January 6, 2003

(202) 434-4120

simmons@khlaw.com

The Society of the Plastics Industry, Inc.

Food, Drug, and Cosmetic Packaging Materials Committee

Dear Ladies and Gentlemen:

Happy New Year from your friends at Keller and Heckman. We wish you a healthy and successful 2003.

In this letter, we report on several recent articles seeking to dispel rumors concerning the use of plastics in the microwave. We also provide an update on the Food and Drug Administration's (FDA) review of acrylamide in food, as well as a lawsuit brought against several fast food chains under California's Proposition 65 for failure to warn customers of the presence of acrylamide in french fries. In addition, we discuss the U.S. Department of Agriculture's (USDA) request for input on the use of irradiation for meat and poultry purchased for school lunch programs. Further, we report on the recently released Codex Alimentarius evaluation report (which recommends that Codex become more active on packaging), as well as the European Commission's (EC) draft 1st Amendment to the Plastics Directive and the EC Scientific Committee on Food's (SCF) adoption of opinions on the 18th, 19th, and 20th additional lists of monomers and additives for plastic food-contact materials. We conclude with several other international items of interest, including an August 1, 2003 Japanese ban on polyvinyl chloride (PVC) food packaging containing bis (2-ethylhexyl) phthalate (DEHP) for certain fatty foods.

1. The Council for Education & Research on Toxics (CERT) Sues Fast-Food Chains under California's Proposition 65 for Failing to Warn Customers that French Fries May Contain Acrylamide
   
   
2. Food Advisory Committee's Subcommittee on Contaminants and Natural Toxicants Meets to Discuss Acrylamide
   
   
3. FDA and Washington Post Articles Seek to Debunk Rumors Concerning Plastics in the Microwave
   
   
4. USDA Seeks Input on Use of Irradiation for Meat and Poultry Purchased for School Lunch Programs
   
   
5. Cosmetic Ingredient Review (CIR) Panel Concludes Phthalates Are Safe for Use in Cosmetics
   
   
6. National Toxicology Program (NTP) Issues Expert Panel Report on Endocrine Disruptor Screening; EPA Requests Comments on Proposed Chemical Selection Approach for Initial Round of Endocrine Disruptor Screening
   
   
7. Codex Alimentarius Releases Evaluation Report; Recommends "New Work" by Codex on Food Packaging Materials
   
   
8. EC Circulates Draft 1st Amendment to Plastics Directive
   
   
9. SCF Releases Opinion on 18th, 19th, and 20th Additional Lists of Monomers and Additives in Plastic Food Packaging
   
   
10. EC's SCF Releases Opinion Regarding the Use of a Fatty Food Consumption Factor in the Estimation of Exposure to Migrants from Food-Contact Materials
    
    
11. European Parliament Rejects Proposal to Expand List of Foods that Can Be Irradiated



12. Geoffrey Podger Confirmed to Head EFSA



13. EU's SCF Issues Request for Electronic Version of Petitions to Accompany Hard Copy



14. Germany Shutters BgVV; Assigns Duties to Other Agencies



15. Dutch Companies Form Association to Promote the Use and Sustainable Development of Plastics



16. Japan to Impose Ban on PVC Food Packaging Containing DEHP for Certain Fatty Foods



17. Health Canada Proposes Approval for Irradiation of Ground Beef and Poultry



18. Taiwan Plastics Industry Association Urges Government to Delay Plastics Ban

1. The Council for Education & Research on Toxics (CERT) Sues Fast-Food Chains under California's Proposition 65 for Failing to Warn Customers that French Fries May Contain Acrylamide

CERT sued McDonald's Corp. and Burger King Corp. under California's Proposition 65 for failing to warn customers that their french fries may contain unhealthy levels of acrylamide. CERT alleges that McDonald's and Burger King have violated Proposition 65 every day since 1990 because they failed to warn customers of the acrylamide exposure. Under Proposition 65, violators are subject to fines of $2500 per day, which means that the lawsuit suggests a potential $11 million fine against each company.

