title: Commission Directive 2011/66/EU of 1 July 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include 4,5-Dichloro-2-octyl-2H-isothiazol-3-one as an active substance in Annex I thereto  Text with EEA relevance

text:
               2.7.2011

               EN

               Official Journal of the European Union

               L 175/10

         COMMISSION DIRECTIVE 2011/66/EU
   of 1 July 2011
   amending Directive 98/8/EC of the European Parliament and of the Council to include 4,5-Dichloro-2-octyl-2H-isothiazol-3-one as an active substance in Annex I thereto
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes 4,5-Dichloro-2-octyl-2H-isothiazol-3-one.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, 4,5-Dichloro-2-octyl-2H-isothiazol-3-one has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to that Directive.

               (3)

               Norway was designated as Rapporteur and submitted the competent authority report, together with a recommendation, to the Commission on 8 September 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

               (4)

               The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 16 December 2010, in an assessment report.

               (5)

               It appears from the evaluations that biocidal products used as wood preservatives and containing 4,5-Dichloro-2-octyl-2H-isothiazol-3-one may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include 4,5-Dichloro-2-octyl-2H-isothiazol-3-one in Annex I to that Directive.

               (6)

               Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (7)

               In view of the risks identified for human health, it is appropriate to require that safe operational procedures are established for products authorised for industrial or professional use, and that those products are used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means.

               (8)

               In view of the risks identified for the aquatic and terrestrial compartments, it is appropriate to require that freshly treated timber is stored after treatment under shelter or on impermeable hard standing, or both, and that any losses from the application of products used as wood preservatives and containing 4,5-Dichloro-2-octyl-2H-isothiazol-3-one are collected for reuse or disposal.

               (9)

               Unacceptable risks for the environment were identified in various scenarios for in-service use of treated wood not covered and not in contact with the ground, which is either continually exposed to the weather or protected from the weather but subject to frequent wetting (use class 3 as defined by OECD (3)) and wood in contact with fresh water (use class 4b as defined by OECD (4)). It is therefore appropriate to require that products are not authorised for the treatment of wood intended for those uses, unless data is submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

               (10)

               It is important that the provisions of this Directive be applied simultaneously in all Member States in order to ensure equal treatment of biocidal products on the market containing the active substance 4,5-Dichloro-2-octyl-2H-isothiazol-3-one and also to facilitate the proper operation of the biocidal products market in general.

               (11)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (12)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (13)

               Directive 98/8/EC should therefore be amended accordingly.

               (14)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   Transposition
   1.   Member States shall adopt and publish, by 30 June 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 July 2013.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 1 July 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

      (2)  OJ L 325, 11.12.2007, p. 3.

      (3)  OECD series on emission scenario documents, Number 2, Emission Scenario Document for Wood Preservatives, Part 2, p. 64.

      (4)  Ibid.

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry is added:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (1)

                     ‘44

                     4,5-Dichloro-2-octyl-2H-isothiazol-3-one

                     4,5-Dichloro-2-octylisothiazol-3(2H)-one
                     EC No: 264-843-8
                     CAS No: 64359-81-5

                     950 g/kg

                     1 July 2013

                     30 June 2015

                     30 June 2023

                     8

                     When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     Products shall not be authorised for treatment of wood that will be continually exposed to the weather, protected from the weather but subject to frequent wetting or in contact with fresh water, unless data have been submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 (1)

                                 for products authorised for industrial or professional use, safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means;

                                 (2)

                                 labels and, where provided, safety data sheets of products authorised shall indicate that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing under roof, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.’

         (1)  For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm


title: Commission Directive 2010/33/EU of 21 May 2010 correcting the Spanish version of Council Directive 2001/112/EC relating to fruit juices and certain similar products intended for human consumption

text:
               22.5.2010

               EN

               Official Journal of the European Union

               L 126/23

         COMMISSION DIRECTIVE 2010/33/EU
   of 21 May 2010
   correcting the Spanish version of Council Directive 2001/112/EC relating to fruit juices and certain similar products intended for human consumption
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption (1), and in particular Article 7 thereof,
   Whereas:

               (1)

               Following the adoption, on 14 August 2009, of Commission Directive 2009/106/EC (2) which amended Council Directive 2001/112/EC, Annex V of the latter Directive now contains an error in the Spanish language version, which needs to be corrected. The other language versions are not affected.

               (2)

               Directive 2001/112/EC should therefore be corrected accordingly.

               (3)

               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
   Concerns only the Spanish version.
   Article 2
   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, by 1 January 2011 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such 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 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, 21 May 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 10, 12.1.2002, p. 58.

      (2)  OJ L 212, 15.8.2009, p. 42.


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31969L0465

Council Directive 69/465/EEC of 8 December 1969 on control of Potato Cyst Eelworm

Official Journal L 323 , 24/12/1969 P. 0003 - 0004 Finnish special edition: Chapter 3 Volume 2 P. 0251  Danish special edition: Series I Chapter 1969(II) P. 0547  Swedish special edition: Chapter 3 Volume 2 P. 0251  English special edition: Series I Chapter 1969(II) P. 0563  Greek special edition: Chapter 03 Volume 5 P. 0021  Spanish special edition: Chapter 03 Volume 3 P. 0172  Portuguese special edition Chapter 03 Volume 3 P. 0172

COUNCIL DIRECTIVE  of 8 December 1969  on control of Potato Cyst Eelworm  (69/465/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof; Having regard to the proposal from the Commission; Having regard to the Opinion of the European Parliament (1); Having regard to the Opinion of the Economic and Social Committee; Whereas potato production occupies an important place in Community agriculture; Whereas the potato yield is constantly threatened by harmful organisms; Whereas, through the protection of potato cultivation against such harmful organisms, not only should productive capacity be maintained, but also agricultural productivity increased; Whereas proctective measures to prevent the introduction of harmful organisms into individual Member States would have only a limited effect if such organisms were not controlled simultaneously and methodically throughout the Community and were not prevented from spreading; Whereas one of the organisms most harmful to potatoes is Potato Cyst Eelworm (Heterodera rostochiensis Woll.); Whereas this pest has occurred in several Member States and there are contaminated areas within the Community; Whereas there is a permanent risk to potato cultivation throughout the Community if effective measures are not taken to control this pest and prevent it from spreading; Whereas, to eradicate this pest, minimum provisions must be adopted for the Community ; whereas Member States must be able to adopt additional or stricter provisions where necessary; Whereas potato varieties which are resistant to certain pathotypes of this pest play an important role ; whereas their use on contaminated plots may be helpful to some extent ; whereas it is therefore in the general interest to publish periodic lists of such varieties; Whereas, for determining the presence of contamination and the resistance of varieties, it appears necessary to apply appropriate methods to which Member States raise no objection; HAS ADOPTED THIS DIRECTIVE:Article 1This Directive concerns the minimum measures to be taken within the Member States to control Potato Cyst Eelworm (Heterodera rostochiensis Woll.) and to prevent it from spreading. Article 2The Member States shall provide that seed potatoes intended for marketing may be produced only on plots which, on official investigation, have been recognised as uncontaminated by Potato Cyst Eelworm.  (1) OJ No 28, 17.2.1967, p. 454/67.  Article 3When an occurrence of Potato Cyst Eelworm is recorded, Member States shall demarcate the contaminated plot. Article 4The Member States shall provide that on contaminated plots: (a) no potatoes may be grown; (b) no plant intended for transplanting may be grown, stored in the ground or otherwise. Article 5The Member States shall provide that seed potatoes which are contaminated or suspected of being contaminated must, if they are distributed as seed potatoes, be treated in such a way that they are no longer contaminated. Article 6The Member States shall revoke the measures taken to control Potato Cyst Eelworm or to prevent it from spreading only if it is no longer found to be present. Article 7The Member States shall prohibit the holding of Potato Cyst Eelworm.    Article 8  1. Member States may authorise: (a) derogations from the measures referred to in Articles 4, 5 and 7 for scientific purposes, tests and selection work; (b) by way of derogation from Article 4 (a), the growing on contaminated plots of varieties of potato which are resistant to pathotypes of Potato Cyst Eelworm found on the plots; (c) by way of derogation from Article 4 (a), the growing on contaminated plots of potatoes other than seed potatoes, provided that it is ensured that such potatoes will be harvested before the cysts of Potato Cyst Eelworm mature; (d) by way of derogation from Article 4 (a), the growing on contaminated plots of potatoes other than seed potatoes, where the ground has been disinfected by appropriate means.   2. The Member States shall ensure that the authorisations referred to in paragraph 1 are granted only where adequate controls guarantee that they do not prejudice the control of Potato Cyst Eelworm and create no risk of the spread of this pest.   3. A potato variety shall be regarded as being resistant to a particular pathotype of Potato Cyst Eelworm if, when that variety is grown, a natural and annual decrease in the population of that pathotype is found to occur.    Article 9Member States may adopt such additional or stricter provisions as may be required to control Potato Cyst Eelworm or to prevent it from spreading.     Article 10  1. The Member States shall communicate to the Commission before 1 January each year a list of all the varieties of potato accepted by them for marketing and which they have found, by official investigation, to be resistant to Potato Cyst Eelworm. They shall state the pathotypes to which the varieties are resistant.   2. The Commission shall ensure that a list of resistant varieties, based on the communications from the Member States, is published each year, if possible before 1 February.     Article 11  The Member States shall ensure that contamination by Potato Cyst Eelworm and the resistance of potato varieties to this pest are determined by appropriate methods to which Member States raise no objection.    Article 12Member States shall bring into force the measures necessary to comply with this Directive within two years following its notification and shall forthwith inform the Commission thereof. Article 13This Directive is addressed to the Member States.Done at Brussels, 8 December 1969. For the Council The President J.M.A.H. LUNS


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31997L0060

Directive 97/60/EC of the European Parliament and of the Council of 27 October 1997 amending for the third time Directive 88/344/EEC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients

Official Journal L 331 , 03/12/1997 P. 0007 - 0009

DIRECTIVE 97/60/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1997 amending for the third time Directive 88/344/EEC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,Having regard to the proposal from the Commission (1),Having regard to the Opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189b of the Treaty (3),Whereas the Scientific Committee for Food has reexamined all the extraction solvents listed in Directive 88/344/EEC (4), with a view to replacing the provisional acceptable daily intakes (ADIs) set in 1981 by definitive figures; whereas this has not always been possible because the information needed, although requested from the industry, has not been communicated; whereas, on the basis of the information received, the Scientific Committee for Food has been able to confirm its agreement for the majority of the solvents; whereas the maximum residues of the solvents in certain foodstuffs can be reduced;Whereas some solvents are no longer used and should thus be taken off the list;Whereas as a result of scientific progress other substances have been developed which can be added to the Directive; whereas a new solvent which has received a favourable opinion from the Scientific Committee should be authorized;Whereas this new solvent, namely 1, 1, 1, 2-tetrafluoroethane, is used solely for the extraction of flavourings and whereas residues in foodstuffs do not exceed 0,02 mg/kg; whereas, apart from those residues, the solvent is fully recycled, so that its use under these conditions has no impact on global warming of the atmosphere;Whereas the amendments needed, in the light of technical and scientific progress, amount to measures of a technical nature; whereas to simplify and speed up the procedure, adoption of these measures should be entrusted to the Commission;Whereas a procedure of this kind makes for quicker placing on the market of innovations, which is to the benefit of both industry and the consumer,HAVE ADOPTED THIS DIRECTIVE:Article 1 Directive 88/344/EEC is hereby amended as follows:(1) The following paragraph shall be added to Article 4:'(a) The necessary amendments to the Annex in the light of scientific and technical progress in the field of the use of solvents, their conditions of use and maximum residue limits.`Former paragraphs (a), (b) and (c) become paragraphs (b), (c), and (d) respectively.(2) The Annex shall be amended as follows:(a) PART IThe substance 'Butyl acetate` shall be deleted.(b) PART IIThe entry for hexane shall be amended as follows:>TABLE>(c) PART III- The substance 'methyl-propan-1-ol` shall be deleted.- The following substance shall be added:>TABLE>Article 2 1. Member States shall amend their laws, regulations and administrative provisions so as to:- authorize trade in products complying with Directive 88/344/EEC, as amended by this Directive by 27 October 1998 at the latest;- ban trade in products not complying with Directive 88/344/EEC, as amended by this Directive, as from 27 April 1999. However, products placed on the market or labelled before that date and not complying with Directive 88/344/EEC, as amended by this Directive, may be marketed until stocks are used up.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 Member States.Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 27 October 1997.For the European ParliamentThe PresidentJ.M. GIL-ROBLESFor the CouncilThe PresidentR. GOEBBELS(1) OJ C 278, 24. 9. 1996, p. 25.(2) OJ C 66, 3. 3. 1997, p. 3.(3) Opinion of the European Parliament of 23 October 1996 (OJ C 347, 18. 11. 1996, p. 58), Council Common Position of 24 March 1997 (OJ C 157, 24. 5. 1997, p. 4) and Decision of the European Parliament of 15 July 1997 (OJ C 286, 22. 9. 1997). Council Decision of 7 October 1997.(4) OJ L 157, 24. 6. 1988, p. 28. Directive as last amended by Directive of the European Parliament and of the Council 94/52/EC (OJ L 331, 21. 12. 1994, p. 10).


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31984L0047

Commission Directive 84/47/EEC of 16 January 1984 adapting to technical progress Council Directive 79/196/EEC on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres employing certain types of protection

Official Journal L 031 , 02/02/1984 P. 0019 - 0021 Finnish special edition: Chapter 13 Volume 13 P. 0187  Spanish special edition: Chapter 13 Volume 16 P. 0003  Swedish special edition: Chapter 13 Volume 13 P. 0187  Portuguese special edition Chapter 13 Volume 16 P. 0003

*****COMMISSION  DIRECTIVE  of 16 January 1984  adapting to technical progress Council Directive 79/196/EEC on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres employing certain types of protection  (84/47/EEC)  THE COMMISSION OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 76/117/EEC of 18 December 1975 on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres (1), and in particular Article 5 thereof,  Having regard to Council Directive 79/196/EEC of 6 February 1979 on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres employing certain types of protection (2), and in particular Article 5 thereof,  Whereas, in view of the present state of technical progress, it is now necessary to adapt the contents of the harmonized standards referred to in Annex I of Directive 79/196/EEC;  Whereas, in view of experience gained since Directive 79/196/EEC was adopted, it seems appropriate to change the design of the distinctive Community mark referred to in Annex II thereto;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaption to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in the Sector of Electrical Equipment for Use in Potentially Explosive Atmospheres,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Annexes I and II to Directive 79/196/EEC are replaced by Annexes I and II to this Directive.  Article 2  1. Member States shall bring into force the necessary provisions in order to comply with this Directive not later than 1 January 1985 and shall forthwith inform the Commission thereof.  2. However, until 1 January 2005, the Member States shall continue to apply the measures provided for in Article 4 of Directive 76/117/EEC as regards the equipment for which conformity to the harmonized standards referred to in Directive 79/196/EEC in its version of 6 February 1979 is attested by the certificate of conformity referred to in Article 8 of Directive 76/117/EEC, provided that this certificate has been issued before 31 December 1987.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 16 January 1984.  For the Commission  Karl-Heinz NARJES  Member of the Commission  (1) OJ No L 24, 30. 1. 1976, p. 45.  (2) OJ No L 43, 20. 2. 1979, p. 20.  ANNEX  I  HARMONIZED STANDARDS  The harmonized standards to which equipment must conform, depending on the type of protection, are the European standards referred to in the table below.  European Standards  (drawn up by Cenelec, 2, rue Bréderode, PO box 5, B-1000 Brussels)  1.2.3.4 //   //   //   //   // Number  // Title  // Edition  // Date  //   //   //   //   // EN 50014  // - Electrical equipment for use in potentially explosive atmospheres: general requirements  // 1  // March 1977  //   // - Amendment 1  //  // July 1979  //   // - Amendment 2  //   // June 1982  //  // - Amendments 3 and 4  //   // December 1982  // EN 50015  // - Electrical equipment for use in potentially explosive atmospheres: oil immersion 'o'  // 1  // March 1977  //   // - Amendment 1  //   // July 1979  // EN 50016  // - Electrical equipment for use in potentially explosive atmospheres: pressurized apparatus 'p'  // 1  // March 1977  //   // - Amendment 1  //   // July 1979  // EN 50017  // - Electrical equipment for use in potentially explosive atmospheres: powder filling 'q'  // 1  // March 1977  //   // - Amendment 1  //  // July 1979  // EN 50018  // - Electrical equipment for use in potentially explosive atmospheres: flameproof enclosure 'd'  // 1  // March 1977  //   // - Amendment 1  //   // July 1979  //   // - Amendment 2  //   // December 1982  // EN 50019  // - Electrical equipment for use in potentially explosive atmospheres: increased safety 'e'  // 1  // March 1977  //  // - Amendment 1  //   // July 1979  //   // - Amendment 2  //   // September 1983  // EN 50020  // - Electrical equipment for use in potentially explosive atmospheres: intrinsic safety 'i'  // 1  // March 1977  //   // - Amendment 1  //   // July 1979  //   //   //   //  ANNEX  II  Distinctive Community mark  All values related to 'a'


title: Commission Directive 2013/9/EU of 11 March 2013 amending Annex III to Directive 2008/57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community  Text with EEA relevance

text:
               12.3.2013

               EN

               Official Journal of the European Union

               L 68/55

         COMMISSION DIRECTIVE 2013/9/EU
   of 11 March 2013
   amending Annex III to Directive 2008/57/EC of the European Parliament and of the Council on the interoperability of the rail system within the Community
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (1), and in particular Article 30(3) thereof,
   Whereas:

               (1)

               Measures designed to amend non-essential elements of Directive 2008/57/EC and relating to the adaptation of Annexes II to IX to that Directive are to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 29(4) of Directive 2008/57/EC.

               (2)

               The United Nations Convention on the Rights of Persons with Disabilities, to which the European Union is a party (2), establishes, in Article 3, accessibility as one of its general principles and requires, in Article 9, that States Parties take appropriate measures to ensure to persons with disabilities access on an equal basis with others. These measures shall include the identification and elimination of obstacles and barriers to accessibility and shall apply, inter alia, to transportation. In accordance with Article 216(2) TFEU, agreements concluded by the Union are binding upon the institutions of the Union and on its Member States, and Directive 2008/57/EC — as an instrument of European Union secondary legislation — is subject to the obligations deriving from the Convention.

               (3)

               Regulation (EC) No 1371/2007 of the European Parliament and of the Council of 23 October 2007 on rail passengers’ rights and obligations (3) states in recital 10 that disabled persons and persons with reduced mobility have the same right as all other citizens to free movement, freedom of choice and non-discrimination and should have opportunities for rail travel comparable to those of other citizens. Article 21 of the Regulation requires railway undertakings and station managers to ensure, through compliance with the TSI for persons with reduced mobility, that stations, platforms, rolling stock and other facilities are accessible to disabled persons and persons with reduced mobility.

               (4)

               An adaptation of Annex III to Directive 2008/57/EC is necessary in order to include therein an explicit reference to accessibility. Accessibility is an essential requirement that is both a general requirement for the interoperability of the rail system and applies specifically to the infrastructure, rolling stock, operations and telematics applications for passengers’ subsystems. Annex III to Directive 2008/57/EC should therefore be amended accordingly.

               (5)

               The measures provided for in this Directive do not in any way affect the principle of gradual implementation set out in Directive 2008/57/EC, notably that target subsystems indicated in a TSI may be obtained gradually within a reasonable timescale and that each TSI should indicate an implementation strategy in order to make a gradual transition from the existing situation to the final situation in which compliance with the TSI will be the norm.

               (6)

               The measures provided for in this Directive are consistent with an approach to achieving access on an equal basis by applying technical solutions or operational measures or both.

               (7)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established pursuant to Article 29(1) of Directive 2008/57/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex III to Directive 2008/57/EC, which sets out Essential Requirements, is hereby amended as follows:

               (1)

               the following paragraphs shall be added to Section 1:
               ‘1.6.   Accessibility

                           1.6.1.

                           The “infrastructure” and “rolling stock” subsystems must be accessible to persons with disabilities and persons with reduced mobility in order to ensure access on an equal basis with others by way of the prevention or removal of barriers, and by way of other appropriate measures. This shall include the design, construction, renewal, upgrade, maintenance and operation of the relevant parts of the subsystems to which the public has access.

                           1.6.2.

                           The “operations” and “telematics applications for passengers” subsystems must provide for the necessary functionality required to facilitate access to persons with disabilities and persons with reduced mobility on an equal basis with others by way of the prevention or removal of barriers, and by way of other appropriate measures.’;

               (2)

               the following paragraph shall be added to subparagraph 1 of Section 2:
               ‘2.1.2.   Accessibility

                           2.1.2.1.

                           Infrastructure subsystems to which the public has access must be accessible to persons with disabilities and persons with reduced mobility in accordance with 1.6.’;

               (3)

               the following paragraph shall be added to subparagraph 4 of Section 2:
               ‘2.4.5.   Accessibility

                           2.4.5.1.

                           Rolling stock subsystems to which the public has access must be accessible to persons with disabilities and persons with reduced mobility in accordance with 1.6.’;

               (4)

               the following paragraph shall be added to subparagraph 6 of Section 2:
               ‘2.6.4.   Accessibility

                           2.6.4.1.

                           Appropriate steps must be taken to ensure that operating rules provide for the necessary functionality required to ensure accessibility for persons with disabilities and persons with reduced mobility.’;

               (5)

               the following paragraph shall be added to subparagraph 7 of Section 2:
               ‘2.7.5.   Accessibility

                           2.7.5.1.

                           Appropriate steps must be taken to ensure that telematics applications for passengers subsystems provide for the necessary functionality required to ensure accessibility for persons with disabilities and persons with reduced mobility.’

         Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2014 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   3.   The obligations for transposition and implementation of this Directive shall not apply to the Republic of Cyprus and the Republic of Malta for as long as no railway system is established within their territories.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 11 March 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 191, 18.7.2008, p. 1.

      (2)  Council Decision 2010/48/EC of 26 November 2009 concerning the conclusion, by the European Community, of the United Nations Convention on the Rights of Persons with Disabilities (OJ L 23, 27.1.2010, p. 35).

      (3)  OJ L 315, 3.12.2007, p. 14.


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31988L0388

Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production

Official Journal L 184 , 15/07/1988 P. 0061 - 0066 Finnish special edition: Chapter 13 Volume 17 P. 0077  Swedish special edition: Chapter 13 Volume 17 P. 0077

*****COUNCIL  DIRECTIVEof 22 June 1988on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production(88/388/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 differences between national laws relating to flavourings hinder the free movement of foodstuffs and may create conditions of unequal competition, thereby directly affecting the establishment or functioning of the common market;Whereas the approximation of those laws is necessary if the free movement of foodstuffs is to be achieved;Whereas laws relating to flavourings for use in foodstuffs should take account primarily of human health requirements but also, within the limit required for the protection of health, of economic and technical needs;Whereas the first step should be to lay down in a framework Directive provisions on general purity criteria, definitions, labelling, and the principles on the basis of which legal differences may subsequently be eliminated;Whereas, on the basis of the inventory or source materials and substances used in the preparation of flavourings established by the Commission on the basis of Decision 88/389/EEC (1), the Council will at a later stage adopt, under the procedure laid down in Article 100a of the Treaty, appropriate provisions concerning individual categories of flavourings and source materials and any necessary measures concerning their use and methods of production;Whereas on the most recent scientific and technical advice certain components on vegetable or animal raw materials used in the preparation of flavourings ought to be limited in foodstuffs;Whereas specific purity criteria for given flavourings, microbiological criteria for flavourings, methods of analysis and sampling of flavourings and the substances listed in the Annexes in and on foodstuffs should be established;Whereas, should the use in a flavouring of a substance or material authorized on the basis of this Directive or provisions adopted at a later stage or the presence of one of the substances listed in Annex II appear to constitute a health risk, Member States should be authorized to suspend or limit such use, or to reduce the maximum limits provided, pending a decision at Community level;Whereas the drawing up of the list of substances or materials authorized as additives necessary for the storage and use of flavourings as solvents and diluents of flavouring, and as processing aids, and the establishment of specific criteria of purity for flavourings, the procedurefor taking samples and the methods of analysis of flavourings in or on foodstuffs and the verification of the maximum limits laid down in the Annexes constitute technical implementing measures; whereas in order to simplify and expedite the procedure, the adoption of such measures should be entrusted to the Commission;Whereas, it is desirable that in all cases where the Council empowers the Commission to implement rules relating to flavourings for use in foodstuffs, provision should be made for a procedure establishing close cooperation between the Member States and the Commission within the Standing Committee for Foodstuffs set up by Decision 69/414/EEC (1);Whereas, without prejudice to the application of national rules which, in the absence of specific Directives on flavouring, apply to certain groups of flavourings, the requirements laid down in the following provisions shall be applied in such a way as to authorize, two years after adoption of this Directive, trade in and use of flavourings complying with the provisions of this Directive and to prohibit, three years after the adoption thereof, trade in and use of flavourings which do not comply therewith,HAS ADOPTED THIS DIRECTIVE:Article 11. This Directive shall apply to 'flavourings' used or intended for use in or on foodstuffs to impart odour and/or taste, and to source materials used for the production of flavourings.2. For the purposes of this Directive:(a) 'flavouring' means flavouring substances, flavouring preparations, process flavourings, smoke flavourings or mixtures thereof;(b) 'flavouring substance' means a defined chemical substance with flavouring properties which is obtained:(i) by appropriate physical processes (including distillation and solvent extraction) or enzymatic or microbiological processes from material of vegetable or animal origin either in the raw state or after processing for human consumption by traditional food-preparation processes (including drying, torrefaction and fermentation),(ii) by chemical synthesis or isolated by chemical processes and which is chemically identical to a substance naturally present in material of vegetable or animal origin as described in (i),(iii) by chemical synthesis but which is not chemically identical to a substance naturally present in material of vegetable or animal origin as described in (i);(c) 'flavouring preparation' means a product, other than the substances defined in (b) (i), whether concentrated or not, with flavouring properties, which is obtained by appropriate physical processes (including distillation and solvent extraction) or by enzymatic or microbiological processes from material of vegetable or animal origin, either in the raw state or after processing for human consumption by traditional food-preparation processes (including drying, torrefaction and fermentation);(d) 'process flavouring' means a product which is obtained according to good manufacturing practices by heating to a temperature not exceeding 180°C for a period not exceeding 15 minutes a mixture of ingredients, not necessarily themselves having flavouring properties, of which at least one contains nitrogen (amino) and another is a reducing sugar;(e) 'smoke flavouring' means a smoke extract used in traditional foodstuffs smoking processes.3. Flavourings may contain foodstuffs as well as other substances as described in Article 6 (1).Article 2This Directive shall not apply to:- edible substances and products intended to be consumed as such, with or without reconstitution,- substances which have exclusively a sweet, sour or salt taste,- material of vegetable or animal origin, having inherent flavouring properties, where they are not used as flavouring sources.Article 3Member States shall take the necessary measures to ensure that flavourings may not be marketed or used if they do not comply with the rules laid down in this Directive.Article 4Member States shall take all measures necessary to ensure that:(a) - flavourings do not contain any element or substance in a toxicologically dangerous quantity;- subject to any exceptions provided for in the specific criteria of purity referred to in Article 6 (2), third indent, they do not contain more than 3 mg/kg of arsenic, 10 mg/kg of lead, 1 mg/kg of cadmium and 1 mg/kg of mercury;(b) the use of flavourings does not result in the presence in foodstuffs as consumed of undesirable substances listed in Annex I in quantities greater than those specified therein;(c) the use of flavourings and of other food ingredients with flavouring properties does not result in the presence of substances listed in Annex II in quantities greater than those specified therein.Article 5The Council, acting in accordance with the procedure laid down in Article 100a of the Treaty, shall adopt:1. Appropriate provisions concerning:- flavouring sources composed of foodstuffs, and of herbs and spices normally considered as foods,- flavouring sources composed of vegetable or animal raw materials not normally considered as foods,- flavouring substances obtained by appropriate physical processes or by enzymatic or microbiological processes from vegetable or animal raw materials,- chemically synthesized or chemically isolated flavouring substances chemically identical to flavouring substances naturally present in foodstuffs or in herbs and spices normally considered as foods,- chemically synthesized or chemically isolated flavouring substances chemically identical to flavouring substances naturally present in vegetable or animal raw materials not normally considered as foods,- chemically synthesized or chemically isolated flavouring substances other than those referred to in the fourth and fifth indents,- source materials used for the production of smoke flavourings or process flavourings, and the reaction conditions under which they are prepared;2. Any special provisions which may be necessary, for the protection of public health or trade, concerning:- the use and methods of production of flavourings, including physical processes or enzymatic or microbiological processes for the production of flavouring preparations and flavouring substances as referred to in Article 1 (2) (b) (i) and (c),- the conditions for the use of the substances and materials referred to in Article 6 (1);3. Amendments concerning the maximum limits laid down in the Annexes.Article 6The following shall be adopted in accordance with the procedure set out in Article 10:1. the list of substances or materials authorized in the Community as:- additives necessary for the storage and use of flavourings,- products used for dissolving and diluting flavourings,- additives necessary for the production of flavourings (processing aids) where such additives are not covered by other Community provisions;2. where necessary:- the methods of analysis needed to verify compliance with the levels referred to in Article 4,- the procedure for taking samples and the methods for qualitative and, where appropriate, quantitative analysis of flavourings in or on foodstuffs,- the specific criteria of purity for given flavourings;3. - the microbiological criteria applicable to flavourings,- the designation criteria given to the more specific names referred to in Article 9 (1) (b);4. the appropriate steps, to be taken by 1 July 1990 to supplement this Directive with labelling rules for flavourings intended for sale to the final consumer.Article 7Provisions that may have effects on public health shall be adopted only after consulting the Scientific Committee for Food.Article 81. Where, as a result of new information or of a re-assessment of existing information made since this Directive or one of the Directives provided for in Article 5 was adopted, a Member State has detailed evidence:- that the presence of one of the substances listed in the Annexes to this Directive or the maximum levels stipulated, while complying with the provisions of this Directive, or- that the use of a flavouring, while complying with the relevant Directive or with this Directive, or- that the presence of a substance similar to those referred to in the Annexesconstitutes a danger to human health, that Member State may temporarily suspend or restrict application of the provisions in question within its territory. It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision. 2. The Commission shall examine as soon as possible the evidence given by the Member State and consult the Standing Committee for Foodstuffs, and shall then deliver its opinion forthwith and take the appropriate measures, which may replace the measures referred to in paragraph 1.3. If the Commission considers that amendments to this Directive or to one of the Directives referred to in Article 5 are necessary in order to alleviate the difficulties mentioned in paragraph 1 and to ensure the protection of human health, it shall initiate the procedure laid down in Article 10, with a view to adopting these amendments; the Member State which has adopted safeguard measures may in that event retain them until the amendments enter into force.Article 91. Flavourings not intended for sale to the final consumer may not be marketed unless their packagings or containers bear the following information, which should be easily visible, clearly legible and indelible:(a) the name or business name and address of the manufacturer or packer, or of a seller established within the Community;(b) the sales description: either the word 'flavouring' or a more specific name or description of the flavouring.Member States may maintain for a period of three years following the adoption of this Directive, more specific names to designate flavourings composed of mixtures of flavouring preparations and flavouring substances.Before this period expires, it shall be decided according to the procedure provided for in Article 10 whether or not these names shall be included in this Directive;(c) either the statement 'for foodstuffs' or a more specific reference to the foodstuff for which the flavouring is intended;(d) a list in descending order of weight of the categories of flavouring substances and flavouring preparations present classified as follows:- natural flavouring substances in the case of flavouring substances defined in Article 1 (2) (b) (i),- flavouring substances identical to natural substances in the case of flavouring substances defined in Article 1 (2) (b) (ii),- artificial flavouring substances in the case of flavouring substances defined in Article 1 (2) (b) (iii),- flavouring preparations in the case of preparations defined in Article 1 (2) (c),- process flavourings in the case of flavourings defined in Article 1 (2) (d),- smoke flavourings in the case of flavourings defined in Article 1 (2) (e);(e) in the case of a mixture of flavourings with other substances or materials referred to in the first and second indents of Article 6 (1), a list in descending order of weight in the mixture of:- the categories of flavourings classified as in (d) of this paragraph,- the names of each of the other substances or materials or, where appropriate, their 'EEC' numbers;(f) an indication of the maximum quantity of each component or group of components subject to quantitative limitation in a foodstuff or appropriate information enabling the purchaser to comply with the Community provisions or, where there are none, national provisions applying to that foodstuff;(g) an indication identifying the consignment;(h) the nominal quantity expressed in units of mass or volume.2. Without prejudice to paragraph 1 (d), the word 'natural', or any other word having substantially the same meaning, may be used only for flavourings in which the flavouring component contains exclusively flavouring preparations as defined in Article 1 (2) (c).If the sales description of the flavouring contains a reference to a foodstuff or a flavouring source, the word 'natural', or any other word having substantially the same meaning, may not be used unless the flavouring component has been isolated by appropriate physical processes, enzymatic or microbiological processes or traditional food-preparation processes solely or almost solely from the foodstuff or the flavouring source concerned.3. By way of derogation from paragraph 1, the information required in paragraph 1 (d), (e) and (f) may appear merely on the trade documents relating to the consignment which are to be supplied with or prior to the delivery, provided the indication 'intended for the manufacture of foodstuffs and not for retail' appears in a conspicuous part of the packaging or container of the products in question.4. Member States shall refrain from laying down requirements more detailed than those contained in this Article concerning the manner in which the particulars provided for are to be shown.The particulars provided for in this Article shall be given in terms easily understood by purchasers unless other measures have been taken to ensure that the purchaser is informed. This provision shall not prevent such particulars from being indicated in various languages.Article 101. Where the procedure laid down in this Article is to be followed, the chairman shall refer the matter to the Standing Committee for Foodstuffs either on his own initiative or at the request of the representative of a Member State. 2. The Commission representative shall submit to the Committee a draft of measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the qualified majority laid down in Article 148(2) of the Treaty. The chairman shall not vote.3. (a) The Commission shall adopt the intended measures when they are in accordance with the Committee's opinion.(b) Where the intended measures are not in accordance with the opinion of the Committee, or in the absence of any opinion, the Commission shall forthwith submit to the Council a proposal relating to the measures to be taken. The Council shall act on a qualified majority.If, on the expiry of three months from the date on which the matter was referred to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures.Article 111. This Directive shall also apply to flavouring intended for use in foodstuffs, and to foodstuffs, imported into the Community.2. This Directive shall apply neither to flavourings, nor to foodstuffs, intended for export outside the Community.Article 121. The Member States may not invoke reasons of composition or labelling of flavourings or their behaviour in foodstuffs to prohibit, restrict, or hamper the marketing or use of flavourings which comply with this Directive and with the Directives referred to in Article 5.2. Paragraph 1 shall not affect national provisions which are applicable in the absence of the Directives as referred to in Article 5.Article 131. Member States shall take the measures necessary to comply with this Directive within 18 months of its adoption. They shall forthwith inform the Commission thereof. The measures taken shall:- authorize, two years after adoption of this Directive, the marketing and use of flavourings complying with this Directive,- prohibit, three years after adoption of this Directive, the marketing and use of flavourings which do not comply with this Directive.2. Paragraph 1 shall not affect those national provisions which, in the absence of the Directives referred to in Article 5, apply to certain groups of flavourings or specify the foodstuffs in or on which flavourings complying with the Directive may be used.Article 14The Directive is addressed to the Member States.Done at Luxembourg, 22 June 1988.For the CouncilThe PresidentM. BANGEMANN(1) OJ No C 144, 13. 6. 1980, p. 9, and OJ No C 103, 24. 4. 1982, p. 7.(2) OJ No C 66, 15. 3. 1982, p. 117 and Decision of 9 March 1988 (not yet published in the Official Journal).(3) OJ No C 138, 9. 6. 1981, p. 42.(4) See page 67 of this Official Journal.(1) OJ No L 291, 19. 11. 1969, p. 9.ANNEX IMaximum limits for certain undesirable substances present in foodstuffs as consumed as a result of the use of flavouringsSubstance  // Foodstuffs   // Beverages  //    //   //   // 3,4 benzopyrene   // 0,03 µg/kg  // 0,03 µg/kgANNEX IIMaximum limits for certain substances obtained from flavourings and other food ingredients with flavouring properties present in foodstuffs as consumed in which flavourings have been usedSubstances  // Foodstuffs mg/kg  // Beverages mg/kg   // Exceptions and/or special restrictions  //  //  //  //  //  //  //  //  // Agaric acid (1)   // 20  // 20   // 100 mg/kg in alcoholic beverages and foodstuffs containing mushrooms   // Aloin (1)   // 0,1   // 0,1   // 50 mg/kg in alcoholic beverages   // Beta asarone (1)   // 0,1  // 0,1   // 1 mg/kg in alcoholic beverages and seasonings used in snack foods   // Berberine (1)   // 0,1   // 0,1   // 10 mg/kg in alcoholic beverages   // Coumarin (1)   // 2   // 2  // 10 mg/kg in certain types of caramel confectionery   //  //   //   // 50 mg/kg in chewing gum   //   //   //   // 10 mg/kg in alcoholic beverages   // Hydrocyanic acid (1)   // 1  // 1   // 50 mg/kg in nougat, marzipan or its substitutes or similar products   //   //   //   // 1 mg/ % volume of alcohol in alcoholic beverages   //   //   //   // 5 mg/kg in canned stone fruit   // Hypericine (1)   // 0,1   // 0,1   // 10 mg/kg in alcoholic beverages   //   //   //   // 1 mg/kg in confectionery   // Pulegone (1)   // 25   // 100   // 250 mg/kg in mint or peppermint-flavoured beverages   //   //   //  // 350 mg/kg in mint confectionery   // Quassine (1)   // 5  // 5   // 10 mg/kg in confectionery in pastille form 50 mg/kg in alcoholic beverages   // Safrole and isosafrole (1)   // 1  // 1   // 2 mg/kg in alcoholic beverages with not more than 25 % volume of alcohol   //   //   //   // 5 mg/kg in alcoholic beverages with more than 25 % volume of alcohol   //   //   //  // 15 mg/kg in foodstuffs containing mace and nutmeg  // Santonin (1)   // 0,1   // 0,1   // 1 mg/kg in alcoholic beverages with more than 25 % volume of alcohol   // Thuyone (alpha and beta) (1)   // 0,5   // 0,5   // 5 mg/kg in alcoholic beverages with not more than 25 % volume of alcohol  //   //   //   // 10 mg/kg in alcoholic beverages with more than 25 % volume of alcohol   //   //   //   // 25 mg/kg in foodstuffs containing preparations based on sage   //   //  //   // 35 mg/kg in bitters   //    //   //   //(1) May not be added as such to foodstuffs or to flavourings. May be present in a foodstuff either naturally or following the addition of flavourings prepared from natural raw materials.


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31988L0344

Council Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients

Official Journal L 157 , 24/06/1988 P. 0028 - 0033 Finnish special edition: Chapter 13 Volume 17 P. 0066  Swedish special edition: Chapter 13 Volume 17 P. 0066

*****COUNCIL  DIRECTIVE  of 13 June 1988  on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients  (88/344/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 differences between national laws relating to extraction solvents hinder the free movement of foodstuffs and may create conditions of unequal competition thereby directly affecting the establishment or functioning of the common market;  Whereas the approximation of those laws is therefore necessary if the free movement of foodstuffs is to be achieved;  Whereas laws relating to extraction solvents for use in foodstuffs should take account primarily of human health requirements but also, within the limits required for the protection of health, of economic and technical needs;  Whereas such approximation must involve the establishment of a single list of extraction solvents for the preparation of foodstuffs or food ingredients; whereas general purity criteria should also be specified;  Whereas the use of an extraction solvent under conditions of good manufacturing practice should result in the removal of all or the major part of the solvent residues from the foodstuff or food ingredient;  Whereas, under such conditions, the presence of residues or derivatives in the final foodstuff or food ingredient may be unintentional but technically unavoidable;  Whereas, although in general a specific limitation is useful, it need not be laid down for substances listed in Part I of the Annex which have been found acceptable from the point of view of safety to the consumer when used under conditions of good manufacturing practice;  Whereas to take account of protection of public health, the conditions of use of other extraction solvents listed in Parts II and III of the Annex and residues permitted in food and food ingredients must be established;  Whereas, pending the adoption of Community rules on flavourings, Member States should not be prevented from authorizing, as extraction solvents for certain flavourings, substances used for diluting and dissolving such materials;  Whereas the provisions on certain extraction solvents should be reviewed within a period of time on the basis of the ongoing scientific and technical research on the acceptability of such solvents and the conditions for their use;  Whereas specific purity criteria for extraction solvents and methods of analysis and sampling of extraction solvents in and on foodstuffs should be established;  Whereas, should the use of an extraction solvent provided for in this Directive appear to constitute a health risk as a result of new information, Member States should be able to suspend or limit such use, or to reduce existing limits, pending a decision at Community level;  Whereas the establishment of sampling procedures and of the methods of analysis required for checking the substances listed and their purity standards constitute technical implementing measures; whereas in order to simplify and expedite these procedures and facilitate their application it is desirable to ensure close cooperation between the Member States and the Commission within the Standing Committee for Foodstuffs set up by Council Decision 69/414/EEC (1),  HAS ADOPTED THIS DIRECTIVE:  Article 1  1. This Directive applies to extraction solvents used or intended for use in the production of foodstuffs or food ingredients.  This Directive shall not apply to extraction solvents used in the production of food additives, vitamins and other nutritional additives, unless such food additives, vitamins or nutritional additives are listed in the Annex.  However, the Member States shall ensure that the use of food additives, vitamins and other nutritional additives does not result in foodstuffs containing extraction solvent residue levels dangerous to human health.  2. This Directive does not affect the laws of the Member States relating to the use of methanol, propan-1-ol, propan-2-ol and tricholoroethylene as extraction solvents in the production of foodstuffs or food ingredients.  3. For the purposes of this Directive:  (a) 'solvent' means any substance for dissolving a foodstuff or any component thereof, including any contaminant present in or on that foodstuff;  (b) 'extraction solvent' means a solvent which is used in an extraction procedure during the processing of raw materials, of foodstuffs, or of components or ingredients of these products and which is removed but which may result in the unintentional, but technically unavoidable, presence of residues or derivatives in the foodstuff or food ingredient.  Article 2  1. Member States shall authorize the use as extraction solvents in the manufacture of foodstuffs or food ingredients of those substances and materials listed in the Annex, under the conditions of use and where appropriate within the maximum residue limits therein specified.  Member States may not prohibit, restrict or obstruct the marketing of foodstuffs or food ingredients on grounds relating to the extraction solvents used or their residues if these comply with the provisions of this Directive.  2. Member States shall not authorize the use of other substances and materials as extraction solvents, nor extend the conditions or use or permitted residues of the extraction solvents listed in the Annex beyond those specified therein.  3. Until the adoption of Community provisions on substances used for diluting and dissolving flavourings Member States may, on their territory, allow the use, as solvents for the extraction of flavourings from natural flavouring materials, of substances used for diluting or dissolving flavourings.  4. Water, to which substances regulating acidity or alkalinity may have been added, other food substances which possess solvent properties and ethanol are authorized as extraction solvent the manufacture of foodstuffs or food ingredients.  5. Within two years of the adoption of this Directive, the Commission shall, after consulting the Scientific Committee for Food, re-examine the provisions relating to Part I of the Annex hereto and to the following substances and shall propose any necessary amendments acting in accordance with the procedure laid down in Article 100a of the Treaty:  Butan-1-ol  Butan-2-ol  Methyl-propan-1-ol  Methyl-propan-2-ol  Methyl acetate  Cyclohexane  Dichloromethane  Hexane  Ethylmethylketone  Isobutane  Diethyl ether  As part of this amendment, the Council shall decide whether the residues of the extraction solvents listed in Part III of the Annex should refer to flavourings rather than foodstuffs.  6. The Commission, after consulting the Scientific Committee for Food, shall re-examine the situation with regard to the substances referred to in Article 1 (2) and submit any appropriate proposal to the Council:  - three years after the adoption of this Directive with regard to methanol, propan-1-ol and propan-2-ol,  - seven years after the adoption of this Directive with regard to trichloroethylene.  Article 3  Member States shall take all measures to ensure that the substances and materials listed as extraction solvents in the Annex satisfy the following purity criteria:  (a) they shall not contain a toxicologically dangerous amount of any element or substance;  (b) subject to any exceptions deriving from the specific purity criteria referred to in (c), they shall not contain more than 1 mg/kg of arsenic or more than 1 mg/kg of lead;  (c) they shall satisfy the specific purity criteria determined in accordance with Article 4.  Article 4  The following shall be determined in accordance with the procedure laid down in Article 6:  (a) the methods of analysis necessary to verify compliance with the general and specific purity criteria referred to in Article 3;  (b) the procedure for taking samples and the methods for qualitative and quantitative analysis of the extraction solvents cited in the Annex used in foodstuffs or food ingredients;  (c) if necessary, the specific purity criteria for the extraction solvents listed in the Annex, and in particular maximum permitted limits of mercury and cadmium in the extraction solvents; these criteria are to be adopted within three years from the date of adoption of this Directive.  Article 5  1. Where a Member State, as a result of new information or of a reassessment of existing information made since the Directive was adopted, has detailed grounds for establishing that the use in foodstuffs of any substance listed in the Annex or the level of one or more of the components referred to in Article 3 contained in such substances might endanger human health although it complies with the conditions laid down in this Directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory. It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision.  2. The Commission shall examine as soon as possible the evidence given by the Member State concerned and consult the Standing Committee for Foodstuffs, and shall then deliver its opinion forthwith and take the appropriate measures, which may replace the measures referred to in paragraph 1.  3. If the Commission considers that amendments to the Directive are necessary in order to resolve the difficulties mentioned in paragraph 1 and to ensure the protection of human health, it shall initiate the procedure laid down in Article 6 with a view to adopting these amendments. Any Member State which has adopted safeguard measures may in that event retain them until the amendments enter into force in its territory.  Article 6  1. Where the procedure laid down in this Article is to be followed, the chairman shall refer the matter to the Standing Committee for Foodstuffs.  2. The Commission representative shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a period fixed by the chairman according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.  3. (a) The Commission shall adopt the intended measures when they are in accordance with the Committee's opinion.  (b) Where the intended measures are not in accordance with the opinion of the Committee, or in the absence of any opinion, the Commission shall forthwith submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.  (c) If, on the expiry of three months from the date on which the matter was referred to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures.  Article 7  1. Member States shall take all the necessary measures to ensure that the substances listed in the Annex and intended for use as extraction solvents in foodstuffs may not be marketed unless their packaging, containers or labels carry the following information in such a way as to be easily visible, clearly legible and indelible:  (a) the commercial name as given in the Annex;  (b) a clear indication that the material is of a quality suitable for use for the extraction of food or food ingredients;  (c) a reference by which the batch or lot may be identified;  (d) the name or business name and address of the manufacturer or packer or of a seller established within the Community; (e) the net quantity given as units of volume;  (f) if necessary, the special storage conditions or conditions of use.  2. By way of derogation from paragraph 1, the information specified in points (c), (d), (e) and (f) of that paragraph may appear merely on the trade documents relating to the batch or lot which are to be supplied with or prior to the delivery.  3. This Article is without prejudice to more precise or more extensive Community provisions regarding weights and measures or provisions applying to the classification, packaging and labelling or dangerous substances and preparations.  4. Member States shall refrain from laying down requirements more detailed than those already contained in this Article concerning the manner in which the particulars provided are to be shown.  Member States shall, however, ensure that the sale of extraction solvents within their own territories is prohibited if the particulars provided for in this Article do not appear in a language easily understood by purchasers, unless other measures have been taken to ensure that the purchaser is informed. This provision shall not prevent such particulars from being indicated in various languages.  Article 8  1. This Directive shall apply equally to extraction solvents used or intended for use in the production of foodstuffs or ingredients imported into the Community.  2. This Directive shall not apply to extraction solvents, or foodstuffs intended for export outside the Community.  Article 9  Member States shall take the measures necessary to comply with this Directive within three years of its adoption, so as to authorize from that date trade in and use of extraction solvents complying with the provisions of this Directive and to prohibit trade in and use of extraction solvents which do not comply therewith. They shall immediately inform the Commission thereof.  Article 10  This Directive is addressed to the Member States.  Done at Luxembourg, 13 June 1988.  For the Council  The President  I. KIECHLE  (1) OJ No C 312, 17. 11. 1983, p. 3, and  OJ No C 77, 23. 3. 1985, p. 7.  (2) OJ No C 12, 14. 1. 1985, p. 152, and  OJ No C 68, 14. 3. 1988, p. 51.  (3) OJ No C 206, 6. 8. 1984, p. 7.  (1) OJ No L 291, 19. 11. 1969, p. 9.  ANNEX  EXTRACTION SOLVENTS WHICH MAY BE USED DURING THE PROCESSING OF RAW MATERIALS, OF FOODSTUFFS, OF FOOD COMPONENTS OR OF FOOD INGREDIENTS  PART I  Extraction solvents to be used in compliance with good manufacturing practice for all uses (1)  Name  Propane  Butane  Butyl acetate  Ethyl acetate  Ethanol  Carbon dioxide  Acetone  Nitrous oxide  (1) An extraction solvent is considered as being used in compliance with good manufacturing practice if its use results only in the presence of residues or derivatives in technically unavoidable quantities presenting no danger to human health.  PART II  Extraction solvents for which conditions of use are specified  1.2.3 //  //  //  // Name  // Conditions of use (summary description of extraction)  // Maximum residue limits in the extracted foodstuff or food ingredient  //  //  //  // Hexane (1)   // Production or fractionation of fats and oils and production of cocoa butter   // 5mg/kg in the fat or oil or cocoa butter   //   // Preparation of protein products and defatted flours   // 10 mg/kg in the food containing the protein products and defatted flours   //   // Preparation of defatted cereal germs   // 5 mg/kg in the defatted cereal germ  //   // Defatted soya products   // 30 mg/kg in the soya product as sold to the final consumer   // Methyl acetate  // Decaffeination of, or removal of irritants and bitterings from coffee and tea   // 20 mg/kg in the coffee or tea   //  // Production of sugar from molasses   // 1 mg/kg in the sugar   // Ethylmethylketone   // Fractionation of fats and oils  // 5 mg/kg in the fat or oil   //   // Decaffeination of, or removal of irritants and bitterings from coffee and tea   // 20 mg/kg in the coffee or tea   // Dichloromethane  // Decaffeination of, or removal of irritants and bitterings from coffee and tea   // 10 (2) mg/kg in the roasted coffee and 5 mg/kg in the tea   //    //   //  (1) Hexane means a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64 °C und 70 °C.  (2) This level will be reduced to 5 mg/kg three years after adoption of this Directive.  PART III  Extraction solvents for which conditions of use are specified  1.2 //  //  // Name  // Maximum residue limits in the foodstuff due to the use of extraction solvents in the preparation of flavourings from natural flavouring materials  //    //   // Diethyl ether   // 2 mg/kg   // Isobutane   // 1 mg/kg   // Hexane   // 1 mg/kg   // Cyclohexane   // 1 mg/kg  // Methyl acetate   // 1 mg/kg   // Butan-1-ol   // 1 mg/kg  // Butan-2-ol   // 1 mg/kg   // Ethylmethylketone   // 1 mg/kg   // Dichloromethane   // 0,1 mg/kg (1)   // Methyl-propan-1-ol   // 1 mg/kg   //    //  (1) Exception: 1 mg/kg in confectionery and pastry products containing flavourings which are characteristic of the foodstuff and are obtained from extracts of alcoholic beverages of an alcoholic strength of over 35°.