title: Commission Directive 2008/45/EC of 4 April 2008 amending Council Directive 91/414/EEC as regards an extension of the use of the active substance metconazole (Text with EEA relevance)

text:
               5.4.2008

               EN

               Official Journal of the European Union

               L 94/21

      COMMISSION DIRECTIVE 2008/45/EC
   of 4 April 2008
   amending Council Directive 91/414/EEC as regards an extension of the use of the active substance metconazole
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the second indent of the second subparagraph of Article 6(1) thereof,
   Whereas:

               (1)

               By Commission Directive 2006/74/EC (2) metconazole was included as active substance in Annex I to Directive 91/414/EEC.

               (2)

               When applying for the inclusion of metconazole its notifier BASF Aktiengesellschaft submitted data on uses to control fungi which supported the overall conclusion that it may be expected that plant protection products containing metconazole will fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. Therefore, metconazole was included in Annex I to that Directive with the specific provisions that Member States may only authorise uses as fungicide.

               (3)

               In addition to the control of fungi in certain agricultural uses, the notifier now has applied for an amendment to those specific provisions as regards the use as a plant growth regulator. In order to support such an extension of the use, the notifier submitted additional information.

               (4)

               Belgium evaluated the information and data submitted by the notifier. It informed the Commission in October 2007 that it concluded that the requested extension of use does not cause any risks in addition to those already taken into account in the specific provisions for metconazole in Annex I to Directive 91/414/EEC and in the Commission review report for that substance. This is particularly the case since the extension covers applications at rates that are lower than those necessary for a use as fungicide while the other application parameters as set out in the specific provisions of Annex I to Directive 91/414/EEC remain unchanged.

               (5)

               Therefore it is justified to modify the specific provisions for metconazole.

               (6)

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

               (7)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 5 August 2008 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 6 August 2008.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 4 April 2008.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2008/41/EC (OJ L 89, 1.4.2008, p. 12).

      (2)  OJ L 235, 30.8.2006, p. 17.

      ANNEX
      In Annex I to Directive 91/414/EEC, row 136 is replaced by the following:

                     ‘136

                     Metconazole
                     CAS No 125116-23-6 (unstated stereo-chemistry)
                     CIPAC No 706

                     (1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol

                     ≥ 940 g/kg
                     (sum of cis-and trans-isomers)

                     1 June 2007

                     31 May 2017

                     Part A
                     Only uses as fungicide and plant growth regulator may be authorised.
                     Part B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on metconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.
                     In this overall assessment:

                                 —

                                 Member States must pay particular attention to the protection of aquatic organisms, birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate,

                                 —

                                 Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate.’


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32000L0017

Council Directive 2000/17/EC of 30 March 2000 amending Directive 77/388/EEC on the common system of value added tax - transitional provisions granted to the Republic of Austria and the Portuguese Republic

Official Journal L 084 , 05/04/2000 P. 0024 - 0025

Council Directive 2000/17/ECof 30 March 2000amending Directive 77/388/EEC on the common system of value added tax - transitional provisions granted to the Republic of Austria and the Portuguese RepublicTHE 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 Community,Having regard to the opinion of the European Parliament(1),Having regard to the opinion of the Economic and Social Committee(2),Whereas:(1) Point 2(e) of Part IX "Taxation" of Annex XV to the 1994 Act of Accession authorised the Republic of Austria to derogate from Article 28(2) of 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(3), (hereinafter referred to as the "sixth VAT Directive") and to apply a reduced rate to the letting of immovable property for residential use until 31 December 1998, provided that the rate was not lower than 10 %.(2) Under Article 13(B)(b) of the sixth VAT Directive, the letting of immovable property for residential use in Austria has been exempt from VAT since 1 January 1999 without the right to deduct input tax. However, under Article 13(C)(a) of that Directive, Austria may allow taxpayers the right to opt for taxation. In that case, the normal VAT rate and the normal rules for the right to deduction apply.(3) The Republic of Austria considers that the measure is still essential, mainly because the transitional VAT regime is still in force and the situation has not really changed since the negotiation of the 1994 Act of Accession.(4) The Republic of Austria also considers that dispensing with the reduced rate of 10 % would inevitably lead to an increase in the price of immovable property rental for the final consumer.(5) The Portuguese Republic applied a reduced rate of 8 % to restaurant services as at 1 January 1991. Under Article 28(2)(d) of the sixth VAT Directive, Portugal was permitted to continue applying that rate. However, after a comprehensive amendment of the rates and for political and budgetary reasons, restaurant services were made subject to the normal rate from 1992.(6) The Portuguese Republic wishes to reintroduce a reduced rate on these services on the basis that maintaining the normal rate had adverse consequences, in particular job losses and an increase in undeclared employment, and that application of the normal rate increased the price of restaurant services for the final consumer.(7) As the derogations in question concern supplies of services within a single Member State, the risk of distortion of competition can be considered non-existent.(8) In these circumstances, return to the previous situation may be considered for both the Republic of Austria and the Portuguese Republic, provided that application of the derogations is limited to the transitional period referred to in Article 281 of the sixth VAT Directive. However, the Republic of Austria must take the necessary steps to ensure that the reduced rate has no adverse effects on the European Communities' own resources accruing from VAT, the basis of assessment for which must be reconstituted in accordance with Regulation (EEC, Euratom) No 1553/89(4),HAS ADOPTED THIS DIRECTIVE:Article 1The following points shall be added to Article 28(2) of the sixth VAT Directive:"j) the Republic of Austria may apply one of the two reduced rates provided for in the third subparagraph of Article 12(3)(a) to the letting of immovable property for residential use, provided that the rate is not lower than 10 %;k) the Portuguese Republic may apply one of the two reduced rates provided for in the third subparagraph of Article 12(3)(a) to restaurant services, provided that the rate is not lower than 12 %."Article 21. The Member States referred to in Article 1 shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.When the 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 for making such a reference shall be laid down by the Member States.2. The Member States referred to in Article 1 shall communicate to the Commission the text of the provisions of national law which they adopt in the field governed by this Directive.Article 3This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.It shall apply as from 1 January 1999 until the end of the transitional period referred to in Article 281 of the sixth VAT Directive.Article 4This Directive is addressed to the Member States.Done at Brussels, 30 March 2000.For the CouncilThe PresidentJ. Sócrates(1) Opinion delivered on 15 March 2000 (not yet published in the Official Journal).(2) OJ C 75, 15.3.2000, p. 21.(3) OJ L 145, 13.6.1977, p. 1. Directive as last amended by Directive 1999/85/EC (OJ L 277, 28.10.1999, p. 34).(4) OJ L 155, 7.6.1989, p. 9.


