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Päivi Jokiniemi and Paul Trouth
Article related to: REACH
Accurate substance identification key to successful registration
Correct substance identity matters for a successful REACH registration. It also enables the different REACH processes to function in a smooth and timely manner. What are the key issues when considering the identity of your substance and how can you describe your substance identity better?
Each substance that needs to be registered under REACH or notified under CLP has to be properly identified. Unambiguous substance identification shows clearly which substance is being registered and makes it possible to decide if two substances are the same. This is particularly important because registrants of the same substance have to share data to avoid unnecessary testing on animals and reduce costs. Only accurate substance identification can guarantee that potential registrants can share data and submit their registrations jointly, following the 'one substance, one registration' principle.
Clear and accurate substance identification is also important when:
- making read-across proposals, so as to avoid animal testing;
- classifying and labelling a substance; and
- ECHA is adding new substances to the Authorisation and Restriction lists.
Clear substance identification is not only a pre-requisite for successful registration – it also decreases the processing time of the registration and minimises the need for ECHA to request further information from you during the different REACH processes.
How to describe substance identity
The REACH Regulation lists the substance identification information that needs to be included in the registration dossier.
- Firstly, the dossier has to contain the name or another identifier of the substance. This could be, for example, the IUPAC name, EINECS or ELINCS number, or CAS number.
- Secondly, it must include information related to the molecular and structural formula of the substance.
- Finally, the composition of the substance needs to be described. This includes, for example, the concentration and structure of the main constituent(s), the degree of purity and the number of impurities.
Some substances, for example, substances that are of unknown or variable composition, complex reaction products or biological materials (UVCBs), need further information. For example, starting materials and reaction types are often used to generate a name for these substances.
If it is not possible to include some of this information in the registration dossier, the reasons for that should be clearly described. This will make the substance identification more transparent.
What are the common problems?
Having consistent information in the dossier creates a foundation for reliable substance identification. Therefore, it is important to make sure that all identifiers in the dossier refer to the same substance and that the information is presented in a consistent way throughout the whole dossier. If, for example, the name of the substance includes three main constituents, the dossier should also include three main constituent blocks.
In addition to consistency, it is essential that enough information is given to describe the substance. It is difficult to determine the identity of the substance if, for example, the following elements are missing:
- IUPAC names for the substances and its constituents;
- structural formulae;
- purity of the substance;
- concentration ranges for the constituents;
- spectral data and quantitative analysis.
When describing the substance, the use of specific abbreviations, trade names and industry specific language should be avoided, or should only be included as complementary information.
Analytical information about the substance acts as confirmation of the substance identity.
Finally, it is important to remember that one registration can only cover one substance. To verify that this is the case, the substance must be unambiguously identified.
Need more support?
ECHA's website contains the Guidance for identification and naming of substances under REACH and CLP. In addition to explaining how substance identification needs to be done, it gives practical examples to clarify the requirements. There is also a Q&A page on substance identification.
Concerns and issues around substance identity are also discussed with the Member States and ECHA's stakeholders. At the beginning of October 2014, ECHA organised a workshop on substance identity and substance sameness. The aim of the workshop was to develop generic criteria and methodologies for determining substance sameness. The proceedings from the workshop will be published on ECHA's website.
The substance identity web pages are currently being updated and the new and improved pages will be published in early 2015.
Screening campaign to improve substance identity
ECHA carried out a substance identity screening campaign in spring 2014 to detect dossiers with substance identity issues. As a result of the screening, 1 350 letters were sent to 449 registrants concerning 309 substances. The registrants were given three months to improve the quality of their dossiers. More than 80 % of the affected dossiers have been updated or will be updated shortly. ECHA has commenced legally binding compliance checks on dossiers from registrants who did not update their dossiers.
Text by Päivi Jokiniemi
Top image: Fotolia
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
Committee for Socio-Economic
18-22 March (tentative)
Management Board meeting:
Member State Committee:
13-17 May (tentative)