ChemSafety Blog: 2013

Tuesday, December 17, 2013

17 Dec 2013, ECHA adds 7 new substances to SVHC candidate list

17 Dec 2013, ECHA has added another 7 new substances to the SVHC Candidate List, a list that now contains a total of 151 substances. The 7 substances are Cadmium sulphide, C.I. Direct Red 28, C.I. Direct Black 38, Dihexyl phthalate, Imidazolidine-2-thione (2-imidazoline-2-thiol), Lead di(acetate), and Trixylyl phosphate

The full list of 7 newly added substances and their CAS no. can be found below:

http://echa.europa.eu/view-article/-/journal_content/title/echa-updates-the-candidate-list-for-authorisation-with-seven-new-substances-of-very-high-concern-svhcs-

SVHC are defined in Article 57 of Regulation (EC) No 1907/2006 ("the REACH Regulation") and include substances which are:

carcinogenic, mutagenic or toxic to reproduction (CMRs);
persistent, bio-accumulative and toxic (PBTs) or very persistent and bio-accumulative (vPvBs);
Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to human health or the environment of an equivalent level of concern as those above (e.g. endocrine disrupters)

Download SVHC Candidate List and Find What It Means to You.

Reminder: Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply. Switzerland has its own chemical regulations adopting REACH-like registration and restriction requirements. Please refer to Swiss Chemicals Ordinance (ChemO) and Swiss Chemical Risk Reduction Ordinance (ORRChem) for more info.

New Taiwan TCSCA - Toxic Chemical Substances Control Act (TCSCA)

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.

What is New? Taiwan EPA Releases the English version of the Regulation on New and Existing Chemical Registration in Feb

The regulation has set out detailed chemical registration requirements under TCSCA and it can be accessed here. It is recommended that you also read our summary of TCSCA registration requirements first.

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;

A new substance is defined as a substance that is not listed in Taiwan national existing substance inventory.

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 andsmall volume registration.

What is New? Top 10 Differences between Taiwan TCSCA and EU REACH Compared

Taiwan TCSCA is another new important REACH-like chemical regulation that imitates EU REACH regulation. Despite many similarities, Taiwan TCSCA and EU REACH are different in many aspects. In this article, we have summarized the top 10 differences between Taiwan TCSCA and EU REACH to help you comply with TCSCA.

Sunday, September 22, 2013

GHS in Thailand

On 1 February 2012, the Ministry of Industry in Thailand issued the Notification on the Hazard Classification and Communication System for Hazardous Substances (B.E. 2555) (GHS Notification), subsequently published on 12 March 2012 in the Government Gazette. The notification, issued pursuant to Thailand's Hazardous Substances Act, is based on the third revised edition (2009) of UN GHS. Besides, FDA is in the process of GHS implementation over Household and Public Health Use while Department of Agriculture (DOA) is in the process of GHS implementation over agricultural chemicals.

Transition period

Effective date	Requirements
12 March 2013	Substances Re-classify, labeling and SDS should be updated by manufacturers and importers
12 March 2017	Mixtures Re-classify, labeling and SDS should be updated by manufacturers and importers
	Exception: chemical wastes and chemical substances used electronic devices

Labeling

The basic elements on labels required in Thailand (B.E.2555 Annex, Table 1) are to be consistent with UN GHS (4th revised).

Language on labels:Thai.

SDS

Under the GHS Notification, manufacturers and importers are obligated to provide safety data sheets (SDS) for all hazardous substances. The required format and contents are set out in Table 2 of the Annex, including standard 16-section headings and sub-headings, in accordance with Annex 4 of the 4th revised UN GHS.

For information on ingredients, regulations on confidential business information (CBI) established by governmental agencies shall take priority.

Related GHS Info & Resources

GHS Implementation in Taiwan

GHS has been implemented for selected chemicals in Taiwan since 2008. Full GHS implementation is scheduled in 2016 for all hazardous chemicals with physical and health hazards in workplace. Both TCSCA and OSHA require chemical suppliers to label the packages and containers of toxic chemicals or hazardous chemicals and provide safety data sheets prepared in accordance with relevant GHS regulations and standards in Taiwan.

CNS 15030 Classification and Labelling of Chemicals

CNS 15030 Classification and Labelling of Chemicals is the main national standard for chemical classification and labelling in Taiwan. All other GHS-related regulations have referred to this standard. The standard was firstly issued by the Bureau of Standards, Metrology and Inspection (BSMI) of the Ministry of Economic Affairs based on GHS Purple Book Rev 1 and was amended in 2009 in accordance with UN GHS Rev. 2. Right now, BSMI is revising this standard based on UN GHS Rev. 4.

Taiwan has adopted all building blocks of UN GHS. Companies can directly refer to the English version of the GHS purple book to classify their chemicals. The English version of this standard can be purchased here. Please search "15030".

