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ANNEX

Restrictions and specifications related to plasticisers used in gaskets in lids

a

‘SML’ means specific migration limit.

b

SML(T) in this specific case means that the specific migration limit shall not be exceeded by the sum of the migration levels of the substances mentioned with reference numbers 88640, 30401, 76815, 93760, 56800 and 30340.

Ref. NoCAS NoNameRestrictions and/or specifications
(1)(2)(3)(4)
88640008013-07-8Soybean oil, epoxidised (ESBO)

For materials and articles intended for or brought into contact with foods for which simulant D testing is required by Directive 85/572/EEC SML(T)a b = 300 mg/kg of food or food simulants or 50 mg/dm2 of the total food contact surface of lid and sealed container.

For materials and articles intended for or brought into contact with infant formulae and follow-on formulae as defined by Commission Directive 91/321/EEC on infant formulae and follow-on formulae and products according to Directive 96/5/EC on processed cereal-based foods and baby foods for infants and young children SML = 30 mg/kg of food or food simulant.

For materials and articles intended for or brought into contact with all other types of foods SML(T)b = 60 mg/kg of food or food simulants or 10 mg/dm2 of the total food contact surface of lid and sealed container.

30401Acetylated mono- and diglycerides of fatty acids

For materials and articles intended for or brought into contact with foods for which simulant D testing is required by Directive 85/572/EEC SML(T)b = 300 mg/kg of food or food simulants or 50 mg/dm2 of the total food contact surface of lid and sealed container.

For materials and articles intended for or brought into contact with all other types of foods SML(T)b = 60 mg/kg of food or food simulants or 10 mg/dm2 of the total food contact surface of lid and sealed container.

76815Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids

For materials and articles intended for or brought into contact with foods for which simulant D testing is required by Directive 85/572/EEC SML(T)b = 300 mg/kg of food or food simulants or 50 mg/dm2 of the total food contact surface of lid and sealed container.

For materials and articles intended for or brought into contact with all other types of foods SML(T)b = 60 mg/kg of food or food simulants or 10 mg/dm2 of the total food contact surface of lid and sealed container.

93760000077-90-7Tri-n-butyl acetyl citrate

For materials and articles intended for or brought into contact with foods for which simulant D testing is required by Directive 85/572/EEC SML(T)b = 300 mg/kg of food or food simulants or 50 mg/dm2 of the total food contact surface of lid and sealed container.

For materials and articles intended for or brought into contact with all other types of foods SML(T)b = 60 mg/kg of food or food simulants or 10 mg/dm2 of the total food contact surface of lid and sealed container.

56800030899-62-8Glycerol monolaurate diacetate

For materials and articles intended for or brought into contact with foods for which simulant D testing is required by Directive 85/572/EEC SML(T)b = 300 mg/kg of food or food simulants or 50 mg/dm2 of the total food contact surface of lid and sealed container.

For materials and articles intended for or brought into contact with all other types of foods SML(T)b = 60 mg/kg of food or food simulants or 10 mg/dm2 of the total food contact surface of lid and sealed container.

30340330198-91-912-(Acetoxy)stearic acid, 2,3-bis(acetoxy)propyl ester

For materials and articles intended for or brought into contact with foods for which simulant D testing is required by Directive 85/572/EEC SML(T)b = 300 mg/kg of food or food simulants or 50 mg/dm2 of the total food contact surface of lid and sealed container.

For materials and articles intended for or brought into contact with all other types of foods SML(T)b = 60 mg/kg of food or food simulants or 10 mg/dm2 of the total food contact surface of lid and sealed container.

76866Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C12-C18 or n-octanol and/or n-decanolSML = 30 mg/kg of food or food simulants or 5 mg/dm2 of the total food contact surface of lid and sealed container.