FDA Food Safety Modernization Act publication translated

The Food Safety Law and the Rulemaking Process: Putting FSMA to Work now available in four languages: Español (Spanish), 中文 (Chinese), 日本 (Japanese), and ไทย (Thai).

EU passes mandatory nutrition labeling regulation

Since the vote of the European Parliament in July, we have been waiting for the EU Food Information Regulation to be issued in final form. It was published in the Official Journal (L) of the European Union on November 22. The citation is Reg. (EU) 1169/2011. OJ(L) 304/18, 22 Nov 2011.

This Regulation revises 20 years of EP and EC Directives and Regulations. Among the changes, the regulation requires nutrition label declaration of the "Big 7"—energy, fat, saturated fat, carbohydrates, sugars, protein, and salt by Dec. 13, 2016. There are also new rules on allergen labeling and legibility. The regulation introduces a minimum font size of 1.2 mm for all mandatory label information, and 0.9 mm for products whose packaging has a largest surface of less than 80 square cm.

The full text of the Regulation (66 pages), European Union's Food Information to Consumers Regulation, is available at: www.food-label-compliance.com. Hat tip to Charles Woodhouse.

Symposium: The Role of Public and Private Regulation in Detecting and Responding to Foodborne Disease Outbreaks

A symposium will be held at the University of Wisconsin-Madison on November 21, 2011, 1:30 to 4:30pm. In this final event, a multidisciplinary team will evaluate and compare the current systems for detecting and responding to foodborne outbreaks in the U.S. and the European Union. In the context of recent, produce-related foodborne outbreaks in the EU and the US, the team will examine and compare the respective approaches, assessing challenges in surveillance, detection, trace-back and identification of a contaminated food item. Finally, we will consider lessons learned from recent outbreaks by examining issues of public health, responsibilities of industry, and comparisons of regulatory frameworks.

Those speaking include;

— Dr. Jeri Barak-Cunningham, Assistant Professor, Plant Pathology, University of Wisconsin – Madison. "Fresh produce – no longer surprising but now a major source of foodborne illness." 

—  Dr. Robert Tauxe, Deputy Director, Division of Foodborne, Waterborne and Environmental Diseases, US CDC. "The cycle of public health:  Can we detect, investigate,and control foodborne outbreaks faster?"

— Dr. Jordi Serratosa-Vilageliu, EFSA Liaison Officer at FDA.  "Improving public health decision making with tools of risk analysis."

To register, please send an email to Lorna Zach (lzach@engr.wisc.edu) with your name, affiliation, and email contact information. A webcast may be available.

US businesses face rude shock as EU health claims laws loom

US businesses face rude shock as EU health claims laws loom:

US companies need to get up to speed with European Union health claim changes or face big hits on existing trade or missed opportunities, according to the chief of a leading UK supplements group.

US FDA, multilaterals team up for product safety

From the time you take your morning vitamin until you brush your teeth at night, U.S. consumers use many products imported from other countries. According to the U.S. Food and Drug Administration (FDA), 40% of fresh produce are imported into the United States. Sometimes products may contain only one ingredient or component part from another country, while other times the entire product may come from one or many countries.

Because the neighborhood grocery and corner drug store are now global marketplaces, the FDA ensures the safety and effectiveness of products sold domestically by working through multilateral organizations to improve cooperation and collaboration with other countries. Multilateral organizations are groups of more than two countries banded together to work on specific issues. Participation in these groups offers the FDA opportunities to expand reach and increase knowledge.

The FDA is working with three multilateral organizations on projects that aim to improve food safety, as well as the safety of medical products for people and animals. FDA's partners are:

• World Health Organization (WHO)—The FDA has given WHO nearly $400,000 to help develop a plan for a global information system to make it easier to share information on food safety problems, including contamination that leads to a product recall.

• Pan American Health Organization (PAHO)—The FDA, through a $904,000 award, is helping PAHO develop an information hub for the Americas through which countries in the region can share data, standards, and guidelines for regulators. FDA has also worked with PAHO to establish technical standards for drugs and biologics in the Americas.

• World Organization for Animal Health—With a grant of $565,000, the FDA is aiding the World Organization for Animal Health in its effort to strengthen agencies that regulate veterinary medical products.

Through its work with multilateral organizations and the FDA's own international offices, the agency is supporting efforts to strengthen regulatory agencies in developing nations and create internationally accepted standards of safety, efficacy, and quality.

More information is available here.

