European Packaging Legislation and Packaging Waste Recovery

Transcription

1 22 European Packaging Legislation and Packaging Waste Recovery P Fielding Packaging Consultant, DuPont Nonwovens, Luxembourg The primary objective of the European Commission s new approach to environmental matters is to achieve sustainable development. This is to be accomplished by better utilisation of our resources for both the manufacture of products and also the supply of services. To do this, we must ensure that we use less materials and generate less waste. The easiest area on which to focus is waste hence the hierarchy of actions first, prevention, then reuse, followed by recovery, and, the last resort, disposal via landfill. The Commission has decided that the best way to encourage us to be more environmentally responsible will be by the use of fiscal means taxes, levies. This will mean that in future the price of our medical devices will include an element which reflects the environmental cost of recovery/disposal, etc. Medical device manufacturers have a producer responsibility to assess all elements of material selection, manufacture, distribution, use and final disposal. Packaging was one of the first commodities to be selected for the new approach. No doubt this was because the general public (and politicians) feel that most products are over packaged, i.e. too much packaging, but do not understand or want to accept that packaging MEDICAL DEVICES MANUAL Euromed Communications Ltd 2001 (Rev 3) 22.1

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3 P Fielding hexavalent chromium. The main areas of concern for medical packaging are printing inks and the use of recycled materials (i.e. post-consumer waste). To be recoverable by at least one, if not more, of the following processes: Recycling of the materials into marketable products. Incineration with energy recovery i.e. the materials show a calorific gain when burnt under clean conditions in an incinerator that can recover the energy from the heat generated. Composting i.e. the materials are biodegradable. This means that most of the finished compost ultimately decomposes into carbon dioxide, biomass and water. Reuse (if claimed) i.e. designed for a number of trips. The package must be capable of being cleaned and repaired after emptying and then refilled. Reusable packaging also must meet the above essential requirements. France and the UK have introduced specific essential requirements regulations and guidance for manufacturers whereas other member states have, so far, simply included the relevant clauses from the Directive in their legislation. Finally, the use of Life Cycle Assessment (LCA) is to be encouraged in the selection of packaging materials and the design of the packaging system. LCA is the study of the environmental impacts from the abstraction of basic raw materials, through product manufacture and distribution, to use and final disposal. Environmental impacts include energy usage, waste generation, air emissions, water discharges, etc. Unfortunately, although a major application of LCA has been to packaging materials and systems, it is of little help when considering the rather unique and complex materials used as primary packaging for many medical devices. CEN Standards Guidance on how to meet the Essential Requirements of the P&PWD has been developed in a series of CEN standards and reports. This work has been carried out by a number of working groups within CEN/TC261/SC4, the CEN committee responsible for standards concerned with packaging (Rev 5) 22.3

4 European Packaging Legislation and Packaging Waste Recovery and the environment. Six main standards have been prepared: EN "Packaging Requirements for the use of European Standards in the field of packaging and packaging waste" EN "Packaging Requirements specific to manufacturing and composition Prevention by source reduction" EN "Packaging Reuse" EN "Packaging Requirements for packaging recoverable by material recycling" EN "Packaging Requirements for packaging recoverable in the form of energy recovery, including specification of minimum inferior calorific value" EN "Requirements for packaging recoverable through composting and biodegradation Test scheme and evaluation criteria for the final acceptance of packaging" The last five of these standards (ENs to 13432) are all mandated whereas the first one (EN 13427), which is also known as the "Umbrella" or "Foundation" standard, is not. Nevertheless, EN is an important document as it explains how the other standards and reports are related. Brief details of the information contained in these standards are as follows: EN Prevention by Source Reduction. This standard sets out a self-assessment procedure for determining the minimum adequate weight and/or volume of packaging that can be used. The basis for complying is the identification of the critical factor that prevents any further reduction in the amount of packaging used. A range of performance criteria are listed including protection of the product, the packing/filling process, user/consumer acceptance, etc. EN Reuse This standard identifies a number of criteria which must be met if the packaging is to be considered fit for reuse. For example: Packer/fillers must intend to reuse the pack for its original purpose. i.e. it must not be used for a different application. The packaging must be capable of being cleaned, washed and repaired after emptying whilst still retaining its ability to perform its intended function (Rev 5)

