ISO 16128 provides ingredient definitions and methods for calculating natural, natural-origin, organic and organic-origin content. COSMOS is a certification scheme with ingredient, processing, manufacturing, packaging and labelling rules. An ISO-based percentage does not establish COSMOS certification.[5][6][9]

Choose the route before asking a laboratory to finalise the formula. A brief that says only “natural and organic” does not tell the formulator which requirements to meet or what evidence the brand will need. Specify the calculation or certification you need in your cosmetic formulation brief.

ISO 16128 versus COSMOS at a glance

This comparison uses the public ISO abstracts and the COSMOS criteria.[5][6][9] A brand may use an ISO calculation internally while pursuing COSMOS, but it must keep the calculations and evidence distinct.

What ISO 16128 does, and what it leaves to the brand

Part 1 defines ingredient categories. Part 2 describes approaches to ingredient indexes and product-content calculations. Both explicitly exclude product communication, human and environmental safety, socio-economic considerations, packaging characteristics and applicable cosmetic regulations from their scope.[5][6]

A statement such as “97% natural origin, calculated using ISO 16128” therefore needs more than a supplier’s marketing description. The brand needs the exact formula, evidence supporting the ingredient categories and indexes, and a documented calculation basis. The percentage alone does not demonstrate efficacy, biodegradability or suitability for sensitive skin.[5][6]

Check spreadsheet templates against the published standards and their amendments. ISO’s public catalogue currently lists ISO 16128-1:2016 and ISO 16128-2:2017, with Amendment 1:2022 to Part 2. Replacement projects are under development; a project listing is not a published replacement standard.[5][6][7]

The full ISO texts are paid publications. This article uses their public scope and catalogue information; it does not verify any particular formula’s ISO calculation. The formulator responsible for your calculation should have the applicable standards and record the version used.

What COSMOS certification checks

COSMOS version 4.2 applies from 1 September 2025. Its requirements cover raw-material eligibility and processing, product composition, manufacturing controls, packaging, environmental management and communication. Certification by an authorised certification body includes documentary validation and an on-site inspection.[8][9]

For finished products, the two routes are:

• COSMOS NATURAL has no minimum requirement for organic ingredients. The other applicable scheme requirements still apply.
• COSMOS ORGANIC has organic-content requirements at both ingredient-category and total-product levels.[9]

Under the general COSMOS ORGANIC rules, at least 95% of physically processed agro-ingredients must be organic, and at least 20% of the total product must be organic. The total-product minimum is 10% for rinse-off products, non-emulsified aqueous products, and products containing at least 80% minerals or ingredients of mineral origin. Check the specific ingredient requirements and adapted rules for some soap and alcohol-based products as well.[9]

The 95% ingredient-category requirement applies to physically processed agro-ingredients, not to the finished cream as a whole. COSMOS also has a separate labelling rule: the product must not be called “organic”, for example “organic shampoo”, unless at least 95% of the total product is organic. A product can therefore meet the certification threshold without qualifying for that wording.[9]

Water and minerals cannot be calculated as organic under COSMOS. A product with a high natural-origin percentage may still have much lower organic content.[9]

Check the commercial grade, not just the INCI name

An INCI name identifies an ingredient for labelling; it does not give the full manufacturing history or establish the eligibility of every commercial grade. Materials with the same INCI name may differ in source, processing or supplied composition, so they may need different supporting assessments.

For an ISO calculation, request the ingredient categories and indexes, with evidence of how they were determined. For COSMOS, request the documentation needed to assess the exact material and process, together with any relevant approval or organic certification. Ask about the carrier and preservative system in botanical blends, not only the named plant extract. COSMOS requires complete traceability of ingredients and finished products within its manufacturing quality-control system.[6][9]

Keep a register connecting each supplier code to its documents, approved use and revision. Your raw-material documentation process should flag substitutions before purchasing accepts them. Review the evidence for a substitute even when its INCI name is unchanged.

COSMOS APPROVED status for a non-organic raw material means that ingredient is acceptable for use under the standard. It is not finished-product certification. Check which material or product the supplier’s document covers.[9]

Hypothetical cream: 97% natural origin and 15% organic

Consider a fictional leave-on emulsion. The following indexes and organic contributions are assumptions for illustration; they are not assessed supplier data or a complete ISO calculator.

Multiplying each formula share by its assumed natural-origin index gives 80 + 15 + 2 + 0 = 97%. The 97% includes the direct water, which contributes no organic content in this example. An actual ISO claim needs the applicable methodology and verified ingredient data, including water treatment and blend composition.[6]

Assume, separately, that the formula has 15% organic content under COSMOS rules and is not in a category eligible for the 10% exception. It misses the general 20% total-product requirement for COSMOS ORGANIC, even if its physically processed agro-ingredients satisfy their separate organic requirement.[9]

It does not automatically qualify for COSMOS NATURAL either. The certification body must still assess every ingredient and the applicable process, manufacturing, packaging and labelling requirements. Have the certification body review the proposed formula before commissioning final stability batches.

What to agree before development

The following steps are project recommendations, not additional legal or certification requirements:

1. Write the intended pack claim and any retailer certification requirement. Decide whether the objective is a calculated percentage, COSMOS NATURAL or COSMOS ORGANIC.
2. Ask the laboratory to identify the exact grades it proposes, the evidence it can obtain and any ingredients that need a certification-body decision.
3. Agree who owns the calculation file, supplier submissions, certification application and artwork review. Ask for a quotation that states whether certification work is included.
4. Review ingredient eligibility, organic sourcing and packaging before freezing the formula. Confirm change-notification duties for suppliers and the manufacturer.
5. Keep separate evidence for content claims, cosmetic safety and performance. Recheck each when the formula or supplier changes.

Ask about the laboratory’s certification experience when choosing a cosmetic lab, but check your proposed product’s certification status separately.

Support safety and performance claims separately

Neither a natural-origin calculation nor organic certification replaces EU cosmetic safety obligations. The responsible person must ensure a safety assessment and cosmetic product safety report before market placement. EU cosmetic claims also need adequate, verifiable evidence and must not mislead consumers.[10][11]

Claims such as “safer”, “non-toxic” or “hypoallergenic” need their own evidence; the source of an ingredient is not enough. Assess preservation and any fragrance allergens for the actual formula rather than inferring safety from its origin. Record the proposed wording and supporting evidence in your cosmetic claims substantiation plan.

If a content percentage meets the brief, document it using the applicable ISO framework. If a customer or retailer needs COSMOS certification, plan the formula and production arrangements around that requirement. Approve the evidence and exact claim wording before printing the packaging.