title: Commission Implementing Regulation (EU) No 714/2011 of 20 July 2011 fixing the rates of the refunds applicable to eggs and egg yolks exported in the form of goods not covered by Annex I to the Treaty

text:
               21.7.2011

               EN

               Official Journal of the European Union

               L 190/70

         COMMISSION IMPLEMENTING REGULATION (EU) No 714/2011
   of 20 July 2011
   fixing the rates of the refunds applicable to eggs and egg yolks exported in the form of goods not covered by Annex I to the Treaty
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural market and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 164(2) thereof,
   Whereas:

               (1)

               Article 162(1)(b) of Regulation (EC) No 1234/2007 provides that the difference between prices in international trade for the products referred to in Article 1(1)(s) and listed in Part XIX of Annex I to that Regulation and prices within the Union may be covered by an export refund where these goods are exported in the form of goods listed in Part V of Annex XX to that Regulation.

               (2)

               Commission Regulation (EU) No 578/2010 of 29 June 2010 implementing Council Regulation (EC) No 1216/2009 as regards the system of granting export refunds on certain agricultural products exported in the form of goods not covered by Annex I to the Treaty, and the criteria for fixing the amount of such refunds (2), specifies the products for which a rate of refund is to be fixed, to be applied where these products are exported in the form of goods listed in Part V of Annex XX to Regulation (EC) No 1234/2007.

               (3)

               In accordance with Article 14(1) of Regulation (EU) No 578/2010, the rate of the refund per 100 kilograms for each of the basic products in question is to be fixed for a period of the same duration as that for which refunds are fixed for the same products exported unprocessed.

               (4)

               Article 162(2) of Regulation (EC) No 1234/2007 lays down that the export refund for a product contained in a good may not exceed the refund applicable to that product when exported without further processing.

               (5)

               The currently applicable refunds have been fixed by Commission Implementing Regulation (EU) No 401/2011 (3). Since new refunds should be fixed, that Regulation should therefore be repealed.

               (6)

               The Management Committee for the Common Organisation of Agricultural Markets has not delivered an opinion within the time limit set by its Chair,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The rates of the refunds applicable to the basic products listed in Annex I to Regulation (EU) No 578/2010 and in Part XIX of Annex I to Regulation (EC) No 1234/2007, and exported in the form of goods listed in Part V of Annex XX to Regulation (EC) No 1234/2007, shall be fixed as set out in the Annex to this Regulation.
   Article 2
   Implementing Regulation (EU) No 401/2011 is hereby repealed.
   Article 3
   This Regulation shall enter into force on 21 July 2011.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 July 2011.

            For the Commission, On behalf of the President,

         Heinz ZOUREK

            Director-General for Enterprise and Industry

      (1)  OJ L 299, 16.11.2007, p. 1.

      (2)  OJ L 171, 6.7.2010, p. 1.

      (3)  OJ L 105, 21.4.2011, p. 14.

      ANNEX

         Rates of the refunds applicable from 21 July 2011 to eggs and egg yolks exported in the form of goods not covered by Annex I to the Treaty

                  (EUR/100 kg)

                  CN code

                  Description

                  Destination (1)

                  Rate of refund

                  0407 00

                  Birds' eggs, in shell, fresh, preserved or cooked:

                  – Of poultry:

                  0407 00 30

                  – – Other:

                              (a)

                              On exportation of ovalbumin of CN codes 3502 11 90 and 3502 19 90

                  02

                  0,00

                  03

                  19,00

                  04

                  0,00

                              (b)

                              On exportation of other goods

                  01

                  0,00

                  0408

                  Birds' eggs, not in shell and egg yolks, fresh, dried, cooked by steaming or by boiling in water, moulded, frozen or otherwise preserved, whether or not containing added sugar or other sweetening matter:

                  – Egg yolks:

                  0408 11

                  – – Dried:

                  ex 0408 11 80

                  – – – Suitable for human consumption:

                  not sweetened

                  01

                  74,00

                  0408 19

                  – – Other:

                  – – – Suitable for human consumption:

                  ex 0408 19 81

                  – – – – Liquid:

                  not sweetened

                  01

                  22,00

                  ex 0408 19 89

                  – – – – Frozen:

                  not sweetened

                  01

                  22,00

                  – Other:

                  0408 91

                  – – Dried:

                  ex 0408 91 80

                  – – – Suitable for human consumption:

                  not sweetened

                  01

                  38,00

                  0408 99

                  – – Other:

                  ex 0408 99 80

                  – – – Suitable for human consumption:

                  not sweetened

                  01

                  9,00

         (1)  The destinations are as follows:

                  01

                  Third countries. For Switzerland and Liechtenstein these rates are not applicable to the goods listed in Tables I and II to Protocol No 2 to the Agreement between the European Community and the Swiss Confederation of 22 July 1972,

                  02

                  Kuwait, Bahrain, Oman, Qatar, United Arab Emirates, Yemen, Turkey, Hong Kong SAR and Russia,

                  03

                  South Korea, Japan, Malaysia, Thailand, Taiwan and the Philippines,

                  04

                  all destinations except Switzerland and those of 02 and 03.


title: Commission Implementing Regulation (EU) No 366/2013 of 22 April 2013 approving the active substance Bacillus firmus I-1582, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
                  23.4.2013

                  EN

                  Official Journal of the European Union

                  L 111/30

         COMMISSION IMPLEMENTING REGULATION (EU) No 366/2013
         of 22 April 2013
         approving the active substance Bacillus firmus I-1582, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,
         Whereas:

                     (1)

                     In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For Bacillus firmus I-1582 the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2011/123/EU (3).

