170-english

This is an unofficial translation. Only the German version is binding.
XVII. Poly(terephthalic acid diol esters)

As of 01.06.2013

There are no objections to the use of poly(terephthalic acid diol esters) in the manufacture of
commodities in the sense of § 2, Para. 6, No 1 of the Food and Feed Code (Lebensmittel- und
Futtermittelgesetzbuch), provided they are suitable for their intended purpose and the following
conditions are met:
1. The use of starting materials for poly(terephthalic acid diol esters) is subject to the
The evaluation presented in the following refers to polymers from the following monomeric starting substances: Ethylene glycol Butanediol-1,4 1,4-Dihydroxymethylcyclohexane Terephthalic acid Isophthalic acid, max. 25 % Adipic acid Azelaic acid Sebacic acid Terephthalic acid dimethyl ester Azelaic acid dimethyl ester Sebacic acid dimethyl ester Oligomeric diglycidethers of 4,4-Dioxydiphenyl-2,2-propane (Bisphenol A-diglycid ethers), Polyethyleneglycol, max. 10 % The following polymers may be added to the poly(terephthalic acid diol esters) made from the mentioned starting substances: a) Polyethylene complying with Recommendation III, max. 5.0 % or b) Polypropylene complying with Recommendation VII, max. 5.0 % 2. Additives permitted by the Commission Regulation (EU) No 10/2011 may be used in compliance with the restrictions laid down therein. In addition to these, from manufacture and processing, only the following production aids, in the maximum amounts given, may be contained in the finished products: a) Catalysts and their residues: Phosphate polyester (mean mol. wt. 354), made from monoethyleneglycol, di-ethyleneglycol and phosphorus pentoxide. Phosphorus content of the finished product must not exceed 125 mg/kg, the amount of this ester must not exceed 0.2 %. Federal Institute for Risk Assessment

Oxides of antimony1, calcium, gallium, germanium, cobalt1, lithium, manganese1, phosphorus, zinc and titanium2, maximum amounts: 350 mg/kg (= 350 ppm) antimony 20 mg/kg (= 20 ppm) gallium 100 mg/kg (= 100 ppm) germanium 125 mg/kg (= 125 ppm) cobalt 130 mg/kg (= 130 ppm) lithium 140 mg/kg (= 140 ppm) manganese 80 mg/kg (= 80 ppm) zinc 120 mg/kg (=120 ppm) titanium Finished products whose intended use does not involve them being subjected to a temperature of more than 80 °C for extended periods of time may also contain residual lead oxides, provided that their concentration does not exceed 40 mg/kg (= 40 ppm). 2-(2H-Benzotriazol-2-yl)-6-dodecyl-4-methyl-phenol, branched and linear, 3. If commodities made of poly(terephthalic acid diol esters) are coated with other plastics so as to reduce their permeability to water vapour, these must comply with the Commission Regulation (EU) No 10/2011 and the corresponding BfR Recommendations.3 4. For the inner coating of commodities made from poly(terephthalic acid diol esters) the following substance may be used: Silicon dioxide coatings made from the monomers hexamethyldisiloxane and hexamethyl- disilazane. The transfer of the residual monomers to the food must be not more than 0.05 mg/kg (determined as hexamethyldisiloxane). 1 Permitted in accordance with the Commission Regulation (EU) No 10/2011. Migration of this substance into foodstuffs is regulated by the Commission Regulation (EU) No 10/2011. 2 Permitted as additives by the Commission Regulation (EU) No 10/2011 are: calcium oxide, zinc oxide, titanium 3 As a rule, polyethylene and copolymers of vinylidene chloride are used.

Source: http://kse.zadi.de/kse/faces/resources/pdf/170-english.pdf