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32002L0081

Commission Directive 2002/81/EC of 10 October 2002 amending Council Directive 91/414/EEC to include flumioxazine as active substance (Text with EEA relevance)

Official Journal L 276 , 12/10/2002 P. 0028 - 0030

Commission Directive 2002/81/ECof 10 October 2002amending Council Directive 91/414/EEC to include flumioxazine as active substance(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant-protection products on the market(1), as last amended by Commission Directive 2002/64/EC(2), and in particular Article 6(1) thereof,Whereas:(1) In accordance with Article 6(2) of Directive 91/414/EEC, France received on 2 May 1994 an application from Sumitomo SA for the inclusion of the active substance flumioxazine in Annex I to Directive 91/414/EEC. Commission Decision 97/631/EC(3) of 12 September 1997 confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.(2) For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The nominated rapporteur Member State, submitted a draft assessment report concerning the substance to the Commission on 20 January 1998.(3) The draft assessment report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 28 June 2002 in the format of the Commission review report for flumioxazine.(4) The dossier and the information from the review were also submitted to the Scientific Committee for Plants. The Committee was asked to comment on the test protocols used in higher tier studies to assess effects of the active substance on aquatic plants and earthworms and on development effects seen in animal studies. In its opinion(4) the Committee noted that the available higher tier study in aquatic plants is insufficient for a full assessment of exposure/effect relationships. The studies in earthworms and those on developmental toxicity were considered sufficient and adequate to support the risk assessments. The observations of the Scientific Committee were taken into consideration in formulating this Directive and the relevant review report. A revised risk assessment for aquatic plants was made on the basis of the available standard study.(5) It has appeared from the various examinations made that plant protection products containing flumioxazine may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include flumioxazine in Annex I, in order to ensure that in all Member States the authorisations of plant-protection products containing this active substance can be granted in accordance with the provisions of that Directive.(6) The Commission review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Directive 91/414/EEC. It is, therefore, appropriate to provide that the finalised review report, except for confidential information, should be kept available or made available by the Member States for consultation by any interested parties.(7) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant-protection products containing flumioxazine and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.(8) It is therefore appropriate to amend Directive 91/414/EEC accordingly.(9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.Article 2Member States shall keep available the review report for flumioxazine, except for confidential information within the meaning of Article 14 of Directive 91/414/EEC, for consultation by any interested parties or shall make it available to them on specific request.Article 3Member States shall adopt and publish by 30 June 2003 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 July 2003.When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 41. Member States shall review the authorisation for each plant-protection product containing flumioxazine to ensure that the conditions relating to this active substance set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw the authorisation in accordance with Directive 91/414/EEC before 30 June 2003.2. Member States shall, for each authorised plant-protection product containing flumioxazine as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 1 January 2003, re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 30 June 2004 at the latest, they shall amend or withdraw the authorisation for each such plant-protection product.Article 5This Directive shall enter into force on 1 January 2003.Article 6This Directive is addressed to the Member States.Done at Brussels, 10 October 2002.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 189, 18.7.2002, p. 27.(3) OJ L 262, 24.9.1997, p. 7.(4) Opinion of the Scientific Committee on Plants regarding the inclusion of flumioxazine in Annex I to Council Directive 91/414/EEC concerning the placing of plant-protection products on the market (SCP/FLUMIO/002 - final, 23.5.2001).ANNEXIn Annex I the following row is added at the end of the table: ">TABLE>"(1) Further details on identity and specification of active substances are provided in the review report.


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31992L0068

Council Directive 92/68/EEC of 20 July 1992 amending Directive 90/684/EEC on aid to shipbuilding

Official Journal L 219 , 04/08/1992 P. 0054 - 0055

COUNCIL DIRECTIVE 92/68/EEC  of 20 July 1992  amending Directive 90/684/EEC on aid to shipbuildingTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 92 (3) (d) and Article 113 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the shipbuilding industry is important for the structural development of the coastal region of the territories of the former German Democratic Republic;  Whereas the shipbuilding industry, as it existed in those territories at the time of their incorporation into the Community, requires urgent and comprehensive restructuring in order to become competitive; whereas the direct application of the common  maximum ceiling for production aid does not allow for such measures and a special transitional arrangement should therefore be introduced to enable the shipbuilding industry in those territories to operate during the period fo gradual restructuring  which should enable it to comply with the State aid rules applicable throughout the Community;  Whereas, moreover, competition considerations dictate that the sector of the shipbuilding industry of the territories in question should contribute significantly to the reduction of the excess capacity which, worldwide, continues to impede the  restoration of normal market conditions for the shipbuilding industry;  Whereas Directive 90/684/EEC (4) should therefore be amended,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 90/684/EEC is amended as follows:  1. the title of chapter IV shall be replaced by the following:  'SPAIN, GREECE AND THE TERRITORY OF THE FORMER GERMAN DEMOCRATIC REPUBLIC';  2. the following Article shall be inserted:  'Article 10a  1. With the exception of Article 4 (6) and (7), Chapter II shall not apply to the shipbuilding and ship conversion activities of yards operating in the territories of the former German Democratic Republic on 1 July 1990.  2. Until 31 December 1993, operating aid for the shipbuilding and ship conversion activities of the yards referred to in paragraph 1 may be considered compatible with the common market provided that:  (a) aid to facilitate the continued operation of the yards during that period does not, for any of these yards, exceed a maximum ceiling of 36 % of a reference annual turnover calculated on the basis of three years of shipbuilding and ship conversion  activites after restructuring; this aid must be paid by 31 December 1993;  (b) no further production aid is granted on contracts signed between 1 July 1990 and 31 December 1993;  (c) the German Government agrees to carry out, according to a timetable approved by the Commission and in any case before 31 December 1995, a genuine and irreversible reduction of capacity of 40 % net of the capacity of 545 000 cgt existing on 1 July  1990;  (d) the German Government provides evidence to the Commission, in the form of annual reports by an independent chartered accountant, that aid payments are strictly limited to the activities of yards situated in the former German Democratic Republic; the  first such report must be submitted to the Commission at the latest by the end of February 1993.  3. The Commission shall ensure that the aid referred to in this Article does not affect trading conditions to an extent contrary to the common interest.'  Article 2  This Directive is addressed to the Member States. Done at Brussels, 20 July 1992. For the Council  The President  D. HURD   (1) OJ No C 155, 20. 6. 1992, p. 20. (2) Opinion delivered on 9 July 1992 (not yet published in the Official Journal). (3) Opinion delivered on 1 July 1992 (not yet published in the Official Journal). (4) OJ No L 380, 31. 12. 1990, p. 27.


title: Commission Directive 2010/20/EU of 9 March 2010 amending Council Directive 91/414/EEC to remove tolylfluanid as active substance and on the withdrawal of authorisations for plant protection products containing that substance (Text with EEA relevance)

text:
               10.3.2010

               EN

               Official Journal of the European Union

               L 60/20

         COMMISSION DIRECTIVE 2010/20/EU
   of 9 March 2010
   amending Council Directive 91/414/EEC to remove tolylfluanid as active substance and on the withdrawal of authorisations for plant protection products containing that substance
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the third indent of Article 6(1) thereof,
   Whereas:

               (1)

               Tolylfluanid is included in Annex I to Directive 91/414/EEC, which sets out the list of active substances authorised for use in plant protection products.