                     (2)

                     In accordance with Article 6(2) of Directive 91/414/EEC France received on 4 August 2010 an application from Bayer CropScience AG for the inclusion of the active substance Bacillus firmus I-1582 in Annex I to Directive 91/414/EEC. Decision 2011/123/EU confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

                     (3)

                     For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 12 July 2011.

                     (4)

                     The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the review of the pesticide risk assessment of the active substance Bacillus firmus I-1582 (4) on 20 August 2012. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and the draft assessment report was finalised on 15 March 2013 in the format of the Commission review report for Bacillus firmus I-1582.

                     (5)

                     It has appeared from the various examinations made that plant protection products containing Bacillus firmus I-1582 may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Bacillus firmus I-1582.

                     (6)

                     A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

                     (7)

                     Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing Bacillus firmus I-1582. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

                     (8)

                     The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

                     (9)

                     In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (6) should be amended accordingly.

                     (10)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Approval of active substance
            The active substance Bacillus firmus I-1582, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

            Article 2
            Re-evaluation of plant protection products

               1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing Bacillus firmus I-1582 as an active substance by 31 March 2014.
               By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.

               2.   By way of derogation from paragraph 1, for each authorised plant protection product containing Bacillus firmus I-1582 as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 September 2013 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
               Following that determination Member States shall:

                           (a)

                           in the case of a product containing Bacillus firmus I-1582 as the only active substance, where necessary, amend or withdraw the authorisation by 31 March 2015 at the latest; or

                           (b)

                           in the case of a product containing Bacillus firmus I-1582 as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

            Article 3
            Amendments to Implementing Regulation (EU) No 540/2011
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

            Article 4
            Entry into force and date of application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 October 2013.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 22 April 2013.

                  For the Commission

                  The President

               José Manuel BARROSO

            (1)  OJ L 309, 24.11.2009, p. 1.

            (2)  OJ L 230, 19.8.1991, p. 1.

            (3)  OJ L 49, 24.2.2011, p. 40.

            (4)  EFSA Journal 2012; 10(9):2868. Available online: www.efsa.europa.eu

            (5)  OJ L 366, 15.12.1992, p. 10.

            (6)  OJ L 153, 11.6.2011, p. 1.

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                           Bacillus firmus I-1582
                        Collection number: CNCMI-1582

                        Not applicable

                        Minimum concentration: 7,1 × 1010 CFU/g

                        1 October 2013

                        30 September 2023

                        For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus firmus I-1582, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
                        In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Bacillus firmus I-1582 is to be considered as a potential sensitiser.
                        Conditions of use shall include risk mitigation measures, where appropriate.

               (1)  Further details on identity and specification of active substance are provided in the review report.

            ANNEX II
            In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                           Number

                           Common Name, Identification Numbers

                           IUPAC Name

                           Purity (*1)

                           Date of approval

                           Expiration of approval

                           Specific provisions

                           ‘36

                              Bacillus firmus I-1582
                           Collection number: CNCMI-1582

                           Not applicable

                           Minimum concentration: 7,1 × 1010 CFU/g

                           1 October 2013

                           30 September 2023

                           For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus firmus I-1582, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
                           In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Bacillus firmus I-1582 is to be considered as a potential sensitiser.
                           Conditions of use shall include risk mitigation measures, where appropriate.’

               (*1)  Further details on identity and specification of active substance are provided in the review report.


title: Commission Implementing Regulation (EU) 2015/1502 of 8 September 2015 on setting out minimum technical specifications and procedures for assurance levels for electronic identification means pursuant to Article 8(3) of Regulation (EU) No 910/2014 of the European Parliament and of the Council on electronic identification and trust services for electronic transactions in the internal market (Text with EEA relevance)

text:
               9.9.2015

               EN

               Official Journal of the European Union

               L 235/7

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/1502
   of 8 September 2015
   on setting out minimum technical specifications and procedures for assurance levels for electronic identification means pursuant to Article 8(3) of Regulation (EU) No 910/2014 of the European Parliament and of the Council on electronic identification and trust services for electronic transactions in the internal market
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (1), and in particular Article 8(3) thereof,
   Whereas:

               (1)

               Article 8 of Regulation (EU) No 910/2014 provides that an electronic identification scheme notified pursuant to Article 9(1) needs to specify assurance levels low, substantial and high for electronic identification means issued under that scheme.

               (2)

               Determining the minimum technical specifications, standards and procedures is essential in order to ensure common understanding of the details of the assurance levels and to ensure interoperability when mapping the national assurance levels of notified electronic identification schemes against the assurance levels under Article 8 as provided by Article 12(4)(b) of Regulation (EU) No 910/2014.

               (3)

               International standard ISO/IEC 29115 has been taken into account for the specifications and procedures set out in this implementing act as being the principle international standard available in the domain of assurance levels for electronic identification means. However, the content of Regulation (EU) No 910/2014 differs from that international standard, in particular in relation to identity proofing and verification requirements, as well as to the way in which the differences between Member State identity arrangements and the existing tools in the EU for the same purpose are taken into account. Therefore the Annex, while building on this international standard should not make reference to any specific content of ISO/IEC 29115.

