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31980L0154

Council Directive 80/154/EEC of 21 January 1980 concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in midwifery and including measures to facilitate the effective exercise of the right of establishment and freedom to provide services

Official Journal L 033 , 11/02/1980 P. 0001 - 0007 Finnish special edition: Chapter 6 Volume 2 P. 0045  Greek special edition: Chapter 06 Volume 2 P. 0075  Swedish special edition: Chapter 6 Volume 2 P. 0045  Spanish special edition: Chapter 06 Volume 2 P. 0089  Portuguese special edition Chapter 06 Volume 2 P. 0089

COUNCIL DIRECTIVE  of 21 January 1980  concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in midwifery and including measures to facilitate the effective exercise of the right of establishment and freedom to provide services  (80/154/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 49, 57 and 66 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 to practise as a midwife and also to the 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 and freedom to provide services in respect of the activities of midwives;  Whereas, pursuant to 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 issued for mutual recognition of diplomas, certificates and other evidence of formal qualifications;  Whereas it would appear advisable that, contemporaneously with the mutual recognition of diplomas, provision should be made for coordinating the conditions governing the training of midwives ; whereas such coordination is the subject of Directive 80/155/EEC (4);  Whereas in the Member States the law makes the right to take up and pursue the activities of midwife dependent upon the possession of a midwifery diploma;  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  (1)OJ No C 18, 12.2.1970, p. 1. (2)OJ No C 101, 4.8.1970, p. 26. (3)OJ No C 146, 11.12.1970, p. 17. (4)See page 8 of this Official Journal.  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, in the case of the provision of services, the requirement of registration with or membership of professional organizations or bodies, since it is related to the fixed and permanent nature of the activity pursued in the host country, would undoubtedly constitute an obstacle to the person wishing to provide the service, by reason of the temporary nature of his activity ; whereas this requirement should therefore be abolished ; whereas however, in this event, control over professional discipline, which is the responsibility of these professional organizations or bodies, should be guaranteed ; whereas, to this end, it should be provided, subject to the application of Article 62 of the Treaty, that the person concerned may be required to submit to the competent authority of the host Member State particulars relating to the provision of services;  Whereas, with regard to the requirements relating 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 to practise it;  Whereas, as far as the activities of employed midwives 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 of midwives are subject in all Member States to possession of a diploma, certificate or other evidence of formal qualification in midwifery ; whereas such activities 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 this Directive to employed midwives,  HAS ADOPTED THIS DIRECTIVE:    CHAPTER I SCOPE  Article 1 1. This Directive shall apply to the activities of midwives as defined by each Member State, without prejudice to Article 4 of Directive 80/155/EEC, and pursued under the following professional titles:  in the Federal Republic of Germany: - "Hebamme";  in Belgium: - "accoucheuse/vroedvrouw";  in Denmark: - "jordemoder";  in France: - "sage-femme";  in Ireland: - midwife;  in Italy: - "ostetrica";  in Luxembourg: - "sage-femme";  in the Netherlands - "verloskundige";  in the United Kingdom: - midwife.   CHAPTER II DIPLOMAS, CERTIFICATES AND OTHER EVIDENCE OF FORMAL QUALIFICATIONS IN MIDWIFERY  Article 2 1. Each Member State shall recognize the diplomas, certificates and other evidence of formal qualifications in midwifery awarded to nationals of Member States by the other Member States and listed in Article 3 which satisfy the minimum programme mentioned in Article 1 (1), (3) and (4) of Directive 80/155/EEC and comply with one of the following conditions:    - full-time training in midwifery lasting at least three years:      - either subject to possession of a diploma, certificate or other evidence of formal qualifications giving right of admittance to university or higher-education establishments or, failing this, attesting an equivalent level of knowledge,       - or followed by professional practice for which the certificate referred to in Article 4 of this Directive is issued,  (1)OJ No L 257, 19.10.1968, p. 2.        - full-time training in midwifery lasting at least two years or 3 600 hours subject to possession of a diploma, certificate or other evidence of formal qualifications as a nurse responsible for general care, referred to in Article 3 of Directive 77/452/EEC (1),       - full-time training in midwifery lasting at least 18 months or 3 000 hours subject to possession of a diploma, certificate or other evidence of formal qualifications as a nurse responsible for general care referred to in Article 3 of Directive 77/452/EEC and followed by professional practice for which the certificate referred to in Article 4 of this Directive is issued.         2. Each Member State shall, as far as the right to take up and pursue the activities of midwives in a self-employed capacity is concerned, give diplomas, certificates and other evidence of formal qualifications recognized by it the same effect in its territory as those which the Member State itself awards.   Article 3 The diplomas, certificates and other evidence of formal qualifications referred to in Article 2 are the following:    (a) in the Federal Republic of Germany:      - the "Hebammenprüfungszeugnis" awarded by the State-appointed examining board,           - the certificates issued by the competent authorities of 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 listed in the first indent;                  (b) in Belgium:  the "diplôme d'accoucheuse/vroedvrouwdiploma" awarded by schools set up or approved by the State or by the "Jury central";       (c) in Denmark:  the "bevis for bestået jordemodereksamen" awarded by "Danmarks Jordemoderskole";       (d) in France:  the "diplôme de sage-femme" awarded by the State;       (e) in Ireland:  the certificate in midwifery awarded by "An Bord Altranais";       (f) in Italy:  the "diploma d'ostetrica" awarded by schools approved by the State;       (g) in Luxembourg:  the "diplôme de sage-femme" awarded by the Minister for Health following a decision by the examining board;       (h) in the Netherlands:  the "vroedvrouwdiploma" awarded by the examining body designated by the State;       (i) in the United Kingdom:  the certificate of admission to the Roll of Midwives, awarded in England and Wales by the Central Midwives Board for England and Wales, in Scotland by the Central Midwives Board for Scotland, and in Northern Ireland by the Northern Ireland Council for Nurses and Midwives.          Article 4 The certificate provided for in Article 2 shall be issued by the competent authorities of the Member State of origin or of the Member State from which the foreign national comes. It shall certify that the holder has satisfactorily, after qualifying as a midwife, carried out all the activities of a midwife in a hospital or other health establishment approved for this purpose, for a period fixed as follows:    - two years in the case provided for in the second sub-indent of the first indent of Article 2 (1),       - one year in the case provided for in the third indent of Article 2 (1).          CHAPTER III EXISTING CIRCUMSTANCES  Article 5 1. In the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications do not satisfy all the minimum training requirements laid down in Article 1 of Directive 80/155/EEC, each Member State shall recognize as sufficient evidence the diplomas, certificates and other evidence of the formal qualifications of midwives awarded by those Member States prior to and during a period of not more than six years after the notification of this Directive, accompanied by a certificate stating that those nationals have effectively and lawfully been engaged in the activities in question for at least three years during the five years prior to the date of issue of the certificate.  (1)OJ No L 176, 15.7.1977, p. 1.   