title: Directive 2009/101/EC of the European Parliament and of the Council of 16 September 2009 on coordination of safeguards which, for the protection of the interests of members and third parties, are required by Member States of companies within the meaning of the second paragraph of Article 48 of the Treaty, with a view to making such safeguards equivalent (Text with EEA relevance)

text:
               1.10.2009

               EN

               Official Journal of the European Union

               L 258/11

      DIRECTIVE 2009/101/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 16 September 2009
   on coordination of safeguards which, for the protection of the interests of members and third parties, are required by Member States of companies within the meaning of the second paragraph of Article 48 of the Treaty, with a view to making such safeguards equivalent
   (codified version)
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 44(2)(g) thereof,
   Having regard to the General Programme for the abolition of restrictions on freedom of establishment (1), and in particular Title VI thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (2),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
   Whereas:

               (1)

               First Council Directive 68/151/EEC of 9 March 1968 on coordination of safeguards which, for the protection of the interests of members and others, are required by Member States of companies within the meaning of the second paragraph of Article 58 of the Treaty, with a view to making such safeguards equivalent throughout the Community (4) has been substantially amended several times (5). In the interests of clarity and rationality that Directive should be codified.

               (2)

               The coordination of national provisions concerning disclosure, the validity of obligations entered into by, and the nullity of, companies limited by shares or otherwise having limited liability is of special importance, particularly for the purpose of protecting the interests of third parties.

               (3)

               The basic documents of the company should be disclosed in order that third parties may be able to ascertain their contents and other information concerning the company, especially particulars of the persons who are authorised to bind the company.

               (4)

               Without prejudice to substantive requirements and formalities established by the national law of the Member States, companies should be able to choose to file their compulsory documents and particulars by paper means or by electronic means.

               (5)

               Interested parties should be able to obtain from the register a copy of such documents and particulars by paper means as well as by electronic means.

               (6)

               Member States should be allowed to decide to keep the national gazette, designated for publication of compulsory documents and particulars, in paper form or electronic form, or to provide for disclosure by equally effective means.

               (7)

               Cross-border access to company information should be facilitated by allowing, in addition to the mandatory disclosure made in one of the languages permitted in the company’s Member State, voluntary registration in additional languages of the required documents and particulars. Third parties acting in good faith should be able to rely on the translations thereof.

               (8)

               It is appropriate to clarify that the statement of the compulsory particulars set out in this Directive should be included in all company letters and order forms, whether they are in paper form or use any other medium. In the light of technological developments, it is also appropriate to provide that these statements be placed on any company website.

               (9)

               The protection of third parties should be ensured by provisions which restrict to the greatest possible extent the grounds on which obligations entered into in the name of the company are not valid.

               (10)

               It is necessary, in order to ensure certainty in the law as regards relations between the company and third parties, and also between members, to limit the cases in which nullity can arise and the retroactive effect of a declaration of nullity, and to fix a short time limit within which third parties may enter objection to any such declaration.

               (11)

               This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex I, Part B,

         HAVE ADOPTED THIS DIRECTIVE:
   CHAPTER 1

      SCOPE

   Article 1
   The coordination measures prescribed by this Directive shall apply to the laws, regulations and administrative provisions of the Member States relating to the following types of company:

               —

               Belgium:

                           naamloze vennootschap,

                           société anonyme,

                           commanditaire vennootschap op aandelen,

                           société en commandite par actions,

                           personenvennootschap met beperkte aansprakelijkheid;

                           société de personnes à responsabilité limitée;

               —

               Bulgaria:
               акционерно дружество, дружество с ограничена отговорност, командитно дружество с акции;

               —

               Czech Republic:
               společnost s ručením omezeným, akciová společnost;

               —

               Denmark:
               aktieselskab, kommanditaktieselskab, anpartsselskab;

               —

               Germany:
               die Aktiengesellschaft, die Kommanditgesellschaft auf Aktien, die Gesellschaft mit beschränkter Haftung;

               —

               Estonia:
               aktsiaselts, osaühing;

               —

               Ireland:
               Companies incorporated with limited liability;

               —

               Greece:
               ανώνυμη εταιρία, εταιρία περιωρισμένης ευθύνης, ετερόρρυθμη κατά μετοχές εταιρία;

               —

               Spain:
               la sociedad anónima, la sociedad comanditaria por acciones, la sociedad de responsabilidad limitada;

               —

               France:
               société anonyme, société en commandite par actions, société à responsabilité limitée, société par actions simplifiée;

               —

               Italy:
               società per azioni, società in accomandita per azioni, società a responsabilità limitata;

               —

               Cyprus:
               δημόσιες εταιρείες περιορισμένης ευθύνης με μετοχές ή με εγγύηση, ιδιωτικές εταιρείες περιορισμένης ευθύνης με μετοχές ή με εγγύηση;

               —

               Latvia:
               akciju sabiedrība, sabiedrība ar ierobežotu atbildību, komanditsabiedrība;

               —

               Lithuania:
               akcinė bendrovė, uždaroji akcinė bendrovė;

               —

               Luxembourg:
               société anonyme, société en commandite par actions, société à responsabilité limitée;

               —

               Hungary:
               részvénytársaság, korlátolt felelősségű társaság;

               —

               Malta:
               kumpannija pubblika/public limited liability company, kumpannija privata/private limited liability company;

               —

               The Netherlands:
               naamloze vennootschap, besloten vennootschap met beperkte aansprakelijkheid;

               —

               Austria:
               die Aktiengesellschaft, die Gesellschaft mit beschränkter Haftung;

               —

               Poland:
               spółka z ograniczoną odpowiedzialnością, spółka komandytowo-akcyjna, spółka akcyjna;

               —

               Portugal:
               a sociedade anónima de responsabilidade limitada, a sociedade em comandita por acções, a sociedade por quotas de responsabilidade limitada;

               —

               Romania:
               societate pe acțiuni, societate cu răspundere limitată, societate în comandită pe acțiuni;

               —

               Slovenia:
               delniška družba, družba z omejeno odgovornostjo, komaditna delniška družba;

               —

               Slovakia:
               akciová spoločnosť, spoločnosť s ručením obmedzeným;

               —

               Finland:
               yksityinen osakeyhtiö/privat aktiebolag, julkinen osakeyhtiö/publikt aktiebolag;

               —

               Sweden:
               aktiebolag;

               —

               United Kingdom:
               Companies incorporated with limited liability.

         CHAPTER 2

      DISCLOSURE

   Article 2
   Member States shall take the measures required to ensure compulsory disclosure by companies as referred to in Article 1 of at least the following documents and particulars:

               (a)

               the instrument of constitution, and the statutes if they are contained in a separate instrument;

               (b)

               any amendments to the instruments mentioned in point (a), including any extension of the duration of the company;

               (c)

               after every amendment of the instrument of constitution or of the statutes, the complete text of the instrument or statutes as amended to date;

               (d)

               the appointment, termination of office and particulars of the persons who either as a body constituted pursuant to law or as members of any such body:

                           (i)

                           are authorised to represent the company in dealings with third parties and in legal proceedings; it must be apparent from the disclosure whether the persons authorised to represent the company may do so alone or must act jointly;

                           (ii)

                           take part in the administration, supervision or control of the company;

               (e)

               at least once a year, the amount of the capital subscribed, where the instrument of constitution or the statutes mention an authorised capital, unless any increase in the capital subscribed necessitates an amendment of the statutes;

               (f)

               the accounting documents for each financial year which are required to be published in accordance with Council Directives 78/660/EEC (6), 83/349/EEC (7), 86/635/EEC (8) and 91/674/EEC (9);

               (g)

               any change of the registered office of the company;

               (h)

               the winding-up of the company;

               (i)

               any declaration of nullity of the company by the courts;

               (j)

               the appointment of liquidators, particulars concerning them, and their respective powers, unless such powers are expressly and exclusively derived from law or from the statutes of the company;

               (k)

               the termination of the liquidation and, in Member States where striking off the register entails legal consequences, the fact of any such striking off.

