The European Union Goes “Green” With Environmental Directives

By Evangeline Loh

If you have traveled through the European Union recently—even on a quick jaunt through the region— you surely saw the now-famous “green dot” symbol on packaging for many products.  Pick up a candy bar and examine the nutrition labeling (though, one wonders why anyone seeking a sweet treat would torture him/herself with such details), and a prominently displayed green dot most likely appears next to the calorie listing. This symbol, known as “der Grüne Punkt,” is courtesy of a packaging directive aimed at environmental conservation. (Note: Not all candy manufacturers are compliant with the directive and, presumably, not all candy manufacturers that display the symbol may be compliant.)

The Packaging and Packaging Waste Directive 94/62/EC has been transposed into national law—the green dot scheme is just one program that meets the terms of the directive—and it is applicable to medical device manufacturers. Yet, many manufacturers aren’t quite meeting those provisions.

The multitude of directives that have become mandatory in recent years highlights the importance of the environment to the European Union and the government’s interest in “going green.” But these directives, as transposed into national laws, present a certain challenge to the free movement of products within the European Union as they impose complicated national registrations. In addition, how well are member states enforcing the directives after they become a law?

Although this column has explored some of these directives in the past, they are constantly evolving and more environmentally friendly initiatives are being introduced. Therefore, it is important to periodically review these requirements.

Packaging and Packaging Waste

Directive 94/62/EC, amended by Directive 2004/12/EC, previously required that member states introduce systems for the return or collection of used packaging to attain prescribed targets by June 30, 2001 (original directive) and then Dec. 31, 2008 (amended directive). A more recent directive (2005/20/EC) extended the deadline to Dec. 31, 2012, for the 10 newer EU member states.

As a reminder, to be compliant in each member state, the manufacturer registers and pays the applicable fees in each country. This obviously poses a challenge, as packaging with the green dot should be placed only in member states where the manufacturer has registered its product.

While some question the effectiveness of the packaging directive, member states appear to have reached their targets of recovering the prescribed percentage of packaging waste and reducing greenhouse gas emissions. However, debate continues about how well member states enforce the directive in terms of medical device packaging. A report by the European Commission acknowledged that “packaging prevention is both complex and difficult to implement effectively.” One mechanism that has been identified as a successful way to enforce compliance is to ensure that public authorities in each state require compliance with environmental regulations before granting the device access to the purchasing and tender process.

Electrical and Electronic Equipment Waste

Similar to the packaging directive is the Directive on Waste Electrical and Electronic Equipment (WEEE) (2002/96/EC). Producers of electrical and electronic equipment—medical devices included (Annex IB, paragraph 8)—are required to provide financing for the collection, treatment, recovery and environmentally sound disposal of medical devices that contain electrical or electronic components. Since August 2005 (Article 10), member states have been obligated to ensure that electronics producers mark this type of equipment with the “crossed-out wheelie bin” symbol (per Annex IV). Manufacturers that include this symbol on their products must register the product with the national Producer Compliance Scheme (PCS) and pay the associated fees.

Although transposition of the WEEE directive initially was delayed in the United Kingdom, the directive became law on Jan. 1, 2007. In the United Kingdom, a manufacturer must have been registered with a PCS as of March 2007 or be fined up to 5,000 English pounds in a magistrate’s court—or even receive an unlimited fine in a Crown court. BS EN 50419:2006, a voluntary standard, further describes the WEEE marking requirements related to symbol position, visibility, dimensions and location. (Note: This information only pertains to compliance with the WEEE in the United Kingdom; thus, producers must investigate the requirements for each member state in which they intend to market their medical devices.)    

Waste From Batteries and Accumulators

Get ready, because Directive 2006/66/EC must be transposed by member states and in effect by Sept. 26, 2008. This directive establishes rules regarding the placement of batteries and accumulators in the market, and it also outlines rules for the collection, treatment, recycling and disposal of waste from these items. Specifically, member states must restrict the placement of batteries and accumulators that contain more than 0.0005% of mercury by weight.

As with the other environmentally conscious directives, member states are required to develop schemes for the collection of waste from batteries and accumulators; in addition, member states have been provided with collection targets to achieve minimum collection rates. And, the WEEE directive’s “crossed-out wheelie bin” symbol similarly is used to indicate separate collection of batteries and accumulators.

Mercury

Directive 2007/51/EC, which will become law as of Oct. 3, 2008, restricts the placement of new non-electrical measuring devices containing mercury intended for sale to the general public. Medical products falling under this device category include thermometers such as those you use to check for a fever, as well as manometers and sphygmanometers. The directive is intended to reduce the amount of mercury to benefit the environment and, in the future, to benefit human health by decreasing the amount of mercury entering the waste stream.

Although the directive will be transposed this fall, member states won’t be required to enforce their national laws until April 3, 2009. In addition, mercury-containing devices that already are on the market or are sold second hand will not be impacted.

Phthalates

Among other modifications, Directive 2007/47/EC (in accord with Annex I of Directive 67/548/EEC) addresses the European Union’s increasing concern about leakage from devices containing substances that may be carcinogenic, mutagenic or toxic to pregnant women and their fetuses. Phthalate—which can be toxic to humans—was of particular concern.

Per Annex I, Essential Requirement 7.5, if a device administers or removes medicinal products, or transports or stores bodily fluids, and contains phthalates that are carcinogenic, mutagenic or toxic, the product must be labeled accordingly. A special consideration must be given for devices that are intended for use with children, pregnant women or those who are breastfeeding. In addition, the European Commission now is charged with requesting that CEN, the European Committee for Standardization, provide technical requirements and a label for devices that contain phthalates.  


Various EU directives not described in this article also pertain to waste management and the restriction of certain substances. The intent of this column is to simply demonstrate the region’s attention to environmental issues and illustrate what’s been enacted by the European Union to do its part to be more eco-friendly. Simultaneously, it serves as a reminder of the rash of new directives that impose national schemes to which a medical device must adhere. As a medical device manufacturer, one needs to ensure compliance with the applicable directives as transposed and consider the label expectations and be sure you are meeting these “green” requirements—or that you are preparing to do so as necessary.

Evangeline Loh, PhD, RAC is director regulatory affairs of Emergo Group, a consulting firm that provides quality assurance, regulatory affairs and distribution services. Emergo Group has offices in the United States, Europe, Canada and Australia. Evangeline can be reached at [email protected].