Substance

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. Non-polymeric substances (on their own or within a preparation) either manufactured or imported in quantities ≥ 1 Metric Ton per Year (MTPA) per EU manufacturer or EU importer are in scope. Polymers are exempt, however, monomers and other reactants making up ≥ 2% weight of the polymer must be (pre) registered by someone in your supply chain.

Preparation

A mixture or solution composed of two or more substances. In Lubrizol parlance, a preparation is often a product (e.g. Lubrizol 4980A). While there is no obligation to (pre) register preparations under REACH, each of the individual substances has to be (pre) registered by the EU manufacturer, EU importer or their ‘Only Rep’, unless the substance is exempt.

Article

An object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition. Any producer or importer of articles shall submit a (pre)registration if the following conditions are met:

The substance(s) is present in those articles over one tonne per producer or importer per year
The substance(s) is intended to be released under normal or reasonably foreseeable conditions of use (e.g. dyes in an article of clothing which can be released by washing).

Further, there are additional responsibilities for articles containing >0.1 w/w of an SVHC substance (see article 7(2)). It is the responsibility of the producer or the importer of an article to ensure compliance.

If there is no intended release, then (pre)registration is not required.

This document is provided for information purposes only and does not constitute legal advice. While every effort has been made to ensure the accuracy of the information contained herein, The Lubrizol Corporation cannot be held liable for any errors in or any reliance upon this information.

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Scope of Materials Affected by REACH