2. In the case of nationals of Member States whose diplomas, certificates and other evidence of formal qualifications satisfy all the minimum training requirements laid down in Article 1 of Directive 80/155/EEC, but, by virtue of Article 2 of the present Directive, need be recognized only if they are accompanied by the certificate of professional practice referred to in Article 4, each Member State shall recognize as sufficient evidence the diplomas, certificates and other evidence of formal qualifications of midwives awarded by those Member States prior to the entry into force of the present Directive, accompanied by a certificate stating that those nationals have effectively and lawfully been engaged in the activities in question for at least two years during the five years prior to the date of issue of the certificate.   CHAPTER IV USE OF ACADEMIC TITLE  Article 6 1. Without prejudice to Article 15, host Member States shall ensure that nationals of Member States who fulfil the conditions laid down in Articles 2 and 5 have the right to use the lawful academic title, inasmuch as it is not identical to the professional title, or, where appropriate, the abbreviation thereof of their Member State of origin or of the Member State from which they come, in the language or languages 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 a suitable form to be indicated by the host Member State.   CHAPTER V PROVISIONS TO FACILITATE THE EFFECTIVE EXERCISE OF THE RIGHT OF ESTABLISHMENT AND FREEDOM TO PROVIDE SERVICES IN RESPECT OF THE ACTIVITIES OF MIDWIVES  A. Provisions specifically relating to the right of establishment  Article 7 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 activity 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 occurred outside its territory prior to the establishment of the person concerned in that State and which 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 in that Member State the taking up of the activity in question. The authorities in that State shall decide on the nature and extent of the investigation 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 8 1. Where, in a host Member State, provisions laid down by law, regulation or administrative 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 has occurred prior to the establishment of the person concerned in that State outside its territory and which 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 investigation 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 9 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 national a certificate issued by a competent authority in that State corresponding to the certificates issued in the host Member State.   Article 10 Documents issued in accordance with Articles 7, 8 and 9 may not be presented more than three months after their date of issue.   Article 11 1. The procedure for authorizing the person concerned to take up any activity referred to in Article 1, pursuant to Articles 7, 8 and 9 must be completed as soon as possible and not later than three months after presentation of all the documents relating to such person, without prejudice to delays resulting from any appeal that may be made upon the termination of this procedure.  2. In the cases referred to in Articles 7 (3) and 8 (2), a request for re-examination shall suspend the period stipulated in paragraph 1.  The Member State consulted shall give its reply within three months.  On receipt of the reply or at the end of the period the host Member State shall continue with the procedure referred to in paragraph 1.   Article 12 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 person concerned.  B. Provisions specifically relating to the provision of services  Article 13 1. Where a Member State requires of its own nationals wishing to take up or pursue any of the activities referred to in Article 1 an authorization, or membership of or registration with a professional organization or body, that Member State shall in the case of the provision of services exempt the nationals of Member States from that requirement.  The person concerned shall provide services with the same rights and obligations as the nationals of the host Member State ; in particular he shall be subject to the rules of conduct of a professional or administrative nature which apply in that Member State.  Where a host Member State adopts a measure pursuant to the second subparagraph or becomes aware of facts which run counter to these provisions, it shall forthwith inform the Member State where the person concerned is established.  2. The host Member State may require the person concerned to make a prior declaration to the competent authorities concerning the provision of his services where they involve a temporary stay in its territory.  In urgent cases this declaration may be made as soon as possible after the services have been provided.  3. Pursuant to paragraphs 1 and 2, the host Member State may require the person concerned to supply one or more documents containing the following particulars:    - the declaration referred to in paragraph 2,       - a certificate stating that the person concerned is lawfully pursuing the activities in question in the Member State where he is established,       - a certificate that the person concerned holds one or other of the diplomas, certificates of other evidence of formal qualification appropriate for the provision of the services in question and referred to in this Directive.          4. The document or documents specified in paragraph 3 may not be produced more than 12 months after their date of issue.  5. Where a Member State temporarily or permanently deprives, in whole or in part, one of its nationals or a national of another Member State established in its territory of the right to pursue one of the activities referred to in Article 1, it shall, as appropriate, ensure the temporary or permanent withdrawal of the certificate referred to in the second indent of paragraph 3.   Article 14 Where registration with a public social security body is required in a host Member State for the settlement with insurance bodies of accounts relating to services rendered to persons insured under social security schemes, that Member State shall exempt nationals of Member States established in another Member State from this requirement in cases of provision of services entailing travel on the part of the person concerned.  However, the persons concerned shall supply information to this body in advance, or, in urgent cases, subsequently, concerning the services provided.  C. Provisions common to the right of establishment and freedom to provide services  Article 15 Where in a host Member State the use of the professional title relating to one of the activities referred to in Article 1 is subject to rules, nationals of other Member States who fulfil the conditions laid down in Articles 2 and 5 shall use the professional title of the host Member State which, in that State, corresponds to those conditions of qualification, and shall use the abbreviated title.   Article 16 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. In the case of establishment, 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 within the competent authorities and bodies which they must designate within the period laid down in Article 20 (1).  3. Member States shall see to it that, where appropriate, the persons concerned acquire, in their own interest and in that of their patients, the linguistic knowledge necessary for the exercise of their profession in the host Member State.   CHAPTER VI FINAL PROVISIONS  Article 17 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 evidence of 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 80/155/EEC.   Article 18 Within the time limit laid down in Article 20 (1) Member States shall designate the authorities and bodies competent to issue or receive the diplomas, certificates and other evidence of 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 19 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 20 1. Member States shall bring into force the measures necessary to comply with this Directive within three years of its notification 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 21 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 Committee of Senior Officials on Public Health set up under Decision 75/365/EEC (1), as last amended by Decision 80/157/EEC (2).  Where necessary, the Commission shall submit appropriate proposals to the Council.   Article 22 This Directive is addressed to the Member States.     Done at Brussels, 21 January 1980.  For the Council  The President  G. MARCORA  (1)OJ No L 167, 30.6.1975, p. 19. (2)See page 15 of this Official Journal.