               (4)

               This Regulation has been developed as an outcome based approach as being the most appropriate which is also reflected in the definitions used to specify the terms and concepts. They take into account the aim of Regulation (EU) No 910/2014 in relation to assurance levels of the electronic identification means. Therefore, the Large-Scale Pilot STORK, including specifications developed by it, and the definitions and concepts in ISO/IEC 29115 should be taken into the utmost account when establishing the specifications and procedures set out in this implementing act.

               (5)

               Depending on the context in which an aspect of evidence of identity needs to be verified, authoritative sources can take many forms, such as registries, documents, bodies inter alia. Authoritative sources may be different in the various Member States even in a similar context.

               (6)

               Requirements for identity proofing and verification should take into account different systems and practices, while ensuring sufficiently high assurance in order to establish the necessary trust. Therefore, acceptance of procedures used previously for a purpose other than the issuance of electronic identification means should be made conditional upon confirmation that those procedures fulfil the requirements foreseen for the corresponding assurance level.

               (7)

               Certain authentication factors such as shared secrets, physical devices and physical attributes are usually employed. However, the usage of a greater number of authentication factors, especially from different factor categories, should be encouraged to increase the security of the authentication process.

               (8)

               This Regulation should not affect representation rights of legal persons. However, the Annex should provide for requirements for the binding between the electronic identification means of natural and legal persons.

               (9)

               The importance of information security and service management systems should be recognised, as should be the importance of employing recognised methodologies and applying the principles embedded in standards such as the ISO/IEC 27000 and the ISO/IEC 20000 series.

               (10)

               Good practices in relation to assurance levels in the Member States should also be taken into account.

               (11)

               IT security certification based on international standards is an important tool for verifying the security compliance of products with the requirements of this implementing act.

               (12)

               The Committee referred to in Article 48 of Regulation (EU) No 910/2014 has not delivered an opinion within the time limit laid down by its chair,

         HAS ADOPTED THIS REGULATION:
   Article 1
   1.   Assurance levels low, substantial and high for electronic identification means issued under a notified electronic identification scheme shall be determined with reference to the specifications and procedures set out in the Annex.
   2.   The specifications and procedures set out in the Annex shall be used to specify the assurance level of the electronic identification means issued under a notified electronic identification scheme by determining the reliability and quality of following elements:

               (a)

               enrolment, as set out in section 2.1 of the Annex to this Regulation pursuant to Article 8(3)(a) of Regulation (EU) No 910/2014;

               (b)

               electronic identification means management, as set out in section 2.2 of the Annex to this Regulation pursuant to Article 8(3)(b) and (f) of Regulation (EU) No 910/2014;

               (c)

               authentication, as set out in section 2.3 of the Annex to this Regulation pursuant to Article 8(3)(c) of Regulation (EU) No 910/2014;

               (d)

               management and organisation, as set out in section 2.4 of the Annex to this Regulation pursuant to Article 8(3)(d) and (e) of Regulation (EU) No 910/2014.

         3.   When the electronic identification means issued under a notified electronic identification scheme meets a requirement listed in a higher assurance level then it shall be presumed to fulfil the equivalent requirement of a lower assurance level.
   4.   Unless otherwise stated in the relevant part of the Annex, all elements listed in the Annex for a particular assurance level of the electronic identification means issued under a notified electronic identification scheme shall be met in order to match the claimed assurance level.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 8 September 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 257, 28.8.2014, p. 73.

      ANNEX

         Technical specifications and procedures for assurance levels low, substantial and high for electronic identification means issued under a notified electronic identification scheme

      1.   Applicable definitions

      For the purposes of this Annex, the following definitions shall apply:

                  (1)

                  ‘authoritative source’ means any source irrespective of its form that can be relied upon to provide accurate data, information and/or evidence that can be used to prove identity;

                  (2)

                  ‘authentication factor’ means a factor confirmed as being bound to a person, which falls into any of the following categories:

                              (a)

                              ‘possession-based authentication factor’ means an authentication factor where the subject is required to demonstrate possession of it;

                              (b)

                              ‘knowledge-based authentication factor’ means an authentication factor where the subject is required to demonstrate knowledge of it;

                              (c)

                              ‘inherent authentication factor’ means an authentication factor that is based on a physical attribute of a natural person, and of which the subject is required to demonstrate that they have that physical attribute;

                  (3)

                  ‘dynamic authentication’ means an electronic process using cryptography or other techniques to provide a means of creating on demand an electronic proof that the subject is in control or in possession of the identification data and which changes with each authentication between the subject and the system verifying the subject's identity;

                  (4)

                  ‘information security management system’ means a set of processes and procedures designed to manage to acceptable levels risks related to information security.

            2.   Technical specifications and procedures

      The elements of technical specifications and procedures outlined in this Annex shall be used to determine how the requirements and criteria of Article 8 of Regulation (EU) No 910/2014 shall be applied for electronic identification means issued under an electronic identification scheme.
      2.1.   Enrolment

      2.1.1.   Application and registration

                  Assurance level

                  Elements needed

                  Low

                              1.

                              Ensure the applicant is aware of the terms and conditions related to the use of the electronic identification means.

                              2.

                              Ensure the applicant is aware of recommended security precautions related to the electronic identification means.

                              3.

                              Collect the relevant identity data required for identity proofing and verification.

                  Substantial

                  Same as level low.

                  High

                  Same as level low.

            2.1.2.   Identity proofing and verification (natural person)

                  Assurance level

                  Elements needed

                  Low

                              1.

                              The person can be assumed to be in possession of evidence recognised by the Member State in which the application for the electronic identity means is being made and representing the claimed identity.

