(1)

The error appears in all language versions of the text of recital (4), as well as point (1)(a) and points (2)(a) and (b) of Annex I and point (1)(c)(ii) of Annex II to Commission Delegated Regulation (EU) 2021/577 (2), as regards the erroneous use of the word ’veterinary‘ where the text is to be related both to veterinary medicinal products and medicinal products for human use. Therefore, the term ‘medicinal product’ should be used, encompassing both of those products.

(2)

Delegated Regulation (EU) 2021/577 should therefore be corrected accordingly.

(3)

This Regulation should be applicable from 28 January 2022 in accordance with the date of application of Regulation (EU) 2021/577.

(4)

In accordance with Article 147(5) of Regulation (EU) 2019/6, the Commission has consulted experts designated by each Member State,

(1)

The Portuguese language version of Commission Implementing Regulation (EU) 2019/947 (2) contains errors in Article 11(5)(a), as well in Appendix 1, Chapter I, Attachment A, point 1(a)(viii), of the Annex and in Appendix 3, point 4(b), of the Annex, that alter the meaning of the provisions.

(2)

The German language version of Implementing Regulation (EU) 2019/947 contains an error in Article 14(5)(a)(i) that alters the meaning of the provision.

(3)

The German and Portuguese language versions of Implementing Regulation (EU) 2019/947 should therefore be corrected accordingly. The other language versions are not affected.

(4)

Given the need to have the same level playing field for all operators, the overriding interest of the integrity of the internal market as well as the need for legal certainty, this Regulation should apply from 31 December 2020.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 127 of Regulation (EU) 2018/1139,

(1)

Article 10(3) of Commission Implementing Regulation (EU) 2017/39 (2) lays down the minimum percentage of the on-the-spot checks to be carried out on the premises of aid applicants dealing with the supply and distribution of products and with accompanying educational measures in the framework of the scheme referred to in Article 23 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council (3) (the ‘school scheme’). Article 10(3), fourth subparagraph, of Implementing Regulation (EU) 2017/39 provides that, where the aid applicant is not an educational establishment, the on-the-spot check carried out on the premises of the applicant is to be supplemented by on-the-spot checks on the premises of at least two educational establishments or at least 1 % of the educational establishments recorded by the applicant in accordance with Article 6 of Commission Delegated Regulation (EU) 2017/40 (4), whichever is the greater.

(2)

Due to the measures in place to address the COVID-19 pandemic, in particular the closure of educational establishments and the restrictions of access of external visitors to their premises, Member States may encounter difficulties with the planning and execution of timely on-the-spot checks on the premises of aid applicants or educational establishments in school year 2021/2022. Therefore, it is appropriate to provide that where Member States are not in a position to carry out those on-the-spot checks as required by Article 10(3) of Implementing Regulation (EU) 2017/39, they may decide to carry such on-the-spot checks remotely, for instance via videoconferences.

(3)

Article 10(6) of Implementing Regulation (EU) 2017/39 lays down the rules and methods applicable to the reporting of the checks and their results. In order to ensure transparency, Member States should justify the need for the derogation provided for in this Regulation and report on its use in the control report to be drawn up for each on-the-spot check carried out remotely.

(4)

It is therefore appropriate to derogate from certain provisions of Implementing Regulation (EU) 2017/39 in respect of school year 2021/2022.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

(1)

On 11 December 2018, Procter & Gamble Services Company NV submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a single biocidal product named ‘ARIEL chlorine Professional System 5 chlorine bleach for white wash’ of product type 2, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under case number BC-ER045796-14 in the Register for Biocidal Products.

(2)

‘ARIEL chlorine Professional System 5 chlorine bleach for white wash’ contains active chlorine released from sodium hypochlorite as the active substance included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.

(3)

On 25 November 2020, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

(4)

On 5 July 2021, the Agency submitted to the Commission an opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘ARIEL chlorine Professional System 5 chlorine bleach for white wash’ and the final assessment report on the single biocidal product in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5)

The opinion concludes that ‘ARIEL chlorine Professional System 5 chlorine bleach for white wash’ is a single biocidal product within the meaning of Article 3(1), point (r), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.

(6)

On 30 July 2021, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘ARIEL chlorine Professional System 5 chlorine bleach for white wash’.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

(1)

Regulation (EU) 2016/429 requires that consignments of animals, germinal products and products of animal origin must come from a third country or territory, or zone or compartment thereof, listed in accordance with Article 230(1) of that Regulation in order to enter the Union.

(2)

Commission Delegated Regulation (EU) 2020/692 (2) lays down the animal health requirements with which consignments of certain species and categories of animals, germinal products and products of animal origin from third countries or territories, or zones thereof, or compartments thereof, in the case of aquaculture animals, must comply with in order to enter the Union.

