title: Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events   (Text with EEA relevance)

text:
               1.10.2005

               EN

               Official Journal of the European Union

               L 256/32

      COMMISSION DIRECTIVE 2005/61/EC
   of 30 September 2005
   implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (1), and in particular points (a) and (i) of the second paragraph of Article 29 thereof,
   Whereas:

               (1)

               Directive 2002/98/EC lays down standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and for their processing, storage and distribution when intended for transfusion so as to ensure a high level of human health protection.

               (2)

               In order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of quality and safety, Directive 2002/98/EC calls for the establishment of specific technical requirements dealing with traceability, a Community procedure for notifying serious adverse reactions and events and the notification format.

               (3)

               Notification of suspected serious adverse reactions or serious adverse events should be submitted to the competent authority as soon as known. This Directive therefore establishes the notification format defining the minimum data needed, without prejudice to the faculty of Member States to maintain or introduce in their territory more stringent protective measures which comply with the provisions of the Treaty as provided under Article 4(2) of Directive 2002/98/EC.

               (4)

               This Directive lays down those technical requirements, which take account of Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community (2), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3), Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (4), and certain recommendations of the Council of Europe.

               (5)

               Accordingly, blood and blood components imported from third countries, including those used as starting material or raw material for the manufacture of medicinal products derived from human blood and human plasma, intended for distribution in the Community, should meet equivalent Community standards and specifications relating to traceability and serious adverse reaction and serious adverse event notification requirements as set out in this Directive.

               (6)

               It is necessary to determine common definitions for technical terminology in order to ensure the consistent implementation of Directive 2002/98/EC.

               (7)

               The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2002/98/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Definitions
   For the purposes of this Directive, the following definitions shall apply:

               (a)

               ‘traceability’ means the ability to trace each individual unit of blood or blood component derived thereof from the donor to its final destination, whether this is a recipient, a manufacturer of medicinal products or disposal, and vice versa;

               (b)

               ‘reporting establishment’ means the blood establishment, the hospital blood bank or facilities where the transfusion takes place that reports serious adverse reactions and/or serious adverse events to the competent authority;

               (c)

               ‘recipient’ means someone who has been transfused with blood or blood components;

               (d)

               ‘issue’ means the provision of blood or blood components by a blood establishment or a hospital blood bank for transfusion to a recipient;

               (e)

               ‘imputability’ means the likelihood that a serious adverse reaction in a recipient can be attributed to the blood or blood component transfused or that a serious adverse reaction in a donor can be attributed to the donation process;

               (f)

               ‘facilities’ means hospitals, clinics, manufacturers, and bio-medical research institutions to which blood or blood components may be delivered.

         Article 2
   Traceability
   1.   Member States shall ensure the traceability of blood and blood components through accurate identification procedures, record maintenance and an appropriate labelling system.
   2.   Member States shall ensure that the traceability system in place in the blood establishment enables the tracing of blood components to their location and processing stage.
   3.   Member States shall ensure that every blood establishment has a system in place to uniquely identify each donor, each blood unit collected and each blood component prepared, whatever its intended purpose, and the facilities to which a given blood component has been delivered.
   4.   Member States shall ensure that all facilities have a system in place to record each blood unit or blood component received, whether or not locally processed, and the final destination of that received unit, whether transfused, discarded or returned to the distributing blood establishment.
   5.   Member States shall ensure that every blood establishment has a unique identifier that enables it to be precisely linked to each unit of blood that it has collected and to each blood component that it has prepared.
   Article 3
   Verification procedure for issuing blood or blood components
   Member States shall ensure that the blood establishment, when it issues units of blood or blood components for transfusion, or the hospital blood bank has in place a procedure to verify that each unit issued has been transfused to the intended recipient or if not transfused to verify its subsequent disposition.
   Article 4
   Record of data on traceability
   Member States shall ensure that blood establishments, hospital blood banks, or facilities retain the data set out in Annex I for at least 30 years in an appropriate and readable storage medium in order to ensure traceability.
   Article 5
   Notification of serious adverse reactions
   1.   Member States shall ensure that those facilities where transfusion occurs have procedures in place to retain the record of transfusions and to notify blood establishments without delay of any serious adverse reactions observed in recipients during or after transfusion which may be attributable to the quality or safety of blood and blood components.
   2.   Member States shall ensure that reporting establishments have procedures in place to communicate to the competent authority as soon as known all relevant information about suspected serious adverse reactions. The notification formats set out in Part A and Part C of Annex II shall be used.
   3.   Member States shall ensure that reporting establishments:

               (a)

               notify to the competent authority all relevant information about serious adverse reactions of imputability level 2 or 3, as referred to in Part B of Annex II, attributable to the quality and safety of blood and blood components;

               (b)

               notify the competent authority of any case of transmission of infectious agents by blood and blood components as soon as known;

               (c)

               describe the actions taken with respect to other implicated blood components that have been distributed for transfusion or for use as plasma for fractionation;

               (d)

               evaluate suspected serious adverse reactions according to the imputability levels set out in Part B of Annex II;

               (e)

               complete the serious adverse reaction notification, upon conclusion of the investigation, using the format set out in Part C of Annex II;

               (f)

               submit a complete report on serious adverse reactions to the competent authority on an annual basis using the format set out in Part D of Annex II.

         Article 6
   Notification of serious adverse events
   1.   Member States shall ensure that blood establishments and hospital blood banks have procedures in place to retain the record of any serious adverse events which may affect the quality or safety of blood and blood components.
   2.   Member States shall ensure that reporting establishments have procedures in place to communicate to the competent authority as soon as known, using the notification format set out in Part A of Annex III, all relevant information about serious adverse events which may put in danger donors or recipients other than those directly involved in the event concerned.
   3.   Member States shall ensure that reporting establishments:

               (a)

               evaluate serious adverse events to identify preventable causes within the process;

               (b)

               complete the serious adverse event notification, upon conclusion of the investigation, using the format set out in Part B of Annex III;

               (c)

               submit a complete report on serious adverse events to the competent authority on an annual basis using the format set out in Part C of Annex III.

