title: Council Directive (EU) 2019/997 of 18 June 2019 establishing an EU Emergency Travel Document and repealing Decision 96/409/CFSP

text:
                  20.6.2019

                  EN

                  Official Journal of the European Union

                  L 163/1

         COUNCIL DIRECTIVE (EU) 2019/997
         of 18 June 2019
         establishing an EU Emergency Travel Document and repealing Decision 96/409/CFSP
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union, and in particular the second paragraph of Article 23 thereof,
         Having regard to the proposal from the European Commission,
         Having regard to the opinion of the European Parliament (1),
         Acting in accordance with a special legislative procedure,
         Whereas:

                     (1)

                     Citizenship of the Union is the fundamental status of nationals of the Member States. It confers on every citizen of the Union the right to enjoy, in the territory of a third country in which the Member State of which they are nationals is not represented, the protection of the diplomatic and consular authorities of another Member State under the same conditions as the nationals of that Member State. Council Directive (EU) 2015/637 (2) gives effect to that right by laying down the cooperation and coordination measures necessary to facilitate consular protection for unrepresented citizens of the Union.

                     (2)

                     Directive (EU) 2015/637 refers to emergency travel documents as one type of consular assistance to be provided by embassies and consulates of Member States to unrepresented citizens of the Union. An emergency travel document is a single-journey document, allowing the bearer to return home, or, exceptionally, to another destination, in the event that they do not have access to their regular travel documents, for example because they were stolen or lost. Another destination could be, for example, a neighbouring or similarly close country where the unrepresented citizen's Member State of nationality has an embassy or consulate.

                     (3)

                     Decision 96/409/CFSP of the Representatives of the Governments of the Member States, meeting within the Council (3) established a common emergency travel document for issuance by Member States to citizens of the Union in places where those citizens' Member State of nationality have no permanent diplomatic or consular representation. It is now necessary to update the rules of that Decision and to establish a modernised and more secure format for the EU Emergency Travel Document (‘EU ETD’). Consistency should be ensured between the specific conditions and procedure for issuing EU ETDs and the general rules on consular protection laid down by Directive (EU) 2015/637, since that Directive, including the financial procedure provided for in Article 14 thereof, applies to the issuance of EU ETDs to unrepresented citizens. This Directive should provide additional rules to be applied alongside those set out in Directive (EU) 2015/637 where necessary.

                     (4)

                     Upon his or her request, an EU ETD should be issued to any unrepresented citizen in a third country whose passport or travel document has been lost, stolen or destroyed, or can otherwise not be obtained within a reasonable time, for example to newborns born during travel or to persons whose documents have expired and cannot be easily replaced by the Member State of nationality. An EU ETD should be issued once the Member State assisting the unrepresented citizen has received confirmation of the citizen's nationality and identity from the Member State of nationality.

                     (5)

                     Since the loss of a passport or travel documents can cause significant distress to unrepresented citizens in third countries, it is necessary to establish a simplified procedure for cooperation and coordination between the assisting Member State and the unrepresented citizen's Member State of nationality. Member States should ensure that consultations are carried out as quickly as possible, typically within a few working days. At the same time, it is necessary to maintain sufficient flexibility in exceptional cases. The assisting Member State should only be allowed to issue EU ETDs without prior consultation of the Member State of nationality in cases of extreme urgency. Before doing so, Member States should normally have exhausted all available means of communication with the Member State of nationality. For example, Member States should first attempt to transmit part of the relevant information, such as the name, nationality and date of birth of the applicant. In these situations, the assisting Member State should notify the Member State of nationality as soon as possible of the assistance granted on its behalf to ensure that the Member State of nationality is adequately informed.

                     (6)

                     For security reasons, recipients of EU ETDs should return them once they have returned home safely, for example to border officials or to the authorities responsible for issuing passports. Moreover, a copy or scan of each EU ETD issued should be stored at the issuing authority of the assisting Member State and another copy or scan should be sent to the recipient's Member State of nationality. The returned EU ETDs and stored copies should be destroyed as soon as possible.

                     (7)

                     Unrepresented citizens should be able to apply for an EU ETD at the embassy or consulate of any Member State. As provided for in Directive (EU) 2015/637, it is possible for Member States to conclude practical arrangements for the purpose of sharing responsibilities for issuing EU ETDs to unrepresented citizens. Member States that receive EU ETD applications should assess, on a case by case basis, whether it is appropriate to issue the EU ETD or if the case should be transferred to the embassy or consulate which is designated as competent under the terms of any arrangement already in place.

                     (8)

                     In line with its purpose as a single-journey document, the EU ETD should be valid for the period required to make that journey. In view of the possibilities and speed of modern-day travel, the validity of an EU ETD should, save in exceptional circumstances, not exceed 15 calendar days.

                     (9)

                     In addition to issuing EU ETDs to unrepresented citizens in third countries, this Directive should not preclude Member States from issuing EU ETDs in other situations, taking into account national law and practice. Member States should also be able to issue EU ETDs to their own nationals, to Union citizens who are not represented within the territory of the Member States, and to citizens of another Member State which is represented in the country where they seek to obtain an EU ETD. When doing so, Member States should take the necessary measures in order to prevent abuse and fraud. However, Member States might also decide not to issue EU ETDs in such situations.

                     (10)

                     In accordance with Article 5 of Directive (EU) 2015/637, and with a view to ensuring the effectiveness of the right enshrined in point (c) of Article 20(2) of the Treaty on the Functioning of the European Union (TFEU) and the right to respect for private and family life as recognised in Article 7 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), and taking into account national law and practice, an assisting Member State should be able to issue EU ETDs to family members, who are not Union citizens, accompanying Union citizens, where those family members are legal residents in a Member State, taking into account the individual circumstances of each case.

                     (11)

                     Certain family members who are not Union citizens might be required to obtain, in addition to the EU ETD, visas to return to the territory of the Union. Pursuant to Article 5(2) of Directive 2004/38/EC of the European Parliament and of the Council (4), family members who are not nationals of a Member State are only required to have an entry visa in accordance with Regulation (EU) 2018/1806 of the European Parliament and of the Council (5) or, where appropriate, with national law. Possession of a valid residence card referred to in Article 10 of Directive 2004/38/EC exempts such family members from the visa requirement. Member States are to grant such persons every facility to obtain the necessary visas. Such visas are to be issued free of charge as soon as possible and on the basis of an accelerated procedure.

                     (12)

                     The EU ETD should consist of a uniform EU ETD form and a uniform EU ETD sticker. The EU ETD should contain all the necessary information and meet high technical standards, in particular as regards safeguards against counterfeiting and falsification. It should be cost-effective, suitable for use by all Member States and bear universally recognisable security features clearly visible to the naked eye.

