Avis juridique important

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31974L0651

Council Directive 74/651/EEC of 19 December 1974 on the tax reliefs to be allowed on the importation of goods in small consignments of a non-commercial character within the Community

Official Journal L 354 , 30/12/1974 P. 0057 - 0058 Greek special edition: Chapter 09 Volume 1 P. 0043  Spanish special edition: Chapter 09 Volume 1 P. 0047  Portuguese special edition Chapter 09 Volume 1 P. 0047

COUNCIL DIRECTIVE  of 19 December 1974  on the tax reliefs to be allowed on the importation of goods in small consignments of a non-commercial character within the Community  (74/651/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 99 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 (2);  Whereas the tax impediments at present hindering the dispatch from one Member State to another of small consignments of goods intended for private persons constitute an obstacle to the creation of an economic market with characteristics similar to those of a domestic market ; and whereas the elimination of such impediments is the corollory to freedom of movement and freedom of establishment for persons in the Community;  Whereas such impediments should be reduced as far as possible in respect of small consignments from one private person to another in order to assist personal and family contacts between private persons in different Member States,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1. Goods dispatched from a Member State in small consignments of a non-commercial character by a private person, wherever may be his permanent or usual residence or his principal place of business, intended for another private person in another Member State shall be allowed relief from turnover taxes and excise duties payable on importation.  2. For the purpose of paragraph 1, small consignments of a non-commercial character mean consignments of goods which:    (a) have been acquired in the Community subject to the taxation normally imposed in the domestic market in one of the Member States and without relief from turnover taxes and/or excise duties;       (b) are not intended for commercial use and appear from their nature and quantity to be intended solely for the personal or family use of the recipient;       (c) are not sent against payment of any kind by the recipient ; and       (d) do not have a total value exceeding 40 units of account for each consignment.         3. Notwithstanding the foregoing provisions of this Article, Member States shall have power to  (1)OJ No C 129, 11.12.1972, p. 58. (2)OJ No C 142, 31.12.1972, p. 3.   reduce the relief allowed for small consignments for products which are subject to the quantitative limits referred to in Article 4 (1) of Council Directive No 69/169/EEC (1) of 28 May 1969 on the harmonization of provisions laid down by law, regulation or administrative action relating to the relief from turnover taxes and excise duty collected on importation in international passenger traffic, as amended by Council Directive No 72/230/EEC (2), or to exclude those products from the benefit of the said relief.   Article 2 1. Member States shall put into operation the measures necessary to comply with this Directive not later than 1 April 1975.  2. Each Member State shall inform the Commission of the measures it takes to apply this Directive. The Commission shall communicate this information to the other Member States.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 19 December 1974.  For the Council  The President  J. P. FOURCADE  (1)OJ No L 133, 4.6.1969, p. 6. (2)OJ No L 139, 17.6.1972, p. 28.


Avis juridique important

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31993L0040

Council Directive 93/40/EEC of 14 June 1993 amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products

Official Journal L 214 , 24/08/1993 P. 0031 - 0039 Finnish special edition: Chapter 13 Volume 24 P. 0187  Swedish special edition: Chapter 13 Volume 24 P. 0187