               (2)

               By Commission Decision 2007/322/EC of 4 May 2007 laying down protective measures concerning uses of plant protection products containing tolylfluanid leading to the contamination of drinking water (2) it was decided that Member States in which ozone is used for the treatment of drinking water are to prohibit any uses of tolylfluanid which may result in a contamination of drinking water with nitrosamines. The reason for that measure was that it had been discovered that by such a treatment a metabolite of that active substance, N,N-dimethylsulfamide, may be converted into nitrosamines which are harmful to human health.

               (3)

               Under Decision 2007/322/EC Member States further had to ensure that the notifier at whose request tolylfluanid had been included in Annex I to Directive 91/414/EEC submitted studies on the leaching behaviour of that active substance and on the conditions under which the formation of nitrosamines can be excluded.

               (4)

               On 5 July 2007, the notifier Bayer CropScience submitted the required studies to the rapporteur Member State, including studies and information on the physical, chemical and toxicological fate and behaviour of the metabolite N,N-dimethylsulfamide and on its ecotoxicological properties.

               (5)

               An addendum to the assessment report, concerning the evaluation of those studies and information, was submitted by the rapporteur Member State to the Commission on 20 February 2008. This addendum was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health on 22 January 2010.

               (6)

               In this addendum it was concluded that the concerns as regards the leaching behaviour of tolylfluanid and the formation of nitrosamines could not be eliminated. In addition, it was found that the use of plant protection products containing tolylfluanid may lead to unacceptable concentrations of the metabolite N,N-dimethylsulfamide in groundwater. Consequently, it was concluded that tolylfluanid no longer satisfies the requirements of Article 5(1)(a) and (b) of Directive 91/414/EEC.

               (7)

               The notifier submitted its comments on the addendum to the assessment report. Those comments were carefully examined. However, despite the arguments put forward by the notifier, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted and its evaluation have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing tolylfluanid satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.

               (8)

               Tolylfluanid should therefore be removed from Annex I to Directive 91/414/EEC.

               (9)

               Measures should be taken to ensure that authorisations granted for plant protection products containing tolylfluanid are withdrawn within a fixed period of time as short as possible and are not renewed and that no new authorisations for such products are granted.

               (10)

               Given the nature of the risks caused by that active substance, any period of grace granted by a Member State for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing tolylfluanid should be as short as possible and should expire at latest 1 year from the entry into force of this Directive.

               (11)

               This Directive does not prejudice the submission of an application for tolylfluanid in accordance with Article 6(2) of Directive 91/414/EEC in view of a possible inclusion in Annex I to that Directive.

               (12)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Annex I to Directive 91/414/EEC, row 122, concerning tolylfluanid, is deleted.
   Article 2
   Member States shall adopt and publish, by 31 August 2010 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 September 2010.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   Member States shall ensure that:

               (a)

               authorisations for plant protection products containing tolylfluanid are withdrawn by 30 November 2010 at the latest;

               (b)

               no authorisations for plant protection products containing tolylfluanid are granted or renewed from 1 December 2010.

         Article 4
   Any period of grace granted by Member States in accordance with Article 4(6) of Directive 91/414/EEC shall be as short as possible and shall expire on 31 May 2011 at the latest.
   Article 5
   This Directive shall enter into force on 1 June 2010.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 9 March 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 119, 9.5.2007, p. 49.


Avis juridique important

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31999L0073

Commission Directive 1999/73/EC of 19 July 1999 including an active substance (spiroxamine) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)

Official Journal L 206 , 05/08/1999 P. 0016 - 0018

COMMISSION DIRECTIVE 1999/73/ECof 19 July 1999including an active substance (spiroxamine) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Council Directive 99/1/EC(2), hereafter referred to as the Directive, and in particular Article 6(1);(1) Whereas in accordance with Article 6(2) of Directive 91/414/EEC Germany received on 13 October 1995 an application from Bayer AG, hereafter referred to as the applicant, for the inclusion of the active substance spiroxamine in Annex I to the Directive;(2) Whereas in accordance with the provisions of Article 6(3) of the Directive the Commission confirmed in Decision 96/522/EC of 29 July 1996 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of spiroxamine in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market(3) that the dossier submitted for spiroxamine could be considered as satisfying, in principle, the data and information requirements of Annex II and for a plant protection product containing this active substance, of Annex III to the Directive;(3) Whereas, in accordance with Article 5(1) of the Directive, an active substance should be included for a period not exceeding 10 years in Annex I when it may be expected that there will not be any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment;(4) Whereas for spiroxamine, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of the Directive, for the uses proposed by the applicant; whereas Germany acting as nominated rapporteur Member State, has submitted to the Commission on 5 February 1997 the assessment report concerned;(5) Whereas the submitted report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health; whereas this review has been finalised on 12 May 1999 in the format of the Commission review report for spiroxamine; whereas it may be necessary to update this report to take account of technical and scientific developments; whereas in such case the conditions for the inclusion of spiroxamine in Annex I to Directive 91/414/EEC will also need to be amended pursuant to Article 6(1) of that Directive;(6) Whereas the dossier and the information from the review have also been submitted to the Scientific Committee on Plants for opinion; whereas this Committee has given its opinion on 18 December 1998(4); whereas this Committee identified potential risks to algae, sediment - dwelling organisms and possibly plants; whereas therefore, where appropriate, risk mitigation measures must be taken; whereas for operator exposure, this Committee concluded that with the use of personal protective equipment (PPE), the estimated operator exposure was acceptable; whereas therefore appropriate protective measures will need to be taken in order to ensure operator safety; whereas these conclusions are also consistent with the issues highlighted in the review carried out within the framework of the Standing Committee on Plant Health;(7) Whereas it has appeared from the various examinations made that plant protection products containing the active substance concerned may be expected to satisfy in general the requirements laid down in Article 5(1)(a), (b) and (3) of the Directive, in particular with regard to the uses which were examined; whereas therefore it is necessary to include the active substance concerned in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing the active substance concerned can be granted in accordance with the provisions of the said Directive;(8) Whereas after inclusion a reasonable period is necessary to permit Member States to implement the provisions of Directive 91/414/EEC on plant protection products containing spiroxamine and in particular to review, within this period, existing provisional authorisations or to grant, by the end of this period at the latest, new authorisations in accordance with the provisions of the Directive; whereas a longer period may also be required for plant protection products containing spiroxamine and other active substances included in Annex I;(9) Whereas it is appropriate to provide that the finalised review report (except for confidential information in the meaning of Article 14 of the Directive) is kept available or made available by the Member States for consultation by any interested parties;(10) Whereas the review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Annex VI to the Directive, where these principles refer to the evaluation of the Annex II data which were submitted for the purpose of the inclusion of the active substance in Annex I of the Directive;(11) Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health delivered on the 12 May 1999;HAS ADOPTED THIS DIRECTIVE:Article 1Spiroxamine is hereby designated as an active substance in Annex I to Directive 91/414/EEC, as set out in the Annex hereto.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, at the latest by 1 January 2000.2. However, for plant protection products containing spiroxamine together with another active substance which is in Annex I to Directive 91/414/EEC, the period referred to in paragraph 1 is extended to the extent that a longer implementation period is provided for by the provisions laid down in the Directive concerning the inclusion of the other active substance in Annex I to Directive 91/414/EEC.3. Member States shall keep available the review report (except for confidential information in the meaning of Article 14 of the Directive) for consultation by any interested parties or shall make it available to them on specific request.4. When Member States adopt the measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be laid down by the Member States.Article 3This Directive shall enter into force on 1 September 1999.Article 4This Directive is addressed to the Member States.Done at Brussels, 19 July 1999.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 21, 28.1.1999, p. 21.(3) OJ L 220, 30.8.1996, p. 23.(4) SCP/Spirox/004-final dated l8 January 1999.ANNEXSPIROXAMINE1. Identity(IUPAC) (8-tert-Butyl-1,4-dioxa-spiro [4.5] decan-2-ylmethyl)-ethyl-propyl-amine2. Conditions to be fulfilled:2.1. The active substance shall have a minimum purity of 940 g/kg technical product (diastereomers A and B combined).2.2. Only uses as a fungicide may be authorised.2.3. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on spiroxamine, and in particular the Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 May 1999 shall be taken into account. Furthermore, in this overall assessment Member States:- must pay particular attention to operator safety and must ensure that the conditions of authorisation include appropriate protective measures,and,- must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.3. Expiry date of the inclusion: 1 September 1999.


