Citation: 31 Food Drug Cosm. L.J. 218 1976 Content downloaded/printed from HeinOnline Wed Oct 12 03:28:44 2016 -- Your use of this HeinOnline PDF indicates your acceptance of HeinOnline's Terms and Conditions of the license agreement available at http://heinonline.org/HOL/License -- The search text of this PDF is generated from uncorrected OCR text. -- To obtain permission to use this article beyond the scope of your HeinOnline license, please use: Copyright Information Food Law-International By JULIUS G. ZIMMERMAN Mr. Zimmerman, an Attorney in New- York City, Is Editor of Foreign Law of the Food Drug Cosmetic Law Journal. T HIS IS THE THIRD TIME that I have had the privilege of reporting to the Food, Drug and Cosmetic Law Section of the New York State Bar Association on the progress of foreign food laws and the international situation in this field. My first two reports were made in 1959 and 1969 with each report covering the preceding decade.' Now another seven years have passed and we can look back on a quarter of a century which virtually witnessed the development of modern food law. In my last report, I -described the outstanding characteristic of the period as an "explosion of food law" which had its beginning at about mid-century after the end of the Second World War, a war that had slyarked an almost incredible development of science and technology on a worldwide scale. In fact, the pace of this technological development seems to be accelerating, as does the growth of food law. A number of reasons explain this trend: (1) the population explosion of the post-war era; (2) the development of modern transportation ; (3) the development of the news media facilities which transmit information to all parts of the world within minutes; (4) the electronic collection and processing of data by computer; (5) the development of modern packaging methods for foods; and (6) the growing interest and awareness of consumers in the field of nutrition and the concept of a balanced diet. Zimmerman, J. G., "Progress of Food Law Developments in the Past Foreign Food Law," 14 Foon DRu-, Decade," 24 FoOD DRUG COSMETIC LAW COSMETIC LAW JOURNAL 189 I(March JOURNAL 184 (April 1969). 1959); Zimmerman, J. G., "International FOOD DRUG COSMETIC LAW JOURNAL-APRIL, 1976-PAGE 218 In recent years, three additional reasons reinforced this trend: (1) an ever-growing number of new sovereign nations; (2), the ever-widening scope of legislation affecting food; and (3) the piecemeal method of legislating which prevails in many countries. (1) Growing Number of Sovereign Nations: In 1945, when the charter of the United Nations was signed in San Francisco on June 26, there were 51 original member nations-including the United States-which ratified the charter. By December of 1975, that number had increased to 143. Thus, the membership of the United Nations almost tripled during the past 30 years. This was due primarily to the transformation of former colonies into independent countries. All these new countries are issuing new legislation of their own in an increasing number of languages, which complicates the study of food law on a worldwide basis. (2) Widening Scope of Legislation: The scope of legislation affecting food and food law has also widened considerably in recent years by the growing demands for the additional protection of the health and pocketbook of the consumer, the protection of environment, etc., Much of this concern goes beyond the boundaries of "food law" in the strict meaning of the term. (3) Piecemeal Method of Legislating: Because much of recent legislation has been prompted by political and/or economic pressures in a fast-changing world, we notice in many countries a proliferation of laws and regulations which overlap both in substance and in 'the assignment of administrative jurisdictions. However, during the past 15 years, a few countries have introduced comprehensive legislative reforms in the field of food law, namely Italy (1962), Belgium (1964), Sweden (1971), Denmark (1973), the Federal Republic of Germany (1974) and Austria (1975). Any comparative study of food law on a worldwide scale depends on the availability of at least the text material of laws and regulations which deal with the production, manufacture, processing, packaging, labeling and distribution of food in its various stages from raw materials to the packaged item offered to the consumer. Here in the United States, we are fortunate in having a very well-developed and up-to-date system of government and private publications. This makes it easy for the 'scholar-as well as for interested members of the public-to obtain or to peruse the original legislative texts, court PAGt 219,FOOD LAW-INTERNATIONAL decisions, commentaries, etc. which form the body of the food, drug and cosmetic law (both federal and state) in force in the United States. Numerous professional journals supplement this information, as do