OVERENSSTEMMELSESERKLÆRING
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1 AKTIESELSKAB Produceret for : FM Paperlinx A/S Bastrupgårdsvej 8-10 Karlslunde d Holstedbro OVERENSSTEMMELSESERKLÆRING Identifikation af produktet Produktnummer Varenr: Format 250X450/50+40X0,03 Antalis CC & Co. varenr. : Produktnavn Anvendt råvare Anvendelse Fødevaretype Kontakttid Kontakttemperatur Low Density Polyethylen / Linear Low Density Polyethylen (Metallocene) EXCEED 1018EB + EXCEED 1327ED + EXXONMOBIL HTA108 EXXONMOBIL LD150AC (En mixed folie) Fede, tørrede, ferske fødevarer samt fødevare i lage (alkohol, vand og eddike) Alle typer 10 dage Max. 40 i 10 dage eller max. 70 i 2 timer eller stuetemperatur i hele produktets holdbarhedstid Kan også anvendes til frost ned til -35, såfremt folien kvaliteten er min. 40 My. Identifikation af producenten Firmanavn Norlip A/S Adresse Svejsegangen 12 DK 2690 Karlslunde Kontaktperson adresse Website Jesper Philipsen [email protected] - på website findes link til FVST s besøgsrapporter Positivliste Polymeren består udelukkende af monomerer og indgangsstoffer, der forekommer på positivlisten (Annex I) i EU-forordning 10/2011/EC og efterfølgende ændringer Underskrift: 20/05/2016 SMG (Specifikke Migrations Grænser) Alle indgangsstoffer er kontrolleret i Annex I i forordning 10/2011/EC og efterfølgende ændringer, og følgende stoffer har SMG-værdier- ingen oplyst Kemisk navn CAS nr. REF. no. SMG Mængde i produktet (%)
2 Dual use additiver Forekommer der dual use additiver i produktet? Ja: Nej: Hvis ja hvilke dual use additiver er tilsat produktet? Kemisk navn Cas. Nr. Mængde i produktet ( ) Alpha-tocopherol Cas nr ,10 Talc Cas nr ,85 Funktionel barriere Indeholder produktet en funktionel barriere? Hvis ja, ønskes dokumentation for, at den er i overensstemmelse med EU-forordning 10/2011/EC Nej Ja Den funktionelle barriere er i overensstemmelse med EU-forordning 10/2011/EC Underskrift: 20/05/2016 Global migrationstest I overensstemmelse med den fremtidige brug af produktet, skal der udføres globale migrationstest i henhold til direktiv 82/711/EC og 85/572/EC. En kopi af migrationstesten er medsendt. Specifik migrationstest Hvis der er angivet SMG-værdier ovenfor skal produktet testes for specifik migration i henhold til EUdirektiv 82/711/EC og 85/572/EC. Der er ikke foretaget specifik migrationstest da de nedenfor angivet råvarerne kun indeholder stoffer der er omfattet af positivlisten Annex l i forordning 10/2011/EC, og er fremstillet af stoffer, der ikke er pålagt restriktioner mht. specifik migration. Dette ses på vedhæftede dokument fra EXXON/RESINEX & KROGH - Regulatory Declaration for råvarene EXCEED 1018EB, EXCEED 1327ED, EXXONMOBIL HTA108, EXXONMOBIL LD150AC (side 8 i deklarationen) Overensstemmelse Produktet er fremstillet i henhold til retningslinierne i EU-forordning 2023/2006 og forårsager ingen fare for menneskers sundhed eller miljøet i henhold til artikel 3 i rammedirektiv 1935/2004/EC. Produktet er i overensstemmelse med den gældende EU-lovgivning (EU-direktiv 2002/72/EC og efterfølgende ændringer). Vi forpligter os hermed til at informere om ændringer i produktet. Dato Navn Jesper Philipsen Underskrift Version 2 d. 25/2-2015
3 ExxonMobil Chemical Belgium A Division of ExxonMobil Petroleum & Chemical, BVBA Registered Office: Polderdijkweg B-2030 Antwerp, RPR Antwerpen An ExxonMobil Subsidiary Mail Address : P.O. Box 100, B-2060 Antwerp 6, Belgium RESINEX DANMARK A/S DORTE SCHROLL RESINEX DANMARK A/S HELLERUPVEJ 17 A 2900 HELLERUP Address: [email protected] Issue Date: 11 SEP 2014 Subject: Regulatory Declaration and/or Product Stewardship Information Statement(s) - Request Dear Sir/Madam: In response to your request, please find enclosed the regulatory declaration and/or product stewardship information statement(s) for the following product(s): EXCEED 1018KB EXCEED 1327KD EXXONMOBIL HTA108 These statements are provided by or on behalf of the above referenced ExxonMobil selling affiliate. If you have any questions or need additional information please contact your ExxonMobil sales representative. Enclosure(s): EXCEED 1018KB - EUROPEAN FOOD LAW EXCEED 1018KB - USA FOOD LAW (FDA) EXCEED 1327KD - EUROPEAN FOOD LAW EXCEED 1327KD - USA FOOD LAW (FDA) EXXONMOBIL HTA108 - EUROPEAN FOOD LAW EXXONMOBIL HTA108 - USA FOOD LAW (FDA) Reference Number: PAGE 1 of 15
4 STATEMENT Issue Date: 11 SEP 2014 At request of: RESINEX DANMARK A/S Product Name(s): EXCEED 1018KB Material Code(s): With regard to the compliance status of the ExxonMobil Chemical product referenced above with the regulation(s) identified below the following can be declared: EU FOOD-CONTACT REGULATION The monomer(s) and the additive(s) intentionally used in the above polymer grade are listed in Annex 1 or are authorized in accordance with the requirements of Commission Regulation (EU) No 10/2011 of 14 January 2011, as amended up to Regulation (EU) No 202/2014, on plastic materials and articles intended to come into contact with food. The above polymer grade complies with the relevant requirements of Regulation (EC) No 1935/2004 in as far as: * the grade is produced using Good Manufacturing Practice as required in article 3.1 of Regulation (EC) No 1935/2004 and meets the guidelines for Good Manufacturing Practice as specified in Regulation (EC) No 2023/2006 (on good manufacturing practice for materials and articles intended to come in contact with food). * the production of the above grade ensures traceability as required in article 17.1 of Regulation (EC) No 1935/2004. * the polymer production aids and aids to polymerization are either permitted in one or more EU Member State(s) and/or have been risk assessed based on the following assumptions: 100% migration, 1kg/food packed with 6dm2 of packaging, article thickness of 250 microns EU MEMBER STATES As for the compliance status with EU Member States laws and/or recommendations where specific requirements exist for substances other than monomers and additives, the following can be stated: The polymer production aids ("PPA") possibly present in the above polymer are permitted in the following countries. Belgium - "Arrêté royal du 3 juillet 2005 relatif aux matériaux et aux objets en matière plastique destinés à entrer en contact avec les denrées alimentaires", as amended up to "Arrêté royal du 10 février 2011" France - "Arrêté du 2 janvier 2003 relatif aux matériaux et objets en PAGE 2 of 15
