title: Commission Directive 2008/43/EC of 4 April 2008 setting up, pursuant to Council Directive 93/15/EEC, a system for the identification and traceability of explosives for civil uses (Text with EEA relevance)

text:
               5.4.2008

               EN

               Official Journal of the European Union

               L 94/8

      COMMISSION DIRECTIVE 2008/43/EC
   of 4 April 2008
   setting up, pursuant to Council Directive 93/15/EEC, a system for the identification and traceability of explosives for civil uses
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 93/15/EEC of 5 April 1993 on the harmonisation of the provisions relating to the placing on the market and supervision of explosives for civil uses (1), and in particular the second sentence of the second paragraph of Article 14 thereof,
   Whereas:

               (1)

               Directive 93/15/EEC lays down rules for ensuring the safe and secure circulation of explosives on the community market.

               (2)

               As provided for in that Directive, it is necessary to ensure that undertakings in the explosives sector possess a system for keeping track of explosives in order to be able to identify those holding the explosives at any time.

               (3)

               Unique identification of explosives is essential if accurate and complete records of explosives are to be kept at all stages of the supply chain. This should allow the identification and the traceability of an explosive from its production site and its first placing on the market until its final user and its use with a view to preventing misuse and theft and to assisting law enforcement authorities in the tracing of the origin of lost or stolen explosives.

               (4)

               The measures provided for in this Directive are in accordance with the opinion of the Management Committee established pursuant to Article 13(1) of Directive 93/15/EEC,

         HAS ADOPTED THIS DIRECTIVE:
   CHAPTER 1
   GENERAL PROVISIONS
   Article 1
   Subject matter
   This Directive sets up a harmonised system for the unique identification and traceability of explosives for civil uses.
   Article 2
   Scope
   This Directive shall not apply to the following:

               (a)

               explosives transported and delivered unpackaged or in pump trucks for their direct unloading into the blast-hole;

               (b)

               explosives manufactured at the blasting sites, and that are loaded immediately after being produced (in situ production);

               (c)

               ammunitions.

         CHAPTER 2
   PRODUCT IDENTIFICATION
   Article 3
   Unique identification
   1.   Member States shall ensure that undertakings in the explosives sector which manufacture or import explosives or assemble detonators shall mark explosives and each smallest packaging unit with a unique identification.
   Where an explosive is subject to further manufacturing processes, manufacturers shall not be required to mark the explosive with a new unique identification unless the original unique identification is no longer marked in compliance with Article 4.
   2.   Paragraph 1 shall not apply where the explosive is manufactured for export and is marked with an identification in accordance with the requirements of the importing country, which allows traceability of the explosive.
   3.   The unique identification shall comprise the components described in the Annex.
   4.   Each manufacturing site shall be attributed a three-digit code by the national authority of the Member States where it is established.
   5.   Where the manufacturing site is located outside the Community, the manufacturer being established in the Community shall contact a national authority of the Member State of import in order for the manufacturing site to be attributed a code.
   Where the manufacturing site is located outside the Community and the manufacturer is not established in the Community, the importer of the explosives concerned shall contact a national authority of the Member State of import in order for the manufacturing site to be attributed a code.
   6.   Member States shall ensure that distributors which repackage explosives make sure that the unique identification is affixed to the explosive and the smallest packaging unit.
   Article 4
   Marking and affixation
   The unique identification shall be marked on or firmly affixed to the article concerned in a durable way and so as to ensure that it is clearly legible.
   Article 5
   Cartridged explosives and explosives in sacks
   For cartridged explosives and explosives in sacks, the unique identification shall consist of an adhesive label or direct printing on each cartridge or sack. An associated label shall be placed on each case of cartridges.
   In addition, undertakings may use a passive inert electronic tag attached to each cartridge or sack and similarly, an associated electronic tag for each case of cartridges.
   Article 6
   Two-component explosives
   For packaged two-component explosives, the unique identification shall consist of an adhesive label or direct printing on each smallest packaging unit containing the two components.
   Article 7
   Plain detonators and fuses
   For plain detonators or fuses, the unique identification shall consist of an adhesive label or direct printing or stamping on the detonator shell. An associated label shall be placed on each case of detonators or fuses.
   In addition, undertakings may use a passive inert electronic tag attached to each detonator or fuse, and an associated tag for each case of detonators or fuses.
   Article 8
   Electric, non-electric and electronic detonators
   For electric, non-electric and electronic detonators, the unique identification shall consist either of an adhesive label on the wires or tube, or an adhesive label or direct printing or stamping on the detonator shell. An associated label shall be placed on each case of detonators.
   In addition, undertakings may use a passive inert electronic tag attached to each detonator, and an associated tag for each case of detonators.
   Article 9
   Primers and boosters
   For primers and boosters, the unique identification shall consist of an adhesive label or direct printing on the primer or booster. An associated label shall be placed on each case of primers or boosters.
   In addition, undertakings may use a passive inert electronic tag attached to each primer or booster, and an associated tag for each case of primers or boosters.
   Article 10
   Detonating cords and safety fuses
   For detonating cords and safety fuses, the unique identification shall consist of an adhesive label or direct printing on the bobbin. The unique identification will be marked every 5 meters on either the external envelope of the cord or fuse or the plastic extruded inner layer immediately under the exterior fibre of the cord or fuse. An associated label shall be placed on each case of detonating cord or fuse.
   In addition, undertakings may use a passive inert electronic tag inserted within the cord, and an associated tag for each case of cord or fuse.
   Article 11
   Cans and drums containing explosives
   For cans and drums containing explosives, the unique identification shall consist of an adhesive label or direct printing on the can or drum containing the explosives.
   In addition, undertakings may use a passive inert electronic tag attached to each can and drum.
   Article 12
   Copies of the original label
   Undertakings may attach adhesive detachable copies of the original label to the explosives for use by their clients. Those copies shall be visibly marked as copies of the original to prevent misuse.
   CHAPTER 3
   DATA COLLECTION AND RECORD-KEEPING
   Article 13
   Data collection
   1.   Member States shall ensure that undertakings in the explosives sector put in place a system for collecting data in relation to explosives including their unique identification throughout the supply chain and life cycle.
   2.   The data collection system shall allow the undertakings to keep track of the explosives in such a way that those holding the explosives can be identified at any time.
   3.   Member States shall ensure that the data collected including the unique identifications is kept and maintained for a period of 10 years after the delivery or whenever known after the end of the life cycle of the explosive even if undertakings have ceased trading.
   Article 14
   Obligations of undertakings
   Member States shall ensure that the undertakings in the explosives sector fulfil the following:

               (a)

               keeping a record of all identifications of explosives, together with all pertinent information including the type of explosive, the company or person to the custody of whom it was given;

               (b)

               recording the location of each explosive while the explosive is in their possession or custody until it is either transferred to another undertaking or used;

               (c)

               at regular interval testing their data collection system in order to ensure its effectiveness and the quality of the data recorded;

               (d)

               keeping and maintaining the data collected including the unique identifications for the period specified in paragraph 3 of Article 13;

               (e)

               protecting the data collected against accidental or malicious damage or destruction;

               (f)

               providing the competent authorities, upon their request, with the information concerning the origin and location of each explosive during its life cycle and throughout the supply chain;

               (g)

               providing the responsible Member State authorities with the name and contact details of a person able to provide the information described in point (f) outside normal business hours.

