1 2013 GHS Developments in La6n America Le$cia Cuevas Regulatory Analyst
2 First North American Country to adopt GHS Mexico When? Adopted UN GHS 3 rd edi$on June 4, 2011 Why? To assist the chemical industry already burdened with dual labeling and safety data sheet requirements. Before GHS adop$on, NOM STPS mandatory for chemical industry AXer GHS, chemical industry has op$on of using GHS (voluntary), or using NOM STPS (s$ll in force)
3 First North American Country to adopt GHS Highlights: Mexico GHS contains 5 Annexes that mirror the UN Purple Book 3rd Edi$on (2009) Annex 1 describes the alloca$on of labeling elements Annex 4 fully explains the 16- Sec$on format and content of the Safety Data Sheet. It is a voluntary standard, therefore there are no transi$onal periods When using GHS, all communica$on must be wricen in Spanish (as is required by NOM STPS- 2000)
4 Central American Countries soon to adopt GHS Guatemala GHS Pending Implementa$on Highlights Under second revision by the Ministry of Environment and Natural Resources GHS Regula$ons targeted for 2013 for Chemicals and Transport Include Classifica$on, Labeling and Safety Data Sheet requirements Currently, because there is no current regula$on in place, Guatemala accepts UN Purple Book
5 Central American Countries soon to adopt GHS El Salvador GHS Pending Implementa$on Highlights El Salvador has been working toward: Approved tariff codes related to pes%cides and ozone- deple%ng substances. On transport of dangerous goods. El Salvador accepts the codes set forth in the framework of the U.N. On special substance macer: waste and hazardous waste regula$on issued through (Decree No. 41, June 2000). Ar$cles 52 to 69 establish the kinds of iden$fica$on of dangerous materials and the type of labeling (which correspond to those that are accepted interna$onally for the transport of dangerous goods of the UN (Orange Book) and the emergency response Guidebook).
6 Central American Countries soon to adopt GHS Honduras GHS Pending Implementa$on Highlights The Ministry of the Environment and Natural Resources published: Environmentally Ra$onal Management of Hazardous Chemicals, which is the drax of the GHS regula$on. Classifica$on, Labeling and Safety Data Sheet requirements for hazardous chemicals Wai$ng to be signed by President of Honduras Like Guatemala, Honduras accepts UN Purple Book
7 South American GHS Countries Brazil ABNT NBR 14725: Chemicals - Informa$on about safety, health and environment (2009) Part 1: Terminology Part 2: Hazard Classifica$on Part 3: Labeling Part 4: Safety data sheet for chemicals (SDS) With the excep$on of Part 2, currently in review, the transi$onal periods have changed since 2009:
8 South American GHS Countries Brazil (con$nued) ABNT NBR Revisions Part 1: Terminology, Chemicals Informa$on about safety, health and environment- Corrected version: 2010 (in force) Part 2: Hazard Classifica$on (ABNT 14725:2009) - Corrected version 2010 (in force) - Under revision (update expected mid- 2013) Part 3: Labeling (ABNT 14725:2012) - June 14, Corrected version: Aug. 16, 2012 Part 4: Safety data sheet for chemicals (SDS) (ABNT 14725:2012) - Aug. 3, 2012
9 South American GHS Countries Brazil (con$nued) ABNT NBR Transi$onal Periods Ø While Part 2: Classifica$on, is s$ll being revised and, according to ABNT, should be ready some$me in 2013, the transi$onal periods under this regula$on: February 26, 2011 for Substances already expired June 1, 2015 for Mixtures Ø Part 3: Labeling of June 14, 2012 transi$onal period for Substances, has expired. Ø December 10, 2012 However, for Mixtures, using this standard is op$onal un$l: Ø May 31, 2015, BUT as of Ø June 1, 2015, chemical products MUST BE LABELED in accordance to ABNT :2012
10 South American GHS Countries Brazil (con$nued) ABNT NBR Transi$onal Periods Basis for ABNT was based on Ordinance SIT No. 229 (NR26) of May 24, 2011, issued by the Ministry of Labor and Employment Ø Part 4: Safety Data Sheet of August 3, 2012 transi$onal period for Substances, has expired: Ø February 3, 2013 But the transi$onal period for Mixtures is: June 1, 2015 ABNT :2012 is a 16- Sec$on Format based on UN Purple Book 3 rd Edi$on Language Requirement: the Safety Data Sheet must be prepared in Brazilian Portuguese
11 South American GHS Countries Uruguay GHS implemented through Presidential Decree 307/009 of July 3, 2009 Entry into force originally 120 days after publication in Official Gazette Transition period for labeling of chemicals was one year after its publication in Official Gazette. Annex 1 - Labels Annex 2 - Safety Data Sheets (SDS) adopt the guidelines of the GHS
12 South American GHS Countries Uruguay (Continued) But Decree 346/011 of September 28, 2011, published on Oct. 13, 2011: To extend the transi$onal period to give companies sufficient $me to comply with the labeling requirements To require min. labeling informa$on (Annex I) Substances (Dec. 31, 2012 expired) Mixtures (Dec. 31, 2017) To require min. informa$on on SDS (Annex II) Safety Data Sheet requirements mirror UN Purple Book - 16 Sec$ons, etc. Language Requirement: The SDS must be in Spanish language no macer where the chemical product was manufactured.
13 GHS Status of South American Countries Safety Data Sheet Argen$na IRAM Standards and GHS Alignment IRAM standard No /2006 of October 02 is an iden$cal adop$on of ISO (1: ) chemical safety data sheet with 16 sec$ons. According to IRAM, the standard is being revised for alignment with the GHS 4 th edi$on. (It was scheduled for late 2012 release, but now it needs to be updated with observa$ons ; therefore, a future release date is unknown.) Labeling IRAM on labeling of chemicals is also being revised. When published, it will also be aligned with GHS 4th Edi$on and will repeal IRAM 3797, currently in force. At this $me, the standard is up for public comments.
