title: Council Directive 2006/117/Euratom of 20 November 2006 on the supervision and control of shipments of radioactive waste and spent fuel

text:
               5.12.2006

               EN

               Official Journal of the European Union

               L 337/21

         COUNCIL DIRECTIVE 2006/117/EURATOM
   of 20 November 2006
   on the supervision and control of shipments of radioactive waste and spent fuel
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Articles 31(2) and 32 thereof,
   Having regard to the proposal from the Commission drawn up after obtaining the opinion of a group of persons appointed by the Scientific and Technical Committee from among scientific experts in the Member States, in accordance with Article 31 of the Treaty, and after having consulted the European Economic and Social Committee (1),
   Having regard to the opinion of the European Parliament (2),
   Whereas:

               (1)

               Operations involved in shipments of radioactive waste or spent fuel are subject to a number of requirements under Community and international legal instruments regarding in particular the safe transport of radioactive material and the conditions under which radioactive waste or spent fuel is disposed of or stored in the country of destination.

               (2)

               Further to these requirements, the health protection of workers and the general public requires that shipments of radioactive waste or spent fuel between Member States and into and out of the Community be subject to a compulsory and common system of prior authorisation.

               (3)

               As stated in Council Resolution of 22 May 2002 on the establishment of national systems for surveillance and control of the presence of radioactive materials in the recycling of metallic materials in the Member States (3), it is important to minimise the radiological risk deriving from the presence of radioactive materials among metallic materials destined for recycling.

               (4)

               Council Directive 92/3/Euratom of 3 February 1992 on the supervision and control of shipments of radioactive waste between Member States and into and out of the Community (4) established a Community system of strict control and prior authorisation for shipments of radioactive waste that has proved satisfactory. It needs, nevertheless, to be amended in the light of experience in order to clarify and add concepts and definitions, to address situations that had been omitted in the past, to simplify the existing procedure for the shipment of radioactive waste between Member States and to guarantee consistency with other Community and international provisions, and in particular with the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management (hereinafter referred to as Joint Convention), to which the Community acceded on 2 January 2006.

               (5)

               In the framework of the Fifth Phase of the SLIM (Simpler Legislation for the Internal Market) initiative, a working group of representatives of Member States and of users was set up in order to address a number of concerns expressed by users of Directive 92/3/Euratom, while bringing it into line with current international rules and instruments.

               (6)

               The procedure laid down in Directive 92/3/Euratom has been applied in practice only to shipments of spent fuel for which no further use is intended, considered thus as ‘radioactive waste’ for the purposes of that Directive. From a radiological point of view, excluding the application of such supervision and control procedure to spent fuel where it is intended for reprocessing is not justified. It is therefore appropriate that this Directive cover all shipments of spent fuel, whether it is intended for disposal or for reprocessing.

               (7)

               Each Member State should remain fully responsible for the choice of its own policy on the management of the nuclear waste and spent fuel within its jurisdiction, some choosing reprocessing of spent fuel, others aiming at final disposal of spent fuel with no other use foreseen. This Directive should therefore be without prejudice to the right of Member States to export their spent fuel for reprocessing and nothing in this Directive should imply that a Member State of destination has to accept shipments of radioactive waste and spent fuel for final treatment or disposal except in the case of reshipment. Any refusal of such shipments should be justified on the basis of the criteria set out in this Directive.

               (8)

               Simplification of the existing procedure should not hamper the existing rights of the Member States to object to, or impose conditions in relation to, a shipment of radioactive waste which require their consent. Objections should not be arbitrary and should be founded on relevant national, Community or international law. This Directive should be without prejudice to rights and obligations under international law, and in particular to the exercise, by ships and aircraft, of maritime, river and air navigation rights and freedoms, as provided for under international law.

               (9)

               The possibility for a Member State of destination or of transit to refuse the automatic procedure for granting consent to shipments imposes an unjustified administrative burden and generates uncertainty. The mandatory acknowledgement of receipt of the application by the authorities of the countries of destination and transit, together with the extension of the period for granting consent, should allow tacit approval to be assumed with a high degree of certainty.

               (10)

               The ‘authorisations’ for shipments in the sense of this Directive should not replace any specific national requirements for the shipments such as transport licences.

               (11)

               To protect human health and the environment against the dangers arising from radioactive waste, account should be taken of risks occurring outside the Community. In the case of radioactive waste and spent fuel leaving the Community, the third country of destination should not only be informed of the shipment, but should also give its consent to it.

               (12)

               The competent authorities of the Member State of destination should cooperate and liaise with the other competent authorities involved in order to avoid undue delays and to ensure a smooth operation of the consent procedure laid down by this Directive.

               (13)

               The requirement that the person responsible for the shipment take corrective safety measures where necessary in case of shipment failure should not prevent the application of mechanisms established by the Member States at national level.

               (14)

               The requirement that the holder be liable for costs arising in case of shipment failure should not prevent that mechanisms established by the Member States at national level or any contractual arrangement between the holder and any other person involved in the shipment, apply.

               (15)

               While radioactive waste should, as far as is compatible with the safe management of such material, be disposed of in the State in which it was generated it is recognized that Member States should promote agreements between themselves in order to facilitate the safe and efficient management of radioactive waste or spent fuel from Member States that produced it in small quantities and where the establishment of appropriate facilities would not be justified from a radiological point of view.

               (16)

               When an arrangement between a consignee in a third country and a holder in a third country has been concluded pursuant to Article 27 of the Joint Convention, the same arrangement could be used for the purpose of this Directive.

               (17)

               For the purposes of this Directive and in the light of past experience it is appropriate to adapt the existing standard document. For the sake of clarity the obligation to establish the new standard document by the date of transposition of this Directive should be laid down. However, should this deadline not be met, transitional provisions should provide for the use of the existing standard document. Moreover, clear rules on the use of languages should allow for legal certainty and prevent unjustified delays.

               (18)

               Periodical reporting from Member States to the Commission and from the Commission to the European Parliament, to the Council and to the European Economic and Social Committee should provide a useful overview of authorisations given Community-wide and should identify possible difficulties encountered in practice by the Member States and solutions applied.

               (19)

               Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation (5), applies, inter alia, to the transport, import to and export from the Community of radioactive substances and provides for a reporting and authorisation system of practices involving ionising radiation. Those provisions are therefore relevant to the field covered by this Directive.

               (20)

               In the light of the foregoing, it is necessary, for reasons of clarity, to repeal and replace Directive 92/3/Euratom. This Directive should not prejudice the obligations of the Member States concerning the deadlines for transposition into national law and application of the repealed Directive.

               (21)

               In accordance with paragraph 34 of the interinstitutional agreement on better law making (6) Member States are encouraged to draw up, for themselves and in the interest of the Community, their own tables which will, as far as possible, illustrate the correlation between this Directive and the transposition measures and to make them public,

         HAS ADOPTED THIS DIRECTIVE:
   CHAPTER 1
   PRELIMINARY PROVISIONS
   Article 1
   Subject matter and scope
   1.   This Directive lays down a Community system of supervision and control of transboundary shipments of radioactive waste and spent fuel, so as to guarantee an adequate protection of the population.
   2.   This Directive shall apply to transboundary shipments of radioactive waste or spent fuel whenever:

               (a)

               the country of origin or the country of destination or any country of transit is a Member State of the Community; and

               (b)

               the quantities and concentration of the consignment exceed the levels laid down in Article 3(2) points (a) and (b) of Directive 96/29/Euratom.

