General Counsel's Report To The Society of The Plastics Industry, Inc.'s Food, Drug, and Comestics Packaging Materials Committee

June 21-23, 1999
Keller and Heckman LLP

INTRODUCTION

Ladies and Gentlemen: We are pleased to present this report on the status of matters involving our activities on behalf of The Society of the Plastics Industry, Inc.'s (SPI) Food, Drug, and Cosmetic Packaging Materials Committee (FDCPMC) ¹ since our December 3-4, 1998 meeting.

TABLE OF CONTENTS

I. Legislative Update
A. SPI Continues to Work for the Funding Necessary to Ensure Implementation of the Notification Program for Food-Contact Materials

II. Food and Drug Administration Activities
A. FDA Releases Draft Guidances for Food-Contact Notification Program and Holds Stakeholders Meeting; SPI Testifies and Submits Comments on FDA's Proposals
B. SPI Provides Scientific and Regulatory Expertise in an Effort to Balance Magazine Articles and Television Programs Questioning Endocrine Effects of Plastics
C. FDCPMC to Discuss Compliance Issues with NSF International Concerning Plastics in Contact with Drinking Water
D. FDCPMC Seeks to Make It Easier for Ophthalmic Drug Manufacturers to Use Different Sources for their Plastic Drug Containers

III. International Activities
A. Fifth Amendment to the Monomers Directive Approved by the Standing Committee on Foodstuffs on May 5, 1999
B. The European Commission's Scientific Committee on Food Issues Opinion on BADGE
C. Packaging Waste Directive
1. Work on the Revision of the Packaging and Packaging Waste Directive Awaits a New Environment Commissioner
2. The European Commission Takes Denmark to the European Court of Justice over Its Implementation of Directive 94/62/EC on Packaging and Packaging Waste

I. Legislative Update

A. SPI Continues to Work for the Funding Necessary to Ensure Implementation of the Notification Program for Food-Contact Materials

From our letters over the last year, we hope you are aware of the work by the Committee and government affairs personnel of SPI and member companies to ensure that the food-contact notification (FCN) system is implemented by FDA in a manner that is most beneficial to the industry. The notification program is supposed to take effect on October 1, 1999, but only if FDA receives the sufficient funding for the program from Congress.

As in the last Congress, we are working with SPI and member companies to urge Congress to fund the notification program. In the fiscal year (FY) 1999 budget, SPI was successful in obtaining $500,000 in funds for FDA to implement food-contact notification. FDA has used this funding to prepare and develop guidance documents and procedures to implement the program.

This year we are again working with the same group of SPI and member company government affairs representatives to obtain full funding ($3 million for FY 2000) so that the program can begin as scheduled on October 1, 1999. SPI is making contacts with House and Senate Appropriations Committee staffers and has been providing information on the need to fund food-contact notification.

Along with trying to obtain appropriated funds for the notification program in the budget, SPI is still supporting reasonable cost-recovery fees as originally intended. The fees proposed for the notification program, where each applicant is paying for an added, proprietary benefit (i.e., the faster review of a specific company's notification), are readily distinguishable from fees for general regulatory oversight activities.

FDA is seeking to persuade Congress to pass legislation authorizing user fees to reduce the review times for food-contact notifications, food additive petitions, and medical devices. Although FDA intended to send its proposal to Capitol Hill in February, for various reasons it was just released by the Agency at the time this report was drafted. Since we just received this document, we have not had a full opportunity to review it in detail, nor have we engaged in any discussions with FDA on the specifics of the proposal.

It is not yet clear whether any member of Congress has agreed to introduce the legislation in either the House of Representatives or the Senate, but reportedly there is little enthusiasm, at least in the House, for doing so. FDA has been in close touch with Congressman Dingell of the House Commerce Committee and perhaps other members of Congress, most of whom, we understand, are unhappy with the FDA proposal for a variety of reasons. The main reason for such lack of Congressional support is the intense opposition the bill will face from the medical device community and the fact that the bill combines fees for food additive petitions, food-contact notifications, and medical devices into a single legislative vehicle. There is also opposition to the proposal from the food additive manufacturing community because of the manufacturer registration fees contained in the legislation.