(3)

Commission Implementing Regulation (EU) 2021/404 (3) establishes the lists of third countries, or territories, or zones or compartments thereof, from which the entry into the Union of the species and categories of animals, germinal products and products of animal origin falling within the scope of Delegated Regulation (EU) 2020/692 is permitted.

(4)

More particularly, Annexes V and XIV to Implementing Regulation (EU) 2021/404 set out the lists of third countries, or territories, or zones thereof authorised for the entry into the Union, respectively, of consignments of poultry, germinal products of poultry, and of fresh meat from poultry and game birds.

(5)

The United Kingdom notified the Commission of an outbreak of highly pathogenic avian influenza in poultry. The outbreak is located near Beith, North Ayrshire, Scotland, United Kingdom and was confirmed on 18 March 2022 by laboratory analysis (RT-PCR).

(6)

In addition, the United Kingdom notified the Commission of an outbreak of highly pathogenic avian influenza in poultry. The outbreak is located near Strichen, Aberdeenshire, Scotland, United Kingdom and was confirmed on 19 March 2022 by laboratory analysis (RT-PCR).

(7)

Moreover, the United Kingdom notified the Commission of an outbreak of highly pathogenic avian influenza in poultry. The outbreak is located near Woodbridge, East Suffolk, Suffolk, England, United Kingdom and was confirmed on 20 March 2022 by laboratory analysis (RT-PCR).

(8)

Additionally, the United States notified the Commission of outbreaks of highly pathogenic avian influenza in poultry. The outbreaks are located in Hanson county, state of South Dakota, United States, and in Kingsbury county, state of South Dakota, United States and were confirmed on 18 March 2022 by laboratory analysis (RT-PCR).

(9)

Furthermore, the United States notified the Commission of an outbreak of highly pathogenic avian influenza in poultry. The outbreak is located in Hutchinson county, state of South Dakota, United States and was confirmed on 20 March 2022 by laboratory analysis (RT-PCR).

(10)

In addition, the United States notified the Commission of outbreaks of highly pathogenic avian influenza in poultry. The outbreaks are located in Butler county, state of Nebraska, United States, Cumberland county, state of Maine, United States, in Beadle county, state of South Dakota, United States, in the already affected Charles Mix County, state of South Dakota, United Sates, and in Hanson county, state of South Dakota, United States, and were confirmed on 22 March 2022 by laboratory analysis (RT-PCR).

(11)

Moreover, the United States notified the Commission of outbreaks of highly pathogenic avian influenza in poultry. The outbreaks are located in the already affected Beadle county, state of South Dakota, United States, in Edmunds county, state of South Dakota, United States, and in Kingsbury county, state of South Dakota, United States, and were confirmed on 23 March 2022 by laboratory analysis (RT-PCR).

(12)

Additionally, the United States notified the Commission of outbreaks of highly pathogenic avian influenza in poultry. The outbreaks are located in the already affected Butler county, state of Nebraska, United States, in Jerauld county, state of South Dakota, United States, and in the already affected Buena Vista county, state of Iowa, United States, and were confirmed on 24 March 2022 by laboratory analysis (RT-PCR).

(13)

Furthermore, the United States notified the Commission of outbreaks of highly pathogenic avian influenza in poultry. The outbreaks are located in Franklin county, state of Iowa, United States, and in Meeker county, state of Minnesota, United States, and were confirmed on 25 March 2022 by laboratory analysis (RT-PCR).

(14)

In addition, the United States notified the Commission of an outbreak of highly pathogenic avian influenza in poultry. The outbreak is located in Stearns county, state of Minnesota, United States, and was confirmed on 26 March 2022 by laboratory analysis (RT-PCR).

(15)

The veterinary authorities of the United Kingdom and the United States established a 10 km control zone around the affected establishments and implemented a stamping-out policy in order to control the presence of highly pathogenic avian influenza and limit the spread of that disease.

(16)

The United Kingdom and the United States have submitted information to the Commission on the epidemiological situation on their territory and the measures they have taken to prevent the further spread of highly pathogenic avian influenza. That information has been evaluated by the Commission. On the basis of that evaluation and in order to protect the animal health status of the Union, the entry into the Union of consigments of poultry, germinal products of poultry, and fresh meat from poultry and game birds from the areas under restrictions established by the veterinary authorities of the United Kingdom and the United States due to the recent outbreaks of highly pathogenic avian influenza should no longer be authorised.

