Mossop s Honey Date: 3 rd May 2016 761 State Highway 29 Tauriko RD1, Tauranga 3171 Attention: Wendy Mossop Dear Wendy, This is to confirm that products for Mossop s Honey as listed are manufactured as below: Pharmapac do not use any additives or processing aids in the manufacture of products. The products as listed below supplied by Pharmapac Ltd are controlled and manufactured in accordance with our quality management system. Part Number PPB06200 PPB06201 PPB06202 PPB06203 PPB06250 PPB06251 PPB06252 PPB06253 PPB06260 PPB06261 PPB06262 PPB06263 PPB06300 PPB06301 PPB06302 PPB06303 PPB06400 PPB06401 PPB06402 PPB06403 PPB06500 PPB06501 PPB06502 PPB06503 PPB05800 PPB05810 PPB05801 PPB05811 Description SQUARE JARS Jar 250gm / 200ml Clear Square Pallet (3648 per pallet) 57mm neck Jar 250gm / 200ml Clear Square Carton (336 per carton) 57mm neck Jar 250gm / 200ml Amber Square Pallet (3648 per pallet) 57mm neck Jar 250gm / 200ml Amber Square Carton (336 per carton) 57mm neck Jar 375gm / 270ml Clear Square [PLT2805] 60mm neck Jar 375gm / 270ml Clear Square [CTN210] 60mm neck Jar 375gm / 270ml Amber Square [PLT2805] 60mm neck Jar 375gm / 270ml Amber Square [CTN210] 60mm neck Jar 375gm / 270ml Clear Tall Square [PLT3040] 57mm neck Jar 375gm / 270ml Clear Tall Square [CTN270] 57mm neck Jar 375gm / 270ml Amber Tall Square [PLT3040] 57mm neck Jar 375gm / 270ml Amber Tall Square [CTN270] 57mm neck Jar 500gm / 400ml Clear Square Pallet (2295 per pallet) 60mm neck Jar 500gm / 400ml Clear Square Carton (175 per carton) 60mm neck Jar 500gm / 400ml Amber Square Pallet (2295 per pallet) 60mm neck Jar 500gm / 400ml Amber Square Carton (175 per carton) 60mm neck Jar 1kg / 817ml Clear Square Pallet (1144 per pallet) 83mm neck Jar 1kg / 817ml Clear Square Carton (95 per carton) 83mm neck Jar 1kg / 817ml Amber Square Pallet (1144 per pallet) 83mm neck Jar 1kg / 817ml Amber Square Carton (95 per carton) 83mm neck Jar 2 Kg Clear Square Pallet (480 per pallet) Jar 2 Kg / 1600ml Clear Square Carton ( 36 per carton) 100mm neck Jar 2 Kg Amber Square Pallet (480 per pallet) Jar 2 Kg / 1600ml Amber Square Carton ( 36 per carton) 100mm neck HEX JARS Jar 250gm / 200ml Clear Hex Pallet (4104 per pallet) 57mm neck Jar 250gm / 200ml Clear Hex Carton (371 per carton) 57mm neck Jar 250gm / 200ml Amber Hex Pallet (4104 per pallet) 57mm neck Jar 250gm / 200ml Amber Hex Carton (371 per carton) 57mm neck
PPB05900 PPB05910 PPB05901 PPB05911 PPB06000 PPB06002 PPB06001 PPB06003 PPB06070 PPB06072 PPB06071 PPB06073 PPB06050 PPB06052 PPB06051 PPB06053 PPB06100 PPB06102 PPB06101 PPB06103 PPB22100 PPB22110 PPB22101 PPB22111 PPB22150 PPB22160 PPB22151 PPB22161 PPB22200 PPB22210 PPB22201 PPB22211 Jar 500gm / 400ml Clear Hex Pallet (2376 per pallet) 60mm neck Jar 500gm / 400ml Clear Hex Carton (200 per carton) 60mm neck Jar 500gm / 400ml Amber Hex Pallet (2376 per pallet) 60mm neck Jar 500gm / 400ml Amber Hex Carton (200 per carton) 60mm neck Jar 750ml / 1Kg Clear Hex Pallet (1152 per pallet) 83mm neck Jar 750ml / 1kg Clear Hex Carton (84 per carton) 83mm neck Jar 750ml / 1Kg Amber Hex Pallet (1152 per pallet) 83mm neck Jar 750ml / 1Kg Amber Hex Carton (84 per carton) 83mm neck Jar 800ml / 1Kg Clear Tall Hex Pallet (1050 per pallet) 83mm neck Jar 800ml / 1Kg Clear Tall Hex Carton (84 per carton) 83mm neck Jar 800ml / 1Kg Amber Tall Hex Pallet (1050 per pallet) 83mm neck Jar 800ml / 1Kg Amber Tall Hex Carton (84 per carton) 83mm neck Jar 850ml / 1Kg Clear Hex Pallet (1152 per pallet) 83mm neck Jar 850ml / 1Kg Clear Hex Carton (84 per carton) 83mm neck Jar 850ml / 1Kg Amber Hex Pallet (1152 per pallet) 83mm neck Jar 850ml / 1Kg Amber Hex Carton (84 per carton) 83mm neck Jar 1500ml / 2Kg Clear Hex Pallet (516 per