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POLYfill PPC T20020 / T20040 PP Copolymer

    • Product Name: POLYfill PPC T20020 / T20040 PP Copolymer
    • Factroy Site: Yudu County, Ganzhou, Jiangxi, China
    • Price Inquiry: admin@ascent-chem.com
    • Manufacturer: Ascent Petrochem Holdings Co., Limited
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    Specifications
    HS Code 964396
    Density T20020 0.905 g/cm³
    Density T20040 0.905 g/cm³
    Melt Flow Rate T20020 20 g/10 min (230°C, 2.16 kg)
    Melt Flow Rate T20040 40 g/10 min (230°C, 2.16 kg)
    Tensile Yield Strength T20020 28 MPa
    Tensile Yield Strength T20040 27 MPa
    Elongation At Yield T20020 10%
    Elongation At Yield T20040 8%
    Flexural Modulus T20020 1200 MPa
    Flexural Modulus T20040 1300 MPa
    Notched Izod Impact 23c T20020 5.0 kJ/m²
    Notched Izod Impact 23c T20040 4.0 kJ/m²
    Heat Deflection Temperature 0 45mpa T20020 100 °C
    Heat Deflection Temperature 0 45mpa T20040 102 °C
    Vicat Softening Temperature A 10n T20020 150 °C
    Vicat Softening Temperature A 10n T20040 150 °C
    Melting Temperature T20020 165 °C
    Melting Temperature T20040 165 °C
    Rockwell Hardness T20020 R-95
    Rockwell Hardness T20040 R-95

    As an accredited POLYfill PPC T20020 / T20040 PP Copolymer factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing Supplied as 25 kg bags of PP copolymer granules; POLYfill PPC T20020/T20040 ensures consistent processing and reliable performance.
    Container Loading (20′ FCL) 20′ FCL loading: 20 MT of POLYfill PPC T20020/T20040 PP copolymer packed in 25 kg bags, palletized and shrink-wrapped.
    Shipping POLYfill PPC T20020/T20040 PP Copolymer ships as solid pellets in 25 kg bags or bulk containers. It is not regulated as dangerous goods for road, sea, rail, or air transport. Store and transport in dry, covered conditions away from moisture and direct sunlight. Handle gently to prevent bag damage and dust accumulation.
    Storage Store POLYfill PPC T20020/T20040 PP Copolymer in a cool, dry, well-ventilated area, away from direct sunlight, heat sources, and open flames. Keep containers tightly sealed to prevent moisture absorption and contamination. Avoid stacking excessively. Maintain stable temperatures, and use within the manufacturer’s recommended shelf life to preserve material properties.
    Shelf Life Shelf life is one year from manufacture when stored in original unopened packaging, kept cool, dry, and protected from sunlight.
    Application of POLYfill PPC T20020 / T20040 PP Copolymer

    In thin-wall dairy cup and microwaveable tray manufacture, the use of POLYfill PPC T20020 with a melt flow rate of 20 g/10 min and POLYfill PPC T20040 with a melt flow rate of 40 g/10 min under ISO 1133-1:2022 is directed at controlling injection pressure drop across hot runner valve gates with diameters between 0.8 mm and 1.2 mm and maintaining minimum fill time below 0.8 s on stack moulds with cavity counts in excess of 24. Production-scale trials on accumulator-assisted high-speed injection machines with clamp force from 1500 kN to 3500 kN indicate that a melt temperature window of 220°C to 250°C and a mould temperature of 10°C to 30°C are necessary to prevent flow marks and gate blush; when mould temperature exceeds 40°C, cycle time lengthens beyond 7 s, and cavity vacuum holes at 0.3 mm diameter can plug with volatiles and release agents. Pre-drying is not required at ambient RH below 60%, but if silo condensation raises surface moisture above 0.10 wt%, a dry-air hopper with a dew point ≤ -40°C or vented barrel degassing is used to prevent splay. For direct food contact, the monolayer finished article is evaluated under EU 10/2011 overall migration limits of 10 mg/dm² for general food-contact articles and 60 mg/kg for articles intended for infants and young children; under FDA 21 CFR 177.1520, the olefin polymer is permitted as a component subject to end-use testing, and heavy-metal restrictions under EU 94/62/EC are normally capped at 100 ppm combined lead, cadmium, hexavalent chromium and mercury. In formulation, colour masterbatch is added at 2 wt% to 4 wt%, slip or antiblock concentrate at 0.05 wt% to 0.20 wt%, and a nucleating agent at 0.10 wt% to 0.30 wt% when wall stock falls below 1.5 mm and rapid solidification is required for ejection without puncture. No mineral filler is added above 1 wt% in transparent or high-clarity containers because haze under ASTM D1003 increases beyond acceptable thresholds. Terminal articles include stackable dairy cups, deli lids, microwaveable trays and portion-control containers used in cold-storage and reheat applications.

