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Efsa proposed Titanium dioxide (E171) as not safe!

EFSA 2021 safety assessment of titanium dioxide (E171)

1. What is titanium dioxide?

Titanium dioxide is used a food colour (E171) and, as with all food colours, its technological function is to make food more visually appealing, to give colour to food that would otherwise be colourless, or to restore the original appearance of food. Titanium dioxide is also present in cosmetics, paints, and medicines.

You can find more information about EFSA’s work in the area of food additives on the website. Also you can contact us for titanium dioxide test.

2. What foods contain titanium dioxide?

The main food categories contributing to dietary exposure of E171 are fine bakery wares, soups, broths and sauces (for infants, toddlers and adolescents); and soups, broths, sauces, salads and savoury based sandwich spreads (for children, adults and the elderly). Processed nuts are also a main contributing food category for adults and the elderly.

3. What is EFSA saying in its 2021 opinion on the safety of titanium dioxide as a food additive?

After conducting a review of all the relevant available scientific evidence, EFSA concluded that a concern for genotoxicity of TiO2 particles cannot be ruled out. Based on this concern, EFSA’s experts no longer consider titanium dioxide safe when used as a food additive. This means that an Acceptable Daily Intake (ADI) cannot be established for E171.

EFSA’s evaluation is related to the risks of TiO2 used as a food additive, not to other uses.

4. Should I stop eating products that contain TiO2?

Although the evidence for general toxic effects was not conclusive, on the basis of the new data and strengthened methods our scientists could not rule out a concern for genotoxicity and consequently they could not establish a safe level for daily intake of TiO2 as a food additive.

In their role as risk managers, the European Commission and Member States will now reflect on EFSA’s scientific advice and decide upon any appropriate regulatory measures or advice for consumers.

5. Is EFSA banning titanium dioxide?

No. EFSA’s role was limited to evaluating the risks linked to titanium dioxide as a food additive. This included an assessment of relevant scientific information on TiO2, its potential toxicity, and estimates of human dietary exposure. Any legislative or regulatory decisions on the authorisations of food additives are the responsibility of the risk managers (i.e. European Commission and Member States).

6. What happens next?

EFSA’s scientific advice will be used by risk managers (the European Commission, Member States) to inform any decisions they take on possible regulatory actions.

Please contact us for Titanium dioxide test.

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Amazon laboratory for dietary supplements

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In order to achieve this, there are 2 ways for a laboratory:

1) Identification CoA that your ingredient is tested by PCR ,

and if not possible;

2) A CoA by input, from an accredited laboratory who can form an input CoA for you with the information you provide including production details.

Fortunately we can do both!

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We need you to supply:

• Finished Product Specification (a detailed description of the product, all the requirements related to the production process as well as technical and functional aspects of the product)

• Batch Records (Blending Discharge, Blending Discharge Table and Blending Yields) – that means your production charts that you keep when producing.

· Input weights of each ingredient + run total weight must be clearly visible.

· Serving size (fill weights) clearly visible

• Picture of product (Lot # and Supplement Table) – thats we have already

• Deviation documentation (if applicable)

• Manufacture + Expiration date (if applicable)

• Name of Product and active compounds to appear EXACTLY as it should on COA.

 

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USDA organic and UK organic are interchangeable now! : Trade of organic products between United States and United Kingdom

Directly quoted from usda.gov:

Until January 1, 2021, the European Union (EU) organic regulations and U.S.-EU equivalence arrangement apply to the trade of organic products between the United States and the United Kingdom. Please visit the U.S.- EU International Trade Policies page for more information about the equivalence arrangement.

Effective January 1, 2021, the United States (U.S.) has an equivalence arrangement with the United Kingdom (UK), which includes Great Britain (England, Scotland, Wales) and Northern Ireland. This means that organic products certified to either the USDA or UK organic standards may be labelled and sold as organic in both countries, as long as the products meet the terms of the arrangement.

This page will be updated as more information becomes available from the UK.

Scope. This equivalence is limited to organic products that have been either raised within the U.S. or UK, or products for which the final processing or packaging occurs within the U.S. or UK. This includes products processed or packaged in the U.S. or UK that contain organic ingredients from third countries that have been certified to the USDA or UK organic standards.

Allowed product categories: Crops, Wild Crops, Livestock, Processed Products.

Terms of the Arrangement. Generally, USDA and UK certified organic products are eligible for trade under this equivalence, but there are some stipulations.

