Smaller World The Implications of GHS and REACH
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Smaller World The Implications of GHS and REACH

Both were developed in the international arena and both have already influenced chemical policy well beyond their original borders.

By Marisabel Torres, Government Affairs Associate, SGIA

Regardless if your business deals directly with international markets, in the chemicals world, what happens in other parts of the globe may very well affect your business too.

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  • Such is the case with two significant chemical policies: The Globally Harmonized System (GHS) for chemical classification and labeling, and the Registration, Evaluation and Authorization of Chemicals (REACH). Both were developed in the international arena and both have already influenced chemical policy well beyond their original borders.

    These are topics SGIA has been following for some time. REACH is now in effect in the European Union, and the U.S. Occupational Safety and Health Administration (OSHA) has promised to issue its final rule on the adoption of GHS by December 2008. This final rule would lay out the exact provisions of the GHS that OSHA will adopt. These provisions, referred to in the GHS' official text as "building blocks," will bring changes to OSHA's Hazard Communication (HazCom) Standard.

    The key difference between these two chemicals policies is that GHS is a voluntary framework that countries chose to adopt while REACH is actual legislation carrying legal requirements for any company producing, importing, using or placing a substance, preparation or article in the EU market.

    GHS
    The GHS was created by the United Nations after the 1992 Conference on Environment and Development. It was part of an initiative backed by the UN General Assembly to strengthen international efforts concerning the environmentally sound management of chemicals. At this conference, it was recognized that in order to ensure all countries could develop a program for the safe use of chemicals, an internationally harmonized approach to chemical classification and labeling would be necessary.

    What GHS lays out is criteria for identifying hazards associated with chemicals; classification processes that use the available data on chemicals and compares it with defined hazardous criteria; and, the tools necessary for effective hazard communication. This system is specifically focused on changing the existing information provided to chemical users on labels and Material Safety Data Sheets. If you are familiar with today's ways of presenting this kind of information, you may know there is no consistency in it. GHS hopes to change this.

    For OSHA, adoption of GHS means modifying the current HazCom Standard, a standard which has not been modified for almost 20 years. OSHA say the standard covers more than 7 million workplaces, more than 100 million employees and around 945,000 hazardous chemical products.

    Any workplace that has hazardous chemicals is required by OSHA to have a hazard communication program, including proper training on container labels and material safety data sheets. An important characteristic of the current HazCom Standard is that it is "performance-oriented," meaning it has established requirements for labels and safety data sheets. However, it does not provide specific language to communicate this information, nor a format in which it is to be presented.

    The GHS, as OSHA proposes to adopt it, would modify the HazCom Standard to a specification-based system, changing the look of labels and MSDS, as well as chemical classifications. OSHA hopes the GHS adoption will result in an elimination of incompatibilities and inconsistencies in the ways chemical hazards are communicated. GHS would introduce uniformity in both the substances contained in labels and MSDS' as well as in their formats.

    The use of mandatory pictograms also would be required. They would help in overcoming language and reading barriers. In this regard, it becomes apparent how a globally harmonized approach to these issues will facilitate in ensuring the safety around the world for workers whose jobs require them to come into contact with hazardous chemicals.

    REACH: EU and Beyond
    The chemical sector is the European Union's third-largest manufacturing industry. The EU is the world's leading chemical-producing area, with the global production of chemicals totaling around 400 million tons annually. Chemicals are prevalent in our world. However, as prevalent as they are, there is still much we do not know about the long-term effects their exposure has to us or to the environment.

    It is for this reason that REACH was originally proposed. Before REACH, EU chemical legislation distinguished between chemicals put on the market after 1981, called "new" substances, and those put on the market before 1981, or "existing" substances. New substances were tested and notified to the authorities before they were marketed. There was not enough information on existing chemicals for public authorities in charge of this process to keep up with the demand for information. REACH hopes to fix this.

    REACH requires any importer and manufacturer of substances in quantities greater than 1 ton per year to register with the European Chemicals Agency. REACH also requires the registration of substance mixtures imported or manufactured in quantities of more than one ton per year. Chemical manufacturers and importers of chemicals have to be established in the EU in order to register. Non-EU manufacturers can appoint an EU-based representative for the purposes of registration. This can be a subsidiary, consultant or any natural or legal citizen with chemical-handling experience.

    Authorities from each EU member state are allowed to examine registrations in order to evaluate if a substance presents a risk to human health or the environment, and determine the need for possible authorization or restrictions (in terms of marketing or use). There are different categories for substances requiring authorization each time they are used. They are grouped according to the level of toxic elements they contain and the impact they may have on humans and the environment. At the evaluation stage, the agency can ask registrants to provide additional information on substances, and determine if the substance is subject to authorization.

    Authorization is required for substances of "very high concern," a category that includes carcinogens and chemicals that are mutagenic and toxic to reproduction; substances that are persistent, bioaccumulative and toxic; endocrine disruptors and substances which "give rise to an equivalent level of concern."

    This stage of REACH is independent from registration and evaluation, so even substances that are not subject to registration can be subject to authorization. Authorization will be granted if a user is able to demonstrate risks can be adequately controlled. If there isn't substantial evidence, authorization will only be granted if the socio-economic advantages of the specific substances use outweigh the risks.

    Member states can make the proposal to the European Chemicals Agency to ban or restrict the marketing and use of a substance. The agency will make an opinion on it, and leave it up to the European Commission for a final decision. If a substance is restricted at the EU level, it cannot be authorized for a particular use.

    In short, REACH puts the burden on business to show the chemicals they use are safe. Even more importantly, the overall aim of REACH is to encourage the replacement of hazardous chemicals with safer ones, and spur the chemicals sector in researching and developing more new products.

    Although REACH will truly only affect companies that do business with or within the EU, the kind of information gathering this legislation will generate has piqued the interest of other countries. To date, the United States, Canada and Mexico are moving forward in a joint effort to take inventory of the chemicals in commerce within the three countries. This trialogue is focused on chemical management in North America and will most likely address risk evaluation and the prioritization of chemicals, issues that caused much tension during the development of REACH in the EU.

    In today's global economy, these issues become more and more relevant. Gaps in information can lead to serious consequences to the safety and health of workers who come in contact with these chemicals in their occupation, or their personal lives, as well as to the environment.

    The threat of chemicals being used as weapons also exists. All of these scenarios point to the need for as much information on chemicals as we can have. The tricky part for governments will be to balance this against over-regulation of the chemical industry, to the point in which companies can no longer afford to stay in business because the regulation cost is too high. In the next five to 10 years, we will definitely see a shift in the way chemical information and hazards are communicated on a worldwide scale. The requirements placed on industry will hopefully only serve to drive innovation, and contribute to a healthier and more prosperous future.

    This article appeared in the SGIA Journal, 4th Quarter 2007 Issue and is reprinted with permission. Copyright 2007 Specialty Graphic Imaging Association (www.sgia.org). All Rights Reserved.

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