(fra kommisjonsforordningen)

(1) Commission Regulation (EU) 2023/915 sets maximum levels for certain contaminants in foodstuffs, including inorganic arsenic in a range of foodstuffs. 

(2) Arsenic is a ubiquitous metalloid present at low concentrations in rocks, soil and natural ground water. Anthropogenic activity has contributed to increasing the levels of arsenic in the environment through industrial emissions (mining, smelting of nonferrous metals and burning of fossil fuels) as well as through the use of arsenic as an ingredient in fertilisers, wood preservatives, insecticides or herbicides. Although dermal and inhalation exposure is possible, food and drinking water are the principal routes of exposure to arsenic. 

(3) On 12 October 2009, the European Food Safety Authority (‘the Authority’) adopted an opinion on arsenic in food in which it concluded that inorganic arsenic can cause lung, bladder and skin cancers and skin lesions and it identified a range of ‘benchmark dose lower confidence limit’ (BMDL01) values between 0,3 and 8 μg/kg b.w. per day. As the estimated dietary exposures to inorganic arsenic for average and high consumers in Europe are within the range of the BMDL01 values identified, the possibility of a risk to some consumers cannot be excluded. Therefore, maximum levels were set for inorganic arsenic in various terrestrial foods by means of Commission Regulation (EU) 2015/1006. 

(4) In its scientific report of 2021, the Authority assessed the chronic dietary exposure of the European population to inorganic arsenic, taking into account the most recent occurrence data for inorganic arsenic in food and besides confirming the relevance of terrestrial foods to the exposure, it also concluded that in the adult population food groups such as ‘fish and other seafood’ were among the apparent sources of inorganic arsenic exposure in certain countries. 

(5) On the basis of the most recent occurrence data, and pending consultations as regards potential maximum levels for arsenic in fish and other seafood, Commission Regulation (EU) 2023/465 lowered the maximum level for inorganic arsenic in white rice and laid down maximum levels for certain terrestrial foods. 

(6) On 28 November 2023, the Authority adopted its scientific opinion on an update of the risk assessment on inorganic arsenic in food. It concluded that epidemiological studies show that the chronic intake of inorganic arsenic via the diet and/or drinking water is associated with an increased risk of several adverse outcomes including lung, bladder and skin cancers. The Authority used the BMDL05 of 0,06 μg /kg b.w. per day and applied a margin of exposure (MOE) approach. It considered that in adults the MOEs are low (range between 2 and 0,4 for average consumers and between 0,9 and 0,2 at the 95th percentile exposure) and it concluded that, therefore, the current exposure to inorganic arsenic raises a health concern despite the uncertainties. 

(7) In order to continue lowering the exposure of the population to inorganic arsenic, it is therefore appropriate to establish maximum levels for fish and other seafood, which contribute to that exposure. 

(8) Regulation (EU) 2023/915 should therefore be amended accordingly. 

(9) Taking into account that certain foodstuffs covered by this Regulation have a long shelf life and in order to prevent food waste, fish and other seafood that were lawfully placed on the market before the date of entry into force of this Regulation should be allowed to remain on the market until their date of minimum durability or use-by date.