title: Commission Directive 2011/4/EU of 20 January 2011 amending Council Directive 91/414/EEC to include cycloxydim as active substance and amending Decision 2008/934/EC  Text with EEA relevance

text:
               21.1.2011

               EN

               Official Journal of the European Union

               L 18/30

         COMMISSION DIRECTIVE 2011/4/EU
   of 20 January 2011
   amending Council Directive 91/414/EEC to include cycloxydim as active substance and amending Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included cycloxydim.

               (2)

               In accordance with Article 11e of Regulation (EC) No 1490/2002 the applicant withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report. Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of cycloxydim.

               (3)

               Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

               (4)

               The application was submitted to Austria, which had been designated rapporteur Member State by Regulation (EC) No 451/2000. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               Austria evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 2 November 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on cycloxydim to the Commission on 30 June 2010 (6). The draft assessment report, the additional 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 finalised on 23 November 2010 in the format of the Commission review report for cycloxydim.

               (6)

               It has appeared from the various examinations made that plant protection products containing cycloxydim may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include cycloxydim in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

               (7)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit to the Commission, further information on methods for the analysis of residues of cycloxydim in plant and animal products.

               (8)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

               (9)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing cycloxydim to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (10)

               The experience gained from previous 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 (7) 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.

               (11)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (12)

               Decision 2008/934/EC provides for the non-inclusion of cycloxydim and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning cycloxydim in the Annex to that Decision.

               (13)

               It is therefore appropriate to amend Decision 2008/934/EC accordingly.

               (14)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   The line concerning cycloxydim in the Annex to Decision 2008/934/EC is deleted.
   Article 3
   Member States shall adopt and publish by 30 November 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 December 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 4
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing cycloxydim as an active substance by 30 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to cycloxydim are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing cycloxydim as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning cycloxydim. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing cycloxydim as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

               (b)

               in the case of a product containing cycloxydim as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 5
   This Directive shall enter into force on 1 June 2011.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 20 January 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

      (3)  OJ L 224, 21.8.2002, p. 23.

      (4)  OJ L 333, 11.12.2008, p. 11.

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance cycloxydim. Summary: EFSA Journal 2010; 8(7):1669. [73 pp.]. doi:10.2903/j.efsa.2010.1669. Available online: www.efsa.europa.eu

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

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘321

                     Cycloxydim
                     CAS No: 101205-02-1
                     CIPAC No: 510

                     (5RS)-2-[(EZ)-1-(ethoxyimino)butyl]-3-hydroxy-5-[(3RS)-thian-3-yl]cyclohex-2-en-1-one

                     ≥ 940 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on cycloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the risk to non-target plants.
                     Conditions of use shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall request the submission of further information concerning the methods for analysis of residues of cycloxydim in plant and animal products.
                     The Member States concerned shall ensure that the applicant submits such methods of analysis to the Commission by 31 May 2013.’

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


Avis juridique important

|

32000L0046

Directive 2000/46/EC of the European Parliament and of the Council of 18 September 2000 on the taking up, pursuit of and prudential supervision of the business of electronic money institutions

