Avis juridique important

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32002L0065

Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services and amending Council Directive 90/619/EEC and Directives 97/7/EC and 98/27/EC

Official Journal L 271 , 09/10/2002 P. 0016 - 0024

Directive 2002/65/EC of the European Parliament and of the Councilof 23 September 2002concerning the distance marketing of consumer financial services and amending Council Directive 90/619/EEC and Directives 97/7/EC and 98/27/ECTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 47(2), Article 55 and Article 95 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 251 of the Treaty(3),Whereas:(1) It is important, in the context of achieving the aims of the single market, to adopt measures designed to consolidate progressively this market and those measures must contribute to attaining a high level of consumer protection, in accordance with Articles 95 and 153 of the Treaty.(2) Both for consumers and suppliers of financial services, the distance marketing of financial services will constitute one of the main tangible results of the completion of the internal market.(3) Within the framework of the internal market, it is in the interest of consumers to have access without discrimination to the widest possible range of financial services available in the Community so that they can choose those that are best suited to their needs. In order to safeguard freedom of choice, which is an essential consumer right, a high degree of consumer protection is required in order to enhance consumer confidence in distance selling.(4) It is essential to the smooth operation of the internal market for consumers to be able to negotiate and conclude contracts with a supplier established in other Member States, regardless of whether the supplier is also established in the Member State in which the consumer resides.(5) Because of their intangible nature, financial services are particularly suited to distance selling and the establishment of a legal framework governing the distance marketing of financial services should increase consumer confidence in the use of new techniques for the distance marketing of financial services, such as electronic commerce.(6) This Directive should be applied in conformity with the Treaty and with secondary law, including Directive 2000/31/EC(4) on electronic commerce, the latter being applicable solely to the transactions which it covers.(7) This Directive aims to achieve the objectives set forth above without prejudice to Community or national law governing freedom to provide services or, where applicable, host Member State control and/or authorisation or supervision systems in the Member States where this is compatible with Community legislation.(8) Moreover, this Directive, and in particular its provisions relating to information about any contractual clause on law applicable to the contract and/or on the competent court does not affect the applicability to the distance marketing of consumer financial services of Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgements in civil and commercial matters(5) or of the 1980 Rome Convention on the law applicable to contractual obligations.(9) The achievement of the objectives of the Financial Services Action Plan requires a higher level of consumer protection in certain areas. This implies a greater convergence, in particular, in non harmonised collective investment funds, rules of conduct applicable to investment services and consumer credits. Pending the achievement of the above convergence, a high level of consumer protection should be maintained.(10) Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts(6), lays down the main rules applicable to distance contracts for goods or services concluded between a supplier and a consumer. However, that Directive does not cover financial services.(11) In the context of the analysis conducted by the Commission with a view to ascertaining the need for specific measures in the field of financial services, the Commission invited all the interested parties to transmit their comments, notably in connection with the preparation of its Green Paper entitled "Financial Services - Meeting Consumers' Expectations". The consultations in this context showed that there is a need to strengthen consumer protection in this area. The Commission therefore decided to present a specific proposal concerning the distance marketing of financial services.(12) The adoption by the Member States of conflicting or different consumer protection rules governing the distance marketing of consumer financial services could impede the functioning of the internal market and competition between firms in the market. It is therefore necessary to enact common rules at Community level in this area, consistent with no reduction in overall consumer protection in the Member States.(13) A high level of consumer protection should be guaranteed by this Directive, with a view to ensuring the free movement of financial services. Member States should not be able to adopt provisions other than those laid down in this Directive in the fields it harmonises, unless otherwise specifically indicated in it.(14) This Directive covers all financial services liable to be provided at a distance. However, certain financial services are governed by specific provisions of Community legislation which continue to apply to those financial services. However, principles governing the distance marketing of such services should be laid down.(15) Contracts negotiated at a distance involve the use of means of distance communication which are used as part of a distance sales or service-provision scheme not involving the simultaneous presence of the supplier and the consumer. The constant development of those means of communication requires principles to be defined that are valid even for those means which are not yet in widespread use. Therefore, distance contracts are those the offer, negotiation and conclusion of which are carried out at a distance.(16) A single contract involving successive operations or separate operations of the same nature performed over time may be subject to different legal treatment in the different Member States, but it is important that this Directive be applied in the same way in all the Member States. To that end, it is appropriate that this Directive should be considered to apply to the first of a series of successive operations or separate operations of the same nature performed over time which may be considered as forming a whole, irrespective of whether that operation or series of operations is the subject of a single contract or several successive contracts.(17) An "initial service agreement" may be considered to be for example the opening of a bank account, acquiring a credit card, concluding a portfolio management contract, and "operations" may be considered to be for example the deposit or withdrawal of funds to or from the bank account, payment by credit card, transactions made within the framework of a portfolio management contract. Adding new elements to an initial service agreement, such as a possibility to use an electronic payment instrument together with one's existing bank account, does not constitute an "operation" but an additional contract to which this Directive applies. The subscription to new units of the same collective investment fund is considered to be one of "successive operations of the same nature".(18) By covering a service-provision scheme organised by the financial services provider, this Directive aims to exclude from its scope services provided on a strictly occasional basis and outside a commercial structure dedicated to the conclusion of distance contracts.(19) The supplier is the person providing services at a distance. This Directive should however also apply when one of the marketing stages involves an intermediary. Having regard to the nature and degree of that involvement, the pertinent provisions of this Directive should apply to such an intermediary, irrespective of his or her legal status.(20) Durable mediums include in particular floppy discs, CD-ROMs, DVDs and the hard drive of the consumer's computer on which the electronic mail is stored, but they do not include Internet websites unless they fulfil the criteria contained in the definition of a durable medium.(21) The use of means of distance communications should not lead to an unwarranted restriction on the information provided to the client. In the interests of transparency this Directive lays down the requirements needed to ensure that an appropriate level of information is provided to the consumer both before and after conclusion of the contract. The consumer should receive, before conclusion of the contract, the prior information needed so as to properly appraise the financial service offered to him and hence make a well-informed choice. The supplier should specify how long his offer applies as it stands.(22) Information items listed in this Directive cover information of a general nature applicable to all kinds of financial services. Other information requirements concerning a given financial service, such as the coverage of an insurance policy, are not solely specified in this Directive. This kind of information should be provided in accordance, where applicable, with relevant Community legislation or national legislation in conformity with Community law.(23) With a view to optimum protection of the consumer, it is important that the consumer is adequately informed of the provisions of this Directive and of any codes of conduct existing in this area and that he has a right of withdrawal.(24) When the right of withdrawal does not apply because the consumer has expressly requested the performance of a contract, the supplier should inform the consumer of this fact.(25) Consumers should be protected against unsolicited services. Consumers should be exempt from any obligation in the case of unsolicited services, the absence of a reply not being construed as signifying consent on their part. However, this rule should be without prejudice to the tacit renewal of contracts validly concluded between the parties whenever the law of the Member States permits such tacit renewal.(26) Member States should take appropriate measures to protect effectively consumers who do not wish to be contacted through certain means of communication or at certain times. This Directive should be without prejudice to the particular safeguards available to consumers under Community legislation concerning the protection of personal data and privacy.(27) With a view to protecting consumers, there is a need for suitable and effective complaint and redress procedures in the Member States with a view to settling potential disputes between suppliers and consumers, by using, where appropriate, existing procedures.(28) Member States should encourage public or private bodies established with a view to settling disputes out of court to cooperate in resolving cross-border disputes. Such cooperation could in particular entail allowing consumers to submit to extra-judicial bodies in the Member State of their residence complaints concerning suppliers established in other Member States. The establishment of FIN-NET offers increased assistance to consumers when using cross-border services.(29) This Directive is without prejudice to extension by Member States, in accordance with Community law, of the protection provided by this Directive to non-profit organisations and persons making use of financial services in order to become entrepreneurs.(30) This Directive should also cover cases where the national legislation includes the concept of a consumer making a binding contractual statement.(31) The provisions in this Directive on the supplier's choice of language should be without prejudice to provisions of national legislation, adopted in conformity with Community law governing the choice of language.(32) The Community and the Member States have entered into commitments in the context of the General Agreement on Trade in Services (GATS) concerning the possibility for consumers to purchase banking and investment services abroad. The GATS entitles Member States to adopt measures for prudential reasons, including measures to protect investors, depositors, policy-holders and persons to whom a financial service is owed by the supplier of the financial service. Such measures should not impose restrictions going beyond what is required to ensure the protection of consumers.(33) In view of the adoption of this Directive, the scope of Directive 97/7/EC and Directive 98/27/EC of the European Parliament and of the Council of 19 May 1998 on injunctions for the protection of consumers' interests(7) and the scope of the cancellation period in Council Directive 90/619/EEC of 8 November 1990 on the coordination of laws, regulations and administrative provisions relating to direct life assurance, laying down provisions to facilitate the effective exercise of freedom to provide services(8) should be adapted.