Notifications for European Union (1104 notifications)

This draft Commission Implementing Regulation provides that the approval of the active substance fenpyrazamine is amended in accordance with Regulation (EC) No 1107/2009. EU Member States shall review authorisations for plant protection products containing fenpyrazamine as an active substance, where relevant. The amendment of the conditions of approval is based on the evaluation to clarify the technical specification proposed in the approval of fenpyrazamine for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009.This decision only concerns the placing on the market of this substance and plantprotection products containing it and does not affect the Maximum Residue Levels (MRLs) for residues of the concerned pesticide; the impurity was considered not to be new in the commercial produced batches. This draft Commission Implementing Regulation was also notified under the TBT Agreement in notice G/TBT/N/EU/TBT/735.

This Implementing Regulation updates the measures to prevent the introduction into and the spread within the Union of Tomato brown rugose fruit virus (ToBRFV). After the adoption of Implementing Decision (EU) 2019/1615, more recent scientific information has been collected on the spread of the specified pest and on testing methods, which justifies the need for more detailed measures than those provided for under Implementing Decision (EU) 2019/1615. In particular, seeds of Solanum lycopersicum L. and Capsicum spp. should be tested regardless of their origin. This is necessary because of the uncertainties surrounding the presence of the pest worldwide.

The notified Regulation supplements rules that are already laid down in the EU Animal Health Law (Regulation (EU) 2016/429) concerning registration and approval of aquaculture establishments, record keeping including traceability obligations for operators, registers of aquaculture establishments and transporters of aquatic animals in the EU. In that regard it lays down the rules for:(a)        the approval of certain aquaculture establishments in the EU keeping aquaculture animals posing a significant animal health risk and derogations therefrom;(b)        the information to be included in the registers of registered and approved aquaculture establishments to be kept by the competent authorities of the EU Member States;(c)        record-keeping obligations of operators of aquaculture establishments and transporters of aquatic animals intended for those establishments and for release into the wild in the EU; (d)        transitional measures.

The notified Regulation supplements rules that are already laid down in the EU Animal Health Law (Regulation (EU) 2016/429) concerning surveillance, eradication programmes, and disease-free status in the European Union for certain listed and emerging diseases. In that regard it lays down:(a)        the rules and conditions for surveillance conducted by the competent authority to ensure the detection of listed diseases and, where relevant, of emerging diseases in the EU;(b)        the criteria used to determine which disease will require a Union surveillance programme and rules setting up the requirements for these Union surveillance programmes, to be implemented by competent authorities of the EU Member States;(c)        the rules setting out how competent authorities are to implement compulsory and optional eradication programmes in the EU for specific listed diseases focusing on their disease control strategies, their intermediate and final targets and their period of application;(d)        measures to be implemented by the competent authority and the operators in the EU under the compulsory and optional eradication programmes;(e)        the detailed rules for granting disease-free status to EU Member States, and zones and in case of aquatic animals, compartments;(f)         the detailed rules for surveillance and biosecurity measures to be implemented by competent authorities and operators in the EU for maintaining disease-free status of EU Member States, zones and compartments;(g)        supplementary rules for the suspension, withdrawal and restoration of disease-free status in the EU; (h)        rules necessary to ensure a smooth transition from the rules existing prior to the Animal Health Law.

The notified Regulation supplements rules that are already laid down in Animal Health Law (Regulation (EU) 2016/429) concerning animal health requirements for movements within the European Union of terrestrial animals and hatching eggs.The rules laid down in this Delegated Regulation are largely based on those laid down in existing European Union acts establishing animal health requirements for movements within the EU of terrestrial animals and hatching eggs, as these rules have proven effective in preventing the spread of listed diseases within the Union. The rules have been adapted to the new legal framework, taking account of lessons learned, updates of international standards, scientific progress and recent EFSA opinions. In that regard it lays down:(a)        biosecurity measures for the means of transport and containers transporting terrestrial animals and hatching eggs in the EU;(b)       animal health requirements for movements of terrestrial animals and hatching eggs between EU Member States;(c)        specific rules for assembly operations in respect of ungulates and poultry moved in the EU; (d)        animal health certification and notification requirements for movements of terrestrial animals and hatching eggs between EU Member States.

