Ferré & Consulting Blog (English Version)

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, food contact materials

Ingredients EFSA, FL-no 16.116, FL-no 16.120, flavour

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 aspartame, E951, EFSA

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.

• Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain

• Outcome of the public consultation on the draft scientific opinion on Guidance on risk assessment concerning potential risks arising from applications of nanoscience and nanotechnologies to food and feed

Food Safety, Technology EFSA, Nanomaterial

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 BakeryandSnacks.com 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 EFSA, High-fibre foods, resistant starch

The European Parliament’s Environment committee is pushing for a warning label on products containing aspartame stating that they may not be suitable for pregnant women – despite opinions from EFSA and the French food safety ANSES that scientific evidence does not warrant a reconsideration of the sweetener’s safety.

An amendment to the food labelling proposal, currently in second reading, that would require the words “Contains aspartame (a source of phenylalanine; might be unsuitable for pregnant women)” was put forward by French MEP Corinne Lepage.

It follows the publication of a study Danish epidemiological study that saw a statistical association between the consumption of soft drinks containing sweeteners and increased risk of preterm delivery as a result of a medical decision following complications. The authors said the results, whether or not there is a causal link, needs to be confirmed by other studies.

This study, together with another from Italy reporting increased incidence of cancer in male mice fed very high doses of aspartame, has been reviewed by EFSA and by the French food safety agency ANSES, who said that preliminary examination give no grounds for amending the ADI of 40mg.kg.bw, but that further studies would be monitored.

Fair hearing or role-playing?

Moreover, last month an EFSA scientist took part in a hearing at the European Parliament on aspartame, to explain the work the authority has carried out on the sweetener over the years and the review of the latest studies.

After the hearing, however, Corinne Lepage, invoked the precautionary principle and accused industry, as risk managers, and EFSA, as risk assessor, of “role playing”.

She said that no independent evaluation of the studies had taken place, and that there sound be recommendations for pregnant women so pregnant women can be aware there is some uncertainty over aspartame and decide whether or not to expose themselves to it.

EFSA responded with disappointment over the reporting of the meeting’s outcome. It said in a statement: “Unfortunately, when reporting the outcomes of this meeting, the organisers of the hearing continue to repeat errors and misinformation. EFSA reaffirms that any possible risks from aspartame have been considered by scientific bodies worldwide and the current Acceptable Daily Intake (ADI) ensures consumers are protected…

“EFSA’s most critical commitment is to provide independent scientific advice of the highest quality and it has put in place a very stringent set of procedures and processes to guarantee the independence of its scientific decision-making – as organisers of this event know very well”

Ignoring EFSA?

It is not yet certain that the warning label on aspartame will be included in the new regulation, as the next stage of the law-making process is a series of trilogues between the Parliament, Council and Commission ahead of a vote in plenary in July.

However the amendment on aspartame is not the first time MEPs have sought a warning label on additives for which the Commission’s risk assessor has found no grounds for altering the ADI.

Following the publication of the controversial ‘Southampton study’ which reported a link between cocktails of certain food colourings plus sodium benzoate with hyperactivity in children, MEPs voted on a mandatory warning label on any products containing them – despite EFSA’s opinion that the Southampton study, in its own right, was no grounds for changing recommendations.

EFSA has since lowered the ADIs of some of the colours in question – but for reasons other than a link with hyperactivity, which has not been substantiated in studies on the individual colours.

More recently, MEPs put forward a motion to prohibit a European Food Safety Authority (EFSA) and European Commission (EC)-approved DHA omega-3 eye health claim on breast milk substitute products. The motion was narrowly rejected in a vote.

Source: Food navigator

Food Safety aspartame, EFSA, food labelling, pregnancy

The Comprehensive Database contains data from a total of 32 different dietary surveys from 22 Member States, including those obtained through an EFSA “Article 36”[1] grant focused on children’s food consumption data[2].

Summary statistics from the database enable quick screening for chronic and acute exposure to substances that may be found in the food chain. These statistics will be available to the public on the EFSA web site. In the database, dietary surveys and food consumption data for each country are divided by category; these include: age, from infants to adults aged 75 years or older[3]; food group (nearly 160) and type of consumption, covering both regular and high consumption thus allowing calculations to be tailored to each category of consumer. The statistics on food consumption are reported in grams per day, as well as grams per day per kg of body weight.

