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

December 3-4, 1998
Jerome H. Heckman
Ralph A. Simmons

INTRODUCTION

Ladies and Gentlemen:

We are pleased to present this report on the status of matters in which we have been involved or which we have monitored on behalf of The Society of the Plastics Industry, Inc.'s (SPI's) Food, Drug, and Cosmetic Packaging Materials Committee (FDCPMC) since the June 1998 meeting of the Committee.

TABLE OF CONTENTS

1. Legislative Activities
   1. Congress Approves Limited Funding for Food-Contact Notification Program and Delays Implementation
   2. Congress Passes Bill to Protect Biomaterials Suppliers from Unfounded Lawsuits
   3. Regulation of Antimicrobials for Food Packaging Returned to FDA

2. Food and Drug Administration Activities
   1. Dr. Jane Henney Confirmed as FDA Commissioner
   2. CFSAN Announces Priorities to Improve Performance and Customer Service
   3. Agency Decisions on Butadiene and Styrene Forthcoming

3. Update on Endocrine Issues
   1. EDSTAC Report Released
   2. New Study of Bisphenol A Has Found No Evidence of Estrogenic Effects from Low-Dose Exposures

4. International Issues
   1. Adoption of the Fifth Amendment to the Monomers Directive Is Further Delayed
   2. Interest Grows in Using Mutual Recognition to Market Food- Contact Materials in the EU
   3. The EU Commission Seeks to Support the European Recycling Industry

On October 21, 1998, President Clinton signed the Omnibus Spending Bill (H.R. 4328) into law. This bill appropriates money for the Food and Drug Administration (FDA) during the 1999 fiscal year (FY) and, importantly, includes funds to implement the Food-Contact Notification (FCN) program. As you undoubtedly will recall, the FDCPMC was instrumental in obtaining passage of legislation last year that called for the creation of a new regulatory system for food-contact substances. Upon implementation of this notification program, passed as part of the Food and Drug Administration Modernization Act of 1997 (FDAMA) and now codified at 21 U.S.C. § 409(h), manufacturers and suppliers of food-contact substances should be able to submit a notification to FDA in lieu of submitting a food additive petition. The program is designed so that, if FDA does not object in writing to the intended use of the material within 120 days following receipt of the notification, the submitter may begin marketing the product.

Unfortunately, FDAMA also provides that the FCN program needs to be funded at a certain level before FDA is required to implement the program. This funding language was inserted by Congress in place of the filing fees agreed to by the food packaging industry and FDA. A few key members of Congress were ideologically and politically opposed to the inclusion of any type of fees, so an eleventh hour compromise was reached to keep the FCN program in the bill with the requirement for funding from FDA's budget. Specifically, FDAMA provided that the FCN program would become effective on April 1, 1999, if Congress appropriated $1.5 million in FY 1999 and $3 million annually thereafter (or such lesser amount as might be requested by the President).

In an effort to ensure that this important reform is actually implemented, SPI member company personnel, the SPI governmental affairs staff, and Keller and Heckman worked intensively over the last year with members of Congress and their staffs to obtain the necessary funding. While various types of language were included in different versions of the appropriations bills, the final version that was passed by Congress was developed in a legislative conference between the House and Senate after consultation with FDA. Specifically, the appropriations bill as enacted states as follows:

. . . an amount of $500,000 shall be made available for the development of systems, regulations, and pilot programs, if any, that would be required to permit full implementation, consistent with section 409(h)(5) of that Act [the Federal Food, Drug, and Cosmetic Act], in fiscal year 2000 of the food contact substance notification program under Section 409(h) of such Act;

In a surge of activity right before the August recess, Congress passed the long-anticipated Biomaterials Access Assurance Act of 1998 (H.R. 872), which had been reintroduced in this Congress by Representative George Gekas (R-PA). After both the House and Senate passed the bill by voice vote on July 30, the President signed the bill into law on August 13, 1998 (P.L. 105-230). The Act provides protection from unfounded product liability lawsuits against suppliers of raw materials and components for medical implants. H.R. 872 was passed because of concerns over the depletion of stocks of raw materials due to a reluctance by many companies to supply the medical device market based on concerns over rising litigation costs. Even though, to our knowledge, no biomaterials supplier has ever been found liable in a lawsuit involving defective implants, in many cases, suppliers have been forced to incur enormous defense costs before obtaining dismissal of the litigation. Congress was concerned that, if the present situation continued, it would jeopardize the availability of many implants and increase the costs to consumers of available implants.