         For the purpose of point (d), the undertaking shall, in the case of explosives manufactured or imported before the date specified in the second subparagraph of Article 15(1), maintain records in accordance with existing national provisions.
   CHAPTER 4
   FINAL PROVISIONS
   Article 15
   Transposition
   1.   Member States shall adopt and publish, by 5 April 2009 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 5 April 2012.
   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 16
   Entry into force
   This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
   Article 17
   This Directive is addressed to the Member States.

      Done at Brussels, 4 April 2008.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 121, 15.5.1993, p. 20. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      ANNEX
      The unique identification shall comprise:

                  1.

                  a human readable part of the identification containing the following:

                              (a)

                              the name of the manufacturer;

                              (b)

                              an alphanumerical code containing:

                                          (i)

                                          two letters identifying the Member State (place of production or import onto the Community market, e.g. AT = Austria);

                                          (ii)

                                          three digits identifying the name of the manufacturing site (attributed by the national authorities);

                                          (iii)

                                          the unique product code and logistical information designed by the manufacturer;

                  2.

                  an electronic readable identification in barcode and/or matrix code format that relates directly to the alphanumerical identification code.
                  Example:

                  3.

                  For articles too small to affix the unique product code and logistical information designed by the manufacturer, the information under 1(b)(i), 1(b)(ii) and 2 shall be considered sufficient.


Avis juridique important

|

31987L0140

Commission Directive 87/140/EEC of 6 February 1987 amending Annex II to Council Directive 71/307/EEC on the approximation of the laws of the Member States relating to textile names

Official Journal L 056 , 26/02/1987 P. 0024 - 0025 Finnish special edition: Chapter 15 Volume 7 P. 0208  Swedish special edition: Chapter 15 Volume 7 P. 0208

*****COMMISSION  DIRECTIVE  of 6 February 1987  amending Annex II to Council Directive 71/307/EEC on the approximation of the laws of the Member States relating to textile names  (87/140/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 71/307/EEC, of 26 July 1971, on the approximation of the laws of the Member States relating to textile names (1), as last amended by Directive 83/623/EEC (2), and in particular Article 15a (1) thereof,  Whereas Annex II to Directive 71/307/EEC, which sets out the agreed allowances to be applied to the anhydrous mass of each fibre during the determination by analysis of the fibre content of textile products, gives, in items 1-2 and 3, two different agreed allowances for calculating the composition of carded or combed fibres containing wool and/or animal hair; whereas laboratories cannot always tell whether a product is carded or combed, and consequently inconsistent results can be obtained by applying this provision during checks on the conformity of textile products carried out in the Community; whereas laboratories should therefore be authorized to apply a single agreed allowance in doubtful cases;  Whereas in item 28 in the aforementioned Annex there is no need to distinguish between the different types of polyamide or nylon, the agreed allowances for which should therefore be brought into line;  Whereas in item 38 (glass fibre) the word 'filament' should be deleted since this fibre can also exist in a discontinous form;  Whereas the provisions in this Directive are in accordance with the opinion of the Committee for Directives relating to Textile Names and Labelling,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Items 1-2, 3, 28 and 38 in Annex II to Directive 71/307/EEC are hereby amended in accordance with the Annex to this Directive.  Article 2  1. Member States shall bring into force the provisions necessary to comply with this Directive not later than 1 September 1988 and shall forthwith inform the Commission thereof.  2. As soon as this Directive has been notified, Member States shall also inform the Commission, in sufficient time for it to submit its comments, of any draft laws, regulations or administrative provisions which they intend to adopt in the field covered by this Directive.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 6 February 1987.  For the Commission  Grigoris VARFIS  Member of the Commission  (1) OJ No L 185, 16. 8. 1971, p. 16.  (2) OJ No L 353, 15. 12. 1983, p. 8.  ANNEX  1. The following items are hereby amended as follows:  1.2 // 1-2 and 3:   // A footnote reference '(1)' is inserted after the figure 17,00 opposite carded fibres under the headings 'Wool and animal hair' and 'Animal hair'.   // 28:  // The text in the columns headed 'Fibres' and 'Percentages' shall read as follows:  1.2 //   // 'Polyamide or nylon:   //  // discontinuous fibre 6,25  //  // filament 5,75'. 1.2 // 38:   // The text in the columns headed 'Fibres' and 'Percentages' shall read as follows:   //   // 'Glass fibre:   //   // With an average diameter of over 5 mm 2,00  //  // with an average diameter of 5 mm or less 3,00'.  2. Footnote (1) shall read as follows:  '(1) The agreed allowances of 17,00 % shall also be applied where it is impossible to ascertain whether the textile product containing wool and/or animal hair is combed or carded.'


title: Commission Directive 2011/19/EU of 2 March 2011 amending Council Directive 91/414/EEC to include tau-fluvalinate as active substance and amending Decision 2008/934/EC  Text with EEA relevance

text:
               3.3.2011

               EN

               Official Journal of the European Union

               L 58/41

         COMMISSION DIRECTIVE 2011/19/EU
   of 2 March 2011
   amending Council Directive 91/414/EEC to include tau-fluvalinate as active substance and amending Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

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

               (2)

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

               (3)

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

               (4)

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

               (5)

               Denmark evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 1 October 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on tau-fluvalinate to the Commission on 17 June 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 January 2011 in the format of the Commission review report for tau-fluvalinate.

               (6)

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

               (7)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit further information confirming the results of the risk assessment on the basis of most recent scientific knowledge, as regards the risk to aquatic organisms, the risk to non-target arthropods and on the possible impact on the environment of the potential enantio-selective degradation in environmental matrices.

               (8)

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

               (9)

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

               (10)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I.

