Posts Tagged ‘EFSA’

EFSA Panel reports re-evaluation of emulsifier E471 as food additive

January 13th, 2018
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During the last days, the recent ”Re-evaluation of mono- and diglycerides of fatty acids (E471) as food additives” conducted by an EFSA panel has attracted attention also in food magazines and websites. Previously on this blog, the US FDA evaluation of various emulsifiers was discussed and in that context it was mentioned that other studies are pending.

Now, the European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food (ANS) has provided a scientific opinion re-evaluating the safety of mono- and di-glycerides of fatty acids (E 471). It is concluded that “no evidence for adverse effects was reported in short-term, subchronic studies, chronic, reproductive and developmental toxicity studies. Neither carcinogenic potential nor a promotion effect in initiation/promotion was reported. The available studies did not raise any concern with regard to genotoxicity.”

Moreover, the panel found that there is “no need for a numerical acceptable daily intake (ADI) and that the food additive mono- and di-glycerides of fatty acids (E 471) was of no safety concern at the reported uses and use levels.”

However, the panel does point to the need for modifying some of the current EU specifications for E471. Here, it is specifically proposed to lower the acceptable level of toxic elements such as arsenic, cadmium and lead. Also, the specification should be revised to further secure that E471 is not contaminated during production with any of the trace impurities that can be found in the raw materials or with any processing aids such as for instance solvents. The panel also call for more data to “decrease the uncertainty about the occurrence of compounds of toxicological concern”, i.e. 3-MCPD and glycidyl esters. Finally, the panel proposes to lower the limits for trans fatty acids and for erucic acid since these can be constituents of the oils used in manufacturing E471.

Clearly, there will constantly be new, scientific studies helping us to better understand where improvements are needed. This is the only way to make sure that food ingredients are not only safe – but most importantly, constantly getting safer.



Ingredients ,

EFSA to give advice on the intake of sugar added to food

March 25th, 2017
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EFSA will provide scientific advice on the daily intake of added sugar in food by early 2020. The Authority aims to establish a science-based cut-off value for daily exposure to added sugars from all sources which is not associated with adverse health effects. The work will be carried out following a request from Denmark, Finland, Iceland, Norway and Sweden.

Added sugars from all sources comprise sucrose, fructose, glucose, starch hydrolysates such as glucose syrup, high-fructose syrup, and other sugar preparations consumed as such or added during food preparation and manufacturing.

The adverse health effects under consideration will include body weight, glucose intolerance and insulin sensitivity, type-2-diabetes, cardiovascular risk factors, as well as dental caries. In its assessment, EFSA will look at the general healthy population, including children, adolescents, adults and the elderly.

The advice will guide Member States when establishing recommendations for the consumption of added sugars and in planning food-based dietary guidelines.

Sweden is coordinating the request to EFSA on behalf of the five Nordic countries. Annica Sohlström, the Director General of the Swedish National Food Agency, said: “We welcome EFSA’s acceptance of the mandate which reflects the need to scientifically evaluate the links between added sugar and health at a European level.”

What is going to happen next?

EFSA will establish an ad-hoc working group with expertise in dietary exposure, epidemiology, human nutrition, diet-related chronic diseases and dentistry. The five Nordic countries that initiated this mandate will be invited to the working group as observers.

EFSA will use its established methodology to develop a protocol on how to carry out the assessment. Known as Prometheus – PROmoting METHods for Evidence Use in Scientific assessments – the method shows how EFSA selects evidence, how this evidence contributes to the risk assessment and how EFSA reports on the entire process and it results.

In line with its commitment to openness and transparency, EFSA will engage with stakeholders throughout the assessment process. It will hold two public consultations, inviting feedback on the draft protocol in the first half of 2018 and on the draft opinion in late 2019, which will also involve a face-to-face meeting with stakeholders.


In 2010, EFSA published its Scientific Opinion on Dietary Reference Values for carbohydrates and dietary fibre, which also included sugar. At this time, the available evidence was insufficient to set an upper limit for the daily intake of total or added sugars. New scientific evidence has come to light since then. There has also been growing public interest in the impact of the consumption of sugar-containing foods and beverages on human health.

Source: EFSA


Health, Ingredients , ,

EFSA Defends Conclusion to its Assessment of Glyphosate Safety

January 16th, 2016
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EFSA has replied to criticism of the EU assessment of glyphosate that was overseen by the Authority last year. 

Prof. Christopher Portier sent a letter to Vytenis Andriukaitis, the EU Commissioner for Health and Food Safety, on behalf of a consortium of nearly 100 academics, in which he raised a number of objections to the process and the conclusions of EFSA’s assessment. Prof. Portier is a scientist who contributed to a report on glyphosate by the International Agency for Research on Cancer (IARC).