the various annual Symposia, such as the Educational Conference sponsored by the Food and Drug Law Institute (FDLI) in cooperation with the Food and Drug Administration. The proceedings are published in the FOOD DRUG COSMETIC LAW JOURNAL, which, incidentally, published 129 articles about foreign and international food law during the past 22 years. Its entire May 1973 issue was devoted to papers presented at the international Conference held in Budapest, Hungary on November 3 and 4, 1972 tinder the sponsorship of the FDLI. Rely on Translations A very good -documentation about food and drug law can be found also in Canada, the United Kingdom and other developed countries. But, because so many different languages are used in this field, one has to rely on translations into English and/or French, the most commonly known and used languages in the field of foreign and international food and drug law. Such translations are frequently very difficult to obtain. There are few information centers or law libraries which have a complete collection of national Official Gazettes, not to speak of specialized material dealing with food law and related matters. Highly specialized in this field are the World Health Organization (WHO) in Geneva and the Food and Agricultural Organization of the United Nations (FAO) in Rome, particularly the Legislation Branch of the FAO. However, their publications, which deal with food law proper and which are available to the general public, are frequently only digests (WHO International Digest of Health Legislation, a quarterly) or excerpts (FAO Food and Agricultural Legislation-semi-annual) and are not meant to be a complete and up-todate record of food legislation. They are, however, available in an English edition. The FAO is also publishing a series of legislative studies (not available for purchase) which includes such titles as No. 4 "Legal Systems for Environment Protection (Japan, Sweden, United States) by P. H. Sand (1972), and No. 7 "An Outline of Food Law-Structure, Principles, Main Provisions" by Alain Gfrard (1975). Gerard's study contains an appendix with a bibliography on food law listing works in English, French and German, as follows: (1) works on food law in general; FOOD DRUG COSMETIC LAW JOURNAL-APRIL, 1976PAGE 220 (2) the work of international organizations-selected periodical publications, reports and miscellaneous documents; (3) specialized food law journals; (4) monographs, selected books, studies and articles(A) international law and comparative law; (B) national law (Belgium, Canada, France, the Federal Republic of Germany, India, Italy, Japan, Sweden, Tunisia, Turkey, the United Kingdom and the United States). Comprehensive Study of Comparative Food Law At this point, special mention must be made of the first comprehensive study of comparative food law ever made, under the joint authorship of the late Professor E. J. Bigwood and Dr. Alain G~rar.d (Brussels University Food Law, Research Centre). It was published in four volumes (1967-1971) under the title "Fundamental Principles and Objectives of a Comparative Food Law" by S. Karger in Basel. This study covers the food laws of 13 West European countries, Canada and the United States. The Food Law Research Centre in Brussels has just completed another very important comparative study which is being published in loose-leaf form by Elsevier Scientific Publishing Company in Amsterdam and New York. It is entitled "Food Additives Tables" and provides a comparative survey of the legal regulations governing food additives in the 20 most important countries exporting and importing food products: 16 West European countries (Austria, Belgium, Denmark, Finland, France, the Federal Republic of Germany, Ireland, Italy, Luxemburg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, the United Kingdom) and Canada, Israel, Japan and the United States. This work will consist of one volume of about 800 pages to be published in four parts and to be completed by the end of 1976. After completion, the work will be kept up-to-date by publication of annual supplements. The growing interest in the study of comparative food law in Europe illustrates the fact that, in spite of all the efforts by governments and international organizations to "harmonize" the food laws of the individual countries, many differences still continue to exist, which is a great obstacle to international trade in food, a most undesirable situation in a world where no single country is completely self-sufficient with respect to its available food supplies. There are few fields of law with a greater diversity of national legislation than IFooI LAW-INTERNATIONAL PAGE 221 food law. This is due to differences in the constitutional, administrative and general legal background and the degree of industrialization and technological development which, in turn, depends on whether a country is primarily a producer and exporter