still met. Therefore, the amendment increases the SML to 10 mg/kg.
The two substances added to Annex I are 1, 2, 3, 4-tetrahydronaphtalene-2, 6-dicarboxylic acid, dimethyl ester (FCM substance No. 1066) and [3-(2,3-epoxypropoxy) propyl] trimethoxy silane (FCM substance No. 1068). In relation to the first substance, the EFSA concluded that it is not a safety concern for the consumer if it is used as a co-monomer in certain specified circumstances. The addition stipulates that the substance can be used for the manufacturing of a polyester non-food contact layer intended to be used as an inner layer in a plastic multilayer material intended for contact with foods for which food simulants A, B, C, and/or D1 are assigned in Annex III of the Plastics Regulation.
As regards the second new substance, the EFSA determined that, although the substance has genotoxic potential, it is not a safety concern due to its low exposure, if any, when used in particular circumstances. The amendment provides that the substance can only be used as a component of a sizing agent to treat glass fibres in glass-fibre-reinforced low diffusivity plastics in contact with all foodstuffs.
Hong Kong producers should note that plastic materials and articles which comply with the existing provisions of the Plastics Regulation prior to the present amendments may be placed on the market until 26 June 2019 and may remain on the market after that date until the exhaustion of stocks.
For full details on the new amendments please click on the following: Commission Regulation 2018/831.