5 matière plastique mis ou destinés à être mis au contact des denrées, produits et boissons alimentaires", as amended up to "Arrêté du 1er avril 2011" Germany - "Bedarfsgegenständeverordnung in der Fassung der Bekanntmachung vom 23. Dezember 1997 (BGBl I S. 5)", as amended up to "Verordnung vom ( BGBl. I S. 1682)" - BfR Empfehlung III "Polyethylen" from the Bundesinstitut fuer Risikobewertung "BfR" Italy - "Decreto 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari o con sostanze d'uso personale", as amended up to "Decreto 04 febbraio 2013, n. 23 (G.U. Serie Generale n. 71 del 25 marzo 2013)" Spain - "Real Decreto 866/2008, de 23 de mayo, por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto con los alimentos y se regulan determinadas condiciones de ensayo", as amended up to "Orden PRE/628/2011, de 22 de marzo" The Netherlands - "Regeling Verpakkingen- en gebruiksartikelen (Warenwet)" as amended up to "Regeling Verpakkingen- en gebruiksartikelen Staatscourant Nr VGP/VC " from February 14, 2011 Hoofdstuk 1 - Kunststof SWITZERLAND: The composition of the above polymer grade meets the requirements of the Swiss Ordinance on material and objects in Plastic, SR of 23 Nov 2005 (stand 1 April 2013). - The composition of the base polymeric component(s) in this polymer grade complies with the positive lists for allowed monomers in the above referenced legislation. - The additives that may be present comply with the lists for additives in the above referenced legislation, unless explicitly referred to in the additives note below. Information regarding additives subject to a restriction in food (dual use additives) and information on lipophilic substances are not applicable in Switzerland. # Monomer restrictions: The above grade is manufactured with a monomer that has the following SML restriction: 1-Hexene: SML = 3 mg/kg (EC Ref No 18820) Under the current SML restrictions given in the EC Directive, there is no need for checking any monomer specific migration limit other PAGE 3 of 15
6 than 1-hexene, whatever the thickness of the food-contact article involved. # Presence of additives with SML The above polymer grade does contain one or more additive(s) that is/are subject to a Specific Migration Limit (SML). # Presence of dual use additives The above polymer grade does contain one or more additive(s) that is/are subject to a restriction in food as referred to in Article 11.3 of EU Regulation 10/2011. Note For information purpose only This note contains information relative to the presence of additives subject to a restriction according to Regulation (EU) 10/2011, as described in this statement. Additive : Tris(nonylphenyl) phosphite EC Ref. No : Max. conc.* : 1800 ppm Restriction : SML = 30mg/kg food - Lipophilic substance Additive : Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate EC Ref. No : Max. conc* : 360 ppm Restriction : SML = 6mg/kg food - Lipophilic substance Additive : Talc EC Ref. No : Max. conc.* : 1800 ppm Restriction : Dual use additive Additive : Inorganic antiblocking agents (Calcium Carbonate, Magnesium Oxide) Max. Conc.* : 50 ppm Restriction : Dual use additive Additive : Polyethylene glycol sorbitan monolaurate EC Ref. No : Max. conc.* : 30 ppm Restriction : Dual use additive Additive : Polyethylene glycol EC Ref. No : Max. conc.* : 680 ppm Restriction : Dual use additive * This information is provided for general guidance purposes only and ExxonMobil Chemical provides no guarantees or warranties in respect of this information and has no responsibility or liability for any use by any third party of this information. PAGE 4 of 15
7 Note on Overall Migration Limit ("OML") and on Specific Migration Limits ("SML's"), where applicable In all EU countries and Switzerland, finished plastics food-contact materials or articles, made from or containing this product, need to comply with Overall Migration Limit ("OML") requirements and Specific Migration Limits ("SML"), where applicable and when tested on the food-contact surface with the appropriate food simulants and time/temperature test conditions. This is the responsibility of the user of this polymer product. In addition to the above compositional compliance status certification, the polymer user is required to carry out the appropriate overall migration ("OML") and specific migration ("SML") tests on the final material or article to determine the regulatory suitability for contact with different food-types (aqueous, fat/oil, alcoholic, etc.) and various end-use conditions (material or article thickness, pure or in blends, volume, contact time of packaging, temperature of use, etc.), all of which are beyond control of the polymer manufacturer. GENERAL NOTE The manufacturer of food-contact materials and articles - made from or containing this polymer grade - must ensure that the finished materials or articles meet the general regulatory requirements that they do not bring about an unacceptable change in the composition of the foodstuffs or a deterioration in the organoleptic characteristics thereof and do not release constituents in foodstuffs in quantities that can endanger human health. In addition, the finished food-contact material or article must be technically suitable for the intended use. VALIDITY DATE: This document is valid until the next relevant legislative and/or regulatory change with a maximum of one year as of the date of issue of the statement. Reference Number: PAGE 5 of 15