of agricultural raw materials or engages in the manufacture, processing and packaging of food products, or both. A higher industrialization requires a more sophisticated law. Combination of Food and Drug Law One of the most striking differences in the national food laws is the scope of what products are being regulated under this topic. In the United States, the basic Federal Food, Drug and Cosmetic Act regulates food, drugs, devices and cosmetics. The combination of food and drug law in the basic legislation is also the tradition in many countries of the British Commonwealth, but not on the European continent. The Federal Republic of Germany, for instance, promulgated, on August 20, 1974, a comprehensive law intended to completely reform the existing Food Law Act of January 17, 1936 as amended. This new law, which came into force on January 1, 1975, authorized the Minister of Youth, Family and Health, in cooperation with the Minister of Nutrition and Agriculture, and the Minister of Economy to implement the law by regulations and to invalidate all obsolete and conflicting provisions which still may be on the statute books. The new Act is entitled "Law on the Traffic with Foods, Tobacco Products, Cosmetics and other objects of daily use" and covers specifically foods (whether raw or processed) with their edible wrappings, additives, tobacco products intended for smoking, chewing and snuffing, cosmetics, and objects and wrappings which come into contact with foods, cosmetics, tobacco products or the human body, not just casually, such as clothing, bed linen, bracelets, frames for eyeglasses, toys, cleaning products for household use and insecticides. This list does not include any items which may fall under the separate German Drug Act. Legal Terminology Another sector with great diversity is legal terminology. Thus the term "food additive" or its equivalent !in foreign languages is in universal use but the definition -differs in many countries. The German' Food Law Act of 1974 abolished the concept of "foreign substances" of the 1936 Act and introduced a new concept of "food additives" in Article 1, Section 2 which reads as follows: FOOD DRUG COSMETIC LAW JOURNAL-APRIL, 1976PAGE 222 "Additives, in the meaning of this law, are substances which are intended to be added to foods to influence their condition or to endow them with certain characteristics or .effects; not included in this definition are substances of natural origin or substances which are chemically identical with natural substances and are generally considered by the public as being used primarily because of their nutritional, olfactory or taste value, or as luxury items. Not included are drinking and table water." This definition differs from the official definition of "food additive" for the purpose of the "Codex Alimentarius" which reads as follows: "Food additive means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, :the intentional addition of which to food for a technological (including organoleptic) purpose in- the manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food results, or may be reasonably expected to result, (directly or indirectly) in it or its byproducts becoming a component of or otherwise affecting the characteristics of such foods. The iterm does not include 'contaminants' or substances added to food for maintaining or improving nutritional qualities." ' Both definitions differ from the definition in Section 201(s) of the Federal Food, Drug and Cosmetic Act. One has to keep this problem of definition in mind when making a comparative study of "additive" regulations. Virtually all countries have now adopted the principle of "positive lists" which means that only the use of additives which have been specifically authorized by regulation is permitted. Progress of International Harmonization Ever since the creation of the United Nations and its specialized agencies FAO and WHO, concerted efforts have been made on regional and worldwide levels to bring about a harmonization of food laws. I gave a historical overview of this development in my two previous reports to this Section and in a special report to the InterAmerican Ba.r Association (TABA) in Quito, Ecuador, in 1972. 3 The progress of harmonization in the European Economic Community (EEC) is recorded in the loose-leaf reporter service of Commerce Clearing House, Inc. and published in the English language. 4 Procedural Manual of ithe ,Codex "Food Regulation in Latin America," Alimentarius C'ommission, p. 26 (4th 28 FooD DRUG COSMETIC LAW JOURNAL Ed.) 585 (Sept. 1973). 'Zimmerman, J. G., "Harmoniza- ' See also Gerard, Alain, "Food tion of Food' Laws and Food Stan- Law in the 'Common Market," 27 FOOD dards in Latin America," 27 FOOD DRUG DRUG COSMETIC LAW JOURNAL 483 (Aug. COSMETIc LAW JOURNAL 645 (Oct. 172). 