(34) Since the objectives of this Directive, namely the establishment of common rules on the distance marketing of consumer financial services cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principles of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary to achieve that objective,HAVE ADOPTED THIS DIRECTIVE:Article 1Object and scope1. The object of this Directive is to approximate the laws, regulations and administrative provisions of the Member States concerning the distance marketing of consumer financial services.2. In the case of contracts for financial services comprising an initial service agreement followed by successive operations or a series of separate operations of the same nature performed over time, the provisions of this Directive shall apply only to the initial agreement.In case there is no initial service agreement but the successive operations or the separate operations of the same nature performed over time are performed between the same contractual parties, Articles 3 and 4 apply only when the first operation is performed. Where, however, no operation of the same nature is performed for more than one year, the next operation will be deemed to be the first in a new series of operations and, accordingly, Articles 3 and 4 shall apply.Article 2DefinitionsFor the purposes of this Directive:(a) "distance contract" means any contract concerning financial services concluded between a supplier and a consumer under an organised distance sales or service-provision scheme run by the supplier, who, for the purpose of that contract, makes exclusive use of one or more means of distance communication up to and including the time at which the contract is concluded;(b) "financial service" means any service of a banking, credit, insurance, personal pension, investment or payment nature;(c) "supplier" means any natural or legal person, public or private, who, acting in his commercial or professional capacity, is the contractual provider of services subject to distance contracts;(d) "consumer" means any natural person who, in distance contracts covered by this Directive, is acting for purposes which are outside his trade, business or profession;(e) "means of distance communication" refers to any means which, without the simultaneous physical presence of the supplier and the consumer, may be used for the distance marketing of a service between those parties;(f) "durable medium" means any instrument which enables the consumer to store information addressed personally to him in a way accessible for future reference for a period of time adequate for the purposes of the information and which allows the unchanged reproduction of the information stored;(g) "operator or supplier of a means of distance communication" means any public or private, natural or legal person whose trade, business or profession involves making one or more means of distance communication available to suppliers.Article 3Information to the consumer prior to the conclusion of the distance contract1. In good time before the consumer is bound by any distance contract or offer, he shall be provided with the following information concerning:(1) the supplier(a) the identity and the main business of the supplier, the geographical address at which the supplier is established and any other geographical address relevant for the customer's relations with the supplier;(b) the identity of the representative of the supplier established in the consumer's Member State of residence and the geographical address relevant for the customer's relations with the representative, if such a representative exists;(c) when the consumer's dealings are with any professional other than the supplier, the identity of this professional, the capacity in which he is acting vis-à-vis the consumer, and the geographical address relevant for the customer's relations with this professional;(d) where the supplier is registered in a trade or similar public register, the trade register in which the supplier is entered and his registration number or an equivalent means of identification in that register;(e) where the supplier's activity is subject to an authorisation scheme, the particulars of the relevant supervisory authority;(2) the financial service(a) a description of the main characteristics of the financial service;(b) the total price to be paid by the consumer to the supplier for the financial service, including all related fees, charges and expenses, and all taxes paid via the supplier or, when an exact price cannot be indicated, the basis for the calculation of the price enabling the consumer to verify it;(c) where relevant notice indicating that the financial service is related to instruments involving special risks related to their specific features or the operations to be executed or whose price depends on fluctuations in the financial markets outside the supplier's control and that historical performances are no indicators for future performances;(d) notice of the possibility that other taxes and/or costs may exist that are not paid via the supplier or imposed by him;(e) any limitations of the period for which the information provided is valid;(f) the arrangements for payment and for performance;(g) any specific additional cost for the consumer of using the means of distance communication, if such additional cost is charged;(3) the distance contract(a) the existence or absence of a right of withdrawal in accordance with Article 6 and, where the right of withdrawal exists, its duration and the conditions for exercising it, including information on the amount which the consumer may be required to pay on the basis of Article 7(1), as well as the consequences of non-exercise of that right;(b) the minimum duration of the distance contract in the case of financial services to be performed permanently or recurrently;(c) information on any rights the parties may have to terminate the contract early or unilaterally by virtue of the terms of the distance contract, including any penalties imposed by the contract in such cases;(d) practical instructions for exercising the right of withdrawal indicating, inter alia, the address to which the notification of a withdrawal should be sent;(e) the Member State or States whose laws are taken by the supplier as a basis for the establishment of relations with the consumer prior to the conclusion of the distance contract;(f) any contractual clause on law applicable to the distance contract and/or on competent court;(g) in which language, or languages, the contractual terms and conditions, and the prior information referred to in this Article are supplied, and furthermore in which language, or languages, the supplier, with the agreement of the consumer, undertakes to communicate during the duration of this distance contract;(4) redress(a) whether or not there is an out-of-court complaint and redress mechanism for the consumer that is party to the distance contract and, if so, the methods for having access to it;(b) the existence of guarantee funds or other compensation arrangements, not covered by Directive 94/19/EC of the European Parliament and of the Council of 30 May 1994 on deposit guarantee schemes(9) and Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor compensation schemes(10).2. The information referred to in paragraph 1, the commercial purpose of which must be made clear, shall be provided in a clear and comprehensible manner in any way appropriate to the means of distance communication used, with due regard, in particular, to the principles of good faith in commercial transactions, and the principles governing the protection of those who are unable, pursuant to the legislation of the Member States, to give their consent, such as minors.3. In the case of voice telephony communications(a) the identity of the supplier and the commercial purpose of the call initiated by the supplier shall be made explicitly clear at the beginning of any conversation with the consumer;(b) subject to the explicit consent of the consumer only the following information needs to be given:- the identity of the person in contact with the consumer and his link with the supplier,- a description of the main characteristics of the financial service,- the total price to be paid by the consumer to the supplier for the financial service including all taxes paid via the supplier or, when an exact price cannot be indicated, the basis for the calculation of the price enabling the consumer to verify it,- notice of the possibility that other taxes and/or costs may exist that are not paid via the supplier or imposed by him,- the existence or absence of a right of withdrawal in accordance with Article 6 and, where the right of withdrawal exists, its duration and the conditions for exercising it, including information on the amount which the consumer may be required to pay on the basis of Article 7(1).The supplier shall inform the consumer that other information is available on request and of what nature this information is. In any case the supplier shall provide the full information when he fulfils his obligations under Article 5.4. Information on contractual obligations, to be communicated to the consumer during the pre-contractual phase, shall be in conformity with the contractual obligations which would result from the law presumed to be applicable to the distance contract if the latter were concluded.Article 4Additional information requirements1. Where there are provisions in the Community legislation governing financial services which contain prior information requirements additional to those listed in Article 3(1), these requirements shall continue to apply.2. Pending further harmonisation, Member States may maintain or introduce more stringent provisions on prior information requirements when the provisions are in conformity with Community law.3. Member States shall communicate to the Commission national provisions on prior information requirements under paragraphs 1 and 2 of this Article when these requirements are additional to those listed in Article 3(1). The Commission shall take account of the communicated national provisions when drawing up the report referred to in Article 20(2).4. The Commission shall, with a view to creating a high level of transparency by all appropriate means, ensure that information, on the national provisions communicated to it, is made available to consumers and suppliers.Article 5Communication of the contractual terms and conditions and of the prior information1. The supplier shall communicate to the consumer all the contractual terms and conditions and the information referred to in Article 3(1) and Article 4 on paper or on another durable medium available and accessible to the consumer in good time before the consumer is bound by any distance contract or offer.2. The supplier shall fulfil his obligation under paragraph 1 immediately after the conclusion of the contract, if the contract has been concluded at the consumer's request using a means of distance communication which does not enable providing the contractual terms and conditions and the information in conformity with paragraph 1.3. At any time during the contractual relationship the consumer is entitled, at his request, to receive the contractual terms and conditions on paper. In addition, the consumer is entitled to change the means of distance communication used, unless this is incompatible with the contract concluded or the nature of the financial service provided.Article 6Right of withdrawal1. The Member States shall ensure that the consumer shall have a period of 14 calendar days to withdraw from the contract without penalty and without giving any reason. However, this period shall be extended to 30 calendar days in distance contracts relating to life insurance covered by Directive 90/619/EEC and personal pension operations.The period for withdrawal shall begin:- either from the day of the conclusion of the distance contract, except in respect of the said life assurance, where the time limit will begin from the time when the consumer is informed that the distance contract has been concluded, or- from the day on which the consumer receives the contractual terms and conditions and the information in accordance with Article 5(1) or (2), if that is later than the date referred to in the first indent.Member States, in addition to the right of withdrawal, may provide that the enforceability of contracts relating to investment services is suspended for the same period provided for in this paragraph.2. The right of withdrawal shall not apply to:(a) financial services whose price depends on fluctuations in the financial market outside the suppliers control, which may occur during the withdrawal period, such as services related to:- foreign exchange,- money market instruments,- transferable securities,- units in collective investment undertakings,- financial-futures contracts, including equivalent cash-settled instruments,- forward interest-rate agreements (FRAs),- interest-rate, currency and equity swaps,- options to acquire or dispose