COUNCIL DIRECTIVE 93/40/EEC of 14 June 1993 amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal productsTHE 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 it is important to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market shall comprise an area without internal frontiers in which the movement of  goods, persons, services and capital is ensured;  Whereas despite the progress achieved by Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (4), further measures are necessary to abolish the remaining  barriers to the free movement of veterinary medicinal products within the Community;  Whereas, with the exception of those veterinary medicinal products which are subject to the centralized Community authorization procedure established by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the  authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (5), an authorization to place a veterinary medicinal product on the market in one Member State  ought in principle to be recognized by the competent authorities of the other Member States unless there are serious grounds for supposing that the authorization of the veterinary medicinal product concerned may present a risk to human or animal health,  or to the environment; whereas, in the event of a disagreement between Member States about the quality, the safety or the efficacy of a veterinary medicinal product, a scientific evaluation of the matter should be undertaken by the Committee for  Veterinary Medicinal Products attached to the European Agency for the Evaluation of Medicinal Products, lead to a single decision on the area of disagreement, binding on the Member States concerned; whereas this Decision should be adopted by a rapid  procedure ensuring close cooperation between the Commission and the Member States;  Whereas in order better to protect human and animal health and avoid any unnecessary duplication of effort during the examination of application for authorization to place veterinary medicinal products on the market, Member States should systematically  prepare assessment reports in respect of each veterinary medicinal product which is authorized by them, and exchange the reports upon request; whereas, furthermore, a Member State should be able to suspend the examination of an application for  authorization to place a veterinary medicinal product on the market which is currently under active consideration in another Member State with a view to recognizing the decision reached by the latter Member State;  Whereas following the establishment of the internal market, specific controls to guarantee the quality of veterinary medicinal products imported from third countries can be waived only if appropriate arrangements have been made by the Community to  ensure that the necessary controls are carried out in the exporting country;  Whereas it is desirable to codify and improve the cooperation and exchange of information between Member States relating to the surveillance of veterinary medicinal products and in particular the monitoring of adverse reactions under practical  conditions of use through the national pharmacovigilance systems;  Whereas in order to improve the protection of public health it is necessary to specify that foodstuffs for human consumption may not be taken from animals which have been used in clinical trials of veterinary medicinal products unless a maximum residue  limit has been laid down for residues of the veterinary medicinal product concerned in accordance with the provisions of Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue  limits of veterinary medicinal products in foodstuffs of animal origin (6),  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 81/851/EEC is hereby amended as follows:  1. the first subparagraph of Article 4 (1) is replaced by the following:  'No veterinary medicinal product may be placed on the market of a Member State unless a marketing authorization has been issued by the competent authorities of that Member State in accordance with this Directive or a marketing authorization has been  granted in accordance with Council Regulation (EEC) 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing an European Agency for the evaluation  of medicinal products (*).  (*) OJ No L 214, 24. 8. 1993, p. 1.';  2. the following subparagraph is inserted at the end of Article 4 (2):  'From 1 January 1997 the Member States shall not permit foodstuffs for human consumption to be taken from test animals unless maximum residue limits have been established by the Community in accordance with the provisions of Regulation (EEC) No 2377/90  and an appropriate withdrawal period has been established to ensure that this maximum limit will not be exceeded in the foodstuffs.';  3. insert the following subparagraph after the first subparagraph in Article 5:  'The person responsible for placing veterinary medicinal products on the market shall be established in the Community. In respect of veterinary medicinal products authorized on the date of implementation of this Directive, the Member States shall if  necessary apply this provision at the time of the five-yearly renewal of the marketing authorization provided for in Article 15.';  4. in Article 5 (2), point 13 is replaced by the following:  '13. Copies of any authorization obtained in another Member State or in a third country to place the relevant veterinary medicinal product on the market, together with a list of those Member States in which an application for authorization submitted in  accordance with this Directive is under examination. Copies of the summary of the product characteristics proposed by the applicant in accordance with Article 5a or approved by the competent authority of the Member State in accordance with Article 5b  and copies of the package insert proposed, details of any decision to refuse authorization, whether in the Community or a third country and the reasons for that decision.  This information shall be updated on a regular basis.';  5. Article 5b is replaced by the following:  'Article 5b When the marketing authorization referred to in Article 4 (1) is issued, the person responsible for placing that veterinary medicinal product on the market shall be informed, by the competent authorities of the Member State concerned, of the summary of  the product characteristics as approved by it. The competent authorities shall take all necessary measures to ensure that the information given in the summary is in conformity with that accepted when the marketing authorization is issued or  subsequently. The competent authorities shall forward to the European Agency for the Evaluation of Medicinal Products a copy of the authorization together with the summary of the product characteristics referred to in Article 5a.  Furthermore, the competent authorities shall draw up an assessment report and comments on the dossier as regards the results of the analytical and pharmacotoxicological tests and the clinical trials of the veterinary medicinal product concerned. The  assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality, safety or efficacy of the veterinary medicinal product concerned.';  6. Article 8 is replaced by the following:  'Article 8 1. Member States shall take all appropriate measures to ensure that the procedure for granting an authorization to place a veterinary medicinal product on the market is completed within 210 days of the submission of a valid application.  2. Where a Member State notes that an application for authorization submitted after 1 January 1995 is already under active examination in another Member State in respect of that veterinary medicinal product, the Member State concerned may decide to  suspend the detailed examination of the application in order to await the assessment report prepared by the other Member State in accordance with Article 5b.  The Member State concerned shall inform the other Member State and the applicant of its decision to suspend detailed examination of the application in question. As soon as it has completed the examination of the application and reached a decision, the  other Member State shall forward a copy of its assessment report to the Member State concerned.  Within 90 days of the receipt of the assessment report, the Member State concerned shall either recognize the decision of the other Member State and the summary of the product characteristics as approved by it or, if it considers that there are grounds  for supposing that the authorization of the veterinary medicinal product concerned may present a risk to human or animal health or the environment (*), it shall apply the procedures set out in Articles 18 to 22 of this Directive.  (*) The expression "risk to human or animal health or the environment " refers to the quality, safety and efficacy of the veterinary medicinal product.';  7. insert the following Article 8a:  'Article 8a With effect from 1 January 1998, where a Member State is informed in accordance with point 13 of the second paragraph of Article 5 that another Member State has authorized a veterinary medicinal product which is the subject of an application for  authorization in the Member State concerned, that Member State shall forthwith request the authorities of the Member State which has granted the authorization to forward to it the assessement report referred to in the second paragraph of Article 5b.  Within 90 days of the receipt of the assessment report, the Member State concerned shall either recognize the decision of the first Member State and the summary of the product characteristics as approved by it or, if it considers that there are grounds  for supposing that the authorization of the veterinary medicinal product concerned may present a risk to human or animal health or the environment (*), it shall apply the procedures set out in Articles 18 to 22 of this Directive.  (*) The expression "risk to human or animal health or the environment " refers to the quality, safety and efficacy of the veterinary medicinal product.';  8. the first subparagraph of Article 14 (4) is replaced by the following:  'After an authorization has been issued, the person responsible for placing the veterinary medicinal product on the market must, in respect of the methods of preparation and control provided for in points 4 and 9 of the second subparagraph of Article 5,  take account of technical and scientific progress and introduce any changes that may be required to enable that veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods. These changes shall be subject  to the approval of the competent authority of the Member State concerned.';  9. Article 15 is replaced by the following:  'Article 15 1. Authorization shall be valid for five years and shall be renewable for five-year periods, on application by the holder at least three months before the expiry date and after consideration of a dossier updating the information previously submitted.  2. In exceptional circumstances, and following consultation with the applicant, an authorization may be granted subject to certain specific obligations, and subject to annual review, including:  - the carrying out of further studies following the granting of authorization,  - the notification of adverse reactions to the veterinary medicinal product.  These exceptional decisions may only be adopted for objective and verifiable reasons.';  10. Chapter IV is replaced by the following:  'CHAPTER IV Committee for Veterinary Medicinal Products Article 16 1. In order to facilitate the adoption of common decisions by Member States on the authorization of veterinary medicinal products on the basis of the scientific criteria of quality, safety and efficacy, and to achieve thereby the free movement of  veterinary medicinal products within the Community, a Committee for Veterinary Medicinal Products, hereinafter referred to as "the Committee ", is hereby set up. The Commission shall be part of the European Agency for the Evaluation of Medicinal  Products established by Regulation (EEC) No 2309/93, hereinafter referred to as "the Agency ".  