Environmental and industrial contaminants
Regulation (EU) 2017/2158 establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food, has applied to food businesses from 11 April 2018. The publication of the EU Commission guidance for food business operators on the application of the legislation has been delayed. It will be published in due course on the Commission website.
The future monitoring recommendation on acrylamide levels in foods, which was endorsed at Standing Committee in June, has also been delayed. Once the Commission internal procedures are finalised this will be published in the official journal. The monitoring recommendation will be addressed to both Member States and food business operators and is intended to gather further information on levels of acrylamide in certain foods of interest. Once published the existing monitoring Recommendation (2013/647) will be repealed.
The Commission will start discussions in November to consider setting maximum levels for acrylamide in foods for infants and young children.
The Commission confirmed that performance criteria for acrylamide, already included within Regulation 2017/2158 (Annex III), will be included in the next amendment to Regulation 333/2007.
3-monochloropropane diol esters (3-MCPD esters) and Glycidyl esters (GE)
Commission discussions continue for the possible setting of maximum levels for 3-MCPD esters. The table below details the proposed levels for vegetable oils and fats, vegetable oils and fats for baby foods, infant formula, follow-on formula and foods for special medical purposes (powder and liquid) and fish oil.
Possible maximum levels for GE in fish oils, as detailed in the table below. The Commission are proposing to introduce a transitional measure for the lower levels of GE in infant formulas post July 2019, via the 3-MCPD esters measure.
These suggested maximum levels went to Standing Committee in September for information before being subject to a targeted stakeholder consultation. After this consultation the Commission will bring a proposal for vote at a future Standing Committee meeting.
The Commission has put out the consultation to targeted EU stakeholder associations. The deadline for comments and data to be submitted to the Commission is 2 November 2018. The FSA strongly encourages all interested parties to feed any comments on the feasibility of meeting the proposed limits into the European Commission through relevant EU industry associations.
Initial discussions have centred on setting levels for oils however, the Commission will then consider whether it is appropriate to set levels for these process contaminants in other foods in which it can be formed.
The EURL confirmed the extended range of recovery for MCPD esters as 70-125% as part of the analytical criteria in Regulation 333/2007.
Maximum levels for discussion for 3-MCPDE and GE in view of targeted stakeholder consultation (only the new suggested possible maximum levels (provisions in bold) are subject to targeted stakeholder consultation.
Maximum level (µg/kg)
|4.1.1||Hydrolysed vegetable protein||20|
Glycidyl fatty acid esters expressed as glycidol
|4.2.1||Vegetable oils and fats placed on the market for the final consumer or for use as an ingredient in food with the exception of the foods referred to in 4.2.2||1000|
|4.2.2||Vegetable oils and fats destined for the production of baby food and processed cereal-based food for infants and young children||500|
|4.2.3||Infant formula, follow-on formula and foods for special medical purposes intended for infants and young children (powder)||
75 until 30.6.2019:
50 as from 1.7.2019 (*)
|4.2.4||Infant formula, follow-on formula and foods for special medical purposes intended for infants and young children (liquid)||
10.0 until 30.6.2019:
6.0 as from 1.7.2019 (*)
|4.2.5||Fish oils placed on the market for the final consumer or for use as ingredient in food||1000|
|4.3||Sum of Free 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD|
Vegetable oils and fats and fish oils placed on the market for the final consumer or for use as an ingredient in food falling within the following categories, with the exception of the foods referred to in 4.3.2
|Oil and fats from coconut, maize, rapeseed, sunflower, soybean and palm kernel and mixtures of oils and fats with oils and fats only from this category||1250|
|Other vegetable oils and fish oil and mixtures of oils and fats with oils and fats only from this category||2500|
|Mixtures of oils and fats from the two categories||2500 (**)|
|4.3.2||Vegetable oils and fats destined for the production of baby food and processed cereal-based food for infants and young children||750|
|4.3.3||Infant formula, follow-on formula and foods for special medical purposes intended for infants and young children (powder)||125 (***)|
|4.3.4||Infant formula, follow-on formula and foods for special medical purposes intended for infants and young children (liquid)||15 (***)|
(*) foodstuffs that were lawfully placed on the market before the entry into application of the maximum level may remain on the market until 31 December 2019
(**) The oils and fats used as ingredient for the mixture shall comply with the maximum level established for the oil and fat. Therefore, the level of the sum of free 3- monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3- MCPD in the mixture shall not exceed the level calculated according to Article 2 (c) of this Regulation. In case the quantitative composition of the mixture is not determined, the level of the sum of free 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters, expressed as 3-MCPD in the mixture shall not exceed 2500 μg/kg.
(***) level to be reviewed in view of lowering the maximum within 2 years from the date of application
Following a discussion at Standing Committee in September the Commission has put out the consultation to targeted EU stakeholder associations. The deadline for comments and data to be submitted to the Commission is 2 November 2018. The FSA strongly encourages all interested parties to feed any comments on the feasibility of meeting the proposed limits into the European Commission through relevant EU industry associations.
After this consultation the Commission will bring a proposal for vote at a future Standing Committee meeting.
