Next-Phase GHS 2015 Deadlines Loom: Time to Re-Author, Re-Label, and Refocus on Mixtures
Within the next 12-18 months, companies are facing multiple deadlines for various country adaptations of the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). These include major re-evaluations of how chemical mixtures and substances are classified, re-authoring of Safety Data Sheets (SDS), and re-labeling requirements for the U.S., the European Region, Brazil, Serbia, Malaysia, Australia, and South Africa. Each country or region has adopted various building block elements of the UN GHS model system as well as varying requirements for how these building blocks are applied.
|Malaysia||April 17, 2015|
|U.S. OSHA HCS 2012||June 1 2015|
|EU CLP Mixtures||June 1 2015|
|Brazil Mixtures||June 1, 2015|
|Serbia Mixtures||June 1, 2015|
|South Africa Mixtures||January 1, 2016|
|Australia||December 31, 2016|
The deadlines are at times only applicable to mixtures, while for other countries, the deadline to meet these vast changes could impact any applicable chemical product.
At this point, ideally most manufacturers should have begun the process for the necessary re-evaluation of each product subject to the regulations and started to re-author or at least implement the steps needed to re-author existing Material Safety Data Sheets (MSDS) or SDSs to the new SDS criteria and formats required in each country/region.
Re-labeling is also one of the most time intensive aspects of these regulations. With the requirements to include specific labeling elements, not previously utilized in many of these countries/regions, manufacturers and distributors should have started planning and designing new label templates as well as assessing how much anticipated time could be needed to re-label inventory.
Below are summaries of some of the key points for hazard evaluation, SDS, and label generation for each country/region.
For the U.S., on May 26, 2012, the Occupational Safety and Health Administration (OSHA) issued a final rule modifying its Hazard Communication Standard (HCS) to conform to the UN GHS, Revision 3. In the final rule, OSHA drastically modified the process for which hazards are classified and the elements required on MSDSs, now called SDSs, as well as labels.
The regulatory implementation phase is currently underway. The deadline to train employees on the new label and SDS format was December 1, 2013. The deadline for all labels and SDSs to meet the new criteria is June 1, 2015, for everyone except distributors who may ship products with the old labels until December 1, 2015.
The scope of the new rule is primarily the same as it requires any chemical manufacturer or importer to classify the hazards of their chemicals and all employers to provide hazardous chemical information to their employees.
The most significant changes occur in the means by which chemical hazards are defined. There are six new Appendices — five are considered mandatory and one is provided as guidance. Appendices A and B contain the criteria for classification for health and physical hazards for substances and mixtures. Appendix C includes the required elements for labels and Appendix D includes the required elements for the SDS. Appendix E relates exclusively to trade secrets. The optional guidance in Appendix F relates to carcinogenicity classification.
The SDS requirements also clearly stipulate the document must be 16 sections and that Sections 12, 13, 14, and 15 are included to maintain consistency with GHS, but contain non-mandatory information as these are directly related to other agency jurisdictions like Section 14 for transportation classification and the U.S. Department of Transportation (DOT).
For more details on the specifics, see online.
For the European Region, the next phase of implementation for the Classification, Labelling and Packaging regulation (CLP) (EC No. 1272/2008) deadline coincides with the U.S. The CLP deadline differs from the U.S. in that it is the second of two deadlines. The first was December 1, 2010, for applicable substances and replaced Directive 67/548/EEC. The June 1, 2015, deadline is for applicable mixtures and replaces Directive 1999/45/EEC.
The CLP regulation came into force on January 20, 2009, and included both a list-based approach and criteria-based approach for classification of substances. The CLP regulation is currently in its 5th Adaptation (Commission Regulation (EU) No. 944/2013). The scope is similar to the previous substance and preparations directives that this regulation replaces and more details are located in Article 1 Purpose and Scope.
The list of regulated substances along with any applicable concentration dependent labeling is located in Tables 3.1 and 3.2 of Annex IV. The criteria are detailed in Annex I Part 2 for physical hazards, Annex I Part 3 for health hazards, and Annex I Part 4 for environmental hazards. The criteria are meant to align with the UN GHS, but there are many aspects of the EU Adaptation that are unique to that regulation and careful consideration is needed when assessing substances and mixtures to ensure compliance.
The labeling requirements are more intensive than those detailed in the UN GHS with required elements, including specified package, pictogram, and text dimensions. There is also consideration made to limit the number of precautionary phrases on a label, which deviates from the UN GHS as well as the U.S. versions. There is helpful guidance available through the European Chemicals Agency (ECHA) for navigating this aspect (see online).
The SDS design and content are not located with the CLP regulations, but rather are specified in Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation No. 1907/2006, which replaced Directive 91/155/EEC. The SDS regulation went into force on June 1, 2007, and included the necessary elements to accommodate the June 1, 2015, mixtures requirements from CLP. The SDS-specific provisions are found in Annex II (see online).