1972). See also Bledel, Enrique E., PAGE 223FOOD LAW-INTERNATIONAL The task of developing worldwide food standards is now primarily concentrated in the Joint FAO/WHO Codex Alimentarius Commission, the organization and function of which is described in a Procedural Manual (fourth edition) published by the Commission. At the time of its first session in 1963, it had some 30 members, mostly developed countries. By 1976, its membership had increased to 114 countries of which number more than two-thirds are developing countries. Altogether the Commission has had ten sessions, the last one in July of 1974. The eleventh session is scheduled for March of 1976. Detailed reports of each session are published with a summary of the activities of its various committees. Among its subsidiary bodies are six Worldwide Codex General Subject Committees, -eleven Worldwide Codex Commodity Committees and three geographically limited Coordinating Committees for Europe, Africa and Latin America. An additional Committee for Asia is in the process of being formed. These coordinating committees explQre the need for and the practicality of regional harmonization on a continental scale. The procedure for the elaboration of worldwide and regional Codex standards provides for eleven steps in accordance with the Procedural Manual. Step nine is the recommended standard which is sent to all member states and associate members of FAO and WHO for acceptance in accordance with the acceptance procedure laid down under the General Principles of the Codex Alimentarius which provides for three options: (1) full acceptance; (2) target acceptance; and (3) acceptance with specified deviations. International Standards According to a report prepared by G. E. Kermode, Chief of the FAO/WHO Food Standards Programme for the European Food Law Association (EFLA) Conference in Parma (September of 1975), so far 70 international standards have 'been finalized and adopted by the Commission and have been or will be sent to governments for acceptance. An additional 40 international standards for milk and milk products have been elaborated and adopted by the joint FAO/WHO Committee of Government Experts on the Code of Principles concerning Milk and Milk Products, a subsidiary body of the Commission, and sent to governments for acceptance. Acceptances have been and continue to be forthcoming. I refer for details to the Session Reports of the Codex Alimentarius Commission and to the December 1975 "List of Standards. Codes of Practice and other Documents alFOOD DRUG COSMETIC LAW JOURNAL-APRIL, 1976PAGE 224 ready adopted by the Codex Alimentarius Commission and those under Elaboration."5 Another very valuable source of information about regional developments are the professional associations. In the western hemisphere, there is the IABA which meets every two years. It last met in Cartagena, Colombia, in September of 1975. Since 1957, it has had a special section (now -a separate Committee XIX) for food and drug law. I would like now to present a special report about EFLA, a new professional association whose first international Conference was held in Parma, Italy on September 28 and 29, 1975. The European 'Food Law Association The EFLA was created on May 4, 1973 in Brussels as an international nonprofit association with a scientific purpose under Belgian law. Its Constitution was adopted by its first General Assembly and approved by Belgian Royal Decree of October 8, 1973 which gave it the status of legal entity. Its French language name is "Association Europ6enne pour le droit de l'Alimentation" (AEDA). The objectives of EFLA are described in Article 2-1 as follows: "to contribute in Europe, by all appropriate means: (a) to a better knowledge of food law considered as a specialized sector of the general law; (b) to the development of food law and to its international harmonization with due regard to its interdisciplinary character and, to its particular role in the field of consumer protection." It is to serve as: (1) a permanent structure for cooperation in considering current food law problems; (2) a permanent structure for information and consultation by the spreading of information in the field of food law, the publication of reviews, monographs or scientific papers, the organization of conferences and seminars, and finally cooperation, as a consultative international association, with organizations and administrations endowed with political responsibility; (3) the framework for responding to requests to address international organizations, or governments, with recommendations that could influence the evolution or harmonization of food law. The EFLA is meant to be an independent.