Substance identification is a process by which the identity of the substance is established.
Accurate identification of a substance is a pre-requisite to most REACH, CLP and biocides processes. In particular, it enables joint REACH registrations to be prepared efficiently and correctly, and ensures that test data is appropriate for the substance registered under REACH. This leads to a robust hazard and risk assessment of the registered substance.
The correct identification of a substance will also enable:
- The sharing of information to prevent unnecessary animal testing and costs;
- The use of test data across companies and read-across within a group of substances;
- The assessment of whether a substance is included in the Authorisation List, the list of restrictions or has a harmonised classification and labelling.
Typically the identity of a substance can be described by:
- a chemical name, for example, benzene;
- a number, for example, EC number 200-753-7, and
- a chemical composition, for example, >99 % benzene and <1% toluene. The composition is determined by chemical analysis.
Regulatory processes where substance identification plays a key role are:
Companies planning to register a non-phase-in substance or a phase-in substance they have not pre-registered, have a duty to inquire from ECHA whether a registration has already been submitted for that substance.
Accurate identification of a substance is important in the inquiry process to ensure that the companies planning to register or that have already registered the same substance are correctly put into contact with one another. This ensures that data is shared appropriately.
Registration is based on the "one substance, one registration" principle. This means that manufacturers and importers of the same substance are obligated to submit their registration jointly.
Accurate identification of a substance is important in the registration process to ensure that registrants of the same substance belong to the same joint registration. It also sets the scope of the joint registration as it facilitates the development of the substance identity profile (SIP) and the reporting of the boundary composition.
Substances intended to be used for product and process orientated research and development (PPORD) can be exempted from the obligation of registration for a period of five years. Companies that want to benefit from this exemption must submit a PPORD notification to ECHA.
Accurate identification of a substance is important in the PPORD exemption process to understand, for example, what is planned to be covered by the exemption.
ECHA and the Member States evaluate the information submitted by companies to examine the quality of the registration dossiers and testing proposals. In addition, evaluation aims to clarify if a given substance constitutes a risk to human health or the environment.
Accurate identification of a substance is important for the evaluation processes as it allows ECHA and the Member States to determine that each registration covers only one substance and that the test data is appropriate for that substance. The substance identity profile (SIP) and the reporting of the boundary composition ensure transparency in terms of the relevance of the test data.
Companies should assess whether their substance is included in the Authorisation List, the list of restrictions or has a harmonised classification and labelling. This can only be done accurately if the substance is correctly identified.
The Biocidal Products Regulation (BPR) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria, by the action of the active substances contained in the biocidal product.
Accurate identification of a biocidal substance ensures that test data is appropriate for the substance and that it is shared correctly. This leads to a robust hazard and risk assessment of the biocidal substance.