| HS Code | 631942 |
| Density Astm D792 | 0.920 g/cm³ |
| Melt Flow Index Astm D1238 190 C 2 16 Kg | 1.0 g/10 min |
| Tensile Strength At Yield Astm D638 | 13 MPa |
| Tensile Strength At Break Astm D638 | 28 MPa |
| Elongation At Break Astm D638 | 700% |
| Flexural Modulus Astm D790 | 275 MPa |
| Shore D Hardness Astm D2240 | 55 |
| Melting Point Dsc | 122 °C |
| Vicat Softening Temperature Astm D1525 | 100 °C |
| Brittleness Temperature Astm D746 | -80 °C |
| Dart Drop Impact F50 Astm D1709 | 120 g |
| Puncture Resistance | 60 J/cm |
As an accredited NOVAPOL LLDPE FP-120-D factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | NOVAPOL LLDPE FP-120-D: linear low-density polyethylene pellets supplied in 25 kg bags, palletized and shrink-wrapped; larger bulk quantities available. |
| Container Loading (20′ FCL) | One 20′ FCL container loaded with NOVAPOL LLDPE FP-120-D, securely packed and weight-optimized for safe transport. |
| Shipping | NOVAPOL LLDPE FP-120-D ships as non-hazardous polyethylene resin pellets. It is transported in lined bags, bulk bags, or hopper trucks/railcars. Keep dry, avoid excessive heat and sharp impact. Standard plastic-handling procedures apply, with no special regulatory shipping requirements. |
| Storage | Store NOVAPOL LLDPE FP-120-D in a cool, dry, well-ventilated area away from direct sunlight, heat, and ignition sources. Keep containers tightly sealed to prevent moisture, dust, or contamination. Avoid stacking excessively and maintain good housekeeping to prevent dust accumulation. No special hazardous storage is required, but keep away from strong oxidizers. |
| Shelf Life | When stored indoors in original, unopened packaging away from heat, moisture, and sunlight, NOVAPOL LLDPE FP-120-D has an indefinite shelf life. |
On a monolayer blown-film line equipped with a 70 mm grooved-feed extruder and an L/D ratio of 30:1, NOVAPOL LLDPE FP-120-D is processed into heavy-duty industrial sacks, box liners, and bulk powder inserts. The resin is characterised by a nominal density of 0.920 g/cm³ and a melt flow index of 1.0 g/10 min at 190 °C under a 2.16 kg load per ISO 1133-1:2022. Melt temperature is held between 204 °C and 232 °C. The annular die gap is set at 2.0-2.5 mm. Blow-up ratio is maintained between 2.2:1 and 2.8:1. Frost line height is fixed at 8-10 die diameters. Field practice on 70-80 mm dies indicates that air-ring heat removal, rather than extruder torque, becomes the output-limiting factor when film gauge exceeds 200 µm and line speed remains above 25 m/min. A dual-lip air ring with internal bubble cooling is used on larger lines to raise cooling capacity. No pre-drying is required at ambient relative humidity below 60 %. Above 60 % RH, hopper condensation can introduce surface splay and variable feed stability, particularly in open-bridge hoppers without hopper heating.
The conversion recipe starts with 100 phr of FP-120-D and dry-blends 0.15-0.30 phr of a synthetic silica antiblock masterbatch with 0.20-0.40 phr of an erucamide slip masterbatch. For high-shear lines, 0.02-0.05 phr of a fluoropolymer process-aid masterbatch is added to suppress die-lip oxidation build-up and reduce shark-skin melt fracture above 600 s⁻¹. If the sack is exposed to outdoor storage, a 40 % carbon black masterbatch is let down at 5.0-7.5 wt% to reach a final carbon black level of 2.0-3.0 wt%. The bubble must not be operated with a frost line below 6 die diameters; at that position, MD orientation increases but gauge uniformity deteriorates to more than ±6 % across the web. Above 12 die diameters, bubble sag and TD relaxation reduce dart impact and increase film blocking. Screen packs are configured with 20/40/60 mesh layers before the breaker plate to trap gel particles and carbon black agglomerates.