With regard to the proposed fees for Food Contact Substance Notifications in FDA's proposal, the fees essentially are tiered by dietary exposure levels: (1) $5,000 for notifications with uses resulting in an incremental increase in dietary exposure to a substance of less than 0.5 parts per billion (ppb) or those not requiring review of additional safety data; (2) $20,000 for notifications with uses resulting in an incremental increase in dietary exposure to a substance of between 0.5 ppb and 50 ppb, inclusive, or those not requiring review of more than one animal toxicity study with a duration of 90 days or more; and (3) $40,000 for notifications not falling under categories (1) and (2) and for all new food-contact materials.

We believe that the proposed fee levels for the Tier 2 and 3 notifications are inordinately high, and suspect this feeling is shared by others. We will be working with members of the Committee to develop a response to the proposed legislation that can be sent to FDA and Congress, and we will work to ensure that any bill that is enacted is fully acceptable to the plastics industry. FDA understands that, unless the user fee bill has the full support of the regulated industry, it has no chance of passage, so we believe that there may be flexibility in the fee levels and other parts of the proposal. We also have been advised that FDA will not oppose separation of the various product types so that fees for some items can be passed independently if others are too controversial. This could prove important for our purposes because fees for review of medical devices and direct food additives are sure to encounter significant opposition. Congressional opposition to additional fees of any kind also may remain a significant obstacle.

II. Food and Drug Adminstration Activities

A. FDA Releases Draft Guidances for Food-Contact Notification Program and Holds Stakeholders Meeting; SPI Testifies and Submits Comments on FDA's Proposals

Many of you know about the stakeholders meeting on food-contact notification and SPI's draft comments from our earlier letters, but we use this opportunity to recap the events of the last few months. As discussed above, FDA has used the $500,000 appropriation that SPI helped to obtain from Congress for FY 1999 to prepare to implement the FCN program. Using these funds, the Agency developed three draft guidance documents concerning administrative, toxicology, and chemistry requirements for the FCN program. FDA also organized a Stakeholders Meeting that was held on March 12, 1999 at the National Institutes of Health in Bethesda, Maryland to discuss the program. Several FDA officials, who were part of the team designated to design and develop guidance for the program, discussed FDA's thoughts on implementation. The testimony from FDA largely summarized the material that was released in the draft guidance documents. A brief discussion of the highlights of the documents is presented below.

The Agency has proposed that genetic toxicity testing should be required for notifications where the dietary exposure for the substances is greater than 0.5 ppb. Formerly, FDA has required only acute toxicity data (an LD50, for example) where exposure to a food-contact material is 50 ppb or less in the diet. The Agency's draft guideline states that FDA intends to require an Ames-type test and a chromosomal aberration-type test, such as a mouse lymphoma assay, in every case of dietary exposure above 0.5 ppb, to determine whether a material should be tested further as a potential genotoxic carcinogen.

FDA last published its guidance for chemistry data for indirect food additive petitions in 1995. The requirements the Agency has proposed for notifications are very similar to those in the latest chemistry guidance for food additive petitions, although a few improvements have been made. For instance, the new document specifically provides for diffusion modeling, in lieu of migration studies, in appropriate circumstances. In addition, the Agency has refined some of its consumption factors.

The Administrative guidance establishes a 1 part per million (ppm) cutoff for notifications. If the EDI for a material is above 1 ppm, FDA has proposed a rebuttable presumption that a petition should be filed.

The Administrative guidance document also contains a proposal for a rebuttable presumption that, if the estimated dietary intake (EDI) for a substance is not at least a factor of 5 times below the acceptable dietary intake (ADI) for the material, a petition should be filed.

