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Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices

Dispersed-nanoparticles-used-as-performance-additives

Due to the great interest surrounding nanomaterials, the fights around a possible definition (mainly regarding the scale of these particles), and the recent evaluation of the antimicrobial action of silver nanoparticles, I find interesting this press release from DG Sanco.

Today, the European Commission and its non-food Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), have launched a public consultation on the preliminary opinion ‘Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’.

The consultation will run until 03 October 2014. Interested parties are invited to provide comments on the scientific evidence of this preliminary opinion online:

http://ec.europa.eu/health/scientific_committees/open_consultation/index_en.htm

Here you can find the preliminary opinion:

http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_045.pdf

The aim of the opinion is to address the use of nanomaterials in medical devices and to provide information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials. According to the EU Recommendation for the definition of a nanomaterial ( Commission Recommendation 2011/969/EU, EC 2011) any particulate substance with at least one dimension in the size range between 1 and 100 nm is considered a nanomaterial. These particles (nanoparticles) exhibit specific characteristics that differ from the characteristics of larger sized particles with the same chemical composition.

This Guidance is aimed at providing information to help with safety evaluation and risk assessment on the use of nanomaterials in medical devices and it should be considered in conjunction with the ISO 10993-1:2009 standard ‘Biological evaluation of medical devices’. The Guidance highlights the need for special considerations in relation to the safety evaluation of nanomaterials, in view of the possible distinct properties, interactions, and effects that may differ from conventional forms of the same materials.

For the risk evaluation of the use of nanomaterials in medical devices, the SCENIHR recommends a phased approach based on potential release and characteristics of the nanomaterials.

For more information on the work of the Commission’s independent scientific committees:

http://ec.europa.eu/health/scientific_committees/policy/index_en.htm

(Source: DG Sanco)

Plant health: Xylella fastidiosa outbreak in Italy and damages to olive trees

Olive_trees_on_Thassos

Xylella fastidiosa is a bacterium in the class Gammaproteobacteria, is an important plant pathogen that causes phoney peach disease in the southern United States, bacterial leaf scorcholeander leaf scorch, and Pierce’s disease, and citrus variegated chlorosis disease (CVC) in Brazil.

Recently found for the first time on EU territories, the strain of Xylella fastidiosa identified in Italy (province of Lecce, in the Apulia region) attacks mainly olive trees, which show leaf scorching, branch desiccation and quick decline symptoms, leading in the most severe cases to the death of the trees. Olive cultivation is widespread throughout the Mediterranean region and is vital for the rural economy, local heritage and the environment.

On November 2013, EFSA provided urgent advice to the Commission, stating that:

Transmitted by certain types of sap-sucking hopper insects, the bacteria X. fastidiosa, has been identified in the current disease outbreak that has affected 8000 hectares of olive trees in the Puglia region of Southern Italy.  The bacteria can be hosted in a very broad range of plants including almond, peach, plum, apricot, grapevines, citrus, coffee and olive as well as oak, elm, Ginkgo and sunflower. Importantly, plants can carry the bacteria without showing signs of disease.

X.fastidiosa is regulated as a harmful organism in the European Union (EU), whose introduction into, and spread within, all Member States is banned. In light of the current outbreak, the European Commission requested EFSA to provide urgent scientific advice outlining the list of known plant hosts, identifying the different ways that infected plant species and carrier insects could enter the EU as well as identifying and evaluating possible preventive measures.

Plant health experts at EFSA have concluded that X. fastidiosa has a very broad range of known host plants in the EU, including many grown for agricultural production as well as indigenous wild species common in Europe.  Additionally, there are a large number of species that could potentially be infected by the bacteria but have never been exposed, making it difficult to establish what the likely impact would be.  Importantly, the sap-sucking hopper insects found in the EU that could potentially carry the disease are likely to have different feeding habits and patterns. As the only natural means for spreading X. fastidiosa is by the sap-sucking hopper insects that generally can fly short distances of up to 100 metres, movement of infected plants for planting is the most efficient way for long-distance dispersal of X. fastidiosa. In addition, the transport of the insects that carry the bacteria in plant shipments and consignments has been identified as a concern.  The main source of X. fastidiosa into the EU is therefore trade and thereafter the movement of plants intended for planting.

Other potential sources of infection were assessed including fruit, wood, cut flowers, seeds and ornamental foliage. However, these were considered either negligible or low in terms of potential pathways for introduction of the bacteria. There is no record of successful eradication of X. fastidiosa once it has been established outdoors.

EFSA therefore recommends that preventative strategies for containment of outbreaks should focus on the two main routes of infection (plants for planting and infective insects in plant consignments) and be based on an integrated system approach.”

Following this rapid assessment, EFSA’s Plant Health Panel will conduct a comprehensive assessment of the risk posed by this bacteria Xylella fastidiosa to the EU crops and plants. In February 2014, on the ground of emergency the EU adopted the Commission Implementing Decision of 13 February 2014 as regards measures to prevent the spread within the Union of Xylella fastidiosa (Decision 2014/87/EU).

The measures provide conditions on the import and movement of particular plants which host, or are likely to host this bacterium, its timely identification in the affected areas as well as its eradication. They include obligations to notify any outbreak, official annual surveys, demarcation of infected areas, sampling, testing and monitoring, and removal and destruction of infected plants.

Here above you can find, finally, the FVO report (just published) of an audit performed in Italy from 10th to 14th February 2014, assessign the situation. The findings are not so positive and the audit team issued 10 recommendations to the Competent Authorities:

“The objective of the audit was to evaluate the situation and official controls for Xylella fastidiosa (Well and Raju) (hereafter “Xf”). This organism is listed as a harmful organism in Annex I, Section A, Part I of Council Directive 2000/29/EC, which means that it is not present in the EU and if found, Member States must eradicate it, or if that is impossible, inhibit its spread.

It was identified in the Lecce province in the Puglia region of Italy in October 2013. As part of a complex of harmful organisms it has caused devastating die back in olive groves over a substantial area in Lecce. In view of the seriousness of this organism and the potential risk to the EU, this audit was added to the FVOs planned 2014 audit programme.

The audit found that, the competent authorities have taken significant steps since the finding of a new strain of Xf (Salento strain) in Lecce province, in October 2013. Based on regional legislation, adopted in 2013, measures are in place establishing conditions for the production and movement of plants for planting in nurseries located in Lecce province. An extensive survey activity is still being carried out in order to delimit the spread of the disease in the province and to define infected and buffer zones. However, significant parts of the survey were not carried out in the most favourable time of the year. The survey is planned to be concluded by the end of March 2014.

No eradication or containment measures have been taken and the disease has spread very rapidly. Diseased trees are left in place, acting as a reservoir of infection. Unless action is taken, further rapid spread of the disease must therefore be anticipated.

The ELISA test for plant species other than olive is not yet fully reliable. In addition, the testing of dormant woody material (e.g. Vitis) during the winter and the limited sample sizes used also affect the reliability of the testing. In these circumstances, there is a risk of obtaining false negative results. Until this is addressed the authorities cannot say for sure that plants listed in the annexes of Decision 2014/87/EU are actually free from Xf prior to permitting their movement within the EU.

This represents a potential risk of spreading the organism to other parts of Italy and to other Member States. Although research work has been carried out and is continuing, key factors regarding the epidemiology of Xf remain to be clarified”

Food recalls in EU – Week 28

lasagna-supreme

This week on the RASFF database (Rapid Alert System for Food and Feed) we have two recalls from consumers in EU in the alert notifications:

- Organoleptic aspects: too low acidity in white lasagna sauce, following company’s own check. Origin Switzerland, notified by United Kingdom, distributed also to Ireland;

Composition: unauthorised substance sibutramine and sildenafil in food supplement, following an official control on the market. Origin Netherlands, notified by France.

Between the alert notifications, followed by a withdrawal from the market of the product, we find:

Heavy metals: mercury in frozen swordfish steaks, following an official control on the market. Origin Spain, notified by Italy;

Pathogenic micro-organisms: Listeria Monocytogenes in chilled smoked salmon, following company’s own check. Origin Poland, notified by France;

Poor or insufficient controls: inadequate thermal processing in frozen cordon bleu, following company’s own check. Origin Germany, notified by Netherlands;

Pesticide residues: metamidophos in pattypan, following a company’s own check. Origin South Africa, notified by Netherlands, distributed also to Belgium, Czech Republic, Estonia, Lithuania, Qatar, Romania and United Kingdom;

We have also a seizure for suspicion of shigatoxin-producing Escherichia coli in frozen deer meat from Germany. Notified by Belgium, distributed also to Italy.

Amongst border rejections we have aflatoxins in peanuts from China, salted pistachio nuts from Iran, shelled pistachios from Turkey, groundnut kernels from India (via Egypt) and Bombay biryani spice mix from Pakistan. Ochratoxin A in chili powder from Mexico, high count of Enterobacteriaceae in brine shrimp eggs from China, poor temperature control of frozen shallow-water cape hake from Namibia, residue level above MRL for oxytetracycline in frozen shrimps from Vietnam, carbendazim in green tea extract from China and in fresh lemons from Argentina, formetanate and clofentezine in fresh peppers from Turkey, etoxazole in green beans and chlorothalonil in snow pea from Kenya, imazalil and orthophenylphenol in oranges from Egypt, methamidophos, monocrotophos and acephate in okra from India, bitertanol and abamectin in yard long beans from the Dominican Republic, dithiocarbamates, malathion, lambda-cyhalothrin, dimethomorph, azoxystrobin, boscalid, myclobutanil, pyraclostrobine and quinoxyfen in vine leaves in brine from Turkey.

For feed, we have a border rejection for Salmonella Spp. in fish meal from Mauritania.

For food contact materials we have a border rejection for migration of chromium and of manganese from stainless steel strainers from China.

