Buyer guide
Cosmetics factory rooms: what ISO 22716 and regulators say about premises
ISO 22716 gives guidelines for the production, control, storage and shipment of cosmetic products, and in the EU, manufacture that follows the relevant harmonised standards is presumed to meet good manufacturing practice. FDA's checklist and Health Canada's page give no particle class or air change rate for premises, so room design comes from your products and your risk review.
By ZY Cleanroom · Updated · Sources at the end of the page
What the regulators write about premises
FDA's checklist page was current as of 18 November 2025. Health Canada's page was last modified on 29 October 2019. Both are summarised here in short form.
| Topic | FDA checklist | Health Canada |
|---|---|---|
| Surfaces | Smooth floors, walls and ceilings that are easy to clean and in good repair | Walls and floors suit the work and are in good repair |
| Overhead services | Fixtures, ducts and pipes placed so drips and condensate cannot reach materials | Ducts and pipes in good repair |
| Air | Ventilation suits the operation and staff comfort | Adequate air supply quality |
| Water and waste | Water supply, washing and toilet facilities, drainage and sewage support sanitary work | Water supply, drainage and toilets suit the work |
| Pests | Not mentioned on this page | A pest control programme is in place |
Where the rules stand
EU Regulation 1223/2009 Article 8 says manufacture shall comply with good manufacturing practice. It says compliance is presumed where manufacture follows relevant harmonised standards published in the Official Journal.
Health Canada says it endorses the use of ISO 22716. FDA's MoCRA page says the law requires FDA to establish GMP regulations for cosmetic facilities. FDA describes its checklist as guidelines that may serve for self-inspection. As of its 29 October 2026 update, the MoCRA page lists a draft GMP guidance but no proposed or final GMP rule.
Other items in FDA's checklist
Cleaned portable equipment should be stored with contact surfaces covered, to protect it from splashes and dust. Eating, drinking and tobacco use should be limited to designated areas.
Raw materials should be protected from heat, cold, sunlight and moisture. Bagged or boxed materials should be stored off the floor.
ISO's listing says the standard covers product quality. It does not address staff safety or environmental protection, and research and development and the distribution of finished products are outside it. ISO last reviewed and confirmed the 2007 edition in December 2022.
A room list to start from
This list is a suggestion, not clause text. Raw material store. Weighing. Bulk manufacture. Filling and packing. Finished goods store. Quality control lab. Washing area. Waste area. Hygiene and gowning facilities.
FDA's checklist asks that water used as an ingredient be tested regularly. So ask which products are water-based, and give the filling area finishes that withstand wet cleaning.
Questions for a project brief (suggested)
Which products are water-based, anhydrous, powder or aerosol? Which steps open the product to room air? How do waste and returns leave the building?
How many products share one line, and how is the line cleaned between them? Who in quality signs off the room design?
Write the answers into the brief before you ask for a layout. Rooms then follow the product, not the other way round.
Worked example (illustrative layout check)
Draw the product path from receipt to shipment on the plan. Mark every point where a people route crosses a material route. Say a plan shows 4 crossings. That gives 4 decisions to make, each with an airlock, a time rule or a different door.
Fewer crossings usually means fewer rules to enforce, so fix the layout before you set finishes.
If you have a room list for a cosmetics plant, send it to ZY Cleanroom and we will review the panel, door and ceiling scope with you.
Questions
Common questions
Does a cosmetics factory need a classified cleanroom?
These sources set no class for cosmetics. Decide from product risk, such as water content and shelf life.
What does the EU require?
Article 8 requires good manufacturing practice and presumes it when harmonised standards are followed.
Is the FDA checklist a regulation?
FDA describes it as guidelines for self-inspection. MoCRA requires FDA to set GMP regulations.
Is pest control covered?
Health Canada lists a pest control programme. The FDA page does not mention it, so add it to your own brief.
Related guides
- HEPA and ULPA filters: EN 1822, ISO 29463 and integrity testing
- EU GMP grades A to D compared with ISO classes
- Cleanroom failed particle count: causes and fixes
- Cleanroom air changes per hour: published values and their limits
- Turnkey cleanroom contractor
- Room list builder
Sources
- Regulation (EC) No 1223/2009 on cosmetic products, Article 8 (30 November 2009, recast; text as shown on legislation.gov.uk; checked 1 November 2026)
- ISO 22716:2007, Cosmetics, Good Manufacturing Practices (GMP), Guidelines on Good Manufacturing Practices (edition 1, November 2007, confirmed December 2022; ISO listing; checked 1 November 2026)
- FDA, Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics (page current as of 18 November 2025; checked 1 November 2026)
- FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA) (page current as of 29 October 2026; checked 1 November 2026)
- Health Canada, Good Manufacturing Practices (GMPs) for Cosmetic Products (modified 29 October 2019; checked 1 November 2026)
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
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