Avis juridique important

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31989L0666

Eleventh Council Directive 89/666/EEC of 21 December 1989 concerning disclosure requirements in respect of branches opened in a Member State by certain types of company governed by the law of another State

Official Journal L 395 , 30/12/1989 P. 0036 - 0039 Finnish special edition: Chapter 17 Volume 1 P. 0099  Swedish special edition: Chapter 17 Volume 1 P. 0099

ELEVENTH COUNCIL DIRECTIVE of 21 December 1989 concerning disclosure requirements in respect of branches opened in a Member State by certain types of company governed by the law of another State (89/666/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 54 thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas in order to facilitate the exercise of the freedom of establishment in respect of companies covered by Article 58 of the Treaty, Article 54 (3) (g) and the general programme on the elimination of restrictions on the freedom of establishment  require coordination of the safeguards required of companies and firms in the Member States for the protection of the interests of members and others;  Whereas hitherto this coordination has been effected in respect of disclosure by the adoption of the First Directive 68/151/EEC (4) covering companies with share capital, as last amended by the 1985 Act of Accession; whereas it was continued in the  field of accounting by the Fourth Directive 78/660/EEC (5) on the annual accounts of certain types of companies, as last amended by the 1985 Act of Accession, the Seventh Directive 83/349/EEC (6) on consolidated accounts, as amended by the 1985 Act of  Accession, and the Eighth Directive 84/253/EEC (7) on the persons responsible for carrying out the statutory audits of accounting documents;  Whereas these Directives apply to companies as such but do not cover their branches; whereas the opening of a branch, like the creation of a subsidiary, is one of the possibilities currently open to companies in the exercise of their right of  establishment in another Member State;  Whereas in respect of branches the lack of coordination, in particular concerning disclosure, gives rise to some  disparities, in the protection of shareholders and third parties, between companies which operate in other Member States by opening branches and those which operate there by creating subsidiaries;  Whereas in this field the differences in the laws of the Member States may interfere with the exercise of the right of establishment; whereas it is therefore necessary to eliminate such differences in order to safeguard, inter alia, the exercise of that  right;  Whereas to ensure the protection of persons who deal with companies through the intermediary of branches, measures in respect of disclosure are required in the Member State in which a branch is situated; whereas, in certain respects, the economic and  social influence of a branch may be comparable to that of a subsidiary company, so that there is public interest in disclosure of the company at the branch; whereas to effect such disclosure it is necessary to make use of the procedure already  instituted for companies with share capital within the Community;  Whereas such disclosure relates to a range of important documents and particulars and amendments thereto;  Whereas such disclosure, with the exception of the powers of representation, the name and legal form and the winding-up of the company and the insolvency proceedings to which it is subject, may be confined to information concerning a branch itself  together with a reference to the register of the company of which that branch is part, since under existing Community rules all information covering the company as such is available in that register;  Whereas national provisions in respect of the disclosure of accounting documents relating to a branch can no longer be justified following the coordination of national law in respect of the drawing up, audit and disclosure of companies' accounting  documents; whereas it is accordingly sufficient to disclose, in the register of the branch, the accounting documents as audited and disclosed by the company;  Whereas letters and order forms used by a branch must give at least the same information as letters and order forms used by the company, and state the register in which the branch is entered;  Whereas to ensure that the purposes of this Directive are fully realized and to avoid any discrimination on the basis of a company's country of origin, this Directive must also cover branches opened by companies governed by the law of non-member countries and set up in legal forms comparable to companies to which Directive 68/151/EEC applies; whereas for these branches it  is necessary to apply certain provisions different from those that apply to the branches of companies governed by the law of other Member States since the Directives referred to above do not apply to companies from non-member countries;  Whereas this Directive in no way affects the disclosure requirements for branches under other provisions of, for example, employment law on workers' rights to information and tax law, or for statistical purposes;  HAS ADOPTED THIS DIRECTIVE:   SECTION I Branches of companies from other Member States Article 1 1.  Documents and particulars relating to a branch opened in a Member State by a company which is governed by the law of another Member State and to which Directive 68/151/EEC applies shall be disclosed pursuant to the law of the Member State  of the branch, in accordance with Article 3 of that Directive.  2.  Where disclosure requirements in respect of the branch differ from those in respect of the company, the branch's disclosure requirements shall take precedence with regard to transactions carried out with the branch.  Article 2 1.  The compulsory disclosure provided for in Article 1 shall cover the following documents and particulars only:  (a)  the address of the branch;  (b)  the activities of the branch;  (c)  the register in which the company file mentioned in Article 3 of Council Directive 68/151/EEC is kept, together with the registration number in that register;  (d) the name and legal form of the company and the name of the branch if that is different from the name of the company;  (e) the appointment, termination of office and particulars of the persons who are authorized to represent the company in dealings with third parties and in legal proceedings;  - as a company organ constituted pursuant to law or as members of any such organ, in accordance with the disclosure by the company as provided for in Article 2 (1) (d) of Directive 68/151/EEC,  - as permanent representatives of the company for the activities of the branch, with an indication of the extent of their powers;  (f) the winding-up of the company, the appointment of liquidators, particulars concerning them and their powers and the termination of the liquidation in accordance with disclosure by the company as provided for in Article 2 (1) (h), (j) and (k) of  Directive 68/151/EEC,  - insolvency proceedings, arrangements, compositions, or any analogous proceedings to which the company is subject;  (g) the accounting documents in accordance with Article 3;  (h) the closure of the branch.  2.  