In his eight page letter, Portier said: “The EFSA decision, based upon the Renewal Assessment Report provided by the German Federal Institute for Risk Assessment (BfR), runs counter to the finding earlier this year by the International Agency for Research on Cancer (IARC), the highly respected cancer arm of the World Health Organization that glyphosate is a probable human carcinogen. This IARC classification is based on a comprehensive assessment of the peer-reviewed toxicologic and epidemiologic literature undertaken over a 12-month period by a Working Group of 17 independent expert scientists. The IARC review linked glyphosate to dose-related increases in malignant tumors at multiple anatomical sites in experimental animals and to an increased incidence of non- Hodgkin lymphoma in exposed humans.

“We reviewed these two differing decisions on the human carcinogenicity of glyphosate and conclude that the IARC WG decision is by far the more credible. The IARC WG decision was reached relying on open and transparent procedures by independent scientists who completed thorough conflict-of-interest statements and were not affiliated or financially supported in any way by the chemical manufacturing industry. It is fully referenced and depends entirely on reports published in the open, peer-reviewed biomedical literature. It is part of a long tradition of deeply researched and highly credible reports on the carcinogenicity of hundreds of chemicals issued over the past four decades by IARC and used today by international agencies and regulatory bodies around the world as a basis for risk assessment, regulation and public health policy. In contrast, the BfR decision is not credible because it is not supported by the evidence and it was not reached in an open and transparent manner.

“Accordingly, we urge you and the European Commission to disregard the flawed EFSA finding on glyphosate in your formulation of glyphosate health and environmental policy for Europe and to call for a transparent, open and credible review of the scientific literature.”

Bernhard Url, EFSA’s Executive Director, sent a detailed reply to Prof. Portier that addresses the points raised in his letter, stating that glyphosate is currently a keenly debated issue, which makes it especially incumbent on those involved in its evaluation to describe clearly the legal frameworks [in which we work].

He further stated that, “IARC evaluations can represent a first step in carcinogen risk assessment to be considered – if available – by national and international authorities such as EFSA when carrying out their own assessments.

“I agree that IARC carries out an important role in the screening assessment of the carcinogenic potential of agents. However, we should not compare this first screening assessment with the more comprehensive hazard assessment done by authorities such as EFSA, which are designed to support the regulatory process for pesticides in close cooperation with the Member States in the EU.”

Url continues by stating that, in order to clarify certain differences of opinion, EFSA has agreed to meet with IARC in the early part of 2016 to discuss the different evidence and methodologies the two organisations have used. He highlighted that IARC’s broad screening covered both the active substance glyphosate and glyphosate-based pesticide formulations, whereas EFSA only covered the active substance as required by EU legislation.



Food Safety, Ingredients ,

EFSA to Release Report on Bisphenol A in January 2015

January 3rd, 2015
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efsa-logoExperts from the European Food Safety Authority (EFSA) have finalised and adopted their scientific opinion on the risks to public health from bisphenol A (BPA) in foodstuffs. The milestone follows a comprehensive risk assessment of this substance. BPA is a chemical used to manufacture plastics and resins that are used in a variety of food contact materials as well as other consumer and industrial products.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids adopted the opinion during its plenary meeting last December 10-11. EFSA will publish the opinion by the end of January 2015, allowing the necessary time for formatting and a thorough editorial check, which is standard for all EFSA scientific opinions.

EFSA has carried out an extensive consultation and engaged with national authorities and stakeholders to ensure the widest possible range of scientific views and information have been considered, including similar scientific assessments currently underway at Member State level.

For more information on Bisphenol A, click here

Source: Asia Food Journal


Food Safety, Health , ,

Lallemand Yeast Gets EU Marketing Authorization

July 12th, 2014
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efsa-logoFollowing EFSA’s earlier positive recommendation, the European Commission has granted marketing authorisation for Lallemand Inc.’s Vitamin D baker’s yeast (Saccharomyces cerevisiae). This development helps make bread and other yeast-leavened bakery products to become even healthier foods for European consumers by being new daily sources of vitamin D when baked with Lallemand’s VitaD baker’s yeast.

The major source of vitamin D is exposure to sunlight. But now, world populations are living indoor lifestyles and increasingly uses sunscreens when outside. Therefore, it is becoming more important to acquire vitamin D through dietary sources.