Representatives from SPI and a number of member companies attended the March 12 Stakeholders Meeting. Dr. Donald Naragon of Bayer Corporation, Chairman of the Committee , Mr. Jerome H. Heckman, General Counsel for SPI, and Dr. Lester Borodinsky, Technical Advisor to the Committee, gave presentations at the meeting on behalf of SPI. A copy of Mr. Heckman's testimony is attached to this report.

In addition to Mr. Heckman's and Dr. Borodinsky's oral testimony, we drafted written comments that were submitted to FDA on behalf of SPI. A copy of these comments also is enclosed. The comments discuss several significant issues of interest to the plastic packaging industry, including our position that (1) all notifications should be excluded from the requirement for an environmental assessment, (2) FDA should respond in writing to each notifier for submissions that become effective, and (3) the Agency should permit the notification of entire formulations, as well as individual materials.

B. SPI Provides Scientific and Regulatory Expertise in an Effort to Balance Magazine Articles and Television Programs Questioning Endocrine Effects of Plastics

Over the last few months, several articles and one network television program have questioned the safety of certain plastic materials. We have worked closely with the SPI staff, representatives of several SPI-member companies, and in coordination with the American Plastics Council (APC) to obtain a balanced view of the issues. The focus of the media in these events has been somewhat convoluted; concerns over issues such as endocrine disruptors, polyvinyl chloride, plasticizers, and microwave cooking have been entangled and confused. In several cases, we participated in telephone conversations with media representatives, and provided technical expertise to explain the issues involved and provide safety data where needed. We also have used our contacts at FDA to ensure that the Agency was aware of the media interest and to determine whether officials at FDA had any concerns or questions with regard to the issues involved. So far, FDA has found no reason to revisit the safety of plastics that have been cleared for food-contact use.

More specifically, both Consumers Union and The New York Times published articles on the safety of plasticizers in PVC films. Mr. Heckman spoke with the author of The New York Times article, Marian Burros, and explained the industry side of the story. We felt that the resulting article was reasonably balanced, except for the unsupported statement at the end of the article that no films should be used in the microwave. Around this same time, Dr. Lester Borodinsky, formerly with FDA and now one of the staff scientists at Keller and Heckman and Technical Advisor to the FDCPMC, along with several representatives from SPI and APC, met with Good Housekeeping and Time magazines to discuss their articles on these issues.

Following the print articles, we learned that the ABC News magazine program, 20/20, was preparing an episode on the safety of plastics in contact with food, focusing especially on polycarbonate and certain plasticizers. Dr. Borodinsky, along with several representatives from SPI and APC, held a telephone conference with the producer of the 20/20 segment, Ms. Brenda Breslauer, to discuss the scientific issues relating to the safety of plastic food packaging materials. During this conversation, Dr. Borodinsky and the other representatives were able to provide background on the available safety data on various plasticizers, bisphenol A, and studies that did not replicate the work on alleged endocrine disruptors that were conducted by Dr. Frederick vom Saal, who claimed that very small amounts of bisphenol A could produce adverse health effects in humans.

The 20/20 program aired on April 19, 1999, and coincided with the Consumers Union alert urging parents to dispose of polycarbonate baby bottles. During the program, Dr. James Lamb, a toxicologist representing industry, stressed that both FDA and the industry experts have determined that the great weight of toxicological data supports the safety of plastics used in compliance with FDA's regulations. Dr. Lamb also discussed the recent study cosponsored by SPI, which attempted but failed to replicate Dr. vom Saal's results. Dr. vom Saal, who was interviewed on the program, questioned the industry study results and continued to stand by his study. The program also briefly discussed the Consumers Union 1998 report regarding the migration of plasticizers from flexible polyvinyl chloride (PVC) film. Again, the input from SPI and APC introduced at least some measure of balance into the 20/20 program.

