March 23, 2004

simmons@khlaw.com

The Society of the Plastics Industry, Inc.

Food, Drug, and Cosmetic Packaging Materials Committee

Dear Ladies and Gentlemen:

In this letter, we report on the European Commission's proposal to amend the Framework Directive for food-contact materials (Council Directive 89/109/EEC) and the new proposed directive on food-contact plastics, commonly referred to as the Super Directive, which would replace the existing Plastics Directive (formerly known as the Monomers Directive). We also report on the First Amendment to the Plastics Directive, which has enacted some of the proposals of the Super Directive, and the draft amendment to the Plastics Directive that proposes to ban azodicarbonamide as a blowing agent in plastic materials and articles, as well as the new Directive on regenerated cellulose films. We discuss the retirement of Joseph Levitt as Director of the FDA's Center for Food Safety and Applied Nutrition (CFSAN), and longtime FDA and USDA official Dr. Lester Crawford taking over as Acting Commissioner of the Agency upon the appointment of Commissioner Dr. Mark McClellan to head up Medicare. Finally, we address the Compliance Policy Guide on Prior Notice of Food Imports under FDA's Bioterrorism Regulations and, specifically, an issue that was raised regarding the labeling of products intended for food-contact use but which also could be used as direct additives.

Table of Contents

1. EU Adopts First Amendment to the Plastics Directive and Proposed Ban on Azodicarbonamide
   
   
2. European Commission Releases New Draft of Super Directive on Food-Contact Plastic Materials
   
   
3. EU Proposes Amendment to Framework Directive on Food-Contact Materials
   
   
4. FDA Commissioner Dr. Mark McClellan Is Nominated to Head Medicare, and Dr. Lester Crawford Resumes his Role as Acting Commissioner; Joseph Levitt Resigns as Director of FDA's CFSAN
   
   
5. FDA and Customs Release Compliance Policy Guide on Prior Notice of Food Imports under Bioterrorism Regulations
   
   
6. EU Passes New Directive on Regenerated Cellulose Films
   
   

1. EU Adopts First Amendment to the Plastics Directive and Proposed Ban on Azodicarbonamide

The European Commission has issued the First Amendment to the Plastics Directive (formerly known as the Monomers Directive). The Amendment formally establishes new deadlines for making the list of additives under the Directive legally binding, meaning that only additives on the list will be permitted in the EU. Under the First Amendment (as proposed in the Super Directive, see Article 2 in this letter), the list of additives will become a binding or "positive" list no later than December 31, 2007. To facilitate meeting this deadline, the Amendment also requires that data to support listing of additives must be submitted by December 31, 2006.

In addition, the Amendment includes a number of other revisions to the Plastics Directive. There is now a definition of "polymeric additive," also as proposed in the Super Directive, which describes this category as "a polymer and/or oligomer which may be added to plastics in order to achieve a technical effect, but which cannot be used in the absence of another polymer as principal structural component." These polymeric additives will be required to be listed on the "additives list" under the Plastics Directive in accordance with the deadlines described above.

The Amendment also contains specific changes to listings for food-contact monomers and additives and their specifications.

The European Commission also has prepared a draft Commission Directive to amend the Plastics Directive to ban azodicarbonamide as a blowing agent in plastic materials and articles. The Plastics Directive currently allows the use of azodicarbonamide as a blowing agent in accordance with the opinion of the Scientific Committee on Food (SCF). The proposed amendment is based on the findings of the European Food Safety Authority (EFSA) (which has replaced the SCF) that azodicarbonamide decomposes into semicarbazide under heating conditions applied to make sealing gaskets for the lids of glass jars and bottles. In an October 15, 2003 press release, EFSA acknowledged that the risk to both infants and adults eating foods containing semicarbazide is probably very small, but recommended that semicarbazide found in baby foods should be reduced as quickly as technologically possible. EFSA also recommended that the European Commission establish a monitoring program for timely implementation of alternative packaging solutions.

Notwithstanding EFSA's finding of no imminent threat, the European Commission has proposed the suspension of azodicarbonamide from the list of authorized substances while additional information on semicarbazide is researched. The Commission also believes that alternatives to azodicarbonamide will be available shortly and will allow for a transition period of one year for the continued evaluation of these alternatives. Industry is working with EU officials to provide realistic exposure information to ensure the safe use of azodicarbonamide.