Official Journal L 275 , 27/10/2000 P. 0039 - 0043

Directive 2000/46/EC of the European Parliament and of the Councilof 18 September 2000on the taking up, pursuit of and prudential supervision of the business of electronic money institutionsTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular the first and third sentences of Article 47(2) thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Having regard to the opinion of the European Central Bank(3),Acting in accordance with the procedure laid down in Article 251 of the Treaty(4),Whereas:(1) Credit institutions within the meaning of Article 1, point 1, first subparagraph (b) of Directive 2000/12/EC(5) are limited in the scope of their activities.(2) It is necessary to take account of the specific characteristics of these institutions and to provide the appropriate measures necessary to coordinate and harmonise Member States' laws, regulations and administrative provisions relating to the taking up, pursuit and prudential supervision of the business of electronic money institutions.(3) For the purposes of this Directive, electronic money can be considered an electronic surrogate for coins and banknotes, which is stored on an electronic device such as a chip card or computer memory and which is generally intended for the purpose of effecting electronic payments of limited amounts.(4) The approach adopted is appropriate to achieve only the essential harmonisation necessary and sufficient to secure the mutual recognition of authorisation and prudential supervision of electronic money institutions, making possible the granting of a single licence recognised throughout the Community and designed to ensure bearer confidence and the application of the principle of home Member State prudential supervision.(5) Within the wider context of the rapidly evolving electronic commerce it is desirable to provide a regulatory framework that assists electronic money in delivering its full potential benefits and that avoids hampering technological innovation in particular. Therefore, this Directive introduces a technology-neutral legal framework that harmonises the prudential supervision of electronic money institutions to the extent necessary for ensuring their sound and prudent operation and their financial integrity in particular.(6) Credit institutions, by virtue of point 5 of Annex I to Directive 2000/12/EC, are already allowed to issue and administer means of payment including electronic money and to carry on such activities Community-wide subject to mutual recognition and to the comprehensive prudential supervisory system applying to them in accordance with the European banking Directives.(7) The introduction of a separate prudential supervisory regime for electronic money institutions, which, although calibrated on the prudential supervisory regime applying to other credit institutions and Directive 2000/12/EC except Title V, Chapters 2 and 3 thereof in particular, differs from that regime, is justified and desirable because the issuance of electronic money does not constitute in itself, in view of its specific character as an electronic surrogate for coins and banknotes, a deposit-taking activity pursuant to Article 3 of Directive 2000/12/EC, if the received funds are immediately exchanged for electronic money.(8) The receipt of funds from the public in exchange for electronic money, which results in a credit balance left on account with the issuing institution, constitutes the receipt of deposits or other repayable funds for the purpose of Directive 2000/12/EC.(9) It is necessary for electronic money to be redeemable to ensure bearer confidence. Redeemability does not imply, in itself, that the funds received in exchange for electronic money shall be regarded as deposits or other repayable funds for the purpose of Directive 2000/12/EC.(10) Redeemability should always be understood to be at par value.(11) In order to respond to the specific risks associated with the issuance of electronic money this prudential supervisory regime must be more targeted and, accordingly, less cumbersome than the prudential supervisory regime applying to credit institutions, notably as regards reduced initial capital requirements and the non-application of Directive 93/6/EEC(6) and Title V, Chapter 2, Sections II and III of Directive 2000/12/EC.(12) However, it is necessary to preserve a level playing field between electronic money institutions and other credit institutions issuing electronic money and, thus, to ensure fair competition among a wider range of institutions to the benefit of bearers. This is achieved since the abovementioned less cumbersome features of the prudential supervisory regime applying to electronic money institutions are balanced by provisions that are more stringent than those applying to other credit institutions, notably as regards restrictions on the business activities which electronic money institutions may carry on and, particularly, prudent limitations of their investments aimed at ensuring that their financial liabilities related to outstanding electronic money are backed at all times by sufficiently liquid low risk assets.(13) Pending the harmonisation of prudential supervision of outsourced activities for credit institutions it is appropriate that electronic money institutions have sound and prudent management and control procedures. With a view to the possibility of operational and other ancilliary functions related to the issuance of electronic money being performed by undertakings which are not subject to prudential supervision it is essential that electronic money institutions have in place internal structures which should respond to the financial and non-financial risks to which they are exposed.(14) The issuance of electronic money may affect the stability of the financial system and the smooth operation of payments systems. Close cooperation in assessing the integrity of electronic money schemes is called for.(15) It is appropriate to afford competent authorities the possibility of waiving some or all of the requirements imposed by this Directive for electronic money institutions which operate only within the territories of the respective Member States.(16) Adoption of this Directive constitutes the most appropriate means of achieving the desired objectives. This Directive is limited to the minimum necessary to achieve these objectives and does not go beyond what is necessary for this purpose.(17) Provision should be made for the review of this Directive in the light of experience of developments in the market and the protection of bearers of electronic money.(18) The Banking Advisory Committee has been consulted on the adoption of this Directive,HAVE ADOPTED THIS DIRECTIVE:Article 1Scope, definitions and restriction of activities1. This Directive shall apply to electronic money institutions.2. It shall not apply to the institutions referred to in Article 2(3) of Directive 2000/12/EC.3. For the purposes of this Directive:(a) "electronic money institution" shall mean an undertaking or any other legal person, other than a credit institution as defined in Article 1, point 1, first subparagraph (a) of Directive 2000/12/EC which issues means of payment in the form of electronic money;(b) "electronic money" shall mean monetary value as represented by a claim on the issuer which is:(i) stored on an electronic device;(ii) issued on receipt of funds of an amount not less in value than the monetary value issued;(iii) accepted as means of payment by undertakings other than the issuer.4. Member States shall prohibit persons or undertakings that are not credit institutions, as defined in Article 1, point 1, first subparagraph of Directive 2000/12/EC, from carrying on the business of issuing electronic money.5. The business activities of electronic money institutions other than the issuing of electronic money shall be restricted to:(a) the provision of closely related financial and non-financial services such as the administering of electronic money by the performance of operational and other ancillary functions related to its issuance, and the issuing and administering of other means of payment but excluding the granting of any form of credit; and(b) the storing of data on the electronic device on behalf of other undertakings or public institutions.Electronic money institutions shall not have any holdings in other undertakings except where these undertakings perform operational or other ancillary functions related to electronic money issued or distributed by the institution concerned.Article 2Application of Banking Directives1. Save where otherwise expressly provided for, only references to credit institutions in Directive 91/308/EEC(7) and Directive 2000/12/EC except Title V, Chapter 2 thereof shall apply to electronic money institutions.2. Articles 5, 11, 13, 19, 20(7), 51 and 59 of Directive 2000/12/EC shall not apply. The mutual recognition arrangements provided for in Directive 2000/12/EC shall not apply to electronic money institutions' business activities other than the issuance of electronic money.3. The receipt of funds within the meaning of Article 1(3)(b)(ii) does not constitute a deposit or other repayable funds according to Article 3 of Directive 2000/12/EC, if the funds received are immediately exchanged for electronic money.Article 3Redeemability1. A bearer of electronic money may, during the period of validity, ask the issuer to redeem it at par value in coins and bank notes or by a transfer to an account free of charges other than those strictly necessary to carry out that operation.2. The contract between the issuer and the bearer shall clearly state the conditions of redemption.3. The contract may stipulate a minimum threshold for redemption. The threshold may not exceed EUR 10.Article 4Initial capital and ongoing own funds requirements1. Electronic money institutions shall have an initial capital, as defined in