pallet) Jar 1500ml / 2Kg Clear Hex Carton ( 36 per carton) Jar 1500ml / 2Kg Amber Hex Pallet (516 per pallet) Jar 1500ml / 2Kg Amber Hex Carton ( 36 per carton) ROUND JARS Jar 250gm / 200ml Clear Round Pallet (3888 per pallet) 57mm neck Jar 250gm / 200ml Clear Round Carton (350 per carton) 57mm neck Jar 250gm / 200ml Amber Round Pallet (3888 per pallet) 57mm neck Jar 250gm / 200ml Amber Round Carton (350 per carton) 57mm neck Jar 340gm / 270ml Clear Round Pallet (2640 per pallet) 60mm neck Jar 340gm / 270ml Clear Round Carton (240 per carton) 60mm neck Jar 340gm / 270ml Amber Round Pallet (2640 per pallet) 60mm neck Jar 340gm / 270ml Amber Round Carton (240 per carton) 60mm neck Jar 500gm / 400ml Clear Round Pallet (2376 per pallet) 60mm neck Jar 500gm / 400ml Clear Round Carton (200 per carton) 60mm neck Jar 500gm / 400ml Amber Round Pallet (2376 per pallet) 60mm neck Jar 500gm / 400ml Amber Round Carton (200 per carton) 60mm neck PPB22250 PPB22251 Jar 500gm / 400ml Clear Tall Round Pallet (2304 per pallet) 60mm neck Jar 500gm / 400ml Amber Tall Round Pallet (2304 per pallet) 60mm neck TEST VIALS PPS02100 60ml Test Vial and Cap (Ctn 500) PPC00464 PPC00467 PPC00476 PPC00475 PPC00478 Cap 57mm White Pressure Seal Wad Cap 57mm Blue Pressure Seal Wad 250GM / 57mm CAPS 560 Per Carton Cap 57mm Black Pressure Seal Wad Cap 57mm Green Pressure Seal Wad Cap 57mm Honey Gold Pressure Seal Wad Cap 57mm Clear Pressure Seal Wad
PPC00803 PPC00809 PPC00818 PPC00817 PPC00825 PPC00674 PPC00670 PPC00682 PPC00681 PPC00676 PPC00771 Cap 60mm White Pressure Seal Wad Cap 60mm Blue Pressure Seal Wad 500GM / 60mm CAPS 805 per carton Cap 60mm Black Pressure Seal Wad Cap 60mm Green Pressure Seal Wad Cap 60mm Honey Gold Pressure Seal Wad 1KG CAPS 432 Per Carton Cap 83mm White Pressure Seal Wad Cap 83mm Blue Pressure Seal Wad Cap 83mm Black Pressure Seal Wad Cap 83mm Green Pressure Seal Wad Cap 83mm Honey Gold Pressure Seal Wad Cap 83mm Clear Pressure Seal Wad Cap 100mm White Pressure Seal Wad 2KG CAPS 255 Per Carton Materials Used Brand Resin Code & EU Codes EastPET A12 EC Regulation/EU directive: Under regulations administered by the Commission of the European Communities, EASTPET A12 may lawfully be used as articles or components of articles intended for use in contact with food subject to provisions in the Commission Regulation (EU) No. 10/2011 (including amendment EU 202/2014 and EU 2015/174), 93/8/EEC, EU10/2011. A sample of EASTPET A12 has been tested for overall migration with the simulants and test conditions defined in EC Directives 97/48/EEC and in UK Statutory Instrument 1376(1998). The overall migration results obtained for each of the tests specified were below the overall migration limit specified in Commission Regulation (EU) No. 10/2011 (including amendment EU 202/2014 and EU 2015/174), 93/8/EEC, EU10/2011. Under regulations administered by the U.S. Food and Drug Administration (), EASTPET A12 polyethylene terephthalate (PET) may lawfully be used as articles or components of articles intended for use in contact with food subject to provisions in 21 CFR 177.1630. EASTPET A12, as supplied by EastWest Chemical, comply with the compositional requirements of regulations at 21 CFR 177.1630 as validated by extraction studies done by an accredited independent laboratory. No phthalates used in the manufacture as listed below: BIS(2-ethyl(hexyl) phthalate (DEHP), Disononyl phthalate (DINP), Dibutyl phthalate (DBP), Di-n-octyl phthalate (DNOP), Butyl benzyl phthalate(bbp), Diisodecyl phthalate (DIDP)