The following products may not be exported to the U.S. as certified organic:

Agricultural products derived from animals treated with antibiotics.
Aquatic animals (e.g. fish, shellfish)
Wine must be produced and labelled according to the organic regulations of the destination country.

BEFORE January 1, 2021: For USDA organic products shipped before January 1, 2021, a USDA-accredited certifying agent must, complete an electronic Certificate of Inspection (COI) through the European Union’s (EU) Trade Control and Expert System (TRACES) for products shipped to the UK. All USDA organic products must comply with the terms of the U.S.-EU organic equivalence.
TRACES login for Certificate of Inspection

ON/AFTER January 1, 2021: All organic goods imported from non-EU countries must continue to have a valid COI. There will be a new UK import process for all USDA organic products traded under the arrangement. Different documentation is required depending on whether the USDA organic product is exported to the UK-Great Britain (England, Scotland, Wales) or the UK-Northern Ireland.
USDA organic products exported to the UK-Great Britain: A USDA-accredited certifying agent must issue a paper Certificate of Inspection (COI) before the products leave the U.S. and send to the UK Port Health Authority (PHA)/Local Authority (LA), usually by courier. The PHA/LA can endorse a copy if the original hasn’t arrived in order to clear the goods, though the original will need to be endorsed within 10 working days for the consignment to be sold on as organic. The NOP will link to the GB Certificate of Inspection as soon as it is available.
USDA organic products exported to the UK-Northern Ireland: Pursuant to the Northern Ireland/Ireland Protocol, the EU organic regulations will remain applicable in Northern Ireland. Exports from the U.S. to Northern Ireland will continue to adhere to the EU procedures and will continue to require an EU COI. A USDA-accredited certifying agent must complete an electronic Certificate of Inspection (COI) through the European Union’s Trade Control and Expert System (TRACES) before the product leaves the U.S. Certain edits to the COI may only be made within 10 days of issuing the original COI.
U.S. organic businesses that encounter issues with USDA organic exports arriving in the UK are encouraged to work with their UK importer. You may also email the UK authorities at Organic.Imports@defra.gov.uk

Documentation – Imports of UK Organic Products. A certifying agent supervised by the UK’s Department of Environment, Food and Rural Affairs (DEFRA) and accredited in compliance with the UK’s organic regulations must complete a U.S. National Organic Program (NOP) Import Certificate, Form 2110-1, for all UK organic products traded under the arrangement whether originating from Great Britain or Northern Ireland.

The equivalence arrangement only covers products certified in and exported from the U.S. or the UK.

USDA Organic Certifying Agents
UK Organic Certifying Agents
Labeling. Exported products must meet the labelling requirements in the destination country. For UK retail products destined for the U.S., the labels must state the name of the UK certifying agent.

USDA Organic Seal
Visit the Government of the UK website for more information about labelling. https://www.gov.uk/guidance/trading-and-labelling-organic-food-from-1-january-2021

Please see the original release for further information and documentation.

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Pesticide risk assessment of the active substance garlic extract

Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659, lays down the procedure for the renewal of the approval of active substances submitted under Article 14 of Regulation (EC) No 1107/2009. The list of those substances is established in Commission Implementing Regulation (EU) No 686/2012. Garlic extract is one of the active substances listed in Regulation (EU) No 686/2012.

In accordance with Article 1 of Regulation (EU) No 844/2012, the rapporteur Member State (RMS), Ireland, and co‐rapporteur Member State (co‐RMS), Denmark, received an application from Ecospray Limited for the renewal of approval of the active substance garlic extract. In addition, the applicant submitted an application for inclusion of the substance in Annex IV of Regulation (EC) No 396/2005.

An initial evaluation of the dossier on garlic extract was provided by the RMS in the renewal assessment report (RAR) and subsequently, a peer review of the pesticide risk assessment on the RMS evaluation was conducted by EFSA in accordance with Article 13 of Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The following conclusions are derived.

The uses of garlic extract according to the representative uses as a repellent, insecticide and nematicide on a wide range of crops in agriculture, horticulture, amenity, as proposed at European Union (EU) level result in a sufficient efficacy against the target organisms.

The assessment of the data package revealed no issues that need to be included as critical areas of concern with respect to the identity, physical, chemical and technical properties of garlic extract or the representative formulations. A data gap was identified for monitoring method in groundwater.

There are no critical areas of concern identified in the mammalian toxicology area.