         Article 7
   Requirements for imported blood and blood components
   1.   Member States shall ensure that for imports of blood and blood components from third countries blood establishments have a system of traceability in place equivalent to that provided for in Article 2(2) to (5).
   2.   Member States shall ensure that for imports of blood and blood components from third countries blood establishments have a system of notification in place equivalent to that provided for in Articles 5 and 6.
   Article 8
   Annual reports
   Member States shall submit to the Commission an annual report, by 30 June of the following year, on the notification of serious adverse reactions and events received by the competent authority using the formats in Part D of Annex II and Part C of Annex III.
   Article 9
   Communication of information between competent authorities
   Member States shall ensure that their competent authorities communicate to each other such information as is appropriate with regard to serious adverse reactions and events in order to guarantee that blood or blood components known or suspected to be defective are withdrawn from use and discarded.
   Article 10
   Transposition
   1.   Without prejudice to Article 7 of Directive 2002/98/EC, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 August 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 11
   Entry into force
   This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
   Article 12
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 30 September 2005.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 33, 8.2.2003, p. 30.

      (2)  OJ L 203, 21.7.1998, p. 14.

      (3)  OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34).

      (4)  OJ L 91, 30.3.2004, p. 25.

      ANNEX I
      Record of data on traceability as provided for in Article 4
      BY BLOOD ESTABLISHMENTS

                  1.

                  Blood establishment identification

                  2.

                  Blood donor identification

                  3.

                  Blood unit identification

                  4.

                  Individual blood component identification

                  5.

                  Date of collection (year/month/day)

                  6.

                  Facilities to which blood units or blood components are distributed, or subsequent disposition.

            BY FACILITIES

                  1.

                  Blood component supplier identification

                  2.

                  Issued blood component identification

                  3.

                  Transfused recipient identification

                  4.

                  For blood units not transfused, confirmation of subsequent disposition

                  5.

                  Date of transfusion or disposition (year/month/day)

                  6.

                  Lot number of the component, if relevant.

      ANNEX II
      NOTIFICATION OF SERIOUS ADVERSE REACTIONS
      PART A
      Rapid notification format for suspected serious adverse reactions

         Reporting establishment

         Report identification

         Reporting date (year/month/day)

         Date of transfusion (year/month/day)

         Age and sex of recipient

         Date of serious adverse reaction (year/month/day)

         Serious adverse reaction is related to

                  —

                     Whole blood

                  —

                     Red blood cells

                  —

                     Platelets

                  —

                     Plasma

                  —

                     Other (specify)

         Type of serious adverse reaction(s)

                  —

                     Immunological haemolysis due to ABO incompatibility

                  —

                     Immunological haemolysis due to other allo-antibody

                  —

                     Non-immunological haemolysis

                  —

                     Transfusion-transmitted bacterial infection

                  —

                     Anaphylaxis/hypersensitivity

                  —

                     Transfusion related acute lung injury

                  —

                     Transfusion-transmitted viral infection (HBV)

                  —

                     Transfusion-transmitted viral infection (HCV)

                  —

                     Transfusion-transmitted viral infection (HIV-1/2)

                  —

                     Transfusion-transmitted viral infection, Other (specify)

                  —

                     Transfusion-transmitted parasitical infection (Malaria)

                  —

                     Transfusion-transmitted parasitical infection, Other (specify)

                  —

                     Post-transfusion purpura

                  —

                     Graft versus host disease

                  —

                     Other serious reaction(s) (specify)

         Imputability level (NA, 0-3)

      PART B
      Serious adverse reactions — imputability levels
      Imputability levels to assess serious adverse reactions.

                  Imputability level

                  Explanation

                  NA

                  Not assessable

                  When there is insufficient data for imputability assessment.

                  0

                  Excluded

                  When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to alternative causes.

                  Unlikely

                  When the evidence is clearly in favour of attributing the adverse reaction to causes other than the blood or blood components.

                  1

                  Possible

                  When the evidence is indeterminate for attributing adverse reaction either to the blood or blood component or to alternative causes.

                  2

                  Likely, Probable

                  When the evidence is clearly in favour of attributing the adverse reaction to the blood or blood component.

                  3

                  Certain

                  When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to the blood or blood component.

            PART C
      Confirmation format for serious adverse reactions

         Reporting establishment

         Report identification

         Confirmation date (year/month/day)

         Date of serious adverse reaction (year/month/day)

         Confirmation of serious adverse reaction (Yes/No)

         Imputability level (NA, 0-3)

         Change of type of serious adverse reaction (Yes/No)

         If Yes, specify

         Clinical outcome (if known)

                  —

                     Complete recovery

                  —

                     Minor sequelae

                  —

                     Serious sequelae

                  —

                     Death

            PART D
      Annual notification format for serious adverse reactions

         Reporting establishment

         Reporting period

                  This Table refers to

                     [ ] Whole blood

                     [ ] Red blood cells

                     [ ] Platelets

                     [ ] Plasma

                     [ ] Other

                     (use separate table for each component)

                  Number of units issued (total number of units issued with a given number of blood components)

                  Number of recipients transfused (total number of recipients transfused with a given number of blood components) (if available)

                  Number of units transfused (the total number of blood components (units) transfused over the reporting period) (if available)

                  Total number reported

                  Number of serious adverse reactions with imputability level 0 to 3 after confirmation (see Annex IIA)

                  Number of deaths

                  not assessable

                  Level
                  0

                  Level
                  1

                  Level
                  2

                  Level
                  3

                  Immunological Haemolysis

                  Due to ABO incompatibility

                  Total

                  Deaths

                  Due to other allo-antibody

                  Total

                  Deaths

                  Non-immunological haemolysis

                  Total

                  Deaths

                  Transfusion-transmitted bacterial infection

                  Total

                  Deaths

                  Anaphylaxis/hypersensitivity

                  Total

                  Deaths

                  Transfusion related acute lung injury

                  Total

                  Deaths

                  Transfusion-transmitted viral Infection

                  HBV

                  Total

                  Deaths

                  HCV

                  Total

                  Deaths

                  HIV-1/2

                  Total

                  Deaths

                  Other (specify)

