Notifications for European Union (1104 notifications)
This draft Directive updates certain annexes to Directive 2001/18/EC as regards the environmental risk assessment of GMOs, in order to adapt them to technical progress and in the light of the Guidance documents of the European Food safety Authority concerning the environmental risk assessment of genetically modified plants. The list of information that notifyers must provide under Directive 2001/18/EC is also updated accordingly.
The proposal notified in G/SPS/N/EU/163 (6 April 2016) is now adopted as Commission Regulation (EU) 2016/1822 of 13 October 2016 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for aclonifen, deltamethrin, fluazinam, methomyl, sulcotrione and thiodicarb in or on certain products (Text with EEA relevance) [OJ L 281, 18 October 2016, pp. 1-44]. This Regulation applies from 7 November 2016. http://members.wto.org/crnattachments/2016/SPS/EEC/16_4546_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_4546_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_4546_00_s.pdf
These notified annexes to the draft Regulation set proposed maximum residue levels for fluopyram, hexachlorociclohexane (HCH), alpha-isomer, hexachlorociclohexane (HCH), beta-isomer, hexachlorociclohexane (HCH), sum of isomers, except the gamma isomer, lindane (hexachlorociclohexane (HCH), gamma-isomer), nicotine and profenofos in or on certain products in Annex II and V to Regulation (EC) No 396/2005. MRLs for these substances in certain commodities are changed: either increased, lowered, or deleted. Higher MRLs are set to accommodate new uses in the European Union and in third countries which export those commodities to the European Union. Lower MRLs are set after updating the limit of determination and/or deleting old uses which are not authorized any more in the European Union or for which there is not enough data for an MRL to be set. Deleted MRLs for hexachlorociclohexane (HCH), sum of isomers, except the gamma isomer are replaced by specific MRLs for hexachlorociclohexane (HCH), alpha-isomer and hexachlorociclohexane (HCH) beta-isomer.
The proposal notified in G/SPS/N/EU/158 (14 March 2016) is now adopted as Commission Regulation (EU) 2016/1866 of 17 October 2016 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 3-decen-2-one, acibenzolar-S-methyl and hexachlorobenzene in or on certain products (Text with EEA relevance) [OJ L 286, 21 October 2016, pp. 4-31]. This Regulation applies from 10 May 2017. http://members.wto.org/crnattachments/2016/SPS/EEC/16_4538_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_4538_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_4538_00_s.pdf
The legal text notified in G/SPS/N/EU/27 on 23 July 2012 has been amended as "Commission Implementing Decision (EU) 2016/1359 of 8 August 2016 amending Implementing Decision 2012/270/EU as regards emergency measures to prevent the introduction into and the spread within the Union of Epitrix cucumeris (Harris), Epitrix similaris (Gentner), Epitrix subcrinita (Lec.) and Epitrix tuberis (Gentner)" [OJ L 215, 10 August 2016, pp. 29-30]. The Regulation entered into force on 30 August 2016. http://members.wto.org/crnattachments/2016/SPS/EEC/16_3821_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_3821_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_3821_00_s.pdf
These notified annexes to the draft Regulation set proposed maximum residue levels for fenpyroximate, triadimenol and triadimefon in or on certain products in Annexes II and V to Regulation (EC) No 396/2005. MRLs for these substances in certain commodities are changed: either increased or lowered. Higher MRLs are set to accommodate new uses in the European Union and in third countries which export those commodities to the European Union. Lower MRLs are set after updating the limit of determination and/or deleting old uses which are not authorized any more in the European Union or for which there is not enough data for an MRL to be set.