The new law applies to all actions brought in state or federal courts under a claim for product liability. The law basically codifies certain common law defenses already available in many states to biomaterials suppliers in these types of lawsuits. The rationale behind these defenses is that the manufacturer of a final product is in a better position to judge the suitability of the product for its intended use and it is the manufacturer that owes the duty of care to the patient. While limiting the scope of liability for biomaterial suppliers under product liability actions, the new law does not affect suits for breach of warranty or contract. In addition, suits brought alleging harm from silicone breast implants are not affected by the law.

The true benefit of the new law is not that biomaterials suppliers will avoid liability for harm from medical implants unrelated to a defect caused by the supplier: courts had never found suppliers liable for these injuries in the past. The true benefit is that the new law will limit the costs that a supplier could incur from being named as a defendant in a lawsuit. As described in more detail below, in most cases under the new law, a biomaterials supplier is entitled to expedited dismissal from a lawsuit and is only subject to a claimant's discovery requests in very limited circumstances. The Act contains a narrow procedure by which a supplier may be brought back into a lawsuit after judgement and be found liable, but only if evidence was introduced during the trial demonstrating that the biomaterials supplier was negligent or committed intentional misconduct.

Specifically, the Act's liability protection is available to those persons who supply, directly or indirectly, a component part or raw material that is used in an implant² provided that the supplier (1) was not the manufacturer of the implant (i.e., did not engage in the manufacture, preparation, propagation, compounding, or processing of the implant); (2) was not the seller of the implant (i.e., did not in the course of business sell, distribute, lease, package, label, or otherwise place the implant in the stream of commerce); or (3) did not furnish raw materials or component parts for the implant that failed to meet contractual requirements, its own published specifications, or those specifications required by law or regulation.

A supplier may be found liable as a manufacturer of the implant if the supplier was registered or was required to register as a manufacturer of an implant under the medical device regulations, or if the supplier was required to include the implant on a list of devices filed with the Agency. Alternatively, a supplier may be found liable as a manufacturer if the court finds that the supplier was related by common ownership or control to a liable manufacturer, where the manufacturer lacks sufficient financial resources to satisfy a judgment in favor of the claimant.

A supplier may be found liable as a seller only if it held title to the implant and then acted as a seller after its initial sale, acted under contract as seller to arrange for transfer to the person claiming liability after the initial sale, or if the court finds that the supplier was related by common ownership or control to a seller meeting the above requirements and the seller lacks sufficient financial resources to satisfy a possible judgment.

The third exception to the liability protection for suppliers under the Act allows a claimant or manufacturer to bring suit against the supplier if the supplier failed to meet contractual requirements or required specifications for the material and the failure to meet those standards was an actual or proximate cause of the injury to the claimant. These requirements and specifications include those contained in (1) the contract between the supplier and the device manufacturer, (2) accepted standards pursuant to law, (3) standards published by the supplier itself, (4) standards provided by the biomaterials supplier to the device manufacturer, or (5) specifications and standards for the product contained in a master file or other submission to FDA for the purpose of the premarket approval or review of the medical device.

As stated above, the advantage of this legislation to biomaterials suppliers is that suppliers will be able to be dismissed quickly from lawsuits and will not have to incur the costs and endure the inconvenience of defending unmeritorious civil actions. Under the new law, a biomaterials supplier may move to be dismissed from the case at any time. Once the motion to dismiss is filed, no discovery against the supplier is permitted except for very limited purposes. The discovery limitations should be a significant benefit to a supplier named in a lawsuit, because pretrial motions for discovery can be expensive, inconvenient, and often can force the disclosure of sensitive documents.

Although the new law contains a provision by which a supplier may be subsequently found liable after being dismissed from a case, the conditions under which this provision can be brought into play are extremely limited. It is doubtful that this provision will have much impact on the industry. In fact, the Committee Report that accompanied the bill states that the provision is intended to be used only in egregious cases. The report goes on to state that "[t]he Committee has not found a single case that has gone to final judgment where a biomaterials supplier has been held liable. While this procedure may identify such a case, if one ever arises, courts should police its use to ensure that it does not become a routine post-trial motion. It is for extreme, unusual cases."

In past reports to the FDCPMC, we had reported on the unintended consequence of the Food Quality Protection Act of 1996 (FQPA) in which the regulation of antimicrobials in food- contact materials was moved from FDA to the Environmental Protection Agency (EPA). We can now report to the Committee that, at last, some resolution has come to the matter, and jurisdiction over clearance of antimicrobials for food packaging and some other food-contact applications has been returned to FDA, although these substances may be required to be registered with EPA as pesticides, in addition to being cleared by FDA.