With respect to the residues in food and feed, the use of garlic extract as plant protection product according to the good agricultural practice (GAP), even at the most conservative estimate of potential residues, it is not expected to pose an acute or chronic health risk to the consumer. Data have also been provided showing that intake of garlic extract by lamb and other ruminants such as cattle should not pose a health risk to these animals.

A maximum residue level (MRL) application for inclusion of garlic extract into Annex IV of Regulation (EC) No 396/2005 has also been submitted. The inclusion of garlic extract into Annex IV of Regulation (EC) No 396/2005 is supported.

In the area of the environmental fate and behaviour, no critical areas of concern were identified.

In the area of ecotoxicology, the risk assessment for aquatic organisms could not be finalised for all representative uses except for the granular product to be applied below the soil surface in potatoes and parsnips (in both field and greenhouses).

Source: EFSA

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EFSA assesses health risks of aflatoxins in food

The European Food Safety Authority (EFSA) has published a risk assessment on aflatoxins in food.

The report evaluates toxicity of aflatoxins to humans, estimates dietary exposure of the European Union population to these mycotoxins, and assesses the human health risks due to estimated dietary exposure. The risk assessment by the Panel on Contaminants in the Food Chain is an update of similar work in 2007 and 2018.

It covers aflatoxin B1 (AFB1), AFB2, AFG1, AFG2 and AFM1. More than 200,000 analytical results on occurrence of aflatoxins were part of the evaluation. Grains and grain‐based products made the largest contribution to the mean chronic dietary exposure to AFB1 in all age groups, while liquid milk and fermented milk products were the main contributors to the AFM1 mean exposure.

The most frequently found aflatoxin in contaminated food is AFB1. Aflatoxin‐producing fungi are found in areas with a hot, humid climate and aflatoxins in food are a result of pre‐ and post‐harvest fungal contamination. Climate change is believed to impact their presence in Europe.

Possible health issues
In short‐term studies of seven to 90 days, AFB1 had negative effects on rodents including inhibition of normal growth, liver and kidney damage, and sustained alterations in the intestinal microbiota. For AFG1, AFG2, AFB2 or AFM1, no new short‐term toxicity or gut microbiota studies were identified.

AFB1 affects reproductive and developmental parameters and aflatoxins, especially AFB1, can produce an immunotoxic effect in rodents. The no‐observed‐adverse‐effect‐levels (NOAELs) for effects were around 30 μg/kg body weight (bw) per day.

There is evidence for genotoxic effects of AFB1 in pregnant mice, fetuses and young animals. It is not possible, based on available data, to make a quantitative comparison of the genotoxic potency of the other compounds. AFB1, AFG1 and AFM1 are carcinogenic when delivered orally via the diet.

The CONTAM panel said liver carcinogenicity of aflatoxins remains the pivotal effect for the risk assessment but in view of its genotoxic properties, it was not appropriate to establish a tolerable daily intake.

The highest AFB1 and AFT mean concentrations were for legumes, nuts and oilseeds, in particular pistachios, peanuts and other seeds. The top AFM1 mean concentrations were reported for milk and dairy products and milk‐based foods in the category food for infants and small children.

Public consultation feedback
In the international Codex Committee on Contaminants in Food, discussions on maximum levels and an associated sampling plan for aflatoxins in different foodstuffs are ongoing.

Maximum levels are set in EU regulation for AFB1 and the sum of AFB1, AFB2, AFG1 and AFG2 in tree nuts, apricot kernels, ground nuts (peanuts) and other oilseeds, dried fruit, cereals, and some spices as well as their processed products. For AFB1, limits exist for baby food and processed cereal‐based food for infants and young children and in dietary foods for special medical purposes intended for infants.

The panel said aflatoxin occurrence should continue to be monitored because of potential increases due to climate change using methods with high levels of sensitivity for detection.

The draft scientific opinion involved public consultation from October until November 2019 and had 14 comments from seven countries. Respondents included the Federation of European Rice Millers, European Flour Millers, European Dairy Association and European Snacks Association.

The U.K. Food Standards Agency, Istituto Superiore di Sanità in Italy, German Federal Institute for Risk Assessment (BfR) and National Institute for Public Health and the Environment (RIVM) also submitted comments.

EFSA has also published a scientific opinion on the risks for animal and human health of chlorinated paraffins in feed and food.

