Natural and Organic Cosmetics: What COSMOS, ISO 16128 and "Clean Beauty" Labels Actually Mean
“Natural”, “organic” and “clean” are among the most common words on skincare and personal care packaging, and among the least understood. Consumers read them as a promise. Brand owners often treat them as a design choice. In most markets, however, only one of the three is tied to a formal, checkable standard — and even that depends on who is doing the checking.
Quick answer: In Malaysia, the European Union and the United States, there is no general legal definition of a “natural” or “clean” cosmetic, and “organic” is defined mainly through voluntary private certification. The two reference points most brands use are ISO 16128, a guideline that tells a formulator how to calculate natural and organic content, and COSMOS, a certification scheme that sets minimum thresholds and audits the product and its manufacturer. ISO 16128 alone is not a certification and does not permit a logo. “Clean beauty” is a retailer and marketing concept with no agreed meaning. Brand owners who want to make natural or organic claims should decide early which basis they will use, because it changes raw materials, preservatives, cost and the choice of factory.
Key takeaways
- “Natural” and “clean” are not legally defined for cosmetics in most markets; the general rule is that any claim must be truthful and supportable.
- ISO 16128 is a calculation method, not a label. It produces a “natural origin index” and an “organic origin index” but sets no pass mark.
- COSMOS ORGANIC and COSMOS NATURAL are certified signatures: ingredients, processing, preservatives, packaging and the manufacturing site are all checked by an authorised certification body.
- Because water and minerals cannot be organic, a genuinely organic cream may still show an organic percentage of the total product in the low tens, not ninety-something.
- “Natural” does not mean safer. Plant extracts and essential oils can be allergens and still need the same safety assessment as any other ingredient.
- The decision is a manufacturing decision as much as a marketing one: certified raw materials, a restricted preservative list and site approval all affect lead time and unit cost.
Who this is for: founders and brand owners planning a skincare, hair care, body care or personal care line that will carry natural, organic or “clean” positioning, and product developers briefing an OEM or ODM manufacturer on such a range.
Is there a legal definition of “natural” cosmetics?
In most major markets, no. There is no general statutory definition of a “natural” cosmetic in Malaysia, the EU or the US; instead, the word is governed by the broader rule that cosmetic claims must be truthful, supportable and not misleading.
In the European Union, Commission Regulation (EU) No 655/2013 sets common criteria for all cosmetic claims — legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making — rather than defining individual words. In the United States, the Food and Drug Administration states on its “Organic” Cosmetics page that it does not define “organic” for cosmetics, and that the term is regulated by the U.S. Department of Agriculture’s National Organic Program only where the product contains agricultural ingredients that can be certified. In Malaysia, cosmetics are placed on the market through the National Pharmaceutical Regulatory Agency (NPRA) notification system, and the Guidelines for Control of Cosmetic Products in Malaysia expect claims to be justified; they do not create a separate natural or organic certification.
The practical result is that the regulator asks “can you support this claim?” rather than “did you meet a published threshold?”. The general principles behind that question are covered in more detail in this blog’s guide to what health and beauty brands can legally claim.
What does ISO 16128 actually measure?
ISO 16128 measures how much of a formula comes from natural or organic origin; it does not decide whether a product is “natural enough” to be labelled as such.
The standard has two parts. ISO 16128-1:2016 defines ingredient categories: natural ingredients, derived natural ingredients (which ISO defines as more than 50% natural origin by molecular weight), mineral and mineral-derived ingredients, organic and derived organic ingredients, and non-natural ingredients. ISO 16128-2:2017 then gives the method for calculating a natural origin index and an organic origin index for each ingredient and for the finished product.
Three limits matter for brand owners:
- No threshold. ISO 16128 does not say that a product with, say, 90% natural origin content may be called natural. It only produces the number.
- No logo and no audit. There is no ISO 16128 certification mark. The calculation is usually done by the formulator or manufacturer and documented in the product file.
- Narrow scope. The standard does not address toxicology, environmental impact, packaging or social criteria. A high natural origin index says nothing about whether a product is gentle, biodegradable or sustainably packed.
Its main value is transparency. A statement such as “96% of natural origin, calculated according to ISO 16128” tells a regulator or retailer exactly how the figure was reached, which makes it far easier to support than an unqualified “natural”.
What does COSMOS certification require?
COSMOS certification requires a product to meet published thresholds for ingredient origin, processing, preservatives and packaging, and to be inspected by an authorised certification body before it may carry a COSMOS signature.
The COSMOS-standard is managed by a Brussels-based non-profit association whose founding members are BDIH (Germany), Cosmebio and Ecocert (France), ICEA (Italy) and the Soil Association (UK). According to the COSMOS-standard association, more than 31,100 products in 80 countries carried a COSMOS ORGANIC or COSMOS NATURAL signature as of January 2026, and certification is carried out by 12 authorised certification bodies in Europe, Australia and Asia.