title: Directive 2005/84/EC of the European Parliament and of the Council of  14 December 2005  amending for the 22nd time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles)

text:
               27.12.2005

               EN

               Official Journal of the European Union

               L 344/40

      DIRECTIVE 2005/84/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 14 December 2005
   amending for the 22nd time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles)
   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 (1),
   Having regard to the opinion of the European Economic and Social Committee (2),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
   Whereas:

               (1)

               Article 14 of the Treaty establishes an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured.

               (2)

               Work on the internal market should improve the quality of life, health protection and consumer safety. This Directive complies with the requirements of ensuring a high level of health protection and of consumer protection in the definition and implementation of all Community policies and activities.

               (3)

               The use of certain phthalates in toys and childcare articles made of plasticised material or including parts made of plasticised material should be prohibited as the presence of certain phthalates presents or could potentially present risks related to the health of children. Toys and childcare articles which, although not intended for that purpose, can be put in the mouth, may under certain circumstances present a risk to the health of small children if they are made of plasticised material, or include parts made of plasticised material, which contains certain phthalates.

               (4)

               The Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE), after being consulted by the Commission, has delivered opinions on the health risks raised by these phthalates.

               (5)

               Commission Recommendation 98/485/EC of 1 July 1998 on childcare articles and toys intended to be placed in the mouth by children of less than three years of age, made of soft PVC containing certain phthalates (4), invited Member States to take measures to ensure a high level of child health protection with regard to these products.

               (6)

               Since 1999, the use of six phthalates in toys and childcare articles intended to be placed in the mouth by children under the age of three is subject to a temporary ban at European Union level following the adoption of Commission Decision 1999/815/EC (5) in the framework of Council Directive 92/59/EEC of 29 June 1992 on general product safety (6). This Decision is being renewed regularly.

               (7)

               Limitations already adopted by certain Member States on the placing on the market of toys and childcare articles because of their phthalate content directly affect the completion and functioning of the internal market. It is therefore necessary to approximate the laws of the Member States in this field and consequently to amend Annex I to Directive 76/769/EEC (7).

               (8)

               The precautionary principle should be applied where scientific evaluation does not allow the risk to be determined with sufficient certainty in order to ensure a high level of protection of health, in particular for children.

               (9)

               Children as developing organisms are particularly vulnerable to reprotoxic substances. Therefore, the exposure of children to all practically avoidable sources of emissions of these substances, especially from articles which are put into the mouth by children, should be reduced as far as possible.

               (10)

               During risk assessments and/or within the framework of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (8), di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) and benzyl butyl phthalate (BBP) have been identified as reprotoxic substances and have therefore been classified as reprotoxic, category 2.

               (11)

               Scientific information regarding di-isononyl phthalate (DINP), di-isodecyl phthalate (DIDP) and di-n-octyl phthalate (DNOP) is either lacking or conflictual, but it cannot be excluded that they pose a potential risk if used in toys and childcare articles, which are by definition produced for children.

               (12)

               The uncertainties in the evaluation of exposure to these phthalates, such as mouthing times and exposure to emissions from other sources, require that precautionary considerations be taken into account. Therefore, restrictions on the use of these phthalates for toys and childcare articles and on the placing on the market of such articles should be introduced. However, the restrictions for DINP, DIDP and DNOP should be less severe than the ones proposed for DEHP, DBP and BBP for reasons of proportionality.

               (13)

               The Commission should review other applications of articles made from plasticised material or including parts made from plasticised material which may expose people to risks, especially those used in medical devices.

               (14)

               In line with the Commission Communication on the Precautionary Principle, the measures based on this principle should be subject to review in the light of new scientific information.

               (15)

               The Commission, in cooperation with the Member State authorities responsible for market surveillance and enforcement for toys and childcare articles, and in consultation with the relevant organisations of producers and importers, should monitor the use of phthalates and other substances as plasticisers in toys and childcare articles.

               (16)

               For the purpose of Directive 76/769/EEC, the term ‘childcare article’ should be defined.

               (17)

               In accordance with paragraph 34 of the Interinstitutional Agreement on Better Law-making (9), Member States are encouraged to draw up, for themselves and in the interest of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

               (18)

               The Commission will review the use of the phthalates listed in Annex I to Directive 76/769/EEC in other products when the risk evaluation under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (10) will have been concluded.