Chlorinated paraffins (CPs) are complex mixtures of polychlorinated n-alkanes. They may be released into the environment during product use and though incorrect disposal. There is also potential for contamination of the feed and food chain. CPs bio-concentrate in fish and mollusks and food is considered the main source of human exposure to them.

A preliminary risk characterization based on consumption of fish was performed, and calculated margins of exposure suggested no health concern.

This work also had a public consultation in August and September 2019 with 11 comments being received from seven countries including the BfR, RIVM and Federal Office of Consumer Protection and Food Safety (BVL) in Germany.

Please notice that Labsgate offers you accredited Aflatoxin (AFLA B1,B2,G1,G2) inn all commodities.

Soruce: foodsafetynews.com

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A scientific opinion on the three-event stack soybean

Following the submission under Regulation (EC) No 1829/2003 of application EFSA-GMO-NL-2015-
126 from Monsanto Company, the Panel on Genetically Modified Organisms of the European Food Safety Authority  was asked to deliver a scientific opinion on genetically modified (GM) soybean MON 87705 9 MON 87708 9 MON 89788 (hereafter referred to as ‘the three-event stack soybean’). The scope of application EFSA-GMO-NL-2015-126 is for the placing on the market of the three-event stack soybean for food and feed uses, import and processing.
Soybean MON 87705 9 MON 87708 9 MON 89788 (three-event stack soybean) was produced by conventional crossing to combine three single soybean events: MON 87705, MON 87708 and MON 89788. This combination is intended to alter the fatty acid profile in the seed (in particular increasing the levels of oleic acid) and tolerance to glyphosate-based and dicamba herbicides. The Genetically Modified Organisms Panel previously assessed the three single soybean events and did not identify safety concerns. No new data on the single soybean events, leading to modification of the original
conclusions on their safety have been identified. The molecular characterisation, comparative analysis
(agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological,
allergenicity and nutritional assessment indicate that the combination of the single soybean events and
of the newly expressed proteins in the three-event stack soybean does not give rise to food and feed
safety and nutritional concerns. In the case of accidental release of viable three-event stack soybean
seeds into the environment, this would not raise environmental safety concerns. The post-market
environmental monitoring plan and the reporting intervals are in line with the intended uses of soybean
MON 87705 9 MON 87708 9 MON 89788. Considering the altered fatty acid profile of the three-event
stack soybean, a proposal for post-market monitoring needs to be provided by Monsanto. The GM O
Panel notes that in the context of this application EFSA-GMO-NL-2015-126 Monsanto did not provide
a 90-day study on MON 87705 soybean in line with the applicable legal requirements. Therefore, the
GMO Panel is not in the position to finalise the risk assessment of soybean MON 87705 9 MON
87708 9 MON 89788 under the current regulatory frame.
Source: EFSA
oi: 10.2903/j.efsa.2020.6111
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Bisphenol S (BPS) New information on Bisphenol S (BPS) /Decision 1 – REACH Regulation (EC) No 1907/2006

Bisphenol S (BPS) is  that is used as a monomer in plastic food contact materials (FCM) which has a Specific Migration Limit (SML) of 0.05 mg/kg food is currently authorised under Regulation (EU) No 10/2011. The European Commission (EC) asked EFSA to assess the impact on the current authorisation of BPS in plastic FCM.

The new data shows that BPS is rapidly metabolised and eliminated from rats. Based solely on the studies , EFSA concluded that the lowest NOAEL of 20 mg/kg bw per day from the EOGRTS neither affects the current SML for BPS of 0.05 mg/kg food nor BPS current authorisation under Regulation (EU) No 10/2011.

EFSA recommends the collection of data on the use of BPS in plastic FCM and on its occurrence and migration intofoodin the context of its possible use as an alternative to bisphenol A (BPA).

Reference: https://efsa.onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2020.EN-1844

Please contact us if you have any questions or need testing about feed additives & food contact materials.

