Document DvXZ9gD7nGnv2V9GB6oLwEX45

mm ASSOCIATION OP PLASTICS MANUFACTURERS IN EUROPE Documents tabled at Tripartite workshops, 10 October 1933 Workshop on Food Contact Issues Following documents have been distributed to the workshop attendants. 1. JPIF "Presentation at the Food Contact Workshop of the Tripartite Meeting". "Recent Aspects relating to Plastics in Contact with Food in Japan", October 1983, Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA) and Japan Hygienic PVC Association (JHPA). 2. SPI "Recent Developments in United States Regulation of Food Packaging", Jerome H. Heckman, Keller & Heckman. 3. APME "Introductory statement for the tripartite workshop on Food Contact Issues" (ref. 13.12/6.0/83.10.05). see 5-1795 ASSOCIATION OP PLASTICS MANUFACTURERS IN EUROPE Corrected version of original statement 13.12/6.0/33,10.05 WK/DP/rnf page i of 3 Introductory statement for the tripartite workshop on Food contact issues to be held in Dusseldorf on 10 October 1933 The APME Food Packaging Committee is concerned with regulatory developments in Europe relating to food contact safety of plastics applications including packaging, food contacting utensils, toys, pharmaceutical and medical articles. The Committee represents the industry towards EEC and other supranational authorities and monitors national developments. In the past two years it has dealt with legislation reported as follows. 1. European Communities 1.1 Adopted Directives 1.1.1. Directive laying down the basic rules for testing migration (O.J. no L 297/26 of 23.10.82). This, directive defines "plastics", lays down the field of application and gives the four food simulants and the time/temperature conditions which have to be used for migration determination. Furthermore procedures are laid down to adapt the directive to progress made in scientific and technical knowledge and to actual conditions which are basically different from specified test conditio;* 1.1.2. Directive concerning materials and articles made of regenerated cellulose (O.J. no L 123/31 of 11.05,83). The directive includes a positive list of additives which may be used and which are limited in their content in the final object. There are no migration limits. The directive is not applicable to films which have a coating of more than 50 mg/dm2 and for sausage skins. Concerning phthalates, which are listed amongst the additives in the directive, member states may refuse authorisation. 1.2. Proposed directives. 1.2.1. Directives for toys (O.J. no C 203/1 of 29.07.83). These directives lay down the requirements for finished toys in respect of mechanical and physical properties and to flammability. Further directives are planned which will deal with chemical and electrical properties. 1.2.2. Directive laying down a conventional classification of foodstuffs (not yet published, but expected end 83/beginning 84). This directive will contain a comprehensive list of foods and beverages and specify which food simulants represent each different foodstuff. Adaptation factors '"ill also be given :n SCC -1796 ASSOCIATION OF PLASTICS MANUFACTURERS IN EUROPE L3.L2/6,0/S3.1G';05' WK/DP/mt page 2 of 3 certain cases, e.g. it is expected that migration into butter will be calculated by halving experimental values obtained by olive oil. 1.3, Draft directives under deliberation. 1.3. 1, Monomer list. A working group of the Commission of the European Communities has listed all monomers which are approved or accepted by national authorities for the manufacture of plastics. This working group consists of representatives of national authorities and of industrial organisations, including APME and Eutraplast. The EC Commission is proposing to classify these monomers into two groups. The monomers in the first group would have no specific limitation apart from a general overall migration limit of 60mg/kg. The monomers in the second group would have specific limitations regarding migration or content in the final object. Each group would be subdivided into monomers for general use and monomers approved only for certain plastics. The representatives of the national authorities have not yet discussed these principles in the working group, a long and hot debate can be expected. The EC scientific committee for food, an advisory committee of toxicologists from Member States, has reviewed all monomers and in many cases has asked for additional toxicological data which makes the situation more difficult. 