Draft maximum levels for discussion in view of targeted stakeholder consultation
Suggested levels – (mg/kg)
|Fruits and vegetables||0.05|
with the exception of:
Cucurbitaceae, kale, leafy vegetables except
spinach, rucola, and herbs
|Tea (Camellia sinensis), dried||0.75|
|Herbal and fruit infusions, dried||0.75|
Infant formula, follow-on formula and processed cereal based food
Furan and methylfurans
The Commission continues to consider future risk management approaches and the possibility of setting maximum levels for some foods (baby foods initially) and considering what action to take for others, including the possibility of future monitoring of furan and methylfurans in various foods.
The EURL confirmed that performance criteria are available for 2- and 3-methylfuran but not yet for 2,5-dimethylfuran.
The European Food Safety Authority (EFSA) has reviewed monitoring data from 2014 to current to inform discussions on possible lowering of existing maximum levels and possible new maximum levels to be set for vegetables, cereals, starchy roots, tubers, oil seeds and certain fruits, that are not currently regulated. Initial discussions have started at Commission working group as well as sharing information from those Member States which have undertaken research looking at farming practices which may reduce levels of cadmium.
Mercury and methylmercury in fish
There have been long standing discussions on mercury in fish. At Standing Committee meeting in September, the Commission confirmed that at this present time there will be no changes.
Polycyclic aromatic hydrocarbons (PAHs)
The derogation (Commission Regulation 1327/2014) covering small-scale, traditional smoked meat and fish products sold on national territory, and which included the UK, was reviewed earlier in 2018 and a revision was agreed for those Member States wishing to continue to benefit from it. Based on information available, the UK decided that further cover was not necessary. Nevertheless, the revised amendment is yet to be published and come into force.
Agricultural Contaminants and Plant Toxins
Ochratoxin A (OTA)
Following concerns from some Member States that the EFSA opinion on OTA might be outdated, the European Commission has requested EFSA to carry out an updated exposure assessment and if necessary, update the risk assessment. Recent toxicity data on OTA will be considered and an opinion is expected by July 2019. Risk management actions will be considered after this.
Discussions continue on setting maximum levels (MLs) for ergot alkaloids in cereal-based products. Initially, MLs are being discussed for milling products (barley, wheat, oats, spelt and rye). It is possible that MLs will also be set for cereal-based foods for infants and young children. It has also been suggested that the current ML for ergot sclerotia in cereal grains could be lowered from 0.5 g/kg to 0.1 g/kg. Analytical capabilities and the fact that some whole grain flours may need to be considered separately are also being discussed.
Discussions continue on managing possible risk from the presence of Alternaria toxins - alternariol (AOH), alternariol monomethyl ether (AME), tenuazonic acid (TeA) and tentoxin (TEN). Since there are no specific toxicity data for these mycotoxins, setting guidance levels for AOH, AME and TeA combined with a recommendation to monitor levels of these mycotoxins (including TEN) is being considered.
Foods considered for guidance levels: processed tomato products, paprika powder, sunflower seeds, cereal based foods for infants and young children. For TeA, guidance levels for millet grains, dried figs and (certain) tree nuts might be considered.
Citrinin in red yeast rice supplements
There has been wide support for lowering the current ML of 2000 µg/kg to 100 µg/kg for food supplements based on rice fermented with red yeast Monascus purpureus on the basis of recent data.
Discussions continue on setting the following MLs for erucic acid in oils and fats:
|Vegetable oils and fats*||20 g/kg|
|Infant formulae and follow-on formulae*||4 g/kg|
|Mustard as a condiment (whole weight)||35 g/kg|
*the maximum level refers to the level of erucic acid, calculated on the total level of fatty acids in food.
Since borage oil, camelina oil and mustard oil will not be able to achieve this ML and based on the evidence sent to the Commission, higher MLs could be proposed or these oils could be exempted from the MLs.
Pyrrolizidine alkaloids in honey, tea, herbal infusions and food supplements
Following the EFSA’s conclusion that there is a possible concern for human health related to the exposure to pyrrolizidine alkaloids (PAs), discussions on appropriate risk management measures for their presence in food continue. Proposals include setting MLs or action levels for PAs in teas, herbal teas, plant-based food supplements, culinary herbs and honey.
EFSA’s dietary exposure assessment to tropane alkaloids concluded that some population groups – especially infants, toddlers and children could exceed the safety guideline levels for atropine and scopolamine. Currently, MLs exist for processed cereal-based foods and baby foods for infants and young children, containing millet, sorghum, buckwheat or their derived products. Occurrence data have shown that corn (maize) can also be contaminated with tropane alkaloids; therefore, the existing MLs will be extended to processed cereal foods and baby foods for infant and young children containing corn. Since higher concentrations of atropine and scopolamine can also be found in products derived from buckwheat, millet and sorghum (milling products) as well as herbal infusions, popped cereals (cornflakes), cereal bars and spices, regulatory measures such as setting of MLs are being considered for these categories also.
Persistent Organic Pollutants
EFSA has adopted a new Scientific Opinion on the risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food. This was presented at the POPs Working Group on 10 September but is still undergoing internal review and is not expected to be published until towards the end of this year.
EFSA has adopted a new Scientific Opinion on the risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food. It was presented at the Environmental & Industrial Contaminants Working Group in June and has been reviewed by the UK Committee on Toxicity (COT) as reserved business but, as with the dioxin opinion, is still undergoing internal review prior to publication. A further EFSA opinion on other perfluorinated compounds is expected in mid-2019.