               (19)

               This Directive applies without prejudice to Community legislation laying down minimum requirements for the protection of workers contained in 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 (11) and in individual directives based thereon, in particular Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (12) and Council Directive 98/24/EC of 7 April 1998 on protection of health and safety of workers from the risk related to chemical agents at work (13),

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 76/769/EEC is amended as follows:

               1.

               the following point shall be added to Article 1(3):

                           ‘(c)

                           “childcare article” means any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.’

                     ;

               2.

               Annex I shall be amended as set out in the Annex to this Directive.

         Article 2
   The Commission shall re-evaluate, by 16 January 2010 at the latest, the measures provided for in Directive 76/769/EEC as amended by this Directive in the light of new scientific information on substances described in the Annex to this Directive and their substitutes, and if justified, these measures shall be modified accordingly.
   Article 3
   1.   By 16 July 2006 Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
   They shall apply these measures from 16 January 2007.
   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 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 Strasbourg, 14 December 2005.

            For the European Parliament

            The President

         J. BORRELL FONTELLES

            For the Council

            The President

         C. CLARKE

      (1)  OJ C 116 E, 26.4.2000, p. 14.

      (2)  OJ C 117, 26.4.2000, p. 59.

      (3)  Opinion of the European Parliament of 6 July 2000 (OJ C 121, 24.4.2001, p. 410), Council Common Position of 4 April 2005 (OJ C 144 E, 14.6.2005, p. 24), Position of the European Parliament of 5 July 2005 (not yet published in the Official Journal) and Council Decision of 23 November 2005.

      (4)  OJ L 217, 5.8.1998, p. 35.

      (5)  OJ L 315, 9.12.1999, p. 46. Decision as last amended by Decision 2004/781/EC (OJ L 344, 20.11.2004, p. 35).

      (6)  OJ L 228, 11.8.1992, p. 24. Directive repealed by Directive 2001/95/EC of the European Parliament and of the Council (OJ L 11, 15.1.2002, p. 4).

      (7)  OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission Directive 2004/98/EC (OJ L 305, 1.10.2004, p. 63).

      (8)  OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1).

      (9)  OJ C 321, 31.12.2003, p. 1.

      (10)  OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (11)  OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC) No 1882/2003.

      (12)  OJ L 196, 26.7.1990, p. 1. Directive repealed by Directive 2004/37/EC of the European Parliament and of the Council (OJ L 158, 30.4.2004, p. 50).

      (13)  OJ L 131, 5.5.1998, p. 11.

      ANNEX
      The following points shall be added to Annex I to Directive 76/769/EEC:

                     ‘[XX.] The following phthalates (or other CAS- and EINECS numbers covering the substance):

                                 bis (2-ethylhexyl) phthalate (DEHP)
                                 CAS No 117-81-7
                                 Einecs No 204-211-0

                                 dibutyl phthalate (DBP)
                                 CAS No 84-74-2
                                 Einecs No 201-557-4

                                 benzyl butyl phthalate (BBP)
                                 CAS No 85-68-7
                                 Einecs No 201-622-7

                     Shall not be used as substances or as constituents of preparations, at concentrations of greater than 0,1 % by mass of the plasticised material, in toys and childcare articles.
                     Such toys and childcare articles containing these phthalates in a concentration greater than the limit mentioned above shall not be placed on the market.

                     [XXa.] The following phthalates (or other CAS- and EINECS numbers covering the substance):

                                 di-“isononyl” phthalate (DINP)
                                 CAS No 28553-12-0 and 68515-48-0
                                 Einecs No 249-079-5 and 271-090-9

                                 di-“isodecyl” phthalate (DIDP)
                                 CAS No 26761-40-0 and 68515-49-1
                                 Einecs No 247-977-1 and 271-091-4

                                 di-n-octyl phthalate (DNOP)
                                 CAS No 117-84-0
                                 Einecs No 204-214-7

                     Shall not be used as substances or as constituents of preparations, at concentrations of greater than 0,1 % by mass of the plasticised material, in toys and childcare articles which can be placed in the mouth by children.
                     Such toys and childcare articles containing these phthalates in a concentration greater than the limit mentioned above shall not be placed on the market.’


Avis juridique important

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31993L0072

Commission Directive 93/72/EEC of 1 September 1993 adapting to technical progress for the nineteenth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances

Official Journal L 258 , 16/10/1993 P. 0029 - 0030 Finnish special edition: Chapter 13 Volume 25 P. 0040  Swedish special edition: Chapter 13 Volume 25 P. 0040