The Member State in which the branch has been opened may provide for the disclosure, as referred to in Article 1, of (a)  the signature of the persons referred to in paragraph 1 (e) and (f) of this Article;  (b)  the instruments of constitution and the memorandum and articles of association if they are contained in a separate instrument in accordance with Article 2 (1) (a), (b) and (c) of Directive 68/151/EEC, together with amendments to those documents;  (c)  an attestation from the register referred to in paragraph 1 (c) of this Article relating to the existence of the company;  (d)  an indication of the securities on the company's property situated in that Member State, provided such disclosure relates to the validity of those securities.  Article 3 The compulsory disclosure provided for by Article 2 (1) (g) shall be limited to the accounting documents of the company as drawn up, audited and disclosed pursuant to the law of the Member State by which the company is governed in accordance  with Directives 78/660/EEC, 83/349/EEC and 84/253/EEC.  Article 4 The Member State in which the branch has been opened may stipulate that the documents referred to in Article 2 (2) (b) and Article 3 must be published in another official language of the Community and that the translation of such documents  must be certified.  Article 5 Where a company has opened more than one branch in a Member State, the disclosure referred to in Article 2 (2) (b) and Article 3 may be made in the register of the branch of the company's choice.  In this case, compulsory disclosure by the other branches shall cover the particulars of the branch register of which disclosure was made, together with the number of that branch in that register.  Article 6 The Member States shall prescribe that letters and order forms used by a branch shall state, in addition to the information prescribed by Article 4 of Directive 68/151/EEC, the register in which the file in respect of the branch is kept  together with the number of the branch in that register.   SECTION II Branches of companies from third countries Article 7 1.  Documents and particulars concerning a branch opened in a Member State by a company which is not governed by the law of a Member State but which is of a legal form comparable with the types of company to which Directive 68/151/EEC applies  shall be disclosed in accordance with the law of the Member State of the branch as laid down in Article 3 of that Directive.  2.  Article 1 (2) shall apply.  Article 8 The compulsory disclosure provided for in Article 7 shall cover at least the following documents and particulars:  (a)  the address of the branch;  (b)  the activities of the branch;  (c)  the law of the State by which the company is governed;  (d)  where that law so provides, the register in which the company is entered and the registration number of the company in that register;  (e) the instruments of constitution, and memorandum and articles of association if they are contained in a separate instrument, with all amendments to these documents;  (f) the legal form of the company, its principal place of business and its object and, at least annually, the amount of subscribed capital if these particulars are not given in the documents referred to in subparagraph (e);  (g) the name of the company and the name of the branch if that is different from the name of the company;  (h) the appointment, termination of office and particulars of the persons who are authorized to represent the company in dealings with third parties and in legal proceedings:  - as a company organ constituted pursuant to law or as members of any such organ,  - as permanent representatives of the company for the activities of the branch.  The extent of the powers of the persons authorized to represent the company must be stated, together with whether they may do so alone or must act jointly;  (i) - the winding-up of the company and the appointment of liquidators, particulars concerning them and their powers and the termination of the liquidation;  - insolvency proceedings, arrangements, compositions or any analogous proceedings to which the company is subject;  (j) the accounting documents in accordance with Article 7;  (k) the closure of the branch.  Article 9 1.  The compulsory disclosure provided for by Article 8 (1) (j) shall apply to the accounting documents of the company as drawn up, audited and disclosed pursuant to the law of the State which governs the company. Where they are not drawn up  in accordance with or in a manner equivalent to Directives 78/660/EEC and 83/349/EEC, Member States may require that accounting documents relating to the activities of the branch be drawn up and disclosed.  2.  Articles 4 and 5 shall apply.  Article 10 The Member States shall prescribe that letters and order forms used by a branch state the register in which the file in respect of the branch is kept together with the number of the branch in that register. Where the law of the State by which  the company is governed requires entry in a register, the register in which the company is entered, and the registration number of the company in that register must also be stated.   SECTION III Indication of branches in the company's annual report Article 11 The following subparagraph is added to Article 46 (2) of Directive 78/660/EEC:  '(e) the existence of branches of the company'.  SECTION IV Transitional and final provisions Article 12 The Member States shall provide for appropriate penalties in the event of failure to disclose the matters set out in Articles 1, 2, 3, 7, 8 and 9 and of omission from letters and order forms of the compulsory particulars provided for in  Articles 6 and 10.  Article 13 Each Member State shall determine who shall carry out the disclosure formalities provided for in this Directive.  Article 14 1.  Articles 3 and 9 shall not apply to branches opened by credit institutions and financial institutions covered by Directive 89/117/EEC (8).  2.  Pending subsequent coordination, the Member States need not apply Articles 3 and 9 to branches opened by insurance companies.  Article 15 Article 54 of Directive 78/660/EEC and Article 48 of Directive 83/349/EEC shall be deleted.  Article 16 1.  Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1992. They shall forthwith inform the Commission thereof.  2.  Member States shall stipulate that the provisions referred to in paragraph 1 shall apply from 1 January 1993 and, with regard to accounting documents, shall apply for the first time to annual accounts for the financial year beginning on 1 January  1993 or during 1993.  3.  Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.  Article 17 The Contact Committee set up pursuant to Article 52 of Directive 78/660/EEC shall also:  (a)  facilitate, without prejudice to Articles 169 and 170 of the Treaty, the harmonized application of this Directive, through regular meetings dealing, in particular, with practical problems arising in connection with its application;  (b)  advise the Commission, if necessary, on any additions or amendments to this Directive.  Article 18 This Directive is addressed to the Member States.   Done at Brussels, 21 December 1989.  For the Council The President E. CRESSON   (1) OJ No C 105, 21. 4. 1988, p. 6. (2) OJ No C 345, 21. 12. 1987, p. 76 and OJ No C 256,  9. 10. 1989, p. 27. (3) OJ No C 319, 30. 11. 1987, p. 61. (4) OJ No L 65, 14. 3. 1968, p. 8. (5) OJ No L 222, 14. 8. 1978, p. 11. (6) OJ No L 193, 18. 7. 1983, p. 1. (7) OJ No L 126, 12. 5. 1984, p. 20.(8) OJ No L 44, 16. 2. 1989, p. 40.