2. In addition to the other responsibilities conferred upon it by Community law, the Committee shall examine any question relating to the granting, variation, suspension or withdrawal of authorization for a veterinary medicinal product which is  submitted to it in accordance with the provisions of this Directive.  3. The Committee shall adopt own rules of procedure.  Article 17 1. In order to obtain the recognition according to the procedure laid down in this Chapter in one or more of the Member States of an authorization issued by a Member State in accordance with Article 4, the holder of the authorization shall submit an  application to the competent authorities of the Member State or Member States concerned, together with the information and particulars referred to in Articles 5, 5a and 5b. He shall testify that the dossier is identical to that accepted by the first  Member State, or shall identify any additions or amendments it may contain. In the latter case, he shall certify that the summary of the product characteristics proposed by him in accordance with Article 5a is identical to that accepted by the first  Member State in accordance with Article 5b. Moreover, he shall certify that all the dossiers filed as part of this procedure are identical.  2. The holder of the marketing authorization shall notify the Committee of this application, inform it of the Member States concerned and of the dates of submission of the application and send it a copy of the authorization granted by the first Member  State. He shall also send the Committee copies of any such authorization which may have been granted by the other Member States in respect of the veterinary medicinal product concerned, and shall indicate whether any application for authorization is  currently under consideration in any Member State.  3. Except in cases referred to in Article 8a, before submitting the application, the holder of the authorization shall inform the Member State which granted the authorization on which the application is based that an application is to be made in  accordance with this Directive and shall notify it of any additions to the original dossier; that Member State may require the applicant to provide it with all the particulars and documents necessary to enable it to check that the dossiers filed are  identical.  In addition the holder of the authorization shall request the Member State which granted the initial authorization to prepare an assessment report in respect of the veterinary medicinal product concerned, or, if necessary, to update any existing  assessment report. That Member State shall prepare the assessment report, or update it, within 90 days of the receipt of the request.  At the same time as the application is submitted in accordance with paragraph 1 the Member State which granted the initial authorization shall forward the assessment report to the Member State or Member States concerned by the application.  4. Save in the exceptional case provided for in Article 18 (1), each Member State shall recognize the marketing authorization granted by the first Member State within 90 days of receipt of the application and the assessment report. It shall inform the  Member State which granted the initial authorization, the other Member States concerned by the application, the Committee, and the person responsible for placing the veterinary medicinal product on the market.  Article 18 1. Nothwithstanding Article 17 (4), where a Member State considers that there are grounds for supposing that the authorization of the veterinary medicinal product concerned may present a risk to human or animal health or the environment (*), it shall  forthwith inform the applicant, the Member State which granted the initial authorization, any other Member States concerned by the application and the Committee. The Member State shall state its reason in detail and shall indicate what action may be  necessary to correct any defect in the application.  2. All the Member States concerned shall use their best endeavours to reach agreement on the action to be taken in respect of the application. They shall provide the applicant with the opportunity to make his point of view known orally or in writing.  However, if the Member States have not reached agreement within the time limit referred to in Article 17 (4) they shall forthwith refer the matter to the Committee for the application of the procedure laid down in Article 21.  3. Within the time limit referred to in paragraph 2, the Member States concerned shall provide the Committee with a detailed statement of the matters on which they have been unable to reach agreement and the reasons for their disagreement. The applicant  shall be provided with a copy of this information.  4. As soon as he is informed that the matter has been referred to the Committee, the applicant shall forthwith forward to the Committee a copy of the information and particulars referred to in Article 17 (1).  (*) The expression "risk to human or animal health or the environment " refers to the quality, safety and efficacy of the veterinary medicinal product.  Article 19 If several applications submitted in accordance with Articles 5 and 5a have been made for marketing authorization for a particular veterinary medicinal product and Member States have adopted divergent decisions concerning the authorization of that  veterinary medicinal product, or its suspension or withdrawal from the market, a Member State, or the Commission, or the person responsible for placing the aforementioned product on the market may refer the matter to the Committee for application of the  procedure laid down in Article 21.  The Member State concerned, the person responsible for placing the veterinary medicinal product on the market or the Commission shall clearly identify the question which is referred to the Committee for consideration and, if appropriate, shall inform  the aforementioned person thereof.  The Member States and the person responsible for placing the veterinary medicinal product on the market shall forward to the Committee all available information relating to the matter in question.  Article 20 The Member States or the Commission or the applicant or holder of the marketing authorization may, in specific cases where the interests of the Community are involved, refer the matter to the Committee for the application of the procedure laid down in  Article 21 before reaching a decision on a request for a marketing authorization or on the suspension or withdrawal of an authorization, or on any other variations to the terms of a marketing authorization which appears necessary, in particular to take  account of the information collected in accordance with Chapter VIa.  The Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the person responsible for placing the veterinary medicinal product on the market.  The Member States and the aforementioned person shall forward to the Committee all available information relating to the matter in question.  Article 21 1. When reference is made to the procedure described in this Article, the Committee shall consider the matter concerned and issue a reasoned opinion within 90 days of the date on which the matter was referred to it.  However, in cases submitted to the Committee in accordance with Articles 19 and 20, this period may be extended by 90 days.  In case of urgency, on a proposal from its Chairman, the Committee may agree to impose a shorter deadline.  2. In order to consider the matter, the Committee may appoint one of its Members to act as rapporteur. The Committee may also appoint individual experts to advise it on specific questions. When appointing experts, the Committee shall define their tasks  and specify the time limit for the completion of these tasks.  3. In the cases referred to in Articles 18 and 19, before issuing its opinion, the Committee shall provide the person responsible for placing the veterinary medicinal product on the market with an opportunity to present written or oral explanations.  In the case referred to in Article 20, the person responible for placing the veterinary medicinal product on the market may be asked to explain himself orally or in writing.  If it considers it appropriate, the Committee may invite any other person to provide information relating to the matter before it.  The Committee may suspend the time limit referred to in paragraph 1 in order to allow the person responsible for placing the veterinary medicinal product on the market to prepare explanations.  4. Where the opinion of the Committee is that:  - the application does not satisfy the criteria for authorization, or - the summary of the product characteristics proposed by the applicant in accordance with Article 5a should be amended, or - the authorization should be granted subject to conditions, with regard to conditions considered essential for the safe and effective use of the veterinary medicinal product including pharmacovigilance, or - a marketing authorization should be suspended, varied or withdrawn,  the Agency shall forthwith inform the person responsible for placing the veterinary medicinal product on the market. Within 15 days of the receipt of the opinion, the aforementioned person may notify the Agency in writing of his intention to appeal. In  that case, he shall forward the detailed grounds for appeal to the Agency within 60 days of receipt of the opinion. Within 60 days of receipt of the grounds for appeal, the Committee shall consider whether its opinion should be revised, and the  conclusions reached on the appeal shall be annexed to the assessment report referred to in paragraph 5.  5. Within 30 days of its adoption, the Agency shall forward the final opinion of the Committee to the Member States, the Commission and the person responsible for placing the veterinary medicinal product on the market together with a report describing  the assessment of the veterinary medicinal product and the reasons for its conclusions.  In the event of an opinion in favour of granting or maintaining an authorization to place the veterinary medicinal product concerned on the market, the following documents shall be annexed to the opinion:  (a) a draft summary of the product characteristics, as referred to in Article 5a; where necessary this will reflect differences in the veterinary conditions pertaining in the Member States.  (b) any conditions affecting the authorization within the meaning of paragraph 4.  Article 22 1. Within 30 days of the receipt of the opinion, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account Community law.  In the event of a draft decision which envisages the granting of marketing authorization, the documents referred to in Article 21 (5) (a) and (b) shall be annexed.  Where, exceptionally, the draft decision is not in accordance with the opinion of the Agency, the Commission shall also annex a detailed explanation of the reasons for the differences.  The draft decision shall be forwarded to the Member States and the applicant.  2. A final decision on the application shall be adopted in accordance with the procedure laid down in Article 42k.  3. The rules of procedure of the Committee referred to in Article 42k shall be adjusted to take account of the tasks incumbent upon it in accordance with this Directive.  These adjustments shall involve the following:  - except in cases referred to in the third subparagraph of paragraph 1, the opinion of the Standing Committee shall be obtained in writing,  - each Member State is allowed at least 28 days to forward written observations on the draft decision to the Commission,  - each Member State is able to require in writing that the draft decision be discussed by the Standing Committee, giving its reasons in detail.  Where, in the opinion of the Commission, the written observations of a Member State raise important new questions of a scientific or technical nature which have not been addressed in the opinion of the Agency, the Chairman shall suspend the procedure  and refer the application back to the Agency for further consideration.  