of any instruments referred to in this point including equivalent cash-settled instruments. This category includes in particular options on currency and on interest rates;(b) travel and baggage insurance policies or similar short-term insurance policies of less than one month's duration;(c) contracts whose performance has been fully completed by both parties at the consumer's express request before the consumer exercises his right of withdrawal.3. Member States may provide that the right of withdrawal shall not apply to:(a) any credit intended primarily for the purpose of acquiring or retaining property rights in land or in an existing or projected building, or for the purpose of renovating or improving a building, or(b) any credit secured either by mortgage on immovable property or by a right related to immovable property, or(c) declarations by consumers using the services of an official, provided that the official confirms that the consumer is guaranteed the rights under Article 5(1).This paragraph shall be without prejudice to the right to a reflection time to the benefit of the consumers that are resident in those Member States where it exists, at the time of the adoption of this Directive.4. Member States making use of the possibility set out in paragraph 3 shall communicate it to the Commission.5. The Commission shall make available the information communicated by Member States to the European Parliament and the Council and shall ensure that it is also available to consumers and suppliers who request it.6. If the consumer exercises his right of withdrawal he shall, before the expiry of the relevant deadline, notify this following the practical instructions given to him in accordance with Article 3(1)(3)(d) by means which can be proved in accordance with national law. The deadline shall be deemed to have been observed if the notification, if it is on paper or on another durable medium available and accessible to the recipient, is dispatched before the deadline expires.7. This Article does not apply to credit agreements cancelled under the conditions of Article 6(4) of Directive 97/7/EC or Article 7 of Directive 94/47/EC of the European Parliament and of the Council of 26 October 1994 on the protection of purchasers in respect of certain aspects of contracts relating to the purchase of the right to use immovable properties on a timeshare basis(11).If to a distance contract of a given financial service another distance contract has been attached concerning services provided by the supplier or by a third party on the basis of an agreement between the third party and the supplier, this additional distance contract shall be cancelled, without any penalty, if the consumer exercises his right of withdrawal as provided for in Article 6(1).8. The provisions of this Article are without prejudice to the Member States' laws and regulations governing the cancellation or termination or non-enforceability of a distance contract or the right of a consumer to fulfil his contractual obligations before the time fixed in the distance contract. This applies irrespective of the conditions for and the legal effects of the winding-up of the contract.Article 7Payment of the service provided before withdrawal1. When the consumer exercises his right of withdrawal under Article 6(1) he may only be required to pay, without any undue delay, for the service actually provided by the supplier in accordance with the contract. The performance of the contract may only begin after the consumer has given his approval. The amount payable shall not:- exceed an amount which is in proportion to the extent of the service already provided in comparison with the full coverage of the contract,- in any case be such that it could be construed as a penalty.2. Member States may provide that the consumer cannot be required to pay any amount when withdrawing from an insurance contract.3. The supplier may not require the consumer to pay any amount on the basis of paragraph 1 unless he can prove that the consumer was duly informed about the amount payable, in conformity with Article 3(1)(3)(a). However, in no case may he require such payment if he has commenced the performance of the contract before the expiry of the withdrawal period provided for in Article 6(1) without the consumer's prior request.4. The supplier shall, without any undue delay and no later than within 30 calendar days, return to the consumer any sums he has received from him in accordance with the distance contract, except for the amount referred to in paragraph 1. This period shall begin from the day on which the supplier receives the notification of withdrawal.5. The consumer shall return to the supplier any sums and/or property he has received from the supplier without any undue delay and no later than within 30 calendar days. This period shall begin from the day on which the consumer dispatches the notification of withdrawal.Article 8Payment by cardMember States shall ensure that appropriate measures exist to allow a consumer:- to request cancellation of a payment where fraudulent use has been made of his payment card in connection with distance contracts,- in the event of such fraudulent use, to be re-credited with the sum paid or have them returned.Article 9Unsolicited servicesWithout prejudice to Member States provisions on the tacit renewal of distance contracts, when such rules permit tacit renewal, Member States shall take the necessary measures to:- prohibit the supply of financial services to a consumer without a prior request on his part, when this supply includes a request for immediate or deferred payment,- exempt the consumer from any obligation in the event of unsolicited supplies, the absence of a reply not constituting consent.Article 10Unsolicited communications1. The use by a supplier of the following distance communication techniques shall require the consumer's prior consent:(a) automated calling systems without human intervention (automatic calling machines);(b) fax machines.2. Member States shall ensure that means of distance communication other than those referred to in paragraph 1, when they allow individual communications:(a) shall not be authorised unless the consent of the consumers concerned has been obtained, or(b) may only be used if the consumer has not expressed his manifest objection.3. The measures referred to in paragraphs 1 and 2 shall not entail costs for consumers.Article 11SanctionsMember States shall provide for appropriate sanctions in the event of the supplier's failure to comply with national provisions adopted pursuant to this Directive.They may provide for this purpose in particular that the consumer may cancel the contract at any time, free of charge and without penalty.These sanctions must be effective, proportional and dissuasive.Article 12Imperative nature of this Directive's provisions1. Consumers may not waive the rights conferred on them by this Directive.2. Member States shall take the measures needed to ensure that the consumer does not lose the protection granted by this Directive by virtue of the choice of the law of a non-member country as the law applicable to the contract, if this contract has a close link with the territory of one or more Member States.Article 13Judicial and administrative redress1. Member States shall ensure that adequate and effective means exist to ensure compliance with this Directive in the interests of consumers.2. The means referred to in paragraph 1 shall include provisions whereby one or more of the following bodies, as determined by national law, may take action in accordance with national law before the courts or competent administrative bodies to ensure that the national provisions for the implementation of this Directive are applied:(a) public bodies or their representatives;(b) consumer organisations having a legitimate interest in protecting consumers;(c) professional organisations having a legitimate interest in acting.3. Member States shall take the measures necessary to ensure that operators and suppliers of means of distance communication put an end to practices that have been declared to be contrary to this Directive, on the basis of a judicial decision, an administrative decision or a decision issued by a supervisory authority notified to them, where those operators or suppliers are in a position to do so.Article 14Out-of-court redress1. Member States shall promote the setting up or development of adequate and effective out-of-court complaints and redress procedures for the settlement of consumer disputes concerning financial services provided at distance.2. Member States shall, in particular, encourage the bodies responsible for out-of-court settlement of disputes to cooperate in the resolution of cross-border disputes concerning financial services provided at distance.Article 15Burden of proofWithout prejudice to Article 7(3), Member States may stipulate that the burden of proof in respect of the supplier's obligations to inform the consumer and the consumer's consent to conclusion of the contract and, where appropriate, its performance, can be placed on the supplier.Any contractual term or condition providing that the burden of proof of the respect by the supplier of all or part of the obligations incumbent on him pursuant to this Directive should lie with the consumer shall be an unfair term within the meaning of Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts(12).Article 16Transitional measuresMember States may impose national rules which are in conformity with this Directive on suppliers established in a Member State which has not yet transposed this Directive and whose law has no obligations corresponding to those provided for in this Directive.Article 17Directive 90/619/ECIn Article 15(1) of Directive 90/619/EEC the first subparagraph shall be replaced by the following: "1. Each Member State shall prescribe that a policyholder who concludes an individual life-assurance contract shall have a period of 30 calendar days, from the time when he was informed that the contract had been concluded, within which to cancel the contract."Article 18Directive 97/7/ECDirective 97/7/EC is hereby amended as follows:1. the first indent of Article 3(1) shall be replaced by the following: "- relating to any financial service to which Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services and amending Council Directive 90/619/EEC and Directives 97/7/EC and 98/27/EC(13) applies,";2. Annex II shall be deleted.Article 19Directive 98/27/ECThe following point shall be added to the Annex of Directive 98/27/EC: "11. Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services and amending Council Directive 90/619/EEC and Directives 97/7/EC and 98/27/EC(14)."Article 20Review1. Following the implementation of this Directive, the Commission shall examine the functioning of the internal market in financial services in respect of the marketing of those services. It should seek to analyse and detail the difficulties that are, or might be faced by both consumers and suppliers, in particular arising from differences between national provisions regarding information and right of withdrawal.2. Not later than 9 April 2006 the Commission shall report to the European Parliament and the Council on the problems facing both consumers and suppliers seeking to buy and sell financial services, and shall submit, where appropriate, proposals to amend and/or further harmonise the information and right of withdrawal provisions in Community legislation concerning financial services and/or those covered in Article 3.Article 21Transposition1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 9 October 2004. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a 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 governed by this Directive together with a table showing how the provisions of this Directive correspond to the national provisions adopted.Article 22Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 23AddresseesThis Directive is addressed to the Member States.Done at Brussels, 23 September 2002.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentM. Fischer Boel(1) OJ C 385, 11.12.1998, p. 10 andOJ C 177 E, 27.6.2000, p. 21.(2) OJ C 169, 16.6.1999, p. 43.(3) Opinion of the European Parliament of 5 May 1999 (OJ C 279, 1.10.1999, p. 207), Council Common Position of 19 December 2001 (OJ C 58 E, 5.3.2002, p. 32) and Decision of the European Parliament of 14 May 2002 (not yet published in the Official Journal). Council Decision of 26 June 2002 (not yet published in the Official Journal).(4) OJ L 178, 17.7.2000, p. 1.(5) OJ L 12, 16.1.2001, p. 1.(6) OJ L 144, 4.6.1997, p. 19.(7) OJ L 166, 11.6.1998, p. 51. Directive as last amended by Directive 2000/31/EC (OJ L 178, 17.7.2001, p. 1).(8) OJ L 330, 29.11.1990, p. 50. Directive as last amended by Directive 92/96/EEC (OJ L 360, 9.12.1992, p. 1).(9) OJ L 135, 31.5.1994, p. 5.(10) OJ L 84, 26.3.1997, p. 22.(11) OJ L 280, 29.10.1994, p. 83.(12) OJ L 95, 21.4.1993, p. 29.(13) OJ L 271, 9.10.2002, p. 16.(14) OJ L 271, 9.10.2002, p. 16.