8 STATEMENT Issue Date: 11 SEP 2014 At request of: RESINEX DANMARK A/S Product Name(s): EXCEED 1018KB Material Code(s): With regard to the compliance status of the ExxonMobil Chemical product referenced above with the regulation(s) identified below the following can be declared: This product complies with FDA regulation 21 CFR (Olefin polymers), paragraphs (c)3.1a and (c)3.2a, and may be used as articles or components of articles intended for use in contact with food, including use in articles used for packing or holding food during cooking. Finished articles may contact all food types identified in Table 1 of 21 CFR (c) under Conditions of Use A through H as described in Table 2 of 21 CFR (c). This product is produced under conditions of good manufacturing practice as required by 21 CFR 174.5(a) and is of a purity suitable for its intended use in food contact applications as allowed by the regulatory citations identified above. The manufacturer of any food, direct or indirect food additive, or food contact substance or article containing this product has the responsibility to ensure compliance with applicable FDA regulations and to ensure that any finished food contact article is technically suitable for the intended use. VALIDITY DATE: This document is valid until the next relevant legislative and/or regulatory change with a maximum of one year as of the date of issue of the statement. Reference Number: PAGE 6 of 15
9 STATEMENT Issue Date: 11 SEP 2014 At request of: RESINEX DANMARK A/S Product Name(s): EXCEED 1327KD Material Code(s): With regard to the compliance status of the ExxonMobil Chemical product referenced above with the regulation(s) identified below the following can be declared: EU FOOD-CONTACT REGULATION The monomer(s) and the additive(s) intentionally used in the above polymer grade are listed in Annex 1 or are authorized in accordance with the requirements of Commission Regulation (EU) No 10/2011 of 14 January 2011, as amended up to Regulation (EU) No 202/2014, on plastic materials and articles intended to come into contact with food. The above polymer grade complies with the relevant requirements of Regulation (EC) No 1935/2004 in as far as: * the grade is produced using Good Manufacturing Practice as required in article 3.1 of Regulation (EC) No 1935/2004 and meets the guidelines for Good Manufacturing Practice as specified in Regulation (EC) No 2023/2006 (on good manufacturing practice for materials and articles intended to come in contact with food). * the production of the above grade ensures traceability as required in article 17.1 of Regulation (EC) No 1935/2004. * the polymer production aids and aids to polymerization are either permitted in one or more EU Member State(s) and/or have been risk assessed based on the following assumptions: 100% migration, 1kg/food packed with 6dm2 of packaging, article thickness of 250 microns EU MEMBER STATES As for the compliance status with EU Member States laws and/or recommendations where specific requirements exist for substances other than monomers and additives, the following can be stated: The polymer production aids ("PPA") possibly present in the above polymer are permitted in the following countries. Belgium - "Arrêté royal du 3 juillet 2005 relatif aux matériaux et aux objets en matière plastique destinés à entrer en contact avec les denrées alimentaires", as amended up to "Arrêté royal du 10 février 2011" France - "Arrêté du 2 janvier 2003 relatif aux matériaux et objets en PAGE 7 of 15
10 matière plastique mis ou destinés à être mis au contact des denrées, produits et boissons alimentaires", as amended up to "Arrêté du 1er avril 2011" Germany - "Bedarfsgegenständeverordnung in der Fassung der Bekanntmachung vom 23. Dezember 1997 (BGBl I S. 5)", as amended up to "Verordnung vom ( BGBl. I S. 1682)" - BfR Empfehlung III "Polyethylen" from the Bundesinstitut fuer Risikobewertung "BfR" Italy - "Decreto 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari o con sostanze d'uso personale", as amended up to "Decreto 04 febbraio 2013, n. 23 (G.U. Serie Generale n. 71 del 25 marzo 2013)" Spain - "Real Decreto 866/2008, de 23 de mayo, por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto con los alimentos y se regulan determinadas condiciones de ensayo", as amended up to "Orden PRE/628/2011, de 22 de marzo" The Netherlands - "Regeling Verpakkingen- en gebruiksartikelen (Warenwet)" as amended up to "Regeling Verpakkingen- en gebruiksartikelen Staatscourant Nr VGP/VC " from February 14, 2011 Hoofdstuk 1 - Kunststof SWITZERLAND: The composition of the above polymer grade meets the requirements of the Swiss Ordinance on material and objects in Plastic, SR of 23 Nov 2005 (stand 1 April 2013). - The composition of the base polymeric component(s) in this polymer grade complies with the positive lists for allowed monomers in the above referenced legislation. - The additives that may be present comply with the lists for additives in the above referenced legislation, unless explicitly referred to in the additives note below. Information regarding additives subject to a restriction in food (dual use additives) and information on lipophilic substances are not applicable in Switzerland. # Monomer restrictions: The above grade is manufactured with a monomer that has the following SML restriction: 1-Hexene: SML = 3 mg/kg (EC Ref No 18820) Under the current SML restrictions given in the EC Directive, there is no need for checking any monomer specific migration limit other PAGE 8 of 15
11 than 1-hexene, whatever the thickness of the food-contact article involved. # Presence of additives with SML The above polymer grade does contain one or more additive(s) that is/are subject to a Specific Migration Limit (SML). # Presence of dual use additives The above polymer grade does contain one or more additive(s) that is/are subject to a restriction in food as referred to in Article 11.3 of EU Regulation 10/2011. Note For information purpose only This note contains information relative to the presence of additives subject to a restriction according to Regulation (EU) 10/2011, as described in this statement. Additive : Tris(nonylphenyl) phosphite EC Ref. No : Max. conc.* : 1800 ppm Restriction : SML = 30mg/kg food - Lipophilic substance Additive : Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate EC Ref. No : Max. conc* : 360 ppm Restriction : SML = 6mg/kg food - Lipophilic substance Additive : Talc EC Ref. No : Max. conc.* : 600 ppm Restriction : Dual use additive Additive : Inorganic antiblocking agents (Calcium Carbonate, Magnesium Oxide) Max. Conc.* : 50 ppm Restriction : Dual use additive Additive : Polyethylene glycol sorbitan monolaurate EC Ref. No : Max. conc.* : 10 ppm Restriction : Dual use additive Additive : Polyethylene glycol EC Ref. No : Max. conc.* : 680 ppm Restriction : Dual use additive * This information is provided for general guidance purposes only and ExxonMobil Chemical provides no guarantees or warranties in respect of this information and has no responsibility or liability for any use by any third party of this information. PAGE 9 of 15