               (11)

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

               (12)

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

               (13)

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

               (14)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   The line concerning tau-fluvalinate in the Annex to Decision 2008/934/EC is deleted.
   Article 3
   Member States shall adopt and publish by 30 November 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 December 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 4
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing tau-fluvalinate as an active substance by 30 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to tau-fluvalinate are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing tau-fluvalinate as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning tau-fluvalinate. 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 tau-fluvalinate as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

               (b)

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

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

      Done at Brussels, 2 March 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

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

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

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance tau-fluvalinate. EFSA Journal 2010; 8(7):1645. [70 pp.]. doi:10.2903/j.efsa.2010.1645. Available online: www.efsa.europa.eu

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

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

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘335

                     Tau-fluvalinate
                     CAS No: 102851-06-9
                     CIPAC No: 786

                     (RS)-α-cyano-3-phenoxybenzyl N-(2-chloro- α,α α- trifluoro-p-tolyl)-D-valinate
                     (Isomer ratio 1:1)

                     ≥ 920 g/kg
                     (1:1 ratio of R-α-cyano and S-α-cyano isomers)
                     Impurities:
                     Toluene: not more than 5 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as insecticide and acaricide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tau-fluvalinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the risk to aquatic organisms and ensure that conditions of use prescribe the application of adequate risk mitigation measures;

                                 (b)

                                 the risk to non-target arthropods and ensure that conditions of use prescribe the application of adequate risk mitigation measures;

                                 (c)

                                 the test material used in the toxicity dossiers shall be compared and verified against the specification of the technical material commercially manufactured.

                           The Member States concerned shall request the submission of confirmatory information as regards:

                                 —

                                 the risk of bioaccumulation/biomagnification in the aquatic environment,

                                 —

                                 the risk to non-target arthropods.

                           The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.
                     The Member States concerned shall ensure that the applicant submits confirmatory information, two years after the adoption of specific guidance, as regards:
                     the possible impact on the environment of the potential enantio-selective degradation in environmental matrices.’

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


title: Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices  Text with EEA relevance

text:
               22.12.2011

               EN

               Official Journal of the European Union

               L 341/50

         COMMISSION DIRECTIVE 2011/100/EU
   of 20 December 2011
   amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices (1), and in particular Article 14 thereof,
   Whereas:

               (1)

               In accordance with Article 14(1)(a) of Directive 98/79/EC, the United Kingdom has requested that the Commission take the necessary measures to add ‘Variant Creutzfeldt-Jakob disease’ (vCJD) assays to List A of Annex II to that Directive.

               (2)

               In order to ensure the highest level of health protection and ensure that the conformity of vCJD assays with the essential requirements set out in Annex I to Directive 98/79/EC is verified by notified bodies, vCJD assays for blood screening, diagnosis and confirmation should be added to List A of Annex II to Directive 98/79/EC.

               (3)

               The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 6(2) of Council Directive 90/385/EEC (2) and referred to in Article 7(1) of Directive 98/79/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex II to Directive 98/79/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2012 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   Member States shall apply those provisions from 1 July 2012.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 20 December 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 331, 7.12.1998, p. 1.

      (2)  OJ L 189, 20.7.1990, p. 17.

      ANNEX
      The following indent is added at the end of List A of Annex II to Directive 98/79/EC:

                  ‘—

                  Variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation.’


Avis juridique important

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31986L0215

Council Directive 86/215/EEC of 26 May 1986 amending Directive 66/403/EEC on the marketing of seed potatoes

Official Journal L 152 , 06/06/1986 P. 0046 - 0046 Finnish special edition: Chapter 3 Volume 21 P. 0073  Swedish special edition: Chapter 3 Volume 21 P. 0073

*****COUNCIL  DIRECTIVE  of 26 May 1986  amending Directive 66/403/EEC on the marketing of seed potatoes  (86/215/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Whereas Directive 66/403/EEC (2), as last amended by Regulation (EEC) No 3768/85 (3), provides that in principle from 1 July 1975 onwards Member States may no longer determine for themselves the equivalence of seed potatoes harvested in third countries with basic seed potatoes or certified seed potatoes harvested within the Community and complying with that Directive;  Whereas, however, since work to establish Community equivalence for all the third countries concerned had not been completed, Article 15 (2a) of that Directive permitted Member States to extend to 31 January 1984 the period of validity of equivalences which they had already determined in respect of certain countries not covered by the Community equivalences;  Whereas the said work is still incomplete and the said final date should be deferred to dates determined in accordance with Member States' obligations under the common rules on plant health laid down by Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products (4), as last amended by Regulation (EEC) No 3768/85;  Whereas this measure does not affect the aforementioned obligations and, in respect of seed potatoes produced in Canada, the extension can therefore be used only by the Hellenic Republic and the Italian Republic, within the limits set up by Commission Decision 86/120/EEC (5) and by the Kingdom of Spain and the Portuguese Republic which, under the terms of the Act of Accession, will not be implementing the provisions of the aforementioned Directive before 30 June 1986,  HAS ADOPTED THIS DIRECTIVE:  Article 1  In Article 15 (2a) of Directive 66/403/EEC, '31 January 1984' is replaced by '31 March 1986' and the following sentence added:  'With regard to Spain and Portugal, "31 March 1986" shall be replaced by "30 June 1986" and "1 July 1975" by "1 January 1986".'  Article 2  This Directive is addressed to the Member States.  Done at Brussels, 26 May 1986.  For the Council  The President  G. BRAKS  (1) Opinion delivered on 16 May 1986 (not yet published in the Official Journal).  (2) OJ No 125, 11. 7. 1966, p. 2320/66.  (3) OJ No L 362, 31. 12. 1985, p. 8.  (4) OJ No L 26, 31. 1. 1977, p. 20.  (5) OJ No L 99, 15. 4. 1986, p. 31.


title: Council Directive 2011/97/EU of 5 December 2011 amending Directive 1999/31/EC as regards specific criteria for the storage of metallic mercury considered as waste

text:
               10.12.2011

               EN

               Official Journal of the European Union

               L 328/49

         COUNCIL DIRECTIVE 2011/97/EU
   of 5 December 2011
   amending Directive 1999/31/EC as regards specific criteria for the storage of metallic mercury considered as waste
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1102/2008 of the European Parliament and of the Council of 22 October 2008 on the banning of exports of metallic mercury and certain mercury compounds and mixtures and the safe storage of metallic mercury (1), and in particular Article 4(3) thereof, as well as to Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (2), and in particular Article 16 thereof,
   Having regard to the proposal from the European Commission,
   Whereas:

               (1)

               Regulation (EC) No 1102/2008 stipulates that, by way of derogation from Article 5(3)(a) of Directive 1999/31/EC, metallic mercury that is considered as waste may, in appropriate containment, be temporarily stored for more than 1 year or permanently stored in certain types of landfills.