No Bisphenol A (BPA), Bisphenol F (BPF), and Bisphenol S (BPS) are used in the manufacture of EastPET A12. Although EastPET A12 has not specifically been analyzed for the presence of these chemical substances, based on the supplier s knowledge of the materials and processes used in its manufacturing, none are expected to be present except as possible trace impurities. Borouge RE 420MO EC Regulation/EU directive: Regulation (EC) No 1935/2004 so far applicable to polymer pellets. The organoleptic characteristics of food contact materials are influenced by converting conditions, time and temperature of storage and type of food, therefore compliance with article 3 must be verified and tested by the producer of the final packaging material. Commission Regulation (EU) 10/2011 amended and corrected by Regulation (EU) 1282/2011 Commission Regulation (EC) 1895/2005 BADGE, NOGE and BFDGE are not used for the production of this grade. Annex I to Regulation (EU) n 10/2011 was amended on 3 March 2014 by the new Regulation (EU) n 202/2014. This amendment relates more particularly to the addition of two substances (2-phenyl-3,3-bis (4-hydroxyphenyl) phthalimidine and 1,3-bis (isocyanatomethyl) benzene) in the Union list of the table 1 (FCM n 872 and 988) of Regulation (EU) n 10/2011. This update does not have any impact on the supplier of the resin and thus they do not prepare separate letters for this change., CFR, Title 21, 177.1520 (a)(1)(i), (b) and (c)1.1a Olefin Polymers Test samples made from this product fulfilled the extraction requirements according to CFR 21 177.1520(c), as defined for the type of polymer described above. Therefore this product may be used in contact with all food types as described in table 1 of CFR 21 176.170(c), under conditions of use A through H as described in table 2 of CFR 21 176.170(c) (including articles used for packing or holding food during cooking).it is the responsibility of the converter or food packer to control that the final packaging complies with the requirements of the intended and foreseeable conditions of use. The use of DEP, DEHP or DIBP in the catalyst system may result in traces of these phthalates in the product typically in concentrations below 1 ppm. Bisphenols and their compounds (e.g. NOGE, BFDE, BADGE) is not used or intentionally incorporated in the manufacture of resin. Borouge HE 125 MO EU Regulation/EC directive Regulation (EC) No 1935/2004 so far applicable to polymer pellets. The organoleptic characteristics of food contact materials are influenced by
Axieo White GDE109836 Honey Gold converting conditions, time and temperature of storage and type of food, therefore compliance with article 3 must be verified and tested by the producer of the final packaging material. Commission Regulation (EU) 10/2011 as amended. Commission Regulation (EC) 1895/2005 BADGE, NOGE and BFDGE are not used for the production of this grade. Monomers and additives used for the manufacturing of this grade are not regulated with specific migration limits. Substances also authorised as direct food additives ( Dual use additives ) are either not used for the manufacturing of this product, kind of not migrating, or only present in quantities that in case of their migration don't allow relevant contribution to exceed of the limits as set in the applicable food legislation. In accordance with Article 12 of Commission Regulation (EU) 2011/10, the overall migration shall not exceed 10 mg/dm2 from plastic materials and articles, with the exception for plastic materials and articles intended to contact infant or child food (60 mg/kg). Annex I to Regulation (EU) n 10/2011 was amended on 3 March 2014 by the new Regulation (EU) n 202/2014. This amendment relates more particularly to the addition of two substances (2-phenyl-3,3-bis (4-hydroxyphenyl) phthalimidine and 1,3-bis (isocyanatomethyl) benzene) in the Union list of the