Polymere fødevarekontaktmaterialer udenfor Plastforordningen Jens Sinding Chefkonsulent
Hvilke polymer materialer er ikke specifikt reguleret af EU? Lim Gummi (TPE falder under 10/2011/EU) Ionbytterharpikser Tryksværte Siliconer Tekstiler Lak og overfladebehandlinger Voksarter
Hvordan kan vi demonstrere overholdelse af 1935/2004/EF? Ingen specifik EU-lovgivning, National lovgivning, BfR, FDA, COE eller EFSA data benyttes til Sundhedsmæssig vurdering Fransk lovgivning (http://www.contactalimentaire.com/index.php?id=218&l=1) Hollandsk Lovgivning: Warenwet og Verpakkingen- en gebruiksartikelenbesluit BfR, Bundesinstitut für Risikobewertung (Tysk) (http://bfr.zadi.de/kse/faces/dbempfehlung_en.jsp) EDQM/Europarådet (http://chp.edqm.eu/packaging/) SANCO (https://webgate.ec.europa.eu/sanco_foods/main/?sector=fcm&auth=sancas) Code of Federal Regulations (USA) Regler (http://www.ecfr.gov/cgi-bin/textidx?sid=59b63ae6b17a920ee8f73ef39c52ef68&node=21:3.0.1.1.8&rgn=div5) FDA database (http://www.accessdata.fda.gov/scripts/fcn/fcnnavigation.cfm?rpt=ialisting) Man skal handle ud fra den bedste tilgængelige viden! (men hvad er det?)
Eksempel 1: Gummidims
Evaluering af Gummidims: Sammensætning Materialespecifikation for Gummidims Natural Rubber, Air Dried Sheets (Cas Number: 9006-04-6) Carbon Black (Cas Number: 1333-86-4) Styrene-butadiene-rubber (SBR) (Cas Number: 9003-55-8) Zinc stearate (Cas Number: 557-05-1) Accelerator X (Cas Number: xx-xx-xx) Poly xyz (Cas Number: xxxx-xx-x) Sulfur Vulcanising Agent-0,5% (Cas Number: 7704-34-9) Mineral Oil: < 0,2 % (Cas Number: 64742-55-8) Antioxidant: 2,6-Di-tert-butyl-4-methyl-phenol (CAS Nr. 128-37-0) Antioxidant: 2,2,4-Trimethyl-1,2-Dihydrochinolin,polymerized. 0,3% (Cas Number: 26780-96-1)
Fabrikantens evaluering Materialespecifikation for Gummidims Factory evaluation of Gummidims based on BfR XXI, Category 3, 01.03.2011 Natural Rubber, Air Dried Sheets (Cas Number: 9006-04-6) Carbon Black (Cas Number: 1333-86-4) Styrene-butadiene-rubber (SBR) (Cas Number: 9003-55-8) Zinc stearate (Cas Number: 557-05-1) Accelerator X (Cas Number: xx-xx-xx) Poly xyz (Cas Number: xxxx-xx-x) Sulfur Vulcanising Agent-0,5% (Cas Number: 7704-34-9) Mineral Oil: < 0,2 % (Cas Number: 64742-55-8) Antioxidant: 2,6-Di-tert-butyl-4-methyl-phenol (CAS: 128-37-0) Antioxidant: 2,2,4-Trimethyl-1,2- Dihydrochinolin,polymerized- 0,3% (Cas Number: 26780-96-1) Natural Rubber-Non-Smoked Sorts (OK) 3 % Carbon Black (Max. 30%) (According to the BfR 21: For powdered foodstuffs only acetylene carbon black)- Gummidims does not contain acetylene carbon black) According to the BfR 21 we do not have any information about the content of lithium salt and other additives (catalyst + stabilizer + antioxidant, etc.) used by polymerization process from the producer. According to the BfR 21 must be max.3,0 %. Gummidims contains only 0,5%. OK. No information in the list of BfR 21 No information in the list of BfR 21 The name of sulfur is present in the list of BfR 21 but no max. value. No information in the list of BfR 21 Must be max. 1,0 % Gummidims contains only 0,19%. OK. No information in the list of BfR 21
