2019 Compliance Review: K-REACH Updates

The Act on Registration and Evaluation of Chemicals , hereinafter referred to as K-REACH, has been implemented for five years. It is another international influential chemical regulation act after EU REACH. The implementation of K-REACH has a huge influence on global chemical industry. The management method of K-REACH is quite similar with EU-REACH, such as the registration, evaluation, authorization and restriction of chemicals and downstream products. For chemical suppliers outside Korea, they need to complete the registration through the only representative (OR) in Korea. On January 1, 2019, the new version of K-REACH was officially implemented, which comprehensively revised the implementation of the regulations, expanded the number of registered substances, introduced pre-registration, and increased penalties. A series of new measures have strengthened the management of high-tonnage and hazardous chemicals, and have reduce requirements for low-risk, low-tonnage materials. Compliance Review Notification of CMR List and Priority Substance Chemicals、Exemption Substance List Published…

Feb. 29th, 2020

When is the Good Time to Join CICO after Pre-registration?

According to Article 10 (3) of K-REACH, pre-registration and Late pre-registration are required in order to have access to a grace period –so long as enterprises manufacture or import more than one ton of existing chemical substances per year. For enterprises that wish to register the same substance, it is necessary to join CICO first and then establish a “consortium” to prepare for joint registration during the grace period. In CICO, companies can play three roles: lead registrant, active Lead Registrant (LR), Active Member (AM) and Passive Member (PM) are the three roles in CICO, all bearing different responsibilities and burdens. The LR is the leader of the joint-registration and the AM plays the role of main supporter for the LR. These two roles are jointly responsible for the operation of CICO, formulating cost sharing rules, preparing the registration dossier and paying the early data testing costs. PM are charged…

Feb. 29th, 2020

New Requirements for Nanomaterials under EU REACH

With the rapid development of nanotechnology, nanomaterials are now widely used across many fields. At present, the most commonly used nano-materials for industrial purposes in Europe are silicon dioxide, titanium dioxide, carbon nanotubes, carbon black, and etc. According to scientific studies, the toxicity of nano-form substances and their impact on the human environment may differ from traditional substances. Therefore, since 2012, ECHA has established a Nano Expert Panel (ECHA-NMEG) to study and formulate the registration requirements and scientific as well as technical guidelines for nanomaterials under EU REACH regulations. In December 2018, the European Commission issued a REACH Regulation Amendment (Commission Regulation (EU) 2018/1881), which proposed new regulatory requirements for nanomaterials to ensure that enterprises can provide enough information for the safe use of nanomaterials. The amendment will officially be implemented on January 1, 2020. This means enterprises which have completed registration of nanomaterials will have to update their dossiers…

Feb. 29th, 2020

How to Protect Your EU REACH Registration Number?

The registration number is a necessary condition for enterprises to enter the EU market, and it’s very difficult to distinguish whether the registration number is true or not in the industry sometimes. Generally, importers with strong compliance awareness will actively contact their only representative (OR) to confirm the authenticity of the REACH document. REACH24H also received many inquiries from importers, and in the process of authenticity on registration number, we deed identified a number of “forged” documents. Among the most common compliance documents, Confirmation Letter of REACH Registration, Submission Report, and REACH Compliance Import Certificate are the most frequently forged. Even importers have repeatedly received tampered REACH documents. REACH24H’s RSCC system is a platform designed to help enterprises meet the requirements of REACH regulations. Its principles  can be summarized as follows: OR does not recognize the information confirmed by non-trade parties; OR will not be responsible for the records generated…

Feb. 29th, 2020

MEM Officially Issues the Guideline for Hazchem Enterprises on Emergency Preparations for Production Safety Accidents

Takehome: The Guideline introduces the fourteen essential factors in the emergency preparation and provides a worksheet containing the specifics of these factors as annex for reference. The emergency management administrations shall strengthen the publicity and education of the Guideline and the local administrations shall be responsible for the supervision, inspection, and instruction. On December 26th, 2019, China’s Ministry of Emergency Management (MEM) issued a Notice [1] to publish the Guideline for Hazchem Enterprises on Emergency Preparations for Production Safety Accidents. Major accidents involving hazardous chemicals have been a big problem for China and have garnered huge attention both domestically and overseas. To combat and prevent these accidents, China has introduced a series of regulations and standards for the safe production of hazardous chemicals. (ChemLinked News Ⅰ [2], Ⅱ [3]) The Guideline was formulated to further improve the ability of enterprises to effectively prevent and respond to hazardous chemical accidents. The…

