Notifications for European Union (1104 notifications)

Regulation (EU) 2017/625 of the European Parliament and of the Council establishes the framework for official controls and other official activities to verify compliance with the Union agri-food chain legislation. That framework includes official controls performed on animals and goods entering the Union.Article 44 of Regulation (EU) 2017/625 requires that the competent authorities shall perform official controls regularly, on a risk basis and with appropriate frequency, on animals and goods entering the Union and to which Articles 47 and 48 of that Regulation do not apply. The competent authorities of the Member States may decide appropriate place where to perform such controls, including border control posts (Article 44(3) of Regulation (EU) 2017/625).Article 45(4) of Regulation (EU) 2017/625 provides delegating powers for the Commission to lay down rules concerning the cases where and the conditions under which competent authorities may request operators to notify the arrival of certain goods entering the Union other than those subject to official controls at border control posts in accordance with Article 47(1) of Regulation (EU) 2017/625.The purpose of this Delegated Regulation is to establish the cases where and the conditions under which competent authorities may request operators to notify the arrival of consignments of goods not subject to official controls at border control posts in accordance with Article 47(1) of Regulation (EU) 2017/625.The competent authority will be able to request operators to notify the arrival of goods entering the Union where it considers that a notification is necessary in order to organise official controlson those goods in view of the risks to human, animal or plant health, animal welfare or, as regards genetically modified organisms and plant protection products, also to the environment, which are associated with those goods, or the history of compliance with the requirements established by the rules referred to in Article 1(2) of Regulation (EU) 2017/625 applicable to those goods.

This draft Commission Regulation concerns the prohibition of use in food of certain plant preparations containing hydroxyanthracene derivatives based on the scientific opinion of EFSA and following a period of Union scrutiny during which food business operators, or any other interested parties, may submit scientific data to demonstrate the safety of plant preparations in question. On 22 November 2017, the European Food Safety Authority (EFSA) adopted a scientific opinion on the evaluation of the safety of hydroxyanthracene derivatives for use in food. In that opinion it concluded that there is a possibility of harmful effects on health associated with the use of Rheum, Cassia and Rhamnus and their preparations in food, but scientific uncertainty persists. Consequently, pursuant to the procedure laid down in Article 8(2) of Regulation (EC) No 1925/2006, the plant preparations concerned were put under Union scrutiny by means of Regulation (EU) 2021/468 of 18 March 2021 for a period of four years from the entry into force of that Regulation, which allowed interested parties to provide EFSA with evidence of safety within 24 months.On 20 March 2024, EFSA adopted a scientific opinion on additional scientific data related to the safety of preparations of Rheum palmatum L., Rheum officinale Baill. and their hybrids, Rhamnus purshiana DC., Rhamnus frangula L., and Cassia senna L. submitted pursuant to Article 8(4) of Regulation (EC) No 1925/2006. In its opinion, EFSA concluded that the safety of plant preparations under evaluation cannot be established based on the submitted studies. Therefore, pursuant to the procedure of Article 8(5) of Regulation (EC) No 1925/2006, the plant preparations concerned should be included in Part A of Annex III to Regulation (EC) No 1925/2006, which means that their use in food will be prohibited.

Removing the flavouring substance 4-Methyl-2-phenylpent-2-enal (FL No 05.100) from the Union list, as the European Food Safety Authority (EFSA) indicated concerns for aneugenicity and the relevant FBOs didn’t submit the additional data requested by EFSA.

The proposal notified in G/SPS/N/EU/734 (5 March 2024) is now adopted by Commission Regulation (EU) 2024/1987 of 30 July 2024 amending Regulation (EU) 2023/915 as regards maximum levels of nickel in certain foodstuffs (Text with EEA relevance).The Regulation shall apply from 1 July 2025.

