Cosmetics GMP is not food GMP and it is not pharmaceutical GMP, and treating it as either produces the wrong facility. ISO 22716 sets expectations around premises, equipment and production that are lighter than pharmaceutical GMP but considerably more demanding than general food manufacturing, particularly on microbiological control and batch traceability.

Projex Solutions provides engineering design, hygienic design support and project delivery for personal care and cosmetics manufacturers, covering emulsions, surfactant systems, fragranced products and aerosol filling.

What makes this work different

The regulatory frame is product-led. Assimilated Regulation (EC) No 1223/2009 with the Cosmetic Products Enforcement Regulations 2013 governs cosmetic products in Great Britain, with Northern Ireland following the EU regime. The product regulation shapes what the plant has to be able to demonstrate on traceability, contamination control and batch records.

Microbiological control is the dominant quality risk. Water-based emulsions are excellent growth media. Water system design, preservative addition, vessel cleanability and hold times determine whether control is achievable rather than merely intended.

Ethanol inventory is often significant. Fragranced products, alcohol-based sanitisers and some hair products bring flammable liquid inventory that requires hazardous area classification under DSEAR and can approach COMAH thresholds.

Aerosol filling is a specialist hazard. Propellant handling, filling room design, ventilation and gas detection are governed by their own conventions, and aerosol filling halls are among the higher-hazard rooms in FMCG manufacturing.

Powder handling appears where least expected. Talc, pigments and mineral powders in colour cosmetics bring both exposure control and dust hazard.

High SKU count drives changeover. Colour cosmetics and fragrance ranges mean frequent changeover, and cleaning validation and cross-contamination control become the throughput constraint.

Where we help

  • Hygienic and GMP-appropriate facility design aligned to ISO 22716 expectations
  • Water system design for purified water, including sanitisation and sampling
  • Emulsion and mixing plant design, including heat transfer and homogenisation
  • DSEAR assessment and hazardous area classification for ethanol and propellant service
  • Aerosol filling area design, covering ventilation, detection and separation
  • Powder handling, exposure control and dust explosion assessment
  • Changeover and cleaning design to reduce lost production between SKUs
  • Feasibility, FEED, detailed design and EPCM delivery under ISO 9001:2015

Typical reasons clients get in touch

  • Microbiological control issues trace back to water system or vessel design
  • Ethanol inventory has grown and DSEAR or COMAH status needs establishing
  • An aerosol filling line is being introduced or relocated
  • Changeover time is limiting how many SKUs the plant can carry
  • A retailer or brand audit has raised facility findings
  • Capacity has to rise without extending the building

Related

Part of our work across the FMCG sector. See also detergents, soaps and household chemicals, and flavours, fragrances and aroma chemicals.

Standards and regulations we work to

  • Assimilated Regulation (EC) No 1223/2009 with the Cosmetic Products Enforcement Regulations 2013 in Great Britain
  • ISO 22716, Good Manufacturing Practice for cosmetics
  • DSEAR 2002, with ACOP L138 (second edition, 2013), for ethanol and propellants
  • BS EN IEC 60079-10-1:2021 for vapour, and BS EN 60079-10-2 for dust
  • COMAH 2015, where ethanol inventory crosses threshold
  • COSHH 2002, with ACOP L5 (sixth edition, 2013)
  • PUWER 1998, with ACOP L22 (fourth edition, 2014, amended 2018)
  • Environmental Permitting (England and Wales) Regulations 2016 (as amended)
  • CDM 2015 and ISO 9001:2015

Frequently asked questions

Should we be building to pharmaceutical GMP?
Generally not, and doing so wastes money. ISO 22716 sets expectations that are meaningfully lighter than pharmaceutical GMP but considerably more demanding than general food manufacturing, particularly around microbiological control, cleaning and batch traceability. Designing to the right standard is the point.

Our microbiological failures seem random. Where should we look?
Usually at the water system and vessel cleanability rather than at preservative levels. Dead legs, inadequate loop velocity, poor drainability and long hold times all create conditions that preservative systems are then asked to compensate for.

Does ethanol inventory really need a DSEAR assessment?
If you hold and transfer it in any quantity, yes. Fragranced products and alcohol-based formats can carry surprisingly large inventories, and some sites are closer to a COMAH threshold than they realise.

Changeover is killing our capacity. What helps most?
Usually a combination of dedicated equipment for the most problematic colours or fragrances, cleaning design that reduces validated cycle time, and better scheduling of product sequence. It is rarely one change.

Can you design an aerosol filling area from scratch?
Yes, including ventilation, gas detection, separation and the layout constraints that propellant handling imposes. It is one of the higher-hazard areas in FMCG manufacturing and benefits from being designed rather than adapted.

How do you approach purified water system design?
Around sanitisation and sampling from the outset. Loop velocity, dead-leg elimination and drainability determine whether microbiological control is achievable, and they are difficult to retrofit into an installed loop.

Talk to us about your facility. Request a call