title: Commission Directive 2011/79/EU of 20 September 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include fipronil as an active substance in Annex I thereto  Text with EEA relevance

text:
               21.9.2011

               EN

               Official Journal of the European Union

               L 243/10

         COMMISSION DIRECTIVE 2011/79/EU
   of 20 September 2011
   amending Directive 98/8/EC of the European Parliament and of the Council to include fipronil 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 fipronil for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to the Directive.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, fipronil has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18.

               (3)

               France was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007 on 6 February 2009.

               (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 6 May 2011, in an assessment report.

               (5)

               It appears from the evaluations that biocidal products used as insecticides and containing fipronil may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include fipronil in Annex I to that Directive.

               (6)

               Not all potential uses have been evaluated in the Union level assessment, which only addressed professional use indoors by application in locations normally inaccessible to man and domestic animals after application. It is therefore appropriate to require 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)

               The provisions of this Directive should be applied at the same time in all Member States in order to ensure equal treatment on the Union market of biocidal products containing the active substance fipronil, and also to facilitate the proper operation of the biocidal products market in general.

               (8)

               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.

               (9)

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

               (10)

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

               (11)

               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
   1.   Member States shall adopt and publish, by 30 September 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 October 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, 20 September 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.

      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)

                     ‘47

                     fipronil

                     (±)-5-amino-1-(2,6-dichloro-α,α,α,-trifluoro-p-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile (1:1)
                     EC No: 424-610-5
                     CAS No: 120068-37-3

                     950 g/kg

                     1 October 2013

                     30 September 2015

                     30 September 2023

                     18

                     Only professional use indoors by application in locations normally inaccessible after application to man and domestic animals has been addressed in the Union level risk assessment. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where 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.’

         (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


Avis juridique important

|

31981L0632

Thirty-eighth Commission Directive 81/632/EEC of 16 July 1981 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs

Official Journal L 231 , 15/08/1981 P. 0030 - 0030

*****THIRTY-EIGHTH  COMMISSION DIRECTIVE  of 16 July 1981  amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs  (81/632/EEC)  THE COMMISSION OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1), as last amended by Thirty-seventh Commission Directive 81/332/EEC (2), and in particular Article 6 thereof,  Whereas Directive 70/524/EEC provides that the content of the Annexes must be regularly amended in order to keep abreast of developments in scientific and technical knowledge;  Whereas tests on certain uses of virginiamycine and carbadox, which are provided for in Annex II and may therefore be authorized at national level, have not yet been completed; whereas it is therefore desirable to extend the period of authorization of these additives for a finite period;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Annex II to Directive 70/524/EEC is hereby amended as follows:  1. In part A 'Antibiotics', the text of item No 21 'Virginiamycine' is replaced by the following:  1.2.3.4.5.6.7.8.9 //   //   //   //   //   //   //   //   //  // 21  // Virginiamycine  // I. C28H35N3O7  // piglets  // 4 months  // 5  // 50  //   // 30 June 1981  //   //   // II. C43H49N7O10  // calves  // 16 weeks  // 5  // 50  //   // 30 June 1982  //   //   //   //   //   //   //   //   //  2. In part F 'growth promotors', for item No 2 'Carbadox', '30 June 1981' in the column headed 'Period of authorization' is replaced by '30 November 1981.'  Article 2  This Directive is addressed to the Member States.  Done at Brussels, 16 July 1981.  For the Commission  The President  Gaston THORN  (1) OJ No L 270, 14. 12. 1970, p. 1.  (2) OJ No L 131, 18. 5. 1981, p. 1.


Avis juridique important

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31988L0182

Council Directive 88/182/EEC of 22 March 1988 amending Directive 83/189/EEC laying down a procedure for the provision of information in the field of technical standards and regulations

Official Journal L 081 , 26/03/1988 P. 0075 - 0076 Finnish special edition: Chapter 13 Volume 17 P. 0036  Swedish special edition: Chapter 13 Volume 17 P. 0036