Avis juridique important

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31998L0081

Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms

Official Journal L 330 , 05/12/1998 P. 0013 - 0031

COUNCIL DIRECTIVE 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organismsTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 103s(1) thereof,Having regard to the proposal from the Commission (1),Having regard to the opinion of the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189c of the Treaty (3),(1) Whereas, within the meaning of the Treaty, action by the Community relating to the environment should be based on the principle that preventive action is to be taken and shall have as its objective to preserve, protect and improve the environment and to protect human health;(2) Whereas contained uses of genetically modified micro-organisms (GMMs) should be classified in relation to the risks they present for human health and the environment; whereas such classification should be in line with international practice and based on an assessment of the risk;(3) Whereas in order to ensure a high level of protection the containment and other protective measures applied to a contained use must correspond to the classification of the contained use; whereas in case of uncertainty the appropriate containment and other protective measures for the higher classification should be applied until less stringent measures are justified by appropriate data;(4) Whereas appropriate measures should be adopted and used for the control of the disposal of material from contained uses of GMMs;(5) Whereas GMMs which are disposed of without appropriate provisions for specific containment measures to limit their contact with the general population and the environment do not fall within the scope of the present Directive; other Community legislation such as Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (4) may apply;(6) Whereas exemptions pursuant to this Directive do not entail exemptions pursuant to any other Community legislation that may apply, such as Directive 90/220/EEC;(7) Whereas for all activities involving GMMs the principles of good microbiological practice and good occupational safety and hygiene should apply in accordance with relevant Community legislation;(8) Whereas the containment and other protective measures applied to contained uses should be reviewed periodically;(9) Whereas people employed in contained uses should be consulted in accordance with the requirements of relevant Community legislation, in particular Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (5);(10) Whereas weaknesses have been identified in Directive 90/219/EEC (6); whereas the administrative procedures and notification requirements should be linked to the risk of the contained uses;(11) Whereas Directive 90/219/EEC did not permit sufficient adaptation to technical progress; whereas the technical parts of that Directive need to be adapted to technical progress;(12) Whereas the implementation of Directive 90/219/EEC could benefit from the addition of a list of GMMs that are safe for human health and the environment; whereas these GMMs should meet certain criteria in order to establish their safety;(13) Whereas, to take account of the pace at which biotechnology is advancing, the nature of the criteria to be developed and the limited scope of this list, it is appropriate for the Council to define and revise these criteria;(14) Whereas there is now considerable experience and knowledge of the risks associated with the contained use of GMMs;(15) Whereas Directive 90/219/EEC should therefore be amended accordingly,HAS ADOPTED THIS DIRECTIVE:Article 1 Directive 90/219/EEC is hereby amended as follows:1. Articles 2 to 16 shall be replaced by the following:'Article 2For the purposes of this Directive:(a) "micro-organism" shall mean any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, animal and plant cells in culture;(b) "genetically modified micro-organism" (GMM) shall mean a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.Within the terms of this definition:(i) genetic modification occurs at least through the use of the techniques listed in Annex I, Part A;(ii) the techniques listed in Annex I, Part B, are not considered to result in genetic modification;(c) "contained use" shall mean any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with the general population and the environment;(d) "accident" shall mean any incident involving a significant and unintended release of GMMs in the course of their contained use which could present an immediate or delayed hazard to human health or the environment;(e) "user" shall mean any natural or legal person responsible for the contained use of GMMs;(f) "notification" shall mean the presentation of the requisite information to the competent authorities of a Member State.Article 3Without prejudice to Article 5(1) this Directive shall not apply:- where genetic modification is obtained through the use of the techniques/methods listed in Annex II, Part A, or- for contained uses involving only types of GMMs meeting the criteria listed in Annex II, Part B which establish their safety to human health and the environment. These types of GMMs shall be listed in Annex II, Part C.Article 4Article 5(3) and 5(6) and Articles 6 to 12 shall not apply to the transport of GMMs by road, rail, inland waterway, sea or air.This Directive shall not apply to the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market in accordance with Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (*) or pursuant to other Community legislation, which provides for a specific environmental risk assessment similar to that laid down in the said Directive, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market.(*) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Commission Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).Article 51. Member States shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the contained use of GMMs.2. To this end the user shall carry out an assessment of the contained uses as regards the risks to human health and the environment that these contained uses may incur, using as a minimum the elements of assessment and the procedure set out in Annex III, sections A and B.3. The assessment referred to in paragraph 2 shall result in the final classification of the contained uses in four classes applying the procedure set out in Annex III, which will result in the assignment of containment levels in accordance with Article 6:>TABLE>4. Where there is doubt as to which class is appropriate for the proposed contained use, the more stringent protective measures shall be applied unless sufficient evidence, in agreement with the competent authority, justifies the application of less stringent measures.5. The assessment referred to in paragraph (2) shall especially take into account the question of disposal of waste and effluents. Where appropriate, the necessary safety measures shall be implemented in order to protect human health and the environment.6. A record of the assessment referred to in paragraph (2) shall be kept by the user and made available in an appropriate form to the competent authority as part of the notification pursuant to Articles 7, 9 and 10 or on request.Article 61. The user shall apply, except to the extent that paragraph 2 of Annex IV allows other measures to be applied, the general principles and the appropriate containment and other protective measures set out in Annex IV corresponding to the class of the contained use, so as to keep workplace and environmental exposure to any GMMs to the lowest reasonably practicable level, and so that a high level of safety is ensured.2. The assessment referred to in Article 5(2) and the containment and other protective measures applied shall be reviewed periodically, and forthwith if:(a) the containment measures applied are no longer adequate or the class assigned to the contained uses is no longer correct, or(b) there is reason to suspect that the assessment is no longer appropriate judged in the light of new scientific or technical knowledge.Article 7When premises are to be used for the first time