                  Total

                  Deaths

                  Transfusion-transmitted parasitical infection

                  Malaria

                  Total

                  Deaths

                  Other (specify)

                  Total

                  Deaths

                  Post-transfusion purpura

                  Total

                  Deaths

                  Graft versus host disease

                  Total

                  Deaths

                  Other serious reactions (specify)

                  Total

                  Deaths

      ANNEX III
      NOTIFICATION OF SERIOUS ADVERSE EVENTS
      PART A
      Rapid Notification Format for Serious Adverse Events

         Reporting establishment

         Report identification

         Reporting date (year/month/day)

         Date of serious adverse event (year/month/day)

                     Serious adverse event, which may affect quality and safety of blood component due to a deviation in:

                     Specification

                  Product defect

                  Equipment failure

                  Human error

                  Other

                     (specify)

                  Whole blood collection

                  Apheresis collection

                  Testing of donations

                  Processing

                  Storage

                  Distribution

                  Materials

                  Others (specify)

            PART B
      Confirmation Format for Serious Adverse Events

                     Reporting establishment

                     Report identification

                     Confirmation date
                     (year/month/day)

                     Date of serious adverse event
                     (year/month/day)

                     Root cause analysis (details)

                     Corrective measures taken (details)

            PART C
      Annual Notification Format for Serious Adverse Events

         Reporting establishment

                     Reporting period

                     1 January-31 December (year)

         Total number of blood and blood components processed:

                     Serious adverse event, affecting quality and safety of blood component due to a deviation in:

                     Total number

                     Specification

                  Product defect

                  Equipment failure

                  Human error

                  Other

                     (specify)

                  Whole blood collection

                  Apheresis collection

                  Testing of donations

                  Processing

                  Storage

                  Distribution

                  Materials

                  Others (specify)


Avis juridique important

|

31992L0011

Council Directive 92/11/EEC of 3 March 1992 amending Directive 89/396/EEC on indications or marks identifying the lot to which a foodstuff belongs

Official Journal L 065 , 11/03/1992 P. 0032 - 0032

COUNCIL DIRECTIVE 92/11/EEC  of 3 March 1992  amending Directive 89/396/EEC on indications or marks identifying the lot to which a foodstuff belongsTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas it is necessary to take account of the insurmountable technical problems which made it impossible to implement Directive 89/396/EEC (4), as amended by Directive 91/238/EEC (5), by 20 June 1991; whereas it is therefore necessary to postpone the  implementation date,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The second indent of the first subparagraph of Article 7 of Directive 89/396/EEC is hereby replaced by the following:  '- prohibit trade in products not complying with this Directive with effect from 1 July 1992. However, trade in products placed on the market or labelled before that date and not conforming with this Directive may continue until stocks run out.'  Article 2  This Directive is addressed to the Member States. Done at Brussels, 3 March 1992. For the Council  The President  Arlindo MARQUES CUNHA   (1) OJ No C 219, 22. 8. 1991, p. 11. (2) OJ No C 305, 25. 11. 1991, p. 54 and Decision of 12 February 1992 (not yet published in the Official Journal). (3) OJ No C 40, 17. 2. 1992, p. 12. (4) OJ No L 186, 30. 6. 1989, p. 21. (5) OJ No L 107,  27. 4. 1991, p. 50.


Avis juridique important

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32001L0115

Council Directive 2001/115/EC of 20 December 2001 amending Directive 77/388/EEC with a view to simplifying, modernising and harmonising the conditions laid down for invoicing in respect of value added tax

