Nitrosamine | EUROLAB

What Is Nitrosamines?

N-nitrosamines are compounds formed by the reaction of secondary amines with nitrosating agents. They are not deliberately added to cosmetics; they can arise as a raw material impurity or form via reaction within the formulation. Analysis is generally done by LC-MS/MS.

Purpose of Nitrosamines

The purpose is to determine whether nitrosamines have formed in the product. EU 1223/2009 lists nitrosamines among prohibited substances and restricts raw materials that could be used together with nitrosating agents.

Which Products Is Nitrosamines Applied To?

Cosmetics with raw materials containing secondary amines
Shampoo and bubble bath products
Rubber pacifiers, teats and balloons (separate regulation)
Cutting fluids and personal care products

In Which Sectors Is Nitrosamines Used?

CosmeticsPersonal CareRetailChemistry

Standards Related to Nitrosamines

EU 1223/2009 Annex II (prohibited substances — nitrosamines)
EN 12868 (child care articles — release of N-nitrosamines from elastomer)
EU 10/2011 (food-contact materials — where applicable)
Cosmetics Regulation (Türkiye)

Nitrosamines Conditions

Method: LC-MS/MS; verification by GC-MS if necessary
Target compounds: NDELA and other N-nitrosamines as defined in the specification
Sample preparation: Extraction and purification with solid phase
Quality control: Matrix spiked recovery and blank sample

Equipment for Nitrosamines

LC-MS/MS system
Solid-phase extraction setup
Analytical balance and concentration system
Controlled storage conditions

Sample Requirements for Nitrosamines

The product must be sent in its original, unopened packaging.
Batch number, manufacturing and expiry dates must be stated.
The ingredients list (INCI) and formulation information, if any, must be shared.
The required quantity varies by number of analyses; confirmation must be obtained before shipment.
Light- and temperature-sensitive products must be transported under suitable conditions.

Duration of Nitrosamines

The analysis is generally completed within a few working days.

Nitrosamines Procedure

1The product's formulation and nitrosamine formation risk are assessed.
2The sample is weighed and extracted with a suitable solvent.
3The extract is cleaned up with a solid-phase column.
4Concentration is performed if required.
5Measurement is made by LC-MS/MS.
6Detected compounds are confirmed with confirmation transitions.
7The result is reported.

Nitrosamines Acceptance Criteria

The acceptance criterion for cosmetic products does not come from a single test but from the product's safety assessment report and the regulation. EU 1223/2009 and the Cosmetics Regulation define prohibited and restricted substances, microbiological expectations, and labelling requirements; this page therefore does not give a fixed limit.

Evaluation of Results

Nitrosamines are prohibited substances in cosmetics; if detected, the source (raw material impurity or in-formulation formation) is investigated and the formulation reviewed. The decision is made within the product safety assessment.

Nitrosamines Report

Product name, batch number, and packaging information
Sample receipt date and storage conditions
Method applied and reference standard
Test conditions and conditioning, if any
Measurement results and units
Measurement uncertainty (if requested)
A statement that the result applies only to the specimen submitted for testing

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

EU 1223/2009 Cosmetic Products Regulation
Cosmetics Regulation (Türkiye)
Cosmetic Product Safety Report (CPSR) requirements
ISO 22716 (good manufacturing practice in cosmetics)

Kozmetik Testleri — What Does This Testing Field Cover?

The section below describes the field that the Nitrosamines 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 Nitrosamines

If nitrosamine is not added to the product, how is it found?

It is not deliberately added. When a raw material containing a secondary amine and a nitrosating component are present in the same formulation, it can form via reaction over the shelf life; the analysis is therefore generally repeated at the end of stability as well.

Which raw materials are risky?

Surfactants bearing a secondary amine structure and certain emulsifiers are risky. The regulation stipulates that these substances not be used together with nitrosating components.