Notifications for European Union (1104 notifications)

Import requirements and internal measures are put in place in relation to Tomato brown rugose fruit virus (ToBRFV)

Additional emergency import requirements are put in place in relation to Spodoptera frugiperda (Smith), amending Commission Implementing Decision (EU) 2018/638. In particular, the geographic scope is enlarged to all non-EU countries and the measures are applying until 30 June 2021.

The proposed draft Regulation concerns the review of existing MRLs for chromafenozide, fluometuron, pencycuron, sedaxane, tau-fluvalinate and triazoxide 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 proposed draft Regulation concerns the review of existing MRLs for myclobutanil, napropamide and sintofen 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.

It follows from Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, animal health and welfare, plant health and plant protection products, that certain categories of animals and goods coming from third countries must be subject to specific official controls at the border control posts.This Regulation lays down rules for the uniform application of the appropriate frequency rate of identity checks and physical checks on consignments of animals and goods referred to in Article 47(1) (a), (b) and (c) of Regulation (EU) 2017/625 intended to be placed on the market.The appropriate level of frequency rates on identity checks and physical checks are established taking into account information regarding the risks associated with the categories of animals and goods.The regulation establish the procedures for modification of the frequency rates for identity checks and physical checks and rules for the uniform application of the frequency rates.To ensure the effectiveness of the official controls the Regulation establish procedure for the selection of the consignment for identity checks and physical checks in such a way that it is not possible for the operator responsible for the consignments to predict whether any particular consignment will be subject of checks.For certain third countries with which the Union has reached agreement on equivalency, a reduction in the physical checks on certain products can be applied, Therefore the level of frequencies of physical checks specified in these veterinary agreements are applied in this Regulation.The rules laid down in this Regulation ensure a continuation of the requirements on establishing the minimum frequency rate for identity checks and physical checks. Date of application: 14 December 2019

This Regulation - amendment of the Regulation (EC) 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority (EFSA) and laying down procedures in matters of food safety ("General Food Law") and eight other sectoral acts - intends to improve the transparency of the EU risk assessment process carried out by EFSA, strengthen the long-term sustainability of EFSA and improve risk communication. Among others, the new Regulation will adapt the existing EU food safety system as follows:·            Proactive public disclosure/Confidentiality/Public consultations of submitted studiesAll scientific data, studies and other information supporting applications as well as other requests for a scientific output by EFSA shall be made publicly available proactively, with the exception of duly justified confidential information, early on in the EU risk assessment process. To that effect, closed lists of clearly-defined information items for which confidentiality may be claimed under certain conditions, with the exception of safety relevant information, are set out in the General Food Law and in seven other sectoral acts. More specifically: When an applicant submits a request for authorisation accompanied by scientific data, studies and other supporting information, it may request certain parts of the submitted data, studies and other information to be kept confidential. This request must be duly justified (proof of "potential harm to a significant degree" in case of public disclosure). The applicant should submit a non-confidential version and a confidential version of the submitted data, studies and other information. Without delay and once an application is found valid or admissible, EFSA would make the non-confidential version of those studies, as submitted by the applicant, public. In parallel, EFSA would assess the confidentiality claim within 10 weeks. Once the assessment is completed, any additional data and information for which confidentiality requests has been considered as unjustified would also be made public (final non-confidential version as assessed by EFSA). Upon receipt of the confidentiality decision by EFSA, applicants would have the right to make a confirmatory application asking EFSA to reconsider its decision. Following public disclosure, EFSA will launch public consultations on the submitted data, studies and other information to ensure access to the widest evidence-base possible before it delivers its scientific output.The public disclosure of all information supporting applications or other requests for scientific output by EFSA shall be without prejudice to any existing rules concerning Intellectual Property Rights (which may set out limitations on certain uses of the disclosed documents on their content), and ‘data exclusivity rules'. The disclosure to the public shall not be considered as an explicit or implicit permission or licence for the relevant data and information and their content to be used. EFSA shall ensure that clear undertakings or signed statements are given to that effect by those accessing the relevant documents, prior to their disclosure.·            Notification of studiesEFSA shall establish and manage a database of studies commissioned or carried out (at pre-submission phase) by business operators to support a future application or notification in relation to which Union law makes provisions for EFSA to provide a scientific output, including a scientific opinion. Business operators shall, without delay, notify EFSA of the title and the scope of the study, the laboratory or testing facility carrying out the study, and the starting and planned completion dates of any study commissioned or carried out by them to support an application or a notification. The notification obligation shall also apply to laboratories and other testing facilities located in the Union carrying out those studies, and also to laboratories and other testing facilities located in third countries insofar as set out in relevant agreements and arrangements. Certain procedural consequences of non-compliance with the notification requirement are also foreseen, e.g. an application or notification shall not be considered valid or admissible where it is supported by studies that have not been notified, unless the applicant or notifier provides a valid justification for non-notification of such studies.·            Fact-finding missionsWithin four years after the entry into application of the Regulation, Commission experts shall perform fact-finding missions in member States to assess the application by laboratories and other testing facilities of the relevant standards for carrying out tests and studies submitted to EFSA as part of an application, as well as the compliance with the notification obligation. Commission experts shall also perform fact-finding missions to assess the application of relevant standards by laboratories and other testing facilities located in third countries insofar as set out in relevant agreements and arrangements. The Commission, EFSA and the member States shall ensure the appropriate follow-up to these non-compliances. The outcome of the fact-finding missions shall be presented in an overview report, on which basis the Commission shall - if appropriate - submit a legislative proposal as regards any necessary control procedures, including audits.