         Article 3
   1.   In each Member State, a file shall be opened in a central register, commercial register or companies register, for each of the companies registered therein.
   2.   For the purposes of this Article, ‘by electronic means’ shall mean that the information is sent initially and received at its destination by means of electronic equipment for the processing (including digital compression) and storage of data, and entirely transmitted, conveyed and received in a manner to be determined by Member States by wire, by radio, by optical means or by other electromagnetic means.
   3.   All documents and particulars which must be disclosed pursuant to Article 2 shall be kept in the file, or entered in the register; the subject matter of the entries in the register must in every case appear in the file.
   Member States shall ensure that the filing by companies, as well as by other persons and bodies required to make or assist in making notifications, of all documents and particulars which must be disclosed pursuant to Article 2 is possible by electronic means. In addition, Member States may require all, or certain categories of, companies to file all, or certain types of, such documents and particulars by electronic means.
   All documents and particulars referred to in Article 2 which are filed, whether by paper means or by electronic means, shall be kept in the file, or entered in the register, in electronic form. To this end, Member States shall ensure that all such documents and particulars which are filed by paper means are converted by the register to electronic form.
   The documents and particulars referred to in Article 2 that have been filed by paper means up to 31 December 2006 shall not be required to be converted automatically into electronic form by the register. Member States shall nevertheless ensure that they are converted into electronic form by the register upon receipt of an application for disclosure by electronic means submitted in accordance with the measures adopted to give effect to paragraph 4.
   4.   A copy of the whole or any part of the documents or particulars referred to in Article 2 must be obtainable on application. Applications may be submitted to the register by paper means or by electronic means as the applicant chooses.
   Copies as referred to in the first subparagraph must be obtainable from the register by paper means or by electronic means as the applicant chooses. This shall apply in the case of all documents and particulars already filed. However, Member States may decide that all, or certain types of, documents and particulars filed by paper means on or before a date which may not be later than 31 December 2006 shall not be obtainable from the register by electronic means if a specified period has elapsed between the date of filing and the date of the application submitted to the register. Such specified period may not be less than 10 years.
   The price of obtaining a copy of the whole or any part of the documents or particulars referred to in Article 2, whether by paper means or by electronic means, shall not exceed the administrative cost thereof.
   Paper copies supplied shall be certified as ‘true copies’, unless the applicant dispenses with such certification. Electronic copies supplied shall not be certified as ‘true copies’, unless the applicant explicitly requests such a certification.
   Member States shall take the necessary measures to ensure that certification of electronic copies guarantees both the authenticity of their origin and the integrity of their contents, by means at least of an advanced electronic signature within the meaning of Article 2(2) of Directive 1999/93/EC (10).
   5.   Disclosure of the documents and particulars referred to in paragraph 3 shall be effected by publication in the national gazette designated for that purpose by the Member State, either of the full text or of a partial text, or by means of a reference to the document which has been deposited in the file or entered in the register. The national gazette designated for that purpose may be kept in electronic form.
   Member States may decide to replace publication in the national gazette with equally effective means, which shall entail at least the use of a system whereby the information disclosed can be accessed in chronological order through a central electronic platform.
   6.   The documents and particulars may be relied on by the company as against third parties only after they have been disclosed in accordance with paragraph 5, unless the company proves that the third parties had knowledge thereof.
   However, with regard to transactions taking place before the sixteenth day following the disclosure, the documents and particulars shall not be relied on as against third parties who prove that it was impossible for them to have had knowledge thereof.
   7.   Member States shall take the necessary measures to avoid any discrepancy between what is disclosed in accordance with paragraph 5 and what appears in the register or file.
   However, in cases of discrepancy, the text disclosed in accordance with paragraph 5 may not be relied on as against third parties; such third parties may nevertheless rely thereon, unless the company proves that they had knowledge of the texts deposited in the file or entered in the register.
   Third parties may, moreover, always rely on any documents and particulars in respect of which the disclosure formalities have not yet been completed, save where non-disclosure causes them not to have effect.
   Article 4
   1.   Documents and particulars which must be disclosed pursuant to Article 2 shall be drawn up and filed in one of the languages permitted by the language rules applicable in the Member State in which the file referred to in Article 3(1) is opened.
   2.   In addition to the mandatory disclosure referred to in Article 3, Member States shall allow documents and particulars referred to in Article 2 to be disclosed voluntarily in accordance with Article 3 in any official language(s) of the Community.
   Member States may prescribe that the translation of such documents and particulars be certified.
   Member States shall take the necessary measures to facilitate access by third parties to the translations voluntarily disclosed.
   3.   In addition to the mandatory disclosure referred to in Article 3, and to the voluntary disclosure provided for under paragraph 2 of this Article, Member States may allow the documents and particulars concerned to be disclosed, in accordance with Article 3, in any other language(s).
   Member States may prescribe that the translation of such documents and particulars be certified.
   4.   In cases of discrepancy between the documents and particulars disclosed in the official languages of the register and the translation voluntarily disclosed, the latter may not be relied upon as against third parties. Third parties may nevertheless rely on the translations voluntarily disclosed, unless the company proves that the third parties had knowledge of the version which was the subject of the mandatory disclosure.
   Article 5
   Member States shall prescribe that letters and order forms, whether they are in paper form or use any other medium, are to state the following particulars:

               (a)

               the information necessary in order to identify the register in which the file mentioned in Article 3 is kept, together with the number of the company in that register;

               (b)

               the legal form of the company, the location of its registered office and, where appropriate, the fact that the company is being wound up.

         Where, in those documents, mention is made of the capital of the company, the reference shall be to the capital subscribed and paid up.
   Member States shall prescribe that company websites are to contain at least the particulars mentioned in the first paragraph and, if applicable, a reference to the capital subscribed and paid up.
   Article 6
   Each Member State shall determine by which persons the disclosure formalities are to be carried out.
   Article 7
   Member States shall provide for appropriate penalties at least in the case of:

               (a)

               failure to disclose accounting documents as required by Article 2(f);

               (b)

               omission from commercial documents or from any company website of the compulsory particulars provided for in Article 5.

         CHAPTER 3

      VALIDITY OF OBLIGATIONS ENTERED INTO BY THE COMPANY

   Article 8
   If, before a company being formed has acquired legal personality, action has been carried out in its name and the company does not assume the obligations arising from such action, the persons who acted shall, without limit, be jointly and severally liable therefor, unless otherwise agreed.
   Article 9
   Completion of the formalities of disclosure of the particulars concerning the persons who, as an organ of the company, are authorised to represent it shall constitute a bar to any irregularity in their appointment being relied upon as against third parties unless the company proves that such third parties had knowledge thereof.
   Article 10
   1.   Acts done by the organs of the company shall be binding upon it even if those acts are not within the objects of the company, unless such acts exceed the powers that the law confers or allows to be conferred on those organs.
   However, Member States may provide that the company shall not be bound where such acts are outside the objects of the company, if it proves that the third party knew that the act was outside those objects or could not in view of the circumstances have been unaware of it; disclosure of the statutes shall not of itself be sufficient proof thereof.
   2.   The limits on the powers of the organs of the company, arising under the statutes or from a decision of the competent organs, may not be relied on as against third parties, even if they have been disclosed.
   3.   If the national law provides that authority to represent a company may, in derogation from the legal rules governing the subject, be conferred by the statutes on a single person or on several persons acting jointly, that law may provide that such a provision in the statutes may be relied on as against third parties on condition that it relates to the general power of representation; the question whether such a provision in the statutes can be relied on as against third parties shall be governed by Article 3.
   CHAPTER 4

      NULLITY OF THE COMPANY

   Article 11
   In all Member States whose laws do not provide for preventive, administrative or judicial control, at the time of formation of a company, the instrument of constitution, the company statutes and any amendments to those documents shall be drawn up and certified in due legal form.
   Article 12
   The laws of the Member States may not provide for the nullity of companies otherwise than in accordance with the following provisions:

               (a)

               nullity must be ordered by decision of a court of law;

               (b)

               nullity may be ordered only on the grounds:

                           (i)

                           that no instrument of constitution was executed or that the rules of preventive control or the requisite legal formalities were not complied with;

                           (ii)

                           that the objects of the company are unlawful or contrary to public policy;

                           (iii)

                           that the instrument of constitution or the statutes do not state the name of the company, the amount of the individual subscriptions of capital, the total amount of the capital subscribed or the objects of the company;

                           (iv)

                           of failure to comply with the provisions of the national law concerning the minimum amount of capital to be paid up;

                           (v)

                           of the incapacity of all the founder members;

                           (vi)

                           that, contrary to the national law governing the company, the number of founder members is less than two.

         Apart from the foregoing grounds of nullity, a company shall not be subject to any cause of non-existence, absolute nullity, relative nullity or declaration of nullity.
   Article 13
   1.   The question whether a decision of nullity pronounced by a court of law may be relied on as against third parties shall be governed by Article 3. Where the national law entitles a third party to challenge the decision, he may do so only within six months of public notice of the decision of the court being given.
   2.   Nullity shall entail the winding-up of the company, as may dissolution.
   3.   Nullity shall not of itself affect the validity of any commitments entered into by or with the company, without prejudice to the consequences of the company’s being wound up.
   4.   The laws of each Member State may make provision for the consequences of nullity as between members of the company.
   5.   Holders of shares in the capital shall remain obliged to pay up the capital agreed to be subscribed by them but which has not been paid up, to the extent that commitments entered into with creditors so require.
   CHAPTER 5

      GENERAL PROVISIONS

   Article 14
   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 15
   The Commission shall present to the European Parliament and to the Council, by no later than 1 January 2012, a report, together with a proposal, if appropriate, for amendment of the provisions of Article 2(f) and Articles 3, 4, 5 and 7 in the light of the experience acquired in applying those provisions, of their aims and of the technological developments observed at the time.
   Article 16
   Directive 68/151/EEC, as amended by the acts listed in Annex I, Part A, is hereby repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex I, Part B.
   References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex II.
   Article 17
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 18
   This Directive is addressed to the Member States.

      Done at Strasbourg, 16 September 2009.

            For the European Parliament

            The President

         J. BUZEK

            For the Council

            The President

         C. MALMSTRÖM

      (1)  OJ 2, 15.1.1962, p. 36/62.

      (2)  OJ C 204, 9.8.2008, p. 25.

      (3)  Opinion of the European Parliament of 17 June 2008 (not yet published in the Official Journal) and Council Decision of 13 July 2009.

      (4)  OJ L 65, 14.3.1968, p. 8.

      (5)  See Annex I, Part A.

      (6)  Fourth Council Directive 78/660/EEC of 25 July 1978 based on Article 54(3)(g) of the Treaty on the annual accounts of certain types of companies (OJ L 222, 14.8.1978, p. 11).

