Medical Device Link.

Originally Published IVD Technology January/February 2005

Regulations & Standards

Philipp Novales-Li, PhD, DMedSc, DPhil, is director of scientific and regulatory affairs at BioGenex Laboratories Inc. (San Ramon, CA) and can be reached at philippn@biogenex.com.

IVD products containing packaging materials that are introduced into the European Union (EU) market are required to comply with the European Council Directive on Packaging and Packaging Waste (94/62/EC). This directive focuses on four major areas: preventing packaging waste, reusing packaging materials, recycling, and other forms of recovering packaging waste.¹ In order to support a proenvironment policy, the directive’s main objective is reducing the overall volume of packaging waste brought into the EU market, and also limiting the impact of packaging waste on the environment.
The first installment of this article (IVD Technology, November/December 2004) presented an overview of the directive, highlighting its history, enforcement status, and essential requirements.² The directive’s essential requirements cover various measures that are imposed on EU member states and IVD manufacturers.

One of the requirements involves recovery and recycling issues. Member states are required to reach certain target goals by implementing measures that ensure recovery of packaging waste and recycling a portion of the recovered waste.

Another requirement focuses on the return and collection of used packaging waste from end-users through waste management programs. Manufacturers are also required to use a marking and identification system that indicates the nature of the materials used in the packaging.³ In addition, reducing the toxicity of packaging waste by eliminating the use of heavy metals, such as lead, cadmium, mercury, and hexavalent chromium, is required.⁴

This installment will discuss the compliance schemes that IVD manufacturers may use. This article will also address standards and guidance documents that are germane to this packaging regulation, as well as new developments on the implementation of the directive.

Complying with the Directive

Directive 94/62/EC covers all packaging that is placed on the EU market, regardless of whether it comes from products used at home, or in hospitals and labs. Packaging can be categorized into three groups: primary or sales packaging used by end-users (e.g., bottles, carrier bags); secondary or grouped packaging for shipping products (e.g., cardboard boxes); and tertiary or transport packaging used by industry rather than consumers (e.g., crates, pallets).

Since the directive does cover packaging used in IVD products, IVD manufacturers must address two main compliance areas to meet the requirements of the directive. The first area stipulates that manufacturers need to label their packaging using the appropriate marking and identification system. For example, the Möbius loop, proposed by the International Organization for Standardization (ISO; Geneva), is the international symbol that indicates an item can be recycled. However, use of this particular symbol is still voluntary. Consequently, manufacturers must ensure that their vendors comply with the essential requirements by providing packaging materials that adhere to the acceptable limits of heavy metals, recoverable materials, etc.

The second area pertains to the recovery of packaging waste. The directive indirectly calls for IVD manufacturers to be responsible for their products and packaging throughout their entire life cycle. Manufacturers and distributors must either implement their own packaging waste take-back schemes or participate in third-party collection systems that manage packaging waste. Such third-party collection systems would assume a manufacturer’s responsibility for meeting the recovery and recycling requirements of the directive.

Take-Back Schemes

For small- to medium-sized IVD manufacturers, it does not make economic sense to implement a company-operated packaging waste take-back scheme. Such take-back burdens are even more of a morass for U.S. and other non-European companies that will pay more in shipping costs to have packaging waste transported back to the countries of origin. A more efficient approach for compliance is participating in third-party waste recovery schemes.

One popular scheme is the Green Dot program, which is operated by the Duales System Deutschland AG (Dual System of Germany; Berlin). This program is licensed to other countries through a pan-European organization called Packaging Recovery Organization Europe (PRO-Europe). Founded by the EU member states, PRO-Europe is an umbrella organization of national compliance schemes responsible for the recovery and recycling of packaging waste. The Green Dot symbol is a registered trademark of PRO-Europe, and has been sublicensed to 19 European countries.