*****COUNCIL  DIRECTIVE  of 22 March 1988  amending Directive 83/189/EEC laying down a procedure for the provision of information in the field of technical standards and regulations  (88/182/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 100A, 213 and 43 thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market shall comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;  Whereas experience in implementing Directive 83/189/EEC (4) has shown that certain amendments would be appropriate in order to increase its effectiveness as an instrument intended to facilitate the free movement of goods within the Community by preventing the creation of new barriers to trade;  Whereas the Standing Committee set up pursuant to Article 5 of Directive 83/189/EEC should be consulted on the draft standardization requests referred to in Article 6 (3) of that Directive;  Whereas the introduction of national measures must not be allowed to compromise the adoption, by the Council, of Commission proposals in the same field; whereas, to this end, it is necessary to provide for a 12-month standstill period to take effect from the date of submission of the said proposals, during which Member States must refrain from adopting technical regulations in the field in question,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 83/189/EEC is hereby amended as follows:  1. The following recital is added after the fifth recital:  'Whereas the Member State concerned must take account of these amendments when formulating the definitive text of the measure envisaged;'.  2. The following is added to Article 1 (1):  'and the production methods and procedures for agricultural products as defined in Article 38 (1) of the Treaty and for products intended for human and animal consumption and for medicinal products as defined in Article 1 of Directive 65/65/EEC (1), as last amended by Directive 87/21/EEC. (2)  (1) OJ No 22, 9. 2. 1965, p. 369/65.  (2) OJ No L 15, 15. 1. 1987, p. 36.'.  3. Article 1 (7) is replaced by the following:  '(7) "product", any industrially manufactured product and any agricultural product.'.  4. The following indent is added to Article 6 (3):  '- identify the areas where harmonization appears necessary, and, should the case arise, undertake appropriate harmonization in a given sector.'.  5. The following is added to Article 6 (4):  '(e) on the requests to the standards institutions referred to in the first indent of paragraph 3.'.  6. The following is added to the end of the first subparagraph of Article 8 (1):  'Where appropriate, Member States shall simultaneously communicate the text of the basic legislative or regulatory provisions principally and directly concerned, should knowledge of such text be necessary to assess the implications of the draft technical regulation.'.  7. The second subparagraph of Article 8 (1) is replaced by the following:  'The Commission shall immediately notify the other Member States of any draft it has received; it may also refer this draft to the Committee referred to in Article 5 and, if appropriate, to the Committee responsible for the field in question for its opinion.'.  8. Article 9 is amended as follows:  (a) in paragraph 1, 'Without prejudice to paragraph 2' is replaced by 'Without prejudice to paragraphs 2 and 2 (a)';  (b) the following text is added at the end of paragraph 1:  'The Member State concerned shall report to the Commission on the action it proposes to take on such detailed opinions. The Commission shall comment on this reaction.';  (c) the following paragraph is inserted:  '2 (a) If the Commission ascertains that a communication pursuant to Article 8 (1) relates to a subject covered by a proposal for a directive or regulation submitted to the Council, it shall inform the Member State concerned of this fact within three months of receiving the communication.  Member States shall refrain from adopting technical regulations on a subject covered by a proposal for a directive or regulation submitted by the Commission to the Council before the communication provided for in Article 8 (1) for a period of 12 months from the date of its submission.  Recourse to paragraphs 1, 2 and 2 (a) of this Article cannot be cumulative.';  (d) paragraph 3 is replaced by the following:  '3. Paragraphs 1, 2 and 2 (a) shall not apply in those cases where, for urgent reasons relating to the protection of public health or safety, the protection of health and life of animals or plants, a Member State is obliged to prepare technical regulations in a very short space of time in order to enact and introduce them immediately without any consultations being possible. The Member State shall give, in the communication referred to in Article 8, the reasons which warrant the urgency of the measures taken. The Commission shall take appropriate action in cases where improper use is made of this procedure.'.  9. Article 10 is replaced by the following:  'Article 10  Articles 8 and 9 shall not apply where the Member States fulfil their obligations as arising out of Community directives and regulations; the same shall apply in the case of obligations arising out of international agreements which result in the adoption of uniform technical specifications in the Community.'.  10. The following subparagraph is added to Article 11:  'The Commission shall report annually to the European Parliament on the results of the application of this Directive.'.  Article 2  1. Member States shall take the measures necessary to comply with this Directive not later than 1 January 1989. They shall forthwith inform the Commission thereof.  2. Member States shall ensure that they communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 22 March 1988.  For the Council  The President  M. BANGEMANN  (1) OJ No C 71, 19. 3. 1987, p. 12 and OJ No C 3, 7. 1. 1988, p. 6.  (2) OJ No C 345, 21. 12. 1987 and Decision of 10 February 1988 (not yet published in the Official Journal).  (3) OJ No C 319, 30. 11. 1987, p. 20.  (4) OJ No L 109, 26. 4. 1983, p. 8.


title: Commission Directive 2009/118/EC of 9 September 2009 amending Annexes II to V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community

text:
               10.9.2009

               EN

               Official Journal of the European Union

               L 239/51

      COMMISSION DIRECTIVE 2009/118/EC
   of 9 September 2009
   amending Annexes II to V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular points (c) and (d) of the second paragraph of Article 14 thereof,
   After consulting the Member States concerned,
   Whereas:

               (1)

               Directive 2000/29/EC provides for certain zones to be recognised as protected zones.

               (2)

               Certain regions and parts of regions in Austria were recognised for a limited time as protected zones with respect to Erwinia amylovora (Burr.) Winsl. et al. by Commission Regulation (EC) No 690/2008 (2). Austria has submitted information showing that Erwinia amylovora (Burr.) Winsl. et al. is now established on its territory. Those regions and parts of regions should therefore no longer be recognised as protected zones.

               (3)

               In Greece, Crete and Lesvos were recognised as protected zones with respect to Cryphonectria parasitica (Murrill) Barr. Greece has submitted information showing that Cryphonectria parasitica (Murrill) Barr is now established in those regions. Crete and Lesvos should therefore no longer be recognised as protected zones in respect of that harmful organism.

               (4)

               As a result of previous amendments some of the cross-references and a reference to a protected zone in Annex IV to Directive 2000/29/EC have become obsolete and should be deleted.

               (5)

               Certain codes of wood and articles of wood of the Combined Nomenclature have been amended by Commission Regulation (EC) No 1031/2008 (3). It is necessary to adapt Directive 2000/29/EC to those technical developments.

               (6)

               Annexes II to V to Directive 2000/29/EC should therefore be amended accordingly.

               (7)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes II to V to Directive 2000/29/EC are amended in accordance with the Annex to this Directive.
   Article 2
   Member States shall adopt and publish, by 30 November 2009 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 December 2009.
   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 a 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, 9 September 2009.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 169, 10.7.2000, p. 1.

      (2)  OJ L 193, 22.7.2008, p. 1.

      (3)  OJ L 291, 31.10.2008, p. 1.

      ANNEX
      Annexes II to V to Directive 2000/29/EC are amended as follows:

                  1.

                  Part B of Annex II is amended as follows:

                              (a)

                              In point 2 of heading (b), in the third column, protected zone(s), the words ‘A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria and Vienna),’ are deleted.

                              (b)

                              In point 0.1 of heading (c), in the third column, protected zone(s), the words ‘EL (Crete, Lesvos),’ are deleted.

                  2.

                  Part B of Annex III is amended as follows:

                              (a)

                              In point 1, in the second column, protected zone(s), the words ‘A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria and Vienna),’ are deleted.

                              (b)

                              In point 2, in the second column, protected zone(s), the words ‘A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria and Vienna),’ are deleted.

                  3.

                  Annex IV is amended as follows:

                              (a)

                              Part A is amended as follows:

                                          (i)

                                          In point 16.5 of Section I, in the second column, special requirements, in the first sentence, the words ‘Annex III(B)(2), (3), and’ are deleted.

                                          (ii)

                                          In point 46 of Section I, in the second column, special requirements, in the first sentence, number ‘(45),’ is deleted.

                              (b)

                              Part B is amended as follows:

                                          (i)

                                          In points 1, 2, 3, 4, 5 and 6, in the second column, special requirements, in the first sentence, the words ‘Annex IV(A)(I)(1.1), (1.2), (1.3), (1.4), (1.5), (7)’ are replaced by ‘Annex IV(A)(I)(1.1), (1.2), (1.3), (1.4), (1.5), (1.6), (1.7)’.

                                          (ii)

                                          In points 6.3 and 14.9, in the third column, protected zone(s), the words ‘EL (Crete, Lesvos),’ are deleted.

                                          (iii)

                                          In point 14.9, in the third column, protected zone(s), the word ‘DK,’ is deleted.

                                          (iv)

                                          In point 21, in the third column, protected zone(s), the words ‘A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria and Vienna),’ are deleted.

                                          (v)

                                          In point 21.3, in the third column, protected zone(s), the words ‘A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria and Vienna),’ are deleted.

                  4.

                  Annex V is amended as follows:

                              (a)

                              In point I.1.7.(b) of Part A, in the first column of the table, CN code, the code ‘ex 4401 30 90’ is replaced by ‘ex 4401 30 80’.

                              (b)

                              In point I.6.(b) of Part B, the fourth entry

                                          ‘4401 30 10

                                          Sawdust’

                                    is replaced by

                                          ‘ex 4401 30 40

                                          Sawdust, not agglomerated in logs, briquettes, pellets or similar forms’

                              (c)

                              In point I.6.(b) of Part B, in the first column of the table, CN code, the code ‘ex 4401 30 90’ is replaced by ‘ex 4401 30 80’.


title: Directive 2004/40/EC of the European Parliament and of the Council of 29 April 2004 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)

text:
               30.4.2004

               EN

               Official Journal of the European Communities

               L 159/1

         Directive 2004/40/EC of the European Parliament and of the Council
   of 29 April 2004
   on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/39 I/EEC)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof,
   Having regard to the proposal from the Commission (1), presented after consultation with the Advisory Committee on Safety, Hygiene and Health Protection at Work,
   Having regard to the Opinion of the European Economic and Social Committee (2),
   Following consultation of the Committee of the Regions,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
   Whereas:

               (1)

               Under the Treaty the Council may, by means of directives, adopt minimum requirements for encouraging improvements, especially in the working environment, to guarantee a better level of protection of the health and safety of workers. Such directives are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings.

               (2)

               The communication from the Commission concerning its action programme relating to the implementation of the Community Charter of the Fundamental Social Rights of Workers provides for the introduction of minimum health and safety requirements regarding the exposure of workers to the risks caused by physical agents. In September 1990 the European Parliament adopted a Resolution concerning this action programme (4), inviting the Commission in particular to draw up a specific directive on the risks caused by noise and vibration and by any other physical agents at the workplace.

               (3)

               As a first step, the European Parliament and the Council adopted Directive 2002/44/EC of 25 June 2002 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (vibration) (16th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (5). Next, on 6 February 2003, the European Parliament and the Council adopted Directive 2003/10/EC on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (noise) (17th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (6).

               (4)

               It is now considered necessary to introduce measures protecting workers from the risks associated with electromagnetic fields, owing to their effects on the health and safety of workers. However, the long-term effects, including possible carcinogenic effects due to exposure to time-varying electric, magnetic and electromagnetic fields for which there is no conclusive scientific evidence establishing a causal relationship, are not addressed in this Directive. These measures are intended not only to ensure the health and safety of each worker on an individual basis, but also to create a minimum basis of protection for all Community workers, in order to avoid possible distortions of competition.

               (5)

               This Directive lays down minimum requirements, thus giving Member States the option of maintaining or adopting more favourable provisions for the protection of workers, in particular the fixing of lower values for the action values or the exposure limit values for electromagnetic fields. The implementation of this Directive should not serve to justify any regression in relation to the situation which already prevails in each Member State.

               (6)

               A system of protection against electromagnetic fields should limit itself to a definition, free of excessive detail, of the objectives to be attained, the principles to be observed and the fundamental values to be applied, in order to enable Member States to apply the minimum requirements in an equivalent manner.

               (7)

               The level of exposure to electromagnetic fields can be more effectively reduced by incorporating preventive measures into the design of workstations and by selecting work equipment, procedures and methods so as to give priority to reducing the risks at source. Provisions relating to work equipment and methods thus contribute to the protection of the workers involved.

               (8)

               Employers should make adjustments in the light of technical progress and scientific knowledge regarding risks related to exposure to electromagnetic fields, with a view to improving the safety and health protection of workers.

               (9)

               Since this Directive is an individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (7), that Directive therefore applies to the exposure of workers to electromagnetic fields, without prejudice to more stringent and/or specific provisions contained in this Directive.

               (10)

               This Directive constitutes a practical step towards creating the social dimension of the internal market.

               (11)

               The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8).

               (12)

               Adherence to the exposure limit and action values should provide a high level of protection as regards the established health effects that may result from exposure to electromagnetic fields but such adherence may not necessarily avoid interference problems with, or effects on the functioning of, medical devices such as metallic prostheses, cardiac pacemakers and defibrillators, cochlear implants and other implants; interference problems especially with pacemakers may occur at levels below the action values and should therefore be the object of appropriate precautions and protective measures,

         HAVE ADOPTED THIS DIRECTIVE:
   SECTION I
   GENERAL PROVISIONS

      Article 1

   Aim and scope
   1.   This Directive, which is the 18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC, lays down minimum requirements for the protection of workers from risks to their health and safety arising or likely to arise from exposure to electromagnetic fields (0 Hz to 300 GHz) during their work.
   2.   This Directive refers to the risk to the health and safety of workers due to known short-term adverse effects in the human body caused by the circulation of induced currents and by energy absorption as well as by contact currents.
   3.   This Directive does not address suggested long-term effects.
   4.   This Directive does not address the risks resulting from contact with live conductors.
   5.   Directive 89/391/EEC shall apply fully to the whole area referred to in paragraph 1, without prejudice to more stringent and/or more specific provisions contained in this Directive.

      Article 2

   Definitions
   For the purposes of this Directive, the following definitions shall apply:

               (a)

               "electromagnetic fields": static magnetic and time-varying electric, magnetic and electromagnetic fields with frequencies up to 300 GHz;

               (b)

               "exposure limit values": limits on exposure to electromagnetic fields which are based directly on established health effects and biological considerations. Compliance with these limits will ensure that workers exposed to electromagnetic fields are protected against all known adverse health effects;

               (c)

               "action values": the magnitude of directly measurable parameters, provided in terms of electric field strength (E), magnetic field strength (H), magnetic flux density (B) and power density (S), at which one or more of the specified measures in this Directive must be undertaken. Compliance with these values will ensure compliance with the relevant exposure limit values.

      Article 3

   Exposure limit values and action values
   1.   The exposure limit values are as set out in the Annex, Table 1.
   2.   The action values are as set out in the Annex, Table 2.
   3.   For the assessment, measurement and/or calculation of workers' exposure to electromagnetic fields, until harmonised European standards from the European Committee for Electrotechnical Standardisation (CENELEC) cover all relevant assessment, measurement and calculation situations, Member States may employ other scientifically-based standards or guidelines.
   SECTION II
   OBLIGATIONS OF EMPLOYERS

      Article 4

   Determination of exposure and assessment of risks
   1.   In carrying out the obligations laid down in Articles 6(3) and 9(1) of Directive 89/391/EEC, the employer shall assess and, if necessary, measure and/or calculate the levels of electromagnetic fields to which workers are exposed. Assessment, measurement and calculation may, until harmonised European standards from CENELEC cover all relevant assessment, measurement and calculation situations, be carried out in accordance with the scientifically-based standards and guidelines referred to in Article 3 and, when relevant, by taking into account the emission levels provided by the manufacturers of the equipment when it is covered by the relevant Community Directives.
   2.   On the basis of the assessment of the levels of electromagnetic fields undertaken in accordance with paragraph 1, if the action values referred to in Article 3 are exceeded, the employer shall assess and, if necessary, calculate whether the exposure limit values are exceeded.
   3.   The assessment, measurement and/or calculations referred to in paragraphs 1 and 2 need not be carried out in workplaces open to the public provided that an evaluation has already been undertaken in accordance with the provisions of Council Recommendation 1999/519/EC of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields (O Hz to 300 GHz) (9), and the restrictions as specified therein are respected for workers and safety risks are excluded.
   4.   The assessment, measurement and/or calculations referred to in paragraphs 1 and 2 shall be planned and carried out by competent services or persons at suitable intervals, taking particular account of the provisions of Article 7 and Article 11 of Directive 89/391/EEC concerning the necessary competent services or persons and the consultation and participation of workers. The data obtained from the assessment, measurement and/or calculation of the level of exposure shall be preserved in a suitable form so as to permit consultation at a later stage.
   5.   Pursuant to Article 6(3) of Directive 89/391/EEC, the employer shall give particular attention, when carrying out the risk assessment, to the following:

               (a)

               the level, frequency spectrum, duration and type of exposure;

               (b)

               the exposure limit values and action values referred to in Article 3 of this Directive;

               (c)

               any effects concerning the health and safety of workers at particular risk;

               (d)

               any indirect effects, such as:

                           (i)

                           interference with medical electronic equipment and devices (including cardiac pacemakers and other implanted devices);

                           (ii)

                           the projectile risk from ferromagnetic objects in static magnetic fields with a magnetic flux density greater than 3 mT;

                           (iii)

                           initiation of electro-explosive devices (detonators);

                           (iv)

                           fires and explosions resulting from ignition of flammable materials by sparks caused by induced fields, contact currents or spark discharges;

               (e)

               the existence of replacement equipment designed to reduce the levels of exposure to electromagnetic fields;

               (f)

               appropriate information obtained from health surveillance, including published information, as far as possible;

               (g)

               multiple sources of exposure;

               (h)

               simultaneous exposure to multiple frequency fields.

         6.   The employer shall be in possession of an assessment of the risk in accordance with Article 9(l)(a) of Directive 89/391/EEC and shall identify which measures must be taken in accordance with Articles 5 and 6 of this Directive. The risk assessment shall be recorded on a suitable medium, according to national law and practice; it may include a justification by the employer that the nature and extent of the risks related to electromagnetic fields make a further detailed risk assessment unnecessary. The risk assessment shall be updated on a regular basis, particularly if there have been significant changes which could render it out of date, or when the results of health surveillance show it to be necessary.

      Article 5

   Provisions aimed at avoiding or reducing risks
   1.   Taking account of technical progress and of the availability of measures to control the risk at source, the risks arising from exposure to electromagnetic fields shall be eliminated or reduced to a minimum.
   The reduction of risks arising from exposure to electromagnetic fields shall be based on the general principles of prevention set out in Directive 89/39 I/EEC.
   2.   On the basis of the risk assessment referred to in Article 4, once the action values referred to in Article 3 are exceeded, the employer, unless the assessment carried out in accordance with Article 4(2) demonstrates that the exposure limit values are not exceeded and that safety risks can be excluded, shall devise and implement an action plan comprising technical and/or organisational measures intended to prevent exposure exceeding the exposure limit values, taking into account in particular:

               (a)

               other working methods that entail less exposure to electromagnetic fields;

               (b)

               the choice of equipment emitting less electromagnetic fields, taking account of the work to be done;

               (c)

               technical measures to reduce the emission of electromagnetic fields including, where necessary, the use of interlocks, shielding or similar health protection mechanisms;

               (d)

               appropriate maintenance programmes for work equipment, workplaces and workstation systems;

               (e)

               the design and layout of workplaces and workstations;

               (f)

               limitation of the duration and intensity of the exposure;

               (g)

               the availability of adequate personal protection equipment.

         3.   On the basis of the risk assessment referred to in Article 4, workplaces where workers could be exposed to electromagnetic fields exceeding the action values shall be indicated by appropriate signs in accordance with Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and/or health signs at work (ninth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC (10), unless the assessment carried out in accordance with Article 4(2) demonstrates that the exposure limit values are not exceeded and that safety risks can be excluded. The areas in question shall be identified, and access to them limited where this is technically possible and where there is a risk that the exposure limit values could be exceeded.
   4.   In any event, workers shall not be exposed above the exposure limit values.
   If, despite the measures taken by the employer to comply with this Directive, the exposure limit values are exceeded, the employer shall take immediate action to reduce exposure below the exposure limit values. He shall identify the reasons why the exposure limit values have been exceeded, and shall amend the protection and prevention measures accordingly in order to prevent them being exceeded again.
   5.   Pursuant to Article 15 of Directive 89/391/EEC, the employer shall adapt the measures referred to in this Article to the requirements of workers at particular risk.

      Article 6

   Worker information and training
   Without prejudice to Articles 10 and 12 of Directive 89/391/EEC, the employer shall ensure that workers who are exposed to risks from electromagnetic fields at work and/or their representatives receive any necessary information and training relating to the outcome of the risk assessment provided for in Article 4(1) of this Directive, concerning in particular:

               (a)

               measures taken to implement this Directive;

               (b)

               the values and concepts of the exposure limit values and action values and the associated potential risks;

               (c)

               the results of the assessment, measurement and/or calculations of the levels of exposure to electromagnetic fields carried out in accordance with Article 4 of this Directive;

               (d)

               how to detect adverse health effects of exposure and how to report them;

               (e)

               the circumstances in which workers are entitled to health surveillance;

               (f)

               safe working practices to minimise risks from exposure.

      Article 7

   Consultation and participation of workers
   Consultation and participation of workers and/or of their representatives shall take place in accordance with Article 11 of Directive 89/39 I/EEC on the matters covered by this Directive.
   SECTION III
   MISCELLANEOUS PROVISIONS

      Article 8

   Health surveillance
   1.   With the objective of prevention and early diagnosis of any adverse health effects due to exposure to electromagnetic fields, appropriate health surveillance shall be carried out in accordance with Article 14 of Directive 89/391/EEC.
   In any event, where exposure above the limit values is detected, a medical examination shall be made available to the worker(s) concerned in accordance with national law and practice. If health damage resulting from such exposure is detected, a reassessment of the risks shall be carried out by the employer in accordance with Article 4.
   2.   The employer shall take appropriate measures to ensure that the doctor and/or the medical authority responsible for the health surveillance has access to the results of the risk assessment referred to in Article 4.
   3.   The results of health surveillance shall be preserved in a suitable form so as to permit consultation at later date, taking account of confidentiality requirements. Individual workers shall, at their request, have access to their own personal health records.
   Article 9
   Sanctions
   Member States shall provide for adequate sanctions to be applicable in the event of infringement of national legislation adopted pursuant to this Directive. These sanctions must be effective, proportionate and dissuasive.

      Article 10

   Technical amendments
   1.   Modifications of the exposure limit values and action values set out in the Annex shall be adopted by the European Parliament and the Council in accordance with the procedure laid down in Article 137(2) of the Treaty.
   2.   Amendments to the Annex of a strictly technical nature in line with:

               (a)

               the adoption of Directives in the field of technical harmonisation and standardisation with regard to the design, building, manufacture or construction of work equipment and/or workplaces;

               (b)

               technical progress, changes in the most relevant harmonised European standards or specifications, and new scientific findings concerning electromagnetic fields

         shall be adopted in accordance with the regulatory procedure referred to in Article 11(2).

      Article 11

   Committee
   1.   The Commission shall be assisted by the Committee referred to in Article 17 of Directive 89/391/EEC.
   2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months.
   3.   The Committee shall adopt its rules of procedure.
   SECTION IV
   FINAL PROVISIONS

      Article 12

   Reports
   Every five years Member States shall provide a report to the Commission on the practical implementation of this Directive, indicating the points of view of the social partners.
   Every five years the Commission shall inform the European Parliament, the Council, the European Economic and Social Committee and the Advisory Committee on Safety and Health Protection at Work of the content of these reports, of its assessment of developments in the field in question and of any initiative, in particular as regards exposure to static magnetic fields, that may be warranted in the light of new scientific knowledge.

      Article 13

   Transposition
   1.   The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than ... (11). They shall forthwith inform the Commission thereof.
   When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   2.   Member States shall communicate to the Commission the provisions of national law which they adopt or have already adopted in the field covered by this Directive.

      Article 14

   Entry into force
   This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

      Article 15

   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 29 April 2004.

         For the European Parliament
         The President
         P. COX

         For the Council
         The President
         M. McDOWELL

      (1)  OJ C 77, 18.3.1993, p. 12 and OJ C 230, 19.8.1994, p. 3.

      (2)  OJ C 249, 13.9.1993, p. 28.

      (3)  Opinion of the European Parliament of 20 April 1994 (OJ C 128, 9.5.1994, p. 146) confirmed on 16 September 1999 (OJ C 54, 25.2.2000, p. 75), Council Common Position of 18 December 2003 (OJ C E 66, 16.3.2004, p. 1), Position of the European Parliament of 30 March 2004 (not yet published in the Official Journal) and Council Decision of 7 April 2004.

      (4)  OJ C 260, 15.10.1990, p.167.

      (5)  OJ L 177, 6.7.2002, p. 13.

      (6)  OJ L 42, 15.2.2003, p. 38.

      (7)  OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (8)  OJ L 184, 17.7.1999, p. 23.

      (9)  OJ L 199, 30.7.1999, p. 59.

      (10)  OJ L 245, 26.8.1992, p. 23.

      (11)  4 years after the entry into force of this Directive.

      ANNEX
      EXPOSURE LIMIT AND ACTION VALUES FOR ELECTROMAGNETIC FIELDS
      The following physical quantities shall be used to describe the exposure to electromagnetic fields:

         Contact current (IC) between a person and an object is expressed in amperes (A). A conductive object in an electric field can be charged by the field.

         Current density (J) is defined as the current flowing through a unit cross section perpendicular to its direction in a volume conductor such as the human body or part of it, expressed in amperes per square metre (A/m2).

         Electric field strength is a vector quantity (E) that corresponds to the force exerted on a charged particle regardless of its motion in space. It is expressed in volts per metre (V/m).

         Magnetic field strength is a vector quantity (H), which, together with the magnetic flux density, specifies a magnetic field at any point in space. It is expressed in amperes per metre (A/m).

         Magnetic flux density is a vector quantity (B), resulting in a force that acts on moving charges, expressed in teslas (T). In free space and in biological materials, magnetic flux density and magnetic field strength can be interchanged using the equivalence 1 A/m = 4p 10-7 T.

         Power density (S) is the appropriate quantity used for very high frequencies, where the depth of penetration in the body is low. It is the radiant power incident perpendicular to a surface, divided by the area of the surface and is expressed in watts per square metre (W/m2).

         Specific energy absorption (SA) is defined as the energy absorbed per unit mass of biological tissue, expressed in joules per kilogram (J/kg). In this directive it is used for limiting non-thermal effects from pulsed microwave radiation.

         Specific energy absorption rate (SAR) averaged over the whole body or over parts of the body, is defined as the rate at which energy is absorbed per unit mass of body tissue and is expressed in watts per kilogram (W/kg). Whole body SAR is a widely accepted measure for relating adverse thermal effects to radio frequency (RF) exposure. Besides the whole body average SAR, local SAR values are necessary to evaluate and limit excessive energy deposition in small parts of the body resulting from special exposure conditions. Examples of such conditions are: a grounded individual exposed to RF in the low MHz range and individuals exposed in the near field of an antenna.
      Of these quantities, magnetic flux density, contact current, electric and magnetic field strengths and power density can be measured directly.
      A.   EXPOSURE LIMIT VALUES
      Depending on frequency, the following physical quantities are used to specify the exposure limit values of electromagnetic fields:

                  —

                  exposure limit values are provided for current density for time-varying fields up to 1 Hz, to prevent effects on the cardiovascular and central nervous system,

                  —

                  between 1 Hz and 10 MHz exposure limit values are provided on current density to prevent effects on central nervous system functions,

                  —

                  between 100 kHz and 10 GHz exposure limit values on SAR are provided to prevent whole-body heat stress and excessive localised heating of tissues. In the range 100 kHz to 10 MHz, exposure limit values on both current density and SAR are provided,

                  —

                  between 10 GHz and 300 GHz an exposure limit value on power density is provided to prevent excessive tissue heating at or near the body surface.

         Table 1: Exposure limit values (Article 3(1)). All conditions to be satisfied

                  Frequency range

                  Current density for head and trunk
                  J
                  (mA/m2)
                  (rms)

                  Whole body average SAR
                  (W/kg)

                  Localised SAR
                  (head and trunk)
                  (W/kg)

                  Localised SAR
                  (limbs)
                  (W/kg)

                  Power density
                  S
                  (W/m2)

                  Up to 1 Hz

                  40

                  –

                  –

                  –

                  –

                  1 - 4 Hz

                  40/f

                  –

                  –

                  –

                  –

                  4 - 1 000 Hz

                  10

                  –

                  –

                  –

                  –

                  1 000 Hz – 100 kHz

                  f/100

                  –

                  –

                  –

                  –

                  100 kHz – 10 MHz

                  f/100

                  0,4

                  10

                  20

                  –

                  10 MHz –10 GHz

                  –

                  0,4

                  10

                  20

                  –

                  10 – 300 GHz

                  –

                  –

                  –

                  –

                  50

         Notes:

                  1.

                  f is the frequency in Hertz.

                  2.

                  The exposure limit values on the current density are intended to protect against acute exposure effects on central nervous system tissues in the head and trunk of the body. The exposure limit values in the frequency range 1 Hz to 10 MHz are based on established adverse effects on the central nervous system. Such acute effects are essentially instantaneous and there is no scientific justification to modify the exposure limit values for exposure of short duration. However, since the exposure limit values refer to adverse effects on the central nervous system, these exposure limit values may permit higher current densities in body tissues other than the central nervous system under the same exposure conditions.

                  3.

                  Because of the electrical inhomogeneity of the body, current densities should be calculated as averages over a cross-section of 1 cm perpendicular to the current direction.

                  4.

                  For frequencies up to 100 kHz, peak current density values can be obtained by multiplying the rms value by (2)½.

                  5.

                  For frequencies up to 100 kHz and for pulsed magnetic fields, the maximum current density associated with the pulses can be calculated from the rise/fall times and the maximum rate of change of magnetic flux density. The induced current density can then be compared with the appropriate exposure limit value. For pulses of duration tp, the equivalent frequency to apply for the exposure limit values should be calculated as f=1/(2tp).

                  6.

                  All SAR values are to be averaged over any six-minute period.

                  7.

                  Localised SAR averaging mass is any 10 g of contiguous tissue; the maximum SAR so obtained should be the value used for estimating exposure. These 10 g of tissue are intended to be a mass of contiguous tissue with nearly homogeneous electrical properties. In specifying a contiguous mass of tissue, it is recognised that this concept can be used in computational dosimetry but may present difficulties for direct physical measurements. A simple geometry such as cubic tissue mass can be used provided that the calculated dosimetric quantities have conservative values relative to the exposure guidelines.

                  8.

                  For pulsed exposures in the frequency range 0,3 to 10 GHz and for localised exposure of the head, in order to limit and avoid auditory effects caused by thermoelastic expansion, an additional exposure limit value is recommended. This is that the SA should not exceed 10 mJ/kg averaged over 10 g of tissue.

                  9.

                  Power densities are to be averaged over any 20 cm2 of exposed area and any 68/f1,05-minute period (where f is in GHz) to compensate for progressively shorter penetration depth as the frequency increases. Spatial maximum power densities averaged over 1 cm2 should not exceed 20 times the value of 50 W/m2.

                  10.

                  With regard to pulsed or transient electromagnetic fields, or generally with regard to simultaneous exposure to multiple frequency fields, appropriate methods of assessment, measurement and/or calculation capable of analysing the characteristics of the waveforms and nature of biological interactions have to be applied, taking account of European harmonised standards developed by CENELEC.

            B.   ACTION VALUES
      The action values referred to in Table 2 are obtained from the exposure limit values according to the rationale used by the International Commission on Non-ionising Radiation Protection (ICNIRP) in its guidelines on limiting exposure to non-ionising radiation (ICNIRP 7/99).

         Table 2: Action values (Article 3(2)) (unperturbed rms values)

                  Frequency range

                  Electric field strength, E (V/m)

                  Magnetic field strength, H (A/m)

                  Magnetic flux density, B (µT)

                  Equivalent plane wave power density, Seq (W/m2)

                  Contact current, Ic (mA)

                  Limb induced current, IL (mA)

                  0 – 1Hz

                  –

                  1,63x105

                  2x105

                  –

                  1,0

                  –

                  1 – 8 Hz

                  20000

                  1,63x105/f2

                  2x105/f2

                  –

                  1,0

                  –

                  8 – 25 Hz

                  20000

                  2x104/f

                  2,5x104/f

                  –

                  1,0

                  –

                  0,025 – 0,82kHz

                  500/f

                  20/f

                  25/f

                  –

                  1,0

                  –

                  0,82 – 2,5 kHz.

                  610

                  24,4

                  30,7

                  –

                  1,0

                  –

                  2,5 – 65 kHz

                  610

                  24,4

                  30,7

                  –

                  0,4 f

                  –

                  65 – 100 kHz

                  610

                  1600/f

                  2000/f

                  –

                  0,4 f

                  –

                  0,1 – 1 MHz

                  610

                  1,6/f

                  2/f

                  –

                  40

                  –

                  1 – 10 MHz

                  610/f

                  1,6/f

                  2/f

                  –

                  40

                  –

                  10 – 110 MHz

                  61

                  0,16

                  0,2

                  10

                  40

                  100

                  110 – 400 MHz

                  61

                  0,16

                  0,2

                  10

                  –

                  –

                  400 – 2000 MHz

                  3f½

                  0,008f½

                  0,01f½

                  f/40

                  –

                  –

                  2 – 300 GHz

                  137

                  0,36

                  0,45

                  50

                  –

                  –

         Notes:

                  1.

                  f is the frequency in the units indicated in the frequency range column.

                  2.

                  For frequencies between 100 kHz and 10 GHz, Seq, E2, H2, B2 and IL
                     2 are to be averaged over any six-minute period.

                  3.

                  For frequencies exceeding 10 GHz, Seq, E2, H2 and B2 are to be averaged over any 68/f1.05-minute period (f in GHz).

                  4.

                  For frequencies up to 100 kHz, peak action values for the field strengths can be obtained by multiplying the rms value by (2)½. For pulses of duration tp, the equivalent frequency to apply for the action values should be calculated as f=l/(2tp).
                  For frequencies between 100 kHz and 10 MHz, peak action values for the field strengths are calculated by multiplying the relevant rms values by 10a, where a = (0,665 log (f/105) + 0,176), f in Hz.
                  For frequencies between 10 MHz and 300 GHz, peak action values are calculated by multiplying the corresponding rms values by 32 for the field strengths and by 1000 for the equivalent plane wave power density.

                  5.

                  With regard to pulsed or transient electromagnetic fields, or generally with regard to simultaneous exposure to multiple frequency fields, appropriate methods of assessment, measurement and/or calculation capable of analysing the characteristics of the waveforms and nature of biological interactions have to be applied, taking account of harmonised European standards developed by CENELEC.

                  6.

                  For peak values of pulsed modulated electromagnetic fields, it is also suggested that, for carrier frequencies exceeding 10 MHz, Seq as averaged over the pulse width should not exceed 1 000 times the Seq action values or that the field strength should not exceed 32 times the field strength action values for the carrier frequency.


Avis juridique important

|

31986L0562

Commission Directive 86/562/EEC of 6 November 1986 adapting to technical progress Council Directive 71/127/EEC on the approximation of the laws of the Member States relating to the rear-view mirrors of motor vehicles

Official Journal L 327 , 22/11/1986 P. 0049 - 0049 Finnish special edition: Chapter 13 Volume 16 P. 0046  Swedish special edition: Chapter 13 Volume 16 P. 0046

*****COMMISSION  DIRECTIVE  of 6 November 1986  adapting to technical progress Council Directive 71/127/EEC on the approximation of the laws of the Member States relating to the rear-view mirrors of motor vehicles  (86/562/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of Member States relating to the type-approval of motor vehicles and their trailers (1), as last amended by Directive 80/1267/EEC (2), and in particular Article 11 thereof,  Having regard to Council Directive 71/127/EEC of 1 March 1971 on the approximation of the laws of the Member States relating to the rear-view mirrors of motor vehicles (3), as last amended by Commission Directive 85/205/EEC (4);  Whereas all rear-view mirrors EEC component typeapproved after 1 October 1986 must bear the EEC component type-approval mark with the sequence number 02; whereas sequence number 01 may still be used for Class I, II and III mirrors for so long as the requirements for those three classes of rear-view mirrors remain unchanged;  Whereas a great many rear-view mirrors incorporate protective plastic casings and whereas a change to a single digit of the component type-approval mark would involve a major, if not complete modification of the moulding equipment used; whereas the cost of these modifications wuold be unjustifiably out of proportion to the intended aim;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of Directives on the removal of technical barriers to trade in the motor vehicles sector,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 71/127/EEC is hereby amended as follows:  1. The following is added to the end of item 4.2 of Appendix 2 in Annex II:  'Sequence number 01 may, however, be retained for Class I, II and III rear-view mirrors if the requirements relating to these three classes of mirror remain unchanged.'  2. A new item 1.3 as follows is added to Annex III:  '1.3. Vehicles having received EEC type-approval in respect of the fitting of their rear-view mirrors in pursuance of this Directive may, either fully or in part, be fitted with Class I, II or III rear-view mirrors bearing within their EEC component type-approval number sequence number 01, on condition that the requirements relating to these three classes of rear-view mirror remain unchanged.'  Article 2  Member States shall bring into force the provisions necessary to comply with this Directive by 31 December 1986. They forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 6 November 1986.  For the Commission  COCKFIELD  Vice-President  (1) OJ No L 42, 23. 2. 1970, p. 1.  (2) OJ No L 375, 21. 12. 1980, p. 34.  (3) OJ No L 68, 22. 3. 1971, p. 1.  (4) OJ No L 90, 29. 3. 1985, p. 1.