      (7)  Seventh Council Directive 83/349/EEC of 13 June 1983 based on the Article 54(3)(g) of the Treaty on consolidated accounts (OJ L 193, 18.7.1983, p. 1).

      (8)  Council Directive 86/635/EEC of 8 December 1986 on the annual accounts and consolidated accounts of banks and other financial institutions (OJ L 372, 31.12.1986, p. 1).

      (9)  Council Directive 91/674/EEC of 19 December 1991 on the annual accounts and consolidated accounts of insurance undertakings (OJ L 374, 31.12.1991, p. 7).

      (10)  Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures (OJ L 13, 19.1.2000, p. 12).

      ANNEX I
      PART A

         Repealed Directive with list of its successive amendments

      (referred to in Article 16)

                  Council Directive 68/151/EEC
                  (OJ L 65, 14.3.1968, p. 8)

                  Point III.H of Annex I to the 1972 Act of Accession
                  (OJ L 73, 27.3.1972, p. 89)

                  Point III.C of Annex I to the 1979 Act of Accession
                  (OJ L 291, 19.11.1979, p. 89)

                  Point II.D of Annex I to the 1985 Act of Accession
                  (OJ L 302, 15.11.1985, p. 157)

                  Point XI.A of Annex I to the 1994 Act of Accession
                  (OJ C 241, 29.8.1994, p. 194)

                  Directive 2003/58/CE of the European Parliament and of the Council (OJ L 221, 4.9.2003, p. 13)

                  Point 1.4.A of Annex II to the 2003 Act of Accession
                  (OJ L 236, 23.9.2003, p. 338)

                  Council Directive 2006/99/EC
                  (OJ L 363, 20.12.2006, p. 137)

                  Only point A.1 of the Annex

            PART B

         List of time limits for transposition into national law

      (referred to in Article 16)

                  Directive

                  Time limit for transposition

                  68/151/EEC

                  11 September 1969

                  2003/58/EC

                  30 December 2006

                  2006/99/EC

                  1 January 2007

      ANNEX II

         CORRELATION TABLE

                  Directive 68/151/EEC

                  This Directive

                  Article 1

                  Article 1

                  Article 2

                  Article 2

                  Article 3(1)

                  Article 3(1)

                  Article 3(2)

                  Article 3(3)

                  Article 3(3)

                  Article 3(4)

                  Article 3(4)

                  Article 3(5)

                  Article 3(5)

                  Article 3(6)

                  Article 3(6), first and second subparagraphs

                  Article 3(7), first and second subparagraphs

                  Article 3(7)

                  Article 3(7), third subparagraph

                  Article 3(8)

                  Article 3(2)

                  Article 3a

                  Article 4

                  Article 4

                  Article 5

                  Article 5

                  Article 6

                  Article 6

                  Article 7

                  Article 7

                  Article 8

                  Article 8

                  Article 9

                  Article 9

                  Article 10

                  Article 10

                  Article 11

                  Article 11, introductory wording

                  Article 12, introductory wording

                  Article 11, point 1

                  Article 12, point (a)

                  Article 11, point 2, introductory wording

                  Article 12, point (b), introductory wording

                  Article 11, point 2, points (a) to (f)

                  Article 12, point (b), points (i) to (vi)

                  Article 12

                  Article 13

                  Article 13, first, second and third paragraphs

                  —

                  Article 13, fourth paragraph

                  Article 14

                  Article 14

                  Article 18

                  —

                  Article 15

                  —

                  Article 16

                  —

                  Article 17

                  —

                  Annex I

                  —

                  Annex II


Avis juridique important

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Commission Directive 2003/73/EC of 24 July 2003 amending Annex III to Directive 1999/94/EC of the European Parliament and of the Council (Text with EEA relevance)

Official Journal L 186 , 25/07/2003 P. 0034 - 0035

Commission Directive 2003/73/ECof 24 July 2003amending Annex III to Directive 1999/94/EC of the European Parliament and of the Council(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Directive 1999/94/EC of the European Parliament and of the Council of 13 December 1999 relating to the availability of consumer information on fuel economy and CO2 emissions in respect of the marketing of new passenger cars(1), and in particular Article 9 thereof,Whereas:(1) Annex III to Directive 1999/94/EC lays down a format for a poster which has to be exhibited at any point of sale of new passenger cars.(2) Provision should be made for the use of modern communication tools (electronic display), and to prevent the use of poster updating techniques which are less consumer-friendly.(3) Annex III to Directive 1999/94/EC should therefore be amended accordingly.(4) Consumer organisations and interested parties have been consulted.(5) The measures provided for in this Directive are in accordance with the opinion of the Committee established under Article 10 of Directive 1999/94/EC,HAS ADOPTED THIS DIRECTIVE:Article 1Annex III to Directive 1999/94/EC is replaced by the Annex to this Directive.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within one year of publication in the Official Journal of the European Union. They shall forthwith inform the Commission thereof.When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such a reference shall be adopted by 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 3This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 24 July 2003.For the CommissionMargot WallströmMember of the Commission(1) OJ L 12, 18.1.2000, p. 16.ANNEX"ANNEX IIIDESCRIPTION OF THE POSTER/DISPLAY TO BE DISPLAYED AT THE POINT OF SALEThe Member States must ensure that the poster/display meets, as a minimum, the following requirements:1. the poster or display is a minimum size of 70 cm x 50 cm;2. the information is easy to read;3. in a display where information is provided on an electronic screen, the screen size shall be at least 25 cm x 32 cm (17 inches). The information may be shown using scroll techniques;4. the passenger car models are grouped and listed separately according to fuel type (e.g. petrol or diesel etc.). Within each fuel type, models are ranked in order of increasing CO2 emissions, with the model with the lowest official fuel consumption being placed at the top of the list;5. for each passenger car model in the list the make, the numerical value of the official fuel consumption and the official specific emissions of CO2 are given. The value of the official fuel consumption is expressed in either litres per 100 kilometres (l/100 km), kilometres per litre (km/l), or an appropriate combination of these, and is quoted to one decimal place. The official specific emissions of CO2 are quoted to the nearest whole number in grams per kilometre (g/km).Such values may be expressed in different units (gallons and miles) to the extent compatible with the provisions of Directive 80/181/EEC.A suggested format is shown below:>PIC FILE= "L_2003186EN.003503.TIF">6. the poster/display contains the following text regarding the availability of the guide on fuel economy and CO2 emissions: "A guide on fuel economy and CO2 emissions which contains data for all new passenger car models is available at any point of sale free of charge"; in the case of a display featuring an electronic screen this message must be permanently visible;7. the poster/display contains the following text: "In addition to the fuel efficiency of a car, driving behaviour as well as other non-technical factors play a role in determining a car's fuel consumption and CO2 emissions. CO2 is the main greenhouse gas responsible for global warming"; in the case of a display featuring an electronic screen this message must be permanently visible;8. the poster/display will be updated at least every six months. Where an electronic display is used, the information shall be updated at least every three months;9. the poster/display may be substituted completely and permanently by an electronic screen. In this case the electronic screen shall be presented in such a way that it attracts the awareness of the consumer at least with the same intensity as a poster/display would have achieved."


title: Council Directive 2004/85/EC of 28 June 2004 amending Directive 2003/54/EC of the European Parliament and of the Council as regards the application of certain provisions to Estonia

text:
               7.7.2004

               EN

               Official Journal of the European Union

               L 236/10

      COUNCIL DIRECTIVE 2004/85/EC
   of 28 June 2004
   amending Directive 2003/54/EC of the European Parliament and of the Council as regards the application of certain provisions to Estonia
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty concerning the accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic to the European Union (Treaty of Accession) and in particular Article 2(3) thereof,
   Having regard to the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded, (Act of Accession), and in particular Article 57 thereof,
   Having regard to the request of Estonia,
   Having regard to the proposal from the Commission,
   Whereas:

               (1)

               During the accession negotiations, Estonia invoked the specific characteristics of its electricity sector to request a transitional period for the application of Directive 96/92/EC of the European Parliament and of the Council of 19 December 1996 concerning common rules for the internal market in electricity (1).

               (2)

               In Annex VI of the Act of Accession, Estonia was granted a transitional period until 31 December 2008 for the application of Article 19(2) of Directive 96/92/EC, relating to the gradual opening of the market.

               (3)

               Declaration No 8 annexed to the Treaty of Accession recognised moreover that the specific situation relating to the restructuring of the oil shale sector in Estonia was going to require particular efforts until the end of 2012.

               (4)

               Directive 96/92/EC was replaced by Directive 2003/54/EC which has to be implemented by 1 July 2004 and which has the effect of speeding up the opening of the electricity market.

               (5)

               By letter of 17 September 2003, Estonia transmitted a request aimed at not applying Article 21(1)(b) of Directive 2003/54/EC, on the opening of the market to non-household customers, until 31 December 2012. In a further letter of 5 December 2003, Estonia indicated that it was planning to achieve the complete opening of the market provided for in Article 21(1)(c) of that Directive by 31 December 2015.

               (6)

               The request by Estonia is based on a credible restructuring plan for the oil shale sector extending until 31 December 2012.

               (7)

               Oil shale is the only real indigenous energy resource in Estonia and national production represents almost 84 % of world production. 90 % of the electricity produced in Estonia is from this solid fuel. It is therefore of great strategic importance for security of supply in Estonia.

               (8)

               The granting of a further derogation for the period 2009 to 2012 will guarantee security of investments in generating plants and security of supply in Estonia while allowing the serious environmental problems created by those plants to be resolved.

