Ferré & Consulting Blog (English Version)

Safety decisions concerning one-third of the more than 10,000 substances that may be added to human food were made by food manufacturers and a trade association without review by the U.S. Food and Drug Administration (FDA), according to an analysis spearheaded by the Pew Health Group.

The report, published  in the peer-reviewed journal Comprehensive Reviews in Food Science and Food Safety, illustrates potential problems with the U.S. food additive regulatory program.

“Congress established our food additive regulatory program more than 50 years ago, and it does not stand up well to scrutiny based on today’s standards of science and public transparency,” said Tom Neltner, Food Additives Project director in the Pew Health Group.

The research also found that the FDA developed an expedited process in the mid-1990′s that essentially eliminated the opportunity for public involvement in decision making prior to FDA’s safety determination. This shift doubled the rate of industry requests for FDA review. In contrast, standard operating procedure for other federal regulatory decisions regarding drug, workplace, and environmental safety requires public notice and an opportunity to comment.

“While the shift to a new regulatory process–one in which companies make safety decisions and ask FDA to confirm them–has sped up agency review, it has also bypassed the public,” Neltner said. “Subjecting safety decisions to comment from competitors, academic scientists, public interest groups, and the general public can result in stronger protections for consumers. In an age of growing demand for government transparency, there is virtually no meaningful opportunity for participation in decisions about large classes of substances added to the food supply.”

When Congress passed the Food Additives Amendment of 1958, it created a structure that has limited the FDA’s ability to effectively regulate substances added to food because the law:

Allows manufacturers to determine that the use of an additive is “generally recognized as safe” (GRAS), and then use that substance without notifying the FDA. As a result, the agency is unaware of many substances that may be added to food and lacks the ability to ensure that safety decisions were properly made.

Does not require that manufacturers inform the FDA when health reports suggest new hazards associated with additives already used in food. Therefore, the agency has no access to unpublished reports and must expend limited resources sifting through published information to identify potential problems and set priorities.

In addition to the article examining the state of the food additive regulation, a piece in the same publication summarizes a workshop, co-sponsored by the Institute of Food Technologists and the journal Nature, examined how FDA evaluates the potential hazards posed by substances added to food. The two-day session, held in April 2011, brought together science and food policy experts from government, industry, academia, and public interest organizations. Issues discussed at the workshop and presented in the journal article include:

The need for clear procedures to develop validated toxicological tests and regularly revise guidance documents to reflect advances in science;

Opportunities to improve academic research to make it more usable for regulatory decision making and enhance coordination between federal agencies; and

Challenges to reassessing a chemical’s safety after it is on the market.

Both journal articles appear in the November issue of Comprehensive Reviews in Food Science and Food Safety. They are the first in a series of the Pew Health Group’s assessments of the scientific evidence and FDA’s regulatory system, evaluating whether the agency ensures chemicals added to food are safe as required by law. Future articles will consider other aspects of the scientific analysis and the law, and will provide case studies of issues raised about the FDA’s food additives program. The Pew Health Group will develop policy recommendations to reduce unnecessary and hidden risks that are informed by their evaluation.

Source: The Pew Charitable Trusts

Food Safety food safety, regulations

Obesity is on the rise in Europe. According to the World Health Organisation, many European countries have seen obesity rates triple since the 1980s, with spiking levels of childhood obesity being particularly worrying. In some European states, more than 10% of deaths can be at least partly attributed to obesity.

As has been unequivocally stated on many occasions by a wide range of organisations and governments, this thoroughly modern problem has to be tackled by a multi-pronged campaign to encourage healthy eating and daily exercise while warning the public about the dangers of consistently overeating.

But what role can the food packaging industry play in slowing this rising trend? After all, packaging is the average consumer’s first point of reference when looking for nutritional information on a pre-packaged food product. This is the debate that has been flowing back and forth in the European Parliament for much of the last year.

The EU labelling debate

On 7 December last year, after months of work by EU Council Working Groups, MEPs agreed on a new set of food labelling requirements at the Health Council. The most fundamental proposal is a new mandatory requirement to set out clear, legible nutritional information on most pre-packaged foods.

While many details (such as minimum font sizes for the information, although a 3mm minimum has been proposed) are still to be finalised in later readings of the legislation due in the European Parliament later in the year, some facts are clear.

Mandatory information on the amount of certain nutrients is being demanded on most products, with energy, fat, saturated fat, salt and sugars being specifically mentioned. These must be expressed as a percentage of an adult’s guideline daily amount (GDA), based on a 100mg or 100ml portion.

As well as nutritional information, the EU debated for the first time on including country-of-origin on food labels.

It was decided that origin information would be made mandatory for fresh meat products, as well as in cases where not to include the information would actively mislead consumers. Checks on the authenticity of origin claims will also be bolstered, including providing further information on the place of origin.

Traffic light labelling system derailed

One of the most contentious outcomes of the new EU proposals is the rejection of the “traffic light” nutrition labelling scheme, which marks nutritional values in green, amber or red depending on their relative healthiness, in favour of simply stating percentages of GDAs. For the European food industry, this is a welcome move, as many companies have stated that the traffic light system unfairly demonises fatty products that can be eaten as part of a healthy diet. Paul Kelly, director of Irish food industry trade association Food and Drink Industry Ireland, was particularly strong in stating his organisation’s support for GDAs over any other nutrition information scheme.