14 GHS Status of South American Countries Ecuador INEN Standards and GHS Classifica$on, Labeling and Packaging of Hazardous Chemicals Ecuador s GHS version was published in the Official Gazece No. 881 on January 29, Currently, the standard is voluntary, but once Technical Regula$on No. 078 is published, which could be in late 2013, INEN 2266:2013 will become mandatory. When this happens, both the standard and the Technical Regula$on will be required. The purpose of INEN 2266:2013: Ø It establishes the requirements that must be met for the transport, storage and handling of hazardous materials. Its Scope: Ø It applies to ac$vi$es in produc$on, marke$ng, transport, storage and handling of hazardous materials.
15 GHS Status of South American Countries Ecuador (Con$nued) INEN Standards and GHS The Safety Data Sheet (SDS) is found in Annex B, which has 16 Sec$ons and requires the SDS to be wricen in Spanish. The standard also specifies that the labeling of containers and packaging must also be in Spanish. NTE INEN 2266: 2013 combines the UN Purple and Orange Books: Annexes A through D are the Purple Book Component. Annexes F through L belong to the Transport Component (Orange Book). Labeling INEN 2288: 2000 This labeling standard for hazardous industrial chemicals is s$ll in force and it is mandatory. The standard contains label precau$ons and specifica$ons.
16 GHS Status of South American Countries GHS Status Peru Peru does not have a regulatory framework for labeling of chemicals and for Safety Data Sheets; however, it is working on ways to implement the GHS within its regulatory framework. Labeling and Safety Data Sheets Peru accepts labeling and Safety Data Sheets created under the UN GHS System Purple Book
17 Regional GHS Developments Mercosur- GHS There is a current ini$a$ve in coopera$on with the EC to implement GHS into Mercosur. Why? Total Harmoniza$on According to some experts, currently there is no total harmoniza$on, at least in La$n American countries: In Mexico there are a set of standard rules that implement the GHS regarding the classifica$on, labeling and chemical safety data sheets. However, they are voluntary. In Brazil there is a similar situa$on to the one in Mexico, we have a series of standards concurring with GHS, but some are believed to be voluntary. Argen$na has a voluntary standard concurrent also with GHS, but its Safety Data Sheet standard is voluntary. Ecuador s GHS standard is quite unusual with two Books in one, and un$l the Technical Regula$on is published, it is just a voluntary standard. Uruguay decree, which was modified to extend the deadline for implementa$on of substances and mixtures, requires the applica$on of the GHS.
18 GHS Standards Voluntary or Mandatory? Japan Japan s GHS concurring standards have obligated companies to use best efforts to comply. However, on 27 March, Japan published a new GHS- based standard, JIS Z 7253, combining two current standards. Under the new standard, the Japanese Ministry of Health, Labor and Welfare obligates companies to comply with the standard at the latest by 31 December 2016, when the transi$onal period ends and use of the two current standards is no longer allowed. Implementa$on of the standard, is 1 April Russia To determine whether Russia s GHS standards (GOSTs and GOST R) are voluntary or mandatory: Law on Technical Regula%on, N 184- ФЗ (as amended through March 3, 2012) specifies: Ø Art. 2 - GOSTs and GOST R are voluntary Ø Art GOSTs and GOST R are mandatory if: 1. related to environment or health, and 2. no specific technical regula$on pertaining to the subject is adopted Because Russia has no technical regula6ons on this subject maaer classifica6on, labeling and SDS, the GOST and GOST R are to be followed - mandatory)
19 Global GHS Developments Croa$a Now, Countries such as Croa$a are just concluding the prepara$on and capacity- building ac$vi$es for EC CLP and GHS. Highlights: Croa$a is to become the newest member of EU on July 1, ü Published on February 15 in the Official Gazece: Decision on the Proclama6on of the Chemicals Act (18/2013). - establishes the legal framework for implemen6ng in Croa6a the REACH, CLP, and Prior Informed Consent (PIC) Regula6ons (i.e., 1907/2006/EC, 1272/2008/EC, and 689/2008/EC), among others. ü Approved two amendments on February 6, 2013 to its current laws: implemen$ng the European Union s REACH and CLP Regula$ons, respec$vely.
20 Global GHS Developments Croa$a (con$nued) ü Published, on February 15, 2013, amendments (that enter into force July 1, 2013 on the day Croa$a officially joins the European Union): To expand the Ministry of Health s execu$ve powers with regard to the laws, sanc$oning it to issue regula$ons for REACH s and CLP s implementa$on in Croa$a, and To authorize other government agencies to act in its stead to do the same. - Most provisions of the act refer directly to EU legisla6on, applying community requirements for chemicals classifica6on, SDS compila6on, import and export, and marke6ng and use. - The act preserves some provisions specific to Croa6a, including the obliga6on to electronically no6fy the Croa6an Ins6tute for Toxicology and An6doping (CITA; before chemicals are placed on the domes6c market.
21 Global GHS Developments India has a drax concurrent with GHS, $tled, Hazardous Substances Rules, Published by Ministry of Environment and Forests on July 8, 2011 on: Classifica$on, Packaging and Labeling It covers 685 chemicals and classifies 9 classes of physical hazards The Labeling component is Harmonized with the transport of dangerous goods (UN Orange Book) Ø The Safety Data Sheet (SDS) has 16 sec$ons in a GHS format Ø AXer publica$on in the Official Gazece, the regula$on will become effec$ve 360 days axer publica$on.
22 2013 GHS Developments in La6n America Thank you.