Page 28 - CITDBooklet

Guide on the application of REACH Regulation

REACH defines article as mentioned below:

■ Article: “means 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”

[A shirt is an article as it has definite shape, surface and design. It is meant to cover, protect
the wearers’ body and for aesthetic / fashion purpose. It does not matter whether shirt is
made of cotton, nylon, polyester, rayon, wool etc.]

Thus textile garments, leather shoes, belts, garments, batteries, electronic goods,
household articles, handicrafts are few examples of Articles.

Care should be exercised while defining an article - particularly differentiating
between an “article containing substance for intended release” and “container
containing substance for intended release”

[A scented eraser is an ‘article containing substance intended for release’ viz. the
scent/perfume. On the other hand a scent/perfume bottle containing perfume is a
container containing perfume. This is not an article. Here the perfume is a substance
and needs to be registered.]

Applicability of REACH to articles is subject to two main conditions and both conditions
need to be met with simultaneously.

Article 7.1 of REACH [Registration and notification of substances in articles]:

Registration of Substances in Articles

Any producer or importer of articles must submit a registration to the Agency for any
substances contained in those articles, if both the following conditions are met

■ The substance is present in those articles, in quantities over 1 tonne per producer or
importer per year.

■ The substance is intended to be released under normal or reasonably foreseeable
conditions of use.

It is important to note that amounts intended to be released as well as amounts not
intended to be released, but present in article, need be jointly taken into account for
purpose of tonnage bands for registration if above conditions apply.

And even if the above criteria are met, the substance does not have to be registered
if it has been registered for that use by up-stream manufacturer.

Notification of Substances in Articles

Article 7.2: Any producer or importer of articles shall notify the Agency, in accordance
with para 4 of this article, if a substance meets the criteria in Article 57 [SVHC = i.e.
substance is CMR, PBT, vPvB or endocrine disruptor] and is identified in accordance
with Article 59(1), if both conditions are met

■ The substance is present in those articles in quantities totaling over 1 tonne per
producer or importer per year and

■ The substance is present in those articles above a concentration of 0.1% weight
by weight

Note: Substance concentration threshold of 0.1% applies to the article as produced
or imported

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