The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) compliance deadline is fast approaching. If you are a producer, supplier, importer or exporter of chemicals or chemical-containing products in the EU as well as various other countries worldwide, then mark June 1, 2015, on your calendar -- this is the official implementation date.
GHS was adopted by the United Nations in 2003 in response to the major problems facing the chemical industry worldwide due to inconsistencies between national and regional systems for chemical classifications.
Manufacturers and distributors have the responsibility to gather the relevant information and review this data to determine the hazards relating to the product in question. These products have to be classified using the GHS criteria, incorporating bridging principles as necessary to determine the hazards for mixtures. The GHS format of the Safety Data Sheet (SDS) has to be followed. This consists of 16 sections, each with its own specific requirements. Labels have to match the SDS provided, and therefore must be updated accordingly.
Many countries worldwide have adopted the GHS requirements and are at varying stages of implementation. Even under GHS, there are specific requirements for each country and these may differ by region due to adoption of different building blocks and languages.
Throughout the manufacturing industry, one concern of the small and medium sized enterprises (SME) is the authoring of a compliant SDS. In many cases, the SME cannot afford a full-time employee for this purpose, and with so many variations in GHS adoption, not to say the different revisions of GHS that have been implemented, the additional work involved for an already over-worked employee makes the task almost impossible. And what about new products? Where would you start?
An SDS is required to have specific information in each of its 16 sections. Generally speaking, the SDS should be written in the language of the country to which it is supplied, but should also be produced in the language of the manufacturing site to safeguard the companies own workforce.
A summary of each section is as follows (based upon the GHS legislation and not the country-specific variations):
Section 1: Identification – product identifiers, other means of identification such as synonyms, company product codes. Recommended use/uses advised against. Manufacturer/Suppliers details. Emergency contact number.
Section 2: Hazard Identification – Classification of the substance/mixture. Pictograms. Signal word. Hazard statements. Precautionary statements. Other non-GHS hazards.
Section 3: Composition/information on ingredients -- common names, synonyms, CAS number, percentage composition.
Section 4: First aid measures – immediate first aid measures for inhalation, ingestion, eye contact and skin contact. Also delayed symptoms for each.
Section 5: Fire-fighting measures – suitable and unsuitable fire extinguishing media. Hazards arising from the chemical. Advice for fire fighters.
Section 6: Accidental release measures – personal precautions for non-emergency personnel and emergency responders. Environmental precautions. Methods and materials for containment and clean up.
Section 7: Handling and storage – precautions for safe handling and storage including incompatibilities.
Section 8: Exposure controls/personal protection – control parameters, engineering controls, PPE, exposure limits specific to the country in question.
Section 9: Physical and chemical properties – such as color, odor, melting point (a full list is available online).
Section 10: Stability and reactivity – Reactivity, chemical stability, hazardous reactions, conditions to avoid, incompatible materials, decomposition products.
Section 11: Toxicological information – acute toxicity, skin corrosion/irritation, serious eye damage/irritation, respiratory/skin sensitization, germ cell mutagenicity, carcinogenicity, reproductive toxicity, STOT single/repeated exposure, aspiration hazard. Toxicological data LD50/LC50s for each component. Routes of exposure, symptoms relating to these characteristics, both acute and chronic.
Section 12: Ecological information – aquatic toxicity (fish, daphnia, algae), persistence and degradability, bioaccumulation potential, mobility in soil, other adverse effects.
Section 13: Disposal considerations – disposal methods for both empty containers/packaging and waste products.
Section 14: Transport Information – UN number, proper shipping name, transport hazard classes, packing group, environmental hazards, special precautions for user, MARPOL/IBC code categories where appropriate.
Section 15: Regulatory information – safety health and environmental regulations specific for the product and relevant to the countries in question.
Section 16: Other information – date of preparation, abbreviations and acronyms, references and sources.
When a company creates a new product, it may be difficult to know where to start with respect to SDS authoring. The key section on the SDS is Section 3. This is what the whole SDS revolves around. The components of a product dictate its classifications where there is no test data available.
SMEs may have a problem in producing specific product test data especially toxicological data due to the costs involved, and in accordance to the legislation, it is possible to use that of the individual components to aid classification. By looking at each component in turn, and using bridging principles as found in the legislation, these classifications can be calculated. These can then be used to assess and complete most of the other sections of the SDS, to produce a GHS compliant SDS. There are various sources online that can assist in the completion of acute toxicity data for the individual components as can affiliation to a regulatory service.
Sharon Brody is a an MSDS author and GHS compliance consultant at GTS Translation Services. Sharon has an M.Sc. in Environmental Resources from the University of Salford in the UK. GTS is a translation company that specializes in international MSDS compliance and translation of MSDS in compliance with relevant national regulations.