    Does Low-Temperature Ductility Constrain Talc-Filled Interior Carrier Stock?

    At the compounding stage, POLYfill PPC T20020 is introduced as the base polymer for talc-filled interior carrier compounds when the post-compounding melt flow rate must remain above 12 g/10 min; PPC T20040 is selected for thin-ribbed door panel carriers with flow lengths exceeding 300 mm and wall stock below 2.0 mm. Twin-screw compounding on corotating extruders with 40:1 L/D and side stuffing ports introduces talc at 15 wt% to 25 wt%, impact modifier at 8 wt% to 15 wt%, and a phenolic or ester-based antioxidant package at 0.3 wt% to 0.8 wt%. The addition of talc above 25 wt% has been observed on production lines to depress Charpy notched impact at -30°C below 3.0 kJ/m² under ISO 179-1:2010, producing localised fracture in demoulding pins and increasing in-mould stress cracking at fastener bosses. Vacuum devolatilization on the twin-screw extruder is maintained below 20 kPa absolute pressure to keep total volatile content under 50 µg/g for later VDA 278 emission testing. Injection of the finished compound on toggle clamp presses from 4000 kN to 8000 kN typically uses melt temperatures of 230°C to 250°C and mould temperatures of 20°C to 40°C; screw speed is limited to 80 rpm to 120 rpm because shear heating above 260°C has been linked to nozzle gas burns and delamination at talc agglomerates. Industry compliance includes IATF 16949 manufacturing control, ISO 3795 burn rate not exceeding 100 mm/min, OEM-specific VOC and odour limits under VDA 278 and VDA 270, and REACH SVHC declarations with threshold descriptions based on 0.1 wt% candidate list substances. Terminal articles include lower door panel carriers, seat back covers, glove box substrate parts and cowl side trim. Because supplier datasheets for this specific talc-filled configuration may not include the full filler-to-impact interaction curve, pilot-scale trials should be completed before tool qualification.

    Under IEC 60335-1 clause 30.2, unfilled PP copolymer housings for unattended portable appliances are normally assessed for glow-wire ignition at 750°C with flame persistence not exceeding 2 s, while attended appliances may be assessed at 650°C; unmodified PP copolymer does not carry a V-0 classification, so either part design or a halogen-free intumescent flame-retardant masterbatch at 5 wt% to 12 wt% is required to meet the glow-wire end-product criterion without changing the base resin to an FR grade. Compliance also extends to RoHS Directive 2011/65/EU Annex II substance limits of 0.1 wt% for lead, mercury and hexavalent chromium and 0.01 wt% for cadmium at the homogeneous material level, and REACH SVHC disclosure for imported articles under Article 33. Formulation for pigmented appliance parts uses colour masterbatch at 1 wt% to 3 wt%, antistatic masterbatch at 0.2 wt% to 0.5 wt% for dust-control surfaces, and UV stabiliser masterbatch at 0.2 wt% to 0.4 wt% on parts exposed to indirect window light. Processing on multi-cavity hot-runner tools with valve gates and clamp force from 4500 kN to 9000 kN is performed at melt temperatures of 230°C to 250°C and mould temperatures of 20°C to 40°C; ribs and snap-fit beams are filled at injection velocities above 200 mm/s with holding pressures of 35 MPa to 55 MPa. Field-scale moulding has shown that rib thickness below 0.8 mm at the root can produce sink marks at opposite faces after packing, and that ejection temperatures above 60°C cause boss cracking around brass inserts. Terminal product types include vacuum cleaner canisters, air-purifier shells, rice-cooker outer covers and garment steamer housings.