         3.   This Directive shall not apply to shipments of disused sources to a supplier or manufacturer of radioactive sources or to a recognised installation.
   4.   This Directive shall not apply to shipments of radioactive materials recovered, through reprocessing, for further use.
   5.   This Directive shall not apply to transboundary shipments of waste that contains only naturally occurring radioactive material which does not arise from practices.
   6.   This Directive is without prejudice to rights and obligations under international law.
   Article 2
   Reshipments related to processing and reprocessing operations
   This Directive shall not affect the right of a Member State or an undertaking in the Member State to which:

               (a)

               radioactive waste is to be shipped for processing; or

               (b)

               other material is to be shipped with the purpose to recover the radioactive waste,

         to return the radioactive waste after treatment to its country of origin. Nor shall it affect the right of a Member State or an undertaking in that Member State to which spent fuel is to be shipped for reprocessing to return to its country of origin radioactive waste recovered from the reprocessing operation.
   Article 3
   Transboundary shipments of spent fuel for reprocessing
   Without prejudice to the competence of each Member State to define its own spent fuel cycle policy, this Directive shall not affect the right of a Member State to export spent fuel for reprocessing, taking into account the principles of the nuclear common market, in particular the free movement of goods. Those shipments and exports shall be supervised and controlled in accordance with the procedures laid down in this Directive.
   Article 4
   Reshipment related to non-authorised shipments and undeclared radioactive waste
   This Directive shall not affect the right of a Member State to safely return to its country of origin:

               (a)

               shipments of radioactive waste and spent fuel which fall under the scope of this Directive but which were not duly authorised in accordance with this directive; and

               (b)

               radioactively contaminated waste or material containing a radioactive source where this material has not been declared as radioactive waste by the country of origin.

         Article 5
   Definitions
   For the purposes of this Directive the following definitions shall apply:

               1.

               ‘radioactive waste’ means radioactive material in gaseous, liquid or solid form for which no further use is foreseen by the countries of origin and destination, or by a natural or legal person whose decision is accepted by these countries, and which is controlled as radioactive waste by a regulatory body under the legislative and regulatory framework of the countries of origin and destination;

               2.

               ‘spent fuel’ means nuclear fuel that has been irradiated in and permanently removed from a reactor core; spent fuel may either be considered as usable resource that can be reprocessed or be destined for final disposal with no further use foreseen and treated as radioactive waste;

               3.

               ‘reprocessing’ means a process or operation, the purpose of which is to extract radioactive isotopes from spent fuel for further use;

               4.

               ‘shipment’ means the whole of operations involved in moving radioactive waste or spent fuel from the country or the Member State of origin to the country or the Member State of destination;

               5.

               ‘intra-community shipment’ means a shipment carried out where the country of origin and the country of destination are Member States;

               6.

               ‘extra-community shipment’ means a shipment carried out where the country of origin and/or the country of destination are third countries;

               7.

               ‘disposal’ means the emplacement of radioactive waste or spent fuel in an authorised facility without the intention of retrieval;

               8.

               ‘storage’ means the holding of radioactive waste or spent fuel in a facility that provides for its containment, with the intention of retrieval;

               9.

               ‘holder’ means any natural or legal person who, before carrying out a shipment of radioactive waste or spent fuel is responsible under the applicable national law for such materials and plans to carry out a shipment to a consignee;

               10.

               ‘consignee’ means any natural or legal person to whom radioactive waste or spent fuel is shipped;

               11.

               ‘country or Member State of origin’ and ‘country or Member State of destination’ respectively means any country or Member State from which a shipment is planned to be initiated or is initiated, and any country or Member State to which a shipment is planned or takes place;

               12.

               ‘country or Member State of transit’ means any country or Member State other than the country or the Member State of origin or the country or the Member State of destination, through the territory of which a shipment is planned or takes place;

               13.

               ‘competent authorities’ means any authority which, under the law or regulations of the countries of origin, transit or destination, are empowered to implement the system of supervision and control of shipments of radioactive waste or spent fuel;

               14.

               ‘sealed source’ has the meaning given to it by Directive 96/29/Euratom and includes the capsule, where applicable, enclosing the radioactive material as an integral part of the source;

               15.

               ‘disused source’ means a sealed source which is no longer used or intended to be used for the practice for which authorisation was granted;

               16.

               ‘recognised installation’ means a facility located in the territory of a country authorised by the competent authorities of that country in accordance with national law for the long-term storage or disposal of sealed sources or an installation duly authorised under national law for the interim storage of sealed sources;

               17.

               ‘duly completed application’ means the standard document that complies with all the requirements, as established in accordance with Article 17.

         CHAPTER 2
   INTRA-COMMUNITY SHIPMENTS
   Article 6
   Application for shipment authorisation
   1.   A holder who plans to carry out an intra-Community shipment of radioactive waste or spent fuel or to arrange for such a shipment to be carried out shall submit a duly completed application for authorisation to the competent authorities of the Member State of origin.
   2.   The application may be sent in respect of more than one shipment, provided that:

               (a)

               the radioactive waste or the spent fuel to which it relates essentially has the same physical, chemical and radioactive characteristics; and

               (b)

               the shipments are to be made from the same holder to the same consignee and involve the same competent authorities, and

               (c)

               where shipments involve transit through third countries, such transit is via the same frontier post of entry to and/or exit from the Community and via the same frontier post(s) of the third country or countries concerned, unless otherwise agreed between the competent authorities concerned.

         Article 7
   Transmission of the application to the competent authorities
   1.   The competent authorities of the Member State of origin shall send the duly completed application referred to in Article 6 for consent to the competent authorities of the Member State of destination and of the Member States of transit, if any.
   2.   The competent authorities of the Member States involved shall take the necessary measures to ensure that all information regarding shipments covered by this Directive is handled with due care and protected against any misuse.
   Article 8
   Acknowledgement of receipt and request for information
   1.   Within 20 days following the receipt of the application, the competent authorities of the Member State of destination and transit shall verify that the application is duly completed, within the meaning of Article 5(17).
   2.   In case the application is duly completed, the competent authorities of the Member State of destination shall send an acknowledgement of receipt to the competent authorities of the Member State of origin and copy it to the other competent authorities concerned, not later than 10 days after expiry of the 20 days period set out in paragraph 1.
   3.   If any of the competent authorities of the Member States concerned consider that the application is not duly completed, they shall request the missing information from the competent authorities of the Member State of origin and inform the other competent authorities of such request. This request shall be made not later than the expiry of the period set out in paragraph 1.
   The competent authorities of the Member State of origin shall transmit the requested information to the competent authorities concerned.
   Not later than 10 days after the date of receipt of the missing information and not earlier than after expiry of the 20 days period set out in paragraph 1, the competent authorities of the Member State of destination shall send an acknowledgement of receipt to the competent authorities of the Member State of origin and copy it to the other competent authorities concerned.
   4.   The time periods set out in paragraphs 1, 2 and 3 for issuing the acknowledgement of receipt may be shortened if the competent authorities of destination and transit are satisfied that the application is duly completed.
   Article 9
   Consent and refusal
   1.   Not later than two months from the date of acknowledgement of receipt the competent authorities of all Member States concerned shall notify the competent authorities of the Member State of origin of their consent, or of the conditions which they consider necessary for giving their consent, or of their refusal to grant consent.
   However, the competent authorities of the Member State of destination or of any Member State of transit may request a further period of not more than one month in addition to the period referred to in the first subparagraph to make their position known.
   2.   If upon expiry of the periods set out in paragraph 1, no reply has been received from the competent authorities of the Member State of destination and/or the intended Member State of transit, those countries shall be deemed to have given their consent for the shipment requested.
   3.   Reasons shall be given by Member States for any refusal to grant consent, or for conditions attached to their consent, which shall be based:

               (a)

               for Member States of transit, on the relevant national, Community or international legislation applicable to the transport of radioactive material;

               (b)

               for the Member State of destination, on relevant legislation applicable to the management of radioactive waste or spent fuel or on relevant national, Community or international legislation applicable to the transport of radioactive material.

         Any conditions imposed by the competent authorities of the Member States, whether they are the country of transit or of destination, may not be more stringent than those laid down for similar shipments within those Member States.
   4.   The Member State or States which gave consent to transit for a given shipment may not refuse to give consent to reshipment in the following cases:

               (a)

               when the initial consent concerned material being shipped for treatment or reprocessing purposes, if the reshipment concerns radioactive waste or other products equivalent to the original material after treatment or reprocessing, and all relevant legislation is respected;

               (b)

               under the circumstances described in Article 12, if the reshipment is undertaken on the same conditions and with the same specifications.

         5.   Unjustified delays and/or lack of cooperation by the competent authorities of another Member State shall be reported to the Commission.
   Article 10
   Authorisation of shipments
   1.   If all the consents necessary for shipment have been given, the competent authorities of the Member State of origin shall be entitled to authorise the holder to carry out the shipment and shall inform the competent authorities of the Member State of destination and of any Member State or third country of transit accordingly.
   2.   The authorisation referred to in paragraph 1 shall not in any way affect the responsibility of the holder, the transporters, the owner, the consignee or any other natural or legal person involved in the shipment.
   3.   A single authorisation may cover more than one shipment, where the conditions set out in Article 6(2) are met.
   4.   Any authorisation shall be valid for a period of not more than three years.
   When establishing this period of validity, Member States shall take into account any conditions set out in the consent given by the Member States of destination or of transit.
   Article 11
   Acknowledgement of receipt of the shipment
   1.   Within 15 days of receipt, the consignee shall send the competent authorities of the Member State of destination an acknowledgement of receipt of each shipment.
   2.   The competent authorities of the Member State of destination shall send copies of the acknowledgement of receipt to the Member State of origin and any Member State or third country of transit.
   3.   The competent authorities of the Member State of origin shall send a copy of the acknowledgement of receipt to the original holder.
   Article 12
   Shipment failure
   1.   The Member State of destination, origin or transit may decide that the shipment may not be completed if the conditions for shipment are no longer complied with in accordance with this Directive, or are not in accordance with the authorisations or consents given pursuant to this Directive.
   Such Member State shall forthwith inform the competent authorities of the other Member States involved in the shipment of this decision.
   2.   Where a shipment cannot be completed or if the conditions for shipment are not complied with in accordance with this Directive, the competent authorities of the Member State of origin shall ensure that the radioactive waste or the spent fuel in question is taken back by the holder, unless an alternative safe arrangement can be made. These competent authorities shall ensure that the person responsible for the shipment takes corrective safety measures where necessary.
   3.   The holder shall be liable for costs arising in cases where the shipment cannot or may not be completed.
   CHAPTER 3
   EXTRA-COMMUNITY SHIPMENTS
   Article 13
   Imports into the Community
   1.   Where radioactive waste or spent fuel falling within the scope of this Directive is to enter the Community from a third country and the country of destination is a Member State, the consignee shall submit an application for authorisation to the competent authorities of that Member State. The application may be sent in respect of more than one shipment, under the conditions set out in Article 6(2).
   The application shall include evidence that the consignee has made an arrangement with the holder established in the third country, and which has been accepted by the competent authorities of that third country, obliging that holder to take back the radioactive waste or the spent fuel where a shipment cannot be completed in accordance with this Directive, as provided for in paragraph 5 of this Article.
   2.   The competent authorities of the Member State of destination shall send the application referred to in paragraph 1 for consent to the competent authorities of the Member States of transit, if any.
   Articles 8 and 9 shall apply.
   3.   If all the consents necessary for the shipment have been granted, the competent authorities of the Member State of destination shall be entitled to authorise the consignee to carry out the shipment and shall inform the competent authorities of any Member State or third country of origin or of transit accordingly.
   Article 10(2), (3) and (4) shall apply.
   4.   Within 15 days of receipt of the shipment, the consignee shall send the competent authorities of the Member State of destination an acknowledgement of receipt of each shipment. The competent authorities of the Member State of destination shall send copies of the acknowledgement to the country of origin and to any Member State or third country of transit.
   5.   The Member State of destination or any Member State of transit may decide that the shipment may not be completed if the conditions for shipment are no longer complied with in accordance with this Directive, or are not in accordance with the authorisations or consents issued pursuant to this Directive. Such Member State shall forthwith inform the competent authorities of the country of origin of this decision.
   6.   The consignee shall be liable for costs arising in cases where the shipment cannot or may not be completed.
   Article 14
   Transit through the Community
   1.   Where radioactive waste or spent fuel is to enter the Community from a third country and the country of destination is not a Member State, the natural or legal person who has the responsibility for managing the shipment within the Member State through whose customs post radioactive waste or spent fuel is first to enter the Community (first Member State of transit) shall submit an application for authorisation to the competent authorities of that Member State. The application may be sent in respect of more than one shipment, under the conditions set out in Article 6(2).
   The application shall include evidence that the consignee established in the third country has made an arrangement with the holder established in the third country, and accepted by the competent authorities of that third country, obliging that holder to take back radioactive waste or the spent fuel where a shipment cannot be completed in accordance with this Directive, as provided for in paragraph 5 of this Article.
   2.   The competent authorities of the first Member State of transit shall send the application referred to in paragraph 1 for consent to the competent authorities of other Member States of transit, if any.
   Articles 8 and 9 shall apply.
   3.   If all the consents necessary for shipment have been granted, the competent authorities of the first Member State of transit shall be entitled to authorise the person responsible referred to in paragraph 1 to carry out the shipment and shall inform the competent authorities of any other Member State or third country of transit or of origin accordingly.
   Article 10(2), (3) and (4) shall apply.
   4.   The person responsible referred to in paragraph 1 shall notify the competent authorities of the first Member State of transit that the radioactive waste or spent fuel has reached its destination in the third country within 15 days of the date of arrival and shall indicate the last customs post in the Community through which the shipment passed.
   The notification shall be substantiated by a declaration or certification by the consignee stating that the radioactive waste or spent fuel has reached its proper destination and indicating the customs post of entry in the third country.
   5.   A Member State of transit may decide that the shipment may not be completed if the conditions for shipment are no longer complied with in accordance with this Directive, or are not in accordance with the authorisations or consents issued pursuant to this Directive. Such Member State shall forthwith inform the competent authorities of the country of origin of this decision. The person responsible referred to in paragraph 1 shall be liable for costs arising in cases where the shipment cannot or may not be completed.
   Article 15
   Exports out of the Community
   1.   Where radioactive waste or spent fuel is to be exported from the Community to a third country, the holder shall submit an application for authorisation to the competent authorities of the Member State of origin. The application may be sent in respect of more than one shipment, under the conditions set out in Article 6(2).
   2.   The competent authorities of the Member State of origin shall:

               (a)

               notify the competent authorities of the country of destination of the planned shipment and ask their consent; and

               (b)

               send the application referred to in paragraph 1 for consent to the competent authorities of the Member States of transit, if any.

         Article 8 shall apply.
   3.   If all the consents necessary for shipment have been given, the competent authorities of the Member State of origin shall be entitled to authorise the holder to carry out the shipment and shall inform the competent authorities of the third country of destination and of any Member State or third country of transit accordingly.
   Article 10(2), (3) and (4) shall apply.
   4.   The holder shall notify the competent authorities of the Member State of origin that the radioactive waste or spent fuel has reached its destination in the third country within 15 days of the date of arrival and shall indicate the last customs post in the Community through which the shipment passed.
   The notification shall be substantiated by a declaration or certification by the consignee stating that the radioactive waste or spent fuel has reached its proper destination and indicating the customs post of entry in the third country.
   5.   The Member State of origin or any Member State of transit may decide that the shipment may not be completed if the conditions for shipment are no longer complied with in accordance with this Directive, or are not in accordance with the authorisations or consents issued pursuant to this Directive. Such Member State of transit shall forthwith inform the competent authorities of the Member State of origin of this decision.
   Article 12(2) and (3), shall apply.
   Article 16
   Prohibited exports
   1.   The competent authorities of Member States shall not authorise shipments:

               (a)

               to a destination south of latitude 60° south; or

               (b)

               to a State which is party to the Partnership Agreement between the members of the African, Caribbean and Pacific Group of States of the one part, and the European Community and its Member States, of the other part, (Cotonou ACP-EC Agreement) which is not a Member State, without prejudice to Article 2, or

               (c)

               to a third country which does not, in the opinion of the competent authorities of the Member State of origin, in accordance with the criteria referred to in paragraph 2 of this Article, have the administrative and technical capacity and regulatory structure to manage the radioactive waste or spent fuel safely, as stated in the Joint Convention. In coming to an opinion on this issue, Member States shall take duly into account any relevant information from other Member States. In this respect, Member States shall inform the Commission and the Advisory committee, as set up under Article 21 on a yearly basis.

         2.   The Commission shall, in accordance with the procedure laid down in Article 21, establish criteria, taking due account of, inter alia, relevant safety standards of the International Atomic Energy Agency (IAEA), facilitating Member States to evaluate whether requirements for exports are met.
   CHAPTER 4
   GENERAL PROVISIONS
   Article 17
   Use of a standard document
   1.   A standard document shall be used for all shipments within the scope of this Directive.
   2.   The Commission shall, in accordance with the procedure laid down in Article 21, establish the standard document which shall include as an Annex a list of the minimum requirements of a duly completed application.
   The standard document and its Annexes shall be published in the Official Journal of the European Union and be made available in electronic form not later than 25 December 2008. If necessary, it shall be updated following the same procedure.
   3.   The application for authorisation shall be completed and any further documentation and information referred to in Articles 10, 13, 14 and 15 shall be supplied in a language that is acceptable to the competent authorities of the Member State to whom the application for authorisation is submitted in accordance with this Directive.
   An authenticated translation shall be supplied by the holder at the request of the competent authorities of the country of destination or transit in a language acceptable to them.
   4.   Any additional requirements for authorising a shipment shall be attached to the standard document.
   5.   Without prejudice to any other accompanying documents required under other relevant legal provisions, the completed standard document certifying that the authorisation procedure has been duly complied with shall accompany each shipment falling under the scope of this Directive, including cases where the authorisation relates to more than one shipment in a single document.
   6.   These documents shall be available to the competent authorities of the country of origin and destination and any country of transit.
   Article 18
   Competent authorities
   1.   Member States shall forward to the Commission not later than 25 December 2008 the name(s) and the address(es) of the competent authority or authorities and all necessary information for rapidly communicating with such authorities.
   2.   Member States shall regularly forward to the Commission any changes to such data.
   Article 19
   Transmission
   1.   The Commission shall, in accordance with the procedure laid down in Article 21, establish recommendations for a secure and effective system of transmission of the documents and information relating to the provisions of this Directive.
   2.   The Commission shall establish and maintain an electronic communication platform to publish;

               (a)

               the name(s) and address(es) of the competent authority or authorities of each Member State;

               (b)

               the languages acceptable to the competent authorities of each Member State; and

               (c)

               all general conditions and additional requirements, if any, necessary for the competent authorities of each Member State to authorise a shipment.

         Article 20
   Regular reports
   1.   By 25 December 2011 and every three years afterwards, Member States shall forward to the Commission reports on the implementation of this Directive.
   2.   On the basis of these reports, the Commission shall, in accordance with the procedure laid down in Article 21, establish a summary report for the European Parliament, the Council and the European Economic and Social Committee, paying particular attention to the implementation of Article 4.
   Article 21
   Advisory committee
   1.   In performing the tasks laid down in Articles 16(2), 17(2), 19(1) and Article 20(2) the Commission shall be assisted by a Committee of an advisory nature composed of representatives of the Member States and chaired by a representative of the Commission (hereinafter referred to as the Committee).
   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.
   3.   The opinion shall be recorded in the minutes. Each Member State shall have the right to ask to have its position recorded in the minutes.
   4.   The Commission shall take 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.
   Article 22
   Transposition
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 25 December 2008. They shall forthwith inform the Commission thereof.
   When they are adopted by the Member States, these measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 23
   Repeal
   1.   Directive 92/3/Euratom shall be repealed with effect from 25 December 2008, without prejudice to the obligations of the Member States relating to the time limit for transposition into national law and application of that Directive.
   2.   References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in the Annex.
   Article 24
   Transitional provisions
   1.   Where the application for authorisation has been duly approved by or submitted to the competent authorities of the country of origin before 25 December 2008, Directive 92/3/Euratom shall apply to all shipment operations covered by the same authorisation.
   2.   When deciding on applications for authorisation submitted before 25 December 2008, for more than one shipment of radioactive waste or spent fuel to a third country of destination, the Member State of origin shall take account of all relevant circumstances, and in particular:

               (a)

               the planned time schedule for carrying out all shipments covered by the same application;

               (b)

               the justification for including all shipments in the same application;

               (c)

               the appropriateness of authorising a number of shipments lower than that covered by the application.

