Notifications for European Union (1104 notifications)

The legislative measure concerning the renewal of the authorization of zinc chelate of methionine sulfate as a feed additive for all animal species to be classified in the additive category "nutritional additives" subsequent to the evaluation by the European Food Safety Agency (EFSA) Article 4 of Regulation (EC) 1831/2003.

The legislative measure concerning the authorisation of L-threonine produced by Escherichia coli CGMCC 7.232 as a feed additive for all animal species to be classified in the additive category "nutritional additives" subsequent to the evaluation by the European Food Safety Agency (EFSA) Article 4 of Regulation (EC) 1831/2003.

It follows from Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of plant health and plant protection products, that certain categories of goods entering the Union must be subject to specific official controls.Based on Article 77(1)(d) of Regulation (EU) 2017/625 this draft Delegated Regulation lays down rules for performance of specific official controls of wood packaging material or wood products (excluding paper products) intended for supporting, protecting or carrying a commodity entering the Union territory, whether or not actually in use in transport of objects of all kind.This Regulation does not apply to wood packaging material concerning the exemptions provided under the International Standard for Phytosanitary Measures No 15 - Regulation of Wood Packaging Material in International Trade (ISPM15). Regulation also establishes cases where and conditions under which the competent authorities may request operators to notify the arrival of certain consignments entering the Union territory in which wood packaging material is present and establishes measures to be taken in cases when non-compliances is found during physical checks.

In accordance with Regulation (EU) 2017/625, certain categories of animals and goods from third countries should always be presented at a border control post for official controls to be performed prior to their entry into the Union.This Implementing Regulation establishes the lists of the different animals and products of animal origin, germinal products, animal by-products and derived products, hay and straw and composite products to be presented for official controls at border control posts with the indication of their respective Combined Nomenclature (CN) code provided for in Council Regulation (EEC) No 2658/87. As new conditions for the entry into the Union of composite products will apply from 21 April 2021 in accordance with Commission Delegated Regulation (EU) 2019/625, the current rules on composite products in Decision 2007/275/EC should continue to apply until then. Hence, this Regulation does not apply to composite products.

Transmission of the link to the Draft Regulation:

The proposed draft Regulation concerns the review of the existing maximum residue levels (MRLs) for the substances dimethoate and omethoate. MRLs for these substances in cherries are 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 proposal notified in G/SPS/N/EU/287 (11 December 2018) was adopted as Commission Regulation (EU) 2019/1176 of 10 July 2019 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 2,5-dichlorobenzoic acid methylester, mandipropamid and profoxydim in or on certain products [OJ L 185, 11 July 2019, p. 1]. This Regulation shall apply from 31 January 2020.

It follows from Regulation (EU) 2017/625 that in case of suspected fraud by an operator, or in the case of serious or repeated infringements of the rules referred to in Article 1(2) of that Regulation, official controls on consignments with the same use or origin should be intensified by the competent authorities at the border control posts. The competent authorities' decision to perform such intensified controls is to be notified to the Commission and the Member States. In order to ensure a harmonised approach, this Implementing Regulation establishes detailed procedures for the coordinated performance of those controls, including rules on the role of the IMSOC in this respect.

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.The draft Delegated Regulation on establishing specific rules for official controls at the border control posts on the transhipment, transit and onward transportation of animals and goods based on Article 51(1) and 77(1)(c) of Regulation (EU) 2017/625 requires that certain consignments delivered to vessels leaving the Union to NATO or US military base, shall be accompanied by an official certificate.Therefore, based on Articles 77(3)(a) and 90(a) of Regulation (EU) 2017/625 this draft Delegated Regulation lays down: - establish the model of certificate accompanying consignments of products of animal origin, germinal products, animal by-products, derived products, hay and straw and composite products from third countries which are delivered to vessels leaving the Union or to NATO or Unites States' military bases; - rules for issuing official certificate.

Animal health requirements for entry into the European Union of live animals, germinal products and products of animal origin for human consumption.