(not a pressure group), scientific (nonprofit) and consultative (it has no responsibility or power in the political or economic fields) organization. While it is primarily 'Document CX/GEN 75/1. PAGE 225FOOD LANNI , INTERNATIONAL concerned with the evolution of food law in Europe, :it welcomes cooperation with any person or institution, public or private, national or international, even if established outside Europe, that pursues similar aims. The First International Congress of EFLA took place in Parma, Italy on September 26 and 27, 1975. It was attended by more than 100 members of EFLA and numerous guests from nine West European countries, Poland and the United States, including high government officials concerned with health and food legislation and representatives of national and international associations and organizations such as FAO, WHO, EEC, BENELUX and Council of Europe. The morning session of September 26, chaired by Dr. D. M. Caponera, Chief of the Legislation Section of FAO, was devoted to general addresses by Dr. R. Piccinino, the President of the Association, who stressed the necessity of harmonizing the food laws, and Professor M. J. L. Dols, Vice-President of EFLA who read a message from Professor E. J. Bigwood who regretted not being present on account of illness. Also read were several other messages of greetings from WHO, EEC, Council of Europe, the FDLI in Washington (Mr. Daniel F. O'Keefe, Jr.) and officials of the Italian Government and the City of Parma, notably the Chamber of Commerce which had contributed greatly to the organization of this Conference. Consumer Protection and Food Labeling Following these'iintroductory remarks, Dr. D. Eckert, Ministerial Dirigent of the Federal Ministry of Youth, Family and Health in Bonn, reported about "New Developments in European Food Legislation." Such developments proceeded at an accelerated pace during the past 15 years, resulting in comprehensive new food acts in Italy (1962), Belgium (1964), Sweden (1971), Denmark (1973), the Federal Republic of Germany (1974) and Austria (1975) with the emphasis on consumer protection an( food labeling. Comprehensive new labeling regulations were issued -in the United Kingdom (1970), Sweden (1971), France (1972), Austria (1973) and Norway (1975). A very important Directive on Food Labeling is now being prepared in EEC. The main topics under discussion are: (1) the complete list of ingredients; (2) the date marking; (3) nutritional labeling; and (4) claims. The afternoon session of September 26, chaired by Professor M. J. L. Dols, former President of the FAO/WHO Codex Alimentarius Commission, was devoted to the topic'of "Drafting and Acceptance FOOD DRUG COSMETIC LAW JOURNAL-APRIL, 1976PAGE 226 of International Food Standards." Professor Alain Gerard, Secretary General of EFLA, presented a detailed paper on the "Juridical and Institutional Aspects" of this procedure which discussed: (1) the general theory of drafting and acceptance of international food standards; (2) the role of the international organizations in the field of standardization of food products, namely: Inter-governmentalorganizations Joint FAO/WHO Codex Alimentarius Commission; Economic Commission for Europe (ECE/UN); Organization for Economic Co-operation and Development (OECD); Council of Europe; European Economic Community; BENELUX Economic Union; International Olive Oil Council (COI French); International Vine and Wine Office (IWO) (OIV Fr.); Non-governmentalorganizations International Organization for Standardization (ISO); International Dairy Federation (IDF) (FIL Fr.); International Organization of Consumers Unions (IOCU). The second day, September 27, was devoted to the subject of "Reception" or incorporation of international food standards within the national laws of the individual countries. The morning session was chaired by R. A. Dehove, member of the Council of EFLA and former Director of the Central Laboratory of the Ministry of Agriculture of France in Paris. The first paper was a report by Robert Delville, Director of European Affairs of Coca-Cola Europe, on the "Legal and Institutional Aspects" of such Reception. The procedure differs depending on the organization which elaborated the international standard, such as the Joint FAO/WHO Codex Alimentarius Commission, EEC, BENELUX Economic Union or ISO. Mr. Delville reviewed specifically the procedure in the United Kingdom, France, Germany and BENELUX, but concluded that the acceptance of international standards must overcome many difficulties based on political or economic considerations and the different historical backgrounds which account for the peculiarities of the individual national laws. The second speaker was Professor R. Monacelli of the Superior Institute of Health -in Rome, and Secretary General of the Italian PAGE 227FOOD LA\V-NTERNATIONAL Society of Food Science, who spoke about "The Scientific, Technological and Social Aspects" of Reception. Afternoon Session The afternoon session, chaired by Dr. R. Piccinino, had several special problems on the agenda: (1) a paper on "Canned Products" by G. Jumel, Director General of the National Chamber of the Canning Industry in Paris; (2) "apaper about "Meat and Meat Products" by Dr. H. Schulze, lecturer