The resulting film is converted at 150-250 µm into industrial liners, chemical sack inserts, and bulk powder packaging. Mechanical acceptance commonly references ASTM D1709 for dart impact, ASTM D882 for tensile properties, ASTM D1922 for Elmendorf tear, and ASTM F88 for heat-seal strength. Seal-bar temperature is set between 135 °C and 165 °C with dwell time of 0.5-1.0 s. When the sack is used for dry food contact, the unpigmented film falls under FDA 21 CFR 177.1520 as an olefin polymer, provided the finished structure satisfies end-use migration limits. For industrial chemical liners, compatibility with organic acids and alkalis is assessed case by case because the polyethylene layer provides barrier performance mainly as a stress-crack-resistant liner rather than as a permeation barrier.
Frozen food packaging film at 25-60 µm is run on a low-stalk LLDPE bubble. The bubble becomes unstable when the frost line is raised beyond 10 die diameters, particularly in high-humidity chill rooms where process air temperature fluctuates by more than 3 °C. With FP-120-D, the 1.0 g/10 min melt flow index produces a relatively high melt viscosity; therefore, draw resonance is less likely than with lower-viscosity LLDPE, but freeze-line movement causes gauge bands and poor roll conformation. The processing window is narrow because film for frozen food must simultaneously retain dart impact after conditioning at -18 °C and avoid excessive blocking on the seal surface. Blocking tendency is assessed with ASTM D3354 at 23 °C and 50 % RH; the test does not capture low-temperature blocking after freezer storage, so line trials are required.
To widen bubble stability, processors pre-blend 10-20 wt% of a high-pressure LDPE homopolymer with a melt flow index from 0.3 g/10 min to 1.0 g/10 min. The LDPE fraction reduces melt pressure and stabilises the stalk, but it also shifts the seal initiation temperature down by approximately 2-5 °C and reduces low-temperature dart impact. Published data for the exact FP-120-D/LDPE blend at -18 °C is limited; line trials are required. The formulation also contains 0.2-0.4 phr erucamide slip masterbatch and 0.1-0.2 phr synthetic silica antiblock. Erucamide migration to the film surface reaches a plateau only after 72 h at 23 °C; immediate slip testing after winding underestimates final coefficient of friction. At freezer storage temperatures, migration is retarded, and a low-storage-temperature wrapper may show a coefficient of friction above 0.4 unless a higher initial slip concentration is validated.
The end products are pillow packs for frozen vegetables, ice cream pouches, and frozen seafood bags sealed on constant-heat or impulse sealers at 135-155 °C with dwell times of 0.5-0.8 s. Direct food contact requires compliance with EU 10/2011 and its overall migration limit of 10 mg/dm²; the polyethylene layer must be verified for the intended food simulant. For North American use, the unpigmented resin is covered under FDA 21 CFR 177.1520. Cold-temperature impact is commonly benchmarked by ASTM D1709 after the specimen is conditioned for at least 24 h at -18 °C.
Carrier bag film gauge reduction from 18 µm to 10 µm shifts the dominant failure mode from tensile yield to puncture propagation at stress concentrations such as crease lines and heat seals. In this gauge range, FP-120-D is processed on blown-film dies with a die gap of 1.8-2.0 mm and a blow-up ratio between 2.5:1 and 3.5:1. Melt temperatures are kept between 190 °C and 215 °C to limit thermal oxidation and gel formation. The frost line height is set at 6-8 die diameters for a low-stalk bubble; higher frost lines reduce TD film toughness and increase bag gusset failures during filling. Non-contact beta gauges are used to record transverse thickness profiles; for a 10 µm film, a 1 µm local deviation creates a 10 % stress concentration at the thin spot. The resulting puncture resistance is dominated by gauge uniformity at the frost line rather than by resin melt flow.
The conversion recipe uses 5-15 wt% in-house edge trim re-pelletised from the same film, 0.1-0.2 phr synthetic silica antiblock, and 0.2-0.4 phr erucamide slip masterbatch. Recycled content above 20 wt% is not recommended because gel counts and contamination from paper fibres or adhesive labels produce random bubble holes. Screen filtration with 100 mesh packs is used when recycled content exceeds 10 wt%. Seal strength is measured by ASTM F88, with jaw temperature calibrated at 120-150 °C. The seal bar must be maintained at a uniform temperature within ±3 °C; temperature cycling on high-speed bag machines causes fluctuating seal initiation and can create pinholes at the bag mouth.