Article 34(2), subparagraphs (1) and (2) of Directive 2000/12/EC, of not less than EUR 1 million. Notwithstanding paragraphs 2 and 3, their own funds, as defined in Directive 2000/12/EC, shall not fall below that amount.2. Electronic money institutions shall have at all times own funds which are equal to or above 2 % of the higher of the current amount or the average of the preceding six months' total amount of their financial liabilities related to outstanding electronic money.3. Where an electronic money institution has not completed a six months' period of business, including the day it starts up, it shall have own funds which are equal to or above 2 % of the higher of the current amount or the six months' target total amount of its financial liabilities related to outstanding electronic money. The six months' target total amount of the institution's financial liabilities related to outstanding electronic money shall be evidenced by its business plan subject to any adjustment to that plan having been required by the competent authorities.Article 5Limitations of investments1. Electronic money institutions shall have investments of an amount of no less than their financial liabilities related to outstanding electronic money in the following assets only:(a) asset items which according to Article 43(1)(a) (1), (2), (3) and (4) and Article 44(1) of Directive 2000/12/EC attract a zero credit risk weighting and which are sufficiently liquid;(b) sight deposits held with Zone A credit institutions as defined in Directive 2000/12/EC; and(c) debt instruments which are:(i) sufficiently liquid;(ii) not covered by paragraph 1(a);(iii) recognised by competent authorities as qualifying items within the meaning of Article 2(12) of Directive 93/6/EEC; and(iv) issued by undertakings other than undertakings which have a qualifying holding, as defined in Article 1 of Directive 2000/12/EC, in the electronic money institution concerned or which must be included in those undertakings' consolidated accounts.2. Investments referred to in paragraph 1(b) and (c) may not exceed 20 times the own funds of the electronic money institution concerned and shall be subject to limitations which are at least as stringent as those applying to credit institutions in accordance with Title V, Chapter 2, Section III of Directive 2000/12/EC.3. For the purpose of hedging market risks arising from the issuance of electronic money and from the investments referred to in paragraph 1, electronic money institutions may use sufficiently liquid interest-rate and foreign-exchange-related off balance-sheet items in the form of exchange-traded (i.e. not OTC) derivative instruments where they are subject to daily margin requirements or foreign exchange contracts with an original maturity of 14 calendar days or less. The use of derivative instruments according to the first sentence is permissible only if the full elimination of market risks is intended and, to the extent possible, achieved.4. Member States shall impose appropriate limitations on the market risks electronic money institutions may incur from the investments referred to in paragraph 1.5. For the purpose of applying paragraph 1, assets shall be valued at the lower of cost or market value.6. If the value of the assets referred to in paragraph 1 falls below the amount of financial liabilities related to outstanding electronic money, the competent authorities shall ensure that the electronic money institution in question takes appropriate measures to remedy that situation promptly. To this end, and for a temporary period only, the competent authorities may allow the institution's financial liabilities related to outstanding electronic money to be backed by assets other than those referred to in paragraph 1 up to an amount not exceeding the lower of 5 % of these liabilities or the institution's total amount of own funds.Article 6Verification of specific requirements by the competent authoritiesThe competent authorities shall ensure that the calculations justifying compliance with Articles 4 and 5 are made, not less than twice each year, either by electronic money institutions themselves, which shall communicate them, and any component data required, to the competent authorities, or by competent authorities, using data supplied by the electronic money institutions.Article 7Sound and prudent operationElectronic money institutions shall have sound and prudent management, administrative and accounting procedures and adequate internal control mechanisms. These should respond to the financial and non-financial risks to which the institution is exposed including technical and procedural risks as well as risks connected to its cooperation with any undertaking performing operational or other ancillary functions related to its business activities.Article 8Waiver1. Member States may allow their competent authorities to waive the application of some or all of the provisions of this Directive and the application of Directive 2000/12/EC to electronic money institutions in cases where either:(a) the total business activities of the type referred to in Article 1(3)(a) of this Directive of the institution generate a total amount of financial liabilities related to outstanding electronic money that normally does not exceed EUR 5 million and never exceeds EUR 6 million; or(b) the electronic money issued by the institution is accepted as a means of payment only by any subsidiaries of the institution which perform operational or other ancillary functions related to electronic money issued or distributed by the institution, any parent undertaking of the institution or any other subsidiaries of that parent undertaking; or(c) electronic money issued by the institution is accepted as payment only by a limited number of undertakings, which can be clearly distinguished by:(i) their location in the same premises or other limited local area; or(ii) their close financial or business relationship with the issuing institution, such as a common marketing or distribution scheme.The underlying contractual arrangements must provide that the electronic storage device at the disposal of bearers for the purpose of making payments is subject to a maximum storage amount of not more than EUR 150.2. An electronic money institution for which a waiver has been granted under paragraph 1 shall not benefit from the mutual recognition arrangements provided for in Directive 2000/12/EC.3. Member States shall require that all electronic money institutions to which the application of this Directive and Directive 2000/12/EC has been waived report periodically on their activities including the total amount of financial liabilities related to electronic money.Article 9GrandfatheringElectronic money institutions subject to this Directive which have commenced their activity in accordance with the provisions in force in the Member State in which they have their head office before the date of entry into force of the provisions adopted in implementation of this Directive or the date referred to in Article 10(1), whichever date is earlier, shall be presumed to be authorised. The Member States shall oblige such electronic money institutions to submit all relevant information to the competent authorities in order to allow them to assess within six months from the date of entry into force of the provisions adopted in implementation of this Directive, whether the institutions comply with the requirements pursuant to this Directive, which measures need to be taken in order to ensure compliance, or whether a withdrawal of authorisation is appropriate. If compliance is not ensured within six months from the date referred to in Article 10(1), the electronic money institution shall not benefit from mutual recognition after that time.Article 10Implementation1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 27 April 2002. They shall immediately inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.2. Member States shall communicate to the Commission the text of the main provisions of national law, which they adopt in the field covered by this Directive.Article 11ReviewNot later than 27 April 2005 the Commission shall present a report to the European Parliament and the Council on the application of this Directive, in particular on:- the measures to protect the bearers of electronic money, including the possible need to introduce a guarantee scheme,- capital requirements,- waivers, and- the possible need to prohibit interest being paid on funds received in exchange for electronic money,accompanied where appropriate by a proposal for its revision.Article 12Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 13This Directive is addressed to the Member States.Done at Brussels, 18 September 2000.For the European ParliamentThe PresidentN. FontaineFor the CouncilThe PresidentH. Védrine(1) OJ C 317, 15.10.1998, p. 7.(2) OJ C 101, 12.4.1999, p. 64.(3) OJ C 189, 6.7.1999, p. 7.(4) Opinion of the European Parliament of 15 April 1999 (OJ C 219, 30.7.1999, p. 415), confirmed on 27 October 1999, Council Common Position of 29 November 1999 (OJ C 26, 28.1.2000, p. 1) and Decision of the European Parliament of 11 April 2000 (not yet published in the Official Journal). Decision of the Council of 16 June 2000.(5) Directive 2000/12/EC of the European Parliament and of the Council of 20 March 2000 relating to the taking up and pursuit of the business of credit institutions (OJ L 126, 26.5.2000, p. 1). Directive as last amended by Directive 2000/28/EC (see page 37 of this Official Journal).(6) Council Directive 93/6/EEC of 15 March 1993 on the capital adequacy of investment firms and credit institutions (OJ L 141, 11.6.1993, p. 1). Directive as last amended by Directive 98/33/EC (OJ L 204, 21.7.1998, p. 29).(7) Council Directive 91/308/EEC of 10 June 1991 on prevention of the use of the financial system for the purpose of money laundering (OJ L 166, 28.6.1991, p. 77).