COMMISSION DIRECTIVE 93/72/EEC of 1 September 1993 adapting to  technical progress for the nineteenth time Council Directive 67/548/EEC on the approximation of the  laws, regulations and administrative provisions relating to the classification, packaging and  labelling of dangerous substancesTHE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws,  regulations and administrative provisions relating to the classification, packaging and labelling  of dangerous substances  (1), as last amended by Commission Directive 93/21/EEC  (2), and in  particular Articles 28 and 29 thereof, Whereas Annex I of Council Directive 67/548/EEC contains a list of dangerous substances, together  with particulars of the classification and labelling procedures in respect of each substance and  whereas Council Directive 92/32/EEC  (3) amended the provisions relating to the classification and  labelling of dangerous substances; Whereas, therefore, it is necessary to revise the classification of certain substances in Annex I  and, further, to include, where appropriate in Annex I, the EEC number; Whereas Germany requested a change in the labelling of a number of substances and notified the  Commission accordingly under Article 23 of Directive 67/548/EEC as amended by Directive 79/831/EEC   (4); Whereas examination of the list of dangerous substances in the said Annex I has shown that this  list needs to be adapted in the light of present scientific and technical knowledge; Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the  Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to  Trade in Dangerous Substances and Preparations, HAS ADOPTED THIS DIRECTIVE: Article 1 Annex I to Directive 67/548/EEC is replaced by Annex I to this  Directive. Article 2 1.  Not later than 1 July 1994 the Member States shall implement the laws, regulations  and administrative provisions necessary to comply with this Directive. 2.  Member States shall immediately inform the Commission thereof. 3.  When Member States adopt these provisions, these shall contain a reference to this Directive or  shall be accompanied by such reference at the time of their official publication. The procedure for  such reference shall be adopted by Member States. Article 3 This Directive is addressed to the Member States. Done at Brussels, 1 September 1993. For the Commission Yannis PALEOKRASSAS Member of the Commission  Annex to Commission Directive 93/72/EEC of 1 September 1993 adapting to technical progress for  the nineteenth time Council Directive 67/548/EEC on the approximation of the laws, regulations and  administrative provisions relating to the classification, packaging and labelling of dangerous  substances  (1) Annex to Commission Directive 93/72/EEC of 1 September 1993  adapting to technical progress for the nineteenth time Council Directive 67/548/EEC on the  approximation of the laws, regulations and administrative provisions relating to the  classification, packaging and labelling of dangerous substances  (1) Nos 001-001-00-9 to  650-015-00-7 FOREWORD TO ANNEX I Introduction Annex I is an index of dangerous substances for which  harmonized classification and labelling have been agreed at Community level in accordance with the  procedure laid down in Article 4.3 of Directive 67/548/EEC. Numbering of entries Entries in Annex I are listed according to the atomic number of the element  most characteristic of the substances' properties. A list of the chemical elements, arranged  according to atomic number, is shown in Table A. Organic substances, because of their variety, have  been placed in the usual classes, as shown in Table B. The index number for each substance is in the form of a digit sequence of the type: ABC - RST - VW  - Y, where ABC is either the atomic number of the most characteristic chemical element (preceded by one or two  zeros to make up the sequence) or the usual class number for organic substances; RST is the consecutive number of the substance in the series ABC; VW denotes the form in which the substance is produced or placed on the market; and Y is the check-digit calculated in accordance with the ISBN (International Standard Book Number)  method. As an example, the index number for sodium chlorate is 017-005-00-9. For dangerous substances in the European Inventory of Existing Commercial Chemical Substances  (Einecs, OJ No C 146A, 15. 6. 1990) the Einecs number is included. This number is a seven-digit  system of the type XXX-XXX-X which starts at 200-001-8. For dangerous substances notified under the provisions of Directive 67/548/EEC, the number of the  substance in the European List of Notified Substances (Elincs) is included. This number is a  seven-digit system of the type XXX-XXX-X which starts at 400-010-9. The Chemical Abstracts Service (CAS) number is also included to assist identification of the entry.  It should be noted that the Einecs number includes both anhydrous and hydrated forms of a  substance, whilst there are frequently different CAS numbers for anhydrous and hydrated forms. The  CAS number included in all cases is for the anhydrous form only, and therefore the CAS number shown  does not always describe the entry as accurately as the Einecs number. Einecs, Elincs or CAS numbers are not usually included for entries which comprise more than three  individual substances. The structure of well defined substances is also shown to assist in the identification of the  substance. Nomenclature Wherever possible dangerous substances are designated by their Einecs or Elincs  names. Other entries not listed in Einecs or Elincs are designated using an internationally  recognized chemical name (e.g. ISO, IUPAC). An additional common name is included in some cases. Impurities, additives and minor components are normally not mentioned unless they contribute  significantly to the classification of the substance. Some substances are described as a 'mixture of A and B`. These entries refer to one specific  mixture. In some cases where it is necessary to characterize the substance put on the market, the  proportions of the main substances in the mixture are specified. Some substances are described with a specific percentage purity. Substances containing a higher  content of active material (e.  g. an organic peroxide) are not included in the Annex I entry and  may have other hazardous properties (e.  g. explosive). Where specific concentration limits are  shown, these apply to the substance or substances shown in the entry. In particular, in the case of  entries which are mixtures of substances or substances described with a specific percentage purity,  the limits apply to the substance as described in Annex I and not the pure substance. Format of entries The following information is given for each substance in Annex I: (a)  the classification: (i)  classification consists of placing a substance in a category of danger as defined in Article  2.2 of Directive 67/548/EEC and assigning the qualifying risk phrase(s). The classification has  consequences not only for labelling but also other legislation and regulatory measures on dangerous  substances; (ii)  the classification in each category of danger is shown in separate boxes. Each box includes,  in general, a description of the category of danger and a qualifying risk phrase(s). However in  some cases (i.  e. substances classified as flammable, sensitizing and some substances classified  as dangerous for the environment) only the risk phrase(s) appears as this gives sufficient  information; (iii)  the description of the categories of danger is shown below: Explosive: E Oxidizing: O Extremely Flammable: F+ Highly Flammable: F Flammable: R10 Very Toxic: T+ Toxic: T Harmful: Xn Corrosive: C Irritant: Xi Sensitizing: R42 and/or R43 Carcinogenic: Carc. Cat.  (1) Mutagenic: Mut. Cat.  (1) Reproductive toxin: Repr. Cat.  (1) Dangerous for the Environment: N or R52, R53, R59; (iv)  additional risk phrases which have been assigned to describe other properties (see sections  2.2.6 and 3.2.8 of the labelling guide) are shown in separate boxes; (b)  the label, including: (i)  the symbol(s), if allocated, and indications of danger assigned to the substance in accordance  with Annex II (see Article 23 (2) (c)); (ii)  the risk phrases, denoted as a series of numbers preceded by the letter R indicating the  nature of the special risks, in accordance with Annex III (see Article 23 (2) (d)). The numbers are  separated by either: a dash (-) to denote separate statements concerning special risks (R); or an oblique stroke (/) to denote a combined statement, in a single sentence, of the special risks as  set out in Annex III; (iii)  the safety phrases denoted as a series of numbers preceded by the letter S indicating the  recommended safety precautions, in accordance with Annex IV (see Article 23 (2) (e)). Again the  numbers are separated by either a dash or an oblique stroke, the significance of which is as in  (ii) above, except that the combined statements of recommended safety precautions are set out in  Annex IV. The safety phrases shown apply only to substances; for preparations, phrases are selected  according to the usual rules. Note that for certain dangerous substances and preparations sold to the general public certain  S-phrases are mandatory. S  1, S  2 and S  45 are obligatory for all very toxic, toxic and corrosive substances and  preparations sold to the general public. TABLA A - TABEL A - TABELLE A - ÐÉÍÁÊÁÓ Á - TABLE A - TABLEAU A - TABELLA A - TABEL A -  TABELA A Lista de los elementos químicos clasificados por su número atómico  (Z) Liste over  grundstoffer, ordnet efter deres atomvaegt  (Z) Liste der chemischen Elemente, geordnet nach der  Ordnungszahl  (Z) ÊáôUEëïãïò ÷çìéêþí óôïé÷aassùí ôáîéíïìçìÝíùí óýìoeùíá ìaa ôïí áôïìéêue ôïõò áñéèìue   (AE) List of chemical elements listed according to their atomic number  (Z) Liste des éléments  chimiques classés selon leur numéro atomique  (Z) Elenco degli elementi chimici ordinati secondo  il loro numero atomico  (Z) Lijst van chemische elementen, gerangschikt naar atoomgewicht  (Z)  Lista dos elementos químicos ordenados segundo o seu número atómico  (Z) >TABLE> TABEL B - TABELA B Clasificación especial para las sustancias orgánicas Saerlig inddeling af  organiske stoffer Spezielle Anordnung fuer die organischen Stoffe AAéaeéêÞ ôáîéíueìçóç ôùí  ïñãáíéêþí ïõóéþí Special classification for organic substances Classification particulière aux  substances organiques Classificazione speciale per le sostanze organiche Speciale indeling voor  de organische stoffen Classificação especial para as substâncias orgânicas >TABLE> >REFERENCE TO A GRAPHIC>


title: Commission Directive 2008/91/EC of 29 September 2008 amending Council Directive 91/414/EEC to include diuron as active substance (Text with EEA relevance)

text:
               1.10.2008

               EN

               Official Journal of the European Union

               L 262/31

      COMMISSION DIRECTIVE 2008/91/EC
   of 29 September 2008
   amending Council Directive 91/414/EEC to include diuron as active substance
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 703/2001 (3) lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included diuron. By Commission Decision 2007/417/EC (4) it was decided not to include diuron in Annex I to Directive 91/414/EEC.