Avis juridique important

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31997L0050

Directive 97/50/EC of the European Parliament and of the Council of 6 October 1997 amending Directive 93/16/EEC to facilitate the free movement of doctors and the mutual recognition of their diplomas, certificates and other evidence of formal qualifications

Official Journal L 291 , 24/10/1997 P. 0035 - 0037

DIRECTIVE 97/50/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 October 1997 amending Directive 93/16/EEC to facilitate the free movement of doctors and the mutual recognition of their diplomas, certificates and other evidence of formal qualificationsTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Articles 49, 57 (1) and (2), first and third sentences, and 66 thereof,Having regard to the proposal from the Commission (1),Having consulted the Economic and Social Committee (2),Acting in accordance with the procedure laid down in Article 189b of the Treaty (3) in the light of the joint text approved on 28 May 1997 by the Conciliation Committee,Whereas it is necessary to introduce appropriate procedures for updating Articles 5 (3), 7 (2), 26 and 27 of Directive 93/16/EEC (4) to take into account the frequent changes in the training and designations of medical specializations in the various Member States;Whereas use of these procedures which are set out in Council Decision 87/373/EEC of 13 July 1987 laying down the procedures for the exercise of implementing powers conferred on the Commission (5) would make it possible to improve the efficiency of the Community's decision making in order to facilitate the effective exercise of the right of establishment of, and freedom to provide services by, those medical specialists whose rights are dependent on the updating of the said provisions;Whereas the procedures laid down in Decision 87/373/EEC will be applied on the basis of the modus vivendi (6) relating to the committee procedure as agreed by the European Parliament, the Council and the Commission until such time as a revision of the Treaties is carried out pursuant to Article N (2) of the Treaty on European Union;Whereas it is necessary to update Articles 5 (3) and 7 (2) in relation to medical specializations as and when they are recognized by two or more Member States and to add those Member States to the relevant lists of designations of specializations as and when the training in those Member States complies with the minimum requirements set out in Directive 93/16/EEC;Whereas it is necessary to set in Articles 26 and 27 of the said Directive the minimum length of the training courses for the specializations when they are introduced and to update others as and when necessary;Whereas the Commission assisted by the Committee of Senior Officials on Public Health set up by Decision 75/365/EEC (7) in an advisory capacity will be able to carry out the necessary changes to Articles 5 (3) and 7 (2);Whereas it is appropriate that in assisting the Commission to carry out those changes to Articles 26 and 27, the said Committee should be acting as a management committee;Whereas the Advisory Committee on Medical Training established within the Commission by virtue of Decision 75/364/EEC (8) communicates to the Commission and to the Member States its opinion and recommendations in the framework of the application of Directive 93/16/EEC;Whereas for the nationals of Member States who hold qualifications awarded in third countries, relevant problems in the context of the application of the sectoral Directives should be addressed in the framework of the general system of recognition of higher education diplomas awarded on completion of professional education and training,HAVE ADOPTED THIS DIRECTIVE:Article 1 Directive 93/16/EEC shall be amended as follows:1. the following paragraph 4 shall be added in Article 5:'4. The list of designations in paragraph 3 shall be amended in accordance with the procedure laid down in Article 44a (2).`;2. the following paragraph 3 shall be added to Article 7:'3. The list of designations in paragraph 2 shall be amended in accordance with the procedure laid down in Article 44a (2).`;3. the following paragraph shall be added to Articles 26 and 27:'The list of the minimum lengths of the specialized training courses referred to in this Article shall be amended in accordance with the procedure laid down in Article 44a (3).`;4. the following Article shall be added:'Article 44a1. Where the procedure laid down in this Article is to be followed, the Commission shall be assisted by the Committee of Senior Officials on Public Health, set up under Decision 75/365/EEC (*).2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account.3. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chaiman shall not vote.The Commission shall adopt measures which apply immediately. However, if these measures are not in accordance with the opinion of the committee, they shall be communicated by the Commission to the Council forthwith.In that event:(a) the Commission shall defer application of the measures which it has decided for a period of two months from the date of such communication;(b) the Council, acting by a qualified majority, may take a different decision within the time limit referred to in point (a).(*) OJ L 167, 30. 6. 1975, p. 19. Decision as last amended by Decision 80/157/EEC (OJ L 33, 11. 2. 1980, p. 15).`Article 2 This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities.Article 3 This Directive is addressed to the Member States.Done at Brussels, 6 October 1997.For the European ParliamentThe PresidentJ. M. GIL-ROBLESFor the CouncilThe PresidentJ. POOS(1) OJ C 389, 31. 12. 1994, p. 19 andOJ C 28, 1. 2. 1996, p. 7(2) OJ C 133, 31. 5. 1995, p. 10.(3) Opinion of the European Parliament of 29 June 1995 (OJ C 183, 17. 7. 1995, p. 24), Council common position of 18 June 1996 (OJ C 248, 26. 8. 1996, p. 71) and Decision of the European Parliament of 22 October 1996 (OJ C 347, 18. 11. 1996, p. 31). Decision of the European Parliament of 17 July 1997. Council Decision of 24 July 1997.(4) OJ L 165, 7. 7. 1993, p. 1. Directive as amended by the 1994 Act of Accession.(5) OJ L 197, 18. 7. 1987, p. 33.(6) OJ C 102, 4. 4. 1996, p. 1.(7) OJ L 167, 30. 6. 1975, p. 19. Decision as last amended by Decision 80/157/EEC (OJ L 33, 11. 2. 1980, p. 15).(8) OJ L 167, 30. 6. 1975, p. 17.Commission Statement Re recital 7b (new)The Commission stresses that the need to establish the equivalence of diplomas awarded to doctors outside the European Union is one of the relevant problems to be tackled.


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31998L0094

Council Directive 98/94/EC of 14 December 1998 amending Directive 94/4/EC and extending the temporary derogation applicable to Germany and Austria

Official Journal L 358 , 31/12/1998 P. 0105 - 0106

COUNCIL DIRECTIVE 98/94/EC of 14 December 1998 amending Directive 94/4/EC and extending the temporary derogation applicable to Germany and AustriaTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 99 thereof,Having regard to the Commission proposal (1),Having regard to the opinion of the European Parliament (2),Having regard to the opinion of the Economic and Social Committee (3),Whereas Article 3(2) of Directive 94/4/EC (4) provided for the application until 31 December 1997 of a temporary derogation to the Federal Republic of Germany and the Republic of Austria concerning the application of an allowance of not less than ECU 75 to goods imported by travellers entering German or Austrian territory by a land frontier linking the two Member States to countries other than Member States and EFTA members or, where applicable, by means of coastal navigation coming from those countries;Whereas account is taken of the economic difficulties likely to be caused by the amount of the allowances applicable to travellers importing goods into the Community in the situations described above;Whereas, by letters of 24 June and 23 July 1997, the Federal Republic of Germany and the Federal Republic of Austria requested an extension of the derogation provided for in Article 3(2) of Directive 94/4/EC; whereas their request is based on the fact that the economic difficulties that had prompted the adoption of Directives 94/4/EC and 94/75/EC had persisted and, in some cases, worsened;Whereas account should be taken of the situation described by the two Member States;Whereas an extension of the derogation should, however, be accompanied by the fixing of a deadline for bringing the allowance applied by Germany and Austria into line with that in force on that date in the other Member States, the raising of the limit applicable to the two Member States from 1 January 1999 in order to limit distortions of competition and an undertaking by those Member States that they will gradually and jointly further raise the limit in order to bring it into line with the Community limit by 1 January 2003,HAS ADOPTED THIS DIRECTIVE:Article 1 1. With effect from 1 January 1998, the first subparagraph of Article 3(2) of Directive 94/4/EC shall be replaced by the following:'2. By way of derogation from paragraph 1, the Federal Republic of Germany and the Republic of Austria shall be authorised to bring into force the measures necessary to comply with this Directive by 1 January 2003 at the latest for goods imported by travellers entering German or Austrian territory by a land frontier linking Germany or Austria to countries other than Member States and the EFTA members or, where applicable, by means of coastal navigation coming from the said countries.`2. With effect from 1 January 1999, the second subparagraph of Article 3(2) of Directive 94/4/EC shall be replaced by the following:'However, those Member States shall apply an allowance of not less than ECU 100 from 1 January 1999 to imports by the travellers referred to in the preceding subparagraph. They shall jointly increase that amount gradually, with a view to applying the limit in force in the Community to the said imports by 1 January 2003 at the latest.`Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 1999. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their publication. The methods of making such a reference shall be laid down by the Member States.2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive.Article 3 This Directive shall enter 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 Brussels, 14 December 1998.For the CouncilThe PresidentW. MOLTERER(1) OJ C 273, 2. 9. 1998, p. 8.(2) Opinion delivered on 3 December 1998 (not yet published in the Official Journal).(3) Opinion delivered on 15 October 1998 (not yet published in the Official Journal).(4) OJ L 60, 3. 3. 1994, p. 14. Directive as amended by Directive 94/75/EC (OJ L 365, 31. 12. 1994, p. 52).