This draft Regulation consolidates in one single act the measures on increased official controls laid down in Commission Regulation (EC) No 669/2009 and the emergency measures for food and feed laid down in Commission Regulations (EU) No 884/2014, (EU) No 2015/175, (EU) No 2017/186 and (EU) 2018/1660. It will apply from 14 December 2019.The draft Regulation lays down the list of food and feed of non-animal origin from certain third countries subject to a temporary increase of official controls at their entry into the Union, established in Annex I, in accordance with Article 47(2)(b) of Regulation (EU) 2017/625. The list consists of an updated list of food and feed laid down in Commission Regulation (EC) 669/2009, as amended by Commission Regulation (EU) 2019/890 and by the 30th review of Annex I to Regulation (EC) 669/2009. The frequency of identity checks and physical checks for the food and feed listed in Annex I is also laid down in that Annex.The draft Regulation also lays down special import conditions (emergency measures) in accordance with Article 53(1)(b)(ii) of Regulation (EC) 178/2002 for the entry into the Union of food and feed of non-animal origin from certain third countries listed in Table 1 to Annex II and of compound food containing any of the food listed in Table 1 to Annex II due to the risk of contamination by aflatoxins in a quantity above 20% of either a single product or as the sum of those products and falling within the CN Codes: ex- 1704 90, ex- 1806 and ex- 1905. The list of food and feed of non–animal origin in Table 1 of Annex II consists of the updated lists laid down in Regulations (EU) No 2015/175, (EU) No 2017/186, (EU) 2018/1660 (EU) and 884/2014, as amended by Regulation (EU) 2019/890. The frequency of identity checks and physical checks for the food and feed listed in Annex II is also laid down in that Annex.The draft Regulation provides that each consignment of food and feed listed in Annex II must be accompanied by the results of sampling and analyses and by an official certificate issued by the competent authority of the third country of origin or of the third country where the consignment is consigned from if that country is different from the country of origin. A new single model official certificate is established, in accordance with Article 53(1)(b)(ii) of Regulation (EC) 178/2002, which replaces the model official certificates laid down in Commission Regulations (EU) No 884/2014, (EU) No 2015/175, (EU) No 2017/186 and (EU) 2018/1660.The draft Regulation provides that the Commission must review the lists set out in Annexes I and II on a regular basis not exceeding a period of six months.A transitional period is laid down in Article 14(3) to allow entry into the Union until the 13 June 2019 of consignments of food and feed accompanied by the relevant certificates issued before 14 February 2020 in accordance with the provisions of Regulation (EU) No 884/2014, Regulation (EU) 2018/1660, Regulation (EU) No 2015/175 and Regulation (EU) 2017/186.The draft Regulation will mainly affect the third countries of origin of the food and feed listed in Annexes I and II (Argentina, Azerbaijan, Bolivia, Brazil, China, Dominican Republic, Egypt, Ethiopia, Georgia, Ghana, Gambia, Indonesia, India, Iran, Kenya, Cambodia, Lebanese Republic, Sri Lanka, Madagascar, Malaysia, Nigeria, Pakistan, Serbia, Sierra Leone, Senegal, Sudan, Syria, Thailand, Turkey, Uganda, United States, Uzbekistan, Viet Nam).However, the draft Regulation is also likely to affect other trading partners, namely the third countries of dispatch of the products listed in Annexes I and II, if they are different from the third country of origin, as well as the third countries of dispatch of compound foods covered by this draft Regulation.

This legislative measure updates the list of feed intended for particular nutritional purposes and the respective requirements and replaces Directive 2008/38/EC by a Regulation.

The proposal notified in G/SPS/N/EU/281 (24 October 2018) was adopted as Commission Delegated Regulation (EU) 2019/478 of 14 January 2019 amending Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the categories of consignments to be subjected to official controls at border control posts (Text with EEA relevance) [OJ L 82, 25 March 2019, p. 4]. This Regulation shall apply from 14 December 2019.

The proposals notified in G/SPS/N/EU/278 (12 October 2018) were adopted as:1) Commission Delegated Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption (Text with EEA relevance) [OJ L 131, 17 May 2019, p. 18].This Regulation shall apply from 14 December 2019. However, the requirements laid down in Article 12, and Articles (14)(1) and (2) shall apply from 21 April 2021. 2) Commission Implementing Regulation (EU) 2019/626 of 5 March 2019 concerning lists of third countries or regions thereof authorised for the entry into the European Union of certain animals and goods intended for human consumption, amending Implementing Regulation (EU) 2016/759 as regards these lists (Text with EEA relevance) [OJ L 131, 17 May 2019, p. 31]. >This Regulation shall apply from 14 December 2019. 3) Commission Implementing Regulation (EU) 2019/628 of 8 April 2019 concerning model official certificates for certain animals and goods and amending Regulation (EC) No 2074/2005 and Implementing Regulation (EU) 2016/759 as regards these model certificates (Text with EEA relevance) [OJ L 131, 17 May 2019, p. 101]. >This Regulation shall apply from 14 December 2019.

The proposals notified in G/SPS/N/EU/277 (12 October 2018) were adopted as:1.      Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No 2074/2005 as regards official controls (Text with EEA relevance) [OJ L 131, 17 May 2019, p. 51.This Regulation shall apply from 14 December 2019.2.      Commission Delegated Regulation (EU) 2019/624 of 8 February 2019 concerning specific rules for the performance of official controls on the production of meat and for production and relaying areas of live bivalve molluscs in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (Text with EEA relevance) [OJ L 131, 17 May 2019, p. 1].This Regulation shall apply from 14 December 2019.

The proposal notified in G/SPS/N/EU/271 (25 September 2018) was adopted as Commission Regulation (EU) 2019/37 of 10 January 2019 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance) [OJ L 9, 11 January 2019, p. 88]. This Regulation entered into force on 31 January 2019.

The proposal notified in G/SPS/N/EU/276 (12 October 2018) was adopted as Commission Delegated Regulation (EU) 2019/829 of 14 March 2019 supplementing Regulation (EU) 2016/2031 of the European Parliament and of the Council on protective measures against pests of plants, authorizing member States to provide for temporary derogations in view of official testing, scientific or educational purposes, trials, varietal selections, or breeding [OJ L 137, 23 May 2019, p. 15]. This Regulation shall apply from 14 January 2019.

The proposal notified in G/SPS/N/EU/294 (11 January 2019) was adopted as Commission Delegated Regulation (EU) 2019/934 of 12 March 2019 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards wine-growing areas where the alcoholic strength may be increased, authorised oenological practices and restrictions applicable to the production and conservation of grapevine products, the minimum percentage of alcohol for by-products and their disposal, and publication of OIV files [OJ L 149, 7 June 2019, p. 1]. This Regulation shall apply from 7 December 2019.

The measure concerns authorizing the placing on the market of Yarrowia lipolytica yeast biomass as a novel food for use in food supplements.

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) which is now amended by this Regulation.This addendum concerns the removal of the flavouring substance furan-2(5H)-one (FL-no 10.066) from the European Union list of flavourings following the European Food Safety Authority opinion published at the end of January 2019 which concluded that this substance is genotoxic in vivo and therefore its use as a flavouring substance raises a safety concern.The measure has been taken in urgency in view of this EFSA assessment indicating a serious risk (genotoxicity) of this flavouring substance FL 10.066 on the basis of new scientific data. Therefore, its addition to foods should be stopped swiftly. It has not been possible to notify the draft measure in view of the nature of the risk involved.According to the European Association of producers of flavourings (EFFA) as reported in the opinion by EFSA, the poundage for this substance in Europe is very low (zero in 2017).This substance furan-2(5H)-one (FL No 10.066) can also be identified with CAS No. 497-23-4, JECFA No 2000 and JECFA name "4-hydroxy-2-butenoic acid gamma lactone".The EFSA opinion is available as EFSA Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxicity potential for alpha, beta unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones; EFSA Journal 2019;17(1):5568.