                     (13)

                     The uniform EU ETD form should contain blank pages so that visas, if required, can be affixed directly to the form. That form should serve as the carrier for the uniform EU ETD sticker, which contains the relevant information on the recipient. The uniform EU ETD sticker should be modelled upon the uniform format for visas as laid down by Council Regulation (EC) No 1683/95 (6) and should contain similar security features. The uniform EU ETD sticker should be filled in in the assisting Member State's embassy or consulate using the same printers as for visas. In the event of technical force majeure, it should be possible for the uniform EU ETD sticker to be filled in manually. To avoid reduced acceptance and security risks, manual filling-in should be limited as much as possible and should take place only where it is not possible to issue the uniform EU ETD sticker filled in by means of a printer within a reasonable time.

                     (14)

                     In order to increase the security and speed of the issuing process, a facial image of the applicant used for the EU ETD should be taken live at the embassy or consulate by digital camera or equivalent means. Only where this is not feasible, a photograph may be used after the embassy or consulate has ensured that it matches the applicant. The same facial image or photograph should then be transferred to the Member State of nationality for confirmation of the identity of the applicant.

                     (15)

                     This Directive should lay down specifications that should not be kept secret. Where appropriate, those specifications may need to be supplemented by further secret specifications to prevent counterfeiting and falsification.

                     (16)

                     In order to ensure that the information on additional technical specifications is not made available to more persons than necessary, each Member State should designate a body having responsibility for producing the uniform EU ETD forms and stickers. For the purpose of efficiency, Member States are encouraged to designate one single body. Member States should be able to change the body designated by them, if necessary. For security reasons, each Member State should communicate the name of that body to the Commission and to the other Member States.

                     (17)

                     In order to address the need to adapt the specifications of the uniform EU ETD form and sticker in response to technical progress, as well as to change the Member State responsible for providing specimens for the notification of the uniform EU ETD format to third countries, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (7). In particular, to ensure equal participation in the preparation of delegated acts, the Council receives all documents at the same time as Member States' experts, and its experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

                     (18)

                     In order to ensure uniform conditions for the implementation of this Directive regarding any additional technical specifications and indicators for the monitoring of the application of this Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (8).

                     (19)

                     In order to increase the acceptance of EU ETDs, Union delegations in third countries should notify the uniform EU ETD format and any subsequent modifications to the relevant authorities of third countries, report on the acceptance of the EU ETD by third countries and promote its use. The specimens used for this purpose should be provided to the European External Action Service (EEAS) by a Member State with the support of the Commission.

                     (20)

                     This Directive should not affect more favourable national provisions in so far as they are compatible with this Directive.

                     (21)

                     Regulation (EU) 2016/679 of the European Parliament and of the Council (9) should apply to the processing of personal data carried out by Member States when implementing this Directive. The EU ETD system requires the processing of the personal data necessary for the purpose of verifying the identity of the applicant, printing the uniform EU ETD sticker and facilitating travel of the data subject concerned. It is necessary to further specify safeguards applicable to the personal data processed, such as the maximum retention period of personal data collected. A maximum retention period of 180 days for the assisting Member State and two years for the Member State of nationality is necessary to ensure the collection of any applicable fees and to prevent possible abuses or other fraudulent activities. The erasure of personal data of applicants should not affect Member States' abilities to monitor the application of this Directive.

                     (22)

                     In accordance with paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, the Commission should evaluate this Directive, in particular on the basis of information collected through specific monitoring arrangements, in order to assess the effects of this Directive and the need for any further action. That evaluation could also take into account future technical developments allowing for the introduction of electronic emergency travel documents (eETD).

                     (23)

                     Since the objective of this Directive, namely to establish the measures necessary to facilitate consular protection of unrepresented citizens by means of the issuance of safe and widely accepted emergency travel documents, cannot be sufficiently achieved by the Member States but can rather, by reason of the need to avoid fragmentation and resulting decreased acceptance of emergency travel documents issued by Member States to unrepresented citizens, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

                     (24)

                     This Directive aims to promote consular protection as guaranteed by Article 46 of the Charter. It respects the fundamental rights and observes the principles recognised in particular by the Charter, including the right to respect for private and family life and the right to the protection of personal data. This Directive should be interpreted and applied in accordance with those rights and principles.

                     (25)

                     Decision 96/409/CFSP should be repealed,

               HAS ADOPTED THIS DIRECTIVE:
         CHAPTER I

            SUBJECT MATTER AND DEFINITIONS

            Article 1
            Subject matter
            This Directive lays down rules on the conditions and procedure for unrepresented citizens in third countries to obtain an EU Emergency Travel Document (‘EU ETD’) and establishes a uniform format for such document.

            Article 2
            Definitions
            For the purposes of this Directive, the following definitions apply:

                        (1)

                        ‘unrepresented citizen’ means any citizen holding the nationality of a Member State which is not represented in a third country as set out in Article 6 of Directive (EU) 2015/637;

                        (2)

                        ‘applicant’ means the person applying for an EU ETD;

                        (3)

                        ‘recipient’ means the person being issued an EU ETD;

                        (4)

                        ‘assisting Member State’ means the Member State receiving an application for an EU ETD;

                        (5)

                        ‘Member State of nationality’ means the Member State of which the applicant claims to be a national;

                        (6)

                        ‘working days’ means all days other than public holidays or weekends observed by the authority required to act.

         CHAPTER II

            THE EU EMERGENCY TRAVEL DOCUMENT

            Article 3
            The EU Emergency Travel Document

               1.   The EU Emergency Travel Document (‘EU ETD’) is a travel document that shall be issued by a Member State to an unrepresented citizen in a third country for a single journey to the citizen's Member State of nationality or residence, as requested by the citizen, or exceptionally, to another destination. Member States may also decide to issue EU ETDs to other recipients in accordance with Article 7.

               2.   Member States shall issue EU ETDs to unrepresented citizens in third countries whose passports or travel documents have been lost, stolen or destroyed, or can otherwise not be obtained within a reasonable time, in accordance with the procedure set out in Article 4.

            Article 4
            Procedure

               1.   Where a Member State receives an application for an EU ETD, it shall, as soon as possible, and no later than two working days after receipt of the application, consult the Member State of nationality in accordance with Article 10(2) of Directive (EU) 2015/637 for the purpose of verifying the nationality and identity of the applicant.

               2.   The assisting Member State shall provide the Member State of nationality with all relevant information, including:

                           (a)

                           the applicant's surname and given name(s), nationality, date of birth and sex;

                           (b)

                           a facial image of the applicant taken by the authorities of the assisting Member State at the time of application or, only where this is not feasible, a scanned or digital photograph of the applicant, based on the standards established by part 3 of International Civil Aviation Organization (ICAO) Document 9303 on Machine Readable Travel Documents (Seventh Edition, 2015) (‘ICAO Document 9303’);

                           (c)

                           a copy or scan of any available means of identification, such as an identity card or driving license, and, where available, the type and number of the document replaced and the national registration or social security number.