                              2.

                              The evidence can be assumed to be genuine, or to exist according to an authoritative source and the evidence appears to be valid.

                              3.

                              It is known by an authoritative source that the claimed identity exists and it may be assumed that the person claiming the identity is one and the same.

                  Substantial

                  Level low, plus one of the alternatives listed in points 1 to 4 has to be met:

                              1.

                              The person has been verified to be in possession of evidence recognised by the Member State in which the application for the electronic identity means is being made and representing the claimed identity
                              and
                              the evidence is checked to determine that it is genuine; or, according to an authoritative source, it is known to exist and relates to a real person
                              and
                              steps have been taken to minimise the risk that the person's identity is not the claimed identity, taking into account for instance the risk of lost, stolen, suspended, revoked or expired evidence;
                              or

                              2.

                              An identity document is presented during a registration process in the Member State where the document was issued and the document appears to relate to the person presenting it
                              and
                              steps have been taken to minimise the risk that the person's identity is not the claimed identity, taking into account for instance the risk of lost, stolen, suspended, revoked or expired documents;
                              or

                              3.

                              Where procedures used previously by a public or private entity in the same Member State for a purpose other than the issuance of electronic identification means provide for an equivalent assurance to those set out in section 2.1.2 for the assurance level substantial, then the entity responsible for registration need not to repeat those earlier procedures, provided that such equivalent assurance is confirmed by a conformity assessment body referred to in Article 2(13) of Regulation (EC) No 765/2008 of the European Parliament and of the Council (1) or by an equivalent body;
                              or

                              4.

                              Where electronic identification means are issued on the basis of a valid notified electronic identification means having the assurance level substantial or high, and taking into account the risks of a change in the person identification data, it is not required to repeat the identity proofing and verification processes. Where the electronic identification means serving as the basis has not been notified, the assurance level substantial or high must be confirmed by a conformity assessment body referred to in Article 2(13) of Regulation (EC) No 765/2008 or by an equivalent body.

                  High

                  Requirements of either point 1 or 2 have to be met:

                              1.

                              Level substantial, plus one of the alternatives listed in points (a) to (c) has to be met:

                                          (a)

                                          Where the person has been verified to be in possession of photo or biometric identification evidence recognised by the Member State in which the application for the electronic identity means is being made and that evidence represents the claimed identity, the evidence is checked to determine that it is valid according to an authoritative source;
                                          and
                                          the applicant is identified as the claimed identity through comparison of one or more physical characteristic of the person with an authoritative source;
                                          or

                                          (b)

                                          Where procedures used previously by a public or private entity in the same Member State for a purpose other than the issuance of electronic identification means provide for an equivalent assurance to those set out in section 2.1.2 for the assurance level high, then the entity responsible for registration need not to repeat those earlier procedures, provided that such equivalent assurance is confirmed by a conformity assessment body referred to in Article 2(13) of Regulation (EC) No 765/2008 or by an equivalent body
                                          and
                                          steps are taken to demonstrate that the results of the earlier procedures remain valid;
                                          or

                                          (c)

                                          Where electronic identification means are issued on the basis of a valid notified electronic identification means having the assurance level high, and taking into account the risks of a change in the person identification data, it is not required to repeat the identity proofing and verification processes. Where the electronic identification means serving as the basis has not been notified, the assurance level high must be confirmed by a conformity assessment body referred to in Article 2(13) of Regulation (EC) No 765/2008 or by an equivalent body
                                          and
                                          steps are taken to demonstrate that the results of this previous issuance procedure of a notified electronic identification means remain valid.

                                    OR

                              2.

                              Where the applicant does not present any recognised photo or biometric identification evidence, the very same procedures used at the national level in the Member State of the entity responsible for registration to obtain such recognised photo or biometric identification evidence are applied.

            2.1.3.   Identity proofing and verification (legal person)

                  Assurance level

                  Elements Needed

                  Low

                              1.

                              The claimed identity of the legal person is demonstrated on the basis of evidence recognised by the Member State in which the application for the electronic identity means is being made.

                              2.

                              The evidence appears to be valid and can be assumed to be genuine, or to exist according to an authoritative source, where the inclusion of a legal person in the authoritative source is voluntary and is regulated by an arrangement between the legal person and the authoritative source.

                              3.

                              The legal person is not known by an authoritative source to be in a status that would prevent it from acting as that legal person.

                  Substantial

                  Level low, plus one of the alternatives listed in points 1 to 3 has to be met:

                              1.

                              The claimed identity of the legal person is demonstrated on the basis of evidence recognised by the Member State in which the application for the electronic identity means is being made, including the legal person's name, legal form, and (if applicable) its registration number
                              and
                              the evidence is checked to determine whether it is genuine, or known to exist according to an authoritative source, where the inclusion of the legal person in the authoritative source is required for the legal person to operate within its sector
                              and
                              steps have been taken to minimise the risk that the legal person's identity is not the claimed identity, taking into account for instance the risk of lost, stolen, suspended, revoked or expired documents;
                              or

                              2.

                              Where the procedures used previously by a public or private entity in the same Member State for a purpose other than issuance of electronic identification means provide for an equivalent assurance to those set out in section 2.1.3 for the assurance level substantial, then the entity responsible for registration need not to repeat those earlier procedures, provided that such equivalent assurance is confirmed by a conformity assessment body referred to in Article 2(13) of Regulation (EC) No 765/2008 or by an equivalent body;
                              or

                              3.

