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:
Here you can find the preliminary opinion:
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:
(Source: DG Sanco)
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.
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!
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)
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.”
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:
products not listed in Annex I to the Treaty; and
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:
processing operations for the production of milk and milk products in processing facilities in place on 3 January 2013;
slaughtering of animals and cutting and deboning of carcasses;
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
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.
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.
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.
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:
(Source: DG Sanco Website)
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.
Question for written answer
to the Commission
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 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.
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.
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.
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
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)
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.
Arnold I. Friede
Of Counsel, Senior Food and Drug Law Attorney