for contained uses, the user shall be required to submit to the competent authorities, before commencing such use, a notification containing at least the information listed in Annex V, Part A.Article 8Following the notification referred to in Article 7, subsequent class 1 contained use may proceed without further notification. Users of GMMs in class 1 contained uses shall be required to keep the record of each assessment referred to in Article 5(6), which shall be made available to the competent authority on request.Article 91. For first and subsequent class 2 contained uses to be carried out in premises notified in accordance with Article 7, a notification containing the information listed in Annex V, Part B shall be submitted.2. If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification.The applicant can, however, himself request a decision on a formal authorisation from the competent authority. The decision must be made within a maximum of 45 days from the notification.3. If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2 contained use may, in the absence of any indication to the contrary from the competent authority, proceed 45 days after submission of the notification referred to in paragraph 1, or earlier with the agreement of the competent authority.Article 101. For first and subsequent class 3 or class 4 contained uses to be carried out in premises notified in accordance with Article 7, a notification containing the information listed in Annex V, Part C shall be submitted.2. A class 3 or higher class of contained use may not proceed without the prior consent of the competent authority which shall communicate its decision in writing:(a) at the latest 45 days after submission of the new notification, in the case of premises which have been the subject of a previous notification to carry out class 3 or a higher class of contained uses and where any associated consent requirements have been satisfied for the same or a higher class than the contained use with which it is intended to proceed;(b) at the latest 90 days after submission of the notification, in other cases.Article 111. Member States shall designate the authority or authorities competent to implement the measures which they adopt in application of this Directive and to receive and acknowledge the notifications referred to in Articles 7, 9 and 10.2. The competent authorities shall examine the conformity of the notifications with the requirements of this Directive, the accuracy and completeness of the information given, the correctness of the assessment referred to in Article 5(2) and the class of contained uses and, where appropriate, the suitability of the containment and other protective measures, the waste management, and emergency response measures.3. If necessary, the competent authority may:(a) ask the user to provide further information or to modify the conditions of the proposed contained use or to amend the class assigned to the contained use(s). In this case the competent authority may require that the contained use, if proposed, does not begin, or, if in progress, is suspended or terminated, until the competent authority has given its approval on the basis of the further information obtained or of the modified conditions of the contained use;(b) limit the time for which the contained use should be permitted or subject it to certain specific conditions.4. For the purpose of calculating the periods referred to in Articles 9 and 10, any period of time during which the competent authority:- is awaiting any further information which it may have requested from the notifier in accordance with paragraph 3(a), or- is carrying out a public inquiry or consultation in accordance with Article 13shall not be taken into account.Article 12If the user becomes aware of relevant new information or modifies the contained use in a way which could have significant consequences for the risks posed by it, the competent authority shall be informed as soon as possible and the notification pursuant to Articles 7, 9 and 10 shall be modified.If information subsequently becomes available to the competent authority which could have significant consequences for the risks posed by the contained use, the competent authority may require the user to modify the conditions of, or suspend or terminate, the contained use.Article 13Where a Member State considers it appropriate, it may provide that the public shall be consulted on aspects of the proposed contained use, without prejudice to Article 19.Article 14The competent authorities shall ensure that before a contained use commences:(a) an emergency plan is drawn up for contained uses where failure of the containment measures could lead to serious danger, whether immediate or delayed, to humans outside the premises and/or to the environment, except where such an emergency plan has been drawn up under other Community legislation;(b) information on such emergency plans, including the relevant safety measures to be applied, is supplied in an appropriate manner, and without their having to request it, to bodies and authorities liable to be affected by the accident. The information shall be updated at appropriate intervals. It shall also be made publicly available.The Member States concerned shall at the same time make available to other Member States concerned, as a basis for all necessary consultation within the framework of their bilateral relations, the same information as that which is disseminated to their nationals.Article 151. Member States shall take the necessary measures to ensure that, in the event of an accident, the user shall be required to inform immediately the competent authority specified in Article 11 and provide the following information:- the circumstances of the accident,- the identity and quantities of the GMMs concerned,- any information necessary to assess the effects of the accident on the health of the general population and the environment,- the measures taken.2. Where information is given pursuant to paragraph 1, the Member States shall be required to:- ensure that any measures necessary are taken, and immediately alert any Member States which could be affected by the accident,- collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit the effects thereof.Article 161. Member States shall be required to:(a) consult with other Member States, likely to be affected in the event of an accident, on the proposed implementation of emergency plans;(b) inform the Commission as soon as possible of any accident within the scope of this Directive, giving details of the circumstances of the accident, the identity and quantities of the GMMs concerned, the response measures taken and their effectiveness and an analysis of the accident, including recommendations to limit its effects and avoid similar accidents in the future.2. The Commission, in consultation with the Member States, shall establish a procedure for the exchange of information pursuant to paragraph 1. It shall also set up and keep at the disposal of the Member States a register of accidents within the scope of this Directive, including an analysis of the causes of the accidents, experience gained and measures taken to avoid similar accidents in the future.