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I wanted to pass on some key points from this lecture to give you an idea of how hugely beneficial and important probiotics are in shaping who we are, how we respond to the world, and how our health is affected by these billions of tiny bacterias residing in the gut.
They form a protective layer within the intestinal lining to block harmful bacteria from forming. They act as the gatekeepers at the tight junctions within the intestines (along with zonulin), preventing toxins and waste products from passing through into the bloodstream.
As unusual as it may sound, healthy intestinal bacteria are also linked to balanced emotions. Mood disorders, including anxiety, insomnia, panic disorders and addiction are a significant issue in the U.S.
GABA – The probiotics in the gut create this strong mood stabilizer that increases the body’s level of serotonin. 99% of serotonin deficient people fail to perform the 2nd step – clearly a gut bacteria issue! The Enteric Nervous system is located within your gut and functions autonomously in the body. Irritable Bowel Syndrome (IBS), Small Intestinal Bacterial Overgrowth (SIBO), constant illness or susceptibility to colds, constipation, diarrhea, foggy brain, multiple food allergies, depression, to name a few.
Antibiotics wipe our nearly all of the good bacteria in our gut, leaving our immune system weakened and our gut vulnerable to infections and “bad”bacteria build up. Stress can alter gut motor function leading to sensitivity to foods (diarrhea) or hypersensitivity and leaky gut. With age, more drugs are prescribed, the diet may negatively change and the body becomes more frail. Within our environment, we are bombarded with toxins, pollutants & chemicals that are absorbed into our body and stored up over time, damaging our gut health and weakening out probiotics over time. Eliminate artificial foods, sugars, chemicals, pesticides, processed meats and Genetically Modified Foods (GMO’s) from the diet. Work with your doctor and nutritionist to decrease Rx drug use and improve diet to be as balancing and nutritious as possible. Herbal support that enhances the intestinal health, which can vary according to a person’s constitution. In summary – your gut health is hugely important to nearly every main function in your body and can drastically contribute to or diminish your susceptibility to chronic disease. Mission StatementOur mission is to improve lives within the Richmond community using a holistic model that provides compassionate individualized medicine through education, collaboration, transparency, integrity, and prevention. The heat was on today in the European Parliament (EP).  The reason for that was that the new Novel Foods Regulation was put to vote in a plenary session.
Today (28 October 2015), the EP adopted the latest proposal for a Regulation on Novel Foods [insert final text]. In the initial Commission proposal, the various product categories had not been exhaustively defined.
Contrary to the ENVI proposal, the current text of the Regulation no longer mentions food derived from cloned animals or their descendants as a separate product category. In one of our previous blogs relating to the marketing of insects as food products, we reported that due to the lack of clarity regarding the status of insects (Novel Foods or not?), some Member States issued their own guidance. On 8 October 2015, EFSA published its Risk profile related to production and consumption of insects as food and feed ordered by the Commission. Ultimate date for filing authorisation for continued marketing of insects as food: 1 January 2020.
This means that roughly speaking 4 years from now, FBO’s offering insects as food should still obtain a Novel Food authorisation.
The adoption of the new Novel Foods Regulation has been a process with quite a few hick-ups and some surprising results. Karin Verzijden presented a topic on the status quo of Novel Foods (NF) in the EU under the new Regulation, in which she focused on the rationale of NF legislation for ingredient innovations. Developments in alternative proteins, meaning proteins derived from other than animal sources, was a key trend at Vitafoods, reported FoodIngredientsFirst. Such history of safe use was already established for various algae, like for instance specific types of the Chlorella and Laminaria algae. Duckweed is reported to contain, depending on its cultivation procedure, 40 % proteins, whereas it grows much quicker than algae. Since the entry into force of the Food Information to Consumers Regulation (“FIC Regulation”) on 13 December 2014, some experience has been gained with the new labelling rules applicable to all food products sold to end consumers.
The FIC Regulation aims to modernize, simplify and clarify the food-labelling scene by recasting the horizontal labelling provisions and merging them into one single Regulation. In general, food information shall not be misleading, must be accurate and shall not attribute pharmaceutical characteristics to food. Article 9 of the FIC Regulation lists the mandatory particulars to be stated on all labels. Declaring the presence of any of the 14 listed allergenic ingredients has been a requirement since 2003. As of 1 April 2015 Country of Origin Labelling (‘COOL’) has been extended from beef to other unprocessed meats widely consumed in the EU. Under the FIC Regulation, a nutrition declaration will become mandatory for most food products as from 13 December 2016.
The nutrition declaration should state the energy value in calories and the amounts of fat, saturates, carbohydrates, sugars, protein and salt. Further developments in Brussels took place since we last reported on the new Novel Foods Regulation.
The legislation takes as a starting point that food production processes involving nanotechnologies require specific risk assessment methods. During the long term discussions on the renewal of the Novel Food Regulation, it was decided that the subject of food from cloned animals would be left out. Contrary to current legislation, the initial draft Novel Food Regulation contained an open product definition, where the listed categories of products merely served as examples.