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the original notifier submitted on 26 June 2007 a new application to Denmark, which had been designated rapporteur Member State by Regulation (EC) No 451/2000.

               (3)

               Denmark assessed the information submitted by the notifier and prepared an additional report on 15 November 2007, recommending the inclusion of the substance in Annex I.

               (4)

               Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5), entered into force on 25 January 2008. In the case of diuron the rapporteur Member State completed the assessment of the additional information submitted by the notifier before the entry into force of that Regulation, taking into account the same criteria as provided for in Article 15 of that Regulation. Given this situation the Commission evaluated the additional report, and where relevant the draft assessment report, and the recommendation by the Member State in accordance with Article 20 of Regulation (EC) No 33/2008.

               (5)

               The draft review report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health, and finalised on 11 July 2008 in the format of the Commission review report for diuron. It concentrated on the concerns that lead to the non-inclusion. Those were the unacceptable operator exposure, the inconclusive nature of the assessment of a possible risk for groundwater, due to uncertainties as regards the fate of certain metabolites, and the lack of data demonstrating that the risk to birds and mammals is acceptable.

               (6)

               As set out in that report the instructions by the notifier now require applications to be made with significantly smaller quantities of diuron. As a result, acceptable levels of operator exposure can be demonstrated, some of them linked to the use of protective equipment. As regards the risk to groundwater, the degradation pattern of certain metabolites has been clarified by the notifier and reviewed by the rapporteur Member State which agreed that when applied to the models for groundwater, the trigger value is not exceeded. Finally, on the basis of the refined assessments that have now been submitted by the notifier, the risk to birds and mammals may be considered as acceptable.

               (7)

               Consequently, the additional data provided by the notifier permit to eliminate the specific concerns that led to the non-inclusion. No other open scientific questions have arisen. Consequently, the consultation of the European Food Safety Authority was not considered necessary.

               (8)

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

               (9)

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

               (10)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall bring into force by 31 March 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.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   This Directive shall enter into force on 1 October 2008.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 29 September 2008.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

      (3)  OJ L 98, 7.4.2001, p. 6.

      (4)  OJ L 156, 16.6.2007, p. 32.

      (5)  OJ L 15, 18.1.2008, p. 5.

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

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘198

                     Diuron
                     CAS No: 330-54-1
                     CIPAC No: 100

                     3-(3,4-dichlorophenyl)-1,1-dimethylurea

                     ≥ 930 g/kg

                     1 October 2008

                     30 September 2018

                     PART A
                     Only uses as herbicide at rates not exceeding 0,5 kg/ha (areic average) may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on diuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the operator safety where conditions of use shall prescribe the use of personal protective equipment, if appropriate,

                                 —

                                 the protection of aquatic organisms and non-target plants.

                           Conditions of authorisation shall include risk mitigation measures, where appropriate.’

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


title: Commission Directive 2007/67/EC of 22 November 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress (Text with EEA relevance)

text:
               23.11.2007

               EN

               Official Journal of the European Union

               L 305/22

      COMMISSION DIRECTIVE 2007/67/EC
   of 22 November 2007
   amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III 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)

               According to the assessment strategy for hair dye substances, it was agreed with the Member States and stakeholders that the date of July 2005 would be appropriate for the submission to the Scientific Committee on Consumer Products (SCCP) of the additional information on the hair dye substances listed in Part 2 of Annex III to Directive 76/768/EEC.

               (2)

               Commission Directive 2006/65/EC of 19 July 2006 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III thereto to technical progress (2), extended until 31 December 2007 the provisional use of fifty six hair dye substances listed in Part 2 of Annex III.

               (3)

               For 14 hair dye substances listed in Part 2 of Annex III to Directive 76/768/EEC additional information has not been submitted. Therefore their use in hair dye products was banned by Directive 2007/54/EC.

               (4)

               For 42 hair dye substances listed in Part 2 of Annex III to Directive 76/768/EEC additional information has been submitted by the industry. This information is currently being evaluated by the SCCP. Definitive regulation of those hair dye substances, on the basis of such evaluations, and its implementation into the laws of Member States will take place at the latest by the 31 December 2009. Therefore, their provisional use in cosmetic products under the restrictions and conditions laid down in Part 2 of Annex III thereto should be extended until 31 December 2009.

               (5)

               Annex III to Directive 76/768/EEC should therefore be amended accordingly.

               (6)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   In reference numbers 3, 4, 5, 6, 7, 9, 10, 11, 12, 14, 16, 18, 19, 20, 21, 22, 24, 25, 26, 27, 28, 29, 31, 32, 33, 34, 35, 36, 37, 38, 39, 44, 47, 48, 49, 50, 55, 56, 57, 58, 59, and 60 of column g in Part 2 of Annex III to Directive 76/768/EEC, the date ‘31.12.2007’ is replaced by ‘31.12.2009’.
   Article 2
   1.   Member States shall adopt and publish, by 31 December 2007 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 January 2008.
   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 that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 22 November 2007.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2007/54/EC (OJ L 226, 30.8.2007, p. 21).

      (2)  OJ L 198, 20.7.2006, p. 11.


Avis juridique important

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32001L0049

Commission Directive 2001/49/EC of 28 June 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include DPX KE 459 (flupyrsulfuron-methyl) as an active substance