2. European Commission Releases New Draft of Super Directive on Food-Contact Plastic Materials

The European Commission is continuing work on a new directive on food-contact plastics, the so-called "Super Directive" that seeks to consolidate, revise and repeal several Community Directives relating to food-contact plastic materials. The Super Directive has been through several drafts. This Committee has submitted comments to the Commission on two occasions in response to proposed versions of the Super Directive, including the most recent one.

As proposed most recently, the Super Directive would extend the scope of the current Plastics Directive to cover multilayer materials, where one or more layers is not made entirely of plastics, provided that the layer in contact with food consists of plastic. This would expand the scope of the current Plastics Directive, which applies only to materials that are made exclusively of plastic.

The draft of the Super Directive indicates that those multilayer materials that fall within its scope must consist entirely of "authorized substances," meaning that the materials must be listed under a Commission Directive or, if no Directive applies, the materials must be cleared under "the national law." The most significant aspect of this provision is that plastic portions of multilayer articles with non-plastic components must be made from monomers and additives listed under the Directive (this will apply to additives when that list becomes binding). As to the non-plastic components, they are already subject to compliance with national laws (or, in very few cases, to listing under a Directive). Fortunately, compliance with the national laws is facilitated by the principle of "mutual recognition" based on the Treaty of Rome. That principle allows the marketing in all EU Member States of products that are lawful in any single member state.

In adopting this new position on multilayer articles including materials other than plastics, the proposed Super Directive would take the positive step of formally recognizing the "functional barrier" principle in the EU. Specifically, the draft Super Directive provides that materials on the non food-contact side of a functional barrier would not need to be "authorized" under EU or national laws.

On the downside, the EU remains in a quandary about the limit of detection (LOD) for establishing that there is no migration of "unauthorized substances" through the functional barrier. An initial draft of the Super Directive proposed an LOD of 1.5 parts per billion (ppb) (this would be an LOD in food or food simulants). This Committee commented that the recommended LOD was below levels supported by the available science. In the next draft, the Commission proposed to increase the LOD to 10 ppb, certainly an improvement, but probably still unnecessarily low in many circumstances. The most recent draft of the Super Directive has a value of "X", so the recommended LOD has become an unknown. The functional barrier exemption also would not apply to substances classified as carcinogenic, mutagenic, or toxic for reproduction under the EU chemical control legislation.

In commenting on the most recent draft, this Committee once again has urged the European Commission to establish the LOD for establishing a functional barrier at a level that is supported by the scientific literature, including recent papers providing a basis for a higher threshold of regulation than FDA's 0.5 ppb in the diet (not just migration to food).

Another serious drawback to the functional barrier exemption as proposed in the Super Directive is the inclusion of a requirement to disclose to the Commission and Member State authorities the identity of any "unauthorized" substance used on the basis of the exemption. This would call upon companies to disclose the identity of substances, which may well constitute trade secrets, even though there will be no significant exposure.

In general, the Super Directive requires disclosure of potentially confidential information without specifying how that information will be protected against unauthorized public disclosure. The Super Directive would expand the declaration of compliance that is already required and mandate disclosure of supporting documentation to "enforcement authorities." Yet, there is no provision for protection of trade secret or other confidential information.

Another very interesting item in the most recent draft of the Super Directive resides in Footnote 26, which discusses a potential approach to the regulation of "polymerization production aids."¹ The text of the Super Directive (in Article 5) continues to call for the listing of permitted "polymerization production aids." Although the definition of this term and the examples given are somewhat ambiguous, we would expect the category to include other substances covered by what we refer to in the United States as the "Basic Resin Doctrine," such as catalysts, initiators, and chain transfer and chain terminating agents. Therefore, as drafted, the Super Directive appears to require public disclosure of basic resin substances, which often are closely held trade secrets.

Footnote 26 reports on an industry proposal on this subject that we understand is currently under discussion with the Commission. The proposal is described as follows:

This Committee has not been advised of the status of discussions on this subject between EU industry and the Commission. The proposal described in Footnote 26, however, certainly would be beneficial in avoiding the public listing of polymerization aids. Such listing would compromise trade secrets or, more likely, limit technological developments for the EU market.

The proposed Super Directive also includes several other features that we want to bring to the attention of the Committee. In Annex VIII, the Commission proposes an additional safety factor to reduce the established specific migration limit (SML) for a material used in articles intended for infants (children under the age of 12 months) and young children (children aged between one and three years). The additional safety factor would be determined based on advice from EFSA. It is our view, however, that the scientific literature supports an additional safety margin (over those already employed in risk assessment) with respect to children only for substances where there is evidence of postnatal developmental toxicity and an adequate toxicity database has not been assembled to address these concerns.

