REACH requires manufacturers, importers and only representatives registering a substance to provide extensive and correct information on substance identity in the registration dossier. The European Chemicals Agency (“ECHA”) has indicated in its annual progress reports on evaluation under REACH that not all registrants have been providing full substance identification information. ECHA has therefore recently provided further guidance on common pitfalls when completing a registration dossier.
In order to improve the quality of information in registration dossiers, ECHA has developed IT screening methods that can be used to screen its whole database. ECHA has now conducted its first IT-based screening of all REACH registrations concerning the required information elements for substance identity. At the beginning of April, ECHA sent 350 informal letters concerning 309 substances to 449 registrants whose dossiers were picked up by the screening. Legally binding measures such as compliance checks will follow if the recipients do not address the issues raised.
ECHA has identified ten main shortfalls with the dossiers and the annex to the information letters provides a useful guide for future registrants on how to compile a REACH-compliant dossier, particularly with regard to substance identity.
Missing concentration ranges
The lower and upper limit of the concentration ranges for all constituents, impurities and additives, as well as their typical concentrations, must be provided. Values must be representative for the substance as manufactured or imported by the registrant and theoretical values should not be reported.
Typical concentration outside concentration range
The typical concentration for every constituent, additive and impurity should fall inside the corresponding concentration range. An inconsistent typical concentration would cast doubt on the reliability of the composition of the substance. Values must be representative for the substance as manufactured or imported and theoretical values should not be reported.
No constituents reported
The composition of each substance must be described using at least one constituent and information on the concentration range and the typical concentration must be provided. Further constituents, impurities and additives should be specified as appropriate.
Low or ambiguous degree of purity for well-defined substances
Registrants should ensure that the purity indicated accurately describes the substance as manufactured/imported. A low or very wide degree of purity range indicates great variability in the composition of the substance and raises questions about whether the dossier covers a single substance or various substances. Justification should be provided if the purity range is low or very wide.
Unidentified constituent or impurity present at significant concentration limits
The constituents of well-defined substances are expected to be present at =80% (mono-constituent) or =10 – <80% (multi-constituent) and should be identified completely by substance identifiers, a chemical name, and molecular and structural information. Impurities present at a concentration =1% should be identified by at least one of: chemical name, CAS-number and EC-number and/or molecular formula.
For UVCB substances, all known constituents and all constituents present at concentrations = 10% should be individually identified by substance identifiers, a chemical name, and molecular and structural information. The terms ‘constituents’ and ‘impurities’ are not regarded as relevant for UVCB substances, and all constituents should be reported as ‘constituents’. Unknown constituents should be identified as far as possible by a generic description of their chemical nature.
In all cases, impurities (or ‘constituents’ for UVCB substances) that are relevant for classification and/or PBT assessment should always be specified, whatever their concentration.
Well-defined substances with inconsistency between degree of purity and constituent concentrations
For well-defined substances, the degree of purity should correspond to the overall concentration range of the constituents:
The sum of the maximum concentrations of all the constituents should never be below the maximum degree of purity. Similarly, the sum of the minimum concentrations of all the constituents should never be above the minimum degree of purity.
A constituent should not be present at a concentration higher than the maximum degree of purity.
The maximum concentration of each constituent added to the minimum concentrations of the remaining constituents must not be higher than the maximum degree of purity of that composition.
Well-defined substances with inconsistency between degree of purity and impurity concentrations
For well-defined substances, the impurities and the degree of purity should together add up to 100% of the composition:
The sum of the minimum concentrations of the impurities should be consistent with the maximum degree of purity. Similarly, the sum of the maximum concentrations of the impurities should be consistent with the minimum degree of purity. These two values are consistent if their sum does not exceed 100%.
An impurity should not be present at a concentration which is not consistent with the minimum degree of purity.
The maximum concentration of each impurity added to the minimum concentrations of the remaining impurities should be consistent with the indicated minimum degree of purity. The maximum concentration level of an impurity added to the minimum concentrations of the remaining impurities and to the minimum purity level of the substance cannot exceed 100%.
No spectral and analytical data provided
REACH requires registrants to include specific spectral and analytical data in the dossier. Analytical data are a crucial part of the registration dossier in order to verify the composition and therefore the identity of the substance.
Analytical data must be generated on the substance as manufactured/imported. Data copied from other EU manufacturers/importers, generated on a sample provided from a different manufacturer/importer, or generated on a different substance are not acceptable. Even if a registered substance is being imported as part of a mixture, analytical information on each substance present in the mixture are required.
Additives without stabilising function
Only those substances that have been intentionally added to chemically stabilise a substance are regarded as additives under REACH and therefore considered to be an intrinsic part of the substance. A substance intentionally added to provide a technical function other than stabilisation is not part of the substance composition and should not be reported as an additive (although it may need separate registration). Only additives with a stabilisation function should be taken into account when calculating the mass balance.
Inconsistent identifiers of constituents, impurities and additives.
In order to unmistakeably identify the registered substance, a set of identifiers needs to be provided in the registration dossier. These identifiers may originate from the EC inventory or external databases like Chemical Abstracts and/or can be generated by the registrant on the basis of chemical structure and following established conventions. The registrant should ensure that all identifiers provided for a reference substance in the dossier are consistent and lead to the same molecular structure.
ECHA will also organize a webinar in the very near future on how to improve dossiers with regard to substance identity information which will be made publicly available.