Official Journal L 176 , 29/06/2001 P. 0061 - 0063

Commission Directive 2001/49/ECof 28 June 2001amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include DPX KE 459 (flupyrsulfuron-methyl) as an active substanceTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2001/236/EC(2), and in particular Article 6(1) thereof,Whereas:(1) In accordance with Article 6(2) of Directive 91/414/EEC (hereinafter referred to as "the Directive") on 26 October 1995 France received an application from Du Pont de Nemours SAS, ("the applicant") for the inclusion of the active substance DPX KE 459 (flupyrsulfuron-methyl) in Annex I to the Directive.(2) In accordance with the provisions of Article 6(3) of the Directive Commission Decision 97/164/EC(3) concluded that the dossier submitted for flupyrsulfuron-methyl could be considered as satisfying, in principle, the data and information requirements of Annex II, and for a plant protection product containing this active substance, of Annex III to the Directive.(3) The effects of flupyrsulfuron-methyl on human and animal health and the environment have been assessed by France, acting as nominated rapporteur Member State, in accordance with the provisions of Article 6(2) and (4) of the Directive, for the uses proposed by the applicant France submitted its draft assessment report concerning the substance to the Commission on 2 December 1997.(4) The dossier and the information from the review of flupyrsulfuron-methyl were also submitted to the Scientific Committee on Plants for opinion on 15 July 1999. This Committee gave its opinion on 20 November 2000(4).(5) In the light of these examinations, it appears that plant protection products containing flupyrsulfuron-methyl may be expected to satisfy, in general, the requirements laid down in Article 5(1) and (3) of the Directive, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include it in Annex I to the Directive, in order to ensure that in all Member States plant protection products containing it can be authorised in accordance with the Directive.(6) After inclusion, a reasonable period is necessary to permit Member States to implement the provisions of this Directive and in particular to review, provisional authorisations granted for plant protection products containing flupyrsulfuron-methyl, which should be replaced by authorisations granted under Article 4 of Directive 91/414/EEC. A longer period may also be required for plant protection products containing flupyrsulfuron-methyl and other active substances included in Annex I.(7) The review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Annex VI to the Directive which refer to the evaluation of the data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive. It is appropriate to provide that the finalised review report (except for confidential information in the meaning of Article 14 of the Directive) is kept available or made available by the Member States for consultation by any interested party.(8) Should this review report be updated to take account of technical and scientific developments, the conditions for the inclusion of flupyrsulfuron-methyl in Annex I to the Directive may also need to be amended in accordance with the procedure specified in the Directive.(9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health delivered on 27 April 2001,HAS ADOPTED THIS DIRECTIVE:Article 1The table in Annex I to Directive 91/414/EEC shall be amended to include the entry in respect of DPX KE 459 (flupyrsulfuron-methyl) set out in the Annex hereto.Article 2Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, at the latest by 31 December 2001. They shall forthwith inform the Commission thereof.When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 3However, with regard to the review of provisional authorisations granted in the light of the review report and for the application of the Uniform Principles provided in Annex VI to Directive 91/414/EEC, the provisional authorisations shall be withdrawn and where appropriate, replaced by a full authorisation by 30 November 2002. However for plant protection products containing DPX KE 459 (flupyrsulfuron-methyl) together with another active substance not yet in Annex I, the period referred to above is extended to the extent that a longer implementation period is provided for by the provisions laid down in the Directive amending Annex I to Directive 91/414/EEC to include the other substance in the Annex.Article 4Member States shall keep available the review report for DPX KE 459 flupyrsulfuronmethyl (except for confidential information within the meaning of Article 14 of the Directive) for consultation by any interested parties or shall make it available to them on specific request.Article 5This Directive shall enter into force on 1 July 2001.Article 6This Directive is addressed to the Member States.Done at Brussels, 28 June 2001.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 164, 20.6.2001, p. 1.(3) OJ L 64, 5.3.1997, p. 7.(4) Opinion of the Scientific Committee on Plants regarding the evaluation of flupyrsulfuron-methyl in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/FLUPYR/002, final dated 11 December 2000.ANNEXENTRY TO BE INSERTED IN THE TABLE IN ANNEX I TO DIRECTIVE 91/414/EEC">TABLE>"


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31988L0320

Council Directive 88/320/EEC of 9 June 1988 on the inspection and verification of Good Laboratory Practice (GLP)

Official Journal L 145 , 11/06/1988 P. 0035 - 0037 Finnish special edition: Chapter 15 Volume 8 P. 0091  Swedish special edition: Chapter 15 Volume 8 P. 0091