The provisions necessary for the implementation of this paragraph shall be adopted by the Commission in accordance with the procedure laid down in Article 42j.  4. A decision adopted in accordance with this Article shall be addressed to the Member States concerned by the matter and to the person responsible for placing the veterinary medicinal product on the market. The Member States shall either grant or  withdraw marketing authorization, or vary the terms of a marketing authorization as necessary to comply with the decision within 30 days of its notification. They shall inform the Commission and the Committee thereof.  5. The procedure referred to in Articles 16 to 22 shall not apply in the cases provided for in Article 9 (2) of Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the approximation of the laws of the Member  States on veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products (*).  (*) OJ No L 297, 13. 10. 1992, p. 12.  Article 23 Any application by the person responsible for placing the veterinary medicinal product on the market to vary a marketing authorization which has been granted in accordance with the provisions of this Chapter shall be submitted to all the Member States  which have previously authorized the veterinary medicinal product concerned.  The Commission shall, in consultation with the Agency, adopt appropriate arrangements for the examination of variations to the terms of a marketing authorization.  These arrangements shall include a notification system or administration procedures concerning minor variations and define precisely the concept of "a minor variation".  These arrangements shall be adopted by the Commission in the form of an implementing Regulation in accordance with the procedure laid down in Article 42j.  The procedure laid down in Articles 21 and 22 shall apply by analogy to variations made to marketing authorizations for products subject to the Commission's arbitration.  Article 23a 1. Where a Member State considers that the variation of the terms of a marketing authorization which has been granted in accordance with the provisions of this Chapter or its suspension or withdrawal is necessary for the protection of human or animal  health or the environment, the Member State concerned shall forthwith refer the matter to the Committee for the application of the procedures laid down in Articles 21 and 22.  2. Without prejudice to the provisions of Article 20, in exceptional cases, where urgent action is essential to protect human or animal health or the environment, until a definitive decision is adopted, a Member State may suspend the marketing and the  use of the veterinary medicinal product concerned on its territory. It shall inform the Commission and the other Member States no later than the following working day of the reasons for its action.  Article 23b Articles 23 and 23a shall apply by analogy to veterinary medicinal products authorized by Member States following an opinion of the Committee given in accordance with Article 4 of Directive 87/22/EEC before 1 January 1995.  Article 23c 1. The Agency shall publish an annual report on the operation of the procedures laid down in this Chapter and shall forward that report to the European Parliament and the Council for information.  2. By 1 January 2001, the Commission shall publish a detailed review of the operation of the procedures laid down in this Chapter and shall propose any amendments which may be necessary to improve these procedures.  The Council shall decide, under the conditions provided for in the Treaty, on the Commission proposal within one year of its submission.';  11. the third subparagraph of Article 30 (1) is replaced by the following:  'In the case of veterinary medicinal products imported from a third country, where appropriate arrangements have been made by the Community with the exporting country to ensure that the manufacturer of the veterinary medicinal product applies standards  of good manufacturing practice at least equivalent to those laid down by the Community and to ensure that the controls referred to under (b) have been carried out in the exporting country, the qualified person may be relieved of responsibility for  carrying out those controls.';  12. the following Chapter VIa is inserted after Article 42:  'CHAPTER VIa Pharmacovigilance Article 42a In order to ensure the adoption of appropriate regulatory decisions concerning the veterinary medicinal products authorized within the Community, having regard to information obtained about suspected adverse reactions to medicinal products under normal  conditions of use, the Member States shall establish a pharmacovigilance system. This system shall be used to collect information useful in the surveillance of veterinary medicinal products, with particular reference to adverse reactions in animals, and  to evaluate such information scientifically.  Such information shall be collated with data on consumption of veterinary medicinal products.  This system shall also collate information on frequently observed misuse and serious abuse of veterinary medicinal products.  Article 42b For the purpose of this Directive, the following definitions shall apply:  - "adverse reaction " means a reaction which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or the modification of physiological function.  - "serious adverse reaction " means an adverse reaction which is fatal, life-threatening, lesion-producing, disabling, incapacitating, or which results in permanent or prolonged symptoms in the animals treated,  - "unexpected adverse reaction " means an adverse reaction which is not mentioned in the summary of the product characteristics,  - "serious unexpected adverse reaction " means an adverse reaction which is both serious and unexpected.  Article 42c The person responsible for placing the veterinary medicinal product on the market shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.  That qualified person shall be responsible for the following:  (a) the establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the company, including its representatives, is collected and collated at a single point;  (b) the preparation for the competent authorities of the reports referred to in Article 42d, in such form as may be laid down by those authorities, in accordance with the relevant national or Community guidelines;  (c) ensuring that any request from the competent authorities for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a veterinary medicinal product is answered fully and promptly, including the  provision of information about the volume of sales or prescriptions of the veterinary medicinal product concerned.  Article 42d 1. The person responsible for placing the veterinary medicinal product on the market shall be required to record and to report all suspected serious adverse reactions which are brought to his attention to the competent authorities immediately, and in  any case within 15 days of their receipt at the latest.  2. In addition, the person responsible for placing the veterinary medicinal product on the market shall be required to maintain detailed records of all other suspected adverse reactions which are reported to him.  Unless other requirements have been laid down as a condition of the granting of authorization, these records shall be submitted to the competent authorities immediately upon request or at least every six months during the first two years following  authorization, and once a year for the following three years. Thereafter, the records shall be submitted at five-yearly intervals together with the application for renewal of the authorization, or immediately upon request. These records shall be  accompanied by a scientific evaluation.  Article 42e The Member States shall take all appropriate measures to encourage the reporting of suspected adverse reactions to the competent authorities.  Article 42f The Member States shall ensure that reports of suspected serious adverse reactions are immediately brought to the attention of the Agency and the person responsible for placing the veterinary medicinal product on the market, and in any case within 15  days of their notification, at the latest.  Article 42g In order to facilitate the exchange of information about pharmacovigilance within the Community, the Commission, in consultation with the Agency, Member States and interested parties, shall draw up guidance on the collection, verification and  presentation of adverse reaction reports.  This guidance shall take account of international harmonization work carried out with regard to terminology and classification in the field of pharmacovigilance when use of such work can be made in the field of the veterinary medicinal product  concerned.  Article 42h Where as a result of the evaluation of adverse reaction reports a Member State considers that a marketing authorization should be varied, suspended or withdrawn, it shall forthwith inform the Agency and the person responsible for placing the veterinary  medicinal product on the market.  In case of urgency, the Member State concerned may suspend the marketing of a veterinary medicinal product, provided the Agency is informed no later than on the following working day.  Article 42i Any amendments which may be necessary to update the provisions of this Chapter to take account of scientific and technical progress shall be adopted in accordance with the procedure laid down in Article 42j.';  13. the following Chapter VIb is inserted after Article 42i:  'Chapter VIb Standing Committee procedure Article 42j Where the procedure laid down in this Article is to be followed the Commission shall be assisted by the Standing Comittee on Veterinary Medicinal Products.  The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The  opinion shall be delivered by the 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.  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.  If on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.  Article 42k Where the procedure laid down in this Article is to be followed the Commission shall be assisted by the Standing Committee on Veterinary Medicinal Products.  The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The  opinion shall be delivered by the 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.  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.  If on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple  majority.';  14. in Articles 1 (5) and 27a of Directive 81/851/EEC, the reference to Article 2c of Directive 81/852/EEC shall be replaced by reference to Article 42j.  Article 2  The Committee referred to in Article 2b of Directive 81/852/EEC shall be called the 'Standing Committee on Veterinary Medicinal Products'.  Article 3  Member States shall take all appropriate measures to comply with this Directive, with the exception of Article 1 (7), before 1 January 1995. They shall forthwith inform the Commission thereof.  Member States shall take all appropriate measures to comply with Article 1 (7) of this Directive before 1 January 1998. They shall forthwith inform the Commission thereof.  When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such a reference shall be laid down by Member States.   Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field governed by this Directive.  Article 4  This Directive is addressed to the Member States.  Done at Luxembourg, 14 June 1993.  For the Council The President J. TROEJBORG (1) OJ No C 330, 31. 12. 1990, p. 25 and OJ No C 310, 30. 11. 1991, p. 25.(2) OJ No C 183, 15. 7. 1991, p. 194 and OJ No C 150, 31. 5. 1993.(3) OJ No C 269, 14. 10. 1991, p. 84.(4) OJ No L 317, 6. 11. 1981, p. 1. Directive last amended by Directive 90/676/EEC of 13 December 1990 (OJ No L 373, 31. 12. 1990, p. 15).(5) See page 1 of this Official Journal.(6) OJ No L  224, 18. 8. 1990, p. 1. Regulation last amended by Regulation (EEC) No 762/92 (OJ No L 83, 28. 3. 1992, p. 14).