    Medical Diagnostic Housing Precision and Cleanroom Molding Boundary Conditions

    For non-implantable laboratory disposables produced in ISO Class 8 cleanrooms, POLYfill PPC T20020 is typically processed without mould-release sprays because external lubricants can migrate into polymerase chain reaction buffers and inhibit amplification efficiency in diagnostic cassettes. Biocompatibility assessment follows ISO 10993-5:2009 and ISO 10993-10:2010 on the finished article; material certification may be required against USP Class VI, FDA 21 CFR 177.1520 and EP 3.1.3 for polyolefins, depending on the intended sample-contact duration and the regulatory registration route of the diagnostic device. Only opacitying additives are used in most diagnostic applications; titanium dioxide is metered at 1 wt% to 3 wt% for light-blocking cassette bases, carbon black at 0.5 wt% to 1.0 wt% for optically dark plates, and a process aid at 0.05 wt% to 0.10 wt% where low-shear screw recovery demands viscosity reduction without increasing extractables. Moulding is conducted on small-clamp injection presses from 800 kN to 1800 kN with general-purpose polyolefin screws, melt temperature of 220°C to 240°C, mould water temperature of 15°C to 25°C, and closed-loop holding pressure of 25 MPa to 40 MPa; hot runner tips are specified at 0.4 mm to 0.6 mm to prevent stringing into the part ejection area. Published extractables data for this specific grade is limited, so replacement of a validated polypropylene in a diagnostic platform requires a full ISO 10993-1:2018 risk re-evaluation. Terminal product types include specimen collection cups, diagnostic cassette bases, petri dish carriers and centrifuge tube racks.

    Stacking Load Collapse Occurs When Rib Roots Drop Below 0.5 mm in Reusable Containers

    Reusable logistics crates and ventilated agricultural trays manufactured from POLYfill PPC T20020/T20040 require rib networks that distribute static stacking loads from the top frame into sidewall columns; a 600 mm × 400 mm container loaded to 25 kg may impose approximately 0.7 MPa compressive stress on the corner columns depending on the top rim contact area. Solid rib root radii are specified at 0.5 mm to 1.0 mm, sidewall draft angles at to , and floor reinforcement ribs at 1.5 mm to 2.5 mm depth to avoid ejection deformation and top-load buckling. Compliance for food-contact logistics applications is verified under EU 10/2011 and FDA 21 CFR 177.1520, while compression and stacking durability may be assessed under ISO 12048; general chemical compliance requires REACH and RoHS Directive 2011/65/EU declarations for imported articles. For outdoor agricultural trays and fish boxes stored at subzero temperatures, a HALS-based UV stabiliser masterbatch is added at 0.3 wt% to 0.6 wt%, colour masterbatch at 1 wt% to 3 wt%, and an impact modifier at 8 wt% to 12 wt% when drop impact at -20°C must remain above 3.0 kJ/m² under ISO 179-1:2010. Injection moulding is performed on large clamp presses from 8000 kN to 15000 kN with accumulator-assisted injection, melt temperatures of 230°C to 255°C, mould temperatures of 15°C to 30°C, and sequential valve gating across the long-flow direction; gas channel length above 450 mm without proper sequencing has been observed to cause short shots around vent regions in unvented tools. Terminal articles include collapsible distribution crates, ventilated agricultural trays, freezer-grade fish boxes and tote containers.

    Under high-speed multi-cavity closure manufacturing, the higher flow of PPC T20040 reduces gate freeze time and injection pressure drop in a 48-cavity stack tool, but increases ovality risk in tamper-evident ring geometry when melt temperature exceeds 245°C and pack pressure is reduced below 30 MPa. Closure applications require food-contact compliance under FDA 21 CFR 177.1520 and EU 10/2011; sensory and migration limits for dairy closures are evaluated with appropriate food simulants under EU 10/2011 Annex III, and torque retention may be measured under ASTM D2063/D2063M-12 for continuous-thread closure systems. The formulation uses erucamide slip agent at 0.05 wt% to 0.10 wt% to reduce release torque, colour masterbatch at 1 wt% to 2 wt%, and no mineral filler; for taste-neutral dairy closures, erucamide is limited to 0.05 wt% because higher migratory slip concentrations can introduce off-flavour compounds above sensory threshold levels. Production on high-cavitation moulds with valve-gated hot runners runs at melt temperatures of 220°C to 245°C, mould water at 8°C to 15°C, and cycle times of 6 s to 10 s; part mass variance across 96 cavities above 0.15% has been traced to imbalanced hot-runner tip temperatures and can cause cap leakage in continuous-thread closures. Terminal products include flip-top dispensing closures, tamper-evident dairy caps and personal care overcaps.