12 Note on Overall Migration Limit ("OML") and on Specific Migration Limits ("SML's"), where applicable In all EU countries and Switzerland, finished plastics food-contact materials or articles, made from or containing this product, need to comply with Overall Migration Limit ("OML") requirements and Specific Migration Limits ("SML"), where applicable and when tested on the food-contact surface with the appropriate food simulants and time/temperature test conditions. This is the responsibility of the user of this polymer product. In addition to the above compositional compliance status certification, the polymer user is required to carry out the appropriate overall migration ("OML") and specific migration ("SML") tests on the final material or article to determine the regulatory suitability for contact with different food-types (aqueous, fat/oil, alcoholic, etc.) and various end-use conditions (material or article thickness, pure or in blends, volume, contact time of packaging, temperature of use, etc.), all of which are beyond control of the polymer manufacturer. GENERAL NOTE The manufacturer of food-contact materials and articles - made from or containing this polymer grade - must ensure that the finished materials or articles meet the general regulatory requirements that they do not bring about an unacceptable change in the composition of the foodstuffs or a deterioration in the organoleptic characteristics thereof and do not release constituents in foodstuffs in quantities that can endanger human health. In addition, the finished food-contact material or article must be technically suitable for the intended use. VALIDITY DATE: This document is valid until the next relevant legislative and/or regulatory change with a maximum of one year as of the date of issue of the statement. Reference Number: PAGE 10 of 15
13 STATEMENT Issue Date: 11 SEP 2014 At request of: RESINEX DANMARK A/S Product Name(s): EXCEED 1327KD Material Code(s): With regard to the compliance status of the ExxonMobil Chemical product referenced above with the regulation(s) identified below the following can be declared: This product complies with FDA regulation 21 CFR (Olefin polymers), paragraphs (c)3.1a and (c)3.2a, and may be used as articles or components of articles intended for use in contact with food, including use in articles used for packing or holding food during cooking. Finished articles may contact all food types identified in Table 1 of 21 CFR (c) under Conditions of Use A through H as described in Table 2 of 21 CFR (c). This product is produced under conditions of good manufacturing practice as required by 21 CFR 174.5(a) and is of a purity suitable for its intended use in food contact applications as allowed by the regulatory citations identified above. The manufacturer of any food, direct or indirect food additive, or food contact substance or article containing this product has the responsibility to ensure compliance with applicable FDA regulations and to ensure that any finished food contact article is technically suitable for the intended use. VALIDITY DATE: This document is valid until the next relevant legislative and/or regulatory change with a maximum of one year as of the date of issue of the statement. Reference Number: PAGE 11 of 15
14 STATEMENT Issue Date: 11 SEP 2014 At request of: RESINEX DANMARK A/S Product Name(s): EXXONMOBIL HTA108 Material Code(s): With regard to the compliance status of the ExxonMobil Chemical product referenced above with the regulation(s) identified below the following can be declared: EU FOOD-CONTACT REGULATION The monomer(s) and the additive(s) intentionally used in the above polymer grade are listed in Annex 1 or are authorized in accordance with the requirements of Commission Regulation (EU) No 10/2011 of 14 January 2011, as amended up to Regulation (EU) No 202/2014, on plastic materials and articles intended to come into contact with food. The above polymer grade complies with the relevant requirements of Regulation (EC) No 1935/2004 in as far as: * the grade is produced using Good Manufacturing Practice as required in article 3.1 of Regulation (EC) No 1935/2004 and meets the guidelines for Good Manufacturing Practice as specified in Regulation (EC) No 2023/2006 (on good manufacturing practice for materials and articles intended to come in contact with food). * the production of the above grade ensures traceability as required in article 17.1 of Regulation (EC) No 1935/2004. * the polymer production aids and aids to polymerization are either permitted in one or more EU Member State(s) and/or have been risk assessed based on the following assumptions: 100% migration, 1kg/food packed with 6dm2 of packaging, article thickness of 250 microns EU MEMBER STATES As for the compliance status with EU Member States laws and/or recommendations where specific requirements exist for substances other than monomers and additives, the following can be stated: The polymer production aids ("PPA") possibly present in the above polymer are permitted in the following countries. Belgium - "Arrêté royal du 3 juillet 2005 relatif aux matériaux et aux objets en matière plastique destinés à entrer en contact avec les denrées alimentaires", as amended up to "Arrêté royal du 10 février 2011" France - "Arrêté du 2 janvier 2003 relatif aux matériaux et objets en PAGE 12 of 15
