Last Updated on October 24, 2025 by Hafsa J.

Why Natural & Organic Cosmetic Claims Need More Than Just Marketing

More and more cosmetic brands are calling their products “natural” or “organic.” But behind those beautiful labels, regulators and consumers are asking one big question — can you prove it?

That’s where ISO 16128 and ISO 22716 come together. ISO 16128 defines what “natural” actually means for ingredients and formulations. ISO 22716 ensures those formulations are made under strict Good Manufacturing Practice (GMP).

In my experience helping cosmetic manufacturers across ASEAN and Europe, most claim-related non-conformities happen not because the product isn’t natural — but because the documentation can’t prove it.

In this guide, I’ll show you how these two standards complement each other — one covers what’s inside your formula, and the other covers how it’s produced. Get this synergy right, and your claims become both credible and compliant.

Understanding the Two Standards – ISO 22716 vs ISO 16128 in Plain English

Let’s keep it simple.

ISO 22716 is all about how you make cosmetics — your hygiene, equipment, processes, and documentation. It’s the global reference for cosmetic GMP.

ISO 16128, on the other hand, is about what’s in your formula. It tells you how to calculate your product’s natural origin index or organic content. It helps you define what percentage of your ingredients truly come from nature.

Here’s the quick comparison:

Aspect	ISO 22716	ISO 16128
Focus	Manufacturing process (GMP)	Ingredient origin & formula claims
Audience	Production & Quality teams	R&D & Marketing teams
Output	Safe, consistent product	Credible natural/organic claim
Type	Certifiable GMP standard	Guideline (not certifiable)

Pro Tip:
Think of ISO 22716 as your factory discipline and ISO 16128 as your formulation truth. One keeps your process under control, the other keeps your claims honest.

Why Combine Them – The Compliance & Marketing Synergy

When your formula and your process work together, you get a powerful combination — marketing credibility backed by manufacturing proof.

Here’s how it works:

• ISO 16128 gives you the natural origin calculation.
• ISO 22716 ensures that calculation is traceable through your GMP documentation — from supplier approval to batch release.

That means if a regulator asks how your cream is “98% natural,” you can show ingredient origin records, supplier declarations, and batch data — all tied to your GMP system.

Example:
A skincare brand in Malaysia used ISO 16128 to calculate that 94% of its ingredients were natural origin. They then logged those details in their ISO 22716-compliant batch records. When auditors reviewed their claims, every number was traceable.

Common Mistake:
Treating ISO 16128 like a marketing checklist. It’s not. If your GMP system doesn’t back it up, your claims won’t hold during inspection.

Key Integration Points – Where ISO 22716 Meets ISO 16128

4.1 Ingredient Procurement & Supplier Qualification

Start with your supply chain. ISO 16128 requires ingredient origin data — certificates, COAs, sustainability documents.
Under ISO 22716, that data belongs in your supplier approval files.

Pro Tip:
Create a “Natural Ingredient Register” in your GMP system that links each supplier’s ISO 16128 classification (natural, derived natural, synthetic) to their approval status.

4.2 Formulation Development & Change Control

When you calculate your natural or organic percentages, record those results in your formulation file. Then, under ISO 22716, treat that file as a controlled document.

Why it matters:
If Marketing changes the label claim from “90% natural” to “100% natural,” R&D and Quality must approve it. That’s change control — and it keeps claims consistent with documentation.

4.3 Labeling & Marketing Claims Verification

Your labels should never make promises your GMP records can’t prove.
Cross-check all marketing claims against your ISO 16128 calculations and ISO 22716 batch documentation.

Pro Tip:
Keep a “Claim Verification Dossier” — one folder linking your natural index, batch data, and label approvals. It saves hours during audits.

4.4 Audit & Certification Readiness

If an auditor asks for proof of your “organic claim,” you’ll need to show both sides — ISO 16128 calculations and ISO 22716 process records.

Example:
During an ASEAN GMP audit, a client of mine was asked to prove ingredient origin. Their ISO 16128 index sheet, signed off under GMP, instantly satisfied the requirement.

Implementation Strategy – Building a Unified Compliance Framework

If you’re already ISO 22716-certified, you’re halfway there. Integrating ISO 16128 just means expanding your documentation scope.

Here’s how to start:

1. Run a Gap Analysis: Compare your GMP documentation with ISO 16128’s ingredient classification requirements.
2. Map the Overlaps: Identify where existing batch or supplier records already capture natural origin data.
3. Add a Natural-Claims Module: Create one controlled file for your ISO 16128 calculations and claim summaries.
4. Train Teams Together: Marketing, R&D, and QA should all understand what “natural origin index” means.
5. Review Annually: During internal audits, verify that claims and GMP data still match.

Pro Tip:
Audit your formulas and your marketing claims in the same session. It’s more efficient and keeps everyone aligned.

Benefits – Beyond Compliance

When ISO 22716 and ISO 16128 work together, you gain more than certification.

• Credibility: Your “natural” claim is backed by real data.
• Market Access: Easier compliance with EU, ASEAN, and global regulators.
• Consumer Trust: Transparency strengthens your brand image.
• Audit Readiness: Clear documentation reduces non-conformities during inspections.

Example:
A European brand integrated both standards before launch. Their “organic serum” passed ASEAN notification and EU portal submission with zero corrections — all because every claim was traceable through GMP.

FAQs – Clarifying Common Doubts

Q1: Is ISO 16128 certification mandatory?
No — ISO 16128 isn’t a certifiable standard. It’s a guideline for classifying and calculating natural or organic content.

Q2: Does ISO 22716 certification prove my product is organic?
No. ISO 22716 proves you follow GMP. ISO 16128 provides the framework for your organic or natural claim.

Q3: Can I combine both in one audit?
Yes. Many certification bodies and consultants can review your GMP and ISO 16128 data together to streamline verification.

Turning Standards Into Brand Strength

Consumers are smarter than ever. “Natural” and “organic” claims now demand proof — not just pretty words.

By aligning ISO 22716 and ISO 16128, you create a system where your product’s origin and process tell the same story.
It’s not just about compliance; it’s about brand integrity.

I’ve seen countless manufacturers transform their credibility just by connecting these two frameworks. Once your GMP system supports your natural claims, your marketing becomes more believable — and your audits, much easier.

Next Step:
Download QSE Academy’s ISO 22716 + ISO 16128 Integration Checklist, or book a consultation to align your formulation data with your GMP documentation today.