Related articles

FVO report – GM Papaya export from Thailand

papaya-ringworm

This report is of extreme interest because it refers to one of the emerging problems stressed by RASFF notifications and statistics during the last months.

The report describes the outcome of a Food and Veterinary Office (FVO) audit in Thailand, carried out between 29 January to 07 February 2014. Genetically modified (GM) papaya is not authorised in the European Union (EU). The objective of the audit was to assess the system of controls to ensure that GM papaya and GM papaya products are not exported to the EU.

The audit was carried out due to RASFF notifications of genetically modified organism (GMO) in papaya and papaya products from Thailand issued in 2012 and 2013. Although GM papaya has never been authorised for cultivation in Thailand, the CA detected a
significant presence of GM papaya. The origin of the GM papaya is not known. There is an incentive for farmers to use GM papaya as non-GM plants are susceptible to the serious disease PRSV. The farmers met had been using farm saved papaya seed for a number of years and the original seed was sourced before official GMO controls started.

In response to the RASFF notifications issued by the EU from 2012, the CA has put in place a system to ensure that GM papaya is not exported to the EU. The system is based on obligatory export certification, and papaya intended for export to the EU must be sampled and analysed for GMO presence. However, DOA does not verify whether sampling for export certification is representative. The CA requires GMP certification of packing facilities and performs official annual surveillance schemes. Certification of papaya growers to the GAP scheme is encouraged and includes systematic testing for GMOs. However, GAP certification is currently not compulsory and a number of growers of papaya for export to the EU are not certified.

Some shortcomings were identified in the GMO laboratories such as sensitivity and quality control procedures. Official controls are supported by additional private controls.

While the control measures are capable of ensuring that papaya exported to the EU is not GM, the system put in place requires more time to be completed. At the time of the audit it was too early to conclude on its effectiveness.

 

Food recalls in EU – Week 27

Clostridium_difficile

This week on the RASFF database (Rapid Alert System for Food and Feed) we have one recall from consumers in EU in the alert notifications:

Allergens: undeclared wheat in ice cream, following company’s own check. Origin Finland, notified by Finland, distributed also to Estonia.

Between the information for attention, followed by a recall from consumers:

Foreign bodies: metal pieces in canned sardines in oil, following company’s own check. Origin Portugal, notified by France.

Between the alert notifications, followed by a withdrawal from the market of the product, we find:

Pathogenic micro-organisms: suspicion of Clostridium Botulinum in pesto sauce with black truffles, following food poisoning. Origin Hungary, notified by Hungary, distributed also to Hong Kong and Slovakia;

- Pathogenic micro-organisms: Salmonella enteritidis in frozen chicken leg, following an official control on the market. Origin Poland, notified by Latvia;

Pathogenic micro-organisms: Salmonella typhimurium in frozen chicken carcasses, following company’s own check. Origin France, notified by France, distributed also to Bulgaria, Guadeloupe, Italy, Japan, Netherlands, New Caledonia, Portugal, United Arab Emirates and Macedonia;

Mycotoxins: aflatoxins in sunflower seeds, following an official control on the market. Origin Argentina (via United Kingdom), notified by Germany;

Pathogenic micro-organisms: enteropathogenic Escherichia Coli in raw goat milk cheese, following an official control on the market. Origin France, notified by France, distributed also to Belgium, Gabon, Germany, Luxembourg, South Africa and Switzerland;

Poor or insufficient controls: inadequate thermal processing on chilled liver sausage, following a consumer complaint. Origin Poland, notified by Poland, distributed also to Sweden;

Pathogenic micro-organisms: foodborne outbreak caused by Salmonella enteritidis in deep frozen pork tenderloin, following food poisoning. Origin Hungary, notified by Slovakia;

Residues of medicinal veterinary products: prohibited substance diethylstilbestrol in pork, following an official control on the market. Origin Denmark/Germany, notified by Germany, distributed also to Australia, Belgium, Bulgaria, Croatia, Czech Republic, Greece, Hong Kong, Ireland, Italy, Japan, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Singapore, Slovakia, Slovenia, Sweden, Switzerland, United Kingdom and United States;

- Organoleptic aspects: unsuitable organoleptic characteristics in cocktail shrimps, following a consumer complaint. Origin India, notified by Germany, distributed also to Belgium, Netherlands and Poland.

Amongst border rejections we have Salmonella spp. in boneless bovine meat from Brazil and in frozen poultry preparation from Argentina, suspicion of shigatoxin-producing Escherichia coli in chilled boneless beef from Argentina, aflatoxins in groundnut kernels from China and chilli powder from India, absence of certified analytical report and of Common Entry Document (CED) for melon seeds from Nigeria, frozen cheese from the United States with defective packaging, illegal import of and Salmonella spp. in paan leaves from Bangladesh, unauthorised genetically modified papaya from Thailand, chlorpyriphos-methyl in chickpeas from Argentina, cypermethrin and cyhalothrin in chilli peppers from the Dominican Republic, formetanate in fresh peppers from Turkey, poor temperature control of frozen tuna from South Africa and frozen squid, mercury in frozen squid from Peru, benzo(a)pyrene and polycyclic aromatic hydrocarbons in non-refined soybean oil from Ukraine, unauthorised substance sildenafil and novel food (Scutellaria elliptica & incana) in food supplement from the United States.

For feed, we don’t have any relevant notification this week.

For food contact materials we have a border rejection for migration of bis(2-ethylhexyl) terephthalate (DOTP) from lid of jar containing garlic paste from Thailand.

Related articles

FVO report – FNAO and primary production in Polonia (sprouts and sprouting seeds)

Escherichia_coli_13776880

This report describes the outcome of a Food and Veterinary Office audit in Poland which took place from 12 to 22 November 2013 under the provisions of Regulation (EC) No 882/2004 of the European Parliament and the Council of 29 April 2004.

The objectives of the audit were to evaluate the system of official controls in the area of food hygiene for primary production of Food of Non-Animal Origin (FNAO) and the system of official controls in the area of traceability and import of seeds intended for sprouting and sprouts, microbiological criteria and approval of sprout producing establishments.

Although there are competent authorities designated for official controls in the sectors of primary production of FNAO, the official control system applied is not risk based and cover only production activities during and post harvest in a limited number of establishments. This means that the potential risks arising from microbiological contamination are not systematically taken into account in the planning of official controls. The Polish competent authorities plan to incorporate primary production of FNAO in the risk based official control system. The shortcoming identified in the capacity of the official control laboratories visited could affect the reliability of the analytical results for Verocytotoxin producing Escherichia coli testing.

The Union legislation on seeds intended for sprouting and sprouts has not been adequately implemented. There are deficiencies concerning the approval of sprouting establishments as required by Regulation (EU) No 210/2013 and the own-check systems for monitoring of food safety criteria for sprouts as required by Regulation (EC) No 7023/2005.

The report makes a number of recommendations to the competent authorities aimed at rectifying the shortcomings identified and enhancing the implementation of control measures.

FSA released revised E.coli O157 control of cross-contamination guidance

E.coli O157 H7

The FSA E.coli O157 control of cross-contamination guidance has been revised and updated to take into account the results from independent research into the effectiveness of disinfecting complex equipment, and the views of industry and local authority stakeholders. The aim of the guidance is to ensure that businesses manage the risk to consumer health from the presence of E.coli in food.

The revised guidance will be published for an eight-week review period (from 4th July to 29th August 2014), allowing businesses and others to provide comments on the revised guidance that they would like to be considered.

The revised guidance clarifies that:

  • Businesses do not need to have separate areas for handling raw and ready to eat foods (RTE) where they can demonstrate that separation by time with effective cleaning and disinfection will manage the risk of cross-contamination.
  • Less complex equipment, such as temperature probes, mixers and weighing scales, may be used for both raw and RTE foods subject to the business being able to demonstrate that such equipment will be effectively cleaned and disinfected between uses.
  • It may now be possible to effectively clean and disinfect vacuum packers, slicers and mincers between uses as long as such machines are completely dismantled to allow all surfaces to be thoroughly cleaned. In practice, however, it is unlikely to be practical for a business to regularly change the use of vacuum packers as a competent engineer would need to undertake what is a complicated dismantling and reassembling process. However, cleaning to allow a more permanent change of use, for example to re-commission and buy and sell second-hand vacuum packers, may be feasible. In the case of slicers and mincers, dismantling, cleaning and disinfecting may be more straightforward but is unlikely to be feasible during normal business operations. Businesses wishing to use such machines for raw and RTE foods would need to fully assess the risks and to demonstrate to the relevant local authority that cleaning between uses will provide effective controls.

Food recalls in EU – Week 26 – 2014

cauliflower-212x159-480x360

This week on the RASFF database (Rapid Alert System for Food and Feed) we have one recall from consumers in EU in the alert notifications:

Pesticide residues: dimethoate in cauliflower, following an official control on the market. Origin Belgium, notified by Belgium, distributed also to Luxembourg, and France.

Between the information for attention, followed by a recall from consumers:

- Pesticide residues: unauthorised substance carbofuran in limes, following a border control. Origin Brazil, notified by Italy.

Between the alert notifications, followed by a withdrawal from the market of the product, we find:

Biotoxins: Paralytic Shellfish Poisoning (PSP) toxins in shucked scallop, following an official control on the market. Origin United Kingdom, notified by United Kingdom, distributed also to France;

Foreign bodies: stones (3mm) in bulgur, following an official control on the market. Origin Turkey (via Germany), notified by Austria;

Mycotoxins: Ochratoxin A in raisins, following an official control on the market. Origin Uzbekistan, notified by Slovakia, distributed also to Austria and Slovenia;

Mycotoxins: alfatoxins in sunflower seeds, following an official control on the market. Origin Argentina (via United Kingdom), notified by Germany;

- Residues of medicinal veterinary products: prohibited substance nitrofuran (metabolite) furazolidone (AOZ) in veal, following an official control on the market. Origin Netherlands, notified by Netherlands, distributed also to Belgium, France, Germany and Italy;

Pathogenic micro-organisms: Salmonella kedougou in raw milk cheese Reblochon, following food poisoning. Origin France, notified by France, distributed also to Austria, Belgium, Czech Republic, Denmark, Germany, Japan, Jordan, Luxembourg, Netherlands, New Caledonia, Nigeria, Philippines, Portugal, Slovakia, Spain, Switzerland, United Arab Emirates and United Kingdom.

