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Chapter 07 — Wastes from organic chemical processes Non-Hazardous

EWC Code

07 05

Wastes from manufacture, formulation, supply and use of pharmaceuticals

EUR-Lex Commission Decision 2000/532/EC — Official Journal L 226, 06/09/2000

Annual Volume

~500 kt–1 Mt/year pharmaceutical manufacturing waste

Valorisation Range

Solvent recovery €150–600/t; precious metal catalyst recovery €1000–5000/t

Primary Route

Solvent recovery and reuse

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Waste Classification

EWC 07 05 covers wastes from active pharmaceutical ingredient (API) synthesis, drug formulation, and associated laboratory and clinical waste. Key hazardous sub-codes: 07 05 01* (aqueous washing liquids and mother liquors), 07 05 03* (halogenated solvents), 07 05 04* (other solvents), 07 05 07* (halogenated still bottoms), 07 05 08* (other still bottoms). Non-hazardous pharmaceutical solid waste is 07 05 14.

Multi-step organic synthesis for API production generates large solvent volumes — the pharmaceutical industry is one of the highest users of solvents per kg of product (E-factor up to 100 in complex synthesis). Key solvents: dichloromethane, THF, acetonitrile, methanol, IPA, toluene. Solvent recovery by distillation is standard practice; recovered solvents reused on-site or sold. Fermentation-derived APIs generate biological waste streams — spent fermentation broth, mycelium cake.

Cytotoxic and antibiotic manufacturing wastes require segregated incineration — cytotoxics (anticancer drugs) to prevent environmental mutagenic/carcinogenic contamination; antibiotics to prevent antibiotic resistance dissemination. Homogeneous and heterogeneous precious metal catalysts (Pd, Pt, Rh) are recovered by specialist refiners with high economic return.

Typical Generators

API manufacturers (fine chemical synthesis)
Generic and branded drug formulation plants
Biotech and fermentation producers

Disposal & Valorisation Routes

Established valorisation pathways for EWC 07 05, ranked by economic value and market depth. Solvent recovery and reuse is the primary route.

Solvent recovery and reuse

Primary

Mother liquors and solvent wash streams distilled to recover DMF, DCM, acetonitrile, THF and other solvents. Recovered solvent tested by GC analysis against acceptance specification before return to formulation or sale. Distillation still bottoms (07 05 07*, 07 05 08*) separately managed.

Precious metal catalyst recovery

Secondary

Spent Pd/C, Pd(OH)₂, Pt/C and Rh catalysts returned to precious metal refiners (Johnson Matthey, Umicore) under consignment/weighback agreements. Typical Pd recovery 97–99%. Return credit substantially reduces net waste management cost.

Incineration — cytotoxic and antibiotic waste

Backstop

Cytotoxic drug waste (mother liquors, still bottoms, out-of-spec API) incinerated at ≥1100°C at permitted hazardous waste facility. Antibiotic waste incinerated to prevent AMR dissemination. Full combustion verification required; no co-disposal with general pharmaceutical waste.

These are the established routes for EWC 07 05. Which one your stream qualifies for depends on its composition, volume and region.

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NACE Receiving Industries

Primary & secondary off-takers

01
Manufacture of basic pharmaceutical products

API manufacturers generate the majority of 07 05 waste; in-house solvent recovery and catalyst management

02
Precious metals production

Specialist refineries recover palladium, platinum and rhodium from spent pharmaceutical catalysts

03
Manufacture of other chemical products

Specialist solvent recovery contractors serve pharmaceutical industry under GMP-compliant logistics

04
Treatment and disposal of hazardous waste

Cytotoxic and antibiotic waste incineration operators

Source: NACE Rev.2 — Eurostat, 2008

Regulatory Context

Key legislative frameworks governing EWC 07 05 classification, transport, and treatment.

IED 2010/75/EU — Pharmaceutical BREF

API synthesis plants above threshold are IED installations. BAT covers solvent recovery efficiency (≥85%), mother liquor treatment, fermentation waste deactivation and catalyst precious metal mass balance. VOC ELV: ≤10–20 mg C/Nm³ depending on sector.

EU Action Plan on Antimicrobial Resistance

European Chemicals Agency (ECHA) and EMA recommend incineration as preferred disposal route for antibiotic manufacturing waste to prevent AMR dissemination. Discharge of antibiotic-containing effluent to waterways requires biological treatment removing ≥90% antibiotic activity.

GMP Annex 15 — Pharmaceutical waste segregation

EU GMP guidelines require segregation of pharmaceutical waste by product type, prevention of mix-up and full traceability from site to final disposal. Cytotoxic materials require closed transfer system and dedicated incineration contract with destruction certificate.

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Industries That Use This Waste

Sectors that valorise EWC 07 05 as an input material or secondary raw material.

Explore EU waste flows — Waste Atlas

Visualise 17 years of E-PRTR industrial facility data. See how EWC 07 05 and related waste streams flow across European industries and sectors.

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Source: EUR-Lex Commission Decision 2000/532/EC · NACE Rev.2 — Eurostat 2008

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