                              Where electronic identification means are issued on the basis of a valid notified electronic identification means having the assurance level substantial or high, it is not required to repeat the identity proofing and verification processes. Where the electronic identification means serving as the basis has not been notified, the assurance level substantial or high must be confirmed by a conformity assessment body referred to in Article 2(13) of Regulation (EC) No 765/2008 or by an equivalent body.

                  High

                  Level substantial, plus one of the alternatives listed in points 1 to 3 has to be met:

                              1.

                              The claimed identity of the legal person is demonstrated on the basis of evidence recognised by the Member State in which the application for the electronic identity means is being made, including the legal person's name, legal form, and at least one unique identifier representing the legal person used in a national context
                              and
                              the evidence is checked to determine that it is valid according to an authoritative source;
                              or

                              2.

                              Where the procedures used previously by a public or private entity in the same Member State for a purpose other than issuance of electronic identification means provide for an equivalent assurance to those set out in section 2.1.3 for the assurance level high, then the entity responsible for registration need not to repeat those earlier procedures, provided that such equivalent assurance is confirmed by a conformity assessment body referred to in Article 2(13) of Regulation (EC) No 765/2008 or by an equivalent body
                              and
                              steps are taken to demonstrate that the results of this previous procedure remain valid;
                              or

                              3.

                              Where electronic identification means are issued on the basis of a valid notified electronic identification means having the assurance level high, it is not required to repeat the identity proofing and verification processes. Where the electronic identification means serving as the basis has not been notified, the assurance level high must be confirmed by a conformity assessment body referred to in Article 2(13) of Regulation (EC) No 765/2008 or by an equivalent body
                              and
                              steps are taken to demonstrate that the results of this previous issuance procedure of a notified electronic identification means remain valid.

            2.1.4.   Binding between the electronic identification means of natural and legal persons

      Where applicable, for binding between the electronic identification means of a natural person and the electronic identification means of a legal person (‘binding’) the following conditions apply:

                  (1)

                  It shall be possible to suspend and/or revoke a binding. The life-cycle of a binding (e.g. activation, suspension, renewal, revocation) shall be administered according to nationally recognised procedures.

                  (2)

                  The natural person whose electronic identification means is bound to the electronic identification means of the legal person may delegate the exercise of the binding to another natural person on the basis of nationally recognised procedures. However, the delegating natural person shall remain accountable.

                  (3)

                  Binding shall be done in the following manner:

                              Assurance level

                              Elements Needed

                              Low

                                          1.

                                          The identity proofing of the natural person acting on behalf of the legal person is verified as having been performed at level low or above.

                                          2.

                                          The binding has been established on the basis of nationally recognised procedures.

                                          3.

                                          The natural person is not known by an authoritative source to be in a status that would prevent that person from acting on behalf of the legal person.

                              Substantial

                              Point 3 of level low, plus:

                                          1.

                                          The identity proofing of the natural person acting on behalf of the legal person is verified as having been performed at level substantial or high.

                                          2.

                                          The binding has been established on the basis of nationally recognised procedures, which resulted in the registration of the binding in an authoritative source.

                                          3.

                                          The binding has been verified on the basis of information from an authoritative source.

                              High

                              Point 3 of level low and point 2 of level substantial, plus:

                                          1.

                                          The identity proofing of the natural person acting on behalf of the legal person is verified as having been performed at level high.

                                          2.

                                          The binding has been verified on the basis of a unique identifier representing the legal person used in the national context; and on the basis of information uniquely representing the natural person from an authoritative source.

            2.2.   Electronic identification means management

      2.2.1.   Electronic identification means characteristics and design

                  Assurance level

                  Elements needed

                  Low

                              1.

                              The electronic identification means utilises at least one authentication factor.

                              2.

                              The electronic identification means is designed so that the issuer takes reasonable steps to check that it is used only under the control or possession of the person to whom it belongs.

                  Substantial

                              1.

                              The electronic identification means utilises at least two authentication factors from different categories.

                              2.

                              The electronic identification means is designed so that it can be assumed to be used only if under the control or possession of the person to whom it belongs.

                  High

                  Level substantial, plus:

                              1.

                              The electronic identification means protects against duplication and tampering as well as against attackers with high attack potential

                              2.

                              The electronic identification means is designed so that it can be reliably protected by the person to whom it belongs against use by others.

            2.2.2.   Issuance, delivery and activation

                  Assurance level

                  Elements needed

                  Low

                  After issuance, the electronic identification means is delivered via a mechanism by which it can be assumed to reach only the intended person.

                  Substantial

                  After issuance, the electronic identification means is delivered via a mechanism by which it can be assumed that it is delivered only into the possession of the person to whom it belongs.

                  High

                  The activation process verifies that the electronic identification means was delivered only into the possession of the person to whom it belongs.

            2.2.3.   Suspension, revocation and reactivation

                  Assurance level

                  Elements needed

                  Low

                              1.

                              It is possible to suspend and/or revoke an electronic identification means in a timely and effective manner.

                              2.

                              The existence of measures taken to prevent unauthorised suspension, revocation and/or reactivation.

                              3.

                              Reactivation shall take place only if the same assurance requirements as established before the suspension or revocation continue to be met.

                  Substantial

                  Same as level low.

                  High

                  Same as level low.

            2.2.4.   Renewal and replacement

                  Assurance level

                  Elements needed

                  Low

                  Taking into account the risks of a change in the person identification data, renewal or replacement needs to meet the same assurance requirements as initial identity proofing and verification or is based on a valid electronic identification means of the same, or higher, assurance level.

