SUNIVO REACH Newsletter(8)
ISSUE 8-8th May 2009
If you failed to meet the pre-registration deadline of 1 Dec. 2008 for your substances, you still can pass through us to continue your business in Europe. And our pre-registration is totally free.
SUNIVO has already created experts team and pre-registered 1405 substances to ECHA. This means, SUNIVO is legally authorized importing and selling these products in Europe. We have taken part in the consortium to discuss within SIEF. The sharing of data is in order to reduce costs for companies.
From the 6th and 7th issue you can have an overview of Chemical Safety Assessment Process. And CSA is required when a substance is manufactured or imported at 10 tonnes or more per year. This issue we will focus on Hazard Assessment, which is the beginning of CSA.
Hazard Assessment
The information collected or generated in the CSA will be used for classification and labelling, PBT/vPvB assessment and for deriving threshold or non-threshold levels for human health and the environment.
In general, information gathering consists of the following steps:
● Gather and share existing information;
● Consider information requirements and further information needs;
● Identify information gaps;
● Generate new data / propose testing strategy
Different types of information may need to be collected or generated for conducting a CSA. Such information may be obtained from a variety of sources such as in-house data of companies, or by sharing information with other manufacturers and importers of the substance by cooperation in a substance information exchange forum (SIEF).
The hazard assessment shall be conducted based on all available information, and on the basis of the information required in accordance with Annexes VI-XI of REACH.
Alternative information may be available or generated that can be used instead of in-vivo (animal) test data. Such information includes results of in-vitro tests and information obtained by use of non-testing methods (incl. Quantitative Structure Activity Relationships (QSAR), Structure Activity Relationships (SAR), read-across, categorisation of substances, etc.). Separate guidance is available on integrated test strategies (ITS) in Part B and Chapter R.7.
In some cases, minimal or negligible exposure and risk can be expected for certain populations or environmental compartments. When such low-risk exposure situations exist, waiving of hazard data may be possible. Specific guidance on this issue is available in Chapter R.5. Additional information may be needed as a result of the outcome of the exposure estimation and risk characterisation, so called exposure-triggered testing. If risks to man or the environment are indicated in the CSA, additional data may need to be collected or generated in order to refine the hazard information. At any particular stage, proposals for further testing may be developed so that the necessary information is obtained. Before proposing additional animal testing, use of alternative methods and all other options must be considered.
SUNIVO Recommendation: Dangerous substances and preparations must be classified and labelled according to Directives 67/548/EEC and 1999/45/EC respectively. It should be noted that these Directives will be replaced in the near future with an EU Regulation for Classification, Labelling and Packaging of Substances and Mixtures (CLP) implementing the Globally Harmonized System in the EU.
Sources: European Chemicals Agency (ECHA)
SUNIVO is involved in the many consortia in order to prepare SIEF organization.
If you have any issue facing with REACH or trade in Europe,
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