`2. Articles 18, 19 and 20 shall be replaced by the following:'Article 181. Member States shall send to the Commission, at the end of each year, a summary report on class 3 and class 4 contained uses notified during that year pursuant to Article 10 including the description, purpose and risks of the contained use(s).2. Every three years, Member States shall send the Commission a summary report on their experience with this Directive, the first time being on 5 June 2003.3. Every three years, the Commission shall publish a summary based on the reports referred to in paragraph 2, the first time being on 5 June 2004.4. The Commission may publish general statistical information on the implementation of this Directive and related matters, as long as it contains no information likely to cause harm to the competitive position of a user.Article 191. Where its disclosure affects one or more of the items mentioned in Article 3(2) of Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment (*), the notifier may indicate the information in the notifications submitted pursuant to this Directive that should be treated as confidential. Verifiable justification must be given in such cases.2. The competent authority shall decide, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision.3. In no case may the following information, when submitted according to Articles 7, 9 or 10, be kept confidential:- the general characteristics of the GMMs, name and address of the notifier, and location of use,- class of contained use and measures of containment,- the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment.4. The Commission and the competent authorities shall not divulge to third parties any information decided to be confidential according to paragraph 2 and notified or otherwise provided pursuant to this Directive, and shall protect intellectual property rights relating to the data received.5. If, for whatever reasons, the notifier withdraws the notification, the competent authority must respect the confidentiality of the information supplied.(*) OJ L 158, 23.6.1990, p. 56.Article 20Amendments necessary to adapt Annex II, Part A, and Annexes III to V to technical progress and to adapt Annex II, Part C, shall be decided in accordance with the procedure laid down in Article 21.`3. The following Article shall be inserted:'Article 20aBefore 5 December 2000 Annex II, Part B, listing the criteria for inclusion of types of GMMs into Annex II, Part C, shall be adopted by the Council acting by qualified majority on a proposal from the Commission. Amendments to Annex II, Part B, shall be adopted by the Council acting by qualified majority on a proposal from the Commission.`4. The Annexes are replaced by the Annexes shown in the Annex hereto.Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 18 months after the date of its entry into force. 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 on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.Article 3 This Directive enters into force on the day of its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Luxembourg, 26 October 1998.For the CouncilThe PresidentW. SCHÜSSEL(1) OJ C 356, 22.11.1997, p. 14 andOJ C 369, 6.12.1997, p. 12.(2) OJ C 295, 7.10.1996, p. 52.(3) Opinion of the European Parliament of 12 March 1997 (OJ C 115, 14.4.1997, p. 59), Council common position of 16 December 1997 (OJ C 62, 26.2.1998, p. 1) and Decision of the European Parliament of 16 June 1998 (OJ C 210, 6.7.1998).(4) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Commission Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).(5) OJ L 374, 31.12.1990, p.1. Directive as last amended by Commission Directive 97/59/EC (OJ L 282, 15.10.1997, p. 33).(6) OJ L 117, 8.5.1990, p. 1. Directive as amended by Commission Directive 94/51/EC (OJ L 297, 18.11.1994, p. 29).ANNEX 'ANNEX IPART ATechniques of genetic modification referred to in Article 2(b)(i) are, inter alia:1. Recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation.2. Techniques involving the direct introduction into a micro-organism of heritable material prepared outside the micro-organism including micro-injection, macro-injection and micro-encapsulation.3. Cell fusion or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.PART BTechniques referred to in Article 2(b)(ii) which are not considered to result in genetic modification, on condition that they do not involve the use of recombinant-nucleic acid molecules or GMMs made by techniques/methods other than techniques/methods excluded by Annex II, PART A:(1) in vitro fertilisation;(2) natural processes such as: conjugation, transduction, transformation;(3) polyploidy induction.ANNEX IIPART ATechniques or methods of genetic modification yielding micro-organisms to be excluded from the Directive on the condition that they do not involve the use of recombinant-nucleic acid molecules or GMMs other than those produced by one or more of the techniques/methods listed below:1. Mutagenesis.2. Cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic material by known physiological processes.3. Cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions.4. Self-cloning consisting in the removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent) with or without prior enzymic or mechanical steps, into cells of the same species or into cells of phylogenetically closely related species which can exchange genetic material by natural physiological processes where the resulting micro-organism is unlikely to cause disease to humans, animals or plants.Self-cloning may include the use of recombinant vectors with an extended history of safe use in the particular micro-organisms.PART BCriteria establishing the safety of GMMs to human health and the environment:. . . (to be completed in accordance with the procedures in Article 20a)PART CTypes of GMMs which meet the criteria listed in Part B:. . . (to be completed in accordance with the procedure in Article 21)ANNEX IIIPRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO IN ARTICLE 5(2)This Annex describes in general terms the elements to be considered and the procedure to be followed to perform the assessment referred to in Article 5(2). It will be supplemented, as regards in particular section B, by guidance notes to be developed by the Commission in accordance with the procedure set out in Article 21.These guidance notes shall be completed no later than 5 June 2000.A. ELEMENTS OF ASSESSMENT1. The following should be considered as potentially harmful effects:- disease to humans including allergenic or toxic effects,- disease to animals or plants,- deleterious effects due to the impossibility of treating a disease or providing an effective prophylaxis,- deleterious effects due to establishment or dissemination in the environment,- deleterious effects due to the natural transfer of inserted genetic material to other organisms.2. The assessment referred to in Article 5(2) should be based on the following:(a) the identification of any potentially harmful effects, in particular those associated with:(i) the recipient micro-organism;(ii) the genetic material inserted (originating from the donor organism);(iii) the vector;(iv) the donor micro-organism (as long as the donor micro-organism is used during the operation);(v) the resulting GMM;(b) the characteristics of the activity;(c) the severity of the potentially harmful effects;(d) the likelihood of the potentially harmful effects being realised.B. PROCEDURE3. The first stage in the assessment process should be to identify the harmful properties of the recipient and, where appropriate, the donor micro-organism, any harmful properties associated with the vector or inserted material, including any alteration in the recipient's existing properties.4. In general, only GMMs which show the following characteristics would be considered appropriate for inclusion in class 1 as defined in Article 5:(i) the recipient or parental micro-organism is unlikely to cause disease to humans, animals or plants (1);(1) This would only apply to animals and plants in the environment likely to be exposed.