Avis juridique important

|

31994L0057

Council Directive 94/57/EC of 22 November 1994 on common rules and standards for ship inspection and survey organizations and for the relevant activities of maritime administrations

Official Journal L 319 , 12/12/1994 P. 0020 - 0027 Finnish special edition: Chapter 7 Volume 5 P. 0178  Swedish special edition: Chapter 7 Volume 5 P. 0178

COUNCIL DIRECTIVE 94/57/EC of 22 November 1994 on common rules and standards for ship inspection and survey organizations and for the relevant activities of maritime administrationsTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community and in particular Article 84 (2) thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure referred to in Article 189c of the Treaty (3),Whereas in its resolution of 8 June 1993 on a common policy on safe seas, the Council has set the objective of removing all substandard vessels from Community waters and has given priority to Community action to secure the effective and uniform implementation of international rules by elaborating common standards for classification societies (4);Whereas safety and pollution prevention at sea may be effectively enhanced by strictly applying international conventions, codes and resolutions while furthering the objective of freedom to provide services;Whereas the control of compliance of ships with the uniform international standards for safety and prevention of pollution of the seas is the responsibility of flag and port States;Whereas Member States are responsible for the issuing of international certificates for safety and pollution provided for under conventions such as Solas 74, Load Lines 66 and Marpol 73/78, and for the implementation of the provisions thereof;Whereas in compliance with such conventions all Member States may authorize to a various extent technical organizations for the certification of such compliance and may delegate the issue of the relevant safety certificates;Whereas worldwide a large number of the existing classification societies do not ensure either adequate implementation of the rules or reliability when acting on behalf of national administrations as they do not have adequate structures and experience to be relied upon and to enable them to carry out their duties in a highly professional manner;Whereas the objective of submitting classification societies to adequate standards cannot be sufficiently achieved by the Member States acting individually and can be better achieved by the Community;Whereas the appropriate way to act is by means of a Council Directive laying down minimum criteria for recognition of organizations, while leaving recognition itself, the means of enforcement, and the implementation of the Directive to the Member States;Whereas EN 45004 and EN 29001 standards combined with International Association of Classification Societies (IACS) standards constitute an adequate guarantee of performance quality of organizations;Whereas the issue of the Cargo Ship Safety Radio Certificate may be entrusted to private bodies having sufficient expertise and qualified personnel;Whereas organizations wishing to be recognized for the purpose of this Directive must submit to the Member States complete information and evidence of their compliance with the minimum criteria, and the Member States must notify to the Commission and to the other Member States the organizations they have recognized;Whereas a three-year recognition may be granted by the Commission for organizations which do not meet the criteria fixing the minimum number and tonnage of classed vessels and minimum number of exclusive surveyors laid down in the Annex but meet all the other criteria; whereas such organizations should be granted an extension of recognition after the period of three years provided they continue to meet the same criteria; whereas the effects of the three-year recognition should be limited to the requesting Member States, for that period only;Whereas the establishment of the internal market involves free circulation of services so that organizations meeting a set of common criteria which guarantee their professionalism and reliability cannot be prevented from supplying their services within the Community provided a Member State has decided to delegate such statutory duties; whereas such a Member State may nevertheless restrict the number of organizations it authorizes in accordance with its needs based on objective and transparent grounds, subject to control exercised by the Commission through the comitology procedures;Whereas the implementation of the principle of freedom to provide ship inspection and survey services could be gradual, but not beyond prescribed time limits;Whereas a tighter involvement of the national administrations in ship surveys and in the issue of the related certificates is necessary to ensure full compliance with the international safety rules even if the Member States rely upon organizations outside their administration for carrying out statutory duties; whereas it is appropriate, therefore, to establish a close working relationship between the administrations and the organizations, which may require that the organization has a local representation on the territory of the Member State on behalf of which it performs its duties;Whereas a committee of a regulatory nature should be established in order to assist the Commission in its effort to ensure effective application of the existing maritime safety and environmental standards while taking account of the national ratification procedures;Whereas the Commission must act according to the procedure laid down in Article 13 in order to take due account of progress in international fora and to update the minimum criteria;Whereas on the basis of the information provided in accordance with Article 11 by the Member States about the performance of the organizations working on their behalf, the Commission will decide whether it will request Member States to withdraw the recognition of recognized organizations which no longer fulfil the set of common minimum criteria, acting in accordance with the procedure of Article 13;Whereas Member States must nevertheless be left the possibility of suspending their authorization to an organization for reasons of serious danger to safety or environment; whereas the Commission must rapidly decide in accordance with the procedure referred to above whether it is necessary to overrule such national measure;Whereas each Member State should periodically assess the performance of the organizations working on its behalf and provide the Commission and all the other Member States with precise information related to such performance;Whereas Member States, as port authorities, are required to enhance safety and prevention of pollution in Community waters through priority inspection of vessels carrying certificates of organizations which do not fulfil the common criteria, thereby ensuring no more favourable treatment to vessels flying the flag of a third State;Whereas the procedure by which the committee will decide should be Procedure III A of Article 2 of Council Decision 87/373/EEC of 13 July 1987 laying down the procedures for the exercise of implementing powers conferred on the Commission (5);Whereas classification societies must update and enforce their technical standards in order to harmonize safety rules and ensure uniform implementation of international rules within the Community;Whereas at present there are not uniform international standards to which all ships must conform at the building stage and during their entire life, as regards hull, machinery and electrical and control installations; whereas such standards may be fixed according to the rules of recognized classification societies or to equivalent standards to be decided by the national administrations in accordance with the procedure laid down in Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (6),HAS ADOPTED THIS DIRECTIVE:Article 1 This Directive establishes measures to be followed by the Member States and organizations concerned with the inspection, survey and certification of ships for compliance with the international conventions on safety at sea and prevention of marine pollution, while furthering the objective of freedom to provide services. This process includes the development and implementation of safety requirements for hull, machinery and electrical and control installations of ships falling under the scope of the international conventions.Article 2 For the purpose of this Directive:(a) 'ship` means a ship falling within the scope of the international conventions;(b) 'ship flying the flag of a Member State` means a ship registered in and flying the flag of a Member State in accordance with its legislation, including ships registered in Euros once that register is approved by the Council. Ships not corresponding to this definition are assimilated to ships flying the flag of a third country;(c) 'inspections and surveys` means inspections and surveys made mandatory by the international conventions;(d) 'international conventions` means the 1974 International Convention for the Safety of Life at Sea, the 1966 International Convention on Load Lines and the 1973/78 International Convention for the Prevention of Pollution from Ships, together with the protocols and amendments thereto, and related codes of mandatory status in all Member States, in force at the date of adoption of this Directive;(e) 'organization` means a classification society or other private body carrying out safety assessment work for an administration;(f) 'recognized organization` means an organization recognized in conformity with Article 4;(g) 'authorization` means an act whereby a Member State grants an authorization or delegates powers to a recognized organization;(h) 'certificate` means a certificate issued by or on behalf of a Member State in accordance with the international conventions;(i) 'class certificate` means a document issued by a classification society certifying the structural and mechanical fitness of a ship for a particular use or service in accordance with its rules and regulations;(j) 'cargo ship safety radio certificate` means the certificate introduced by the amended Solas 74/78 Radio Regulations, adopted by the IMO and includes, during a transitional period ending on 1 February 1999, the Cargo Ship Safety Radiotelegraphy Certificate and the Cargo Ship Safety Radiotelephony Certificate;(k) 'location` refers to the place of the registered office, central administration or principal place of business of an organization.Article 3 1. In assuming their responsibilities and obligations under the international conventions, Member States shall ensure that their competent administrations can assure an appropriate enforcement of the provisions of the international conventions, in particular with regard to the inspection and survey of ships and the issue of certificates and exemption certificates.2. Where for the purpose of paragraph 1 a Member State decides with respect to ships flying its flag:(i) to authorize organizations to undertake fully or in part inspections and surveys related to certificates including those for the assessment of compliance with Article 14 and, where appropriate, to issue or renew the related certificates; or(ii) to rely upon organizations to undertake fully or in part the inspections and surveys referred to in subparagraph (i);it shall entrust these duties only to recognized organizations.The competent administration shall in all cases approve the first issue of the exemption certificates.However for the cargo ship safety radio certificate these duties may be entrusted to a private body recognized by a competent administration and having sufficient expertise and qualified personnel to carry out specified safety assessment work on radio-communication on its behalf.3. This Article does not concern the certification of specific items of marine equipment.Article 4 1. Member States may only recognize such organizations which fulfil the criteria set out in the Annex. The organizations shall submit to the Member States from which recognition has been requested complete information concerning, and evidence of, compliance with these criteria. The Member States will notify the organizations in an appropriate manner of their recognition.2. Each Member State shall notify to the Commission and the other Member States those organizations it has recognized.3. Member States may submit to the Commission a request for a recognition of three years for organizations which meet all the criteria of the Annex other than those set out under paragraph 2 and 3 of the section 'General` of the Annex.Such recognition shall be granted in accordance with the procedure laid down in Article 13. The effects of this recognition shall be limited to the Member States which have submitted a request for such recognition.4. All the organizations which are granted recognition shall be closely monitored by the committee set up under Article 7, also in view of deciding about extension of the recognition of organizations referred to in paragraph 3. A decision on the extension of such recognition shall not take into account the criteria set out under paragraphs 2 and 3 of the section 'General` of the Annex. The limitation of the effects of the recognition provided for in paragraph 3 shall no longer apply.5. The Commission shall draw up and update a list of the organizations notified by the Member States in compliance with paragraphs 1, 3 and 4. The list shall be published in the Official Journal of the European Communities.Article 5 1. In applying Article 3 (2) (i), Member States shall in principle not refuse to authorize any of the recognized organizations located in the Community to undertake such functions, subject to the provisions of Articles 6 and 11. However, they may restrict the number of organizations they authorize in accordance with their needs provided there are transparent and objective grounds for so doing. At the request of a Member State, the Commission shall, in accordance with the procedure laid down in Article 13, adopt appropriate measures.2. By way of derogation, Member States may be temporarily exempted by the Commission from the implementation of the provisions of paragraph 1 until 31 December 1997.3. In order for a Member State to accept that an organization located in a third State is to carry out the duties mentioned in Article 3 or part of them it may request that the said third State grant a reciprocal recognition for those recognized organizations which are located in the Community.Article 6 1. Member States which decide to act as described in Article 3 (2), shall set out a working relationship between their competent administration and the organizations acting on their behalf.2. The working relationship shall be regulated by a formalized written and non-discriminatory