Health Canada's Proposed Approach to Managing Caffeinated Energy Drinks

Health Canada has proposed regulations for energy drinks intended to prevent overconsumption of caffeine and other ingredients such as vitamins. The proposed change would require most energy drinks to be labeled with nutrition information, including the amount of caffeine in the product, and to identify groups for whom high levels of caffeine are not recommended, such as children and pregnant and breastfeeding women. The proposed measures would also limit the amount of caffeine in energy drinks to 180mg per serving – about the amount in an average cup of coffee. They would require manufacturers to ensure that types and levels of vitamins are within safe limits, and to add a warning advising not to mix the product with alcohol.
 
"The growth of energy drink consumption in recent years has resulted in higher levels of caffeine consumption among younger people than has previously been the case," Health Canada said. "…Canadians tend to think of and consume energy drinks not as health products but as soft drinks. Health Canada's proposals will assess the safety of these products according to how they are consumed to provide the best protection for Canadian consumers."

Health Canada is accepting comments on the proposed regulatory changes until November 15. More information and details of how to submit comments are available here.  Hat tip to Caroline Scott-Thomas, Canada outlines proposed regulations for energy drinks.

Denmark introduces world's first food fat tax

The BBC reports that Denmark has introduced what is believed to be the world's first fat tax—a surcharge on foods that are high in saturated fat. Butter, milk, cheese, pizza, meat, oil, and processed food are now subject to the tax if they contain more than 2.3% saturated fat. Danish officials say they hope the new tax will help limit the population's intake of fatty foods. However, some scientists think saturated fat may be the wrong target. They say salt, sugar, and refined carbohydrates are more detrimental to health and should be tackled instead.

EFSA chief warns EU vulnerable to food safety threats

Image via WikipediaThe European Union (EU) is particularly susceptible to food safety threats, European Food Safety Authority (EFSA) executive director Catherine Geslain-Lanéelle has warned.

“Europe is the biggest global trader in food products and the openness of the European market leaves us particularly vulnerable to food safety threats.”

A single food product could contain ingredients from across the world, many of which were produced to non-European standards.

Visit FoodProductionDaily.com for further information.

EU Community Legislation on Food Additives

The European Commission maintains a useful Web site of EU community legislation on food additives, which consists of a framework Directive and three specific Directives: colours; sweeteners; the remaining food additives. The Community Legislation on food additives is based on the principle that only those additives that are explicitly authorised may be used. Most food additives may only be used in limited quantities in certain foodstuffs. If no quantitative limits are foreseen for the use of a food additive, it must be used according to good manufacturing practice, i.e. only as much as necessary to achieve the desired technological effect. Food additives may only be authorised if (1) there is a technological need for their use; (2) they do not mislead the consumer; (3) they present no health hazard to the consumer.  Prior to their authorisation, food additives are evaluated for their safety by the European Food Safety Authority.

Summary of Key Provisions of the Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), which signed into law by President Obama on January 4, 2011, amends the Federal Food, Drug, and Cosmetic Act to shift the focus of the Food and Drug Administration (FDA) from primarily reacting to food safety problems to prevention.

A summary of key new provisions and their impact is available on the Institute for Food Laws & Regulations website here.

EFFL-Workshop on Health Claims

On Wednesday, 29 June 2011, the EFFL-Workshop on Health Claims will be held at the Club University Foundation in Brussels. This half-day workshop will present a number of currently debated issues regarding the regulation on health and nutrition claims. Special rates are offered for subscribers of the European Food and Feed Law Review EFFL and for full-time academics. Visit here for more information and online registration.

Note:  Summer Academy on Global Food Law & Policy +++ 25-29 July 2011 +++ Lake Como, Italy +++ few places available +++  www.lexxion.eu/conferences +++ Apply now!

U.S. Dept. of Commerce’s seeks comments on regulatory cooperation between U.S., EU

The Dept. of Commerce's International Trade Administration (ITA) seeks input on opportunities for cooperation to reduce or eliminate divergent regulatory measures that impede trade in goods in the transatlantic marketplace. The ITA identified specific possible types of regulatory cooperation (e.g., mutual recognition agreements) for which it invites comments. The U.S. Administration also seeks recommendations for specific current or emerging product sectors that may benefit from regulatory cooperation between the EU and U.S. Interested parties are encouraged to submit comments jointly. Details of this notice and comment submittal are accessible at:http://www.gpo.gov/fdsys/pkg/FR-2011-05-03/pdf/2011-10713.pdf

Public Morals Proposed as a Grounds to Ban GMOs

Public morals, public order, "social policy objectives," and "historical heritage" are some of the reasons the European Commission has proposed as grounds for a national ban of genetically modified crops. The plan presented by John Dalli, the European commissioner for health and consumer policy, is to give governments greater leeway to ban GM crop cultivation for factors other than health or environmental grounds. The legal service of the Council of Ministers criticized the proposal as contrary to World Trade Organization (WTO) rules and the EU's own single market. More information is available from Jennifer Rankin, Growing GM crops 'could pose a threat to public order,' EuropeanVoice.com (Feb. 3, 2011).