               (2)

               Storage of metallic mercury that is considered as waste is already regulated by Union legislation on waste management.

               (3)

               The storage of metallic mercury that is considered as waste for up to 1 year is subject to the permit requirements according to Article 23 of Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste (3).

               (4)

               Directive 1999/31/EC and Council Decision 2003/33/EC of 19 December 2002 establishing criteria and procedures for the acceptance of waste at landfills pursuant to Article 16 of and Annex II to Directive 1999/31/EC (4) apply to facilities for the storage of metallic mercury for more than 1 year according to Article 3(1) of Regulation (EC) No 1102/2008.

               (5)

               This implies, in particular, that all facilities for the storage of metallic mercury for more than 1 year need a permit according to Articles 7, 8 and 9 of Directive 1999/31/EC and that such facilities are subject to the control and monitoring requirements laid down in Article 12 of that Directive, as well as, in the case of underground storage, to the safety assessment requirements according to Appendix A of Decision 2003/33/EC.

               (6)

               In addition, such facilities are subject to the general provisions on record keeping as laid down in Directive 2008/98/EC.

               (7)

               In addition, the provisions of Council Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous substances (5) apply to facilities for the temporary above-ground storage according to Article 3(2) of Regulation (EC) No 1102/2008.

               (8)

               However, those provisions do not fully address the specific characteristics of metallic mercury, and additional requirements are therefore needed.

               (9)

               Those additional requirements should take into account research activities on safe disposal options, including the solidification of metallic mercury. There is progress in the development of environmentally sound solidification options but it is premature to decide on the large-scale viability of such options.

               (10)

               Additional assessments of the long-term behaviour of metallic mercury in underground storage are needed for the determination of sound and knowledge-based requirements for permanent storage. The requirements laid down in this Directive should therefore be limited to temporary storage and are considered as appropriate and representing the best available techniques for the safe storage of metallic mercury for a time span of up to 5 years.

               (11)

               Directive 1999/31/EC should therefore be amended accordingly.

               (12)

               No opinion was given by the committee referred to in Article 16 of Directive 1999/31/EC. It is therefore appropriate for the Council to adopt this Directive,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes I, II and III to Directive 1999/31/EC are hereby amended as set out in the Annex to this Directive.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 March 2013. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the third 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, 5 December 2011.

            For the Council

            The President

         W. PAWLAK

      (1)  OJ L 304, 14.11.2008, p. 75.

      (2)  OJ L 182, 16.7.1999, p. 1.

      (3)  OJ L 312, 22.11.2008, p. 3.

      (4)  OJ L 11, 16.1.2003, p. 27.

      (5)  OJ L 10, 14.1.1997, p. 13.

      ANNEX
      Annexes I, II and III to Directive 1999/31/EC are amended as follows:

                  (1)

                  the following section is added to Annex I:
                  ‘8.   Temporary storage of metallic mercury
                  For the purposes of temporary storage for more than 1 year of metallic mercury, the following requirements shall apply:

                              —

                              Metallic mercury shall be stored separately from other waste.

                              —

                              Containers shall be stored in collecting basins suitably coated so as to be free of cracks and gaps and impervious to metallic mercury with a containment volume adequate for the quantity of mercury stored.

                              —

                              The storage site shall be provided with engineered or natural barriers that are adequate to protect the environment against mercury emissions and a containment volume adequate for the total quantity of mercury stored.

                              —

                              The storage site floors shall be covered with mercury-resistant sealants. A slope with a collection sump shall be provided.

                              —

                              The storage site shall be equipped with a fire protection system.

                              —

                              Storage shall be arranged in a way to ensure that all containers are easily retrievable.’;

                  (2)

                  the following section is added to Annex II:
                  ‘6.   Specific requirements for metallic mercury
                  For the purposes of temporary storage for more than 1 year of metallic mercury, the following requirements shall apply:

                              A.

                              Composition of the mercury
                              Metallic mercury shall comply with the following specifications:

                                          —

                                          mercury content greater than 99,9 % per weight,

                                          —

                                          no impurities capable of corroding carbon or stainless steel (e.g. nitric acid solution, chloride salts solutions).

                              B.

                              Containment
                              Containers used for the storage of metallic mercury shall be corrosion- and shock-resistant. Welds shall therefore be avoided. The containers shall comply in particular with the following specifications:

                                          —

                                          container material: carbon steel (ASTM A36 minimum) or stainless steel (AISI 304, 316L),

                                          —

                                          containers shall be gas and liquid tight,

                                          —

                                          the outer side of the container shall be resistant against the storage conditions,

                                          —

                                          the design type of the container shall successfully pass the drop test and the leakproofness tests as described in Chapters 6.1.5.3 and 6.1.5.4 of the UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria.

                                    The maximum filling ratio of the container shall be 80 % by volume to ensure that sufficient ullage is available and neither leakage nor permanent distortion of the container can occur as a result of an expansion of the liquid due to high temperature.

                              C.

                              Acceptance procedures
                              Only containers with a certificate complying with the requirements set out in this Section shall be accepted.
                              Acceptance procedures shall comply with the following:

                                          —

                                          only metallic mercury which fulfils the minimum acceptance criteria set out above shall be accepted,

                                          —

                                          containers shall be visually inspected before storage. Damaged, leaking or corroded containers shall not be accepted,

                                          —

                                          containers shall bear a durable stamp (made by punching) mentioning the identification number of the container, the construction material, its empty weight, the reference of the manufacturer and the date of construction,

                                          —

                                          containers shall bear a plate permanently fixed to the container mentioning the identification number of the certificate.

                              D.

                              Certificate
                              The certificate indicated in subsection C shall include the following elements:

                                          —

                                          name and address of the waste producer,

                                          —

                                          name and address of the responsible for the filling,

                                          —

                                          place and date of filling,

                                          —

                                          quantity of the mercury,

                                          —

                                          the purity of the mercury and, if relevant, a description of the impurities, including the analytical report,

                                          —

                                          confirmation that the containers have been used exclusively for the transport/storage of mercury,

                                          —

                                          the identification numbers of the containers,

                                          —

                                          any specific comments.

                                    Certificates shall be issued by the producer of the waste or, in default, by the person responsible for its management.’;

                  (3)

                  the following section is added to Annex III:
                  ‘6.   Specific requirements for metallic mercury
                  For the purposes of temporary storage for more than 1 year of metallic mercury, the following requirements shall apply:

                              A.