                  Substantial

                  Same as level low.

                  High

                  Level low, plus:
                  Where renewal or replacement is based on a valid electronic identification means, the identity data is verified with an authoritative source.

            2.3.   Authentication

      This section focuses on the threats associated with the use of the authentication mechanism and lists the requirements for each assurance level. In this section controls shall be understood to be commensurate to the risks at the given level.
      2.3.1.   Authentication mechanism

      The following table sets out the requirements per assurance level with respect to the authentication mechanism, through which the natural or legal person uses the electronic identification means to confirm its identity to a relying party.

                  Assurance level

                  Elements needed

                  Low

                              1.

                              The release of person identification data is preceded by reliable verification of the electronic identification means and its validity.

                              2.

                              Where person identification data is stored as part of the authentication mechanism, that information is secured in order to protect against loss and against compromise, including analysis offline.

                              3.

                              The authentication mechanism implements security controls for the verification of the electronic identification means, so that it is highly unlikely that activities such as guessing, eavesdropping, replay or manipulation of communication by an attacker with enhanced-basic attack potential can subvert the authentication mechanisms.

                  Substantial

                  Level low, plus:

                              1.

                              The release of person identification data is preceded by reliable verification of the electronic identification means and its validity through a dynamic authentication.

                              2.

                              The authentication mechanism implements security controls for the verification of the electronic identification means, so that it is highly unlikely that activities such as guessing, eavesdropping, replay or manipulation of communication by an attacker with moderate attack potential can subvert the authentication mechanisms.

                  High

                  Level substantial, plus:
                  The authentication mechanism implements security controls for the verification of the electronic identification means, so that it is highly unlikely that activities such as guessing, eavesdropping, replay or manipulation of communication by an attacker with high attack potential can subvert the authentication mechanisms.

            2.4.   Management and organisation

      All participants providing a service related to electronic identification in a cross-border context (‘providers’) shall have in place documented information security management practices, policies, approaches to risk management, and other recognised controls so as to provide assurance to the appropriate governance bodies for electronic identification schemes in the respective Member States that effective practices are in place. Throughout section 2.4, all requirements/elements shall be understood as commensurate to the risks at the given level.
      2.4.1.   General provisions

                  Assurance level

                  Elements needed

                  Low

                              1.

                              Providers delivering any operational service covered by this Regulation are a public authority or a legal entity recognised as such by national law of a Member State, with an established organisation and fully operational in all parts relevant for the provision of the services.

                              2.

                              Providers comply with any legal requirements incumbent on them in connection with operation and delivery of the service, including the types of information that may be sought, how identity proofing is conducted, what information may be retained and for how long.

                              3.

                              Providers are able to demonstrate their ability to assume the risk of liability for damages, as well as their having sufficient financial resources for continued operations and providing of the services.

                              4.

                              Providers are responsible for the fulfilment of any of the commitments outsourced to another entity, and compliance with the scheme policy, as if the providers themselves had performed the duties.

                              5.

                              Electronic identification schemes not constituted by national law shall have in place an effective termination plan. Such a plan shall include orderly discontinuations of service or continuation by another provider, the way in which relevant authorities and end users are informed, as well as details on how records are to be protected, retained and destroyed in compliance with the scheme policy.

                  Substantial

                  Same as level low.

                  High

                  Same as level low.

            2.4.2.   Published notices and user information

                  Assurance level

                  Elements needed

                  Low

                              1.

                              The existence of a published service definition that includes all applicable terms, conditions, and fees, including any limitations of its usage. The service definition shall include a privacy policy.

                              2.

                              Appropriate policy and procedures are to be put in place in order to ensure that users of the service are informed in a timely and reliable fashion of any changes to the service definition and to any applicable terms, conditions, and privacy policy for the specified service.

                              3.

                              Appropriate policies and procedures are to be put in place that provide for full and correct responses to requests for information.

                  Substantial

                  Same as level low.

                  High

                  Same as level low.

            2.4.3.   Information security management

                  Assurance level

                  Elements needed

                  Low

                  There is an effective information security management system for the management and control of information security risks.

                  Substantial

                  Level low, plus:
                  The information security management system adheres to proven standards or principles for the management and control of information security risks.

                  High

                  Same as level substantial.

            2.4.4.   Record keeping

                  Assurance level

                  Elements needed

                  Low

                              1.

                              Record and maintain relevant information using an effective record-management system, taking into account applicable legislation and good practice in relation to data protection and data retention.

                              2.

                              Retain, as far as it is permitted by national law or other national administrative arrangement, and protect records for as long as they are required for the purpose of auditing and investigation of security breaches, and retention, after which the records shall be securely destroyed.

                  Substantial

                  Same as level low.

                  High

                  Same as level low.

            2.4.5.   Facilities and staff

      The following table represents the requirements with respect to facilities and staff and subcontractors, if applicable, who undertake duties covered by this Regulation. Compliance with each of the requirements shall be proportionate to the level of risk associated with the assurance level provided.

                  Assurance level

                  Elements needed

                  Low

                              1.

                              The existence of procedures that ensure that staff and subcontractors are sufficiently trained, qualified and experienced in the skills needed to execute the roles they fulfil.

                              2.

                              The existence of sufficient staff and subcontractors to adequately operate and resource the service according to its policies and procedures.

                              3.

