Published: 12 August, 2019
According to the Ministry of Environment and Urbanisation (MoEU), companies have submitted nearly 48,000 pre-registrations so far under Turkey’s REACH regulation (KKDIK).
Under KKDIK, substances manufactured/imported ≥ 1 tonne/year must be pre-registered by 31 December 2020 and registered by 31 December 2023.
The MoEU has recently received funding from the EU, part of which will be used to upgrade its IT system KKS. There have previously been issues with the system, including glitches that have rendered it out of action temporarily.
7 institutions have also now been approved by the MoEU to deliver chemical assessment expert training.
On 9th July, the Ministry of Ecology and Environment (MEE) has published a draft regulation “Regulation on environmental risk assessment and control of chemical substances” to revise the existing “Measures for the Environmental Management of New Chemical Substances” (MEP Order 7). The Ministry is accepting public comments until 16th August 2019.
The amendment aims at tightening the rules for managing chemicals of high risk and at promoting green chemistry. The main changes are as follows:
Ref: MEE announcement
On 21st June 2019, Ministry of Ecology and the Environment (MEE) published an announcement regarding nominating substances into IECSC. Chinese importers/ manufacturers, foreign companies or industrial associations are allowed to nominate their substances into IECSC by 30 September 2019 if the substances meet all of the following criteria:
Industry can submit the following information to MEE to apply for the nomination:
The MEE has said it will evaluate the information in 10 working days and will publish the result on the MEE website. There are two potential outcomes of the MEE review:
Ref: MEE notice
Japan’s Ministries of Economy, Trade and Industry (METI) and Health, Labour and Welfare and (MHLW) have released new standards on the classification of chemicals, labelling and Safety Data Sheets. The below standards align to UN GHS Revision 6:
Companies have three years (until 24 May 2022) to implement the changes. Before this time, the previous versions (published in 2012 and 2014) can be used. METI is in the process of drafting guidance documents to help the industry understand the changes.
Ministry of Health, Labour and Welfare (MHLW) publishes the quarterly Official Gazette in which 194 chemicals are designated as existing substances under the Industrial Safety and Health Law (ISHL).
The ISHL number and the English name found in the CHRIP database while the Japanese name and the ISHL number can be found in the Gazette.
On 19th June, the Ministry of Health, Labor and Welfare (MHLW) amended the list of poisonous and deleterious substances, adding eight substances into the Deleterious Substances List and removing three from it.
Substances added into the Deleterious Substances List
Substances removed from the Deleterious Substances List
The additions to the PDSL came into effect on 1st July 2019 (with a grace period until September 30 this year), and the removals came into effect upon the release of the amendment.
National Institution of Technology and Evaluation (NITE) concluded that the substances 1,2,5,6,9,10-hexabromocyclododecane (HBCD) and decabromodiphenyl ether (decaBDE) are of low concern for Japanese people.
Ref: NITE announcement
30th June 2019 was the pre-registration deadline under K-REACH. Companies that pre-registered the substances by this date have been granted grace periods in which to put a K-REACH registration in place. Companies that have pre-registered must now state their intention to become the Lead Registrant, and Active Registrant or a Passive Registrant within each substance SIEF.
Companies manufacturing/importing above 1 t/y for the first time after 30 June 2019 can submit a late pre-registration through the online system and should retain evidence of the manufacture/import volumes being <1 t/y, as evidence in case of inspection. Those who imported above 1 t/y before the pre-registration deadline but who missed the opportunity to pre-register should put the registration in place immediately.
Notification of products containing Priority Control Substances starts
According to K-REACH, products satisfying one of the following criteria will need to be notified through the online system.
The information required includes the name, use, content, hazard, exposure information of the substance. There are 672 Priority Control Substances, and these are divided into two lists.
On 8th July, the Ministry of Environment (MOE) added 128 substances to the list of substances hazardous for use in children’s products under the Environmental Health Act. There are now 263 substances on the list. The MOE will conduct risk assessments on them for their toxicity or carcinogenicity for human health.
On 2nd July, EPA published an announcement on the “clock stop” process during new chemical registration and PLC confirmation.
If, during the review of new substance registrations, the EPA decides to “clock stop”, the applicant should submit the data required within 30 working days. If the relevant data cannot be submitted during this time due to technical issues, the applicant can apply for an extension by notifying the EPA. The EPA will review the application and agree to a date for data submission. Once the date is set by the authority, it cannot be changed. It is also important to note that a registrant will only have two chances to supplement the dossier.
Ref: EPA announcement
A proposal for Thailand’s new chemical law (B.E. No. 1/2562) has been published, which would replace the current Hazardous Substance Act. The draft intends to adopt a risk-based approach to chemical management. A national chemicals agency would support the processes required by the regulation and would provide information on how hazardous substances should be managed. The draft proposes three new substance classifications:
The above substance classifications would replace the current type 1, 2, 3 and 4 hazardous substance classes. A national inventory of existing chemicals is expected around 2020.
NICNAS has released answers to the most commonly asked questions about the new Industrial Chemicals Introduction Scheme (AICIS).
Ref: Q&A section
New Zealand’s national chemical inventory has been updated. The latest amendment adds 159 chemicals, change the status of 3 and deletes 28.
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Authors: Tan Sun and Sophie Guinard