Introduction
The Taiwan OSHA (previously as “LSHA”) passed its third reading on 18 Jun 2013 and was promulgated on 3 July 2013 by President Order 10200127211. The newly approved OSHA includes 55 articles. Taiwan OSHA will be implemented in two distinct phases with articles being implemented on specific dates. Article 7~9, 11, 13~15 and 31 are subject to Phase 2 implementation on 1 Jan 2015. All other articles were subject to Phase 1 implementation on 3 Jul 2014. To efficiently enforce Taiwan OSHA, up to 60 supporting regulations and measures will be revised, of which 28 require a complete update (41 for Phase 1, 19 for Phase 2 implementation).
1. Competent Authority
The Council of Labor Affairs (CLA) was renamed as the Ministry of Labor (MoL) and officially took power on the 17th of Feb 2014. The Occupational Safety and Health Administration, affiliated to the MoL, were set up on the same date to primarily manage the implementation of Taiwan OSHA.
Fig 1. Organization Structure of MoL (Reference: http://english.mol.gov.tw)
2. Legislative Progress
The legislative progress of the revised Taiwan OSHA is summarized as below,
Sep 2011, handed to the Legislative Yuan for approval the first time
Nov 2011, passed by the Social Welfare and Environmental Affairs Committee under the Legislative Yuan
Dec 2011, third reading failed, and sent back to CLA for further review
Nov 2012, handled to the Legislative Yuan for approval the second time
Apr 2013, passed by the Social Welfare and Environmental Affairs Committee again
18 Jun 2013, third reading passed by the Legislative Yuan
3 July 2013, promulgated by President Order
3. How to Comply
New Chemical Substance Registration under OSHA
OSHA Article 13: Manufacturers or importers shall not manufacture or import chemicals containing a new chemical substance without prior submission of a chemical safety report to the central competent authority and subsequent approval for registration of the new substance.
The new chemical registration requirements under OSHA did become effective on 1 Jan 2015, while the registration details were not finalized until 31 Dec 2014 when the Regulation of New Chemical Substances Registration published. Substances not listed in the Existing Chemical Substance Inventory (Taiwan ECSI) are new chemical substances and subject to new chemical substance registration under OSHA as well as Taiwan TCSCA.
Exemption Conditions:
Registration regulations do not apply to the chemical substances listed below:
(1) Naturally occurring substances
(2) Chemical substances in machines and equipment
(3) Inseparable intermediates from chemical reaction in reaction vessels or in production process
(4) Chemical substances for national defense purposes
(5) Incidental reaction products or impurities without intended commercial purpose
(6) Chemical substances under customs supervision
(7) Wastes
(8) Polymer applicable to the 2 % Rule &listed in Taiwan ECSI
(9) Mixture (not applicable to constituent chemicals are new chemical substances)
(10) Articles (not applicable if the new chemical substances contained in the article will be intentionally released during normal use)
(11) Others designated by the central competent authority
Under OSHA, new chemical substance registration is divided into three types, i.e. standard registration, simplified registration, and low-volume registration. Four tonnage bands are set for standard registration, including 1-10t/y, 10-100t/y, 100-1000t/y, and above 1000/y. However, if a substance is categorized as CMRs, the corresponding regulatory requirements will increase. For example, the CRMs (1-10t/y) should submit dossiers required under Band 2.
Tonnage Band | Annual Volume (Q) | Annual Volume (Q) |
General New Substances | CMR Substances | |
Band 1 | 1 t ≤ Q < 10 t | Q < 1 t |
Band 2 | 10 t ≤ Q < 100 t | 1 t ≤ Q < 10 t |
Band 3 | 100 t ≤ Q < 1,000 t | 10 t ≤ Q < 100 t |
Band 4 | Q ≥ 1,000 t | Q ≥ 100 t |
Based on the tonnage and usage information, different registration types are applicable.
Fig. 2 - New Chemical Substance Registration Type under Taiwan OSHA
Different registration types have specific information requirements for chemical safety report (CSR). The details are specified as below.
Note:
General new substances in volumes of 1 ton or more, and less than 10 tons, or substances which are not CMRs are exempt from hazard assessment and exposure assessment requirements.
Chemical substances which do not possess health hazards or environmental hazard, manufactured or imported in annual volumes of 10 tons or more, and for which physical and chemical properties are not classified as hazardous to human health are exempt from submission of exposure assessment.
Chemical substances which are classified as On-site Isolated Intermediates, Polymers, Scientific Research and Development, or PPORD, are exempt from submission of hazard assessment and exposure assessment.
Joint Submission
Two or more manufactures or importers applying for registration of the same new chemical substance may jointly or successively submit application for registration approval. Tonnage accumulation is required for joint submission, which may result in higher data requirements and thus higher costs to share in the consortium.
Subsequent registrants can apply for incorporation into the original registration within the original registration certificate validity with the previous registrant’s consent. The joint registration is formed by aggregating the chemical substance quantity from each individual registrant. The certificate issuance date and validity period remains the same as the original registration.
However, different from other countries, Taiwan’s EPA set an additional clause reserving the right to modify the registration type of a new chemical substance when the total annual volume manufactured or imported nationally reaches a certain amount.
Transitional Measures
For new chemical substances manufactured or imported into Taiwan before the 1st of Jan 2015, companies can register these chemicals between the 1st of Jan 2015 and the 31st of Mar 2015 with evidence proving their previous manufacture/importation and the CSR for low-volume registration. A one-year grace period can also be granted.
For new chemical substances manufactured or imported into Taiwan between 1 Jan 2015 and 31 Dec 2015, companies can register these chemicals between 1 Jan 2015 and 31 Dec 2015 with CSR for low-volume registration. A one-year grace period can be granted.
Registration Certificate
After registration, the registration certificate will be issued. The registration certificate includes the following information:
Registrant basic information
New chemical substance serial number
Approved registered usage
Approved registration type
Issuance date and valid period
The validity period varies for different registration type. Some new substances can be included into the ECSI after the registration. The details are specified as below.
Registration Type | Certificate Validity | Extension | Taiwan ECSI Inclusion |
Standard Registration | 5 years | N/A | when registration certificate validity expires (5 years) |
Simplified Registration | 1 years | Apply for extension within 3 months prior to the end of the validity period | N/A |
Low-quantity Registration | 1 years | N/A | |
Polymer of Low Concern Registration(>1 t/y, applicable to low-quantity registration) | 5 years | N/A | when registration certificate validity expires (5 years) |
*The validity period for the simplified registration certificate and low-volume registration certificate will be changed to 2 years as is used in the TCSCA.
News
18 Mar 2015 Taiwan TCSCA and OSHA Single Registration System
30 Dec 2014 Taiwn Not to Implment OR Concept
5 Dec 2014 MoL drafts New Chemical Registration Fee under Taiwan OSHA
13 Sep 2013 A Series of Free Seminars to be Held for Taiwan New and Existing Chemical Management
21 June 2013 Taiwan OSHA Passed Third Reading in Legislative Yuan
11 Apr 2013 Conflicts Unsettled on Taiwan Legislation on Nanomaterial and New Chemical Substance Management
20 Nov 2012 Taiwan OSHA Passed by Executive Yuan