C. FDCPMC to Discuss Compliance Issues with NSF International Concerning Plastics in Contact with Drinking Water

In March, the Committee organized a self-funded task group to address concerns regarding the certification of products for use in drinking water applications under the American National Standards Institute (ANSI)/NSF International Standard 61. Several products that have been certified under Standard 61 for many years are now the subject of questions raised by NSF International about their eligibility for recertification. In addition, the certification of new products may be in question. This is a widespread issue affecting many types of plastics used in contact with potable water, and the questions have arisen despite the fact that no changes have been made in the products that would affect their compliance with the standard. At the request of SPI, a meeting was scheduled for May 21, 1999 with senior NSF International management to discuss these issues.

D. FDCPMC Seeks to Make It Easier for Ophthalmic Drug Manufacturers to Use Different Sources for their Plastic Drug Containers

We have been working with the Committee's Drug Packaging Subcommittee to seek clarification from FDA on the interchangeability of like resins supplied by different manufacturers for ophthalmic drug containers. (This is a specially funded activity paid for by those with an interest in this area.) Occasionally, ophthalmic drug manufacturers find it necessary or desirable to change suppliers of a polymer that has been approved for use in making packaging for ophthalmic drugs. Some drug manufacturers have interpreted FDA regulations at 21 C.F.R. § 314.70 to require the filing of a Supplemental New Drug Application as the only vehicle for notifying FDA of even minor changes in ophthalmic drug packaging. The Subcommittee believes that this interpretation is overly restrictive, and that a change in this interpretation could benefit not only the drug packaging suppliers, but also the Agency with its limited review resources.

On September 28, 1998 we submitted a proposal to FDA's Center for Drug Evaluation and Research (CDER) on behalf of the Subcommittee requesting the Agency's views on the use of the United States Pharmacopeia (USP) monograph on containers for ophthalmic drugs as a basis for demonstrating equivalence of like polymers supplied by different manufacturers. Although FDA's initial response, which we received on January 25, 1999, was not receptive to our proposal, we have subsequently had several discussions with CDER, and are currently working on a revised proposal which we intend to submit to the Agency shortly. The revised proposal contemplates performance of suitability and compatibility testing by drug manufacturers in addition to compliance with USP standards. It is our belief that such testing should enable FDA to interpret a change in resin suppliers as an "insignificant change" in the drug container only requiring notification in a drug manufacturer's annual report.

III. International Activities

A. Fifth Amendment to the Monomers Directive Approved by the Standing Committee on Foodstuffs on May 5, 1999

The Standing Committee on Foodstuffs, which is made up of representatives of the European Union's 15 Member States, voted on, and approved, the Fifth Amendment to the Monomers Directive (90/128/EEC) on May 5, 1999. The draft that has been approved by the Standing Committee on Foodstuffs is quite similar to the Fourth draft, which was discussed in our January 6, 1999 report; however, a few changes have been made.

Specifically, one new monomer, vinyltrimethoxysilane, has been added to the list of substances to be inserted into Section A of Annex II (the actual positive list of permitted monomers and starting substances). Vinyltrimethoxysilane is proposed to be included in Section A with a QM (maximum permitted quantity of the substance in the finished material or article) restriction of 5 mg/kg. In addition, norbornene has been added as an alternative chemical name to describe bicyclo(2.2.1)hep-2ene.

The approved draft also includes a clarification of the restriction on methacrylic acid, 2,3-epoxypropyl ester, which currently appears in Section B of Annex II (the list of substances that are temporarily authorized) of the Monomers Directive. The current QM(T) (maximum permitted residual level of the material expressed as total of moiety or substance) is listed as "5 mg/kg in FP [food product] (expressed as epoxy)." This limit is being clarified to read "5 mg/kg in FP (expressed as epoxy group, molecular weight equal to 43)."