         3.   Until the standard document provided for in Article 17 of this Directive becomes available, the standard document established by Commission Decision 93/552/Euratom (7) shall be used mutatis mutandis for the purposes of this Directive.
   Article 25
   Entry into force
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 26
   This Directive is addressed to the Member States.

      Done at Brussels, 20 November 2006.

            For the Council

            The President

         J. KORKEAOJA

      (1)  OJ C 286, 17.11.2005, p. 34.

      (2)  Opinion delivered on 5 July 2006 (not yet published in the Official Journal).

      (3)  OJ C 119, 22.5.2002, p. 7.

      (4)  OJ L 35, 12.2.1992, p. 24.

      (5)  OJ L 159, 29.6.1996, p. 1.

      (6)  OJ C 321, 31.12.2003, p. 1.

      (7)  Commission Decision 93/552/Euratom of 1 October 1993 establishing the standard document for the supervision and control of shipments of radioactive waste referred to in Council Directive 92/3/Euratom (OJ L 268, 29.10.1993, p. 83).
   ANNEX
   CORRELATION TABLE

               Directive 92/3/Euratom

               This Directive

               Article 1

               Article 1

               Article 2

               Article 5

               Article 3

               First recital

               Article 4, first subparagraph, first sentence

               Article 6(1)

               Article 4, first subparagraph, second sentence

               Article 7(1)

               Article 4, second subparagraph

               Article 17(1)

               Article 4, third subparagraph

               none

               Article 5(1)

               Article 6(2)

               Article 5(2)

               Article 10(4)

               Article 6(1), first subparagraph

               Article 9(1)

               Article 6(1), second subparagraph

               Article 17(1)

               Article 6(2)

               Article 9(3)

               Article 6(3)

               Article 9(1), second subparagraph

               Article 6(4)

               Article 9(2)

               Article 7, first subparagraph

               Article 10(1)

               Article 7, second subparagraph

               Article 17(1)

               Article 7, third subparagraph

               Article 10(2)

               Article 8

               Article 17(5)

               Article 9(1), first part of the sentence

               Article 11(1)

               Article 9(1), end part of the sentence

               Article 17(1)

               Article 9(2), first sentence

               Article 11(2)

               Article 9(2), second sentence

               Article 11(3)

               Article 10(1)

               Article 13

               Article 10(1), end of the first sentence

               Article 17(1)

               Article 10(2)

               Article 14

               Article 10(3)

               Article 13

               Article 11

               Article 16(1)

               Article 12(1)

               Article 15(1)

               Article 12(2)

               Article 15(3)

               Article 12(3)

               Article 10(2)

               Article 12(4)

               Article 17(1)

               Article 12(5)

               Article 15(4), first subparagraph

               Article 12(6)

               Article 15(4), second subparagraph

               Article 13

               Article 1(3)

               Article 14

               Article 2

               Article 15(1)

               Article 12(2)

               Article 15(2)

               Article 13(1), second subparagraph

               Article 16

               Article 9(4)

               Article 17

               Article 18

               Article 18

               Article 20

               Article 19

               Article 21

               Article 20, (first, second and third indents)

               Article 17(1)

               Article 20, fourth indent

               Article 16(2)

               Article 20, fifth indent

               Article 20(2)

               Article 21

               Article 22

               Article 22

               Article 26

               Article 3(new)

               Article 4(new)

               Article 8(new)

               Article 19(new)

               Article 23(new)

               Article 24(new)

               Article 25(new)


title: Commission Directive 2013/46/EU of 28 August 2013 amending Directive 2006/141/EC with regard to protein requirements for infant formulae and follow-on formulae  Text with EEA relevance

text:
               29.8.2013

               EN

               Official Journal of the European Union

               L 230/16

         COMMISSION DIRECTIVE 2013/46/EU
   of 28 August 2013
   amending Directive 2006/141/EC with regard to protein requirements for infant formulae and follow-on formulae
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (1), and in particular Article 4(1) thereof,
   Whereas:

               (1)

               Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (2) lays down, inter alia, compositional and labelling rules for infant formulae and follow-on formulae.

               (2)

               Directive 2006/141/EC specifically provides for infant formulae and follow-on formulae to only be manufactured from protein sources defined in that Directive. Those protein sources are cows’ milk proteins and soya protein isolates, alone or in a mixture, as well as protein hydrolysates.

               (3)

               On request from the Commission, the European Food Safety Authority delivered, on 28 February 2012, a scientific opinion on the suitability of goat milk protein as a source of protein in infant formulae and in follow-on formulae. That opinion concluded that protein from goats’ milk can be suitable as a protein source for infant formulae and follow-on formulae provided that the final product complies with the compositional criteria laid down in Directive 2006/141/EC.

               (4)

               On the basis of that opinion, infant formulae and follow-on formulae manufactured from goats’ milk proteins should be allowed on the market provided that the final product complies with the compositional criteria laid down in Directive 2006/141/EC. Directive 2006/141/EC should therefore be amended accordingly.

               (5)

               On request from the Commission, the European Food Safety Authority delivered, on 5 October 2005, a scientific opinion on the safety and suitability for particular nutritional use by infants of formula based on whey protein partial hydrolysates with a protein content of at least 1,9 g/100 kcal, which was below the minimum level provided for in the Union legislation at that time. That opinion concluded that infant formula, based on hydrolysates of whey protein derived from cows’ milk with a protein content of 1,9 g/100 kcal (0,47 g/100 kJ) and corresponding to the protein formulation assessed, is safe and suitable for use as the sole source of nutrition of infants. On the basis of that opinion, Directive 2006/141/EC, as amended by Commission Regulation (EC) No 1243/2008 of 12 December 2008 amending Annexes III and VI to Directive 2006/141/EC as regards compositional requirements for certain infant formulae (3), authorises the marketing of infant formulae manufactured from protein hydrolysates with such a protein content provided that the product complies with certain specific criteria set out therein.

               (6)

               That opinion also concluded that, while no data on follow-on formulae based on hydrolysed whey protein with a protein content of 1,9 g/100 kcal (0,47 g/100 kJ) had been submitted, a formula with that protein formulation would be suitable for older infants in conjunction with complementary foods.

               (7)

               On the basis of that opinion, and in order to allow the development of innovative products, such follow-on formulae should be allowed on the market. Directive 2006/141/EC should therefore be amended accordingly.

               (8)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, and neither the European Parliament nor the Council have opposed them,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 2006/141/EC is amended as follows:

               (1)

               Article 7 is amended as follows:

                           (a)

                           in paragraph 1, the second subparagraph is replaced by the following:
                           ‘In the case of infant formulae manufactured from cows’ milk or goats’ milk proteins defined in point 2.1 of Annex I with a protein content between the minimum and 0,5 g/100 kJ (2 g/100 kcal), the suitability of the infant formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies.’;

                           (b)

                           in paragraph 2, the following subparagraph is added:
                           ‘In the case of follow-on formulae manufactured from protein hydrolysates defined in point 2.2 of Annex II with a protein content between the minimum and 0,56 g/100 kJ (2,25 g/100 kcal), the suitability of the follow-on formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies and shall be in accordance with the appropriate specifications set out in Annex VI.’;

               (2)

               in Article 12, the introductory phrase is replaced by the following:
               ‘The name under which infant formulae and follow-on formulae manufactured entirely from cows’ milk or goats’ milk proteins are sold shall be respectively:’;

               (3)

               Annexes I, II, III and VI are amended in accordance with the Annex to this Directive.

