Notifications for European Union (1104 notifications)

This notified draft Regulation sets maximum residue levels for linuron to the limit of determination by application of Article 14 (1) (a) and Article 17 of Regulation (EC) No 396/2005 and following the revocation of national authorisations of plant protection products containing this active substance in the EU. National authorisations of plant protection products containing this active substance were revoked by application of Commission Implementing Regulation (EU) 2017/244 of 10 February 2017 concerning the non-renewal of approval of the active substance linuron, notified to the WTO Committee on Technical Barriers to Trade (G/TBT/N/EU/409).

This Regulation reviews the list of imports of feed and food of non-animal origin which are subject to an increased level of official controls.The changes to Annex I of Regulation (EC) No 669/2009 concern: the listing of okra from India (previously listed in Regulation (EU) No 885/2014), goji berries from China and turnips prepared or preserved by vinegar or acetic acid ("pickled turnips") from Lebanon and Syria; the de-listing of brassica oleracea from China, peas with pods from Kenya, aubergines and Ethiopian eggplant from Uganda, strawberries from Egypt, dried grapes from Iran and yardlong beans from Thailand; the decrease in the frequency of identity and physical controls to be performed on consignments of pineapples from Benin, and lemons and pomegranates from Turkey; the modification of the list of pesticides to be tested in case of tea from China; the modification of the scope of the existing entry concerning okra from Vietnam to include frozen okra; the modification to the existing entries "Apricots, otherwise prepared or preserved" (apricot pulp) to provide that, under certain conditions, identity and physical checks on consignments of such products may be carried out by the competent authorities of the place of destination as indicated in the common entry document (CED), if appropriate at the premises of the food business operator. This Regulation also amends Regulation (EC) No 669/2009 to provide that:in case of consignments entering the Union by air transport from a third country, which are unloaded for the purposes of being loaded on another aircraft in the same airport for onward travel to another airport in the Union, the designated point of entry shall be the latter airport; the provisions in Article 3(b) regarding transhipped consignments shall also apply to consignments which will travel onward to a port or airport in the same EU Member State; where the competent authority at the designated point of entry does not permit the introduction of a consignment of feed and food listed in Annex I due to non-compliance with a maximum residue level set out in Regulation (EC) No 396/2005, it shall immediately notify such border rejection in accordance with Article 19(3) of Regulation (EC) No 882/2004. This Regulation also amends Annex I to Regulation (EU) No 885/2014 by deleting the entry concerning okra from India.

The proposal notified in G/SPS/N/EU/218 (15 June 2017) was adopted as Commission Regulation (EU) 2018/62 of 17 January 2018 replacing Annex I to Regulation (EC) No 396/2005 of the European Parliament and of the Council (Text with EEA relevance) [OJ L 18, 23 January 2018, p. 1].  This Regulation is applicable since 1 January 2018.

The proposed draft Regulation concerns the review of existing MRLs for acetamiprid in certain food commodities to consider the new toxicological reference values, which were recommended by the European Food Safety Authority and recently endorsed in the European Union.

The proposed draft Regulation concerns the review of existing MRLs for bromuconazole, carboxin, fenbutatin oxide, fenpyrazamine and pyridaben in certain food commodities. MRLs for these substances in certain commodities are changed: either increased or lowered. Lower MRLs are set after updating the limits of determination and/or deleting old uses which are not authorised any more in the European Union or for which a human health concern may not be excluded. The residue definition for some substances has also been updated.

The proposal notified in G/SPS/N/EU/233 (22 February 2018) was adopted as Commission Regulation (EU) 2018/831 of 5 June 2018 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance) [OJ L 140, 6 June 2018, p. 35].This Regulation shall enter into force on 26 June 2018.

The proposal notified in G/SPS/N/EU/226 (15 September 2017) was adopted as Commission Regulation (EU) 2018/686 of 4 May 2018 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorpyrifos, chlorpyrifos-methyl and triclopyr in or on certain products (Text with EEA relevance) [OJ L 121, 16 May 2018, p. 30].This Regulation shall apply from 5 December 2018.

The proposal notified in G/SPS/N/EU/217 (15 June 2017) was adopted as Commission Regulation (EU) 2018/78 of 16 January 2018 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 2-phenylphenol, bensulfuron-methyl, dimethachlor and lufenuron in or on certain products (Text with EEA relevance) [OJ L 14, 19 January 2018, p. 6].This Regulation shall apply from 8 August 2018.

The Union list of flavourings and source materials is laid down in Annex I to Regulation (EC) No 1334/3008. It was established by Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances notified in G/SPS/N/EU/13/Add.1.Commission Regulation (EU) No 873/2012 provided for an extended transitional period, ending on 22 April 2018, for the flavourings belonging to specific categories of the Union list ("flavouring preparations", "thermal process flavourings", "flavour precursors", "other flavourings" and "source materials"). Flavourings belonging to these categories had to be subject of an application for authorization in order to be allowed to remain on the EU market pending the completion of the application procedure.An application was submitted for the product pyroligneous distillate (Fl no. 21.001) belonging to the category "other flavourings". This application was assessed by the European Food Safety Authority.This draft Commission Regulation amends the Union list by providing temporary authorization for five years for the product pyroligneous distillate (Fl no. 21.001), commercially known as rum ether under the category "other flavourings", to be added only to certain specific traditional spirits. This authorization at Union level replaces the national authorizations, which ceased to apply after the end of the transition period.