               3.   As soon as possible, and no later than three working days after receipt of the information referred to in paragraph 2, the Member State of nationality shall respond to the consultation in accordance with Article 10(3) of Directive (EU) 2015/637 and shall confirm whether the applicant is its national. If the Member State of nationality is unable to respond within three working days, it shall, within that period, inform the assisting Member State and shall provide an estimate of when the response is to be expected. The assisting Member State shall inform the applicant accordingly. Upon confirmation of the applicant's nationality, the assisting Member State shall provide the applicant with the EU ETD as soon as possible and no later than two working days after receipt of the confirmation.

               4.   If the Member State of nationality objects to an EU ETD being issued to one of its nationals, it shall inform the assisting Member State. In that case, the EU ETD shall not be issued and the Member State of nationality shall assume responsibility for providing consular protection to its citizen in accordance with its legal obligations and practice. The assisting Member State, in close consultation with the Member State of nationality, shall inform the applicant accordingly.

               5.   In justified cases, the Member States may take longer than the time limits laid down in paragraphs 1 and 3.

               6.   In cases of extreme urgency, the assisting Member State may issue an EU ETD without prior consultation of the Member State of nationality. Before doing so, the assisting Member State shall have exhausted the available means of communication with the Member State of nationality. The assisting Member State shall notify the Member State of nationality, as soon as possible, of the fact that an EU ETD has been issued and of the identity of the person to whom the EU ETD was issued. That notification shall include all data which were included on the EU ETD.

               7.   The authority of the Member State issuing the EU ETD shall store a copy or scan of each EU ETD issued and shall send another copy or scan to the applicant's Member State of nationality.

               8.   The recipient of an EU ETD shall be asked to return the EU ETD, regardless of whether it has expired, upon arrival at the final destination.

               9.   The Commission may adopt implementing acts establishing a standard EU ETD application form which shall contain information on the obligation to return the EU ETD upon arrival. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 12(2).

            Article 5
            Financial provisions

               1.   The assisting Member State shall charge the applicant such fees as it charges its own nationals for the issuance of national emergency documents.

               2.   The assisting Member State may waive the charging of fees generally or in specific situations determined by it.

               3.   Where applicants are unable to pay any applicable fees to the assisting Member State when submitting their application, they shall undertake to repay their Member State of nationality such fees using the standard form set out in Annex I of Directive (EU) 2015/637. In such cases, Article 14(2) and Article 15 of Directive (EU) 2015/637 shall apply.

            Article 6
            Validity
            An EU ETD shall be valid for the period required for completion of the journey for which it is issued. In calculating that period, allowance shall be made for necessary overnight stops and for making travel connections. The period of validity shall include an additional ‘period of grace’ of two days. Save in exceptional circumstances, the validity of an EU ETD shall not exceed 15 calendar days.

            Article 7
            Optional issuance of EU ETDs

               1.   Where the applicant's passport or travel document has been lost, stolen or destroyed or can otherwise not be obtained within a reasonable time, a Member State may issue EU ETDs:

                           (a)

                           to its own nationals;

                           (b)

                           to Union citizens who are not represented within the territory of the Member States, including the overseas countries and territories referred to in the first subparagraph of Article 355(2) TFEU;

                           (c)

                           to citizens of another Member State which is represented in the country where they seek to obtain the EU ETD and where arrangements between the relevant Member States exist to that effect;

                           (d)

                           to family members, who are not Union citizens, accompanying Union citizens who are not represented in a third country or Union citizens referred to in points (a), (b) or (c), where those family members are legal residents in a Member State, without prejudice to any applicable visa requirements;

                           (e)

                           to other persons to whom that Member State or another Member State is obliged under international or national law to provide protection and who are legal residents in a Member State.

               2.   Where a Member State issues EU ETDs in accordance with:

                           (a)

                           point (b) or (c) of paragraph 1 of this Article, the consultation set out in Article 4 shall involve the Member State of nationality of Union citizens;

                           (b)

                           point (d) of paragraph 1 of this Article, the consultation set out in Article 4 shall involve the Member State of nationality of the accompanied Union citizen and, where necessary, the Member State of residence of the family member. By derogation from Article 4(6), no EU ETD shall be issued without prior consultation of the Member State of nationality of the accompanied Union citizen and, where necessary, the Member State of residence of the family member;

                           (c)

                           point (e) of paragraph 1 of this Article, the consultation set out in Article 4 shall involve the Member State obliged under international or national law to provide protection to the applicant, which shall be the destination country indicated on the EU ETD.

         CHAPTER III

            UNIFORM FORMAT FOR EU ETDs

            Article 8
            Uniform format for EU ETDs

               1.   EU ETDs shall consist of a uniform EU ETD form and a uniform EU ETD sticker. That form and that sticker shall conform to the specifications set out in Annexes I and II and the additional technical specifications established in accordance with Article 9.

               2.   When the uniform EU ETD sticker is filled in, the sections set out in Annex II shall be completed and the machine-readable zone filled in, in line with ICAO Document 9303.

               3.   In order to achieve the objectives of this Directive, in particular to ensure the exercise of the right to consular protection on the basis of a modern and secure EU ETD format, the Commission is empowered to adopt delegated acts in accordance with Article 11 to amend Annexes I and II as well as references to the standards established by ICAO as referred to in paragraph 2 of this Article and Article 4(2)(b), in response to technical progress.

               4.   Member States may add any necessary national entries in the ‘remarks’ section of the uniform EU ETD sticker as referred to in point 9 of Annex II. Those national entries shall not duplicate the sections set out in Annex II.

               5.   All entries on the uniform EU ETD sticker, including the facial image, shall be printed. No manual changes shall be made to a printed uniform EU ETD sticker.
               Exceptionally, in the event of technical force majeure, uniform EU ETD stickers may be filled in manually and a photograph affixed. In such cases, the photograph shall have additional protection against photo substitution. No changes shall be made to the uniform EU ETD sticker which has been filled in manually.

               6.   If an error is detected on the uniform EU ETD sticker which has not yet been affixed to the uniform EU ETD form, the uniform EU ETD sticker shall be invalidated and destroyed. If an error is detected after the uniform EU ETD sticker has been affixed to the uniform EU ETD form, both shall be invalidated and destroyed and a new uniform EU ETD sticker shall be produced.

               7.   The printed uniform EU ETD sticker containing the completed sections shall be affixed to the uniform EU ETD form in accordance with Annex I.