Amongst border rejections we have Hepatitis A virus in razor shells from Morocco, norovirus (group I) in frozen boiled saltwater clams from Vietnam, shigatoxin-producing Escherichia coli in frozen lamb meat from New Zealand, unauthorised genetically modified rice cakes from China, carbendazim in basmati rice from Pakistan and in fresh bell peppers and peppers from Turkey, prohibited substance nitrofuran (metabolite) furazolidone (AOZ) in frozen peeled shrimps from India, residue level above MRL for tetracycline in frozen shrimps from Vietnam, unauthorised placing on the market (Azadirachta indica) of food supplement from India, malathion in white pea beans from Ethiopia, formetanate in fresh peppers from Turkey, chlorpyriphos-methyl in olives in brine from Egypt, dried apricots from Uzbekistan infested with live larvae of insectsSalmonella spp. in paan leaves and sesame seeds from India and in frozen poultry meat preparation from Brazil, high content of biogenous amines in frozen dried lizard fish (raw) from Thailand, unauthorised substance dichlorvos in dried beans and profenofos, cypermethrin and cyhalothrin and unauthorised substance dichlorvos in beans from Nigeria, too high content of E 211 – sodium benzoate in mango juice drink from Pakistan, absence of health certificate(s) and absence of certified analytical report for sesame and groundnuts paste from China, via Hong Kong, poor temperature control of frozen hens crests from Argentina and of frozen poultry meat from Brazil, aflatoxins in peanuts and groundnuts in shell from China.

For feed, we don’t have any relevant notification this week.

For food contact materials we have border rejections for absence of declaration of compliance for plastic barrels intended for food contact from Morocco, migration of bis(2-ethylhexyl) terephthalate (DOTP) from lids of glass jars containing coriander paste from Thailand and migration of chromium, of nickel and of manganese from oil cruet with cork bottle cap from China.

Related articles

FVO Reports – Pesticide controls in UK? Not the best probably…

FoodLawfinal

From the following report of the Food Veterinary Office (here you can read the executive summary) seems that United Kingdoms not doing so well about pesticides controls. Click here to read and download the full report.

The report describes the outcome of a Food and Veterinary Office (FVO) audit in the United Kingdom, carried out between 14 to 22 October 2013, under the provisions of Regulation (EC) No 882/2004 on official food and feed controls and Regulation (EC) No 1107/2009 on the placing of plant protection products on the market.

The objective of the audit was to evaluate the system of authorisation and the controls on the marketing and use of pesticides. A comprehensive system is in place in the UK for the authorisation of pesticides. Authorisation procedures are fully in line with EU requirements. However, the deadlines prescribed in EU legislation for authorisation and re-registration of pesticides are not met in about ten percent of the cases.

There are no systematic, risk-based controls on the marketing of pesticides. Compliance of pesticides with requirements of the authorisation, including labels are not checked at distributors. Instead, investigations are initiated only in response to complaints or information on potential non-compliances obtained from external sources. There are certain initiatives for coordinated controls by the relevant authorities in order to combat illegal pesticides.

Although the formulation laboratory has the necessary capability for comprehensive controls, the number of pesticide samples analysed and the method of sampling does not provide adequate assurance for detection of non-compliances. Although there are regular risk based controls on the use of pesticides at growers, in the framework of the cross compliance controls, the system does not cover about 10-15% of professional users in the UK, including numerous large and medium size fruit and vegetable farms.

Different central competent authorities (CAs) are responsible for official controls in the different countries of the UK. The central competent authorities have no information about the controls carried out by the local authorities. Therefore the UK does not provide an annual report to the Commission on the scope and results of official controls on the marketing and use of pesticides, as required by EU legislation.

There are detailed procedures in place for enforcement in the case of non-compliances, including prosecution and the application of penalties. However, the CAs do not always take appropriate actions to ensure that the operator remedies the situation. Sanctions are not always effective, proportionate and dissuasive.

The report makes a number of recommendations to the CAs, aimed at rectifying the shortcomings identified and enhancing the implementation of control measures.

Allergens Labelling (FIC Regulation n. 1169/2011) on Foodservice Consultant

Food-allergens-cropped

As usual, I have to thank you Foodservice Consultant, and the editors Michael Jones and Ellie Clayton, for publishing again one of my articles on their magazine. This time we talk briefly about allergens labeling in  of the new EU FIC Regulation (n. 1169/2011).

We have a well established mutual cooperation, and my presence on their magazine/newsletter will be quarterly.

Foodservice Consultant is a quarterly publication for worldwide members of Foodservice Consultants Society International (FCSI), and is also distributed to an additional audience of 50,000 senior decision makers from the hospitality, leisure and construction sectors. Foodservice Consultant features interviews with leading FCSI consultants, hoteliers, chefs and architects and addresses topics ranging from sustainability, cuisine and nutrition to design, regulation and technology.

Foodservice Consultants Society International (FCSI) is the premier association promoting professionalism in foodservice and hospitality consulting. With over 1,300 members in over 46 countries, FCSI members offer a wide range of consulting services including concept development, feasibility studies, food safety, design, marketing, operations and training.

It has been a real pleasure working again with them!

Plant Health report: import controls are an effective tool in protecting EU consumers

Plant-and-Sun

A Commission report published today presents key findings on the controls carried out at Europe’s borders to prevent harmful plant pests from entering the EU market.

This EUROPHYT report reveals that 7.000 consignments mainly imported from non-EU countries were intercepted in 2013. In about one third of the cases insects, fungi, bacteria or viruses were found; the number of interceptions with such harmful organisms increased by 18%, compared to 2012. Fruit and vegetables fall amongst the highest category of consignments that were prevented from entering the EU marketplace. These included mainly mangoes, gourds, basil, aubergines, guavas and peppers, coming from India, Pakistan, Ghana, Dominican Republic, Cambodia, Sri Lanka, Kenya and Bangladesh. As a result of specific EU safeguard measures, the number of interceptions from Thailand, Vietnam and Israel decreased significantly in 2013. There were over 2.000 interceptions of wood packaging material, originating mainly from Russia, China, USA, Belarus and India. EUROPHYT is an IT rapid alert system, managed by the Commission, which facilitates the cross-border flow of information and notifications between national authorities in the EU and Switzerland.

What is EUROPHYT?

EUROPHYT brings together the words ‘European’ and ‘Phytosanitary’ and describes a notification and rapid alert system dealing with Interceptions for plant health reasons of consignments of plants and plant products imported into the EU or being traded within the EU itself. EUROPHYT is established and run by the Directorate General for Health and Consumers of the European Commission.

With the increase in trade over the last decades, the risk of introducing new pests and diseases has increased and, given favourable weather conditions and a lack of natural enemies, they can spread and lead to environmental damage, destruction of native plant species, substantial economic losses in agricultural production and an increase in the use of pesticides. Therefore measures to prevent their introduction and spread are essential. EUROPHYT provides an essential support for the implementation of preventative measures by ensuring that the data on risks to plant health from trade in plants and plant products is up-to-date and accurate

For knowing more:

(Source: DG Sanco)

Food recalls in EU – Week 25 – 2014

brie

This week on the RASFF database (Rapid Alert System for Food and Feed) we have four recalls from consumers in EU in the alert notifications:

Pesticide residues: dimethoate in green beans, following an official control on the market. Origin Morocco, notified by Luxembourg, distributed also to Germany and France;

Pathogenic micro-organisms: Listeria Monocytogenes in raw milk soft cheese, following an official control on the market. Origin France, notified by Germany;

- Food additives and flavorings: undeclared sulphite in pickled lime, following an official control on the market. Origin Thailand (via Netherlands), notified by Denmark;

-  Food additives and flavorings: undeclared sulphite in water chestnuts in brine, following an official control on the market. Origin Thailand (via Netherlands), notified by Denmark.

Between the information for attention and the information for follow-up notification, followed by a recall from consumers:

Food additives and flavorings: too high content of colour E 110 – Sunset Yellow FCF in soft drinks, following an official control on the market. Origin India (via United Kingdom), notified by Ireland;

Pathogenic micro-organisms: Listeria Monocytogenes in milkshakes produced from sterilised milk preparation, following company’s own check. Origin France/Belgium, notified by France;

Between the alert notifications, followed by a withdrawal from the market of the product, we find:

Allergens: too high content of gluten in corn meal, following an official control on the market. Origin Poland, notified by Poland, distributed also to Belgium, Germany, Ireland, Latvia, Ireland, Netherlands, Poland, Sweden and United Kingdom;

Allergens: undeclared milk ingredient in flapjack cake, following a consumer complaint. Origin United Kingdom, notified by United Kingdom, distributed also to Germany, Ireland, Slovakia and Malta;

Allergens; undeclared sesame and nuts in cookies, following an official control on the market. Origin Lebanon (via Germany), notified by Denmark;

Heavy metals: high content of lead in green lentils, following an official control on the market. Origin Czech Republic, notified by Slovakia;

Mycotoxins: aflatoxins in pistachio nuts, following an official control on the market. Origin United States (via Germany), notified by Netherlands;

Mycotoxins: aflatoxins in pistachio nuts, following an official control on the market. Origin Iran (via Germany), notified by Netherlands;

- Pathogenic micro-organisms: Salmonella Spp. in ground ginger, following an official control on the market. Origin Netherlands, notified by Netherlands, distributed also to Germany;

Pathogenic micro-organisms: Bacillus cereus in ginger powder, following an official control on the market. Origin India (via United Kingdom), notified by France, distributed also to Italy;

Pathogenic micro-organisms: shigatoxin-producing Escherichia coli in vacuum packed beef, following an official control on the market. Origin Netherlands, notified by Italy;

Pathogenic micro-organisms: Salmonella Coein in black pepper, following an official control on the market. Origin Belgium/Netherlands, notified by Netherlands, distributed also to France;

Pesticide residues: carbendazim in pears, following a border control. Origin Argentina, notified by Greece, distributed also to Bulgaria;

- Residues of veterinary medicinal products: residue level above MRL for oxytetracycline in pork meat, following an official control on the market. Origin Belgium, notified by Belgium, distributed also to Bulgaria, Estonia, France, Germany, Hong Kong, Hungary, Italy, Luxembourg, Moldova, Netherlands, Philippines, Poland, South Africa and United Kingdom.