agreement or equivalent legal arrangements setting out the specific duties and functions assumed by the organizations and including at least:- the provisions set out in Appendix II of IMO Resolution A.739 (18) on guidelines for the authorization of organizations acting on behalf of the administration as it stands at the date of adoption of this Directive,- provisions for a periodical audit by the administration or by an impartial external body appointed by the administration into the duties the organizations are undertaking on its behalf,- the possibility for random and detailed inspections of ships,- provisions for reporting essential information about their classed fleet, changes of class or declassing of vessels.3. The agreement or equivalent legal arrangement may set the requirement that the recognized organization has a local representation on the territory of the Member State on behalf of which it performs the duties referred to in Article 3. A local representation of a legal nature ensuring legal personality under the law of the Member State and the competence of its national courts may satisfy such requirement.4. Each Member State shall provide the Commission with precise information on the working relationship established in accordance with this Article. The Commission shall subsequently inform the other Member States.Article 7 A committee composed of the representatives of the Member States and chaired by the representative of the Commission is hereby instituted to assist the Commission. This committee shall be called by the Commission at least once a year and whenever required in the case of suspension of authorization of an organization by a Member State under the provisions of Article 10.The Committee shall draw up its rules of procedure.Article 8 1. This Directive may be amended in accordance with the procedure laid down in Article 13, in order to:- apply, for the purposes of this Directive, subsequent amendments to the international codes and resolution mentioned in Articles 2 (d) and 6 (2), which have entered into force,- update the criteria in the Annex taking into account, in particular, the relevant decisions of the IMO.2. Following the adoption of new instruments or protocols to the conventions referred to in Article 2 (d), the Council, acting on a proposal from the Commission, shall decide, taking into account the Member States parliamentary procedures as well as the relevant procedures within IMO, on the detailed arrangements for ratifying those new instruments or protocols, while ensuring that they are applied uniformly and simultaneously in the Member States.Article 9 1. Each Member State may be requested, in accordance with the procedure laid down in Article 13, to withdraw the recognition of recognized organizations referred to in Article 4 which no longer fulfil the criteria set out in the Annex, where applicable.2. In preparing drafts for a decision relating to the matters referred to in paragraph 1, the Commission shall take into account the reports and information mentioned in Articles 11 and 12. In preparing such draft measures, the Commission shall pay particular attention to the safety and pollution prevention performance records of the organizations. Draft decisions relating to the matters referred to in paragraph 1 shall also be submitted to the committee by the Commission upon its own initiative or at the request of a Member State.Article 10 Notwithstanding the criteria specified in the Annex, where a Member State considers that a recognized organization can no longer be authorized to carry out on its behalf the tasks specified in Article 3 it may suspend such authorization.In the above circumstances the following procedure shall apply:(a) the Member State shall inform the Commission and the other Member States of its decision without delay, giving substantiated reasons therefore;(b) the Commission shall examine whether the suspension is justified for reasons of serious danger to safety or environment;(c) acting in accordance with the procedure laid down in Article 13, the Commission shall inform the Member State whether or not its decision to suspend the authorization is justified for reasons of serious danger to safety or environment and, if it is not justified, request the Member State to withdraw the suspension.Article 11 1. Each Member State must satisfy itself that the recognized organizations acting on its behalf for the purpose of Article 3 (2), effectively carry out the functions referred to in that Article to the satisfaction of its competent administration and that such organizations fulfil the criteria specified in the Annex. It may do so by having the recognized organizations directly monitored by its competent administration or, in the case of organizations located in another Member State, by relying upon the corresponding monitoring of such organizations by the administration of another Member State.2. Each Member State shall carry out this task on a biennial basis and shall provide the other Member States and the Commission with a report of the results of this monitoring at the latest by 31 March of each year following the years for which compliance has been assessed.3. Where a Member State chooses, for the purpose of carrying out this task, to rely upon monitoring by another Member State, its report shall be provided at the latest by 30 June of each year following the year for which compliance has been assessed.4. Member States shall forward to the Commission and the other Member States any information relevant to the assessment of the performance of organizations.Article 12 1. In exercising their inspection rights and obligations as port states:(a) Member States shall ensure that ships flying a third State flag are not treated more favourably than ships entitled to fly the flag of a Member State. To this end the fact that the ship certificates and the class certificate are known to have been delivered by an organization which does not fulfil the criteria of the Annex, with the exception of organizations recognized in accordance with Article 4 (3) and (4), shall be taken as one of the primary criteria for selecting ships for inspection.(b) Member States shall take appropriate measures when ships do not meet the internationally agreed standards and shall report to the Commission and the Secretariat of the Memorandum of Understanding on Port State Control the discovery of any issue of valid certificates by organizations acting on behalf of a flag State to a ship which does not fulfil the relevant requirements of the international conventions, or any failure of a ship carrying a valid class certificate and relating to items covered by that certificate.2. Each Member State shall establish a performance record of the organizations acting on behalf of flag States. This performance record shall be updated yearly and distributed to the other Member States and the Commission.Article 13 The following procedure shall apply for matters covered by Article 4 (3) and (4), Article 5 (1) and Articles 8, 9, 10 and Article 14 (2):(a) The representative of the Commission shall submit to the committee referred to in Article 7 a draft of the measures to be taken.(b) The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.(c) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.(d) If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measure to be taken. The Council shall act by a qualified majority. If, within three months from the date of referral to it, the Council has not acted, the proposed measure shall be adopted by the Commission.Article 14 1. Each Member State shall ensure that ships flying its flag shall be constructed and maintained in accordance with the hull, machinery and electrical and control installation requirements of a recognized organization.2. A Member State may decide to use rules it considers equivalent to those of a recognized organization only on the proviso that it immediately notified them to the Commission in conformity with the procedure of Directive 83/189/EEC and to the other Member States and they are not objected to by another Member State or the Commission and found through the procedure of Article 13 not to be equivalent.Article 15 1. The recognized organizations shall consult with each other periodically with a view to maintaining equivalence of their technical standards and the implementation thereof. They shall provide the Commission with periodic reports on fundamental progress in standards.2. The recognized organizations shall demonstrate willingness to cooperate with port State control administrations when a ship of their class is concerned, in particular, in order to facilitate the rectification of reported deficiencies or other discrepancies.3. The recognized organizations shall provide all relevant information to the administration about changes of class or declassing of vessels.4. The recognized organizations shall not issue certificates to a ship declassed or changing class for safety reasons before consulting the competent administration of the flag State to determine whether a full inspection is necessary.Article 16 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the Directive no later than 31 December 1995.2. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.3. The Member States shall immediately communicate to the Commission the text of all the provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.Article 17 This Directive is addressed to the Member States.Done at Brussels, 22 November 1994.For the CouncilThe PresidentM. WISSMANN(1) OJ No C 167, 18. 6. 1993, p. 13.(2) OJ No C 34, 2. 2. 1994, p. 14.(3) Opinion of the European Parliament of 9 March 1994 (OJ No C 91, 28. 3. 1994, p. 9), Council common position of 19 September 1994 (OJ No C 301, 27. 10. 1994, p. 75) and Decision of the European Parliament of 16 November 1994 (not yet published in the Official Journal).(4) OJ No C 271, 7. 10. 1993, p. 1.(5) OJ No L 197, 18. 7. 1987, p. 33.(6) OJ No L 109, 26. 4. 1983, p. 8. Directive as last amended by Directive 94/10/EC (OJ No L 100, 19. 4. 1994, p. 30).ANNEX MINIMUM CRITERIA FOR ORGANIZATIONS REFERRED TO IN ARTICLE 3 A. GENERAL 1. The recognized organization must be able to document extensive experience in assessing the design and construction of merchant ships.2. The organization should have in its class a fleet of at least 1 000 ocean-going vessels (over 100 GRT) totalling no less than 5 million GRT.3. The organization must employ a technical staff commensurate with the number of vessels classed. As a minimum, 100 exclusive surveyors would be needed to meet the requirements in paragraph 2.4. The organization should have comprehensive rules and regulations for the design, construction and periodic survey of merchant ships, published and continually upgraded and improved through research and development programmes.5. The organization should have its register of vessels published on an annual basis.6. The organization should not be controlled by shipowners or shipbuilders, or by others engaged commercially in the manufacture, equipping, repair or operation of ships. The organization should not be substantially dependent on a single commercial enterprise for its revenue.B. SPECIFIC 1. The organization is established with:(a) a significant technical, managerial, support and research staff commensurate to the tasks and to the vessels classed, catering also for capability - developing and upholding rules and regulations;(b) world-wide coverage by its exclusive technical staff or through exclusive technical staff of other recognized organizations.2. The organization is governed by a code of ethics.3. The organization is managed and administered in such a way as to ensure the confidentiality of information required by the administration.4. The organization is prepared to provide relevant information to the administration.5. The organization's management has defined and documented its policy and objectives for, and commitment to, quality and has ensured that this policy is understood, implemented and maintained at all levels in the organization.6. The organization has developed, implemented and maintains an effective internal quality system based on appropriate parts of internationally recognized quality standards and in compliance with EN 45004 (inspection bodies) and with EN 29001, as interpreted by the IACS Quality System Certification Scheme Requirements, and which, inter alia, ensures that:(a) the organization's rules and regulations are established and maintained in a systematic manner;(b) the organization's rules and regulations are complied with;(c) the requirements of the statutory work for which the organization is authorized are satisfied;(d) the responsibilities, authorities and interrelation of personnel whose work affects the quality of the organization's services are defined and documented;(e) all work is carried out under controlled conditions;(f) a supervisory system is in place which monitors the actions and work carried out by surveyors and technical and administrative staff employed directly by the organization;(g) the requirements of major statutory work for which the organization is authorized are only carried out or directly supervised by its exclusive surveyors or through exclusive surveyors of other recognized organizations;(h) a system for qualification of surveyors and continuous updating of their knowledge is implemented;(i) records are maintained, demonstrating achievement of the required standards in the items covered by the services performed, as well as the effective operation of the quality system; and(j) a comprehensive system of planned and documented internal audits of the quality related activities in all locations.7. The organization must demonstrate ability:(a) to develop and keep updated a full and adequate set of own rules and regulations on hull, machinery and electrical and control equipment having the quality of internationally recognized technical standards on the basis of which Solas Convention and Passenger Ship Safety Certificates (as regards adequacy of ship structure and essential shipboard machinery systems) and Load Line Certificates (as regards adequacy of ship strength) can be issued;(b) to carry out all inspections and surveys required by the international conventions for the issue of certificates, including the means of assessing, through the use of qualified professional staff, the application and maintenance of the safety management system, both shore-based and on board ships, intended to be covered in the certification.8. The organization is subject to certification of its quality system by an independent body of auditors recognized by the administration of the State in which it is located.9. The organization should allow participation in the development of its rules and/or regulations by representatives of the administration and other parties concerned.