It follows from Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, animal health and welfare, plant health and plant protection products, that certain categories of animals and goods coming from third countries must be subject to specific official controls at the border control posts.Article 49(1) of Regulation (EU) 2017/625 requires the competent authorities to perform official controls on those animals and goods upon their arrival at the border control posts. Those official controls must include documentary checks, identity checks and physical checks.This Regulation lays down detailed rules concerning performance of the documentary checks, identity checks and physical checks at border control posts.The current operations carried out during documentary checks, identity checks and physical checks have proven to be effective and ensure a high level of performance of checks. Therefore, the rules laid down in this Regulation ensure a continuation of the requirements on operations to be carried out during and after these checks at the border control posts.Date of application: 14 December 2019

Change (lowering) of existing MRL diflubenzuron.

The proposal notified in G/SPS/N/EU/288 (11 December 2018) was adopted as Commission Regulation (EU) 2019/973 of 13 June 2019 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 bispyribac, denatonium benzoate, fenoxycarb, flurochloridone, quizalofop-P-ethyl, quizalofop-P-tefuryl, propaquizafop, tebufenozide in or on certain products [OJ L 157, 14 June 2019, p. 3]. This Regulation shall apply from 4 January 2020.

The proposal notified in G/SPS/N/EU/321 (6 May 2019) was adopted as Commission Implementing Regulation (EU) 2019/1177 of 10 July 2019 amending Regulation (EU) No 142/2011 as regards imports of gelatine, flavouring innards and rendered fats [OJ L 185, 11 July 2019, p.26].This Regulation shall apply from 31 July 2019.

The proposal notified in G/SPS/N/EU/322 (8 May 2019) was adopted as Commission Regulation (EU) 2019/1338 of 8 August 2019 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food [OJ L 209, 9 August 2019, p.5].This Regulation shall apply from 29 August 2019.

The proposal notified in G/SPS/N/EU/301 (23 January 2019) was adopted as Commission Delegated Regulation (EU) 2019/1012 of 12 March 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council by derogating from the rules on the designation of control points and from the minimum requirements for border control posts [OJ L 165, 21 June 2019, p.4]. This Regulation shall apply from 14 December 2019.

The proposal notified in G/SPS/N/EU/311 (15 March 2019) was adopted as Commission Implementing Regulation (EU) 2019/1262 of 25 July 2019 amending Implementing Regulation (EU) 2016/1141 to update the list of invasive alien species of Union concern [OJ L 199, 26 July 2019, p. 1]. This Implementing Regulation shall apply from 15 August 2019.

The deadline for comments on this draft Commission Delegated Regulation is 30 September 2019.

The draft Regulation lays down phytosanitary import conditions for plants, plant products and other objects that may pose a phytosanitary risk to the European Union. The draft is based on the current import conditions as laid down in the Council Directive 2000/29/EU, which will be repealed and replaced with the provisions notified herewith, and on the existing plant health rules for marketing of certain seeds and propagating material.The draft Regulation contains a number of Annexes that establish the list of plants, plant products and other objects (regulated articles) that shall be accompanied by a Phytosanitary Certificate when introduced into the European Union, the EU lists of quarantine pests and regulated non-quarantine pests, the list of protected zones in the European Union and the list of quarantine pests relevant thereto, the list of regulated articles the import of which into the European Union is prohibited and the lists of phytosanitary requirements that imported regulated articles shall comply with when introduced into the European Union or into specific protected zones.In addition, the draft Regulation also contains several Annexes establishing the rules for the internal movement of regulated articles in the European Union. These Annexes are provided for information and clarity purposes.

The draft Regulation establishes a maximum level of citrinine in food supplements based on rice fermented with red yeast Monascus purpureus.

The draft Regulation amends and establishes  maximum levels of several undesirable substances in certain feed materials and feed additives arsenic in leonardite, peat and dimanganese chloride trihydroxide, fluorine in calcareous marine algae, mercury in canned wet feed material for direct feeding of dogs and cats, gossypol in whole cottonseed and dioxins, sum of dioxins and dioxin-like PCBs and for non-dioxin-like PCBs in feed additives belonging to the functional group of binders and anti-caking agents. In addition errors as regards provisions on lead, introduced by the previous amendment to the Directive, are corrected by this Regulation.

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 jackfruit (Artocarpus heterophyllus) from Malaysia, groundnuts (peanuts) from the United States of America and apricot kernels from Turkey; the increase in the frequency of identity and physical controls to be performed on consignments of tea and goji berries from China and peppers and yardlong beans from the Dominican Republic; the decrease in the frequency of identity and physical controls to be performed on consignments of apricots from Turkey; the modification of the scope of the existing entry concerning turnips (Brassica rapa spp. Rapa) from Lebanon and from Syria; The modification of the scope of the testing to be performed on goji berries from China to include nicotine.

The draft Regulation provides for the continuation of the derogation granted to certain traditionally smoked meat and meat products and traditionally smoked fish and fishery products for local production and consumption in certain Member States. In addition, the Regulation establishes a maximum level for PAH in powders from food of plant origin used for the preparation of beverages by dissolution.

The draft Regulation establishes a maximum level of erucic acid in vegetable oils and in mustard and corrects the existing provision as regards hydrocyanic acid in raw apricot kernels.