               (9)

               The request made by Estonia should be granted and Directive 2003/54/EC amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Article 26 of Directive 2003/54/EC, the following paragraph shall be added:

      ‘3.   Estonia shall be granted a temporary derogation from the application of Article 21(1)(b) and (c) until 31 December 2012. Estonia shall take the measures necessary to ensure the opening of its electricity market. This shall be carried out gradually over the reference period with the aim of complete opening of the market by 1 January 2013. On 1 January 2009, the opening of the market must represent at least 35 % of consumption. Estonia shall communicate annually to the Commission the consumption thresholds extending eligibility to final customers.’

   Article 2
   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2004. They shall forthwith communicate to the Commission the text of those measures.
   When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   Article 3
   This Directive shall enter into force on the 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 Luxembourg, 28 June 2004.

            For the Council

            The President

         M. CULLEN

      (1)  OJ L 27, 30.1.1997, p. 20. Directive repealed by Directive 2003/54/EC (OJ L 176, 15.7.2003, p. 37).


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32003L0022

Commission Directive 2003/22/EC of 24 March 2003 amending certain Annexes to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community

Official Journal L 078 , 25/03/2003 P. 0010 - 0011

Commission Directive 2003/22/ECof 24 March 2003amending certain Annexes to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the CommunityTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), as last amended by Council Directive 2002/89/EC(2), and in particular Article 14(c) thereof,Whereas:(1) From information supplied by Sweden based on updated surveys, certain areas in the county of Skåne should no longer be recognised as a protected zone in respect of Beet necrotic yellow vein virus as it appears that this harmful organism is established in these areas.(2) From information supplied by Italy based on updated surveys, certain areas in the region of Veneto should no longer be recognised as a protected zone in respect of Erwinia amylovora (Burr.) Winsl. et al. as it appears that this harmful organism is established in these areas.(3) The amendments are in accordance with the requests of Italy and Sweden.(4) The current provisions against Tilletia indica Mitra should be modified to take into account of the updated information on the presence of this harmful organism in South Africa.(5) The relevant Annexes to Directive 2000/29/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 Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1Annexes I, II, III, IV and V to Directive 2000/29/EC are amended in accordance with the Annex to this Directive.Article 21. Member States shall adopt and publish, by 31 March 2003 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 April 2003.When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made.2. Member States shall immediately communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof.Article 3This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 24 March 2003.For the CommissionDavid ByrneMember of the Commission(1) OJ L 169, 10.7.2000, p. 1.(2) OJ L 355, 30.12.2002, p. 45.ANNEXThe Annexes to Directive 2000/29/EC are amended as follows:1. in Part B of Annex I, under heading (b), in point 1, the entry in the right hand column is replaced by the following:"DK, F (Britanny), IRL, P (Azores), FIN, S (with the exception of the District Council areas of Bromölla, Hässleholm, Kristianstad and Östra Göinge in the county of Skåne), UK (Northern Ireland)";2. in Part B of Annex II, under heading (b), in point 2, the entry in the right hand column is replaced by the following:"E, F (Corsica), IRL, I (Abruzzi; Apulia; Basilicata; Calabria; Campania; Emilia-Romagna: provinces of Forlí-Cesena, Parma, Piacenza and Rimini; Friuli-Venezia Giulia; Lazio; Liguria; Lombardy; Marche; Molise; Piedmont; Sardinia; Sicily; Tuscany; Trentino-Alto Adige: autonomous provinces of Bolzano and Trento; Umbria; Valle d'Aosta; Veneto: except in the province of Rovigo the communes Rovigo, Polesella, Villamarzana, Fratta Polesine, San Bellino, Badia Polesine, Trecenta, Ceneselli, Pontecchio Polesine, Arquà Polesine, Costa di Rovigo, Occhiobello, Lendinara, Canda, Ficarolo, Guarda Veneta, Frassinelle Polesine, Villanova del Ghebbo, Fiesso Umbertiano, Castelguglielmo, Bagnolo di Po, Giacciano con Baruchella, Bosaro, Canaro, Lusia, Pincara, Stienta, Gaiba, Salara, and in the province of Padova the communes Castelbaldo, Barbona, Piacenza d'Adige, Vescovana, S. Urbano, Boara Pisani, Masi, and in the province of Verona the communes Palù, Roverchiara, Legnago, Castagnaro, Ronco all'Adige, Villa Bartolomea, Oppeano, Terrazzo, Isola Rizza, Angiari), and for A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria, Vienna), P, FIN, UK (Northern Ireland, Isle of Man and Channel Islands)";3. in Part B of Annex III, in point (1), the entry in the right hand column is replaced by the following:"E, F (Corsica), IRL, I (Abruzzi; Apulia; Basilicata; Calabria; Campania; Emilia-Romagna: provinces of Forlí-Cesena, Parma, Piacenza and Rimini; Friuli-Venezia Giulia; Lazio; Liguria; Lombardy; Marche; Molise; Piedmont; Sardinia; Sicily; Tuscany; Trentino-Alto Adige: autonomous provinces of Bolzano and Trento; Umbria; Valle d'Aosta; Veneto: except in the province of Rovigo the communes Rovigo, Polesella, Villamarzana, Fratta Polesine, San Bellino, Badia Polesine, Trecenta, Ceneselli, Pontecchio Polesine, Arquà Polesine, Costa di Rovigo, Occhiobello, Lendinara, Canda, Ficarolo, Guarda Veneta, Frassinelle Polesine, Villanova del Ghebbo, Fiesso Umbertiano, Castelguglielmo, Bagnolo di Po, Giacciano con Baruchella, Bosaro, Canaro, Lusia, Pincara, Stienta, Gaiba, Salara, and in the province of Padova the communes Castelbaldo, Barbona, Piacenza d'Adige, Vescovana, S. Urbano, Boara Pisani, Masi, and in the province of Verona the communes Palù, Roverchiara, Legnago, Castagnaro, Ronco all'Adige, Villa Bartolomea, Oppeano, Terrazzo, Isola Rizza, Angiari), and for A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria, Vienna), P, FIN, UK (Northern Ireland, Isle of Man and Channel Islands)";4. In Part B of Annex IV, in points 20.1, 20.2, 22, 23, 25, 26, 27.1, 27.2 and 30, the entry in the right hand column is replaced by the following:"DK, F (Britanny), IRL, P (Azores), FIN, S (with the exception of the District Council areas of Bromölla, Hässleholm, Kristianstad and Östra Göinge in the county of Skåne), UK (Northern Ireland)";5. in Part B of Annex IV, in point 21:(a) the text in the middle column under point (a) is replaced by the following:"(a) the plants originate in the protected zones E, F (Corsica), IRL, I (Abruzzi; Apulia; Basilicata; Calabria; Campania; Emilia-Romagna: provinces of Forlí-Cesena, Parma, Piacenza and Rimini; Friuli-Venezia Giulia; Lazio; Liguria; Lombardy; Marche; Molise; Piedmont; Sardinia; Sicily; Tuscany; Trentino-Alto Adige: autonomous provinces of Bolzano and Trento; Umbria; Valle d'Aosta; Veneto: except in the province of Rovigo the communes Rovigo, Polesella, Villamarzana, Fratta Polesine, San Bellino, Badia Polesine, Trecenta, Ceneselli, Pontecchio Polesine, Arquà Polesine, Costa di Rovigo, Occhiobello, Lendinara, Canda, Ficarolo, Guarda Veneta, Frassinelle Polesine, Villanova del Ghebbo, Fiesso Umbertiano, Castelguglielmo, Bagnolo di Po, Giacciano con Baruchella, Bosaro, Canaro, Lusia, Pincara, Stienta, Gaiba, Salara, and in the province of Padova the communes Castelbaldo, Barbona, Piacenza d'Adige, Vescovana, S. Urbano, Boara Pisani, Masi, and in the province of Verona the communes Palù, Roverchiara, Legnago, Castagnaro, Ronco all'Adige, Villa Bartolomea, Oppeano, Terrazzo, Isola Rizza, Angiari), and for A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria, Vienna), P, FIN, UK (Northern Ireland, Isle of Man and Channel Islands)";(b) the entry in the right hand column is replaced by the following:"E, F (Corsica), IRL, I (Abruzzi; Apulia; Basilicata; Calabria; Campania; Emilia-Romagna: provinces of Forlí-Cesena, Parma, Piacenza and Rimini; Friuli-Venezia Giulia; Lazio; Liguria; Lombardy; Marche; Molise; Piedmont; Sardinia; Sicily; Tuscany; Trentino-Alto Adige: autonomous provinces of Bolzano and Trento; Umbria; Valle d'Aosta; Veneto: except in the province of Rovigo the communes Rovigo, Polesella, Villamarzana, Fratta Polesine, San Bellino, Badia Polesine, Trecenta, Ceneselli, Pontecchio Polesine, Arquà Polesine, Costa di Rovigo, Occhiobello, Lendinara, Canda, Ficarolo, Guarda Veneta, Frassinelle Polesine, Villanova del Ghebbo, Fiesso Umbertiano, Castelguglielmo, Bagnolo di Po, Giacciano con Baruchella, Bosaro, Canaro, Lusia, Pincara, Stienta, Gaiba, Salara, and in the province of Padova the communes Castelbaldo, Barbona, Piacenza d'Adige, Vescovana, S. Urbano, Boara Pisani, Masi, and in the province of Verona the communes Palù, Roverchiara, Legnago, Castagnaro, Ronco all'Adige, Villa Bartolomea, Oppeano, Terrazzo, Isola Rizza, Angiari), and for A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria, Vienna), P, FIN, UK (Northern Ireland, Isle of Man and Channel Islands)";6. In Part B of Annex V, under heading I, in points 1 and 8, the text ", South Africa" is inserted after "Pakistan".


