ISO 16217 — Standard

About the Standard

Scope title: water resistance of cosmetics (SPF)

ISO 16217 is a standard published by International Organization for Standardization (ISO). The international standards organisation; it publishes the widest body of management system, test method and product standards.

See the other 310 codes from ISO

Coverage areas

Kozmetik Testleri — What Does This Testing Field Cover?

The section below describes the field that code ISO 16217 belongs to; it is not the text of the standard or the regime itself. The scope title of the code is given above, and technical requirements are shared at the quotation stage.

Cosmetics testing shows that a product stays microbiologically safe throughout its use, delivers the performance it claims and contains no restricted substances. There is NO PRODUCT APPROVAL in this family: no authority approves a cosmetic product; responsibility rests entirely with the manufacturer and with the responsible person established in the EU.

This responsibility model shapes how the field works. Before the product is placed on the market a product information file (PIF) is prepared, a safety assessment (CPSR) is carried out and notification is completed. Inspection comes afterwards and asks for the file; if the file is incomplete the product is withdrawn from the market. Test reports form the evidence base of that file.

On the microbiological side there are two different questions and each is answered by a separate test. The CURRENT microbiological quality of the product is measured by enumeration and testing for specified microorganisms. The EFFECTIVENESS of the preservative system is examined by deliberately inoculating the product with microorganisms (challenge test): can the product resist repeated contamination throughout its use? A jar of cream is touched by a finger at every use; the preservative system must cope with that.

On the performance side, claim substantiation studies are carried out. For sunscreens, determination of SPF and UVA protection and measurement of water resistance are mandatory and are the basis of the value declared on the label. Evidence is also produced by in vivo or in vitro methods for claims such as moisturisation, appearance of wrinkles, hair care and colour retention.

On the chemical side, banned and restricted substances are screened: heavy metals, prohibited colorants, preservative concentrations, UV filter levels and contaminants such as nitrosamines. Products containing nanomaterials carry a separate notification obligation.

The BAN ON ANIMAL TESTING is the most defining constraint of the field. Animal testing cannot be carried out on finished products or ingredients, and a product tested on animals cannot be placed on the market. Alternative in vitro methods (reconstructed human skin models, cell culture based tests) are therefore at the centre of the field, and toxicological assessment rests largely on existing data, read-across approaches and in vitro results.

Stability and packaging compatibility studies determine shelf life and the period after opening (PAO). The interaction of the product with its packaging is also assessed: an active substance may migrate into the packaging, and substances that should not be present may pass from the packaging into the product.

On the process side, good manufacturing practice is demonstrated through ISO 22716; this is separate from product testing but a mandatory part of the file.

Method groups in this field

Microbiological quality
Enumeration of aerobic mesophilic bacteria, yeasts and moulds; testing for Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and E. coli.
Preservative efficacy
Resistance of the preservative system to repeated contamination by challenge test (ISO 11930).
Sun protection
In vivo SPF determination, in vitro UVA protection determination, water resistance and critical wavelength measurements.
Chemical analysis
Heavy metals, banned and restricted substances, quantification of preservatives and UV filters, contaminant screening.
Safety assessment
In vitro irritation and sensitisation methods, toxicological risk assessment, exposure calculations.
Stability and compatibility
Real-time and accelerated stability, packaging compatibility, PAO determination, sensory and physicochemical monitoring.

Commonly confused in this field

There is NO CE marking on cosmetics; conformity is demonstrated through the PIF, the safety assessment and notification.
The responsible person must be established in the EU; unless the exporter arranges this, the product cannot be placed on the market.
Microbiological quality and preservative efficacy are different tests; a product that comes out clean may still have a weak preservative system.
The animal testing ban covers ingredients too; animal test data generated for another market creates a problem of use.
An SPF claim must be supported by measurement; a formulation change requires a new measurement.
A change of packaging may require the stability and compatibility studies to be repeated.

Which decisions these results support

The product information file and the safety assessment
Verification of the preservative system design
Substantiation of SPF and efficacy claims
Determining shelf life and the period after opening
Compliance with destination market restrictions for export

Structure of the Code

Published by: ISO
Serial number: 16217
Part: without partition

Codes in the library without release year is kept. The current version changes over time; If the year is specified in your specification, that version is taken as basis, if not specified, the most current version is applied.

Scope

Cosmetics Testing

Related Tests and Services

A separate test page based on this code has not yet been released. The code falls within the scope of the following test families.

Cosmetics Testing

Technical Requirements

Standard texts are copyright of the relevant organization; test condition, sample and acceptance criteria cannot be fitted here.

Technical requirements specific to your product, once we clarify the scope At offer stage shared in writing.

Relevant Product Groups and Legislation

This code is included in the standard tag of the product pages below.

These product pages carry notes for the following markets: European Union, United Kingdom, USA. Whether the standard is mandatory in the relevant market varies depending on the product group and the applicable legislation.

Regulations published with this code on the same product pages:

(AB) 2018/858Vehicle Type-Approval FrameworkApproval of motor vehicles and their components. Component and separate technical unit approval run under this framework; the E mark arises from it.
UNECEUNECE 1958 AgreementType-approval under component-specific UNECE regulations (e.g. R10 EMC, R30/R54 tyres, R43 glazing).
UNECE R10UNECE R10Electromagnetic compatibility approval for vehicles and their components.
2011/65/EURoHSRestriction of hazardous substances in electrical and electronic equipment.
2000/53/ATELVEnd-of-life vehicles. Sets heavy-metal restrictions and recoverability targets.
(EU) 2017/745MDRThe Medical Device Regulation. Classification (I, IIa, IIb, III), clinical evaluation, technical documentation and post-market surveillance obligations; the notified body's role grows as the class rises.
(EU) 2017/746IVDRThe In Vitro Diagnostic Medical Devices Regulation. In vitro diagnostic devices fall under this regulation instead of the MDR.
(AB) 2017/745 art. 33EUDAMEDThe European medical device database. From 28 May 2026, the actor registration, UDI/device, certificate and market surveillance modules are mandatory; placing on the market is not possible without a valid SRN.
2006/42/ATMachinery Directive (overlap)Relevant essential requirements also apply to medical devices that also qualify as machinery.
(EC) 1907/2006REACHRegistration, evaluation, authorisation and restriction of chemicals; SVHC notification.
(EU) 2023/1230Machinery RegulationReplaces 2006/42/EC and becomes mandatory on 20 January 2027 with no further transition period. Requires notified-body involvement for Annex I high-risk machinery.
2014/35/EULVDThe Low Voltage Directive. Governs electrical safety in the 50–1000 V AC range.
2014/30/EUEMCThe Electromagnetic Compatibility Directive. Emission and immunity are covered together.
2014/34/ABATEXEquipment and protective systems used in explosive atmospheres. The category and conformity route are determined by zone classification.
2000/14/ATNoise EmissionNoise emitted into the environment by outdoor equipment. Machinery within scope requires a sound-power-level declaration and marking.
2014/68/EUPEDThe Pressure Equipment Directive for pressurised parts; the category is determined by pressure and volume.
(EU) 2024/573F-GasRefrigerant type, GWP value and leak-tightness obligations for systems containing a refrigerant.
(AB) 547/2012Ecodesign (water pumps)Ecodesign requirements for water pumps. Sets minimum efficiency index and product-information requirements.
(AB) 2019/1781Ecodesign (electric motors)Efficiency class requirements for electric motors and variable-speed drives.
(AT) 1935/2004Food Contact MaterialsGeneral requirements for equipment in contact with food; material conformity is required for valves in food lines.
(AB) 2020/2184Drinking Water Contact ProductsHygiene requirements for materials in contact with water under the Drinking Water Directive.
2014/29/ABSimple Pressure VesselsA separate directive for series-produced simple pressure vessels; its scope must be distinguished from the PED.
2010/35/ABTransportable Pressure EquipmentThe pi mark and periodic inspection regime for transportable pressure equipment.
2009/48/ECToy SafetyThe Toy Safety Directive. Regulates mechanical, physical, flammability, chemical and electrical safety requirements together; a technical file and safety assessment are mandatory.
EN 62115Electrical toysSafety for electric toys; applies to mains-connected or battery-powered toys.
(AT) 1907/2006 Annex XVII item 51-52Phthalate RestrictionRestriction of certain phthalates in toys and childcare articles.
(EU) 2023/1542Batteries RegulationBattery obligations and a removability requirement for toys containing a battery.
(AB) 1007/2011Textile LabellingTextile fibre names and labelling. Declaration of fibre composition and regulation of the label language.
(AT) 1907/2006 Annex XVII item 43Azo Dye RestrictionRestriction of certain azo dyes in textiles in contact with skin.
(AB) 2019/1021PFAS / PFOA RestrictionRestriction of PFOA and its derivatives under the Persistent Organic Pollutants Regulation.
(EU) 2023/988GPSRThe General Product Safety Regulation. The safety framework for consumer products not covered by sector-specific legislation.
(EU) 2016/425Personal Protective Equipment (overlap)The PPE Regulation's scope and category are determined for textiles with a protective function.
(AB) 10/2011Plastics in Food ContactPlastic materials in contact with food. The list of authorised substances, and overall and specific migration limits.
(AT) 2023/2006Good Manufacturing PracticeGood manufacturing practice (GMP) for food-contact materials.
(AB) 2025/40Packaging and Packaging WasteThe Packaging and Packaging Waste Regulation. Recyclability, recycled-content and packaging-reduction obligations; replaces 94/62/EC.
(AB) 2022/1616Recycled PlasticRecycled plastic materials in contact with food.
(EU) 2024/3110Construction Products RegulationDeclaration of performance and CE marking for construction products. Most provisions apply from 8 January 2026; it progressively replaces (EU) 305/2011.
(AB) 305/2011CPR (transition)Continues to apply during the transition period for product groups where a new harmonised standard has not been published.
EN 13501-1Reaction-to-Fire ClassificationReaction-to-fire class for construction products; a mandatory item of the declaration of performance.
(EU) 2023/1115Deforestation (wood-based)A deforestation-free supply declaration for wood and derived construction materials.
(AT) 1223/2009Cosmetic Products RegulationThe Cosmetic Products Regulation. Appointing a responsible person, the product information file (PIF), the safety assessment (CPSR) and CPNP notification are mandatory; there is no product approval, and responsibility rests with the manufacturer.
(AT) 1223/2009 Annexes II-VIProhibited and Restricted SubstancesLists of prohibited substances, restricted substances, and permitted preservatives, colorants and UV filters.
(AT) 1223/2009 art. 16Nanomaterial NotificationA separate notification six months before placing on the market for products containing nanomaterials.
(AT) 1223/2009 art. 18Animal Testing BanA ban on animal testing of finished products and ingredients, and on placing animal-tested products on the market.
(AT) 178/2002General Food LawThe general principles of food law, traceability and food safety responsibility.
(AT) 852/2004Food HygieneHygiene rules for food businesses and the obligation for a HACCP-based system.
(AB) 1169/2011Food Information to ConsumersFood labelling; nutrition declaration, allergen information and origin information.
(AB) 2023/915ContaminantsMaximum levels of contaminants in food.
(AT) 396/2005Pesticide residuesMaximum residue limits in food of plant and animal origin.
(AT) 2073/2005Microbiological CriteriaMicrobiological criteria for foodstuffs.

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Frequently Asked Questions

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