Food used exclusively in food supplements within the Union before 15 May 1997, where it is intended for use in other foods than food supplements. Some of the categories mentioned above were already included in the 1997 Regulation, being those mentioned above under (1), (2), (3) and (7).
As a good example of foods obtained from cellular cultures, the in-vitro burger engineered by Prof. We welcome that the open product definition for Novel Foods has been abandoned, as this increases legal certainty. It is expected that the current draft legislation for the new Novel Foods Regulation will not be the final text. Do bugs have a place on your dinner plate other than the fly that lands on it or the caterpillar that accidently ended up in your dish, as it happened to live in the cauliflower you prepared for dinner? In other parts of the world certain insects are part of people’s diet and are sometimes even considered as a delicate and exclusive bite. During the abovementioned conference it became clear that there was an urgent need to develop legislation on edible insects to give the food and feed industry clear guidance on the requirements they have to meet. In Belgium the placing on the market of the species included in the table below is tolerated, provided that the requirements of food legislation are met, especially and among others the application of good hygiene practices, traceability, compulsory notification, labelling and organisation of a self-checking system based on the HACCP principles. Also France and the United Kingdom seem to tolerate the sale of edible insects in their countries. The NVWA asked to assess the chemical, microbiological and parasitological risks of consuming heat-treated and non-heat-treated insects.
In the Netherlands, the Laboratory of Entomology from Wageningen University is involved in research on edible insects. The question has been raised whether Regulations regarding to slaughtering animals are also applicable to the killing of insects for consumption. Novel Food or not, despite the lack of (legal) guidance and certainty regarding the regulatory status of insects on EU level, it is clear that the attitude towards the use of insects for food and feed is positive.  Therefore, some Member States take action to allow the marketing of insects as food in their country until a clear position has been reached at European level. In one of our previous blog posts this year, we provided a summary of the Commission’s proposal for a new Regulation on Novel Foods. The EP Rapporteur is a 69 years old Irish citizen, who belongs to the European Conservatives and Reformists Group.
The current authorisation process has been criticised for being too expensive and too lengthy. The proposal for the new NF Regulation moves from a personal to a generic authorisation system.
Amongst the measures proposed for the area’s of concern, the one relating to the NF product definition certainly is the best.
On 24 September 2014 our firm organizes a seminar addressing the developments in Functional and Medical Foods.
The Institute of Medicine has designated functional food as “any food or food ingredient that provides a health benefit beyond its nutritional benefit”. Functional foods are just one step away from medical foods, catering for particular nutritional needs that regular foods do not supply. The regulatory requirements for health and nutrition claims offer a chance and a challenge.
The slides of our seminar on medical and functional foods can be found here and also via our SlideShare account.
Early this week the Academy of European Law’s Annual Conference on Food Law took place on 5 and 6 May in Trier and offered a unique opportunity to receive an analysis of recent legislation, case law and ongoing policy developments in the field of food law (for an overview of the full programme, click here). Novel Foods (NF) are all foods that were not used for human consumption to a significant degree within the EU prior to 1997. In order to find a solution for the sensible issue of food from cloned animals, the current proposal for the NF Regulation simply no longer covers such food.
General criteria for the NF definition remain unchanged: they should be safe and not mislead the consumer. It should be observed that it is unclear if this list of categories is of an exhaustive enumeration.
The new proposal for the NF Regulation aims to simplify and streamline the regulatory process, while it continues to ensure food safety.
The new NF Regulation introduces a simplified and more proportionate procedure for placing on the market traditional foods from third countries, provided that a history of safe use can be demonstrated. On request of the applicant, data protection is available for newly developed scientific evidence or scientific data supporting the application.
NF that were authorized prior to the entry into force of the new NF Regulation, will be included in the Union list too.
Over time many food business operators started to doubt if a new proposal for the NF Regulation would be published at all. If you like to add a new ingredient to – for example – a beverage or want to start selling ‘superberries’ or an exotic seed from Asia in the EU, you should always check whether the food is a so-called novel food. The Regulation does not apply to food additives, flavourings and extraction solvents used in the production of foodstuffs. A food product is not a novel food within the meaning of the Regulation if it has been used for human consumption to a significant degree in the EU. To view our latest issue of Probiotic News please click on the picture below or click here.
One night, while putting Sarah to bed, Julianne pulled the pajama top over her daughter’s head, when Sarah suddenly exclaimed “Ouch!
Early sexual development in girls, known as precocious puberty, seems to be happening everywhere.
A groundbreaking study in 1997 on 17,000 girls sent shock waves through the medical community.
The development of secondary sexual characteristics in girls is a significant event, signaling the onset of physiological and psychological ranges of profound importance.
But the most disturbing consequence of early puberty in females is the well-established risk for pre- and postmenopausal breast cancer as well as ovarian cancer.
Early puberty in males can increase their incidence of testicular cancer, lower fertility rates and impair growth, leading to a shorter stature.