Jan. 10th, 2020

Japan MHLW Proposes Addition of Six Poisonous or Deleterious Chemical Substances

Takehome: Japan MHLW proposed to designate six more poisonous or deleterious substances. On December 5, 2019, the Japanese Ministry of Health, Labor and Welfare (MHLW) held an internal meeting. Based on preliminary findings it was proposed that six substances could be designated as poisonous or deleterious substances. The details of the six substances are shown in the table below. Substance Name CAS No. Toxicity Test Item(s) Result Dibutyltin Dichloride 683-18-1 Acute toxicity (inhalation) Poisonous substance 3-Amino-1-propanol 156-87-6 Skin corrosion/ Serious eye damage Deleterious substance Triacetoxyethylsilane 17689-77-9 Skin corrosion Deleterious substance 9-Octadecen-1-amine, (9Z)- 112-90-3 Skin corrosion Deleterious substance 1-Chloro-4-nitrobenzene 100-00-5 Acute toxicity (oral)/ Acute toxicity (dermal) Deleterious substance 2,4-Dichlorophenol 120-83-2 Acute toxicity (dermal), skin corrosion, and serious eye damage Deleterious substance Later on December 20, the MHLW issued a notice [1] to chemical industry associations in the country, with a view to soliciting applications for a review of the finding mentioned…

Dec. 27th, 2019

EU Says NO to the Import of Toys Containing Lead and Phenol

In order to ensure the protection of children against risks caused by chemical substances in toys, on October 28, 2018, an amendment to EU Directive 2017/738 on lead limits in Appendix II of the Toy Safety Directive 2009/48/EC was officially approved. In the table under point 13 of part III of Annex II to Directive 2009/48/EC, the entry for lead has been replaced by the following: Element Lead In dry, brittle, powder-like or pliable toy material (mg/kg) In liquid or sticky toy material (mg/kg) In scraped-off toy material (mg/kg) Under original Directive 13.5 3.4 160 Under amended Directive EU 2017/738 2.0 0.5 23 In addition to this latest amendment, Directive 2009/48/EC on the safety of toys had already issued a limitation in the values of phenol allowed in toy materials back in May 2017. According to this amendment, values of phenol in toys intended for children under 36 months and…

Oct. 29th, 2018

ECHA offers speedier processing times for REACH dossiers

The European Chemicals Agency (ECHA) has just released a notification for companies that are interested in submitting their REACH dossier in the face of its current May 31st 2018 deadline. Companies that submit their dossiers before the end of March will receive ECHA’s decision on the registration within three weeks of filing. The agency is expecting high levels of submissions in the months of April and May, thus companies filing REACH dossiers over these later months may need to wait up to three months to receive ECHA’s decision. In order for a dossier to be submitted, it must first be uploaded in REACH-IT, and then it must successfully pass completeness check. As the completeness check carried out by ECHA staff not follow a prescribed time, REACH24H strongly recommends its clients to submit their REACH dossiers if possible before March 31st. This should provide sufficient time to receive a registration number…

Mar. 16th, 2018

The U.S TSCA Inventory “Reset” Rule Comes into Effect with A Reporting Period of Only 180 Days

The U.S. Toxic Substances Control Act (TSCA) final rule on the TSCA Inventory Notification (Active-Inactive) Requirements was published in the Federal Register on August 11, 2017, becoming effective as of the same date. This is the third TSCA framework rule under the 2016 TSCA Reform Act, which requires EPA to designate chemical substances on the TSCA Chemical Substance Inventory as either “active” or “inactive” in U.S. commerce. To accomplish that, EPA finalized the rule requiring industry reporting of chemicals manufactured, imported or processed in the U.S. over the past 10 years. This reporting will be used to identify which chemical substances on the TSCA Inventory are “active” in U.S. commerce and will help inform the prioritization of chemicals for risk evaluation. The rule on the TSCA Inventory Notification Requirements includes the following provisions: 1、A Retrospective Reporting with the EPA for chemical substances on the TSCA Inventory that were manufactured (or…

Sep. 14th, 2017

List of K-REACH Lead Registrants Published for 316 PECs

News Source: ChemLinked Takehome: 8 PECs subject to K-REACH joint registration finished LR (lead registrants) election in Apr 2017. So far LR election has been completed for 316 PECs and there are still 194 PECs requiring LR election. Updated on 28 Apr 2017, 316 priority existing chemical substances (PECs) have finished LR election, of which 8 PECs newly completed the election process. The details of the 8 PECs are specified as below. CAS No. Chemical Name LR Election Name of LR 74-94-2 Dimethylamine borane ; DMAB Apr 4, 2017 주식회사 켐토피아 124-63-0 Methanesulfonyl chloride Apr 10, 2017 주식회사 우진화인켐 79-04-9 Chloroacetyl chloride Apr 13, 2017 주식회사 에스피상사 50-00-0 Formaldehyde ; Formalin Apr 13, 2017 삼양화학실업㈜ 122-19-0 Benzyldimethyl-octadecyl ammonium chloride Apr 19, 2017 신원통상 13463-41-7 Zinc pyrithione Apr 20, 2017 ㈜켐토피아 14915-37-8 2-Pyridinethiol-1-oxide, copper salt Apr 24, 2017 ㈜켐토피아 25154-52-3 Nonylphenol Apr 25, 2017 ㈜켐토피아 The LR election results were published with…

May. 05th, 2017
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