               8.   Member States shall ensure theft-proof storage of blank uniform EU ETD forms and stickers.

            Article 9
            Additional technical specifications

               1.   The Commission shall adopt implementing acts containing additional technical specifications for EU ETDs relating to the following:

                           (a)

                           design, format and colours of the uniform EU ETD form and sticker;

                           (b)

                           requirements for the material and printing techniques of the uniform EU ETD form;

                           (c)

                           security features and requirements including enhanced anti-forgery, counterfeiting and falsification standards;

                           (d)

                           other rules to be observed for the filling in and issuing of the EU ETD.

                     Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 12(2).

               2.   It may be decided that the additional technical specifications referred to in paragraph 1 shall be secret and not be published. In that case, they shall be made available only to the bodies designated by the Member States as responsible for the production of EU ETDs and to persons duly authorised by a Member State or the Commission.

            Article 10
            Production of EU ETDs

               1.   Each Member State shall designate a body having responsibility for producing uniform EU ETD forms and stickers. The same body may be designated by several or all Member States.

               2.   Each Member State shall communicate the name of the body producing its uniform EU ETD forms and stickers to the Commission and to the other Member States. Where a Member State changes its designated body, it shall inform the Commission and the other Member States accordingly.

            Article 11
            Exercise of the delegation

               1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

               2.   The power to adopt delegated acts referred to in Articles 8(3) and 13(1) shall be conferred on the Commission for an indeterminate period of time from 10 July 2019.

               3.   The delegation of power referred to in Articles 8(3) and 13(1) may be revoked at any time by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated act already in force.

               4.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

               5.   As soon as it adopts a delegated act, the Commission shall notify it to the Council.

               6.   A delegated act adopted pursuant to Articles 8(3) and 13(1) shall enter into force only if no objection has been expressed by the Council within a period of two months of notification of that act to the Council or if, before the expiry of that period, the Council has informed the Commission that it will not object. That period shall be extended by two months at the initiative of the Council.

               7.   The European Parliament shall be informed of the adoption of delegated acts by the Commission, of any objection formulated to them, or of the revocation of the delegation of powers by the Council.

            Article 12
            Committee procedure

               1.   The Commission shall be assisted by the Committee established by Article 6 of Regulation (EC) No 1683/95. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

               2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

            Article 13
            Notification to third countries

               1.   Within 21 months of the adoption of the additional technical specifications referred to in Article 9, the Member State holding the Presidency of the Council in accordance with Article 16(9) TEU shall provide specimens of the uniform EU ETD form and sticker to the Commission and the EEAS.
               The Commission is empowered to adopt delegated acts in accordance with Article 11 to amend the first subparagraph of this paragraph by designating another Member State as the state responsible for providing the specimens referred to in that subparagraph, on the basis of objective criteria, such as the presence on its territory of the body designated for the production of EU ETDs by several or all Member States.

               2.   The EEAS shall transmit the specimens of the uniform EU ETD form and sticker to Union delegations in third countries.

               3.   Union delegations in third countries shall notify the relevant authorities in the respective third countries of the usage of the EU ETD as well as its uniform format and main security features, including by providing specimens of the uniform EU ETD form and sticker for reference purposes. The notification of an individual third country shall be repeated upon request of that third country. The notification shall not include specifications which are to be kept secret in accordance with Article 9(2).

               4.   Each time the uniform EU ETD form or sticker is modified, the procedure set out in paragraphs 1 to 3 shall be repeated. The deadline referred to in paragraph 1 shall be 21 months after the adoption of the modified format of the uniform EU ETD form or sticker.

               5.   Where no Union delegation is present in a third country, represented Member States shall decide through local consular cooperation which Member State shall notify the relevant authorities of that third country of the uniform EU ETD format as well as its main security features. The EEAS shall coordinate with the Member State concerned the transmission of specimens of the uniform EU ETD form and sticker for that purpose.

         CHAPTER IV

            FINAL PROVISIONS

            Article 14
            More favourable treatment
            Member States may introduce or retain provisions more favourable than those of this Directive in so far as they are compatible with this Directive.

            Article 15
            Protection of personal data

               1.   Personal data processed for the purposes of this Directive, including the facial image or photograph of the applicant referred to in Article 4(2), shall only be used to verify the identity of the applicant in accordance with the procedure set out in Article 4, to print the uniform EU ETD sticker, and to facilitate travel of that applicant. The assisting Member State and the Member State of nationality shall ensure appropriate security of personal data.

               2.   Without prejudice to Regulation (EU) 2016/679, an applicant to whom an EU ETD is issued shall have the right to verify the personal data contained in the EU ETD and, where appropriate, to ask for corrections to be made by issuing a new document.

               3.   No information in machine-readable form shall be included in an EU ETD unless it also appears in the sections referred to in point 6 of Annex II.

               4.   The assisting Member State and the Member State of nationality shall retain the personal data of an applicant only for as long as necessary, including for the collection of the fees referred to in Article 5. In no case shall that personal data be retained longer than 180 days by the assisting Member State or longer than two years by the Member State of nationality. Upon expiry of the retention period, the personal data of an applicant shall be erased.

               5.   By derogation from paragraph 4, Member States shall ensure the safe destruction of any returned EU ETD and of all related copies as soon as possible.

            Article 16
            Monitoring

               1.   Member States shall regularly monitor the application of this Directive based on the following indicators:

                           (a)

                           number of EU ETDs issued in accordance with Article 3 and the nationality of the recipient;

                           (b)

                           number of EU ETDs issued in accordance with Article 7 and the nationality of the recipient; and

                           (c)

                           number of cases of EU ETD fraud and counterfeits.

               2.   Member States shall organise the production and gathering of the data necessary to measure the change in the indicators set out in paragraph 1, and shall supply that information to the Commission on a yearly basis.

               3.   The Commission may adopt implementing acts establishing additional indicators to those referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 12(2).

            Article 17
            Evaluation

               1.   No sooner than five years after the date of transposition of this Directive, the Commission shall carry out an evaluation of this Directive and present a report on the main findings to the European Parliament and to the Council. The report shall include an evaluation of the appropriateness of the level of security of personal data, the impact on fundamental rights and the possible introduction of a uniform fee for EU ETDs.

               2.   Member States shall provide the Commission with the information necessary for the preparation of the report referred to in paragraph 1.

            Article 18
            Repeal

               1.   Decision 96/409/CFSP is repealed with effect from 36 months after the adoption of the additional technical specifications referred to in Article 9.

               2.   References to the repealed Decision shall be construed as references to this Directive.

               3.   Member States shall ensure the invalidation and destruction of ETD forms produced according to Decision 96/409/CFSP within the time limit referred to in paragraph 1.