Acrylamide has been listed as a known carcinogen by the state of California since 1990, based on industrial exposure studies. The amount of acrylamide found in many french fries sampled exceeds the current Proposition 65 "safe harbor number," 0.2 microgram per day of ingestion exposure. California's Office of Environmental Health Hazard Assessment (OEHHA) is determining whether an "alternative risk level" can be established for food-related acrylamide ingestion. The restaurant chain lawyers have indicated that they believe the alternative risk level provision is applicable, meaning that higher ingestion levels would be allowed when the acrylamide occurs during cooking, or "naturally." OEHHA is expected to make a decision in this regard in early 2003.

2. Food Advisory Committee's Subcommittee on Contaminants and Natural Toxicants Meets to Discuss Acrylamide

FDA's Food Advisory Committee's Subcommittee on Contaminants and Natural Toxicants met on December 4 and 5, 2002 to discuss its action plan for assessing the human health risk of acrylamide in foods. The action plan's focus could shift as the Agency incorporates new findings, such as a recent finding that the amino acid asparagine, found in many carbohydrates, may play a major role in forming acrylamide. New data also indicate that the way consumers cook food in their own homes may play a key role in acrylamide formation. As it now stands, FDA's action plan includes a survey already underway to assess levels of acrylamide in various cooked and prepared foods, determination of variations in each food category, and exploration of rates of exposure in different populations. The plan also calls for toxicity studies.

The World Health Organization (WHO)/Food and Agriculture Organization (FAO) of the United Nations (UN) established the Acrylamide in Food Network as a result of the June 2002 FAO/WHO Consultation on the Health Risks of Acrylamide in Food. The network is operated by the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a research center affiliated with the University of Maryland and FDA. The network will serve as a global resource and inventory of acrylamide research, surveillance, monitoring, and industry investigation. In this regard, all interested parties are invited to share relevant acrylamide data as well as ongoing investigations on the network, which is found at www.acrylamide-food.org.

3. FDA and Washington Post Articles Seek to Debunk Rumors Concerning Plastics in the Microwave

FDA recently attempted to quell persistent Internet and other media-propagated rumors concerning toxins claimed to leach from plastics into microwaved foods. An article appearing in the November-December issue of the FDA Consumer magazine, titled "Plastics in the Microwave," assures consumers that they "can be confident as they heat holiday meals of leftovers in the microwave that the FDA carefully reviews the substances used to make plastics designed for food use."

"It's true that substances used to make plastics can leach into food," says Edward Machuga, Ph.D., a consumer safety officer in FDA's Center for Food Safety and Applied Nutrition. "But as part of the approval process, the FDA considers the amount of a substance expected to migrate into food and the toxicological concerns about the particular chemical." Migration levels of any substance will be "well within the margin of safety based on information available to the agency," the article pointed out.

In addition, other claims have asserted that plastics contain dioxins, a group of contaminants labeled as a "likely human carcinogen" by the Environmental Protection Agency (EPA). In the article, Machuga states that, "[t]he FDA has seen no evidence that plastic containers or films contain dioxins and knows of no reason why they would."

FDA's article is available on the Agency's website at www.fda.gov/fdac/feature/2002/602_plastic.html.

A November 13, 2002 Washington Post article also seeks to refute several widely circulated stories regarding the alleged dangers of plastics used in the microwave. The article points out the absence of evidence that plastics used in microwaving foods contain dioxins or that any dioxins have been detected in foods heated in plastic containers. The author of the Post column is Dr. Robert L. Wolke (www.professorscience.com), a professor emeritus of chemistry at the University of Pittsburgh, a syndicated food columnist of the Post, and a frequent opponent of pseudo-scientific claims. He notes that the dioxin rumor originated from comments by Dr. Edward Fujimoto on a television news program in Hawaii. Dr. Wolke challenges Dr. Fujimoto's credentials, revealing that he is not a medical doctor, a toxicologist, or a chemist with expertise in plastics; he is the director of a Wellness and Lifestyle Medicine Department at the Castle Medical Center in Hawaii. Dr. Wolke acknowledges the widely known fact that "some plastics produce dioxins when burned" (under certain circumstances), but indicates that "it is not known whether dioxins are formed at the much lower temperatures of microwaved foods." Another unknown is how toxic dioxins really are to humans, particularly at low doses.