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31996L0046

Commission Directive 96/46/EC of 16 July 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)

Official Journal L 214 , 23/08/1996 P. 0018 - 0024

COMMISSION DIRECTIVE 96/46/EC of 16 July 1996 amending 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 Commission Directive 96/12/EC (2), and in particular Article 18 (2) thereof,Whereas Annexes II and III to Directive 91/414/EEC set out the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I and for the authorization of a plant protection product;Whereas it is necessary to indicate, in Annexes II and III, to the applicants, as precisely as possible, any details on the required information, such as the circumstances, conditions and technical protocols under which certain data have to be generated; whereas these provisions should be introduced as soon as available in order to permit applicants to use them in the preparation of their files;Whereas it is now possible to introduce more details with regard to the data requirements concerning analytical methods for the active substance provided for in Section 4 of Part A of Annex II;Whereas it is also now possible to introduce more details with regard to the data requirements concerning analytical methods for the plant protection product provided for in Section 5 of Part A of Annex III;Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1 Directive 91/414/EEC is amended as follows:1. in Part A of Annex II the section headed '4. Analytical methods` is replaced by Annex I hereto;2. in Part A of Annex III the section headed '5. Analytical methods` is replaced by Annex II hereto.Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 April 1997. They shall immediately inform the Commission thereof.When Member States adopt these 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 adopted by the Member States.Article 3 This Directive shall enter into force on 1 May 1996.Article 4 This Directive is addressed to the Member States.Done at Brussels, 16 July 1996.For the CommissionFranz FISCHLERMember of the Commission(1) OJ No L 230, 19. 8. 1991, p. 1.(2) OJ No L 65, 15. 3. 1996, p. 20.ANNEX I '4. ANALYTICAL METHODSIntroductionThe provisions of this section only cover analytical methods required for post-registration control and monitoring purposes.For analytical methods used for generation of data as required in this Directive or for other purposes the applicant has to provide a justification for the method used; where necessary separate guidance will be developed for such methods on the basis of the same requirements as defined for methods for post-registration control and monitoring purposes.Descriptions of methods must be provided and include details of equipment, materials and conditions used.As far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment.For this section the following applies:>TABLE>On request the following samples must be provided:(i) analytical standards of the pure active substance;(ii) samples of the active substance as manufactured;(iii) analytical standards of relevant metabolites and all other components included in the residue definition;(iv) if available, samples of reference substances for the relevant impurities.4.1. Methods for the analysis of the active substance as manufacturedFor this point the following definitions apply:(i) SpecificitySpecificity is the ability of a method to distinguish between the analyte being measured and other substances.(ii) LinearityLinearity is defined as the ability of the method, within a given range, to obtain an acceptable linear correlation between the results and the concentration of analyte in samples.(iii) AccuracyThe accuracy of a method is defined as the degree to which the determined value of analyte in a sample corresponds to the accepted reference value (for example ISO 5725).(iv) PrecisionPrecision is defined as the closeness of agreement between independent test results obtained under prescribed conditions.Repeatability: Precision under repeatability conditions, i.e. conditions where independent test results are obtained with the same method on identical test material in the same laboratory by the same operator using the same equipment within short intervals of time.The reproducibility is not required for the active substance as manufactured (for definition of reproducibility see ISO 5725).4.1.1. Methods, which must be described in full, must be provided for the determination of pure active substance in the active substance as manufactured as specified in the dossier submitted in support of inclusion in Annex I to Directive 91/414/EEC. The applicability of existing Cipac methods must be reported.4.1.2. Methods must also be provided for the determination of significant and/or relevant impurities and additives (e.g. stabilizers) in the active substance as manufactured.4.1.3. Specificity, linearity, accuracy and repeatability4.1.3.1. Specificity of methods submitted, must be demonstrated and reported. In addition the extent of interference by other substances present in the active substance as manufactured (e.g. isomers, impurities or additives), must be determined.While interferences due to other components may be identified as systematic errors in the assessment of the accuracy of methods proposed for the determination of pure active substance in the active substance as manufactured, an explanation must be provided for any interference occurring which contributes more than ± 3 % to the total quantity determined. The degree of interference for methods for the determination of impurities must also be demonstrated.4.1.3.2. The linearity of proposed methods over an appropriate range must be determined and reported. For the determination of pure active substance, the calibration range must extend (by at least 20 %) the highest and lowest nominal content of the analyte in relevant analytical solutions. Duplicate calibration determinations must be made at three or more concentrations. Alternatively, five concentrations, each as single measurements, are acceptable. Reports submitted must include the equation of the calibration line and the correlation coefficient and representative and properly labelled documentation from the analysis, e.g. chromatograms.4.1.3.3. Accuracy is required for methods for the determination of pure active substance and significant and/or relevant impurities in the active substance as manufactured.4.1.3.4. For the repeatability in the determination of the pure active substance in principle a minimum of five determinations must be made. The relative standard deviation (% RSD) must be reported. Outliers identified through an appropriate method (e.g. Dixons or Grubbs test), may be discarded. Where outliers have been discarded, that fact must be clearly indicated. An explanation as to the reason for the occurrence of individual outliers, must be attempted.4.2. Methods for the determination of residuesThe methods must be capable of determining the active substance and/or relevant metabolites. For each method and for each relevant representative matrix, the specificity, precision, recovery, and limit of determination must be experimentally determined and reported.In principle, residue methods proposed should be multi-residue methods; a standard multi-residue method must be assessed and reported as to its suitability for residue determination. Where residue methods proposed are not multi-residue methods, or are not compatible with such methods, an alternative method must be proposed. Where this requirement results in an excessive number of methods for individual compounds, a "common moiety method" may be acceptable.For this section the following definitions apply:(i) SpecificitySpecificity is the ability of a method to distinguish between the analyte being measured and other substances.(ii) PrecisionPrecision is defined as the closeness of agreement between independent test results obtained under prescribed conditions.Repeatability: Precision under repeatability conditions, i.e. conditions where independent test results are obtained with the same method on identical test material in the same laboratory by the same operator using the same equipment within short intervals of time.Reproducibility: As the definition of reproducibility in relevant publications (for example, in ISO 5725) is in general not practicable for residue analytical methods, reproducibility in the context of this Directive is defined as a validation of repeatability of recovery, from representative matrices and at representative levels, by at least one laboratory which is independent from that which initially validated the study (this independent laboratory may be within the same company) (independent laboratory validation).(iii) RecoveryThe percentage of the amount of active substance or relevant metabolite originally added to a sample of the appropriate matrix which contains no detectable level of the analyte.(iv) Limit of determinationThe limit of determination (often referred to as limit of quantification) is defined as the lowest concentration tested, at which an acceptable mean recovery is obtained (normally 70 to 110 % with a relative standard deviation of preferably ≤ 20 %; in certain justified cases lower or higher mean recovery rates as well as higher relative standard deviations may be acceptable).4.2.1. Residues in and/or on plants, plant products, foodstuffs (of plant and animal origin), feedingstuffsMethods submitted must be suitable for the determination of all components included in the residue definition as submitted according to the provisions of section 6, points 6.1 and 6.2 in order to enable Member States to determine compliance with established MRL's or to determine dislodgeable residues.The specificity of the methods must enable all components included in the residue definition to be determined, using an additional confirmatory method if appropriate.The repeatability must be determined and reported. The replicate analytical portions for test can be prepared from a common field treated sample, containing incurred residues. Alternatively the replicate analytical portions for test can be prepared from a common untreated sample with aliquots fortified at the required level(s).The results from an independent laboratory validation must be reported.The limit of determination including the individual and mean recovery must be determined and reported. The overall relative standard deviation, as well as the relative standard deviation for each fortification level must be experimentally determined and reported.4.2.2. Residues in soilMethods for analysis of soil for parent compound and/or relevant metabolites must be submitted.The specificity of the methods must enable the parent compound and/or relevant metabolites to be determined, using an additional confirmatory method if appropriate.The repeatability, recovery and the limit of determination including the individual and mean recovery must be determined and reported. The overall relative standard deviation, as well as the relative standard deviation for each fortification level must be experimentally determined and reported.The proposed limit of determination must not exceed a concentration which is of concern with regard to exposure of non-target organisms or because of phytotoxic effects. Normally the proposed limit of determination should not exceed 0,05 mg/kg.4.2.3. Residues in water (including drinking water, ground water and surface water)Methods for analysis in water for parent compound and/or relevant metabolites must be submitted.The specificity of the methods must enable the parent compound and/or relevant metabolites to be determined, using an additional confirmatory method if appropriate.The repeatability, recovery and the limit of determination including the individual and mean recovery must be determined and reported. The overall relative standard deviation, as well as the relative standard deviation for each fortification level must be experimentally determined and reported.For drinking water the proposed limit of determination must not exceed 0,1 ìg/l. For surface water the proposed limit of determination must not exceed a concentration which has an impact on non-target organisms deemed to be unacceptable according to the requirements of Annex VI.4.2.4. Residues in airMethods for the analysis in air of the active substance and/or relevant metabolites formed during or shortly after application must be submitted unless it can be justified that exposure of operators, workers or bystanders is not likely to occur.The specificity of the methods must enable the parent compound and/or relevant metabolites to be determined, using an additional confirmatory method if appropriate.The repeatability, recovery and the limit of determination including the individual and mean recovery must be determined and reported. The overall relative standard deviation, as well as the relative standard deviation for each fortification level must be experimentally determined and reported.The proposed limit of determination must take into account relevant health based limit values or relevant exposure levels.4.2.5. Residues in body fluids and tissuesWhere an active substance is classified as toxic or highly toxic appropriate analytical methods must be submitted.The specificity of the methods must enable the parent compound and/or relevant metabolites to be determined, using an additional confirmatory method if appropriate.The repeatability; recovery and the limit of determination including the individual and mean recovery must be determined and reported. The overall relative standard deviation, as well as the relative standard deviation for each fortification level must be experimentally determined and reported.`ANNEX II '5. ANALYTICAL METHODSIntroductionThe provisions of this section only cover analytical methods required for post-registration control and monitoring purposes.For analytical methods used for generation of data as required in this Directive or for other purposes the applicant has to provide a justification for the method used; where necessary separate guidance will be developed for such methods on the basis of the same requirements as defined for methods for post-registration control and monitoring purposes.Descriptions of methods must be provided and include details of equipment, materials and conditions used.As far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment.For this section the following applies:>TABLE>On request the following samples must be provided:(i) samples of the preparation;(ii) analytical standards of the pure active substance;(iii) samples of the active substance as manufactured;(iv) analytical standards of relevant metabolites and all other components included in the residue definition;(v) if available, samples of reference substances for the relevant impurities.For definitions see Annex II, Section 4, points 4.1 and 4.2.5.1. Methods for the analysis of the preparation5.1.1. Methods, which must be described in full, must be provided for the determination of the active substance in the preparation. In the case of a preparation containing more than one active substance a method capable of determining each, in the presence of the other, should be provided. If a combined method is not submitted, the technical reasons must be stated. The applicability of existing Cipac methods must be reported.5.1.2. Methods must also be provided for the determination in the preparation of relevant impurities, if the composition of the preparation is such that - on the basis of theoretical consideration - such impurities may be formed by its manufacturing process or from degradation during storage.If required, methods for the determination of formulants or constituents of formulants in the preparation must be submitted.5.1.3. Specificity, linearity, accuracy and repeatability5.1.3.1. Specificity of methods submitted, must be demonstrated and reported. In addition the extent of interference by other substances present in the preparation must be determined.While interferences due to other components may be identified as systematic errors in the assessment of the accuracy of methods proposed, an explanation must be provided for any interference occurring which contribute more than ± 3 % to the total quantity determined.5.1.3.2. The linearity of proposed methods over an appropriate range, must be determined and reported. The calibration range must extend (by at least 20 %) the highest and lowest nominal content of the analyte in relevant analytical solutions of the preparation. Duplicate calibration determinations must be made at three or more concentrations. Alternatively, five concentrations, each as single measurements, are acceptable. Reports submitted must include the equation of the calibration line and the correlation coefficient and representative and properly labelled documentation from the analysis, e.g. chromatograms.5.1.3.3. Accuracy will normally only be required for methods for the determination of pure active substance and relevant impurities in the preparation.5.1.3.4. For the repeatability in principle a minimum of five determinations must be made. The relative standard deviation (% RSD) must be reported. Outliers identified through an appropriate method (e.g. Dixons or Grubbs test), may be discarded. Where outliers have been discarded, that fact must be clearly indicated. An explanation as to the reason for the occurrence of individual outliers, must be attempted.5.2. Analytical methods for the determination of residuesAnalytical methods for the determination of residues must be submitted unless it is justified that the methods already submitted according to the requirements of Annex II, Section 4, point 4.2 can be applied.The same provisions as provided in Annex II, Section 4, point 4.2 apply.`