The food consumption database will also represent a basis for instance for the work related to the assessment of nutrient intakes of the EU population. In the area of nutrition, the analysis of dietary intake data is essential to help set science-based public health targets and to assess how dietary intakes compare with recommended intake levels, as well as to monitor progress over time.

The work on this new database began in 2008, when Member States started gathering data for EFSA from national dietary surveys in their countries. While this database is useful for EFSA’s risk assessment work, the data in it was derived using different methodologies, therefore making this unsuitable for direct country-to-country comparisons.

The collection of accurate, harmonised and detailed food consumption data at a European level is important for EFSA’s work and in this regard, cooperation with EU Member States is considered a priority. EFSA is working with Member States to develop food consumption surveys which will allow the collection and analysis of comparable data in EU countries. This initiative is known as “What’s on the Menu in Europe?” (EU MENU); several pilot studies under this initiative are due to be completed by 2012.

• The EFSA Comprehensive European Food Consumption Database

• Guidance for the use of the EFSA Comprehensive European Food Consumption Database
• Evaluation of the FoodEx, the food classification system applied to the development of the EFSA Comprehensive European Food Consumption Database

Food Safety database, EFSA, food consumption

EFSA will issue a scientific statement on two recent studies on the safety of artificial sweeteners by the end of February 2011, responding to a request for technical assistance from the European Commission. Guided by the statement of the Panel on Food Additives and Nutrient Sources added to food (ANS) published today, EFSA’s scientific evaluation will be carried out in close co-operation with the French agency for food, environmental and occupational health safety, ANSES[1], and will help inform the Authority’s ongoing work on artificial sweeteners.

One of the studies published was conducted by the Ramazzini Institute and focuses on the potential carcinogenicity of aspartame in mice (Soffritti et al., 2010[2]). The other is an epidemiological study that examines the association between the consumption of sugar-sweetened and artificially-sweetened soft drinks and the risk of preterm delivery in Danish pregnant women (Halldorsson et al., 2010[3]).

At their plenary meeting on 1 – 3 February 2011, EFSA scientists on the ANS Panel had an initial discussion on these recent publications and highlighted further scientific work which could be considered. The Panel noted that the type and incidence of tumours reported by Soffriti et al (2010) appear spontaneously at high rates in male mice. The Panel also observed that the increased incidence of these tumours in mice exposed to aspartame through feed, whilst statistically significant, remained within the historical control range for these tumours in these mice[4]. EFSA will support the Panel in further analysing the results and conclusions in the Ramazzini paper and will request the complete data set from the authors for possible review.

The ANS Panel also considered the Danish epidemiological study whose findings suggest that the daily intake of artificially sweetened soft drinks may be associated with an increased risk of preterm delivery. These findings are based on a statistical association between the consumption of artificially sweetened soft drinks and preterm delivery observed in a prospective cohort study[5]. This epidemiological study cannot, in and of itself, establish a cause and effect relationship between the intake of artificial sweeteners and risk of preterm delivery. As indicated by the authors, further research (including experimental studies) would be required to confirm or reject these findings. The Panel advised on the need for specialised expertise to provide additional insights on the methodology and statistical aspects of this study, including the implications of possible confounding factors.

EFSA will provide a scientific statement on the two papers by the end of February 2011, responding to a request for technical assistance from the European Commission.

Source: EFSA

Health, Ingredients artificial sweeteners, EFSA, food safety

The European Food Safety Authority has published its final guidance for data required to assess new food flavourings, and is looking to build on experience gained during evaluations to establish a positive list.

EFSA reassessing flavouring substances that are already in use in the EU, numbering around 2800 in all. However it has asked for more tests on some 530 substances, including some that have been assessed by bodies like the FAO/WHO’s JECFA committee. The list of flavouring substances needs to be adopted by the end of 2010, and will be included in the new flavouring regulation 334/2008 was adopted at the end of 2008.

New flavouring substances proposed for foods, however, will have to go through a risk assessment procedure, and petitioners will have to supply data to allow EFSA’s panel to form its opinion.

The draft guidance was published in November 2009 for public consultation, and some meetings have taken place between stakeholders, notably between the European Flavour Association (EFA) and EFSA.