The column by Dr. Wolke also discusses the claimed risk of di(2-ethylhexyl)adipate (DEHA) migrating from plastics to food during microwaving. This story derives from an experiment in which a 10th-grader microwaved plastic wrap immersed in olive oil and found up to 500 parts per million (ppm) of DEHA. While the experiment was real (the student won an American Chemical Society award for it), Dr. Wolke points out that it does not translate into an indication of a real health risk to humans. He bases his position on the fact that DEHA is a suspect but not proven carcinogen and that effects found in rodents at high doses do not demonstrate a statistically significant increased chance of cancer for any individual.

Both articles helpfully remind consumers to use common sense in microwaving food in contact with plastics. They recommend against microwaving fatty foods in actual contact with plastic wrap and against the use (or reuse) of plastic containers that are not intended for microwaving. The articles advise consumers that the real risks are the melting or warping of materials that are misused.

4. USDA Seeks Input on Use of Irradiation for Meat and Poultry Purchased for School Lunch Programs

USDA is seeking input on implementing a requirement in the 2002 Farm Bill that USDA "shall not prohibit the use of any technology to improve food safety that has been approved by the Secretary of Agriculture or has been approved or is otherwise allowed by the Secretary of Health and Human Services" in various commodity purchase programs. Commodity purchase programs include school lunch programs. USDA notes that, when coupled with approved intervention and food safety systems, new food safety technologies, including irradiation, can provide additional food safety protections. USDA also indicates that food irradiation is recognized by WHO as one of the most effective food decontamination methods available for meat and poultry products. USDA has indicated that there is no deadline for comments at this time.

5. Cosmetic Ingredient Review (CIR) Panel Concludes Phthalates Are Safe for Use in Cosmetics

CIR, an industry-funded panel that provides advice to FDA on cosmetic ingredient issues, has concluded that phthalates are safe as currently used in beauty products. The CIR panel reviewed new and existing data on three phthalates-di-methyl phthalate (DMP), di-ethyl phthalate (DEP), and di-butyl phthalate (DBP), and focused on the amount of phthalates that consumers might absorb from the various cosmetic sources. By way of background, in 1985, the CIR panel found that phthalates used in cosmetics and personal care products were safe for use, but in June 2002 voted that the scientific evidence on which its 1985 decision was based was no longer current and further study of available data needed to be done.

Healthcare Without Harm (HCWH), a consumer group, is strongly protesting the CIR panel's findings and alleges that the decision unfairly protects cosmetic manufacturers. HCWH also believes that the panel's assessment was heavily influenced by cosmetic industry science advisors and would not stand up to modern standards for public health.

An FDA official indicated that phthalates are ubiquitous in the environment, and cosmetics represent only a small part of the phthalates issue. The Agency's centers are sharing information and determining whether there is a need for action at this point. FDA is a non-voting participant in the CIR panel and relies on it for advice; however, the Agency is not bound by its recommendations.

6. National Toxicology Program (NTP) Issues Expert Panel Report on Endocrine Disruptor Screening; EPA Requests Comments on Proposed Chemical Selection Approach for Initial Round of Endocrine Disruptor Screening

A report detailing the current status of testing to detect endocrine disrupting effects -- along with a list of substances proposed for the validation of in vitro endocrine disruptor screening methods -- has been issued by NTP, which is part of the Public Health Service of the U.S. Department of Health and Human Services. By way of background, in 1996, Congress directed EPA to develop a screening program to evaluate the hormone-related health effects of pesticides and other substances. EPA's Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) responded with a recommendation that a screening and testing program be implemented for identifying endocrine disruptors. EPA then proposed the Endocrine Disruptor Screening Program, consisting of "Tier 1" screening tests designed to identify substances capable of interacting with the endocrine system, and "Tier 2" testing assays designed to confirm and extend the Tier 1 results.

The Tier 1 in vitro assays include estrogen receptor (ER) and androgen receptor (AR) assays, including either binding assays or transcriptional activation (TA) assays. NTP's Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), which supports the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM), assessed the current validation status of the in vitro test methods, preparing background review documents (BRD) on in vitro ER and AR binding assays and TA assays. As part of its evaluation, the agency asked for development of minimum performance criteria to define acceptable assays.

