Originally published September 1996
While its ultimate impact is as yet unclear, the European Union's (EU) packaging waste directive has serious implications for medical device manufacturers. It is clear that companies operating in Europe or supplying packaged goods to Europe will have to integrate environmental, health, safety, and hygiene requirements into their packaging. The reforms in the "European Parliament and Council Directive 94/62/EC" on packaging and packaging waste also will mean that manufacturers must absorb the costs of meeting new recycling requirements.1
The directive's requirements for manufacturers are vague; however, in the absence of additional guidance, companies will have to make packaging decisions based on the directive alone. As written, the directive includes primary medical packaging--packaging designed to ensure that devices are clean, undamaged, and uncontaminated. Industry associations are concerned that the European Commission may fear opening the door to exceptions, therefore forcing primary packagers to meet the requirements for packaging waste. And, regardless of the commission's ultimate decision, medical packagers will still be responsible for meeting the requirements for secondary and tertiary packaging materials.
Another directive, to be adopted by the end of December 1996, may place an even heavier burden on manufacturers. Currently, manufacturers choose whether to display the recycling and reuse symbols on their packaging. This option enables international companies to omit the symbols rather than use varying ones in individual countries. However, the commission is now reported to be insisting that the directive does mandate use of the symbols. A draft version of the new directive also requires that manufacturers provide technical documentation for the design and manufacture of all packaging to be marketed in Europe.
This article describes the provisions of the current directive on packaging waste and the provisions of the upcoming directive, which focuses on marking of packaging. Both directives could force international manufacturers to devote considerable time and money to choosing materials, marking packaging to meet the new requirements, and recovering and recycling materials.
The waste directive was adopted in December 1994. Member states were required to transpose it into national law by the end of June 1996. So far, very few member states have completed this transposition. Secondary legislation is required by the directive itself to address marking of packaging, materials identification, and database systems to monitor compliance.
THE WASTE DIRECTIVE
Objectives. The directive's stated aim is to reduce the overall impact of packaging on the environment by reducing packaging at source, eliminating harmful materials in packaging waste, maximizing the recovery of packaging for reuse and recycling, and minimizing the quantity of packaging waste going to landfills. The directive is also designed to bring national measures closer together in order to remove obstacles to trade and to avoid distortions of competition.
Targets. Each member state must be recovering between 50 and 65% (by weight) and recycling between 25 and 45% (by weight) of their packaging waste by June 2001. Greece, Ireland, and Portugal have negotiated longer periods in which to achieve these targets because they consume relatively lower levels of packaging. The directive also states that more-demanding recovery and recycling targets, to be reached by June 2006, are to be determined in due course. Whether this will happen remains to be seen.
Member states must also ensure that the concentration levels of lead, cadmium, mercury, and hexavalent chromium in packaging
materials are progressively reduced. Concentrations must not exceed 600 parts per million by June 1998, 250 ppm by June 1999, and 100 ppm by June 2001.
Although the directive states that "the best means of preventing the creation of packaging waste is to reduce the overall volume of packaging," it sets no specific targets for
achieving this goal. The most specific guidance is offered in the essential requirements of the directive, which state that "packaging shall be so manufactured that the packaging volume and weight be limited to the minimum adequate amount to maintain the necessary level of safety, hygiene, and acceptance for the packed product and for the consumer."
Only packaging that complies with the essential requirements of the directive may be placed on the market in the EU after December 1997. It is important to note, however, that although the directive describes these requirements in general terms, detailed
guidance will be provided in a series of standards. The European Commission has mandated the European Committee for Standardization (CEN) to produce these standards, but there is no sign of any to date. It is, therefore, highly unlikely that they will be in place by December 1997. In the absence of guidances, companies and member states will have to make decisions based on the directive itself.