Through the Green Dot program, an IVD manufacturer obtains a license, for which the fees vary from country to country. The license fees are based on the type and weight of the packaging material. In some countries, a volume fee is charged per product unit that is sold. Current Green Dot fees are approximately $0.02 to $1.79 per kg of packaging waste, with plastics having the highest fees, and natural materials and glass the lowest. By obtaining this license, a manufacturer is entitled to imprint the Green Dot logo on its packaging. The Green Dot program then assumes a manufacturer’s responsibility for meeting its packaging waste recovery and recycling requirements.

Applicable Standards

To help IVD manufacturers comply with Directive 94/62/EC, the European Council commissioned the European Committee for Standardization (CEN) to produce a set of standards for satisfying the essential requirements, as set forth in Annex II of this directive. CEN has produced and published six standards.

The published standards include the following:⁵

EN 13427: Using European standards in the field of packaging and packaging waste. This standard is referred to as the umbrella or foundation standard and provides guidance on applying the other five standards that deal with prevention, reuse, and recovery of packaging waste. It stipulates that packaging material suppliers need to coordinate with packers and fillers to ensure that the directive’s essential requirements are met.

EN 13428: Manufacturing and composition; prevention by source reduction. This standard focuses on quantitative prevention of packaging waste (i.e., minimizing packaging weight and volume) and qualitative prevention (i.e., minimizing heavy metals and dangerous substances).

EN 13429: Relevant materials and types of reusable packaging. This standard sets conditions and a verification procedure for determining whether the packaging is suitable for a reuse system. It requires packers and fillers to confirm the packaging’s reusability with the suppliers. End-users (i.e., customers) must also confirm that they will place the packaging in a reuse system.

EN 13430: Packaging recovery by material recycling. This standard requires suppliers to declare the recyclable and nonrecyclable components of a packaging material by stating the percentage weight of the recyclable raw materials. For example, an IVD reagent container may be composed of 90% recyclable glass, 8% recyclable polypropylene, and 2% nonrecyclable foil. In this case, a supplier can declare that the IVD reagent container is 98% recyclable.

EN 13431: Packaging recovery in the form of energy recovery, including specification of minimum inferior calorific value. This standard lists information on calorific value and gain, thermal energy, as well as ash and solid-residue percentages for a wide spectrum of commonly used packaging materials. It also lists substances and materials that either do not comply, have a negative impact, or can cause problems with the energy recovery process.

EN 13432: Packaging recovery through composting and biodegradation; test schemes and evaluation criteria for the final acceptance of packaging. This standard addresses recovery by organic means, whereby composting and biodegradation criteria need to be satisfied by laboratory testing. It only focuses on organic recovery in controlled settings and not in other ways such as landfills.

These standards are probably intended to be used more as guidance documents. Even though they are voluntary, the standards state what the requirements are, unless an IVD manufacturer can justify an acceptable alternative.

In addition, in some EU member states, other national requirements may apply, especially when a laboratory is associated with a hospital. For example, standard VDI 2301 is a German standard that relates to the combustion of waste produced in hospitals. There is also standard DIN 58956-4, which pertains to the waste management of microbial laboratories.

Other Developments

The European Parliament is currently reviewing proposals for amendments to certain provisions of directive 94/62/EC.⁶ Of the 16 amendments being considered, the most notable is the readjustment for more-ambitious recovery and recycling targets that are being aimed for full compliance by June 30, 2006. The proposed amendment revises the target goals to 60–75% for recovery and 55–70% for recycling. Similarly, new recycling targets for specific packaging materials have also been proposed: 20% for plastics, paper, 55%; glass, 60%; and metals, 50%. In addition, Greece, Ireland, and Portugal have been given until June 2009 to meet these goals.

Another development is that lobbying groups representing European medical device and pharmaceutical companies, such as the European Confederation of Medical Device Associations (EUCOMED; Brussels) and the European Sterilization Packaging Association (ESPA; Gloucestershire, UK), have been petitioning for an exemption of primary medical packaging from the directive’s essential requirements. They are basing their actions on article 20 of the directive, which states that “the commission shall determine the technical measures necessary to deal with any difficulties encountered in applying the provisions of this directive, in particular to primary packaging for medical devices and pharmaceutical products.”