(ii) the nature of the vector and the insert is such that they do not endow the GMM with a phenotype likely to cause disease to humans, animals or plants (1), or likely to cause deleterious effects in the environment;(iii) the GMM is unlikely to cause disease to humans, animals or plants (1) and is unlikely to have deleterious effects on the environment.5. In order to obtain the necessary information to implement this process the user may firstly take into account relevant Community legislation (in particular Council Directive 90/679/EEC (2)). International or national classification schemes (e.g. WHO, NIH, etc.) and their revisions due to new scientific knowledge and technical progress may also be considered.These schemes concern natural micro-organisms and as such are usually based on the ability of micro-organisms to cause disease to humans, animals or plants and on the severity and transmissibility of the disease likely to be caused. Directive 90/679/EEC classifies micro-organisms, as biological agents, into four classes of risk on the basis of potential effects on a healthy human adult. These classes of risk can be used as guidance to the categorisation of the contained use activities in the four classes of risk referred to in Article 5(3). The user may also take into consideration classification schemes referring to plant and animal pathogens (which are usually established on a national basis). The abovementioned classification schemes give only a provisional indication of the risk class of the activity and the corresponding set of containment and control measures.6. The hazard identification process carried out in accordance with paragraphs 3 to 5, should lead to the identification of the level of risk associated with the GMM.7. Selection of the containment and other protective measures should then be made on the basis of the level or risk associated with the GMMs together with consideration of:(i) the characteristics of the environment likely to be exposed (e.g. whether in the environment likely to be exposed to the GMMs there are known biota which can be adversely affected by the micro-organisms used in the contained use activity);(ii) the characteristics of the activity (e.g. its scale; nature);(iii) any non-standard operations (e.g. the inoculation of animals with GMMs; equipment likely to generate aerosols).Consideration of items (i) to (iii) for the particular activity may increase, reduce or leave unaltered the level of risk associated with the GMM as identified under paragraph 6.8. The analysis carried out as described above will finally lead to the assignment of the activity to one of the classes described in Article 5(3).9. The final classification of the contained use should be confirmed by reviewing the completed assessment referred to in Article 5(2).(1) This would only apply to animals and plants in the environment likely to be exposed.(2) OJ L 374, 31.12.1990, p. 1. Directive as last amended by Commission Directive 97/59/EC (OJ L 282, 15.10.1997, p. 33).ANNEX IVCONTAINMENT AND OTHER PROTECTIVE MEASURESGeneral principles1. These tables present the normal minimum requirements and measures necessary for each level of containment.Containment is also achieved through the use of good work practices, training, containment equipment and special installation design. For all activities involving GMMs the principles of good microbiological practice and the following principles of good occupational safety and hygiene, shall apply:(i) to keep workplace and environmental exposure to any GMM to the lowest practicable level;(ii) to exercise engineering control measures at source and to supplement these with appropriate personal protective clothing and equipment when necessary;(iii) to test adequately and maintain control measures and equipment;(iv) to test, when necessary, for the presence of viable process organisms outside the primary physical containment;(v) to provide appropriate training of personnel;(vi) to establish biological safety committees or subcommittees, if required;(vii) to formulate and implement local codes of practice for the safety of personnel, as required;(viii) where appropriate to display biohazard signs;(ix) to provide washing and decontamination facilities for personnel;(x) to keep adequate records;(xi) to prohibit eating, drinking, smoking, applying cosmetics or the storing of food for human consumption in the work area;(xii) to prohibit mouth pipetting;(xiii) to provide written standard operating procedures where appropriate to ensure safety;(xiv) to have effective disinfectants and specified disinfection procedures available in case of spillage of GMMs;(xv) to provide safe storage for contaminated laboratory equipment and materials, when appropriate.2. The titles of the tables are indicative:Table I A presents minimum requirements for laboratory activities.Table I B presents additions to and modifications of Table I A for glasshouse/growth-room activities involving GMMs.Table I C presents additions to and modifications of Table I A for activities with animals involving GMMs.Table II presents minimum requirements for activities other than laboratory activities.In some particular cases, it might be necessary to apply a combination of measures, from Table I A and Table II, of the same level.In some cases users may, with the agreement of the competent authority, not apply a specification under a particular containment level or combine specifications from two different levels.In these tables "optional" means that the user may apply these measures on a case-by-case basis, subject to the assessment referred to in Article 5(2).3. Member states may, in implementing this Annex, incorporate in addition the general principles in paragraphs 1 and 2 in the following tables for the sake of clarity of the requirements.>TABLE>Table I BContainment and other protective measures for glasshouses and growth-roomsThe terms "glasshouse" and "growth-room" refer to a structure with walls, a roof and a floor designed and used principally for growing plants in a controlled and protected environment.All provisions of Table I A shall apply with the following additions/modifications:>TABLE>>TABLE>>TABLE>ANNEX VPART AInformation required for the notification referred to in Article 7:- name of user(s) including those responsible for supervision and safety,- information on the training and qualifications of the persons responsible for supervision and safety,- details of any biological committees or subcommittees,- address and general description of the premises,- a description of the nature of the work which will be undertaken,- the class of the contained uses,- only for class 1 contained uses, a summary of the assessment referred to in Article 5(2) and information on waste management.PART BInformation required for the notification referred to in Article 9:- the date of submission of the notification referred to in Article 7,- the name of the persons responsible for supervision and safety and information on the training and qualification,- the recipient, donor and/or parental micro-organism(s) used and, where applicable, the host-vector system(s) used,- the source(s) and the intended function(s) of the genetic material(s) involved in the modification(s),- identity and characteristics of the GMM,- the purpose of the contained use including the expected results,- approximate culture volumes to be used,- description of the containment and other protective measures to be applied, including information about waste management including the wastes to be generated, their treatment, final form and destination,- a summary of the assessment referred to in Article 5(2),- the information necessary for the competent authority to evaluate any emergency response plans if required under Article 14.PART CInformation required for the notification referred to in Article 10:(a) - the date of submission of the notification referred to in Article 7,- the name of the persons responsible for supervision and safety and information on the training and qualification;(b) - the recipient or parental micro-organism(s) to be used,- the host-vector system(s) to be used (where applicable),- the source(s) and intended functions(s) of the genetic material(s) involved in the modification(s),- identity and characteristics of the GMM,- the culture volumes to be used;(c) - description of the containment and other protective measures to be applied, including information about waste management including the type and form of wastes to be generated, their treatment, final form and destination,- the purpose of the contained use including the expected results,- description of the parts of the installation;(d) information about accident prevention and emergency response plans, if any:- any specific hazards arising from the location of the installation,- the preventive measures applied such as safety equipment, alarm systems and containment methods,- procedures and plans for verifying the continuing effectiveness of the containment measures,- a description of information provided to workers,- the information necessary for the competent authority to evaluate any emergency response plans if required under Article 14;(e) a copy of the assessment referred to in Article 5(2).`