On another subject, the draft Super Directive would introduce a "fat (consumption) reduction factor for lipophilic substances to be applied to migration values to take into account that the European consumer daily ingests not more than 200 grams of fat, not 1,000 grams as assumed until today." The Super Directive also would replace QM and QMA (residual) values with specific migration limits (SMLs) for determining compliance. Industry, however, still would be allowed to calculate compliance with the SMLs on the basis of residual values. The Super Directive also would make some changes in recommended migration testing simulants and conditions of time and temperature.

3. EU Proposes Amendment to Framework Directive on Food-Contact Materials

On November 17, 2003, the European Commission proposed legislation to the European Parliament that is intended to replace the existing Framework Directive for food-contact materials (Council Directive 89/109/EEC). The Commission proposal is entitled the "Regulation on Materials and Articles Intended to Come into Contact with Food (COM(2003) 689 Final)." The proposed legislation will apply, as does the current directive, to all food-contact materials. The Commission proposal will now be considered by the Parliament and the European Council. If the Council and Parliament agree on the Commission proposal after the first reading, the proposal will be enacted. If either of the institutions disagree, then a "conciliation committee" will be formed to try and resolve the differences. (Parliament can also reject the proposal entirely by an absolute majority.) The proposal is currently scheduled to be voted on in May 2004.

The new legislation would provide for the regulation of food packaging materials by the use of either "directives" or "regulations." This is exemplified by the fact that the new legislation is presented in the form of a regulation. This change will expedite future regulation of food-contact materials and will eliminate the need to transpose the Commission's positive lists into the national law of each Member State. In the European Union at present, directives must be adopted into the national law of a Member State to become effective in that Member State, while regulations become effective immediately.

The new Framework Regulation would update the current legislation to codify the involvement of the new European Food Safety Authority (EFSA) and provide more detail for the procedure to list new substances. Petitions to list a new substance will need to be submitted to a Member State, instead of directly to the Commission or to the EFSA. A more significant provision establishes a time frame for the EFSA to complete its review of a dossier on a new substance. The proposed regulation calls for the EFSA to provide its opinion within six months of the receipt of a valid application. Once the EFSA provides its opinion on the dossier, the Commission then will make a risk management decision as to whether to list the material and whether any limitations are warranted.

The Framework Regulation would require applicants to inform the Commission of any new scientific or technical information that might affect the safety assessment of authorized substances. The proposed regulation also makes clear that active and intelligent packaging materials are covered by the Framework Regulation and sets forth the basis for a specific "measure" to be promulgated by the Commission covering these materials. The changes in the Framework Regulation for these materials were thought necessary to permit the use of active packaging materials which intentionally release materials to or absorb materials from the food or the environment surrounding the food. Under the Framework Regulation, active and intelligent packaging materials must meet the requirements of other regulations, (i.e., regulations pertaining to direct food additives) and their use may not mislead consumers.

The proposed regulation calls upon the Member States to establish penalties for violations of the regulation within six months of its adoption. Member States must inform the Commission of these penalties. Another provision calls for the creation of Community Reference Laboratories for enforcement of the rules concerning food-contact materials and is similar to the proposal being considered to establish these laboratories for food and animal feed. These laboratories will be funded at the EU level and will coordinate with National Reference Laboratories.

The proposed Framework Regulation has more specific provisions than existing legislation for the protection of confidential information. There is also a new section concerning data protection. Article 19 of the proposal provides that "information in the application…may be used for the benefit of another applicant provided that the substance is the same as the one for which the original application was submitted, including the degree of purity and the nature of impurities and that the other applicant has agreed with the original applicant that such information may be used." The proposed regulation specifically provides in Article 17 that petitions must be made available to the public, excluding confidential information.

Finally, the new proposal calls for specific directives for some types of food-contact materials not previously addressed. Namely, the proposal states that printing inks, ion exchange resins, and adhesives may be covered in the future by specific directives and also states that the Commission may establish and maintain a Community Register of authorized substances, materials, and articles. The creation of a Community Register relates to proposed changes to the Plastics Directive, which, as discussed in Article 2 of this letter, may require that manufacturers report the identity of materials permitted for use by virtue of the fact that they are used behind a functional barrier.

