Notifications for European Union (1104 notifications)

The legislative measure concerns the renewal of the authorization of the substances as feed additives in the category of "compounds of trace elements" following the evaluation by the European Food Safety Agency (EFSA) and based on Article 14 of Regulation (EC) 1831/2003.

The legislative measure authorises the commercialisation of a substance as a feed additive in the category of "silage additives" subsequent to the evaluation by the European Food Safety Agency (EFSA) ex Article 4(1) of Regulation (EC) 1831/2003.

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 one new substance for plastic materials intended to be in contact with foods.

The proposal of the European Commission notified in G/SPS/N/EU/115 (14 November 2014) was adopted as Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (Text with EEA relevance) [OJ L 4, 7 January 2019, p. 1]. This Regulation shall apply from 28 January 2022.

Revision of list of third countries authorized for imports of gelatine, flavouring innards and rendered fats.

The proposal notified in G/SPS/N/EU/290 (19 December 2018) was adopted as Commission Implementing Directive (EU) 2019/523 of 21 March 2019 amending Annexes I to V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community [OJ L 86, 28 March 2019, p. 41].This Directive entered into force on 31 March 2019. The application date is 1 September 2019.ADDITIONAL INFORMATION:As a follow-up to the new EU import requirements applying from 1 September 2019, the European Commission invites all non-EU trading countries to communicate prior to trade, the following information:-          for Tephritidae (non-European) in relation to fruits of Citrus L., Fortunella Swingle, Poncirus Raf., and their hybrids, Mangifera L. and Prunus L., whether the country is free from the harmful organism or the pest free areas of the country, recognized in accordance with the relevant International Standards for Phytosanitary Measures, or in case of export of fruits subjected to a treatment, the treatment method applied. Please note that the information requested above relates only to Tephritidae (non-European) species which are pests of the abovementioned fruits. Please see the new point 16.5 of Annex IV Part A Section I of Council Directive 2000/29/EC.-          for Enarmonia prunivora Walsh, Grapholita inopinata Heinrich and Rhagoletis pomonella (Walsch) in relation to fruits of Malus Mill., whether the country is free from the harmful organism or the pest free areas of the country, recognized in accordance with the relevant International Standards for Phytosanitary Measures, or in case of export of fruits subjected to a treatment, the treatment method applied. Please see point 16.7 of Annex IV Part A Section I of Council Directive 2000/29/EC.-          for Guignardia piricola (Nosa) Yamamoto and Tachypterellus quadrigibbus Say, in relation to fruits of Malus Mill. and Pyrus L., whether the country is free from the harmful organism or the pest free areas of the country, recognized in accordance with the relevant International Standards for Phytosanitary Measures, or in case of export of fruits subjected to a treatment, the treatment method applied. Please see points 16.8 and 16.9 of Annex IV Part A Section I of Council Directive 2000/29/EC.-          for Neoleucinodes elegantalis (Guenée) in relation to fruits of Capsicum annuum L., Solanum aethiopicum L., Solanum lycopersicum L. and Solanum melongena L. whether the country is free from the harmful organism or the pest free areas of the country, recognized in accordance with the relevant International Standards for Phytosanitary Measures. Please see point 25.7.3 of Annex IV Part A Section I of Council Directive 2000/29/EC.As a follow-up to the new import requirements applying from 1 September 2019, the European Commission invites the relevant non-EU trading countries to communicate prior to trade, the following information:-          for Grapholita packardi Zeller in relation to plants intended for planting, other than plants in tissue culture and seeds, of Crataegus L., Cydonia Mill., Malus Mill., Prunus L., Pyrus L. and Vaccinium L. originating in Canada, Mexico and the USA (see point 14.2 of Annex IV Part A Section I of Council Directive 2000/29/EC), the pest free areas of the country, recognized in accordance with the relevant International Standards for Phytosanitary. For the same pest, in the case of exports to the EU of fruits of Malus Mill., Prunus L., Pyrus L. and Vaccinium L., originating in Canada, Mexico and the USA, you are invited to communicate the pest free areas of the country, recognized in accordance with the relevant International Standards for Phytosanitary or the treatment method (see point 16.10 of Annex IV Part A Section I of Council Directive 2000/29/EC).-          for Thaumatotibia leucotreta (Meyrick), in relation to fruits of Capsicum (L.), Citrus L., other than Citrus limon (L.) Osbeck. and Citrus aurantiifolia (Christm.) Swingle, Prunus persica (L.) Batsch and Punica granatum L. originating in countries of the African continent, Cape Verde, Saint Helena, Madagascar, La Reunion, Mauritius and Israel, whether the country is free from the harmful organism or the pest free areas of the country, recognized in accordance with the relevant International Standards for Phytosanitary Measures, or in case of export of fruits to the EU subjected to a treatment, the treatment method applied together with documentary evidence of its effectiveness. Please see the new point 16.6 of Annex IV Part A Section I of Council Directive 2000/29/EC.-          for Bactericera cockerelli (Sulc.) in relation to fruits of Solanaceae originating in Australia, the Americas and New Zealand, whether the country is free from the harmful organism or the pest free areas of the country, recognized in accordance with the relevant International Standards for Phytosanitary Measures. Please see point 25.7.4 of Annex IV Part A Section I of Council Directive 2000/29/EC.The requested information should be sent to the plant health contact point of the European Commission, Directorate General for Health and Food Safety:SANTE-G1-PLANT-HEALTH@ec.europa.euFrom 1 September 2019, the trade of the above mentioned commodities will only be allowed, if the above information has already been provided to the European Commission.