“GDAs give consumers simple nutrition information on key nutrients such as saturated fat, sugars and salt, based on the portion size of the food being eaten,” he said. “They have been put on packs on a voluntary basis by industry since 2006, but it is important that they now become part of the legislation…The traffic light system of labelling is a subjective assessment of the nutrient content of 100g of a food and does not provide consumers with the information needed to choose a balanced diet based on their individual needs. In addition, ‘traffic lights’ fail to take account of portion sizes, and do not put the food in the context of the daily diet.”

Other groups see the move as a victory of industry lobbying over the interests of consumers. Corporate Europe Observatory (CEO), a corporate lobbying watchdog, reported that the Confederation of Food and Drink Industries of the EU (CIAA) had spent more than €1bn to lobby against the traffic light system, including TV adverts, lunch meetings and voting recommendation letters to MEPs.

In an article on its website, CEO stated its (and others’) preference for the stricter traffic light system. “Health and consumer campaigners argue that such labels are less effective because they rely on an arbitrary notion of a portion, and only reflect adult needs, which are not relevant for children – often the target market for snacks and sweets. They favour the traffic-light label which is much easier to understand for a larger audience and the most socially disadvantaged.”

Even with the less intrusive GDA approach, some companies have expressed their discomfort. UK newspaper the Daily Telegraph has reported that Ferrero, the Italian producer of Nutella hazelnut chocolate spread, claims that the new labelling requirements could frighten off potential customers. Even Italy’s Agriculture and Food Minister Giancarlo Galan has criticised the tougher approach, saying: “Sometimes, the strict application of rules…reveals their stupidity.” It seems that as these proposals move forward towards becoming full legislation, they may have found a staunch opponent in Italy.

The long road to legislation

The fact that EU parties have agreed on a framework for legislation does not mean that it will instantly become law; far from it, in fact. According to an interested parties letter from the UK Department for Environment, Food and Rural Affairs (Defra) dated 7 January 2011, the proposals will be subjected to another round of debate during their second reading in the spring of this year.

“The Regulation is expected to be finalised and published in early 2012. There will be appropriate transition periods for all businesses with the Council proposing three years for the labelling provisions although the mandatory requirement for nutrition labelling will not apply for five years,” according to Defra’s letter.

This means that although these issues are being brought to the table now, companies could have up until 2017 before the legislation comes into force.

It also leaves plenty of time for hurdles to be thrown in the path of the legislation by industry bodies or opposing national governments.

These new regulations, if pushed through intact over the next two years, will present new challenges for the food and packaging industries to come up with creative ways to inform consumers while keeping their products looking fresh and appealing on store shelves. But any healthy industry should rise to new challenges, and the changes proposed by the EU could have a significant impact on the ever-growing problem of mass obesity across the continent.

Source: Food Navigator

Food Safety, packaging food labelling, nutritional information, regulations

EU ministers have reached agreement on a range of proposals to be included in a draft regulation on food labelling for the region.

As expected, decision-makers from the 27 members of the European Union today approved the key strands of the legislation that had been hammered out by national negotiators last week.

The main elements given the green light at the Council include:

• Mandatory nutrition labelling that displays the energy value and the quantities of some nutrients – such as fat, saturates, carbohydrates, protein, sugars and salt;

• As a general principle, the energy value and the amounts of these nutrients would have to be expressed per 100g or per 100ml, but could also be indicated as a percentage of reference intakes;

• Food business operators should be allowed to use other systems as long as they do not mislead consumers;

• All elements of the nutrition declaration should appear together in the same field of vision but some elements may be repeated on the “front of pack”;

• Country of origin labelling, compulsory for beef, should be extended to pork, lamb and chicken;

• The European Commission should also submit a report examining the possible extension of the compulsory labelling of the country of origin to further products – such as milk, milk used as an ingredient, meat used as an ingredient, unprocessed foods, single ingredient products, ingredients that represent more than 50% of a food – within three years of the act’s implementation;

• An exemption for certain alcoholic beverages (such as wines, products derived from aromatized wines, mead, beer, spirits, but not alcopops) from nutrition labelling rules as well as from the indication of the list of ingredients. This should be reviewed within five years;

Once a formal version of the draft regulation has been agreed by the Council, the measure will go to the European Parliament for a second reading.

packaging EU, labelling, regulations

Confectionery Production looks at the latest regulatory developments in the EU and the World Trade Organisation

The European Food Safety Authority (EFSA) panel has refused to set an advisory limit for the intake of sugar by European Union consumers. EFSA´s panel on dietetic products, nutrition and allergies has concluded in a comprehensive assessment of dietary requirements for EU consumers “there was insufficient evidence to set an upper limit for sugars”. This, it said, was because the possible health effects of eating sugar and sweet foods was “mainly related to patterns of food consumption – such as the types of foods consumed and how often they are consumed – rather than a relation to the total intake of sugars itself.” This is despite the fact the panel agreed high sugar intake increases tooth decay risk. Policymakers should try and influence the kind of sweet foods people eat rather than the amount of sugar, said the panel.