Amongst border rejections we have Norovirus in frozen clams from Vietnam, residue level above MRL for oxytetracycline in frozen shrimps from Vietnam, too high content of vitamins in food supplements from the United States, unauthorised substances malachite green and leucomalachite green in frozen red tail tin foil barb from Vietnam, parasitic infestation with Anisakis of anchovies from Morocco, absence of health certificate(s) for rice cooking wine and sauces from China, Salmonella Hadar in frozen turkey meat and meat preparation (boneless & skinless) from Brazil, Salmonella spp. in frozen chicken meat and meat preparation from Brazil, Salmonella Brunei and Salmonella Westhampton in desiccated coconut from Indonesia, Salmonella Kentucky in hulled sesame seeds from India, aflatoxins in pistachio nuts from Syria, via Turkey, and from United States and in pistachio nuts in shell from Iran, prohibited substance nitrofuran (metabolite) furazolidone (AOZ) in frozen domestic rabbits and frozen rabbit meat from China, shigatoxin-producing Escherichia coli in frozen lamb meat from New Zealand, unauthorised substance dichlorvos in oluyin beans, peeled beans and dried beans from Nigeria, attempt to illegally import dried beans from Nigeria ,suspicion of attempt to illegally import watermelon seeds from Nigeria, formetanate in fresh peppers from Turkey, carbendazim in fresh green beans from Kenya, in waxberry from China and in fresh peppers from Turkey, clofentezine in fresh peppers from Turkey, acetamiprid and endosulfan in aubergines from the Dominican Republic, chlorpyriphos and hexaconazole in chilled green beans from Kenya, unauthorised substance morpholine in lemons from Argentina and unauthorised genetically modified (35S promotor detected) fresh papaya from Thailand.

For feed, we have a border rejection for Salmonella paratyphi b in fish meal from Peru.

For food contact materials we have an alert notification, followed by a withdrawal from the market for:

- Migration of primary aromatic amines from nylon spoons, following an official control on the market. Origin China (via United Kingdom), notified by Poland.

Border rejections for migration of manganese from cast iron grills, migration of chromium, of nickel and of manganese from stainless steel kitchen utensils and volatile organic compounds in wooden sticks for skewers and cocktail decorations from China.

Related articles

Now, Soccer Fans Can Enjoy Salted Nuts without Guilt

Salt of the Earth Going Nuts with Sodium Reduction

New market research conducted by TNS for the Israel Society of Hypertension shows that 62% of consumers who watch TV eat savory snacks, while 50% eat a variety of salted nuts. During football games like world soccer championship, sodium consumption typically increases dramatically. Salt of the Earth created a low-sodium salt designed to reduce sodium up to 60% in savory formulations using such popular ingredients as peanuts pistachio, almonds and seeds.

“Consumers prefer healthier products but won’t compromise on organoleptic properties like flavor and mouthfeel,” says Giorit Carmi, Marketing Manager of Salt of the Earth. “Eating nuts while watching sports is a core part of our culture—even more common than drinking beer. We identified this niche sports fan market as one of the premium targets for reducing sodium consumption. Zarubi Pitzuchai Hagalil, one of the leading nut companies in Israel, recently added it to their line with great success. Our next step is to introducing this low-sodium ingredient into the global market.”

The new low-sodium ingredient keeps the same salty taste in a formulation, but has much less sodium. It contains high-value potassium chloride derived from the Dead Sea, plus natural, sustainable Red Sea salt. Salt of the Earth relies on Mother Nature’s powers to produce sea salt, without chemical processing and with a minimal ecological footprint. Red Sea salt is rich in essential minerals and microelements that are vital to well-being.

This outstanding sodium-reduction ingredient is heat stable and enables a “low-sodium” label claim. It contains no artificial ingredients or preservatives, and is produced under strict inspection to ensure potency, purity and safety. Zarubi tested the ingredient in multiple lab applications using several kinds of nuts and based on these results decided to launch the low salty nuts line in Israel.

“The test results should encourage savory snack makers to develop low-sodium nut snacks,” adds Carmi. “Nuts and seeds are highly nutritious, but a key challenge is to reduce sodium without impaction salty flavor.”

EU Regulation n. 665/2014: “Mountain product”

paesino_di_montagna

This Regulation, implementation of Regulation (EU) 1151/2012 (“quality package”), establishes the conditions necessary to use the optional quality term “mountain product”.

In particular, in order to prevent consumers being misled, it refers to products of animal origin (Article 1), feed (Article 2), apiculture products (Article 3), products of plant origin (Article 4), other ingredients (Article 5) and to the processing operations that can be carried out outside of the mountain areas, but not as far as 30km from these areas (Article 6).

Article 1 - Products of animal origin

1.   The term ‘mountain product’ may be applied to products produced by animals in mountain areas as defined in Article 31(2) of Regulation (EU) No 1151/2012 and processed in such areas.

2.   The term ‘mountain product’ may be applied to products made from animals that are reared for at least the last two thirds of their life in those mountain areas, if the products are processed in such areas.

3.   By way of derogation from paragraph 2, the term ‘mountain product’ may be applied to products made from transhumant animals that have been reared for at least one quarter of their life in transhumance grazing on pastures in mountain areas.

Article 2 – Feedstuffs

1.   For the purposes of Article 31(1)(a) of Regulation (EU) No 1151/2012, feedstuffs for farm animals shall be deemed to come essentially from mountain areas if the proportion of the annual animal diet that cannot be produced in mountain areas, expressed as a percentage of dry matter, does not exceed 50 % and, in the case of ruminants, 40 %.

2.   By way of derogation from paragraph 1, as regards pigs, the proportion of feedstuffs that cannot be produced in mountain areas, expressed as a percentage of dry matter, shall not exceed 75 % of the annual animal diet.

3.   Paragraph 1 shall not apply to feedstuffs for transhumant animals referred to in Article 1(3) when reared outside mountain areas.

Article 3 – Products of beekeeping

1.   The term ‘mountain product’ may be applied to products of beekeeping if the bees have collected the nectar and the pollen only in mountain areas.

2.   By way of derogation from Article 31(1)(a) of Regulation (EU) No 1151/2012, sugar fed to bees shall not be required to come from mountain areas.

Article 4 – Products of plant origin

By way of derogation from Article 31(1)(a) of Regulation (EU) No 1151/2012, the term ‘mountain product’ may be applied to products of plant origin only if the plant is grown in mountain areas as defined in Article 31(2) of Regulation (EU) No 1151/2012.

Article 5 – Ingredients

When used in products referred to in Articles 1 and 4, the following ingredients may come from outside mountain areas, provided that they do not represent more than 50 % of the total weight of the ingredients:

(a)

products not listed in Annex I to the Treaty; and

(b)

herbs, spices and sugar.

Article 6 – Processing operations outside mountain areas

1.   By way of derogation from Article 31(1)(b) of Regulation (EU) No 1151/2012 and Article 1(1) and (2) of this Regulation, the following processing operations may take place outside mountain areas, provided that the distance from the mountain area in question does not exceed 30 km:

(a)

processing operations for the production of milk and milk products in processing facilities in place on 3 January 2013;

(b)

slaughtering of animals and cutting and deboning of carcasses;

(c)

pressing of olive oil.

2.   As regards products processed on their territory, Member States may determine that the derogation in paragraph 1, point (a) will not apply or that the processing facilities must be located within a distance, to be specified, of less than 30 km from the mountain area in question.

Entry into force and application: June 26th, 2014

New RASFF consumers’ portal and Annual Report 2013

mix-of-fresh-foods

The RASFF celebrates his 35 years launching a new service and publishing the 2013 Annual Report. Launched in June 2014, the RASFF consumers’ portal is a consumer-friendly internet tool providing latest information on food recall notices. It includes also public health warnings issued by food safety authorities and food companies. By using this free tool, EU consumers are able to identify food that has been flagged in the system allowing them to make more informed choices. By selecting any EU country, the user can view the list of recent notices provided by member countries or business operators on consumer recalls. The information can be consulted in the “Published” section of the portal. After a four week period, notifications will be removed from portal. Portal features will be further developed and improved based on users’ feedback.

What about the report? Here some key features:

  • In 2013, a total of 3.205original notifications were transmitted, of which 596 alert, 442 information for follow up, 705 information for attention and 1.462 border rejections;
  • Overall decreasing of the notifications: 4,9 %. It is the first year that we face a decreasing in the last decade;
  • Italy is the top notifying country (534). About the country of origin most issues come from China (433), India (257), Turkey (226), Brazil and Spain (187) and Poland (163).The Commission rejected 231 notifications because RASFF notifications’ criteria were not met. It is an increasing of 245% compared to 2012;
  • More info about the “horsemeat scandal” and why the Commission used the RASFF although there were doubts about the serious risk for human health;
  • Between the case study you can read more about the hepatitis A virus in frozen berry mixes from Italy, with raw material from Bulgaria, Canada, Poland and Serbia;
  • Aflatoxins notifications are consistently decreasing, food supplements from third countries are certain an emerging problem.