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32003L0092

Council Directive 2003/92/EC of 7 October 2003 amending Directive 77/388/EEC as regards the rules on the place of supply of gas and electricity

Official Journal L 260 , 11/10/2003 P. 0008 - 0009

Council Directive 2003/92/ECof 7 October 2003amending Directive 77/388/EEC as regards the rules on the place of supply of gas and electricityTHE 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 European Economic and Social Committee(3),Whereas:(1) Increasing liberalisation of the gas and electricity sector, aimed at completing the internal market for electricity and natural gas, has revealed a need to review the current VAT rules on the place of supply of those goods, set out in 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), in order to modernise and simplify the operation of the VAT system within the context of the internal market, a strategy to which the Commission is committed.(2) Electricity and gas are treated as goods for VAT purposes, and, accordingly, the place of their supply with respect to cross-border transactions has to be determined in accordance with Article 8 of Directive 77/388/EEC. However, since electricity and gas are difficult to track physically it is particularly difficult to determine the place of supply under the current rules.(3) In order to attain a real internal market for electricity and gas without VAT obstacles, the place of supply of gas through the natural gas distribution system and of electricity, before the goods reach the final stage of consumption, should be determined to be the place where the customer has established his business.(4) The supply of electricity and gas in the final stage, from traders and distributors to final consumer, should be taxed at the place where the customer has effective use and consumption of the goods, in order to ensure that taxation takes place in the country where actual consumption takes place. This is normally the place where the meter of the customer is located.(5) Electricity and gas are supplied through distribution networks, to which network operators provide access. In order to avoid double or non-taxation, it is necessary to harmonise the rules governing the place of supply of the transmission and transportation services. Access to and use of the distribution systems and the provision of other services directly linked to these services should therefore be added to the list of specific instances set out in Article 9, paragraph 2(e) of Directive 77/388/EEC.(6) The import of gas through the natural gas distribution system, or of electricity, should be exempted in order to avoid double taxation.(7) Those changes in the rules governing the place of supply of gas through the natural gas distribution system, or of electricity, should be combined with a compulsory reverse charge when the customer is a person identified for VAT purposes.(8) Directive 77/388/EEC should therefore be amended accordingly,HAS ADOPTED THIS DIRECTIVE:Article 1Directive 77/388/EEC is hereby amended as follows:1. in Article 8(1), the following points are added:"(d) in the case of the supply of gas through the natural gas distribution system, or of electricity, to a taxable dealer: the place where that taxable dealer has established his business or has a fixed establishment for which the goods are supplied, or, in the absence of such a place of business or fixed establishment, the place where he has his permanent address or usually resides.'Taxable dealer' for the purposes of this provision means a taxable person whose principal activity in respect of purchases of gas and electricity is reselling such products and whose own consumption of these products is negligible.(e) in the case of the supply of gas through the natural gas distribution system, or of electricity, where such a supply is not covered by point (d): the place where the customer has effective use and consumption of the goods. Where all or part of the goods are not in fact consumed by this customer, these non consumed goods are deemed to have been used and consumed at the place where he has established his business or has a fixed establishment for which the goods are supplied. In the absence of such a place of business or fixed establishment, he is deemed to have used and consumed the goods at the place where he has his permanent address or usually resides.";2. in Article 9(2)(e), the following indent is inserted after the eighth indent:"- the provision of access to, and of transport or transmission through, natural gas and electricity distribution systems and the provision of other directly linked services.";3. in Article 14(1), the following point is added:"(k) import of gas through the natural gas distribution system, or of electricity.";4. Article 21(1)(a), in the version set out in Article 28g, is replaced by the following:"(a) the taxable person carrying out the taxable supply of goods or of services, except for the cases referred to in (b), (c) and (f). Where the taxable supply of goods or of services is effected by a taxable person who is not established within the territory of the country, Member States may, under the conditions determined by them, lay down that the person liable to pay tax is the person for whom the taxable supply of goods or of services is carried out;"5. in Article 21(1), in the version set out in Article 28g, the following point is added:"(f) persons who are identified for value added tax purposes within the territory of the country and to whom goods are supplied under the conditions set out in Article 8(1)(d) or (e), if the supplies are carried out by a taxable person not established within the territory of the country.";6. in Article 22(1)(c), in the version set out in Article 28h, the first intent is replaced by the following:"- Every taxable person, with the exception of those referred to in Article 28a(4), who, within the territory of the country, effects supplies of goods or of services giving him the right of deduction, other than supplies of goods or of services for which tax is payable solely by the customer or the recipient in accordance with Article 21(1)(a), (b), (c) or (f). However, Member States need not identify certain taxable persons referred to in article 4(3),";7. in Article 28a(5)(b) the following indent is added:"- the supply of gas through the natural gas distribution system, or of electricity, under the conditions set out in Article 8(1)(d) or (e)."Article 2Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive on 1 January 2005. 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. 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 Union.Article 4This Directive is addressed to the Member States.Done at Luxembourg, 7 October 2003.For the CouncilThe PresidentG. Tremonti(1) Proposal of 5 December 2002 (not yet published in the Official Journal).(2) Opinion delivered on 13.5.2003 (not yet published in the Official Journal).(3) Opinion delivered on 26.3.2003 (not yet published in the Official Journal).(4) OJ L 145, 13.6.1977, p.1. Directive as last amended by Directive 2002/93/EC (OJ L 331, 7.12.2002, p. 27).


title: Commission Directive 2010/54/EU of 20 August 2010 amending Annex I to Council Directive 91/414/EEC to renew the inclusion of azimsulfuron as active substance  Text with EEA relevance

text:
               21.8.2010

               EN

               Official Journal of the European Union

               L 220/63

         COMMISSION DIRECTIVE 2010/54/EU
   of 20 August 2010
   amending Annex I to Council Directive 91/414/EEC to renew the inclusion of azimsulfuron as active substance
   (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)

               The inclusion of azimsulfuron in Annex I to Directive 91/414/EEC expires on 31 December 2011. A notification was submitted in accordance with Article 4 of Commission Regulation (EC) No 737/2007 of 27 June 2007 on laying down the procedure of the renewal of the inclusion of a first group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (2) for the renewal of the inclusion of azimsulfuron as active substance in Annex I to Directive 91/414/EEC within the time period provided for in that Article.

               (2)

               That notification was found to be admissible by Commission Decision 2008/656/EC of 28 July 2008 on the admissibility of the notifications concerning the renewal of the inclusion in Annex I to Council Directive 91/414/EEC of the active substances azimsulfuron, azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl, prohexadion-calcium and spiroxamin, and establishing the list of the notifiers concerned (3).

               (3)

               Within the time period provided for in Article 6 of Regulation (EC) No 737/2007, the notifier submitted the data required in accordance with Article 6 of Regulation (EC) No 737/2007 together with an explanation as regards the relevance of each new study submitted.

               (4)

               The rapporteur Member State prepared an assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter: ‘the Authority’) and the Commission on 10 June 2009. In addition to the assessment of the substance, that report includes a list of the studies the rapporteur Member State relied on for its assessment.

               (5)

               The Authority communicated the assessment report to the notifier and to all the Member States and forwarded the comments received to the Commission. The Authority also made the assessment report available to the public.

               (6)

               At the request of the Commission, the assessment report was peer reviewed by the Member States and the Authority, and the Authority presented its conclusion on the peer review of the risk assessment of azimsulfuron (4) to the Commission on 12 March 2010. The assessment report and the conclusion from 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 9 July 2010 in the format of the Commission review report for azimsulfuron.

               (7)

               It has appeared from the various examinations made that plant protection products containing azimsulfuron may be expected to continue to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to renew the inclusion of azimsulfuron in Annex I to Directive 91/414/EEC, in order to ensure that plant protection products containing this active substance may continue to be authorised where they comply with that Directive.

               (8)

               Based on the review report which points out that the manufacturing impurity phenol is of toxicological concern a maximum level of 2 g/kg should, however, be set for that impurity in the technical material.

               (9)

               From the new data submitted, it appears that azimsulfuron and its degradation products in aqueous photolysis may cause risks for aquatic organisms. Without prejudice to the conclusion that the inclusion of azimsulfuron is to be renewed, it is therefore appropriate to obtain further information on those specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that the notifier submit further information as regards the assessment of the risks azimsulfuron may pose for aquatic organisms and to complete the identification of its degradation products in aqueous photolysis.

