Nanomaterials require early identification because they can affect an ingredient’s regulatory status, the safety assessment, labelling and the timeline before market placement.
Identifying the nano form of a material
A raw-material trade name often does not show whether an ingredient is present in nano form. Information on identity, particle size and distribution, shape, surface properties, solubility and other characteristics relevant to the applicable definition may be needed.
A supplier statement should identify the specific raw material and specification version. A general assertion that a material contains no nanoparticles, without an evidential basis, is insufficient for expert assessment.
Checking authorisation and conditions of use
Ingredient status is checked against the Regulation’s Annexes and applicable scientific opinions. Certain functions and nano forms may be subject to specific purity, coating, concentration or application conditions.
Permission for a non-nano form does not automatically permit a nano form. The exact supplier material must be connected with the relevant regulatory entry.
Practical checkpoint
Every conclusion should be linked to the exact formula, document and market-material version. This makes it possible to demonstrate which evidence supported the regulatory decision.
Additional notification before market placement
For products containing certain nanomaterials, the Regulation requires additional information to be submitted before market placement, with particular rules for materials already governed by the Annexes.
These timelines need to be built into launch planning. Late discovery of a nano form may delay a project and require additional data, assessment or reformulation.
Safety assessment of the nano form
The CPSR should consider material properties that cannot safely be inferred from data for the conventional form of the same chemical substance. Exposure route, aggregation, surface treatment and behaviour in the finished formula may matter.
The documentation package should allow the assessor to connect toxicological evidence with the material actually used. Inadequate characterisation can prevent a defensible safety conclusion.
Labelling and change control
Where applicable, the ingredient name is followed by the word nano in brackets. The INCI list, PIF, CPSR and CPNP need to describe the same material form.
A supplier or raw-material manufacturing change may alter particle characteristics. Change control should therefore include a fresh nano-status and obligation check.
Frequently asked questions
Is every very fine powder automatically a nanomaterial?
No. Status is determined under the applicable legal definition using appropriate material information.
Is adding the word nano to the INCI list sufficient?
No. Labelling is only one obligation; authorisation, safety and notification must also be assessed.
Can a supplier change affect nano status?
Yes. Material characteristics may differ and the documentation must be reviewed again.
Official sources and further reading
This article is for general information and does not replace an assessment of the specific product, formula and supply chain. Legislation and guidance may change after publication.