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CIRS Regulatory Updates Newsletter

Volume 6, June 2011

In This Issue
Updates about Chemical Control Laws in Asia
Latest Updates about Chemical Laws in EU
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Updates about Chemical Control Laws in Asia

Meeting Grace Ma - Technical Expert Behind CIRS


Ms Grace Ma is a senior regulatory affairs consultant and QSAR modeling specialist in CIRS China. She is now the head of China new chemical notification team in CIRS. She has significant experience with data evaluation, data gap analysis and dossier preparation for China REACH. She has prepared over 20 new chemical notification dossiers since the beginning of 2010, among which 15 have been accepted and approved. She had a M.S. degree in computational chemistry and QSAR modeling.

She has written a technical article about data requirements for new chemical notification in China this month. In this article, data source, data sharing, test agencies, test methods and minimum data requirements for each type of notification are discussed.

This article can be found here.

Korea and Japan Published the List of Harmonized Classifications in June 2011

Korea and Japan have expedited the process of publishing the list of harmonized classifications to facilitate GHS implementation.


On 28 June 2011, National Institute of Environmental Research (NIER) of South Korea published the amended list of GHS classification and labeling for "Toxic Chemical" regulated by TCCA. The list contains 618 chemicals. It will be mandatory for companies to use the GHS classification in the list to prepare SDS and chemical label from 1 July 2011.

The list can be found here.

On 1 June 2011, National Institute of Technology and Evaluation (NITE) of Japan published GHS classifications for another 370 substances. Up to date, there are 2,231 substances on the list of GHS classifications, which are not mandatory. However, it is recommended that companies use that classification to prepare their SDS and label in accordance with Japanese technical standards.

The full list can be found here.

More info about GHS in Korea, Japan and China can be found here.




Latest Updates about Chemical Laws in EU

SVHC Candidate List and REACH Authorization List Updated in June

On 20 June 2011, ECHA has added another 7 substances into SVHC candidate list to make the total number of substances on SVHC candidate list reach 53.

Besides, ECHA has recommended another 13 substances for inclusion in the annex XIV of REACH ("Authorization list") on 15 June 2011. This is the third time ECHA makes such recommendation. Up to date, ECHA has recommended 28 substances for inclusion in Annex XIV and none of the substances are included on authorization list yet. Those substances on authorization list will not be allowed to be used, placed on the market or imported into the EU after a date to be set unless the company is granted an authorization.

For more info about the update history of SVHC candidate list and obligations associated with candidate SVHCs, please click here.

More info about the update history of authorization list and REACH authorization process can be found here.

RoSH 2 Came Into Force on 27 May 2011

Five years after the introduction of RoHS, a new European Union RoHS Directive (known as RoHS2) was adopted by the European Council on 27 May 2011.  The new Member State RoHS2 Regulations will take effect 18 months after its adoption. However, many companies are not aware of the new RoHS2 scope, the obligations of distributors and the associated sample testing requirements.

More info about the main changes of RoHS2 can be found here.