The Union list of flavourings and source materials is laid down in Annex I to Regulation (EC) No 1334/3008. The Union list was established by Commission Implementing Regulation (EU) No 872/2012 which will be amended by the notified measure. This amendment concerns the modification of the conditions of use of the following five substances belonging to the chemical subgroup 2.2 of FGE.19 (FGE.208): p-mentha-1,8-dien-7-ol (FL no. 02.060), myrtenol (FL no. 02.091), myrtenal (FL no. 05.106), p mentha-1,8-dien-7-yl acetate (FL no. 09.278), and myrtenyl acetate (FL no. 09.302). The European Food Safety Authority (EFSA) had requested additional scientific data for completion of the evaluation as flavouring substances of the group of substances FGE.208 composed of ten substances which includes these substances. EFSA evaluated the data on this group of substances in its opinion of 24 June 2015 and concluded that the representative substance of the group p-mentha-1,8-dien-7-al (FL-no 05.117) is genotoxic in vivo and therefore its use as a flavouring substance raises a safety concern. This substance was withdrawn from the Union list with Commission Regulation (EU) 2015/1760 in an urgent procedure. This measure had been notified earlier in G/SPS/N/EU/149. The EFSA opinion is available as Scientific Opinion on Flavouring Group Evaluation 208 Revision 1 (FGE.208Rev1): consideration of genotoxicity data on representatives for ten alicyclic aldehydes with the á,â-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19. EFSA Journal 2015;13(7):4173, 28 pp. doi:10.2903/j.efsa.2015.4173 Online at: http://www.efsa.europa.eu/efsajournal. Four additional substances from this group (2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde, FL no. 05.121, myrtenyl formate, FL no. 09.272, myrtenyl-2-methylbutyrate, FL no. 09.899, and myrtenyl-3-methylbutyrate, FL no. 09.900), not supported by industry, were also withdrawn from the Union list in a separate, later, measure (Commission Regulation (EU) 2016/637). This measure was notified in notification G/SPS/N/EU/157. The current measure concerns a modification of the conditions of use of the abovementioned five remaining substances of the group FGE.208 to better reflect the current real uses in the food categories specified and not in others, pending the evaluation by EFSA of further additional safety studies which were formally requested by the Commission to interested parties. Once the process of evaluation of these new data is completed (which includes the EFSA risk assessment) these substances will be subject of consideration of an appropriate legislative measure taking into account the EFSA assessment.
The proposal notified in G/SPS/N/EU/155 (29 January 2016) is now adopted as Commission Implementing Decision (EU) 2016/1196 of 20 July 2016 amending the Annexes to Decision 2007/275/EC concerning the lists of animals and products to be subject to controls at border inspection posts under Council Directives 91/496/EEC and 97/78/EC (Text with EEA relevance) [OJ L 197, 22 July 2016, pp. 10-27]. This Decision applies from 1 January 2017. http://members.wto.org/crnattachments/2016/SPS/EEC/16_2959_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2959_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2959_00_s.pdf
The final date for comments of the proposal notified in G/SPS/N/EU/166 (20 June 2016) as "Draft Commission Regulation setting out scientific criteria for the determination of endocrine disrupting properties and amending Annex II to Regulation (EC) 1107/2009" is now 31 August 2016.
The proposal notified in G/SPS/N/EU/143 (27 July 2015) has been adopted as "Commission Implementing Regulation (EU) 2016/1141 of 13 July 2016 adopting a list of invasive alien species of Union concern pursuant to Regulation (EU) No 1143/2014 of the European Parliament and of the Council" [OJ L 189, 14 July 2016, p.4]. The Regulation will enter into force on 3 August 2016. http://members.wto.org/crnattachments/2016/SPS/EEC/16_2845_00_E.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2845_00_F.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2845_00_S.pdf
The proposal notified in G/SPS/N/EU/161 (5 April 2016) is now amended as draft Annexes to "Commission Regulation (EU) amending Annexes II, III and V to Regulation (EC) No. 396/2005 of the European Parliament and the Council as regards maximum residue levels for bifenthrin, carbetamide, cinidon-ethyl, fenpropimorph and triflusulfuron in or on certain products". http://members.wto.org/crnattachments/2016/SPS/EEC/16_2847_00_E.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2847_01_E.pdf
The proposal notified in G/SPS/N/EU/152 (14 December 2015) is now adopted as Commission Regulation (EU) 2016/1002 of 17 June 2016 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for AMTT, diquat, dodine, glufosinate and tritosulfuron in or on certain products (Text with EEA relevance) [OJ L 167, 24 June 2016, pp. 1-45]. The Regulation applies from 14 July 2016. http://members.wto.org/crnattachments/2016/SPS/EEC/16_2731_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2731_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2731_00_s.pdf
These notified annexes to the draft Regulation set proposed maximum residue levels for bitertanol, tebufenpyrad and chlormequat in or on certain products in Annex II and V to Regulation (EC) No 396/2005. MRLs for these substances in certain commodities are changed: either increased or lowered. Higher MRLs are set to accommodate new uses in the European Union and in third countries which export those commodities to the European Union. Lower MRLs are set after updating the limit of determination and/or deleting old uses which are not authorized any more in the European Union or for which there is not enough data for an MRL to be set.