            Article 19
            Transposition

               1.   Member States shall adopt and publish, by 24 months of the adoption of the additional technical specifications referred to in Article 9, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately communicate the text of those provisions to the Commission.
               They shall apply those measures from 36 months after the adoption of the additional technical specifications referred to in Article 9.
               When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

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

            Article 20
            Entry into force
            This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            Article 21
            Addressees
            This Directive is addressed to the Member States.

            Done at Luxembourg, 18 June 2019.

                  For the Council

                  The President

               G. CIAMBA

            (1)  Opinion of 16 January 2019 (not yet published in the Official Journal).

            (2)  Council Directive (EU) 2015/637 of 20 April 2015 on the coordination and cooperation measures to facilitate consular protection for unrepresented citizens of the Union in third countries and repealing Decision 95/553/EC (OJ L 106, 24.4.2015, p. 1).

            (3)  Decision 96/409/CFSP of the Representatives of the Governments of the Member States, meeting within the Council of 25 June 1996 on the establishment of an emergency travel document (OJ L 168, 6.7.1996, p. 4).

            (4)  Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States amending Regulation (EEC) No 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC (OJ L 158, 30.4.2004, p. 77).

            (5)  Regulation (EU) 2018/1806 of the European Parliament and of the Council of 14 November 2018 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (OJ L 303, 28.11.2018, p. 39).

            (6)  Council Regulation (EC) No 1683/95 of 29 May 1995 laying down a uniform format for visas (OJ L 164, 14.7.1995, p. 1).

            (7)  OJ L 123, 12.5.2016, p. 1.

            (8)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

            (9)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

            ANNEX I

               UNIFORM EU ETD FORM

            The uniform EU ETD form shall comply with the following specifications:
            1.   Format and size
            The uniform EU ETD form shall be in a trifold design (a single sheet printed on both sides and folded into thirds). When folded, the size of the form shall comply with the ISO/IEC 7810 ID-3 standard.
            2.   Page one: Cover page
            The cover page of the uniform EU ETD form shall contain, in this order, the words ‘EUROPEAN UNION’ in all official languages of the Union and the words ‘EMERGENCY TRAVEL DOCUMENT’ and ‘TITRE DE VOYAGE PROVISOIRE’. It shall also feature twelve golden stars forming a circle.
            3.   Page two: Affixing the uniform EU ETD sticker
            The uniform EU ETD sticker shall be securely affixed to the second page of the uniform EU ETD form in such a way as to prevent easy removal. The uniform EU ETD sticker shall be aligned with and affixed to the edge of the page. The machine-readable zone of the uniform EU ETD sticker shall be aligned with the outer edge of the page. The stamp of the issuing authorities shall be placed on the uniform EU ETD sticker in such a manner that it extends onto the page.
            4.   Pages three and four: Information
            The third and fourth page shall contain translations of ‘Emergency Travel Document’ as well as of the captions of the uniform EU ETD sticker in all official languages of the Union except for English and French. The following text shall also appear:

               ‘This EU Emergency Travel Document is a travel document issued by a Member State of the European Union for a single journey to the holder's Member State of nationality or residence or, exceptionally, to another destination. Authorities of non-EU countries are hereby requested to allow the holder to pass freely without hindrance.
               Le présent titre de voyage provisoire de l'UE est un titre de voyage délivré par un État membre de l'Union européenne aux fins d'un trajet unique vers l'État membre de nationalité ou de résidence du détenteur, ou, à titre exceptionnel, vers une autre destination. Les autorités des pays tiers sont priées d'autoriser le détenteur du titre de voyage provisoire à circuler sans entraves.’

            5.   Pages five and six: Visas and entry/exit stamps
            The fifth and sixth pages shall bear the heading ‘VISA/VISA’ and shall otherwise be left blank.
            These pages shall be reserved for visas and entry/exit stamps.
            6.   Number of the uniform EU ETD form
            A seven-digit number shall be pre-printed on the uniform EU ETD form.

            ANNEX II

               UNIFORM EU ETD STICKER

            The uniform EU ETD sticker shall comply with the following specifications:
            Features of the uniform EU ETD sticker

                        1.

                        The uniform EU ETD sticker shall contain a facial image of the holder, printed to high security standards, except where a photograph is used in accordance with Article 8(5). The facial image or photograph shall be that used for the purposes of Article 4(2).

                        2.

                        The uniform EU ETD sticker shall contain security features ensuring sufficient protection against falsification taking into account, in particular, the security features used for the uniform format for visas.

                        3.

                        The same security features shall be used for all Member States.

                        4.

                        The following shall appear on the uniform EU ETD sticker:

                                    (a)

                                    the abbreviation ‘EU ETD/TVP UE’;

                                    (b)

                                    the words ‘European Union/Union européenne’;

                                    (c)

                                    the three-letter code ‘EUE’ as set out in ICAO Document 9303.

                        5.

                        The uniform EU ETD sticker shall contain the seven-digit number of the uniform EU ETD sticker in horizontal orientation, pre-printed in black. A special font type shall be used. This number shall be preceded by the two-letter country code of the issuing Member State as set out in ICAO Document 9303, which can be either pre-printed or added when the uniform EU ETD sticker is filled in. For security purposes, the same seven-digit number may be pre-printed several times on the uniform EU ETD sticker.

                  Sections to be completed

                        6.

                        The uniform EU ETD sticker shall contain sections for the following information:

                                    (a)

                                    the destination country and any transit country for which the EU ETD is issued;

                                    (b)

                                    issuing Member State and the location of the issuing authority;

                                    (c)

                                    the date of issuance and the date of expiry;

                                    (d)

                                    the EU ETD recipient's surname and given name(s), nationality, date of birth and sex;

                                    (e)

                                    the number of the uniform EU ETD form to which the uniform EU ETD sticker will be affixed as referred to in point 6 of Annex I.

                        7.

                        The captions of the sections to be completed shall appear in English and French and shall be numbered.

                        8.

                        Dates shall be written as follows: the day using two digits, the first of which is a zero if the day in question is a single digit; the month using two digits, the first of which is a zero if the month in question is a single digit; the year using four digits. Day and month shall be followed by a blank space. For example: 20 01 2018 = 20 January 2018.

                        9.

                        The uniform EU ETD sticker shall contain a ‘remarks’ section, which shall be used by the issuing authority to indicate any further necessary information, for example the type and number of the document replaced.

                  Machine-readable information

                        10.

                        The uniform EU ETD sticker shall contain the relevant machine-readable information in line with ICAO Document 9303 to facilitate external border controls. The capital letters ‘AE’ shall be used as the first two characters of the machine-readable zone to designate the document as an EU Emergency Travel Document. The machine-readable zone shall contain a printed text in the visible background printing with the words ‘European Union’ in all the official languages of the Union. That text shall not affect the technical features of the machine-readable zone or its ability to be read.