table 1 (FCM n 872 and 988) of Regulation (EU) n 10/2011. This update does not have any impact on the supplier of the resin and thus they do not prepare separate letters for this change., CFR, Title 21 (2014), 177.1520 (a)(1), (b) and (c)1.1 Olefin polymers. Test samples made from this product fulfilled the extraction requirements according to CFR 21 177.1520(c), as defined for the type of polymer described above. Therefore this product may be used in contact with all food types as described in table 1 of CFR 21 176.170(c), under conditions of use A through H as described in table 2 of CFR 21 176.170(c) (including articles used for packing or holding food during cooking).it is the responsibility of the converter or food packer to control that the final packaging complies with the requirements of the intended and foreseeable conditions of use. The use of DEP and DEHP in the catalyst system may result in traces of these phthalates in the product typically in concentrations below 1 ppm. Bisphenols and their compounds (e.g. NOGE, BFDE, BADGE) is not used or intentionally incorporated in the manufacture of resin. Pigment purity according to AP (89)1. : CFR21 parts 170-179
GCP120431 Green GGP115782 Blue GFP114759 Amber GHT115557 EU directive: All polymers present in this product are characterised as using starting monomer(s) that are listed in Annex1 Table1 of 2011/10/EC and are authorised for use as a monomer as per column 6. All additives or polymer production aids present in this product are listed in Annex1 table1 of 2011/10/EC and are authorised for use as an additive or polymer production aid as per column 5. All salts present in these products are authorised by way of (17) and Article 6 part 3(a)**. Colorants: Colorants are not in the Union list but in Article 6 (Derogations of substances not included in the Union list) colorants may be used subject to the national law. There is no declarable migrating additive which is subject to a restriction in food as referred to in Article 11 item 3 of Commission Regulation (EU) no. 10/2011 Dual Use Additives. and BPA: The masterbatch do not contain Bisphenol A and/or nor are they intentionally added in the manufacturing process. Cabot Plastbak Black PE2813 ** Zinc is present as poly(zinc glycerolate):. Please note that EU10/2011 has an SML for zinc containing materials SML = 25mg/kg expressed as zinc. AS2070-1999 EU Directive: Masterbatch contains polymer produced from monomers and additives fully harmonised that are all detailed in the positive list of Commission Regulation (EU) No 10/2011 on plastics materials and articles intended to come into contact with food published in the Official Journal of the European Union on 14 January 2011 (this Regulation replaces Directive 2002/72/EC and its 6 amendments) and its amendments Reg. (EU) No 321/2011, Reg. (EU) No 1282/2011, Reg. (EU) No 1183/2012, Reg. (EU) No 202/2014 and Reg. (EU) No 2015/174 The carbon black (CAS 1333-86-4, FCM Substance No 411) meets the purity requirements of CE Resolution AP (89) 1 "On the Use of Colourant in Plastic Materials Coming into Contact with Food". It meets as well the carbon black purity requirements and specific restrictions/specifications mentioned in Annex I of the Commission Regulation (EU) No 10/2011. In addition, to be conform to the requirements of Commission Regulation (EU) No 10/2011, the plastic material in contact with food cannot contain more than 10 % masterbatch. Another aspect of Commission Regulation (EU) No 10/2011 relates to overall and specific migration to be tested on final food contact articles containing this masterbatch. There is no SML to check according to Commission Regulation (EU) No 10/2011 and last amendments.