The resolution came in the form of a legislative amendment and a notice of policy interpretation by EPA and FDA that was published in the Federal Register. Specifically, Congress passed the Antimicrobial Regulation Technical Corrections Act (ARTCA) of 1998 (H.R. 4679) on October 7, 1998, which President Clinton signed on October 30, 1998. At almost the same time as Congress acted, EPA and FDA jointly issued a notice of policy interpretation on October 9, 1998, announcing their plans for resolving the jurisdictional issues created by FQPA. 63 Fed. Reg. 54532. Much of the agencies' transition plan, however, was rendered unnecessary by ARTCA.

Prior to FQPA, the term "pesticide chemical" was defined as a substance intended to control pests that was used in the production, storage, or transportation of raw agricultural commodities (RACs). The safety of pesticidal chemical residues was regulated by EPA under Section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA). Pesticide residues on processed foods and food-contact materials, however, were not included in the "pesticide chemical" definition and were regulated by FDA as food additives under Section 409 of FFDCA. The fact that pesticide residues were transformed from pesticide chemicals to food additives upon processing of the food prevented the approval of some pesticides because the residues on processed food could not pass muster under the safety standard for food additives.

FQPA redefined "pesticide chemical" to mean any pesticide, including active and inert ingredients, but the revised definition no longer limited the regulation of pesticide chemicals to pesticide residues on RACs. A corresponding change was made to the definition of "food additive" to exclude pesticide chemical residues on raw or processed food. This change, which gave EPA sole jurisdiction over all pesticide residues on food, was intended to eliminate the conflict that arose when different safety standards were applied to a particular pesticide residue at different stages of food processing.

Unfortunately, FQPA did not completely eliminate the need to distinguish between RACs and processed foods. The distinction persists in the definition of "pest." By regulation, EPA has long defined "pest" to exclude microorganisms (viruses, bacteria, etc.) on, among other things, processed foods and beverages. Under these regulatory definitions, residues of antimicrobials used to control microorganisms on processed foods are not pesticide chemicals because microorganisms on them are not pests. Consequently, under EPA's regulations, even after FQPA, there remained an argument that FDA retained food additive jurisdiction over antimicrobials on processed food and food-contact articles.

Based on FQPA's expanded definition of "pesticide chemical," however, EPA asserted jurisdiction over the use of antimicrobials in areas that FDA had previously regulated or where a custom of dual jurisdiction had arisen without any clear statutory basis: antimicrobials used inside a processing facility on RACs (particularly in process water), food packaging materials, and other food-contact articles. Consequently, a number of food additive petitions that were pending at FDA when FQPA was passed were put on hold while the two agencies sorted out the new allocation of jurisdiction.

The food and packaging industries objected to the transfer of jurisdiction for many antimicrobials from FDA to EPA. Industry believed that the pre-FQPA arrangement was a more efficient, less time-consuming, less expensive, and equally safe approach to regulating the use of antimicrobials in food and food-related applications. The jurisdictional confusion was an unintended consequence of the definitional changes made by FQPA. After two years-with most pending antimicrobial food additive petitions still languishing before FDA-Congress now has passed legislation to correct some of the unintended results of FQPA. The implications of the legislative amendment for the food packaging industry are summarized below.

ARTCA amends the definition of "pesticide chemical" to exclude residues of antimicrobials used in or on food packaging materials.

These residues are subject to FDA's food additive rules under Section 409 of the Federal Food, Drug, and Cosmetic Act.

While jurisdiction over the safety of antimicrobial residues for the above uses will shift to FDA, the products intended for these uses are still pesticides and, as such, are required to be registered with EPA (unless this situation is changed by EPA and FDA through rulemaking as proposed in the agencies' policy interpretation).

The bill also defines "pesticide chemical" to include antimicrobials used on permanent or semipermanent food-contact surfaces other than packaging (such as conveyor belts) and antimicrobials used in a permanent or semipermanent food-contact surface other than packaging where the antimicrobial is intended to have an ongoing effect on the food- contact surface.

Transition rules included in ARTCA provide that approvals granted by either EPA or FDA for antimicrobials for food-related uses remain valid, even if jurisdictional authority to grant those approvals has been changed.

