Registering a substance under the REACH Regulation is not just a documentary exercise: it is a technical process in which correct substance identification is critical. Incomplete or poorly justified characterisation may lead to ECHA comments, delays in the registration process, or even the invalidation of the dossier.
In this context, analytical testing is not a mere formality, but the foundation on which the entire regulatory strategy is built.
REACH requires robust demonstration of:
• Chemical structure
• Composition
• Degree of purity
• Profile of relevant impurities
All of this must be based on analytical data obtained from the substance as manufactured or imported, ensuring that the information accurately reflects the material placed on the market.
The first step in characterisation is to validate chemical identity through spectroscopic techniques. These provide a unique “fingerprint” of the substance.
The most commonly used include:
Combined, these techniques provide strong evidence of molecular structure, a key element within the REACH dossier.
Beyond identity, REACH requires a clear understanding of what the substance actually contains.
Chromatographic techniques such as GC or HPLC allow:
This aspect is particularly critical, as poor definition of composition may compromise correct substance identification or its toxicological profile.
For inorganic substances, UVCBs or complex compositions, standard characterisation is often not sufficient.
In these cases, it is common to rely on techniques such as:
The key is not to apply more techniques, but to select the appropriate ones depending on the nature of the substance and the regulatory approach.
One of the most common mistakes does not occur in the laboratory, but in the interpretation of results.
Analytical data must:
This is where regulatory expertise makes the difference between an accepted dossier and one that is challenged.
Analytical characterisation is not an isolated requirement under REACH: it is the pillar supporting the entire registration. Addressing it strategically helps reduce risks, optimise costs and accelerate the process.
At ServiREACH, we support companies in going beyond analytical data by integrating:
