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31985L0433

Council Directive 85/433/EEC of 16 September 1985 concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the right of establishment relating to certain activities in the field of pharmacy

Official Journal L 253 , 24/09/1985 P. 0037 - 0042 Finnish special edition: Chapter 16 Volume 1 P. 0082  Spanish special edition: Chapter 06 Volume 3 P. 0028  Swedish special edition: Chapter 16 Volume 1 P. 0082  Portuguese special edition Chapter 06 Volume 3 P. 0028

*****COUNCIL  DIRECTIVE  of 16 September 1985  concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the right of establishment relating to certain activities in the field of pharmacy  (85/433/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 49 and 57 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, pursuant to the Treaty, all discriminatory treatment based on nationality with regard to establishment and provision of services is prohibited as from the end of the transitional period; whereas the principle of such treatment based on nationality applies, in particular, to the grant of any authorization required for the practice of certain activities, and also to registration with or membership of professional organizations or bodies;  Whereas it nevertheless seems desirable that certain provisions be introduced to facilitate the effective exercise of the right of establishment;  Whereas, pursuant to Article 54 (3) (h) of the Treaty, the Member States are required not to grant any form of aid likely to distort the conditions of establishment;  Whereas Article 57 (1) of the Treaty provides that Directives be adopted for mutual recognition of diplomas, certificates and other evidence of formal qualifications;  Whereas, in view of the present disparities in training in pharmacy given in the Member States, it is necessary to lay down certain coordinating provisions to enable the Member States to introduce mutual recognition of diplomas, certificates and other evidence of formal qualifications; whereas such coordination has been established by Council Directive 85/432/EEC of 16 September 1985, concerning the coordination of provisions laid down by law, regulation or administrative action in respect of certain activities in the field of pharmacy (4);  Whereas in certain Member States access to certain activities in the field of pharmacy is, apart from the award of the relevant diploma, certificate or other formal qualification, subject to the requirement of additional professional experience; whereas, since there is as yet no convergence of views among the Member States on this point, it is advisable, in order to obviate any difficulties, to recognize as a sufficient condition appropriate practical experience of equal duration acquired in another Member State;  Whereas, under their national policies in the sphere of public health, which seek inter alia to ensure the satisfactory dispensing of medicinal products over their entire territories, certain Member States restrict the number of new pharmacies that may be established, while others have adopted no such provisions; whereas in these circumstances it is premature to provide that the effects of the recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy must also extend to the pursuit of the activities of pharmacist as the controller of a pharmacy open to the public for less than three years; whereas this problem must be re-examined by the Commission and the Council within a certain period;  Whereas, with regard to the possession of a formal certificate of training, since a Directive on the mutual recognition of diplomas does not necessarily imply equivalence in the training covered by such diplomas, the use of such qualifications should be authorized only in the language of the Member State of origin or of the Member State from which the foreign national comes;  Whereas, to facilitate the application of this Directive by the national authorities, Member States may prescribe that, in addition to formal certificates of training, the person who satisfies the conditions of training required by this Directive must provide a certificate from the competent authorities of his country of origin or of the country from which he comes stating that these certificates of training are those covered by the Directive;  Whereas this Directive does not affect the provisions laid down by law, regulation or administrative action in the Member States which prohibit companies from practising certain activities or impose on them certain conditions for such practice;  Whereas it is difficult to assess the extent to which rules aimed at facilitating freedom of pharmacists to provide services could at present be appropriate; whereas, in these circumstances, it is not advisable to adopt such rules for the time being;  Whereas, with regard to good character and good repute, a distinction should be drawn between the requirements to be satisfied on first taking up the profession and those to be satisfied in order to practise it;  Whereas, as far as the activities of employed persons are concerned, Council Regulation (EEC) No 1612/68 of 15 October 1968 on freedom of movement for workers within the Community (1) lays down no specific provisions relating to good character or good repute, professional discipline or use of title for the professions covered; whereas, depending on the individual Member State, such rules are or may be applicable both to employed and self-employed persons; whereas the activities subject in the Member States to possession of a diploma, certificate or other evidence of formal qualification in pharmacy are pursued by both employed and self-employed persons, or by the same persons in both capacities in the course of their professional career; whereas, in order to encourage as far as possible the free movement of those professional persons within the Community, it therefore appears necessary to extend the application of this Directive to employed persons.  HAS ADOPTED THIS DIRECTIVE:  CHAPTER I  Scope  Article 1  This Directive applies to activities, the access to and pursuit of which is subject to conditions of professional qualification in one or more Member States, and which are open to holders of one of the diplomas, certificates or other formal qualifications in pharmacy referred to in Article 4.  CHAPTER II  Diplomas, certificates and other evidence of formal qualifications in pharmacy  Article 2  1. Each Member State shall recognize the diplomas, certificates and other formal qualifications listed in Article 4 awarded to nationals of Member States by other Member States in accordance with Article 2 of Directive 85/432/EEC by giving such qualifications, as regards the right of access to and pursuit of the activities referred to in Article 1, the same effect in its territory as those diplomas, certificates and other formal qualifications, listed in Article 4, which it itself awards.  2. However, Member States need not give effect to the diplomas, certificates and other formal certificates referred to in paragraph 1 with respect to the establishment of new pharmacies open to the public. For the purposes of applying this Directive, pharmacies which have been in operation for less than three years shall also be regarded as new.  Five years after the date stipulated in Article 19 (1), the Commission shall submit a report to the Council on the way in which Member States have implemented the preceding subparagraph and on the possibility of extending the effects of mutual recognition of the diplomas, certificates and other formal certificates referred to in paragraph 1. It shall make any appropriate proposals.  Article 3  1. By way of derogation from Article 2 and without prejudice to Article 45 of the 1979 Act of Accession, the Hellenic Republic shall not be required to give effect as laid down in Article 2 to the diplomas, certificates and other formal qualifications awarded by other Member States except in the case of the pursuit as an employed person in accordance with Regulation (EEC) No 1612/68 of the activities referred to in Article 1.  As long as the Hellenic Republic makes use of this derogation and without prejudice to Article 45 of the 1979 Act of Accession, the other Member States shall not be required to give effect as provided for in Article 2 to the certificates referred to in Article 4 (d) except in the case of the pursuit as an employed person in accordance with Regulation (EEC) No 1612/68 of the activities referred to in Article 1.  2. Ten years after the date stipulated in Article 19, the Commission shall submit to the Council appropriate proposals in order to extend the effects of mutual recognition of diplomas, certificates and other formal qualifications with a view to facilitating the effective exercise of the right of establishment between the Hellenic Republic and the other Member States. The Council shall act on these proposals in accordance with the procedure laid down in the EEC Treaty.  Article 4  The diplomas, certificates and other evidence of formal qualifications referred to in Article 2 are the following:  (a) in Belgium:  Le diplôme légal de pharmacien/het wettelijk diploma van apoteker (the legal diploma in pharmacy) awarded by the faculties of medicine and pharmacy of the Universities, by the Central examining board or by the State examining boards for university education;  (b) in Denmark:  Bevis for bestaaet farmaceutisk kandidateksamen (the university pharmacy certificate);  (c) in the Federal Republic of Germany:  (1) Zeugnis ueber die staatliche Pharmazeutische Pruefung (the State examination certificate in pharmacy) awarded by the competent authorities;  (2) Certificates from the competent authorities the Federal Republic of Germany stating that the diplomas awarded after 8 May 1945 by the competent authorities of the German Democratic Republic are recognized as equivalent to those referred to in point 1 above;  (d) in Greece:  Piatopoiitikó ton armodíon archón, ikanótitas áskisis tis farmakeftikís, chorigoýmeno metá kratikí exétasi (the certificate attesting competence to pursue the activity of a pharmacist) issued by the competent authorities following a State examination;  (e) in France:  The State diploma in pharmacy awarded by the universities or the State diploma of Doctor in Pharmacy awarded by the universities;  (f) in Ireland:  The certificate of Registered Pharmaceutical Chemist;  (g) in Italy:  The diploma or certificate giving the right to practise pharmacy, obtained by passing a State examination;  (h) in Luxembourg:  The State pharmacy diploma awarded by the State Examining Board and signed by the National Minister of Education;  (i) in the Netherlands:  Het getuigschrift van met goed gevolg afgelegd apothekersexamen (the university pharmacy certificate);  (j) in the United Kingdom:  The certificate of Registered Pharmaceutical Chemist.  Article 5  Where, in a Member State, access to or pursuit of one of the activities referred to in Article 1 is subject not only to the possession of a diploma, certificate or other formal qualification mentioned in Article 4 but also to the requirement of additional professional experience, that State shall accept as sufficient evidence in this respect a certificate issued by the competent authorities of the person's Member State of origin or of the Member State from which he comes, attesting that he has pursued the said activities for an equivalent period in his Member State of origin or in the Member State from which he comes.  However, such recognition shall not apply with regard to the two-year period of professional experience required by the Grand Duchy of Luxembourg for the grant of a State public pharmacy concession.  CHAPTER III  Established rights  Article 6  Diplomas, certificates and other university or equivalent qualifications in pharmacy which were awarded to nationals of Member States by Member States and which do not satisfy all the minimum training requirements laid down in Article 2 of Directive 85/432/EEC shall be treated as diplomas satisfying these requirements if:  - they are evidence of training which was completed before the implementation of the said Directive,  or  - they are evidence of training which was completed after but which was commenced before the implementation of the said Directive,  and, in each case, if:  - they are accompanied by a certificate stating that their holders have been effectively and lawfully engaged in one of the activities referred to in Article 1 (2) of Directive 85/432/EEC in a Member State for at least three consecutive years during the five years preceding the award of the certificate, provided that this activity is regulated in that State. CHAPTER IV  Use of academic title  Article 7  1. Without prejudice to Article 14, host Member States shall ensure that nationals of Member States who fulfil the conditions laid down in Articles 2, 5 and 6 have the right to use the lawful academic title and, where appropriate, the abbreviation thereof, of their Member State of origin or of the Member State from which they come, in the language of that State. Host Member States may require this title to be followed by the name and location of the establishment or examining board which awarded it.  2. If the academic title used in the Member State of origin, or in the Member State from which a foreign national comes, can be confused in the host Member State with a title requiring in that State additional training which the person concerned has not undergone, the host Member State may require such a person to use the title employed in the Member State of origin or the Member State from which he comes in suitable wording to be indicated by the host Member State.  CHAPTER V  Provisions to facilitate the effective exercise of the right of establishment  Article 8  1. A host Member State which requires of its nationals proof of good character or good repute when they take up for the first time any of the activities referred to in Article 1 shall accept as sufficient evidence, in respect of nationals of other Member States, a certificate issued by a competent authority in the Member State of origin or in the Member State from which the foreign national comes, attesting that the requirements of the Member State as to good character or good repute for taking up the activity in question have been met.  2. Where the Member State of origin or the Member State from which the foreign national comes does not require proof of good character or good repute of persons wishing to take up the activity in question for the first time, the host Member State may require of nationals of the Member State of origin or of the Member State from which the foreign national comes an extract from the judicial record or, failing this, an equivalent document issued by a competent authority in the Member State of origin or the Member State from which the foreign national comes.  3. If the host Member State has detailed knowledge of a serious matter which, prior to the establishment in that State of the person in question, has occurred outside its territory and is likely to affect the taking up within its territory of the activity concerned, it may inform the Member State of origin or the Member State from which the foreign national comes.  The Member State of origin or the Member State from which the foreign national comes shall verify the accuracy of the facts if they are likely to affect the taking up of the activity in question in that Member State. The authorities in that State shall decide on the nature and extent of the investigations to be made and shall inform the host Member State of any consequential action which they take with regard to the certificates or documents they have issued.  4. Member States shall ensure the confidentiality of the information which is forwarded.  Article 9  1. Where, in a host Member State, provisions laid down by law, regulation or adminsitrative action are in force laying down requirements as to good character or good repute, including provisions for disciplinary action in respect of serious professional misconduct or conviction for criminal offences and relating to the pursuit of any of the activities referred to in Article 1, the Member State of origin or the Member State from which the foreign national comes shall forward to the host Member State all necessary information regarding measures or disciplinary action of a professional or administrative nature taken in respect of the person concerned, or criminal penalties imposed on him when pursuing his profession in the Member State of origin or in the Member State from which he came.  2. If the host Member State has detailed knowledge of a serious matter which, prior to the establishment in that State of the person in question, has occurred outside its territory and is likely to affect the pursuit within its territory of the activity concerned, it may inform the Member State of origin or the Member State from which the foreign national comes.  The Member State of origin or the Member State from which the foreign national comes shall verify the accuracy of the facts if they are likely to affect in that Member State the pursuit of the activity in question. The authorities in that State shall decide on the nature and extent of the investigations to be made and shall inform the host Member State of any consequential action which they take with regard to the information they have forwarded in accordance with paragraph 1.  3. Member States shall ensure the confidentiality of the information which is forwarded. Article 10  Where a host Member State requires of its own nationals wishing to take up or pursue any of the activities referred to in Article 1, a certificate of physical or mental health, that State shall accept as sufficient evidence thereof the presentation of the document required in the Member State of origin or in the Member State from which the foreign national comes.  Where the Member State of origin or the Member State from which the foreign national comes does not impose any requirements of this nature on those wishing to take up or pursue the activity in question, the host Member State shall accept from such nationals a certificate issued by a competent authority in that State corresponding to the certificates issued in the host Member State.  Article 11  The documents referred to in Articles 8, 9 and 10 may not be presented more than three months after their date of issue.  Article 12  1. The procedure for authorizing the person concerned to take up any of the activities referred to in Article 1, pursuant to Articles 8, 9 and 10, must be completed as soon as possible and not later than three months after submission of all the documents relating to such person, without prejudice to delays resulting from any appeal that may be made upon the completion of this procedure.  2. In the cases referred to in Articles 8 (3) and 9 (2), a request for re-examination shall suspend the period stipulated in paragraph 1.  When consulted, the Member State of origin or the Member State from which the foreign national comes shall give its reply within three months.  On receipt of the reply or at the end of that period, the host Member State shall continue with the procedure referred to in paragraph 1.  Article 13  Where a host Member State requires its own nationals wishing to take up or pursue one of the activities referred to in Article 1 to take an oath or make a solemn declaration and where the form of such oath or declaration cannot be used by nationals of other Member States, that Member State shall ensure that an appropriate and equivalent form of oath or declaration is offered to the persons concerned.  Article 14  Where in a host Member State, the use of the professional title relating to one of the activities referred to in Article 1 is regulated, nationals of Member States who fulfil the conditions of professional qualification laid down in Articles 2, 5 and 6 shall be entitled to the professional title of the host Member State which in that State corresponds to those conditions, and shall use the abbreviation thereof.  Article 15  1. Member States shall take the necessary measures to enable the persons concerned to obtain information on the health and social security laws and, where applicable, on the professional ethics of the host Member State.  For this purpose, Member States may set up information centres from which such persons may obtain the necessary information. The host Member States may require the persons concerned to contact these centres.  2. Member States may set up the centres referred to in paragraph 1 under the aegis of the competent authorities and bodies which they shall designate within the period laid down in Article 19 (1).  3. Member States shall see to it that, where appropriate, the persons concerned acquire, in their own interest and in that of their customers, the linguistic knowledge necessary for the practice of their profession in the host Member State.  CHAPTER VI  Final provisions  Article 16  In the event of justified doubts, the host Member State may require of the competent authorities of another Member State confirmation of the authenticity of the diplomas, certificates and other formal qualifications issued in that other Member State and referred to in Chapters II and III, and also confirmation of the fact that the person concerned has fulfilled all the training requirements laid down in Directive 85/432/EEC.  Article 17  Within the time limit laid down inArticle 19 (1), Member States shall designate the authorities and bodies competent to issue or receive the diplomas, certificates and other formal qualifications as well as the documents and information referred to in this Directive and shall forthwith inform the other Member States and the Commission thereof.  Article 18  This Directive shall also apply to nationals of Member States who, in accordance with Regulation (EEC) No 1612/68, are pursuing or will pursue as employed persons one of the activities referred to in Article 1. Article 19  1. Member States shall bring into force the measures necessary to comply with this Directive before 1 October 1987. They shall forthwith inform the Commission thereof.  2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.  Article 20  Where a Member State encounters major difficulties in certain fields when applying this Directive, the Commission shall examine these difficulties in conjunction with that State and shall request the opinion of the Pharmaceutical Committee set up under Decision 75/320/EEC (1).  Where necessary, the Commission shall submit appropriate proposals to the Council.  Article 21  This Directive is addressed to the Member States.  Done at Luxembourg, 16 September 1985.  For the Council  The President  M. FISCHBACH  (1) OJ No C 35, 18. 2. 1981, p. 6 and OJ No C 40, 18. 2. 1984, p. 4.  (2) OJ No C 277, 17. 10. 1983, p. 160.  (3) OJ No C 230, 10. 9. 1981, p. 10.  (4) See page 34 of this Official Journal.  (1) OJ No L 257, 19. 10. 1968, p. 2.  (1) OJ No L 147, 9. 6. 1975, p. 23.


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32000L0008R(01)

Corrigendum to Directive 2000/8/EC of the European Parliament and of the Council of 20 March 2000 amending Council Directive 70/221/EEC on the approximation of the laws of the Member States relating to liquid fuel tanks and rear underrun protection of motor vehicles and their trailers (OJ L 106 of 3.5.2000)

Official Journal L 064 , 06/03/2001 P. 0039 - 0039

Corrigendum to Directive 2000/8/EC of the European Parliament and of the Council of 20 March 2000 amending Council Directive 70/221/EEC on the approximation of the laws of the Member States relating to liquid fuel tanks and rear underrun protection of motor vehicles and their trailers(Official Journal of the European Communities L 106 of 3 May 2000)On page 7, recital 7:for: "... granted under Directive 74/60/EEC (6) ...",read: "... granted under Directive 70/221/EEC ...",and delete the corresponding footnote.On page 14, in the Annex, first line of point 6.3.5.6:for: "... by a screen placed 2 cm +- 1 cm above the fuel level.",read: "... by a screen placed 3 cm +- 1 cm above the fuel level."


title: COMMISSION DIRECTIVE (EU) .../… supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use

text:
               COMMISSION DIRECTIVE (EU) .../…

               of 15.9.2017

               supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
                  1
               , and in particular the first paragraph of Article 47 thereof,

               Whereas:

               (1)Commission Directive 2003/94 EC
                  2
                applies to both medicinal products for human use and investigational medicinal products for human use.

               (2)In accordance with Article 63(1) of Regulation (EU) No 536/2014 of the European Parliament and of the Council
                  3
                the Commission is empowered to adopt a delegated act laying down principles of good manufacturing practice for investigational medicinal products for human use. It is therefore necessary to adapt the provisions of Directive 2003/94/EC by deleting the references to investigational medicinal products for human use.

               (3)The definition of a pharmaceutical quality system and some terminology should be updated to reflect the international developments or the actual usage of that terminology of inspectors and manufacturers.

               (4)All medicinal products for human use manufactured or imported into the Union, including medicinal products intended for export, should be manufactured in accordance with the principles and guidelines of good manufacturing practice. However, for the manufacturer to be able to comply with those principles and guidelines, cooperation between the manufacturer and the marketing authorisation holder, when they are different legal entities, is necessary. The obligations of the manufacturer and marketing authorisation holder vis-à-vis each other should be defined in a technical agreement between them.

               (5)The manufacturer of medicinal products has to ensure that they are fit for their intended use, comply with the requirements of the marketing authorisation and do not place patients at risk due to inadequate quality. To achieve this quality objective reliably the manufacturer must implement a comprehensively designed and correctly implemented pharmaceutical quality system incorporating good manufacturing practice and quality risk management.

               (6)In order to ensure conformity with the principles and guidelines of good manufacturing practice, it is necessary to lay down detailed provisions on inspections by the competent authorities and on certain obligations of manufacturer.

               (7)It is necessary to ensure that all medicinal products available on the EU territory comply with the same quality standards, therefore medicinal products imported into the Union should be manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down in the Union.

               (8)In order to ensure the consistent application of the principles of good manufacturing practice, manufacturers of medicinal products for human use and inspectors should consider the guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC. However, for advanced therapy medicinal products, the guideline referred in Article 5 of Regulation (EU) No 1394/2007
                  4
                should be applied. Principles and guidelines of good manufacturing practice for medicinal products for human use should be set out in relation to quality management, personnel, premises and equipment, documentation, production, quality control, outsourced operations, complaints, product recall, and self-inspections. As regards the advanced therapy medicinal products those principles and guidelines should be adapted to the specific characteristic of those products in accordance with the risk-based approach.

               (9)Since many of the provisions of Directive 2003/94/EC need to be adjusted, for the sake of clarity, that Directive should be repealed.

               (10)The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1
                  Subject-matter

               This Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use whose manufacture or import requires the authorisation referred to in Article 40 of Directive 2001/83/EC.

               Article 2
                  Definitions

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

               (1)'manufacturer' means any person engaged in activities for which the authorisation referred to in Article 40(1) and (3) of Directive 2001/83/EC is required;

               (2)'pharmaceutical quality system' means the total sum of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use;

               (3)'good manufacturing practice' means the part of the quality assurance which ensures that medicinal products are consistently produced, imported and controlled in accordance with the quality standards appropriate to their intended use.

               Article 3
                  Inspections

               1.By means of the repeated inspections referred to in Article 111(1a) of Directive 2001/83/EC, the Member States shall ensure that manufacturers authorised in accordance with Article 40(1) and (3) of Directive 2001/83/EC respect the principles and guidelines of good manufacturing practice laid down by this Directive.

               Member States shall also take into account the compilation, published by the Commission, of Union procedures on inspections and exchange of information.

               2.For the interpretation of the principles and guidelines of good manufacturing practice, manufacturers and the competent authorities shall take into account the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC. In the case of advanced therapy medicinal products, the guidelines on good manufacturing practice specific to advanced therapy medicinal products referred to in Article 5 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products shall be taken into account.

               3.Member States shall establish and implement in their inspectorates a properly designed quality system that shall be complied with by inspectorates' personnel and management. The quality system shall be updated as appropriate.

               Article 4
                  Conformity with good manufacturing practice

               1.The Member States shall ensure that the manufacturing operations are carried out by manufacturers in accordance with good manufacturing practice and with the manufacturing authorisation. This provision shall also apply to medicinal products intended only for export.

               2.For medicinal products imported from third countries, the Member States shall ensure that the products have been manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down in the Union and that such products have been manufactured by manufacturers duly authorised to do so.

               Article 5
                  Compliance with marketing authorisation

               1.The Member States shall ensure that all manufacturing or import operations for medicinal products subject to a marketing authorisation are carried out by manufacturers in accordance with the information provided in the application for that marketing authorisation.

               2.The Member States shall oblige the manufacturer to regularly review his manufacturing methods in light of scientific and technical progress.

               If a variation to the marketing authorisation dossier is necessary, the variation shall take place by the arrangements established in accordance with Article 23b of Directive 2001/83/EC.

               Article 6
                  Pharmaceutical quality system

               The Member States shall ensure that the manufacturers establish, implement and maintain an effective pharmaceutical quality system, involving the active participation of the senior management and the personnel of the different departments.

               Article 7
                  Personnel

               1.The manufacturer shall be obliged to have at each manufacturing or import site a sufficient number of competent and appropriately qualified personnel at his disposal to achieve the objective of the pharmaceutical quality system.

               2.The duties of the managerial and supervisory staff, including the qualified persons referred to in Article 48 of Directive 2001/83/EC, responsible for implementing and operating good manufacturing practice, shall be defined in job descriptions. Their hierarchical relationships shall be defined in an organisation chart. Organisation charts and job descriptions shall be approved in accordance with the manufacturer's internal procedures.

               3.The staff referred to in paragraph 2 shall be given sufficient authority to discharge their responsibility correctly.

               4.The personnel shall receive initial and on-going training, the effectiveness of which shall be verified, covering in particular the theory and application of the concept of quality assurance and good manufacturing practice.

               5.Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes shall, in particular, include procedures relating to health, hygiene practice and clothing of personnel.

               Article 8
                  Premises and equipment

               1.As regards the premises and manufacturing equipment the manufacturer shall be obliged to ensure that they are located, designed, constructed, adapted and maintained to suit the intended operations.

               2.The Member States shall require that the premises and manufacturing equipment are laid out, designed and operated in such a way as to minimise the risk of error and to permit effective cleaning and maintenance in order to avoid contamination, cross contamination and, in general, any adverse effect on the quality of the product.

               3.Premises and equipment to be used for manufacturing or import operations, which are critical to the quality of the products, shall be subjected to appropriate qualification and validation.

               Article 9
                  Documentation

               1.The manufacturer shall be obliged to establish and maintain a documentation system based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the various manufacturing operations performed. The documentation system shall ensure data quality and integrity. Documents shall be clear, free from error and kept up to date. Pre-established procedures for general manufacturing operations and conditions shall be kept available, together with specific documents for the manufacture of each batch. That set of documents shall enable the history of the manufacture of each batch to be traced.

               The manufacturer shall be required to retain the batch documentation for at least one year after the expiry date of the batches to which it relates or at least five years after the certification referred to in Article 51(3) of Directive 2001/83/EC, whichever is the longer period.

               2.When electronic, photographic or other data processing systems are used instead of written documents, the manufacturer shall be required to first validate the systems by showing that the data will be appropriately stored during the anticipated period of storage. Data stored by those systems shall be made readily available in legible form and shall be provided to the competent authorities upon request. The electronically stored data shall be protected, by techniques such as duplication or back-up and transfer to another storage system, against unlawful access, loss or damage of data, and audit trails shall be maintained.

               Article 10
                  Production

               1.The Member States shall ensure that the manufacturers carry out the different production operations in accordance with pre-established instructions and procedures and in accordance with good manufacturing practice. Adequate and sufficient resources shall be made available by the manufacturer for the in-process controls. All process deviations and product defects shall be documented and thoroughly investigated.

               2.The manufacturers shall be required to take appropriate technical and organisational measures to avoid cross contamination and mix-ups.

               3.Any new manufacturing or important modification of a manufacturing process of a medicinal product shall be validated. Critical phases of manufacturing processes shall be regularly re-validated.

               Article 11
                  Quality control

               1.The manufacturer shall be obliged to establish and maintain a quality control system placed under the authority of a person who has the requisite qualifications and is independent of production.

               That person shall have at his disposal, or shall have access to, one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of starting materials and packaging materials and the testing of intermediate and finished medicinal products.

               2.For medicinal products, including those imported from third countries, contract laboratories may be used if authorised in accordance with Article 12 of this Directive and point (b) of Article 20 of Directive 2001/83/EC.

               3.During the final control of the finished medicinal product before its release for sale or distribution, the quality control system shall take into account, in addition to analytical results, essential information such as the production conditions, the results of in-process controls, the examination of the manufacturing documents and the conformity of the product to its specifications, including the final finished pack.

               4.Samples of each batch of finished medicinal product shall be retained for at least one year after the expiry date.

               Samples of starting materials, other than solvents, gases or water, used in the manufacturing process shall be retained for at least two years after the release of the product. That period may be shortened if the period of stability of the material, as indicated in the relevant specification, is shorter. All those samples shall be maintained at the disposal of the competent authorities.

               Other conditions may be defined, by agreement with the competent authority, for the sampling and retaining of starting materials and certain products manufactured individually or in small quantities, or when their storage could raise special problems.

               Article 12
                  Outsourced operations

               1.The Member States shall require that any manufacturing or import operation or operation linked thereto which is outsourced is the subject of a written contract.

               2.The contract shall clearly defined the responsibilities of each party and shall define, in particular, the observance of good manufacturing practice to be followed by the contract-acceptor and the manner in which the qualified person referred to in Article 48 of Directive 2001/83/EC responsible for certifying each batch is to discharge his responsibilities.

               3.The contract-acceptor shall not subcontract any of the work entrusted to him under the contract without written authorisation from the contract-giver.

               4.The contract-acceptor shall comply with the principles and guidelines of good manufacturing practice applicable to the operations concerned laid down in the Union and shall submit to inspections carried out by competent authorities pursuant to Article 111 of Directive 2001/83/EC.

               Article 13
                  Complaints and product recall

               1.The Member States shall ensure that manufacturers implement a system for recording and reviewing complaints together with an effective system for recalling, promptly and at any time, medicinal products in the distribution network. Any complaint concerning a defect shall be recorded and investigated by the manufacturer. The manufacturer shall be required to inform the competent authority and, if applicable, the marketing authorisation holder of any defect that could result in a recall or an abnormal restriction on supply and, in so far as possible, indicate the countries of destination.

               2.Any recall shall be made in accordance with the requirements referred to in Article 123 of Directive 2001/83/EC.

               Article 14
                  Self-inspection

               The manufacturer shall be required to conduct repeated self-inspections as part of the pharmaceutical quality system in order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective measures and/or preventive actions. Records shall be maintained of such self-inspections and any corrective actions subsequently taken.

               Article 15
                  Repeal of Directive 2003/94/EC

               Directive 2003/94/EC is repealed with effect from six months after the date of publication in the Official Journal of the European Union of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014 or 1 April 2018, whichever is the later..

               References to the repealed Directive shall be construed as references to this Directive and to Commission Delegated Regulation xx
                  5
                and read in accordance with the correlation table in the Annex.

               Article 16
                  Transposition

               1.Member States shall adopt and publish, by [31 March 2018] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

               They shall apply those provisions from six months after the date of publication in the Official Journal of the European Union of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014 or 1 April 2018, whichever is the later.

               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

               2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

               Article 17
                  Entry into force

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

               Article 18
                  Addressees

               This Directive is addressed to the Member States.

               Done at Brussels, 15.9.2017

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)
                  OJ L 311, 28.11.2001, p. 67.

                     (2)
                  Commission Directive 2003/94 EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22).

                     (3)
                  Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).

                     (4)
                  Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004, (OJ L 324, 10.12.2007, p. 121).

                     (5)
                  Commission Delegated Regulation xx supplementing Regulation (EU) No 536/2014 of the European Parliament and the Council by specifying principles of and the guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections, (OJ L xx, dd.mm.yyyy, p. xx).

    ---documentbreak---

               ANNEX

               Correlation table

                        Directive 2003/94/EC

                        This Directive

                        Regulation (EU) nn/yyyy

                        [Commission Delegated Regulation supplementing Regulation (EU) No 536/2014 of the European Parliament and the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections]

                        Article 1

                        Article 1

                        Article 1

                        Article 2

                        Article 2

                        Article 2

                        Article 3

                        Article 3

                        -

                        Article 4

                        Article 4

                        Article 3

                        Article 5

                        Article 5

                        Article 4

                        Article 6

                        Article 6

                        Article 5, first paragraph

                        Article 7

                        Article 7

                        Article 6

                        Article 8

                        Article 8

                        Article 7

                        Article 9

                        Article 9

                        Article 8

                        Article 10

                        Article 10

                        Article 9

                        Article 11

                        Article 11

                        Article 10

                        Article 12

                        Article 12

                        Article 13

                        Article 13

                        Article 13

                        Article 14

                        Article 14

                        Article 14

                        Article 15

                        Article 15

                        -

                        -

                        Article 16

                        -

                        -

                        Article 17

                        -

                        -

                        Article 18

                        -

                        -

                        Article 19

                        -

                        -


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31999L0042R(01)

Corrigendum to Directive 1999/42/EC of the European Parliament and of the Council of 7 June 1999 establishing a mechanism for the recognition of qualifications in respect of the professional activities covered by the Directives on liberalisation and transitional measures and supplementing the general systems for the recognition of qualifications (OJ L 201 of 31.7.1999)

Official Journal L 023 , 25/01/2002 P. 0048 - 0048

Corrigendum to Directive 1999/42/EC of the European Parliament and of the Council of 7 June 1999 establishing a mechanism for the recognition of qualifications in respect of the professional activities covered by the Directives on liberalisation and transitional measures and supplementing the general systems for the recognition of qualifications(Official Journal of the European Communities L 201 of 31 July 1999)On page 86, List V (a):for: (liberalisation Directive 64/224/EEC),read: (liberalisation Directives 64/223/EEC and 64/224/EEC);andthe following point shall be inserted before point 1: "0. activities of self-employed persons in wholesale trade, with the exception of wholesale trade in medicinal and pharmaceutical products, in toxic products and pathogens and in coal (ex Group 611);".


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31986L0662

Council Directive 86/662/EEC of 22 December 1986 on the limitation of noise emitted by hydraulic excavators, rope-operated excavators, dozers, loaders and excavator- loaders

Official Journal L 384 , 31/12/1986 P. 0001 - 0011 Finnish special edition: Chapter 15 Volume 7 P. 0185  Swedish special edition: Chapter 15 Volume 7 P. 0185

COUNCIL DIRECTIVE of 22 December 1986 on the limitation of noise emitted by hydraulic  excavators, rope-operated excavators, dozers, loaders and excavator-loaders (86/662/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article  100 thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Parliament(2), Having regard to the opinion of the Economic and Social Committee(3), Whereas the 1973(4) and 1977(5) action programmes of the European Communities on the environment  highlight the importance of the problem of noise nuisance and, in particular, the need for action  to regulate the worst noise sources; Whereas, during the Council meeting of 18 and 19 December 1978, the Ministers for the Environment  declared that the technical requirements relating to the measurement of noise at the operator's  position would have to be included in the Annexes to the special Directives on each type of  equipment under consideration; Whereas the disparity between the provisions applicable in the various Member States concerning the  limitation of the sound emission level of hydraulic and rope-operated excavators and of dozers and  excavator-loaders directly affects the functioning of the common market; whereas it is therefore  appropriate to carry out in this field the approximation of laws for which Article 100 of the  Treaty provides; Whereas Council Directive 84/532/EEC of 17 September 1984 on the approximation of the laws of the  Member States relating to common provisions for construction plant and equipment(6) laid down,  inter alia, the procedures for EEC type-approval verification; whereas it is necessary, pursuant to  that Directive, to prescribe the harmonized requirements which each category of equipment must  satisfy; Whereas Council Directive 79/113/EEC of 19 December 1978 on the approximation of the laws of the  Member States relating to the determination of the noise emission of construction plant and  equipment(7), as amended by Directive 81/1051/EEC(8), laid down the method which should be used for  establishing the acoustic criteria for hydraulic and rope-operated excavators and for dozers,  loaders and excavator-loaders; Whereas, owing to the effect of the noise emitted by hydraulic and rope-operated excavators and by  dozers, loaders and excavator-loaders on the environment and, more particularly, on human  well-being and health, it is necessary to bring about a progressive and appreciable reduction in  the permissible sound emission level of hydraulic and rope-operated excavators and of dozers,  loaders and excavator loaders; Whereas it is appropriate to set a sound emission level applicable when this Directive comes into  force and to make these provisions more stringent on a gradual basis; Whereas it is appropriate to publish, for information purposes, the sound-power level and the  sound-pressure level at the operator's position; Whereas the technical provisions must be supplemented and rapidly adapted to technical progress;  whereas, to this end, provision should be made for application of the procedure defined in Article  5 of Directive 79/113/EEC, HAS ADOPTED THIS DIRECTIVE: Article 1 1.  This Directive shall apply to the sound-power level of airborne noise emitted in  the environment and the sound-pressure level of airborne noise emitted at the operator's position  of hydraulic excavators, rope-operated excavators, dozers, loaders and excavator-loaders,  hereinafter referred to as 'earth-moving machines', used to perform work on civil-engineering and  building sites. 2.  This is a separate Directive within the meaning of Article 3 (2) of Council Directive  84/532/EEC, hereinafter referred to as the 'framework Directive'. Article 2 For the purposes of this Directive: 2.1.Hydraulic or rope-operated excavators means machines combining a self-propelled undercarriage  with an upper structure which can swivel through more than 360°. The machine excavates, lifts,  carries and dumps material by moving either a boom, an arm and bucket (as is the case with a face  shovel or a backhoe) or a bucket controlled by the winding-gear (as is the case with a drag-line or  a clamshell). 2.2.Dozers means self-propelled wheeled or crawler machines fitted in front with a blade which  serves primarily to displace or spread materials. 2.3.Loaders means self-propelled wheeled or crawler machines fitted in front with a bucket. The  machine loads, raises, transports and dumps material by combining its own movements and those of  the bucket. 2.4.Excavator-loaders means self-propelled wheeled or crawler machines, designed to be fitted with  a loading bucket at the front and an excavating arm at the rear as original equipment. The loading  bucket loads, raises, transports and dumps material by combining its own movements with those of  the machine. The excavating arm excavates, raises and dumps material by movements of the boom, arm  and bucket. Article 3 1.  The approved bodies shall issue an EEC type- examination certificate for every type of earth-moving machine referred to in Article 1 (1): (a)during a six-year period from the date on which the Directive enters into force, where the  sound-power level of airborne noise emitted in the environment measured under the conditions of  stationary operation set out in Annex I to Directive 79/113/EEC, as supplemented by Annex I to this  Directive, does not exceed the permissible level specified with reference to the net installed  power in the following table: >TABLE>(b)after expiry of the abovementioned six-year period, where the sound-power level  of airborne noise emitted into the environment measured under the conditions of real dynamic  operation laid down in Annex I to Directive 79/113/EEC, as supplemented by Annex II to this  Directive, does not exceed the permissible level determined pursuant to Article 7. 2.  All applications for an EEC type-examination certificate in respect of the permissible  sound-power levels of a type of earth-moving machine shall be accompanied by an information  document conforming to the model shown in Annex IV. 3.  For each type of earth-moving machine it certifies, the approved body shall complete all the  sections of the type-examination certificate conforming to the model given in Annex III to the  framework Directive. 4.  The period of validity of EEC type-examination certificates shall be limited to six years. However, the certificate granted in accordance with the provisions of paragraph 1 (a) shall cease  to be valid after a period of seven years has elapsed from the date the Directive entered into  force. The conditions for renewing certificates granted shall be determined pursuant to Article 7. 6.  For every earth-moving machine built in conformity with the type certified by EEC  type-examination, the manufacturer shall complete a certificate of conformity conforming to the  model given in Annex IV to the framework Directive and shall indicate thereon the net installed  power and the corresponding swivel system. 7.  Each earth-moving machine built in accordance with the type certified by EEC type-examination  shall bear a clear and permanent mark indicating the -sound-power level in dB(A) in relation to 1 pW, -sound-pressure level in dB(A) in relation to 20 ìPa at the operator's position, guaranteed by the manufacturer and determined as laid down in Annex I to Directive 79/113/EEC, as  amended by Directive 81/1051/EEC and supplemented by Annex I or II and III to this Directive,  together with the symbol 'aa' (epsilon). The model for these marks is given in Annex V to this  Directive. Article 4 The provisions of this Directive shall not affect the Member States' entitlement to  limit, with due observance of the Treaty and, in particular, Articles 30 to 36 thereof, the noise  level observed at the operator's position in earth-moving machines provided that this does not  entail any obligation to adjust earth-moving machines which meet the requirements of this Directive  to different emission specifications within the meaning of Annex I to the Directive. Article 5 Member States may take measures to regulate the use of earth-moving machines in areas  which they consider sensitive. Article 6 Checking of the conformity of production models with the type examined, as provided for  in Article 12 of the framework Directive, shall be carried out using the technical procedure laid  down in Annex VI. Article 7 At the earliest opportunity and at the latest 18 months after the entry into force of  the Directive, the Commission will submit to the Council a proposal aimed at determining, on the  basis of the measurement method to be adopted in accordance with the first indent of Article 8, the  permissible sound levels referred to in Article 3 (1) (b) and also the conditions for possible  extension of EEC type-examination certificates and their period of validity referred to in Article  3 (4). The permissible sound levels shall be so determined that their effect on the environment is  reduced by approximately 3 dB according to the category of power and the type of machine, measured  according to the stationary operation method. The Council will take a decision on the proposal, in accordance with the provisions of the Treaty,  within 24 months of the date on which it was forwarded to the Council. Article 8 The following shall be adopted in accordance with the procedure laid down in Article 5  of Directive 79/113/EEC as amended by Directive 81/1051/EEC: -the real, dynamic method of measurement referred to in Annex II, -the amendments necessary to adapt the requirements of the Annexes to this Directive to technical  progress. Article 9 The Council shall, in accordance with the provisions of the Treaty and within a period  of 18 months, take a decision on the proposal for the reduction of permissible noise-levels which  the Commission will put forward five years after the period referred to in Article 3 (1) (b) has  entered into force. Article 10 Member States shall take all necessary measures to ensure that earth-moving machines  as defined in Article 2 cannot be placed on the market unless they satisfy the provisions of this  Directive and of the framework Directive. Article 11 1.  Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply with this Directive on the day following expiry of a period of 24  months from its notification(1) and shall forthwith inform the Commission thereof. 2.  Member States shall communicate to the Commission the texts of the main provisions of national  law which they adopt in the field covered by this Directive. Article 12 This Directive is addressed to the Member States. Done at Brussels, 22 December 1986. For the CouncilThe PresidentG. SHAW (1)OJ N° C 302, 21. 11. 1981, p. 7.  (2)OJ N° C 66, 15. 3. 1982, p. 95.  (3)OJ N° C 64, 15. 3. 1982, p. 12.  (4)OJ N° C 112, 20. 12. 1973.  (5)OJ N° C 139, 13. 6. 1977.  (6)OJ N° L 300, 19. 11. 1984, p. 111.  (7)OJ N° L 33, 8. 2. 1979, p. 15.  (8)OJ N° L 376, 30. 12. 1981, p. 49.  (1)This Decision was notified to the Member States on 29 December 1986.   ANNEX I METHOD OF MEASUREMENT OF AIRBORNE NOISE EMITTED BY HYDRAULIC EXCAVATORS,  ROPE-OPERATED EXCAVATORS, DOZERS, LOADERS AND EXCAVATOR-LOADERSSCOPE This method of measurement is applicable to hydraulic excavators, rope-operated excavators, dozers,  loaders and excavator-loaders, hereinafter referred to as 'earth-moving machines'. It lays down the  test procedure for determining the sound-power level of such earth-moving machines with a view to  EEC type-examination and checking for conformity. These technical procedures comply with the requirements laid down in Annex I to Directive  79/113/EEC, and the provisions of that Annex are applicable to earth-moving machines subject to the  following additions: 4.CRITERIA TO BE USED FOR EXPRESSING RESULTS 4.1.Acoustic criterion for the environment The acoustic criterion for the environment of an earth-moving machine is expressed by the  sound-power level LWA. 6.2.Operation during measurements The noise emitted is measured with the earth-moving machine stationary and its engine idling. For these measurements, the engine and hydraulic system of the machine must be warmed up in  accordance with the manufacturer's instructions and safety requirements must be observed. 6.2.1.The test is carried out with the earth-moving machine in a stationary position without  operating the working equipment or travelling mechanism. For the purposes of the test the engine  will idle at not less than the rated speed corresponding to the net power as defined and determined  in accordance with Annex I to Council Directive 80/1269/EEC of 16 December 1980. The rated speed and the corresponding net power are stated by the manufacturer of the earth-moving  machine and must appear on the technical instructions for use of the earth-moving machine and on  the certificate of conformity issued to the purchaser. If the earth-moving machine is fitted with several engines, they must work simultaneously during  the test provided that such simultaneous working forms part of the normal working conditions of the  machine. If the engine of the earth-moving machine is fitted with a fan, the latter must operate during the  tests. If the fan can work at several speeds, the tests shall be carried out at its maximum working  speed. The rated speed is set by the manufacturer. The working equipment (bucket or blade of a loader or a  dozer) is positioned at a height of 300 ± 50 millimetres above the ground. In the case of excavators and excavator-loaders, the working equipment must be in the retracted  position. 6.2.2.Tests under load N°t applicable. 6.3.Measuring site The measuring site must be flat and horizontal. This site, including the microphone positions, must  be of concrete or non-porous asphalt. 6.4.Measuring surface, measuring distance, location and number of measuring points 6.4.1.Measuring surface, measuring distance The measuring surface to be used for the test is a hemisphere. The radius of the hemisphere is determined by the basic length l, (see Fig. 1). The radius is: -4 metres when the basic length of the earth-moving machine to be tested is not greater than 1,5 metres, -10 metres when the basic length of the earth-moving machine to be tested is greater than 1,5 metres but not greater than 4 metres, -16 metres when the basic length of the earth-moving machine to be tested is greater than 4 metres. 6.4.2.Location and number of measuring points 6.4.2.1.General For measurements there are six measuring points, i.e. points 2, 4, 6, 8, 10 and 12 arranged as  defined in section 6.4.2.2 of Annex I to Directive 79/113/EEC. For testing the earth-moving machine, the geometrical centre of the basic machine is positioned  vertically above the centre of the hemisphere with the front of the machine facing measuring point  1. 7.1.1.Measurement of extraneous noise Only the backgound noise is to be taken into account for the purpose of corrections. 7.1.5.Presence of obstacles A visual check in a circular zone having a radius three times that of the measuring hemisphere and  the same centre is adequate to ensure that the provisions of the third subparagraph of section 6.3  of Annex I to Directive 79/113/EEC have been complied with. 7.2.If the sound-pressure levels at the measuring points are determined from readings taken from a  sonometer, there must be at least five such readings, taken at regular intervals. 8.5.Calculation of the sound-power level LWA Correcting factor K2 is zero.   ANNEX II REAL, DYNAMIC METHOD OF MEASUREMENT OF AIRBORNE NOISE EMITTED BY HYDRAULIC  EXCAVATORS, ROPE-OPERATED EXCAVATORS, DOZERS, LOADERS AND EXCAVATOR-LOADERSThe operating  conditions of the machine correspond either to normal working conditions or to conventional working  conditions producing, in principle, effects and stress similar to those undergone under actual  working conditions. The method of measurement will be established on the basis of experience and work already carried  out or under way both nationally within the Community and internationally.   ANNEX III METHOD OF MEASUREMENT AT THE OPERATOR'S POSITION OF AIRBORNE NOISE EMITTED BY  HYDRAULIC EXCAVATORS, ROPE-OPERATED EXCAVATORS, DOZERS, LOADERS AND EXCAVATOR-LOADERSThis method  of measurement applies to hydraulic excavators, rope-operated excavators, dozers, loaders and  excavator-loaders, hereinafter referred to as 'earth-moving machines'. It lays down the test  procedures for determining the equivalent continuous sound-pressure level at the operator's  position. These technical procedures comply with the requirements laid down in Annex II to Directive  79/113/EEC, as amended by Directive 81/1015/EEC, and the provisions of that Annex are applicable to  earth-moving machines subject to the following additions: 6.OPERATORS An operator must occupy the operator's position during the test. 6.2.1.Standing operator N°t applicable. 7.1.General The microphone must be located as specified in 7.3. 9.1.General The conditions for installing and operating the machine are those laid down in the method used for  measuring airborne noise emitted into the environment (Annex I or Annex II as appropriate). 9.2.Operation of machines with adjustable features N°ne of the adjustable features referred to in 9.2.1, except those mentioned in 9.2.2, is to be  taken into consideration. 10.2.2.Using the A-weighted sound-pressure level, LpA. If the measurement is taken with a sonometer, T is five seconds. The number of measurements is  five.  tabelle ms 19  ANNEX IV MODEL INFORMATION DOCUMENT FOR A TYPE OF EARTH-MOVING MACHINE1.General 1.1.Name and address of manufacturer (or authorized representative): . 1.2.Make (name of undertaking) . 1.3.Trade name: . 2.Machine 2.1.Type: . Series: . Number: . 2.2.Dimensions chart (Descriptive leaflet): . 2.3.Length (l): . 3.Technical data 3.1.Drive motor: . Make: . Type: . Number: . Net installed power: ............... kW ((1)) at ................. r.p.m. Other motors (if appropriate) Drive motor: . Make: . Type: . Number: . Net installed power: ............... kW ((1)) at ................. r.p.m. 3.2.Hydraulic pumps 3.2.1.Travelling equipment (...) Producer: . Type: . Series: . Number: . Pressure in service: . 3.2.2.Hydraulic system for the working equipment: . Producer: . 3.2.3.Cooling machinery for the hydraulic equipment: . 3.3.Description of the measures taken to attenuate the noise (with photos as far as possible): 4.Attach the descriptive trade leaflet, if any.  (1)Net power defined and determined in accordance with Annex I to Directive 80/1269/EEC  of 16 December 1980.   ANNEX V MODELS OF PLATE STATING THE SOUND-POWER AND SOUND-PRESSURE LEVELS AT THE  OPERATOR'S POSITION GUARANTEED BY THE MANUFACTURER>START OF GRAPHIC>100>END OF GRAPHIC>>START OF  GRAPHIC>100>END OF GRAPHIC> ANNEX VI TECHNICAL PROCEDURE FOR CHECKING THE CONFORMITY OF PRODUCTION MODELS WITH THE  TYPE EXAMINEDThe conformity of production models with the type examined is, if possible, verified  by spot checks. >START OF GRAPHIC><?aa1B><?aeLM30,><?aa8K>Figure 1 <?aa6W><?aa8G>l = Basic length >END OF GRAPHIC>>START OF GRAPHIC><?aa8K>Figure 2 <?aa6W><?aa8G>l = Basic length >END OF GRAPHIC>


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31969L0493

Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass

Official Journal L 326 , 29/12/1969 P. 0036 - 0039 Finnish special edition: Chapter 13 Volume 1 P. 0115  Danish special edition: Series I Chapter 1969(II) P. 0581  Swedish special edition: Chapter 13 Volume 1 P. 0115  English special edition: Series I Chapter 1969(II) P. 0599  Greek special edition: Chapter 13 Volume 1 P. 0042  Spanish special edition: Chapter 13 Volume 1 P. 0170  Portuguese special edition Chapter 13 Volume 1 P. 0170

COUNCIL DIRECTIVE  of 15 December 1969  on the approximation of the laws of the Member States relating to crystal glass  (69/493/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;  Having regard to the proposal from the Commission;  Having regard to the Opinion of the European Parliament (1);  Having regard to the Opinion of the Economic and Social Committee;  Whereas, with regard to the use of a special description for crystal glass products and the consequent obligation concerning the composition of such products, there are differences between the rules of certain Member States ; whereas those differences hinder trade in such products and can lead to distortions in competition within the Community;  Whereas those obstacles to the establishment and proper functioning of the common market can be eliminated by adoption of the same requirements by all the Member States;  Whereas, with regard to the descriptions laid down for the various categories of crystal glass and to the characteristics of those categories, the purpose of the Community provisions to be adopted is to protect both the buyer against fraud and the manufacturer who complies with those provisions;  Whereas implementation of a system of Community rules requires the establishment of standard methods for determining the chemical and physical properties of crystal glass products bearing descriptions laid down in this Directive;  HAS ADOPTED THIS DIRECTIVE:    Article 1 This Directive shall apply to the products falling within heading No 70.13 of the Common Customs Tariff.   Article 2 Member States shall take all necessary steps to ensure that the composition, characteristics of manufacture and labelling of the products referred to in Article 1, and all forms of publicity for such products, conform to the definitions and rules laid down in this Directive and in the Annexes thereto.   Article 3 Member States shall take all necessary steps to prevent the descriptions in column (b) of Annex I from being used commercially for products which do not have the corresponding characteristics specified in columns (d) to (g) of Annex I.   Article 4 1. If a product covered by this Directive bears one of the descriptions listed in column (b) of Annex I, it may also bear the corresponding identifying symbol shown and described in columns (h) and (i) of that Annex.  2. Where a trade mark, the name of an undertaking or any other inscription contains, as a main part, as an adjective or as a root, a description appearing in columns (b) and (c) of Annex I or a description liable to be confused therewith, Member States shall take all necessary steps to ensure that that trade mark, name or inscription is immediately preceded by the following, in very prominent lettering:    (a) the description of the product, where that product has characteristics specified in columns (d) to (g) of Annex I;       (b) a statement of the exact nature of the product, where that product does not have characteristics specified in columns (d) to (g) of annex I.  (1)OJ No C 108, 19.10.1968, p. 35.           Article 5 The description and identifying symbols given in Annex I may appear on one and the same label.   Article 6 The methods laid down in Annex II, and only those methods, shall be used to verify that products bearing descriptions and identifying symbols have the characteristics corresponding thereto as specified in columns (d) to (g) of Annex I.   Article 7 Products intended for export from the Community shall not be subject to the provisions of this Directive.   Article 8 Member States shall put into force the measures needed in order to comply with this Directive within eighteen months of its notification and shall forthwith inform the Commission thereof. As soon as this Directive has been notified, Member States shall also ensure that they inform the Commission in time for it to submit its observations, of any subsequent drafts of main laws, regulations or administrative provisions which they propose to adopt in the field covered by this Directive.   Article 9 This Directive is addressed to the Member States.     Done at Brussels, 15 December 1969.  For the Council  The President  H.J. DE KOSTER    ANNEX I  List of crystal glass categories   >PIC FILE= "T0001941">     ANNEX II  METHODS FOR DETERMINING THE CHEMICAL AND PHYSICAL PROPERTIES OF CATEGORIES OF CRYSTAL GLASS      1. CHEMICAL ANALYSES      1.1. BaO and PbO        1.1.1. Determination of the combination BaO + PbO  Weigh, to within 0.0001 grammes, approximately 0.5 grammes of powdered glass and place in a platinum dish. Moisten with water and add 10 millilitres of a 15 % solution of sulphuric acid and 10 millilitres hydrofluoric acid. Heat in sand bath until white fumes are given off. Allow to cool and treat again with 10 millilitres hydrofluoric acid. Heat until reappearance of white fumes. Allow to cool and rinse the sides of the dish with water. Heat until reappearance of white fumes. Allow to cool, carefully add 10 millilitres of water, then transfer to a 400 millilitres beaker. Rinse the dish several times with a 10 % sulphuric and solution and dilute to 100 millilitres with same solution. Boil for 2-3 minutes. Leave to stand overnight.  Pass through a filtering crucible of 4 porosity, wash first of all with a 10 % solution of sulphuric acid, then two or three times with ethyl alcohol. Dry for one hour in an oven at 150 ºC. Weigh BaSO4 + PbSO4.               1.1.2. Determination of BaO  Weigh, to within 0.0001 grammes, about 0.5 grammes of powdered glass and place in a platinum dish. Moisten with water and add 10 millilitres of hydrofluoric acid and 5 millilitres perchloric acid. Heat in sand bath until white fumes are given off.  Allow to cool and add a further 10 millilitres hydrofluoric acid. Heat until reappearance of white fumes. Allow to cool and rinse the sides of the dish with distilled water. Heat again and evaporate until almost dry. Start again with 50 millilitres of a 10 % solution of hydrochloric acid and heat gently to aid dissolution. Transfer to a 400 millilitres beaker and dilute to 200 millilitres with water. Bring to boil and pass a current of hydrogen sulphide through the hot solution. When the precipitate of lead sulphide drops to the bottom of the beaker, turn off the hydrogen sulphide. Pass through a fine filter paper and wash with cold water saturated with hydrogen sulphide.  Boil the filtrates and then, if necessary, reduce them by evaporation to 300 millilitres. Add to boiling mixture 10 millilitres of a 10 % solution of sulphuric acid. Remove from heat and leave to stand for at least four hours.  Pass through a fine filter paper, wash with cold water. Calcine the precipitate to 1050 ºC, and weigh the BaSO4.           1.2. Determination of ZnO  Evaporate the filtrates from the separation of BaSO4 so as to reduce their volume to 200 millilitres. Neutralise with ammonia in the presence of methyl red and add 20 millilitres of N/10 sulphuric acid. Adjust the pH to 2 (pH meter) by adding N/10 sulphuric acid or N/10 caustic soda whichever the case, and precipitate the zinc sulphide in the cold by passing a current of hydrogen sulphide. Let the precipitate settle for four hours, then collect on a fine filter paper. Wash with cold water saturated with hydrogen sulphide. Dissolve the precipitate on the filter by pouring through it 25 millilitres of a hot 10 % solution of hydrochloric acid. Wash the filter with boiling water until a volume of about 150 millilitres is obtained. Neutralise with ammonia in the presence of litmus paper, then add 1-2 grammes solid urotropine to buffer the solution to about pH 5. Add a few drops of a 0.5 % freshly prepared aqueous solution of xylenol orange and titrate with an N/10 solution of Complexon III until the pink changes to citron yellow.            1.3. Determination of K2O  by precipitation and weighing of potassium tetraphenylborate.  Procedure : 2 grammes of glass are attacked, after crushing and sieving, by  2 millilitres concentrated HNO3  15 millilitres HCO4  25 millilitres HF  in a platinum dish on a water-bath then in a sand bath. After dense fumes of perchloric acid have been given off (continue until dry), dissolve with 20 millilitres of hot water and 2-3 millilitres concentrated HCl.  Transfer to a 200 millilitres graduated flask and adjust to volume with distilled water.  Reagents : 6 % solution of sodium tetraphenylborate : dissolve 1.5 grammes of the reagent in 250 millilitres distilled water. Remove the light cloudiness which remains by adding 1 gramme of hydrated aluminia. Shake for five minutes and filter, taking care to re-filter the first 20 millilitres obtained.  Washing solution for the precipitate : prepare a little of the potassium salt by precipitation in a solution of about 0.1 grammes KCl to 50 millilitres N/10 HCl into which the solution of tetraphenylborate is poured while stirring, until precipitation ceases. Filter through a sinter. Wash with distilled water. Dry in a desiccator at room temperature. Then pour 20-30 milligrammes of that salt into 250 millilitres of distilled water. Stir from time to time. After thirty minutes, add 0.5-1 gramme of hydrated alumina. Stir for a few minutes. Filter.  Method of operation : Take an aliquot of the acid digest corresponding to about 10 milligrammes of K2O. Dilute to about 100 millilitres Slowly add the reagent solution, about 10 millilitres per assumed 5 milligrammes of K2O, while gently stirring. Allow to stand for a maximum of fifteen minutes then filter through a tared sintered crucible of porosity 3 or 4. Wash with washing solution. Dry for thirty minutes at 120 ºC. Conversion factor 0.13143 for K2O.           1.4. Tolerances  ± 0.1 in absolute value for each determination. If the analysis gives a lower value, within the tolerances, than the limits fixed (30,24 or 10 %), the average of at least three analyses must be taken. If that average is greater than or equal to 29.95, 23.95 or 9.95 respectively, the glass must be accepted in the category corresponding to 30,24 and 10 % respectively.       2. PHYSICAL DETERMINATIONS     2.1. Density  Method by hydrostatic balance to within ± 0.01. A sample of at least 20 grammes is weighed in air and weighed immersed in distilled water at 20 ºC.       2.2. Refractive index  The index is measured on the refractometer to within ± 0.001.       2.3. Microhardness  Vickers hardness is to be measured according to the standard ASTM E 92-65 (Revision 1965) but using a load of 50 grammes and taking the average of 15 determinations.