After an extensive literature search, NICEATM and ICCVAM determined that no validation studies have been completed on the assays being considered. Accordingly, they decided to convene an expert panel to evaluate the current status of the assays and to develop recommendations for their future validation. At a meeting in May, the expert panel was charged with developing recommendations for validation of the in vitro endocrine disruptor screening methods. In an October 22, 2002 Federal Register notice (67 Fed. Reg. 64902), NTP announced the availability of the "Expert Panel Report on the Current Validation Status of In Vitro Endocrine Disruptor Screening Methods and a Proposed List of Substances for Validation of In Vitro Endocrine Disruptor Screening Methods." The expert panel report is available at iccvam.niehs.nih.gov.

Several of the chemicals slated for inclusion in the validation study might be of interest to packaging materials manufacturers, including bisphenol A, nonylphenol, octylphenol, cumylphenol, butylbenzyl phthalate, dibutyl phthalate, and diethylhexyl phthalate (DEHP). In addition, in a December 30, 2002 Federal Register notice (67 Fed. Reg. 79611), EPA requested comments on its proposed approach for selecting the first group of chemicals to be screened in the Agency's Endocrine Disruptor Screening Program (EDSP). EPA will accept comments until March 1, 2003. After consideration of comments on this draft approach, EPA indicates that it will then issue a second Federal Register notice setting forth its approach for selecting the first group of chemicals and the chemicals it proposes for this initial list. Following comment on the draft list of specific chemicals, the Agency will then issue the final list. EPA further states that it anticipates that it will modify its chemical selection approach for subsequent Tier 1 screening lists based on experience gained from the results of testing of chemicals on the initial list, the feasibility of incorporating different categories of chemicals and additional pathways of exposure, and the availability of new priority-setting tools.

7. Codex Alimentarius Releases Evaluation Report; Recommends "New Work" by Codex on Food Packaging Materials

The Codex Alimentarius secretariat posted its "Report of the Evaluation of the Codex Alimentarius and Other FAO and WHO Food Standards Work" on its website on December 6, 2002. The Report can be found at www.fao.org/docrep/meeting/005/y7871e/y7871e00.htm. The Report, drafted by an outside evaluation team, contains 42 recommendations for action by Codex itself and by its sponsoring agencies, the UN's FAO and WHO. The first recommendation suggests that Codex should inaugurate some unspecified "new work" on packaging materials.

On behalf of this Committee, Keller and Heckman LLP attended by invitation a December 18, 2002, Food Industry Codex Council (FICC) meeting to discuss the Report. The FICC is composed of food industry trade associations and companies, and is an International Non-Governmental Organization (INGO), permitted to participate directly in Codex activities. Thomas Billy, an official of USDA, and current chairman of the Codex Alimentarius Commission, attended the meeting. He summarized the Evaluation Report, explained the procedure for Codex consideration of implementing the Report, and entertained questions and comments.

At the meeting, we indicated SPI's opposition to Codex becoming more involved in the food packaging area on the basis that (1) there are no health or safety issues related to packaging that need Codex involvement, (2) Codex activity on packaging would be redundant with the existing systems for the regulation of food packaging (i.e., FDA, European Union (EU), Health Canada, MERCOSUR in South America, etc.), which are sufficient to protect public health, and (3) active participation by Codex in packaging issues would require a substantial investment of resources at a time when the organization is attempting to improve its operations on food and direct food additive issues, which are more significant than packaging for public health and nutrition. The FICC members unanimously agreed with these points, and indicated that the FICC would support this position in its comments on the Report. We also anticipate that individual FICC member organizations will direct comments toward this issue.

The Report will be considered by WHO governing bodies in January 2003, by a special Codex Commission session in February 2003, and by FAO governing bodies in May 2003. We submitted comments to the U.S. Codex Office in USDA on behalf of the Committee opposing the Report's recommendations for "new work" on packaging.