4. FDA Commissioner Dr. Mark McClellan Is Nominated to Head Medicare, and Dr. Lester Crawford Resumes his Role as Acting Commissioner; Joseph Levitt Resigns as Director of FDA's CFSAN

After being Commissioner of FDA for only a short time, Dr. Mark McClellan has been nominated by President Bush to run the Medicare program. Reports indicate that Dr. Lester Crawford, longtime official at FDA and at the Department of Agriculture, will resume the role of Acting Commissioner in which he served for the substantial period between the departure of Commissioner David Kessler and the arrival of Commissioner McClellan.

In another high level change at FDA, Commissioner McClellan announced late last year the retirement of Joseph A. Levitt as Director of FDA's Center for Food Safety and Applied Nutrition (CFSAN). Dr. Robert E. Brackett, former Director of Food Safety and Security in CFSAN, was appointed as Levitt's successor.

Dr. Brackett began his career with FDA in March 2000 in CFSAN's Office of Plant and Dairy Foods and Beverages. Since June 2001, he has served as CFSAN's Director of Food Safety and Security. In this role, Dr. Brackett has been heavily involved in CFSAN'S counter terrorism program. Dr. Brackett took office as Director of CFSAN on January 1, 2004.

5. FDA and Customs Release Compliance Policy Guide on Prior Notice of Food Imports under Bioterrorism Regulations

On December 11, 2003, the FDA in conjunction with the U.S. Bureau of Customs and Border Protection (CBP) released the Compliance Policy Guide for prior notice of imported food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Although SPI persuaded FDA to eliminate import notification for food-contact substances, it is required for direct additives and therefore does affect some Committee members. The Compliance Policy Guide was designed to assist in the interpretation of the interim final regulation issued by FDA and CBP on October 10, 2003. The regulation on prior notice of food imports became effective on December 12, 2003, along with the regulation on food facility registration.

The Compliance Policy Guide indicates that, through August, 2004, FDA and CBP will educate firms and individuals who will be affected by the rule. During this time, enforcement of the registration and prior notice rules will be gradually phased in. The Compliance Policy Guide includes three tables that outline the implementation time frame and corresponding treatment of violations. In general, with the exception of those articles that present a threat of serious adverse health consequences or death to humans or animals, violations that occur from March 13, 2004 through May 12, 2004, can result in either education or a CBP assessment of monetary penalties, depending upon whether inaccurate prior notice was given or no prior notice was given. If no prior notice is given between May 12, 2004 and August 12, 2004, then the import should be refused; however, if the violation occurs due to inaccurate prior notice, untimely prior notice, or an unregistered facility, then education or a CBP assessment of monetary penalties should be applied. Full compliance with the rule is expected by August 13, 2004.

An issue was recently brought to our attention concerning the importation of a substance that can have both food-contact and direct food additive use but is intended in this case only for food-contact use. While nothing directly addressing this situation is included in either the Interim Final Rule on Import Notification or in the Compliance Policy Guide, a substance intended only for food-contact use should not be refused entry, even if unlabeled as to intended use. However, as a practical matter, it may be held up while FDA or Customs obtains verification of the intended use. We have advised clients shipping such products with both food and non-food uses that they may want to label the non-food products accordingly to avoid delays in crossing the border. This is particularly true if the product falls within one of the Harmonized Tariff Classifications which have been flagged by FDA as including products that may have food use. The list of the flagged Harmonized Tariff Classifications is available on FDA's website.

The labeling of multiple use products may be a practical necessity, even if not a strictly legal one. Note, however, that this would apply only to multiple use (food and non-food) products, not to products, such as most plastic resins, that have only food-contact applications.

Please contact us if you experience problems with the importation of food-contact materials so that we can address issues of concern with government officials on behalf of the Committee.

6. EU Passes New Directive on Regenerated Cellulose Films

On January 28, 2004, the EU passed a new Directive regarding the use of regenerated cellulose films (i.e. cellophane) in contact with food. The regulation of these films has been fully harmonized in the EU for several years under Directive 93/10/EEC. Under the old Directive, only those materials that were listed in the Annexes to 93/10 were permitted to be used as additives to cellophane or for cellophane coatings. The major new change included in the Directive passed on January 28th allows films to be coated with monomers and additives permitted for use by the Plastics Directive (2002/72/EEC).

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As always, if you have any questions on the above, please do not hesitate to contact Jerry Heckman or me.

Cordially yours,

Ralph A. Simmons

1. The Super Directive defines "Polymerisation production aids" as follows: ". . . substances used to provide a suitable medium in which polymerisation occurs (e.g., emulsifiers, surfactants, buffering agents etc.). They are not intended to be present in the finished materials or articles. . . ."

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