    When Thin-Gauge Sheet Extrusion Requires Low Melt-Temperature Variability

    Thin-gauge PP copolymer sheet for food-grade thermoforming is extruded on single-screw extruders with barrier screws of 30:1 L/D to 35:1 L/D, melt pumps with pressure variation below ±0.1 MPa, and coat-hanger dies with internal deckles adjusted to 0.5 mm to 1.2 mm final sheet thickness. POLYfill PPC T20020 is preferred when melt strength permits sheet haul-off speeds above 20 m/min without edge draw-down; PPC T20040 may be used in coextruded cap layers where lower viscosity improves surface replication on polished roll stacks maintained at 60°C to 80°C. Compliance for direct food packaging follows EU 10/2011 overall migration limits and FDA 21 CFR 177.1520, while sheet thickness uniformity is checked under ISO 4593:1993. Formulation for antistatic and slip-modified sheet uses a combined antistatic/slip masterbatch at 0.2 wt% to 0.5 wt%, colour masterbatch at 1 wt% to 3 wt%, and a clarifying agent at 0.15 wt% to 0.25 wt% when contact clarity is required for fruit punnets. Process limitations include melt fracture when shear rate at the die lip exceeds 1000 s⁻¹ or melt temperature falls below 210°C; production line records show that melt temperature fluctuations above ±5°C across the die width produce gauge bands and thermoforming thinning in corner regions. Terminal product types include hinged clamshell containers, fruit punnets, bakery domes and deli tray inserts.

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    Certification & Compliance
    More Introduction
    POLYfill PPC T20020 and T20040 are unfilled polypropylene impact copolymer grades intended for injection-moulded articles in which a balance of melt flow, low-temperature toughness, and dimensional stability is required. The grade designations separate two melt flow classes: T20020 is specified around a nominal melt mass-flow rate of 20 g/10 min, and T20040 around 40 g/10 min, measured under ISO 1133-1:2022 at 230 °C with a 2.16 kg load. The base polymer is a heterophasic copolymer: a polypropylene continuous phase surrounds a dispersed ethylene-propylene rubber phase. The dispersed phase accounts for the retention of notched impact energy at temperatures below 0 °C, while the continuous phase controls stiffness, heat resistance, and mould shrinkage. Thermal analysis by differential scanning calorimetry typically shows a peak melting endotherm at 160–166 °C and a crystallization exotherm at 115–125 °C under a 10 K/min scan. Certificates of analysis should be reviewed for lot-specific melt flow rate, ethylene content, tensile yield stress, and Charpy notched impact values, because published data for this exact product configuration are limited to the ranges typically associated with impact copolymer grades in these melt flow classes.
    Table 1 – Representative property windows for unfilled PP impact copolymer grades in the 20 g/10 min and 40 g/10 min melt flow classes
    PropertyTest methodT20020 classT20040 class
    Melt mass-flow rateISO 1133-1:202220 g/10 min40 g/10 min
    DensityISO 1183-1:20190.900–0.910 g/cm³
    Tensile yield stressISO 527-2:201224–28 MPa23–27 MPa
    Tensile elongation at yieldISO 527-2:20125–8%
    Flexural modulusISO 178:20191100–1400 MPa
    Charpy notched impact at 23 °CISO 179-1:20108–15 kJ/m²7–12 kJ/m²
    Charpy notched impact at −20 °CISO 179-1:20104.0–6.5 kJ/m²3.0–5.5 kJ/m²
    Vicat softening temperature A50ISO 306:2013148–155 °C
    Heat deflection temperature B, 0.45 MPaISO 75-2:201385–100 °C
    Mould shrinkageISO 294-4:20181.2–1.8%
    The values in Table 1 are class ranges from published polymer processing references and are not production lot guarantees. Batch-to-batch variance in ethylene content can shift Charpy notched impact at −20 °C by approximately ±15% across production campaigns. Finished-article property verification should be based on the certificate of analysis and on moulded test specimens produced under the converter’s actual thermal cycle.

    What Distinguishes T20020 from T20040 in Melt Rheology and Impact Retention?