                              Monitoring, inspection and emergency requirements
                              A continuous mercury vapour monitoring system with a sensitivity of at least 0,02 mg mercury/m3 shall be installed in the storage site. Sensors shall be positioned at ground level and head level. This shall include a visual and acoustic alert system. The system shall be maintained annually.
                              The storage site and containers shall be visually inspected by an authorised person at least once a month. Where leaks are detected, the operator shall immediately take all necessary action to avoid any emission of mercury to the environment and restore the safety of the storage of the mercury. Any leaks shall be considered to have significant adverse environmental effects as referred to in Article 12(b).
                              Emergency plans and adequate protective equipment suitable for handling metallic mercury shall be available on site.

                              B.

                              Record keeping
                              All documents containing the information referred to in Section 6 of Annex II and in point A of this Section, including the certificate accompanying the container, as well as records concerning the destocking and dispatch of the metallic mercury after its temporary storage and the destination and intended treatment shall be kept for at least 3 years after the termination of the storage.’.


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32002L0085

Directive 2002/85/EC of the European Parliament and of the Council of 5 November 2002 amending Council Directive 92/6/EEC on the installation and use of speed limitation devices for certain categories of motor vehicles in the Community

Official Journal L 327 , 04/12/2002 P. 0008 - 0009

Directive 2002/85/EC of the European Parliament and of the Councilof 5 November 2002amending Council Directive 92/6/EEC on the installation and use of speed limitation devices for certain categories of motor vehicles in the CommunityTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 71 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Following consultation of the Committee of the Regions,Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) Transport safety and environmental issues connected with transport are vital in ensuring sustainable mobility.(2) The use of speed limitation devices for heaviest-motor vehicle categories has had a positive effect on the improvement of road safety. It has also contributed to environmental protection.(3) Council Directive 92/6/EEC(4) provides that, depending on technical possibilities and experiences in Member States, the requirements on installation and use of speed limitation devices could subsequently be extended to light goods vehicles.(4) The extension of the scope of Directive 92/6/EEC to vehicles of more than 3,5 tonnes designed for transporting goods or passengers was one of the measures advocated by the Council in its resolution of 26 June 2000 on the improvement of road safety(5), in accordance with the Commission communication of 20 March 2000 on priorities in EU road safety.(5) The scope of Directive 92/6/EEC should be extended to motor vehicles of category M2, to vehicles of category M3 having a maximum mass of more than 5 tonnes but not exceeding 10 tonnes and to vehicles of category N2.(6) Since the objectives of the proposed action, namely the introduction of modifications to the Community-wide arrangements for the installation and use of speed limitation devices on certain heavy vehicle categories, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary to achieve those objectives.(7) Directive 92/6/EEC should therefore be amended accordingly,HAVE ADOPTED THIS DIRECTIVE:Article 1Directive 92/6/EEC is hereby amended as follows:1. Articles 1 to 5 shall be replaced by the following:"Article 1For the purposes of this Directive, 'motor vehicle' means any power-driven vehicle falling within category M2, M3, N2 or N3, intended for use on the road and having at least four wheels and a maximum design speed exceeding 25 km/h.Categories M2, M3, N2 and N3 shall be understood to be those defined in Annex II to Directive 70/156/EEC(6).Article 2Member States shall take the necessary measures to ensure that motor vehicles of categories M2 and M3 referred to in Article 1 may be used on the road only if equipped with a speed limitation device set in such a way that their speed cannot exceed 100 kilometres per hour.Category M3 vehicles registered before 1 January 2005 with a maximum mass exceeding 10 tonnes may continue to be equipped with devices on which the maximum speed is set at 100 kilometres per hour.Article 31. Member States shall take the necessary measures to ensure that motor vehicles of categories N2 and N3 may be used on the road only if equipped with a speed limitation device set in such a way that their speed cannot exceed 90 kilometres per hour.2. Member States shall be authorised to require that the speed limitation device in vehicles registered in their territory and used exclusively for the transport of dangerous goods is set in such a way that those vehicles cannot exceed a maximum speed of less than 90 kilometres per hour.Article 41. For motor vehicles of category M3 having a maximum mass of more than 10 tonnes and motor vehicles of category N3, Articles 2 and 3 shall be applied:(a) to vehicles registered as from 1 January 1994, from 1 January 1994;(b) to vehicles registered between 1 January 1988 and 1 January 1994:(i) from 1 January 1995, in the case of vehicles used for both national and international transport;(ii) from 1 January 1996, in the case of vehicles used exclusively for national transport.2. For motor vehicles of category M2, vehicles of category M3 having a maximum mass of more than 5 tonnes but not exceeding 10 tonnes and vehicles of category N2, Articles 2 and 3 shall apply at the latest:(a) to vehicles registered as from 1 January 2005;(b) to vehicles complying with the limit values set out in Directive 88/77/EEC(7) registered between 1 October 2001 and 1 January 2005:(i) from 1 January 2006 in the case of vehicles used for both national and international transport operations;(ii) from 1 January 2007 in the case of vehicles used solely for national transport operations.3. For a period of no more than three years from 1 January 2005, any Member State may exempt from the provisions of Articles 2 and 3 category M2 vehicles and category N2 vehicles with a maximum mass of more than 3,5 tonnes but not exceeding 7,5 tonnes, registered in the national register and not travelling on the territory of another Member State.Article 51. The speed limitation devices referred to in Articles 2 and 3 must satisfy the technical requirements laid down in the Annex to Directive 92/24/EEC(8). However, all vehicles covered by this Directive and registered before 1 January 2005 may continue to be equipped with speed limitation devices which satisfy the technical requirements laid down by the competent national authorities.2. Speed limitation devices shall be installed by workshops or bodies approved by the Member States."2. The following Article shall be inserted:"Article 6aAs part of the road safety action programme for the period 2002 to 2010, the Commission shall assess the road safety and road traffic implications of adjusting the speed limitation devices used by category M2 vehicles and by category N2 vehicles with a maximum mass of 7,5 tonnes or less to the speeds laid down by this Directive.If necessary, the Commission shall submit appropriate proposals."Article 2Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2005 at the latest. 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 reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.Article 3This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 4This Directive is addressed to the Member States.Done at Brussels, 5 November 2002.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentT. Pedersen(1) OJ C 270 E, 25.9.2001, p. 77.(2) OJ C 48, 21.2.2002, p. 47.(3) Opinion of the European Parliament of 7 February 2002 (not yet published in the Official Journal), Council Common Position of 25 June 2002 (OJ C 228 E, 25.9.2002, p. 14) and decision of the European Parliament of 24 September 2002 (not yet published in the Official Journal).(4) OJ L 57, 2.3.1992, p. 27.(5) OJ C 218, 31.7.2000, p. 1.(6) Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (OJ L 42, 23.2.1970, p. 1). Directive as last amended by Commission Directive 2001/116/EC (OJ L 18, 21.1.2002, p. 1).(7) Council Directive 88/77/EEC of 3 December 1987 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous pollutants from diesel engines for use in vehicles (OJ L 36, 9.2.1988, p. 33). Directive as last amended by Commission Directive 2001/27/EC (OJ L 107, 18.4.2001, p. 10).(8) Council Directive 92/24/EEC of 31 March 1992 relating to speed limitation devices or similar speed limitation on-board systems of certain categories of motor vehicles (OJ L 129, 14.5.1992, p. 154).