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acibenzolar-S-methyl

The approval of acibenzolar-S-methyl was renewed under Regulation (EC) 1107/2009 on 1 April 2016 by Commission Implementing Regulation (EU) 2016/389. It was a specific provision of the approval that the applicant was required to submit to the European Commission further information by 1 June 2017 as regards the relevance and reproducibility of the morphometric changes observed in the cerebellum of foetuses linked to exposure to acibenzolar-S-methyl and whether these changes may be produced via an endocrine mode of action. The information to be submitted shall include a systematic review of the available evidence assessed on the basis of available guidance (e.g. EFSA GD on Systematic Review methodology, 2010). In accordance with the specific provision, the applicant, Syngenta, submitted an updated dossier in May 2017 as well as additional information in February 2019 in line with the EFSA/ECHA guidance for the identification of endocrine disruptors (2018), which was evaluated by the designated rapporteur Member State (RMS), France, in the form of an addendum to the draft assessment report. In compliance with guidance document SANCO 5634/2009-rev.6.1, the RMS distributed the addendum to Member States, the applicant and EFSA for comments on 12 November 2019. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 11 March 2020. EFSA added its scientific views on the reporting table. The current report summarises the outcome of the consultation process organised by the RMS, France, and presents EFSA’s scientific views and conclusions on the individual comments received. The confirmatory data are considered not addressed. During the commenting period the link between developmental neurotoxicity effects (DNT) and T-mediated endocrine effect, supported by the RMS, was still considered to be further discussed and an experts’ consultation should be organised. It is also proposed to discuss the assessment of the endocrine disrupting (ED) properties of acibenzolar-S-methyl both for humans and non-target organisms and which additional test are needed to conclude on the ED properties.

source: EFSA

doi:10.2903/sp.efsa.2020.EN-1846

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Fluopyram MRL review— according to Article 12 of Regulation (EC) No 396/2005

EFSA considered the recent data to assess the occurrence of fluopyram residues in plants, processed commodities, rotational crops and livestock. A consumer risk assesment been carried out with derived proposals for MRL.

The metabolism of fluopyram in plant was investigated in primary and rotational crops. According to the results of the metabolism studies, the plant residue definition for enforcement can be proposed as ‘fluopyram’ and for risk assessment as ‘sum of fluopyram and fluopyram benzamide (M25), expressed as fluopyram’. These residue definitions are also applicable to processed commodities. Fully validated analytical methods are available for the enforcement of the proposed residue definition in all major matrices at the limit of quantification (LOQ) of 0.01 mg/kg. According to the EURLs, the LOQ of 0.01 mg/kg is achievable by using the QuEChERS method in routine analyses.

Please contact us for pesticides multi-residual analysis including  fluopyram.

To continue reading, please visit: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.6059

If you like to receive as pdf, please request by mail: office@labsgate.com

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pesticides analysis laboratory

NOP : Significant new enforcement regulations are coming soon for the National Organic Program.

That was the message from Jennifer Tucker, deputy administrator of the U.S. Department of
Agriculture’s NOP, who spoke Jan. 10 at The Packer’s Global Organic Produce Expo.
“The rule will be a game-changer,” Tucker said.
The “Strengthening Enforcement Rule,” now being reviewed by the Office of Management
and Budget, particularly applies to uncertified handlers and to importers, Tucker said. The
rule is expected to be published soon, Tucker said, and will have a 60-day comment period.
Tucker said the proposed rule will create:
Increased accountability and visibility;
Fewer exemptions with increased handler certifications;
A requirement for all imports to have certificates; and
Enhanced oversight of accreditation and certification.
“The goal is to transform the organic regulations to meet marketing needs,” Tucker said.
“We want to do very targeted actions that impact high-risk areas to increase accountability
and visibility.”
A big part of the rule, she said, will be to allow fewer exemptions, which will increase the
number of handler certifications.
Currently, handlers who deal with packaged organic products, or are brokers, don’t need to
be certified. Tucker said that is going to change.
Congress has asked the USDA to close the loophole of uncertified handlers and mandate
electronic certificates for all imports, she said.
“Customs and Border Protection is at this very moment programming the organic import
certificate into their automated commercial environment,” Tucker said. “There will now be
a mechanism (on the Automated Export System) to identify your products as organic and
they will have to be accompanied by an import certificate once the rule is final.”
Tucker said the technology is being developed by Customs and Border Protection to produce
import certificates in a way that won’t delay trade.
“We care about shipments moving across the border and we will not slow down that
process,” she said.
While CBP will own the automated system that produces the certificates, Tucker said USDA
will have access to the import certificate data for decisions and actions on investigations
and risk-based surveillance.
“We are going to be doing pilot testing this year when CBP finishes building the import
certificate (software),” she said.
The proposed regulation also will address unannounced inspections and inspector training
and tighten the rule on non-retail labeling. The rule also seeks to standardize organic
certificates and modify requirements for information sharing by certifiers, Tucker said.

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