The European Union has endeavored to regulate packaging and to promote recycling since the mid-1980s. However, many of the early packaging waste regulations did not clearly establish the link between waste management and the environment. Further, most national policies were not harmonized, creating a confusing jumble of rules and regulations.
In 1994, the European Council passed the Directive on Packaging and Packaging Waste (94/62/EC). While the directive has been in effect for a decade, many IVD/medical device manufacturers remain largely unaware of its requirement, and thus many are not in compliance. Now, authorities in the UK, Germany, and Italy are ramping up enforcement of the directive, and medical device/IVD manufacturers would do well to brush up on the major tenets of the directive.
The primary objective of the directive is simple: to reduce the volume of packaging waste. The directive also aims to prevent the negative environmental impact caused by improper disposal of non-biodegradable materials or toxic substances. IVD and medical device packaging frequently contains environmentally hazardous materials that the EU will try to phase out over the next few years. For example, many of the stabilizers, dyes, and other additives to device package contain heavy metals like lead, cadmium, and mercury. While authorities certainly recognize that device manufacturers cannot automatically eliminate certain materials which may be necessary for patient safety (regardless of environmental impact), the directive does require that IVD/medical device manufacturers account for and properly dispose of their packaging waste.
The directive concentrates on four areas of waste management: Prevention, Reuse, Recycling, and Recovery.
Prevention requires that manufacturers think through the design phase carefully so as to ensure that their packaging is as efficient and as environmentally friendly so that there is only minimal waste to dispose.
Reuse refers to the producer's responsibility to recover (that is, take back) packaging waste. Ideally, any necessary packaging could be reused for the packaging and shipment of future devices. Obviously, the feasibility of this option depends on the device itself.
If the package cannot be reused, then the directive requires manufacturers to recycle the components of the packaging, such as the plastic, the paper, or the glass, for future use.
If recycling for packaging purposes is not possible, then the directive does not allow the packaging to be dumped in landfills or to be recycled as combustible fuel. They msut still recover the packaging and recycle it organically to produce alternative energy sources like methane.
To be in compliance, IVD/medical device manufacturers must recover their packaging waste, and recycle a portion for future packaging. While the exact numbers vary somewhat by state, the directive states that manufacturers must recover 50-65% of their waste, and must recycle 25-45% of that recovered waste. Many experts expect that these target percentages will be increased when the directive is reviewed every five years. For example, authorities are expected to become much more stringent about the recovery, recycling, and eventual elimination of certain toxins. They are requiring that manufacturers decrease use of elements like lead and cadmium over the next five years.
There are a number of routes to compliance with the Packaging Waste Directive (94/62/EC), and some overlap with the procedures for compliance with other environmental directives, such as WEEE and RoHS. The specific paths are determined by individual member states. Let's examine a few of the largest markets.
Green Dot, in fact, satisfies most European waste management compliance requirements. Eco-Emballages and Valpak, in fact, are the licensing agents for Green Dot in France and the UK, respectively. At present, 22 nations, whether or not they have their own packaging scheme, participate in the Green Dot program.
All compliance-related data (including target percentages) will eventually be catalogued in a pan-European database. For now, though, IVD/medical device manufacturers in the U.S. should review the packaging waste directive and also review the applicable laws in each country in which they sell products. IVD/medical device manufacturers should also be aware that some collection and take-back schemes such as Green Dot require a European-based entity, which can be your Authorized Representative.
Considering some of the challenges facing non-European based manufacturers in complying with the directive, Emergo Group developed a service which allows IVD/medical device manufacturers to participate in the Green Dot scheme. For more information on how Emergo Group can help your company comply with Directive 94/62/EC, please visit www.greendotcompliance.eu.