Since early puberty is a well-established risk for breast cancer, the earlier a woman reaches puberty, the longer her breast tissues will be exposed to potentially harmful-causing agents (chemicals, radiation and estrogen). Is it just the fast foods and sedentary lifestyle that are piling up the leptin-producing fat? In fact, the really guilty party is looking more and more like hormone disrupters found in various foods, ingredients in personal care products and environmental toxins. Hormone disruptors, like silent saboteurs, have invaded the highly sensitive endocrine systems of our children. Hardly a minute goes by without our being exposed to some chemical; perhaps it is car exhaust, room freshener, artificial fragrances, baby shampoo, dry cleaning, colored popcorn, furniture polish, fire retardant on new school clothes, plastic water bottles, fly spray and on and on it goes.
With the red flags waving you would think that the medical profession would be leading the charge against contamination and exposure to hormone disrupting chemicals. It is therefore rather shocking that a report by a nationwide network of physicians suggested that it is perfectly normal for girls as young as six years old to be developing breasts.
The obvious choice for anyone concerned about the health of their children (or their own health, for that matter) is to choose certified organic skincare products, which are the guaranteed to be the purest..
Dr Sherrill Sellman is back in Sydney for three very special events: a seminar on Thursday 3 July, an exclusive soiree on Friday 4 July and an one-day workshop on Saturday 5 July. About ThereseBeyond being the proud mother of Matthew and Miranda Kerr, Therese is a Holistic Health Advocate, Author, Speaker and Director of Divine by Therese Kerr. Riadh Ben Salah (Laboratory of Microorganisms and Biomolecules –LMB-, Centre of Biotechnology of Sfax, University of Sfax, Tunisia) and Dr. The reason is that the gut influences and produces major mood hormones, a function that the presence of probiotics supports.
If the intestinal bacteria is imbalanced, (which can happen if not enough probiotics are present), a negative bacterial overgrowth  can develop, which can cause the kidneys to excrete taurine.
This is a “Distinct Entity – a complete network of neurons, neurotransmitters and special proteins responsible for communications, thinking, remembering and even learning”.
Each of us has a very unique bacterial makeup and there is no one “right”way to eat or supplement.
If you’d like more information about an appointment with Lindsay then please visit out Book An Appointment Page Here. In the debate prior to the vote, the opinions centred between concerns about food safety and the free circulation of goods. As reported in one of our previous posts, the European Commission published an initial proposal for this Regulation in December 2013. Although such a system could present the advantage of flexibility, in fact FBO’s resisted against the legal uncertainty this would create. However, it becomes clear from the recitals in the new Novel Foods Regulation that no change is intended here. In Belgium for instance, the placing on the market of 10 particular insects species as food product is tolerated, provided that specific food law requirements are met. In fact, EFSA was requested to assess the micro-biological, chemical and environmental risks posed by the use of insects in food relative to the risks posed by the use of other protein sources in food. The new Novel Food Regulation provides first of all that these products do not have to be withdrawn from the market.
Assuming that these products have been marketed since the end of 2014 (see for instance the news on the launch of the insect burger sold by Dutch grocery chain JUMBO), this would mean that they were on the market 5 years before. Whereas food from cloned animals for a long time had been the cause of delay, it is surprising to see that this Novel Food category nevertheless ended up within the scope of the new Novel Foods Regulation. For companies active in the ingredient business, this is the yearly meet up to share the latest ingredients insights, to present new products and to prepare actual or future deals. As reported earlier, a new NF Regulation was presented by the Commission in December 2013, which was heavily amended based on the input from EP Rapporteur Nicholson. As a consequence, these ingredients can be used for food products without being subject to NF authorization, both under the current and future legal regime. Under the current NF legal framework, they are not considered to be Novel Foods, at least not explicitly so. Sofie van der Meulen presented a topic on labelling, explaining the new requirements and how these are applied in practice. However, labelling is still not fully harmonised due to language requirements and room for national measures, for example on allergens and additional mandatory information to be stated on the label. The FBO under whose name the food is marketed or the importer into the Union market is responsible for compliance.
However, if health and nutrition claims are used, including a nutrition declaration on the label is already mandatory.
This information should, as a main rule, be expressed per 100 g or 100 ml in order to enable the consumer to compare products and make a choice for a healthy diet.


Draft legislation was approved in this respect by the ENVI Committee, awaiting the first reading of the European Parliament (EP). Others were introduced in the initial Commission proposal for a new Novel Foods Regulation, notably those mentioned above under (8), (9) and (10). Contrary to the use of cellular tissue for the production of food, the use of insects as food goes back to biblical times. We expect active lobbies from FBO’s marketing nano-foods to oppose the adjusted definiton for nanomaterials. This discussion paper provides a look at the regulatory frameworks influencing insects as food and feed at international, regional and national levels.
This tolerance does not apply to food ingredients isolated from insects, such as protein isolates.
According to this report the following insects are currently produced and sold in the Netherlands.
Scientists Arnold van Huis and Marcel Dicke and cooking instructor Henk van Gurp even published a cookbook: the Insect Cookbook. We reported that the proposal contained an open product definition and that it introduced a central authorisation procedure.
He shares his opinions on Novel Foods in the movie entitled Novel Foods: lucrative innovation or health hazard?
However, the important difference in the new NF proposal is the removal of clearly defined categories of what constitutes a Novel Food.
