Wednesday, June 29, 2011

RoSH2 Came Into Force on 27 May 2011

Five years after the introduction of RoHS, a new European Union RoHS Directive (known as RoHS2) was adopted by the European Council on 27 May 2011. The new Member State RoHS2 Regulations will take effect 18 months after its adoption. However, many companies are not aware of the new RoHS2 scope, the obligations of distributors and the associated sample testing requirements.

RoHS
The original RoHS is an EU Directive (2002/95/EC) pertaining to the Restriction of Hazardous Substances in Electrical and Electronic Equipment (EEE). It was adopted by the EU in February 2003 and brought into force 1st of July 2006.

This directive was brought into force in order to limit the component concentration of six hazardous substances found in EEE as they are harmful to the environment, mainly through the pollution of landfills.
RoHS Directive covers a wide range of products, including not only integrated electrical and electronic products but also individual parts, raw materials and packing cases.

This directive is very closely related to the WEEE directive, Waste from Electrical and Electronic Equipment (2002/96/EC) except RoHS regulates hazardous substances in EEE while WEEE regulates the disposal of the same equipment.
RoHS2 is an updated / recast version of RoHS. There are no additions to or difference in the six restricted substances, as can be viewed in table below. However, there is a proposed inclusion of Category 8 (medical devices from 2014) and Category 9 (control and monitoring instruments from 2014) and also a new Category 11, which captures all other ‘grey area’ electrical equipment(from 2019), and encorporates new CE Marking requirements. The date of this proposed inclusion is 2012 or later.

RoHS does not require any specific product labeling, however many manufacturers have adopted their own compliance marks. Examples of the visual indicators in use today include explicit "RoHS compliant" labels, green leaves, check marks, and "PB-Free" markings. Chinese RoHS labels use a lower case "e" within a circle with arrows, which can also designate compliance.

The new proposed RoHS2 directive attempts to address this issue of non-defined/non-approved/non harmonized compliance marks and reduce confusion by mandating the use of the CE mark and by introducing an additional enforcement agency, Trading Standards.

Besides, RoHS2 will work closely with REACH. Controlled substances such as HBCDD, DEHP, BBP and DBP by REACH might also be added to RoHS2 list in the future.

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 and RoHS restriction requirements. Please refer to Swiss Chemical Risk Reduction Ordinance (ORRChem) for more info.



China RoHS2 vs EU RoHS2


May 2015, As China is close to adopting its upgraded China RoHS regulation (China RoHS 2), we feel it necessary to look into this new regulation and compare it with EU RoHS 2. Read more.

What Is New in EU RoHS 2

On 4 June 2015, the EU commission has published a new Directive (EU) 2015/863 to amend Annex II to EU RoHS 2 (Directive 2011/65/EU) to add the following 4 phthalates onto the list of restricted substances.
    • Bis(2-Ethylhexyl) phthalate (DEHP): max 0.1%;
    • Benzyl butyl phthalate (BBP): max 0.1%;
    • Dibutyl phthalate (DBP): max 0.1%;
    • Diisobutyl phthalate (DIBP): max 0.1%.

10 hazardous substances will now be restricted in EEE under EU RoHS 2.

Related Substance Restrictions


  • REACH Substance of Very High Concern (SVHC)
  • REACH Restricted Substances
  • EU RoHS/RoHS 2
  • China RoHS 2
  • Norway PoHS
  • Swiss Chemical Risk Reduction Ordinance
  • California Proposition 65
  • Persistent Organic Pollutants (POPs)
  • Ozone-depleting Substances
  • Mercury and Its Compounds

  • Monday, June 13, 2011

    Japan Industrial Safety and Health Law (ISHL)

    Japan's Industrial Safety and Health Law (ISHL) was firstly enacted in 1972 to ensure the safety and health of workers in workplaces. IHSL designates substances that are prohibited to manufacture or import, substances requiring permission and chemical substances requiring safety data sheets and labels. ISHL also controls new substances and requires manufacturers and importers to notify them to the Ministry of Labor and Welfare (MHLW) prior to production and importation. 

    Chemicals Regulated under Japan ISHL
    The following categories of chemicals are regulated by Japan ISHL:

    - New chemical substances;
    - Harmful substances to be prohibited(~10 substances);
    - Harmful substances to be permitted(~7 substances);
    - Harmful substances to be indicated(~99 substances);
    - Notified substances to be delivered MSDS(~640 substances);


    New Substance Notification under ISHL

    Any substance that is not on ISHL list requires notification prior to manufacture or importation. ISHL list consists of two parts:
      • Existing chemical substances under CSCL(in commerce in Japan before 1973)- approximately 20,600 substances;
      • New substances notified under ISHL and published on government Gazette;

    More info about ISHL list and ISHL can be found below.
    Japan Industrial Safety and Health Law

    Tuesday, June 7, 2011

    Japan Chemical Substances Control Law (CSCL)

    Japanese Chemical Substances Control Law (CSCL) was initially implemented on 16 April 1974, and the latest amended law was published on 20 May 2009. The amended law will enter into force fully from 1 April 2011.

    Scope of Japan CSCL
    Japan CSCL covers general industrial chemical products only, which include both new chemicals and existing chemicals. Food or feed additives, pharmaceuticals, cosmetics, agricultural chemicals and fertilizers are subject to different laws and acts.

    General industrial chemical products might also be subject to the requirements of the Industrial Safety and Health Law(ISHL), the Poisonous and Deleterious Substances Control Act, the Air Pollution Control Law, and the Water Pollution Control Act.

    The three government bodies responsible for the implementation of CSCL are the Ministry of Economy, Trade and Industry (METI), Labor and Welfare (MHLW), and the Ministry of the Environment (MOE).

    Chemicals Regulated under Japan CSCL
    The following categories of chemicals are regulated by Japan CSCL:

    - New Chemical Substances;
    - General Chemicals;
    - Priority Assessment Chemical Substances(~1,000 substances);
    - Monitoring Chemical Substances (~36 substances);
    - Class II Specified Chemical Substances (23 substances);
    - Class I Specified Chemical Substances (16 substances);

    New Chemical Substance Notification under Japan CSCL
    Manufacturers and importers in Japan shall submit new chemical notification to three authorities: METI, MHLW, and MOE, to obtain approval notice from the governments prior to the manufacture or import of the new substance. Foreign manufacturers exporting new chemicals to Japan may also submit new chemical notifications by themselves.

    A new chemical substance is defined as a chemical substance other than those listed as follows:

    - Existing chemical substances (Approx. 20,600 substances): Chemical substances that were already manufactured/imported at the time of the promulgation of the Chemical Substance Control Law (CSCL) in 1973;
    - Notified chemicals by public notice from the three ministries (Approx. 6,100 substances);
    - Class I and II specified chemical substances;
    - Priority assessment chemical substances;


    All existing chemical substances and notified substances are given MITI numbers which are important for custom clearance.

    More info about Japan CSCL and new substance notification under CSCL can be found at:
    Japan CSCL