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31993L0088

Council Directive 93/88/EEC of 12 October 1993 amending Directive 90/679/EEC 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)

Official Journal L 268 , 29/10/1993 P. 0071 - 0082 Finnish special edition: Chapter 5 Volume 6 P. 0106  Swedish special edition: Chapter 5 Volume 6 P. 0106

COUNCIL DIRECTIVE 93/88/EEC of 12 October 1993 amending Directive 90/679/EEC 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)THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 118a thereof,  Having regard to the proposal from the Commission (1), drawn up after consulting the Advisory Committee on Safety, Hygiene and Health Protection at Work,  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Article 18 of Directive 90/679/EEC (4) states that, in accordance with the procedure laid down in Article 118a of the Treaty, the Council must adopt a first list of Group 2, Group 3 and Group 4 biological agents for Annex III to that Directive;   Whereas that first list of biological agents must be classified on the basis of the definitions given in Article 2 (d) (2), (3) and (4) (Groups 2, 3 and 4) of the said Directive;  Whereas the list does not contain genetically modified biological agents;  Whereas, for a number of biological agents details additional to their classification should be given;  Whereas it is appropriate to include in Directive 90/679/EEC a recommended code of practice, for the purpose of furnishing guidelines only, on vaccination of workers exposed to biological agents for which effective vaccines exist,  HAS ADOPTED THIS DIRECTIVE:   Article 1  Directive 90/679/EEC is hereby amended as follows:  1. the following subparagraph shall be inserted after the second subparagraph of Article 14 (3):  'When employers make vaccines available, they should take account of the recommended code of practice set out in Annex VII.';  2. Annex III shall be replaced by the text in Annex I to this Directive;  3. Annex VII appearing in Annex II to this Directive shall be added.   Article 2  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 April 1994. They shall forthwith inform the Commission thereof.  However, in the case of the Portuguese Republic, the date referred to in the first subparagraph shall be 31 December 1995.  2. Member States shall communicate to the Commission the provisions of national law already adopted or which they adopt in the field governed by this Directive.  3. When Member States adopt such provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member  States.   Article 3  This Directive is addressed to the Member States.  Done at Luxembourg, 12 October 1993.  For the Council The President M. SMET  (1) OJ No C 217, 24. 8. 1992, p. 32.  (2) OJ No C 72, 19. 3. 1993, p. 74 and OJ No C 255, 20. 9. 1993.  (3) OJ No C 19, 25. 1. 1993, p. 16.  (4) OJ No L 374, 31. 12. 1990, p. 1.      ANNEX I 'ANNEX III COMMUNITY CLASSIFICATION (Article 18 and Article 2 (d)) Introductory notes 1. In line with the scope of the Directive, only agents which are known to infect humans are to be included in the classified list.  Where appropriate, indicators are given of the toxic and allergic potential of these agents.  Animal and plant pathogens which are known not to affect man are excluded.  In drawing up this first list of classified biological agents consideration has not been given to genetically modified micro-organisms.  2. The list of classified agents is based on the effect of those agents on healthy workers.  No specific account is taken of particular effects on those whose susceptibility may be affected for one or other reason such as pre-existing disease, medication, compromised immunity, pregnancy or breast feeding.  Additional risk to such workers should be considered as part of the risk assessment required by the Directive.  In certain industrial processes, certain laboratory work or certain work with animals involving actual or potential exposure to biological agents of Groups 3 or 4, any technical precautions taken must comply with Article 16 of the Directive.  3. Biological agents which have not been classified for inclusion in Groups 2 to 4 of the list are not implicitly classified in Group 1.  For agents where more than one species is known to be pathogenic to man, the list will include those species which are known to be the most frequently responsible for diseases, together with a more general reference to the fact that other species of the  same genus may affect health.  When a whole genus is mentioned in the classified list of biological agents, it is implicit that the species and strains known to be non-pathogenic are excluded.  4. Where a strain is attenuated or has lost known virulence genes, then the containment required by the classification of its parent strain need not necessarily apply, subject to assessment appropriate for risk in the workplace.  For example, when such a strain is to be used as a product or part of a product for prophylactic or therapeutic purposes.  5. The nomenclature of classified agents used to establish this list reflects and is in conformity with the latest international agreements of the taxonomy and nomenclature of agents at the time the list was prepared.  6. The list or classified biological agents reflects the state of knowledge at the time that it was devised.  It will be updated as soon as it no longer reflects the latest state of knowledge.  7. Member States are to ensure that all viruses which have already been isolated in humans and which have not been assessed and allocated in this Annex are classified in Group 2 as a minimum, except where Member States have proof that they are unlikely  to cause disease in humans.  8. Certain biologocial agents classified in Group 3 which are indicated in the appended list by an asterisk (*), may present a limited risk of infection for workers because they are not normally infectious by the air-borne route.  Member States shall assess the containment measures to be applied to such agents, taking account of the nature of specific activities in question and of the quantity of the agent involved, with a view to determining whether, in particular circumstances,  some of these measures may be dispensed with.  9. The requirements as to containment consequent upon the classification of parasites apply only to stages in the life cycle of the parasite in which it is liable to be infectious to humans at the workplace.  10. This list also gives a separate indication in cases where the biological agents are likely to cause allergic or toxic reactions, where an effective vaccine is available, or where it is advisable to keep a list of exposed workers for more than 10  years.  These indications are shown by the following letters:  A: Possible allergic effects D: List of workers exposed to this biological agent to be kept for more than 10 years after the end of last known exposure T: Toxin production V: Effective vaccine available The application of preventive vaccination should take account of the Code of Practice given in Annex VII.  BACTERIA and similar organisms NB: For biological agents appearing on this list, "spp." refers to other species which are known pathogens in humans.   "" ID="01">Actinobacillus actinomycetemcomitans> ID="02">2"> ID="01">Actinomadura madurae> ID="02">2"> ID="01">Actinomadura pelletieri> ID="02">2"> ID="01">Actinomyces gerencseriae> ID="02">2"> ID="01">Actinomyces israelii> ID="02">2">  ID="01">Actinomyces pyogenes> ID="02">2"> ID="01">Actinomyces spp.> ID="02">2"> ID="01">Arcanobacterium haemolyticum (Corynebacterium haemolyticum)> ID="02">2"> ID="01">Bacillus anthracis> ID="02">3"> ID="01">Bacteroides fragilis> ID="02">2">  ID="01">Bartonella bacilliformis> ID="02">2"> ID="01">Bordetella bronchiseptica> ID="02">2"> ID="01">Bordetella parapertussis> ID="02">2"> ID="01">Bordetella pertussis> ID="02">2> ID="03">V"> ID="01">Borrelia burgdorferi> ID="02">2">  ID="01">Borrelia duttonii> ID="02">2"> ID="01">Borrelia recurrentis> ID="02">2"> ID="01">Borrelia spp.> ID="02">2"> ID="01">Brucella abortus> ID="02">3"> ID="01">Brucella canis> ID="02">3"> ID="01">Brucella melitensis> ID="02">3"> ID="01">Brucella  suis> ID="02">3"> ID="01">Campylobacter fetus> ID="02">2"> ID="01">Campylobacter jejuni> ID="02">2"> ID="01">Campylobacter spp.> ID="02">2"> ID="01">Cardiobacterium hominis> ID="02">2"> ID="01">Chlamydia pneumoniae> ID="02">2"> ID="01">Chlamydia  trachomatis> ID="02">2"> ID="01">Chlamydia psittaci (avian strains)> ID="02">3"> ID="01">Chlamydia psittaci (other strains)> ID="02">2"> ID="01">Clostridium botulinum> ID="02">2> ID="03">T"> ID="01">Clostridium perfringens> ID="02">2">  ID="01">Clostridium tetani> ID="02">2> ID="03">T, V"> ID="01">Clostridium spp.