End products include retail checkout bags, produce bags, and thin industrial liners. Compliance under EU packaging regulations requires the finished bag to comply with the Packaging and Packaging Waste Directive 94/62/EC, with country-specific extended producer responsibility data reported at sale. Mechanical performance is assessed by ASTM D882 for tensile elongation and ASTM D1922 for Elmendorf tear; the latter is critical because MD tear initiates at the bag mouth cut and can propagate along the film orientation direction. In high-speed conversion, the film is run through a gusset board and in-line perforation; excessive MD shrinkage above 3 % after winding creates register errors.
| Application segment | Standard or test method | Scope | Operational boundary |
|---|---|---|---|
| Heavy-duty industrial sacks | ASTM D1709, ASTM D882, ASTM D1922, ASTM F88 | Film impact, tensile, tear, seal strength | Frost line 8-10 die diameters; seal 135-165 °C |
| Frozen food packaging | EU 10/2011, FDA 21 CFR 177.1520, ASTM D1709, ASTM D3354 | Food contact, low-temperature impact, blocking | Overall migration ≤ 10 mg/dm²; conditioning -18 °C |
| Carrier bags | 94/62/EC, ASTM F88, ASTM D1922 | Packaging waste compliance, seal and tear | Recycled content ≤ 20 wt%; gauge ≥ 10 µm |
| Agricultural covers | ISO 4892-2, ISO 527-3, ISO 6383-2 | Accelerated weathering and retained mechanicals | HALS masterbatch 3.0-5.0 wt%; melt ≤ 230 °C |
| Lamination sealant web | ASTM D2578, ASTM F904, EU 10/2011 | Surface energy, bond strength, food contact | Corona 38-42 mN/m; slip ≤ 0.2 phr |
| Stretch hood film | ISO 527-3, ASTM D1709, ASTM D5748 | Tensile elongation, impact, puncture | Melt ≤ 245 °C; mLLDPE addition 10-30 wt% |
In low-tunnel vegetable forcing and silage cover operations, NOVAPOL LLDPE FP-120-D is not used neat because the base resin lacks sufficient multi-season UV stabilisation. A separate UV/HALS masterbatch with 20 % active content is dry-blended at 3.0-5.0 wt%. For carbon-black silage covers, a 40 % carbon black masterbatch is let down at 6.0-7.5 wt% to reach a final carbon black concentration of 2.4-3.0 wt%, which screens ultraviolet radiation in the 320-400 nm range. Films are extruded at 150-250 µm gauge with a die gap of 2.0-2.5 mm and a blow-up ratio of 2.0:1-2.5:1. Melt temperature is limited to 210-230 °C; higher temperatures consume HALS stabiliser and reduce weathering life. The bubble is run at a frost line height of 6-10 die diameters. Output on an 80 mm die typically becomes cooling-limited above 220 kg/h. Published data for this specific resin in multi-season field exposure is limited; artificial weathering alone does not replace field trials in high-solar coastal regions because the spectral distribution of UV radiation and night-time condensation affect stabiliser depletion kinetics.
Terminal products are greenhouse tunnel covers, low-tunnel films, mulch films, and silage covers. Accelerated weathering is screened by ISO 4892-2 with xenon-arc exposure, but the correlation between artificial weathering and field retention of tensile elongation is not linear for HALS-stabilised LLDPE. Mechanical properties after weathering are benchmarked against ISO 527-3 for elongation at break and ISO 6383-2 for tear resistance. Film used in direct contact with animal feed must satisfy EU 10/2011 if the feed is considered a food-contact application; silage cover contact with fermented forage is assessed on a case-by-case basis because organic acids generated during ensiling can accelerate additive extraction and reduce mechanical retention. Carbon black dispersion is monitored by screen-pressure rise; rapid screen blockage indicates agglomerates that can form pinholes in thin mulch films.
When FP-120-D blown film is destined for solventless lamination to PET or biaxially oriented polypropylene, the web is passed through a corona treater at 50-150 m/min. The untreated film surface typically registers 31-33 mN/m; corona treatment raises it to 38-42 mN/m as measured by ASTM D2578. Higher dyne levels above 46 mN/m over-treat the surface and can create low-molecular-weight oxidative species that reduce peel adhesion. The corona dose is set by the treater power calibration, commonly between 1.5 W·min/m² and 3.0 W·min/m²; air-gap and electrode condition must be maintained to avoid backside treatment. Backside treatment increases roll blocking and is detected by a differential dyne pen on the non-treated surface above 34 mN/m. Treatment decays with storage, so lamination should occur within 48 h of corona exposure; otherwise the surface energy can fall below 36 mN/m on humid days.
