Full article reprinted from "The Gray Sheet" - November 17, 2008
U.S. device manufacturers are pushing for more guidance on ways to comply with new European requirements for devices containing chemicals classified as "substances of very high concern."
European “Substances Of Very High Concern” List Published; Now What?
Full article reprinted from "The Gray Sheet" - November 17, 2008
The regulation applies to all companies that manufacture within Europe or import products into Europe.
Beginning immediately, companies whose products or product packaging contain any of the listed substances in concentrations above 0.1% will have to provide their customers with any information they have available on the substance, including, at a minimum, the name of the substance.
The regulation states that this information is to be provided "automatically," a term that has prompted questions from device makers.
In addition, firms must provide consumers, upon request, with any information they have on the safe use of a product containing a listed substance. Company responses should be issued within 45 days of the consumer request, free of charge, according to guidance from the European Chemicals Agency.
By June 2011, companies must notify the European Chemicals Agency if their products contain a substance on the list, but only if quantities of the substance in items produced in or imported into Europe amount to one ton or more per year.
The notification will not be required, however, if the producer or importer of an item can exclude exposure of humans and the environment during use and disposal of the device. In these cases, the company will have to supply appropriate instructions to the customer.
To be designated "very high concern," a substance must be carcinogenic, mutagenic or toxic to reproduction; persistent, bioaccumulative and toxic; very persistent and very bioaccumulative; or of similar concern based on evidence.
The list of substances of very high concern will be updated continuously as eligible substances are identified.
The list is called for under the European Community's broader Registration, Evaluation, Authorization and Restriction of Chemical substances (REACH) regulation, adopted in December 2006. The program overall is aimed at restricting the marketing and use of hazardous chemicals.
On The List: DEHP, Cobalt Dichloride
The Oct. 28 list includes the polyvinyl softening agent di(2-ethylhexyl) phthalate (DEHP) often used in IV-fluid bags, tubing, dialysis machines, blood oxygenators and other plastic medical devices to make them pliable.
In the U.S., FDA has also stepped up research into potential ill health effects of products containing DEHP in the wake of a National Institutes of Health brief citing concern over the potential for neural and behavioral effects in fetuses, infants and children exposed to the chemical (3"The Gray Sheet" May 12, 2008, p. 6).
Also on the substances-of-very-high-concern list is cobalt dichloride, which manufacturers sometimes add to the silicone desiccant packs that go inside device packaging to absorb moisture. The cobalt dichloride turns from blue to pink when it comes in contact with water, providing a visible indicator of moisture in products meant to stay dry, such as assays.
Other such salts are available when an indicating desiccant is needed, "but none used so widely as the cobalt one and none that have as clear a color change," AdvaMed European analyst Sarah Smiley explained.
A cobalt-free humidity indicating card is now available "that everyone is scrambling to move over to," Smiley added.
Compliance Questions Remain
Although the European Chemicals Agency has issued several guidance documents for industry on the REACH program, AdvaMed remains concerned about lack of clarity on a few compliance issues.
For example, companies will have to label any products containing substances on the very-high-concern list, but questions regarding where to put the label and other traditional labeling concerns remain unanswered, Smiley noted.
"It takes time to change package labeling - it doesn't happen overnight - and it doesn't address what happens to the inventory already in the pipeline and on the shelves," she said.
Regarding the requirement to "automatically" provide customers with information on listed substances, "We need to understand exactly what 'automatically' means," Smiley said. "Consultants are making a fortune arguing over things like, 'They do or do not mean a Web site reference.'"
Further, articles containing listed chemicals may be in companies' imported product, sub-assemblies and/or packaging, and "the systems required to identify if a SVHC is present in an article are quite complicated," according to Smiley.
Guidance from the chemicals agency says that "communication with suppliers is the best way for an article supplier to find out whether or not substances of very high concern ... are contained in the articles."
However, Smiley noted, "Contacting suppliers for article composition is a time-consuming and often fruitless exercise, as they often do not know what is in the article, or do not understand the difference between 0% and a less-than-detectable limit."
AdvaMed also hopes that before the European Chemicals Agency adds to the list, the agency will communicate how much time companies have to research the labeling changes they need to make.
Finally, AdvaMed is asking for clarification on whether the requirements apply to inventory already in the pipeline and on the shelves, Smiley explained. "Something like, 'As for inventory already in the pipeline ... that doesn't count ... it's whatever you ship starting the date the list is published," she suggested.
- Ingrid Mezo
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