                        11.

                        Space shall be reserved for the possible addition of a common 2D barcode.


title: Directive (EU) 2019/983 of the European Parliament and of the Council of 5 June 2019 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Text with EEA relevance)

text:
                  20.6.2019

                  EN

                  Official Journal of the European Union

                  L 164/23

         DIRECTIVE (EU) 2019/983 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
         of 5 June 2019
         amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work
         (Text with EEA relevance)
         THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union, and in particular point (b) of Article 153(2), in conjunction with point (a) of Article 153(1) thereof,
         Having regard to the proposal from the European Commission,
         After transmission of the draft legislative act to the national parliaments,
         Having regard to the opinion of the European Economic and Social Committee (1),
         After consulting the Committee of the Regions,
         Acting in accordance with the ordinary legislative procedure (2),
         Whereas:

                     (1)

                     Delivering on the European Pillar of Social Rights (3), proclaimed by the European Parliament, the Council and the Commission at the Social Summit for Fair Jobs and Growth in Gothenburg on 17 November 2017, is a shared political commitment and responsibility. Principle 10 of the European Pillar of Social Rights provides that workers have the right to a healthy, safe and well-adapted work environment. The right of workers to a high level of protection of their health and safety at work and to a working environment adapted to their professional needs also includes protection from carcinogens and mutagens at the workplace, irrespective of the duration of the employment or of the exposure.

                     (2)

                     This Directive respects fundamental rights and observes the principles recognised in the Charter of Fundamental Rights of the European Union, in particular the right to life and the right to fair and just working conditions provided for, respectively, in Articles 2 and 31 thereof.

                     (3)

                     Directive 2004/37/EC of the European Parliament and of the Council (4) aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace. A consistent level of protection from the risks related to carcinogens and mutagens is provided for in that Directive by a framework of general principles to enable Member States to ensure the consistent application of minimum requirements. The aim of those minimum requirements is to protect workers at Union level and to contribute to reducing differences in the levels of protection of workers across the Union and to ensuring a level playing field. Binding occupational exposure limit values are important components of the general arrangements for the protection of workers established by Directive 2004/37/EC. Those limit values need to be evidence-based, proportionate and measurable and should be established on the basis of available information, including up-to-date scientific and technical data, the economic feasibility of implementation and compliance, a thorough assessment of the socioeconomic impact and the availability of exposure measurement protocols and techniques at the workplace. More stringent binding occupational exposure limit values can be set by Member States in close cooperation with the social partners. In addition, Directive 2004/37/EC does not prevent Member States from applying additional measures, such as a biological limit value.

                     (4)

                     Directive 2004/37/EC aims to cover substances or mixtures which meet the criteria for classification as a category 1A or 1B carcinogen or mutagen set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5) as well as substances, mixtures or processes referred to in Annex I to Directive 2004/37/EC. The substances which meet the criteria for classification as a category 1A or 1B carcinogen or mutagen set out in Annex I to Regulation (EC) No 1272/2008 are those with a harmonised classification or classified in accordance with Article 4 or 36 of that Regulation and notified to the European Chemicals Agency (ECHA) pursuant to Article 40 of that Regulation. Those substances are listed in the public Classification and Labelling Inventory maintained by ECHA. For any new addition to the list of substances, mixtures and processes referred to in Annex I to Directive 2004/37/EC in accordance with point (a)(ii) of Article 2 of that Directive, robust scientific evidence of the carcinogenicity of the relevant substance needs to be demonstrated, based on available valid scientific sources such as ECHA’s Committee for Risk Assessment (RAC), the International Agency for Research on Cancer (IARC) and national bodies, paying particular attention to peer-reviewed published literature on that substance.

                     (5)

                     Occupational exposure limit values are part of the risk-management measures under Directive 2004/37/EC. Those limit values should be revised regularly in accordance with the precautionary principle and the principle of the protection of workers, and in light of sound available scientific and technical data concerning carcinogens and mutagens. Consideration should also be given to improving measurement techniques, risk-management measures and other relevant factors. Compliance with those limit values is without prejudice to other employers’ obligations pursuant to that Directive, in particular the reduction of the use of carcinogens and mutagens at the workplace, the prevention or reduction of workers’ exposure to carcinogens or mutagens and the measures which should be implemented to that effect. Those measures should include, in so far as is technically possible, the replacement of the carcinogen or mutagen with a substance, mixture or process which is not dangerous or is less dangerous to workers’ health, the use of a closed system and other measures aiming to reduce the level of workers’ exposure.

                     (6)

                     Hazardous drugs, including cytotoxic drugs primarily used for cancer treatment, could have genotoxic, carcinogenic or mutagenic properties. It is therefore important to protect workers who are exposed to such drugs through work involving: the preparation, administration or disposal of hazardous drugs, including cytotoxic drugs; services related to cleaning, transport, laundry or waste disposal of hazardous drugs or of materials contaminated by such drugs; or personal care for patients treated with hazardous drugs. Hazardous drugs, including cytotoxic drugs, are subject to Union measures providing for minimum requirements for the protection of health and safety of workers, in particular those provided for in Council Directive 98/24/EC (6). Hazardous drugs that contain substances that are also carcinogens or mutagens are subject to Directive 2004/37/EC. The Commission should assess the most appropriate instrument for ensuring the occupational safety of workers exposed to hazardous drugs, including cytotoxic drugs. In doing so, access to the best available treatments for patients should not be jeopardised.

                     (7)

                     For most carcinogens and mutagens, it is not scientifically possible to identify levels below which exposure would not lead to adverse effects. While setting the limit values at the workplace in relation to carcinogens and mutagens pursuant to this Directive does not completely eliminate risks to the health and safety of workers arising from exposure at work (residual risk), it nonetheless contributes to a significant reduction in the risks arising from such exposure in the stepwise and goal-setting approach pursuant to Directive 2004/37/EC. For other carcinogens and mutagens, it is scientifically possible to identify levels below which exposure is not expected to lead to adverse effects.

                     (8)

                     Maximum levels for workers’ exposure to some carcinogens or mutagens are established by values which, pursuant to Directive 2004/37/EC, are not to be exceeded.

                     (9)

                     This Directive strengthens the protection of workers’ health and safety at their workplace. The Commission should review Directive 2004/37/EC on a regular basis and make legislative proposals, if appropriate. New limit values should be set out in that Directive in the light of available information, including new scientific and technical data and evidence-based best practices, techniques and protocols for exposure-level measurement at the workplace. That information should, if possible, include data on residual risks to the health of workers, recommendations of the Scientific Committee on Occupational Exposure Limits (SCOEL) and opinions of the RAC, as well as opinions of the Advisory Committee on Safety and Health at Work (ACSH) and monographs of the IARC. Transparency of information is a tool for prevention in that context and should be ensured. Information related to residual risk is valuable for any future work to limit risks from occupational exposure to carcinogens and mutagens, and should be made publicly available at Union level. This Directive is in line with the specific recommendations of SCOEL, the RAC and the ACSH, the importance of which has been highlighted in previous amendments to Directive 2004/37/EC.

