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HORIZONS
REGULATORY AFFAIRS UPDATE
Twelfth Issue
Fall 2000

INTRODUCTION
In the Spring 2000 issue, we described how and why business and regulatory issues must evolve and expand concurrently. For a variety of reasons, there is an increasing need to provide enhanced information about our products. First there are the established customer data requirements of environmental regulations. In addition there is a need to support the global strategies of many larger end users. Finally, there are the requirements in certain markets to disclose the complete chemical composition of our formulations.

Having the capability to track the materials of construction of a product via the CAS# for each component is key from a regulatory perspective. This capability provides us with a way of searching various global inventories. It also allows toxicological assessment of our products where required by the end user.

The need for this information is primarily driven by the end user, who has defined a development and marketing plan for some printed product. The printer, as a stakeholder, can also be a conduit for required certifications directly with the ink supplier. These disclosure mechanisms not only require interaction with the end users and printers, but also must involve the ink manufacturer’s raw material suppliers. In this information chain, all elements must help to define issues and deliverables, and to work through potential barriers, such as confidentiality of proprietary information.

The ability to track ingredients in products at the CAS level can be an onerous responsibility for ink makers. We use more than 4,000 primary raw materials, and our active formulations number more than 125,000. Because the issues and mechanisms of formula disclosure can be involved, or may not be fully appreciated, we thought it useful to give an overview of this process. This overview should provide clarity and better understanding of this key process within the expanding venue of globalization.

DISCUSSION
The disclosure process requires the ability to pass detailed chemical information through several levels of formulated products all the way to the end users. This process has been dubbed "chemical tracking" within Sun Chemical. But the tracking doesn’t start with us as the ink maker. It starts with the gathering of information from all our raw materials suppliers. The ink maker’s supplier is the first step in the information chain, followed by the ink maker, then the printer, and finally the end user.

Detailed formula information transfer requires support systems and controls. Sun Chemical’s automated tracking and database systems are designed to break down our formulations into individual chemical ingredients. However, the outputs are entirely dependent upon detailed regulatory data, including CAS numbers, from raw materials suppliers. Because needs are not static, there is a continuous need to update our databases and our control processes. For example, with an eye towards satisfying increasing customer focus on global issues, we have recently expanded our raw material reporting requirements through a vendor outreach program.

The changing need for completeness of the chemical data also creates barriers. The new data requirements have created pressure in certain supplier situations, especially where the vendor considers some information to be confidential. Increasingly, the issue is becoming a legal one. Within our industry, legal documentation is routinely put into place to address mutual corporate guidelines for sharing confidential information. So, as a part of doing business, Sun Chemical chooses to establish secrecy agreements, where needed, to surmount barriers. These agreements secure the flow of information from our suppliers and subsequently, in a derivative form based on our formulations, to our customers and end users. Our formula disclosures are only directed downstream under these constraints.

The management of the disclosure processes is a very costly one in large companies such as Sun Chemical. Not only does the creation and maintenance of such a disclosure process call for a substantial investment, but maintaining the databases that automate the process and ensure its quality is labor intensive as well.

STATUS
Now that the need for downstream information and the processes for creating it have been established, it is important to question how it is working. The answer is that it has been successful. But, there have been several problems that we must overcome.

For one thing, approaching suppliers for more detailed data on raw materials has met with some resistance. Most of the initial difficulties were a matter of communications: what information was expected and how to convey it. In some cases, the need to protect proprietary information has required the secrecy agreement pathway. An important point is that the information passed on to customers is filtered through Sun Chemical’s own formulations, using the CAS number as the key. This creates a firewall that never associates a chemical as coming from any specific supplier, thus protecting the confidentiality of all our suppliers.

Another problem has been that large customers or end users often have different information delivery concepts. This inconsistency adds another level of complexity to our processes. In some cases, the requirements are different among locations within one customer. However, most of these difficulties can be resolved by improved communications.

CONCLUSION
In summary, the need to control information about raw materials is considered so important to us that we have restructured the regulatory function. All requests for new raw materials, as well as the coding process, are now within the regulatory purview. All CAS level information about a raw material must be entered into the master database before a code number is issued, allowing the material to be purchased. This is a dramatic change from our previous processes. Only in this way are we able to guarantee our customers and end users that needed information will be available downstream by the time the first pound of a new formulation is sold.

At Sun Chemical, technical innovation is one of our most highly prized values. We think it is important for our customers and end users to also be aware of the commitment to continuous improvement demonstrated by our service groups. Their main mission is to support innovation and your satisfaction.