Overall migration limit

For additives, on the other hand, the list is a partial list currently comprising 289 substances fully evaluated by the SCF whose toxicological characteristics do not necessitate the imposition of any restriction on use other than the overall migration limit. 204 additional substances, fully evaluated by the SCF and 185 of which require a restriction on their use according to the SCF, will be added to the list before long. All of the more important information on the evaluation of substances is to be found in the document entitled Synoptic which is to be distributed on the Internet (address http //cpf.jrc.it/webpack/). 

Packaging Technology and Science 10, No.3, May-June 1997, p.169-75 PVC THERMOFORMED CONTAINERS FOR FOOD PACKAGING ESTABLISHMENT OF RAPID EXTRACTION TEST FOR OVERALL MIGRATION LIMIT COMPLIANCE TESTING Cooper I Goodson A Tice P A PIRA International... 

The finished rubber product will have to meet a specification in which a number of properties (e.g. hardness, tensile strength and elongation) are given target values. A number of other properties can be assessed, and these will depend upon the type of rubber and the application that it is going to be used in. An important example is the overall migration limit test, with the food simulant and test conditions (temperature and time) being dictated by the end use conditions. 

The Resolution also states that rubber products of Categories 1 and 11 should not transfer their constituents to foodstuffs or food simulants in total quantities above an overall migration limit (OML) of 60 mg/kg food or food simulant. 

There is a separate Council of Europe Resolution, APRes (2004), on silicone materials for food contact. The resolution defines the silicone product group being comprised of silicone rubbers, silicone liquids, silicone pastes and silicone resins. Blends of silicone rubber with organic polymers are covered by the resolution where the silicone monomer units are the predominant species by weight. Silicones that are used as food additives or processing aids (e.g. as defoamers in the manufacture of substances such as wine) are not covered by this resolution, but polysiloxanes used as emulsifiers are. The resolution gives an overall migration limit of 10 mg/dm of the surface area of the product or material, or 60 mg/kg of food. There are restrictions on the types of monomers that can be used to produce the silicone polymers and there is an inventory list Technical document No. 1 - List of substances used in the manufacture of silicone used for food contact applications . 

In a separate study overall migration from several plastic films was compared with and without a sticky label attached to film. The overall migration limit was exceeded for selected material/simulant combinations. The author concluded that it could be anticipated, that a certain, possibly very significant, migration of substances from the label to the foodstuff could take place in real packaging also . 

Sets overall migration limits 10 mg/dm2 or 60 mg/kg food where container capacity> 500 ml or for caps... 

Specifies overall migration limit (amended in Directives 92/39, 93/9). 

The EU Directive 2002/72/EC regulates plastics intended to come in contact with food, where the principle of regulation is the establishment of a positive list, which presently is restricted to monomers and start substances. Directive 2002/72/EC (and its amendment 2004/19/EC) contain in their Annexes I-IV, lists of evaluated monomers and additives and the corresponding specific migration limit (SML) values. SML is expressed as the amount of a substance (mg) allowed to migrate from the plastic into 1 kg of food. The law requires compliance with the SML for the end-use material, in addition to the requirement of compliance with the overall migration limit (60 mg/kg food). 

Pedersen GA, Jensen LK, Fankhauser A et al (2008) Migration of epoxidized soybean oil (ESBO) and phthalates from twist closures into food and enforcement of the overall migration limit Food Addit Contam Part A Chem Anal Control Expo Risk Assess 25(4) 503-510 Rasoulpour RJ, LeBaron MJ, EUis-Hutchings RG et al (2011) Epigenetic screening in product safety assessment are we there yet Toxicol Mech Methods 21(4) 298-311. doi 10.3109/ 15376516.2011.557883... 

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