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31982L0711

Council Directive 82/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs

Official Journal L 297 , 23/10/1982 P. 0026 - 0030 Finnish special edition: Chapter 13 Volume 12 P. 0132  Spanish special edition: Chapter 13 Volume 12 P. 0278  Swedish special edition: Chapter 13 Volume 12 P. 0132  Portuguese special edition Chapter 13 Volume 12 P. 0278

*****COUNCIL  DIRECTIVE  of 18 October 1982  laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs  (82/711/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 76/893/EEC of 23 November 1976 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular Article 3 thereof,  Having regard to the proposal from 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 Article 2 of Directive 76/893/EEC laid down inter alia that materials and articles must not transfer their constituents to foodstuffs in quantities which could endanger human health or bring about an unacceptable change in the composition of the foodstuffs;  Whereas in order to achieve this objective in the case of plastic materials the suitable instrument is a specific directive within the meaning of Article 3 of Directive 76/893/EEC, the general rules of which shall also be applicable to the case in question;  Whereas, given the complexity of the problem, the Directive should initially be limited to fixing the basic rules for verification of constituent migration; whereas further directives, to be adopted in accordance with the procedure laid down in Article 10 of Directive 76/893/EEC, will establish the methods of analysis necessary for the verification of such migration;  Whereas this Directive does not affect all aspects of plastic materials and articles; whereas it is therefore necessary to authorize the Member States, on the one hand, not to impose the labelling particulars laid down in Article 7 of Directive 76/893/EEC in accordance with paragraphs 4 and 5 of that Article and, on the other hand, to prohibit the marketing of materials and articles which, although conforming with the standards laid down by that Directive, do not comply with national provisions regarding other possible standards referred to in Article 3 or in the absence of these, with Article 2 of the Directive in question;  Whereas, in view of the analytical difficulties connected with the determination of the migration levels in food products, conventional tests should be chosen (liquids capable of simulating the attack on foodstuffs and standard test conditions) in order to reproduce, as far as possible, the migration phenomena which may occur in contact between the article and the foodstuff;  Whereas if such tests subsequently prove not to reflect reality Member States should be authorized to amend them provisionally, pending a Community decision;  Whereas, in the current state of analytical techniques, it is not possible to determine all the conditions under which conventional migration tests should be performed on materials and articles consisting of two or more layers, one or more of which does not consist entirely of plastics; whereas a decision on the application of this Directive to such materials and articles should therefore be taken at a later date;  Whereas the adaptation of this Directive to technical progress is an implementing measure; whereas, in order to simplify and accelerate the procedure, this should be the responsibility of the Commission;  Whereas in all cases in which the Council confers on the Commission authority to implement the provisions relating to plastic materials and articles intended to come into contact with foodstuffs, a procedure should be laid down establishing close cooperation between Member States and the Commission within the Standing Committee for Foodstuffs set up under Decision 69/414/EEC (1),  HAS ADOPTED THIS DIRECTIVE:  Article 1  1. This Directive is a specific Directive within the meaning of Article 3 of Directive 76/893/EEC.  2. This Directive shall apply to plastic materials and articles, that is to say to materials and articles and parts thereof:  (a) consisting exclusively of plastics, or  (b) composed of two or more layers of materials, each consisting exclusively of plastics, which are bound together by means of adhesives or by any other means,  which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs and are intended for that purpose.  3. For the purposes of this Directive, 'plastics' shall mean the organic macromolecular compounds obtained by polymerization, polycondensation, polyaddition or any other similar process from molecules with a lower molecular weight or by chemical alteration of natural macromolecules. Silicones and other similar macromolecular compounds shall also be regarded as plastics. Other substances or matter may be added to such macromolecular compounds.  However, the following shall not be regarded as 'plastics':  (i) varnished or unvarnished regenerated cellulose film;  (ii) elastomers and natural and synthetic rubber;  (iii) paper and paperboard, whether modified or not by the addition of plastics;  (iv) surface coatings obtained from:  - paraffin waxes, including synthetic paraffin waxes, and/or micro-crystalline waxes,  - mixtures of the waxes listed in the first indent with each other and/or with plastics.  4. This Directive shall not apply to materials and articles composed or two or more layers, one or more of which does not consist exclusively of plastics, even if the one intended to come into direct contact with foodstuffs does consist exclusively of plastics.  A decision on the application of this Directive to the materials and articles referred to in the first subparagraph and on any adaptations to the Directive that may become necessary shall be taken at a later date.  Article 2  1. The migration level of the constituents of the materials and articles referred to in Article 1 into or onto foodstuffs must not exceed the limits laid down in the lists of substances whose use is authorized to the exclusion of any others.  2. In the absence of methods of analysis determined in accordance with Article 9 of Directive 76/893/EEC which make it possible to determine the level of migration into foodstuffs, that level shall be determined in the simulants listed in Chapter I of the Annex.  3. The Council, acting in accordance with the procedure laid down in Article 100 of the Treaty and on a proposal from the Commission, shall draw up a list of substances or matter whose use is authorized to the exclusion of any others and a list of simulants to be used for each foodstuff or group of foodstuffs and shall determine the concentration thereof.  Article 3  1. Verification of a migration in the simulants shall be carried out using conventional migration tests, the basic rules for which are laid down in the Annex to this Directive.  