Protein Innovation

Infographic - The Time is Right for Protein Innovation by Innova Market Insight

High interest in protein content and high-protein lines across the food and drinks market is continuing to develop, despite the fact that most European and North American consumers already get enough protein in their diets. This will be just one of the areas addressed by Innova Market Insights at its “Taste the Trend” Pavilion (Booth #3651) at the IFT Food Expo in New Orleans, June 21-24.

According to Innova Market Insights, the protein trend is driven by increasing health concerns – primarily weight management – plus the move of sports and performance products into the mainstream and targeted at the more generally active, rather than just athletes and sportsmen. Another trend on the rise is the Paleo diet, focusing on lean protein, while avoiding processed foods and sugars.

“The time is right for protein innovation,” says Lu Ann Williams, Director of Innovation at Innova Market Insights. Williams cites a number of drivers, including the need to feed a growing global population, an alarming rise in sarcopenia (declining muscle mass, particularly among an aging population), and the economic and environmental costs of existing protein sources. “Proteins have diverse application potential, with opportunities for alternative vegetarian options, and new protein sources – such as microalgae – alongside existing and novel dairy-based and vegetable sources, such as soy, beans and grains,” she adds.

Innova Market Insights data indicate that nearly 3% of global food and beverage launches in the 12 months ending 31 March, 2014, were marketed on a “high-protein” or “source-of-protein” positioning, rising to 6% in the US.

Demand for whey protein specifically is soaring as a result of growing demand in certain Asian markets, as well as its rising popularity as a natural, healthy ingredient, particularly in sports, medical and infant nutrition, and in weight management. While vegetables lead the list for the number of published protein patents in food and drinks, whey has risen from eighth position in 2012 to third position in 2013. At the same time, the number of nut and seed protein patents has also risen sharply, from single figures in 2012 to more than 200 in 2013. Even more exciting has been the strong activity in patent actions relating to algae-derived proteins.

 

Food recalls in EU- Week 24 – 2014

blue_water_splash_isolated_on_black_background_1345660883

This week on the RASFF database (Rapid Alert System for Food and Feed) we have one recall from consumers in EU in the alert notifications:

- Foreign bodies: black particles in spring still natural mineral water, following a consumer complaint. Origin United Kingdom, notified by United Kingdom. Distributed also to Ireland.

Between the information for attention notification, followed by a recall from consumers:

Chemical contamination: aromatic hydrocarbons in food supplement, following an official control in non-member country. Origin Russia, notified by Germany.

Between the alert notifications, followed by a withdrawal from the market of the product, we find:

Foreign bodies: plastic fragments in organic aioli sauce, following a consumer complaint. Origin Netherlands, notified by Germany, distributed also to Belgium and Portugal;

Heavy metals: arsenic in dried mushrooms, following an official control on the market. Origin Lithuania, notified by Poland;

Mycotoxins: aflatoxins in raw milk and mozzarella cheese, following an official control on the market. Origin Italy, notified by Italy, distributed also to Austria, Czech Republic, Greece, Netherlands, Portugal, Slovenia, Sweden, Switzerland and United Kingdom;

Pathogenic micro organisms: Salmonella Ball in black pepper, following an official control on the market. Origin Hungary, notified by Slovakia;

Pesticide residues: ethephon in pineapple, following company’s own check. Origin South Africa, notified by Netherlands, distributed also to Germany.

Amongst border rejections we have Norovirus (Group II) in frozen clams (Veneridae) and doxycycline unauthorised in frozen whiteleg shrimp from Vietnam, undeclared egg in frozen surimi sticks from China, unauthorised novel food GTF chromium yeast from the United States, damaged packaging of and absence of health mark on chilled yellowfin tuna from Grenada, chlorpyriphos in asparagus beans from the Dominican Republic, formetanate in fresh pepper from Turkey, unauthorised substance dichlorvos in dried beans from Nigeria, unauthorised substance chlorate in organic apples from Argentina, shigatoxin-producing Escherichia coli in frozen lamb meat, hind shanks and legs from New Zealand, E 385 – calcium disodium ethylene diamine tetra acetate (CDEDTA) unauthorised in fruity flavour soft drinks from the United States, aflatoxins in organic groundnuts in shell from Egypt and in Brazil nuts from Bolivia, absence of health certificate(s) and missing import declaration for melon seeds from Nigeria, Salmonella Spp. in sesame seeds from Senegal and in frozen poultry  meat preparations from Brazil and Thailandia.

For feed, we have an alert notification, followed by a withdrawal from the market:

Biotoxins: meadow saffron in hay, following company’s own check. Origin Germany, notified by Netherlands.

For food contact materials we have border rejections for too high level of overall migration from knives from China.

Related articles

EU updates list of imports of plant origin subject to reinforced border checks

Chinese_Broccoli_with_Oyster_sauce

Controls performed at European Union borders on the basis of Regulation (EC) No 669/2009 continue to deliver results and, as a consequence, the EU is removing some products from the list of feed and food of non-animal origin that are subject to an increased level of official controls by national competent authorities at the border. As a result of the satisfactory results reported by Member States, curry from India will be de-listed from the Regulation’s Annex I. This commodity will therefore no longer be subject to the reinforced scheme (the checks performed by competent authorities will again be ‘routine’ ones).

Concerning new listings, the following commodities will be added to the list of feed and food which are subject to reinforced border checks: table grapes (food) from Peru at a control frequency of physical and identity checks of 10% for the possible occurrence of pesticide residues and dried apricots (food) from Turkey at a control frequency of 10% for the possible presence of high levels of sulphites or of undeclared sulphites. Moreover, the control frequency for Brassica oleracea originating from China (‘Chinese broccoli’) will be increased from 20% to 50% in light of the high degree of non-compliance with the relevant Union legislation detected in the course of the controls carried out by the Member States on this commodity.

The Regulation will be amended by extending the transitional period referred to in its Article 19 for an additional term of five years, so as to allow the smooth entry into force of any new requirement that might result from the ongoing review of the provisions applicable to designated points of entry and to border controls in general.

At the meeting of the Standing Committee on the Food Chain and Animal Health on 6 June 2014, Member States endorsed the Commission’s proposal to amend the Annex to the Regulation by reflecting the abovementioned changes.

The amendments are expected to enter into force as of 1 July 2014.

(Source: DG Sanco)

Food recalls in EU – Week 23 – 2014

Bamboo

This week on the RASFF database (Rapid Alert System for Food and Feed) we have two recalls from consumers in EU in the information for attention notifications:

Foreign bodies: glass fragments in sliced bamboo, following company’s own check. Origin China, notified by Germany;

Heavy metals: cadmium in frozen whole squids, following a border control. Origin Argentina, notified by France.

Between the alert notifications, followed by a withdrawal from the market of the product, we find:

Heavy metals: mercury in food supplement, following an official control on the market. Origin Netherlands, notified by Sweden;

Food additives and flavorings: undeclared sulphitesin organic dried dates, following an official control on the market. Origin Tunisia (via Germany), notified by Poland; 

Pathogenic micro organisms: Listeria Monocytogenes in chilled smoked salmon, following an official control on the market. Origin Denmark, notified by Denmark.

Amongst border rejections we have Bacillus cereus in red beancurd sauce from China, Salmonella spp. in frozen poultry preparation from Brazil and in paan leaves from India, aflatoxins in groundnuts and peanuts from India, in corn from Argentina and in groundnuts kernels without shell from India, shigatoxin-producing Escherichia coli in frozen sheep meat and lamb meat from New Zealand, high content of aluminium in noodles from China (via Hong Kong), absence of certified analytical report and of Common Entry Document (CED) for melon seeds from Nigeria and for paan leaves from India, quinalphos in peppers from Sri Lanka and clofentezine in peppers and fresh peppers from Turkey, methoxyfenozide in grape leaves in brine from Turkey, unauthorised substance dichlorvos in oloyin beans from Nigeria, carbendazim in parboiled basmati rice from Pakistan, buprofezin and imidacloprid in oolong tea from China, chlorpyriphos, buprofezin, acetamiprid and imidacloprid in green tea from China, poor temperature control – rupture of the cold chain – of frozen pandalid shrimps and frozen sardins from Morocco, of frozen tuna from New Zealand and of frozen skipjack Tuna from Cape Verde, damaged packaging of chilled greater amberjack from Tunisia, mercury in chilled sea beam from Egypt, parasitic infestation with Anisakis of silver scabbardfish from Morocco.

For feed, we have an alert notification, followed by a withdrawal from the market:

Pathogenic micro-organisms: Salmonella in larynx of horse, following an official control on the market. Origin Poland, notified by Sweden.

For food contact materials we have border rejections for migration of lead from enamel trays and migration of formaldehyde from melamine bowl soccer 2014 from China.

Related articles

EU and US taskforce progress in fighting antimicrobial resistance

Listeria

EU and US progress in the fight against antimicrobial resistance

The European Commission (EC) and the US Department of Health and Human Services (HHS) publish a progress report on the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR). The report outlines the advances made during the first TATFAR implementation period of 2011 to 2013, and renews the commitment of US and EU health authorities to pursue specific goals in their joint battle against antimicrobial resistance (AMR). Notable outcomes of TATFAR activities for the reporting period include:

  • Adoption of procedures for timely international communication of critical events that might indicate new resistance trends with global public health implications
  • Publication of a report on the 2011 workshop, “Challenges and solutions in the development of new diagnostic tests to combat antimicrobial resistance”on the TATFAR website
  • Joint presentations to the scientific community to increase awareness on the available funding opportunities on both sides of the Atlantic

Why a Transatlantic Taskforce?

Antimicrobial resistance is increasingly recognised as serious cross-border health threat of global dimension which requires a multi-sectorial and global response. Studies estimate that antimicrobial-resistant infections result in at least 25 000 deaths in 29 countries in Europe and 23 000 deaths in the US every year. In addition, antimicrobial resistance costs the EU and the US billions every year in avoidable healthcare costs and productivity losses.