Regulation of Labelling and Hazard Communication of Hazardous Chemicals

This is the most important regulation for implementing GHS in Taiwan. It was amended in 2014 by MoL and comes into force on 3 July 2014. The revised regulation requires manufacturers, importers or suppliers to provide labelling and SDSs for all hazardous chemicals with physical and health hazards from 1 Jan 2016.

GHS in workplace is implemented in 4 phases in Taiwan. MoL(previously the Council of Labor) has published 3 lists of hazardous chemicals subject to mandatory GHS compliance.

First Phase: 1062 chemicals;
Second Phase: 1089 chemicals;
Third Phase: 1020 chemicals;
Last Phase: All hazardous chemicals with physical and health hazards(from 1 Jan 2016).

All 3 lists of chemicals subject to mandatory GHS compliance can be downloaded here.

Labelling and SDS Requirements under MoL's Regulations

Standard GHS format & content: Yes;
Language: Traditional Chinese;
Substance name: Both Chinese and English names are required;
GHS labeling of small package(<=100ml): Product identifier, pictogram and signal word;
SDS review: every 3 years.
Out of scope: Consumer products, etc.

Related GHS Info & Resources

Sunday, August 11, 2013

Korea GHS

Korea has fully implemented GHS for both substances and mixtures since 1 July 2013. Suppliers of hazardous chemicals should classify their chemicals according to GHS classification criteria, prepare safety data sheets(SDS) and label the containers or packages of hazardous chemicals according to relevant national standards.

Classification, Labelling and SDS Standard in Korea

The most important and also the latest GHS standard in Korea is MoEL's Public Notice No. 2013-37 - The Standard for Classification Labeling of Chemical Substance and Material Safety Data Sheet. It stipulates chemical classification criteria, the content of SDSs/labelling, and phrases for various hazard and precautionary statements in Korean.

The standard is based on UN GHS Rev. 3. There are 27 hazard classes(not including hazardous to the ozone layer). Compared to UN GHS Rev. 4, the following building blocks are not adopted.

Chemically unstable gas cate. A/B
Aerosols cate. 3
Flammable liquids cate. 4
Acute toxicity cate. 5
Skin corrosion/irritation cate. 3
Acute aquatic toxicity cate. 2 & 3

Labelling Requirements

Both MoE and MoEL have set labelling requirements for hazardous chemicals. In general, MoEL's standard applies.

Product identifier: consistent with SDSs;
Signal word: warning or danger;
Pictograms: Up to 4 pictograms if there are 5 or more pictograms(not mandatory);
Hazard statements: repeated statements can be omitted; similar statements can be combined;
Precautionary statements: Up to 6 p-statements if there are 7 or more p-statements(not mandatory); A sentence pointing to SDS for full statements shall be added;
Supplier Info: The contact info of Korean legal entity needs to be given;
Languages: Korean. However, SDSs and labels for chemicals for lab use & research do not need to be prepared in Korean. Product name, substance name and foreign supplier's contact info can be written in English.
Small package(<=100ml): Hazard and precautionary statements can be omitted.

The picture below is an example of Korean GHS label.

The standard has also set the minimum size requirement of a label and pictogram for different sizes of containers.

For toxic chemicals, MoE's additional requirements apply:

Classification: mandatory to use C&L published by NIER.
Product identifier: For mixture, product name and the content of toxic chemical shall be disclosed;
Pictogram: display all available pictograms published by NIER

To access Korean compulsory GHS classification list for toxic chemicals, please click here.

SDS Requirements

Korea has also adopted standard 16-section SDSs.There are a few things you need to be aware of when you prepare Korean SDSs.

Confidential business information (CBI): Substance name, CAS or content can be hidden. Hazards must be fully disclosed.
Indicating concentration ranges: within 5%. If the contents are less than 5%, the lower limit shall be indicated as ">=1% "(0.1% for carcinogens and germ cell mutagens, 0.2% for respiratory sensitizers, and 0.3% for reproductive toxicants);

Related GHS Info & Resources

Monday, February 25, 2013

China Publishes Updated IECSC(2013)

1 Feb 2013, China MEP has published updated Chinese existing chemical inventory IECSC(2013).

There are now 45612 substances in IECSC. The full list of IECSC(2013) can be downloaded here.

http://www.mep.gov.cn/gkml/W020130131548538924943.rar

This is the first time that the full list is made available to the public for free. There are 42342 substances in the public portion of IECSC(2013) and 3270 substances in the confidential section of IECSC(2013). The substances in the confidential section are shown in category names. No CAS number or molecular structure is given for those confidential substances.

Companies have to submit a formal enquiry to CRC to check whether a substance is new or not. CRC usually issues a letter of confirmation within 2 weeks after an enquiry is submitted.

The enquiry costs 600 RMB(~100 USD) from 1st Jan 2013.

Chemical Inventories

Tuesday, January 8, 2013

ECHA adds 54 more substances to SVHC candidate list

19 December 2012, ECHA has added another 54 substances to the SVHC Candidate List, a list that now contains a total of 138 substances.