Official Journal L 015 , 17/01/2002 P. 0024 - 0028

Council Directive 2001/115/ECof 20 December 2001amending Directive 77/388/EEC with a view to simplifying, modernising and harmonising the conditions laid down for invoicing in respect of value added taxTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 93 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Parliament(2),Having regard to the opinion of the Economic and Social Committee(3),Whereas:(1) The current conditions laid down for invoicing and listed under Article 22(3), in the version given in Article 28h of the Sixth Council Directive 77/388/EEC of 17 May 1977 on the harmonisation of the laws of the Member States relating to turnover taxes - Common system of value added tax: uniform basis of assessment(4), are relatively few in number, thus leaving it to the Member States to define the most important such conditions. At the same time, the conditions are no longer appropriate given the development of new invoicing technologies and methods.(2) The Commission report on the second phase of the SLIM exercise (Simpler Legislation for the Single Market) recommended that a study be carried out to determine what details should be required for VAT purposes when drawing up an invoice and what the legal and technical requirements are as regards electronic invoicing.(3) The conclusions of the Ecofin Council of June 1998 underlined the fact that the development of electronic commerce has made it necessary to establish a legal framework for the use of electronic invoicing to enable tax administrations to continue to perform their controls.(4) It is therefore necessary, in order to ensure that the internal market functions properly, to draw up a list, harmonised at Community level, of the particulars that must appear on invoices for the purposes of value added tax and to establish a number of common arrangements governing the use of electronic invoicing and the electronic storage of invoices, as well as for self-billing and the outsourcing of invoicing operations.(5) Lastly, the storage of invoices should comply with the conditions laid down by Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data(5).(6) Since the introduction of the transitional VAT arrangements in 1993, Greece has adopted the prefix EL rather than the prefix GR laid down in the ISO International Standard No 3166 - alpha 2 referred to in Article 22(1)(d). Given the consequences of amending the prefix in all the Member States, it is important to lay down an exception for Greece providing that the ISO Standard does not apply in Greece.(7) Directive 77/388/EEC should therefore be amended accordingly,HAS ADOPTED THIS DIRECTIVE:Article 1Directive 77/388/EEC is hereby amended in accordance with the following Articles.Article 2At Article 28h (which replaces Article 22 of the same Directive), Article 22 shall be amended as follows:1. The following sentence shall be added to paragraph 1(d): "Nevertheless, the Hellenic Republic shall be authorised to use the prefix 'EL'."2. Paragraph 3 shall be replaced by the following: "3. (a) Every taxable person shall ensure that an invoice is issued, either by himself or by his customer or, in his name and on his behalf, by a third party, in respect of goods or services which he has supplied or rendered to another taxable person or to a non-taxable legal person. Every taxable person shall also ensure that an invoice is issued, either by himself or by his customer or, in his name and on his behalf, by a third party, in respect of the supplies of goods referred to in Article 28b(B)(1) and in respect of goods supplied under the conditions laid down in Article 28c(A).Every taxable person shall likewise ensure that an invoice is issued, either by himself or by his customer or, in his name and on his behalf, by a third party, in respect of any payment on account made to him before any supplies of goods referred to in the first subparagraph and in respect of any payment on account made to him by another taxable person or non-taxable legal person before the provision of services is completed.Member States may impose on taxable persons an obligation to issue an invoice in respect of goods or services other than those referred to in the preceding subparagraphs which they have supplied or rendered on their territory. When they do so, Member States may impose fewer obligations in respect of these invoices than those listed under points (b), (c) and (d).The Member States may release taxable persons from the obligation to issue an invoice in respect of goods or services which they have supplied or rendered in their territory and which are exempt, with or without refund of the tax paid at the preceding stage, pursuant to Article 13, Article 28(2)(a) and Article 28(3)(b).Any document or message that amends and refers specifically and unambiguously to the initial invoice is to be treated as an invoice. Member States in whose territory goods or services are supplied or rendered may allow some of the obligatory details to be left out of such documents or messages.Member States may impose time limits for the issue of invoices on taxable persons supplying goods and services in their territory.Under conditions to be laid down by the Member States in whose territory goods or services are supplied or rendered, a summary invoice may be drawn up for several separate supplies of goods or services.Invoices may be drawn up by the customer of a taxable person in respect of goods or services supplied or rendered to him by that taxable person, on condition that there is at the outset an agreement between the two parties, and on condition that a procedure exists for the acceptance of each invoice by the taxable person supplying the goods or services. The Member States in whose territory the goods or services are supplied or rendered shall determine the terms and conditions of the agreement and of the acceptance procedures between the taxable person and his customer.Member States may impose further conditions on the issue of invoices by the customers of taxable persons supplying goods or services on their territory. For example, they may require that such invoices be issued in the name and on behalf of the taxable person. Such conditions must always be the same wherever the customer is established.Member States may also lay down specific conditions for taxable persons supplying goods or services in their territory in cases where the third party, or the customer, who issues invoices is established in a country with which no legal instrument exists relating to mutual assistance similar in scope to that laid down by Council Directive 76/308/EEC of 15 March 1976 on mutual assistance for the recovery of claims relating to certain levies, duties, taxes and other measures(6), Council Directive 77/799/EEC of 19 December 1977 concerning mutual assistance by the competent authorities of the Member States in the field of direct and indirect taxation(7) and by Council Regulation (EEC) No 218/92 of 27 January 1992 on administrative cooperation in the field of indirect taxation (VAT)(8).(b) Without prejudice to the specific arrangements laid down by this Directive, only the following details are required for VAT purposes on invoices issued under the first, second and third subparagraphs of point (a):- the date of issue;- a sequential number, based on one or more series, which uniquely identifies the invoice,- the VAT identification number referred to in paragraph 1(c) under which the taxable person supplied the goods or services;- where the customer is liable to pay tax on goods supplied or services rendered or has been supplied with goods as referred to in Article 28c(A), the VAT identification number as referred to in paragraph 1(c) under which the goods were supplied or the services rendered to him;- the full name and address of the taxable person and of his customer;- the quantity and nature of the goods supplied or the extent and nature of the services rendered;- the date on which the supply of goods or of services was made or completed or the date on which the payment on account referred to in the second subparagraph of point (a) was made, insofar as that a date can be determined and differs from the date of issue of the invoice;- the taxable amount per rate or exemption, the unit price exclusive of tax and any discounts or rebates if they are not included in the unit price;- the VAT rate applied;- the VAT amount payable, except where a specific arrangement is applied for which this Directive excludes such a detail;- where an exemption is involved or where the customer is liable to pay the tax, reference to the appropriate provision of this directive, to the corresponding national provision, or to any indication that the supply is exempt or subject to the reverse charge procedure;- where the intra-Community supply of a new means of transport is involved, the particulars specified in Article 28a(2);- where the margin scheme is applied, reference to Article 26 or 26a, to the corresponding national provisions, or to any other indication that the margin scheme has been applied;- where the person liable to pay the tax is a tax representative within the meaning of Article 21(2), the VAT identification number referred to in paragraph 1(c) of that tax representative, together with his full name and address.Member States may require taxable persons established on their territory and supplying goods or services on their territory to indicate the VAT identification number referred to in paragraph 1(c) of their customer in cases other than those referred to in the fourth indent of the first subparagraph.Member States shall not require invoices to be signed.The amounts which appear on the invoice may be expressed in any currency, provided that the amount of tax to be paid is expressed in the national currency of the Member State where the supply of goods or services takes place, using the conversion mechanism laid down in Article 11 C(2).Where necessary for control purposes, Member States may require invoices in respect of goods supplied or services rendered in their territory and invoices received by taxable persons in their territory to be translated into their national languages.