With these factors in mind, TATFAR was created following the 2009 US–EU Presidential Summit. The taskforce aims to improve collaboration between the EU and US in three key areas:1) appropriate therapeutic use of antimicrobial drugs in medical and veterinary communities, 2) prevention of healthcare and community-associated drug-resistant infections, and 3) strategies for improving the pipeline of new antimicrobial drugs.

Although significant progress in reducing specific types of infections has been made in the EU and the US, the global problem of AMR continues to grow. Therefore, the original mandate of the taskforce that ran through 2013 has recently been extended for at least two additional years.

What’s next?

TATFAR originally identified and adopted 17 recommendations for collaboration between the EU and the US, where common actions can deliver the best results in the prevention and control of AMR. Of these, 15 will continue, along with one new recommendation, for the EU and US partner agencies to focus on moving forward.

Forthcoming publications from the taskforce during 2014 that will provide a foundation for further specific joint collaborative actions include:

  • A report summarising the strategies hospitals in the EU and US should include as part of their programs to improve antimicrobial prescribing practices
  • A joint publication summarising the existing methods for measuring antimicrobial use in hospital settings
  • A joint publication describing the need for new vaccines for healthcare-associated infections (HAIs)
  • A joint publication comparing the results of the EU and US point prevalence surveys, which are used to estimate the burden of HAIs in each population.

For more information on the fight against AMR in the EU:

http://ec.europa.eu/health/antimicrobial_resistance/policy/index_en.htm

http://ec.europa.eu/food/food/biosafety/antimicrobial_resistance/index_en.htm

(Source: DG Sanco Website)

Food recalls in EU – Week 22 -2014

fresh rucola

This week on the RASFF database (Rapid Alert System for Food and Feed) we have on recall from consumers in EU in the information for attention notifications:

Pathogenic micro-organisms: Listeria Monocytogenes in fresh rucola, following company’s own check. Origin Norway with raw materials from Germany (via Denmark), notified by Norway.

Between the alert notifications, followed by a withdrawal from the market of the product, we find:

Biotoxins: Diarrhoeic Shellfish Poisoning (DSP) toxins in mussels, following an official control on the market. Origin Greece, notified by Greece, distributed also to Italy;

Biotoxins: Diarrhoeic Shellfish Poisoning (DSP) toxins – okadaic acid in frozen mussels, following an official control on the market. Origin Spain, notified by France;

Allergens: undeclared milk ingredient in cake with lemon creme, following an official control on the market. Origin Spain, notified by Slovenia;

Allergens: undeclared gluten in rice and corn snack with cheddar flavour, following an official control on the market. Origin Czech Republic, notified by Czech Republic, distributed also to Hungary and Slovakia;

Pathogenic micro-organisms: Listeria Monocytogenes in smoked salmon, following an official control on the market. Origin Poland, notified by Italy;

Industrial contaminants: benzo(a)pyrene and polycyclic aromatic hydrocarbons in smoked haring in vegetable oil, following an official control on the market. Origin Latvia, notified by Hungary.

We have also a seizure, following an information for follow up notification, of food supplements from United States, because of the presence of unauthorised novel food ingredient Synsepalum dulcificum. Notified by Denmark, distributed also to Austria, Czech Republic, Finland, France, Germany, Hungary, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden and United Kingdom.

Amongst border rejections we have Salmonella Spp. in turkey meat preparations from Brazil, shigatoxin-producing Escherichia coli in frozen lamb from New Zealand, aflatoxins  in pistachio nuts with shell and in pistachio kernels from Iran, in groundnuts from China, in blanched groundnuts and groundnuts kernels from Brazil, in boiled dried figs from Turkey and in whole chilli peppers from India. Carbendazim  in fresh peppers from Turkey, dried sultanas from Iran infested with insects (cockroaches and spiders), benzo(a)pyrene and polycyclic aromatic hydrocarbons in smoked sardinellas from Ghana, mercury in chilled sea bream from Egypt, cadmium in frozen pacific saury from Taiwan, in frozen squids from Argentina and in frozen whole cooked mussels from Chile. Too high content of colour E 110 – Sunset Yellow FCF in dehydrated pineapple core from Thailand, unauthorised use of colour E 102 – tartrazine in noodles from Malaysia, E 521 – aluminium sodium sulphate unauthorised in frozen prefried breaded prawns from Vietnam, residue levels above MRL for ciprofloxacin and for oxytetracycline in frozen peeled raw shrimps from Vietnam, unauthorised novel food ingredient clinoptilolite and unauthorised substances yohimbine, synephrine, 1,3 dimethylamylamine (DMAA) and methylsynephrine in food supplements from the United States.

For feed, we have an alert notification, followed by a withdrawal from the market:

Pathogenic micro-organisms: Salmonella Blockley in dog chews, following an official control on the market. Origin Poland, notified by Sweden.

For food contact materials we have an alert notification, followed by a withdrawal from the market:

Migration: inner coating peeling off  from baking moulds, following an official control on the market. Origin Germany, notified by Germany, distributed also to Austria, France and United Kingdom.

We have also border rejections for migration of chromium from stainless steel kettle for boiling milk from China, via Hong Kong, and from inox knives from China.

Related articles

Written QA to EU Commission – China’s dubious food imports

Rice_p1160004

Question for written answer
to the Commission 
Rule 117
Andreas Mölzer (NI) (20th March 2014)

Subject:  Dubious food imports from China

Since food from China is often considerably lower priced than domestic food, imports from the Middle Kingdom have been steadily increasing in the past few years. However, this is problematic because certain pesticides are allowed in Chinese agriculture that are forbidden in the Member States. According to a newspaper report, increasing quantities of fish, apples, strawberries and jam in particular are from China.

It seems that China is way ahead in terms of statistics for food that has attracted attention on arrival in the EU. In 2013 an EU food authority is said to have reported Chinese imports to the EU-wide Rapid Alert System no fewer than 435 times. Tests show the presence of genetically-modified ingredients, pesticides and even heavy metals.

1. How high is China’s share of food products imported into the EU?

2. What consequences can be drawn for inspections of food imports from countries that are reported so many times in the EU-wide Rapid Alert System?

Answer given by Mr Borg on behalf of the Commission (13th May 2014)

1. China is the fourth commercial partner of the EU as regards the total trade in agricultural and fishery products and accounted for 4.85% of the imports into the EU of these products in 2012.

2. As part of the comprehensive body of legislation in place to ensure that food imported into the Union complies with EU safety requirements, the Commission established in 2010 a list of food and feed of non-animal origin which on the basis of known or emerging risk require an increased level of controls prior to their introduction into the EU. The list appears in Annex I to Regulation (EC) 669/2009 and is regularly reviewed on the basis of information sources which include data resulting from notifications received through the Rapid Alert System for Food and Feed. At present the list features, amongst others, frozen strawberries, ‘Chinese Broccoli’, pomelos and tea originating from China.

When required, more stringent import conditions such as the compulsory presentation of results of sampling and analysis and of a health certificate verified by authorised representatives of the country of origin are adopted. This regime is at present applicable to a number of commodities including groundnuts originating from China due to the possible contamination with aflatoxins and rice products originating from China due to the possible presence of unauthorised genetically modified rice. Special conditions such as the suspension of imports of the food or feed in question can also be imposed if needed.

(Source: European Parliament)

The sweeter the better? EU and US approve advantame use as food additive

sweetener

The following is my first article on LinkedIn as publisher, a special account released by the platform to influencers and valuable bloggers in their respective sector. Here you can find the article on LinkedIn.

Now you can follow me also on LinkedIn to share our thoughts about food safety and regulations on a broader platform. I hope this will give our blog a greater audience!


On 19th May 2014 the United States Food and Drug Administration (FDA) announced the safety of use of the additive advantame in food, with the exception of meat and poultry. The FDA final rule will be effective from 21st May 2014.

Food additives in USA are subjected to premarket review and approval by FDA – like in this case – or have to demonstrate their safety through the so called “GRAS” procedure. “GRAS” is an acronym for the phrase Generally Recognized ASafe and means that if a food additive has been adequately shown to be safe under the conditions of its intended use, there is no need of the premarket approval by FDA.

FDA evaluated data from 37 animal and human studies and did not identify possible toxic effects, such as reproductive, neurological, and cancer-causing effects. Therefore, advantame has been approved for use as a general-purpose sweetener and flavor enhancer and can be used in baked goods, non-alcoholic beverages (including soft drinks), chewing gum, confections and frostings, frozen desserts, gelatins and puddings, jams and jellies, processed fruits and fruit juices, toppings, and syrups.

In the meantime, the European Union was evaluating the approval of the substance as well.

On 31st July 2013 the European Food Safety Authority (EFSA) released a Scientific Opinion on the safety of advantame as food additive. EFSA’s findings were very similar to FDA evaluation and the Authority concluded for the safety of use of the substance.

Anyway, the evaluating Panel noted that there is an indication of advantame instability in acidic beverages and thermally treated foods, and also that there are critical effects observed in animal studies, especially about maternal toxicity (gastrointestinal disturbances) in the prenatal developmental toxicity study in rabbits.

For that reason the Panel established a precautionary ADI (adequate daily intake) of 5 mg/kg bodyweight/day, assessing that conservative estimate of advantame exposure for high level adults and children consumers were below the ADI for the proposed use levels.

On 15th May 2014 was published on the Official Journal of the European Union the new EU Regulation n. 497/2014, which authorize from 4th June 2014 the use of advantame in several categories of food, such as flavoured fermented milk products, confectionery, cocoa and chocolate products, fruit and vegetable preparations excluding compote, jam, jellies, sweetened chestnut puree, chewing gum, breakfast cereals, bakery products, flavoured drinks, fruit nectars, soups, sauces, dietary foods and food supplements. Advantame will be classified and indicated on labels as E 969.