There are two product signatures:
- COSMOS ORGANIC — at least 95% of the physically processed agro-ingredients must be organic, and at least 20% of the total product must be organic (10% for rinse-off products, non-emulsified aqueous products and products with at least 80% minerals or ingredients of mineral origin).
- COSMOS NATURAL — the same rules on permitted ingredients, processes and preservatives, but with no minimum organic content.
Beyond percentages, the scheme restricts which chemical processes may be used to make ingredients, limits the preservatives that may be added, sets packaging and environmental management requirements, and requires the manufacturing site itself to be covered by the certification. It also keeps a public database of certified and approved raw materials, which formulators use to check whether an ingredient is admissible before building a formula around it.
Why is “organic” percentage often lower than people expect?
Organic percentages look low because water, salt, clays and other minerals make up a large share of many cosmetics and cannot be organic, since they are not farmed.
A lotion that is 70% water can have every single plant-derived ingredient certified organic and still reach an organic content of only around 20–25% of the total product. This is why COSMOS ORGANIC separates the two measures: near-total organic status for the agricultural ingredients, and a much lower floor for the product as a whole. Brand owners who see a “20% organic” figure on a certified product are usually looking at a rigorous claim, not a weak one — while a competitor’s unqualified “organic” on the front of the pack may have no calculation behind it at all.
Natural, organic or “clean”: how do the claims compare?
The three claims differ mainly in who defines them, whether anyone checks them, and what they cost to support.
| Claim basis | Who defines it | Minimum threshold | Independent audit | Logo on pack | Typical effect on development |
|---|---|---|---|---|---|
| Unqualified “natural” | Nobody formally | None | No | No | Lowest cost, highest claim risk |
| ISO 16128 index | International Organization for Standardization | None (calculation only) | No | No | Needs ingredient-origin data from every supplier |
| COSMOS NATURAL | COSMOS-standard AISBL | No organic minimum; ingredient and process rules apply | Yes | Yes | Restricted ingredients and preservatives; certified site |
| COSMOS ORGANIC | COSMOS-standard AISBL | 95% of processed agro-ingredients; 20% of total (10% some rinse-offs) | Yes | Yes | Highest raw-material cost and longest lead time |
| “Clean beauty” | Individual retailers and brands | Varies by retailer’s “free-from” list | Only if a retailer checks | Retailer badge only | Formula shaped by an exclusion list rather than a standard |
“Clean beauty” deserves a specific caution. It usually means that a formula avoids a list of ingredients chosen by a retailer or brand — certain preservatives, silicones, sulphates or synthetic fragrance. Those lists differ between retailers, are not based on a single safety assessment, and can imply that approved ingredients are unsafe. That is the same problem this blog discussed in its article on what “recyclable”, “biodegradable” and “refillable” really mean: a word that sounds reassuring is only as strong as the evidence behind it.
What changes in manufacturing when a brand goes natural or organic?
Going natural or organic changes four things in manufacturing: raw material sourcing, preservation, the choice of production site, and paperwork.
Raw materials and documentation
Every ingredient needs origin data — which part is plant-derived, how it was processed and, for organic claims, a valid organic certificate for the specific supplier lot. For COSMOS, ingredients must be certified or approved under the scheme. Supply is thinner than for conventional grades, minimum order quantities for certified materials can be higher, and a single discontinued ingredient can force a reformulation. This is why raw material sourcing and supplier documentation tend to take up a larger share of the timeline for certified ranges than for conventional ones. The wider sourcing process is covered in this blog’s practical guide to ingredients, suppliers and documentation.
Preservation
Natural and organic schemes limit the preservatives a formulator may use. Water-based products still need to pass microbial challenge testing, so the formula must be designed around a narrower toolkit — often a combination of permitted organic acids, careful pH control and packaging that limits contamination, such as airless pumps. The stakes are explained in how preservatives and challenge testing keep products safe. Brands should expect more development rounds and should not accept a shorter shelf life by default without stability data to support it.
The production site
A certified product must be made in a site covered by the certification, with procedures for segregating certified materials and preventing mix-ups with conventional stock. A factory that makes excellent conventional skincare may not be able to produce a COSMOS-certified version without first extending its own certification.
Cost and time
Certified raw materials usually cost more than conventional equivalents, certification carries fees and annual inspection, and the added development and paperwork extend the launch timeline. How these costs flow into a shelf price is set out in the guide to costing a beauty or supplement product.
Why do natural claims face more scrutiny in 2026?
Natural and eco-style claims face more scrutiny because regulators, particularly in the EU, are tightening rules on vague environmental wording and on sustainability labels that are not backed by a certification scheme.