(c) Invoices issued pursuant to point (a) may be sent either on paper or, subject to an acceptance by the customer, by electronic means.Invoices sent by electronic means shall be accepted by Member States provided that the authenticity of the origin and integrity of the contents are guaranteed:- by means of an advanced electronic signature within the meaning of Article 2(2) of Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures(9); Member States may however ask for the advanced electronic signature to be based on a qualified certificate and created by a secure-signature-creation device, within the meaning of Article 2(6) and (10) of the aforementioned Directive;- or by means of electronic data interchange (EDI) as defined in Article 2 of Commission Recommendation 1994/820/EC of 19 October 1994 relating to the legal aspects of electronic data interchange(10) when the agreement relating to the exchange provides for the use of procedures guaranteeing the authenticity of the origin and integrity of the data; however Member States may, subject to conditions which they lay down, require that an additional summary document on paper is necessary.Invoices may, however, be sent by other electronic means subject to acceptance by the Member State(s) concerned. The Commission will present, at the latest on 31 December 2008, a report, together with a proposal, if appropriate, amending the conditions on electronic invoicing in order to take account of possible future technological developments in this field.Member States may not impose on taxable persons supplying goods or services in their territory any other obligations or formalities relating to the transmission of invoices by electronic means. However, they may provide, until 31 December 2005, that the use of such a system is to be subject to prior notification.Member States may lay down specific conditions for invoices issued by electronic means for goods or services supplied in their territory from a country with which no legal instrument exists relating to mutual assistance similar in scope to that laid down by Directives 76/308/EEC and 77/799/EEC and by Regulation (EEC) No 218/92.When batches containing several invoices are sent to the same recipient by electronic means, the details that are common to the individual invoices may be mentioned only once if, for each invoice, all the information is accessible.(d) Every taxable person shall ensure that copies of invoices issued by himself, by his customer or, in his name and on his behalf, by a third party, and all the invoices which he has received are stored.For the purposes of this Directive, the taxable person may decide the place of storage provided that he makes the invoices or information stored there available without undue delay to the competent authorities whenever they so request. Member States may, however, require taxable persons established in their territory to notify them of the place of storage, if it is outside their territory. Member States may, in addition, require taxable persons established in their territory to store within the country invoices issued by themselves or by their customers or, in their name and on their behalf, by a third party, as well as all the invoices which they have received, when the storage is not by electronic means guaranteeing full on-line access to the data concerned.The authenticity of the origin and integrity of the content of the invoices, as well as their readability, must be guaranteed throughout the storage period. As regards the invoices referred to in the third subparagraph of point (c), the information they contain may not be altered; it must remain legible throughout the aforementioned period.The Member States shall determine the period for which taxable persons must store invoices relating to goods or services supplied in their territory and invoices received by taxable persons established in their territory.In order to ensure that the conditions laid down in the third subparagraph are met, Member States referred to in the fourth subparagraph may require that invoices be stored in the original form in which they were sent, whether paper or electronic. They may also require that when invoices are stored by electronic means, the data guaranteeing the authenticity of the origin and integrity of the content also be stored.Member States referred to in the fourth subparagraph may impose specific conditions prohibiting or restricting the storage of invoices in a country with which no legal instrument exists relating to mutual assistance similar in scope to that laid down by Directives 76/308/EEC, 77/799/EEC and by Regulation (EEC) No 218/92 and to the right of access by electronic means, download and use referred to in Article 22a.Member States may, subject to conditions which they lay down, require the storage of invoices received by non-taxable persons.(e) For the purposes of points (c) and (d), transmission and storage of invoices 'by electronic means' shall mean transmission or making available to the recipient and storage using electronic equipment for processing (including digital compression) and storage of data, and employing wires, radio transmission, optical technologies or other electromagnetic means.For the purposes of this Directive, Member States shall accept documents or messages in paper or electronic form as invoices if they meet the conditions laid down in this paragraph."3. The following subparagraph shall be added to paragraph 8: "The option provided for in the first subparagraph cannot be used to impose additional obligations over and above those laid down in paragraph 3."4. The following subparagraph shall be added to paragraph 9(a): "Without prejudice to the provisions laid down in point (d), Member States may not, however, release the taxable persons referred to in the third indent from the obligations referred to in Article 22(3)."5. The following point shall be added to paragraph 9: "(d) Subject to consultation of the Committee provided for in Article 29 and under the conditions which they may lay down, Member States may provide that invoices in respect of goods supplied or services rendered in their territory do not have to fulfil some of the conditions laid down in paragraph 3(b) in the following cases:- when the amount of the invoice is minor, or- when commercial or administrative practice in the business sector concerned or the technical conditions under which the invoices are issued make it difficult to comply with all the requirements referred to in paragraph 3(b).In any case, these invoices must contain the following:- the date of issue,- identification of the taxable person,- identification of the type of goods supplied or services rendered,- the tax due or the information needed to calculate it.The simplified arrangements provided for in this point may not be applied to transactions referred to in paragraph 4(c)."6. The following point shall be added to paragraph 9: "(e) In cases where Member States make use of the option provided for in the third indent of point (a) to refrain from allocating a number as referred to in paragraph 1(c) to taxable persons who do not carry out any of the transactions referred to in paragraph 4(c), and where the supplier or the customer have not been allocated an identification number of this type, the invoice should feature instead another number called the tax reference number, as defined by the Member States concerned.When the taxable person has been allocated an identification number as referred to in paragraph 1(c), the Member States referred to in the first subparagraph may also require the invoice to show:- for services rendered referred to in Article 28b(C), (D), (E) and (F) and for supplies of goods referred to in Article 28c(A) and (E) point 3, the number referred to in paragraph 1(c) and the tax reference number of the supplier;- for other supplies of goods and services, only the tax reference number of the supplier or only the number referred to in paragraph 1(c)."Article 3The following Article shall be inserted: "Article 22aRight of access to invoices stored by electronic means in another Member StateWhen a taxable person stores invoices which he issues or receives by an electronic means guaranteeing on-line access to the data and when the place of storage is in a Member State other than that in which he is established, the competent authorities in the Member State in which he is established shall have a right, for the purpose of this directive, to access by electronic means, download and use these invoices within the limits set by the regulations of the Member State where the taxable person is established and as far as that State requires for control purposes."Article 41. The words "or of the document serving as invoice" shall be deleted from the first and third indents of the third subparagraph of Article 10(2).2. The words "or on any other documents serving as invoices" shall be deleted from Article 24(5) and the words "or on any other document serving as an invoice" shall be deleted from Article 26a(B), point 9.3. The words "or a document in lieu" shall be deleted from point 4 of Article 26a(C).4. The words "or other document serving as invoice" and "or document" shall be deleted from Article 28d(3) and from the second subparagraph of Article 28d(4).5. In Article 28g (which replaces Article 21 of the same Directive), Article 21 shall be amended as follows:- The words "or other document serving as invoice" shall be deleted from paragraph 1(d).6. The words "or on any other document in lieu" shall be deleted from Article 28o(1)(e).Article 5Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 1 January 2004. They shall forthwith inform the Commission thereof.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 a reference shall be laid down by the Member States.Article 6This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Article 7This Directive is addressed to the Member States.Done at Brussels, 20 December 2001.For the CouncilThe PresidentC. Picqué(1) OJ C 96 E, 27.3.2001, p. 145.(2) Opinion delivered on 13 June 2001 (not yet published in the Official Journal).(3) OJ C 193, 10.7.2001, p. 53.(4) OJ L 145, 13.6.1977, p. 1. Directive as last amended by Directive 2001/4/EC (OJ L 22, 24.1.2001, p. 17).(5) OJ L 281, 23.11.1995, p. 31.(6) OJ L 73, 19.3.1976, p. 18. Directive as last amended by Directive 2001/44/EC (OJ L 175, 28.6.2001, p. 17).(7) OJ L 336, 27.12.1977, p. 15. Directive as last amended by the 1994 Act of Accession.(8) OJ L 24, 1.2.1992, p. 1.(9) OJ L 13, 19.1.2000, p. 12.(10) OJ L 338, 28.12.1994, p. 98.