    The separation between the two designations is expressed primarily through melt mass-flow rate. The 40 g/10 min class lowers apparent viscosity under injection shear rates, which permits filling of thin-wall sections at lower injection pressure. Capillary rheometry data for equivalent impact copolymer melts indicate that at 230 °C and a shear rate of 1000 s⁻¹, apparent viscosity is approximately 45–60 Pa·s for the 20 g/10 min class and 25–40 Pa·s for the 40 g/10 min class. The viscosity reduction is not free of trade-off: lower average molecular weight in the high-flow version is associated with a decline in Charpy notched impact at −20 °C of 15–25% when compared with the 20 g/10 min formulation at equal ethylene content. This difference becomes statistically relevant in parts with snap-fit features, living hinges, or bosses that experience high strain-rate loading at cold temperatures. Where service temperatures fall below −20 °C, T20020 is the lower-risk selection unless flow length exceeds 250 mm at a wall thickness below 1.2 mm, in which case T20040 may be processed with higher melt temperature and higher injection speed to achieve complete filling. Exact lot rheology curves should be obtained from the certificate of analysis; published data for this specific commercial configuration are limited. In multi-cavity hot-runner systems, the viscosity difference between the two grades influences cavity-to-cavity mass distribution. Production lines with four-cavity valve-gate hot runners have recorded cavity-to-cavity mass variation of ±0.2 g when manifold balance is not adjusted after switching from T20020 to T20040. Reducing melt temperature by 5 °C or increasing holding pressure by 10 bar improves mass repeatability in such conditions. The grade change also affects gate freeze time: a 1.0 mm diameter pin gate may freeze after 0.5–2.0 s, and holding time should be set to exceed gate freeze time to avoid sink marks.

    Thin-wall conversion requires a melt temperature floor of 215 °C

    Processing records from hydraulic injection moulding machines with screw diameters between 35 mm and 60 mm indicate that short-shot defects and flow marks appear when melt temperature at the nozzle falls below 215 °C for wall thicknesses of 0.8–1.0 mm with T20040. The safe processing window is 220–250 °C for T20040 and 230–260 °C for T20020; melt temperatures above 270 °C increase the risk of oxidative chain scission, yellowing, and a drop in notched impact of 10–15% after residence times longer than 5 min. Barrel settings are typically reverse-profile with the front zone 5–10 °C above the nozzle set point, and back pressure of 0.5–1.0 MPa improves melt homogeneity without excessive shear heating. Injection pressure ranges from 80–140 MPa, with holding pressure held at 50–70% of the peak injection pressure for 3–8 s depending on gate freeze time. Mould temperature should be controlled between 20 °C and 60 °C; higher mould temperatures improve replication of textured surfaces and reduce weld-line weakness, but raise cooling time. Screw geometry for these grades is normally a general-purpose polyolefin screw with L/D of 20:1–24:1 and compression ratio of 2.5:1. Accumulator machines and all-electric machines with velocities above 150 mm/s are used for T20040 in thin-wall packaging; for T20020 in thicker technical parts, injection speed is usually 30–80 mm/s to avoid jetting and gate blush. Moisture uptake is low at relative humidity below 60%. Pre-drying at 80 °C for 2 h is applied only after outdoor storage, condensation, or when visible surface moisture is present. Over-drying above 90 °C for more than 4 h can induce additive migration and should be avoided. Wet granules may produce silver streaks and surface splay during moulding. The melt should not be combined with amine-based nucleating additives that may react with acidic residues in recycled regrind streams. Regrind levels above 20% by mass can shift the melt flow rate and lower Charpy notched impact by up to 10% due to molecular weight reduction from repeated extrusion. Regrind should be kept below 20% unless the quality plan includes melt flow and impact testing per lot. Hot-runner manifold temperatures should be held at 230–250 °C, with nozzle tips below 270 °C to avoid thermal degradation. For very thin wall sections of 0.5 mm, the processing window can narrow to less than ±5 °C; below the lower bound, freeze-off occurs before complete filling, and above the upper bound, drool and filamentation at valve gates may appear. In thin-wall injection moulding of rectangular containers with 0.8 mm nominal sidewall thickness, T20040 is processed at injection speeds above 150 mm/s to prevent premature freeze-off before the flow front reaches the end of the cavity. Flow length to wall thickness ratios up to 250:1 are attainable at melt temperatures of 240–250 °C with gate diameters of 0.8–1.5 mm for pin gates. T20020 is preferred for automotive interior trims, tool boxes, battery housings, and appliance panels where the part is subjected to cold impact or assembly stress. For caps and closures, T20040 provides lower melt viscosity that supports rapid cycle times and reduces injection pressure drop across multi-cavity hot-runner systems; T20020 is selected when closure impact after abuse load is a requirement. The material is not formulated for high optical transparency; light transmission is lower than random polypropylene copolymer, and the products should not be selected for clear packaging applications without pre-evaluation. Differences from polypropylene homopolymer include lower flexural modulus and higher notched impact, while differences from 30% talc-filled polypropylene compounds include lower density, lower modulus, and higher ductility. When compared with glass-fibre reinforced polypropylene, tensile modulus and heat deflection temperature are lower, but surface appearance and post-mould impact retention are different in selection.