> ID="02">2"> ID="01">Corynebacterium diphtheriae> ID="02">2> ID="03">T, V"> ID="01">Corynebacterium minutissimum> ID="02">2"> ID="01">Corynebacterium pseudotuberculosis>  ID="02">2"> ID="01">Corynebacterium spp.> ID="02">2"> ID="01">Coxiella burnetii> ID="02">3"> ID="01">Edwardsiella tarda> ID="02">2"> ID="01">Ehrlichia sennetsu (Rickettsia sennetsu)> ID="02">2"> ID="01">Ehrlichia spp.> ID="02">2">  ID="01">Eikenella corrodens> ID="02">2"> ID="01">Enterobacter aerogenes/cloacae> ID="02">2"> ID="01">Enterobacter spp.> ID="02">2"> ID="01">Enterococcus spp.> ID="02">2"> ID="01">Erysipelothrix rhusiopathiae> ID="02">2"> ID="01">Escherichia coli  (with the exception of non-pathogenic strains)> ID="02">2"> ID="01">Flavobacterium meningosepticum> ID="02">2"> ID="01">Fluoribacter bozemanae (Legionella)> ID="02">2"> ID="01">Francisella tularensis (Type A)> ID="02">3"> ID="01">Francisella  tularensis (Type B)> ID="02">2"> ID="01">Fusobacterium necrophorum> ID="02">2"> ID="01">Gardnerella vaginalis> ID="02">2"> ID="01">Haemophilus ducreyi> ID="02">2"> ID="01">Haemophilus influenzae> ID="02">2"> ID="01">Haemophilus spp.> ID="02">2">  ID="01">Helicobacter pylori> ID="02">2"> ID="01">Klebsiella oxytoca> ID="02">2"> ID="01">Klebsiella pneumoniae> ID="02">2"> ID="01">Klebsiella spp.> ID="02">2"> ID="01">Legionella pneumophila> ID="02">2"> ID="01">Legionella spp.> ID="02">2">  ID="01">Leptospira interrogans (all serovars)> ID="02">2"> ID="01">Listeria monocytogenes> ID="02">2"> ID="01">Listeria ivanovii> ID="02">2"> ID="01">Morganella morganii> ID="02">2"> ID="01">Mycobacterium africanum> ID="02">3> ID="03">V">  ID="01">Mycobacterium avium/intracellulare> ID="02">2"> ID="01">Mycobacterium bovis (except BCG strain)> ID="02">3> ID="03">V"> ID="01">Mycobacterium chelonae> ID="02">2"> ID="01">Mycobacterium fortuitum> ID="02">2"> ID="01">Mycobacterium kansasii>  ID="02">2"> ID="01">Mycobacterium leprae> ID="02">3"> ID="01">Mycobacterium malmoense> ID="02">2"> ID="01">Mycobacterium marinum> ID="02">2"> ID="01">Mycobacterium microti> ID="02">3 (*)"> ID="01">Mycobacterium paratuberculosis> ID="02">2">  ID="01">Mycobacterium scrofulaceum> ID="02">2"> ID="01">Mycobacterium simiae> ID="02">2"> ID="01">Mycobacterium szulgai> ID="02">2"> ID="01">Mycobacterium tuberculosis> ID="02">3> ID="03">V"> ID="01">Mycobacterium ulcerans> ID="02">3 (*)">  ID="01">Mycobacterium xenopi> ID="02">2"> ID="01">Mycoplasma pneumoniae> ID="02">2"> ID="01">Neisseria gonorrhoeae> ID="02">2"> ID="01">Neisseria meningitidis> ID="02">2> ID="03">V"> ID="01">Nocardia asteroides> ID="02">2"> ID="01">Nocardia  brasiliensis> ID="02">2"> ID="01">Nocardia farcinica> ID="02">2"> ID="01">Nocardia nova> ID="02">2"> ID="01">Nocardia otitidiscaviarum> ID="02">2"> ID="01">Pasteurella multocida> ID="02">2"> ID="01">Pasteurella spp.> ID="02">2">  ID="01">Peptostreptococcus anaerobius> ID="02">2"> ID="01">Plesiomonas shigelloides> ID="02">2"> ID="01">Porphyromonas spp.> ID="02">2"> ID="01">Prevotella spp.> ID="02">2"> ID="01">Proteus mirabilis> ID="02">2"> ID="01">Proteus penneri>  ID="02">2"> ID="01">Proteus vulgaris> ID="02">2"> ID="01">Providencia alcalifaciens> ID="02">2"> ID="01">Providencia rettgeri> ID="02">2"> ID="01">Providencia spp.> ID="02">2"> ID="01">Pseudomonas aeruginosa> ID="02">2"> ID="01">Pseudomonas  mallei> ID="02">3"> ID="01">Pseudomonas pseudomallei> ID="02">3"> ID="01">Rhodococcus equi> ID="02">2"> ID="01">Rickettsia akari> ID="02">3 (*)"> ID="01">Rickettsia canada> ID="02">3 (*)"> ID="01">Rickettsia conorii> ID="02">3"> ID="01">Rickettsia  montana> ID="02">3 (*)"> ID="01">Rickettsia typhi (Rickettsia mooseri)> ID="02">3"> ID="01">Rickettsia prowazekii> ID="02">3"> ID="01">Rickettsia rickettsii> ID="02">3"> ID="01">Rickettsia tsutsugamushi> ID="02">3"> ID="01">Rickettsia spp.>  ID="02">2"> ID="01">Rochalimaea quintana> ID="02">2"> ID="01">Salmonella Arizonae> ID="02">2"> ID="01">Salmonella Enteritidis> ID="02">2"> ID="01">Salmonella Typhimurium> ID="02">2"> ID="01">Salmonella Paratyphi A, B, C> ID="02">2> ID="03">V">  ID="01">Salmonella Typhi> ID="02">3 (*)> ID="03">V"> ID="01">Salmonella (other serovars)> ID="02">2"> ID="01">Serpulina spp.> ID="02">2"> ID="01">Shigella boydii> ID="02">2"> ID="01">Shigella dysenteriae (Type 1)> ID="02">3 (*)> ID="03">T">  ID="01">Shigella flexneri> ID="02">2"> ID="01">Shigella sonnei> ID="02">2"> ID="01">Staphylococcus aureus> ID="02">2"> ID="01">Streptobacillus moniliformis> ID="02">2"> ID="01">Streptococcus pneumoniae> ID="02">2"> ID="01">Streptococcus pyogenes>  ID="02">2"> ID="01">Streptococcus spp.> ID="02">2"> ID="01">Treponema carateum> ID="02">2"> ID="01">Treponema pallidum> ID="02">2"> ID="01">Treponema pertenue> ID="02">2"> ID="01">Treponema spp.> ID="02">2"> ID="01">Vibrio cholerae (including El  Tor)> ID="02">2"> ID="01">Vibrio parahaemolyticus> ID="02">2"> ID="01">Vibrio spp.> ID="02">2"> ID="01">Yersinia enterocolitica> ID="02">2"> ID="01">Yersinia pestis> ID="02">3> ID="03">V"> ID="01">Yersinia pseudotuberculosis> ID="02">2">  ID="01">Yersinia spp.> ID="02">2 ""(*) See paragraph 8 of the introductory notes.  >VIRUS (*)  "" ID="01">Adenoviridae> ID="02">2"> ID="01">Arenaviridae"> ID="01">Junin virus> ID="02">4"> ID="01">Lassa fever virus> ID="02">4"> ID="01">Lymphocyctic choriomeningitis virus (neurotropic strains)> ID="02">3"> ID="01">Lymphocytic  choriomeningitis virus (other strains)> ID="02">2"> ID="01">Machupo virus> ID="02">4"> ID="01">Mopeia virus and other Tacaribe viruses> ID="02">2"> ID="01">Astroviridae> ID="02">2"> ID="01">Bunyaviridae"> ID="01">Bunyamwera virus> ID="02">2">  ID="01">Oropouche virus> ID="02">3"> ID="01">California encephalitis virus> ID="02">2"> ID="01">Hantaviruses:"> ID="01">Hantaan (Korean haemorrhagic fever)> ID="02">3"> ID="01">Seoul virus> ID="02">3"> ID="01">Puumala virus> ID="02">2">  ID="01">Prospect Hill virus> ID="02">2"> ID="01">Other hantaviruses> ID="02">2"> ID="01">Nairoviruses:"> ID="01">Crimean-Congo haemorrhagic fever> ID="02">4"> ID="01">Hazara virus> ID="02">2"> ID="01">Phleboviruses:"> ID="01">Rift Valley fever>  ID="02">3> ID="03">V"> ID="01">Sandfly fever> ID="02">2"> ID="01">Toscana virus> ID="02">2"> ID="01">Other bunyaviridae known to be pathogenic> ID="02">2"> ID="01">Caliciviridae"> ID="01">Norwalk virus> ID="02">2"> ID="01">Other Caliciviridae>  ID="02">2"> ID="01">Coronaviridae> ID="02">2"> ID="01">Filoviridae"> ID="01">Ebola virus> ID="02">4"> ID="01">Marburg virus> ID="02">4"> ID="01">Flaviviridae"> ID="01">Australia encephalitis (Murray Valley encephalitis)> ID="02">3">  ID="01">Central European tick-borne encephalitis virus> ID="02">3 (**)> ID="03">V"> ID="01">Absettarov> ID="02">3"> ID="01">Hanzalova> ID="02">3"> ID="01">Hypr> ID="02">3"> ID="01">Kumlinge> ID="02">3"> ID="01">Dengue virus type 1-4> ID="02">3">  ID="01">Hepatitis C virus> ID="02">3 (**)> ID="03">D"> ID="01">Japanese B encephalitis> ID="02">3> ID="03">V"> ID="01">Kyasanur Forest> ID="02">3> ID="03">V"> ID="01">Louping ill> ID="02">3 (**)"> ID="01">Omsk (a)> ID="02">3> ID="03">V">  ID="01">Powassan> ID="02">3"> ID="01">Rocio> ID="02">3"> ID="01">Russian spring-summer encephalitis (TBE) (a)> ID="02">3> ID="03">V"> ID="01">St Louis encephalitis> ID="02">3"> ID="01">Wesselsbron virus> ID="02">3 (**)"> ID="01">West Nile fever  virus> ID="02">3"> ID="01">Yellow fever> ID="02">3> ID="03">V"> ID="01">Other flaviviruses known to be pathogenic> ID="02">2"> ID="01">Hepadnaviridae"> ID="01">Hepatitis B virus> ID="02">3 (**)> ID="03">V, D"> ID="01">Hepatitis D virus (Delta) (b)>  ID="02">3 (**)> ID="03">V, D"> ID="01">Herpesviridae"> ID="01">Cytomegalovirus> ID="02">2"> ID="01">Epstein-Barr virus> ID="02">2"> ID="01">Herpesvirus simiae (B virus)> ID="02">3"> ID="01">Herpes simplex virus types 1 and 2> ID="02">2">  ID="01">Herpesvirus varicella-zoster> ID="02">2"> ID="01">Human B-lymphotropic virus (HBLV-HHV6)> ID="02">2"> ID="01">Orthomyxoviridae"> ID="01">Influenza viruses types A, B and C> ID="02">2> ID="03">V (c)"> ID="01">Tick-borne orthomyxoviridae:  Dhori and Thogoto viruses> ID="02">2"> ID="01">Papovaviridae"> ID="01">BK and JC viruses> ID="02">2> ID="03">D (d)"> ID="01">Human papillomaviruses> ID="02">2> ID="03">D (d)"> ID="01">Paramyxoviridae"> ID="01">Measles virus> ID="02">2> ID="03">V">  ID="01">Mumps virus> ID="02">2> ID="03">V"> ID="01">Newcastle disease virus> ID="02">2"> ID="01">Parainfluenza viruses types 1 to 