General Requirements. Member states are required to set up return, collection, reuse, and recovery systems for packaging waste. In doing so they must take into account environmental and consumer health, safety, and hygiene requirements as well as the technical and quality considerations of the recovered materials. These considerations are particularly important for medical
The directive sets out a framework intended to harmonize policy throughout the EU. It clearly envisions that a wide range of industrial sectors should be involved in the debate on the type of recovery systems to adopt. This framework is intended to deter legislation that could distort competition or discourage imports. Despite this, it is now clear that the various member states are evolving different systems to implement the legislation within their own countries. Companies operating in, or supplying packaged goods to, different countries will therefore be obliged to meet multiple requirements. This will undoubtedly result in an additional workload, increased cost, and confusion.
Medical Packaging. The directive states that the European Commission "shall determine the technical measures necessary to deal with any difficulties encountered in applying the provisions, in particular to primary packaging of medical devices and pharmaceutical products, small packaging, and luxury packaging."
Trade associations representing the medical device and medical packaging industries in Europe (the European Confederation of Medical Devices Associations [EUCOMED] and the European Sterilization Packaging Association [ESPA], respectively) are pressing for the directive to exclude primary medical packaging that forms a microbial barrier around a device. Their justification for this exclusion is as follows:
* Primary medical packaging is necessary to ensure that a medical device remains clean, undamaged, and free from any contamination or infection prior to its use on a patient. Such packaging is recognized as an accessory to the device and therefore should not be subject to this additional legislation.
* Medical devices are normally used in environments that contain harmful materials or highly infectious organisms. Under these
conditions, it is extremely difficult for health-care professionals to ensure that the packaging waste remains uncontaminated. Also it will be difficult and costly to separate for recycling different categories of material such as paper and film.
* Many primary packaging materials consist of two or more chemically different layers that are difficult to separate and are therefore unsuitable for recycling.
The European Commission committee charged with deciding whether to exclude primary medical packaging is known as the Article 21 committee and comprises government experts from the various member states. It is difficult to predict what they will decide. Although the committee is believed to have sympathy with the associations' arguments, it is also known to be concerned about making an exception for medical packaging because this could open the door for other industries to make similar requests.
Another possibility is that some member states could draft national legislation that omits the requirement to recover these materials. This is quite feasible because medical packaging represents a very small proportion of the total packaging used and would therefore have little effect on states' achieving their overall targets. Regardless of what happens to the requirements for primary packaging, the directive will still apply to secondary and tertiary materials. These materials should, however, present fewer problems.
Hospitals. The decision about whether hospitals will be covered by this legislation rests with individual member states. Some, such as the United Kingdom, appear likely to treat hospitals as domestic consumers rather than commercial organizations, in which case the requirements will not apply to them. Other member states, such as Germany, may want to include them.
What is clear is that many hospitals already have problems disposing of packaging waste. Until recently, most hospitals incinerated nearly all of it. Clinical waste will continue to be treated in this way, although it is worth noting that there are significant differences among the member states' interpretations of how clinical waste should be defined.
Incineration of other waste, however, is no longer an option for many hospitals, because tighter controls on air pollution and a lack of heat-recovery equipment have caused the closure of many incinerators. Hospitals have therefore been forced to try to use the public waste network. Although the bulk of this waste material could be described as household waste, many waste handlers refuse to take it because of concerns, generally unfounded, that the mate-rial may be contaminated.
MORE REQUIREMENTS TO COME
The directive provides for, and sets deadlines for, three pieces of underpinning legislation. The first is a European Council directive on the marking of packaging; the second and third are European Commission decisions concerning packaging material identification and arrangements for member states to report data on packaging waste to the commission. The reason marking and material identification are covered by different pieces of legislation seems to be unclear to everyone except the commission.
Marking of Packaging. The Council of Ministers is to adopt a directive on the marking of packaging by the end of December 1996. The commission has issued no formal proposal for this directive for the council to consider; however, the latest draft available at press time has the following key features:
* Two symbols, representing recyclable and reusable packaging, respectively, are specified (see Figure 1). One point to note is that because of registration problems, the symbol for recyclable packaging is different from that to be used by the International Organization for Standardization (ISO). A third symbol representing recycled content was originally included but was excluded because of industry opposition and the difficulty of verifying the legitimacy of its use. The European Commission has reserved the right to introduce this symbol in the future, however.