Directive (EU) 2024/825, known as the Empowering Consumers for the Green Transition Directive, amends EU consumer law to treat generic environmental claims (unless the trader can demonstrate recognised excellent environmental performance), and sustainability labels not based on a certification scheme or set by public authorities, as unfair commercial practices. EU member states are required to apply the new rules from 27 September 2026. The directive is aimed at environmental claims rather than the word “natural” as such, but many natural-positioned products also use “eco”, “green” or self-made leaf badges on the same pack. For Malaysian brands that export to Europe, or sell through platforms that apply EU rules, the direction of travel is clear: self-designed badges and unqualified environmental wording carry more risk than a claim tied to a published standard.
How should a brand owner choose the right approach?
A brand owner should choose the claim basis before the formula is developed, starting from who the customer is and which markets the product will enter.
- Selling mainly in Malaysia or ASEAN to a general audience: a factual, qualified statement — for example a natural origin percentage calculated to ISO 16128 — is often enough and is easier to support than an unqualified “natural”.
- Selling into Europe, or to retailers that ask for certified products: COSMOS NATURAL or COSMOS ORGANIC gives a recognised third-party basis and a logo the retailer can verify.
- Positioning as “clean”: obtain the specific retailer’s criteria in writing, avoid implying that excluded ingredients are unsafe, and keep a clear record of how the formula meets the list.
- Uncertain or early-stage: avoid front-of-pack natural or organic claims until the formula, suppliers and documentation are settled. Adding a claim later is easier than withdrawing one.
Whichever route is chosen, the evidence belongs in the product’s technical documentation. For cosmetics, that means the calculation, supplier certificates and claim support should sit alongside the rest of the Product Information File.
Frequently asked questions
Can I put “organic” on my label if one ingredient is organic?
Doing so risks misleading consumers, because shoppers generally read “organic” as describing the whole product. The safer practice is to name the ingredient instead — for example “with organic aloe vera” — and to hold the supplier’s organic certificate for that lot. A product-level “organic” claim is best supported by certification such as COSMOS ORGANIC.
Is ISO 16128 the same as being certified natural?
No. ISO 16128 is a guideline for calculating natural and organic origin content; it sets no minimum and involves no independent audit or logo. A product can quote an ISO 16128 figure, but that is a calculated disclosure, not a certification. Certification requires a scheme such as COSMOS and an authorised certification body.
Are natural cosmetics safer than conventional ones?
Not automatically. Plant extracts and essential oils can cause irritation or allergy, and some contain fragrance allergens that must be declared on the label under EU cosmetic rules and in several other markets. Every cosmetic, natural or not, needs a safety assessment based on its actual ingredients and use. “Natural” describes origin, not safety.
Do natural products have a shorter shelf life?
Sometimes, but not necessarily. A narrower preservative list can make preservation harder, yet well-designed natural formulas routinely reach the same shelf life as conventional ones. The answer comes from stability and challenge testing on the final formula in its final packaging, not from the claim itself.
Can a Malaysian manufacturer produce COSMOS-certified products?
Yes, provided the manufacturing site is covered by COSMOS certification through an authorised certification body, and the formula uses certified or approved raw materials. Brand owners should ask to see the factory’s current certificate and its scope, rather than relying on a general statement that it “can do organic”.
Does halal certification overlap with natural or organic certification?
They are separate schemes with different purposes. Halal certification assesses the permissibility of ingredients and processes under Islamic requirements; natural and organic schemes assess ingredient origin and processing. A product can hold both, but meeting one does not satisfy the other.
Limitations
This article explains general principles as of September 2026 and is not legal advice. Certification thresholds, permitted ingredients and national claim rules change over time and differ by market and product type. The COSMOS figures quoted are those published by the COSMOS-standard association. Brand owners should confirm current requirements with the relevant regulator, the chosen certification body and their manufacturer before finalising labels.
Sources
- International Organization for Standardization, ISO 16128-1:2016 — Definitions for ingredients and ISO 16128-2:2017 — Criteria for ingredients and products
- COSMOS-standard AISBL, About the COSMOS-standard
- European Union, Commission Regulation (EU) No 655/2013 on common criteria for cosmetic claims
- European Union, Directive (EU) 2024/825 on empowering consumers for the green transition
- U.S. Food and Drug Administration, “Organic” Cosmetics
- National Pharmaceutical Regulatory Agency, Malaysia, Guidelines for Control of Cosmetic Products in Malaysia
Creaton Poh is the pen name of Poh Tze Kheng, founder of ORIZI Group — one of Malaysia's most comprehensive one-stop OEM, ODM, private label and contract manufacturing groups, spanning skincare, cosmetics, personal care, perfume and fragrance, supplements, functional food and nutrition, pet care, home care and medical devices. Across six specialised companies and three manufacturing divisions, the Group brings together 20+ years of industry experience, 5,000+ formulations, and internationally recognised quality, manufacturing and regulatory standards. These articles are written to educate, not to promote.
Written by Creaton Poh
Industry Researcher • Author • Vlogger • Manufacturing Strategist
Turning ideas into products. Turning experience into knowledge.
Connect with Poh Tze Kheng on LinkedIn.
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