5 P Fielding A suitable reuse system must be available in those markets where the product is to be supplied. EN Material Recycling This standard identifies criteria which need to be considered if materials are to be recycled. These include: the suitability of the materials for the recycling process; the design of the package to ensure that it can be effectively emptied and the components separated; the components used and the method of construction must be compatible with collection and sorting systems available. EN Energy Recovery This standard defines packaging claimed to be suitable for energy recovery as that which is combustible and capable of providing calorific gain. A procedure for determining this is specified. Packaging composed of more than 50% (by weight) of organic material is considered recoverable in the form of energy without any pre-testing. Packaging composed of more than 50% (by weight) of inorganic material may be declared recoverable in the form of energy if a net calorific gain can be demonstrated either theoretically or when tested. EN Composting and Biodegradation This standard sets out requirements for both packaging materials and their significant organic constituents, which can be recovered by organic means. They must: be shown to be biodegradable in laboratory tests to criteria laid down in the standard disintegrate in biological waste treatment processes to pass levels set out in the standard, without any observable negative effect on the process. It is important to note that the standard is only concerned with the fate of packaging in controlled waste treatment plants. It does not include packaging disposed of in uncontrolled ways such as litter. have no negative effect on the quality of compost resulting from biological waste treatment. It is assumed that 50% of the original weight of the packaging and 100% of the original amount of hazardous substances will be left in the compost after biological treatment. EN The Umbrella or Foundation Standard Although this standard is not mandated, it is nevertheless a key document as it (Rev 5) 22.5

6 European Packaging Legislation and Packaging Waste Recovery explains how the interlocking mandated standards and reports are to be used. To meet the essential requirements of the P&PWD a supplier must give careful consideration to a number of individual but associated assessment procedures prior to placing the packaging or packed product on the market. Each one is capable of reducing the environmental impact of waste packaging but it is unlikely that they will all simultaneously apply to the same unit of packaging. Also, the optimisation of the effect of one procedure will often require moderation in the application of others. EN establishes the relationship between these procedures. Usually a number of components are combined to form a functional unit of packaging and these may in turn be brought together to form a complete packaging system which could comprise primary, secondary (sales) and tertiary (transport) packaging. EN states that the following requirements should apply to the various levels of this hierarchy: Components should be assessed for prevention of noxious and hazardous substances. Packaging at the level of minimum functional unit should be assessed for reuse, material recovery, energy recovery and/or organic recovery as appropriate. The unit must be suitable for at least one of these processes. Complete packaging systems should be assessed for prevention by source reduction. The procedures that have been adopted in these standards also provide the basis for a system of continuous improvement. This means that it should be fairly easy to integrate them with the ISO 9000 and ISO quality and environmental management systems. In addition to the standards, a two-part CEN Report has also been prepared to provide guidance on heavy metal measurements (CR Part 1) and identification of hazardous materials (CR Part 2). The second part of the report was prepared after the environmental arm of the European Commission (DGXI) expressed concern that the first drafts of the standards made little reference to noxious substances apart from the report (now called Part 1) which dealt with the four heavy metals (cadmium, mercury, lead, and hexavalent chromium). CEN therefore prepared Part 2 that identifies noxious substances as those 22.6 (Rev 5)