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31995L0064

Council directive 95/64/EC of 8 December 1995 on statistical returns in respect of carriage of goods and passengers by sea

Official Journal L 320 , 30/12/1995 P. 0025 - 0040

COUNCIL DIRECTIVE 95/64/ECof 8 December 1995on  statistical returns in respect of carriage of goods and passengers by seaTHE  COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 213  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 to carry out the tasks entrusted to it in the context of the common maritime transport  policy, the Commission must have at its disposal comparable, reliable, synchronized and regular  statistical data on the scale and development of the carriage of goods and passengers by sea to and  from the Community, between Member States and for domestic sea transport; Whereas it is also important for Member States and economic operators to have a good knowledge of  the maritime transport market; Whereas there are currently no comprehensive Community-wide statistics on the transport of goods  and passengers by sea; Whereas Council Decision 93/464/EEC of 22 July 1993 on the framework programme for priority actions  in the field of statistical information 1993 to 1997 (4) stressed the need to compile comprehensive  statistics; Whereas the collection of Community statistical data on a comparable or harmonized basis makes it  possible to establish an integrated system providing reliable, consistent and up-to-date  information; Whereas the data on the transport of goods and passengers by sea have to be made comparable between  Member States and between the different modes of transport; Whereas the Commission is to submit in due course a report reviewing the operation of this  Directive; Whereas provision should be made for a transitional period in order to enable Member States to  adapt their statistics systems to the requirements of this Directive and to initiate a programme of  pilot studies on specific problems posed by the collection of certain data; Whereas the Community should therefore, for the start-up period, make a financial contribution to  Member States in respect of the work involved; Whereas for the application of this Directive, including the arrangements to adapt it to economic  and technical developments, recourse should be had to the Statistical Programme Committee set up  pursuant to Council Decision 89/382/EEC, Euratom (5); Whereas, in accordance with the principle of subisidiarity, the creation of common statistical  standards enabling the production of harmonized information can only be tackled efficiently at  Community level; whereas data will be collected in each Member State under the authority of the  bodies and institutions in charge of compiling official statistics, HAS ADOPTED THIS DIRECTIVE: Article 1 Member States shall collect Community statistics on the carriage of  goods and passengers by seagoing vessels calling at ports in their territories. Article 2 DefinitionsFor the purposes of this Directive: 1. 'carriage of goods and passengers by sea' means the movement of goods and passengers using  seagoing vessels, on voyages which are undertaken wholly or partly at sea. The scope of this Directive shall also include goods: (a) shipped to offshore installations; (b) reclaimed from the seabed and unloaded in ports. Bunkers and stores supplied to vessels shall be excluded from the scope; 2. 'seagoing vessels' means vessels other than those which navigate exclusively in inland waters or  in waters within, or closely adjacent to, sheltered waters or areas where port regulations apply. This Directive shall not apply to fish-catching vessels, fish-processing vessels, vessels for  drilling and exploration, tugs, pusher craft, research and survey vessels, dredgers, naval vessels  or vessels used solely for non-commercial purposes; 3. 'port' means a place having facilities for merchant ships to moor and to load or unload cargo or  to disembark or embark passengers to or from vessels; 4. 'nationality of the maritime transport operator' means the country in which the effective centre  of the transport operator's commercial activity is located; 5. 'maritime transport operator' means any person by whom or on behalf of whom a contract for the  transport for goods or persons by sea is concluded with a shipper or a passenger. Article 3 Data collection characteristics1. Member States shall collect data relating to the  following domains: (a) cargo and passenger information; (b) information on the vessel. Vessels with a gross tonnage of less than 100 may be excluded from the data collection. 2. The characteristics of the data collection, namely the statistical variables in each domain and  the nomenclatures for their classification, as well as their periodicity of observation, are set  out in the Annexes to this Directive. 3. The data collection shall be based, in so far as possible, on available sources, limiting the  burden on respondents. Article 4 Ports1. For the purposes of this Directive, a list of ports, coded and classified  according to countries and maritime coastal areas, shall be drawn up in accordance with the  procedure specified in Article 13. 2. Each Member State shall select from this list any port handling mare than one million tonnes of  goods or recording more than 200 000 passenger movements annually. For a period of no more than tree years from the entry into force of this Directive, each Member  State may select only ports handling more than two million tonnes of goods or recording more than  400 000 passenger movements annually. For each port selected, detailed data are to be provided, in conformity with Annex VIII, for the  domains (goods and passengers) in which that port meets the selection criterion, and with summary  data, if appropriate, for the other domain. 3. For the ports which are not selected from the list, summary data are to be provided in  conformity with Annex VIII, data set A3. Article 5 Accuracy of statisticsThe methods of collecting data shall be such that Community sea  transport statistics display the precision required for the statistical data sets described in  Annex VIII. The standards of accuracy shall be drawn up in accordance with the procedure specified  in Article 13. Article 6 Processing of the results of the collection of dataMember States shall process the  statistical information collected pursuant to Article 3, in order to obtain comparable statistics,  with the standard of accuracy provided for in Article 5. Article 7 Transmission of the results of the collection of data1. Member States shall transmit  the results referred to in Article 3 to the Statistical Office of the European Communities,  including the data declared confidential by the Member States pursuant to domestic legislation or  practice concerning statistical confidentiality, in accordance with Council Regulation (Euratom,  EEC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical confidentiality  to the Statistical Office of the European Communities (1). 2. The results shall be transmitted in accordance with the structure of the statistical data sets  defined in Annex VIII. The technical details for transmission of the results will be specified in  accordance with the procedure laid down in Article 13. 3. The transmission of the results shall take place within five months of the end of the period of  observation for data of quarterly periodicity and within eight months for data of annual  periodicity. The first transmission shall cover the first quarter of 1997. Article 8 Reports1. Member States shall provide the Commission with all relevant information on  the methods used in compiling the data. They shall also forward details of substantial changes in  the methods used to collect the data. 2. After data have been collected over a period of three years, the Commission shall submit a  report to the Council on experience acquired in the work carried out pursuant to this Directive. Article 9 Dissemination of statistical dataThe Commission shall disseminate appropriate  statistical data with a periodicity comparable to that of the results transmitted. The arrangements for publication or dissemination of the statistical data by the Commission shall  be adopted according to the procedure specified in Article 13. Article 10 Transitional period1. During a transitional period of no more than three years,  derogations may, in accordance with the procedure specified in Article 13, be granted pursuant to  this Directive, in so far as the national statistical systems require major adaptation. 2. During the transitional period referred to in paragraph 1 a programme of pilot studies  concerning the following shall be adopted in accordance with the procedure specified in Article  13: (a) feasibility and the cost to Member States and the respondents of collecting the following items  of information: - description of the goods as defined in Annex III and in Annex VIII, data set B1, - passengers transported over short distances, - information concerning feeder services and transport chains, - data relating to the nationality of the maritime transport operator; (b) the possibility of collecting data under the arrangements concluded in the context of the  simplification of trade procedures, the International Standards Organization (ISO), the European  Committee for Standardization (CEN) and international customs rules. The Commission shall inform the Council of the outcome of the pilot studies and shall submit to it  proposals on the possibility of extending the system introduced by this Directive to set up a  regular collection of these items of information. Article 11 Financial contribution1. For the first three years in which the statistical returns  provided for in this Directive are made, Member States shall receive a financial contribution from  the Community towards the cost of the work involved. 2. The amount of the appropriations allocated annually for the financial contribution referred to  in paragraph 1 shall be fixed as part of the annual budgetary procedures. 