The authorization of the feed additive covered by the Act was renewed for a 10-year period for chickens for fattening, turkeys for fattening, other poultry and pigs by Commission Implementing Regulation (EU) 2024/1070. The act concerning the renewal of authorization includes a characterization of the active substance of the additive which is slightly different from the specifications laid down in the previous authorization act for that additive. However, no transitional measures were provided for in Implementing Regulation (EU) 2024/1070 in order to allow interested parties to adapt to the new terms of authorization. Therefore, Commission Implementing Regulation (EU) 2024/2040 is amending Implementing Regulation (EU) 2024/1070 by including such transitional measures and that amendment applies retroactively from the date of entry into force of Implementing Regulation (EU) 2024/1070 in order to prevent market disturbance and detrimental consequences for the operators concerned.

The proposal notified in G/SPS/N/EU/760 (3 May 2024) is now adopted by Commission Implementing Regulation (EU) 2024/2067 of 31 July 2024 amending Implementing Regulation (EU) No 1321/2013 as regards the deletion of entries SF-001 to SF-010 from the Union list of authorised smoke flavouring primary products (Text with EEA relevance).This Regulation entered into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Commission Delegated Regulation (EU) 2022/2292 lays down import conditions for certain food. The draft allows the entry into the Union of certain products of animal origin possible by introducing a number of Combined Nomenclature codes or Harmonized System headings in certain Articles of the Regulation. It clarifies conditions for raw materials used for the entry into the Union of certain products of animal origin. It finally facilitates the entry into the Union of certain gelatine capsules contained in composite products.

This draft Commission Implementing Regulation provides that the approval of the active substance tritosulfuron is not renewed in accordance with Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant protection products containing tritosulfuron as an active substance.In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II thereto) which must be met to enable approval.During the evaluation and peer-review of tritosulfuron, areas that could not be finalised were identified. These are detailed in the conclusion of the European Food Safety Authority (EFSA). Moreover, the outcome of the risk assessment as documented in the EFSA Conclusion identifies the contamination of groundwater by the relevant metabolite TFA at level likely to be above the regulatory limit of 0.1 ug/L.Therefore, and considering that by letter of 8 May 2024, the applicant informed the Commission of its decision to withdraw the application for the renewal of tritosulfuron, the approval should not be renewed.Existing authorisations will need to be withdrawn; EU Member States must withdraw existing plant protection products containing tritosulfuron at the latest by 6 months from the date of entry into force. A period of grace in line with Article 46 of Regulation (EC) No 1107/2009 is allowed for and shall expire at the latest 12 months from the entry into force (allowing for a final season of use).This decision only concerns the placing on the market of this substance and plant protection products containing it. This draft Commission Implementing Regulation was also notified under the TBT Agreement in notice G/TBT/N/EU/1078.

This draft Commission Implementing Regulation provides that the approval of the active substance metribuzin is not renewed in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorizations for plant protection products containing metribuzin as an active substance. The non-renewal of approval is based on the first evaluation of the substance for use as a pesticide active substance in the European Union under Regulation (EC) No 1107/2009. The substance was formerly assessed and approved under Directive 91/414/ EEC.In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II thereto) which must be met to enable approval.During the evaluation and peer-review of metribuzin, a number of concerns and areas that could not be finalized were identified. These are detailed in the statement of the European Food Safety Authority (EFSA).Metribuzin meets the criteria in point 3.6.5 of Annex II to Regulation (EC) No 1107/2009 to be identified as an endocrine disruptor for the thyroid (T)-modality for humans and it has not been demonstrated that the exposure of humans to that active substance in a plant protection product, under realistic proposed conditions of use, is negligible.Bystander and resident exposure estimates exceed the established A(AOEL) value for all representative uses evaluated.The available higher tier studies for bees were not sufficient to exclude a high risk to bees.These concerns mean that metribuzin does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009.Existing authorizations will need to be withdrawn; EU member States must withdraw existing plant protection products containing metribuzin at the latest by six months from the date of entry into force. A period of grace in line with Article 46 of Regulation 1107/2009 is allowed for and shall expire at the latest 12 months from the entry into force (allowing for a final season of use); Protection of human health or safety; Protection of animal or plant life or health; Protection of the environmentThis decision only concerns the placing on the market of this substance and plant protection products containing it. Following non-approval and the expiry of all grace periods for stocks of products containing this substance, 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/1076.