7 P Fielding listed in the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (88/379/EEC). Both these directives set limits, below which the various categories of dangerous substances need not be considered. For example, very toxic materials are acceptable at levels below 0.1%, whilst harmful materials can be present in concentrations up to 1.0%. By referencing these Directives, CEN avoided the introduction of a standard that would require frequent updating. Also, very few, if any, packaging materials contain any of the substances listed in the two Directives at levels above the specified limits. The CEN Standards were published in the fourth quarter of 2000, however, only EN13432 has been harmonised because the Commission did not accept that the other standards met the mandate given to CEN. A new mandate has now been agreed and the various working groups within CEN/TC261/SC4 are currently redrafting the various standards. If they fail to deliver revised standards that the Commission is prepared to harmonise then we may yet get different approaches to satisfying the Essential Requirements in each member state! RECOVERY OF PACKAGING WASTE Recovery and recycling targets Targets currently require Member States to recover between 50 and 65% of packaging waste and recycle 25 to 45% of packaging materials. There is also a requirement for at least 15% for each material e.g. paper, plastic, metal, wood, etc. to be recovered. This can be achieved by re-use, recycling, incineration with energy recovery or composting. New, more ambitious targets are planned for the revised version of the Directive. These will not be finalised until the middle of 2003, at the earliest, due to differences of opinion between the Commission, the Council and the Parliament. Even the date by which member states will have to comply has yet to be agreed. All member states have legislation in place that is designed to implement the directive and meet the current targets. The legislation is however, different in each country. (Rev 5) 22.7

8 European Packaging Legislation and Packaging Waste Recovery National Schemes Following the teething troubles of the German Duales System Deutschland (DSD) system high costs, waste mountains, the recovery schemes in the various member states are very different. The data requirements are often more extensive than the EU, and the costs are frequently directed at the manufacturer. Also, different schemes can apply to products sold in retail markets, pharmacies or hospitals. Medical devices can appear in all these markets. For the medical device manufacturer it is utter confusion probably resulting in a proliferation of packaging and added costs. The problems are best outlined by referencing some of the specific schemes in various Member States: UK Legislation places a legal obligation on any business in the supply chain to recover a certain percentage of the packaging material it passes down the supply chain. The percentage varies depending on your position in the supply chain raw material producer 6%, converter 9%, packer/filler 37% and seller 48%. Unfortunately for medical device manufacturers, a hospital is an end user so they will have both a packer/filler and seller obligation, i.e. 85%. Obligated businesses are those with more than 2 million turnover and handling more than 50 tonnes of packaging materials. The only materials not obligated are those related to special (hazardous) waste. Data have to be provided on the type and tonnage of materials handled and proof is required to show that your obligated tonnage has been recycled. This proof can be obtained by joining a collective scheme and there are a number of these. Germany The Duales System Deutschland (DSD) is a major operation in Germany responsible for the organisation/administration of the collection and recovery of packaging waste. The manufacturer pays a fee related to tonnage of each material type. A "green dot" symbol is then applied to the packaging to indicate that the fee has been paid and the packaging waste can be collected and sorted. BVMed, the German Medical Device Industry Association, has worked with the DSD to provide appropriate guidance to hospitals as to which packaging can be collected in specific areas throughout the hospital. In those with a high rate of clinical activity, the packaging for medical devices amounts to approximately 20% by weight of the overall hospital packaging waste. This represents less than 1% of the total packaging material which 22.8 (Rev 5)

9 P Fielding could be recovered by DSD. An examination of the different packaging materials showed that, by weight, cardboard and paper materials represented approximately 77%, composite materials 16%, films 6% and metals and other materials 1%. France The Eco-Emballages is also an administration organisation but it is directed at consumer products. Again, a green dot can be added. A levy is paid by the manufacturer, but much lower than that required by the DSD. Hospital packaging waste is treated as industrial waste and as such it is the responsibility of the end user, i.e. the hospital. A green dot is not allowed on hospital packaging. Sweden Legislation is directed at producer responsibility which includes companies involved in importing packages, selling packaging, manufacturing packaging materials or packaged goods. Companies must sort waste packaging to make sure it is either re-used, recycled or the energy recovered. There are specific materials companies set up to meet the requirements of the regulations. Specific material levies are applied when the packaging goods are sold. Green dot systems The use of green dot has been adopted in more countries Belgium, Spain, Portugal, Luxembourg, and Ireland. However, there are subtle differences in the actual application of the green dot symbol throughout Europe and great care should be taken in adding green dots to packaging. Current Issues Packaging and packaging waste recovery is a very complex subject particularly in respect of the primary packaging of medical devices. The Commission has set up a special committee to examine problematic areas. This is the Committee for the Adaptation of Scientific and Technical Progress of Directive 94/62/EC on Packaging and Packaging Waste. It is known as the Article 21 Technical Committee, for short. One area this Committee is assessing is medical device packaging. (Rev 5) 22.9