3. The budget authority shall determine the appropriations available for each year. Article 12 Detailed rules of implementationThe detailed rules for implementing this Directive,  including measures for adapting it to economic and technical developments, and in particular: - adaptation of the data collection characteristics (Article 3) and of the content of the Annexes  to this Directive in so far as such adaptation does not involve a substantial increase in cost for  the Member States and/or the burden on respondents, - a list of ports, updated on a regular basis by the Commission, coded and classified by country  and maritime coastal area (Article 4), - accuracy requirement (Article 5), - the description of the composition of a data file and codes for transmission of the results to  the Commission (Article 7), - the arrangements for publication or dissemination of the data (Article 9), - derogations from the provisions of this Directive to be granted during the transitional period,  and the pilot studies scheduled (Article 10), - the equivalent nomenclature in gross tonnage per group of vessels (Annex VII), shall be laid down in accordance with the procedure specified in Article 13. Article 13 Procedure1. The Commission shall be assisted by the Statistical Programme Committee  set up by Decision 89/382/EEC, Euratom. 2. The Commission representative shall submit to the Committee a draft of the measures to be taken.  The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay  down according to the urgency of the matter in question. The opinion shall be delivered by the  majority laid down in Article 148 (2) of the Treaty for the adoption of decisions which the Council  is required to take on a proposal from the Commission. When votes are taken by the Committee, the  votes of the representatives of the Member States shall be weighted as laid down in the above  Article. The chairman shall not vote. 3. (a) The Commission shall adopt the measures, which shall apply immediately. (b) However, if these measures are not in accordance with the opinion of the Committee, they shall  be communicated by the Commission to the Council forthwith. In that event: - the Commission shall defer application of the measures which it has decided for a period of three  months from the date of such communication, - the Council, acting by a qualified majority, may take a different decision within the time limit  referred to in the previous indent. Article 14 Implementation1. The Member States shall adopt the laws, regulations and  administrative provisions necessary to comply with this Directive by 1 January 1997 at the latest.  They shall immediately inform the Commission thereof. The provisions adopted by the Member States shall contain a reference to this Directive or be  accompanied by such a reference when published officially. The procedure for making this reference  shall be laid down by the Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic  law which they adopt in the field governed by the Directive. Article 15 This Directive shall enter into force on the 20th day following its publication in the  Official Journal of the European Communities. Article 16 This Directive is addressed to the Member States. Done at Brussels, 8 December 1995. For the CouncilThe PresidentJ. BORRELL FONTELLES(1) OJ No C 214, 4. 8. 1994,  p. 12. (2) OJ No C 151, 19. 6. 1995, p. 493. (3) OJ No C 397, 31. 12. 1994, p. 6. (4) OJ No L 219, 28. 8. 1993, p. 1. (5) OJ No L 181, 28. 6. 1989, p. 47. (1) OJ No L 151, 15. 6. 1990, p. 1.  ANNEX I VARIABLES AND DEFINITIONS 1. STATISTICAL VARIABLES(a) Cargo and passenger  information: - gross weight of goods in tonnes, - type of cargo, according to the nomenclature shown in Annex II, - description of the goods, using the nomenclature shown in Annex III, - reporting port, - direction of movement, whether inwards or outwards, - for inward cargo: the port of loading (i. e. the port in which the cargo was loaded on to the  ship in which it arrived in the reporting port) using individual ports in the European Economic  Area (EEA) shown in the port list, and the maritime coastal areas outside the EEA, shown in Annex  IV, - for outward cargo: the port of unloading (i. e. the port in which the cargo is to be unloaded  from the ship in which it left the reporting port) using individual ports in the EEA shown in the  port list, and the maritime coastal areas outside the EEA, shown in Annex IV, - number of passengers starting or finishing a voyage. For goods carried in containers or ro-ro units, the following additional particulars shall be  provided: - number of containers with cargo, - number of containers without cargo, - number of mobile (ro-ro) units with cargo, - number of mobile (ro-ro) units without cargo. (b) Information on the vessel: - number of vessels, - deadweight of vessels or gross tonnage, - country or territory of registration of vessels, using the nomenclature shown in Annex V, - type of vessels, using the nomenclature shown in Annex VI, - size of vessels, using the nomenclature shown in Annex VII. 2. DEFINITIONS(a) 'Freight container' means an article of transport equipment: 1. of a permanent nature and accordingly strong enough to be suitable for repeated use; 2. specially designed to facilitate the carriage of goods by one or more modes of transport,  without intermediate reloading; 3. fitted with devices permitting its ready handling, particularly its transfer from one mode of  transport to another; 4. so designed as to be easy to fill and empty; 5. having a length of 20′ or more. (b) 'Ro-ro unit' means wheeled equipment for carrying cargo, such as a truck, trailer or  semi-trailer, which can be driven or towed on to a vessel. Port or ships' trailers are included in  this definition. Classifications should follow United Nations ECE Recommendation No 21 'Codes for  types of cargo, packages and packaging materials'. (c) 'Container cargo' means containers with or without cargo which are lifted on or off the vessels  which carry them by sea. (d) 'Ro-ro cargo' means goods, whether or not in containers, on ro-ro units, and ro-ro units which  are rolled on and off the vessels which carry them by sea. (e) 'Gross weight of goods' means the tonnage of goods carried, including packaging but excluding  the tare weight of containers or ro-ro units. (f) 'Deadweight (DWT)' means the difference in tonnes between the displacement of a ship on summer  load-line in water with a specific gravity of 1,025 and the total weight of the ship, i. e. the  displacement in tonnes of a ship without cargo, fuel, lubricating oil, ballast water, fresh water  and drinking water in the tanks, usable supplies as well as passengers, crew and their  possessions. (g) 'Gross tonnage' means the measure of the overall size of a ship determined in accordance with  the provisions of the International Convention on Tonnage Measurement of Ships, 1969.  ANNEX II TYPE OF CARGO CLASSIFICATION >TABLE> ANNEX III GOODS NOMENCLATURE The goods nomenclature used will conform to the NST/R (1)  until the Commission, having consulted the Member States, decides to replace it. GROUPS OF GOODS>TABLE> ANNEX IV MARITIME COASTAL AREAS The nomenclature to be used is the Geonomenclature,  approved for 1993 by Commission Regulation (EEC) No 208/93 of 1 February 1993 on the country  nomenclature for the external trade statistics of the Community and statistics of trade between  Member States (1), with the following exception: codes 017 and 018 are to be used for Belgium and  Luxembourg respectively whenever they are to be considered separately. The code consists of four digits: the three-digit code from the abovementioned nomenclature,  followed by a zero (e.g. code 0030 for Netherlands), except for countries which are divided into  two or more maritime coastal areas, which are identified by a fourth digit other than zero (from 1  to 7), as below: >TABLE>(1) OJ No L 25, 2. 2. 1993, p. 11.  ANNEX V NATIONALITY OF REGISTRATION OF VESSELS The nomenclature to be used is the  Geonomenclature, approved for 1993 by Commission Regulation (EEC) No 208/93 of 1 February 1993 on  the country nomenclature for the external trade statistics of the Community and statistics of trade  between Member States (1) with the following exception: codes 017 and 018 are to be used for  Belgium and Luxembourg respectively whenever they are to be considered separately. The code consists of four digits: the three-digit code from the abovementioned nomenclature,  followed by a zero (e. g. code 0010 for France), except for countries with more than one register. Where more than one register exists, the countries are to be coded as follows: >TABLE>(1) OJ No L 25, 2. 2. 1993, p. 11.  ANNEX VI TYPE OF SHIP CLASSIFICATION (ICST-COM) >TABLE> ANNEX VII VESSEL SIZE CLASSES in deadweight (DWT) or in gross tonnage (GT)This  classification applies only to vessels with a gross tonnage of 100 or more. >TABLE> ANNEX VIII STRUCTURE FOR STATISTICAL DATA SETS The data sets specified in this Annex  define the periodicity for the maritime transport statistics required by the Community. Each data  set defines a cross classification of a limited set of dimensions at different levels of the  nomenclatures, aggregated across all other dimensions, for which statistics of good quality are  required. The conditions for collecting data set B1 will be decided by the Council on a proposal from the  Commission in the light of the results of the pilot study during a three-year transitional period  as defined in Article 10 of this Directive. SUMMARY AND DETAILED STATISTICS* The data sets to be provided for selected ports for goods and  passengers are A1, A2, B1, C1, D1, E1 and F1. * The data sets to be provided for selected ports for goods but not for passengers are A1, A2, A3,  B1, C1, E1 and F1. * The data sets to be provided for selected ports for passengers but not for goods are A3, D1 and  F1. * The data set to be provided for ports which are not selected is A3. >TABLE>>TABLE>>TABLE>>TABLE>>TABLE>>TABLE  POSITION>>TABLE>>TABLE>