Processing a successful Novel Foods application takes in the average about three years (!) This of course did not stimulate food innovation and in particularly prevented SME’s from filing NF applications.
This mechanism is aligned to the health claims system, according to which authorized claims can be used by anyone, provided that the conditions of use are met. One can argue about the exact phrasing of the proposed product categories, but taking leave of the open product definition provides the required clarity for entrepreneurs whether or not their product qualifies as a Novel Food. Functional foods comprise food supplements, probiotics and other foods having a beneficial effect on human health, which is often advertised by health or nutrition claims as using those claims in connection with this type of foods is very attractive from a marketing point of view. Also, as of 13 December 2014, all food business operators have to comply with very strict, new information requirements on the basis of the Regulation on Food Information to Consumers.
Novel foods are all foods that were not used for human consumption to a significant degree within the EU prior to 15 May 1997. One of the most well known examples is BECEL, a margarine containing plant sterols with a cholesterol lowering activity. Instead, two separate proposals have been prepared: (1) a Directive on the cloning of animals of various species kept and reproduced for farming purposes and (2) a Directive on the placing on the market of food from animal clones.
The definition of NF is however considerably changed, now that food from cloned animals is no longer included. Also, the introduction of nanomaterials may have huge implications for manufacturers of medical or baby foods.
This should be confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a large part of the population of a third country.
As a consequence, a food that was legally placed on the market prior to the application of the new NF Regulation may be further marketed.
The producer, importer or any other person responsible for the placing of a product on the EU market is primarily responsible for compliance with the EU-legislation, including the Novel Foods Regulation. Furthermore genetically modified organisms fall outside the scope of the Regulation since the Regulation on genetically modified food and feed that entered into force on 18 april 2004. The study found that the initial signs of puberty were occurring much earlier than previously recorded. Studies have found that girls who reach puberty earlier tend to have sex earlier, increase the risk of pregnancy, experience more psychological stress, poor mental health, more behavioural problems, are more likely to drink, smoke, have a lower IQ and commit suicide. According to a study that was published in the journal Nature (1989), the risk associated with having an early menarche-for instance, one that takes place at the age of 10-is approximately twice that associated with a menarche that occurs much later, say at the age of 16 or so. It has now been discovered that boys as young as nine years old are developing mature genitalia, are producing sperm and have spontaneous erections.
Carlos Sonnenschein of Tufts University of Medicine warns, “The length and amount of exposure to estrogen is one of the most significant risk factors in breast carcinogenesis. It is absurd to think that early puberty is the result of better nutrition, as many scientists assert. For the past two decades, Puerto Rico has recorded the highest known incidence of premature breast development. In a significant study, the breast development of the Puerto Rican children was linked to phthalate exposure, a ubiquitous chemical plasticizer.
They are common industrial chemicals used in building materials, food packaging and food wrap, toys and other children’s products, medical devices, garden hoses, shoe soles, automobile undercoating, wires and cables, carpet backing, carpet tile, vinyl tile, pool liners, artificial leather, canvas tarps, notebook covers, tool handles, dishwasher baskets, flea collars, insect repellents, skin emollients, hair sprays, nail polish and perfumes. Whether from chemical exposure in the environment or from the hormone laden meats and dairy products, or chemically-laced personal care and household products, exposure to dangerous chemicals has now reached the highest level of exposure in the entire history of human civilization. Beginning in utero, our children are accumulating chemicals in their bodies, little by little, day in and day out for years and years.
After all, they are in the trenches, daily witnessing the rising number of children with precocious puberty.
Holistic healing modalities such as Traditional Chinese Medicine, naturopathy and holistic medical approaches have been able to help get hormonal health back on track. All hormone mimicking chemicals should be avoided, which include non-organic meat, dairy and produce, all commercial personal care products such as suntan lotion, shampoos and bubble bath, hormone disrupting chemicals found in pesticides, herbicides, plasticizers and commercial cleaning products.
Since skin readily absorbs chemicals and other substances deeper into the body- through skin layers, into muscles and fat, and ultimately into the bloodstream, it is imperative that only the purest skincare products ever be used for the entire family. However, there is much that can be done to insure that children do not become teens before their time. Use only organic household cleaning products, personal care products, cosmetic lawn and garden supplies and pet supplies.
Incorporate nutritional support from high quality vitamins, minerals, essential fatty acids and probiotics. Sherrill Sellman’s book What Women MUST Know to Protect Their Daughters From Breast Cancer. Each serving provides extracts of 18 fruit and vegetables, 5 antioxidants and 500 million probiotics. Mehdi Triki  (LMB, Laboratoire des Analyses, Valorisation et Securite Alimentaire –LAVASA- y  Chahia Industry of Tunisia). Since these conditions all have a pattern of imbalances of the mood hormones serotonin, GABA and taurine (which cannot be made without healthy intestinal bacteria) probiotics and mood are inextricably linked. Ninety percent of messages that operate the gut come from the enteric nervous system, not the brain! Pay attention to the foods you eat, the environment that surrounds you and listen to your gut! Other than the expected results of having a healthy digestive system, most people say that they acquire weight loss an a more positive disposition in life.