15 matière plastique mis ou destinés à être mis au contact des denrées, produits et boissons alimentaires", as amended up to "Arrêté du 1er avril 2011" Germany - "Bedarfsgegenständeverordnung in der Fassung der Bekanntmachung vom 23. Dezember 1997 (BGBl I S. 5)", as amended up to "Verordnung vom ( BGBl. I S. 1682)" - BfR Empfehlung III "Polyethylen" from the Bundesinstitut fuer Risikobewertung "BfR" Italy - "Decreto 21 marzo 1973, concernente la disciplina igienica degli imballaggi, recipienti, utensili destinati a venire in contatto con le sostanze alimentari o con sostanze d'uso personale", as amended up to "Decreto 04 febbraio 2013, n. 23 (G.U. Serie Generale n. 71 del 25 marzo 2013)" Spain - "Real Decreto 866/2008, de 23 de mayo, por el que se aprueba la lista de sustancias permitidas para la fabricación de materiales y objetos plásticos destinados a entrar en contacto con los alimentos y se regulan determinadas condiciones de ensayo", as amended up to "Orden PRE/628/2011, de 22 de marzo" The Netherlands - "Regeling Verpakkingen- en gebruiksartikelen (Warenwet)" as amended up to "Regeling Verpakkingen- en gebruiksartikelen Staatscourant Nr VGP/VC " from February 14, 2011 Hoofdstuk 1 - Kunststof SWITZERLAND: The composition of the above polymer grade meets the requirements of the Swiss Ordinance on material and objects in Plastic, SR of 23 Nov 2005 (stand 1 April 2013). - The composition of the base polymeric component(s) in this polymer grade complies with the positive lists for allowed monomers in the above referenced legislation. - The additives that may be present comply with the lists for additives in the above referenced legislation, unless explicitly referred to in the additives note below. Information regarding additives subject to a restriction in food (dual use additives) and information on lipophilic substances are not applicable in Switzerland. # Monomer restrictions: None of the monomers used in the production of this polymer is subject to a Specific Migration Limit (SML). # Presence of additives with SML None of the additives intentionally used in this polymer grade is PAGE 13 of 15
16 subject to a Specific Migration Limit (SML). # Presence of dual use additives None of the additives intentionally used in this polymer grade is subject to a restriction in food as referred to in Article 11.3 of Regulation (EU) 10/2011. Note on Overall Migration Limit ("OML") and on Specific Migration Limits ("SML's"), where applicable In all EU countries and Switzerland, finished plastics food-contact materials or articles, made from or containing this product, need to comply with Overall Migration Limit ("OML") requirements and Specific Migration Limits ("SML"), where applicable and when tested on the food-contact surface with the appropriate food simulants and time/temperature test conditions. This is the responsibility of the user of this polymer product. In addition to the above compositional compliance status certification, the polymer user is required to carry out the appropriate overall migration ("OML") and specific migration ("SML") tests on the final material or article to determine the regulatory suitability for contact with different food-types (aqueous, fat/oil, alcoholic, etc.) and various end-use conditions (material or article thickness, pure or in blends, volume, contact time of packaging, temperature of use, etc.), all of which are beyond control of the polymer manufacturer. GENERAL NOTE The manufacturer of food-contact materials and articles - made from or containing this polymer grade - must ensure that the finished materials or articles meet the general regulatory requirements that they do not bring about an unacceptable change in the composition of the foodstuffs or a deterioration in the organoleptic characteristics thereof and do not release constituents in foodstuffs in quantities that can endanger human health. In addition, the finished food-contact material or article must be technically suitable for the intended use. VALIDITY DATE: This document is valid until the next relevant legislative and/or regulatory change with a maximum of one year as of the date of issue of the statement. Reference Number: PAGE 14 of 15
17 STATEMENT Issue Date: 11 SEP 2014 At request of: RESINEX DANMARK A/S Product Name(s): EXXONMOBIL HTA108 Material Code(s): With regard to the compliance status of the ExxonMobil Chemical product referenced above with the regulation(s) identified below the following can be declared: This product complies with FDA regulation 21 CFR (Olefin polymers), paragraphs (c)2.1 and (c)2.2, and may be used as articles or components of articles intended for use in contact with food, including use in articles used for packing or holding food during cooking. This product is produced under conditions of good manufacturing practice as required by 21 CFR 174.5(a) and is of a purity suitable for its intended use in food contact applications as allowed by the regulatory citations identified above. The manufacturer of any food, direct or indirect food additive, or food contact substance or article containing this product has the responsibility to ensure compliance with applicable FDA regulations and to ensure that any finished food contact article is technically suitable for the intended use. VALIDITY DATE: This document is valid until the next relevant legislative and/or regulatory change with a maximum of one year as of the date of issue of the statement. Reference Number: PAGE 15 of 15
18 Norlip Att.: Jesper Philipsen Svejsegangen Karlslunde Analyserapport - Materialetest Prøvemateriale Sagsidentifikation Migrationstest plastfolie, LDPE Prøvemodtagelse 6. Juli 2009 Antal / Prøvetype Plastfolie, LDPE med følgende identifikation: 60% Exceed 1327 ED, 20% Exceed 1018 EB, 10% LD 150 AC 10% HD HTA108 Analyseperiode 8. juli 25. august 2009 Eurofins Product Testing A/S Smedeskovvej 38 DK-8464 Galten Telefon Telefax [email protected] Dato 3. december 2009 Deres ref. - Vores ref Rev1/JH Anvendte metoder Metodenr. Princip Parameter Detektionsgrænse Analyseusikkerhed 1 EN Gravimetri Global migration til vand, 3% eddikesyre og 10 % ethanol EN Gravimetri og Gaskromatografi (GC/FID) Global migration til olivenolie 1 mg/dm 2 15% (RSD) 2 mg/dm 2 15% (RSD) Princip for migration: Den totale migration fra prøverne til vand, 3% eddikesyre, 10% ethanol og olivenolie bestemmes ved eksponering i 10 dage timer ved 40 C. Testen gennemføres ved neddypning af prøveemner i fødevaresimulanten. Testen er foretaget i henhold til EN og EN Efter eksponering, hvor de opløselige komponenter migrerer fra materialet til simulanten, fjernes emnet fra simulanten. Migration til 3% eddikesyre, 10% ethanol og vand: simulanten inddampes, og inddampningsresten bestemmes ved vejning og angives som migrationen fra emnet til fødevaresimulanten. Migration til olivenolie: Emnet der har været neddyppet i simulanten aftørres og vejes. Adsorberet olie bestemmes ved ekstraktion og efterfølgende GC/FID analyse. Emnets vægt korrigeres for den ekstraherede olie og migrationen bestemmes som vægttab af emnet 1 Analysen udføres som tredobbeltbestemmelse. Dog mindst halvdelen af detektionsgrænsen absolut Eurofins Product Testing A/S John Hansen Civilingeniør, kemi Prøvningsresultaterne gælder udelukkende for de(n) undersøgte prøve(r). Rapporten må ikke gengives, undtagen i sin helhed, uden prøvningslaboratoriets skriftlige godkendelse. I:\SAGER\GALTEN\MATERIALER\184\EXT\MIGRATION\NORLIP\770318REV1_NORLIP.DOC Side 1 af 1