8. EC Circulates Draft 1st Amendment to Plastics Directive

The EC has circulated to industry and to Member State contacts a draft proposal for a first amendment to Commission Directive 2002/72/EC, the "Plastics Directive." The 1st amendment to the Plastics Directive follows along the lines of the previously circulated draft 8th amendment to the Monomers Directive, albeit with some important modifications. Specifically, the draft amendment proposes the following changes to the Directive:

• The amendment would establish a December 31, 2004 deadline for submitting petitions to include additives on the positive list of permitted plastic additives before the list becomes fully harmonized. Currently, the additives list included as Annex III to the Plastics Directive is considered to be "incomplete." Additives that are included on the list are expressly authorized for use in the production of food-contact plastics throughout the EU; however, unlisted additives also may be used if their use complies with the national legislation in place in the individual EU country of interest. There have been several deadlines for "completion" of the additives list, most recently the end of 2004. Under the proposed amendment, the additives list would not be considered as "fully harmonized" until all petitions for substances submitted before December 31, 2004, are evaluated. Once those evaluations are complete, any additives not included on the positive list would not be permitted for use in the EU until a petition demonstrating their safety has been evaluated by the authorities and they are added to the positive list. In an attempt to place a more tangible time limit on completing the additives list, the amendment proposes that the Commission should prepare a draft directive to complete the positive list within 6 months of receiving from the European Food Safety Authority (EFSA) opinions on all of the additives petitioned prior to the December 31, 2004 deadline.
  
  
• The amendment also would update the positive lists of permitted monomers and additives for use in the production of plastics in the EU to include those substances on which the SCF has completed favorable evaluations.
  
  
• Colorants and solvents would be expressly added to the list of material types that are not yet required to be included on the additives list.
  
  
• The amendment would confirm that EU Member States may continue to regulate "active packaging" materials according to national legislation until harmonized rules are adopted.
  
  
• The amendment would clarify the status for use in food-contact plastics of substances that are already permitted for use in the production of direct food additives and flavors. In this regard, the amendment would state that, if a listed monomer or plastic additive also is permitted for direct addition to certain foods as a food additive or flavoring agent, that substance must not migrate from food-contact materials into those foods at levels that would exceed the permitted direct additive level or the level specified in the clearance under the Plastics Directive, whichever is lower. In addition, the amendment would state that, for foods in which the use of a substance as a direct additive or flavoring agent is not separately permitted, the substance must not migrate at levels that would have a technological function in the food.
  
  
• The amendment would provide for the inclusion, in some cases, of more detailed information in written declarations of compliance. The current version of the Plastics Directive requires that written declarations must accompany plastic materials and articles at marketing stages, other than the retail stage, confirming that the materials comply with the rules applicable to them. Such declarations are not required for materials and articles that, by their nature, clearly are intended for food-contact use. The amendment to the Directive would expand this requirement to include all plastic materials and articles, and would add the requirement that such declarations also should include, "where appropriate," information on the presence of substances that are subject to a restriction in food so that the end user may ensure compliance with the restriction.

9. SCF Releases Opinion on 18th, 19th, and 20th Additional Lists of Monomers and Additives in Plastic Food Packaging

The EC's SCF released on November 21, 2002, the minutes of its 134th Plenary Meeting, in which it adopted opinions on the 18th, 19th, and 20th additional lists of monomers and additives for food-contact materials.

By way of background, in May 1997, the SCF's evaluations of monomers and additives used in the manufacture of plastics used for food packaging were compiled into the 42nd Series of Reports of the SCF. Since that date, the committee has evaluated or reevaluated a number of substances, and has published its results in a series of 20 opinions. Those opinions are available on the committee's website at europa.eu.int/comm/food/fs/sc/scf/outcome_en.html.

SCF's opinions classify the listed monomers and additives into safety categories, identified as "SCF Lists," ranging from 0 through 9, and "W" ("waiting list"). Classification of a substance in a list from 0 through 4 generally indicates that the substance has been reviewed by the SCF and determined to be safe for use in food-contact applications. List 5 denotes substances that the SCF has indicated "should not be used" in contact with food, and list 6 applies to substances for which some toxicological concerns have been raised. List 7 applies to substances for which some toxicological data exist, but for which an acceptable daily intake (ADI) or tolerable daily intake (TDI) could not be established. For substances classified in list 8, inadequate data are available for the SCF to complete an evaluation. Substances in list 9 also could not be evaluated due to lack of specifications or lack of an adequate description.

Substances that are the subject of an SCF opinion eventually are added to the Commission of the European Communities (CEC) Synoptic Document "Draft of Provisional List of Monomers and Additives Used in the Manufacture of Plastics and Coatings Intended to Come into Contact with Foodstuffs" (commonly known as the "Synoptic Document") for possible inclusion in a subsequent amendment to Commission Directive 2002/72/EC, known as the "Plastics Directive."

