Sunday, December 14, 2008

What is REACH? - Part 2

According to REACH, there are divided into three product categories.

Product Categories
1. Substance
Substance means a chemical element and its compound 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 effecting the stability of the substance or changing its composition.
(eg. Chromium Sulphate, ethanol)

2. Substance in Preparation
Preparatin means a mixture or solution composed of two or more substances.
(eg. Paint, Shoes cream)

3. Substance in Article
Article means an object which during production is given a special shape, surfce or design which determines its function to a greater degree than does its chemical composition.
(eg. Garment, Pen)

Manufacturer or Importer Obligation to register by different product categories
For product categories: #1 and #2
REGISTRATION required if:
- Substance or substance in Preparation >= 1 tonne per year per manufacturer or importer

For product categories: #3
REGISTRATION required if:
- substance in article is intented to be released under normal and foreseeable conditions of use, and
- substance in Article >= 1 tonne per year per manufacturer or importer

For substances in Artiles classified as SVHC,
NOTIFICATION is required if:
- substance >= 1 tonne per year, and
- substance present in those articles above a concentrtion of 0.1% weight by weight

Documents Requirement
Registration Dossier:
1. Technical Dossier
(for substances >= 1 t/y):
- Identification of registrant ans substance, manufacture and use, classification and lbelling (Safety Data Sheet), proposals for testing...etc

2. Chemical Safety Report (CSR)
(for substances >=10 t/y):
- Chemical Safety Assessment (CSA)
- If classified as SVHC, add:
* Exposure assessment
* Risk characterization

Documents for Notification
- Company identification
- Registration number (if available)
- Substance name and classification
- description of the uses of the substance in articles
- Tonnage range of the substance

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