The sealant layer formulation uses 0.1-0.3 phr synthetic silica antiblock and no more than 0.2 phr erucamide slip masterbatch. Higher slip levels migrate to the interface and can depress lamination bond strength. The film is run at 20-50 µm gauge, with a die gap of 1.8-2.0 mm and a blow-up ratio of 2.0:1-2.5:1. Seal initiation for FP-120-D in a laminated structure is typically verified between 115 °C and 135 °C; the exact value depends on the sealant gauge and the laminating adhesive's thermal history. Hot-tack strength is evaluated on a hot-tack tester under 0.3-0.5 N/mm² sealing pressure with 0.2-0.5 s dwell. At seal temperatures above 160 °C, the film may thin at the seal root and create a weak point at the package headspace.
Terminal applications include liquid pouch films, dry snack laminates, and stand-up pouches where the polyethylene sealant layer is the food-contact ply. The food-contact compliance of the polyethylene layer falls under EU 10/2011 overall migration limits and FDA 21 CFR 177.1520; the adhesive and printing layers are assessed separately. Lamination bond strength is tested under ASTM F904 after 24-48 h of adhesive cure at 23-30 °C. If the laminate is used for liquid packaging with high acid content, the sealant layer is further checked for stress cracking after exposure to the packaged liquid at 40 °C for 7 days.
Stretch hood production with a 1.0 g/10 min LLDPE requires control of the high-molecular-weight fraction because the film must deform uniformly at 20-40 % elongation without localised necking while still absorbing pallet stabilisation forces. FP-120-D is processed at 80-120 µm gauge with a die gap of 2.0-2.5 mm and a blow-up ratio of 2.0:1-2.5:1. Melt temperature is maintained between 210 °C and 230 °C. A 10-30 wt% addition of a metallocene LLDPE with a nominal MI of 0.5 g/10 min and density of 0.918 g/cm³ is often used to shift the necking limit toward lower elongation. Slip and antiblock additives are minimised to preserve cling; if surface slip is required for downstream pallet wrapping, 0.05-0.15 phr of a high-molecular-weight silicone masterbatch is preferred over erucamide because the latter can migrate and reduce cling after 24-48 h.
The extruder screw is configured with a barrier section and lower shear mixing to avoid breaking the high-molecular-weight chains; melt temperature overshoot above 245 °C causes a measurable loss in dart impact and an increase in gel specks. Air-ring cooling is critical because thick gauge at 100-120 µm retains heat and promotes bubble shaking. The frost line is set at 8-10 die diameters. Thickness control by capacitive gauge is maintained at ±3 %; out-of-specification variation at the pallet corner intensifies local stress and accelerates hood failure. Terminal products are pallet stretch hoods used in automated pallet-packing equipment. Tensile elongation is measured by ISO 527-3, puncture resistance by ASTM D5748, and dart impact by ASTM D1709. For export packaging, no food-contact claim is required unless the hood is used over food pallets; in that case, indirect contact only is assessed under EU 1935/2004 rather than a direct food-contact standard.