International European Food and Feed Law Conference

5th International European Food and                      Feed Law Conference                     Regulation of Innovations                     6/7 October 2011 · Logenhaus, Berlin
		This year's EFFL Conference has been scheduled for Thursday and Friday, 6 and 7 October 2011, at the Logenhaus in Berlin. The Regulation of Innovation is the theme of the agenda and will include experts from institutions, sciences, the industry and private legal practice to give insight into the following aspects of this issue: • The new regulation on novel food • Nanotechnology in food and feed • Challenges of the common authorization procedure • Risk assessment of innovations • Specific labelling requirements – an innovation killer? An early bird discount of 10 % is available for registration by 30 June. For more information please visit www.lexxion.eu/conferences.

Summer Academy on Global Food law & Policy 2011

The third Summer Academy in Global Food Law & Policy will take place at Como Lake - Italy, July 25-29, 2011, at the beautiful Villa La Collina. A distinguished faculty from relevant food organizations (WTO, Codex, EFSA, EU Commission), industry (CocaCola) as well as academia (Michigan, Bocconi, HEC Paris) will be animating cutting-edge discussions on the latest developments in global food governance, from food private standards to health claims, from US Food Modernization Act to novel food regulation. 

Among the those presenting are four faculty from the Institute for Food Laws and Regulations (IFLR) at Michigan State University: Neal Fortin, Professor at MSU and IFLR Director along with IFLR guest instructors Alberto Alemmano, Associate Professor of Law at HEC Paris, Gretchen Stanton,  Senior Counsellor at WTO, and Raymond O'Rourke, Barrister, Ireland.

For more information on the program and the faculty, please find the brochure here and more information here and here. Please don't hesitate to contact Nikola Bock (bock@lexxion.de) for more information.

Chinese ban benzoyl peroxide and calcium peroxide as food additives

According to China Daily, on March 1 Chinese authorities banned the production of two food additives used to bleach flour. The additives, benzoyl peroxide and calcium peroxide, were banned because "there is no need to use them in flour processing anymore" as the country's processing techniques and wheat planting have improved, the ministry said in a statement on its website.

EU BPA Ban Now in Effect

A ban prohibiting the manufacture in the European Union of baby bottles containing Bisphenol A (BPA) became effective March 1, 2011. BPA is an organic molecule that is used in the manufacture of polycarbonate plastics. Small amounts of BPA can be released from plastic containers into the food they carry if these containers are heated at high temperatures. According to scientific evidence, infants' ability to eliminate BPA is still building up during their first six months of life. 
The ban of the manufacture of baby bottles with BPA was adopted in January (EU Directive (2011/8/EU) and entered into force on 1 March. For more information, visit Alberto Alemanno's blog here.

Indian Supreme Court bans industry from advisory committee

FoodProductionDaily reports that the Indian Food Safety and Standards Authority (FSSA) has been blocked from including representatives from the food and beverage industry in a scientific panel set up to advise on safety and standards.The Indian Supreme Court found that involvement of food industry figures breached the Food Safety and Standards Act because such panels could not be said to be manned by independent experts.

"We are sorry to say that the panel does not consist of independent persons. It is contrary to the [Food Safety and Standards] Act." stated the ruling.The ruling stated that representatives from the relevant industry and consumer representatives could be invited for deliberations but could not form part of the body giving recommendations.

INFOSAN meeting in Abu Dhabi

The International Food Safety Authorities Network (INFOSAN) began with a keynote speech by Dr. Alan Reilly, Chief Executive of the Food Safety Authority of Ireland. He highlighted the importance of global cooperation in aims to provide the best food safety standards for consumers worldwide.

"The global nature and growing complexity of the food chain means that risks posed by unsafe foods have the potential to quickly evolve from a local problem to an international incident in a short period of time," Dr. Reilly said.