For more details on the specifics, see online.
For Malaysia, the regulation is known as the Occupational Safety and Health (Classification, Labelling and Safety Data Sheet of Hazardous Chemicals) Regulations 2013 or CLASS, which was published on October 11, 2013. The Industry Code of Practice on Chemical Classification and Hazard Communication (ICOP) issued guidance to assist chemical suppliers with the application and provisions of CLASS that are legally binding. The scope is very similar to the UN GHS model and how it applies to products for Malaysia can be found in Part 1 of CLASS. The deadline for implementation is April 17, 2015.
The SDS-specific information is found in Part V and details the requirement elements as well as the order in which these elements are to appear in the document. There is also a part (Part VII) specific to confidential business information that could be utilized for applicable chemistries.
The applicable building blocks and hazard classification approach is similar to the CLP described above in that it includes a list-based required substance classification along with a criteria-based approach for mixtures and substances not listed. These are both located in Part 1 and Part 2 of the ICOP.
The labeling elements appear in Part IV and include specified dimension requirements similar in nature to the ones adopted by the European Region, as well as specifics on precedence of hazard statements and pictograms.
The language requirements for the SDS and label are found in their prospective parts as described above and indicate the “national language and English language” are required. The national language is Bahasa Malaysia (Malay).
For Brazil, the standard is broken into four parts and was based on the UN GHS 3rd Revision, and is closely aligned with all the building blocks and criteria. There are no substance-specific classification requirements much like the U.S.
The implementation was phase-based with the first phase applicable to substances meeting the criteria to comply by 2010. The next deadline applies to mixtures and coincides with both the U.S. and European Region deadlines of June 1, 2015.
The scope and hazard classification criteria are defined by Brazilian standard ABNT NRB 14725-1: 2009 and ABNT NRB 14725-2: 2009. The SDS standard is known as ABNT NRB 14725-4: 2009 and is a standard 16 section SDS design similar to the UN GHS model. The labeling standard, ABNT NRB 14725-3: 2009, allows for much flexibility, but there are some specific elements that are to be considered.
The SDS and label are required to be presented in the national language of Brazil, which is Brazilian Portuguese.
As this is the second phase of this regulation, most manufacturers should have a general working knowledge of how to manage this regulation. For more details, see online.
For Serbia, the official text is known as Official Gazette of the Republic of Serbia No 64/10 and was adopted in 2010. Since Serbia is not part of the European Union (EU), this standard is considered separate from the CLP described above, but there does appear to be a strong correlation between the Serbian GHS regulations and the EU CLP, including the deadline of June 1, 2015, for applicable products.
The hazard classification approach for Serbia appears to be both list- and criteria-based and very closely relates to the CLP with a similar approach to which UN GHS building blocks apply.
The SDS regulation is separate from the classification criteria, similar to the European Region, and is governed by Official Gazette of the Republic of Serbia No 36/09 and No 81/10. It is a standard 16 section format with some specified headers, but it does not appear to require the specific sub-headers that are required in the European Region.
The labeling elements also appear to have the same level of specificity as the CLP, including graphic dimensions and package size requirements, and are located in the official text. The language required for the label is Serbian with provisions for other languages as long as the details appear in all languages presented.
For more details, see online.
For South Africa, the GHS legislation is overseen by many national bodies and is known as SANS 10234:2008. This GHS regulation includes a full adaptation of UN GHS Revision 2 for its basis. The regulation is currently in a transition period, with substances being required by 2012 and mixtures being required by 2016. No month is specified.
The SDS is a standard 16 section format with the UN GHS recommended headers and details.
The labeling requirements are fairly standard and appear to be flexible with template design. There are some unique elements to consider, including specified dimensions, required review periods to ensure new information is properly addressed, and some chemical- and product-specific information requirements.
For more details, see online.
For Australia, the GHS implementation is based on the UN GHS 3rd Revision; except for some variation in building blocks and classification ranges; it is fairly close to the UN model. The legislation is currently in a five-year implementation period, which means that by December 31, 2016, all products must meet the new standard.
The scope for hazardous chemicals, SDS, and labeling appear to be laid out completely in Part 7.1 of the model Work Health and Safety Regulations (WHS), which are under Section 276 of the Work Health and Safety Act. It appears to be similar in nature to U.S. OSHA and the Department of Labor.
The SDS is still a standard 16 section format with traditional headers. There are provisions for the inclusion of the new GHS elements, but it does appear to be very similar in requirements to the existing standard.
The labeling requirements are standard with allowances for reduction precautionary statements when necessary, small container, and research and development considerations. There are some unique elements, like specified dimensions, inclusion of expiry dates, and consideration for nanomaterials.
For more details, see online.
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