About the Standard
Scope title: specified and non-specified micro-organisms in cosmetics
ISO 18415 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.
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Kozmetik Testleri — What Does This Testing Field Cover?
The section below describes the field that code ISO 18415 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 Inspection comes afterwards and asks for the file; if the file is incomplete the product is withdrawn from the market.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
- 18415
- 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
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.
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:
- (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.
- (EC) 1907/2006REACHRegistration, evaluation, authorisation and restriction of chemicals; SVHC notification.
- (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.
Related Standards
Frequently Asked Questions
Is this standard mandatory for my product?
Whether it is mandatory depends on the product group, the target market and the applicable legislation. Once you tell us your product and market, we clarify in writing whether this standard is required.
How long does the test process take?
Duration depends on the scope of the standard, the number of specimens and current capacity. The exact duration is shared, together with the specimen and scope details, at the quote stage.
Do you issue certification against this standard?
Which activity is carried out under which accreditation scope is separately confirmed at the application stage. Up-to-date scope information is published on our corporate page.
What happens if the standard I need is not here?
The library is based on a continuously growing inventory. If you cannot find the code you are looking for, you can send it through the quote form; we will assess the relevant scope and get back to you.