The proposal notified in G/SPS/N/EU/150 (11 December 2015) is now adopted as Commission Regulation (EU) 2016/1015 of 17 June 2016 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 1-naphthylacetamide, 1-naphthylacetic acid, chloridazon, fluazifop-P, fuberidazole, mepiquat and tralkoxydim in or on certain products (Text with EEA relevance) [OJ L 172, 29 June 2016, pp. 1-21]. The Regulation applies from 19 July 2016. http://members.wto.org/crnattachments/2016/SPS/EEC/16_2659_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2659_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2659_00_s.pdf
The proposal notified in G/SPS/N/EU/151 (14 December 2015) is now adopted as Commission Regulation (EU) 2016/1016 of 17 June 2016 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 ethofumesate, etoxazole, fenamidone, fluoxastrobin and flurtamone in or on certain products (Text with EEA relevance) [OJ L 172, 29 June 2016, pp. 22-53]. The Regulation applies from 19 July 2016.
This Regulation reviews the default frequency of the reviews of Annex I and the list of imports of feed and food of non-animal origin which are subject to an increased level of official controls. The changes concern: the de-listing of dried grapes from Afghanistan and almonds from Australia; the listing of hazelnuts from Georgia.
This notification is for transparency purposes and does not prejudge the position of the European Union on the applicability of the SPS Agreement to the notified measures, or on the nature and effects of the measure itself. This draft Commission Regulation sets the specific scientific criteria in relation to the endocrine disrupting properties for the approval of the active substances for use in plant protection products in accordance with Regulation (EC) No 1107/2009. The criteria are based on the definition of endocrine disruptors published in 2002 by the World Health Organisation (WHO) through its International Programme for Chemical Safety (WHO/IPCS). The draft regulation was preceded by an impact assessment and a public consultation. In accordance with Regulation (EC) No 1107/2009 if a substance is found to be an endocrine disruptor according to the criteria set in this draft regulation, it will not be approved for use in plant protection products unless it is demonstrated that the conditions set in Point 3.6.5.2 of Annex II of Regulation (EC) No 1107/2009 are met.
The second proposal notified in G/SPS/N/EU/140 (7 July 2015) is now adopted as Commission Implementing Regulation (EU) 2016/759 of 28 April 2016 drawing up lists of third countries, parts of third countries and territories from which member States are to authorise the introduction into the Union of certain products of animal origin intended for human consumption, laying down certificate requirements, amending Regulation (EC) No 2074/2005 and repealing Decision 2003/812/EC (Text with EEA relevance) [OJ L 67, 14 May 2016, pp. 13-62]. The Regulation applies from 7 June 2016. http://members.wto.org/crnattachments/2016/SPS/EEC/16_2292_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2292_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2292_00_s.pdf
New elements: On 12 May 2016 the European Commission adopted a Decision amending some elements of the Commission Implementing Decision (EU) 2015/789 as regards measures to prevent the introduction into and the spread within the Union of Xylella fastidiosa (Wells et al.). In particular for non-EU member States, specific legal provisions have been introduced for the introduction into the Union territory of specified plants, which have been grown for the entire production cycle in vitro, and originate in an area where Xylella fastidiosa (Wells et al.) is known to be present (Article 17). Additionally, legal provisions as regards the introduction into the Union territory of specified plants originating from a Pest Free Area or Pest Free Country have been lined-up (Article 18), while the list of specified plants (Annex I) has been updated taking into account new findings. http://members.wto.org/crnattachments/2016/SPS/EEC/16_2048_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2048_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2048_00_s.pdf
The use of Propionic acid-propionates is requested for the extension of the shelf-life of tortillas. Propionic acid-propionates are widely used to prevent the growth of moulds in leavened bakery products, due to their minimal effect on yeast and on the odour or taste of the final product. The European Food Safety Authority ("the Authority"), in its opinion on the re-evaluation of propionic acid (E 280), sodium propionate (E 281), calcium propionate (E 282) and potassium propionate (E 283) as food additives, concluded that there would not be a safety concern from the maximum concentrations of those substances at their currently authorised uses and use levels as food additives. The authorisation of the use of propionates in tortillas is an extension which would not lead to additional concern as the exposure assessment done by the Authority covered food category 07.1 Bread and rolls.