EP Rapporteur Nicholson heavily criticised this draft, mainly for its open product definition and for the lack of streamlining the authorisation procedure. As a result, the approved draft by the ENVI Committee identified 10 categories of Novel Foods.
Until specific legislation on food from animal clones enters into force, such food is covered by category nr. In the Netherlands, the Dutch Food Safety Authority and the Health Minister ordered a safety report with respect to three types of insects currently marketed as food in the Netherlands.
EFSA found that for the evaluation of micro-biological and chemical risks, the production method, the substrate used, the stage of harvest, the specific insect species and the method of further processing are of relevance. However, for the continued marketing of such food products a request for authorisation should be filed within 24 months after the date of application of the new Novel Food Regulation.
If no safety concern ever arose so far, it would not be unreasonable to request an exemption from this obligation. As to products providing alternative protein, such as insects, we understand that the safety aspects from rearing to consumption should be carefully assessed. Axon Lawyers was asked to participate in the Conference Program, which this year was committed to three different steams, being “your business”, “your science” and “your product” respectively.
In November 2014, the ENVI Committee accepted draft legislation including most of the Nicholson amendments. The same does not apply to for instance the Rhodymenia palmata, regarding which so far only evidence on use as a food supplement is present. Under the current legal framework, it would certainly be an option to investigate if any substantial equivalence to existing foods could be established. Since a lot of products are sold via the internet nowadays, the FIC Regulation explicitly applies to online sales of food products as well. With regards to prepacked food, the information should be stated directly on the product or on a label attached thereto. For prepacked foods allergens must be listed in the list of ingredients with a clear reference to the name of the allergen as listed in Annex II of the Regulation. In the future, mandatory COOL could be further extended under the FIC Regulation and become applicable to other products such as milk and milk products and also to processed meats.
A Dutch meat trader was recently sentenced to 2.5 years in prison, as he was found guilty of forgery when horsemeat was not declared on the label of beef products. For labelling, this also applies, as the Commission still has to provide input on specific topics and also at national level, there is some room for manoeuvre. Furthermore, an adequate safety assessment on the basis of those methods should have shown that the foods at stake are safe for human consumption. These two proposals have now been turned down by EP, as they did not address the food obtained from clones’s offspring.
Based on his consultations in the field, such open product definition according to him constituted a source of legal uncertainty.
Truly new are therefore only the categories consisting of food derived from cloned animals (4), food obtained from cellular or tissue cultures (5) and food produced from whole animals such as insects and from animal parts (6). This burger was constructed on the basis of a tiny part of meat, using stem cell technology.
Actually, in various European countries including the Netherlands and Belgium, insects are being offered for sale as food. During previous revision efforts of this Regulation, this topic was exactly the bottleneck why the revision could not be completed. Likewise we expect, and we recommend, that FBO’s marketing insects or food from insects will oppose the fact that food made from whole animals like insects qualify as Novel Foods per se. According to the UN Food and Agricultural Organization (FAO), insects can potentially help solving the increasing demand for animal protein.
We also pointed out that the new Regulation provided for a simplified authorisation procedure for traditional foods and for a data protection regime.
Although it may seem ironic that a seasoned politician from a conservative party is heavily involved in the subject of Novel Foods, he did deliver a substantial job in less than a year. The categories listed in the Commission’s proposal are only examples and not an exhaustive list.
It probably also explains why between 2000- 2013, only 70 NF applications have been authorized.
If this is an open end at the beginning of the authorization process, why would one even bother to start it? Provided that the suggestions of the Rapporteur regarding the NF product definition are followed and some more substantial reductions in time in the authorization procedure are achieved, the new proposal is a real improvement.
Furthermore, both types of food are subject to specific legislation regarding health and nutrition claims as well as regarding food information to be provided to consumers.
To what extent does this regulation help the final consumer to make healthy choices and how does this impact the entrepeneur?
Futhermore, only one out of four previous NF categories is maintained, namely food to which a new production process is applied. The Commission subsequently circulates initial national assessments to all Member States (MS).
An applicant who intends to place on the EU-market a traditional food for a third country shall notify that intention to the Commission. A similar mechanism is also contained in the Health Claim Regulation for so-called “new function” claims under article 13.5. However, it is mandatory for those foods to undergo the authorisation procedure laid down in the new NF Regulation.
Also, this proposal contains various positive elements, such as more defined timelines within the authorization procedure for EFSA. Based on a steady stream of questions, our firm has noticed clients struggle with this question. Upon taking a closer look, she noticed that her nipples did appear to be different from what she had remembered. The study found that 27 percent of African-American and almost seven percent of Caucasian girls had the onset of secondary sexual characteristics, i.e.
For boys, it can mean more aggressive, violent behavior, learning disabilities and more drug and alcohol abuse. In addition, girls showing early signs of puberty also have increased risks of polycystic ovarian syndrome, acne, excessive facial hair and infertility. In addition, they have hair growth on the face, under arms and in the pubic area, along with acne problems.
