The biggest challenge in the new global regulatory environment created by REACH will be informational, according to Marc Dillon our Senior Product Manager. In order to be in compliance, chemical manufacturers will need to have all their information readily available in a single location that is auditable and verifiable.
The first step in managing this aspect of the challenge is to simply identify what information is actually needed. We suggest working with stakeholders in the organization to identify sources of information, gather up that data, evaluate the completeness and then try to fill in any existing holes. But maintaining and managing all this information can create its own set of challenges unless you know what to do with it.
Dillon recommends storing the information in a single database that allows users to query the information in multiple ways, view the information and then create the necessary reports. For example, with REACH you need to have information available for submission to the European Chemical Agency’s (Helsinki) IUCLID-5 application (this is the International Uniform Chemical Information Database, which serves as a common format to submit pre-registrations and registrations).
Our Essential Suite™ lets users export information out of their own database and put it into a format that is accepted by IUCLID-5. This is a time and, more importantly, error saver compared to the alternative of going to the agency’s website and filling out forms manually. But you wouldn’t want to buy something for a single use, and we’ve been careful to design Essential Suite so the information it collects can be used in many ways.
The advantage of a multiple-use system like Essential Suite, says Dillon, is that the information is available and can be accessed for other needs as well. The same system and information can be used to do things like generate labels and manage MSDS for chemicals that are stored and tracked in the system in order to comply with product stewardship initiatives.
Aside from the obvious benefit of serving as a data repository, Essential Suite can be used for multiple EH&S needs such as crisis management, risk management and compliance because the required information for associated reports is simply an output of the system.
REACH and other product stewardship initiatives are creating challenges related to what one expert refers to as the “communications circle,” or information sharing between external and internal business partners.
We regard REACH as a compliance issue; but it’s just as important to recognize that it is a supply chain issue. The entire supply chain is affected by REACH and everyone in that supply chain has to be in the know and in compliance for it to work. This is another case in which the information you have collected once, can be managed and output again.
Tags: chemicals compliance iuclid 5 msds product stewardship reach supply chain
July 8th, 2008
New international product laws and regulations are impacting nearly all industry sectors. According to a report recently published by Ernst & Young, regulatory compliance risk is the greatest strategic challenge facing global businesses in 2008. “The continually escalating burden, as well as ever more complex compliance challenges, means this is still the biggest business risk to be addressed.” The report went on to say that “as companies become more and more global, compliance becomes an even greater challenge, forcing them to manage diverse regulations in different markets. Industrial groups have speculated that by 2010, more than 75% of all electronic products will be sold in countries with legislation similar to the European Union (EU) Directives.”
Recent international environmental laws and regulations require comprehensive product requirements and chemical substance registrations designed to restrict the toxic effects of chemicals in products during one or more phases of the products’ life cycle. The most comprehensive regulations are referred to as “directives,” and have been adopted by the EU. It’s not just EU driving this trend. Similar environmental regulations are being adopted around the world, including China, Taiwan, Korea, Japan, Central and South America, as well as several Canadian provinces, and U.S. states.
Noncompliance is really not an option for companies selling their products internationally. Companies that fail to comply with such directives may not be able to sell their products in the EU and other countries. Market pressures like this now require companies to manage the health and environmental impacts across their products’ life cycles.
Three of the most important new EU regulations are the Waste Electrical and Electronic Equipment Directive (WEEE), the restriction of the use of certain hazardous substances in electrical and electronic equipment, or RoHS and the Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH).
WEEE requires producers of electrical and electronic equipment to register, arrange and pay for a product’s end-of-life collection and recycling. WEEE shifts responsibility from governments and the key enforcing authority to the manufacturers themselves.
RoHS requires manufacturers to restrict the use of certain metals and chemicals beyond a specified concentration value in electrical equipment. These substances have historically been critical components in the production of electronic products.
As I’ve mentioned in earlier posts, REACH impacts nearly all chemical manufacturers. The directive requires companies to identify and manage risks from chemical substances and provide safety information to all downstream users. Specifically, REACH requires every importer or producer of more than 1 metric ton of a chemical substance to register the substance and provide detailed information on the risks, hazards, uses and end-of-life characteristics.
As supply chains continue to become more global, these directives will have a significant impact on companies, their production processes and their ability to compete globally. For example, the U.S. electronics and automotive industries have spent millions of dollars complying with the WEEE and RoHS requirements since 2002, and more recently, U.S. chemical manufacturers, pharmaceutical companies and other manufacturers are working toward achieving compliance with other directives such as REACH.
To insure successful compliance with these directives, organizations need to take a proactive approach. This starts with developing a sound strategy, a regulatory road map and incorporation of information management systems to collect the required data, organize it and enable reporting both internally and externally. We are working hard at ESS to insure our software makes this effort easier, faster, more reliable and reduces the costs of compliance.
Tags: chemical substances ernst young eu regulations product stewardship reach rohs weee
June 25th, 2008
