ioplastics, and
ioplastics, and particularly bioplastics that may be random polymers and/or polymers that are manufactured via microbial fermentation, this may result in the need for some additional screening work to identify potential NIAS and assess their safety. Steptoe and Johnson LLP is well positioned to assist companies in bringing new bioplastics and other related food-contact materials to market. Please contact the author with any questions. www.steptoe.com/en/lawyers/joseph-dages.html References: [1] Dages, J.: FDA Authorized? Establishing a Suitable Food-contact Legal Status for Bioplastics in the US, bioplastics MAGAZINE, Vo. 15, Issue 05/20. [2] For a discussion of regulatory interpretations of the term “bioplastic,” please see the aforementioned article in Edition 05/20 of bioplastics MAGAZINE. [3] See Commission Regulation (EC) No. 1935/2004. [4] See Regulation (EU) No 10/2011. [5] See Regulation (EU) No 10/2011, Article 2. The Plastics Regulation also applies to other discrete categories of products that are comprised of plastic, as articulated in Article 2. [6] See Regulation (EU) No 10/2011, Article 3(2). [7] Id. at 3(3). [8] See Union Guidelines on Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food, available at https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_plasticguidance_201110_en.pdf. [9] Certain substances used in plastic food-contact materials are not required to be the subject of a listing on the Plastics Regulation, such as aids to polymerization, as the term is defined in Article 3(10). Substances that are not Carcinogens/Mutagens/toxic to Reproduction (CMRs) or nanomaterials, and that are used behind a “functional barrier” in a multilayer article such that they do not migrate to food at levels exceeding 10 parts per billion (ppb) also can be used in the EU in plastic food-contact applications absent an explicit clearance on the Plastics Regulation. [10] See Union Guidelines on Regulation (EU) No 10/2011 on Plastic Materials and Articles Intended to Come into Contact with Food. [11] See Regulation (EU) No 10/2011, Article 11. [12] If migration studies are needed, the study must be designed by considering the time and temperature conditions of use for the substance in question, as well as the types of food that may be used in contact with the substance. [13] See Regulation (EU) No 10/2011, Article 12. [14] Plastic materials and articles intended to be brought into contact with food intended for infants and young children may not migrate to food in quantities exceeding 60 mg/kg. Id. [15] Rather, the safe use of food-contact materials in the US is typically ensured by placing other kinds of limitations on the clearance for a material. For example, the clearance language for an effective Food Contact Notification (FCN) might provide the authorized substance may only be used in contact with certain food types or at certain use levels. These limitations are designed to ensure the amount of the substance that migrates to food and, in turn, enters the diet, does not exceed a level that might give rise to a safety concern. [16] See Note for Guidance for the Preparation of an Application for the Safety Assessment of a Substance to be Used in Plastic Food Contact Materials, available at https://www.efsa.europa.eu/en/efsajournal/pub/rn-21. [17] In this regard, we note that some of the food simulating solvents recommended in the Plastics Regulation for use in migration testing are different when compared to those recommended by FDA. The recommended time and temperature test conditions in the Plastics Regulation also differ when compared to those recommended by FDA. Stay in the loop! Subscribe for free! @ ogy.de/rubber-newsletter Subscribe for free! @ ogy.de/pu-newsletter Subscribe for free! @ ogy.de/tpe-newsletter 46 bioplastics MAGAZINE [06/20] Vol. 15
© ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ 100% 80% 60% 40% 20% 0% -Institut.eu | 2017 PBS(X) Refining Polymerisation Formulation Processing Use PA Depolymerisation Solvolysis Thermal depolymerisation Enzymolysis Purification Dissolution PET PTT Recycling Conversion Pyrolysis Gasification ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ PBAT PHA Recovery Recovery Recovery © -Institute.eu | 2020 PLA PE Full study available at www.bio-based.eu/markets 4 3 2 1 2011 2012 2013 2014 2015 2016 2017 2018 2019 2024 All figures available at www.bio-based.eu/markets Adipic acid (AA) 11-Aminoundecanoic acid (11-AA) 1,4-Butanediol (1,4-BDO) Dodecanedioic acid (DDDA) Epichlorohydrin (ECH) Ethylene Furan derivatives D-lactic acid (D-LA) L-lactic acid (L-LA) Lactide Monoethylene glycol (MEG) Monopropylene glycol (MPG) Naphtha 1,5-Pentametylenediamine (DN5) 1,3-Propanediol (1,3-PDO) Sebacic acid Succinic acid (SA) © -Institute.eu | 2020 PVC EPDM PP PMMA PE Vinyl chloride Propylene Unsaturated polyester resins Methyl methacrylate PEF Polyurethanes MEG Building blocks Natural rubber Aniline Ethylene for UPR Cellulose acetate 2,5-FDCA Building blocks for polyurethanes Levulinic acid Lignin-based bolymers Naphthta Ethanol PET PFA 5-HMF/5-CMF FDME Waste oils Starch-containing Furfuryl alcohol polymer compounds Natural rubber Saccharose PTF Furfural Hemicellulose 1,3 Propanediol Lignocellulose NOPs Fructose PTT Terephthalic MPG acid Glycerol Starch ECH Plant oils p-Xylene SBR Fatty acids Castor oil 11-AA Glucose Isobutanol THF Sebacic Lysine PBT acid 1,4-Butanediol Succinic acid DDDA PBAT Caprolactame Adipic acid HMDA DN5 Sorbitol 3-HP Lactic acid Itaconic Acrylic PBS(x) acid acid Isosorbide PA Lactide Superabsorbent polymers Epoxy resins ABS PHA APC PLA OH OH O HO diphenolic acid O H 2N OH O 5-aminolevulinic acid O O OH O O levulinate ketal O OR O levulinic ester O O ɣ-valerolactone O HO OH O succinic acid O 5-methyl-2-pyrrolidone Market and Trend Reports Institute for Ecology and Innovation NEW UPDATE MAY 2020 DATA FOR 2019 NEW Chemical recycling – Status, Trends and Challenges Commercialisation updates on bio-based building blocks Bio-based Building Blocks and Polymers – Global Capacities, Production and Trends 2019–2024 Levulinic acid – A versatile platform chemical for a variety of market applications Technologies, policy, start-ups, and key players Polymers Global market dynamics, demand/supply, trends and market potential Primary recycling (mechanical) Virgin Feedstock Plastic recycling and recovery routes Monomer Polymer Plastic Product Product (end-of-use) Renewable Feedstock Secondary recycling (mechanical) Tertiary recycling (chemical) Quaternary recycling (energy recovery) Secondary valuable materials CO 2 capture Energy Chemicals Fuels Others Production capacities (million tonnes) Bio-based building blocks Evolution of worldwide production capacities from 2011 to 2024 O OH O levulinic acid H N Landfill Author: Lars Krause, Florian Dietrich, Pia Skoczinski, Michael Carus, Pauline Ruiz, Lara Dammer, Achim Raschka, nova-Institut GmbH, Germany November 2020 This and other reports on the bio- and CO 2-based economy are available at www.bio-based.eu/reports Author: Doris de Guzman, Tecnon OrbiChem, United Kingdom Updated Executive Summary and Market Review May 2020 – Originally published February 2020 This and other reports on the bio- and CO 2-based economy are available at www.bio-based.eu/reports Authors: Pia Skoczinski, Raj Chinthapalli, Michael Carus, Wolfgang Baltus, Doris de Guzman, Harald Käb, Achim Raschka, Jan Ravenstijn January 2020 This and other reports on the bio- and CO 2- based economy are available at www.bio-based.eu/reports Authors: Achim Raschka, Pia Skoczinski, Raj Chinthapalli, Ángel Puente and Michael Carus, nova-Institut GmbH, Germany October 2019 This and other reports on the bio-based economy are available at www.bio-based.eu/reports THE BEST MARKET REPORTS AVAILABLE Bio- and CO 2 -based Polymers & Building Blocks UPDATE 2019 Succinic acid – From a promising building block to a slow seller Carbon dioxide (CO 2) as chemical feedstock for polymers – technologies, polymers, developers and producers Standards and labels for bio-based products Bio-based polymers, a revolutionary