The proposal notified in G/SPS/N/EU/759 (2 May 2024) is now adopted: Commission Implementing Regulation (EU) 2024/2004 of 23 July 2024 amending Implementing Regulation (EU) 2019/2072 as regards the listing of pests and rules on the introduction into, and movement within, the Union territory of plants, plant products and other objects.

This Implementing Regulation amends three model certificates (model ‘EU-FISH’, model ‘FISH-MOL-CAP’ and model ‘MOL-HC’) of Annex III to Implementing Regulation (EU) 2020/2235 by adding a new public health attestation reflecting the provisions laid down in Delegated Regulation (EU) 2023/905 as regards the application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin exported from third countries to the Union, and corrects one model certificate (model ‘NZ-TRANSIT-SG’) of Annex III to Implementing Regulation (EU) 2020/2235 by deletion of the attestation concerned, erroneously added thereto by Implementing Regulation (EU) 2024/399.

The proposed draft Regulation updates the MRLs for substances belonging to the group of dithiocarbamates (such as maneb, mancozeb, metiram, propineb, thiram and ziram). They degrade to carbon disulfide (CS2), which also occur naturally in plants as phytogenic sulfur compounds and with the existing methodologies in place cannot be distinguished from the presence of residues resulting from the use of dithiocarbamates. The draft Regulation is also proposing a new residue definition for monitoring the presence on these substances.

The proposed draft Regulation concerns the review of existing MRLs for acetamiprid in certain food commodities. MRLs for these substances in certain commodities are lowered.

The Implementing Regulation updates the model certificates for entry into the EU of gelatine, highly refined products and composite products intended for human consumption.

The preparation specified in this Act was initially authorized for a period of 10 years as a feed additive for all animal species in the category ‘technological additives’ and in the functional group ‘silage additives’. An application was submitted for the renewal of this authorization. Further to the favourable assessment by the European Food Safety Authority, the authorization of this preparation  is renewed, subject to certain conditions.

The preparation specified in this Act was initially authorized for a period of 10 years as a feed additive for all animal species in the category ‘technological additives’ and in the functional group ‘silage additives’. An application was submitted for the renewal of this authorization. Further to the favourable assessment by the European Food Safety Authority, the authorization of this preparation  is renewed, subject to certain conditions

The substances covered by the Act were authorized as feed additives for fish. An application was submitted for the reauthorization of these substances in accordance with article 10 of Regulation (EC) No 1831/2003. Further to the positive assessment by the European Food Safety Authority, these substances are reauthorized as feed additives for fish, in the category ‘technological additives’ and in the functional group ‘preservatives’, under certain conditions. A transitional period is included for the interested parties to meet the new authorization’s requirements.

The draft on animal health requirements for imports of used cooking oil intended for technical uses (production of renewable fuels and oleochemical products) introduces harmonized EU requirements and replaces current national rules of 27 EU member States. The main objective of the draft is prevention of entry of used cooking oil into feed for farmed animals within the European Union and thereby to mitigate potential biological hazards in feed.The draft introduced the following requirements:            A consignment of used cooking oil must come from a registered storage or collection plant listed in the EU TRACES system [https://webgate.ec.europa.eu/tracesnt/directory/listing/establishment/publication/index#!/search];            A consignment must be presented at an EU veterinary border control post and be monitored in the European Union until reaches its place of destination after import;            A consignment of used cooking oil must be accompanied by a commercial declaration signed by the importers stated that used cooking oil is not intended for feeding farmed animals and that water and solid particles of more than 6 mm, to reach a combined amount of moisture and solid particles of not more than 10% w/w* at the time of dispatch.

The preparation specified in this Act was initially authorized for a period of 10 years as a feed additive for all animal species in the category ‘technological additives’ and in the functional group ‘silage additives’. An application was submitted for the renewal of this authorization. Further to the favourable assessment by the European Food Safety Authority, the authorization of this preparation is renewed, subject to certain conditions.

The proposed draft Regulation concerns the review of existing MRLs for fenbuconazole and penconazole in certain food commodities. MRLs for these substances in certain commodities are lowered. Lower MRLs are set after deleting old uses which are not authorized any more in the European Union.