The guidance document, was adopted on 20 May but only published this week.

EFSA said its panel considers it important to build on experience gained during the reassessment, and where possible new flavouring substances will be assigned to one of the existing flavouring group evaluations on the basis of structural and metabolic similarities.

For these groups, scientific principles and a group-based approach have already been drawn up. Data requirements for these chemically-defined substances are included in part A of the guidance.

The guidance will be particularly helpful for data submission on new flavourings that cannot be put into any existing group, however, as it sets out a procedure that will allow for individual evaluation. This is included in part B of the guidance.

Generally speaking, the panel will require data on:

• Identity of source materials
• Manufacturing process
• Specifications
• Assessment of dietary exposure
• Toxicological data

New regulation

EFFA president Heinrich Schaper said the main objectives of the new regulation are promoting the effective functioning of the internal market and giving high level of consumer protection.

One major change is the new and more detailed labelling requirements for natural flavours, and the reclassification of nature identical and artificial flavours as ‘flavouring substances’. These new requirements need to be on labels and in documentation by January 2011, but flavour firms’ regulatory and IT teams have been working on making sure the raw materials are classified for compliance for some time.

Food Safety EFSA, food flavourings, lavouring substances

The European Food Safety Authority published new dietary reference values (DRVs) for carbohydrates, sugar, fibre, fats and water confirming proposals made last year. The final levels have drawn criticism from some scientists.

The EU risk assessor was asked by the European Commission to update DRVs for a slate of nutrients on the basis of the most recent scientific evidence, as the last time these were set was in 1993. The values released today are the first of three batches: advice on protein and energy is in the works, and EFSA will start working on vitamins and minerals later this year.

EFSA held public consultations on the new DRVs prior to confirming them. The values will now be used as an evidence base underpinning nutritional policies, public health targets, and consumer info and education programmes.

Carbs, sugar and fibre

EFSA’s advice on total carbohydrates is that intake should comprise between 45 and 60 per cent of total energy intake for both adults and children. A daily intake of 25g of fibre is recommended for normal bowel function in adults; EFSA has also recognised evidence linking fibre to reduced risk of cardiovascular disease and type 2 diabetes, and its role in weight management.

However it could not find sufficient evidence to support the role of the glycaemic index and glycaemic load in maintaining weight and preventing diet-related diseases.

No upper limit for sugars has been set, either, because of insufficient evidence and health effects are a matter of what foods are consumed and how often, rather than the amount of sugar per se. The panel does recognise that there is “good evidence that frequent consumption of foods high in sugars increases the risk of tooth decay”. But says policy makers should consider evidence for consumption patterns of sugar-containing foods when making national nutrition recommendations.

Balancing fats

Overall, EFSA says fat intakes should range between 20 and 35 per cent of total energy for adults (the values for children are adjusted to take account of their developmental needs).

But evidence for impact of different kinds of fat is recognised, such as the link between saturated and trans fats and blood cholesterol levels. Here too, though, EFSA leaves it to national policy makers to decide how to couch the message that mono- and poly-unsaturated fatty acids are better than trans and saturated.

In the case of long-chain omega-3 fatty acids, however, it is more prescriptive. It says a daily intake of 250mg for adults “may reduce the risk of heart disease”. However academics and industry have been lobbying for far higher values than this – ideally over 500mg a day.

Following the publication of the proposed values, a 22-strong of scientists wrote to EFSA to ask it to “reconsider its conclusions and advice on omega-3 fatty acids afresh, right from the beginning.”

The scientists also objected to the proposal that ALA (alpha-linolenic) acid is a “viable precursor” to longer-chain DHA and EPA fatty acids. EFSA’s final opinion states that “ALA cannot be synthesised by the body, is required to maintain metabolic integrity, and is therefore considered to be an essential fatty acid”.

It proposes an adequate intake level of 0.5 per cent of energy, but says there is not enough evidence to set an average requirement, a lower threshold intake or a population reference intake. It also sees no need for a tolerable upper intake level, as it says there is no convincing evidence of any detrimental health effects.

The final DRV included in the current batch is for water. EFSA says 2 litres a day is considered adequate for women, and 2.5 litres for men.

Food Safety, Health dietary reference values, EFSA, fat intakes, sugar intakes