Medical Device Link.

Originally Published IVD Technology November/December 2004

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.

Ann Leonard, PhD, was previously a regulatory associate at BioGenex Laboratories and is presently a regulatory affairs coordinator at Abbott Vascular Devices (Redwood City, CA).

Since it was implemented in December 1994, the European Council Directive on Packaging and Packaging Waste (94/62/EC) has been in effect for nearly a decade. Nonetheless, IVD manufacturers have either ignored this directive or claimed that it does not apply to them. Even today, many European distributors for U.S. IVD companies are nonchalant about the directive or believe that it does not cover medical packaging. This article will discuss and clarify such misconceptions about the directive.

Some of these misconceptions arise from the fact that U.S. IVD manufacturers’ products whose packaging does not comply with Directive 94/62/EC are being allowed entry into Europe. However, in most European Union (EU) member states, this directive is being enforced by overseeing purchasing and tenders, in which public authorities are requiring compliance with environmental regulations before granting approval. Authorities in the United Kingdom, Germany, and Italy have been using such enforcement tactics. Consequently, even though the packaging directive has not been fully enforced in the past, continuing to ignore it may lead to more rejected tenders, resulting in more lost sales and revenue for IVD manufacturers.

Packaging Directive Background

Regulating the use of packaging has been an important issue in the EU for many years. As early as the 1980s, several EU member states introduced their own national legislation on managing packaging waste. One of the earliest directives on packaging was Directive 5/339/EC, which was related to packaging of liquid beverage containers. A few other member states also implemented policies that addressed the impact of packaging and packaging waste management.

However, despite efforts by the EU and certain member states, such measures failed to address the relationship of packaging and packaging waste management with environmental issues. Moreover, the national policies were not even harmonized. Such disparate policies and measures led to calls for the introduction of pan-European legislation on packaging. This ultimately resulted in the adoption of Directive 94/62/EC.

That directive focuses on four major areas regarding packaging waste: prevention, reuse, recycling, and other forms of recovery. With a view toward harmonizing the legislation and management of packaging and packaging waste, the directive’s fundamental objectives are reducing the overall volume of packaging introduced into the market and preventing any impact on the environment, thus providing an ecologically sound fiscal policy. By doing so, trade barriers are removed, which leads to open markets.

Essential Requirements

The essential requirements are described in the articles and Annex II of Directive 94/62/EC.¹ These requirements cover the following areas.

Recovery and Recycling. EU member states must implement measures that require IVD manufacturers not only to recover packaging waste, but also to recycle a portion of the recovered packaging for producing future packaging and for other purposes, such as organic recycling. This type of recycling takes the biodegradable parts of the recovered packaging waste and recycles them through composting or biomethanization treatment methods (e.g., microbial decomposition). The goal is to produce methane or stabilized organic residues for use as alternative energy sources. While organic recycling is permitted under controlled settings, the directive excludes landfill, which is not considered an organic recycling method. Recycling recovered packaging waste into combustible materials to generate energy or heat is also excluded as a form of organic recycling.

As for target goals, the EU expects its member states to recover 50–65% of the packaging waste by weight and recycle 25–45% of the recovered packaging waste. At the very least, a minimum of 15% of the recovered waste should be recycled. However, not all member states must meet these targets. Due to their specific situations, Greece, Ireland, and Portugal have lower targets, with a goal of recovering 25% of packaging waste. These target goals are subject to revisions every 5 years.

Return, Collection, and Reuse. EU member states must devise measures that mandate the return and collection of packaging waste from end-users through waste management programs. Member states should also encourage IVD companies to manufacture and utilize reusable packaging. Such measures will have to take into account other related issues, such as environmental protection, consumer hygiene, effectiveness of the reusable packaging, and commercial rights.

Marking and Identification. To facilitate the recovery of packaging waste for recycling, the European Council proposed a marking and identification system that indicates the materials used in the packaging. This system uses numbers and abbreviations to specify the types of recyclable materials in the packaging. The European Commission released a decision (1997/129/EC) that established the basis for such a numbering and abbreviation system and listed the materials that are subject to the identification system.²

IVD manufacturers may insert identification marks in the center or below a graphical symbol that identifies the packaging as being reusable or recoverable. For example, numbers 1–19 are assigned for plastic, 20–39 for paper and cardboard, 40–49 for metal, 50–59 for wood, 60–69 for textiles, and 70–79 for glass. As for the use of abbreviations, some examples are the following: PETE for polyethylene terephthalate, HDPE for high-density polyethylene, and PVC for polyvinyl chloride. Such graphical symbols are not unique to the EU market but are harmonized with other major international markets.

Concentration Levels of Heavy Metals. The level of toxic concentrations in packaging is a concern since it constitutes a significant portion of the solid waste stream. In landfills, toxins from packaging materials can contaminate the leachate. At waste-to-energy conversion facilities, such toxins may escape as emissions and contaminate ash. Consequently, Directive 94/62/EC addresses the need to eliminate the use of heavy metals in the manufacture of packaging as a first step toward reducing the toxicity of packaging waste. In particular, the directive targets lead, cadmium, mercury, and hexavalent chromium.

