BAKGRUNN (fra kommisjonsforordningen)

(1) For the active substance thiacloprid, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. The European Food Safety Authority (the ‘Authority’) reviewed these MRLs in accordance with Article 12 of Regulation (EC) No 396/2005 and recommended MRLs which it found to be safe for consumers. Commission Regulation (EU) 2015/1200 included these MRLs in Annex II to Regulation (EC) No 396/2005. 

(2) In 2020, the approval of this active substance was not renewed on the basis of Regulation (EC) No 1107/2009 of the European Parliament and of the Council, in view of the critical concerns identified by the Authority in the conclusions of the peer review in relation to the contamination of groundwater with potential carcinogenic metabolites of thiacloprid and its classification, in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council, as toxic for reproduction category 1B. Since the substance did not fulfil the approval criteria, the Authority did not consider it necessary to finalise the assessment of the possible endocrine disrupting properties of thiacloprid on the basis of the most recent criteria in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009. The Authority noted, however, that thiacloprid was considered to meet the criteria for endocrine disrupting properties set out in 2013 and the WHO definition for endocrine disruptors, since it causes adverse effects on the reproductive and endocrine system through an endocrine mode of action. 

(3) All existing authorisations for plant protection products containing thiacloprid have been revoked. It is therefore appropriate to delete the existing MRLs set out for this active substance in Annex II of Regulation (EC) No 396/2005 in accordance with Article 17 of that Regulation in conjunction with Article 14(1), point (a) thereof. In view of the new toxicological reference values, in particular a lower acute reference dose, as proposed in the conclusion of the peer review, the Commission requested the Authority to provide a statement under Article 43 of Regulation (EC) No 396/2005 containing a short-term (acute) dietary risk assessment for the MRLs that are based on non-EU uses, being those that are based on import tolerance requests and those that are based on Codex maximum residue limits (‘CXLs’) set in 2007. 

(4) In its statement, the Authority identified a risk for consumers concerning the CXLs for peaches and sweet peppers/bell peppers. It is therefore appropriate to lower the MRLs for those products to the product-specific limits of determination (‘LODs’). For the MRLs for papayas and tea, which were derived from import tolerances, and for the MRLs for quinces, medlars, loquats/Japanese medlars, apricots, cherries (sweet), plums, strawberries, “cane fruits”, “other small fruits and berries”, kiwis, potatoes, tomatoes, aubergines/eggplants, “cucurbits with edible peel”, melons, watermelons, rapeseeds/canola seeds, mustards seeds, rice, wheat, “animal (swine, bovine, sheep, horse, and other farm animals) products from tissues (muscle, liver, kidney and edible offal)”, poultry (muscle, liver and edible offal), milk and eggs, which are based on CXLs, the Authority did not identify an acute risk for the consumers but concluded that further consideration by risk managers was required.

(5) The risk assessment carried out by the Authority was based on existing toxicological reference values. These toxicological reference values do not necessarily reflect endocrine-related effects because they were not assessed according to the new EU criteria established in 2018. Furthermore, endocrine-related effects frequently occur at low-dose levels and endocrine disruptor substances often do not have a safe threshold. As a result, there remain reasonable grounds for concern that the MRLs that are based on non-EU uses have potentially harmful effects on human health and are inconsistent with the high level of consumer protection in the Union. The Commission has therefore requested the Authority to carry out an additional assessment for thiacloprid taking into account the most recent criteria for endocrine disruptors. 

(6) Pending the conclusion of this additional risk assessment by the Authority, and given the available pertinent information with regard to potentially harmful effects on human health, it is appropriate to provisionally lower the MRLs that are based on non-EU uses. These MRLs will be reviewed once the assessment by the Authority is concluded. 

(7) The Commission consulted the European Union reference laboratories for residues of thiacloprid as regards the need to adapt certain LODs. Those laboratories proposed product specific LODs that are analytically achievable for all products. 

(8) Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account. 

(9) Regulation (EC) No 396/2005 should therefore be amended accordingly. 

(10) To allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products which have been placed on the market in the Union before the new MRLs become applicable, except for pears, peaches, raspberries (red and yellow), sweet peppers/bell peppers, Chinese cabbages/pe-tsai and lettuces for which an acute risk to consumers was identified. This transitional measure is justified and proportionate given the limited range of products for which such a period would effectively apply (mainly long shelf life products and not fresh perishable products) and the low exposure of consumers from such products, as evidenced by recent monitoring data representative for the market collected by the Authority. 

(11) A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs. 

(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,