4> ID="02">2"> ID="01">Respiratory syncytial virus> ID="02">2"> ID="01">Parvoviridae"> ID="01">Human parvovirus (B  19)> ID="02">2"> ID="01">Picornaviridae"> ID="01">Acute haemorrhagic conjunctivitis virus (AHC)> ID="02">2"> ID="01">Coxsackie viruses> ID="02">2"> ID="01">Echo viruses> ID="02">2"> ID="01">Hepatitis A virus (human enterovirus type 72)> ID="02">2>  ID="03">V"> ID="01">Polioviruses> ID="02">2> ID="03">V"> ID="01">Rhinoviruses> ID="02">2"> ID="01">Poxviridae"> ID="01">Buffalopox virus (e)> ID="02">2"> ID="01">Cowpox virus> ID="02">2"> ID="01">Elephantpox virus (f)> ID="02">2">  ID="01">Milkers' node virus> ID="02">2"> ID="01">Molluscum contagiosum virus> ID="02">2"> ID="01">Monkeypox virus> ID="02">3> ID="03">V"> ID="01">Orf virus> ID="02">2"> ID="01">Rabbitpox virus (g)> ID="02">2"> ID="01">Vaccinia virus> ID="02">2">  ID="01">Variola (major minor) virus> ID="02">4> ID="03">V"> ID="01">Whitepox virus ("Variola virus")> ID="02">4> ID="03">V"> ID="01">Yatapox virus (Tana &  Yaba)> ID="02">2"> ID="01">Reoviridae"> ID="01">Coltivirus> ID="02">2"> ID="01">Human  rotaviruses> ID="02">2"> ID="01">Orbiviruses> ID="02">2"> ID="01">Reoviruses> ID="02">2"> ID="01">Retroviridae (h)"> ID="01">Human immunodeficiency viruses> ID="02">3> ID="03">D"> ID="01">Human T-cell lymphotropic viruses (HTLV) types 1 and 2>  ID="02">3> ID="03">D"> ID="01">Rhabdoviridae"> ID="01">Rabies virus> ID="02">3 (**)> ID="03">V"> ID="01">Visicular stomatitis virus> ID="02">2"> ID="01">Togaviridae"> ID="01">Alfaviruses:"> ID="01">Eastern equine encephalomyelitis> ID="02">3>  ID="03">V"> ID="01">Bebaru virus> ID="02">2"> ID="01">Chikungunya virus> ID="02">3 (**)"> ID="01">Everglades virus> ID="02">3 (**)"> ID="01">Mayaro virus> ID="02">3"> ID="01">Mucambo virus> ID="02">3 (**)"> ID="01">Ndumu virus> ID="02">3">  ID="01">O'nyong-nyong virus> ID="02">2"> ID="01">Ross River virus> ID="02">2"> ID="01">Semliki Forest virus> ID="02">2"> ID="01">Sindbis virus> ID="02">2"> ID="01">Tonate virus> ID="02">3 (**)"> ID="01">Venezuelan equine encephalomyelitis>  ID="02">3> ID="03">V"> ID="01">Western equine encephalomyelitis> ID="02">3> ID="03">V"> ID="01">Other known alphaviruses> ID="02">2"> ID="01">Rubivirus (rubella)> ID="02">2> ID="03">V"> ID="01">Toroviridae> ID="02">2"> ID="01">Unclassified  viruses"> ID="01">Blood-borne hepatitis viruses not yet identified> ID="02">3 (**)> ID="03">D"> ID="01">Hepatitis E virus> ID="02">3 (**)"> ID="01">Unconventional agents associated with (i):"> ID="01">Creutzfeldt-Jakob disease> ID="02">3 (**)>  ID="03">D (d)"> ID="01">Gerstmann-Straeussler-Scheinker syndrome> ID="02">3 (**)> ID="03">D (d)"> ID="01">Kuru> ID="02">3 (**)> ID="03">D (d) ""(*) See paragraph 7 of the introductory notes.  (**) See paragraph 8 of the introductory notes.  (a) Tick-borne encephalitis.  (b) Hepatitis D virus is pathogenic in workers only in the presence of simultaneous or secondary infection caused by hepatitis B virus.  Vaccination against hepatitis B virus will therefore protect workers who are not affected by hepatitis B virus against hepatitis D virus (Delta).  (c) Only for types A and B.  (d) Recommended for work involving direct contact with these agents.  (e) Two viruses are identified: one a buffalopox type and the other a variant of the Vaccinia virus.  (f) Variant of cowpox virus.  (g) Variant of Vaccinia.  (h) At present there is no evidence of disease in humans caused by retroviruses of simian origin. As a precaution containment level 3 is recommended for work with them.  (i) There is no evidence in humans of infections caused by the agents responsible for bovine spongiform encephalitis. Nevertheless, containment level 2 is recommended at least as a precaution for laboratory work.  >PARASITES  "" ID="01">Acanthamoeba castellani> ID="02">2"> ID="01">Ancylostoma duodenale> ID="02">2"> ID="01">Angiostrongylus cantonensis> ID="02">2"> ID="01">Angiostrongylus costaricensis> ID="02">2"> ID="01">Ascaris lumbricoides> ID="02">2>  ID="03">A"> ID="01">Ascaris suum> ID="02">2> ID="03">A"> ID="01">Babesia divergens> ID="02">2"> ID="01">Babesia microti> ID="02">2"> ID="01">Balantidium coli> ID="02">2"> ID="01">Brugia malayi> ID="02">2"> ID="01">Brugia pahangi> ID="02">2">  ID="01">Capillaria philippinensis> ID="02">2"> ID="01">Capillaria spp.> ID="02">2"> ID="01">Clonorchis sinensis> ID="02">2"> ID="01">Clonorchis viverrini> ID="02">2"> ID="01">Cryptosporidium parvum> ID="02">2"> ID="01">Cryptosporidium spp.>  ID="02">2"> ID="01">Dipetalonema streptocerca> ID="02">2"> ID="01">Diphyllobothrium latum> ID="02">2"> ID="01">Dracunculus medinensis> ID="02">2"> ID="01">Echinococcus granulosus> ID="02">3"> ID="01">Echinococcus multilocularis> ID="02">3">  ID="01">Echinococcus vogeli> ID="02">3"> ID="01">Entamoeba histolytica> ID="02">2"> ID="01">Fasciola gigantica> ID="02">2"> ID="01">Fasciola hepatica> ID="02">2"> ID="01">Fasciolopsis buski> ID="02">2"> ID="01">Giardia lamblia (Giardia  intestinalis)> ID="02">2"> ID="01">Hymenolepis diminuta> ID="02">2"> ID="01">Hymenolepis nana> ID="02">2"> ID="01">Leishmania brasiliensis> ID="02">3"> ID="01">Leishmania donovani> ID="02">3"> ID="01">Leishmania ethiopica> ID="02">2">  ID="01">Leishmania mexicana> ID="02">2"> ID="01">Leishmania peruviana> ID="02">2"> ID="01">Leishmania tropica> ID="02">2"> ID="01">Leishmania major> ID="02">2"> ID="01">Leishmania spp.> ID="02">2"> ID="01">Loa loa> ID="02">2"> ID="01">Mansonella  ozzardi> ID="02">2"> ID="01">Mansonella perstans> ID="02">2"> ID="01">Naegleria fowleri> ID="02">3"> ID="01">Necator americanus> ID="02">2"> ID="01">Onchocerca volvulus> ID="02">2"> ID="01">Opisthorchis felineus> ID="02">2"> ID="01">Opisthorchis  spp.> ID="02">2"> ID="01">Paragonimus westermani> ID="02">2"> ID="01">Plasmodium falciparum> ID="02">3"> ID="01">Plasmodium spp. (human and simian)> ID="02">2"> ID="01">Sarcocystis suihominis> ID="02">2"> ID="01">Schistosoma haematobium>  ID="02">2"> ID="01">Schistosoma intercalatum> ID="02">2"> ID="01">Schistosoma japonicum> ID="02">2"> ID="01">Schistosoma mansoni> ID="02">2"> ID="01">Schistosoma mekongi> ID="02">2"> ID="01">Strongyloides stercoralis> ID="02">2">  ID="01">Strongyloides spp.> ID="02">2"> ID="01">Taenia saginata> ID="02">2"> ID="01">Taenia solium> ID="02">3"> ID="01">Toxocara canis> ID="02">2"> ID="01">Toxoplasma gondii> ID="02">2"> ID="01">Trichinella spiralis> ID="02">2"> ID="01">Trichuris  trichiura> ID="02">2"> ID="01">Trypanosoma brucei brucei> ID="02">2"> ID="01">Trypanosoma brucei gambiense> ID="02">2"> ID="01">Trypanosoma brucei rhodesiense> ID="02">3"> ID="01">Trypanosoma cruzi> ID="02">3"> ID="01">Wuchereria bancrofti>  ID="02">2 ">FUNGI  "" ID="01">Aspergillus fumigatus> ID="02">2> ID="03">A"> ID="01">Blastomyces dermatitidis (Ajellomyces dermatitidis)> ID="02">3"> ID="01">Candida albicans> ID="02">2> ID="03">A"> ID="01">Coccidioides immitis> ID="02">3> ID="03">A">  ID="01">Cryptococcus neoformans var. neoformans (Filobasidiella neoformans var. neoformans)> ID="02">2> ID="03">A"> ID="01">Cryptococcus neoformans var. gattii (Filobasidiella bacillispora)> ID="02">2> ID="03">A"> ID="01">Emmonsia parva var. parva>  ID="02">2"> ID="01">Emmonsia parva var. crescens> ID="02">2"> ID="01">Epidermophyton floccosum> ID="02">2> ID="03">A"> ID="01">Fonsecaea compacta> ID="02">2"> ID="01">Fonsecaea pedrosoi> ID="02">2"> ID="01">Histoplasma capsulatum var capsulatum  (Ajellomyces capsulatus)> ID="02">3"> ID="01">Histoplasma capsulatum duboisii> ID="02">3"> ID="01">Madurella grisea> ID="02">2"> ID="01">Madurella mycetomatis> ID="02">2"> ID="01">Microsporum spp.> ID="02">2> ID="03">A"> ID="01">Neotestudina  rosatii> ID="02">2"> ID="01">Paracoccidioides brasiliensis> ID="02">3"> ID="01">Penicillium marneffei> ID="02">2> ID="03">A"> ID="01">Sporothrix schenckii> ID="02">2"> ID="01">Trichophyton rubrum> ID="02">2"> ID="01">Trichophyton spp.> ID="02">2'  ">   ANNEX II 'ANNEX VII RECOMMENDED CODE OF PRACTICE ON VACCINATION (Article 14 (3)) 1. If the assessment referred to in Article 3 (2) reveals that there is a risk to the health and safety of workers due to their exposure to biological agents for which effective vaccines exist, their employers should offer them vaccination.  2. Vaccination should be carried out in accordance with national law and/or practice.  Workers should be informed of the benefits and drawbacks of both vaccination and non-vaccination.  3. Vaccination must be offered free of charge to workers.  4. A vaccination certificate may be drawn up which should be made available to the worker concerned and, on request, to the competent authorities.'