    When a Random Copolymer Fails: Low-Temperature Crack Propagation Boundaries

    Random polypropylene copolymer offers higher transparency and a lower seal-initiation temperature, but its impact performance in cold conditions is notably lower. Published values for random PP notched Charpy at 0 °C are frequently in the range of 2–4 kJ/m², and at −20 °C they may fall below 2 kJ/m². An unfilled impact copolymer in the 20 g/10 min class, by contrast, retains 4–6 kJ/m² at −20 °C under the same ISO 179-1:2010 test condition. The difference arises from the heterophasic morphology: the dispersed ethylene-propylene rubber particles act as stress concentrators that induce shear yielding and cavitation in the surrounding polypropylene matrix, increasing energy absorption before crack propagation. This mechanism is suppressed when ethylene content is too low, when rubber particle size is too large, or when the part has sharp internal corners with radii below 0.5 mm. Weld lines, knit lines, and gate vestige areas are the most common initiation sites; production-line failure analysis has shown that cold-impact fracture in impact copolymer parts often begins at a weld line where rubber phase orientation has been disrupted. For this reason, mould filling simulations should be used to position weld lines away from snap-fit arms, mounting bosses, and thin hinge edges. If the loading mode is high-speed puncture rather than notched impact, the ranking between impact copolymer and random copolymer remains, but the absolute energy values depend on part thickness, geometry, and test speed. In talc-filled PP compounds, a 20% w/w talc loading raises flexural modulus from approximately 1200 MPa to 2500 MPa but reduces Charpy notched impact at 23 °C to 2.5–4.0 kJ/m². Glass-fibre reinforced PP with 30% w/w fibre raises tensile modulus to 5000–7000 MPa and HDT B to 145–155 °C, but density increases to 1.10–1.14 g/cm³ and surface gloss drops. The unfilled PPC T20020/T20040 class remains specified when impact, density, and surface finish are weighted above rigidity. The product is not recommended for continuous service above 100 °C in load-bearing applications; heat deflection temperature and the oxidative stabilizer package define the upper end. Ultraviolet exposure above 1000 h in accelerated weathering without UV stabilizer concentrates leads to surface chalking and embrittlement; weatherable grades or secondary operations are required for outdoor applications. Published data for this specific product configuration is limited; end-use testing at the minimum service temperature is the controlling method for final part approval.

    Regulatory Compliance and Food-Contact Documentation

    Food-contact status for polypropylene impact copolymer is established through the base polymer requirements in FDA 21 CFR 177.1520(c) and Regulation (EU) No 10/2011. Compliance with FDA 21 CFR 177.1520(c) covers olefin polymers, but the finished article must be tested for extractives and migration under the intended conditions of use. The EU regulation requires overall migration below 10 mg/dm² for food-contact plastics, and specific migration limits apply to additives and monomers. REACH registration or exemption status and SVHC content below 0.1% w/w per candidate list are typically declared on product safety datasheets. RoHS Directive 2011/65/EU Annex II restrictions for lead, mercury, cadmium, hexavalent chromium, and specified brominated flame retardants are met by unfilled PP formulations. When regrind or recycled feedstocks are used, due diligence is required because contaminated post-consumer streams may introduce restricted substances. The product is not intended for medical or pharmaceutical primary packaging unless specific biocompatibility and purity testing is conducted under ISO 10993-1:2018 and relevant pharmacopoeia monographs.
    Table 2 – Compliance documents typically applicable to unfilled PP impact copolymer grades
    RequirementReferenceScope
    U.S. food-contact base polymerFDA 21 CFR 177.1520(c)Olefin polymers; finished article migration testing required by converter
    EU food-contact plasticsRegulation (EU) No 10/2011Overall migration limit 10 mg/dm²
    REACH SVHCEC 1907/2006Candidate list below 0.1% w/w
    RoHSDirective 2011/65/EUAnnex II restricted substances in electrical and electronic equipment
    Density testISO 1183-1:2019Quality control and material identification
    Melt mass-flow rateISO 1133-1:2022Grade verification and process stability
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