                     (10)

                     It is also necessary, in light of scientific data, to consider the absorption pathways of carcinogens and mutagens other than inhalation, including the possibility of uptake through the skin, and, in such cases, assign a skin notation for relevant substances in order to ensure the best possible level of protection. The amendments to Annex III to Directive 2004/37/EC provided for in this Directive constitute a further step in a longer-term process initiated to update that Directive.

                     (11)

                     The assessment of health effects of carcinogens subject to this Directive was based on the relevant scientific expertise from SCOEL and the RAC.

                     (12)

                     SCOEL, which was set up by Commission Decision 2014/113/EU (7), assists the Commission in particular in identifying, evaluating and analysing in detail the latest available scientific data and in proposing occupational exposure limit values for the protection of workers from chemical risks, which are to be set at Union level pursuant to Directives 98/24/EC and 2004/37/EC.

                     (13)

                     In accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (8), the RAC draws up ECHA opinions concerning the risks of chemical substances to human health and the environment. In the context of this Directive, the RAC prepared its opinion as requested in accordance with point (c) of Article 77(3) of that Regulation.

                     (14)

                     The 2018-to-2019 campaign ‘Healthy Workplaces Manage Dangerous Substances’ is a good example of how the European Agency for Safety and Health at Work (EU-OSHA) can support the implementation of occupational safety and health legislation at Union level. It is desirable that EU-OSHA work closely with Member States to provide tailored information and examples of good practices to workers in contact with certain substances, highlighting policy developments and the legislative framework already in place.

                     (15)

                     Cadmium and many of its inorganic compounds meet the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and are therefore carcinogens within the meaning of Directive 2004/37/EC. It is therefore appropriate, on the basis of available information, including scientific and technical data, to establish a limit value for cadmium and its inorganic compounds in that Directive. In addition, cadmium, cadmium nitrate, cadmium hydroxide and cadmium carbonate have been identified as substances of very high concern pursuant to point (a) of Article 57 of Regulation (EC) No 1907/2006 and are included in the candidate list referred to in Article 59(1) of that Regulation.

                     (16)

                     With regard to cadmium, it is foreseeable that it will be difficult to comply with a limit value of 0,001 mg/m3 in the short term. It is therefore appropriate to introduce a transitional period of eight years, during which the limit value 0,004 mg/m3 (inhalable fraction) should apply. With a view to protecting legitimate expectations and in order to avoid potential disruptions of existing practices in Member States that implement, on the date of the entry into force of this Directive, a biomonitoring system with a biological limit value not exceeding 0,002 mg Cd/g creatinine in urine, the limit value of 0,004 mg/m3 should, in those Member States, be measured as respirable fraction during the transitional period, in light of the SCOEL and ACSH opinions on cadmium and its inorganic compounds.

                     (17)

                     On the basis of available valid scientific sources such as those provided by SCOEL, the RAC and relevant national bodies, the Commission should, no later than three years after the date of entry into force of this Directive, assess the option of amending Directive 2004/37/EC by adding provisions on a combination of an airborne occupational exposure limit and a biological limit value for cadmium and its inorganic compounds.

                     (18)

                     Setting a biological limit value for cadmium and its inorganic compounds would protect workers against their systemic toxicity, which mainly affects the kidneys and bones. Biological monitoring can thus contribute to the protection of workers at the workplace, but only as a means of complementing the monitoring of the concentration of cadmium and its inorganic compounds in the air and therefore within the breathing zone of workers. The Commission should issue practical guidelines for biological monitoring.

                     (19)

                     Beryllium and most inorganic beryllium compounds meet the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and are therefore carcinogens within the meaning of Directive 2004/37/EC. In addition to having carcinogenic properties, beryllium is known to provoke chronic beryllium disease (CBD) and beryllium sensitisation (BeS). It is therefore appropriate, on the basis of the available information, including scientific and technical data, to establish a limit value for beryllium and inorganic beryllium compounds in that Directive and to assign a notation for skin and respiratory sensitisation.

                     (20)

                     With regard to beryllium, it is foreseeable that it will be difficult to comply with a limit value of 0,0002 mg/m3 in the short term. It is therefore appropriate to introduce a transitional period of seven years, during which the limit value of 0,0006 mg/m3 should apply.

                     (21)

                     Arsenic acid and its salts, as well as most inorganic arsenic compounds, meet the criteria for classification as carcinogenic (category 1A) in accordance with Regulation (EC) No 1272/2008 and are therefore carcinogens within the meaning of Directive 2004/37/EC. It is therefore appropriate, on the basis of the available information, including scientific and technical data, to establish a limit value for arsenic acid and its salts, as well as inorganic arsenic compounds in that Directive. In addition, arsenic acid, diarsenic pentaoxide and diarsenic trioxide are identified as substances of very high concern pursuant to point (a) of Article 57 of Regulation (EC) No 1907/2006 and are included in Annex XIV to that Regulation, requiring authorisation before they can be used.

                     (22)

                     With regard to arsenic acid, it is foreseeable that the copper smelting sector will have difficulties in complying with a limit value of 0,01 mg/m3. A transitional period of four years should therefore be introduced.

                     (23)

                     Formaldehyde meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and is therefore a carcinogen within the meaning of Directive 2004/37/EC. Formaldehyde is a local acting genotoxic carcinogen and there is sufficient scientific evidence of its carcinogenicity in humans. Formaldehyde is also a contact allergen for the skin (skin sensitiser). It is therefore appropriate, on the basis of the available information, including scientific and technical data, to establish a long- and short-term limit value for formaldehyde in that Directive and to assign a notation for skin sensitisation. In addition, at the request of the Commission, ECHA is also gathering existing information to assess the potential exposure to formaldehyde and formaldehyde releasers at the workplace, including industrial and professional uses.

                     (24)

                     Formaldehyde fixatives are routinely used in the healthcare sector across the Union because of their convenience of handling, high degree of accuracy and extreme adaptability. In some Member States, it is foreseeable that the healthcare sector will have difficulties in complying, in the short term, with a limit value of 0,37 mg/m3 or 0,3 ppm. It is therefore appropriate to introduce for that sector a transitional period of five years, during which the limit value of 0,62 mg/m3 or 0,5 ppm should apply. The healthcare sector should, however, minimise exposure to formaldehyde and is encouraged to respect the limit value of 0,37 mg/m3 or 0,3 ppm during the transitional period where possible.