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32000L0041

Commission Directive 2000/41/EC of 19 June 2000 postponing for a second time the date after which animal tests are prohibited for ingredients or combinations of ingredients of cosmetic products (Text with EEA relevance)

Official Journal L 145 , 20/06/2000 P. 0025 - 0026

Commission Directive 2000/41/ECof 19 June 2000postponing for a second time the date after which animal tests are prohibited for ingredients or combinations of ingredients of cosmetic products(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(1), as last amended by Commission Directive 2000/11/EC(2), and in particular Article 4(1)(i) thereof,After consulting the Scientific Committee on cosmetic products and non-food products intended for consumers,Whereas:(1) The main objective of Directive 76/768/EEC is to protect public health. To this end it is indispensable to carry out certain toxicological tests to evaluate the safety for human health of ingredients and combinations of ingredients used in cosmetic products.(2) Pursuant to Article 4(1)(i) of Directive 76/768/EEC Member States should prohibit the marketing of cosmetic products containing ingredients or combinations of ingredients tested on animals after 30 June 2000 in order to meet the requirements of the Directive.(3) The second subparagraph of this provision also provides that the Commission should submit draft measures to postpone the date of implementation of this provision if there has been insufficient progress in developing satisfactory methods to replace animal testing, and in particular in those cases where alternative methods of testing, despite all reasonable endeavours, have not been scientifically validated as offering an equivalent level of protection for the consumer, taking into account OECD toxicity test guidelines.(4) In the absence of any scientifically validated alternative methods to animal experiments and any pertinent toxicity test guidelines in the field of alternative methods adopted by the OECD, it was necessary to postpone the date provided for in Article 4(1)(i) of Directive 76/768/EEC for the first time by Commission Directive 97/18/EC in compliance with the second subparagraph of this provision.(5) Three alternative methods have been validated in Europe to date. It is unlikely that the scientific state of the art will change significantly before 30 June 2000. Therefore, the date provided for in Article 4(1)(i) of Directive 76/768/EEC should be postponed for a second time in compliance with the second subparagraph of this provision and Article 2 of Directive 97/18/EC.(6) These three methods are being incorporated into Community law through their entry onto Annex V to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(3), as last amended by Commission Directive 2000/33/EC(4).(7) Council Directive 86/609/EEC(5) of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(6) provides that an animal test shall not be carried out if an alternative method is available.(8) These methods are therefore mandatory for use in all sectors including that of cosmetics.(9) The Commission has proposed a Directive amending for the seventh time Directive 76/768/EEC in order to solve definitively the issue of experiments on animals in the cosmetic products sector. Such a proposal should be adopted by co-decision procedure involving the European Parliament and the Council.(10) Taking into account that it can be expected that validated alternative methods will become available for other tests in the next two years and that the proposed Directive shall be adopted by that point of time, it is appropriate to postpone for the last time the date to 30 June 2002.(11) The measures provided for in this Directive are in accordance with the opinion of the Committee on the adaptation to technical progress of the Directives on the removal of technical barriers to trade in the cosmetic products sector,HAS ADOPTED THIS DIRECTIVE:Article 1The date of "30 June 2000" shall be replaced by "30 June 2002" in the first sentence of Article 4(1)(i) of Directive 76/768/EEC.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 June 2000 at the latest. They shall forthwith inform the Commission thereof.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.Article 3This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Communities.Article 4This Directive is addressed to the Member States.Done at Brussels, 19 June 2000.For the CommissionErkki LiikanenMember of the Commission(1) OJ L 262, 27.9.1976, p. 169.(2) OJ L 65, 14.3.2000, p. 22.(3) OJ L 114, 1.5.1997, p. 43.(4) OJ L 196, 16.8.1967, p. 1.(5) OJ L 136, 8.6.2000, p. 90.(6) OJ L 358, 18.12.1986, p. 1.


