Expert Interpretation of SMCR Regulatory Highlights

The First Summit Meeting on Chemical Regulations in Asia-Pacific (SMCR 2015) was successfully held in Shanghai during 13-14 October 2015, hosted by CIRS, KTR and JEMAI. Officials have been invited to give talks on the regulatory affairs and chemical industrial supervision. CIRS has compiled a summary of all the highlighted contents and has put our experts’ interpretation together in it.


1. Revisions of MEP Order 7

It has been 5 years since the implementation of The Act of New Chemical Substance Management (MEP Order 7). A series of works have been done for collecting public comments for the Guidance of the MEP Order 7.

Mr. Xiaojian Liu from MEP-SCC made some interpretations on the “Guidance”:

1). Technical Materials (TC) and Active Pharmaceutical Ingredient (API) are regulated by other laws when used for other purposes in China. When TC and API are used in industrial chemicals and when they belong to new chemical substances, notification will be required.  

2). Clarification of the testing requirement: a. Testing reports must be filed within the valid period of the qualification of related testing organizations. b. When submitting the notification, if the data has passed 5 year valid period, tests should be re-done using the updated methods. 

3). Update of the data requirement and clarification of the exemption criteria. Major revisions have been made on the data requirement and exemption criteria of mutagenicity, repeated toxicology, toxicokinetics, carcinogenicity, fish-14-day prolonged toxicology, etc.  

4). Management process simplified. Major simplifications are made on the evaluation process of the registration certificate modification and the required information of the annual activity report. The simplified process will increase the evaluation efficiency, which will allow companies to take faster actions for the new chemical substances.

 

2.  Implementation and progress of MEP Order 22

According to quite a few problems existed in MEP Order 22, the revision of MEP Order 22 has begun. Following are some revision thoughts of MEP Order 22

1). Registration Goal Adjusted, Registration Properties Clarified

Registration properties will be clarified to strengthen the hazardous chemical environmental administration.  Registration goal will be adjusted to evaluate and prevent the hazardous chemical environmental and health risk.

2). Registration Scope Set

(1) Enterprises who produce or use PHCs larger than 100kg per year or other hazardous chemicals larger than 1 ton per year will be required to do the Hazardous Chemical Environmental Administration Registration. (2) Enterprises fall in following criteria can be exempted from the registration: using hazardous chemicals for scientific research; using hazardous chemicals for tests; using hazardous chemicals without participating in the production process. Note: Enterprises that produce technical material (TC) or technical concentrate (TK) should do the registration; enterprises that use TC or TK to produce agrochemicals will not be required to do the registration.

3). Registration Document Simplified, Registration Form Simplified

Registration document simplified: environmental accident emergency plan, enterprise environmental supervision report, waste discharge certificate, etc. will not be required in the registration document MEP Order 22. Registration form simplified: environmental sensitive area, label, hazardous classification, environmental risk prevention plan, waste hazardous chemical handling information are all deleted.

4). Risk Assessment Requirement Adjusted, Risk Assessment Method Revised

Mandatory third-party appointment for PHCs risk assessment will be removed. Enterprises can do the risk assessment by themselves or they can appoint a third-party agent to do it if they wish. The requirement for the person who makes the risk assessment will be removed, the supervision level of the assessment contents will be removed, and qualitative assessment will be replaced by quantitative assessment. Emphasis will be put on the exposure and discharge assessment.

5). Supervision and Administration Requirement Weakened

Supervision requirement revised, such as removal of PHCs annually supervision and inspection, addition of other hazardous chemical annual report, addition of publication of hazardous chemical discharge and transition annual report from MEP to public.

The revision of MEP Order 22 will benefit the chemical management in China.

 

3. Regulation Progress in Taiwan

The act of new chemical substance notification and existing chemical substance notification published by Taiwan EPA, and the act of new chemical substance notification published by Taiwan MOL have both implemented since the end of last year and early this year.

For the pre-registration of the existing chemical substances, there is no need to apply for the CBI protection since the importer can not get the substance information (CAS or other information) by searching the registration number. For enterprises that fulfill the criteria for pre-registration can do the pre-registration between Sep 1 2015 and Mar 31 2016. During this period, the importation of the existing chemical substance will not be influenced.

For new chemical substance in Taiwan, both regulations of EPA and MOL should be complied. EPA will be the only window for registration submission. For simplified registration, EPA and MOL will evaluate the documents together and issue the certificate together; for typical registration, EPA and MOL will evaluate the documents separately and issue the certificate separately.

 

4. Highlights of Korean Regulations

1) KOSHA Revised Edition (Unofficial) Released

In the current version of KOSHA, the amount of new chemical substance manufactured or imported larger than 100 kg per year should submit oral acute toxicology, AMES test and mammal red blood cell micronucleus test data to MOE. The revised edition now uses different tonnage bands with different data requirement. 

<1t/a

1-10t/a

>10t/a

oral acute toxicology

oral acute toxicology

AMES test

if AMES shows positive result, the mammal red blood cell micronucleus test will be required

oral acute toxicology

AMES test

mammal red blood cell micronucleus test


2) For new polymer substance, data requirement also revised as follows

Tonnage

<10t/a

10-100t/a

100-1000t/a

>1000t/a

Basic data requirement

Molecular weight and distribution

Monomer information and residual monomer content

Content of copolymer <1000 Dalton

pH stability

Special requirement

none

oral acute toxicology

AMES test

 

oral acute toxicology

AMES test

if AMES shows positive result, the mammal red blood cell micronucleus test will be required

 

oral acute toxicology

AMES test

mammal red blood cell micronucleus test

 

3) K-REACH Trial substance progress. During the SMCR 2015, Korean delegate introduced the progress of the 7 trial substances, which includes: LR election, substance identity confirmation, joint submission proposal confirmation, data gap analysis, EU data purchase, etc. It is expected to submit the chemical dossier by the end of 2017. 

 

5. Global GHS Progress

China GHS

1) For chemicals in the Catalog of Hazardous Chemicals, hazchem registration will be required, as well as SDS and Labels. For chemicals not on the catalog but fall into the category of hazardous chemicals, registration, SDS and Labels are also required.

2) The Guidance will be published soon to provide useful information for enterprises.

3) By the end of Sep 2015, there were about 19,000 hazchem manufacturers, 286 importers have received the registration certificate.

GHS in North America

1) US GHS has implemented since 1 June 2015. Acute toxicology 5, skin corrosion/sensitization 3 and inhalation toxicology 2 were not adopted. Self-ignite gas, simple asphyxia and combustible dust were added. Enterprises should pay attention to these changes and some unclassified hazards as well.

2) Canada GHS WHMIS has passed in Feb 2015 and will be implemented since June 2018. WHMIS is similar to US GHS, many classifications can be applied for both regulations except for the Biohazardous infectious materials and Water-activated toxicants in WHMIS. Moreover, the complied SDS and Labels in Canada should be bilingual.

Malaysia GHS

Malaysia has adopted the 3rd edition of UN GHS since April 17 2015. If substances are on the list of ICOP, it is required to provide the classification information. It is also required that a 24-h emergency phone number should be included in SDS.

Thailand GHS

Thailand has adopted the 3rd UN GHS since 2012. It is required since 2013 that the compliant SDS should be provided for substances. For mixture, after 2017, it will be required to be compliant to GHS. For explosive 1.4 and 1.5, transportation symbol should be provided. Skin corrosion 1 in Health hazards does not have 1A, 1B and 1C classification.


The above content wraps up the main highlights of this SMCR 2015. Thanks for your interests in the summit and should you have any questions, please do not hesitate to contact us.