                     (25)

                     In some Member States, formaldehyde is routinely used for the purposes of embalming deceased persons as part of their cultural or religious practices. It is foreseeable that the funeral sector will have difficulties in complying, in the short term, with the limit value of 0,37 mg/m3 or 0,3 ppm. It is therefore appropriate to introduce for that sector a transitional period of five years, during which the limit value of 0,62 mg/m3 or 0,5 ppm should apply.

                     (26)

                     The notations for sensitisation set in this Directive for beryllium and formaldehyde are introduced to improve clarity. When setting such notations during the update of Directive 2004/37/EC, consistency should be ensured with relevant Union law. This may include adding sensitisation notations for substances for which there is already a specific entry in Annex III to that Directive, where relevant.

                     (27)

                     4,4′-Methylene-bis(2-chloroaniline) (MOCA) meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and is therefore a carcinogen within the meaning of Directive 2004/37/EC. Its carcinogenicity, together with its manifest genotoxic characteristics, has made it possible to classify that substance as carcinogenic to humans. The possibility of a significant uptake through the skin was identified for MOCA. It is therefore appropriate to establish a limit value for MOCA and to assign a skin notation to it. In addition, it was identified as a substance of very high concern pursuant to point (a) of Article 57 of Regulation (EC) No 1907/2006 and included in Annex XIV to that Regulation, requiring authorisation before it can be placed on the market or used. It is possible, on the basis of available information, including scientific and technical data, to set a limit value for MOCA.

                     (28)

                     The Commission has consulted the ACSH. It has also carried out a two-stage consultation of management and labour at Union level in accordance with Article 154 of the Treaty on the Functioning of the European Union. The ACSH has adopted opinions for substances covered by this Directive and proposed a binding occupational exposure limit value for each of them, supporting the relevant notations for some of them.

                     (29)

                     The limit values established in this Directive are to be kept under regular scrutiny and review to ensure consistency with Regulation (EC) No 1907/2006, in particular to take account of the interaction between limit values established in Directive 2004/37/EC and derived no-effect levels for hazardous chemicals under that Regulation in order to protect workers effectively.

                     (30)

                     Since the objective of this Directive, namely to protect workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to carcinogens or mutagens at work, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

                     (31)

                     In implementing this Directive, Member States should avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings. In this regard, Member States and relevant bodies at Union and national level are encouraged to provide incentives, guidance and advice to micro, small and medium-size enterprises to facilitate compliance with this Directive. In that context, social partner agreements, guidance and other joint actions identifying and developing best practices are most welcome.

                     (32)

                     Given that this Directive concerns the protection of the health and safety of workers at their workplace, it should be transposed within two years of the date of its entry into force.

                     (33)

                     Directive 2004/37/EC should therefore be amended accordingly,

               HAVE ADOPTED THIS DIRECTIVE:

            Article 1
            Directive 2004/37/EC is amended as follows:

                        (1)

                        In Article 18a, the following subparagraphs are added:
                        ‘No later than 11 July 2022, the Commission shall assess the option of amending this Directive to add provisions on a combination of an airborne occupational exposure limit and a biological limit value for cadmium and its inorganic compounds.
                        No later than 30 June 2020, the Commission shall, taking into account the latest developments in scientific knowledge, and after appropriate consultation with relevant stakeholders, in particular health practitioners and health professionals, assess the option of amending this Directive in order to include hazardous drugs, including cytotoxic drugs, or to propose a more appropriate instrument for the purpose of ensuring the occupational safety of workers exposed to such drugs. On that basis, the Commission shall present, if appropriate, and after consulting management and labour, a legislative proposal.’;

                        (2)

                        Annex III is amended in accordance with the Annex to this Directive.

            Article 2

               1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 11 July 2021. They shall immediately inform the Commission thereof.
               When Member States adopt those 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 measures of national law which they adopt in the field covered by this Directive.

            Article 3
            This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            Article 4
            This Directive is addressed to the Member States.

            Done at Brussels, 5 June 2019.

                  For the European Parliament

                  The President

               A. TAJANI

                  For the Council

                  The President

               G. CIAMBA

            (1)  OJ C 440, 6.12.2018, p. 145.

            (2)  Position of the European Parliament of 27 March 2019 (not yet published in the Official Journal) and decision of the Council of 21 May 2019.

            (3)  OJ C 428, 13.12.2017, p. 10.

            (4)  Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).

            (5)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

            (6)  Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).

            (7)  Commission Decision 2014/113/EU of 3 March 2014 on setting up a Scientific Committee on Occupational Exposure Limits for Chemical Agents and repealing Decision 95/320/EC (OJ L 62, 4.3.2014, p. 18).

            (8)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

            ANNEX
            In point A of Annex III to Directive 2004/37/EC, the following rows are added:

                           Name of agent

                           EC No (1)

                           CAS No (2)

                           Limit values

                           Notation

                           Transitional measures

                           8 hours (3)

                           Short-term (4)

                           mg/m3 (5)

                           ppm (6)

                           f/ml (7)

                           mg/m3 (5)

                           ppm (6)

                           f/ml (7)

                           ‘Cadmium and its inorganic compounds

                           —

                           —

                           0,001 (11)

                           —

                           —

                           —

                           —

                           —

                           Limit value 0,004 mg/m3
                               (12) until 11 July 2027

                           Beryllium and inorganic beryllium compounds

                           —

                           —

                           0,0002 (11)

                           —

                           —

                           —

                           —

                           —

                           dermal and respiratory sensitisation (13)

                           Limit value 0,0006 mg/m3 until 11 July 2026

                           Arsenic acid and its salts, as well as inorganic arsenic compounds

                           —

                           —

                           0,01 (11)

                           —

                           —

                           —

                           —

                           —

                           —

                           For the copper smelting sector, the limit value shall apply from 11 July 2023

                           Formaldehyde

                           200-001-8

                           50-00-0

                           0,37

                           0,3

                           —

                           0,74

                           0,6

                           —

                           dermal sensitisation (14)

                           Limit value of 0,62 mg/m3 or 0,5 ppm (3) for the health care, funeral and embalming sectors until 11 July 2024

                           4,4′-Methylene-bis (2-chloroaniline)

                           202-918-9

                           101-14-4

                           0,01

                           —

                           —

                           —

                           —

                           —

                           skin (10)

               (11)  Inhalable fraction.

               (12)  Inhalable fraction. Respirable fraction in those Member States that implement, on the date of the entry into force of this Directive, a biomonitoring system with a biological limit value not exceeding 0,002 mg Cd/g creatinine in urine.

               (13)  The substance can cause sensitisation of the skin and of the respiratory tract.

               (14)  The substance can cause sensitisation of the skin.’.