But there are only a few natural food sources of vitamin D, which explains why at least one third of the world’s population is deficient in vitamin D. In Europe, EFSA estimates that a large percentage of the population does not meet the recommended daily allowances of 10?g/day. In 2012, the mean percentile intake of vitamin D from foods among young children varied from 1.7 to 5.6 ?g/day, and from 1.6 to 4.0 ?g/day in adolescents. For adults, estimates of vitamin D mean intake from foods varied from 1.1 to 8.2 ?g/day.

EFSA has approved a number of health claims for vitamin D, which are only granted to nutrients following a rigorous evaluation process. These health claims are related to the importance of vitamin D to the normal absorption of calcium and to the maintenance of healthy bones and teeth, but also include the recent discovery of the crucial importance of vitamin D to the function of the IMMUNE system.

According to an Angus Reid survey conducted in 2012 for Lallemand in nine countries across Europe, a large proportion of European consumers (84%) believe that vitamin D plays a great role in maintaining or improving their health. This survey also offers an interesting new peek into European consumers’ views on vitamin D:

  • The most common health benefits European consumers’ associate with vitamin D are protection against osteoporosis and fracture risk (48%), followed by cardiovascular disease (20%) and influenza (20%).
  • Food sources European consumers associated with Vitamin D: Cod liver oil (41%), followed by salmon (38%) and milk (34%).

“Since many Europeans are not meeting their needs for vitamin D and new dietary sources are needed, the European Commission’s approval now gives the baking industry a unique opportunity to offer a solution to enhance the healthy attributes of bread, benefiting from the growing consumer awareness of the importance of vitamin D to the maintenance of the immune system and bone health, as recognized by EFSA,” Gert Steenkamp, President and General Manager of Lallemand Yeast Group (EMEA Division), commented.

Source: Asia Food Journal


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EFSA gives green light to food contact materials

July 22nd, 2011
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The European Food Safety Authority has said it has no safety concerns about the use of two substances in food contact materials following requests from the UK.

Polymer antioxidant

The agency’s CEF panel delivered its positive scientific opinion on phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl trimesters.

The experts said there was no safety concern for the public if the migration of the substance – expressed as the sum of phosphite and phosphate form of the substance and the hydrolysis product 4-t-amylphenol) – does not exceed 5 mg/kg food.

The migration of the hydrolysis product 2,4-di-t-amylphenol should not exceed 0.05 mg/kg food, it added.

The substance, with CAS number 939402-02-5, European Commission reference number 74050 and the FCM substance No. 974, is for use as an antioxidant in all polymers at a maximum content of 1500 mg/kg polymer for contact with all food types at any time/temperature condition.

The referral to the Parma-based body was made by the UK Food Standards Agency (FSA) on behalf of the applicant Chemtura Corporation, USA.

To read the full opinion click here

Co-monomer fro EVOH and PVOH copolymers

The same panel also delivered a positive assessment on the monomer 3,4-diacetoxy-1-butene under specific conditions.

The EFSA scientists concluded that there was no safety concern for the consumer if the migration of the substance does not exceed 0.05 mg/kg food – including the hydrolysis product 3,4-dihydroxy-1-butene – and is only used as a comonomer for EVOH and PVOH copolymers.

The substance, with CAS No. 18085-02-4, REF. No. 15180 and the FCM substance No. 862, is designated for use as a comonomer in small percentages for the production of ethylene vinyl alcohol copolymer (EVOH) and polyvinyl alcohol copolymer (PVOH).

Stipulations were made depending on whether the substance was to be used as an inner layer or if in direct contact with food.

FCMs containing the copolymer as an inner layer are intended to be used with all types of foodstuffs under conditions of long term storage at room temperature whereas the copolymer layer in direct contact with food is intended for dry and fatty foods only, said the CEF panel.

Overall migration limit from EVOH or PVOH copolymers in direct contact with aqueous foods may be exceeded

The dossier was submitted on behalf of Nippon Gohsei, Japan, by the UK FSA

To read the full opinion click here

Source: Food Production Daily


Food Safety, Packaging ,

EFSA Panel Clears Flavour Usage

June 11th, 2011
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The European Food Safety Authority (EFSA) has said that two artificial flavours, a sulphur substituted pyrimidin-derivative and its hydrochloride salt (FL-no 16.116 and 16.120), can be used in food and drink products as they do not give rise to any safety concerns.

According to the panel, the results do not give any reason for a safety concerns at their levels of dietary intake, estimated on the basis of the maximised survey-derived daily intake (MSDI) approach.

Normal use levels are in the range of 4mg/kg to 10mg/kg food and the maximum use levels are in the range of 8.5mg/kg to 25mg/kg.

The flavours were found in nine out of the 18 food categories listed by the panel, including edible ices, dairy products, cereals and cereal products, confectionery, bakery, meat products, alcoholic and non-alcoholic beverages.