2. (a) However, where a Member State, as a result of new information or of a reassessment of existing information made since this Directive was adopted, has detailed grounds for establishing that for a given plastic material or article the basic rules laid down in the Annex for migration tests are technically unsuitable or because the actual conditions of use are basically different from the test conditions specified in the table in the Annex, that Member State may,  within its territory and only for the particular case, temporarily suspend application of the basic rules referred to in the Annex and permit the use of more appropriate basic rules. It shall immediately inform the other Member States and the Commission thereof and give the reasons for its decision.  (b) The Commission shall examine, as soon as possible, the reasons given by the Member State concerned and shall consult the Member States within the Standing Committee for Foodstuffs and shall then deliver its opinion forthwith and take the appropriate measures.  (c) If the Commission considers that amendments to this Directive are necessary in order to alleviate the difficulties mentioned in subparagraph (a), it shall initiate the procedure laid down in Article 10 of Directive 76/893/EEC; in that case, the Member State which has adopted the more appropriate basic rules may retain them until the said amendments enter into force.  Article 4  Adaptations to be made to Chapter II of the Annex to this Directive in the light of progress in scientific and technical knowledge shall be adopted in accordance with the procedure laid down in Article 10 of Directive 76/893/EEC.  Article 5  This Directive shall not affect national provisions relating to the other rules provided for in Article 3 of Directive 76/893/EEC nor the options open to Member States under Article 7 (4) and (5) of that Directive.  Article 6  Member States shall comply with this Directive not later than such time as a specific directive laying down the limits referred to in Article 2 (1) is implemented.  Article 7  This Directive is addressed to the Member States.  Done at Luxembourg, 18 October 1982.  For the Council  The President  N. A. KOFOED  (1) OJ No L 340, 9. 12. 1976, p. 19.  (2) OJ No C 140, 5. 6. 1979, p. 173.  (3) OJ No C 227, 10. 9. 1979, p. 31.  (1) OJ No L 291, 19. 11. 1969, p. 9.  ANNEX  BASIC RULES NECESSARY FOR TESTING MIGRATION IN SIMULANTS  The determination of migration in simulants is to be carried out using the simulants laid down in Chapter I of this Annex and under the test conditions specified in Chapter II of the Annex.  CHAPTER I  Simulants  1. General case: plastic materials and articles intended to come into contact with foodstuffs of all types  The tests are to be carried out using all the simulants mentioned below, taking a fresh sample of the plastic material or article for each simulant:  - distilled water or water of equivalent quality (= simulant A),  - 3 % acetic acid (w/v) in aqueous solution (= simulant B),  - 15 % ethanol (v/v) in aqueous solution (= simulant C),  - rectified olive oil (1); if for technical reasons connected with the method of analysis it is necessary to use different simulants, olive oil must be replaced by a mixture of synthetic triglycerides (2) or by sunflower oil (= simulant D).  2. Special case: plastic materials and articles intended to come into contact with a single foodstuff or a specific group of foodstuffs  The tests are to be carried out:  - using only the simulants specified as appropriate for the foodstuff or group of foodstuffs in the list referred to in Article 2 (3),  - where the foodstuff or group of foodstuffs is not included in the list referred to in the first indent, selecting the simulant or simulants prescribed in Section 1 which correspond most closely to the extractive capacity of the foodstuff or group of foodstuffs.  CHAPTER II  Test conditions (times and temperatures)  1. The migration tests are to be carried out, selecting from the times and temperatures specified in the table those which correspond most closely to the normal or foreseeable conditions of contact for the plastic materials or articles being studied.  2. If a plastic material or article is intended to be used successively at short intervals in several of the conditions of contact referred to in column 1 of the table, migration will be determined by subjecting that material or article successively to all the corresponding test conditions specified in column 2, using the same simulant.  3. For a given test time, where a plastic material or article passes the test at the higher temperature, the test need not be repeated at the lower temperature.  For a given test temperature, where a plastic material or article passes the test over the longer time, the test need not be repeated over the shorter time.  (1) Characteristics of rectified olive oil:  - iodine index (Wijs) = 80 to 88,  - refraction index at 25 °C = 1;4665 to 1;4679,  - acidity (expressed in % of oleic acid = 0;5 % maximum,  - peroxide index (expressed in milli-equivalents of oxygen per kg of oil) = 10 maximum.  (2) Characteristics of the standard synthetic triglycerides mixture as described in K. Figge's article, 'Food cosmet. Toxicol' 10 (1972) 815.  TABLE  Test conditions (times (t) and temperatures (T)) to be chosen according to conditions of contact in actual use  1.2 //   //   // Conditions of contact in actual use  // Test conditions  //   //   // 1  // 2  //   //   // 1. Contact time: t > 24 hours  //   // 1.1. T µ 5 °C  // 10 days at 5 °C  // 1.2. 5 °C < T µ 40 °C (1)  // 10 days at 40 °C  // 2. Contact time: two hours µ t µ 24 hours  //   // 2.1. T µ 5 °C  // 24 hours at 5 °C  // 2.2. 5 °C < T µ 40 °C  // 24 hours at 40 °C  // 2.3. T > 40 °C  // In accordance with national laws  // 3. Contact time: t < two hours  //   // 3.1. T µ 5 °C  // Two hours at 5 °C  // 3.2. 5 °C < T µ 40 °C  // Two hours at 40 °C  // 3.3. 40 °C < T µ 70 °C  // Two hours at 70 °C  // 3.4. 70 °C < T µ 100 °C  // One hour at 100 °C  // 3.5. 100 °C < T µ 121 °C  // 30 min at 121 °C  // 3.6. T > 121 °C  // In accordance with national laws  //   //  (1) For plastic materials and articles in contact with foodstuffs for which a preservation temperature of less than 20 °C is specified on the labelling or by law, the test conditions will be 10 days at 20 °C.  4.  Where the plastic material or article may in actual use be employed under any conditions of contact time or temperature, only the 10-day tests at 40 °C and the two-hour tests at 70 °C are to be carried out, these being conventionally regarded as the most stringent.  If simulant D is used (rectified olive oil or substitutes for it), only the 10-day test at 40 °C is to be carried out.  5. If it is found that carrying out the tests under the conditions specified in the table causes physical or other changes in the plastic material or article which do not occur under normal or foreseeable conditions of use of that material or article, the migration tests should be carried out under conditions more appropriate to the specific case.


