(1)

Regulation (EU) No 1143/2014 provides that the Commission is to adopt the format of the documents serving as evidence for permits issued by the competent authorities of Member States to carry out research on, or ex-situ conservation of, invasive alien species of Union concern, as set out in Article 8. Permits may also be issued for scientific production and subsequent medicinal use of these species.

(2)

Permits may also be issued by Member States, in exceptional cases and for reasons of compelling public interest, to carry out activities other than those listed in Article 8(1), as set out in Article 9(1), provided an authorisation has been issued by the Commission. According to Article 9(6), such permits must be issued in accordance with Article 8(4) to (8). Hence the same format of the document serving as evidence for the permits must be used for the purposes of both Articles 8 and 9.

(3)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on Invasive Alien Species,

(1)

The approval of the active substance lambda-cyhalothrin, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2), expires on 30 June 2016.

(2)

An application for the renewal of the inclusion of lambda-cyhalothrin in Annex I to Council Directive 91/414/EEC (3) was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (4) within the time period provided for in that Article.

(3)

The applicants submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. The application was found to be complete by the rapporteur Member State.

(4)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 28 February 2013.

(5)

The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(6)

On 11 March 2015, the Authority communicated to the Commission the revised version of its conclusion of 23 April 2014 (5) on whether lambda-cyhalothrin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft review report for lambda-cyhalothrin to the Standing Committee on Plants, Animals, Food and Feed on 28 May 2015.

(7)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 are satisfied. Those approval criteria are therefore deemed to be satisfied.

(8)

The risk assessment for the renewal of the approval of lambda-cyhalothrin is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing lambda-cyhalothrin may be authorised. It is therefore appropriate not to maintain the restriction to uses as an insecticide.

(9)

The Commission however considers that lambda-cyhalothrin is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. The Acceptable Operator Exposure Level (AOEL) is significantly lower than those of the majority of the approved active substances within the group of insecticides. Moreover, lambda-cyhalothrin is a bioaccumulative and toxic substance in accordance with points 3.7.2.2 and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the bioconcentration factor is greater than 2000 and the long-term no-observed effect concentration for freshwater organisms is less than 0,01 mg/L. Lambda-cyhalothrin therefore fulfils the conditions set in the first and second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.

(10)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, necessary to include certain conditions. It is, in particular, appropriate to require further confirmatory information.

(11)

It is therefore appropriate to renew the approval of lambda-cyhalothrin as a candidate for substitution.

(12)

In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(13)

Commission Implementing Regulation (EU) 2015/1885 (6) extended the expiry date of lambda-cyhalothrin to 30 June 2016 in order to allow the renewal process to be completed before the expiry of its approval. However, given that a decision on renewal has been taken ahead of the extended expiry date, this Regulation should apply from 1 April 2016.

(14)

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

(1)

The approval of the active substance iprovalicarb, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2), expires on 30 June 2016.

(2)

An application for the renewal of the inclusion of iprovalicarb in Annex I to Council Directive 91/414/EEC (3) was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (4) within the time period provided for in that Article.

(3)

The applicant submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. The application was found to be complete by the rapporteur Member State.

(4)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 2 September 2013.

(5)

The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(6)

On 14 April 2015 (5) the Authority communicated to the Commission its conclusion on whether iprovalicarb can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft review report for iprovalicarb to the Standing Committee on Plants, Animals, Food and Feed on 8 October 2015.

(7)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied.

(8)

It is therefore appropriate to renew the approval of iprovalicarb.

(9)

In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions. It is, in particular, appropriate to require further confirmatory information.

(10)

The risk assessment for the renewal of the approval of iprovalicarb is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing iprovalicarb may be authorised. It is therefore appropriate not to maintain the restriction to uses as a fungicide. In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(11)

Commission Implementing Regulation (EU) 2015/1885 (6) extended the expiry date of iprovalicarb to allow the renewal process to be completed before the expiry of its approval. However, given that a decision on renewal has been taken ahead of the extended expiry date, this Regulation should apply from 1 April 2016.

(12)

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

(1)

Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (‘the commodities’). It provides that the commodities may only be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto.

(2)

Regulation (EC) No 798/2008 also lays down the conditions for a third country, territory, zone or compartment to be considered as free from highly pathogenic avian influenza (HPAI).

(3)

The United States is listed in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country from which imports into and transit through the Union of the commodities is authorised from the whole of its territory.

(4)

An Agreement between the Union and the United States (4) provides for a swift mutual recognition of regionalisation measures in the event of outbreaks of a disease in the Union or in the United States (‘the Agreement’).

(5)

On 15 January 2016, the United States confirmed the presence of HPAI of subtype H7N8 in one holding in the State of Indiana and it may therefore no longer be considered as free from that disease. The veterinary authorities of the United States immediately suspended issuing veterinary certificates for consignments of commodities intended for export to the Union from the State of Indiana. They have also implemented a stamping-out policy in order to control HPAI and limit its spread.

(6)

The United States has submitted information on the epidemiological situation on its territory and the measures it has taken to prevent the further spread of HPAI which has now been evaluated by the Commission. On the basis of that evaluation, as well as the commitments laid down in the Agreement and the guarantees provided by the United States, it is appropriate to conclude that limiting the restrictions on the introduction into the Union of commodities from the area affected by HPAI, which the veterinary authorities of the United States have placed under restrictions due to the current outbreaks, should be sufficient to cover the risks associated with the introduction into the Union of the commodities.

(7)

Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

(8)

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

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,