         Article 2
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 3
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 February 2014 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 28 August 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 124, 20.5.2009, p. 21.

      (2)  OJ L 401, 30.12.2006, p. 1.

      (3)  OJ L 335, 13.12.2008, p. 25.

      ANNEX
      Annexes I, II, III and VI to Directive 2006/141/EC are amended as follows:

                  (1)

                  Annex I is amended as follows:

                              (a)

                              point 2.1 is amended as follows:

                                          (i)

                                          the title is replaced by the following:
                                          ‘2.1.   Infant formulae manufactured from cows’ milk or goats’ milk proteins’;

                                          (ii)

                                          footnote 1 is replaced by the following:

                                                      ‘(1)

                                                      Infant formulae manufactured from cows’ milk or goats’ milk protein with a protein content between the minimum and 0,5 g/100 kJ (2 g/100 kcal) shall be in accordance with the second subparagraph of Article 7(1).’;

                              (b)

                              in point 2.3, the title is replaced by the following:
                              ‘2.3.   Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins’;

                              (c)

                              in point 10.1, the title is replaced by the following:
                              ‘10.1.   Infant formulae manufactured from cows’ milk or goats’ milk proteins or protein hydrolysates’;

                              (d)

                              in point 10.2, the title is replaced by the following:
                              ‘10.2.   Infant formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins’;

                  (2)

                  Annex II is amended as follows:

                              (a)

                              in point 2.1, the title is replaced by the following:
                              ‘2.1.   Follow-on formulae manufactured from cows’ milk or goats’ milk proteins’;

                              (b)

                              in point 2.2, the table is replaced by the following:

                                          ‘Minimum (1)

                                          Maximum

                                          0,45 g/100 kJ
                                          (1,8 g/100 kcal)

                                          0,8 g/100 kJ
                                          (3,5 g/100 kcal)

                              (c)

                              in point 2.3, the title is replaced by the following:
                              ‘2.3.   Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins’;

                              (d)

                              in point 8.1, the title is replaced by the following:
                              ‘8.1.   Follow-on formulae manufactured from cows’ milk or goats’ milk proteins or protein hydrolysates’;

                              (e)

                              in point 8.2, the title is replaced by the following:
                              ‘8.2.   Follow-on formulae manufactured from soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins’;

                  (3)

                  in point 3 of Annex III, footnote 1 is replaced by the following:

                              ‘(1)

                              L-arginine and its hydrochloride shall only be used in the manufacture of infant formulae referred to in the third subparagraph of Article 7(1) and follow-on formulae referred to in the second subparagraph of Article 7(2).’;

                  (4)

                  the title of Annex VI is replaced by the following:

                     ‘Specification for the protein content and source and the processing of protein used in the manufacture of infant formulae and follow-on formulae with a protein content less than 0,56 g/100 kJ (2,25 g/100 kcal) manufactured from hydrolysates of whey proteins derived from cows’ milk protein’.

         (1)  Follow-on formulae manufactured from protein hydrolysates with a protein content between the minimum and 0,56 g/100 kJ (2,25 g/100 kcal) shall be in accordance with the second subparagraph of Article 7(2).’


Avis juridique important

|

32003L0040

Commission Directive 2003/40/EC of 16 May 2003 establishing the list, concentration limits and labelling requirements for the constituents of natural mineral waters and the conditions for using ozone-enriched air for the treatment of natural mineral waters and spring waters