1.3.2. Additive list. The Commission of the European Communities has compiled a list of additives, which has not yet been checked for completeness nor discu sed by the Commission working group. The Commission intends to adopt a similar approach as for monomers. 2. Council of Europe. Whereas the European Communities (EC) are agreeing directives which have to be transposed into national laws by the 10 member states, the Council of Europe can only give recommendations or propositions to its 21 members states. 2.1. Booklet "Substances used in plastics materials coming into contact with food". A second version of this booklet has been issued. The Council of Europe itself has stated that this booklet is not a compilation or harmonisation of current legislation but contains conclusions of scientific experts and is not legally binding on member states. 2.2. Monographs of the European Pharmacopoeia related to plastics. Up to now only monographs for plastics containers made of HDPE, LDPE and PP have been accepted. A monograph for PVC has been accepted and is now published. More are under discussion. see 5-1797 I&NsE ASSOCIATION OF PLASTICS MANUFACTURERS iN EUROPE 13.12/6.0/83.10.05 V/K/DP/mf page 3 ot 3 2.3. In case industry wants to take part in this work., this must be done via the national authorities as contacts with APME have been shunned by the Council of Europe working group. Coloured plastics for food contact. A working group of the Council of Europe has elaborated working papers regarding the colouration of plastics for food contact. The industries concerned which consist of the plastics manufacturers and both the producers of organic and inorganic colourants are trying to develop harmonised views on these working papers, which are not officially available. Some elements of these working papers, however, have caused great concern. 3. < WHO-Codex Alimentarius commission. The EC have asked APME for certain information concerning AN, VC, Styrene and DEHP, following a similar request to EC from the Codex Alimentarius, APME intends to point to the existing regulations in the national laws concerning these substances. In our opinion it is superflous that the Codex Alimentarius commission should start discussing substances which have already been discussed exhaustively in national and international bodies. 4. -National developments. 4.1. Cadmium. Sweden, having issued a cadmium-ban (with certain exemptions) in 1982, will be followed by Denmark which has published a draft of comparable regulation, intended to come into force in 1984. The influence of such a regulation spreads ' far beyond the national borders as many processors in other countries will not keep two types of stocks and therefore demand ttcadmium free" for all their products. 4.2. Acrylonitrile There are still different limitations for AN migration in different European countries, but the EC do not intend to issue a special directive for AN, like they have done for VC. The EC intend to regulate AN with the monomer list mentioned under 1.3.1. In 1982, the Federal Republic of Germany has published a method for testing AN migration into food, with which migration must be undetectable. The detection limit (reproducibility) of this method is 20 ppb. 4.3. DEHP + DEHA Italy has published a decree (Gazzetta Ufficiale of 11.12.82) limiting the use of DEHP and DEHA to some articles in contact with only certain foodstuffs. 5. APME Product Registration File. The next edition of the APME Product Registration File will be issued by the end of 1983 and will include the contributions from Japan and USA. sec 5~1793 i^2VXE ASSOCIATION OP PLASTICS MANUFACTURERS IN EUROPE TRIPARTITE MEETINGS APME;S?l/J?IF Dusseldorf, 10 October 1983 Workshop on Food Contact fList of participants page 1 Name lVl ./ * /.{. 7 Qrgansation/Company Signature t ' u' . .2cVw?............................ . JpJtyV-. f-C. .. .T... M ................ 7. ?}L kv, ^ ...T,......... <r.?\f.X9:ns;*>.... M ..'TAk'JA'fi................. \y u --J.'/JM TV 7 5>/A > ~ A/). : .* .TPM . JV-'/V* - tt /!_i C^l. '?f. i QL UzL J*; ^ V, n5. J , Ry p *X",.............. JT-. .d.