Document XOGr2jrQd1rVe6NGYy0gD2gjx

20/05 '92 15:16 0875 614555 15. 0 5. 8 2 1 < ! O S IRI SCOTLAND M2B * K ft t o @002 SOI 105/-112 NATEC Institut fur naturwissenschaftlich-technisehe Dienste GmbH Invereak Research International Ltd. Dr. C.B- Patrick Regulatory Affairs Tranent, EH33 gHE SCOTLAND Fax No. 0044 - 875 - <14 555 BefvinsitnsSalSi FttttehWl58S D^OOC Hamburg 50 Telefan: (040) IB30 9--0 TaWax: (040)58309170 Telex) -aie4293ntacd BankksntAn: DeutscheBank4G6522 445 (31220070Q 00) OmdMreantfAG 0808 3SS400 (BLZ 200300001 ' Km Ref.: Unsere Ref er.ie/Dr Telefon: f^flB309-ii Datum: 15/05/1992 Re. I PTC ar 001 - Par prefect EA 9Z 9320 Dear Dr. Patrick, Please find enclosed oar assessment of FVC, product code ex 001.. According to this assessment the composition of tha CV0 material does not fully comply with German regulations. As the additives are atil] subject to the regulation via recommendations. the user in principle la free to deviate from the recommendation, but on his own risk. In ouch case positive assessment may be used, if there are only slight deviations or if substances of very low toxicity are used. Wa feel the use of the first two substances as specified in the assessment for the reasons shown is more then a elicit deviation only and therefore tha composition is considered not acceptable according to present German regulations. Re should furthermore point to the fact that for soma of the additives there" are criteria for purity or certain parameters. Moreover, as derived from EC directive 90/128, the global migrate is limited to 10 mg/dmr (normally no problem for rigid PVC) and the transfer of monomeric vinyl chloride is limited to 10 /ig per kg foodstuff (1.7 Mg/dm2}. In doubt these parameters would have to be checked on the final article or a repreaamative test specimen. 21617002 MAY 20 '92 09'-15 20/05 '92 15:16 00875 614555 is. oe. 'OS' 1 * : O e IRI SCOTLAND M2B kK a '* e 0 003 SO3 N 103/-11 NATEC Institut fur nafurwissenschaftKcft-technische Dienste GmbH BdvinsatnBe154 . R*tfeChS0156S o>iinHBhgn WWdnJW soe-o TeHk(040}8S3a9170 Tetex 2164283rrteed BanMtoptan: Deutsche BankAS 8 S22445 BnU*ibM 30070000 Drc^dnarBankAS 090SOSS 400 B-4drtsahl20080000 of PVC CT 001 uth Regard to Cumin veil1)*"" for nuclei TnCwitd far food Contact Applications HA 92 9320 - > ^ r t...i s rswMft According to the order of Messrs. IRI - Inveresh Research International, Tranent, Scotland, dated March 25, 1992, the composition of a PVC material, t product code CT 001, intended far food contact Applications, was Assessed with? regard to compliance with relevant regulations in the Federal Republic of * Germany. 1 ^ Plastics intended for food contact applications in Germany are regulated genef - rally by the "Lebensmictel- und Bedarfsegenst&ndegesetxn'(UffiG, food end ? eoomodities law) --d in detail for rh monomers by the BedarfsgegenstSndeverordnnng (commodities ordinance) and for the additives by the "Bmpfehlttngen" (recommendations) of the German BGA. For rigid PVC recommendation II applies. r . The composition of the PVC material was communicated to OS by 2HX via fax on March 17, 1992, and acme supportive information supplied subsequently. I* It is concluded that meat components in the amounts used comply with the respective regulations, yet very few components exceed the 7imitations In recommendation II, eomn others are not listed in recomeitdation II at all, part of which is listed elsewhere. In detail, \ , A-bofati'flz) - ' t ;. - Nonylphenoxy polyethylenecry aliylphenol ethoxylate (CAS Ho. 9016-45-9) is used in an amount of 1.25 X- limit in Sec. II: 0.2 Z i -- A.V-Isopropylidenediphenol allyl?C12 - CjcJphosphitei not listed in Rec. II, but contained in the drafted EC list of additives, SCF list 9- ("Sub- atsnces___which could not be evaluated due to laefe ofadeonrp spwirtc ; jey. These groups should be replaced by individual substances actually in use".). I , 1- S l 'W CL*** ,,'v If.' MAY 20 '92 09:16 Vm**ftb*rofTht European Foundationfcrduofliy Managimont MtgMdrSGS-GruDC^8ted<rGe9dbbbeErbH0mbw3*iWTn>9arichtHTiBurgHR814067 Gc9C^nsfijtrr: Oc-mg. Maus PauRs- ErfOdwigMRwdGoteroBsand b0ui{im~ichawufaEoI-- -ww* m' ' *"' * 0875 614555 BFG15767 21617003