In 2013, the sweetener was evaluated also by JECFA (Joint FAO/WHO Expert Committee on Food Additives) which issued the same conclusion again: advantame is safe for the intended use. The Committee proposed an acceptable daily intake (ADI) of 0–5 mg/kg body weight (bw) and agreed that the ADI also applies to those individuals with phenylketonuria, as the formation of phenylalanine from the normal use of advantame would not be significant in relation to this condition.

Advantame is an high-intensity sweetener, offering consumers and the food industry the option to choose from a wider selection of sweeteners, thus reducing the intake of each individual sweetener.

Food recalls in EU – Week 21 – 2014

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This week on the RASFF database (Rapid Alert System for Food and Feed) we have two recalls from consumers in EU in the information for follow up and border rejection notifications:

- Foreign bodies: metal fragments in grill meat, following company’s own check. Origin Austria, distributed also to Germany. Information for follow up;

- Residues of veterinary medicinal products: residue level above MRL for oxytetracycline in frozen shrimps, following a border control. Origin Vietnam, notified by Germany.  Border rejection.

Between the alert notifications, followed by a withdrawal from the market of the product, we find:

- Allergens: undeclared soya in canned beans with spicy sausage, following an official control on the market. Origin Hungary, notified by Slovakia;

Heavy metals: arsenic and mercury in frozen shark steak, following an official control on the market. Origin Suriname, notified by Netherlands, distributed also to Germany and Norway;

Pathogenic micro-organisms: Salmonella Spp. in poultry sausage (chipolata), following company’s own check. Origin France, notified by France, distributed also to Germany;

 - Heavy metals: mercury in frozen slices of blue shark, following an official control on the market. Origin Spain, notified by Italy.

Amongst border rejections we have Salmonella spp. in frozen spiced turkey breasts and frozen poultry meat preparations from Brazil and in paan leaves from Bangladesh, shigatoxin-producing Escherichia coli in frozen lamb meat, lamb chops and mutton legs from New Zealand, norovirus in frozen cooked whole white clams from Vietnam, aflatoxins in pistachio nuts without shell from Turkey, in peanuts kernels from the United States, in blanched groundnut kernels from China and in blanched peanut halves from Argentina. Undeclared colour E 102 – tartrazine and unauthorised use of colour E 127 – erythrosine in fruit juices from the Philippines, unauthorised irradiation of Cassia nomame extract from China, unauthorised substance yohimbine, synephrine, 1,3 dimethylamylamine (DMAA) and methylsynephrine in food supplements from the United States, prohibited substance nitrofuran (metabolite) furazolidone (AOZ) in frozen raw peeled prawns from India, unauthorised novel food ingredient zeolite in zeolite from the United States, rodent excrements in various food products and attempt to illegally import paan leaves from Bangladesh, missing import declaration for pomelos from China, poor temperature control of frozen mullet roe from Mauritania and of frozen hake from Namibia, omethoate  in beans with pod from Cambodia and formetanate in fresh peppers from Turkey.

For feed, we don’t have any relevant notification this week.

For food contact materials we have an information for attention notification, followed by a recall from consumers:

- Migration of primary aromatic amines and too high level of overall migration from plastic ladles, following an official control on the market. Origin China, notified by Cyprus.

Related articles

Q&A to EU Commission – Seafood labelling frauds

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Question for written answer
to the Commission 
Rule 117
Gilles Pargneaux (S&D) (17 th March 2014)

Traceability in the fish industry in France has been tested by the BLOOM and Oceana organisations, by researchers from Inserm (the National Institute of Health and Medical Research) and the National Natural History Museum and by Terra Ecomagazine.

These organisations joined forces in France to conduct a unique investigation into labelling fraud in relation to fish. Over the course of a year, ten regions were sampled and nearly 400 samples were collected from the refrigerated aisles of supermarkets, fishmongers, restaurants, ready meals and frozen foods.

The study showed that species substitution remains rare in France, with fraud at a level of 3.5%.

The results of this inquiry can be compared to similar studies carried out in various European Union countries.

In some countries, the level of labelling fraud is very high: 32% fraud in Italy, 30% of hake alone in Spain, 19% of cod in Ireland.

Can the Commission state whether it will soon draw up a European strategy to combat labelling fraud in the seafood sector?

 

Answer given by Mr Borg on behalf of the Commission (20th May 2014)

The Commission is aware of the study mentioned by the Honourable Member. More generally it closely monitors the works undertaken within or outside the EU aiming to assess the magnitude of fish species substitution.

The available results lead to conclude that discrepancies between the real species and the information conveyed to the consumer occur to different extents according to the species, the countries and the place of the food chain. However they are sometimes detected in significant proportion.

Following the horse meat scandal the Commission has decided to undertake actions to strengthen the ability of the EU control system as a whole to detect and counter food fraud. A key objective is to improve the capabilities of the Member States which are responsible for carrying controls to verify that food products placed on the market comply with the relevant national and EU rules. It is also considered critical to facilitate administrative assistance and cooperation among national enforcers in the case of cross border violations.

In the particular case of mislabelling of fish species, the Commission is currently investigating the detection methods available in the context of official controls before deciding for any further action, for instance in the form of coordinated control plans in accordance with Article 53 of Regulation (EC) No 882/2004.

(Source: European Parliament)

Salt of the Earth Goes Hi-Tech for Packaging

Salt of the Earth Puts €1 Million into Packaging Makeover

Salt of the Earth introduced a new, sophisticated automatic packaging production line to improve quality and expand packaging options. The total investment is €1 million.

The high-tech automatic packaging system is designed for tablets and granular salt products. Using rolls instead of traditional premade polyethylene (PE) bags, the new system enables the expansion of product range to 10kg and 25kg packaging, while significantly improving packaging quality of the company’s products.

Salt of the Earth’s decision to improve production and customer options with an automated packaging system was motivated by its sustainability strategy and continued efforts to stay on the cutting edge of food industry trends.

“This new packaging system is another step toward expanding on our sustainable strategy,” explains Dovik Tal, CEO of Salt of the Earth. “We continue to actively seek ways to reduce energy consumption and resources and, above all, improve product quality—all of which have a direct effect on operating costs. The new system complies with the highest standards of quality and safety.”

The new packaging line, specifically designed to meet the company’s requirements, is fully automated and incorporates a large storage tank, dual packing machine and conveyors that were custom-adjusted to the former packaging lines. This allowed re-use of suitable existing equipment and incorporation of an automatic palletizer robot.

“The majority of malfunction risks in our former production line will now be resolved,” says Ofer Rokni, Managing Director of Salt of the Earth. “Manual soldering is no longer required in the packaging process, and the packaging is of higher quality. Also, raw material is applied accurately via a special weighting system, leading to decreased waste. Post-production, stacking on palettes is also fully automated to provide employees a safer, healthier working environment.”

Production packing capacity is expected to increase from 60 tons across three daily shipments to just one shipment per day. The transition from PE premade bags for packing to rolled packaging materials, is expected to yield annual investment savings to the company.

 

Organic Production – FVO audit in Greece

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The Food and Veterinary Office (FVO) carried out n an audit in Greece from 11 to 22 November 2013, in order to evaluate the control systems in place for organic production and labelling of organic products, in particular, the implementation of the requirements as set out in Regulation (EC) No 834/2007.

A comprehensive control system is in place covering all stages of production, preparation and distribution of organic products. Effective and efficient controls take place at operators covering all relevant aspects, including a systematically performed mass-balance at all types of operators for the entire period between inspections. Adequate communication, co-ordination and co-operation within and between Competent Authorities, Control Bodies and operators takes place allowing for the exchange of information as necessary and for appropriate action to be taken in cases of identified non-compliances. Sanctions and fines imposed are effective, proportionate and dissuasive. The system provides, in general, sufficient guarantees that EU rules for organic production are complied with.

Some shortcomings were identified with regard to checks of cleaning records at processors with parallel production, sampling for pesticide residues and random inspections at operators.

The report makes a number of recommendations to the Greek authorities, aimed at rectifying the shortcomings identified and enhancing the implementing and control measures in place. The most interesting recommendations is the following:

“Ensure that random inspections at operators are unannounced as required by Article 3(2) of Regulation (EC) No 882/2004 and Article 65(4) of Commission Regulation (EC) No 889/2008.”

That should by quite obvious principle but in my experience also in othe MS (Italy included) too often the inspections, especially from the control bodies in the organic sector, are known in advance by the FBO.

Food recalls in EU – Week 20 – 2014

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This week on the RASFF database (Rapid Alert System for Food and Feed) we have four recalls from consumers in EU in the alert notification:

Heavy metals: mercury in frozen sliced swordfish, following an official control on the market. Origin Spain, notified by Italy;

Heavy metals: mercury in frozen swordfish fillets, following an official control on the market. Origin Portugal, notified by Italy;

Composition: risk of overdosage with nicotinic acid from food supplement, following an official control on the market. Origin United Kingdom (via Netherlands), notified by France;

Foreign bodies: glass fragments in pitted green olives, following a consumer complaint. Origin Spain, notified by United Kingdom.

Between the information for attention and the information for follow-up, we find two recalls from consumers:

Composition: unauthorised substance magnesium aspartate in food supplement, following an official control on the market. Origin Sweden, notified by Finland;

- Pathogenic micro-organism: Salmonella Spp. in sausages, following a food poisoning. Origin Spain, notified by France.