at the Veterinarian Faculty of the University of Munich; and (3) a paper on "The Appellations of Origin" by G. P. Mora, President of the Consortium of Parmigiano and Reggiano Cheeses in Parma. In addition to the papers mentioned on the agenda and read during the Conference, the participants received a number of papers which had been prepared specially for this Conference: (1) "The Elaboration of International Food Standards by the FAO/WHO Codex Alimentarius Commission" by G. 0. Kermode, Chief, FAO/WHO Food Standards Programme; (2) "The Harmonization of National Legislations in the EEC" by E. Gaerner, Principal Administrator, Commission of Agriculture of EEC in Brussels; (3) "The Elaboration of International Food Standards within the Framework of the Partial Agreement of the Council of Europe" by Dr. 0. Messer, Deputy Director of Economic and Social Affairs; and (4) "Activities of the United Nations Economic Commission for Europe in the Field of Agricultural and Food Trade Standards," an extract from a -document published by ECE/UN0 ; (5) individual reports about Reception in Austria, Belgium, the Netherlands, 'Luxemburg, France, Germany, Italy, Denmark, Finland, Ireland, Norway, Spain, Sweden, Switzerland and the United Kingdom. All the papers presented, at the Parma Conference were in French or English. Some were read in Italian but simultaneous translations into French and English were provided during the sessions. Tentative plans were made for some regional meetings in 1976 and a full scale Conference in 1977. 1; AGRT/WP. 1/3. FOOD DRUG COSMETIC LAW JOURNAL-APRIL, 1976PACE 228 APPENDIX Food Law-International Selected Bibliography of Publications in the English LanguageArticles published in the FOOD DRUG COSMETIC LAW JOURNAL* Supplement (101) International Aspects of Food and Drug Legislation (Selected Bibliography) by Julius G. Zimmerman (102) Control of Television Advertising in Great Britain by Peter Woodhouse (103) The Changing Complexion of the Food Industry in the Common Market by Paul P. Ashley (104) Reaching the Common Market Consumer by Julius Green (105) Food Law in the Common Mar- ket by Alain Gerard (106) Harmonization of Food Laws and Food Standards in Latin America by Julius G. Zimmerman (107) A Food Lawyer's Report on the Eighth Session of the Codex Alimentarius CommissionCritique and Targets for the Future by Lawrence I. Wood and Stephen A. Weitzman July August July 1971 303-322 1971 328-333 1972 460-464 August 1972 468-482 August 1972 483-501 October 1972 645-650 October 1972 651-656 *,For items 1-100, see Zimmerman, Julius G., "International !Aspects of Food and Drug Legislation," 26 FOOD FOOD LAW-INTERNATIONAL DRu- COSMETIc LAW JOURNAL 303 (July 1971). PAGE: 229 (108) Acceptance and Enforcement of Codex Standards by L. M. Beacham (109) A General Look at Codex Ali- mentarius 'by Eddie F. Kimbrell (110) Current Codex Alimentarius Ac- tivities by L. M. Beacham December 1972 December 1972 January 1973 Paperspresentedat the BudapestFDLI Conference (111) Consumer Interests by Eirlys Roberts (112) The Government's Agency Response to Consumerism by Virgil 0. Wodicka (113) Industry's Concern in Meeting Consumer Needs by T. S. Thompson (114) Codex Alimentarius Commission by Richard Wildner (11.5) International Standards and Food Law by Andras Miklovicz (116) Adapting to Innovation: New Foods and Legislation by G. F. Schubiger (117) Food Additives: Systems of Reg- ulations by Ernst G. Rapp (118) A Food Law for the Future by Robert Delville (119) Perspectives of a Modern Food Law by E. J. Bigwood (120) The Council of Europe's Work in the Fields of Consumer Protection and Food Law by 0. Messer May May May May May May May May May May 1973 301-307 1973 308-316 1973 317-325 1973 326-330 1973 331-339 1973 340-344 1973 345-350 1973 351-358 1973 359-364 1973 365-368 FOOD DRUG COSMETIC LAW JOURNAL-APRIL, 1976 761-765 766-769 79-86 PAGE 230 (121) Comments Made on Papers Delivered at the Budapest Food Industry Symposium on International Food Regulations by Michael F. Markel (122) Establishment in Brussels of the European Food Law Association (123) Food Regulation in Latin America by Enrique E. Bledel (124) EEC Developments Affecting Products-Registration and Liability (Pharmaceuticals) by Jeffrey W. Bartlett (125) Safety, Efficacy and Quality Review in the United Kingdom (Medicines) by J. V. R. Marriott (126) The Canadian Approach to Food and Drug Regulations by A. B. Morrison (127) Canadian Regulation of Food, Drugs, Cosmetics and Devices -an Overview by Robert E. Curran (128) Current Topics in Canadian Food Regulatory Affairs by D. G. Chapman (129) Comments and Views from the Perspective of a Canadian Food Lawyer by James A. Robb j le July 1973 401-406 1973 493-494 September 1973 585-595 August 1975 483-494 August November 1975 November 1975 November 1975 November 1975 1975 495-502 632-643 644-653 654-658 659-664 [The End] FOOD LAW-INTERNATIONAL PAGE 231