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31985L0406

Commission Directive 85/406/EEC of 11 July 1985 adapting to technical progress Council Directive 84/533/EEC on the approximation of the laws of the Member States relating to the permissible sound power level of compressors

Official Journal L 233 , 30/08/1985 P. 0011 - 0015 Spanish special edition: Chapter 15 Volume 6 P. 0073  Portuguese special edition Chapter 15 Volume 6 P. 0073  Finnish special edition: Chapter 15 Volume 7 P. 0050  Swedish special edition: Chapter 15 Volume 7 P. 0050

COMMISSION DIRECTIVEof 11 July  1985adapting to technical progress Council Directive 84/533/EEC on the approximation of the laws  of the Member States relating to the permissible sound power level of  compressors(85/406/EEC)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to  the Treaty establishing the European Economic Community,Having regard to Council Directive  84/533/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to  the permissible sound power level of compressors (1) and in particular Article 7 thereof,Whereas,  in view of experience gained and of the state of the art, it is now necessary to match the  requirements of Annex I and Annex II of Directive 84/533/EEC to the actual test conditions;Whereas  the measures provided for in this Directive are in accordance with the opinion of the Committee on  the Adaptation to Technical Progress of the Directive on the Determination of the Noise Emission of  Construction Plant and Equipment, HAS ADOPTED THIS DIRECTIVE:Article 1Annex I and Annex II to Directive  84/533/EEC are hereby amended in accordance with the Annex to this Directive.Article 2The Member  States shall, by 26 March 1986, adopt and publish the provisions required to comply with this  Directive and shall forthwith inform the Commission thereof.Article 3This Directive is addressed  to the Member States.Done at Brussels, 11 July 1985.For the CommissionStanley  CLINTON DAVISMember of the Commission(1) OJ N° L 300, 19. 11. 1984, p. 123.  ANNEXAMENDMENTS TO ANNEX I TO DIRECTIVE 84/533/EEC6.2.Operation of the sound source  during measurementThe last paragraph of point 6.2.2 shall be reworded as follows:In these operating  conditions, the air flow shall be checked as laid down in point 12 of Annex I.6.3.Measuring siteThe  measuring site must be flat and horizontal. This site, up to and including the vertical projection  of the microphone positions, shall be of concrete or non-porous asphalt. Skid-mounted compressors  shall be placed on supports 0,40 m high unless otherwise required by the manufacturer's conditions  of installation.6.4.1.Measuring surface, measuring distancePoint 6.4.1 shall be reworded as  follows:The measuring surface to be used for the test shall be a hemisphere.The radius shall be:4  m, where the greatest dimension of the compressor to be tested is not more than 1,5 m,10 m, where  the greatest dimension of the compressor to be tested is more than 1,5 m but not morethan 4 m,16  m, where the greatest dimension of the compressor to be tested is more than 4  m.6.4.2.1.GeneralPoint 6.4.2.1 shall be reworded as follows:For measurements there shall be six  measuring points, i.e. point 2, 4, 6, 8, 10 and 12, arranged as defined in section 6.4.2.2 of Annex  I to Directive 79/113/EEC.For testing the compressor, the geometric centre of the compressor shall  be positioned vertically above the centre of the hemisphere.The x axis of the set of coordinates,  in relation to which the positions of the measuring points are fixed, shall be parallel to the main  axis of the compressor.A new point 12 shall be added, worded as follows:12.A METHOD FOR MEASURING  THE AIR VOLUME FLOW RATE OF AIR COMPRESSORS BY MEANS OF CIRCULAR ARC VENTURI NOZZLES UNDER CRITICAL  FLOW CONDITIONS12.1.GeneralThe purpose of this Annex is to provide a simple, quick and economical  method for measuring the flow rate of air compressors.This method has an accuracy of ± 2,5  %.12.2.Test arrangementThe nozzle diameter is to be chosen so as to ensure that the pressure ratio  across the nozzle produces sonic velocity in the throat.The nozzle is to be inserted in a pipe with  a diameter equal to or greater than four times the nozzle throat diameter. Upstream of the nozzle  shall be a length of pipe equal to at least two pipe diameters, in the wall of which are fitted  means for measuring the pressure and temperature of the air flowing through the pipe. At the  upstream end of this pipe, a flow straightener shall be fitted consisting of two perforated plates  mounted one pipe diameter apart. See Figures 1 and 2.Downstream of the nozzle a pipe and silencer  can be fitted provided the pressure drop across this downstream piping does not invalidate the  critical flow conditions across the nozzle. >START OF GRAPHIC>>END OF GRAPHIC>>START OF GRAPHIC>>END OF GRAPHIC>12.3.Circular arc  venturiThe design shall be as shown in Figure 3, the internal surfaces shall be polished and the  throat diameter measured accurately. Suggested dimensions are given in Table 1.12.4.Pressure and  temperature readingsThe pressure shall be read with an accuracy of 0,5 % and the temperature with  an accuracy of ± 1K. >START OF GRAPHIC>>END OF GRAPHIC>>TABLE>12.5.The testWhen steady flow conditions have  been reached the following readings shall be taken:barometric pressure (Pb)nozzle upstream  pressure (PN)nozzle upstream temperature (tn)temperature and pressure at which volume flow rate  is required (to, Po)12.6.Volume rate of flow calculationsqm= 0,1  7 ð  7 B2  7 CD  7 C*  7 PN/[4   7 (R  7 TN)¹/2]Where qmis the mass flow rate in kg/sBis the nozzle diameter in mmCDis the  discharge coefficientC*is the critical flow factorPNis the absolute pressure upstream of the  nozzle in barTNis the absolute temperature upstream of the nozzle in KRis the gas constant in  J/(kg 7K) (for air R = 287,1)C*= 0,684858 + (3,70575   4,76902  7 10-2  7 tN + 2,63019  7 10-4  7  tN2)  7 pN  7 10-4WheretN= temperature upstream of the nozzle in °C. On the basis of test results  and for the accuracy stipulated, CD = 0,9888.When used at the discharge of portable or packaged air  compressors, tn will vary from 20 °C to 70 °C and PN from 2 to 8 bar. C* will therefore vary from  0,6871 to 0,6852 and an average value of 0,6862 can be used. Under these conditions the equation  can be simplified to:qm= 0,1  7 ð  7 B2  7 0,9888  7 0,6862  7 PN/[4  7 (287,1  7 TN)¹/2]= 3,143   7 10-3  7 B2  7 PN/TN ¹/2 kg/sor converted to volume flow rate (qv) under the reference  conditions:qv= 9  7 10-3  7 B2  7 PN  7 To/(Po  7 TN ¹/2)  l/swherePo= is the absolute reference  pressure in barTo= is the absolute reference temperature in K. AMENDMENTS TO ANNEX II TO DIRECTIVE 84/533/EEC3.Operating conditions3.1.4.Motor powerThe text in  brackets 'DIN 6270B' shall be replaced by 'Council Directive 80/1269/EEC'.3.2.4.Nominal air flowThe  words 'ISO 1217' shall be replaced by 'Point 12 of Annex I'.


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31973L0405

Council Directive 73/405/EEC of 22 November 1973 on the approximation of the laws of the Member States relating to methods of testing the biodegradability of anionic surfactants

Official Journal L 347 , 17/12/1973 P. 0053 - 0063 Finnish special edition: Chapter 15 Volume 1 P. 0164  Greek special edition: Chapter 15 Volume 1 P. 0015  Swedish special edition: Chapter 15 Volume 1 P. 0164  Spanish special edition: Chapter 13 Volume 3 P. 0108  Portuguese special edition Chapter 13 Volume 3 P. 0108