An increase in obesity in children and lack of exercise has a direct relationship to this problem. A 20-year study found that the greater the prenatal level of the hormone disrupter, polychlorinated biphenyl (PCB), the heavier the girls were at age 14 and thus statistically earlier their puberty. A 1997 Lancet study showed that soy has plant-based chemicals that mimic estrogen, displaying a wide range of hormonal activities. The researchers measured the presence of certain phthalates in the blood of 41 girls experiencing early breast development with a control group.
For some children the effects may become evident quickly while for others it may take many years or decades before the real harm-the cancers, the multiple sensitivities, the behavioral problems, the learning disabilities, the hormone imbalances and infertility or sterility become apparent. Instead of facing up to the implications of what is contributing to this aberration and leading the charge for immediate investigation into the causes and solutions, the medical community prefers to ignore a looming tragedy.
Since children with symptoms of early puberty often have allergies, food intolerances, candida, digestive problems and high levels of toxicity, it is imperative to correct these health problems. In short, the adoption of the new Novel Foods Regulation will have important consequences for Food Business Operators (FBO’s). As a result, an EP legislative proposal became available, in which the Rapporteur formulated a number of improvements.
Some of these have again been heavily debated, like for instance insects – however without success. These are the mealworm beetle, the lesser mealworm beetle and the locust, regarding which the heat-treated and non-heat treated consumption was evaluated in terms of chemical, microbiological and parasitological risks. It established however that with respect to any of these topics, fairly limited data are available. At any rate, such FBO’s should know that prior to the indicated date of 1 January 2020, they can most likely successfully rebut any enforcement measures by local food safety authorities. Axon Lawyers presented two topics in the business stream, pertaining to EFSA Claims and Regulatory Issues and to Labelling.
This text represents the current status quo of NF legislation and now awaits first reading in the European Parliament (EP). Ingredients that have been marketed as a source of food in the EU prior to 1997 to a significant extent are clearly outside the scope of the Novel Foods Regulation. Such use can be of support to demonstrate the safety thereof, but as a single source will not be enough to market the product as a NF. Also, in practice, various insect based products are effectively marketed – examples can be found here and here.
As a starting point, the protein RuBisCo, that occurs both in duckweed and in many green plants could be taken. Consumers’ have to receive particular information in a webshop prior to the purchase of the food product. Furthermore, the presence must be emphasized by using a different typeset that distinguishes them from the rest of the ingredients. The Dutch Food Safety Authority currently focuses on misleading information on prepacked foods in 2015. Two particular subjects seized most public attention, notably the moratorium proposed on the use of nanomaterials in food and the compulsory labelling of cloned food products. The rationale of all this is the precautionary principle: emerging technologies in food production may have an impact on food safety.


Until food from cloned animals will be covered by revamped Cloning Directives, cloned meat products have been brought within the scope of the Novel Food Regulation and they should be labeled as such. Instead, he suggested re-introducing the former product categories in an updated form in order to make this Resolution future-proof.
As explained above, the category consisting of food obtained from cloned animals is likely to be temporary. For this purpose muscle cells harvested from a living cow were fed and nurtured, so that the single strand of cells multiplied to produce numerous new strands.
For instance, Dutch supermarket chain JUMBO offers edible insects for sale as of October 2014. Also, this does not serve as an incentive for the Commission to adjust its previous proposals for the Cloning Directives at short notice. The chances of success will depend, inter alia, on the expected EFSA report on certain risks of the production and consumption of insects. The European Commission has asked EFSA to deliver a scientific opinion on the risks of insect consumption, but this opinion is expected in 2015 at the earliest. Can we qualify his suggestions for amendments of the Commission’s proposal as substantial enough? After extensive consultation, the Rapporteur found that this open product definition is not satisfactory.
Under a system of generic authorisations, it is all the more important that those investments are protected, at least for a minimum period of time.
As for the suggestions made to further streamline the authorization process, these can be considered merely symbolic. This will all the more be the case, once a corpus of generic authorizations will have been published. When the Commission does not receive any reasoned safety objections within 4 months, the food applied for can be marketed in the EU.
Under both Regulations, data protection implies that data covered may not be used for the benefit of a subsequent application during 5 years, in the case of a NF to be calculated from the inclusion of the NF in the Union list.
Likewise, when a NF is authorized and included in the Union list, the Commission may introduce post-market requirements to monitor the use of the authorized NF, so to ensure that the food is within safe limits as established by EFSA. Good news: this guidance document, recently published by the European Commission brings some relief. Before they have outgrown dollhouses, many young girls are being faced with the confusing moods swings, hormonal changes and sexual attention that accompany physical maturation. Between the late 1970s and the early 1990s, the percentage of overweight children nearly doubled.
The daily exposure to infants who consume soy formulas was 6-11 times higher than adults who consume soy foods.
The fact that early puberty is a known risk for breast cancer should be of great concern to all parents. The earlier these issues are identified and attended to, the greater the success of reversing early puberty. Most of them were included into the draft legislation approved by the ENVI committee by the end of November 2014, which further developed into the text voted today. Based on the outcome, it was recommended to consider these insects as “regular” foods (in the sense of the General Food Law Regulation) and not as Novel Foods. It therefore strongly recommends further research for better assessment of microbiological and chemical risks from insects as food, including studies on the occurrence of hazards when using particular substrates, like food waste and manure. Below, some background with respect to these presentations will be provided and the actual presentations will be shared. As a consequence, they are not subject to pre-market authorization, at least not based on the NF requirements.