| Application segment | Die gap | Blow-up ratio | Melt temperature | Film gauge | Critical control |
|---|---|---|---|---|---|
| Heavy-duty industrial sacks | 2.0-2.5 mm | 2.2:1-2.8:1 | 204-232 °C | 150-250 µm | Frost line 8-10 die diameters |
| Frozen food packaging | 1.8-2.0 mm | 2.0:1-2.5:1 | 204-215 °C | 25-60 µm | Frost line ≤ 10 die diameters; LDPE 10-20 wt% |
| Carrier bags | 1.8-2.0 mm | 2.5:1-3.5:1 | 190-215 °C | 10-18 µm | Gauge uniformity ±1 µm at 10 µm |
| Agricultural covers | 2.0-2.5 mm | 2.0:1-2.5:1 | 210-230 °C | 150-250 µm | Melt ≤ 230 °C to protect HALS |
| Lamination sealant web | 1.8-2.0 mm | 2.0:1-2.5:1 | 190-215 °C | 20-50 µm | Corona 38-42 mN/m |
| Stretch hood film | 2.0-2.5 mm | 2.0:1-2.5:1 | 210-230 °C | 80-120 µm | Melt ≤ 245 °C; cooling rate |
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The NOVAPOL LLDPE FP-120-D grade is a butene-comonomer linear low-density polyethylene supplied as a pelletized blown film resin. The producer’s nominal resin properties include a melt index of 1.0 dg/min at 190 °C with a 2.16 kg load, determined in accordance with ASTM D1238 or ISO 1133-1:2022, and a nominal density of 0.920 g/cm³, determined under ASTM D1505 or ISO 1183-1. The butene comonomer introduces short-chain branching that suppresses crystalline density and lowers heat-seal initiation relative to high-pressure LDPE of equivalent melt index. The “-D” designation identifies a formulated additive package, generally comprising an erucamide-type slip agent and a mineral-based antiblock such as synthetic silica. Exact additive loading and masterbatch composition should be verified against the lot certificate of analysis because film surface behavior depends on additive dispersion and migration kinetics. Melt-flow ratio and molecular-weight distribution are characteristic of a conventional Ziegler-Natta C4 LLDPE, which differentiates the grade from metallocene C6 or C8 LLDPE products with more homogeneous comonomer distribution and different solid-state elastic behavior.
In blown film converting, NOVAPOL LLDPE FP-120-D is placed in monolayer or coextruded structures for general-purpose liners, garment bags, produce bags, industrial liners, and carrier films where moderate toughness, drawdown, and sealability are required. On standard blown film equipment using smooth-bore or grooved-feed extruders from 45 mm to 90 mm diameter and 24:1 to 30:1 L/D, common die gaps fall between 1.5 mm and 2.3 mm. Blow-up ratios are typically maintained between 2.0:1 and 2.8:1; higher blow-up ratios can be used only when bubble stability is supported by internal bubble cooling or optimized die geometry. The resin is not intended for heavy-duty shipping sacks, high-stretch films, or frozen-food packaging requiring the higher dart impact and puncture propagation resistance of C6 or C8 LLDPE or metallocene resins.
During melt processing, the lower crystalline melting peak of butene LLDPE does not translate into a lower melt-viscosity process window. The more linear backbone and higher zero-shear viscosity of FP-120-D produce higher torque and melt pressure at equivalent output compared with a high-pressure LDPE of similar melt index. In commercial blown film operation on a 65 mm grooved-feed extruder with 30:1 L/D, a typical barrel profile is 170–180 °C in zone 1, 185–200 °C in zone 2, 195–210 °C in zone 3, and 200–215 °C at the adapter and die. Melt temperature measured by an immersion probe should be maintained between 205 °C and 225 °C for stable bubble geometry and acceptable gel counts. At melt temperatures below approximately 195 °C, the risk of sharkskin, high melt pressure, and screw overload increases. Above approximately 235 °C, oxidation, gel formation, die-lip drool, and slip-additive volatilization become more probable. Field experience on conventional LLDPE blown film lines indicates that bubble instability can appear when melt temperature exceeds 225 °C at high screw speeds; reducing rear-barrel setpoints by 5–8 °C frequently restores stable bubble geometry.
Pre-drying is normally not required if pellet temperature remains above the dew point. If surface condensation occurs at relative humidity above 60 %, a hopper dryer at 50–60 °C for 2–4 h is adequate to remove surface moisture. Screw design should favor moderate shear and efficient melting rather than aggressive high-shear mixing; compression ratios in the range of 2.5:1 to 3.5:1 are common for smooth-bore LLDPE screws, while grooved-feed extruders often use slightly lower compression and rely on forced solids conveying. Compared with LDPE, lower melt strength makes FP-120-D less suitable for cast film or extrusion coating where neck-in, draw resonance, and edge weave are more severe.
The slip agent in FP-120-D blooms to the film surface over time and lowers the kinetic coefficient of friction. When measured under ASTM D1894 after conditioning at 23 °C and 50 % RH for at least 24 h, blown film based on this resin typically reaches a kinetic coefficient of friction in the range of 0.05–0.20. At lower storage temperatures, migration is slower, and the coefficient of friction may remain above 0.30 until additional conditioning occurs. Blocking resistance, measured under ASTM D3354, depends on antiblock particle size, concentration, film gauge, and winding tension. The mineral antiblock increases surface roughness and reduces film-to-film blocking but can also raise haze and lower gloss.