19 Sagsnr Rev1 Analyseresultater Enhed: mg/dm 2 LDPE: Exceed 1327 ED, Exceed 1018 EB, LD 150 AC, HD HTA108 Parameter 1. bestemmelse 2. bestemmelse 3. bestemmelse Gennemsnit Migration til 3 % eddikesyre < 1 < 1 < 1 < 1 < betyder mindre end Enhed: mg/dm 2 LDPE: Exceed 1327 ED, Exceed 1018 EB, LD 150 AC, HD HTA108 Parameter 1. bestemmelse 2. bestemmelse 3. bestemmelse Gennemsnit Migration til 10% ethanol < 1 < 1 < 1 < 1 < betyder mindre end Enhed: mg/dm 2 LDPE: Exceed 1327 ED, Exceed 1018 EB, LD 150 AC, HD HTA108 Parameter 1. bestemmelse 2. bestemmelse 3. bestemmelse Gennemsnit Migration til olivenolie* 2,0 2,3 2,5 2,3 < betyder mindre end * Denne analyse er ikke omfattet af akrediteringen. Er dog udført under kvalitetsstyringssystemet ISO og er pr. 7. oktober 2009 også omfattet af akkrediteringen. Enhed: mg/dm 2 LDPE: Exceed 1327 ED, Exceed 1018 EB, LD 150 AC, HD HTA108 Parameter 1. bestemmelse 2. bestemmelse 3. bestemmelse Gennemsnit Migration til vand < 1 < 1 < 1 < 1 < betyder mindre end Kommentar I henhold til BEK nr 167 af 03/03/2009 overholder plastfolien, LDPE, kravet om en migration på maksimalt 10 mg/dm 2 for vand, 3% eddikesyre 10% ethanol og olivenolie som simulanter. Prøvningsresultaterne gælder udelukkende for de(n) undersøgte prøve(r). Rapporten må ikke gengives, undtagen i sin helhed, uden prøvningslaboratoriets skriftlige godkendelse. I:\SAGER\GALTEN\MATERIALER\184\EXT\MIGRATION\NORLIP\770318REV1_NORLIP.DOC Side 2 af 2
20 ExxonMobil HDPE HTA 108 High Density Polyethylene Resin Product Description HTA 108 is a homopolymer HDPE film grade designed to improve stiffness and barrier in coextrusion or in PE blends. When blended with LLDPE or metallocene LLDPE, HTA 108 improves their processability. General Availability 1 Africa & Middle East Asia Pacific Europe Additive Antiblock: No Slip: No Thermal Stabilizer: Yes Applications Revision Date 10/2008 Blown Film Bread Bags Collation Shrink Food packaging Form Fill And Seal Packaging Freezer Film General Packaging Industrial Packaging Label Film Lamination Film Multilayer Packaging Film Overwrap Film Packaging Films Shoppers Shrink Film Stand Up Pouches Resin Properties Typical Value (English) Typical Value (SI) Test Based On Density g/cm³ g/cm³ ExxonMobil Method Melt Index (190 C/2.16 kg) 0.70 g/10 min 0.70 g/10 min ASTM D1238 High Load Melt Index (190 C/21.6 kg) 46 g/10 min 46 g/10 min ASTM D1238 Thermal Typical Value (English) Typical Value (SI) Test Based On Vicat Softening Temperature 264 F 129 C ASTM D1525 Film Properties Typical Value (English) Typical Value (SI) Test Based On Tensile Strength at Break MD 9720 psi 67.0 MPa ASTM D882 Tensile Strength at Break TD 5370 psi 37.0 MPa ASTM D882 Elongation at Break MD 490 % 490 % ASTM D882 Elongation at Break TD 3.0 % 3.0 % ASTM D882 Secant Modulus MD - 1% Secant psi 1250 MPa ASTM D882 Secant Modulus TD - 1% Secant psi 1700 MPa ASTM D882 Dart Drop Impact < 20 g < 20 g ASTM D1709A Elmendorf Tear Strength MD 10 g 10 g ASTM D1922 Elmendorf Tear Strength TD 800 g 800 g ASTM D1922 Additional Information Monolayer Film: HTA108 can be added to LDPE, LLDPE or mlldpe films to increase stiffness when high transparency is not mandatory. Legal Statement HTA 108 can - in principle - be used in food contact applications in various EU Member States and in the USA (FDA). Migration or use limitations may apply. Please contact your ExxonMobil Chemical representative for more detailed information and/or actual compliance certification documents for the specific grade of interest. ExxonMobil Polyethylene is not intended for use in medical applications. Typical properties: these are not to be construed as specifications Exxon Mobil Corporation. To the extent the user is entitled to disclose and distribute this document, the user may forward, distribute, and/or photocopy this copyrighted document only if unaltered and complete, including all of its headers, footers, disclaimers, and other information. You may not copy this document to a Web site. ExxonMobil does not guarantee the typical (or other) values. Analysis may be performed on representative samples and not the actual product shipped. The information in this document relates only to the named product or materials when not in combination with any other product or materials. We based the information on data believed to be reliable on the date compiled, but we do not represent, warrant, or otherwise guarantee, expressly or impliedly, the merchantability, fitness for a particular purpose, suitability, accuracy, reliability, or completeness of this information or the products, materials, or processes described. The user is solely responsible for all determinations regarding any use of material or product and any process in its territories of interest. We expressly disclaim liability for any loss, damage, or injury directly or indirectly suffered or incurred as a result of or related to anyone using or relying on any of the information in this document. There is no endorsement of any product or process, and we expressly disclaim any contrary implication. The terms, "we", "our", "ExxonMobil Chemical", or "ExxonMobil" are used for convenience, and may include any one or more of ExxonMobil Chemical Company, Exxon Mobil Corporation, or any affiliates they directly or indirectly steward. ExxonMobil, the ExxonMobil Chemical Emblem, the "Interlocking X" Device, Enable, Exceed, Exact, Exxco, Escorene, Escor, Iotek, NTX, Polybilt, Paxon and Optema are trademarks or service marks of Exxon Mobil Corporation. Download datasheets at July 03, Page: 1 of 2