The notified Regulation supplements rules that are already laid down in the EU Animal Health Law (Regulation (EU) 2016/429) concerning the prevention and control of certain listed diseases in the EU. The rules laid down in this Regulation (Regulation (EU) 2020/687) set out disease control measures, which will apply in the Union in case of outbreaks of animal diseases with serious effects on the livestock. This Regulation is largely 'taking over' rules currently laid down in existing Union acts establishing the disease control measures in the event of such animal diseases occurring in the EU. It incorporates new available scientific knowledge, based on the opinions from EFSA, gained experience and updates the conditions in line with the new EU animal health policy framework and international standards. In that regard it lays down the rules for certain animal diseases as regards:(a)        disease control measures in the event of suspicion and official confirmation of a disease in kept terrestrial and aquaculture animals in the EU;(b)        the establishment of restricted zones in the event of official confirmation of a disease in kept animals in the EU;(c)        disease control measures and the repopulation of the restricted zones in the event of official confirmation of a disease in the EU; (d)        disease control measures in the event of suspicion and official confirmation of a disease in wild terrestrial and aquatic animals in the EU;

The proposal notified in G/SPS/N/EU/390 (12 June 2020) was adopted as Commission Implementing Regulation (EU) 2020/1201 of 14 August 2020 as regards measures to prevent the introduction into and the spread within the Union of Xylella fastidiosa (Wells et al.) [OJ L 269, 17 August 2020, p.2].This Regulation entered into force on 17 August 2020.

This draft Commission Implementing Regulation provides that the approval of the active substance etoxazole is renewed as a candidate for substitution in accordance with Regulation (EC) No 1107/2009. It is however, necessary to include certain conditions and restrictions. In particular, only use on ornamental plants in permanent greenhouses can be approved.Existing authorised plant protection products containing etoxazole will be reviewed in accordance with the restrictions. The restriction is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly approved under Directive 91/414/EEC.This decision only concerns the placing on the market of this substance. Following restriction of the approval and the consequent expiry of all grace periods for stocks of products, separate action will likely be taken on MRLs and a separate notification will be made in accordance with SPS procedures. This draft Commission Implementing Regulation was also notified under the TBT Agreement in notice G/TBT/N/EU/733.

A corrigendum to Commission Regulation (EU) 2020/1085 of 23 July 2020 amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorpyrifos and chlorpyrifos-methyl in or on certain products was published on 30 July 2020 in the Official Journal of the European Union.This Regulation shall apply from 13 November 2020.

The proposal notified in G/SPS/N/EU/360 (12 December 2019) was adopted as Commission Regulation (EU) 2020/1085 of 23 July 2020 amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorpyrifos and chlorpyrifos-methyl in or on certain products (Text with EEA relevance) [OJ L 239, 24 July 2020, p.7]. This Regulation shall apply from 6 August 2020.

The proposal notified in G/SPS/N/EU/347 (17 September 2019) was adopted as Commission Regulation (EU) 2020/770 of 8 June 2020 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 myclobutanil, napropamide and sintofen in or on certain products (Text with EEA relevance) [OJ L 184, 12 June 2020, p.1]. This Regulation shall apply from 2 January 2021.

The draft Regulation establishes maximum levels for acrylamide in biscuits and rusks for infants and young children, baby foods, processed cereal based foods, other than biscuits and rusks, for infants and young children.

The draft Regulation establishes maximum levels for pyrrolizidine alkaloids in herbal infusions, tea, food supplements, pollen and pollen products, borage leaves, dried herbs and cumin seeds.

The Commission Implementing Regulation establishes a maximum level applicable to import of feed and food from affected third countries and imposes conditions as regards the import of wild mushrooms and wild forest berries. The measures provided in the Regulation replaces existing measures and provides for a lowering of the frequency of controls at import.