With respect to additives, four new substances have been inserted into Annex III (the additives list),2 while two additives that appeared in the Fourth draft have been deleted from the approved version.3 In addition, new restrictions have been added in connection with the listings of three additives, while the restriction on one additive has been modified. Specifically, the following new restriction has been added in connection with the additive listings for benzaldehyde and: "Warning: there is a risk that migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the finished product does not comply with the 2nd indent of Article 2 of Directive 89/109/EEC." Further, an additional SML (specific migration limit) restriction has been included in connection with the listing for copper iodine: This listing now includes an additional SML of 1 mg/kg (expressed as iodine). The restriction that has been modified applies to chlorides of choline esters of coconut oil fatty acids; the QMA (maximum permitted quantity of the substance per unit area of the surface in contact with foodstuffs) for this material has been changed from 0.15 mg/dm2 to 0.9 mg/6 dm2. Finally, by way of clarification, the reference to the Drinking Water Directive in connection with the listing of water in Annex II, Section A, has been amended to give the reference to the Directive (98/83/EC).

One substance that did not appear in Appendix 7 of the fourth draft (listing additives for which the Chemical Abstracts Service (CAS) Registry Number has been modified) now appears in Appendix 7 of the approved draft. In particular, nepheline syenite is now listed as a substance for which the CAS number has been modified.

Regarding the "General Specifications" provided in Annex V to the Monomers Directive, the specifications for "waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks," and for "white mineral oils, paraffinic derived from petroleum based hydrocarbon feedstocks," have been modified slightly. In both cases, the restriction previously indicating that the product should have "carbon number less than 25 at the 5% boiling point" has been modified to specify that the content of mineral hydrocarbons with carbon number less than 25 must not exceed 5% (w/w).

Finally, the notes in Annex VI relating to the SML(T) for BADGE (bisphenol A diglycidyl ether) have been modified to more clearly express the SCF's current position on hydrolysis products (see article below). More specifically, note (9) now explicitly references BADGE, BADGE.H2O, BADGE.HCL, BADGE.2HCL, and BADGE.H2O.HCL in connection with the 1 mg/kg SML(T).

Due to the resignation of the European Commissioners, there is no clear indication of when the Fifth Amendment will be finally adopted; however, Dr. Luigi Rossi of the European Commission has indicated to us that he is "optimistic" that, since the adoption of the Fifth Amendment will not have a critical political impact, it will be approved and adopted reasonably soon.

B. The European Commission's Scientific Committee on Food Issues Opinion on BADGE

The European Commission's Scientific Committee on Food (SCF) has now issued an opinion re-evaluating the food-contact status of Bisphenol A diglycidyl ether (BADGE) in light of new toxicological and analytical data. While it is the opinion of the industry that a migration limit is not necessary, the new opinion, dated March 24, 1999, extends the previously recommended upper limit of 1 mg/kg food for BADGE and its hydrolysis product for an additional 3 years, and also extends this limit to also include three chlorohydrin derivatives of BADGE (BADGE.HCL, BADGE.2HCL, and BADGE.H20.HCL). In addition, the SCF is now requiring within 3 years (1) the results of DNA-binding studies on tissues of the upper gastrointestinal tract with pure BADGE or, alternatively, with the results of mutation studies in transgenic rodents so that it can determine whether to continue the 1 mg/kg upper limit of migration of BADGE and its hydrolysis products, and (2) the results of either DNA-binding studies or mutation studies in transgenic rodents with all three of the above-listed chlorohydrin derivatives unless it can be shown by appropriate in vitro studies that these compounds do not possess any genotoxic potential.