COUNCIL DIRECTIVE  of 22 November 1973  on the approximation of the laws of the Member States relating to methods of testing the biodegradability of anionic surfactants  (73/405/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;  Having regard to the Council Directive of 22 November 1973 (1) on the approximation of the laws of the Member States relating to detergents, and in particular Article 4 thereof;  Having regard to the proposal of the Commission;  Having regard to the Opinion of the European Parliament (2);  Having regard to the Opinion of the Economic and Social Committee (3);  Whereas, to enable Member States to determine the level of biodegradability of the anionic surfactant, it is advisable to employ methods of testing already in use for this purpose in certain Member States ; whereas, however, biodegradbility must be tested by a common method in the event of a dispute;  Whereas as concerns the approximation of the laws of the Member States relating to detergents, suitable tolerances for measuring biodegradability should be determined as provided for likewise in Article 4 of Council Directive of 22 November 1973, in order to take account of the unreliability of testing methods which could lead to rejection decisions having important economic consequences and whereas a rejection decision must only be taken therefore if an analysis shows a level of biodegradability less than 80 %,  HAS ADOPTED THIS DIRECTIVE:    Article 1 This Directive concerns the methods of testing the biodegradability of anionic surfactants.   Article 2 In accordance with the provisions of Article 4 of Council Directive of 22 November 1973, due account being taken of the unreliability of testing methods, the Member States shall prohibit the placing on the market and use on their territiory of a detergent if the level of biodegradability of this detergent is less than 80 %, determined on a single analysis in accordance with one of the following methods:    - the method in use in France, approved by decree of 11 December 1970, published in the "Journal Officiel de la République française" No 3 of 5 January 1971, and by experimental standard T 73-260 February 1971, published by the "Association française de normalisation" (AFNGR);       - the method in use in the Federal Republic of Germany, approved by the "Verordnung über die Abbaubarkeit von Detergentien in Wasch- und Reinigungsmitteln" of 1 December 1962, published in the Bundesgesetzblatt, Part I, page 698;       - the OECD method, published in the OECD's technical report of 29 December 1970 on "Determination of the Biodegradability of anionic synthetic surface active agents".          Article 3 Under the procedure laid down in Article 5 (2) of the Council Directive of 22 November 1973, the laboratory opinion on anionic surfactants shall be based  (1)See page 51 of this Official Journal. (2)OJ No C 10, 5.2.1972, p. 29. (3)OJ No C 89, 23.8.1972, p. 13.   on the "Confirmatory test procedure" in the OECD method, described in the Annex to this Directive.   Article 4 1. Member States shall put into force the legal, statutory and administrative measures necessary to comply with this Directive within eighteen months of its notification and shall forthwith inform the Commission thereof.  2. Member States shall ensure that the Commission be informed of the text of the main provisions of national law they adopt in the field covered by this Directive.   Article 5 This Directive is addressed to the Member States.     Done at Brussels 22 November 1973.  For the Council  The President  J. KAMPMANN     ANNEX DETERMINATION OF THE BIODEGRADABILITY OF ANIONIC SURFACTANTS  REFERENCE METHOD  CHAPTER I    1.1. Equipment needed for measurement  The method of measurement employs the small activiated sludge plant shown in figure 1 and in greater detail in figure 2.  The equipment consists of a storage vessel A for synthetic sewage, dosing pump B, aeration vessel C, settling vessel D, air-lift pump E to recycle the activated sludge, and vessel F for collecting the treated effluent.  Vessels A and F must be of glass or suitable transparent plastic and hold at least 24 litres. Pump B must provide a constant flow of synthetic sewage to the aeration vessel ; this vessel during normal operation contains 3 litres of mixed liquor. A sintered aeration cube G is suspended in the vessel C at the apex of the cone. The quantity of air blown through the aerator must be measured by means of a flow meter.       1.2. Synthetic sewage  For the test a synthetic sewage is employed by preparing 24 litres (daily) of a solution containing in each litre of tapwater, the following substances:  160 mg peptone,  110 mg meat extract,  30 mg urea,  7 mg sodium chloride,  4 mg calcium chloride, 2 H2O,  2 mg magnesium sulphate, 7 H2O, and  20 ± 2 mg methylene-blue-active substance (MBAS).  The MBAS is extracted from the product to be tested by the method given in Chapter 2 (2.1.2). The synthetic sewage is freshly prepared daily.       1.3. Preparation of samples      1.3.1. Basic products containing only MBAS may be examined in the original state. The MBAS content must be determined in order to prepare the test solutions (M).           1.3.2. Formulated products are analysed for MBAS and soap content. They must be subjected to an alcoholic extraction in accordance with the following conditions:        1.3.2.1. Isopropanol extraction, if the sample contains less soap than MBAS (see Chapter 2).            1.3.2.2. Isopropanol extraction and removal of the soap, if the sample contains more soap than MBAS (see Chapter 2).   The MBAS content of both extracts must be known in order to prepare the test solutions (M).                   1.4. Operation of equipment  Initially, fill aeration vessel C and settling vessel D with synthetic sewage. The height of vessel D should be so fixed that the volume contained in aeration vessel C is 3 litres. Then set the aerator, air lift E and dosing device B in operation. The synthetic sewage must pass through aeration vessel C at the rate of one litre per hour ; this gives a mean retention time of 3 hours.  The rate of aeration should be regulated so that the contents of vessel C are kept constantly in suspension while the dissolved oxygen content is at least 2 mg/litre. Foaming must be prevented by appropriate means. Antifoaming agents which inhibit the activated sludge or contain MBAS must not be used. Air-lift pump E must be set so that the activated sludge from the settling vessel is continually and regularly recycled to aeration vessel C. Sludge which has accumulated around the top of the aeration vessel C, in the base of the settling vessel D, or in the circulation circuit must be returned to the circulation at least once each day by brushing or some other appropriate means. When sludge fails to settle, its density may be increased by addition of 2 ml portions of a 5 % solution of ferric chloride, repeated as necessary.  The effluent from settling vessel D is accumulated in vessel F for 24 hours, following which a sample is taken after thorough mixing.  Vessel F must be carefully cleaned.       1.5. Checking measuring equipment  The MBAS content (in mg/litre) of the synthetic sewage is determined immediately before use.  The MBAS content (in mg/litre) of the effluent collected over 24 hours in vessel F should be determined analytically by the same method, as soon as possible after collection. The concentration must be determined to the nearest 0 71 mg MBAS/1.  As a check on the efficiency of the process the COD of the filtered synthetic sewage in vessel A is measured at least twice weekly, as well as that of the filtrate of the effluent accumulated in vessel F. The reduction in COD is expressed as a percentage.  The reduction in COD should level off when a roughly regular daily MBAS degradation is obtained, i.e. at the end of the running-in period shown in Figure 3.  The loss on ignition of the dry matter in the activated sludge in the aeration tank should be determined twice a week (in g/litre). If it is more than 2 75 g/l, the excess activated sludge must be discarded.  The test is performed at room temperature ; this should be steady and should never fall below 18º C, nor exceed 30º C.       1.6. Calculation of biodegradability  The percentage degradation of MBAS must be calculated every day on the basis of the MBAS content in mg/litre of the synthetic sewage and the corresponding effluent accumulated in vessel F.  The degradability figures thus obtained should be presented graphically as in Figure 3 (Note 1.7.2).  Degradability of the MBAS should be calculated as the arithmetical mean of the figures obtained over the 21 days which follow the running-in period, during which degradation has been regular and operation of the plant trouble-free. In any case the duration of the acclimatisation period should not exceed six weeks.       1.7. Notes     1.7.1. Some legislation takes account of the soap content when determining the biodegradability.       1.7.2. In some cases it may be permissible to reduce the frequency of sampling to, say, 1 sample every two to three days, but at least 14 results collected over the 21 days mentioned in paragraph 1.6 should be used in calculating the average.          CHAPTER 2 PRELIMINARY TREATMENT OF PRODUCTS TO BE TESTED      2.1. Alcoholic extract  The purpose of the extraction is to eliminate the insoluble and inorganic ingredients of the commercial product, which in some circumstances might upset the degradation test.  Quantitative elimination of these ingredients is not necessary, neither is quantitative extraction of the active ingredients. However, at least 90 % of the methylene-blue-active ingredients of the product to be tested should be concentrated in the extract.  