Avis juridique important

|

32000L0084

Directive 2000/84/EC of the European Parliament and of the Council of 19 January 2001 on summer-time arrangements

Official Journal L 031 , 02/02/2001 P. 0021 - 0022

Directive 2000/84/EC of the European Parliament and of the Councilof 19 January 2001on summer-time arrangementsTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) The eighth Directive, 97/44/EC, of the European Parliament and of the Council of 22 July 1997 on summer-time arrangements(4) introduced a common date and time in all Member States, for the beginning and end of summer time in 1998, 1999, 2000 and 2001.(2) Given that the Member States apply summer-time arrangements, it is important for the functioning of the internal market that a common date and time for the beginning and end of the summer-time period be fixed throughout the Community.(3) Since the summer-time period considered most appropriate by the Member States runs from the end of March to the end of October, it is appropriate that that period therefore be maintained.(4) The proper functioning of certain sectors, not only transport and communications, but also other sectors of industry, requires stable, long-term planning. Provisions concerning summer time should therefore be laid down for an unspecified period. Article 4 of Directive 97/44/EC provides, in that respect, that the European Parliament and the Council are to adopt, by 1 January 2001, the arrangements to apply from 2002 onwards.(5) For reasons of clarity and accuracy of information, a timetable for the implementation of the summer-time period for the following five years should be published every five years.(6) Implementation of this Directive should, moreover, be monitored by means of a report, to be presented by the Commission to the European Parliament, the Council and the Economic and Social Committee, on the impact of these provisions in all of the areas concerned. That report should be based on the information made available to the Commission by the Member States in sufficient time to enable the report to be presented at the specified time.(7) Given that the complete harmonisation of the timetable for the summer-time period with a view to facilitating transport and communications cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may take measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. This Directive does not go beyond what is necessary to achieve those objectives.(8) For geographical reasons, the common summer-time arrangements should not apply to the overseas territories of the Member States,HAVE ADOPTED THIS DIRECTIVE:Article 1For the purposes of this Directive "summer-time period" shall mean the period of the year during which clocks are put forward by 60 minutes compared with the rest of the year.Article 2From 2002 onwards, the summer-time period shall begin, in every Member State, at 1.00 a.m., Greenwich Mean Time, on the last Sunday in March.Article 3From 2002 onwards, the summer-time period shall end, in every Member State, at 1.00 a.m., Greenwich Mean Time, on the last Sunday in October.Article 4The Commission shall publish a communication in the Official Journal of the European Communities(5), for the first time on the occasion of the publication of this Directive, and every five years thereafter, containing the timetable showing the dates on which the summer-time period will begin and end for the following five years.Article 5The Commission shall report to the European Parliament, the Council and the Economic and Social Committee on the impact of the provisions of this Directive on the sectors concerned by 31 December 2007 at the latest.That report shall be drawn up on the basis of the information made available to the Commission by each Member State by 30 April 2007 at the latest.The Commission shall, if necessary and following the conclusions of the report, make appropriate proposals.Article 6This Directive shall not apply to the overseas territories of the Member States.Article 7Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2001 at the latest. They shall forthwith inform the Commission thereof.When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 8This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 9This Directive is addressed to the Member States.Done at Brussels, 19 January 2001.For the European ParliamentThe PresidentN. FontaineFor the CouncilThe PresidentB. Ringholm(1) OJ C 337, 28.11.2000, p. 136.(2) Opinion delivered on 29 November 2000 (not yet published in the Official Journal).(3) Opinion of the European Parliament of 12 December 2000 (not yet published in the Official Journal) and Council Decision of 20 December 2000.(4) OJ L 206, 1.8.1997, p. 62.(5) OJ C 35, 2.2.2001.


title: Commission Directive 2006/33/EC of  20 March 2006  amending Directive 95/45/EC as regards sunset yellow FCF (E 110) and titanium dioxide (E 171)   (Text with EEA relevance)

text:
               21.3.2006

               EN

               Official Journal of the European Union

               L 82/10

         COMMISSION DIRECTIVE 2006/33/EC
   of 20 March 2006
   amending Directive 95/45/EC as regards sunset yellow FCF (E 110) and titanium dioxide (E 171)
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,
   After consulting the European Food Safety Authority,
   Whereas:

               (1)

               Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs (2), sets out the purity criteria for the colours mentioned in Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs (3).