The notice also announces EPA's intention to propose an amendment to the definition of "pest" (40 CFR 152.5(d)) to provide three new exclusions: (1) microorganisms on RACs in a food processing facility or in process water that contacts RACs, (2) microorganisms in food packaging or materials used to produce such packaging, and (3) microorganisms in materials used to produce food-contact articles other than packaging. These exclusions closely track the exclusions from the definition of "pesticide chemical" in ARTCA. By excluding microorganisms in these specific cases from the definition of "pest," FDA would assume sole jurisdiction over antimicrobials used in these situations. FDA's food additive procedures would apply, and there would be no need to obtain an EPA pesticide tolerance or registrations for these materials. To implement this change, EPA will need to promulgate regulations under the standard notice and comment procedures. In light of the legislative corrections, however, it is unclear how much interest remains at EPA for pursuing this rulemaking.

On October 21, the Senate confirmed Dr. Jane Henney as the new commissioner of the U.S. Food and Drug Administration (FDA). Confirmation of Dr. Henney, who becomes the first woman to head the Agency, came by voice vote on the final legislative day of the 105th Congress after Senator Don Nickles (R-Okla.) removed a hold he had placed on the nomination a few days earlier. Apparently, Senator Nickles was concerned that Dr. Henney, who worked under former FDA Commissioner David Kessler, may have had a significant role in soliciting an American manufacturer for the French abortion pill RU-486. In the end, the White House and Dr. Henney promised Senator Nickles that FDA would not solicit a manufacturer for RU-486, and Health and Human Services Secretary Donna Shalala made additional promises to the Republican leadership regarding abortion and tobacco regulation, after which Senator Nickles finally agreed to remove the hold on Dr. Henney's nomination.

Dr. Henney's résumé boasts extensive experience in medical research. She graduated from the University of Indiana Medical School in 1973, became a senior investigator at the National Cancer Institute (NCI), and eventually became Deputy Director of NCI. Dr. Henney then served as President of the University of Kansas Medical School before her stint as Kessler's deputy at FDA beginning in 1992. Since leaving FDA in 1994, Dr. Henney served as Vice President of the University of New Mexico Health Science Center, where she supervised its medical school, its college of pharmacy, and several teaching hospitals. Dr. Henney also is president of the U.S. Pharmacopoeia.

As FDA commissioner, Henney will be met with a number of contentious issues, including the consideration of creating a single food safety agency, which would combine food safety responsibilities currently shared by a number of federal departments. Dr. Henney stated after her confirmation in an October 21 press release that her top priority as FDA commissioner will be the implementation of the Food and Drug Administration Modernization Act, although we expect that Dr. Henney was referring to drug and medical device aspects of FDAMA rather than food-contact notification.

On June 24 and 25, the Center for Food Safety and Applied Nutrition (CFSAN) held a public meeting to discuss the creation of program priorities. As many of you may know, Jerome Heckman and Tom Brown (now with Keller and Heckman, but formerly head of FDA's Indirect Additives Branch in the Office of Premarket Approval) testified at the public meeting regarding the importance of fully funding and implementing the Food-Contact Notification system.

In a September 23 letter to the programs' participants that summarized the themes of the public meeting, Dr. Joseph Levitt, CFSAN Director, indicated that oral comments were received from 38 individuals representing 23 different organizations, including consumer groups, industry associations, and health professional organizations. Dr. Levitt stated that four priority areas were most commonly identified by those giving input to the Center. The Food Safety Initiative (FSI) was identified by most to be CFSAN's top priority. Second was the need to reform the Center's food additive approval process to reduce the backlog of pending petitions and to increase the timeliness of high quality petition reviews. The third and fourth priorities were international harmonization, specifically in the development of international food safety standards by the Codex Alimentarius Commission, and the need for the Center's science base to be maintained at the highest level to ensure that regulatory decisions have the necessary scientific foundation.

We are encouraged by Dr. Levitt's comments that the Center will make reducing the processing and review of food additive petitions a priority, and we hope that FDA reviews the FCN program as an important step toward reaching this goal.

As many of you may already know, for several years, FDA has not acted on indirect additive petitions containing butadiene because the Agency is currently conducting a risk assessment for this substance. We have learned recently that FDA's Health Effects Evaluation Division has completed its toxicological review of the National Toxicity Program (NTP) study on butadiene, and referred the matter to FDA's Cancer Assessment Committee (CAC), which is now beginning its review of butadiene. Once the CAC has finished its review, and assuming, as is likely, that it will find butadiene to be a carcinogen, the matter will proceed to the Quantitative Risk Assessment Committee (QRAC), which will establish a virtually safe dose (VSD) for butadiene. The establishment of a VSD will allow FDA to complete review of any pending Threshold submissions or petitions for substances containing butadiene. We have been informed that FDA's QRAC review may be completed within the next six to eight months.