It will therefore be interesting to see if those products will be subject to enforcement measures of national health authorities. If this is of no avail, it is interesting to know that under the future legal framework, the short cut authorization based on traditional foods from third countries might be available.
These two items have been covered here and here inter alia and will be shortly touched upon below. As soon as specific legislation covering this topic will be in place, such legislation will be applicable to cloned food products instead of the Novel Foods legislation. This has incentivised national authorities to investigate the safety of consumption of insects and to formulate basic requirements for rearing facilities. We are more positive with respect to the introduction of the new category of Novel Foods relating to food produced from cellular cultures.
As of now however, there is already safety evidence which could be relied on pending the final text of the Novel Foods Regulation. Online it is possible to order various kinds of edible insects from around the world, which are not included in the lists above. Making NF applications directly at a Commission level instead of at a national level first will most likely save time.
The Commission therefore introduced protection for newly developed scientific evidence during a period of five years from the authorization date of the NF application.
Instead of shortening a deadline here and introducing another one there, the most important issue has not been addressed. In that case, manufacturers and importers of Novel Foods will no longer have to undergo an authorization process at all regarding authorized products. Speakers are: Bernd Mussler (Innovation Project Manager at DSM), Ruud Albers (CEO at Nutrileads) and us (Karin Verzijden and Sofie van der Meulen).
Novel foods, including food from cloned animals, are subject to pre-market approval, but obtaining market access under the current regime is a lengthy process that can take up 3 to 6 years. This proposal has never been adopted by Union legislator, due to a number of bottlenecks including food produced from cloned animals. Cloning will however not be prohibited for purposes of research or conservation of rare breeds and endangered species. However, in the majority of the 68 NF authorisations granted between 2000 and 2013, such objections were raised and an EFSA safety opinion was obtained.
In case of any objections, the applicant can file a new application taking into account said objections, which the Commission forwards to EFSA.
Such individual authorisation should however not prevent other applicants from filing applications on the basis of their independently generated scientific data, which may be identical with or similar to the protected data.
The new NF Regulation expected to enter into force in 2016 at the earliest, when the Council and the Parliament will have adopted their positions on this topic as well. For instance, if EFSA requests additional information from the applicant, the authorisation for sure will not make it within 18 months.
Reports of early puberty have come from many diverse countries and climates including Australia, Britain, Canada, Europe, Asia and the Caribbean.
By the time girls turn eight years old, one in seven Caucasian girls and 50 percent of Afro-American girls will be starting puberty.
In fact, the blood concentrations of these hormones in the children were 13,000-22,000 times higher than estrogen normally found in the blood. They found that 68 percent of the precocious puberty girls had high levels of phthalates in their blood. If to the contrary, no valid case for a history of safe use can be made, then it is likely that a NF authorization will have to be obtained.
We believe that the longer those products have been marketed the more difficult this will be based on, amongst others, the principle of legal certainty.
Such will depend on the outcome of research into duckweed as a source of food in those countries, regarding which in such case a history of safe use for 25 years will have to be demonstrated. The provision of allergen information for non-prepacked foods sold in, inter alia, cafes, canteens and restaurants are subject to national requirements. This was in line with EFSA recommendations, but it may pose a serious problem to FBO’s currently marketing nano-foods. The draft Novel Food definition currently also covers product categories that were never considered as Novel Foods before, such as insects and food obtained from cellular or tissue cultures.
Obviously, the cell production used for this purpose will have to be increased for this technology to become a viable meat production method. As a result, recommendations were made in the Netherlands that a specific number of insects, such as the mealworm beetle and the locust, should be considered as foods under the General Food Law Regulation (see our previous blogpost for more detailed information also covering other European countries). Furthermore, Wageningen University announced the launch of the first scientific journal focussing on this topic in 2015. According to this Regulation, Novel Foods require pre-market approval in the EU (Do you want to read more about Novel Foods? NVWA does not seem to focus on enforcement in this area as long as food safety is not at stake. Nicholson consulted with local producers, industry experts and food business operators about the Commission’s proposal. As a solution, the Rapporteur suggests re-introducing the previous product categories in an updated form and to add a new product category related to foods for which a new source of starting material has been used. The Rapporteur was concerned however that the Commssion’s proposals do not go far enough in reducing the time factor. Although the Rapporteur welcomes this concept, the is concerned that it will restrict the useful contribution of scientific research to the food industry. Under the new NF proposal, the Commission shall take into account the view of the Member States regarding NF applications it received “where applicable”. Therefore, between 2008 and 2011, a new proposal for a Novel Foods Regulation was published, but this proposal has never been adopted as concilliation failed in March 2011. On 18 December 2013, the Commission has published a new proposal for a NF Regulation, which is the subject of this blog post. Furthermore, cloning will be allowed for the production of pharmaceuticals and medical devices, where the use of this technique can be justified. The current NF regulation does not set a time frame therefore and quite often, the 60 days term for the MS to provide their opinion is not enforced.