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31996L0004

Commission Directive 96/4/EC, Euratom of 16 February 1996 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance)

Official Journal L 049 , 28/02/1996 P. 0012 - 0016

COMMISSION DIRECTIVE 96/4/EC of 16 February 1996 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses (1), and in particular Article 4 thereof,Whereas given the nature of infant formulae and follow-on formulae the detailed rules as to nutrient declaration on the labelling need to be clarified in order to avoid any problems which may arise from the application of other relevant Community legislation;Whereas new scientific data justify certain modifications to the mandatory essential composition of infant formulae and follow-on formulae specified in Annexes I and II to Commission Directive 91/321/EEC (2), as amended by the Act of Accession of Austria, Finland and Sweden;Whereas nucleotides, being the natural constituents of human milk, have been used to supplement infant formulae and follow-on formulae for many years in Member States and third countries without any negative effects; whereas therefore there is no justification for prohibiting their use in the manufacture of these products;Whereas technological progress has resulted in the production of infant formulae, based on protein partial hydrolysates, which due to their low levels of immunoreactive proteins may be useful; whereas for this reason a claim as to these particular characteristics should be permitted; whereas these products are distinct from semi-elemental diet products based on high degree hydrolysates used for the dietary management of diagnosed medical conditions, which are not covered by this Directive;Whereas Directive 91/321/EEC should be amended accordingly;Whereas the Scientific Committee for Food, in accordance with Article 4 of Directive 89/398/EEC, has been consulted on the provisions liable to affect public health;Whereas the measures provided in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1 Directive 91/321/EEC is amended as follows:1. Article 6 is replaced by the following:'Article 6Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children. Necessary maximum levels shall be established without delay.Microbiological criteria shall also be established as necessary.`2. Article 7 is amended as follows:(a) Points (d) and (e) of paragraph 2 are replaced by the following:'(d) in the case of infant formulae and follow-on formulae, the available energy value, expressed in kJ and kcal, and the content of proteins, carbohydrates and lipids, expressed in numerical form, per 100 ml of the product ready for use;(e) in the case of infant formulae and follow-on formulae, the average quantity of each mineral substance and of each vitamin mentioned in Annexes I and II respectively, and where applicable of choline, inositol, carnitine and taurine, expressed in numerical form, per 100 ml of the product ready for use;`(b) The following is inserted as paragraph 2a:'2a. The labelling may bear:(a) the average quantity of nutrients mentioned in Annex III when such declaration is not covered by the provisions of paragraph 2 (e) of this Article, expressed in numerical form, per 100 ml of the product ready for use;(b) for follow-on formulae in addition to numerical information, information on vitamins and minerals included in Annex VIII, expressed as a percentage of the reference values given therein, per 100 ml of the product ready for use, provided that the quantities present are at least equal to 15 per cent of the reference values;`3. The Annexes are amended as shown in the Annex hereto.Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 March 1997. They shall forthwith inform the Commission thereof. Those laws, regulations and administrative provisions shall be applied in such a way as to:- permit trade in products conforming to this Directive no later than 1 April 1997,- prohibit trade in products which do not comply with this Directive, with effect from 31 March 1999.When Member States adopt these provisions, these 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 reference shall be adopted by Member States.Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 16 February 1996.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ No L 186, 30. 6. 1989, p. 27.(2) OJ No L 175, 4. 7. 1991, p. 35.ANNEX The Annexes to Directive 91/321/EEC are amended as follows:1. Annex I is amended as follows:(a) The introductory wording of Section 2 and Sections 2.1 and 2.2 are replaced by the following:'2. Protein(Protein content = nitrogen content × 6,38) for cows' milk proteins.(Protein content = nitrogen content × 6,25) for soya protein isolates and protein partial hydrolysates.The "chemical index" shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein and the quantity of each corresponding amino acid of the reference protein.2.1. Formulae manufactured from cows' milk proteins>TABLE>For an equal energy value, the formula must contain an available quantity of each essential and semi-essential amino acid at least equal to that contained in the reference protein (breast milk, as defined in Annex V); nevertheless, for calculation purposes, the concentration of methionine and cystine may be added together.2.2. Formulae manufactured from protein partial hydrolysates>TABLE>For an equal energy value, the formula must contain an available quantity of each essential and semi-essential amino acid at least equal to that contained in the reference protein (breast milk, as defined in Annex V); nevertheless, for calculation purposes, the concentration of methionine and cystine may be added together.The protein efficiency ratio (PER) and the net protein utilization (NPU) must be at least equal to those of casein.The taurine content shall be equal to at least 10 ìmoles/100 kJ (42 ìmoles/100 kcal) and the L-carnitine content shall be equal to at least 1,8 ìmoles/100 kJ (7,5 ìmoles/100 kcal).`(b) The minimum content for lipids in Section 3 is modified as follows:'Minimum1,05 g/100 kJ(4,4 g/100 kcal)`(c) The third indent of Section 3.1 is deleted.(d) The following shall be added to Section 3.'3.5. The alpha-linolenic acid content shall not be less than 12 mg/100 kJ (50 mg/100 kcal).The linoleic/alpha-linolenic acid ratio shall not be less than 5 nor greater than 15.3.6. The trans fatty acid content shall not exceed 4 % of the total fat content.3.7. The erucic acid content shall not exceed 1 % of the total fat content.3.8. Long-chain (20 and 22 carbon atoms) polyunsaturated fatty acids (LCP) may be added. In that case their content shall not exceed:1 % of the total fat content for n-3 LCP and2 % of the total fat content for n-6 LCP (1 % of the total fat content for arachidonic acid)The eicosapentaenoic acid (20:5 n-3) content shall not exceed that of docosahexaenoic (22:6 n-3) acid content.`(e) The following shall be added in Section 5.1:>TABLE>(f) In Section 6 of Annex I, the reference to nicotinamide is replaced by the following:>TABLE>2. Annex II is amended as follows:(a) In Section 2, first paragraph following the numerical values, add the words: '. . . or breast milk . . .` after the word 'casein`,and at the end of Section 2, add the following paragraph:'For an equal energy value, these formulae must contain an available quantity of methionine at least equal to that contained in breast milk as defined in Annex V.`(b) The third indent of Section 3.1 is deleted.(c) The following shall be inserted in Section 3:'3.5. The trans fatty acid content shall not exceed 4 % of the total fat content.3.6. The erucic acid content shall not exceed 1 % of the total fat content.`3. The following is added as Section 7 to both Annex I and Annex II:'7. The following nucleotides may be added:>TABLE>4. Annex III is amended as follows:(a) The following shall be added to Section 2:>TABLE>(b) The following substances shall be added to Section 3:'cytidine 5'-monophosphate and its sodium salturidine 5'-monophosphate and its sodium saltadenosine 5'-monophosphate and its sodium saltguanosine 5'-monophosphate and its sodium saltinosine 5'-monophosphate and its sodium salt`.5. The following shall be added to Annex IV:>TABLE>6. The following is added as Annex VIII:'ANNEX VIIIREFERENCE VALUES FOR NUTRITION LABELLING FOR FOODS INTENDED FOR INFANTS AND YOUNG CHILDREN>TABLE>


title: Commission Directive 2005/8/EC of 27 January 2005 amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feedText with EEA relevance

text:
               29.1.2005

               EN

               Official Journal of the European Union

               L 27/44

      COMMISSION DIRECTIVE 2005/8/EC
   of 27 January 2005
   amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (1), and in particular Article 8(1) thereof,
   Whereas:

               (1)

               Directive 2002/32/EC provides that the use of products intended for animal feed which contain levels of undesirable substances exceeding the maximum levels laid down in Annex I thereto is prohibited.