change What will a realistic future market look like? Pharmaceutical/Cosmetic Industrial Comprehensive trend report on PHA, PLA, PUR/TPU, PA and polymers based on FDCA and SA: Latest developments, producers, drivers and lessons learnt Acidic ingredient for denture cleaner/toothpaste Antidote Calcium-succinate is anticarcinogenic Efferescent tablets Intermediate for perfumes Pharmaceutical intermediates (sedatives, antiphlegm/-phogistics, antibacterial, disinfectant) Preservative for toiletries Removes fish odour Used in the preparation of vitamin A De-icer Engineering plastics and epoxy curing agents/hardeners Herbicides, fungicides, regulators of plantgrowth Intermediate for lacquers + photographic chemicals Plasticizer (replaces phtalates, adipic acid) Polymers Solvents, lubricants Surface cleaning agent (metal-/electronic-/semiconductor-industry) Fff Bio-based polymers, a revolutionary change Food Succinic Acid Other Jan Ravenstijn March 2017 Bread-softening agent Flavour-enhancer Flavouring agent and acidic seasoning in beverages/food Microencapsulation of flavouring oils Preservative (chicken, dog food) Protein gelatinisation and in dry gelatine desserts/cake flavourings Used in synthesis of modified starch Anodizing Aluminium Chemical metal plating, electroplating baths Coatings, inks, pigments (powder/radiation-curable coating, resins for water-based paint, dye intermediate, photocurable ink, toners) Fabric finish, dyeing aid for fibres Part of antismut-treatment for barley seeds Preservative for cut flowers Soil-chelating agent E-mail: j.ravenstijn@kpnmail.nl Mobile: +31.6.2247.8593 Picture: Gehr Kunststoffwerk Authors: Raj Chinthapalli, Ángel Puente, Pia Skoczinski, Achim Raschka, Michael Carus, nova-Institut GmbH, Germany October 2019 This and other reports on the bio-based economy are available at www.bio-based.eu/reports Authors: Achim Raschka, Pia Skoczinski, Jan Ravenstijn and Michael Carus, nova-Institut GmbH, Germany February 2019 This and other reports on the bio-based economy are available at www.bio-based.eu/reports Authors: Lara Dammer, Michael Carus and Dr. Asta Partanen nova-Institut GmbH, Germany May 2017 This and other reports on the bio-based economy are available at www.bio-based.eu/reports Author: Jan Ravenstijn, Jan Ravenstijn Consulting, the Netherlands April 2017 This and other reports on the bio-based economy are available at www.bio-based.eu/reports Asian markets for bio-based chemical building blocks and polymers Share of Asian production capacity on global production by polymer in 2016 Market study on the consumption of biodegradable and compostable plastic products in Europe 2015 and 2020 A comprehensive market research report including consumption figures by polymer and application types as well as by geography, plus analyses of key players, relevant policies and legislation and a special feature on biodegradation and composting standards and labels Brand Views and Adoption of Bio-based Polymers Wood-Plastic Composites (WPC) and Natural Fibre Composites (NFC) European and Global Markets 2012 and Future Trends in Automotive and Construction Bestsellers APC – cyclic Starch Blends Disposable tableware Biowaste bags Carrier bags Rigid packaging Flexible packaging Author: Wolfgang Baltus, Wobalt Expedition Consultancy, Thailand This and other reports on the bio-based economy are available at www.bio-based.eu/reports Authors: Harald Kaeb (narocon, lead), Florence Aeschelmann, Lara Dammer, Michael Carus (nova-Institute) April 2016 This and other reports on the bio-based economy are available at www.bio-based.eu/reports Author: Dr. Harald Kaeb, narocon Innovation Consulting, Germany January 2016 This and other reports on the bio-based economy are available at www.bio-based.eu/reports Authors: Michael Carus, Dr. Asta Eder, Lara Dammer, Dr. Hans Korte, Lena Scholz, Roland Essel, Elke Breitmayer, Martha Barthn This and other reports on the bio-based economy are available at www.bio-based.eu/reports www.bio-based.eu/reports bioplastics MAGAZINE [06/20] Vol. 15 47