By way of background, as you may recall, the SCF issued an opinion in June, 1996, changing its safety classification of BADGE from "List 4A" (substances for which an Acceptable Daily Intake (ADI) or Tolerable Daily Intake (TDI) could not be established but which could be used if the substance migrating into foods or food simulants is not detectable by an agreed sensitive method) to "List 7" (substances for which some toxicological data exist but for which an ADI or TDI could not be established), and placing a temporary specific migration limit of 1 mg/kg food on BADGE and its hydrolysis products. (The 1 mg/kg limit was determined based, in part, on information submitted by APME (Association of Plastics Manufacturers in Europe), SEFEL (Secretariat Européen des Fabricants d'Emballages Métalliques Légers), and CEPE (Confédération Européenne des Peintures et d'Encres) with the assistance of Keller and Heckman staff and the SPI epoxy resin working group. In June, 1997, in response to a Commission request for a more detailed explanation of the 1996 opinion, the SCF noted that chlorohydrins as reaction products of BADGE may also be of concern; the SCF indicated that confirmation of the presence of these reaction products of BADGE in food would be needed before this concern could adequately be addressed.

Since the 1997 opinion, the SCF has reviewed additional migration test data on BADGE, its hydrolysis products, and its reaction products. According to the March 24, 1999 SCF opinion, these data show that, during 1997 and 1998, migration values of BADGE into canned food reduced dramatically. In canned homogeneous aqueous foods, BADGE and its monoepoxy hydrolysis product were "hardly detectable"; however, in canned non-homogeneous aqueous foods, such as beans, asparagus, and corn, low levels of BADGE and its hydrolysis product could be found. Further, the SCF opinion states that the above-referenced chlorohydrins have been shown to be formed from the reaction of BADGE with any chloride ions present during the curing of vinylic organosol coatings, and that these chlorohydrins can migrate from the cans into food or be formed in salty foods that are processed in cans from which BADGE has migrated.

Regarding toxicology, however, the non-genotoxicity of BADGE in vivo has now been demonstrated. Further, the reproduction and teratology studies reviewed in 1996 showed that BADGE did not possess any potential for a toxic effect on reproduction, was not teratogenic, and did not interfere with the fertility of the test animals. In addition, although in vivo covalent DNA-binding studies show that BADGE has a weak DNA-binding capacity when applied directly to mouse skin, the SCF opinion indicates that two factors (i.e., human epoxide hydrolase has a higher activity than mouse skin epoxide hydrolase and the available oral subacute, one-generation, and two-generation reproduction studies provide evidence that the ingestion of BADGE has no short-term adverse effect on the histology of the stomach and intestinal mucosa) reduce any concern in this regard.

Despite these toxicological conclusions, the SCF indicates that it is still unable to set an ADI or TDI for BADGE pending clarification of any potential for a direct DNA-binding activity of BADGE on the gastrointestinal mucosa following oral exposure, and in the absence of an "adequate oral chronic toxicity/carcinogenicity study." Thus, the Committee has proposed to extend for a period of 3 years the 1 mg/kg food migration limit on BADGE and its hydrolysis products. The SCF has further proposed to extend this limit to include the chlorohydrin derivatives of BADGE in this limit due to the finding that these products could potentially migrate from coatings or be formed in salty foods.

C. Packaging Waste Directive

1. Work on the Revision of the Packaging and Packaging Waste Directive Awaits a New Environment Commissioner

Although the European Commission has begun working on a revision of the Packaging and Packaging Waste Directive (94/62/EC), the Commissioners' mass resignation has now delayed this process. The main issue of the revision is the recovery and recycling targets set forth in Article 6 of the Directive. Currently, the Directive requires that, by June 30, 2001, 50 to 65% of total packaging waste must be recovered, and further requires that 25 to 45% of the total recovered waste (and a minimum of 15% per material) must be recycled. Article 6. 3. (b) of the Directive mandates that the EU Council of Ministers, acting on a proposal from the Commission, must adopt by December 31, 2000, increased recycling and recovery targets, which would need to be met by July, 2006. Since the adoption of the original targets was the subject of unprecedented lobbying efforts, the revisions will no doubt be heavily discussed.