               (2)

               When Directive 2002/32/EC was adopted, the Commission stated that the provisions laid down in Annex I to that Directive would be reviewed on the basis of updated scientific risk assessments and taking into account the prohibition of any dilution of contaminated non-complying products intended for animal feed.

               (3)

               Before a complete review based on an updated scientific risk assessment can be carried out, it is necessary to provide for certain amendments in the light of developments in scientific and technical knowledge.

               (4)

               It is appropriate to clarify the term green fodder.

               (5)

               Since the supply of calcium carbonate, an essential and valuable feed material, could be endangered because the level of total mercury due to normal background contamination is close to or exceeds the maximum level laid down in the Annex I to Directive 2002/32/EC, that maximum level should be amended, taking into account that mercury is present in calcium carbonate in its inorganic form and that the Scientific Committee for Animal Nutrition confirms that mercury in inorganic form is significantly less toxic than organic mercury, in particular methyl mercury.

               (6)

               The maximum level for fluorine in other complementary feedingstuffs is 125 mg/kg per 1 % phosphorus. For environmental reasons, the level of phosphorus in animal feed is restricted and the digestibility and bioavailability of phosphorus is improved by making use of an enzyme such as phytase. It is therefore no longer appropriate to establish the maximum level as per 1 % of phosphorus but to establish the maximum level for complementary feed relative to a feedingstuff with a moisture content of 12 %.

               (7)

               Directive 2002/32/EC should therefore be amended accordingly.

               (8)

               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 2002/32/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive twelve months after the entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 27 January 2005.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 140, 30.5.2002, p. 10. Directive as last amended by Commission Directive 2003/100/EC (OJ L 285, 1.11.2003, p. 33).

      ANNEX
      Annex I to Directive 2002/32/EC is amended as follows:

                  1.

                  In column 2 of row 2, Lead, the following footnote is inserted after the word green fodder:

                              ‘(*)

                              green fodder includes products intended for animal feed such as hay, silage, fresh grass, etc …’.

                  2.

                  Row 3, Fluorine, is amended as follows:

                              (a)

                              Footnotes (1) and (2) are deleted

                              (b)

                              The words ‘Mineral mixtures for cattle, sheep and goats — 2 000 (1)’ and ‘Other complementary feedingstuffs — 125 (2)’ are replaced by the words ‘Complementary feedingstuffs containing ≤ 4 % phosphorus — 500’ and ‘Complementary feedingstuffs containing > 4 % phosphorus — 125 per 1 % phosphorus’.

                  3.

                  Row 4, Mercury, is replaced by the following:

                              Undesirable substances

                              Products intended for animal feed

                              Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 %

                              (1)

                              (2)

                              (3)

                                          ‘4.

                                          Mercury

                              Feed materials with the exception of:

                              0,1

                                          —

                                          feedingstuffs produced by the processing of fish or other marine animals

                              0,5

                                          —

                                          calcium carbonate

                              0,3

                              Complete feedingstuffs with the exception of:

                              0,1

                                          —

                                          complete feedingstuffs for dogs and cats

                              0,4

                              Complementary feedingstuffs except

                                          —

                                          complementary feedingstuffs for dogs and cats

                              0,2’


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31976L0014

First Commission Directive 76/14/EEC of 15 December 1975 amending the Annex to Council Directive 74/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs

Official Journal L 004 , 09/01/1976 P. 0024 - 0024 Greek special edition: Chapter 03 Volume 14 P. 0145  Spanish special edition: Chapter 03 Volume 9 P. 0227  Portuguese special edition Chapter 03 Volume 9 P. 0227  Finnish special edition: Chapter 3 Volume 65 P. 0016  Swedish special edition: Chapter 3 Volume 65 P. 0016

FIRST COMMISSION DIRECTIVE  of 15 December 1975  amending the Annex to Council Directive 74/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs  (76/14/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 74/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs (1), and in particular Article 6 thereof,  Whereas this Directive provides for the contents of the Annex to be regularly amended to take account of developments in scientific and technical knowledge;  Whereas the maximum permitted levels fixed for the undesirable substances listed in Part A of the said Annex must refer to feedingstuffs with a specified moisture content;  Whereas the results of recent scientific or technical tests and findings require that the contents of the Annex should be added to or amended;  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 Annex to the Council Directive of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs shall be amended in accordance with the following Articles.   Article 2 Part A "Substances (ions or elements)" is amended as follows:    1. The heading of the third column shall read as follows:  "Maximum content in mg/kg (ppm) of feedingstuffs referred to a moisture content of 12 %".       2. Under No 1 "Arsenic", in the first indent of the second column add "and dried sugar beet pulp and dried molasses sugar beet pulp" after "and from dried clover".          Article 3 In Part B "Products", No 4 "Theobromine", the second and the third columns shall read as follows: >PIC FILE= "T0009018">    Article 4 The Member States shall bring into force by 1 April 1976 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive and shall forthwith inform the Commission thereof.   Article 5 This Directive is addressed to the Member States.     Done at Brussels, 15 December 1975.  For the Commission  P.J. LARDINOIS  Member of the Commission  (1)OJ No L 38, 11.2.1974, p. 31.