These heavy metals are often found in the inks, dyes, pigments, adhesives, stabilizers, and other additives used in packaging. The target goal is to reduce the concentration levels of these heavy metals in packaging 100–600 ppm by weight within 5 years of the enactment of the directive. An exception is plastic crates and pallets that have been manufactured in a controlled recycling process. These items may exceed the target goal, as approved in European Commission Decision 99/177/EC.³

Database Information. In order to monitor the implementation of the directive’s target goals, EU member states will submit annual reports for a harmonized database that contains qualitative and quantitative information on recycled and recovered packaging waste, concentration levels of heavy metals, and other information. The format for establishing this information database system was issued in a European Commission decision (97/138/EC).⁴ Another commission decision (97/622/EC) put together a set of questionnaires that member states use for preparing their reports to the commission.⁵

Enforcement by Member States

Parliament in the UK passed the producer responsibility obligations (packaging waste) regulations and the packing (essential requirements) regulations as a regulatory framework for reducing packaging and packaging waste. These regulations set strict recovery and recycling targets, along with requirements to discourage overpacking. Authority over the regulations has been given to the Trading Standards Office in each city, which ensures effective monitoring of the regulations through local enforcement. This office investigates complaints of excessive packaging and offers guidance for compliance.

IVD manufacturers in the UK may recover and recycle their own packaging waste, or may join a compliance program. For example, one such program is Valpak, which will assume a manufacturer’s recycling obligations. IVD manufacturers may also fulfill their obligations by purchasing packaging waste recovery notes from accredited reprocessing and recycling agents. In addition, UK regulations require those manufacturers that handle large volumes of packaging waste (more than 50 tn per year) to pay a fee in proportion to the government’s obligations to recycle packaging.

France established the management of packaging and packaging waste under the Lalonde Decree. According to this law, IVD manufacturers have three options: devising a take-back scheme, recovering all packaging themselves, or participating in a government-approved packaging take-back scheme under a collection system. The last option led to the creation of a dedicated organization, called Eco-Emballages, to promote the recycling of packaging. This organization contracts selective packaging collection services with local authorities.

Spain adopted Directive 94/62/EC into its own local legislation: the Packaging and Packaging Waste Act. While the Spanish law is similar to the French model of managing packaging, it is a mixed model since it allows participation in an integral packaging collection system. The law also allows a system of returnable packaging in which consumers pay a deposit on the returnable packaging.

Germany established an ordinance on the avoidance of packaging waste, the Topfer Decree, which calls for IVD manufacturers to take back all types of packaging for reuse or recycling. Manufacturers can receive exemptions from the latter by participating in an established packaging collection system. Specifically, the Duales System Deutschland GmbH (Dual System of Germany), a nonprofit organization, works with waste-management companies to organize the collection and sorting of packaging waste for recycling. Considering the take-back requirements of this ordinance and the license fees involved, manufacturers have been motivated to reduce their packaging waste in order to reduce eventual recycling costs.

Conclusion

Since the release of Directive 94/62/EC, various European Commission decisions have been adopted either to detract provisions or define measures for carrying out specific essential requirements. A proposal for amending certain provisions of this packaging directive has also been on the table for years and is up for final review in the European Parliament.⁶

In addition, EU member states have been enforcing their own national legislation in an effort toward harmonizing national measures with this directive. Consequently, member states are in the process of changing their enforcement approaches to a polluter-pays principle to ensure compliance with the directive.

The second installment of this article will include an update on new developments of this directive, examples of how IVD manufacturers can comply with the essential requirements, and an overview of available guidance documents and standards.

Even though major kinks of Directive 94/62/EC are still being ironed out, it will not be long before across-the-board enforcement becomes a foregone conclusion. U.S. IVD manufacturers must understand the essential requirements of this packaging directive and realize what the implications are for their respective organizations. While enforcement may not be evident for the time being, further delays in compliance may result in inconvenient setbacks.

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. “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.

3. “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.

4. “97/138/EC: Commission Decision of 3 February 1997 Establishing the Formats Relating to the Database System Pursuant to European Parliament and Council Directive 94/62/EC on Packaging and Packaging Waste,” Official Journal of the European Communities L 52 (1997): 22–30.

5. “97/622/EC: Commission Decision of 27 May 1997 Concerning Questionnaires for Member States Reports on the Implementation of Certain Directives in the Waste Sector,” Official Journal of the European Communities L 256 (1997): 13–19.

6. “The Draft Revisions to the CEN Packaging Standards: Implications for Standards Users,” the European Organization for Packaging and the Environment Web site (Brussels: EUROPEN, 2003 [accessed 13 September 2004]); available from Internet: www.europen.be/ whats/censtandsimplic.pdf.

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