21 ExxonMobil Chemical ExxonMobil HDPE HTA 108 High Density Polyethylene Resin Processing Statement The test specimens for Vicat Softening Point were prepared using ASTM D All film properties have been measured on 25 µm (0.98 mil) thick films (BUR of 2.5 : 1, pocket extrusion at 200 C / 392 F). Properties of coextruded films and blends can be found in the HTA108 Fact Sheet. Notes 1 Product may not be available in one or more countries in the identified Availability regions. Contact your Sales Representative for complete Country Availability. Typical properties: these are not to be construed as specifications Exxon Mobil Corporation. To the extent the user is entitled to disclose and distribute this document, the user may forward, distribute, and/or photocopy this copyrighted document only if unaltered and complete, including all of its headers, footers, disclaimers, and other information. You may not copy this document to a Web site. ExxonMobil does not guarantee the typical (or other) values. Analysis may be performed on representative samples and not the actual product shipped. The information in this document relates only to the named product or materials when not in combination with any other product or materials. We based the information on data believed to be reliable on the date compiled, but we do not represent, warrant, or otherwise guarantee, expressly or impliedly, the merchantability, fitness for a particular purpose, suitability, accuracy, reliability, or completeness of this information or the products, materials, or processes described. The user is solely responsible for all determinations regarding any use of material or product and any process in its territories of interest. We expressly disclaim liability for any loss, damage, or injury directly or indirectly suffered or incurred as a result of or related to anyone using or relying on any of the information in this document. There is no endorsement of any product or process, and we expressly disclaim any contrary implication. The terms, "we", "our", "ExxonMobil Chemical", or "ExxonMobil" are used for convenience, and may include any one or more of ExxonMobil Chemical Company, Exxon Mobil Corporation, or any affiliates they directly or indirectly steward. ExxonMobil, the ExxonMobil Chemical Emblem, the "Interlocking X" Device, Enable, Exceed, Exact, Exxco, Escorene, Escor, Iotek, NTX, Polybilt, Paxon and Optema are trademarks or service marks of Exxon Mobil Corporation. Download datasheets at July 03, Page: 2 of 2
22 EXCEED mlldpe EXCEED 1018 Series Blown Film Resins Description Exceed 1018 Series grades are ethylene based polymers produced with metallocene single site catalysts using ExxonMobil's proprietary Exxpol technology. Films made of Exceed 1018 Series grades have outstanding tensile, impact, puncture resistance, and low temperature properties. Exceed 1018 EB and Exceed 1018 FA contain slipagent and antiblock, which makes them suitable for formulations which require good openability and a low friction coefficient. They are ready-to-use versatile polymers for demanding mono layer and multi layer blown film applications. Applications film for frozen foods high speed Form Fill Seal packaging overwrap films, e.g., for tissue thin gauge industrial and consumer films bag in box film trash bags liners Additive Package PPA Antiblock Slip Thermal Stabilizer Exceed 1018EB Yes 2500 ppm 750 ppm Yes Exceed 1018FA Yes 4500 ppm 450 ppm Yes Resin Properties Test Based On Typical Value / Unit Melt Index ASTM D g/10 min Density ASTM D4703 / D g/cm 3 Peak Melting Temperature ASTM D C 244 F Film Properties Tensile Strength MD TD Break MD TD 1% Secant Modulus MD TD ASTM D MPa 35 MPa ASTM D % 510 % ASTM D MPa 180 MPa Haze ASTM D % Gloss, 60 angle ASTM D % 7500 psi 5100 psi psi psi Dart Drop Impact, A/Face ASTM D g/µm 762 g/mil Elmendorf Tear Strength MD TD ASTM D g/µm 15 g/µm 228 g/mil 381 g/mil Puncture Resistance ExxonMobil Method 3 N/µm 16 lb/mil Film properties have been measured on a 25 µm (0.98 mil) thick film made of Exceed 1018EB (BUR = 2.5 and a melt temperature of 210 C, 410 F). Optical film properties have been measured on 25 µm (0.98 mil) thick film made of Exceed 1018EB with addition of 10 % LDPE at the same conditions. Exceed 1018EB and Exceed 1018FA can - in principle - be used in food contact applications in various EU Member States and in the USA (FDA). Migration or use limitations may apply. Please contact your ExxonMobil Chemical representative for more detailed information and/or actual compliance certification documents for the specific grade of interest. Revised 02/ ExxonMobil. To the extent the user is entitled to disclose and distribute this document, the user may forward, distribute, and/or photocopy this copyrighted document only if unaltered and complete, including all of its headers, footers, disclaimers, and other information. You may not copy this document to a Web site. ExxonMobil does not guarantee the typical (or other) values. Analysis may be performed on representative samples and not the actual product shipped. The information in this document relates only to the named product or materials when not in combination with any other product or materials. We based the information on data believed to be reliable on the date compiled, but we do not represent, warrant, or otherwise guarantee, expressly or impliedly, the merchantability, fitness for a particular purpose, suitability, accuracy, reliability, or completeness of this information or the products, materials, or processes described. The user is solely responsible for all determinations regarding any use of material or product and any process in its territories of interest. We expressly disclaim liability for any loss, damage, or injury directly or indirectly suffered or incurred as a result of or related to anyone using or relying on any of the information in this document. There is no endorsement of any product or process, and we expressly disclaim any contrary implication. The terms, we, our, "ExxonMobil Chemical", or "ExxonMobil" are used for convenience, and may include any one or more of ExxonMobil Chemical Company, Exxon Mobil Corporation, or any affiliates they directly or indirectly steward. The ExxonMobil Emblem, the Interlocking X Device and Exceed are trademarks of ExxonMobil Corporation.
