CHEMICAL QUALITY ASSURANCE

Module 2. Legislation and standards of milk and milk products

Lesson 4
INTERNATIONAL REGULATIONS: CODEX, IDF, ISO, FDA, EEC

4.1 Introduction

The different sets of standards arising from the spontaneous and independent development of food laws and standards by different countries inevitably gave rise to trade barriers that were of increasing concern to food traders in the early twentieth century. Trade associations that were formed as a reaction to such barriers pressured governments to harmonize their various food standards so as to facilitate trade in safe foods of a defined quality. The International Dairy Federation (IDF), founded in 1903, was one such association. Its work on standards for milk and milk products later provided a catalyst in the establishment of the Codex Alimentarius Commission and in the setting of its procedures for elaborating standards.

4.2 Codex Alimentarius Commission (CAC)

The FAO and the WHO jointly established the Codex Alimentarius Commission (CAC) in 1962 to implement the joint FAO/WHO food Standards Programme. The aim of the commission is to protect the health of consumers by ensuring observance of fair practices in food trade. It promotes co-ordination of work on formulation of food standards undertaken by international governmental and non-governmental organizations. The Codex Alimentarius Commission shall be responsible for making proposals to, and shall be consulted by, the Directors-General of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) on all matters pertaining to the implementation of the joint FAO/WHO Food Standards Programme. In addition to commodity standards, the Codex Alimentarius includes general standards, which have across-the-board application to all foods and are not product-specific. There are general standards or recommendations for:

• Food labeling;
• Food additives;
• Contaminants;
• Methods of analysis and sampling;
• Food hygiene;
• Nutrition and foods for special dietary uses;
• Food import and export inspection and certification systems;
• Residues of veterinary drugs in foods;
• Pesticide residues in foods.

Most standards take a number of years to develop. Once adopted by the Commission, a Codex standard is added to the Codex Alimentarius. The Codex Alimentarius now has such a well-established reputation as an international reference that it has become customary for health authorities, government food control officials, manufacturers, scientists and consumer advocates to ask first of all: What does the Codex Alimentarius have to say? Adoption of HACCP standards, formulated by CAC, under the sanitary and phytosanitary (SPC) measures has made the HACCP system an instrument of food safety. It has become incumbent on signatory countries of the SPC agreement to implement these standards.

4.3 International Dairy Federation (IDF)

IDF is the pre-eminent source of scientific and technical expertise for all stakeholders of the dairy chain. Membership covers 56 countries and is growing. The mission of IDF is to represent the dairy sector worldwide by providing the best global source of scientific expertise and knowledge in support of the development and promotion of quality milk and dairy products to deliver consumers with nutrition, health and well-being.

IDF publishes jointly with the ISO, standards method of sampling and analysis of milk and milk products.

4.3.1 Work areas of IDF

Fig. 4.1 Areas of IDF

4.4 International Organization for Standardization (ISO)

ISO is a network of the national standards institutes of 158 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a non-governmental organization that forms a bridge between the public and private sectors. It is the world's largest developer and publisher of International Standards. ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society.

"International Organization for Standardization" would have different acronyms in different languages e.g. "IOS" in English, "OIN" in French (Organization international de normalization).

Its founders decided to give it also a short, all-purpose name. They chose "ISO", derived from the Greek isos, meaning "equal". Whatever the country, whatever the language, the short form of the organization's name is always ISO.

4.4.1 Characteristics of ISO standards are

4.4.1.1 Democratic

Every full member of ISO has the right to take part in the development of any standard which it judges to be important to its country's economy. No matter what the size or strength of that economy, each participating member in ISO has one vote. Each country is on an equal footing to influence the direction of ISO's work at the strategic level, as well as the technical content of its individual standards.