Avis juridique important

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31990L0492

Commission Directive 90/492/EEC of 5 September 1990 adapting to technical progress for the second time Council Directive 88/379/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations

Official Journal L 275 , 05/10/1990 P. 0035 - 0038 Finnish special edition: Chapter 15 Volume 10 P. 0003  Swedish special edition: Chapter 15 Volume 10 P. 0003

*****COMMISSION  DIRECTIVE  of 5 September 1990  adapting to technical progress for the second time Council Directive 88/379/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations  (90/492/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (1), as amended by Commission Directive 89/178/EEC (2), and in particular Article 15 thereof,  Whereas, when the abovementioned Directive was adopted, the Commission, at the Council's request, was asked to examine the specific problem of mixtures of gases;  Whereas Annex I to Directive 88/379/EEC includes tables fixing concentration limits, expressed as a mass/mass percentage, to be used in applying the conventional method of assessing health hazards in accordance with Article 3 (5);  Whereas these concentration limits are not appropriate in the case of preparations marketed in gaseous form;  Whereas concentration limits expressed as a volume/volume percentage should therefore be inserted into Annex I; whereas these concentration limits are valid only for gaseous constituents used in preparations in gaseous form;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on Removal of Technical Barriers to Trade in Dangerous Substances and Preparations,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Annex I to Directive 88/379/EEC is amended in the manner set out in the Annex hereto.  Article 2  Member States shall adopt and publish the provisions necessary to comply with this Directive by 1 June 1991 and shall forthwith inform the Commission thereof.  They shall apply the provisions from 8 June 1991 at the latest.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 5 September 1990.  For the Commission  Martin BANGEMANN  Vice-President  (1) OJ No L 187, 16. 7. 1988, p. 14.  (2) OJ No L 64, 8. 3. 1989, p. 18.  ANNEX  Annex I to Directive 88/379/EEC is hereby amended as follows:  (a) The following is added to point 1. Acute lethal effects:  'Gaseous preparations  The concentration limits expressed as a volume/volume percentage in Table 1 A below determine the classification of the gaseous preparation in relation to the individual concentration of the gas(es) present whose classification is also shown.  TABLE I A  1.2,4 //  //  // Classification of the substance (gas)  // Classification of the gaseous preparation  //  // 1.2.3.4 //  // T+   // T   // Xn   //    //   //   //  // T+ with R 26   // concentration  1 %   // 0,2 % concentration 1 %   // 0,02 %  concentration 0,2 %   //    //  //   //   // T with R 23   //   // concentration  5 %   // 0,5 %  concentration 5 %   //    //   //   //   // Xn with R 20  //   //   // concentration  5 %'   //    //   //   //  (b) The following is added to point 2. Non-lethal irreversible effects after a single exposure:  'Gaseous preprations  For gases that produce non-lethal irreversible effects after a single exposure (R 39, R 40), the individual concentration limits specified in Table II A, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation and shall determine which particular R phrase is to be assigned to it.  TABLE II A  1.2,4 //  //  // Classification of the substance (gas)  // Classification of the gaseous preparation  //  // 1.2.3.4 //  // T+   // T   // Xn   //    //   //   //  // T+ with R 39   // concentration  1 % R 39 (*) obligatory  // 0,2 %  concentration 1 % R 39 (*) obligatory   // 0,02 % concentration 0,2 % R 40 (*) obligatory   //    //   //   //  // T with R 39   //   // concentration  5 % R 39 (*) obligatory   // 0,5 %  concentration 5 % R 40 (*) obligatory  //    //   //   //   // Xn with R 40   //   //  // concentration  5 % R 40 (*) obligatory   //    //   //  //  (*) In accordance with the labelling guide of Annex VI, point II (D) to Directive 67/548/EEC and depending on the classification, the standard R phrases R 20, R 23 or R 26 are also to be assigned to indicate route of administration or means of exposure.'  (c) The following is added to point 3. Severe effects after repeated or prolonged exposure:  'Gaseous preparations  For gases that produce severe effects after repeated or prolonged exposure (R 48), the individual concentration limits specified in Table III A below, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation and shall determine which particular R phrase is to be assigned to it. TABLE III A  1.2,3 //  //  // Classification of the substance (gas)  // Classification of the gaseous preparation  // 1.2.3 //  // T   // Xn   //    //   //   // T with R 48  // concentration  5 % R 48 (*) obligatory   // 0,5 % concentration  5 % R 48 (*) obligatory   //    //   //   // Xn with R 48   //   // concentration  5 % R 48 (*) obligatory  //    //   //  (*) In accordance with the labelling guide of Annex VI, point II (D) to Directive 67/548/EEC and depending on the classification, the standard R phrases R 20 or R 23 are also to be assigned to indicate route of administration or means of exposure.'  (d) The following is added to point 4. Corrosive and irritant effects:  'Gaseous preparations  For gases that produce such effects (R 34, R 35) or (R 36, R 37, R 38, R 41), the individual concentration limits specified in Table IV A below, expressed as a volume/volume percentage determine, when appropriate, the classification of the preparation and shall determine which particular R phrase is to be assigned to it.  TABLE IV A  1.2,5 //  //  // Classification of the substance (gas) and/or relevant standard risk phrase  // Classification of the gaseous preparation  //  //  // 1.2.3.4.5 //  // At least C with R 35  // At least C with R 34  // At least Xi with R 41  // At least Xi with R 36, R 37 or R 38   //    //   //   //   //   // At least C with R 35   // concentration 1 % R 35 obligatory  // 0,2 % concentration 1 % R 34 obligatory   //   // 0,02 % concentration 0,2 % R 37 obligatory   //    //   //   //   //  // At least C with R 34   //   // concentration 5 % R 34 obligatory   //   // 0,5 % concentration 5 % R 37 obligatory  //    //   //   //   //   // At least Xi with R 41   //   //  // concentration 5 % R 41 obligatory   // 0,5 % concentration 5 % R 36 obligatory   //    //   //   //   //   // At least Xi with R 36, R 37, R 38   //   //   //   // concentration 5 % R 36, R 37, R 38 obligatory as appropriate'   //    //   //   //  //  (e) The following is added to point 5. Sensitizing effects:  'Gaseous preparations  Gases that produce such effects are classified:  - at least as harmful (Xn) and assigned R 42 or R 42/43 as appropriate.  The individual concentration limits specified in Table V A below, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation, and shall determine which particular R phrase is to be assigned to it. TABLE V A  1.2,3 //  //  // Classification of the substance (gas)  // Classification of the gaseous preparation  // 1.2.3 //  // At least Xn with R 42   //   //    //   //  // At least Xn with R 42   // concentration  0,2 % R 42 obligatory   //   //    //   //   // At least Xn with R 42/43  // concentration  0,2 % R 42/43 obligatory'   //   //    //  //  (f) The following is added to point 6. Carcinogenic/mutagenic/teratogenic effects:  'Gaseous preparations  For gases which produce such effects and for which specific concentration limits do not yet appear in Annex I to Directive 67/548/EEC and for those which, in accordance with point 3.1.1 of Annex III to Directive 83/467/EEC, are provisionally assigned the phrase R 40, the concentration limits laid down in Table VI A, expressed as a volume/volume percentage, shall determine, where appropriate, the classification of the preparation and the compulsory R phrase to be assigned to it.  TABLE VI A  1.2,3 //  //  // Classification of the substance (gas)  // Classification of the gaseous preparation  // 1.2.3 //  // at least T  // at least Xn   //    //   //  // at least T with R 45 for carcinogenic substances of category 1 or 2   // concentration  1 % R 45 obligatory   //  //    //   //   // at least Xn with R 40 for carcinogenic substances of category 3   //   // concentration  0,1 % R 45 obligatory   //    //   //   // at least T with R 46 for mutagenic substances of category 1   // concentration  0,1 % R 46 obligatory   //   //    //   //   // at least Xn with R 46 for mutagenic substances of category 2   //   // concentration 0,1 % R 46 obligatory   //    //   //   // at least Xn with R 40 for mutagenic substances of category 3   //  // concentration  1 % R 40 obligatory   //    //   //   // at least T with R 47 for teratogenic substances of category 1  // concentration  0,2 % R 47 obligatory   //   //    //   //  // at least Xn with R 47 for teratogenic substances of category 2   //   // concentration  1 % R 47 obligatory   //  //   //   // at least Xn with R 40 provisionally in accordance with point 3.1.1 of Annex III to Directive 83/467/EEC   //  // concentration  1 % R 40 obligatory'   //    //   //