(17)

Moreover, the United Kingdom has submitted updated information on the epidemiological situation on its territory in relation to outbreaks of HPAI confirmed in poultry establishments on 14 November 2021 near Salwick, Fylde, Lancashire, England, on 17 November 2021 near Kirkham, Fylde, Lancashire, England, on 2 December 2021 near Tutbury, East Staffordshire, Staffordshire, England and on 15 December 2021 near Wem, North Shropshire, Shropshire, England. The United Kingdom has also submitted the measures it has taken to prevent the further spread of that disease. In particular, following this outbreak of HPAI, the United Kingdom has implemented a stamping out policy in order to control and limit the spread of that disease. In addition, the United Kingdom completed the requisite cleaning and disinfection measures following the implementation of the stamping out policy on the infected poultry establishment on its territory.

(18)

The Commission has evaluated the information submitted by the United Kingdom and concluded that the HPAI outbreaks near Salwick, Fylde, Lancashire, England, near Kirkham, Fylde, Lancashire, England, near Tutbury, East Staffordshire, Staffordshire, England and near Wem, North Shropshire, Shropshire, England in poultry establishments have been cleared and that there is no longer any risk associated with the entry into the Union of poultry commodities from the zones of the United Kingdom from which the entry into the Union of poultry commodities have been suspended due to these outbreaks.

(19)

Annexes V and XIV to Implementing Regulation (EU) 2021/404 should be therefore amended accordingly.

(20)

Taking into account the current epidemiological situation in the United Kingdom and the United States as regards highly pathogenic avian influenza and the serious risk of its introduction into the Union, the amendments to be made to Implementing Regulation (EU) 2021/404 by this Regulation should take effect as a matter of urgency.

(21)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

On 15 May 2012, Pioneer Overseas Corporation, based in Belgium, submitted, on behalf of Pioneer Hi-Bred International, Inc., based in the United States, an application to the national competent authority of the Netherlands (‘the application’) for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified oilseed rape 73496, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003. The application also concerned the placing on the market of products containing or consisting of genetically modified oilseed rape 73496 for uses other than food and feed, with the exception of cultivation.

(2)

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC of the European Parliament and of the Council (2). It also included the information required pursuant to Annexes III and IV to that Directive and a monitoring plan for environmental effects in accordance with Annex VII to that Directive.

(3)

On 17 June 2021, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). The Authority concluded that genetically modified oilseed rape 73496, as described in the application, is as safe as its conventional counterpart and the tested non-genetically modified oilseed rape reference varieties with respect to the potential effects on human and animal health and the environment. The Authority also concluded that the consumption of genetically modified oilseed rape 73496 does not represent any nutritional concern.

(4)

In its scientific opinion, the Authority considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for in Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(5)

The Authority also concluded that the monitoring plan for the environmental effects, submitted by the applicant, consisting of a general surveillance plan, is in line with the intended uses of the products.

(6)

In addition, the Authority recommended implementing a post-market monitoring plan, focusing on the collection of data of imports entering into the Union as regards genetically modified oilseed rape 73496 and products derived from genetically modified oilseed rape 73496 for food and for feed, and on the collection of consumption data for humans and animals in order to verify that that the conditions of use of genetically modified oilseed rape 73496 are those considered during the pre-marketing risk assessment.

(7)

The opinion of the Authority does not justify the imposition of other specific conditions or restrictions for the placing on the market, for the use and handling or for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.

(8)

Taking into account those conclusions, the placing on the market of products containing, consisting of or produced from genetically modified oilseed rape 73496 should be authorised for the uses listed in the application.

(9)

By letter dated 1 November 2021, Pioneer Hi-Bred International, Inc. requested that the Commission transfers the rights and obligations of Pioneer Hi-Bred International, Inc. pertaining to all authorisations and pending applications for genetically modified products, to Corteva Agriscience LLC, based in United States, represented in the Union by Corteva Agriscience Belgium B.V., based in Belgium. By letter dated 1 November 2021, Corteva Agriscience Belgium B.V. confirmed consent to this transfer on behalf of Corteva Agriscience LLC.

(10)

A unique identifier should be assigned to genetically modified oilseed rape 73496 in accordance with Commission Regulation (EC) No 65/2004 (4).

(11)

For the products covered by this Decision, no specific labelling requirements, other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5), appear to be necessary. However, in order to ensure that the use of those products remains within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of genetically modified oilseed rape 73496, with the exception of foods and food ingredients, should contain a clear indication that they are not intended for cultivation.

(12)

The authorisation holder should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan for environment effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC (6).

(13)

The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.

(14)

All relevant information on the authorisation of the products covered by this Decision should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC) No 1829/2003.

(15)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(16)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,