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FSA Contaminants Update, 19 December 2017
The European Food Safety Authority’s (EFSA) opinion on 'Risks for human health related to the presence of pyrrolizidine alkaloids in honey, tea, herbal infusions and food supplements' has now been published.
Mycotoxins and plant toxins
Pyrrolizidine alkaloids in honey, tea, herbal infusions and food supplements
The European Food Safety Authority’s (EFSA) opinion on 'Risks for human health related to the presence of pyrrolizidine alkaloids in honey, tea, herbal infusions and food supplements' has now been published. EFSA concluded that there is a possible concern for human health related to the exposure to PAs, in particular for frequent and high consumers of tea and herbal infusions and that consumption of food supplements based on PA-producing plants could result in exposure levels causing acute/short-term toxicity. Therefore, the European Commission has proposed that risk management actions are undertaken in order to reduce possible risks to consumers. Various appropriate regulatory measures including setting maximum levels for various categories of food are being discussed.
EFSA has published a report on Human and animal dietary exposure to ergot alkaloids which is an updated chronic and acute animal and human exposure assessment to ergot alkaloids taking into account the occurrence data available in the EFSA database. The exposure assessment indicated higher human acute and chronic exposure levels in comparison to those estimated in the previous Scientific Opinion published in 2012. However, the slight exceedance of the group ARfD and TDI was noted only at the maximum upper bound levels in the younger age groups of the high consumer scenarios.
Member States had agreed that appropriate and achievable maximum levels, providing a high level of human health protection, shall be considered for these relevant food categories before 1 July 2017 (EC Regulation No. 1881/2006 as amended). Therefore, the Commission has started discussions on appropriate risk management actions. One of the proposals is to set maximum levels for various cereal-based products. Preliminary proposed maximum levels are as follows (sum (lowerbound) of ergometrine, ergosine, ergocornine, ergotamine, ergocristine, ergocryptine and their respective -inine forms):
Performance criteria will also be specified, including proposed Limits of Quantification (LOQs - 4 µg/kg for milling products and 2 µg/kg for final consumer products with LC-MS or LC-MS/MS the recommended method of analysis.)
Following several rapid alerts that reported high levels of ochratoxin A (OTA) in some foods that currently do not have a maximum level, the Commission has initiated discussions on including MLs. The following foods - with the proposed MLs were discussed:
Stakeholders are invited to submit their views on the setting of MLs for OTA in the above foods as well as the levels proposed.
EFSA’s Scientific Opinion on the Appropriateness to set a group Health Based Guidance Values for T2 and HT2 toxin and its metabolites, established a Tolerable Daily Intake (TDI) for T2 and HT2 of 0.02 µg/kg body weight (bw) per day (reduced from the previous TDI of 0.1 µg/kg bw) and an acute reference dose (ARfD) of 0.3 µg for T2 and HT2/kg bw.
EFSA also carried out a revised exposure assessment to T-2 and HT-2 toxin and its metabolites - published in August 2017. In humans, the mean chronic dietary exposure to the sum of T2 and HT2 was highest in ‘Toddlers’ and ‘Infants’, with maximum upper bound (UB) estimates of 64.8 and 62.9 ng/kg bw per day, respectively. The 95th percentile dietary exposure was highest in ‘Infants’ with a maximum UB estimate of 146 ng/kg bw per day. In the absence of data, potential modiﬁed forms were not included.
EFSA assessed the risk to animal and human health related to Deoxynivalenol (DON), 3-acetyl-DON (3-Ac-DON), 15-acetyl-DON (15-Ac-DON) and DON-3-glucoside in food and feed. Since 3-Ac-DON and 15-Ac-DON are largely deacetylated and DON-3-glucoside cleaved in the intestines the same toxic effects as DON can be expected. The TDI of 1 µg/kg bw per day, that was established for DON was therefore used as a group-TDI for the sum of DON, 3-Ac-DON, 15-Ac-DON and DON-3-glucoside. A group-ARfD of 8 µg/kg bw per eating occasion was calculated.
The estimated mean chronic dietary exposure was above the group-TDI in infants, toddlers and other children, and at high exposure also in adolescents and adults, indicating a potential health concern. Estimates of acute dietary exposures were below this dose and did not raise a health concern in humans.
As mentioned in the previous stakeholder notification in June 2017, the following maximum reviewed levels have been proposed and will be sent for stakeholder consultation by the European Commission shortly:
(*) the maximum level refers to the level of erucic acid, calculated on the total level of fatty acids in food.
Following the publication of EFSA’s survey on citrinin in food, there has been support for further lowering of the current maximum level of 2000 μg/kg in food supplements based on rice fermented with red yeast Monascus purpureus. It has been suggested that good manufacturing practices are available and levels could be lowered to 500 μg/kg in the food supplement.
Environmental and industrial contaminants
Regulation (EU) 2017/2158 establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food was published in the Official Journal of the European Communities on 21 November 2017. The Regulation will apply directly to food businesses from 11 April 2018.
The Commission is working on high level draft guidance for food business operators (FBOs) on the application of the legislation which they hope to have finalised by January 2018. The Commission also plans to undertake awareness campaigns for both consumers and the food industry.
Discussions are expected to start in the new year on a future monitoring recommendation for gathering data mainly on acrylamide levels in foods not within the scope of the Regulation. The Commission will also start discussions to consider whether maximum levels for acrylamide could be set for certain types of food.
The EFSA opinion on Furans was published in October 2017. The Commission is now looking to inform future discussions for possible regulatory approaches in dealing with furan and methylfurans, including determining which foods should be examined taking into consideration that mitigation steps for furan were currently limited and that the number of differing factors and precursors was significant. At present foods indicated to be of most relevance are coffee, foods in jars and baby foods.
EFSA has reviewed new data and exposure levels for perchlorate are still considered to be a potential risk to health. The Commission is looking at setting maximum levels to replace the current levels for intracommunity trade. Initial; discussions on possible maximum levels have started and are expected to continue at working group meetings in the New Year.
Seaweed monitoring Recommendation
The proposed Commission Recommendation on the monitoring of metals and iodine in seaweed was further discussed. The Commission has recently suggested adding feed and also food additives made from seaweed. The Recommendation is expected to be formally agreed in the New year. The recommendation will be voluntary in nature and directed to both Member State competent authorities and also to the food industry. Any data collected would be submitted to EFSA for use in future risk assessments on seaweed consumption.