In the Opinion on the 18th additional list of monomers and additives, the SCF provided its evaluation of the following substances (followed here by their reference number, chemical abstract service registry number (CASRN), and SCF List designation):

acids fatty, unsaturated C18, dimers, distilled -- PM/REF No. 10599/90A; CASRN 61788-89-4 (list 3)
acids fatty, unsaturated C18, dimers, non-distilled -- PM/REF No. 10599/91; CASRN 61788-89-4 (list 3)
acids fatty, unsaturated C18, dimers, hydrogenated, distilled -- PM/REF No. 10599/92A; CASRN 68783-41-5 (list 3)
acids fatty, unsaturated C18, dimers, hydrogenated, non-distilled - PM/REF No. 10599/93; CASRN 68783-41-5 (list 3)
1,3-bis (2-hydroxyethoxy) benzene -- PM/REF No. 13323; CASRN 102-40-9 (list 3)
1,6-hexanediol -- PM/REF No. 18700; CASRN 629-11-8 (list 3)
N-methylolmethacrylamide -- PM/REF No. 21970; CASRN 923-02-4 (list 7)
mixture of (80%) 2,4-diamino-3, 5-diethyltoluene and (20%) 2,6-diamino-3, 5- diethyltoluene -- PM/REF No. 22330/50; CASRN 68479-98-1 (list 7)
N-vinyl-2-pyrrolidone -- PM/REF No. 26230; CASRN 88-12-0 (list 4A)
p-Cresol-dicyclopentadiene/isobutylene, copolymer -- PM/REF No. 45450; CASRN 68610-51-5 (list 3)
triethyleneglycol bis [3-(3-tert-butyl-4-hydroxy-5-methylphenyl) propionate -- PM/REF No. 94400; CASRN 36443-68-2 (list 2)

The Opinion of the SCF on the 19th additional list of monomers and additives includes:

4,4'(1,3,6,8-tetrahydro-1,3,6,8-tetraoxobenzo [lmn] [3,8]phenanthroline-2,7- diyl)bisbenzoic acid, diethyl ester -- PM/REF No. 13317; CASRN 132459-54-2 (list 7)
2-butenoic acid (crotonic acid) -- PM/REF No. 14800; CASRN 3724-65-0 (list 3)
ethylene carbonate -- PM/REF No. 16955; CASRN 96-49-1 (list 7)


The Opinion of the SCF on the 20th additional list of monomers and additives includes:

3,3'-dimethyl-4,4'-diaminodicyclohexyl-methane -- PM/REF No. 16210; CASRN 6864- 37-5 (list 3)
2,2'-[1,3-phenylenebis(oxy)]bis-acetic acid (1,3-PDDA) -- PM/REF No. 23070; CASRN 102-39-6 (list 3)
2-ethylhexyl acrylate-acrylic acid copolymer -- PM/REF No. 31500; CASRN 25134-51- 4 (list 7)
2-cyano-3,3-diphenyl-2-propenoic acid ethyl ester -- PM/REF No. 45640; CASRN 5232-99-5 (list 3)
sodium perchlorate monohydrate -- PM/REF No. 71935; CASRN 7601-89-0 (list 3)
PEG-30 dipolyhydroxystearate -- PM/REF No. 77850; CASRN 70142-34-6 (list 7)

For a copy of the SCF's opinion on the 18th additional list, see europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf; the opinion on the 19th list is available at europa.eu.int/comm/food/fs/sc/scf/out141_en.pdf; and the opinion on the 20th list is available at europa.eu.int/comm/food/fs/sc/scf/out142_en.pdf.