10 European Packaging Legislation and Packaging Waste Recovery SYMBOLS, CONFORMITY ASSESSMENT AND MATERIAL IDENTIFICATION Symbols The European Commission originally proposed two symbols to indicate that packaging can be reused or is recoverable. It was suggested that the use of these symbols would be voluntary, but that other symbols relating to recyclable, reusable materials would not be allowed with the exception of internationally recognised symbols. There were Moebius Loop no recommendations on recycled content. Subsequently ISO agreed that the so-called Moebius Loop symbol could be used to mean either recyclable or include recycled content. If used in the latter context a percentage figure would be added. On 25th February 1999, the European Parliament voted not to use the new Commission symbols. Conformity Assessment Proposals for the documentation required to demonstrate conformity with the P&PWD were published by the Commission in 1996 but have yet to be adopted. Nevertheless, it is reasonable to assume that something similar will eventually emerge. The Commission proposed that the conformity assessment should be based on "Technical Documentation" prepared by the company covering the design and manufacture of the product. This information was to be kept for at least four years after the last date of manufacture. It was to include: a general description of the product conceptual design and manufacture drawings a list of the standards relating to LCA, heavy metals, minimum recycled content, recycling methods, composting methods, etc. test reports. Material Identification Again, to assist the recovery of the packaging waste, it was proposed to (Rev 5)

11 P Fielding have a voluntary material identification code printed on the packaging. The code was to be in two parts a letter to define the material types and a number to describe variations, for example: PP5 Polypropylene PAP21 Non-corrugated fibreboard GL 72 Brown glass Composite materials were to be defined by the most prominent material e.g. 51% plastic/49% paper laminate would be classified as plastic. However, a letter C would be added to identify the composite material and a different set of numbers used. Composite was not fully defined by the Commission s decision on Material Identification (97/129/EC) that came into force in February There has however, been very little, if any, use of this system because industry has preferred to continue using their current practices. For metals and plastics these are well established graphic symbols, whilst for paper and glass, specific material identification is not required. MEDICAL DEVICE PACKAGING Manufacturers of medical devices have been very concerned about the effect that the P&PWD could have on our industry. This is particularly true for some of our primary packaging materials which are unique because of their need to satisfy the requirements of the Medical Devices Directives. It is however recognised that our "sales" (secondary) and "transit" (tertiary) packaging are the same as for the majority of goods supplied by a wide range of industries. The Environmental Focus Group (EFG) within EUCOMED (European Confederation of Medical Devices Association) has prepared, with the assistance of member associations, in particular ESPA (European Sterilization Packaging Association), various position papers for presentation to the Commission and the Article 21 Technical Committee. After much discussion, we have concluded that materials whose function is to preserve the sterility of the device until the point of use are best described as "sterile barrier systems". Such systems, which typically comprise a sealed unit surrounding the device, are an integral part of the device. They therefore fall fully within the scope of (Rev 5) 22.11

12 European Packaging Legislation and Packaging Waste Recovery the Medical Devices Directives and not the Packaging and Packaging Waste Directive. These discussions are continuing, but at this moment all medical device packaging has to meet the requirements of the P&PWD. THE FUTURE The purpose of the P&PWD is to ensure that packaging has a minimum impact on the environment. However, although a lot of effort has been put into the development of systems to make this happen, much still remains to be done. Packaging waste recovery in Europe is very varied and complex and in many cases, it seems likely that the best approach has yet to be identified. Key activities for the medical device industry must be: To continue to discuss with Medical Expert Groups within Member States, the Commission and the Article 21 Committee the issues surrounding medical device packaging; in particular, the concept of sterile barrier systems. To carefully monitor the impact on the medical devices industry of the implementation of legislation in the various Member States. To eliminate barriers to trade within the EU by supporting the harmonisation of CEN standards EN to (Rev 5)