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GHS is Coming! Implications for Chemical Producers and Manufacturers

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The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) is a United Nations program, with a target date for all countries (including the United States, and member states of the European Union) to implement by 2008. GHS addresses classification of chemicals and harmonized hazard communication, including:

  • Labels and safety data sheets
  • Information on physical hazards and toxicity from chemicals
  • Data are made available in order to enhance the protection of human health and the environment during the handling, transport, and use of these chemicals.

GHS provides a basis for harmonization of rules and regulations on chemicals at the national, regional, and worldwide level, which is regarded as an important factor for trade facilitation. It is therefore likely that whether addressing United States, EU, or other worldwide markets, GHS will affect your organization.

GHS requires chemicals to be considered for health hazards including toxicity, irritation, and sensitisation. Substances with concern for carcinogenic, mutagenic, or reproductive toxicity endpoints will be classified as CMRs, and will have mandatory phrases and pictograms that must appear on product labels. Further, because GHS is intended to harmonise rules and regulations worldwide, it is prudent to consider consequences of CMR classification in other countries.

GHS contains provision for classification of products, if the contents are known, without animal testing. This clearly may reduce the need for toxicity studies for each product dossier.

Specialist AdviceEU legislation (Marketing and Use Directive) specifies that products containing chemicals classified as Category 1 or 2 CMRs cannot be made available to the general public. Sales and use are restricted to professional specialist users. After re-registration of agrochemicals and biocides, most other chemicals will be subjected to the EU regulatory framework for Registration, Evaluation and Authorisation of CHemicals (REACH). REACH legislation is expected to be implemented by 2007 and to result in data submission requirements. A large volume of toxicity data will therefore be considered for classification and labeling, and many more chemicals will receive classifications that may impact permitted uses. Decisions taken within Europe under a harmonised system clearly have potential to be disseminated throughout the world, and vice versa. It is as yet unclear how differences between GHS and the current EU classification and labeling system will affect restrictions under the Marketing and Use Directive.

Classification of chemicals for hazard is an additional process to, and very different from, risk assessment. It is not necessarily a simple process. However, getting it wrong has potential to severely affect the financial viability of chemicals and chemical products. Particularly within the EU, proposals for classification have tended to be highly precautionary, with restrictive proposals sometimes being based on open literature publications of unknown quality over GLP studies, and in the absence of critical review or data weighting.

Incorrect classification and labeling is in no-one’s interest. Over-classification affects usage and impairs selection of safer chemicals over those less hazardous. Under-classification clearly may result in inappropriate use of less safe chemicals and products. Additional information on GHS is available at http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html.

FOR MORE INFORMATION CONTACT

Simon Warren is a Managing Scientist in Exponent’s Food and Chemicals practice, with more than 20 years of regulatory toxicology experience. His strengths are in carcinogenicity, endocrinology, and mechanisms of toxicity. He can be reached at 973-292-3031, or swarren@exponent.com.

Dr. Jessica Greene is a Senior Scientist in Exponent’s Food and Chemicals practice. Her experience includes investigating the mechanism of action and effects of toxic compounds on human health and biota. She can be reached at 510-268-5014, or jgreene@exponent.com.