4.4.1.2 Voluntary

ISO standards are voluntary. As a non-governmental organization, ISO has no legal authority to enforce the implementation of its standards. ISO does not regulate or legislate. However, countries may decide to adopt ISO standards - mainly those concerned with health, safety or the environment - as regulations or refer to them in legislation, for which they provide the technical basis. In addition, although ISO standards are voluntary, they may become a market requirement, as has happened in the case of ISO 9001 quality management systems, or of dimensions of freight containers and bank cards. ISO itself does not regulate or legislate.

4.4.1.3 Market-driven

ISO only develops standards for which there is a market requirement. The work is mainly carried out by experts from the industrial, technical and business sectors which have asked for the standards, and which subsequently put them to use.

4.4.1.4 By Consensus

ISO standards are based on international consensus among the experts in the field. Consensus, like technology, evolves and ISO takes account both of evolving technology and of evolving interests by requiring a periodic review of its standards at least every five years to decide whether they should be maintained, updated or withdrawn. In this way, ISO standards retain their position as the state of the art.

4.4.1.5 Globally relevant

ISO standards are technical agreements which provide the framework for compatible technology worldwide. They are designed to be globally relevant - useful everywhere in the world. ISO standards are useful everywhere in the world.

4.5 Food and Drug Administration (FDA or USFDA)

FDA is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

The FDA also enforces other laws, which include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.

The FDA is formed in 1906 and has its headquarters at White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states. In 2008, the FDA started opening offices in foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.

4.5.1 Organizations of FDA

The FDA comprises several offices and centers. Major are

• Center for Biologics Evaluation and Research
• Center for Devices and Radiological Health (CDRH)
• Center for Drug Evaluation and Research (CDER)
• Division of Manufacturing and Product Quality
• Division of New Drugs and Labeling Compliance
• Division of Scientific Investigations
• Division of Drug Marketing, Advertising and Communications8
• Informatics and Computational Safety Analysis Staff (ICSAS)
• Center for Food Safety and Applied Nutrition
• Center for Tobacco Products
• Center for Veterinary Medicine
• National Center for Toxicological Research
• Office of Regulatory Affairs

4.5.2 What does FDA regulates

The FDA regulates more than $1 trillion worth of consumer goods, about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. Much of the expenditures are for goods imported into the United States; the FDA is responsible for monitoring a third of all imports. Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act.

4.5.3 Regulatory programs of FDA

The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labelling, advertising, marketing, efficacy and safety, yet FDA regulation of cosmetics is focused primarily on labelling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. FDA regulates in the following areas:

4.5.3.1 Food and dietary supplements

The Center for Food Safety and Applied Nutrition (CFSAN) is the branch of the FDA that is responsible for ensuring the safety and accurate labelling of nearly all food products in the United States. One exception is meat products derived from traditional domesticated animals, such as cattle and chickens, which fall under the jurisdiction of the United States Department of Agriculture Food Safety and Inspection Service.

CFSAN's activities include establishing and maintaining food standards, such as standards of identity (for example, what the requirements are for a product to be labelled, "yogurt") and standards of maximum acceptable contamination. CFSAN also sets the requirements for nutrition labelling of most foods. Both food standards and nutrition labelling requirements are part of the Code of Federal Regulations. Bottled water is regulated in America by the FDA. State governments also regulate bottled water. Tap water is regulated by state and local regulations, as well as the United States Environmental Protection Agency (EPA).

4.5.3.2 Drugs

The Centre for Drug Evaluation and Research has different requirements for the three main types of drug products: new drugs, generic drugs and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients, is used for a different purpose, or undergoes any substantial change.

4.5.3.3 Vaccines, blood and tissue products, and biotechnology

The Centre for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. The original authority for government regulation of biological products was established by the 1902 Biologics Control Act, with additional authority established by the 1944 Public Health Service Act. Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health; this authority was transferred to the FDA in 1972.

4.5.3.4 Medical and radiation-emitting devices

The Centre for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. A medical device includes products from the simple toothbrush to complex devices such as implantable brain pacemakers. CDRH also oversees the safety performance of non-medical devices that emit certain types of electromagnetic radiation. Examples of CDRH-regulated devices include cellular phones, airport baggage screening equipment, television receivers, microwave ovens, tanning booths, and laser products.