               (10)

               A reasonable period should be allowed to elapse before the inclusion of an active substance in Annex I to Directive 91/414/EEC is renewed in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the renewal.

               (11)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of renewing the inclusion of an active substance in Annex I thereto, Member States should be allowed a period of six months after renewal to review authorisations of plant protection products containing azimsulfuron to make sure that the requirements laid down in Directive 91/414/EEC, in particular in its Article 13, and the relevant conditions set out in Annex I to that Directive, continue to be satisfied. As appropriate, Member States should renew, where appropriate with modifications, or refuse to renew authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (12)

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

               (13)

               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 in accordance with the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 31 January 2012 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 February 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.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing azimsulfuron as an active substance by 31 January 2012.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to azimsulfuron 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 azimsulfuron 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 July 2011 at the latest, Member States shall, where necessary, re-evaluate the products, to take into account developments occurred in the scientific and technical knowledge and 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 azimsulfuron. On the basis of that evaluation, they shall determine whether the product still 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, where necessary, amend or withdraw the authorisation by 31 July 2015.
   3.   By way of derogation from paragraphs 1 and 2, for each authorised plant protection product containing azimsulfuron as one of several active substances, all of which were listed in Annex I to Directive 91/414/EEC by 31 July 2011 at the latest, and at least one of which was included in Annex I to Directive 91/414/EEC between 1 January 2009 and 31 July 2011, 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 azimsulfuron. 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, where necessary, amend or withdraw the authorisation by 31 July 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 4
   This Directive shall enter into force on 1 August 2011.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 20 August 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 169, 29.6.2007, p. 10.

      (3)  OJ L 214, 9.8.2008, p. 70.

      (4)  Conclusion on the peer review of the pesticide risk assessment of the active substance azimsulfuron. EFSA Journal 2010; 8(3):1554. [61 pp.]. doi:10.2903/j.efsa.2010.1554. Available online: www.efsa.europa.eu

      ANNEX
      In Annex I to Directive 91/414/EEC, row No 5 is replaced by the following:

                     No

                     Common Name,
                     Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘5

                     azimsulfuron
                     CAS No 120162-55-2
                     CIPAC No 584

                     1-(4,6-dimethoxypyrimidin-2-yl)-3-[1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-pyrazol-5-ylsulfonyl]-urea

                     ≥ 980 g/kg
                     maximum level of the impurity phenol 2 g/kg

                     1 August 2011

                     31 July 2021

                     PART A
                     Only uses as herbicide may be authorised.
                     Aerial applications may not be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on azimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 July 2010, shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the protection of non-target plants,

                                 —

                                 the potential for groundwater contamination, when the active substance is applied in vulnerable scenarios and/or climatic conditions,

                                 —

                                 the protection of aquatic organisms.

                           Member States must ensure that the conditions of authorisation include risk mitigation measures, where appropriate (e.g. buffer zones, in rice cultivation minimum holding periods for water prior to discharge).
                     The Member States concerned shall request the submission of further studies to finalise the risk assessment on aquatic organisms and further studies to complete the identification of the degradation products in the aqueous photolysis of the substance. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2012.’

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


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32001L0086

Council Directive 2001/86/EC of 8 October 2001 supplementing the Statute for a European company with regard to the involvement of employees