In a pre-resignation working document, the Commission hinted towards the adoption of the current directive's maximum, i.e., 65% recovery and 45% recycling, as the new minimum, with a minimum rate of 25% recycling per material. This latter percentage could be problematic for plastic materials. So far, industry has strongly criticized any attempt at raising existing targets as premature since the Directive has not been properly implemented in Member States and since the effect of the current recovery and recycling percentages remains to be assessed.

Although the revision to Directive 94/62/EC should only concern the recovery and recycling targets, it is expected that Member States and the EU Parliament will seize this opportunity to further amend the Directive. Towards this end, the revision debate has already expanded beyond target rates to, among other issues, the strengthening of the "reuse" option, the definition of packaging waste, the definition of recycling, and the addition of an open Annex of banned or quantity restricted hazardous substances.

The proposed strengthening of the "reuse" option also would be highly controversial; this would involve changing the language of Article 5 of the Directive, which currently states that Member States "may encourage reuse systems," to more definitive language supporting re-use and, thus, is likely to affect the free movement of goods between Member States. Some Member States, including Denmark and Germany, have implemented legislation that favors reuse; these Member States are likely to advocate the reinforcement of reuse as an effective solution to reduce the amount of packaging discarded. However, the revision is being discussed at a time when the Commission is launching legal proceedings against Denmark for its legislation on cans that favors reuse and, therefore, hinders the importation of canned drinks from other EU Member States (see article below).

Despite the controversial nature of the subject, there remains some time to complete the revision process (the Directive requires the Council to act by December, 2000). Thus, the process may still be completed before the deadline.

2. The European Commission Takes Denmark to the European Court of Justice over Its Implementation of Directive 94/62/EC on Packaging and Packaging Waste

On April 21, 1999, the European Commission initiated action before the European Court of Justice against the Danish Order 124/89 that bans the marketing of beer and soft drinks in metal cans and prevents Danish manufacturers from using single use packaging for these same products. The Commission considers that both bans are contrary to Directive 94/62/EC on packaging and packaging waste.

The aim of Directive 94/62/EC is to minimize the effect of packaging waste on the environment; however, it also is to ensure the free circulation of goods within the European Market, notably through the adoption of common technical requirements for packaging. In this regard, Directive 94/62/EC provides that Members States cannot impede the marketing in their territory of packaging that complies with the "essential requirements" set forth by the Directive on the composition and reusable and recoverable nature of the packaging. According to the Commission, metal cans and one-way (i.e., single use) packaging comply with the essential requirements of Directive 94/62/EC and, therefore, should be allowed free circulation in the EU. Denmark argues, however, that, although metal cans meet essential requirements, the ban is necessary to protect the environment, one of the purposes of the Directive. The Commission considers that Danish legislation does not strike an appropriate balance between the two (environmental and free circulation) objectives of the Directive and is a non-justified barrier to trade in the internal market.

It is now up to the European Court of Justice to decide upon the contentions of both parties and the balance to be struck by Member States between the two fundamental objectives of the Directive (the protection of the environment and the free movement of goods).

1 Prepared on May 18, 1999, by Keller and Heckman LLP for the June 21-23, 1999, meeting of The Society of the Plastics Industry, Inc.'s Food, Drug, and Cosmetic Packaging Materials Committee at the Marriott Inner Harbor Hotel in Baltimore, Maryland.

2 (1) 1,2-Bis(3-amino propyl)ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine, (2) bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy) methylammonium chloride, (3) formaldehyde-1-naphthol copolymer [=Poly(1-hydroxynaphthyl methane)], and (4) mixture of (50% w/w) phthalic acid n-decyl n-octyl ester, (25% w/w) phthalic acid di-n-decyl ester, (25% w/w) phthalic acid di-n-octyl ester.

3 (1) Phthalic acid di-n-octyl and/or di-n-decyl and/or n-decyl n-octyl esters, and (2) 1,3-proprane diamine, n, n'-1,2 ethanediylbis polymer with n-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine.

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