Heavy Metal Analysis — EN 16711 / ISO 17072 / EN 71-3 / ICP-MS · Cosmetics Testing

What Is Heavy Metals?

Heavy metal analysis is the determination of the concentration of elements such as lead, cadmium, mercury, arsenic, chromium and nickel in the sample. Measurement is done by ICP-OES or ICP-MS; The decisive factor is the sample preparation step and this step varies depending on the matrix. IN TEXTILES artificial sweat extractable (EN 16711-2) or total (EN 16711-1) metal is measured. IN SKIN ISO 17072 makes the same distinction. IN TOYS EN 71-3 yields metal that migrates from mouthable materials under stomach acid-like conditions. In FOOD, the total element content is determined, and in ENVIRONMENT samples, the concentration in water, soil and waste is determined.

Purpose of Heavy Metals

The aim is to determine whether the risk posed by the heavy metals contained in the product through skin contact, ingestion or release into the environment remains within the limits of the legislation.

Which Products Is Heavy Metals Applied To?

Dyed and printed textiles, baby and children's clothing
Leather shoes, bags and clothing
Toys and child care items
Food products and food contact materials
cosmetic products
Wastewater, drinking water, soil and waste samples

In Which Sectors Is Heavy Metals Used?

TextilesRetailConsumer ProductsLeatherFootwearToyFoodCosmeticsEnvironment

Standards Related to Heavy Metals

TS EN 16711-1 (textile — total metal content, microwave decomposition)
TS EN 16711-2 (tekstil — yapay asidik terle ekstrakte edilebilir metaller)
TS EN 16711-3 (textile — lead and cadmium restriction)
TS EN ISO 17072-1 / -2 (skin — extractable and total metal)
TS EN 71-3 (toy — migration of certain elements)
TS EN 1811 (nickel release in metal accessories)
TS EN 13804 / 13805 (food — element determination and pressure solubilization)
TS EN ISO 17294-2 (water — element determination by ICP-MS)
TS EN 13657 / ISO 11466 (soil and waste — solubilization)

Heavy Metals Conditions

Textiles and leather: Extraction with acidic sweat solution or acid solubilization in microwave
Toy: Migration test in dilute hydrochloric acid medium defined in EN 71-3
food and environment: Pressurized microwave solubilization; direct measurement in water samples
Measurement: ICP-OES or ICP-MS; cold steam technique if necessary for mercury
Unit: mg/kg veya µg/L

Equipment for Heavy Metals

ICP-OES / ICP-MS
Microwave digestion system
Cold vapor/hydride system (for mercury and arsenic)
Water bath and shaker
Analytical balance and mill

Sample Requirements for Heavy Metals

Separate sample for each colour, component and matrix
Metal accessories should be evaluated separately
Each material category in the toy is a separate sample
To avoid metal contamination, the sample should not be cut with metal tools.
Water samples should be sent in a suitable container and protected with acid if necessary.

Duration of Heavy Metals

Sample preparation (extraction or solubilization) and ICP measurement determine the time; Results are usually available within a few business days. As the number of elements and matrix complexity increases, the time increases.

Heavy Metals Procedure

1The sample is separated by matrix and component, ground or cut, and weighed.
2In extractable/migration analysis, it is extracted with the solution defined in the standard.
3In total analysis, it is solubilized with acid in the microwave.
4The solution is filtered and diluted.
5Internal standard is added and ICP and elemental concentrations are measured.
6The result is calculated in the unit appropriate to the matrix.

Heavy Metals Acceptance Criteria

Acceptance criteria vary depending on the matrix and target market: in textiles and leather, REACH Annex The limit to be applied is determined according to the scope of the product and is confirmed from the current text.

Evaluation of Results

Total, extractable and migration results are not interchangeable: in a product with a high total content, the extractable amount may remain below the limit. Which one the specification requires and which limit it is compared to is clearly stated in the report.

Heavy Metals Report

Sample description, matrix and analyzed components
Applied standard and sample preparation method
Result and limit of quantification for each element
Knowledge of measurement technique and internal standards
Compared limit value and its source

Accreditation

EUROLAB holds internationally recognised accreditation obtained from accreditation bodies party to the IAF and ILAC multilateral recognition arrangements, under ISO/IEC 17025 for laboratory testing, ISO/IEC 17020 for inspection and surveillance, and ISO/IEC 17021-1 and ISO/IEC 17065 for system and product certification. This chain ensures the reports and certificates issued are accepted worldwide.

Whether this test can be offered within accredited scope depends on your product and the standard applied; since accreditation is method-based, the scope is confirmed in writing at the quotation stage.

Scope and authorisations

Related Regulations

(EC) 1907/2006 REACH Annex XVII
2009/48/EC Toy Safety Directive
(EU) Regulation 2023/915 on Maximum Levels of Contaminants in Food
(EC) 1223/2009 Cosmetic Products Regulation

Kozmetik Testleri — What Does This Testing Field Cover?

The section below describes the field that the Heavy Metals test belongs to; the conditions and acceptance criteria of this particular test are given in the sections above. The scope specific to your product is confirmed in writing 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

Related Tests

Frequently Asked Questions About Heavy Metals

Is nickel included in this scope?

Nickel release is a separate test (EN 1811) and applies to metal parts in direct prolonged contact with the skin. Accessories such as zippers, snaps and buttons are evaluated separately from fabric or leather.

Should I ask for total or extractable?

If skin contact risk is assessed, extractable method is the right question. Some legislative provisions, such as the lead and cadmium restriction, are defined in terms of total content; Whatever your specification requires is applied.

Can the textile result be used for toys?

Not available. EN 71-3 measures metal migrating under stomach acid-like conditions and defines different limits depending on the material category. The result of sweat extraction taken for textile does not indicate the suitability of the toy.

Is the total chrome result the same as chrome VI?

It is not. Heavy metal analysis gives total chromium and this alone is not a non-compliance. Hexavalent chromium (Cr VI) is restricted in leather and is measured separately by ISO 17075.