                              Facilities used for providing the service are continuously monitored for, and protect against, damage caused by environmental events, unauthorised access and other factors that may impact the security of the service.

                              4.

                              Facilities used for providing the service ensure that access to areas holding or processing personal, cryptographic or other sensitive information is limited to authorised staff or subcontractors.

                  Substantial

                  Same as level low.

                  High

                  Same as level low.

            2.4.6.   Technical controls

                  Assurance level

                  Elements needed

                  Low

                              1.

                              The existence of proportionate technical controls to manage the risks posed to the security of the services, protecting the confidentiality, integrity and availability of the information processed.

                              2.

                              Electronic communication channels used to exchange personal or sensitive information are protected against eavesdropping, manipulation and replay.

                              3.

                              Access to sensitive cryptographic material, if used for issuing electronic identification means and authentication, is restricted to the roles and applications strictly requiring access. It shall be ensured that such material is never persistently stored in plain text.

                              4.

                              Procedures exist to ensure that security is maintained over time and that there is an ability to respond to changes in risk levels, incidents and security breaches.

                              5.

                              All media containing personal, cryptographic or other sensitive information are stored, transported and disposed of in a safe and secure manner.

                  Substantial

                  Same as level low, plus:
                  Sensitive cryptographic material, if used for issuing electronic identification means and authentication is protected from tampering

                  High

                  Same as level substantial.

            2.4.7.   Compliance and audit

                  Assurance level

                  Elements needed

                  Low

                  The existence of periodical internal audits scoped to include all parts relevant to the supply of the provided services to ensure compliance with relevant policy.

                  Substantial

                  The existence of periodical independent internal or external audits scoped to include all parts relevant to the supply of the provided services to ensure compliance with relevant policy.

                  High

                              1.

                              The existence of periodical independent external audits scoped to include all parts relevant to the supply of the provided services to ensure compliance with relevant policy.

                              2.

                              Where a scheme is directly managed by a government body, it is audited in accordance with the national law.

         (1)  Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).


title: Commission Implementing Regulation (EU) No 17/2013 of 14 January 2013 approving the active substance Trichoderma atroviride strain I-1237, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               15.1.2013

               EN

               Official Journal of the European Union

               L 9/5

         COMMISSION IMPLEMENTING REGULATION (EU) No 17/2013
   of 14 January 2013
   approving the active substance Trichoderma atroviride strain I-1237, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Articles 13(2) and 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For Trichoderma atroviride strain I-1237 the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2008/565/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC France received on 28 August 2007 an application from Agrauxine SA for the inclusion of the active substance Trichoderma atroviride strain I-1237 in Annex I to Directive 91/414/EEC. Decision 2008/565/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (3)

               For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 19 April 2011.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the review of the pesticide risk assessment of the active substance Trichoderma atroviride strain I-1237 (4) on 15 May 2012. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 20 November 2012 in the format of the Commission review report for Trichoderma atroviride strain I-1237.

               (5)

               It has appeared from the various examinations made that plant protection products containing Trichoderma atroviride strain I-1237 may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Trichoderma atroviride strain I-1237.

               (6)

               A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

               (7)

               Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing Trichoderma atroviride strain I-1237. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (8)

               The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

               (9)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (6) should be amended accordingly.

               (10)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance Trichoderma atroviride strain I-1237, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing Trichoderma atroviride strain I-1237 as an active substance by 30 November 2013.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing Trichoderma atroviride strain I-1237 as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 May 2013 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

               in the case of a product containing Trichoderma atroviride strain I-1237 as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2014 at the latest; or

               (b)

               in the case of a product containing Trichoderma atroviride strain I-1237 as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2014 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

         Article 3
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 4
   Entry into force and date of application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 June 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 January 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 181, 10.7.2008, p. 49.

      (4)  EFSA Journal 2012; 10(6):2706. Available online: www.efsa.europa.eu

      (5)  OJ L 366, 15.12.1992, p. 10.

      (6)  OJ L 153, 11.6.2011, p. 1.

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                     Trichoderma atroviride strain I-1237
                  CNCM number: I-1237

                  Not applicable

                      cfu/g (
                      spores/g)

                  1 June 2013

                  31 May 2023

                  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma atroviride strain I-1237, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012, shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Trichoderma atroviride strain I-1237 is to be considered a potential sensitiser.
                  Conditions of use shall include risk mitigation measures where appropriate.

         (1)  Further details on identity and specification of active substance are provided in the review report.

      ANNEX II
      In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘32

                        Trichoderma atroviride strain I-1237
                     CNCM number: I-1237

                     Not applicable

                         cfu/g (
                         spores/g)

                     1 June 2013

                     31 May 2023

                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma atroviride strain I-1237, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Trichoderma atroviride strain I-1237 is to be considered a potential sensitiser.
                     Conditions of use shall include risk mitigation measures where appropriate.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


title: Commission Implementing Regulation (EU) No 1022/2011 of 14 October 2011 concerning the non-renewal of the approval of the active substance cyclanilide in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 Text with EEA relevance

text:
               15.10.2011

               EN

               Official Journal of the European Union

               L 270/20

         COMMISSION IMPLEMENTING REGULATION (EU) No 1022/2011
   of 14 October 2011
   concerning the non-renewal of the approval of the active substance cyclanilide in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20 and Article 78(2) thereof,
   Whereas:

               (1)

               The active substance cyclanilide was included in Annex I to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2) for a period expiring on 31 October 2011.

