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2016 Global Chemical Regulations Outlook

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Many areas and countries updated existed chemical regulations or published new chemical regulations in 2015. CIRS has compiled a summary and outlook of all those updated/published chemical regulations around the world. This article will be a useful global regulation summary for your reference.

Regulations for Chemical Registration


1. Europe published Data-Sharing Regulation, which will come into force at the end of January 2016. LRs will have to itemise the structure of the data fee, administration fee. Besides, the reimbursement mechanism will also be provided.

2. Newer edition of REACH-IT will be released in the spring in 2016. Joint submission will be mandatory for all the chemical substances. There will be no individual submission since then.

3. For EU F-GAS regulation, it is required that the annual report for 2015 F-GAS quota be submitted before March 2016. The quota for 2017 can be applied in the middle of 2016.


TSCA reform bill has been passed in 2015. It is anticipated that the new TSCA will be published in 2016 once the president signs. The reform will lead to a significant change in the chemical management in US since 1976.


1. The registration of the first batch of existing chemical substances under K-REACH will keep progressing, especially for the substances with elected LRs. Progress will be made in the aspect of data-sharing policies in 2016.

2. Enterprises that manufacture, import or sell new chemical substances or existing chemical substances (with an amount of larger than one ton per year) will have to submit the annual report before 30 June 2016 in accordance with K-REACH.


DIW announced that an inventory of existing chemical substance will be built, which will be similar to REACH. If it progresses smoothly, the substances that are not notified before 31 Dec 2016 will not be listed into the inventory. All the substances that are not listed in the existing chemical inventory will be treated as new chemical substances. Enterprises located outside of Thailand can appoint an OR to do the registration.


MEP Order 7

1. The IECSC Inquiry fee will be 5000 RMB per substance, starting from 1 Jan 2016.

2. The 2015 annual report for simplified notification and (priority) hazardous chemical substances under typical notification should be submitted before 1 Feb 2016.

3. The documents of typical notification can only be submitted through notification software starting from 1 April 2016.

4. It is anticipated that the “Guidance” will be published in the first half of 2016. The endpoint change should be paid attention by enterprises. Risk assessment should be written according to the template provided in the “Guidance”.


On 31 March 2016, the pre-registration of existing chemical substance will be ended. All manufacturers and importers should finish the related work before this time. At the meantime, new chemical substance notification will be started since TCSCA will come into force by then.

Global GHS


The Catalog of Hazardous Chemicals Substances

“The Catalog of Hazardous Chemical Substance” was published and came into force on 1 May 2015. There are 2828 entries included in the Catalog. “The Guidance for the Catalog (Trial)” was published on 2 Sep 2015. “Guidance (Trial)” provided the recommended classification with some introduction of specific situation.

For substances that are listed in the Catalog, in 2016, enterprises should pay attention to the following contents: registration of hazchem, operation licence, hazchem storage, SDS and labeling. For substances that are NOT listed in the Catalog, enterprises should pay attention to the aspect of hazchem identification, SDS and labeling.

Environmental Administration Registration of Hazardous Chemical Substance (MEP Order 22)

The revision work of MEP Order 22 has been started in 2015. It is anticipated that the new version will be implemented in 2016. Main changes are as follows: registration certificate will be replaced by record; qualitative risk assessment will be replaced by quantitative risk assessment.


Taiwan has implemented the newly revised GHS classification standard CNS15030 since 1 Jan 2016. Except for the 3171 hazardous chemical that were published before, all the other hazardous chemicals will apply for the new standard since 1 Jan 2016. There will be one year grace period for enterprises (1 Jan 2016 to 31 Dec 2016). The published GHS classification for 6000 hazardous substances is NOT mandatory.


Starting from 1 June 2015, it is stipulated that all the chemical including mixtures should comply with the requirement of CLP. After 1 June 2015, the information of DPD of mixture SDS will no longer be required. For mixture placed on market before 1 June 2015, there will be a two-year grace period for them to change the old DPD label to the new CLP label before 1 June 2017.


According to the requirement of Malaysia CLASS2013, before the end of March 2016, importers and manufacturers should finish the submission of Inventory of Hazardous Chemicals. The submitted information should include the classification, name, hazardous contents (mixture) , product hazardous classification, and imported or manufactured tonnage of the imported or manufactured substances of 2015.


It is stipulated that substances should comply with SEA (CLP-like regulation) since 1 June 2015 and mixture should comply with SEA since 1 June 2016. There will be a grace period of about 1.5 to 2 years for enterprises to update the SDS and labels of substances (before 1 Jan 2017) and mixtures (before 1 June 2018).

CIRS provides tailored regulatory service to our clients from all over the world. Should you have any questions, please do not hesitate to contact us at


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