For printing, lamination, or coating, in-line corona treatment should raise surface wetting tension to approximately 38–42 mN/m when measured by ASTM D2578. Because the slip additive continues to migrate to the surface after treatment, corona-treated film may show dyne-level decay within 48–72 h. Immediate secondary conversion or a primer is preferred when storage is unavoidable. Excessive corona dosage above roughly 45 mN/m can create surface oxidation that reduces heat-seal strength and may interact with slip-additive bloom. The exact additive loading for FP-120-D should be confirmed from the lot certificate; common slip-agent loadings in film-grade LLDPE are generally below 1000 ppm, while antiblock loadings often fall between 500 ppm and 3000 ppm, depending on target haze and blocking requirements.
The substitution of FP-120-D for high-pressure LDPE changes bubble stability, tear balance, and seal performance. LDPE has long-chain branching that provides higher melt strength and greater extensibility at typical blown film shear rates; FP-120-D has lower melt strength and therefore requires more careful control of blow-up ratio and frost line height. In contrast, the linear short-chain branching of FP-120-D provides higher tensile strength, dart impact, and Elmendorf tear resistance than LDPE at equivalent gauge, measured under ASTM D882, ASTM D1709, and ASTM D1922. This supports moderate downgauging in non-demanding applications but does not approach the toughness of a well-formulated C6 or C8 LLDPE.
Compared with C6 or C8 LLDPE and metallocene grades, FP-120-D shows lower dart impact, puncture resistance, tear resistance, and hot-tack strength at equivalent gauge because butene gives shorter side branches and a broader interchain spacing distribution. Puncture propagation resistance can be compared using ASTM D5748, and hot-tack performance under ASTM F1921 is generally narrower for C4 Ziegler-Natta LLDPE than for metallocene C6 or C8 resins. These differences limit FP-120-D in high-speed vertical form-fill-seal packaging, over-wrapping of sharp-edged products, and heavy-duty liners. Published data for this specific configuration is limited; lot-specific film property tests are therefore recommended when replacing C6/C8 resins in demanding structures. Within the NOVAPOL LLDPE family, FP-120-D differs primarily from FP-120-A by surface additive package rather than bulk rheology or density. FP-120-A lacks the formulated slip and antiblock system, so converters must add slip or antiblock masterbatch separately if film handling requires it. Mechanical properties measured by ASTM D882 and ASTM D1922 are not expected to differ substantially between A and D versions, but coefficient of friction and blocking force measured under ASTM D1894 and ASTM D3354 can be significantly different.
The base polyolefin chemistry of FP-120-D is generally covered by FDA 21 CFR 177.1520(c) for olefin polymers, but food-contact compliance depends on end-use temperature, food type, film thickness, and the migration behavior of the additive package. Under EU Regulation 10/2011, plastic food-contact materials must comply with the overall migration limit of 10 mg/dm² and with specific migration limits for authorized additives listed in Annex I and Annex II. Simulant selection follows Annex III of EU Regulation 10/2011; aqueous, acidic, alcoholic, and fatty food simulants can produce different additive migration results. Applications involving hot-fill, retort, or direct contact with fatty foods above room temperature require additional verification because slip-agent migration and thermal degradation may shift under those conditions.
| Standard or regulation | Relevant provision | Typical limit or test basis |
|---|---|---|
| FDA 21 CFR 177.1520(c) | Olefin polymers for food contact | End-use migration testing required |
| EU Regulation 10/2011 Annex I/III | Plastic food-contact material overall migration | 10 mg/dm² |
| EU Regulation 10/2011 Annex II | Additive-specific migration limits | Additive-specific |
| REACH (EC) No 1907/2006 | SVHC screening and additive registration | Supplier declaration required |
| RoHS Directive 2011/65/EU Annex II | Pb, Hg, Cr(VI) | 1000 ppm each |
| RoHS Directive 2011/65/EU Annex II | Cd | 100 ppm |
| Directive 94/62/EC Article 11 | Packaging heavy metals sum | 100 mg/kg per component |
No blanket compliance statement is made without supplier documentation and finished-article migration testing. Direct contact with fatty foods at elevated temperature, steam sterilization above 100 °C, and reuse in medical, parenteral, or in-vivo applications are outside the typical operating boundary unless separately validated.