Between the alert notifications, followed by a withdrawal from the market of the product, we find:

Allergens: undeclared soya in spicy pate, following an official control on the market. Origin Poland, notified by Slovakia;

Composition: high content of morphine in blue poppy seeds, following an official control in non-member country. Origin France (packaged in Slovakia, via Czech Republic), notified by Czech Republic;

Heavy metals: cadmium in murex sea snails, following an official control on the market. Origin Italy, notified by Italy, distributed also to Hungary;

Heavy metals: mercury in frozen swordfish, following an official control on the market. Origin Portugal, notified by Spain;

Pathogenic micro-organisms: foodborne outbreak suspected to be caused by cherry tomatoes, following a food poisoning. Origin Morocco (via France), notified by France, distributed also to Czech Republic, Germany, Italy, Slovakia and United Kingdom;

Pathogenic micro-organisms: shigatoxin-producing Escherichia coli in frozen minced meat, following company’s own check. Origin Italy, notified by France.

Regarding border rejections we have, first of all, an recall from consumers for:

Pesticides residues: carbendazim in parboiled basmati rice, following a border control. Origin India, notified by Italy;

Among the others, we have moreover,  aflatoxins in shelled almonds from the United States, groundnuts from China, in pistachio kernels from Syria, via Turkey, in groundnuts in shell from Egypt and in groundnut kernels from India, absence of certified analytical report for fig jam from Turkey, attempt to illegally import shelled groundnuts from Ghana and paan/betel leaves from Bangladesh, dead insects (maggots) in and poor hygienic state of brown and red beans from Nigeria, procymidone in yardlong beans from Thailand, carbendazim in parboiled basmati rice from India, cadmium in frozen cooked mussels from Chile, norovirus in chilled clams from Tunisia, too high content of sulphite in dried fruit (kiwi slices) from China, prohibited substance nitrofuran (metabolite) furazolidone (AOZ) in frozen shrimps from India, residue level above MRL for tetracycline  in frozen shrimps from Vietnam, poor temperature control of frozen tuna from the Seychelles, undeclared egg in frozen crab sticks and lobster tails (surimi) and in frozen surimi preparations from China.

For feed, we don’t have any relevant notification this week.

For food contact materials we have an information for attention notification, followed by a recall from consumers:

Migration of formaldehyde and too high level of overall migration in melamine ware, following an official control on the market. Origin China, notified by Cyprus.

Related articles

Fisheries: European Commission proposes full ban on driftnets

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The European Commission wants to prohibit the use of any kind of driftnets for fishing in all EU waters as of 1 January 2015.

Although rules are already in place to forbid using driftnets to catch certain migratory fishes, the practice continues to be a cause of concern due to the incidental catching of marine mammals, sea turtles and sea birds which are mostly protected under EU legislation. To fight circumvention, the Commission proposal includes a full ban of driftnets fishing in the EU as well as the prohibition of keeping driftnets on board of fishing vessels. Furthermore, to avoid ambiguity, the proposal refines the current definition of a driftnet.

European Commissioner for Maritime Affairs and Fisheries, Maria Damanaki, said: “Fishing with driftnets destroys marine habitats, endangers marine wildlife and threatens sustainable fisheries. I am convinced that the only way to eradicate this once and for all is to have clear rules which leave no room for interpretation. We need to close any possible loopholes and simplify control and enforcement by national authorities. This will in the end also save the livelihood of those fishermen which have applied the rules over the past years. The ban sends out a clear message that we no longer tolerate any irresponsible practices.” 

Driftnets are fishing nets that can drift and operate close to or at the sea surface to target fish species that swim in the upper part of the water column. Since 2002 all driftnets, no matter their size, have been prohibited in EU waters when intended for the capture of highly migratory species such as tuna and swordfish.

However, the current EU legislative framework has shown weaknesses and loopholes. The small-scale nature of the fishing vessels involved and the fact that they do not operate together in the same areas has made it easier to escape monitoring, control and proper enforcement.

Illegal driftnet activities carried out by EU fishing vessels continue to be reported and have been cause of criticism regarding the Union compliance with applicable international obligations.

Banning driftnets responds to the new Common Fisheries Policy’s goal to minimise the impact of fishing activities on the marine ecosystems and to reduce unwanted catches as much as possible. Depending on Member States’ priorities, the European Maritime
Fisheries Fund (EMFF) could be used to support the transition towards a total ban provided that specific conditions are fulfilled.

Background

Following specific United Nations General Assembly (UNGA) Resolutions, which called for a moratorium on the “large-scale pelagic driftnets” (i.e. longer than 2.5 km), the EU developed in the 1990s a series of provisions to implement such a ban for large-scale
driftnets.

The current EU legal framework on driftnets fishing entered fully into force on 1 January 2002. It bans the use of all driftnets, no matter their size, in EU waters when intended for the capture of highly migratory species such as tuna and swordfish.
In the Baltic Sea, the use of driftnets and the keeping on board of any kind of driftnets has been fully banned since 1 January 2008
Despite this entire regulatory framework in place, the rules have not been fully respected.

In April 2013, the Commission therefore published a Roadmap concerning a review of the EU regime on driftnet fisheries and launched two studies1, as well as a public consultation (closed in September 2013) on small-scale driftnet fisheries in order to get an overview of the sector, to assess the impact of driftnets on prohibited and protected species and to decide whether and how to review the implementation of EU rules on the small-scale driftnet fisheries.

Here is the link to the legislative proposal: COM 2014:265

Roadmap (April 2013)

(Source: DG Mare)

Evaporated Cane Juice – Figy v. Lifeway Foods – Arnie Friede comments

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Today we have the pleasure to have a distinguished guest contributor on Foodlawlatest.com: Arnold L. Friede, Of Counsel and Senior Food and Drug Law Attorney with c, P.A.. Prior to joining ST&R, Mr. Friede ran his own law firm specializing in FDA-related legal and regulatory matters. Earlier in his career he served as associate chief counsel in the FDA’s Chief Counsel’s Office, representing the agency in a wide array of significant judicial and administrative proceedings while also serving as counsel to the then-Bureau of Radiological Health, now part of FDA’s Center for Devices and Radiological Health. He has held a number of senior in-house legal positions with major corporations in FDA-regulated industries and has served as adjunct professor of food and drug law at the University of Miami (FL) School of Law.

Arnie offers us today his comments about the following judicial case, Figy v. Lifeway Foods, Case No. 13-CV-04828-THE (May 5, 2014) in the Northern District of California. 

Plaintiff brings this suit on behalf of himself and a putative class of consumers who, within the last four years, purchased certain of Defendant’s food products that he contends Defendant misbranded by deceptively referring to the added sugar contained in each product as “evaporated cane juice” (“ECJ”). 

The focal point of the opinion is whether the primary jurisdiction doctrine is applicable or not in similar situations. The primary jurisdiction doctrine basically allows courts to stay proceedings or to dismiss a complaint without prejudice pending the resolution of an issue within the special competence of an administrative agency.

* * * * *

Courts continue to be divided on whether lawsuits challenging use of the term “evaporated cane juice” in food labeling should be stayed or dismissed under the Doctrine of Primary Jurisdiction in light of FDA’s March 2014 Notice announcing that the agency is now reopening the comment period on its 2009 Draft Guidance on the subject.  In that Draft Guidance, FDA concluded that ECJ was not an appropriate common or usual name of any type of sweetener, including those derived from dried cane syrup.

As I’ve previously observed, FDA’s March 2014 Notice announcing that it was reopening the 2009 Draft ECJ Guidance for additional comment was undoubtedly issued, in large part, in response to food industry pressure to do so.  No matter what one’s view of the underlying the merits of the ECJ controversy, it seems reasonably clear that industry believed that if FDA were to reopen the Draft ECJ Guidance for comment, courts would more readily conclude that the agency had not yet spoken with finality on the matter.  As a result, courts would be more willing to apply the Primary Jurisdiction Doctrine to stay or dismiss these ECJ cases until FDA finalizes its views on the subject.   As a practical matter, then, the thought must have been that these ECJ cases would simply disappear.  And that’s pretty much what Judge Henderson did in this case, at least for a while.

In what might accurately be characterized by some as wishful thinking, the Court held that, because the comment period on the March 2014 FDA Notice expires in early May, and because FDA is actively considering the matter and may well resolve it soon,  it is appropriate to stay the case on Primary Jurisdiction Grounds until the agency acts.   It is not entirely apparent how Judge Henderson squared his conclusion that FDA’s active current consideration of the matter suggests that a decision is forthcoming soon when FDA had not issued a final guidance on ECJ labeling in the 5 years since the Draft Guidance was announced.   The Judge did set a status conference for November 3 to determine if the case should remain stayed in light of intervening action—or, possibly, inaction–by FDA.  Decisions in other recent ECJ cases come out on opposite sides of the Primary Jurisdiction Question.  It seems reasonable to believe that the U.S. Court of Appeals for the Ninth Circuit will soon be asked to decide whether, given where FDA stands on the matter, the Doctrine of Primary Jurisdiciton is properly invoked to stay or dismiss these ECJ case.

One point not addressed by the Court has to do with the actual finality of FDA Draft Guidances.  Even though called Draft, and even though they contain limiting language suggesting that they are not currently operative, are they really “draft” in terms of FDA’s compliance policy in the interim?  Or, are Draft Guidances effectively “final” until modified by FDA in the actual Final Guidance?  Many FDA Draft Guidances remain in place for years before they are finalized.   The status of Draft FDA Guidances is itself a controversial topic.  As one prominent food and drug law blog noted today, the U.S. Senate Health Education and Labor Committee sent a letter to FDA Commissioner Margaret Hamburg earlier this week asking about the agency’s policy on use of Draft Guidances as authoritative and effectively final in their own right.   So the foundation for Judge Henderson’s conclusion, that FDA’s Draft Guidance on ECJ is just a draft, is open to debate.  It is a point that will undoubtedly be raised when the Primary Jurisdiction question in these ECJ cases is before the Ninth Circuit.

Arnie Friede

Arnold I. Friede
Of Counsel, Senior Food and Drug Law Attorney

Sandler, Travis & Rosenberg, P.A.
1000 NW 57th Court, Suite 600 Miami, FL 33126
T: (305) 894-1033 C: (917) 514-9166 

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