               (2)

               To enable applicants to prepare their applications and to enable the Commission to evaluate and decide upon such applications, that inclusion was extended until 31 December 2015 by Commission Directive 2010/77/EU of 10 November 2010 amending Council Directive 91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances (3).

               (3)

               In accordance with Article 78(3) of Regulation (EC) No 1107/2009 that substance was included in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (4) and is to be deemed to have been approved under Regulation (EC) No 1107/2009.

               (4)

               The Commission did not, however, receive any applications for the active substance concerned and the time period for the submission of such applications, as provided for in Article 4(1) of Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (5), has expired.

               (5)

               Consequently, the approval of that active substance should not be renewed and it should be removed from Part A of the Annex to Implementing Regulation (EU) No 540/2011, as from the date on which its approval would have expired had it not been extended by Directive 2010/77/EU.

               (6)

               Member States should be allowed the period necessary to withdraw authorisations granted for plant protection products containing cyclanilide.

               (7)

               This Regulation does not prejudice the submission of an application for this substance pursuant to Article 7 of Regulation (EC) No 1107/2009.

               (8)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Non-renewal of approval
   The approval of the active substance cyclanilide is not renewed.
   Article 2
   Transitional measures
   Member States shall ensure that authorisations for plant protection products containing cyclanilide are withdrawn by 30 April 2012.
   Article 3
   Grace periods
   Any grace period granted by a Member State for plant protection products containing cyclanilide shall expire on 31 October 2012 at the latest for the sale and distribution and on 31 October 2013 at the latest for the disposal, storage, and use of existing stocks.
   Article 4
   Amendments to Implementing Regulation (EU) No 540/2011
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 5
   Entry into force
   This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 October 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 293, 11.11.2010, p. 48.

      (4)  OJ L 153, 11.6.2011, p. 1.

      (5)  OJ L 322, 8.12.2010, p. 10.

      ANNEX
      Row 21 of Part A of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:

                     Number

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘21

                     Cyclanilide
                     CAS No 113136-77-9
                     CIPAC No 586

                     Not available

                     960 g/kg

                     1 November 2001

                     31 October 2011

                     Only uses as a plant growth regulator may be authorised.
                     The maximum content of the impurity 2,4-dichloroaniline (2,4-DCA) in the active substance as manufactured should be 1 g/kg.
                     Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.’

         (1)  Further details on identity and specification of active substances are provided in their review reports.


title: Commission Implementing Regulation (EU) No 918/2014 of 22 August 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance Straight Chain Lepidopteran Pheromones  Text with EEA relevance

text:
               23.8.2014

               EN

               Official Journal of the European Union

               L 251/24

         COMMISSION IMPLEMENTING REGULATION (EU) No 918/2014
   of 22 August 2014
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance Straight Chain Lepidopteran Pheromones
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2)(c) thereof,
   Whereas:

               (1)

               The active substance Straight Chain Lepidopteran Pheromones was included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (5).

               (2)

               In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its view on the draft review report for Straight Chain Lepidopteran Pheromones (6) on 13 December 2013. The Authority communicated its view on Straight Chain Lepidopteran Pheromones to the notifier. The Commission invited it to submit comments on the draft review report for Straight Chain Lepidopteran Pheromones. The draft review report and the view of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalized on 11 July 2014 in the format of the Commission review report for Straight Chain Lepidopteran Pheromones.

               (3)

               It is confirmed that the active substance Straight Chain Lepidopteran Pheromones is to be deemed to have been approved under Regulation (EC) No 1107/2009.

               (4)

               Straight Chain Lepidopteran Pheromones is a group of pheromones naturally produced by insects of the order of Lepidoptera. They share a common structural definition and mechanism of action. The review report of Straight Chain Lepidopteran Pheromones (SANCO/2633/2008) includes a list of individual compounds having the common structural definition of Straight Chain Lepidopteran Pheromones and being contained in authorised plant protection products. That list will be updated, as appropriate.

               (5)

               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 amend the conditions of approval of Straight Chain Lepidopteran Pheromones. In particular, it is appropriate to require further confirmatory information.

               (6)

               The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

               (7)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Amendment to Implementing Regulation (EU) No 540/2011
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   Entry into force
   This Regulation shall enter into force the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 22 August 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

      (3)  Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances (OJ L 344, 20.12.2008, p. 89).

      (4)  Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (OJ L 379, 24.12.2004, p. 13).

      (5)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

      (6)  European Food Safety Authority. Conclusion on the peer review of the pesticide risk assessment of the active substance Straight Chain Lepidopteran Pheromones. EFSA Journal 2014;12(1):3524. 537 pp. doi:10.2903/j.efsa.2014.3524. Available online: www.efsa.europa.eu/efsajournal

      ANNEX
      In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 255 on the active substance Straight Chain Lepidopteran Pheromones is replaced by the following:

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘255

                     Straight Chain Lepidopteran Pheromones

                     Review report (SANCO/2633/2008)

                     Review report (SANCO/2633/2008)

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as attractants may be authorised.
                     PART B
                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.
                     Conditions of use shall include, where appropriate, risk mitigation measures.
                     The notifier shall submit confirmatory information as regards:

                                 (1)

                                 the genotoxic profile of aldehyde group compounds;

                                 (2)

                                 exposure of humans and the environment resulting from the different ways of application of Straight Chain Lepidopteran Pheromones as plant protection product, in comparison with natural background levels of those pheromones.

                           The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 31 December 2015 and the information set out in point (2) by 31 December 2016.’