The proposed draft Regulation concerns the review of existing MRLs for cyflufenamid, fenbuconazole, fluquinconazole and tembotrione 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 imazalil in certain food commodities. MRLs for this substance 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 has also been updated.

The measure concerns the change of the specifications of the novel food coriander seed oil from Coriandrum sativum relating to the saponification value.

The measure concerns an extension of use of a novel food Schizochytrium sp. (ATCC PTA-9695) oil to an additional food category (fruit and vegetable purees). This measure also concerns the change of the designation and of the specific labelling requirement of Schizochytrium sp. (ATCC PTA-9695) oil (removal of the mention of the strain).

The draft Regulation lays down rules for the establishment of reference points for action and methods to assess their safety and it lowers the reference points for action for chloramphenicol, malachite green and nitrofuran metabolites. The amended RPAs will apply from three years after entry into force.

The legislative measure authorises the commercialisation of the substances as feed additives in the category of "silage additive" subsequent to the re-evaluation by the European Food Safety Agency (EFSA) ex Article 10(1)(b) of Regulation (EC) 1831/2003.

Rules on uniform practical arrangements for the performance of official controls on plants, plant products and other objects in order to verify compliance with Union rules on protective measures against pests of plants applicable to those goods

The proposed draft Regulation concerns the review of the existing maximum residue levels (MRLs) for the substances amitrole, fipronil, flufenoxuron, flupyrsulfuron-methyl, imazosulfuron, isoproturon, orthosulfamuron and triasulfuron. 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.

Regulatory framework for authorisation and use of veterinary medicinal products, obligations of applicants, marketing authorisation holders, regulatory authorities. Date of application: 28 January 2022.

The proposed draft Regulation is a new legislative act which updates the list of Invasive Alien Species of Union concern in implementation of the Regulation (EU) No 1143/2014 of the European Parliament and of the Council on the prevention and management of the introduction and spread of invasive alien species. The list was established by Commission Implementing Regulation (EU) No 2016/1141 and was updated by Commission Implementing Regulation (EU) No 2017/1263. The notified proposal for a draft Regulation adds further species to the list.

The proposal notified in G/SPS/N/EU/260 (20 June 2018) was adopted as Commission Regulation (EU) 2019/90 of 18 January 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 bromuconazole, carboxin, fenbutatin oxide, fenpyrazamine and pyridaben in or on certain products (Text with EEA relevance) [OJ L 22, 24 January 2019, p. 52].This Regulation shall apply from 13 August 2019.

The proposal notified in G/SPS/N/EU/262 (13 July 2018) was adopted as Commission Regulation (EU) 2019/58 of 14 January 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 linuron in or on certain products (Text with EEA relevance) [OJ L 12, 15 January 2019, p. 1]. This Regulation shall apply from 4 August 2019.

The proposal notified in G/SPS/N/EU/258 (16 May 2018) was adopted as Commission Regulation (EU) 2019/89 of 18 January 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 bromadiolone, etofenprox, paclobutrazol and penconazole in or on certain products (Text with EEA relevance) [OJ L 22, 24 January 2019, p. 13].This Regulation shall apply from 13 August 2019.

The proposal notified in G/SPS/N/EU/259 (20 June 2018) was adopted as Commission Regulation (EU) 2019/88 of 18 January 2019 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid in certain products (Text with EEA relevance) [OJ L 22, 24 January 2019, p. 1].This Regulation shall apply from 13 August 2019.