Official Journal L 126 , 22/05/2003 P. 0034 - 0039

Commission Directive 2003/40/ECof 16 May 2003establishing the list, concentration limits and labelling requirements for the constituents of natural mineral waters and the conditions for using ozone-enriched air for the treatment of natural mineral waters and spring watersTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 80/777/EEC(1), of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters, as last amended by Directive 96/70/EC of the European Parliament and of the Council(2), and in particular Article 11(1) thereof,Whereas:(1) Constituents may be present in the natural state in certain natural mineral waters because of their hydrogeological origin and may present a risk to public health above a certain concentration. It is therefore deemed necessary to establish concentration limits for these constituents in natural mineral waters.(2) Article 11 of Directive 80/777/EEC makes provision for adopting harmonised concentration limits for the constituents of natural mineral waters after consulting the Scientific Committee for Food, and for labelling requirements to indicate, where applicable, the presence of certain constituents at high concentrations.(3) The Scientific Committee for Food issued an opinion(3), on arsenic, barium, fluoride, boron and manganese and, for other constituents of natural mineral waters, validated the limits recommended by the WHO for drinking water.(4) The revised Codex standard for "natural mineral waters"(4), gives, for health purposes, a list of constituents and maximum limits for these constituents. It was adopted on the basis of the most recent international scientific data and affords sufficient public health protection.(5) It is generally acknowledged that a low-level fluoride intake can have a beneficial effect on teeth. By contrast, excessive fluoride intake across the board can have harmful effects on public health. Thus, it is necessary to lay down a harmonised maximum limit for fluoride in natural mineral waters affording sufficient protection for the population as a whole.(6) The World Health Organisation recommended a guide value of 1,5 mg/l for fluoride for drinking water, which was validated for natural mineral waters by the Scientific Committee for Food in the abovementioned opinion. In order to protect infants and young children, who are the most sensitive to the risk of fluorosis, where the fluoride content of a natural mineral water exceeds this guide value, a reference to this fact, which can be seen easily by the consumer, also needs to be made on the label.(7) The Scientific Committee for Food indicated a guide value for boron in natural mineral waters based on the WHO(5), recommendations of 1996. However, the WHO and other internationally recognised scientific organisations have since then made new appraisals of boron's effect on public health and have recommended higher values. The European Food Safety Authority should therefore be consulted about boron in natural mineral waters so that the new scientific appraisals available can be taken into account and a maximum limit for boron should not be set at this stage.(8) The Scientific Committee for Food also indicated in the above opinion the acceptable level for barium, manganese and arsenic in natural mineral waters. For the other undesirable constituents of natural mineral waters which may have a harmful effect on public health, the revised Codex standard lays down maximum limits that afford sufficient protection for public health. However, the limit for nitrates is deemed to be too low in the light of the available data and should be brought into line with that for drinking water(6).(9) The maximum limit for nitrates laid down in the Codex standard affords sufficient protection for public health and should serve as a reference for Community and international trade in natural mineral waters. However, during the procedure for official recognition of natural mineral water sources referred to in Article 1 of the aforementioned Directive, the Member States' competent authorities must be able to take a lower guide value for nitrates in natural mineral waters collected within their territory.(10) Natural mineral waters whose content in certain constituents exceeds the maximum limits for these constituents shall, for public health purposes, be subjected to the separation treatments for these constituents. In order to enable the operators concerned to make the necessary investment to comply with these new standards, sufficient periods should be allowed before the maximum concentration limits for such constituents come into force, in particular with regard to fluoride and nickel for which no separation treatment has yet been assessed or authorised at Community level.(11) For the purposes of official checks on these constituents, a fluctuation margin around the maximum concentration limits is required corresponding to measurement uncertainties.(12) Article 4(1)(b) of Directive 80/777/EEC (as amended) provides for the separation of iron, manganese, sulphur and arsenic from certain natural mineral waters, using ozone-enriched air treatment, subject to an assessment of this treatment by the Scientific Committee for Food and adoption of the conditions for use of this treatment by the Standing Committee on the Food Chain and Animal Health.(13) The Scientific Committee for Food issued an opinion(7), on this treatment which provides for both given methods and results. However, it is deemed appropriate to stipulate only given results, in order to take account of developments in ozone-enriched air treatment techniques and treatment variability depending on the physico-chemical composition of the water to be treated.(14) Moreover, treatment with ozone-enriched air should not modify the composition in terms of characteristic constituents within the meaning of Article 7(2)(a) of Directive 80/777/EEC, or have a disinfectant action within the meaning of Article 4(3) or generate the formation of treatment residues which may have a harmful effect on public health.(15) Pursuant to Article 7(2)(c) of the above Directive, natural mineral waters treated with ozone-enriched air must bear a reference on the label giving customers sufficient information about the treatment carried out.(16) In accordance with the provisions of Article 9(4)(a) fourth indent of Directive 80/777/EEC, the provisions concerning the treatments provided for in Article 4 of the Directive, and in particular treatment with ozone-enriched air, are applicable to spring waters.(17) The measures laid down in this Directive are in accordance with the opinion of the Scientific Committee on the Food Chain and Animal Health,HAS ADOPTED THIS DIRECTIVE:Article 1This Directive establishes the list of constituents of natural mineral waters which may present a risk to public health, the limits for admissible levels of these constituents, the deadlines for application of these limits and the labelling requirements for certain constituents. These constituents must be present in the water naturally and may not result from contamination at source.It also defines the conditions for using ozone-enriched air for separating compounds of iron, manganese, sulphur and arsenic from natural mineral waters or spring waters, and the labelling requirements for waters which have undergone such treatment.Article 21. By 1 January 2006 at the latest, natural mineral waters shall, at the time of packaging, comply with the maximum concentration limits set out in Annex I for the constituents listed in that Annex.2. However, in the case of fluorides and nickel, the deadline referred to above is extended until 1 January 2008.3. By way of derogation from paragraph 1, during the procedure for official recognition of natural mineral waters collected within their territory, the competent authorities of the Member States may take a lower reference value for nitrates and nitrites, provided that the same reference value is applied to all applications made to them.Article 3For the purposes of official controls, the Member States shall comply with the specifications listed in Annex II for analysing the constituents listed in Annex I.Article 41. Natural mineral waters with a fluoride concentration exceeding 1,5 mg/l shall bear on the label the words "contains more than 1,5 mg/l of fluoride: not suitable for regular consumption by infants and children under 7 years of age".2. The label information laid down in paragraph 1 of this Article shall be placed in immediate proximity to the trade name and in clearly visible characters.3. Natural mineral waters which, under the terms of paragraph 1 of this Article, bear label information, shall indicate the actual fluoride content in relation to the physico-chemical composition in terms of essential constituents, as laid down in Article 7(2)(a) of Directive 80/777/EEC.Article 51. Without prejudice to the provisions of Article 4(1)(b) of Directive 80/777/EEC, application of the treatment of natural mineral waters with ozone-enriched air must be notified in advance to the competent authorities, who shall ensure that:(a) use of such treatment is justified by the composition of the water in terms of compounds of iron, manganese, sulphur and arsenic;(b) the operator takes all measures necessary to guarantee that the treatment is effective and safe and to allow it to be checked by the competent authorities.2. Ozone-enriched air treatment of natural mineral waters must comply with all the following conditions:(a) the physico-chemical composition of the natural mineral waters in terms of essential constituents shall not be modified by the treatment;(b) the natural mineral water before treatment must comply with the microbiological criteria laid down in Article 5(1) and (2) of Directive 80/777/EEC;(c) the treatment shall not lead to the formation of residues with a concentration exceeding the maximum limits laid down in Annex III or residues which could pose a risk to public health.Article 6Pursuant to Article 7(2)(c) of Directive 80/777/EEC, the labelling of natural mineral waters which have been treated with ozone-enriched air shall bear, in proximity to the analytical composition of characteristic constituents, the words "water subjected to an authorised ozone-enriched air oxidation technique".Article 7Without prejudice to the provisions of Article 9(4)(b) of Directive 80/777/EEC, the provisions of Articles 5 and 6 of this Directive shall apply to spring waters.Article 81. The Member States shall take the necessary measures to permit the marketing of products complying with the present Directive by 1 January 2004 at the latest.2. Without prejudice to the deadlines set out in Article 2(1) and (2), the Member States shall prohibit the marketing of products not complying with the present Directive from 1 July 2004. However, products packaged and labelled prior to 1 July 2004 may be sold until stocks are exhausted.Article 9The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2003 at the latest. They shall forthwith inform the Commission thereof.The provisions adopted pursuant to this paragraph shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. Member States shall determine how such reference is to be made.Article 10This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.Article 11This Directive is addressed to the Member States.Done at Brussels, 16 May 2003.For the CommissionDavid ByrneMember of the Commission(1) OJ L 229, 30.8.1980, p. 1.(2) OJ L 299, 23.11.1996, p. 26.(3) Opinion of 13 December 1996 on arsenic, barium, fluoride, boron and manganese in natural mineral waters.(4) Codex standard 108-1981, Rev 1-1997, revised during the 7th session of the CCNMW (October 2000).(5) WHO (1996): guidelines on the quality of drinking water, second edition, volume 2.(6) Council Directive 98/83/EC (OJ L 330 of 5.12.1998, p. 32).(7) Opinion of the Scientific Committee for Food of 7 June 1996 on the use of ozone for separating unstable elements such as iron, manganese and arsenic from natural mineral waters.ANNEX IConstituents naturally present in natural mineral waters and maximum limits which, if exceeded, may pose a risk to public health>TABLE>ANNEX IIPerformance characteristics((Analytical methods for measuring concentrations of the constituents listed in Annex I must be able to measure, as a minimum, concentrations equal to the parametric value with a specified accuracy, precision and detection limit. Whatever the sensitivity of the method of analysis used, the result will be expressed using at least the same number of decimal places as for the maximum limit laid down in Annex I.)) for analysing the constituents in Annex I>TABLE>Note 1:accuracy is the systematic error and is the difference between the average value of a large number of repeated measurements and the exact value.Note 2:precision is the random error and is expressed in general as the standard deviation (within a batch and between batches) of a sample of results from the average. Acceptable precision is equal to twice the relative standard deviation.Note 3:the detection limit is:- either three times the relative standard deviation within a batch of a natural sample containing a low concentration of the parameter,- or five times the relative standard deviation within a batch of a virgin sample.Note 4:the method should make it possible to determine total cyanide in all its forms.ANNEX IIIMaximum limits for residues from treatment of natural mineral waters and spring waters by ozone-enriched air>TABLE>