23 EXCEED mlldpe EXCEED 1327ED Blown Film Resin Description Exceed 1327ED is an ethylene based polymer produced with metallocene single site catalysts using ExxonMobils proprietary Exxpol technology. Applications overwrap mailing films industrial packaging It produces films which have high modulus whilst retaining good toughness. Additionally, Exceed 1327ED is fully formulated with slip and antiblock, giving a versatile ready-to-use polymer for applications such as form fill and seal. Additive Package PPA Antiblock Slip Thermal Stabilizer EXCEED 1327ED Yes 750 ppm 1250 ppm Yes Resin Properties Test Based On Typical Value / Unit Melt Index ASTM D g/10 min Density ASTM D4703 / D g/cm 3 Peak Melting Temperature ASTM D C 253 F Film Properties Tensile Strength MD TD Break MD TD 1% Secant Modulus MD TD ASTM D MPa 39 MPa ASTM D % 620 % ASTM D MPa 320 MPa Haze ASTM D % Gloss, 60 angle ASTM D % 7000 psi 5650 psi psi psi Dart Drop Impact, A/Face ASTM D g/µm g/mil Elmendorf Tear Strength MD TD ASTM D g/µm 17 g/µm g/mil g/mil Puncture Resistance ExxonMobil Method 2.5 N/µm 14 lb/mil COF, I/I ASTM D Film properties have been measured on a 25 µm (0.984 mil) thick film (BUR = 2.5 and temperature setting of 210 C, 410 F). Optical film properties have been measured on 25 µm (0.98 mil) thick film with addition of 10 % LDPE at same conditions. EXCEED 1327ED can - in principle - be used in food contact applications in various EU Member States and in the USA (FDA). Migration or use limitations may apply. Please contact your ExxonMobil Chemical representative for more detailed information and/or actual compliance certification documents for the specific grade of interest. Revised 12/ ExxonMobil. To the extent the user is entitled to disclose and distribute this document, the user may forward, distribute, and/or photocopy this copyrighted document only if unaltered and complete, including all of its headers, footers, disclaimers, and other information. You may not copy this document to a Web site. ExxonMobil does not guarantee the typical (or other) values. Analysis may be performed on representative samples and not the actual product shipped. The information in this document relates only to the named product or materials when not in combination with any other product or materials. We based the information on data believed to be reliable on the date compiled, but we do not represent, warrant, or otherwise guarantee, expressly or impliedly, the merchantability, fitness for a particular purpose, suitability, accuracy, reliability, or completeness of this information or the products, materials, or processes described. The user is solely responsible for all determinations regarding any use of material or product and any process in its territories of interest. We expressly disclaim liability for any loss, damage, or injury directly or indirectly suffered or incurred as a result of or related to anyone using or relying on any of the information in this document. There is no endorsement of any product or process, and we expressly disclaim any contrary implication. The terms, we, our, "ExxonMobil Chemical", or "ExxonMobil" are used for convenience, and may include any one or more of ExxonMobil Chemical Company, Exxon Mobil Corporation, or any affiliates they directly or indirectly steward. The ExxonMobil Emblem, the Interlocking X Device and Exceed are trademarks of ExxonMobil Corporation.
24 ExxonMobil LDPE LD 150 series Blown Film Resin Description LD 150 series are LDPE grades, offering good blend mechanical properties and stiffness. Several additive packages are available according to the required surface properties. Applications medium duty shrink film shopper bags freezer film form fill and seal packaging general purpose Additive Package Antiblock Slip Thermal Stabilizer LD 150BW No No Yes LD 150AC 450 ppm 500 ppm Yes LD 150CS 250 ppm 278 ppm No Resin Properties Test Based On Typical Value / Unit Melt Index ASTM D g/10 min Density ASTM D2839 / D g/cm 3 Peak Melting Temperature ASTM D C 228 F Crystallization Point ASTM D C 205 F Film Properties Tensile Strength MD TD Break MD TD 1% Secant Modulus MD TD ASTM D MPa 23 MPa ASTM D % 570 % ASTM D MPa 260 MPa Haze ASTM D % Gloss, 60 angle ASTM D % 3500 psi 3350 psi psi psi Dart Drop Impact, A/Face ASTM D g/µm 89 g/mil Elmendorf Tear Strength MD TD ASTM D g/µm 4.0 g/µm The film properties have been measured on a 50 µm (1.97 mil) thick film of LD 150BW (Blow-up ratio : 2.5) 102 g/mil 102 g/mil LD 150 series can - in principle - be used in food contact applications in various EU Member States and in the USA (FDA). Migration or use limitations may apply. Please contact your ExxonMobil Chemical representative for more detailed information and/or actual compliance certification documents for the specific grade of interest. Revised 12/ ExxonMobil. To the extent the user is entitled to disclose and distribute this document, the user may forward, distribute, and/or photocopy this copyrighted document only if unaltered and complete, including all of its headers, footers, disclaimers, and other information. You may not copy this document to a Web site. ExxonMobil does not guarantee the typical (or other) values. Analysis may be performed on representative samples and not the actual product shipped. The information in this document relates only to the named product or materials when not in combination with any other product or materials. We based the information on data believed to be reliable on the date compiled, but we do not represent, warrant, or otherwise guarantee, expressly or impliedly, the merchantability, fitness for a particular purpose, suitability, accuracy, reliability, or completeness of this information or the products, materials, or processes described. The user is solely responsible for all determinations regarding any use of material or product and any process in its territories of interest. We expressly disclaim liability for any loss, damage, or injury directly or indirectly suffered or incurred as a result of or related to anyone using or relying on any of the information in this document. There is no endorsement of any product or process, and we expressly disclaim any contrary implication. The terms, we, our, "ExxonMobil Chemical", or "ExxonMobil" are used for convenience, and may include any one or more of ExxonMobil Chemical Company, Exxon Mobil Corporation, or any affiliates they directly or indirectly steward. The ExxonMobil Emblem, the Interlocking X Device and Exceed are trademarks of ExxonMobil Corporation.
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