Colouring rule

Separately, EFSA has ruled that the maximum acceptable daily intake of confectionery and bakery product colouring Brown HT (E155) should be halved to 1.5 milligrams per kilogram of bodyweight (mg/kg bw). This is because of adverse effects – such as slightly reduced weight gain – in animal tests of the additive.

Meanwhile, the EU Council of Ministers has accepted new EU purity criteria for the sweetener neotame, which would under a proposed regulation be 97 per cent pure or more. It is manufactured by reacting aspartame with 3,3-dimethylbutyraldehyde in methanol using a palladium/carbon catalyst under hydrogen pressure.

Investment news

The European Investment Bank (EIB) will lend €15 million to Omnicane to build two sugar refineries in Mauritius, also improving sugar storage and handling facilities, while extending an existing mill.

Meanwhile, the European Bank for Reconstruction & Development (EBRD) is lending $1.2 million (€953,000) to one of the largest ice cream producers in Turkmenistan, to help expand its distribution network and build its brand. Privately-owned Salkyn produces more than 70 types of ice cream. The loan will help Salkyn buy new retail fridges and refrigerated chambers in its regional distribution hubs.

Russia and Turkey

Also, the European Bank for Reconstruction & Development (EBRD) has released plans to invest €10 million in Russian cake and pastry maker the Hlebprom group. The money would help buy and install new production equipment to boost efficiency and hygiene in the production and packaging process.

It is also planning to lend €40 million to Turkey based Continental Confectionery Company (a joint-venture between Turkey’s Ülker Group and Denmark Gumlink). The money will help investments in a new chewing gum and edible confectionery factory.

By contrast, the European Commission is still pumping money into reducing the amount of sugar produced in the EU budget year 2009 into 2010 for the Sugar Restructuring Fund, which helps European sugar producers switch to making and growing different food products.

Meanwhile, a Commission report on the €26.3 million spent by the EU on improving European honey production has unveiled shortcomings in the management of this spending programme. It calls for “better collaboration between Member States and beekeeping organisations” when planning how to spend this money. It added, “The organisations regret, in particular, that in some cases the lack of collaboration has resulted in the budget not always being used in the most appropriate manner.”

In marketing, the European Commission has continued to expand its list of confectionery and sweet bakery products protected under EU geographical indication legislation. Slovenian cake “Prekmurska gibanica”, a Spanish tart “Tarta de Santiago”, the French apple “Pommes des Alpes de Haute Durance” and the Italian apple “Mela di Valtellina” cannot henceforth be sold in the EU unless produced in their historic home regions using traditional production methods.

Safety concerns

There has been a new variant on safety concerns about selling confectionery-imitating products. Bulgarian regulators banned the sale of a Turkish deodoriser branded Erfres, which was sold as oval white bonbons and “can be confused with a foodstuff by children and swallowed”, warned EU consumer alert service Rapex.

At the World Trade Organisation (WTO), Brazil and India have said they are making good on commitments to open their markets duty-free to the 49 poorest countries worldwide, with the confectionery industry benefiting. New Delhi and Brasilia said cocoa and sugar were key exports that would benefit.

Brazil said by mid-2011, 80 per cent of tariff lines for exports from these mostly African and south Asian countries would be duty free; India said governments had to ask for this status – so far only 14 had – and it wants more applications.

In Washington DC, the Us Trade Representative (USTR) office has reallocated its low duty import quotas for sugar covering 2010, giving more market access to countries with a ready supply of exports. The Dominican Republic was given an additional 15,262 tonnes in quota; Brazil 12,574 tonnes; The Philippines 11,709; Australia 7,197; and Guatemala 4,162, out of a reallocation of 81,946 tons to 25 countries.

Next year, the USA global tariff rate import quota for raw sugar will increase by 200,00 tons, although American sugar producers and users had expected a larger increase. US sugar and producer organisations have been pressing the USTR for an early announcement of details of the 2011 quota to ease arrangements for imports.

World sugar prices

Looking at global prices the UN Food & Agriculture Organisation and the Organisation for Economic Cooperation & Development have predicted world sugar prices to 2019 will be above the average of the previous decade but well below the 29 year highs experienced at the end of 2009. Their latest medium-term market assessment says that unlike some other commodities, sugar prices did not rise steeply in 2007/08 by 10-20 per cent.”

Meanwhile, cocoa and sugar exports from Brazil to the EU could get a boost if free trade talks reopened between the European Commission and the Mercosur trade block in South America (also including Argentina, Paraguay and Uruguay) are successful. They were suspended in 2004, after nine years, but Brussels is now hopeful of success.

The Commission has also asked EU ministers to suspend until December 2014 all EU duties on any imports of sweetened dried cranberries, because of a European supply shortage.

And, tying up a loose end, the Commission has announced it is spending €190 million in aid to improve banana production in its Caribbean, African and Pacific suppliers – this was part of the December 2009 agreement that ended the long running WTO trade dispute over banana supplies.

Confectionery, Ingredients Confectionery Production, regulations