-.. RzuCMCx'S. . . . . l4oov?fc see 5-1799 ATTACHMENT 2 Letter from 6. R. Munger to Senator Orrin Hatch re Pre market Notification Procedure for Food Additives see 5-1800 The Society of the Plastics Industry. Inc. 355 Lexington Ave New York, New York 10017 (212) 573-9400 7** December 1, 1983 Honorable Orrin G. Hatch Chairman Committee on Labor and Human Resources 135 Russell Senate Office Building Washington, D.C. 20510 Re; Food Safety Modernization Act Indirect Additives Dear Senator Hatch: The introduction of the Pood Safety Modernization Act of 1983 (FSMA) marked a laudatory step toward food safety reform. You and others involved in this effort are to be commended on a job well done. As you are aware. The Society of The Plastics Industry, Inc. (SPI) has been heavily involved in this legislative effort with our primary interest being the indirect additive provisions of the legislation.1/ Our goals for reform of food-packaging regulations have had two main objectives. One goal, is to require the Pood and Drug Administration (FDA) to issue regulations *[/ SPI represents some 1,200 member companies and is the major national trade association of the plastics industry. Its member ship represents over 95% of the production and about 75% of the sales of plastics materials in the United States. SPI has been the spokesman for the plastics industry in seeking reasonable supervision of food, packaging and cautioning against over-regulation in this area. The Society's involve ment can be traced to testimony in the 1958 congressional hearings which led to the passage of the Food Additives Amendment of 1958. Since 1979, SPI has actively participated in the process that lead to the introduction of legislation last session and testified at the June 1983, Senate hearings. see 5-1801 Honorable Orrln G. Hatch December 1, 1983 Page 3 The scope of FDA's administrative problem was best sum marized by a key FDA staff member in a published interview. He indicated that among the 200 or so people in the Bureau of Foods that work with food additives, approximately 85 percent of their time is spent reviewing packaging. Reform would free much of this staff time to concentrate on real public healthissues. As SPI's written statement demonstrated, the delay facing industry is staggering. Over 73 percent of the pending food additive petitions have been pending in excess of the six-month statutory time limit. Fifty-five percent of the petitions are pending after one year, and 37 percent are pending after two years. Approximately 24 percent are still pending three years after filing. This is so even though the number of petitions filed annually is hardly overwhelming, ranging from a low of 13 in 1978 to a high of 47 in 1982. These figures represent unac ceptable delay and a waste of FDA resources. C. Typical Problems PMNs Can Solve To appreciate the rapid improvements that a PMN system would bring, six brief examples follow. Each example typlifies an existing regulatory trouble-spot which is not adressed by the FSMA in its present form. 1. Expanding clearance within a class of materials In almost all cases, food additive regulations are pro mulgated in response to a food additive petition by a private company seeking to introduce a new or modified product or obtain approval for a new use for an existing product. Due to the nature of this system, companies submitting food additive peti tions limit their petitions to the specific product or applica tion they wish to promote. As such, a number of unwarranted restrictions or limitations appear in regulations simply because the petitioner limited the petition to its particular case. A PMN system would provide a reasonable procedure for correcting these limitations while keeping FDA fully informed. For example, during his testimony before the Senate in June, former Commissioner Jere E. Goyan testified concerning the un acceptable delay the current regulatory system created in pcoraul- scc 5-1802 Honorable Orrin G. Hatch December 1, 1983 Page 5 mechanism. Indeed, the absence o any public health problems from packaging is the best proo that the regulatory roadblock has no justification. 3. Removing non--critical technical barriers Another limitation, similar in nature to the aseptic packaging situation, arises when a cleared material is char acterized by some non-critical parameter that results from a proprietary technology. This may impose a regulatory restric tion that should be removed. For example, assume that a particu lar cleared material is described as being prepared with the use of a solvent. If there are no health or safety concerns regarding the product per se, the same product made without the use of the solvent could be promptly cleared through a PMN sys tem. 4. Clarifying prior-sanctioned or GRAS status A food additive regulation is not required when a pack aging material is prior-sanctioned or generally recognized as safe (GRAS). Often, there is some question concerning the exis tence or scope of the prior sanction or whether a particular material would be considered GRAS for a specific use. The PMN system would provide a ready procedure for filing information with FDA when clarification is needed. Given the cost and time of the food additive petition process, decisions concerning prior sanction and GRAS status are frequently made without FDA involvement. A PMN system would encourage a filing with the Agency in such instances and would keep FDA better informed. 