CERTIFICATE OF COMPLIANCE

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1 Dear Valued Customer, Thank you for your interest in Nordson MEDICAL s Value Plastics line of products. As part of our continuous improvement initiatives, and in order to provide the most timely and effective responses possible, we have created this comprehensive list of the most up to date regulatory compliance information available. The information contained herein generally fulfills the bulk of our customers regulatory requirements, however if there is additional information required that is not provided here, please submit your request to QARA@nordsonmedical.com and we will do our best to obtain and provide the information as soon as possible. Please be informed that Nordson MEDICAL relies on information provided by our suppliers and vendors, whose materials make up the sole content of our products as there are no processing agents or mold releases used in the manufacture of our products. Nordson Medical does not test or analyze these materials for AN specified regulatory requirements; the information provided by the resin manufacturers has simply been compiled in a readily retrievable format as a service to our customers. Ultimately customers and end-users must make their own determinations ensuring the use of these products is safe, lawful and suitable for their intended applications. Because of possible changes in the law and/or in regulations, we encourage our customers to periodically verify the status of the regulatory compliance. These compliance letters are typically updated annually, upon receiving new regulatory information, or as deemed necessary. Please contact us with any further questions you may have. Sincerely, Robert Haynes Regulatory Affairs

2 USE OF THIS REGULATOR INFORMATION The information provided as requested is intended to be used for informational purposes only. Nordson MEDICAL relies on information provided by their suppliers or vendors. Nordson MEDICAL makes no representation or warranty as to the completeness or accuracy of the information contained herein. It is intended for use by persons having technical skill, at their own discretion and risk, who will make their own determination as to its suitability for their purposes prior to use. As with any material, evaluation of compounds under end-use conditions prior to specification is essential. Ultimately, customers must make their own determination that use of this product is safe, lawful, and technically suitable for their intended applications. COMPLIANT COMMENTS ITEM REGULATOR REQUIREMENTS ES NO N/A TBD Comments below are mostly summaries of supplier compliance statements. Detailed supplier s statements available upon request. 1 2-(2 -Hydroxy-3,5 -di-tertbutylphenyl)benzotriazole 2 21 CFR (c) 3.1a Meets FDA requirements 3 Aflatoxins Not intentionally added, and not tested for. 4 Alkylphenols / Alkylphenols ethoxylates 5 Allergens Flint Hills Resources does not use allergens - as defined by FDA as Milk, Eggs, Fish, Crustaceans, Wheat, Soy, Peanuts, Tree Nuts - in the manufacture or formulation of this product. 6 Aromatic Amines 7 Arsenic 8 Azoxy Compounds 9 Beryllium oxide 10 Biocompatibility 11 Bioterrorism Act of 2002 N/A A sample of this material has been tested by the supplier in accordance with USP CLASS VI, and ISO standards. Additional information is available upon request. The facility manufacturing this product s not required to register with the Bioterrorism Act of 2002 because it is not a food facility. 12 BPA

3 13 California s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) Based on available information as of 9/20/2018 this product does not contain any components or chemicals currently known to the State of California to cause cancer, birth defects or reproductive harm at levels which would be subject to Proposition 65. Reformulation, use, or processing of this material may affect its composition and require re-evaluation. 14 CONEG 15 Conflict Minerals Cadmium, chromium, lead, and mercury are not used in manufacture or formulation of product. Tantalum, Tin, Tungsten, and Gold are not used in the manufacture or formulation of product 16 Copper 17 Dimethylfumarate (DMF) 18 Dioxins 19 Drug Master File Listed # EU MDR 21 EU Food Contact N Flint Hills Resources does not use any substances classified as carcinogenic, mutagenic, toxic for reproduction (CMR 1A/1B), or endocrine disrupting substances (EDS) in amounts over 0.1%w/w in P5M6K-080. Flint Hills Resources does not test each raw material or product we produce for these substances. This material does not meet the requirements of Regulation 10/2011 for food contact as it contains an additive not present in Annex I. This additive is proprietary and non-disclosed by the supplier. 22 European Directive (2004/12/EC) Packaging and Packaging Waste This product conforms to the European Commission Directive 2004/12/EC of 11 February 2004 amending Directive 94/62/EC on packaging and packaging waste. We recommend proper recycling of plastics as opposed to dumping plastic products into landfills. This product is recyclable according to the recycle code European Directive 2002/16/EC This product conforms to the European Directive 2002/16/EC and its amendment 2004/13/EC. We do not use 2,2-bis(4- hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (BADGE), bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers (BFDGE) or novolac glycidyl ethers (NOGE) in the manufacture or formulation of this product. We do not test this product for these substances.

4 24 European Directive 2003/11/EC This product conforms to the European Directive 2003/11/EC of 6 February 2003 amending 76/769/EEC of 27 July We do not use Polychlorinated biphenyls (PCB), polychlorinated terphenyls (PCT), Vinyl Chloride, Pentabromo-diphenyl ethers (pentabde), Octabromo-diphenyl ethers (OctaBDE), or Decabromo-diphenyl ethers (decabde) in the manufacture or formulation of this product. We do not test this product for these substances. 25 European Pharmacopoeia N This product has not been tested to the EP or monographs for Polyolefines or Polyproplylene for Containers for Parenteral Preparations. 26 Formaldehyde 27 Genetically Modified Organisms (GMOs) TBD This material utilizes a component in its formulation produced from a plant sourced material of unknown genetic origin. 28 GHS Meets the requirements for classification and labeling as hazardous under GHS requirements. 29 Gluten 30 Iridium 31 Iron 32 Isocyanates 33 Kosher N Flint Hills Resources does not certify this resin to be Kosher or in compliance with Kosher requirements 34 Latex 35 Manganese 36 Melamine 37 Molybdenum 38 Nickel 39 Nitrosamine 40 Osmium

5 41 Ozone Depleting Chemicals Flint Hills Resources does not use Class I or Class II ODCs listed in the Resolution 2037/2000/EC in the manufacture or formulation of this product. 42 Palladium 43 Parabens 44 Perchlorate 45 Perflourooctane sulfonate (PFOS) 46 Perflourooctanoic Acid (PFOA) 47 Persistent Organic Pollutants No substances used in the manufacture or formulation of product that are listed on EC 850/2004 Annex I as amended. 48 Phthalates 49 Platinum 50 Polybrominated Biphenyls, Polychlorinated Biphenyls, Polybrominated Diphenyl Ethers, Polybrominated Terphenyls, Polychlorinated Terphenyls, Brominated compounds, Tributyl-tin, Dibutyl-tin, Monobutyl-tin, and any other organo-tin compound 51 Polychlorinated Naphthalene (PCN) 52 Polycyclic Aromatic Hydrocarbons (PAHs) 53 Polyvinyl Chloride (PVC) 54 Radioactive substances 55 REACH / SVHC As of January, 2019, our supplier does not believe any of the chemicals listed on the EU Candidate List of Substances of Very

6 High Concern are present in this raw material at levels greater than 0.1%. 56 Recycled Materials 57 Rhodium 58 RoHS/RoHS2 The material supplier has declared that this material complies with 2011/65/EC 59 Ruthenium 60 Silicone Oils 61 Tris(2,4-di-(tert)- butylphenyl)phosphate CAS is not intentionally used in the formulation or manufacture of this resin. 62 TSE / BSE 63 USP 661 No tallow or any other animal derived materials used in manufacture or formulation of product A sample was tested in accordance with USP <661>. Under the conditions of this test, the test results met the USP limits. Additional information is available upon request. 64 Vanadium 65 Zinc