The Agency also recently decided to suspend action on petitions that involve styrene monomers and polymers. FDA will make a decision as to whether styrene is a carcinogen and, if so, a VSD for styrene will be established. As with butadiene, this could be a long-term project. In light of the number of pending petitions affected by the current assessment of styrene, however, we understand that FDA considers the situation a "medium-high priority" and, consequently, funding and personnel have been specifically designated in an effort to have this work completed in a timely manner. In addition, FDA contacts have indicated that nearly all of the pending petitions involving styrene as a constituent will be acceptable under the currently projected VSD, if styrene is, in fact, deemed to be a carcinogen.

In our June 1998 General Counsel's report, we discussed the Endocrine Disruptor Screening and Testing Advisory Committee's (EDSTAC's) efforts to develop a conceptual framework and strategy for a screening program to assess the endocrine effects of a large number of chemicals. As you may recall, EPA convened EDSTAC in 1996 to advise the Agency on how it should comply with Congressional mandates under drinking water and pesticide safety laws. On October 5, 1998, EDSTAC presented its final report to EPA and released the report to the public.

As expected, the report sets out a plan that could cost industry millions of dollars to evaluate thousands of commercial pesticides and industrial chemicals for their potential to disrupt the hormone systems in humans and animals. The report estimates that 87,000 chemicals need to be evaluated, including pesticides, commodity chemicals, naturally occurring estrogens (from plant and fungi sources), food additives, cosmetics, and nutritional supplements.

EPA published a Federal Register notice on August 11 describing the major elements of the testing program; operational details, plans for regulatory implementation, and procedures for public comment will be provided in a later Federal Register document, which will likely be issued this year. The EDSTAC report is scheduled to be reviewed in March 1999 by a special committee of EPA's Science Advisory Board. After this review, EPA will attempt to standardize and validate the recommended screening and testing methods.

As of yet there has been no determination of who will pay for this testing and this is expected to be a major issue in the coming months. We will keep the Committee advised since this may be a subject on which comments should be submitted.

A recent study cosponsored by SPI and the Bisphenol A Sector Group of the European Chemical Industry (CEFIC) has reached conclusions on the claimed endocrine effects of bisphenol A (BPA), which is a monomer used primarily to produce polycarbonate and epoxy resins. The results of the study suggest that BPA is not an estrogen modulator at the doses tested, and brings into question the much-publicized 1997 study by Professor Frederick vom Saal at the University of Missouri-Columbia.

Dr. vom Saal reported that low dose exposures (2 and 20 micrograms per kilogram of body weight/day) to estrogenic compounds given orally affected the prostate weight and efficiency of sperm production of male offspring in mice. Based on the reported findings of Dr. vom Saal's research, it has been theorized that the levels of certain compounds to which human and wildlife populations are environmentally exposed may have adverse effects on hormone-based systems. Dr. vom Saal and other scientists subscribe to a "low-dose theory," which postulates that exposures to very small amounts of a substance (below doses at which other effects occur) may indeed have adverse endocrine effects. This theory runs counter to the general axiom that "the dose makes the poison," i.e., for any given substance, there is an exposure level below which exposure does no harm.

The SPI/CEFIC study was an attempt to replicate the vom Saal findings. However, no effects were observed at the identical low dose levels, nor were effects found at doses 10 times higher and 10 times lower. Thus, the SPI/CEFIC results do not support the theory that low oral doses of bisphenol A pose a health concern to humans or wildlife. The SPI/CEFIC study is being submitted for publication in a peer-reviewed scientific journal.

It is now certain that the adoption by the European Commission of the Fifth Amendment to the Monomers Directive (90/128/EEC) on food-contact plastics will not take place before the summer of 1999. In fact, no progress has been made towards the adoption of the Fifth Amendment since last February, when the Commission issued the third draft of the Amendment. Presently, the Commission is preparing a new (fourth) draft, which it had planned to send to Member States this Fall, with the intention that the Amendment would be adopted within the first half of 1999.

According to the Commission, although the fourth draft will be quite similar to the third draft, it will include some technical adjustments. For example, the fourth draft will no longer contain references to substances subject to specific migration limits (SML), where the SML was not agreed upon by the sponsor or representative industry group. Non-controversial substances (e.g. monomers and additives without SMLs) that have been reviewed by the SCF Working Group on food-contact materials, but have yet to be confirmed at a SCF plenary meeting, are included in the fourth draft. SCF confirmation of these additional monomers and additives is expected at the December SCF meeting.