5. Increasing FDA knowledge and awareness Indeed, a PMN system would potentially improve public health protection. Based on our collective experience with the food packaging and processing industries, we have observed that firms which process or package food demand some form of FDA clearance or other assurance of regulatory acceptability. If a PMN system was created as an alternative to the current food additive petition process, marketplace realities would encour age packaging fabricators or resin suppliers to file PMNs even see 5'isoe Honorable Orrin G. Hatch December 1, 1983 Page 7 the Medical Device Amendments of 1976, FDA labeled contact lenses and devices used for laboratory analysis as "drugs" for the simple reason that, unless it did so, the Agency would have had no power over these commodities other than the authority co find adulterated or misbranded articles and seize them or prose cute the sellers. In other words, to permit the Agency to ob tain premarket information, the language of the drug provision of the statute was given an exceptionally expansive reading. The same experience has been true for food packaging. In Monsanto Co. v. Kennedy, 613 F.2d 947 (D.C. Cir. 1979), FDA attempted to exercise jurisdiction over the acrylonitrile bottle by contending that theoretically projected but undetectable migration made the bottle a food additive. This contention can only be understood as the Agency1seffort to find a basis for jurisdiction over a potentially widely-used packaging material. As Section 414 is now written, the same unintended result may well occur. FDA might write the definitional regulations so broadly as to make it virtually impossible for any foodcontact substance to be marketed without going through the food additive petition process. A distortion of legislative intent would be far less likely if a premarket notification system were in place. In that event, the consequences of a broad food additive definition could be ameliorated by.permitting PMNs to be utilized. E. Proposed Language The concept*we support is embodied in the following language which could be added to Section 414: Within two years after the date of enactment of the Food Safety Moderni zation Act of 1983, the Secretary shall, by regulation, establish one or more classes of substances which are rea sonably expected to become a component of food under intended conditions of use for which, in lieu of the food additive petition, a premarket notifica tion may be filed with the Secretary. A premarket notification shall become see 5'1304 ATTACHMENT 3 Roster of Members of FOCPMC Steering Committee see 5-1805 The Society of the Plastics Industry, Inc. 355 Lexington Avenue New York, New York 10017 (212) 573-9400 DECEMBER 27, 1983 FOOD. DRUG & COSMETIC PACKAGING MATERIALS COMMITTEE STEERING COMMITTEE Leo W. Zlemlak - CHAIRMAN 2804 Tlburon Drive New Port Richey, FL 33553 L.O. DeCorte ARCO CHEMICAL COMPANY 3801 West Chester Pike Newtown Square, PA 19073 (215) 359-2000 David Gordon CIBA-GEIGY CORPORATION 3 Skyline Drive Hawthorne, NY 10532 (914) 347-4700 William Hoyle CONTINENTAL GROUP, INC. 711 Jorie Blvd. Oak Brook, IL 60521 (312) 986-0333 George Chandler EASTMAN KODAK COMPANY P.0. Box 431 Kingsport, TN 37662 (615) 229-2000 Peter Mori son EASTMAN KODAK COMPANY Building 150 A Kingsport, TN 37662 (615) 229-3279 Richard Haas GOODYEAR TIRE & RUBBER COMPANY 1144 East Market Street Akron, OH 44316 (216) 794-3840 Shirley Keahey HERCULES, INC. 910 Market Street Wilmington, DE 19899 (302) 575-5000 Donald W. Pugh NATIONAL DISTILLERS & CHEMICALS CORPORATION 4900 Este Avenue Cincinnati, OH 45232 (513) 482-2294 A. Merrill Schnitzer - VICE CHAIRMAN PHILLIPS CHEMICAL COMPANY Seneca Building Bartlesville, OK 74004 (918) 661-5950 David W. Thornburg PHILLIPS CHEMICAL COMPANY Plastics Technical Center Bartlesville, OK 74004 (918) 661-3519 Fran W, Lichtenberg SOCIETY OF THE PLASTICS INDUSTRY, INC. 355 Lexington Avenue New York NY 10017 (212) -57-3-9458 see 5-1806