title: Directive 2008/24/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2006/48/EC relating to the taking up and pursuit of the business of credit institutions, as regards the implementing powers conferred on the Commission (Text with EEA relevance)

text:
               20.3.2008

               EN

               Official Journal of the European Union

               L 81/38

      DIRECTIVE 2008/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 11 March 2008
   amending Directive 2006/48/EC relating to the taking up and pursuit of the business of credit institutions, as regards the implementing powers conferred on the Commission
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular the first and third sentences of Article 47(2) thereof,
   Having regard to the proposal of the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Having regard to the opinion of the European Central Bank (2),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
   Whereas:

               (1)

               Directive 2006/48/EC of the European Parliament and of the Council (4) 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 (5).

               (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 (6) 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 technical adjustments and implementing measures to take account, inter alia, of technical developments in financial markets and to ensure the uniform application of Directive 2006/48/EC. Those measures are designed to specify definitions, modify the scope of exemptions and elaborate or supplement the provisions of that Directive through technical adaptations related to the determination of own funds and the organisation, calculation and evaluation of risks and exposures. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2006/48/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 2006/48/EC provides for a time restriction concerning the implementing powers conferred on the Commission. In their statement concerning Decision 2006/512/EC, the European Parliament, the Council and the Commission stated that Decision 2006/512/EC provides a horizontal and satisfactory solution to the European Parliament’s wish to scrutinise the implementation of instruments adopted under the co-decision procedure and that, accordingly, implementing powers should be conferred on the Commission without time limit. The European Parliament and the Council also declared that they would ensure that the proposals aimed at repealing the provisions in the instruments that provide for a time limit on the delegation of implementing powers to the Commission are adopted as rapidly as possible. Following the introduction of the regulatory procedure with scrutiny, the provision establishing that time restriction in Directive 2006/48/EC should be deleted.

               (6)

               The Commission should, at regular intervals, evaluate the functioning of the provisions concerning the implementing powers conferred on it in order to allow the European Parliament and the Council to determine whether the extent of those powers and the procedural requirements imposed on the Commission are appropriate and ensure both efficiency and democratic accountability.

               (7)

               Directive 2006/48/EC should therefore be amended accordingly.

               (8)

               Since the amendments made to Directive 2006/48/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 2006/48/EC is hereby amended as follows:

               1.

               Article 150 shall be amended as follows:

                           (a)

                           in paragraph 1, the introductory wording shall be replaced by the following:
                           ‘1.   Without prejudice, as regards own funds, to the proposal that the Commission is to submit pursuant to Article 62, the technical adjustments designed to amend non-essential elements of this Directive in the following areas shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 151(2):’;

                           (b)

                           paragraph 2 shall be amended as follows:

                                       (i)

                                       in the introductory wording, the words ‘in accordance with the procedure referred to in Article 151(2)’ shall be deleted;

                                       (ii)

                                       the following subparagraph shall be added:
                                       ‘The measures referred to in points (a), (b), (c) and (f), 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 151(2). The measures referred to in points (d) and (e) shall be adopted in accordance with the regulatory procedure referred to in Article 151(2a).’;

                           (c)

                           paragraphs 3 and 4 shall be deleted;

               2.

               Article 151 shall be amended as follows:

                           (a)

                           paragraph 2 shall be replaced by the following:
                           ‘2.   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.’;

                           (b)

                           the following paragraph shall be inserted:
                           ‘2a.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
                           The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.’;

                           (c)

                           paragraph 3 shall be replaced by the following:
                           ‘3.   By 31 December 2010, and, thereafter, at least every three years, the Commission shall review the provisions concerning its implementing powers and present a report to the European Parliament and to the Council on the functioning of those powers. This report shall examine, in particular, the need for the Commission to propose amendments to this Directive in order to ensure the appropriate scope of the implementing powers conferred on the Commission. The conclusion as to whether or not amendment is necessary shall be accompanied by a detailed statement of reasons. If necessary, the report shall be accompanied by a legislative proposal to amend the provisions conferring implementing powers on the Commission.’

         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)  OJ C 39, 23.2.2007, p. 1.

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

      (4)  OJ L 177, 30.6.2006, p. 1. Directive as last amended by Directive 2007/64/EC (OJ L 319, 5.12.2007, p. 1).

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

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


title: Directive 2012/11/EU of the European Parliament and of the Council of 19 April 2012 amending Directive 2004/40/EC on minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)

text:
               24.4.2012

               EN

               Official Journal of the European Union

               L 110/1

         DIRECTIVE 2012/11/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
   of 19 April 2012
   amending Directive 2004/40/EC on minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 153(2) thereof,
   Having regard to the proposal from the European Commission,
   After transmission of the draft legislative act to the national parliaments,
   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 ordinary legislative procedure (2),
   Whereas:

               (1)

               Following the entry into force of Directive 2004/40/EC of the European Parliament and of the Council (3), stakeholders, in particular those in the medical community, expressed serious concerns about the impact that implementing that Directive could have on the use of medical procedures based on medical imaging, as well as its impact on certain industrial activities.

               (2)

               The Commission examined the arguments put forward by stakeholders and decided to reconsider some provisions of Directive 2004/40/EC, on the basis of new scientific evidence.

               (3)

               The deadline for transposition of Directive 2004/40/EC was postponed, by Directive 2008/46/EC of the European Parliament and of the Council (4), until 30 April 2012, in order to allow a new Directive based on the most recent evidence to be adopted by that date.

               (4)

               On 14 June 2011, the Commission adopted a proposal for a new Directive to replace Directive 2004/40/EC. The aim of the new Directive is to ensure both a high level of health and safety protection for workers and the continuation and development of medical and other industrial activities using electromagnetic fields. Consequently, anticipating the adoption of the new Directive by 30 April 2012, the majority of Member States have not transposed Directive 2004/40/EC.

               (5)

               However, given the technical complexity of the subject matter, it is unlikely that the new Directive will be adopted by 30 April 2012.

               (6)

               Consequently, the deadline of 30 April 2012 should be extended. It is therefore necessary for this Directive to enter into force on the day of its publication,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   In Article 13(1) of Directive 2004/40/EC, the date ‘30 April 2012’ is replaced by ‘31 October 2013’.
   Article 2
   This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.
   Article 3
   This Directive is addressed to the Member States.

      Done at Strasbourg, 19 April 2012.

            For the European Parliament

            The President

         M. SCHULZ

            For the Council

            The President

         M. BØDSKOV

      (1)  Opinion of 22 February 2012 (not yet published in the Official Journal).

      (2)  Position of the European Parliament of 29 March 2012 (not yet published in the Official Journal) and decision of the Council of 11 April 2012.

      (3)  OJ L 159, 30.4.2004, p. 1.

      (4)  OJ L 114, 26.4.2008, p. 88.