Taiwan

• Draft Rules for New Substance and Existing Substance Registration under Revised TCSCA
• TCSCA in Taiwan
• OSHA in Taiwan
• National Existing Substance Inventory in Taiwan

Revised Toxic Chemical Substances Control Act (TCSCA) in Taiwan

7 May 2014 by CIRS

The revised Toxic Chemical Substances Control Act (TCSCA) in Taiwan was officially promulgated by President Ma Ying-jeou on 11 December 2013. The revised TCSCA requires enterprises to register new substances 90 days prior to production or importation and register designated existing substances manufactured or imported above a given quantity. The Act also strengthens the management of Class 4 toxic chemical substances. Enterprises are required to declare relevant toxicological information and obtain approval from competent authorities for Class 4 toxic chemical substances prior to handling. The provisions pertaining to chemical registrations are expected to come into force on 11 Dec 2014 while other provisions will come into force at the date of promulgation.  

Draft rules for the registration of new and existing chemical substances under the revised Toxic Chemical Substances Control Act (TCSCA) was published by Taiwan's Environmental Protection Administration (EPA) on 25 August, the draft is on public consultation stage and the rule will takes effect in 11th December 2014. CIRS summaries major points of the rules. For more info, please here. 

The English version of the fulltext of the revised TCSCA(Non-official translation) can be downloaded here free for charge.

Notes

Taiwan's second supplementary existing chemical substance nomination (ECN) starts on 1 June 2014. Click here for more info.

Background of Revision

TCSCA was firstly issued in Nov 1986 and has gone through 5 revisions with the latest amendment done in 2007. It is the main legislation for industrial chemicals in Taiwan and its primary focus is on the control of toxic chemical substances, requiring business operators to apply for handling permits for designated toxic chemical substances from Environmental Protection Administration (EPA).

The main reason for amendment is that there is no chemical registration scheme in Taiwan. After so many countries (Korea, China, Japan) have implemented REACH-like chemical legislation and required risk assessment of chemical substances, Taiwan may become a test ground for new substances if not having a chemical registration scheme in place. In addition to that, the food plasticizer contamination incident in 2011 made authorities realize that they do not have sufficient power under current TCSCA (i.e, request for toxicology data or requiring license) to control chemical substances for which there is concern of pollution of the environment or the endangerment of human health (Class 4 toxic chemical substances).

Chemical Substance Registration

The following substances require registration

Category	Comments
New Substance	New substance shall be registered 90 days prior to production or import;
Designated Existing Substance at a given quantity or above	The list of designated substances subject to registration will be announced by authorities; Grace period will be given;

 

Note 1:

A new substance is defined as a substance that is not listed in national existing substance inventory published by authority. More info about this inventory can be found here.

Note 2:

Registration information includes manufacturing or importing details, the physical, chemical, and toxicology data, exposure and hazard assessment data and other information designated by the central competent authority. According to substance type and the quantities of manufacturing or importing, there are 3 types of registration: standard registration, simplified registration and small volume registration.

However, guidance on data required for those three types of registration has not been published yet.

Note 3:

OR provisions are not mentioned in revised TCSCA. However, manufacturers outside of Taiwan may appoint a local agent(similar to OR under EU REACH) to carry out registrations according to an official source.

Management of Toxic Chemical Substance

In addition to the establishment of a chemical registration scheme, the revised TCSCA also strengthens the management of Class 4 toxic chemical substance.

The table below shows the definitions of Class 1, 2, 3 & 4 toxic chemical substances and how they are regulated under TCSCA.

Category	Class 1	Class 2	Class 3	Class 4
Hazard	Hard to break down in the environment and easily to pollute the environment and endanger human beings health because of the bioaccumulation, bioconcentration, or biotransformation.	Has the ability to  cause cancer, infertility, birth defects, genetic mutations, or other chronic diseases.	Human beings health and environment will be endangered immediately after exposure to chemicals.	There is a risk to endanger human beings health and the environment.
Management	1. Obtain the permit(manufacture, import or sell toxic substances more than the large scale handling standard) 2.Obtain the registration(use, store and dispose toxic chemical substance more than the large scale handling standard) - like reporting; 3.Obtain approval(manufacture, import, sell, use, store or dispose toxic chemical substance less than the large scale handling standard)			Toxicological information concerning the toxic chemical substances should be submitted and approved.
Label and SDS	yes	yes	yes	Yes

 

Note 1:

The validity period of the permit, the registration document and approval is 5 years.

Note 2:

Only domestic enterprises in Taiwan can apply for handling permits.

Note 3:

Please not some chemicals are banned in Taiwan. If you wish to receive the lists of Class 1, 2, 3 and 4 or banned list in English, please complete this order form and send it to service@cirs-reach.com.

SDS and Label under TCSCA

Under revised TCSCA, the handler shall, pursuant to regulations, mark matters related to toxicity and pollution control on Class 1 to Class 4 toxic chemical substance containers, packaging, handling sites, and facilities, and shall keep safety data sheets for the corresponding toxic chemical substances. GHS SDSs and labels are compulsory for Class 1 to Class 4 toxic chemical substances and mixtures containing them.

More info about Taiwan GHS can be found here.

Penalty

The table summarizes the penalties for failing to register substances under revised TCSCA.

Category	Comments
Failure to notify new substance;	Fine: NT$200,000 to NT$2,000,000; Repeated infringement: business suspension or returned export.
Failure to register designated existing substance.	Fine:  NT$30,000 to NT$300,000; Repeated infringement: business suspension or returned export.

 

Our TCSCA Services

• General consultancy & training;
• Search and confirm if a substance is new in Taiwan;
• Dossier preparation and submission of new substance notification and existing substance registration(full, simplified, small volume);
• Test monitoring/translation of study reports;
• Preparation of SDS and label in compliance with Taiwan GHS;
• Regulatory update monitoring.

About Us and Contact

NEW ! Mr. Jefferson Shih from DG Specialty Inc will give a public speech on Registration requirements under the revised Toxic Chemical Substance Control Act (TCSCA) in Taiwan during the 4th Shanghai Summit Meeting on Chemical Regulations in China, Korea and Japan (SMCR 2014), 15-16 October, Shanghai. If you are interested in this topic, please register our meeting. Registration before Oct 1 will avail an Early-bird rate in registration fees. More info please click here.