Such associations argue that in serving to ensure the integrity and stability of medical devices up to the point of use, primary packaging should be regarded as an integral part of the device itself and not be subjected to compliance with the directive. To date, not much progress has been made on this issue. However, regardless of the outcome, IVD device manufacturers will still be responsible for at least the recovery and recycling of secondary and tertiary packaging.

Conclusion

The enforcement of Directive 94/62/EC will have far-reaching implications for IVD manufacturers. Compliance with the directive demands attention to details that manufacturers have largely ignored. Manufacturers will have to work closely with their packaging vendors (e.g., fillers, packers, raw material manufacturers, etc.) to ensure that the packaging materials meet environmental, health, safety, and hygiene requirements, and may be reused and recycled. The choice, design, and manufacture of such materials are subject to regulatory oversight by the EU, which reserves the right to demand and review technical documentation pertaining to packaging.

Regarding the mandate requiring the recovery of packaging waste, the most likely approach, particularly for small IVD manufacturers, will be to enlist the services of EU-recognized reclamation agencies, such as Valpak, Eco-Emballages, and Green Dot. Enlisting such agencies will necessitate an additional expense for manufacturers, as most take-back schemes operate on a producer-pays principle. However, such reclamation agencies remain the more attractive option compared with the infrastructure and shipping costs that may be incurred to implement such take-back programs on an individual basis.

As the pending publication of the revised CEN packaging standards moves forward, IVD manufacturers should be able to gain a better understanding of the fundamental approaches to compliance. While the revised CEN standards should harmonize better with the internationally recognized ISO standards, manufacturers may expect stricter enforcement of the use of reuse and recycle symbols and material identification numbers, which is currently voluntary The revised CEN standards will hopefully provide more insight into this matter as well.

Some IVD manufacturers may ask, “Why bother with all of this legislation?” The answer is that the EU offers potentially the fastest-growing market for international distributors and manufacturers of IVDs. For example, 10 more countries joined the EU this year, and four more countries are in the candidate phase, while one other country is in the application phase. Using harmonized directives should facilitate the traffic and delivery of goods across and through member states. The potential to reap profits from a unified and harmonized European trade sector will far outweigh the resources needed for compliance. If IVD manufacturers intend to maintain a profitable European market presence, it may be well worth getting familiar with the Packaging Directive.

References

1. “Directive 94/62/EC of the European Parliament and of the Council of 20 December 1994 on Packaging and Packaging Waste,” Official Journal of the European Communities L 365 (1994): 10–23.

2. P Novales-Li and A Leonard, “European Packaging Standards, Part 1: Requirements and Enforcement,” IVD Technology 10, no. 9 (2004): 22–25.

3. “97/129/EC: Commission Decision of 28 January 1997 Establishing the Identification System for Packaging Materials Pursuant to European Parliament and Council Directive 94/62/EC on Packaging and Packaging Waste,” Official Journal of the European Communities L 50 (1997): 28–31.

4. “99/177/EC: Commission Decision of 8 February 1999 Establishing Conditions for a Derogation for Plastic Crates and Plastic Pallets in Relation to Heavy Metal Concentration Levels Established in Directive 94/62/EC on Packaging and Packaging Waste,” Official Journal of the European Communities L 56 (1999): 47–48.

5. P Fielding, “Packaging and the Environment: A Regulation Update,” Medical Device Technology 11, no. 3 (2000): 26–28.

6. “Opinion on the Proposal for a Council Directive Amending Directive 94/62/EC on Packaging and Packaging Waste,” the European Parliament Web site (Brussels: 2002 [accessed 28 October 2004]); available from Internet:
www.europarl.eu.int/registre/recherche/Notice Detaillee.cfm?docid=4902&doclang=EN.

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