According to the panel, both fall within the Flavouring Group Evaluation 301 and chemical group 30 under commission regulation and neither of the substances has been reported to occur naturally in any food items, however, the flavours were confirmed to be safe.

Source: Foodprocessing technology


Ingredients , , ,

EFSA defends aspartame work, denies dossier loss

June 11th, 2011
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The European Food Safety Authority (EFSA) has denied a suggestion by two MEPs that it may have lost data relating to a previous safety evaluation of the high intensity sweetener aspartame (E951) and that it failed to examine it properly in the first place.

MEPs Corinne Lepage and Antonyia Parvanova, from the Alliance of Liberals and Democrats welcomed the news that a full evaluation of aspartame’s safety profile would be completed before July 2012.

Mystery dossier

But calling for further public information on uncertainties concerning the health implications of aspartame intake to be made available – particularly for pregnant women – they said in a joint statement: “We should denounce how careless the EFSA and the Commission have been until handling this case until now.

“Recent exchanges of letter between NGOs [non-governmental organisations] and the EFSA seem to indicate that the EFSA never took the time to look at the original evaluation, and that data has even been lost.”

The specific exchange relates to a request from French NGO Réseau Environnement Santé (RES) to EFSA, asking the authority to communicate toxicology studies upon which the Admissible Daily Intake (ADI) of aspartame in Europe is based.

Hugh Kenigswald replied on May 24 that EFSA did not have the relevant dossier, and contacts with his colleagues at the European Commission suggested that they no longer possessed it.

In a public hearing on aspartame in the European Parliament on March 16, the MEPs asked EFSA (RES has also) to release toxicology data on the Admissible Daily Intake (ADI), and to recalculate levels based on manufacturer-independent studies of aspartame.

Presented with the data loss claim, an EFSA spokeswoman said: “EFSA has not lost any data…[and] is undertaking a risk assessment of the safety of this food additive based on all available scientific and technical data.”

She added that, had any evidence been found to date that would have led EFSA to reconsider the safety of aspartame or its ADI, then it would have done so.

This included two recent papers from 2010 that have in part prompted the European Commission to ask EFSA for a review, a carcinogenicity study in mice exposed to aspartame, and an epidemiological study that linked drinks sweetened with aspartame to premature child birth.

Extensive aspartame work

Mentioning EFSA’s recent call for data on E951, with a deadline for submissions of September 30 2011, the spokeswoman said that the authorisation granted to aspartame in 1994 for food additive use was based on a 1984 toxicological assessment by the Scientific Committee on Food (SCF) which published a further opinion in 2002.

“Furthermore, it is not as if EFSA has done no work on aspartame. It has carried out a substantial body of work on the substance over the years,” the spokeswoman added.

“Its experts issued two scientific opinions on aspartame in 2009, which took into consideration a study on the carcinogenicity of rats carried out by the European Ramazzini Foundation and all other available evidence.

“They concluded there was no indication of any genotoxic or carcinogenic potential of aspartame and no reason to revise the previously established ADI. An earlier opinion of 2006, following the first study on aspartame by the ERF, had also confirmed the safety of the sweetener.”

Source: Confectionery News


Food Safety , ,

EFSA publishes first practical guidance for assessing nano applications in food & feed

May 13th, 2011
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The European Food Safety Authority has today published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed. The guidance is the work of the Authority’s Scientific Committee and is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain. The guidance covers risk assessments for food and feed applications including food additives, enzymes, flavourings, food contact materials, novel foods, feed additives and pesticides.

The EFSA guidance, prepared in response to a request from the European Commission, sets out the considerations for risk assessment of ENM that may arise from their specific characteristics and properties. Importantly, the ENM guidance complements existing guidance documents for substances and products submitted for risk assessment in view of their possible authorisation in food and feed. It stipulates the additional data needed for the physical and chemical characterisation of ENM in comparison with conventional applications and outlines different toxicity testing approaches to be followed by applicants.

Commenting on the publication of the EFSA guidance, Professor Vittorio Silano, Chair of EFSA’s Scientific Committee explained, “A thorough characterisation of the engineered nanomaterials followed by adequate toxicity testing is essential for the risk assessment of these applications. Yet we recognise uncertainties related to the suitability of certain existing test methodologies and the availability of data for ENM applications in food and feed. The guidance makes recommendations about how risk assessments should reflect these uncertainties for food and feed applications.”

To assist with the practical use of the guidance, six scenarios are presented which outline different toxicity testing approaches. For each scenario, the guidance indicates the type of testing required.