Two methods are suitable for making alcoholic extracts, one using ethanol and one using isopropanol. The isopropanol method is particularly appropriate when large amounts of material are involved, as required for the confirmatory test.        2.1.1. Ethanol extract          2.1.1.1. Preparation of the sample            (i) Powders  Prepare a sample of approximately 250 g, either by quartering or according to ISO Recommendation No 607.  Pulverise this sample in a household rotor-type grinder until the resulting powder contains no particles over 200 microns.  Mix the powder thoroughly and transfer it to a suitable container.   (ii) Liquids   Weigh out, to within 0 71 g, about 40 g of the homogenized substance and place in the round-bottomed flask described at 2.1.1.2 (iii) below.  Add 50 ml of ethanol (2.1.1.2) (ii) and evaporate to dryness over a water-bath, drawing off volatile products by suction, until two consecutive weighings differ by not more than 0 71 g. Any suitable balance weighing to within 0 701 g may be used.                    2.1.1.2. Preparation of the solution in ethanol            (i) Principle:  Ethanol extraction of enough of the substance to determine the content of soap or other anionics, and for biological assay.                       (ii) Reagent:  95 % to 96 % ethanol.                       (iii) Apparatus:  Usual laboratory equipment, including specifically:  1 l round-bottomed, short-necked flask, with 29-32 female ground joint;  400 mm vertical condenser, with 29-32 male ground joint;  10-20 microns sintered glass filter, 1 litre graduated flask.                                          2.1.1.3. Procedure   Put a known weight E (i.e. 40 g ± 1 g) of the substance (2.1.1.1 (i)) into the 1-litre flask, or use the flask containing the dried extract prepared as in 2.1.1.1 (ii).  Add 500 ml of ethanol (2.1.1.2 (ii)) connect up the condenser and reflux for 15 minutes. Then decant the liquid layer and filter hot through sintered glass with suction. Repeat the operation twice on the residue in the flask, using 200 ml ethanol each time. Collect the extracts and filter washings quantitatively in the graduated flask, make up to 1 litre with ethanol and mix thoroughly.                              2.1.2. Isopropanol extract   The amount needed to give an MBAS content of about 50 g in the extract is calculated from the MBAS content of the commercial product. This amount is enough for two confirmatory tests.        2.1.2.1. Apparatus  According to the scale of the operation:  Vessels : Capacity 3-25 l, e.g. a long-necked flask or enamelled vessel.  Agitators : A fast-rotating, stirrer of the basket or ball type.  Suction filters (Büchner). Of up to 30 cm diameter.  Vacuum flasks : Up to 20-litre capacity.  Separating funnels : Up to 20-litre capacity.  Distillation flasks : Up to 10-litre capacity.  Receivers : Up to 10-litre capacity.  Porcelain dishes : Of about 20-cm diameter.  Distillation columns, condensers, water-baths.               2.1.2.2. Reagents  Distilled or demineralised water.  Isopropanol, pure.  Potassium carbonate (K2C03), chemically pure.  Caustic potash (KOH), 10 per cent solution.  Sodium sulphite (Na2SO3), pure, anhydrous.               2.1.2.3. Procedure          (i) Preliminary treatment  Solid commercial products : mix with distilled water (2.1.2.4 (i)) to a thin paste, in order to break down any particulate structure present (stir for 10 minutes). For each 100 g of water used, add 60 g of potassium carbonate and continue stirring (10 minutes) until dissolved.  Liquid or semi-liquid commercial products : treat in essentially the same way as solid ones. The liquid fraction lost on drying on a water-bath, as determined by a preliminary test on about 10 g of the substance, should be taken as the water content, even when there are volatile organic solvents still present. The quantity of potassium carbonate added will depend on the water content determined as above.  Acidic suspensions or solutions : neutralize with the 10 % caustic potash solution before adding the potassium carbonate.  Commercial products containing available chlorine : reduce by adding sodium sulphite to the aqueous suspension or solution before neutralization. An excess of sodium sulphite is not detrimental.                   (ii) Extraction   Add Isopropanol, stir the mixture for 30 minutes and filter by suction. Repeatedly wash the residue remaining on the suction filter with small quantities of isopropanol. The filtrate, which must in all cases separate out into two layers in the vacuum flask, must be rinsed out with isopropanol into a separating funnel. Draw off the lower aqueous layer and reject it ; filter the upper isopropanol layer through a fluted filter into a distillation flask and then distil it off over a water-bath as completely as possible (2.1.2.4 (iii)). Transfer quantitively the distillation residue into a porcelain dish by washing with isopropanol and then concentrate the contents over a water-bath with frequent stirring. Continue the concentration process until two successive weighings taken at an interval of one hour differ by less than 10 g. Dissolve the extract in water over the water-bath and determine the MBAS content of this solution.  Then: >PIC FILE= "T0004954">                            2.1.2.4. Remarks   The following should be borne in mind in carrying out the extraction:         (i) The diversity of commercial preparations is such that it is not possible to specify the optimum relative proportions of water and isopropanol to be used in testing a given product, as this will vary from case to case. However, experience has shown that the quantities needed are within the following proportions: >PIC FILE= "T0004955">   In principle, however, there are no upper limits for water and isopropanol.  The more the substance tends to aggregate in the suspension, the more water is needed ; water should be added until no sediment remains on the bottom during stirring.  The volume of isopropanol used should in practice not be less than the following:  Commercial product : Isopropanol = 1 : 1  A greater volume of isopropanol is needed when the MBAS content of the commercial product greatly exceeds 10 % or if on stirring there is a rapid separation of the isopropanol and aqueous phases.               (ii) The aqueous phase should be saturated with potassium carbonate ; a small excess is not detrimental. If the potassium carborate concentration is too small, then either the layers do not separate out or the isopropanol phase remains too aqueous, both of which adversely affect the extraction process.               (iii) The isopropanol distillate contains water and should be saturated with potassium carbonate ; the lower layer which then separates out must be rejected. The isopropanol remaining can be used for a fresh extraction. The distillates obtained when testing liquid commercial products should be rejected, however, since other solvents may be present.                                                 2.2. Separation of soap from isopropanol extract    MBAS biodegradability testing of a commercial product may be distorted even when using isopropanol (IPA) extract. The degradation curves of inherently readily degradable MBAS can then at times appear similar to those of poorly degradable TBS. Before testing MBAS degradability it is then necessary to separate the distorting soap from the alcohol extract.  This specification is designed to secure the preparatory removal of fairly large quantities of soap from the IPA extract. The extract obtained is used only for testing MBAS degradability and must not be used for further analytical determinations and separations.      2.2.1. Principle of soap separation  Sufficient IPA extract to yield at least 25 g MBAS is dissolved in methanol. The solution is acidified with hydrochloric acid to release the soap fatty acids. After the addition of water in the proportion of 80 : 20 methanol/water, the fatty acids are extracted with petroleum ether and the extract is rejected. The water-methanol phase is again made alkaline and evaporated to dryness.  The dry residue is used directly for the degradation test after its MBAS content has been determined.           2.2.2. Procedure   In a 2-litre Erlenmeyer flask dissolve a quantity of IPA extract containing at least 30 g MBAS in about 100 ml methanol while heating gently. After adding a total of 800 ml methanol, add 5 to 10 drops bromophenol blue solution (0.04 %) and titrate to pH 3 (yellow colouring) with 2N hydrochloric acid. Taking account of the volume of hydrochloric acid added, make up with distilled water to a total of 1 litre. Bromophenol blue solution : 0.4 g bromophenol blue dissolved in 200 ml 96 % ethanol and make up to one litre with distilled water.   To extract the fatty acids, shake the solution once with 300 ml and twice with 200 ml n-hexane in a separating funnel of appropriate dimensions. If necessary, the extraction can be performed in several small separating funnels. If turbid intermediate layers appear, these are added to the lower phase in the first two extractions and to the upper phase in the last extraction. If the mean volume of solution is not sufficient for dissolving and extraction in the case of very high soap contents, corresponding multiples can be used.  Collect the n-hexane fractions and wash with 200 ml methanol-water (80 : 20). Turbid intermediate layers are retained in the n-hexane phase, which is rejected.  Collect the methanol-water fractions and titrate to pH 9 with 1N sodium hydroxide in the presence of phenol-phthalein. Concentrate the solution in the water-bath until the methanol has evaporated and redisolve the extract in water in the waterbath. The MBAS content of this solution is then determined by means of the method described above.                    >PIC FILE= "T0004956">    >PIC FILE= "T0004957">    >PIC FILE= "T0004958">