10. EC's SCF Releases Opinion Regarding the Use of a Fatty Food Consumption Factor in the Estimation of Exposure to Migrants from Food-Contact Material

On December 12, 2002, the EC's SCF released its opinion regarding the introduction of a "Fat (Consumption) Reduction Factor (FRF) in the estimation of the exposure to a migrant from food contact materials." This opinion was released in response to an industry initiative seeking to introduce the concept of food type consumption factors into exposure estimates for substances migrating from food packaging into foodstuffs. Industry provided data indicating that no more than 200 grams of fat are consumed per day by an individual, and suggested that this fact should be taken into account when estimating exposure to specific migrants. The SCF evaluated the industry proposal, and agreed that assuming that an individual's entire diet consisted of 1 kilogram of fat exaggerated actual exposure. The SCF also agreed that 200 g fat/person/day can be considered a realistic maximum intake. As to the industry proposal regarding the application of the FRF, however, the SCF recommended several additional limitations. The actual parameters of the FRF as accepted by the SCF are unclear at present. The opinion is available on the SCF website at europa.eu.int/comm/food/fs/sc/scf/out149_en.pdf.

We will continue to consult with the SCF and industry contacts to determine what, if any, changes will be made to the EU Plastics Directive (2002/72/EC) or to the various testing directives to implement this opinion.

11. European Parliament Rejects Proposal to Expand List of Foods that Can Be Irradiated

On December 17, 2002, the European Parliament rejected a proposal to expand the list of foods that can be irradiated within the EU based on its conclusion that there is insufficient evidence proving that it is safe to eat irradiated foods. Currently, only dried herbs and spices and vegetable stock can be irradiated in the EU. The approved amendment stated that the current list should continue to be the only items approved for irradiation until adequate scientific research proving irradiation's safety is conducted. The Parliament defeated a less restrictive amendment that called on the EC to yield to WHO in commissioning and disseminating information and research on the safety of irradiated foods.

12. Geoffrey Podger Confirmed to Head EFSA

As a follow up to our previous report that Geoffrey Podger, chief executive of the United Kingdom (UK) Food Standards Agency, was nominated in October to head the EFSA, Podger has now been confirmed as executive director of EFSA, and will assume his duties in February 2003. The selection of Podger required the approval of the EFSA management board, the EC, and the European Parliament. Immediate tasks for Podger will include putting in place the final cornerstones of the Authority - the Advisory Forum and the Scientific Committee and Panels, and the recruitment of the main staff. More information on the EFSA is available at >www.efsa.eu.intl.

13. EU's SCF Issues Request for Electronic Version of Petitions to Accompany Hard Copy

The secretariat of the EU's SCF has distributed a request asking that petitions relating to the evaluation or re-evaluation of food-contact substances now be accompanied by a compact disc (CD) that contains all of the data transmitted in the hard copy of the petition. The inclusion of an electronic version of the data will enable the SCF (and later, the EFSA) to better manage the petitions.

The instruction is likely to become mandatory in January 2003, when an updated version of the EC's "Note for Guidance of Petitioner When Presenting an Application for Safety Assessment of a Substance Used in Food Contact Materials Prior to its Authorization" (known as the "Note for Guidance") is expected to be published.

14. Germany Shutters BgVV; Assigns Duties to Other Agencies

In an effort to establish a clear delineation between risk assessment and risk management, Germany has restructured its consumer health and food safety functions, dissolving in the process its Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV). The food-related responsibilities of the BgVV have been assumed by two federal institutions: the Federal Agency for Consumer Protection and Food Safety (BVL), and the Federal Institute for Risk Assessment (BfR).

October 31, 2002 was the last working day for the eight-year-old BgVV. Established in 1994 as a successor institution to the Federal Health Office (BGA), the BgVV played a role in a variety of health-related issues: dioxins; Bovine Spongiform Encephalopathy (BSE); food-borne pathogens; and antibiotic resistance. Sources at the BgVV report that the Plastic Commission, which works on the "BgVV Recommendations," will be managed under the BVL. The BgVV Recommendations are widely respected and relied upon throughout Europe as a source of guidance for establishing the safety and suitability of food-packaging materials. While many details still need to be worked out, it appears that the way in which the group operates should basically remain the same, and the petition process for bringing about listings in the Recommendations should remain the same.

15. Dutch Companies Form Association to Promote the Use and Sustainable Development of Plastics

Dutch polymer and additive producers, importers, and distributors formed a national organization to promote the use and sustainable development of plastics, the Association of Dutch Plastics Suppliers, in October 2002. The Association has 20 member companies representing more than 50% of the sector's total annual sales in the Netherlands, and aims to work with trade groups that represent plastics and rubber processors and chemical companies. It hopes to become involved in matters including training, safety, health, and environmental protection, and expects to lobby national and European legislators.