The final step is approval by the Standing Committee on Food. If the Standing Committee on Food, which consists of the of the agricultural ministers of the 15 EU countries, unanimously approves the 5th Amendment, it will be published as a Directive by the European Commission without going before the European Parliament.

In the absence of significant progress towards further harmonization of the Member States' laws on food-contact materials, the European chemical industry is increasingly interested in exploring to what extent the principle of "mutual recognition" can be used as an alternative to market food-contact materials in the EU. Mutual recognition is the principle of EU law that facilitates trading among Member States by providing that, in most cases, products permitted in one Member State should be allowed to be marketed in all Member States. The Food Contact Additives Panel (FCA) of the European Chemicals Council (CEFIC) recently organized meetings with the European Commission and with the French officials to pursue applying the principle of mutual recognition to food-contact substances. On September 3, 1998, a delegation from CEFIC FCA, accompanied by Jean-Philippe Montfort of Keller and Heckman's Brussels office, met with responsible officials of the European Commission Directorate General XV (Interior Market and Financial Services) regarding the use of the principle of mutual recognition to market food-contact materials in the EU. The goals of the meeting were (1) to inform the European Commission that CEFIC FCA is interested in using the principle of mutual recognition to ensure the free circulation of food-contact materials in the EU until the harmonization of the Member States' legislation in this area is completed; (2) to better understand the European Commission's position regarding the application of the mutual recognition principle to food-contact materials; and (3) to identify means of enhancing the practical use of mutual recognition for food-contact materials. Industry explained to the Commission that the free movement of food-contact materials is not yet a reality due to the incompleteness of the harmonization process for these materials and because the following factors restrain the efficient use of the principle of mutual recognition as a means of gaining market access: (1) the lack of Court of Justice precedent; (2) the resistance of national enforcement authorities to applying the principle; (3) the differences in the general frameworks of Members States' legislation; (4) the inadequacy of a judicial remedy for failure to permit the free movement of goods; and (5) the difficulty of convincing traders that mutual recognition is a viable alternative. For its part, the European Commission is working on a proposed Interpretative Communication on the Use of Article 30 (Mutual Recognition) in the Industrial Sector (this document will contain only general principles, applicable to the whole industrial sector) and an update of the Commission Communication on the free circulation of foodstuffs.

After completing a survey of the industries involved in recycling in the EU, the European Commission has issued a Communication on the "Competitiveness of the Recycling Industries" (July 1998). Since recycling forms an integral part of the European policy on packaging waste, the competitiveness of the European recycling industry is critical to a successful EU waste policy. The Commission Communication is general in nature, but in discussing future trends is likely to influence EU legislative initiatives on waste.

The Communication first identifies the difficulties faced by the recycling and secondary materials industries. On the supply side, the Commission stresses the cost of collecting and sorting processes due to structural difficulties in establishing proper collection schemes and mentions such technical difficulties as the complexity of new material designs and the lack of information on packaging contents that could contaminate secondary material. On the demand side, the Commission confirms that secondary materials have an image problem, and are affected by regulations, such as food packaging regulations, that set stringent requirements on the use of recycled materials.

To address these problems, the Commission proposed a series of actions, including standardization, market development, and the adoption of new regulations. These actions could have serious repercussions for packaging and consumer goods industries.

In the area of standardization, EU authorities suggest products could be required to be designed to accommodate recycling, dangerous substances could be required to be reduced or eliminated, distinctions between raw materials and secondary materials could be removed, and a marking system could be put into place to foster selective collection and facilitate sorting. With regard to market development, better information and statistics on waste and secondary material production could help in the promotion of secondary material use (for example, through the creation of an ecological label).

The Communication also suggested new legislative initiatives aimed at fostering recycling. For example, legislation could require inclusion of the costs of alternatives to recycling (e.g., landfill costs) in the product price. Legislative actions also could attempt to reduce the presence of hazardous substances when alternatives are available and prescribe minimum secondary material content in specific products.

On a final note, the EU Commission is working at the moment on a draft Communication on Waste Prevention that is very likely to follow the line initiated in the Communication on the Competitiveness of the EU Recycling Industry and elaborate on the proposals for actions contained in the latter Communication. Although the content of the new Communication is not known, it is expected that it will reemphasize reducing the amount of hazardous substances in packaging and the importance of designing packaging to facilitate recycling and, more generally, of limiting its impact on the environment.

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