               (2)

               Sunset yellow FCF (E 110) is authorised under Directive 94/36/EC as a colour for use in certain foodstuffs. There is scientific evidence that under certain circumstances, Sudan I (1-(phenylazo)-2-naphthalenol) may be formed as an impurity during the production of sunset yellow. Sudan I is an unauthorised colour and an undesired substance in food. Its presence in sunset yellow should therefore be restricted to an amount below the limit of detection, i.e. 0,5 mg/kg. The purity criteria for sunset yellow FCF (E 110) should therefore be amended accordingly.

               (3)

               Account should be taken of the specifications and analytical techniques for additives set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). JECFA began the implementation of a systematic programme to replace the test for heavy metals (as lead) in all existing food additive specifications with appropriate limits for individual metals of concern. These limits for sunset yellow FCF (E 110) should therefore be amended accordingly.

               (4)

               Titanium dioxide (E 171) is authorised under Directive 94/36/EC as a colour for use in certain foodstuffs. Titanium dioxide can be manufactured to obtain crystals in the anatase or in the rutile form. The platelet form of rutile titanium dioxide differs from the anatase form in structure and optical properties (pearlescence). There is a technological need for the use of the platelet form of rutile titanium dioxide as a colour in foodstuffs and in film coatings for food supplement tablets. On 7 December 2004 the European Food Safety Authority stated that the use of rutile titanium dioxide in the platelet or amorphous forms would not pose any safety concerns. The purity criteria for titanium dioxide (E 171) should therefore be amended in order to include both the anatase and the rutile form of the substance.

               (5)

               Directive 95/45/EC should therefore be amended accordingly.

               (6)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   The Annex to Directive 95/45/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 10 April 2007 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 20 March 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (2)  OJ L 226, 22.9.1995, p. 1. Directive as last amended by Directive 2004/47/EC (OJ L 113, 20.4.2004, p. 24).

      (3)  OJ L 237, 10.9.1994, p. 13. Directive as amended by Regulation (EC) No 1882/2003.

      ANNEX
      In the Annex to Directive 95/45/EC, Part B is amended as follows:

                  (1)

                  The text concerning sunset yellow FCF (E 110) is replaced by the following:

                              ‘E 110 SUNSET YELLOW FCF

                                 Synonyms

                              CI Food Yellow 3, Orange Yellow S

                                 Definition

                              Sunset Yellow FCF consists essentially of disodium 2-hydroxy-1-(4-sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.
                              Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.

                              Class

                              Monoazo

                              Colour Index No

                              15985

                              EINECS

                              220-491-7

                              Chemical names

                              Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate

                              Chemical formula

                              C16H10N2Na2O7S2

                              Molecular weight

                              452,37

                              Assay

                              Content not less than 85 % total colouring matters calculated as the sodium salt
                              E1 %
                                 1 cm 555 at ca 485 nm in aqueous solution at pH 7

                                 Description

                              Orange-red powder or granules

                              Identification

                                          A.

                                          Spectrometry

                              Maximum in water at ca 485 nm at pH 7

                                          B.

                                          Orange solution in water

                              Purity

                              Water insoluble matter

                              Not more than 0,2 %

                              Subsidiary colouring matters

                              Not more than 5,0 %

                              1-(Phenylazo)-2-naphthalenol (Sudan I)

                              Not more than 0,5 mg/kg

                              Organic compounds other than colouring matters:

                              4-aminobenzene-1-sulfonic acid
                              3-hydroxynaphthalene-2,7-disulfonic acid
                              6-hydroxynaphthalene-2-sulfonic acid
                              7-hydroxynaphthalene-1,3-disulfonic acid
                              4,4′-diazoaminodi(benzene sulfonic acid)
                              6,6′-oxydi(naphthalene-2-sulfonic acid)

                              Total not more than 0,5 %

                              Unsulfonated primary aromatic amines

                              Not more than 0,01 % (calculated as aniline)

                              Ether extractable matter

                              Not more than 0,2 % under neutral conditions

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 2 mg/kg

                              Mercury

                              Not more than 1 mg/kg

                              Cadmium

                              Not more than 1 mg/kg’

                  (2)

                  The text concerning titanium dioxide (E 171) is replaced by the following:

                              ‘E 171 TITANIUM DIOXIDE

                                 Synonyms

                              CI Pigment White 6

                                 Definition

                              Titanium dioxide consists essentially of pure anatase and/or rutile titanium dioxide which may be coated with small amounts of alumina and/or silica to improve the technological properties of the product.

                              Class

                              Inorganic

                              Colour Index No

                              77891

                              EINECS

                              236-675-5

                              Chemical names

                              Titanium dioxide

                              Chemical formula

                              TiO2

                              Molecular weight

                              79,88

                              Assay

                              Content not less than 99 % on an alumina and silica-free basis

                                 Description

                              White to slightly coloured powder

                              Identification

                              Solubility

                              Insoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulfuric acid.

                              Purity

                              Loss on Drying

                              Not more than 0,5 % (105 oC, 3 hours)

                              Loss on Ignition

                              Not more than 1,0 % on a volatile matter free basis (800 oC)

                              Aluminum oxide and/or silicon dioxide

                              Total not more than 2,0 %

                              Matter soluble in 0,5 N HCl

                              Not more than 0,5 % on an alumina and silica-free basis and, in addition, for products containing alumina and/or silica, not more than 1,5 % on the basis of the product as sold.

                              Water soluble matter

                              Not more than 0,5 %

                              Cadmium

                              Not more than 1 mg/kg

                              Antimony

                              Not more than 50 mg/kg by total dissolution

                              Arsenic

                              Not more than 3 mg/kg by total dissolution

                              Lead

                              Not more than 10 mg/kg by total dissolution

                              Mercury

                              Not more than 1 mg/kg by total dissolution

                              Zinc

                              Not more than 50 mg/kg by total dissolution.’.


title: Commission Directive 2010/70/EU of 28 October 2010 amending Council Directive 91/414/EEC as regards the expiry date for inclusion in Annex I of the active substance carbendazim  Text with EEA relevance

text:
               29.10.2010

               EN

               Official Journal of the European Union

               L 283/27

         COMMISSION DIRECTIVE 2010/70/EU
   of 28 October 2010
   amending Council Directive 91/414/EEC as regards the expiry date for inclusion in Annex I of the active substance carbendazim
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the second indent of the second subparagraph of Article 6(1) thereof,
   Whereas:

               (1)

               By Commission Directive 2006/135/EC (2) carbendazim was included as an active substance in Annex I to Directive 91/414/EEC. That inclusion expires on 31 December 2010.

               (2)

               On request the inclusion of an active substance may be renewed for a period not exceeding ten years. On 6 August 2007 the Commission received such a request from the notifier regarding the renewal of the inclusion for this substance.

               (3)

               On 10 January 2008 the notifier submitted a technical dossier to the rapporteur Member State Germany in support of its request. Germany delivered its draft reassessment report on 27 July 2009. The European Food Safety Authority then performed a peer review which was finalised on 30 April 2010.

               (4)

               Since it is impossible to complete the renewal procedure before the date when the inclusion of carbendazim will expire and since the request for renewal was made in sufficient time, in accordance with Article 5(5) of Directive 91/414/EEC a renewal should be granted for the period necessary to complete that procedure.

               (5)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (6)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Annex I to Directive 91/414/EEC, in row No 149 (carbendazim (unstated stereochemistry) CAS No 10605-21-7 CIPAC No 263), in the sixth column (expiration of inclusion), the words ‘31 December 2010’ are replaced by the words ‘13 June 2011’.
   Article 2
   Member States shall adopt and publish by 31 December 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 January 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 28 October 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 349, 12.12.2006, p. 37.