EFSA shall subsequently adopt, within 6 months from the date of a valid application, its safety opinion.
Furthermore, the authorisation of traditional foods from third countries will take, as a very minimum, 13 months if an EFSA opinion is requested. Even more startling was the finding that 1 percent of Caucasian and 3 percent of African-American girls showed these characteristics by the age of three. However, a transition period of 24 months after such publication has been provided before its actual application. Whereas the ENVI draft still specified the highly debated 10 % threshold for a food ingredient to qualify as nano (instead of the 50 % threshold proposed by the Commission), no such threshold is contained in the current text. Therefore, we consider that alternative protein products that were marketed for a number of years without any problems reported should not be subject to further barriers.
The language used on the label should be a language that is easy understandable in the Member State where the food product is marketed. In the Netherlands this information can be provided orally, but for example in Ireland this information has to be provided in a written format. Using the 10 % threshold would imply that quite a few product currently marketed would, under the new Novel Foods Regulation, qualify as Novel Food whereas it currently does not.
However, now that the feasibility of this method in essence has been demonstrated, its application is not inconceivable.
As a result, a draft EP legislative Resolution is available, which is the subject of this blogpost.
He has therefore made amendments consisting of stating deadlines where there were not and shorting deadlines as initially proposed by the Commission.
He therefore proposes that once the conditions for data protection are met, such protection should also be granted if the data at stake are published in a scientific journal. The text seems to suggest that this will not be a standard procedure, but this is not clear. One of the sensitive issues was food from cloned animals. In order to find a solution for this issue, the latest proposal for a Regulation on Novel Foods no longer covers such food. Finally, the Commission shall publish a draft authorisation decision within 3 months from the date of publication of the EFSA opinion. In line with the number of times an EFSA opinion is requested for NF, it is not unrealistic to expect this will happen most of the times. Although this is no doubt a compromise solution, it is expected it shall give rise to new discussions. Anyhow, FBO’s should be aware of their rights of continued marketing of such products, at least for four more years to come. In practice most FBO’s decide to use the official language of the Member State on their labels, or, as a very minimum, on their website. When in future, lab-burgers like the one from Maastricht will be marketed as food products, they will need to obtain pre-market authorization based on the current draft for the new Novel Food Regulation. In Luxemburg for example, the marketing of edible insects, pending an EFSA opinion awaited for July this year, is prohibited.
It is striking that up to and including the first Report by Rapporteur James Nicholson, whole animals such as insects never formed part of the Novel Food product definition.
At this moment the European Commission has not explicitly decided on whether insects should be considered Novel Foods or not. For instance, where the Commission proposal provides that an authorisation decision should be published within 9 months after a positive EFSA opinion, the Rapporteur considers such term could be shortened to 6 months. Under the new NF Regulation, an application for a NF authorisation should be directly made to the Commission.
The procedure provided is therefore not necessarily “simplified” in view of a food that in other parts of the world is considered safe. Those higher levels of insulin appear to stimulate the production of sex hormones from the ovary and adrenals. This is understandable, as the use of this technique and starting material for food production is completely new and their safety needs to be established.
Where the Commission requests a safety opinion, EFSA shall adopt such opinion within 9 months from the date of receipt of a valid application. Also, the proposal still does not contain at all a fixed term in which the MS should provide their reasoned objections, if applicable. At any rate, many items covered by the NF Regulation are still open, since the NF definition does not seem to be of an exhaustive nature.
This is not consistent with current practise of various Member States and will pose a problem for many FBO’s actually marketing food produced from insects.
Finally, the system of data protection seems promising, but experience regarding a similar system contained in the Health Claim Regulation has shown that its effect is limited. Subsequently, the Commission shall publish a draft authorisation decision within 9 months from the date of publication of the EFSA opinion.
Furthermore, the Commission has received implementing powers to (i) decide whether a particular food falls within the NF definition, (ii) design a procedure to collect information on human consumption of particular foods prior to 1997 and (iii) update the Union list. Furthermore, there seems to be a substantial amount of evidence for safe consumption of insects, at least in the Netherlands. If third parties for instance produce the same data as the protected data based on independent research, nothing will prevent them from using those data. The system of individual authorisations will be replaced by a system of generic authorisations and the “simplified procedure” based on substantial equivalence will cease to exist.
Finally, legal uncertainty is bound to arise regarding already authorized NF, as they will have to undergo the authorization procedure again under the new NF Regulation.
Therefore, instead of qualifying whole animals as insects instantly as Novel Foods, as an alternative for providing international industry standards, it could be considered to include a list of recommended edible insects into the Codex Alimentarius. Taking this into account, it is completely unclear how data protection can be enforced regarding data that have been published in scientific reviews, as suggested by the Rapporteur. Today, many food products consisting of or containing insects are marketed in various Member States.
It is therefore important to establish what will be the consequences of considering insects as Novel Foods. In order to answer that question, the provisions laying down the transition regime are of interest. Furthermore, by way of background, a number of safety evaluations of insects as food are briefly discussed.



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