Supplerende evaluering Materials for Gummidims Styrene-butadiene-rubber (SBR) (Cas Number: 9003-55-8) Accelerator X (Cas Number: xx-xx-xx) Poly xyz (Cas Number: xxxx-xx-x) Mineral Oil: < 0,2 % (Cas Number: 64742-55-8) Antioxidant 2,2,4-Trimethyl-1,2- Dihydrochinolin,polymerized- 0,3% (Cas Number: 26780-96-1) Vurdering af sikkerheden No safety issue for this application, but a declaration of compliance should be obtained from the supplier. Permitted under US CFR Title 21, 177.2600 Permitted under US CFR Title 21, 177.2600 Also known as technical mineral oil, liquid parafins (BfR XXI) or Distillates, Petroleum, Hydrotreated light paraffinic Permitted under US CFR Title 21, 177.2600/178.3620, and BfR XXI. Purity requirements are specified in both cases. The substance with this CAS nr. is listed as PROHIBITED in US CFR Title 21, 189.220 189.220 Flectol H. (a) Flectol H is the chemical 1,2-dihydro-2,2,4-trimethylquinoline, polymerized, C 12 H 15 N. It is a synthetic chemical not found in natural products, and has been used as a component of food packaging adhesives. (b) Food containing any added or detectable level of this substance is deemed to be adulterated in violation of the act based upon an order published in the FEDERAL REGISTER of April 7, 1967 (32 FR 5675). Several other antioxidants of the same family are allowed under CFR Title 21, 177.2600, namely: 1,2-Dihydro-2,2,4-trimethyl-6-dodecylquinoline. CAS 89-28-1 1,2-Dihydro-2,2,4-trimethyl-6-ethoxyquinoline. CAS 91-53-2 (though not on the US-FDA list of indirect food additives) 1,2-Dihydro-2,2,4-trimethyl-6-phenylquinoline. CAS 3562-69-4 The antioxidant should be replaced by an accepted alternative for use in food contact materials
Resultat Gummimaterialet vil, ud fra sammensætningen, kunne overholde CFR 21 177.2600, hvis Flectol H erstattes med en anden antioxidant Dette vil kunne bruges som grundlag for at erklære overensstemmelse med 1935/2004/EF, jf. BEK 822 Der mangler dog stadig en test i af det færdige materiale
Regler for coatings Ingen specifik EU lovgivning, bortset fra 1895/2005/EF (epoxy) 1935/2004/EF og 2023/2006/EØF gælder fortsat. Fødevarekontaktmaterialebekendtgørelsen nr. 822 af 26.06.2013. Krav om overensstemmelseserklæring og baggrundsdokumentation i bilag 5, stk. 5.
Hvilken baggrundsdokumentation? Fransk lovgivning (coatings behandles som plast) NL: Verpakkingen- en gebruiksartikelenbesluit BfR: f.eks. BfR: LI. Temperature Resistant Polymer Coating Systems for Frying, Cooking and Baking Utensils CoE: P.S. Concerning coatings intended to come into contact with foodstuffs CEPE Guidelines: European Council of the Paint, Printing Ink and Artists' Colours... USA: CFR Title 21 175.210-175.390, Substances for use as components of coatings
CEPE Overensstemmelseserklæring CEPE har guidelines på flere coatingtyper Guidelines og skabelon for overensstemmelseserklæring kan downloades fra http://www.cepe.org/epub/easnet.dll/execreq/page? eas:template_im=100087&eas:dat_im=05043d Husk at der er tale om industri guidelines og ikke lovgivning
Overordnede krav til dokumentation Du skal kunne dokumentere at materialet er sikkert, dvs: At det ikke afgiver sundhedsskadelige stoffer At sporbarheden er på plads At det er produceret efter GMP Baggrundsdokumentationen skal være baseret på anerkendte videnskabelige principper, f.eks. En lovgivning der er baseret på en risikovurdering af de enkelte stoffer