SANCAP Pressure Seal Wad There is no declarable migrating additive which is subject to a restriction in food as referred to in Article 11 item 3 of Commission Regulation (EU) No 10/2011 (Dual Use Additives). Cabot has not determined whether a compound produced from PLASBLAK PE2813 masterbatch will be in conformity with the limits as described in Commission Regulation (EU) No 10/2011. The components are specifically approved under CFR Title 21 as follows: - Polyethylene base polymer - 177.1520 Olefin polymers, par(c) 2.1 therefore being allowed for use in articles intended to contact food below cooking temperatures, provided the article is technically suitable for the intended use. - Carbon black - 178.3297 Colorants for polymers. and DEHP are not intentionally added to the masterbatch. These chemicals, therefore, are not expected to be present in the masterbatch. BPA Cabot is not intentionally adding or using Bisphenol A in the production of the masterbatch. EU Directive: The pressure seal cap liners are in compliance with the EC Waste Directive 94/62/EC and amendments and Directive 2002/72/EC of regulation 10/2011 related to plastic material intended to come in contact with food stuff, amended by EU2023/2006, GMP (amendment 282/2008),EU 1895/2005, EU 450/2009, and these modifiers; EU 1282/2011, EU 321/2011, EU 528/2012, EU 1183/2012, EU 202/2014 and EU 174/2015. The cap lining materials are in compliance with 1069/2009 EEC concerning TSE/BSE, EU 1895/2005(epoxy derivatives), and do not come in contact with material of animal origin during manufacture. These lining materials are in compliance with 2007/19/EC: Plastic Directive. The lining materials are in compliance with Regulation EC No. 1935/2004, as amended by Regulation (EC) 596/2009. These lining materials are in compliance with European Pharmacopoeia 3.2.2 relating to paper and plastic material and articles intended to come in contact with food stuffs. The products are manufactures using GMP. There are no GMO and no nano materials used in SANCAP Liner materials. Status- Complies with Federal Regulations of HEW, Sections 175.125, 175.300, 177.1640, 178.3010 and 178.3710. It is entered in SANCAP Liner s food master file FMF166 and drug file DMF 2518 Phthalate and BPA: The lining material does not contain Disononyl phthalate, Di-2-ethylhexyl phthalate, Dibutyl phthalate, Di-n-octyl phthalate, Benzyl butyl phthalate or BPA.
Glory Charm Polycell Wad EPE 54/S Conforms to CFR 21 177.1210 The LDPE material conforms to 21 CFR 177.1520 EU directive: Complies with the overall migration, specific migration of Primary Aromatic Amine, heavy metal and specific migration of BHA and BHT requirement(s) as stated in European Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. DEHP was not detected when tested by an external laboratory. The test report was provided by the supplier. Bisphenol A With reference to EN13130-13 Material and articles in contact with foodstuffs Plastics substances subject to limitation Part 13: Determination of 2,2-bis(4- hydroxyphenyl)propane (Bisphenol A) in food stimulants. The specific migration of Bisphenol A was analysed by High Performance Liquid Chromatography (HPLC). Test conditions: 3% Acetic Acid, 40 C for 1 hour. T Test Item Result Method detection Maximum permissible (mg/kg) limit (mg/kg) limit * (mg/kg) Specific <0.01 0.01 0.6 migration of BPA *denotes specification was quoted from EU 10/2011 The test report was provided by the supplier. Please note that compliance with the overall and specific migration limits as described by the above standard must be measured from the final packaging intended to come into contact with foodstuff by using real food or appropriate food simulants at the intended and foreseeable conditions of use as specified in Directives 82/711/EEC (as amended) and Annex III of Commission Regulation (EU) 2011/10. It is the responsibility of the converter or food packer to verify that the final packaging complies with the overall and specific migration limits as set out by the applicable legislation. The information above is provided to us by our suppliers. Pharmapac do not conduct any tests on the raw materials used in the manufacture of products. Pharmapac do not accept any responsibility for ensuring that the finished food contact article complies with EU Regulations and Pharmapac gives no warranty in this regard. Pharmapac cannot guarantee that the status of the products/raw materials will remain unchanged due to possible changes from our suppliers and also in regulations. We, therefore, recommend that customers continuing to use these products verify the status periodically. Yours Faithfully RP Singh Raman Pal Singh Quality Manager Pharmapac Ltd