Avis juridique important

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31978L0743

Twenty-Fourth Commission Directive 78/743/EEC of 28 July 1978 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs

Official Journal L 247 , 09/09/1978 P. 0025 - 0027 Greek special edition: Chapter 03 Volume 22 P. 0205

****( 1 ) OJ NO L 270 , 14 . 12 . 1970 , P . 1 .  ( 2 ) OJ NO L 198 , 22 . 7 . 1978 , P . 10 .        TWENTY-FOURTH COMMISSION DIRECTIVE   OF 28 JULY 1978   AMENDING THE ANNEXES TO COUNCIL DIRECTIVE 70/524/EEC CONCERNING ADDITIVES IN FEEDINGSTUFFS  ( 78/743/EEC )   THE COMMISSION OF THE EUROPEAN   COMMUNITIES ,   HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY ,   HAVING REGARD TO COUNCIL DIRECTIVE 70/524/EEC OF 23 NOVEMBER 1970 CONCERNING ADDITIVES IN FEEDINGSTUFFS ( 1 ), AS LAST AMENDED BY TWENTY-THIRD COMMISSION DIRECTIVE 78/613/EEC  ( 2 ), AND IN PARTICULAR ARTICLE 6 THEREOF ,   WHEREAS DIRECTIVE 70/524/EEC PROVIDES FOR THE CONTENT OF THE ANNEXES TO BE SUBJECT TO CONSTANT REVISION IN THE LIGHT OF THE DEVELOPMENT OF SCIENTIFIC AND TECHNICAL KNOWLEDGE ;   WHEREAS IT IS NECESSARY TO CHANGE THE CONDITIONS OF USE OF BACITRACIN-ZINC SHOWN IN ANNEX I ; WHEREAS CERTAIN USES OF THIS ADDITIVE WHICH HAVE BEEN WIDELY TESTED AT NATIONAL LEVEL SHOULD BE AUTHORIZED AT COMMUNITY LEVEL ;   WHEREAS IT CANNOT BE COMPLETELY RULED OUT THAT OLEANDOMYCIN MAY GIVE RISE , IN CERTAIN CIRCUMSTANCES , TO UNDESIRABLE SECONDARY EFFECTS ; WHEREAS IT SHOULD THEREFORE BE PROHIBITED FOR ANIMAL NUTRITION AFTER A CERTAIN PERIOD ;   WHEREAS THE AMMONIUM SALTS OF FORMIC ACID AND OF PROPIONIC ACID HAVE ANALOGOUS PRESERVATIVE EFFECTS TO THOSE OF THE OTHER SALTS OF THESE ACIDS ALREADY AUTHORIZED AT COMMUNITY LEVEL ; WHEREAS THEIR USE MAY THEREFORE BE AUTHORIZED AT NATIONAL LEVEL ;   WHEREAS THE MEASURES PROVIDED FOR IN THIS DIRECTIVE ARE IN ACCORDANCE WITH THE OPINION OF THE STANDING COMMITTEE FOR FEEDINGSTUFFS ,   HAS ADOPTED THIS DIRECTIVE :   ARTICLE 1   THE ANNEXES TO DIRECTIVE 70/524/EEC ARE HEREBY AMENDED AS FOLLOWS :   1 . IN ANNEX I :  ( A ) IN PART A ' ANTIBIOTICS ' :  ( AA ) POSITION NO E 700 ' BACITRACIN ZINC '  IS AMENDED AS FOLLOWS : ****   //   //  //  //  //  //  //  MINIMUM CONTENT //  MAXIMUM CONTENT //   // EEC NO  //  ADDITIVES  //  CHEMICAL NAME ; DESCRIPTION  //  ANIMAL SPECIES  //  MAXIMUM AGE  //  PPM OF COMPLETE FEEDINGSTUFF //  OTHER PROVISIONS   // E 700 //  BACITRACIN ZINC //  C66H103O16 //  TURKEYS //  FOUR WEEKS //  5 // 50 //  //  //  //  //  FIVE TO 26 WEEKS //  5 //  20 //  //  //  N17S ZN  ( POLYPEPTIDE CONTAINING 12 TO 20 % ZINE ) //  OTHER POULTRY , EXCLUDING DUCKS , GEESE , LAYING HENS , PIGEONS //  FOUR WEEKS FIFTH WEEK TO 16 WEEKS //  5 5 //  50 20 //  //  //  //  CALVES , LAMBS , KIDS //  16 WEEKS 17TH WEEK TO SIX MONTHS //  5 5  //  50 20 //  //  //  //  //   -  //  5 //  80 //  MILK FEEDS ONLY //  //  //  //  PIGLETS //  FOUR MONTHS //  5 //  50 //  //  //  //  //   -  //  5 //  80 //  MILK FEEDS ONLY //  //  //  //  PIGS //  OVER FOUR MONTHS TO SIX MONTHS //  5 //  20 //  //  //  //  ANIMALS BRED FOR FUR //   -  //  5 //  20 //    ( BB ) POSITION NO E 704 ' OLEANDOMYCIN '  IS WITHDRAWN .   2 . IN ANNEX II :  ( A ) IN PART A ' ANTIBIOTICS ' :  ( AA ) IN POSITION NO 15 ' BACITRACIN ZINC ' , THE EXISTING PROVISIONS ARE WITHDRAWN APART FROM THOSE PRESCRIBED FOR LAYING HENS ;  ( BB ) POSITION NO 19 ' OLEANDOMYCIN '  IS AMENDED TO READ AS FOLLOWS :    //   //  //  //  //  //  //  MINIMUM CONTENT //  MAXIMUM CONTENT //   // EEC NO  //  ADDITIVES  //  CHEMICAL NAME ; DESCRIPTION  //  ANIMAL SPECIES  //  MAXIMUM AGE  //  PPM OF COMPLETE FEEDINGSTUFF //  OTHER PROVISIONS  //  PERIOD OF AUTHORIZATION   // 19 //  OLEAN- DOMYCIN //  C35H61O12N  //  TURKEYS //  26 WEEKS //  2 //  10 //  //  //  ( BASE ) ( MACROLIDE ) //  OTHER POULTRY , EXCEPT DUCKS , GEESE , LAYING HENS , PIGEONS //  16 WEEKS //  2 //  10 //  //  30 SEPTEMBER 1979 //  //  //  //  PIGS //  SIX MONTHS //  2 //  10 //  ( CC ) THE FOLLOWING POSITION IS ADDED :   //   //  //  //  //  //  //  MINIMUM CONTENT //  MAXIMUM CONTENT //   // EEC NO  //  ADDITIVES  //  CHEMICAL NAME ; DESCRIPTION  //  ANIMAL SPECIES  //  MAXIMUM AGE  //  PPM OF COMPLETE FEEDINGSTUFF //  OTHER PROVISIONS  //  PERIOD OF AUTHORIZATION   // 24 //  MOCIMYCIN //  C43H60N2O12 //  CHICKENS FOR  -  //  //  1 //   5 //  //  //  ( MIXTURE OF CETO-ENOL- AND ISOMOCIMYCIN ) //  PIGLETS PIGS //  FOUR MONTHS OVER FOUR MONTHS TO SIX MONTHS //  1 1 //  10   5 //  //  31 DECEMBER 1980 //   ( B ) IN PART B ' COCCIDIOSTATS AND OTHER MEDICINAL SUBSTANCES '  THE FOLLOWING POSITION IS ADDED :    //   //  //  //  //  //  //  MINIMUM CONTENT //  MAXIMUM CONTENT //   // EEC NO  //  ADDITIVES  //  CHEMICAL NAME ; DESCRIPTION  //  ANIMAL SPECIES  //  MAXIMUM AGE  //  PPM OF COMPLETE FEEDINGSTUFF //  OTHER PROVISIONS  //  PERIOD OF AUTHORIZATION   // 24 //  LASALOCIDE SODIUM //  C34H35O8NA //  CHICKENS FOR FATTENING //   -  //  75  //  125  //  USE PROHIBITED FROM AT LEAST FIVE DAYS BEFORE SLAUGHTER // 31 DECEMBER 1980 //   ( C ) IN PART D ' PRESERVATIVES '  THE FOLLOWING POSITIONS ARE ADDED :    //   //  //  //  //  //  //  MINIMUM CONTENT //  MAXIMUM CONTENT //   // EEC NO  //  ADDITIVES  //  CHEMICAL NAME ; DESCRIPTION  //  ANIMAL SPECIES  //  MAXIMUM AGE  //  PPM OF COMPLETE FEEDINGSTUFF //  OTHER PROVISIONS  //  PERIOD OF AUTHORIZATION   // 17 //  AMMONIUM FORMATE //  //  //  ALL ANIMAL SPECIES //   -  //   -  //  ALL FEEDINGSTUFFS //  31 DECEMBER // 18 //  AMMONIUM PROPIONATE //  //  //  //  //  1979 //   ARTICLE 2   MEMBER STATES SHALL BRING INTO FORCE THE LAWS , REGULATIONS OR ADMINISTRATIVE PROVISIONS NECESSARY TO COMPLY WITH ARTICLE 1 ( 1 ) NOT LATER THAN 31 DECEMBER 1978 . THEY SHALL IMMEDIATELY INFORM THE COMMISSION THEREOF .   ARTICLE 3   THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .   DONE AT BRUSSELS , 28 JULY 1978 .   FOR THE COMMISSION   FINN GUNDELACH   VICE-PRESIDENT


title: Commission Directive 2006/75/EC of 11 September 2006 amending Council Directive 91/414/EEC to include dimoxystrobin as active substance   (Text with EEA relevance)

text:
               12.9.2006

               EN

               Official Journal of the European Union

               L 248/3

      COMMISSION DIRECTIVE 2006/75/EC
   of 11 September 2006
   amending Council Directive 91/414/EEC to include dimoxystrobin as active substance
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   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)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 28 November 2001 an application from BASF for the inclusion of the active substance dimoxystrobin in Annex I to Directive 91/414/EEC. Commission Decision 2002/593/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (2)

               For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The designated rapporteur Member State submitted draft assessment report concerning the substance dimoxystrobin to the European Food Safety Authority (EFSA) on 14 August 2003.

               (3)

               The draft assessment report has been peer reviewed by the Member States and the EFSA within its Working Group Evaluation and presented to the Commission on 10 August 2005 in the format of the EFSA Scientific Report for dimoxystrobin (3). This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 4 April 2006 in the format of the Commission review report for dimoxystrobin.

               (4)

               It has appeared from the various examinations made that plant protection products containing the active substance concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include dimoxystrobin in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.

               (5)

               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 six months after inclusion to review existing provisional authorisations of plant protection products containing dimoxystrobin 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 transform existing provisional authorisations into full authorisations, amend them or withdraw them 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.

               (6)

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

               (7)

               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
   1.   Member States shall adopt and publish by 31 March 2007 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 April 2007.
   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.
   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
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing dimoxystrobin as active substance by 31 March 2007. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to dimoxystrobin are met, with the exception of those identified in part B of the entry concerning those active substances, 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.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing dimoxystrobin 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 30 September 2006 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 dimoxystrobin. 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 dimoxystrobin as the only active substance, where necessary, amend or withdraw the authorisation by 31 March 2008 at the latest; or

               (b)

               in the case of a product containing dimoxystrobin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 2008 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 4
   This Directive shall enter into force on 1 October 2006.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 11 September 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/74/EC (OJ L 235, 30.8.2006, p. 17).

      (2)  OJ L 192, 20.7.2002, p. 60.

      (3)  EFSA Scientific Report (2005) 46, 1-82: conclusion regarding the peer review of the pesticide risk assessment of the active substance dimoxystrobin (finalised: 10 August 2005).

      ANNEX
      In Annex I to Directive 91/414/EEC, the following rows are added at the end of the table:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘129

                     Dimoxystrobin
                     CAS No 149961-52-4
                     CIPAC No 739

                     (E)-o-(2,5-dimethylphenoxymethyl)-2-methoxyimino-N-methylphenylacetamide

                     ≥ 980 g/kg

                     1 October 2006

                     30 September 2016

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing dimoxystrobin for indoor uses, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on dimoxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.
                     In this overall assessment Member States

                                 —

                                 must pay particular attention to the protection of groundwater, when the active substance is applied in a situation with a low crop interception factor, or in regions with vulnerable soil and/or climate conditions;

                                 —

                                 must pay particular attention to the protection of aquatic organisms.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The concerned Member States shall request the submission of

                                 —

                                 a refined risk assessment for birds and mammals considering the formulated active substance;

                                 —

                                 a comprehensive aquatic risk assessment considering the high chronic risk to fish and the effectiveness of potential risk mitigation measures, particularly taking into account run-off and drainage.

                           They shall ensure that the notifiers at whose request dimoxystrobin has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.’

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