*****COUNCIL  DIRECTIVE  of 9 June 1988  on the inspection and verification of Good Laboratory Practice (GLP)  (88/320/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100A thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the application of standardized organizational processes and conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing of chemicals for the protection of man, animals and the environment, hereinafter referred to as 'Good Laboratory Practice' (GLP), contributes to the reassurance of Member States as to the quality of the test data generated;  Whereas, in Annex 2 to its Decision on 12 May 1981 on the mutual acceptance of data in the assessment of chemicals, the council of the Organization for Economic Cooperation and Development (OECD) adopted principles of good laboratory practice which are accepted within the Community and are specified in Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (4);  Whereas, in the conduct of tests on chemicals, it is desirable that specialist manpower and testing laboratory resources should not be wasted owing to the need to duplicate tests because of differences in laboratory practices from one Member State to another; whereas this applies especially for animal protection which requires that the number of experiments on animals be restricted in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (5); whereas mutual recognition of the results of tests obtained using standard and recognized methods is an essential condition for reducing the number of experiments in this area;  Whereas, however, in order to ensure that test data generated by laboratories in one Member State are also recognized by other Member States, it is necessary to provide for a harmonized system for study audit and inspection of laboratories to ensure that they are working under GLP conditions;  Whereas Member States designate the authorities responsible for carrying out monitoring on compliance with GLP;  Whereas a committee, the members of which will be appointed by the Member States, would be of assistance to the Commission in the technical application of this Directive and would cooperate in its efforts to encourage the free movement of goods by the mutual recognition by Member States of procedures for monitoring compliance  with GLP; whereas the committee set up by Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1), as last amended by Directive 87/432/EEC (2), may be used for this purpose;  Whereas this committee may assist the Commission not only in the application of this Directive but also in contributing to the exchange of information and experience in this field,  HAS ADOPTED THIS DIRECTIVE:  Article 1  1. This Directive applies to the inspection and verification of the organizational processes and the conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing, carried out in accordance with the rules and regulations, of all chemicals (e. g. cosmetics, industrial chemicals, medicinal products, food additives, animal feed additives, pesticides) in order to assess the effect of such products on man, animals and the environment.  2. For the purposes of this Directive, the GLP, is described in Directive 87/18/EEC.  3. This Directive is not concerned with the interpretation and evaluation of test results.  Article 2  1. Using the procedure laid down in Article 3, Member States shall verify the compliance with GLP of any testing laboratory within their territory claiming to use GLP in the conduct of tests on chemicals.  2. Where the provisions of paragraph 1 have been complied with, and the results of the inspection and verification are satisfactory, the Member State in question may provide endorsement of a claim by a laboratory that it and the tests that it carries out comply with GLP, using the formula 'Assessment of conformity with GLP according to Directive 88/320/EEC on . . . (date)'.  Article 3  1. Member States shall designate the authorities responsible for the inspection of laboratories within their territories and for the audit of studies carried out by laboratories to assess compliance with GLP.  2. The authorities referred to in paragraph 1 shall inspect the laboratory and audit the studies in accordance with the provisions laid down in the Annex.  Article 4  1. Each year, Member States shall draw up a report relating to the implementation of GLP within their territory.  This report shall contain a list of laboratories inspected, the date on which such inspection was carried out and a brief summary of the conclusions of the inspections.  2. The reports shall be forwarded to the Commission each year, not later than 31 March. The Commission shall communicate them to the committee referred to in Article 7. The committee may request information in addition to those elements mentioned in paragraph 1.  3. Member States shall ensure that commercially sensitive and other confidential information to which they gain access as a result of GLP compliance monitoring activities is made available only to the Commission, to national regulatory and designated authorities and to a laboratory or study sponsor directly concerned with a particular inspection or study audit.  4. The names of laboratories subject to inspection by a designated authority, their GLP compliance status and the dates upon which laboratory inspections or study audits have been conducted shall not be considered to be confidential.  Article 5  1. Without prejudice to Article 6, the results of laboratory inspections and study audits on GLP compliance carried out by a Member State shall be binding on the other Member States.  2. Where a Member State considers that a laboratory within its territory claiming GLP compliance does not in fact comply with GLP to the extent that the integrity or authenticity of the studies it performs might be compromised, it shall forthwith inform the Commission. The Commission shall inform the other Member States.  Article 6  1. Where a Member State has sufficient reason to believe that a laboratory in another Member State claiming GLP compliance has not carried out a test according to GLP, it may request further information from that Member State and in particular may request a study audit, possibly in conjunction with a new inspection.  Should it not be possible for the Member States concerned to reach agreement, the Member States in question shall immediately inform the other Member States and the Commission, giving reasons for their decision.  2. The Commission shall examine as soon as possible the reasons put forward by the Member States within the Committee; it shall then take the appropriate measures in accordance with procedure laid down in Article 8. It may in this connection ask for expert opinions from the designated authorities in the Member States.  3. If the Commission considers that amendments to this Directive are necessary in order to resolve the matters to in paragraph 1, it shall initiate the procedure laid down in Article 8 with a view to adopting those amendments.  Article 7  1. The committee set up by Article 20 of Directive 67/548/EEC, hereinafter called 'the Committee', may examine any question which is referred to it by its chairman either on his own initiative or at the request of a representative of a Member State, concerning the implementation of this Directive and in particular regarding:  - cooperation between the authorities designated by the Member States in technical and administrative matters arising from the implementation of GLP, and  - the exchange of information on the training of inspectors.  2. The amendments necessary for the adaptation of the formula referred to in Article 2 (2) and of the Annex to this Directive to take account of technical progress shall be adopted in accordance with the procedure set out in Article 8.  Article 8  1. The representative of the Commission shall submit to the Committee a draft of the measures to be adopted. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.  2. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.  If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.  3. If within three months of submission of the proposal the Council has not acted, the proposed measures shall be adopted by the Commission.  Article 9  Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 1 January 1989. They shall forthwith inform the Commission thereof.  Article 10  This Directive is addressed to the Member States.  Done at Luxembourg, 9 June 1988.  For the Council  The President  N. BLUEM  (1) OJ No C 13, 17. 1. 1987, p. 5.  (2) OJ No C 156, 15. 6. 1987, p. 190 and OJ No C 122, 9. 5. 1988.  (3) OJ No C 232, 31. 8. 1987, p. 1.  (4) OJ No L 15, 17. 1. 1987, p. 29.  (5) OJ No L 358, 18. 12. 1986, p. 1.  (1) OJ No 196, 16. 8. 1967, p. 1/67.  (2) OJ No L 239, 21. 8. 1987, p. 1.  ANNEX  Programme for the inspection of laboratories and audit of studies  The provisions concerning the inspection of laboratories and audit of studies are those contained in Annexes 4 (Guide for Compliance of Monitoring Procedures for Good Laboratory Practice) and 6 (Guidance for the Conduct of Laboratory Inspections and Study Audits) of the final report of the Working Party of the OECD Environment Committee on the mutual of recognition of compliance with GLP (OECD ENV/CHEM/CM/87.7).


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32004L0021

Commission Directive 2004/21/EC of 24 February 2004 relating to restrictions on the marketing and use of "azo colourants" (thirteenth adaptation to technical progress of Council Directive 76/769/EEC) (Text with EEA relevance)

Official Journal L 057 , 25/02/2004 P. 0004 - 0005

Commission Directive 2004/21/ECof 24 February 2004relating to restrictions on the marketing and use of "azo colourants" (thirteenth adaptation to technical progress of Council Directive 76/769/EEC)(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Directive 2002/61/EC(1) of the European Parliament and of the Council of 19 July 2002 amending for the nineteenth time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (azocolourants)and in particular Article 2 thereof,Whereas:(1) According to Directive 2002/61/EC amending for the nineteenth time Council Directive 76/769/EEC(2) of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of dangerous substances and preparations certain azocolourants are not to be used in textiles and leather articles. Those textiles or leather articles may not be placed on the market unless they conform to the requirements set out in that Directive.(2) Article 2 of Directive 2002/61/EC requires the adoption of testing methods for the application of point 43 of Annex I to Directive 76/769/EEC.(3) The European Committee for Standardisation (CEN) has developed testing methods, which should be used for testing textile and leather articles in accordance with the application of point 43 of Annex I to Directive 76/769/EEC.(4) This Directive should apply without prejudice to Community legislation laying down minimum requirements for the protection of workers, in particular 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(3), and Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to carcinogens at work (Sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC(4)).(5) The measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directives on the removal of technical barriers to trade in dangerous substances and preparations,HAS ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 76/769/EEC is amended as set out in the Annex to this Directive.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2004 at the latest. They shall forthwith inform the Commission thereof.When Member States adopt those provisions, these 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 3This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 24 February 2004.For the CommissionErkki LiikanenMember of the Commission(1) OJ L 243, 11.9.2002, p. 15.(2) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Directive 2003/53/EC of the European Parliament and of the Council (OJ L 178, 17.7.2003, p. 24).(3) 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).(4) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive 1999/38/EC (OJ 138, 1.6.1999, p. 66).ANNEXAnnex I to Directive 76/769/EEC is amended as follows:1. In point 43, Azocolourants, in the second column point 1 is replaced by the following:"1. Azodyes which, by reductive cleavage of one or more azo groups, may release one or more of the aromatic amines listed in the Appendix, in detectable concentrations, i.e. above 30 ppm in the finished articles or in the dyed parts thereof, according to the testing methods listed in that Appendix, may not be used in textile and leather articles which may come into direct and prolonged contact with the human skin or oral cavity, such as:- clothing, bedding, towels, hairpieces, wigs, hats, nappies and other sanitary items, sleeping bags,- footwear, gloves, wristwatch straps, handbags, purses/wallets, briefcases, chair covers, purses worn round the neck,- textile or leather toys and toys which include textile or leather garments,- yarn and fabrics intended for use by the final consumer."2. In point 43 of the Appendix the following is added:"List of testing methods>TABLE>"