Avis juridique important

|

31985L0586

Council Directive 85/586/EEC of 20 December 1985 introducing technical adjustments, on account of the accession of Spain and Portugal, to Directives 64/432/EEC, 64/433/EEC, 77/99/EEC, 77/504/EEC, 80/217/EEC and 80/1095/EEC relating to the veterinary field

Official Journal L 372 , 31/12/1985 P. 0044 - 0045 Spanish special edition: Chapter 03 Volume 40 P. 0111  Portuguese special edition Chapter 03 Volume 40 P. 0111  Finnish special edition: Chapter 3 Volume 20 P. 0074  Swedish special edition: Chapter 3 Volume 20 P. 0074

COUNCIL  DIRECTIVE of 20 December 1985 introducing technical adjustments, on account of the accession of  Spain and Portugal, to Directives 64/432/EEC, 64/433/EEC, 77/99/EEC, 77/504/EEC, 80/217/EEC and  80/1095/EEC relating to the veterinary field (85/586/EEC)THE COUNCIL OF THE  EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community,  Having regard to the Act of Accession of Spain and Portugal, and in particular Article 396 thereof,  Having regard to the proposal from the Commission, Whereas to take account of the accession of  Spain and Portugal, the lists of laboratories drawn up under Community rules should be  supplemented, namely Council Directive 64/432/EEC of 26 June 1964 on animal health problems  affecting intra-Community trade in bovine animals and swine  (1), as last amended by Directive  85/320/EEC  (2), and Council Directive 80/217/EEC of 22 January 1980 introducing Community measures  for the control of classical swine fever (3), as last amended by Directive 84/645/EEC  (4); Whereas  it is advisable to adapt the Community certificates covering trade in live cattle and pigs and the  health marking of fresh meat and meat products; whereas this adaptation concerns Directive  64/432/EEC, Council Directive 64/433/EEC of 26 June 1964 on health problems affecting  intra-Community trade in fresh meat  (5), as last amended by Directive 85/325/EEC  (6), and Council  Directive 77/99/EEC of 21 December 1976 on health problems affecting intra-Community trade in meat  products  (7), as last amended by Directive 85/328/EEC  (8); Whereas Council Directive 75/504/EEC  of 25 July 1977 on pure-bred breeding animals of the bovine species  (9), as last amended by the  Act of Accession of Greece  (10), should be amended in order to take into account the derogation  provided for in respect of Portugal in Article 343 of the 1985 Act of Accession; Whereas the  control measures which Portugal and Spain will be called upon to apply with a view to eradicating  classical swine fever should be laid down in accordance with a Community procedure; whereas Council  Directive 80/1095/EEC of 11 November 1980 laying down conditions designed to render and keep the  territory of the Community free from classical swine fever  (11), as last amended by Directive  81/47/EEC  (12), should be adopted to that end; Whereas the concept of 'region', as referred to in  Directive 64/432/EEC, should be further defined in order to take account of the accession of Spain  and Portugal; Whereas, by virtue of Article 2 (3) of the Treaty of Accession of Spain and Portugal  the institutions of the Community may adopt before accession the measures referred to in Article  396 of the Act of Accession, subject to and on the date of the entry into force of this Treaty, HAS  ADOPTED THIS DIRECTIVE: Article 1Directive 64/432/EEC is hereby amended as  follows: 1.  The following indents shall be added to Article 2 (o):'-  Spain: Provincia,   -Portugal: mainland: distrito, and other parts of Portugal's territory: região autónoma'. 2.  In  Annex B, the following points shall be added to point 12:'(k)  Spain - Laboratorio de Sanidad y  Producción Animal, Granada,  (l)Portugal - Laboratório Nacional de Investigação Veterinária -  Lisboa'. 3.In Annex C, the following shall be added to point A.9:'(k)Spain - Centro Nacional de  Brucelosis de Murcia,  (l)Portugal - Laboratório Nacional de Investigação Veterinária - Lisboa'. 4.   In Annex F, footnote (4) to Model I is hereby supplemented by the following:'Spain: Inspector  Veterinario;Portugal: Inspector veterinário'. 5.In Annex F, footnote (5) to Model II is hereby  supplemented by the following:'in Spain: Inspector Veterinario;in Portugal: Inspector veterinário.'  6.In Annex F, footnote (4) to Model III is hereby supplemented by the following:'in Spain:  Inspector Veterinario;in Portugal: Inspector veterinário.' 7.In Annex F, the footnote (5) to Model  IV is hereby supplemented by:'in Spain: Inspector Veterinario;in Portugal: Inspector veterinário.'  8.In Annex G, the following shall be added to point A.2:'(j)  Spain: Laboratorio de Sanidad y  Producción Animal de Barcelona,(k)Portugal: Laboratório Nacional de Investigação Veterinária -  Lisboa.' Article 2In Chapter X.49 (a) of Annex I to Directive 64/433/EEC, the first indent is  hereby supplemented by: ' - ESP - P,'. Article 3In the first indent of point 33 (a) of Chapter  VII of Annex A to Directive 77/99/EEC, 'ESP - P' shall be inserted after 'E'. Article 4Article 2  of Directive 77/504/EEC shall be supplemented by the following paragraph:    'However, Portugal is  hereby authorized to maintain, until 31 December 1990 at the latest, import restrictions for bovine  animals, as described in the first indent of the previous paragraph, where the breeds concerned do  not appear on the list of breeds authorized in Portugal. Portugal shall notify the Commission and  the Member States of the list of authorized breeds.' Article 5The list of national swine fever  laboratories in Annex II to Directive 80/217/EEC is hereby supplemented by the following:     'Spain: Laboratorio de Sanidad y Producción Animal de BarcelonaPortugal: Laboratório Nacional de  Investigação Veterinária - Lisboa'. Article 6Directive 80/1095/EEC is hereby amended as  follows:1.  The following subparagraph shall be added to Article 3 (2): 'The status of Portugal and  Spain will be defined in accordance with the same procedure before 1 July 1986 with a view to  specifying such control measures as may prove appropriate.'2.Article 12 (2) shall be supplemented  by the following: 'and, in the case of Portugal and Spain, before 1 July 1992.' Article 7Subject  to the entry into force of the Treaty of Accession of Spain and Portugal, Member States shall bring  into force not later than 1 January 1986, the laws, regulations and administrative provisions  necessary to comply with this Directive. They shall forthwith inform the Commission thereof.  Article 8This Directive is addressed to the Member States. Done at Brussels, 20  December 1985. For the Council The President R. STEICHEN                                             (1)  OJ No 121, 29. 7. 1964, p. 1977/64. (2)  OJ No L 168, 28. 6. 1985, p. 36. (3)  OJ No L 47, 21. 2. 1980, p. 11. (4)  OJ No L 339, 27. 12. 1984, p. 33. (5)  OJ No 121, 29. 7. 1964, p. 2012/64. (6)  OJ No L 168, 28. 6. 1985, p. 47. (7)  OJ No L 26, 31. 1. 1977, p. 85. (8)  OJ No L 168, 28. 6. 1985, p. 50. (9)  OJ No L 206, 12. 8. 1977, p. 8. (10)  OJ No L 291, 19. 11. 1979, p. 17. (11)  OJ No L 325, 1. 12. 1980, p. 5. (12)  OJ No L 186, 8. 7. 1981, p. 20.