Description of content:Regulation (EU) 2017/625 (‘Official Controls Regulation') empowers the Commission to adopt, by way of implementing acts, model official certificates, official attestations and declarations which accompany animals and goods entering the Union, and rules for the issuance of official certificates. Regulation (EU) 2016/429 (‘Animal Health Law') empowers the Commission to lay down, by way of implementing acts, rules concerning animal health and welfare provisions to be contained in those model official certificates, official attestations and declarations.The purpose of this Regulation is to lay down rules for the issuance of official certificates and to lay down specific models of official certificates, official attestations and declarations with regard to the category of terrestrial animals and germinal products thereof.The Regulation is launched as part of a package together with Implementing Regulation concerning model official certificates for certain aquatic animals and Implementing Regulation concerning model official certificates for certain goods.

There is a correction to notification G/SPS/N/EU/396, dated 15 July 2020:The link to the document related to current and new MRLs and the one related to footnotes the listed in box 5 of notification G/SPS/N/EU/396 has been changed.The link is now corrected and it should read as follows: All other attachments provided in G/SPS/N/EU/396 are correct and remain unchanged.

Regulation (EU) 2017/625 (‘Official Controls Regulation') empowers the Commission to adopt, by way of implementing acts, model official certificates and declarations which accompany animals and goods entering the Union, and rules for the issuance of such certificates. Regulation (EU) 2016/429 (‘Animal Health Law') empowers the Commission to lay down, by way of implementing acts, rules concerning animal health provisions to be contained in those official certificates and declarations.The purpose of this Regulation is to lay down rules for the issuance of official certificates and to lay down specific model certificates and a model declaration with regard to the category of aquatic animals and certain products thereof.The Regulation is launched as part of a package together with Implementing Regulation concerning model official certificates for certain terrestrial animals and Implementing Regulation concerning model official certificates for certain goods.

Regulation (EU) 2017/625 (‘Official Controls Regulation') empowers the Commission to adopt, by way of implementing acts, model official certificates which accompany animals and goods entering the Union, and rules for the issuance of such certificates. Regulation (EU) 2016/429 (‘Animal Health Law') empowers the Commission to lay down, by way of implementing acts, rules concerning animal health provisions to be contained in those model official certificates.The purpose of this Regulation is to lay down rules for the issuance of such official certificates and to lay down specific models with regard to the category of goods and animals. The Regulation is launched as part of a package together with Implementing Regulation concerning model official certificates for certain terrestrial animals and Implementing Regulation concerning model official certificates for certain aquatic animals.

The Regulation authorises conjugated linoleic acid (t10, c12)-methylester as a zootechnical additive for pigs for fattening and dairy cows

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). This list is now amended by the draft "Commission Regulation (EU) amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances".This addendum concerns the withdrawal of the following 5 substances: alpha-damascone (Fl no 07.134) (representative substance of the group), delta-damascone (Fl no. 07.130), cis-1-(2,6,6-trimethyl-2-cyclohexen-1-yl)but-2-en-1-one (Fl no. 07.225), trans-1-(2,6,6-trimethyl-2-cyclohexen-1-yl)but-2-en-1-one (Fl no. 07.226) and alpha-damascenone (Fl no. 07.231) from the list of authorised flavouring substances in the European Union.The European Food Safety Authority (EFSA) has evaluated these substances in the framework of the completion of their evaluation as flavourings substances. EFSA concluded that the concern for genotoxicity cannot be ruled out for the five concerned substances. It is therefore not established that the concerned substances do not pose a safety risk to the health of the consumer. On the basis of the scientific evidence submitted within the framework set out for the substances pending the completion of their evaluation, the use of the concerned substances does not comply with the general conditions of use for flavourings set out in Article 4 of Regulation (EC) No 1334/2008. The measure includes transitional measures for food to which any of these substances has been added.