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32004L0007

Council Directive 2004/7/EC of 20 January 2004 amending Directive 77/388/EEC concerning the common system of value added tax, as regards conferment of implementing powers and the procedure for adopting derogations

Official Journal L 027 , 30/01/2004 P. 0044 - 0045

Council Directive 2004/7/ECof 20 January 2004amending Directive 77/388/EEC concerning the common system of value added tax, as regards conferment of implementing powers and the procedure for adopting derogationsTHE 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,Having regard to the opinion of the European Parliament(1),Having regard to the opinion of the European Economic and Social Committee(2),Whereas:(1) Articles 27 and 30 of 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(3), lay down procedures that may result in the tacit approval of derogations by the Council.(2) In the interests of transparency and legal certainty, it is preferable to ensure that every derogation authorised under Article 27 or Article 30 of Directive 77/388/EEC takes the form of an explicit decision adopted by the Council acting on a proposal from the Commission.(3) The possibility of tacit approval by the Council on the expiry of a given period should therefore be removed.(4) In order to ensure that a Member State which has submitted a request for derogation is not left in doubt as to what action the Commission plans to take in response, time limits should be laid down within which the Commission must present to the Council either a proposal for authorisation or a communication setting out its objections.(5) In order to enable Member States to follow more closely the processing of their requests, the Commission should be required, once it has all the information it considers necessary for appraising a request, to notify the requesting Member State accordingly and transmit the request, in its original language, to the other Member States.(6) In the second sentence of paragraph 1 of Article 27 of Directive 77/388/EEC it is emphasised that the assessment of the negligible extent of the effect of the simplification measure on the amount of tax due at the final consumption stage is made in a global manner by reference to macroeconomic forecasts relating to the likely impact of the measure on the Community's own resources provided from VAT.(7) In the absence of any mechanism for the adoption of binding measures to govern the implementation of Directive 77/388/EEC, the application of rules laid down in that Directive varies from one Member State to another.(8) In order to improve the functioning of the internal market, it is essential to ensure more uniform application of the current VAT system. The introduction of a procedure for the adoption of measures to ensure the correct implementation of existing rules would represent a major step forward in that respect.(9) Those measures should, in particular, address the problem of double taxation of cross-border transactions which can occur as the result of divergences between Member States in the application of the provisions of Directive 77/388/EEC governing the place of supply.(10) However, the scope of each implementing measure should remain limited since, albeit designed to clarify a provision laid down in Directive 77/388/EEC, it could never derogate from such a provision.(11) Although the scope of the implementing measures would be limited, those measures would have a budgetary impact which for one or more Member States could be significant.(12) The impact of such measures on the budgets of Member States justifies the Council reserving the right to exercise powers for the implementation of Directive 77/388/EEC itself.(13) Given the restricted scope of the measures envisaged, measures implementing Directive 77/388/EEC should be adopted by the Council acting unanimously on a proposal from the Commission.(14) Since, for those reasons, the objectives of this Directive cannot be sufficiently achieved by the Member States acting alone and can therefore be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.(15) Directive 77/388/EEC should therefore be amended accordingly,HAS ADOPTED THIS DIRECTIVE:Article 1Directive 77/388/EEC is amended as follows:1. In Article 27, paragraphs 1, 2, 3 and 4 shall be replaced by the following:"1. The Council, acting unanimously on a proposal from the Commission, may authorise any Member State to introduce special measures for derogation from the provisions of this Directive, in order to simplify the procedure for charging the tax or to prevent certain types of tax evasion or avoidance. Measures intended to simplify the procedure for charging the tax, except to a negligible extent, may not affect the overall amount of the tax revenue of the Member State collected at the stage of final consumption.2. A Member State wishing to introduce the measure referred to in paragraph 1 shall send an application to the Commission and provide it with all the necessary information. If the Commission considers that it does not have all the necessary information, it shall contact the Member State concerned within two months of receipt of the application and specify what additional information is required. Once the Commission has all the information it considers necessary for appraisal of the request it shall within one month notify the requesting Member State accordingly and it shall transmit the request, in its original language, to the other Member States.3. Within three months of giving the notification referred to in the last sentence of paragraph 2, the Commission shall present to the Council either an appropriate proposal or, should it object to the derogation requested, a communication setting out its objections.4. In any event, the procedure set out in paragraphs 2 and 3 shall be completed within eight months of receipt of the application by the Commission."2. In Title XVII, the following Article 29a shall be inserted:"Article 29aImplementing measuresThe Council, acting unanimously on a proposal from the Commission, shall adopt the measures necessary to implement this Directive."3. Article 30 shall be replaced by the following:"Article 30International agreements1. The Council, acting unanimously on a proposal from the Commission, may authorise any Member State to conclude with a third country or an international organisation an agreement which may contain derogations from this Directive.2. A Member State wishing to conclude such an agreement shall send an application to the Commission and provide it with all the necessary information. If the Commission considers that it does not have all the necessary information, it shall contact the Member State concerned within two months of receipt of the application and specify what additional information is required. Once the Commission has all the information it considers necessary for appraisal of the request it shall within one month notify the requesting Member State accordingly and it shall transmit the request, in its original language, to the other Member States.3. Within three months of giving the notification referred to in the last sentence of paragraph 2, the Commission shall present to the Council either an appropriate proposal or, should it object to the derogation requested, a communication setting out its objections.4. In any event, the procedure set out in paragraphs 2 and 3 shall be completed within eight months of receipt of the application by the Commission."Article 2This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.Article 3This Directive is addressed to the Member States.Done at Brussels, 20 January 2004.For the CouncilThe PresidentC. McCreevy(1) Opinion delivered on 16 December 2003 (not yet published in the Official Journal).(2) Opinion delivered on 30 October 2003 (not yet published in the Official Journal).(3) OJ L 145, 13.6.1977, p. 1. Directive as last amended by Directive 2003/92/EC (OJ L 260, 11.10.2003, p. 8).


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31995L0042

Commission Directive 95/42/EC of 19 July 1995 amending Directive 93/102/EC amending Directive 79/112/EEC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer

Official Journal L 182 , 02/08/1995 P. 0020 - 0020

COMMISSION DIRECTIVE 95/42/EC of 19 July 1995 amending Directive 93/102/EC amending Directive 79/112/EEC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 79/112/EEC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (1), as last amended by Commission Directive 93/102/EC (2), and in particular Article 6 (5) (b) thereof, first and second indent,Whereas Article 3 of Directive 93/102/EC states that Member States shall, if appropriate, amend their laws, regulations and administrative provisions so that they prohibit trade in products not complying with the Directive with effect from 30 June 1996;Whereas trade in products labelled before that date whose list of ingredients states the name of a category of ingredients not appearing in the Directive 93/102/EC is not permitted after that date;Whereas relabelling of the foodstuffs is difficult to envisage technically and a clause providing for disposal of stocks labelled before the transposition deadline therefore needs to be included;Whereas the measures laid down by this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1 The following sentence shall be added to Article 3, second paragraph, second indent, of Directive 93/102/EC:'However, trade in products placed on the market or labelled before that date and not complying with this Directive shall be permitted for as long as stocks last`.Article 2 The present Directive enters into effect on the 20th day following its publication in the Official Journal of the European Communities.Article 3 This Directive is addressed to the Member States.Done at Brussels, 19 July 1995.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ No L 33, 8. 2. 1979, p. 1.(2) OJ No L 291, 25. 11. 1993, p. 14.