EFSA conducted a public consultation on its preparatory work, acknowledging the importance of developing risk assessment methodologies in this field to support innovation whilst ensuring the safety of food and feed. In total 256 comments were received from 36 organisations spanning from academia, NGOs, industry to Member State and international authorities. All of these contributions were considered and incorporated into the guidance document where appropriate.

Risk assessment of engineered nanomaterials is under fast development and consequently, in keeping with EFSA’s commitment to review its guidance for risk assessment on an ongoing basis, this work will be revised as appropriate.



Food Safety, Technology ,

EFSA backing for resistant starch claim may spur bakery innovation

April 22nd, 2011
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The European Food Safety Authority’s backing for a functional health claim for resistant starch should be good news for bread, biscuit and cereal manufacturers wanting to tap into the functional foods market.

In the fourth batch of article 13 general function health claims, EFSA issued a positive opinion for a claim that resistant starch (RS) can reduce post-prandial glycaemic and insulinaemic responses when replacing digestible starches in high carbohydrate baked goods by at least 14 per cent.

However, the Panel on Dietetic Products, Nutrition and Allergies (NDA) did not approve the additonal claims for RS in relation to ‘digestive health benefits’ and ‘favours a normal colon metabolism’ as it said these did not refer to “any specific health claim as required by Regulation (EC) No 1924/2006.”

The NDA said most of the studies provided for the healthy blood glucose/sugar levels health claim for RS reported a significant decrease in post prandial glycaemic responses, without significantly increasing insulinaemic responses, following intake of RS type 2 “as a partial replacement of digestible starch in baked goods.”

While RS type 2 from high amylose maize was subject of the claim, the NDA found that the effect of replacing digestible starch in foods with RS on post prandial glycaemic responses could be expected from all RS types, and that “this effect is not specific to RS2 from high amylose maize.”

The panel thus concluded that causality had been established between the consumption of resistant starch from all sources, when replacing digestible starch in baked foods, and a reduction of post prandial glycaemic responses.

RS ingredient development

Resistant starch (RS) is so called because of its ability to resist digestion in the small intestine, unlike most other starches. RS passes through to the large intestine where it acts like dietary fibre.

RS occurs naturally in foods such as unripe bananas and cooked and cooled potatoes, but commercially produced RS ingredients have started to appear on the market in order to allow food manufacturers to incorporate the ingredient into their products.

This has provided the industry with another means to tap into opportunities gleaned from the growing trend for health and wellness foods, with resistant starch fitting squarely into the low-glycaemic food trend.

Companies like National Starch with its Hi-Maize ingredient, which is derived from corn, have been very active in building the science behind the ingredient.


High-fibre foods demand

A 2010 Datamonitor consumer survey found products positioned as high in fibre can influence buying behavior. It also reported that three out of ten (30 per cent) European consumers claim to purchase functional foods on a regular basis, an improvement on the previous year’s 23 per cent who claimed to do so.

However, Datamonitor analyst Mike Hughes that the key challenge for manufacturers to further boost growth is to overcome consumer skepticism that exists towards functional foods in Europe, with the 2010 survey finding that only 25 per cent of European shoppers trust functional health claims.

“If premium prices are going to be charged for functional bread offerings, this trust barrier needs to be overcome,” he cautioned.

RS fortified biscuits and cereals

A study, published in the journal LWT – Food Science and Technology in June last year, found that substituting wheat flour for resistant starch may be an easy way for formulators to boost the health profile of a product without affecting taste or acceptance.

Up to 40 per cent of the wheat flour in a short dough biscuit could be replaced by RS without detrimentally affecting the taste, sweetness and overall acceptance, claimed the findings from Spanish researchers based in the Instituto de Agroquímica y Tecnología de Alimentos (CSIC) in Valencia.

And last month, a Turkey based scientist, writing in the International Journal of Food Science and Technology, said that food engineers should focus more on designing processes that may lead to breakfast cereal products with substantial amounts of RS.

Ayten Alsaffar, noting that changes in moisture, temperature, the duration of heating and subsequent cooling can influence the RS content of foods, found that the current RS levels in commercially available breakfast cereals are not high enough to deliver its beneficial effects.

“The highest RS value, 3.6 g/100 g food (as eaten), is found in corn flakes. These RS values, however, does not appear to be nutritionally significant (Englyst & Cummings, 1987).

The challenge is to generate breakfast cereals with much higher RS contents (such as 10–20 per cent) to make a substantial difference to the physiological properties of these foods,” observes Alsaffar.

Meanwhile, Euromonitor International predicts that the global fortified bakery products market will be worth over €27bn in 2015 from a market value of over €21bn in 2010.

Source: Bakery and Snacks


Bakery , ,