On 15 June 2016 a draft legal act setting criteria to identify endocrine disruptors under the plant protection products regulation was issued by the European Commission (Commission). This proposal was notified in G/SPS/N/EU/166 on 20 June 2016.In December 2016, this draft legal act was split into two parts without any change in content: one text containing the criteria for identifying endocrine disruptors, and the other containing a proposed amendment to the derogation possibility based on negligible exposure.Information regarding developments in the legislative process was provided by the EU in G/SPS/GEN/1594 on 20 December 2017.The text containing the criteria for identifying endocrine disrupting properties for plant protection products was adopted as Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (Text with EEA relevance) [OJ L 101, 20 April 2018, p. 33].On 2 May 2018 a Corrigendum – referring to the date of application – was published to Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties [OJ L 111, 2.5.2018, p. 10–10].This Regulation shall apply from 10 November 2018.

The Union list of flavourings and source materials is laid down in Annex I to Regulation (EC) No 1334/3008. It was established by Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances notified in G/SPS/N/EU/13/Add.1 (12 October 2012).Commission Regulation (EU) No 873/2012 provided for an extended transitional period, ending on 22 April 2018, for the flavourings belonging to specific categories of the Union list ("flavouring preparations", "thermal process flavourings", "flavour precursors", "other flavourings" and "source materials").Flavourings belonging to these categories had to be subject of an application for authorisation in order to be allowed to remain on the market until the end of the transition period.An application was submitted for the product "grill flavour concentrate (vegetable)" (Fl no. 21.002), belonging to the category "other flavourings". The European Food Safety Authority proceeded with the evaluation of this application and requested on 5 October 2017 additional studies to be submitted before 5 August 2018. As this deadline elapses after the end of the transition period, this draft Commission Regulation extends the transitional period for the flavouring product "grill flavour concentrate (vegetable)" (Fl no. 21.002) by two years, in order to allow for the completion of its safety assessment by the European Food Safety Authority and the subsequent completion of the application procedure.Pyroligneous distillate (FL no. 21.001) is currently the only flavouring added to the Union list of flavourings belonging to the category "other flavourings". Consequently, since 23 April 2018, the "grill flavour concentrate (vegetable)", (FL no. 21.002) and pyroligneous distillate (FL no. 21.001) are the only flavourings belonging to the category ‘other flavourings' that can be added to food placed on the market in the EU.

The proposal notified in G/SPS/N/EU/230 (24 October 2017) was adopted as Commission Implementing Regulation (EU) 2018/307 of 28 February 2018 extending the special guarantees concerning Salmonella spp. laid down in Regulation (EC) No 853/2004 of the European Parliament and of the Council to meat derived from broilers (Gallus gallus) intended for Denmark (Text with EEA relevance) [OJ L 60, 2 March 2018, p. 5].This Regulation entered into force on 12 March 2018.

Additional emergency import requirements are put in place in relation to Spodoptera frugiperda (Smith) which is already regulated as harmful organism in the EU.

The proposed draft Regulation concerns the review of existing MRLs for bromadiolone, etofenprox, paclobutrazol and penconazole in certain food commodities to reflect recent monitoring data submitted by the European Food Safety Authority and food business operators, which show that residues of those substances no longer occur at levels above the relevant limits of determination in the European Union.

The text amends the specifications for E 491 Sorbitan monostearate, E 492 Sorbitan tristearate and E 495 Sorbitan monopalmitate as a follow-up to an application and safety evaluation performed by EFSA. The Annex to Regulation (EU) No 231/2012 (specifications for food additives) is amended accordingly.

The text amends the title and the specifications for Cochineal, Carminic acid, Carmines (E 120) as a follow up to the recommendations made in the EFSA opinion re-evaluating safety of this food additive. Annex II to Regulation (EC) No 1333/2008 (Union list of food additives approved for use in foods and conditions of use) and the Annex to Regulation (EU) No 231/2012 (specifications for food additives) are amended accordingly.

The text removes octyl gallate (E 311) and dodecyl gallate (E 312) from the Union list of authorised food additives in Regulation (EC) No 1333/2008, since due to the absence of appropriate toxicological data it is not possible to assess the risk posed by the use of these substances as a food additive to human health. Therefore, the inclusion of these substances in the Union list of authorised food additives can no longer be justified. Annexes II and III to Regulation (EC) No 1333/2008 (authorised uses and use levels for food additives) and the Annex to Regulation (EU) No 231/2012 (specifications for food additives) are amended accordingly.

The proposal notified in G/SPS/N/EU/221 (7 August 2017) has been adopted as "Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods" (Text with EEA relevance) [OJ L 77, 20 March 2018, p. 6].The Commission Implementing Regulation will enter into force on 9 April 2018.

The European Union provides the link to the draft Regulation associated with notification G/SPS/N/EU/247.

The European Union provides the link to the draft Regulation associated with notification G/SPS/N/EU/248.