4.5.3.5 Cosmetics

Cosmetics are regulated by the Centre for Food Safety and Applied Nutrition, the same branch of the FDA that regulates food. Cosmetic products are not in general subject to premarket approval by the FDA unless they make "structure or function claims", which make them into drugs. However, all color additives must be specifically approved by the FDA before they can be included in cosmetic products sold in the U.S. The labelling of cosmetics is regulated by the FDA, and cosmetics that have not been subjected to thorough safety testing must bear a warning to that effect.

4.5.3.6 Veterinary products

The Centre for Veterinary Medicine (CVM) is the branch of the FDA that regulates food, food additives, and drugs that are given to animals, including food animals and pets. CVM does not regulate vaccines for animals; these are handled by the United States Department of Agriculture. CVM's primary focus is on medications that are used in food animals and ensuring that they do not affect the human food supply. The FDA's requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers.

4.5.3.7 Tobacco products

Since the Family Smoking Prevention and Tobacco Control Act became law in 2009, the FDA also has had the authority to regulate tobacco products. In 2009, Congress passed a law requiring color warnings on cigarette packages and on printed advertising, in addition to text warnings from the U.S. Surgeon General. The nine new graphic warning labels were announced by the FDA in June 2011 and are required to appear on packaging by September 2012.

4.6 What Doesn’t FDA Regulate?

FDA does not regulate:

• advertising (except for prescription drugs, medical devices, and tobacco products)
• alcoholic beverages
• some consumer products, such as paint, child-resistant packages, baby toys, and household appliances (except for those that give off radiation)
• illegal drugs of abuse, such as heroin and marijuana
• health insurance
• meat and poultry (except for game meats, such as venison, ostrich, and snake)
• restaurants and grocery stores

FDA shares the responsibility for regulating these products with other government agencies:

pesticides (FDA, the U.S. Department of Agriculture, and the Environmental Protection Agency regulate these)

4.7 FDA and India

FDA’s activities in India are to ensure that food and medical products exported from India to the U.S. are safe, are good quality, and are effective; these efforts include obtaining better and more robust information to help FDA officials in the various FDA headquarter Offices and centers and at the borders make better decisions about products from India that are being developed for the U.S. market. This includes products being reviewed for marketing authorization in the U.S., and that are already on the U.S. market.

To this end, FDA activities in India include:

• Engaging with Indian counterpart regulatory authorities to ensure the timely exchange of information regarding clinical trials that are conducted that support marketing applications in the U.S.

• Partnering with Indian counterpart agencies on various bilateral and regional capacity building initiatives

• Working with regulated product industries in India that wish to export their products to the U.S. to assure their understanding of our standards and expectations regarding FDA-regulated products

• Coordinating and collaborating daily on product quality and safety issues with other U.S. government agencies that have complementary missions to assess conditions and events in those areas that might have an impact on the safety and quality of FDA-regulated products being exported to the U.S.

• Increased FDA inspections of relevant high-risk facilities; and by working with private- and public-sector entities that wish to engage with FDA on third-party certification efforts regarding these products.

The European Economic Community (EEC) (sometimes simply known as the European Community, also known as the Common Market in the English-speaking world) was an international organisation created with a view to bring about economic integration (including a common market) among its six original members—Belgium, France, Germany, Italy, Luxembourg and the Netherlands.

4.8 Aims and Achievements

The main aim of the EEC, as stated in its preamble, was to "preserve peace and liberty and to lay the foundations of an ever closer union among the peoples of Europe". Calling for balanced economic growth, this was to be accomplished through:

• The establishment of a customs union with a common external tariff
• Common policies for agriculture transport and trade
• Enlargement of the EEC to the rest of Europe

For the customs union, the treaty provided for a 10% reduction in custom duties and up to 20% of global import quotas.