Substance identification Sample Clauses

Substance identification. A 'substance' is defined under REACH as "a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition" (European Parliament and Council 2006). The concept of substance therefore goes beyond a pure chemical compound defined by a single molecular structure and includes different constituents such as impurities and additives. Each manufacturer or importer of substances is required under REACH to include in his technical dossier sufficient information in line with REACH Article 10 "Information to be submitted for general registration purposes", which enables the correct and unambiguous identification of the composition(s) of the substance that he intends to register. Annex VI Section 2 of REACH lists the set of information that shall be used to identify a substance (Table 3.1). Annex VI Section 2 explicitly states that the information provided for each substance shall be sufficient to enable the identification of each substance. Consequently, sufficient information relating to the identity of the substance, its composition(s) and the corresponding analytical data that enable the identity and composition verification needs to be included. Where additional identifiers/characterizers are needed to identify the substance, the information included according to this section needs to address them. REACH does not define the rules for identifying and naming substances; however, the "Guidance for identification and naming of substances under REACH and CLP" (ECHA 2016a), hereinafter referred to as the Guidance on Substance Identification (Figure 3.1), outlines the principles of substance identification under REACH and provides the elements that can be considered relevant for substance identity. Thus, it is fundamental for proper implementation REACH on aspects related to substance identification. The methodology to be used for identifying and naming a substance must be carefully selected depending on the substance type. Substances can be divided into three main groups: well-defined substances, well-defined substances that require additional identifiers, and substances that qualify as UVCB (Unknown or Variable composition, Complex reaction products or Biological materials) substances.