title: Commission Directive 2012/15/EU of 8 May 2012 amending Directive 98/8/EC of the European Parliament and of the Council to include margosa extract as an active substance in Annex I thereto  Text with EEA relevance

text:
               9.5.2012

               EN

               Official Journal of the European Union

               L 123/39

         COMMISSION DIRECTIVE 2012/15/EU
   of 8 May 2012
   amending Directive 98/8/EC of the European Parliament and of the Council to include margosa extract as an active substance in Annex I thereto
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes margosa extract.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, margosa extract has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive. The evaluation concerned margosa extract from the kernels of Azadirachta indica extracted with water and further processed with organic solvents. Any possible other substances complying with the definition of margosa extract in the list of active substances to be assessed in Regulation (EC) No 1451/2007 have not been evaluated, and should therefore not be included in Annex I to Directive 98/8/EC based on this evaluation.

               (3)

               Germany was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 26 November 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

               (4)

               The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 9 December 2011, in an assessment report.

               (5)

               It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing margosa extract may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include margosa extract in Annex I to that Directive.

               (6)

               Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (7)

               In view of the risks identified for surface water, sediment and non-target arthropods, it is appropriate to require that product authorisations are subject to appropriate risk mitigation measures.

               (8)

               The provisions of this Directive should be applied at the same time in all Member States in order to ensure equal treatment on the Union market of biocidal products containing the active substance margosa extract and also to facilitate the proper operation of the biocidal products market in general.

               (9)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (10)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (11)

               Directive 98/8/EC should therefore be amended accordingly.

               (12)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 30 April 2013 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 May 2014.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 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, 8 May 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

      (2)  OJ L 325, 11.12.2007, p. 3.

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry is added:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (1)

                     ‘55

                        margosa extract

                     IUPAC name: Not applicable
                     CAS-No: 84696-25-3
                     EC No: 283-644-7
                     Description: margosa extract from the kernels of Azadirachta indica extracted with water and further processed with organic solvents

                     1 000 g/kg

                     1 May 2014

                     30 April 2016

                     30 April 2024

                     18

                     When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     Member States shall ensure that authorisations are subject to appropriate risk mitigation measures for the protection of surface water, sediment and non-target arthropods.’

         (1)  For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm


title: Commission Directive 2013/6/EU of 20 February 2013 amending Directive 98/8/EC of the European Parliament and of the Council to include diflubenzuron as an active substance in Annex I thereto  Text with EEA relevance

text:
               21.2.2013

               EN

               Official Journal of the European Union

               L 48/10

         COMMISSION DIRECTIVE 2013/6/EU
   of 20 February 2013
   amending Directive 98/8/EC of the European Parliament and of the Council to include diflubenzuron as an active substance in Annex I thereto
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes N-[[(4-chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide, which is a synonym for diflubenzuron.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, diflubenzuron has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive.

               (3)

               Sweden was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 19 November 2007 in accordance with Article 10(5) and (7) of Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, and amending Regulation (EC) No 1896/2000 (3).

               (4)

               The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 21 September 2012, in an assessment report.

               (5)

               It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing diflubenzuron may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include diflubenzuron for use in product-type 18 in Annex I to that Directive.

               (6)

               Not all potential uses and exposure scenarios have been evaluated at Union level. For example, outdoor use, use by non-professionals, and exposure of livestock were not assessed. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (7)

               In the light of the findings in the assessment report that there is a possible indirect human exposure via consumption of food as a result of those uses represented in the assessment, it is appropriate to require, where relevant, verification of the need to set new or to amend existing maximum residue levels in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (4) or with Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (5). Special consideration should be given to the in vivo genotoxic metabolite PCA. Measures should be adopted ensuring that the applicable maximum residue levels are not exceeded.

               (8)

               In view of the assumptions made during the risk assessment, it is appropriate to require that professional users of products containing diflubenzuron wear appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to workers and operators can be reduced to an acceptable level.

               (9)

               In view of the risks identified for the environment, it is appropriate to require, unless it can be demonstrated in the application for product authorisation that risks to the aquatic and terrestrial ecosystems can be reduced to an acceptable level, that products are not authorised in water systems, and that products authorised for use on manure are only used on dry manure, which has to undergo complete aerobic composting prior to application of the manure on arable land.

               (10)

               The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product-type 18 containing the active substance diflubenzuron and also to facilitate the proper operation of the biocidal products market in general.

               (11)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (12)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (13)

               Directive 98/8/EC should therefore be amended accordingly.

               (14)

               In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (6), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

               (15)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 31 January 2014 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 February 2015.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 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, 20 February 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

      (2)  OJ L 325, 11.12.2007, p. 3.

      (3)  OJ L 307, 24.11.2003, p. 1.

      (4)  OJ L 152, 16.6.2009, p. 11.

      (5)  OJ L 70, 16.3.2005, p. 1.

      (6)  OJ C 369, 17.12.2011, p. 14.

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry is added:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum degree of purity of the active substance (1)

                     Date of inclusion

                     Deadline for compliance with Article 16(3), unless one of the exceptions indicated in the footnote to this heading applies (2)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (3)

                     ‘63

                     diflubenzuron

                     1-(4-chlorophenyl)-3-(2,6-difluorobenzoyl)urea
                     EC No: 252-529-3
                     CAS No: 35367-38-5

                     960 g/kg

                     1 February 2015

                     31 January 2017

                     31 January 2025

                     18

                     The Union level risk assessment did not address all potential uses and exposure scenarios; certain uses and exposure scenarios, such as outdoor use, use by non-professionals, and exposure of livestock were excluded. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     For products containing diflubenzuron that may lead to residues in food or feed, Member States shall verify the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, with special consideration to the in vivo genotoxic metabolite PCA, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.
                     Member States shall ensure that authorisations are subject to the following conditions unless it can be demonstrated in the application for product authorisation that the risks can be reduced to an acceptable level:

                                 (1)

                                 Professional users shall wear appropriate personal protective equipment.

                                 (2)

                                 Product information shall include the requirement that products shall only be used on dry manure, and that the manure must undergo complete aerobic composting by professionals prior to application on arable land.

                                 (3)

                                 Products shall not be used in water systems.’

         (1)  The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 11. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated substance.

         (2)  For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the last of its active substances to be included in this Annex. For products for which the first authorisation has been granted later than 120 days before the deadline for compliance with Article 16(3) and a complete application has been submitted for mutual recognition in accordance with Article 4(1) within 60 days of the granting of the first authorisation, the deadline for compliance with Article 16(3) in relation to that application is extended to 120 days after the date of reception of the complete application for mutual recognition. For products for which a Member State has proposed to derogate from mutual recognition in accordance with Article 4(4), the deadline for compliance with Article 16(3) is extended to 30 days after the date of the Commission Decision adopted in accordance with the second subparagraph of Article 4(4).

         (3)  For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm