title: Directive 2008/27/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred on the Commission

text:
               20.3.2008

               EN

               Official Journal of the European Union

               L 81/45

      DIRECTIVE 2008/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 11 March 2008
   amending Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred on the Commission
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   After consulting the Committee of the Regions,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Directive 2001/18/EC of the European Parliament and of the Council (3) provides that certain measures are to 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 (4).

               (2)

               Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced the regulatory procedure with scrutiny for the adoption of measures of general scope and designed to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, inter alia, by deleting some of those elements or by supplementing the instrument with new non-essential elements.

               (3)

               In accordance with the statement by the European Parliament, the Council and the Commission (5) concerning Decision 2006/512/EC, for the regulatory procedure with scrutiny to be applicable to instruments adopted in accordance with the procedure referred to in Article 251 of the Treaty which are already in force, those instruments must be adjusted in accordance with the applicable procedures.

               (4)

               The Commission should be empowered to adopt the measures necessary for the implementation of Directive 2001/18/EC. Those measures are designed to adapt certain annexes, establish criteria for the notification and fix minimum thresholds. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2001/18/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

               (5)

               Directive 2001/18/EC should therefore be amended accordingly.

               (6)

               Since the amendments made to Directive 2001/18/EC by this Directive are technical in nature and concern committee procedure only, they do not need to be transposed by the Member States. It is therefore not necessary to lay down provisions to that effect,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments
   Directive 2001/18/EC is hereby amended as follows:

               1.

               Article 16(2) and (3) shall be replaced by the following:
               ‘2.   The criteria and information requirements referred to in paragraph 1, as well as any appropriate requirements for a summary of the dossier, shall be established. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted, after consultation of the relevant Scientific Committee, in accordance with the regulatory procedure with scrutiny referred to in Article 30(3). The criteria and information requirements shall be such as to ensure a high level of safety of human health and the environment and shall be based on the available scientific evidence concerning such safety and on experience gained from the release of comparable GMOs.
               The requirements set out in Article 13(2) shall be replaced by those adopted in accordance with the first subparagraph, and the procedure set out in Article 13(3), (4), (5) and (6) and Articles 14 and 15 shall apply.
               3.   Before the regulatory procedure with scrutiny referred to in Article 30(3) is initiated with a view to a decision on criteria and information requirements referred to in paragraph 1, the Commission shall make the proposal available to the public. The public may make comments to the Commission within 60 days. The Commission shall forward any such comments, together with an analysis, to the Committee established pursuant to Article 30.’;

               2.

               Article 21(2) shall be replaced by the following:
               ‘2.   For products where adventitious or technically unavoidable traces of authorised GMOs cannot be excluded, a minimum threshold may be established below which these products shall not have to be labelled in accordance with paragraph 1.
               Threshold levels shall be established according to the product concerned. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 30(3).’;

               3.

               Article 21(3) shall be replaced by the following:
               ‘3.   For products intended for direct processing, paragraph 1 shall not apply to traces of authorised GMOs in proportions no higher than 0,9 % or lower thresholds, provided that these traces are adventitious or technically unavoidable.
               The threshold levels referred to in the first subparagraph may be established. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 30(3).’;

               4.

               Article 23(2) shall be replaced by the following:
               ‘2.   Within 60 days of the date of receipt of the information transmitted by the Member State, a decision shall be taken on the measure taken by that Member State in accordance with the regulatory procedure referred to in Article 30(2). For the purpose of calculating the 60-day period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of the Scientific Committee or Committees which has or have been consulted shall not be taken into account. The period of time during which the Commission is awaiting the opinion of the Scientific Committee or Committees consulted shall not exceed 60 days.
               Likewise, the period of time the Council takes to act in accordance with the regulatory procedure referred to in Article 30(2) shall not be taken into account.’;

               5.

               Article 26(2) shall be replaced by the following:
               ‘2.   Conditions for the implementation of paragraph 1 shall be established, without duplicating or creating inconsistencies with labelling provisions laid down in existing Community legislation. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 30(3). In so doing, account should be taken, as appropriate, of labelling provisions established by Member States in accordance with Community legislation.’;

               6.

               Article 27 shall be replaced by the following:
               ‘Article 27
               Adaptation of annexes to technical progress
               The adaptation to technical progress of Sections C and D of Annex II, Annexes III to VI, and Section C of Annex VII, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 30(3).’;

               7.

               Article 30(3) shall be replaced by the following:
               ‘3.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

               8.

               the first paragraph of Annex II shall be replaced by the following:
               ‘This Annex describes in general terms the objective to be achieved, the elements to be considered and the general principles and methodology to be followed to perform the environmental risk assessment (e.r.a.) referred to in Articles 4 and 13. Technical guidance notes may be developed in accordance with the regulatory procedure referred to in Article 30(2) in order to facilitate the implementation and explanation of this Annex.’;

               9.

               the introductory wording to Annex IV shall be replaced by the following:
               ‘This Annex describes in general terms the additional information to be provided in the case of notification for placing on the market and the information for labelling requirements regarding GMOs as or in products to be placed on the market and GMOs exempted under the second subparagraph of Article 2(4). Technical guidance notes, as regards, inter alia, the description of how the product is intended to be used, may be developed in accordance with the regulatory procedure referred to in Article 30(2) in order to facilitate the implementation and explanation of this Annex. The labelling requirements for exempted organisms set out in Article 26 shall be met by providing appropriate recommendations for, and restrictions on, use.’;

               10.

               the first and second paragraphs of Annex VII shall be replaced by the following:
               ‘This Annex describes in general terms the objective to be achieved and the general principles to be followed in the design of the monitoring plan referred to in Article 13(2), Article 19(3) and Article 20. Technical guidance notes may be developed in accordance with the regulatory procedure referred to in Article 30(2) in order to facilitate the implementation and explanation of this Annex.’

         Article 2
   Entry into force
   This Directive shall enter into force on the day following its publication in the Official Journal of the European Union.
   Article 3
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 11 March 2008.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         J. LENARČIČ

      (1)  OJ C 161, 13.7.2007, p. 45.

      (2)  Opinion of the European Parliament of 14 November 2007 (not yet published in the Official Journal) and Council Decision of 3 March 2008.

      (3)  OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

      (4)  OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

      (5)  OJ C 255, 21.10.2006, p. 1.


title: Council Directive of 30 March 1971 amending the Directives of 14 June 1966 on the marketing of beet seed, fodder plant seed, cereal seed and seed potatoes, the Directive of 30 June 1969 on the marketing of seed of oil and fibre plants and the Directive of 29 September 1970 on the marketing of vegetable seed

text:
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31971L0162

Council Directive 71/162/EEC of 30 March 1971 amending the Directives of 14 June 1966 on the marketing of beet seed, fodder plant seed, cereal seed and seed potatoes, the Directive of 30 June 1969 on the marketing of seed of oil and fibre plants and the Directive of 29 September 1970 on the marketing of vegetable seed

Official Journal L 087 , 17/04/1971 P. 0024 - 0028 Danish special edition: Series I Chapter 1971(I) P. 0209  English special edition: Series I Chapter 1971(I) P. 0232  Greek special edition: Chapter 03 Volume 6 P. 0176  Spanish special edition: Chapter 03 Volume 4 P. 0171  Portuguese special edition Chapter 03 Volume 4 P. 0171  Finnish special edition: Chapter 3 Volume 3 P. 0182  Swedish special edition: Chapter 3 Volume 3 P. 0182

COUNCIL DIRECTIVE  of 30 March 1971  amending the Directives of 14 June 1966 on the marketing of beet seed, fodder plant seed, cereal seed and seed potatoes, the Directive of 30 June 1969 on the marketing of seed of oil and fibre plants and the Directive of 29 September 1970 on the marketing of vegetable seed  (71/162/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 it is appropriate, for the reasons set out in the following recitals, to amend certain provisions of the Council Directives of 14 June 1966 on the marketing of beet seed (2), as amended by the Directive of 18 February 1969 (3), on the marketing of fodder plant seed (4), as amended by the Directive of 18 February 1969 (5), on the marketing of cereal seed (6), as amended by the Directive of 18 February 1969 (7), and on the marketing of seed potatoes (8), as amended by the Directive of 18 February 1969 (9), of the Directive of 30 June 1969 (10) on the marketing of seed of oil and fibre plants and of the Directive of 29 September 1970 (11) on the marketing of vegetable seed;  Whereas a common catalogue of varieties of agricultural plant species was provided for in the Council Directive of 29 September 1970 (12);  Whereas basically technical amendments to the Annexes should be facilitated by an expeditious procedure;  Whereas it is necessary to authorise in future the use of adhesive labels;  Whereas the provisions concerning comparative tests should be expanded;  Whereas it is appropriate to subdivide certain genera of fodder plant into several species of greatest importance to agriculture, and to amend certain technical provisions;  Whereas in the case of seed of oil and fibre plants, the species castor bean and sesame need not be maintained within the scope of the Directive ; whereas, on the other hand, it is appropriate to lay down particular provisions in respect of monoecious;  HAS ADOPTED THIS DIRECTIVE:    Article 1 The Directive of 14 June 1966 on the marketing of beet seed shall be amended as follows:    1. The following shall be substituted for Article 6:  "The Member States shall provide that the description of the genealogical components which may be required is, if the breeder so requests, treated as confidential."  (1)OJ No C 101, 4.8.1970, p. 44. (2)OJ No 125, 11.7.1966, p. 2290/66. (3)OJ No L 48, 26.2.1969, p. 4. (4)OJ No 125, 11.7.1966, p. 2298/66. (5)OJ No L 48, 26.2.1969, p. 8. (6)OJ No 125, 11.7.1966, p. 2309/66. (7)OJ No L 48, 26.2.1969, p. 1. (8)OJ No 125, 11.7.1966, p. 2320/66. (9)OJ No L 48, 26.2.1969, p. 7. (10)OJ No L 169, 10.7.1969, p. 3. (11)OJ No L 225, 12.10.1970, p. 7. (12)OJ No L 225, 12.10.1970, p. 1.        2. The following shall be added to Article 11 (1) (a) after the words "for certified seed;"  "the use of adhesive labels shall be authorised ; these may be used as official seals;"       3. The date 1 July 1972 shall be substituted for the date given in the last sentence of Article 16 (2).       4. The following shall be substituted for Article 20 (1):  "1. Community comparative tests shall be carried out within the Community for the post-control of samples of certified beet seed taken during check sampling. Satisfaction of the conditions with which the seed must comply may be checked during the post-control tests. The arrangements for holding the tests and their results shall be submitted to the Committee referred to in Article 21."       5. The following Article shall be added after Article 21:  "Article 21a  The Council, acting on a proposal from the Commission and in the light of current scientific and technical knowledge, shall adopt any amendments to be made to the Annexes."          Article 2 The Directive of 14 June 1966 on the marketing of fodder plant seed shall be amended as follows: >PIC FILE= "T0010568">  >PIC FILE= "T0010569">   6. In Article 3 (1), for the words:  "Lolium spec."  there shall be substituted the following:  "Lolium multiflorum  Lam.  Lolium perenne L.  Lolium x hybridum  Hausskn."    7. The following shall be substituted for Article 6:  "The Member States shall provide that the description of the genealogical components which may be required is, if the breeder so requests, treated as confidential."   8. The following shall be added to Article 10 (1) (a) after the words "for commercial seed;":  "the use of adhesive labels shall be authorised, these may be used as official seals;".   9. The date 1 July 1972 shall be substituted for that given in the last sentence of Article 16 (2).   10. The following shall be substituted for Article 20 (1):  "1. Community comparative tests shall be carried out within the Community for the post-control of samples of basic seed, with the exception of that of hybrid or synthetic varieties, and of certified seed of fodder plants, taken during check sampling. Satisfaction of the conditions with which the seed must comply may be checked during the post-control tests. The arrangements for holding the tests and their results shall be submitted to the Committee referred to in Article 21."   11. The following Article shall be added after Article 21:  "Article 21a  The Council, acting on a proposal from the Commission and in the light of current scientific and technical knowledge, shall adopt any amendments to be made to the Annexes."   12. In Annex II (I) (3) (A) (a), the words "Agrostis gigantea Roth" shall be substituted for the words "Agrostis alba" and the words "Lolium multiflorum Lam." for the words "Lolium multiflorum spec."   13. In Annex II (I) (3) (A) (b), the figure "1.5" shall be substituted for the figure "0.1" indicating the maximum content in weed seed for Hedysarum coronarium L.   14. The following shall be added to Annex II (I) (3) (B):  "(f) The number of seeds of Rumex obstusifolius and of Rumex crispus shall not exceed 2 in a 5 gramme sample."   15. The following shall be substituted for the text of Annex II (I) (3) (C) (a):  "(a) The percentage by number of seeds of another colour shall not exceed 2 in the case of bitter lupin and 1 in the case of other lupins."   16. The following shall be substituted for the text of Annex II (III) (4) (a):  "The percentage by number of seeds of another colour shall not exceed 4 in the case of bitter lupin and 2 in the case of other lupins."   17. The following item shall be added to Annex IV (A) (a):  "10. For seed of grass varieties for which no examination as to value for cropping and use has been made under Article 4 (2) (a) of the Council Directive of 29 September 1970 (1) on the common catalogue of varieties of agricultural plant species : "not intended for the production of fodder"."     Article 3 The directive of 14 June 1966 on the marketing of cereal seed shall be amended as follows:  1.   >PIC FILE= "T0010570">   2. The following shall be substituted for Article 6:  "The Member States shall provide that the description of genealogical components which may be required is, if the breeder so requests, treated as confidential."   3. The following shall be added to Article 10 (1) (a) after the words "of the second generation;":  "the use of adhesive labels shall be authorised ; these may be used as official seals;".   4. The date 1 July 1972 shall be substituted for that given in the last sentence of Article 16 (2).   5. The following shall be substituted for Article 20 (1):  "Community comparative tests shall be carried out within the Community for the post-control of samples of basic seed, with the exception of that of hybrid or synthetic varieties, and of certified seed of all kinds of cereal, taken during check  (1)OJ No L 225, 12.10.1970, p. 1.   sampling. Satisfaction of the conditions with which the seed must comply may be checked during the post-control tests. The arrangements for holding the tests and their results shall be submitted to the Committee referred to in Article 21."   6. The following Article shall be added after Article 21:  "Article 21a  The Council, acting on a proposal from the Commission and in the light of current scientific and technical knowledge, shall adopt any amendments to be made to the Annexes."     Article 4 The Directive of 14 June 1966 on the marketing of seed potatoes shall be amended as follows:    1. Article 5 shall be deleted.       2. The following shall be added to Article 14 (1):  "Satisfaction of the other minimum conditions laid down in Annex I may also be checked during the comparative tests."       3. The date 1 July 1972 shall be substituted for that given in the last sentence of Article 15 (2).       4. The following Article shall be added after Article 19:  "Article 19a  The Council, acting on a proposal from the Commission and in the light of current scientific and technical knowledge, shall adopt any amendments to be made to the Annexes."          Article 5 The Directive of 30 June 1969 on the marketing of seed of oil and fibre plants shall be amended as follows:    1. In Article 2 the words "Ricinus communis L - Castor bean" and "Sesamum orientale L - Sesame" and all references to castor bean and sesame shall be deleted.       2. The following shall be added to Article 2 (1):      (a) at the end of Section B (b), the words:  "or, where appropriate, "certified seed, third generation";"           (b) in Section C, before the word "hemp", the word "dioecious"           (c) in Section D, after the word "groundnut", the words "monoecious hemp"           (d) in Section D (b), after the words "certified seed, second generation", the words:  "or, where appropriate, of the category "certified seed, third generation","           (e) at the end of Section E (b), the words:  "or, where appropriate, which is intended for the production of seed of the category "certified seed, third generation";"           (f) after Section E the following:  "E a Certified seed, second generation (monoecious hemp) : seed        (a) which is of direct descent from certified seed of the first generation which has been established and officially controlled with a special view to the production of certified seed of the second generation;               (b) which is intended for the production of hemp to be harvested in flower;               (c) which satisfies the conditions laid down in Annexes I and II for certified seed ; and               (d) which has been found by official examination to satisfy the abovementioned conditions."                                 3. The following shall be substituted for Article 6:  "The Member States shall provide that the description of genealogical components which may be required is, if the breeder so requests, treated as confidential."       4. The following shall be added to Article 10 (1) after the words "for commercial seed":  "the use of adhesive labels shall be authorised ; these may be used as official seals;"       5. The date 1 July 1973 shall be substituted for that given in the last sentence of Article 15 (2).        6. The following shall be substituted for Article 19 (1):  "1. Community comparative tests shall be carried out within the Community for the post-control of samples of basic seed, with the exception of that of hybrid or synthetic varieties, and of certified seed of all kinds of oil and fibre plants, taken during check sampling. Satisfaction of the conditions with which the seed must comply may be checked during the post-control tests. The arrangements for holding the tests and their results shall be submitted to the Committee referred to in Article 20."       7. The following Article shall be added after Article 20:  "Article 20a  The Council, acting on a proposal from the Commission and in the light of current scientific and technical knowledge, shall adopt any amendments to be made to the Annexes."       8. In Annex I (5) and Annex II (1) (2) (A), the words "castor bean" and "Ricinus communis", "Sesamum orientale L", and all specifications relating thereto, shall be deleted.       9. In Annex II (1) (2) (B) (e), the words "Cannabis sativa" shall be substituted for the words "Linum usitatissimum".          Article 6 The Directive of 29 September 1970 on the marketing of vegetable seed shall be amended as follows:    1. The following shall be substituted for Article 39 (1):  "1. Community comparative tests shall be carried out within the Community for the post-control of samples of basic seed, with the exception of that of hybrid and synthetic varieties, and of certified or standard vegetable seed, taken during check sampling. Satisfaction of the conditions with which the seed must comply may be checked during the post-control tests. The arrangements for holding the tests and their results shall be submitted to the Committee referred to in Article 40."       2. The following Article shall be added after Article 40:  "Article 40a  The Council, acting on a proposal from the Commission and in the light of current scientific and technical knowledge, shall adopt any amendments to be made to the Annexes."          Article 7 The Member States shall bring into force the laws, regulations or administrative provisions necessary to comply:    (a) with effect from 1 July 1970, with the provisions of Article 1 (3), of Article 2 (9), of Article 3 (4), of Article 4 (3) and of Article 5 (1), (2) and (7);       (b) not later than 1 July 1972, with the provisions of Article 1 (1), of Article 2 (7) and (17), of Article 3 (2), of Article 4 (1), of Article 5 (3) and of Article 6;       (c) not later than 1 July 1971, with the other provisions of this Directive.          Article 8 This Directive is addressed to the Member States.     Done at Brussels, 30 March 1971.  For the Council  The President  M. SCHUMANN


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31969L0061

Council Directive 69/61/EEC of 18 February 1969 amending the Council Directive of 14 June 1966 on the marketing of beet seed

Official Journal L 048 , 26/02/1969 P. 0004 - 0006 Danish special edition: Series I Chapter 1969(I) P. 0047  English special edition: Series I Chapter 1969(I) P. 0052  Greek special edition: Chapter 03 Volume 4 P. 0083  Spanish special edition: Chapter 03 Volume 3 P. 0065  Portuguese special edition Chapter 03 Volume 3 P. 0065  Finnish special edition: Chapter 3 Volume 2 P. 0168  Swedish special edition: Chapter 3 Volume 2 P. 0168

COUNCIL DIRECTIVE of 18 February 1969 amending the Council Directive of 14 June 1966 on the marketing of beet seed (69/61/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 certain provisions of the Council Directive of 14 June 1966 (2) on the marketing of beet seed should be amended;  Whereas the Directive should be adapted to the latest recommendations of the International Institute for Sugar Beet Research and to the scheme for sugar beet and fodder beet seed adopted by the Organisation for Economic Cooperation and Development;  Whereas it is appropriate, furthermore, to amplify the provisional measures;  Whereas, in respect of seed satisfying less stringent requirements, certain requirements as regards marking should be reduced and the colour of the label should be altered;  HAS ADOPTED THIS DIRECTIVE:    Article 1 The Council Directive of 14 June 1966 on the marketing of beet seed shall be amended as prescribed in the following Articles.   Article 2 All references in the Directive, including its preamble, to type and to a list of types, and to identity and purity of type, shall be deleted.   Article 3 1. Article 2 shall be renumbered Article 2 (1).  2. The following shall be substituted for Article 2 (1) (E):  "E. Precision seed : seed designed for use in precision drills which, as required under Annex I (B) (3) (b) (bb), gives single seedlings."  3. The following paragraph 2 shall be added to Article 2;  "2. Member States may, during a transitional period of not more than four years after the entry into force of the laws, regulations or administrative provisions necessary to comply with this Directive, and by way of derogation from paragraph 1 (C), certify as certified seed, seed which is of direct descent from seed officially controlled in a Member State under the scheme in operation at that time and which affords the same assurances as basic seed certified in accordance with the principles of this Directive."   Article 4 Article 8 shall be deleted.   Article 5 In Article 9 the word "lots" shall be substituted for the word "consignments".  (1)OJ No C 108, 19.10.1968, p. 30. (2)OJ No 125, 11.7.1966, p. 2290/66.    Article 6 The following shall be substituted for Article 10 (2):  "2. Packages which have been officially sealed shall not be resealed, whether one or more times, except officially. If packages are resealed, the fact of resealing, the most recent date of resealing and the authority responsible therefor shall be stated on the label required under Article 11 (1)."   Article 7 The following shall be substituted for Article 11 (1) (b):  "(b) contain an official document, in the same colour as the label, giving the same information as that required under Annex III (A) (3), (4), (5), (10) and (11) for the label ; this document is not necessary if the information is printed indelibly on the container."   Article 8 The following subparagraph (c) shall be added to Article 14 (2):  "(c) increase the minimum percentages of clusters giving single seedlings laid down for precision seed in Annex I (B) (3) (b) (bb)."   Article 9 The following shall be substituted for Article 15:  "Article 15  The Member States shall provide that beet seed produced directly from basic seed certified in one Member State and harvested in another Member State or in a third country may be certified in the State which produced the basic seed if that seed has undergone field inspection satisfying the conditions laid down in Annex I (A) and if official examination has shown that the conditions laid down in Annex I (B) for certified seed are satisfied."   Article 10 The date "1 July 1970" shall be substituted for the date given in the last sentence of Article 16 (2).   Article 11 In Article 17 (2) the word "brown" shall be substituted for the words "dark yellow".   Article 12 The following shall be substituted for the text of Annex I (A) (5):  "5. The minimum distances from neighbouring seed producing crops shall be: >PIC FILE= "T0001915">   These distances apply also to isolation from plants or fields of beet grown for root production and flowering at the same time as the seed production fields.  The distances can be disregarded if there is sufficient protection from any undesirable foreign pollination."    Article 13 1. The following shall be substituted for the text of Annex I (B) (3) (a):  "(a) >PIC FILE= "T0001916">   The percentage by weight of other seeds shall not exceed 0.3, including not more than 0.1 of weed seeds. For this purpose at least 200 grammes of the sample shall be examined."  2. The English text of the first sentence of Annex I (B) (3) (b) does not require the amendment made by this paragraph.  3. The following shall be substituted for the text of Annex I (B) (3) (b) (bb):  "(bb) Precision seed:  In the case of varieties with a percentage of diploids exceeding 85, at least 58 % of the germinated clusters shall give single seedlings. In the case of all other seeds, at least 63 % of the germinated clusters shall give single seedlings.  The percentage of clusters giving three or more seedlings shall not exceed 5, calculated on the germinated clusters."   Article 14 In Annex II the number "500" shall be substituted for the number "300".   Article 15 1. The following shall be substituted for the text of Annex III (A) (1) and (2):  "  1. "EEC rules and standards."   2. Certification authority and Member State or their initials." 2. Item 9 of Annex III (a) is hereby deleted.  3. The English text of Annex III (A) (11) does not require the amendment made by this paragraph.  4. However, labels giving the information required under Annex III (a) (1), (9) and (11) of the Council Directive of 14 June 1966 on the marketing of beet seed may be used up to but not later than 30 June 1970.   Article 16 The Member States shall, not later than 1 July 1969, bring into force the laws, regulations or administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.   Article 17 This Directive is addressed to the Member States.     Done at Brussels, 18 February 1969.  For the Council  The President  J.P. BUCHLER


title: Commission Directive 2007/17/EC of 22 March 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes III and VI thereto to technical progress (Text with EEA relevance )

text:
               23.3.2007

               EN

               Official Journal of the European Union

               L 82/27

         COMMISSION DIRECTIVE 2007/17/EC
   of 22 March 2007
   amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes III and VI thereto to technical progress
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof,
   After consulting the Scientific Committee on Consumer Products,
   Whereas:

               (1)

               Annex VI to Directive 76/768/EEC establishes a list of preservatives allowed in cosmetic products. The substances listed in Annex VI marked with the symbol (*) may be used in concentrations other than those fixed in that Annex for non-preservative purposes, if the specific purpose is apparent from the presentation of the product. Nevertheless, the use of these substances may be restricted in other Annexes to that Directive.

               (2)

               The substances listed in Annex VI without the symbol (*) may not be used in concentrations other than those listed in that Annex and the other restrictions set out therein also apply when those substances are used for other specific purposes.

               (3)

               The Scientific Committee on Consumer Products, hereinafter ‘the SCCP’, has issued an opinion stating that the restrictions for usage level and warnings in Annex VI should also apply if the preservatives marked with the symbol (*) are used for other specific purposes.

               (4)

               The Commission therefore called upon the industry to submit safety files for substances listed with the symbol (*) when used in higher concentrations for other specific purposes.

               (5)

               On the basis of those safety-files, the SCCP concluded that the use of several of the preservative substances in Annex VI for other specific purposes in higher concentrations is safe.

               (6)

               The safe concentration limits for those preservative substances when used for other specific purposes should be included in Annex III to Directive 76/768/EEC. For the sake of clarity, it should be indicated for the relevant entries in Annex III that the same substance is listed in Annex VI to that Directive.

               (7)

               Substances that were not considered to be safe by the SCCP when used in concentrations other than those laid down in Annex VI for other specific purposes should be subject to the restrictions laid down in that Annex for use as preservatives. The symbol (*) should therefore be deleted from those substances in Annex VI.

               (8)

               In order to ensure a coherent approach, all substances listed in Annex VI which may also be added to cosmetic products, for other specific purposes, in higher concentrations than those laid down in that Annex should be marked with the symbol (*).

               (9)

               Moreover, the SCCP considered it safe to increase the maximum concentration of benzoic acid and its sodium salt in rinse-off products and oral-care products and to increase the maximum concentration of zinc pyrithione in rinse-off hair products for preservative use. It is therefore appropriate to amend reference numbers 1 and 8 of Annex VI to Directive 76/768/EEC accordingly.

               (10)

               The SCCP is also of the opinion that methyldibromo glutaronitrile should not be present in any cosmetic products, as no safe use-levels in cosmetic leave-on and rinse-off products have been established. It is therefore necessary to delete that substance from reference number 36 of Annex VI to Directive 76/768/EEC.

               (11)

               Directive 76/768/EEC should therefore be amended accordingly.

               (12)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes III and VI to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
   Article 2
   Member States shall take all necessary measures to ensure that from 23 March 2008 no cosmetic products which fail to comply with this Directive are placed on the market by Community manufacturers or by importers established within the Community.
   Member States shall take all necessary measures to ensure that those products are not sold or disposed of to the final consumer after 23 June 2008.
   Article 3
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 23 September 2007 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 22 March 2007.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2007/1/EC (OJ L 25, 1.2.2007. p. 9).
   ANNEX
   Directive 76/768/EEC is amended as follows:

               (1)

               Annex III, Part 1, is amended as follows:
               Reference numbers 98 to 101 are added as indicated below:

                           Reference No

                           Substance

                           Restrictions

                           Conditions of use and warnings which must be printed on the label

                           Field of application and/or use

                           Maximum authorised concentration in the finished cosmetic product

                           Other limitations and requirements

                           a

                           b

                           c

                           d

                           e

                           f

                           ‘98

                           Salicylic acid (1)

                           (CAS No 69-72-7)

                                       a)

                                       Rinse-off hair products

                                       b)

                                       Other products

                                       a)

                                       3,0 %

                                       b)

                                       2,0 %

                           Not to be used in preparations for children under three years of age, except for shampoos.
                           For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

                           Not to be used for children under three years of age (2)

                           99

                           Inorganic sulfites and bisulfites (3)

                                       a)

                                       Oxidative hair dye products

                                       b)

                                       Hair straightening products

                                       c)

                                       Self tanning products for the face

                                       d)

                                       Other self tanning products

                                       a)

                                       0,67 % expressed as free SO2

                                       b)

                                       6,7 % expressed as free SO2

                                       c)

                                       0,45 % expressed as free SO2

                                       d)

                                       0,40 % expressed as free SO2

                           For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

                           100

                           Triclocarban (4)

                           (CAS No 101-20-2)

                           Rinse-off products

                           1,5 %

                           Purity criteria:

                                       3,3',4,4'-Tetrachloroazobenzene ≤ 1 ppm

                                       3,3',4,4'-Tetrachloroazoxybenzene ≤ 1 ppm

                                 For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

                           101

                           Zinc pyrithione (5)

                           (CAS No 13463-41-7)

                           Leave-on hair products

                           0,1 %

                           For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

               (2)

               Annex VI, Part 1, is amended as follows:

                           a)

                           In column b, the symbol ‘(*)’ is deleted for the reference numbers 1, 2, 4, 7, 12, 14, 18, 19, 21, 22, 24, 25, 26, 27, 28, 29, 30, 32, 33, 35, 37, 42 and 47.

                           b)

                           In column b, the symbol ‘(*)’ is added for the reference numbers 5 and 43.

                           c)

                           Reference number 1 is replaced by the following:

                                       Reference No

                                       Substance

                                       Maximum authorised concentration

                                       Limitations and requirements

                                       Conditions of use and warnings which must be printed on the label

                                       a

                                       b

                                       c

                                       d

                                       e

                                       ‘1

                                       Benzoic acid (CAS No 65-85-0) and its sodium salt (CAS No 532-32-1)

                                       Rinse-off products, except oral care products: 2,5 % (acid)
                                       Oral care products: 1,7 % (acid)
                                       Leave-on products: 0,5 % (acid)

                                       1a

                                       Salts of benzoic acid other than that listed under reference number 1 and esters of benzoic acid

                                       0,5 % (acid)’

                           d)

                           Reference number 8 is replaced by the following:

                                       Reference No

                                       Substance

                                       Maximum authorised concentration

                                       Limitations and requirements

                                       Conditions of use and warnings which must be printed on the label

                                       a

                                       b

                                       c

                                       d

                                       e

                                       ‘8

                                       Zinc pyrithione (*)
                                       (CAS No 13463-41-7)

                                       Hair products: 1,0 %
                                       Other products: 0,5 %

                                       Rinse-off products only.
                                       No use in products for oral hygiene.’

                           e)

                           Reference number 36 is deleted.

      (1)  As a preservative, see Annex VI, Part 1, No 3.

      (2)  Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.

      (3)  As a preservative, see Annex VI, Part 1, No 9.

      (4)  As a preservative, See Annex VI, Part 1, No 23.

      (5)  As a preservative, see Annex VI, Part 1, No 8.’


Avis juridique important

|

31989L0667

Twelfth Council Company Law Directive 89/667/EEC of 21 December 1989 on single-member private limited-liability companies

Official Journal L 395 , 30/12/1989 P. 0040 - 0042 Finnish special edition: Chapter 17 Volume 1 P. 0103  Swedish special edition: Chapter 17 Volume 1 P. 0103

TWELFTH COUNCIL COMPANY LAW DIRECTIVE of 21 December 1989 on single-member private limited-liability companies (89/667/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 54 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 certain safeguards which, for the protection of the interests of members and others, are required by Member States of companies and firms within the meaning of the second paragraph of Article 58 of the Treaty should be coordinated with a view to  making such safeguards equivalent throughout the Community;  Whereas, in this field, Directives 68/151/EEC (4) and 78/660/EEC (5), as last amended by the Act of Accession of Spain and Portugal, and Directive 83/349/EEC (6), as amended by the Act of Accession of Spain and Portugal, on disclosure, the validity of  commitments, nullity, annual accounts and consolidated accounts, apply to all share capital companies; whereas Directives 77/91/EEC (7) and 78/855/EEC (8), as last amended by the Act of Accession of Spain and Portugal, and Directive 82/891/EEC (9) on  formation and capital, mergers and divisions apply only to public limited-liability companies;  Whereas the small and medium-sized enterprises (SME) action programme (10) was approved by the Council in its Resolution of 3 November 1986;  Whereas reforms in the legislation of certain Member States in the last few years, permitting single-member private limited-liability companies, have created divergences between the laws of the Member States;  ¹ ¹ OJ No C 291, 20. 11. 1989, p. 53.  ¹ ¹ ¹ ¹ ¹ ¹ ¹ Whereas it is important to provide a legal instrument allowing the limitation of liability of the individual entrepreneur throughout the Community, without prejudice to the laws of the Member States which, in exceptional circumstances, require that  entrepreneur to be liable for the obligations of his undertaking;  Whereas a private limited-liability company may be a single-member company from the time of its formation, or may become one because its shares have come to be held by a single shareholder; whereas, pending the coordination of national provisions on the  laws relating to groups, Member States may lay down certain special provisions and penalties for cases where a natural person is the sole member of several companies or where a single-member company or any other legal person is the sole member of a  company; whereas the sole aim of this provision is to take account of the differences which currently exist in certain national laws; whereas, for that purpose, Member States may in specific cases lay down restrictions on the use of single-member  companies or remove the limits on the liabilities of sole members; whereas Member States are free to lay down rules to cover the risks that single-member companies may present as a consequence of having single members, particularly to ensure that the  subscribed capital is paid;  Whereas the fact that all the shares have come to be held by a single shareholder and the identity of the single member must be disclosed by an entry in a register accessible to the public;  Whereas decisions taken by the sole member in his capacity as general meeting must be recorded in writing;  Whereas contracts between a sole member and his company as represented by him must likewise be recorded in writing, insofar as such contracts do not relate to current operations concluded under normal conditions,  HAS ADOPTED THIS DIRECTIVE:    Article 1 The coordination measures prescribed by this Directive shall apply to the laws, regulations and administrative provisions of the Member States relating to the following types of company:  - in Germany:  Gesellschaft mit beschraenkter Haftung,  - in Belgium:  Société privée à responsabilité limitée/de besloten vennootschap met beperkte aansprakelijkheid,  - in Denmark:  Anpartsselskaber,  - in Spain:  Sociedad de responsabilidad limitada,  - in France:  Société à responsabilité limitée,  - in Greece:  Etaireia periorismenis efthynis,  - in Ireland:  Private company limited by shares or by guarantee,  - in Italy:  Società a responsabilità limitata,  - in Luxembourg:  Société à responsabilité limitée,  - in the Netherlands:  Besloten vennootschap met beperkte aan- sprakelijkheid,  - in Portugal:  Sociedade por quotas,  - in the United Kingdom:  Private company limited by shares or by guarantee.  Article 2 1.  A company may have a sole member when it is formed and also when all its shares come to be held by a single person (single-member company).  2.  Member States may, pending coordination of national laws relating to groups, lay down special provisions or sanctions for cases where:  (a)  a natural person is the sole member of several companies;  (b)  a single-member company or any other legal person is the sole member of a company.  Article 3 Where a company becomes a single-member company because all its shares come to be held by a single person, that fact, together with the identity of the sole member, must either be recorded in the file or entered in the register within the  meaning of Article 3 (1) and (2) of Directive 68/151/EEC or be entered in a register kept by the company and accessible to the public.  Article 4 1.  The sole member shall exercise the powers of the general meeting of the company.  2.  Decisions taken by the sole member in the field referred to in paragraph 1 shall be recorded in minutes or drawn up in writing.  Article 5 1.  Contracts between the sole member and his company as represented by him shall be recorded in minutes or drawn up in writing.  2.  Member States need not apply paragraph 1 to current operations concluded under normal conditions.  Article 6 Where a Member State allows single-member companies as defined by Article 2 (1) in the case of public limited companies as well, this Directive shall apply.  Article 7 A Member State need not allow the formation of single-member companies where its legislation provides that an individual entrepreneur may set up an undertaking the liability of which is limited to a sum devoted to a stated activity, on  condition that safeguards are laid down for such undertakings which are equivalent to those imposed by this Directive or by any other Community provisions applicable to the companies referred to in Article 1.  Article 8 1.  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1992. They shall inform the Commission thereof.  2.  Member States may provide that, in the case of companies already in existence on 1 January 1992, this Directive shall not apply until 1 January 1993.  3.  Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.  Article 9 This Directive is addressed to the Member States.   Done at Brussels, 21 December 1989.  For the Council The President E. CRESSON  (1) OJ No C 173, 2. 7. 1988, p. 10.(2) OJ No C 96, 17. 4. 1989, p. 92 and(3) OJ No C 318, 12. 12. 1988, p. 9.(4) OJ No L 65, 14. 3. 1968, p. 8.(5) OJ No L 222, 14. 8. 1978, p. 11.(6) OJ No L 193, 18. 7. 1983, p. 1.(7) OJ No L 26, 30. 1. 1977,  p. 1.(8) OJ No L 295, 20. 10. 1978, p. 36.(9) OJ No L 378, 31. 12. 1982, p. 47. (10) OJ No C 287, 14. 11. 1986, p. 1.