16. Japan to Impose Ban on PVC Food Packaging Containing DEHP for Certain Fatty Foods

Japan has imposed a ban, effective August 1, 2003, on the packaging of certain "fatty" foods in plastics made with PVC that contains DEHP. The ban affects all packaging that contains PVC at levels greater than 50 percent. Memoranda issued by Japan's Food Hygiene Department, Pharmaceutical Bureau, Ministry of Health, Labor and Welfare, stipulate that the ban does not apply to materials used in a way that prevents the DEHP from migrating to the food. (See, Government Notification No. 267 by Ministry of Health, Labor and Welfare, August 2, 2002; SHOKU-HATSU No. 0802005, August 2, 2002; and SHOKU-KI-HATSU No. 0802001, August 2, 2002.)

One of PVC's primary markets in food packaging applications is meat wrap; PVC containing DEHP will no longer be allowed for such uses unless it can be demonstrated that the DEHP does not "elute or weep to mix into food." At issue is "oil/fat or fatty-food-containing food," which is defined as "food with oil/fat content in the food or at the food surface" of 20 percent or more, excluding dry solid food. Cited examples of food in that category include beef tallow, vegetable oil, ham, bacon, beef, pork, chocolate, potato chips, tempura, fried bean curd, croquette, fried pork cutlet, mayonnaise, dressing, cheese, and butter. In addition, items of food that contain one or more of those ingredients are included in the definition, as are fried and roasted foods.

Packaging that does not come directly into contact with food will nonetheless be subject to the revised regulation if the wrapping is likely to come into contact with the food during transportation or handling, as in the case of coverings for cooked food, or when oil or fat transmits through the exterior paper packaging that is directly in contact with the food. In addition, the regulation applies to the use of DEHP-containing PVC gloves used in food handling applications.

As to the standard for determining whether DEHP "elutes or weeps" or migrates to food, the regulation limits the amount of DEHP in packaging to "below 0.1 percent" in the material. With regard to the amount of DEHP that can migrate to food, the limit is 1 ppm. The low limits will serve effectively to ban the ordinary use of the plasticizers in packaging for fatty foods.

During the grace period leading up to the ban, manufacturers are requested to refrain from producing or marketing such products as far as possible. PVC plastic containing DEHP as a raw material may be used when the application is clearly limited to food other than "fatty" foods.

17. Health Canada Proposes Approval for Irradiation of Ground Beef and Poultry

Health Canada (HC) recently scheduled public hearings in seven cities to gauge public opinion on irradiation for a variety of foods, and will accept comments on this topic until late February 2003. If there is not strong opposition to the plan, HC possibly will give companies permission to irradiate ground beef, poultry, shrimp, prawns, and mangoes as soon as late 2003. HC already permits irradiation of wheat, flour, potatoes, onions, spices, and dehydrated seasonings. All irradiated products must be labeled as "irradiated" and bear the radura symbol; HC does not allow alternative labeling such as cold pasteurization. In addition, HC plans to introduce a code of practice to ensure that irradiated products are handled correctly and to ensure that irradiation is not used to mask food spoilage. HC research, as well as a review of scientific literature, affirms that irradiation poses no risk to human health or food nutrition, and effectively controls pathogens such as E. coli and Salmonella, along with reducing insect infestations and extending the shelf-life of many products.

18. Taiwan Plastics Industry Association Urges Government to Delay Plastics Ban

Representatives from a Taiwan plastics industry association recently urged the government to delay its plans to ban the use of plastic bags and disposable plastic tableware until a comprehensive approach to the waste disposal problem can be developed. A representative of the association indicated that, since Taiwan's Environmental Protection Administration began implementing the first stage of its ban on various types of plastic containers in government institutions and state-run schools in March 2002, the association's members experienced a 37% average business income decrease, while one-third of the members declared bankruptcy. The Environmental Protection Administration plans to begin the second stage of the policy in January 2003, when the ban will be extended to department stores, supermarkets, fast food restaurants, and retail shops.

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As always, if you have any comments, or if we can provide additional information regarding any of the issues discussed above, please do not hesitate to contact Jerry Heckman, Colleen Evale, or me.

Cordially yours,

Ralph A. Simmons

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