ISO 22716 and BRCGS: How Cosmetics GMP Maps to Enhanced Hygiene Expectations

By Robert Low, Lead Management System Specialist and BRCGS Approved Trainer

If you manufacture cosmetics or personal care products, the Issue 5 draft’s introduction of enhanced hygienic conditions probably caught your eye, and possibly raised your blood pressure. Here is the reassuring part: if you are already running a genuine ISO 22716 system, you have built most of what enhanced hygiene expectations are looking for. The work is in mapping and evidencing it within your BRCGS system, not building from scratch.

Why Cosmetics Sites Are in Scope

The concept behind the new section is straightforward. Some consumer products can support microbiological growth or survival, or are subject to hygienic manufacturing legislation, and those products need manufacturing conditions a general merchandise site does not. Cosmetics tick both boxes: global cosmetics regulations impose hygienic manufacture obligations, and water-based formulations are exactly the products where microbiological control matters. If that is you, expect the enhanced expectations to apply.

Where ISO 22716 Already Covers You

Think about what a proper 22716 system already includes. Segregated production areas with controlled flow of personnel and materials. Water quality management for water used as an ingredient, with treatment, monitoring and records. Validated cleaning and sanitisation of product contact surfaces. Dedicated protective clothing with controlled changing arrangements. Personal hygiene rules covering jewellery, nails and hand washing. Premises designed for hygienic manufacture, with attention to drains, air handling and materials of construction. Every one of those has a counterpart in the enhanced hygiene expectations of the Issue 5 draft. I have written extensively about what 22716 requires in my ISO 22716 section by section series, and readers of that series will recognise the overlap immediately.

Where the Gaps Usually Are

Three places, in my experience. First, validation evidence: 22716 sites often clean well but hold thin evidence that cleaning methods were formally validated against defined criteria. Second, risk assessment lineage: BRCGS expects a documented risk assessment trail identifying which products and areas need enhanced conditions, not just a site that happens to operate hygienically. Third, integration: the hygiene controls need to be embedded in your HARA and your documented system, auditable as one coherent whole, rather than living in a parallel 22716 world. That integration exercise is precisely the kind of work to do between the October 2026 publication and your first Issue 5 audit.

For the wider context of what Issue 5 changes, my full Issue 5 draft article covers everything. And if you want your 22716 system mapped against the final BRCGS text when it lands, that is a service I deliver remotely, and one I would argue no cosmetics site should skip. Buttons below.