* The marking system will be voluntary in the following sense. Member states are required to ensure that companies are aware that they can use the symbols, and that the symbols are used only on packaging that conforms to the applicable definition. Member states are required to prohibit the use of
other symbols to signify that packaging is reusable or recyclable. However, companies apparently may choose whether to identify these facts at all.
For companies that trade internationally, it may be easier to omit the symbols rather than to use different ones around the world. However, at press time, the commission is reported to be insisting that the directive does mandate use of the symbols.
* A provision for establishing a conformity procedure for marking of packaging (now referred to specifically in the title) is included in the directive. This self-assessment procedure for internal production control requires that manufacturers provide technical documentation covering the design and manufacture of packaging. If a manufacturer or a representative is not established within the EU, the obligation to provide the documentation will fall on whoever places the product on the market there.
Technical documentation must include a general description of the packaging, its design specification, an explanation of the design and method of production, a list of standards applied and description of the solutions adopted, and the results of design calculations and tests conducted. Companies must keep this documentation for at least four years after the packaging has been manufactured. All documentation must be available for inspection by national authorities. A conformity mark itself is not necessary because the product is automatically deemed to comply with the essential requirements as soon as it is placed on the market.
Material Identification. The commission decision on material identification establishes a system of abbreviations and numerical codes to appear on packaging to indicate its content, therefore facilitating their recovery or reuse. The essential features of the latest draft are as follows:
* Identification codes, using numbering and abbreviations, are set out for different categories of the five main material types (plastics, paper and fiberboard, metals, wood materials, and textile materials) as well as for composites. Plastics are indicated by a number and by generally accepted abbreviations. Paper and board and aluminum also have alphanumeric designations. The most widely used codes are identified in Table I. The draft decision defines composites as packaging made up of different materials that cannot be separated by hand. If packaging contains more than a specified percentage by weight of one material, then it does not qualify as a composite. The percentages are not specified in the decision, but are deferred to a subsequent decision to be adopted by the European Commission no later than the end of December 1997. Potential exemptions for some materials will be established by the same procedure.
* Initially, use of the identification system is to be voluntary. Within four years of the effective date of the decision, the commission is to have decided whether to make the system compulsory for any or all material types.
Formats for the Database System. The directive requires the European Commission and member states to establish harmonized databases to monitor compliance with the directive. The commission decision implementing this requirement contains a number of tables to be completed by member states. States must provide, by material type and in metric tons, information such as the quantity of packaging placed on the market, the quantity and rate of circulation of reusable packaging items, the amount of packaging waste, and the amount of waste recovered or disposed of. Completion of the table entries is mandatory in some cases, but in others (such as the entries relating to reuse of packaging, for which the directive sets no targets), it is voluntary.
The decision sets forth a four-stage process for member states to provide the required data. First, the states complete the tables--initially on the basis of their available data--and submit them and other specified information to the European Commission by the end of December 1996.
Second, based on the information submitted in the first step, the commission will adopt a "binding harmonized framework for member states' provision of data." This framework is to ensure consistency in filling in the tables. The commission will establish this framework in a decision to be adopted by the end of December 1997.
Third, member states are required to complete the tables, in accordance with the framework, for every calendar year starting with 1997. Data for a given year are to be submitted within 18 months of the end of that year. Finally, the Article 21 committee will oversee modifications to any formats if the commission determines it is necessary.
What does this all mean for medical device companies exporting to Europe? The most important point is that both packaging materials supplied prior to use and those already containing a product must meet the requirements of the legislation. The importer is responsible for ensuring that packaging meets the requirements. Legislation in each member state will determine how importers will monitor compliance.
A framework and goals are now in place. Member states are in the process of drafting legislation, although some are further along than others. And, although the national legislation was to have been in place by the end of June 1996, it will be some time before many states implement it. It remains to be seen whether primary medical packaging will be included, but whether this happens or not, the medical device industry must remember that the legislation will apply to the secondary and tertiary packaging industry and must be ready to meet its requirements.
1. "European Parliament and Council Directive 94/62/EC," Official J European Communities, No L 365, 31(12):1023, 1994.
Paul Fielding is regulatory affairs manager for Rexam Medical Packaging in the United Kingdom.