Official Journal L 294 , 10/11/2001 P. 0022 - 0032

Council Directive 2001/86/ECof 8 October 2001supplementing the Statute for a European company with regard to the involvement of employeesTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 308 thereof,Having regard to the amended 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) In order to attain the objectives of the Treaty, Council Regulation (EC) No 2157/2001(4) establishes a Statute for a European company (SE).(2) That Regulation aims at creating a uniform legal framework within which companies from different Member States should be able to plan and carry out the reorganisation of their business on a Community scale.(3) In order to promote the social objectives of the Community, special provisions have to be set, notably in the field of employee involvement, aimed at ensuring that the establishment of an SE does not entail the disappearance or reduction of practices of employee involvement existing within the companies participating in the establishment of an SE. This objective should be pursued through the establishment of a set of rules in this field, supplementing the provisions of the Regulation.(4) Since the objectives of the proposed action, as outlined above, cannot be sufficiently achieved by the Member States, in that the object is to establish a set of rules on employee involvement applicable to the SE, and can therefore, by reason of the scale and impact of the proposed 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 these objectives.(5) The great diversity of rules and practices existing in the Member States as regards the manner in which employees' representatives are involved in decision-making within companies makes it inadvisable to set up a single European model of employee involvement applicable to the SE.(6) Information and consultation procedures at transnational level should nevertheless be ensured in all cases of creation of an SE.(7) If and when participation rights exist within one or more companies establishing an SE, they should be preserved through their transfer to the SE, once established, unless the parties decide otherwise.(8) The concrete procedures of employee transnational information and consultation, as well as, if applicable, participation, to apply to each SE should be defined primarily by means of an agreement between the parties concerned or, in the absence thereof, through the application of a set of subsidiary rules.(9) Member States should still have the option of not applying the standard rules relating to participation in the case of a merger, given the diversity of national systems for employee involvement. Existing systems and practices of participation where appropriate at the level of participating companies must in that case be maintained by adapting registration rules.(10) The voting rules within the special body representing the employees for negotiation purposes, in particular when concluding agreements providing for a level of participation lower than the one existing within one or more of the participating companies, should be proportionate to the risk of disappearance or reduction of existing systems and practices of participation. That risk is greater in the case of an SE established by way of transformation or merger than by way of creating a holding company or a common subsidiary.(11) In the absence of an agreement subsequent to the negotiation between employees' representatives and the competent organs of the participating companies, provision should be made for certain standard requirements to apply to the SE, once it is established. These standard requirements should ensure effective practices of transnational information and consultation of employees, as well as their participation in the relevant organs of the SE if and when such participation existed before its establishment within the participating companies.(12) Provision should be made for the employees' representatives acting within the framework of the Directive to enjoy, when exercising their functions, protection and guarantees which are similar to those provided to employees' representatives by the legislation and/or practice of the country of employment. They should not be subject to any discrimination as a result of the lawful exercise of their activities and should enjoy adequate protection as regards dismissal and other sanctions.(13) The confidentiality of sensitive information should be preserved even after the expiry of the employees' representatives terms of office and provision should be made to allow the competent organ of the SE to withhold information which would seriously harm, if subject to public disclosure, the functioning of the SE.(14) Where an SE and its subsidiaries and establishments are subject to Council Directive 94/45/EC of 22 September 1994 on the establishment of a European Works Council or a procedure in Community-scale undertakings and Community-scale groups of undertakings for the purposes of informing and consulting employees(5), the provisions of that Directive and the provision transposing it into national legislation should not apply to it nor to its subsidiaries and establishments, unless the special negotiating body decides not to open negotiations or to terminate negotiations already opened.(15) This Directive should not affect other existing rights regarding involvement and need not affect other existing representation structures, provided for by Community and national laws and practices.(16) Member States should take appropriate measures in the event of failure to comply with the obligations laid down in this Directive.(17) The Treaty has not provided the necessary powers for the Community to adopt the proposed Directive, other than those provided for in Article 308.(18) It is a fundamental principle and stated aim of this Directive to secure employees' acquired rights as regards involvement in company decisions. Employee rights in force before the establishment of SEs should provide the basis for employee rights of involvement in the SE (the "before and after" principle). Consequently, that approach should apply not only to the initial establishment of an SE but also to structural changes in an existing SE and to the companies affected by structural change processes.(19) Member States should be able to provide that representatives of trade unions may be members of a special negotiating body regardless of whether they are employees of a company participating in the establishment of an SE. Member States should in this context in particular be able to introduce this right in cases where trade union representatives have the right to be members of, and to vote in, supervisory or administrative company organs in accordance with national legislation.(20) In several Member States, employee involvement and other areas of industrial relations are based on both national legislation and practice which in this context is understood also to cover collective agreements at various national, sectoral and/or company levels,HAS ADOPTED THIS DIRECTIVE:SECTION IGENERALArticle 1Objective1. This Directive governs the involvement of employees in the affairs of European public limited-liability companies (Societas Europaea, hereinafter referred to as "SE"), as referred to in Regulation (EC) No 2157/2001.2. To this end, arrangements for the involvement of employees shall be established in every SE in accordance with the negotiating procedure referred to in Articles 3 to 6 or, under the circumstances specified in Article 7, in accordance with the Annex.Article 2DefinitionsFor the purposes of this Directive:(a) "SE" means any company established in accordance with Regulation (EC) No 2157/2001;(b) "participating companies" means the companies directly participating in the establishing of an SE;(c) "subsidiary" of a company means an undertaking over which that company exercises a dominant influence defined in accordance with Article 3(2) to (7) of Directive 94/45/EC;(d) "concerned subsidiary or establishment" means a subsidiary or establishment of a participating company which is proposed to become a subsidiary or establishment of the SE upon its formation;(e) "employees' representatives" means the employees' representatives provided for by national law and/or practice;(f) "representative body" means the body representative of the employees set up by the agreements referred to in Article 4 or in accordance with the provisions of the Annex, with the purpose of informing and consulting the employees of an SE and its subsidiaries and establishments situated in the Community and, where applicable, of exercising participation rights in relation to the SE;(g) "special negotiating body" means the body established in accordance with Article 3 to negotiate with the competent body of the participating companies regarding the establishment of arrangements for the involvement of employees within the SE;(h) "involvement of employees" means any mechanism, including information, consultation and participation, through which employees' representatives may exercise an influence on decisions to be taken within the company;(i) "information" means the informing of the body representative of the employees and/or employees' representatives by the competent organ of the SE on questions which concern the SE itself and any of its subsidiaries or establishments situated in another Member State or which exceed the powers of the decision-making organs in a single Member State at a time, in a manner and with a content which allows the employees' representatives to undertake an in-depth assessment of the possible impact and, where appropriate, prepare consultations with the competent organ of the SE;(j) "consultation" means the establishment of dialogue and exchange of views between the body representative of the employees and/or the employees' representatives and the competent organ of the SE, at a time, in a manner and with a content which allows the employees' representatives, on the basis of information provided, to express an opinion on measures envisaged by the competent organ which may be taken into account in the decision-making process within the SE;(k) "participation" means the influence of the body representative of the employees and/or the employees' representatives in the affairs of a company by way of:- the right to elect or appoint some of the members of the company's supervisory or administrative organ, or- the right to recommend and/or oppose the appointment of some or all of the members of the company's supervisory or administrative organ.SECTION IINEGOTIATING PROCEDUREArticle 3Creation of a special negotiating body1. Where the management or administrative organs of the participating companies draw up a plan for the establishment of an SE, they shall as soon as possible after publishing the draft terms of merger or creating a holding company or after agreeing a plan to form a subsidiary or to transform into an SE, take the necessary steps, including providing information about the identity of the participating companies, concerned subsidiaries or establishments, and the number of their employees, to start negotiations with the representatives of the companies' employees on arrangements for the involvement of employees in the SE.2. For this purpose, a special negotiating body representative of the employees of the participating companies and concerned subsidiaries or establishments shall be created in accordance with the following provisions:(a) in electing or appointing members of the special negotiating body, it must be ensured:(i) that these members are elected or appointed in proportion to the number of employees employed in each Member State by the participating companies and concerned subsidiaries or establishments, by allocating in respect of a Member State one seat per portion of employees employed in that Member State which equals 10 %, or a fraction thereof, of the number of employees employed by the participating companies and concerned subsidiaries or establishments in all the Member States taken together;(ii) that in the case of an SE formed by way of merger, there are such further additional members from each Member State as may be necessary in order to ensure that the special negotiating body includes at least one member representing each participating company which is registered and has employees in that Member State and which it is proposed will cease to exist as a separate legal entity following the registration of the SE, in so far as:- the number of such additional members does not exceed 20 % of the number of members designated by virtue of point (i), and- the composition of the special negotiating body does not entail a double representation of the employees concerned.If the number of such companies is higher than the number of additional seats available pursuant to the first subparagraph, these additional seats shall be allocated to companies in different Member States by decreasing order of the number of employees they employ;(b) Member States shall determine the method to be used for the election or appointment of the members of the special negotiating body who are to be elected or appointed in their territories. They shall take the necessary measures to ensure that, as far as possible, such members shall include at least one member representing each participating company which has employees in the Member State concerned. Such measures must not increase the overall number of members.Member States may provide that such members may include representatives of trade unions whether or not they are employees of a participating company or concerned subsidiary or establishment.Without prejudice to national legislation and/or practice laying down thresholds for the establishing of a representative body, Member States shall provide that employees in undertakings or establishments in which there are no employees' representatives through no fault of their own have the right to elect or appoint members of the special negotiating body.3. The special negotiating body and the competent organs of the participating companies shall determine, by written agreement, arrangements for the involvement of employees within the SE.To this end, the competent organs of the participating companies shall inform the special negotiating body of the plan and the actual process of establishing the SE, up to its registration.4. Subject to paragraph 6, the special negotiating body shall take decisions by an absolute majority of its members, provided that such a majority also represents an absolute majority of the employees. Each member shall have one vote. However, should the result of the negotiations lead to a reduction of participation rights, the majority required for a decision to approve such an agreement shall be the votes of two thirds of the members of the special negotiating body representing at least two thirds of the employees, including the votes of members representing employees employed in at least two Member States,- in the case of an SE to be established by way of merger, if participation covers at least 25 % of the overall number of employees of the participating companies, or- in the case of an SE to be established by way of creating a holding company or forming a subsidiary, if participation covers at least 50 % of the overall number of employees of the participating companies.Reduction of participation rights means a proportion of members of the organs of the SE within the meaning of Article 2(k), which is lower than the highest proportion existing within the participating companies.5. For the purpose of the negotiations, the special negotiating body may request experts of its choice, for example representatives of appropriate Community level trade union organisations, to assist it with its work. Such experts may be present at negotiation meetings in an advisory capacity at the request of the special negotiating body, where appropriate to promote coherence and consistency at Community level. The special negotiating body may decide to inform the representatives of appropriate external organisations, including trade unions, of the start of the negotiations.6. The special negotiating body may decide by the majority set out below not to open negotiations or to terminate negotiations already opened, and to rely on the rules on information and consultation of employees in force in the Member States where the SE has employees. Such a decision shall stop the procedure to conclude the agreement referred to in Article 4. Where such a decision has been taken, none of the provisions of the Annex shall apply.The majority required to decide not to open or to terminate negotiations shall be the votes of two thirds of the members representing at least two thirds of the employees, including the votes of members representing employees employed in at least two Member States.In the case of an SE established by way of transformation, this paragraph shall not apply if there is participation in the company to be transformed.The special negotiating body shall be reconvened on the written request of at least 10 % of the employees of the SE, its subsidiaries and establishments, or their representatives, at the earliest two years after the abovementioned decision, unless the parties agree to negotiations being reopened sooner. If the special negotiating body decides to reopen negotiations with the management but no agreement is reached as a result of those negotiations, none of the provisions of the Annex shall apply.7. Any expenses relating to the functioning of the special negotiating body and, in general, to negotiations shall be borne by the participating companies so as to enable the special negotiating body to carry out its task in an appropriate manner.In compliance with this principle, Member States may lay down budgetary rules regarding the operation of the special negotiating body. They may in particular limit the funding to cover one expert only.Article 4Content of the agreement1. The competent organs of the participating companies and the special negotiating body shall negotiate in a spirit of cooperation with a view to reaching an agreement on arrangements for the involvement of the employees within the SE.2. Without prejudice to the autonomy of the parties, and subject to paragraph 4, the agreement referred to in paragraph 1 between the competent organs of the participating companies and the special negotiating body shall specify:(a) the scope of the agreement;(b) the composition, number of members and allocation of seats on the representative body which will be the discussion partner of the competent organ of the SE in connection with arrangements for the information and consultation of the employees of the SE and its subsidiaries and establishments;(c) the functions and the procedure for the information and consultation of the representative body;(d) the frequency of meetings of the representative body;(e) the financial and material resources to be allocated to the representative body;(f) if, during negotiations, the parties decide to establish one or more information and consultation procedures instead of a representative body, the arrangements for implementing those procedures;(g) if, during negotiations, the parties decide to establish arrangements for participation, the substance of those arrangements including (if applicable) the number of members in the SE's administrative or supervisory body which the employees will be entitled to elect, appoint, recommend or oppose, the procedures as to how these members may be elected, appointed, recommended or opposed by the employees, and their rights;(h) the date of entry into force of the agreement and its duration, cases where the agreement should be renegotiated and the procedure for its renegotiation.3. The agreement shall not, unless provision is made otherwise therein, be subject to the standard rules referred to in the Annex.4. Without prejudice to Article 13(3)(a), in the case of an SE established by means of transformation, the agreement shall provide for at least the same level of all elements of employee involvement as the ones existing within the company to be transformed into an SE.Article 5Duration of negotiations1. Negotiations shall commence as soon as the special negotiating body is established and may continue for six months thereafter.2. The parties may decide, by joint agreement, to extend negotiations beyond the period referred to in paragraph 1, up to a total of one year from the establishment of the special negotiating body.Article 6Legislation applicable to the negotiation procedureExcept where otherwise provided in this Directive, the legislation applicable to the negotiation procedure provided for in Articles 3 to 5 shall be the legislation of the Member State in which the registered office of the SE is to be situated.Article 7Standard rules1. In order to achieve the objective described in Article 1, Member States shall, without prejudice to paragraph 3 below, lay down standard rules on employee involvement which must satisfy the provisions set out in the Annex.The standard rules as laid down by the legislation of the Member State in which the registered office of the SE is to be situated shall apply from the date of the registration of the SE where either:(a) the parties so agree; or(b) by the deadline laid down in Article 5, no agreement has been concluded, and:- the competent organ of each of the participating companies decides to accept the application of the standard rules in relation to the SE and so to continue with its registration of the SE, and- the special negotiating body has not taken the decision provided in Article 3(6).2. Moreover, the standard rules fixed by the national legislation of the Member State of registration in accordance with part 3 of the Annex shall apply only:(a) in the case of an SE established by transformation, if the rules of a Member State relating to employee participation in the administrative or supervisory body applied to a company transformed into an SE;(b) in the case of an SE established by merger:- if, before registration of the SE, one or more forms of participation applied in one or more of the participating companies covering at least 25 % of the total number of employees in all the participating companies, or- if, before registration of the SE, one or more forms of participation applied in one or more of the participating companies covering less than 25 % of the total number of employees in all the participating companies and if the special negotiating body so decides,(c) in the case of an SE established by setting up a holding company or establishing a subsidiary:- if, before registration of the SE, one or more forms of participation applied in one or more of the participating companies covering at least 50 % of the total number of employees in all the participating companies; or- if, before registration of the SE, one or more forms of participation applied in one or more of the participating companies covering less than 50 % of the total number of employees in all the participating companies and if the special negotiating body so decides.If there was more than one form of participation within the various participating companies, the special negotiating body shall decide which of those forms must be established in the SE. Member States may fix the rules which are applicable in the absence of any decision on the matter for an SE registered in their territory. The special negotiating body shall inform the competent organs of the participating companies of any decisions taken pursuant to this paragraph.3. Member States may provide that the reference provisions in part 3 of the Annex shall not apply in the case provided for in point (b) of paragraph 2.SECTION IIIMISCELLANEOUS PROVISIONSArticle 8Reservation and confidentiality1. Member States shall provide that members of the special negotiating body or the representative body, and experts who assist them, are not authorised to reveal any information which has been given to them in confidence.The same shall apply to employees' representatives in the context of an information and consultation procedure.This obligation shall continue to apply, wherever the persons referred to may be, even after the expiry of their terms of office.2. Each Member State shall provide, in specific cases and under the conditions and limits laid down by national legislation, that the supervisory or administrative organ of an SE or of a participating company established in its territory is not obliged to transmit information where its nature is such that, according to objective criteria, to do so would seriously harm the functioning of the SE (or, as the case may be, the participating company) or its subsidiaries and establishments or would be prejudicial to them.A Member State may make such dispensation subject to prior administrative or judicial authorisation.3. Each Member State may lay down particular provisions for SEs in its territory which pursue directly and essentially the aim of ideological guidance with respect to information and the expression of opinions, on condition that, on the date of adoption of this Directive, such provisions already exist in the national legislation.4. In applying paragraphs 1, 2 and 3, Member States shall make provision for administrative or judicial appeal procedures which the employees' representatives may initiate when the supervisory or administrative organ of an SE or participating company demands confidentiality or does not give information.Such procedures may include arrangements designed to protect the confidentiality of the information in question.Article 9Operation of the representative body and procedure for the information and consultation of employeesThe competent organ of the SE and the representative body shall work together in a spirit of cooperation with due regard for their reciprocal rights and obligations.The same shall apply to cooperation between the supervisory or administrative organ of the SE and the employees' representatives in conjunction with a procedure for the information and consultation of employees.Article 10Protection of employees' representativesThe members of the special negotiating body, the members of the representative body, any employees' representatives exercising functions under the information and consultation procedure and any employees' representatives in the supervisory or administrative organ of an SE who are employees of the SE, its subsidiaries or establishments or of a participating company shall, in the exercise of their functions, enjoy the same protection and guarantees provided for employees' representatives by the national legislation and/or practice in force in their country of employment.This shall apply in particular to attendance at meetings of the special negotiating body or representative body, any other meeting under the agreement referred to in Article 4(2)(f) or any meeting of the administrative or supervisory organ, and to the payment of wages for members employed by a participating company or the SE or its subsidiaries or establishments during a period of absence necessary for the performance of their duties.Article 11Misuse of proceduresMember States shall take appropriate measures in conformity with Community law with a view to preventing the misuse of an SE for the purpose of depriving employees of rights to employee involvement or withholding such rights.Article 12Compliance with this Directive1. Each Member State shall ensure that the management of establishments of an SE and the supervisory or administrative organs of subsidiaries and of participating companies which are situated within its territory and the employees' representatives or, as the case may be, the employees themselves abide by the obligations laid down by this Directive, regardless of whether or not the SE has its registered office within its territory.2. Member States shall provide for appropriate measures in the event of failure to comply with this Directive; in particular they shall ensure that administrative or legal procedures are available to enable the obligations deriving from this Directive to be enforced.Article 13Link between this Directive and other provisions1. Where an SE is a Community-scale undertaking or a controlling undertaking of a Community-scale group of undertakings within the meaning of Directive 94/45/EC or of Directive 97/74/EC(6) extending the said Directive to the United Kingdom, the provisions of these Directives and the provisions transposing them into national legislation shall not apply to them or to their subsidiaries.However, where the special negotiating body decides in accordance with Article 3(6) not to open negotiations or to terminate negotiations already opened, Directive 94/45/EC or Directive 97/74/EC and the provisions transposing them into national legislation shall apply.2. Provisions on the participation of employees in company bodies provided for by national legislation and/or practice, other than those implementing this Directive, shall not apply to companies established in accordance with Regulation (EC) No 2157/2001 and covered by this Directive.3. This Directive shall not prejudice:(a) the existing rights to involvement of employees provided for by national legislation and/or practice in the Member States as enjoyed by employees of the SE and its subsidiaries and establishments, other than participation in the bodies of the SE;(b) the provisions on participation in the bodies laid down by national legislation and/or practice applicable to the subsidiaries of the SE.4. In order to preserve the rights referred to in paragraph 3, Member States may take the necessary measures to guarantee that the structures of employee representation in participating companies which will cease to exist as separate legal entities are maintained after the registration of the SE.Article 14Final provisions1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive no later than 8 October 2004, or shall ensure by that date at the latest that management and labour introduce the required provisions by way of agreement, the Member States being obliged to take all necessary steps enabling them at all times to guarantee the results imposed by this Directive. They shall forthwith inform the Commission thereof.2. 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 the Member States.Article 15Review by the CommissionNo later than 8 October 2007, the Commission shall, in consultation with the Member States and with management and labour at Community level, review the procedures for applying this Directive, with a view to proposing suitable amendments to the Council where necessary.Article 16Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 17AddresseesThis Directive is addressed to the Member States.Done at Luxembourg, 8 October 2001.For the CouncilThe PresidentL. Onkelinx(1) OJ C 138, 29.5.1991, p. 8.(2) OJ C 342, 20.12.1993, p. 15.(3) OJ C 124, 21.5.1990, p. 34.(4) See page 1 of this Official Journal.(5) OJ L 254, 30.9.1994, p. 64. Directive as last amended by Directive 97/74/EC (OJ L 10, 16.1.1998, p. 22).(6) OJ L 10, 16.1.1998, p. 22.ANNEXSTANDARD RULES(referred to in Article 7)Part 1: Composition of the body representative of the employeesIn order to achieve the objective described in Article 1, and in the cases referred to in Article 7, a representative body shall be set up in accordance with the following rules.(a) The representative body shall be composed of employees of the SE and its subsidiaries and establishments elected or appointed from their number by the employees' representatives or, in the absence thereof, by the entire body of employees.(b) The election or appointment of members of the representative body shall be carried out in accordance with national legislation and/or practice.Member States shall lay down rules to ensure that the number of members of, and allocation of seats on, the representative body shall be adapted to take account of changes occurring within the SE and its subsidiaries and establishments.(c) Where its size so warrants, the representative body shall elect a select committee from among its members, comprising at most three members.(d) The representative body shall adopt its rules of procedure.(e) The members of the representative body are elected or appointed in proportion to the number of employees employed in each Member State by the participating companies and concerned subsidiaries or establishments, by allocating in respect of a Member State one seat per portion of employees employed in that Member State which equals 10 %, or a fraction thereof, of the number of employees employed by the participating companies and concerned subsidiaries or establishments in all the Member States taken together.(f) The competent organ of the SE shall be informed of the composition of the representative body.(g) Four years after the representative body is established, it shall examine whether to open negotiations for the conclusion of the agreement referred to in Articles 4 and 7 or to continue to apply the standard rules adopted in accordance with this Annex.Articles 3(4) to (7) and 4 to 6 shall apply, mutatis mutandis, if a decision has been taken to negotiate an agreement according to Article 4, in which case the term "special negotiating body" shall be replaced by "representative body". Where, by the deadline by which the negotiations come to an end, no agreement has been concluded, the arrangements initially adopted in accordance with the standard rules shall continue to apply.Part 2: Standard rules for information and consultationThe competence and powers of the representative body set up in an SE shall be governed by the following rules.(a) The competence of the representative body shall be limited to questions which concern the SE itself and any of its subsidiaries or establishments situated in another Member State or which exceed the powers of the decision-making organs in a single Member State.(b) Without prejudice to meetings held pursuant to point (c), the representative body shall have the right to be informed and consulted and, for that purpose, to meet with the competent organ of the SE at least once a year, on the basis of regular reports drawn up by the competent organ, on the progress of the business of the SE and its prospects. The local managements shall be informed accordingly.The competent organ of the SE shall provide the representative body with the agenda for meetings of the administrative, or, where appropriate, the management and supervisory organ, and with copies of all documents submitted to the general meeting of its shareholders.The meeting shall relate in particular to the structure, economic and financial situation, the probable development of the business and of production and sales, the situation and probable trend of employment, investments, and substantial changes concerning organisation, introduction of new working methods or production processes, transfers of production, mergers, cut-backs or closures of undertakings, establishments or important parts thereof, and collective redundancies.(c) Where there are exceptional circumstances affecting the employees' interests to a considerable extent, particularly in the event of relocations, transfers, the closure of establishments or undertakings or collective redundancies, the representative body shall have the right to be informed. The representative body or, where it so decides, in particular for reasons of urgency, the select committee, shall have the right to meet at its request the competent organ of the SE or any more appropriate level of management within the SE having its own powers of decision, so as to be informed and consulted on measures significantly affecting employees' interests.Where the competent organ decides not to act in accordance with the opinion expressed by the representative body, this body shall have the right to a further meeting with the competent organ of the SE with a view to seeking agreement.In the case of a meeting organised with the select committee, those members of the representative body who represent employees who are directly concerned by the measures in question shall also have the right to participate.The meetings referred to above shall not affect the prerogatives of the competent organ.(d) Member States may lay down rules on the chairing of information and consultation meetings.Before any meeting with the competent organ of the SE, the representative body or the select committee, where necessary enlarged in accordance with the third subparagraph of paragraph (c), shall be entitled to meet without the representatives of the competent organ being present.(e) Without prejudice to Article 8, the members of the representative body shall inform the representatives of the employees of the SE and of its subsidiaries and establishments of the content and outcome of the information and consultation procedures.(f) The representative body or the select committee may be assisted by experts of its choice.(g) In so far as this is necessary for the fulfilment of their tasks, the members of the representative body shall be entitled to time off for training without loss of wages.(h) The costs of the representative body shall be borne by the SE, which shall provide the body's members with the financial and material resources needed to enable them to perform their duties in an appropriate manner.In particular, the SE shall, unless otherwise agreed, bear the cost of organising meetings and providing interpretation facilities and the accommodation and travelling expenses of members of the representative body and the select committee.In compliance with these principles, the Member States may lay down budgetary rules regarding the operation of the representative body. They may in particular limit funding to cover one expert only.Part 3: Standard rules for participationEmployee participation in an SE shall be governed by the following provisions(a) In the case of an SE established by transformation, if the rules of a Member State relating to employee participation in the administrative or supervisory body applied before registration, all aspects of employee participation shall continue to apply to the SE. Point (b) shall apply mutatis mutandis to that end.(b) In other cases of the establishing of an SE, the employees of the SE, its subsidiaries and establishments and/or their representative body shall have the right to elect, appoint, recommend or oppose the appointment of a number of members of the administrative or supervisory body of the SE equal to the highest proportion in force in the participating companies concerned before registration of the SE.If none of the participating companies was governed by participation rules before registration of the SE, the latter shall not be required to establish provisions for employee participation.The representative body shall decide on the allocation of seats within the administrative or supervisory body among the members representing the employees from the various Member States or on the way in which the SE's employees may recommend or oppose the appointment of the members of these bodies according to the proportion of the SE's employees in each Member State. If the employees of one or more Member States are not covered by this proportional criterion, the representative body shall appoint a member from one of those Member States, in particular the Member State of the SE's registered office where that is appropriate. Each Member State may determine the allocation of the seats it is given within the administrative or supervisory body.Every member of the administrative body or, where appropriate, the supervisory body of the SE who has been elected, appointed or recommended by the representative body or, depending on the circumstances, by the employees shall be a full member with the same rights and obligations as the members representing the shareholders, including the right to vote.


Avis juridique important

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31993L0008

Commission Directive 93/8/EEC of 15 March 1993 amending Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs

Official Journal L 090 , 14/04/1993 P. 0022 - 0025 Finnish special edition: Chapter 13 Volume 24 P. 0016  Swedish special edition: Chapter 13 Volume 24 P. 0016

COMMISSION DIRECTIVE 93/8/EEC of 15 March 1993 amending Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffsTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 89/109/EEC of 21 December 1988 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,  Whereas the Community measures envisaged by this Directive are not only necessary but also indispensable for the attainment of the objectives of the internal market; whereas these objectives cannot be achieved by Member States individually, and whereas  furthermore their attainment at Community level is already provided for by Directive 89/109/EEC;  Whereas Commission Directive 90/128/EEC of 23 February 1990 relating to plastic materials and articles intended to come into contact with foodstuffs (2), as amended by Directive 92/39/EEC (3), provides the possibility of carrying out the migration tests  either on foodstuffs or on food simulants, whilst Council Directive 82/711/EEC (4) requires the migration tests to be carried out only on food simulants unless the method of analysis which enables migration into foodstuffs to be established has been  adopted officially; whereas this discrepancy is capable of affecting the proper application of the Directives and whereas it is therefore necessary to eliminate it;  Whereas the increasing use of microwave ovens makes it necessary to establish new specific test conditions;  Whereas it is necessary to remove the possibility given to the Member States to adopt national rules for high-temperature testing in order to eliminate the existing discrepancies;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 82/711/EEC is amended as follows:  1. Articles 2 and 3 are replaced by the following:  'Article 2 The overall and specific migration levels of constituents of the materials and articles referred to in Article 1 into or onto foodstuffs or food simulants must not exceed the limits laid down in Commission Directive 90/128/EEC (*) or in any other  relevant specific directive.  Article 3 1. Verification of compliance of migration into foodstuffs with the migration limits shall be carried out under the most extreme conditions of time and temperature foreseeable in actual use.  Verification of compliance of migration into food simulants with the migration limits 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 States concerned and shall consult the Member States within the Standing Committee for Foodstuffs and shall then deliver its opinion forthwith and amend this  Directive, if necessary. In that case, the Member State which has adopted the more appropriate basic rules may retain them until the said amendments enter into force.  (*) OJ No L 75, 21. 3. 1990, p. 19, amended by OJ No L 349, 13. 12. 1990, p. 26.' 2. The Annex is replaced by the Annex hereto.  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive as from 1 April 1994. They shall immediately inform the Commission thereof.  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 is addressed to the Member States.  Done at Brussels, 15 March 1993.  For the Commission Martin BANGEMANN Member of the Commission (1) OJ No L 40, 11. 2. 1989, p. 38.  (2) OJ No L 75, 21. 3. 1990, p. 19, rectified by OJ No L 349, 13. 12. 1990, p. 26.  (3) OJ No L 168, 23. 6. 1992, p. 21.  (4) OJ No L 297, 23. 10. 1982, p. 26.    ANNEX  'ANNEX BASIC RULES FOR TESTING MIGRATION IN FOOD SIMULANTS The determination of migration in food simulants shall be carried out using the food simulants laid down in Chapter I of Annex and under the test conditions specified in Chapter II of Annex. However the determination of migration shall be restricted to  the food simulant(s) and to the condition(s) of test which, in the specific case under examination, may be considered to be the most severe on the basis of experience.  CHAPTER I Food simulants 1. General case: plastic materials and articles intended to come into contact with foodstuffs of all types The tests shall be carried out using the food 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) (= simulant D); if for technical reasons connected with the method of analysis it is necessary to use different food simulants, olive oil shall be replaced by a mixture of synthetic triglycerides (2) or by sunflower oil. If all  the food simulants provided in this indent are inappropriate, other food simulants and conditions of time and temperature may be used.  However, the simulant A shall be used only in the cases mentioned specifically in the Table of this Annex.  2. Special case: plastic materials and articles intended to come into contact with a single foodstuff or a specific group of foodstuffs The tests shall be carried out:  - using only the food simulant(s) specified as appropriate for the foodstuff or group of foodstuffs in the Directive 85/572/EEC (3),  - where the foodstuff or group of foodstuffs is not included in the list referred to in the first indent, selecting the food simulant(s) 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, but are not less than, the normal or foreseeable conditions of contact for the plastic materials or  articles being studied.  2. Where a material or article passes a test at a given time and temperature, it need not to be tested for a shorter time at the same temperature, nor for the same time at a lower temperature.  3. However if a plastic material or article is intended for a food contact application covered by two or more combinations of time and temperature taken from the Table, migration will be determined by subjecting that material or article successively to  all the applicable test conditions, using the same aliquot of food simulant.  4. If a plastic material or article is intended to come into contact with foodstuffs at any condition of time, the conditions for testing will be the following:  (a) where the plastic material or article may in actual use be employed at any temperature up to and including 70 °C and that is indicated by an appropriate labelling or instructions, only the 10 day test(s) at 40 °C shall be carried out;  (b) where a plastic material or article may in actual use be employed at a temperature above 70° C:  (i) where no labelling or instructions are given to indicate temperature expected in real use, simulants B and C shall be used at reflux temperature, if possible, or at two-hour test(s) at 100° C and simulant D shall be used for two hours at 175° C;  (ii) where labelling or instructions are given to indicate conditions expected in real use, time and temperatures from the Table shall be selected.  5. By derogation from the conditions provided in the table and in paragraph 2, if the plastic material or article may in actual use be employed for periods of less than 15 minutes at temperatures between 70° C and 100° C and that is indicated by an  appropriate labelling or instructions, only the two-hour test at 70° C and the 10-day test at 40° C shall be carried out. These tests shall be carried out separately taking different samples. For each of these two types of test, use a new sample of the  same material or article to be examined.  6. 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 of foreseeable conditions of use of that material or article,  the migration tests shall be carried out under conditions more appropriate to the specific case.  7. For materials and articles intended for use in microwave ovens, migration testing shall use a conventional oven and appropriate time and temperature conditions selected from the Table.  Table  /* Tables: see OJ */      (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) 81.5.  (3) OJ No L 372, 31. 12. 1985, p. 14.


Avis juridique important

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31989L0381

Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma

Official Journal L 181 , 28/06/1989 P. 0044 - 0046 Finnish special edition: Chapter 13 Volume 19 P. 0018  Swedish special edition: Chapter 13 Volume 19 P. 0018

*****COUNCIL  DIRECTIVE  of 14 June 1989  extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma  (89/381/EEC)  THE 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 disparities in the laws, regulations or administrative provisions of Member States may hinder trade in medicinal products derived from human blood or human plasma within the Community;  Whereas the essential aim of any rules governing the production, distribution or use of medicinal products must be to ensure a high level of protection of public health;  Whereas the provisions laid down by Directive 65/65/EEC (4), as last amended by Directive 87/21/EEC (5), and by Directive 75/319/EEC (6), as last amended by Directive 83/570/EEC (7), both concerning the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, although appropriate, are inadequate with regard to medicinal products derived from human blood or human plasma;  Whereas in accordance with Article 5 of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national provisions relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology (8); the Commission is required to submit proposals to harmonize, along the lines of Directive 75/319/EEC, the conditions for authorizing the manufacture and placing on the market of medicinal products derived from human blood or human plasma;  Whereas the Community entirely supports the efforts of the Council of Europe to promote voluntary unpaid blood and plasma donation to attain self-sufficiency throughout the Community in the supply of blood products, and to ensure respect for ethical principles in trade in therapeutic substances of human origin;  Whereas the rules designed to guarantee the quality, safety and efficacy of medicinal products derived from human blood or human plasma must be applied in the same manner to both public and private establishments, and to blood and plasma imported from third countries;  Whereas, before an authorization to market a medicinal product derived from human blood or human plasma can be granted, the manufacturer must demonstrate his ability to guarantee batch-to-batch consistency and the absence of specific viral contamination, to the extent that the state of technology permits;  Whereas the Commission should be empowered to adopt, in close cooperation with the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in Medicinal Products, any necessary changes in the requirements for the testing of proprietary medicinal products set out in the Annex to Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (1), as last amended by Directive 87/19/EEC (2), to take account of the special nature of medicinal products derived from human blood or human plasma so as to ensure a higher level of quality, safety and efficacy,  HAS ADOPTED THIS DIRECTIVE:  Article 1  1. By way of derogation from Article 34 of Directive 75/319/EEC, and subject to the provisions of this Directive, Directives 65/65/EEC and 75/319/EEC shall aplly to medicinal products based on blood constituents which are prepared industrially by public or private establishments, hereinafter referred to as 'medicinal products derived from human blood or human plasma'; these medicinal products include, in particular albumin, coagulating factors and immunoglobulins of human origin.  2. This Directive shall not apply to whole blood, to plasma or to blood cells of human origin.  3. This Directive shall be without prejudice to Council Decision 86/346/EEC of 25 June 1986 accepting on behalf of the Community the European Agreement relating to the Exchange of Therapeutic Substances of Human Origin (3).  Article 2  1. The quantitative particulars of a medicinal product derived from human blood or human plasma shall be expressed by mass or by international units or by units of biological activity as appropriate to the product concerned.  2. In Directives 65/65/EEC and 75/319/EEC the expressions 'qualitative and quantitative particulars of the constituents' shall include particulars relating to biological activity and 'qualitative and quantitative composition' shall include the composition of the product expressed in terms of biological activity.  3. In any document drawn up for the purposes of this Directive, where the name of a medicinal product derived from human blood or human plasma is expressed, the common or scientific name of the active constituents shall also be included at least once; it may be abbreviated in the remaining references.  Article 3  In respect of the use of human blood or human plasma as a starting material for the manufacture of medicinal products:  1. Member States shall take the necessary measures to prevent the transmission of infectious diseases. Insofar as this is covered by the amendments referred to in Article 6, as well as the application of the monographs of the European Pharmacopoeia regarding blood and plasma, these measures shall comprise those recommended by the Council of Europe and the World Health Organization, particularly with reference to the selection and testing of blood and plasma donors;  2. Member States shall take the necessary measures to ensure that human blood and human plasma donors and donation centres are always clearly identifiable;  3. All the safety guarantees referred to in paragraphs 1 and 2 must also be given by importers of human blood or human plasma from third countries;  4. Member States shall take the necessary measures to promote Community self-sufficiency in human blood or human plasma. For this purpose, they shall encourage the voluntary unpaid donation of blood and plasma and shall take the necessary measures to develop the production and use of products derived from human blood or human plasma coming from voluntary unpaid donations. They shall notify the Commission of such measures.  Article 4  1. Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from human blood or human plasma are properly validated, attain batch-to-batch consistency and guarantee, insofar as the state of technology permits, the absence of specific viral contamination. To this end manufacturers shall notify the competent authorities of the method used to reduce or eliminate pathogenic viruses liable to be transmitted by medicinal products derived from human blood or human plasma. The ocmpetent authority may submit samples of the bulk and/or finished product for testing by a State laboratory or a laboratory designated for that purpose, either during the examination of the application pursuant to Article 4 of Directive 75/319/EEC, or after a marketing authorization has been granted.  2. For the purpose of implementing Article 8 of Directive 65/65/EEC and Article 27 of Directive 75/319/EEC, Member States may require manufacturers of medicinal products derived from human blood or human plasma to submit to a competent authority copies of all the control reports signed by the qualified person, in accordance with Article 22 of Directive 75/319/EEC.  3. Where, in the interests of public health, the laws of a Member State so provide, the competent authorities may require persons responsible for marketing medicinal products derived from human blood or human plasma to submit samples from each batch of the bulk and/or finished product for testing by a State laboratory or a laboratory designated for that purpose before being released into free circulation, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications. Member States shall ensure that any such examination is completed within sixty days of the receipt of the samples.  Article 5  The procedure laid down in Directive 87/22/EEC shall be extended as necessary to cover medicinal products derived from human blood or human plasma.  Article 6  Any necessary amendments to the testing requirements for medicinal products set out in the Annex to Directive 75/318/EEC to take account of the extension of the scope of Directives 65/65/EEC and 75/319/EEC to cover medicinal products derived from human blood or human plasma shall be adopted in accordance with the procedure laid down in Article 2c of Directive 75/318/EEC.  Article 7  1. Save in the case provided for in paragraph 2, Member States shall take the necessary measures to comply with this Directive before 1 January 1992. They shall forthwith inform the Commission thereof.  2. In the event of the amendments to Directive 75/318/EEC referred to in Article 6 not being adopted by the date referred to in paragraph 1, this date shall be replaced by the date of adoption of the said amendments.  3. Requests for marketing authorization for the products concerned lodged after the date of application of this Directive shall comply with the provisions thereof.  4. This Directive shall be progressively extended, before 31 December 1992, to existing medicinal products derived from human blood or human plasma, referred to in Article 1 (1).  Article 8  This Directive is addressed to the Member States.  Done at Luxembourg, 14 June 1989.  For the Council  The President  P. SOLBES  (1) OJ No C 308, 3. 12. 1988, p. 21.  (2) OJ No C 290, 14. 12. 1988, p. 134 and  OJ No C 120, 16. 5. 1989.  (3) OJ No C 208, 8. 8. 1988, p. 64.  (4) OJ No 22, 9. 2. 1965, p. 369/65.  (5) OJ No L 15, 17. 1. 1987, p. 36.  (6) OJ No L 147, 9. 6. 1975, p. 13.  (7) OJ No L 332, 28. 11. 1983, p. 1.  (8) OJ No L 15, 17. 1. 1987, p. 38.  (1) OJ No L 147, 9. 6. 1975, p. 1.  (2) OJ No L 15, 17. 1. 1987, p. 31.  (3) OJ No L 207, 30. 7. 1986, p. 1.