Notifications for European Union (1104 notifications)

Regulation (EU) 2017/625 requires that certain categories of animals and goods entering the Union are made subject to official controls at border control posts of first arrival, depending on the risk they pose to public and animal health.This draft Delegated Regulation adds composite products, hay and straw to the already existing categories.The draft Delegated Regulation is linked to other acts which will establish new import conditions for composite products and a new list of composite products exempted from border controls, to be applicable from 21 April 2021. Until this date the current import conditions and exemptions will apply.

The legislative measure authorizes the commercialisation of two substances as feed additives in the category of "technological additives" subsequent to the re-evaluation by the European Food Safety Agency (EFSA) ex Article 10(2) of Regulation (EC) 1831/2003.

The two draft Regulations lay down official controls in products of animal origin intended for human consumption. They replace the current rules of Regulation (EC) No 854/2004 which will be repealed. The controls mainly concern fresh meat (meat inspection), bivalve molluscs, fishery products, milk and dairy products.Draft Delegated Regulation focuses on who should carry out the meat inspection and provides derogations to the basic requirements laid down in Article 18 of Regulation (EU) 2017/625 on official controls.Draft Implementing Regulation lays down practical arrangements (what and how) for the official controls in the products of animal origin.These draft Regulations intend to provide continuity of the current rules of Regulation (EC) No 854/2004 introducing adaptation to better define to adapt to currently most relevant hazards, using a risk-based approach based on scientific opinions of the European Food Safety Authority. The two texts are notified together because they are linked to each other. One focuses on who is responsible for the official controls and the other on the specific tasks to be carried out. >

The three draft Regulations lay down import conditions, mainly for products of animal origin intended for human consumption. They replace the current import conditions of Regulation (EC) No 854/2004 which will be repealed.The draft Delegated Regulation indicates for which food listing of the country of origin, listing of the establishment and/or certification is required for entry into the European Union. It also sets the conditions for such listings.The draft Implementing Regulation (EU) establishing lists of third countries or regions thereof authorised for the entry into the European Union of certain animals and goods intended for human consumption and amending Implementing Regulation (EU) 2016/759 as regards these lists lays down the list of countries authorised to enter specific food into the European Union.The draft Commission Implementing Regulation (EU) laying down model official certificates for certain animals and goods in accordance with Article 90 of Regulation (EU) 2017/625 of the European Parliament and of the Council and amending Implementing Regulation (EU) 2016/759 as regards model certificates lays down the model health certificates to be used to enter specific food into the European Union.The draft Regulations intend to provide continuity of the current import conditions in Regulation (EC) No 854/2004 but extend the list of food of animal origin subject to these harmonised EU import conditions with insects, reptile meat and composite products. The three texts are notified together because they are linked to each other and references are made to all texts.

This draft Regulation lays down the conditions for derogation from the import prohibition or the standard phytosanitary procedures laid down in Regulation (EU) 2016/2031, under which specified pests and plants, plant products and other objects may be introduced into, or moved, held, multiplied or used within, the Union, or protected zones therein, for official testing, scientific or educational purposes, trials, varietal selection or breeding.The scope of the draft legislation covers: Union quarantine pests, listed pursuant to Article 5 of Regulation (EU) 2016/2031; Pests subject to the measures adopted pursuant to Article 30(1) of that Regulation; Protected zone quarantine pests, listed pursuant to Article 32(3) of that Regulation; Plants, plant products or other objects listed pursuant to Articles 40(2), 41(2), 42(2), 49(1), 53(2) and 54(2) of that Regulation.

The proposal notified in G/SPS/N/EU/254 (19 April 2018) was adopted as Commission Regulation (EU) 2018/1481 of 4 October 2018 amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards octyl gallate (E 311) and dodecyl gallate (E 312) (Text with EEA relevance) [OJ L 251, 5 October 2018, p. 13].This Regulation shall apply from 25 October 2018.

The measure concerns the inclusion of powder as an allowed form of lactitol to be used in food supplements.

The measure concerns the deletion of the term "synthetic" from the designation of the novel food as listed in the Union list and from the labelling of foodstuffs containing it.

The proposal notified in G/SPS/N/EU/13/Add.9 (22 May 2018) was adopted as Commission Regulation (EU) 2018/1246 of 18 September 2018 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of pyroligneous distillate in the Union list of flavourings (Text with EEA relevance) [OJ L 235, 19 September 2018, p. 3].This Regulation shall apply from 23 April 2018 until 19 September 2023.

This text contains the list of high-risk plants, plant products or other objects within the meaning of Article 42 of Regulation (EU) 2016/2031 and the list of plants that are exempted from carrying a phytosanitary certificate within the meaning of Article 73 of Regulation (EU) 2016/2031.The introduction into the European Union of plants, plant products or other objects listed as high-risk plants within the meaning of Article 42 of Regulation (EU) 2016/2031 will be prohibited pending a complete risk assessment.The list of high-risk plants, plant products and other objects contains:- 34 genera and one species of plants for planting (Acacia sp., Acer sp., Albizia sp., Alnus sp., Annona sp., Bauhinia sp., Berberis sp., Betula sp., Caesalpinia sp., Cassia sp., Castanea sp., Cornus sp., Corylus sp., Crataegus sp., Diospyros sp., Fagus sp., Ficus caricaFraxinus sp., Hamamelis sp., Jasminum sp., Juglans sp., Ligustrum sp., Lonicera sp., Malus sp., Nerium sp., Persea sp., Populus sp., Prunus sp., Quercus sp., Robinia sp., Salix sp., Sorbus sp., Taxus sp., Tilia sp., Ulmus),- one plant (Ullucus tuberosus),- one fruit (Momordica genus), and- one wood (wood of Ulmus genus).The list of plants that are exempted from carrying a phytosanitary certificate within the meaning of Article 73 of Regulation (EU) 2016/2031 contains 5 fruits: Ananas comosusCocos nuciferaDurio zibethinusMusa sp., Phoenix dactilifera

On the basis of Regulation (EC) No 1831/2003, the measure denies the authorisation of the substance as a feed additive in the category of "nutritional additives" subsequent to the opinion of the European Food Safety Agency (EFSA) of 7 March 2018 (published in the EFSA Journal 2018;16(3):5223). The measure concerns only riboflavin (80 %) produced by the specific strain Bacillus subtilis KCCM-10445 and does not affect riboflavin produced by other strains, which are currently allowed on the EU market for use as a feed additive.

The proposed Commission Regulation would amend Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. Regulation (EU) No 10/2011 is a specific Regulation within the framework Regulation (EC) No 1935/2004. The latter sets out principles and procedures applicable to food contact materials. This amendment authorises 3 new substances, modifies the conditions of use of one substance, introduces a group migration limit for one substance, clarifies the types of migrants that are to be used in foods with a certain pH, introduces requirements for the migration testing for the migrating oligomers for one of the newly authorised substance when it is used for the production or polycarbonates other than the ones covered by the specific authorisation, and corrects minor typographical errors.

The measure concerns the authorisation on the extension of use of oil from the micro algae Schizochytrium sp. (T18) as a novel food in fruit/vegetable puree.

The measure concerns the correction of the Union list of novel foods established by Implementing Regulation (EU) 2017/2470.

The legislative measure authorises the commercialisation of nine compounds of copper as feed additives in the category of "nutritional additives" subsequent to the re-evaluation by the European Food Safety Authority (EFSA) ex Article 10(2) of Regulation (EC) 1831/2003.

The measure concerns the authorizing an extension of use of UV-treated baker's yeast (Saccharomyces cerevisiae) as a novel food to additional food categories, namely, pre-packed fresh and dry yeast for home baking and in food supplements without indication of maximum permitted levels. In addition, the specification regarding vitamin D2 content was amended.

The measure concerns authorizing an extension of use levels of UV-treated mushrooms as a novel food. In particular, authorisation concerns higher levels of vitamin D2 in UV-treated mushrooms (Agaricus bisporus) than already authorized.

The measure concerns authorizing the placing on the market of hen egg white lysozyme hydrolysate as a novel food for use in food supplements intended for adult population.

This draft Regulation set proposed maximum residue levels (MRLs) for the substances buprofezin, diflubenzuron, ethoxysulfuron, ioxynil, molinate, picoxystrobin and tepraloxydim. 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 of the substance ioxynil has also been updated.

This notified draft Regulation sets maximum residue levels for iprodione to the limit of determination by application of Article 14(1)(a) and Article 17 of Regulation (EC) No 396/2005 and following the revocation of national authorisations of plant protection products containing this active substance in the EU. National authorisations of plant protection products containing this active substance were revoked by application of Commission Implementing Regulation (EU) 2017/2091 of 14 November 2017 concerning the non-renewal of approval of the active substance iprodione, notified to the WTO Committee on Technical Barriers to Trade (G/TBT/N/EU/495).